(Name, Telephone, E-mail and/or Facsimile
number and Address of Company Contact Person)
1,978,930 American Depositary
Receipts 232,894,900 Ordinary Shares
Certain matters discussed
in this report, including matters discussed under the caption “Item 5. Operating and Financial Review and Prospects,”
may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the
Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or achievements to be materially different from the future results, performance
or achievements expressed or implied by such forward-looking statements. In some instances, you can identify these forward-looking
statements by words such as “anticipates,” “believes,” “estimates,” “expects,”
“intends,” “may,” “plan,” “potential,” “will,” “should,”
“would,” or similar expressions, including their negatives. These forward-looking statements include, without limitation,
statements relating to our expectations and beliefs regarding:
Our actual results
may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including,
without limitation, those discussed under “Item 3. Key Information–Risk Factors,” “Item 4. Information
on the Company,” “Item 5. Operating and Financial Review and Prospects,” and elsewhere in this report, as well
as factors which may be identified from time to time in our other filings with the Securities and Exchange Commission, or the SEC,
or in the documents where such forward-looking statements appear. All written or oral forward-looking statements attributable to
us are expressly qualified in their entirety by these cautionary statements.
Forward-looking statements
contained in this report reflect our views and assumptions only as of the date this report is signed. Therefore, you should not
place undue reliance on any forward-looking statement as a prediction of future results. Forward-looking statements made in this
report and the documents incorporated by reference are made as of the date of the respective documents, and we undertake no obligation
to update them in light of new information or future results. Except as required by law, we assume no responsibility for updating
any forward-looking statements.
PART I
Unless the context
requires otherwise, references in this report to “XTL,” “the Company,” “we,” “us”
and “our” refer to XTL Biopharmaceuticals Ltd, an Israeli company and our consolidated subsidiaries. We have prepared
our consolidated financial statements in United States, or US, dollars and in accordance with International Financial Reporting
Standards, or IFRS. All references herein to “dollars” or “$” are to US dollars, and all references to
“Shekels” or “NIS” are to New Israeli Shekels.
ITEM 1. IDENTITY OF DIRECTORS, SENIOR
MANAGEMENT AND ADVISERS
Not applicable
ITEM 2. OFFER STATISTICS AND EXPECTED
TIMETABLE
Not applicable
ITEM 3. KEY INFORMATION
|
A.
|
Selected Financial Data
|
The tables below present
selected financial data for the fiscal years ended as of December 31, 2013, 2012, 2011, 2010 and 2009. We have derived the selected
financial data for the fiscal years ended December 31, 2013, 2012 and 2011, and as of December 31, 2013 and 2012, from our audited
consolidated financial statements, included elsewhere in this report and prepared in accordance with International Financial Reporting
Standards (“IFRS”) issued by the International Accounting Standards Board (“IASB”). The selected financial
data for the fiscal years ended as of December 31, 2013, 2012, 2011, 2010 and 2009 are presented in accordance with IFRS. You should
read the selected financial data in conjunction with “Item 5. Operating and Financial Review and Prospects,” “Item
8. Financial Information” and “Item 18. Financial Statements.”
Consolidated Statements of Comprehensive
income:
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
2010
|
|
|
2009
|
|
|
|
U.S Dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
2,369
|
|
|
|
938
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Cost of revenues
|
|
|
(741
|
)
|
|
|
(380
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
1,628
|
|
|
|
558
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs
|
|
|
(113
|
)
|
|
|
(99
|
)
|
|
|
(158
|
)
|
|
|
(64
|
)
|
|
|
-
|
|
Selling and marketing expenses
|
|
|
(1,691
|
)
|
|
|
(848
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
General and administrative (expenses) income
|
|
|
(2,048
|
)
|
|
|
(2,769
|
)
|
|
|
(1,078
|
)
|
|
|
(1,222
|
)
|
|
|
2,429
|
)*
|
Impairment loss of intangible assets
|
|
|
(1,729
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Other gains, net
|
|
|
1,059
|
|
|
|
802
|
|
|
|
12
|
|
|
|
30
|
|
|
|
139
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
(2,894
|
)
|
|
|
(2,356
|
)
|
|
|
(1,224
|
)
|
|
|
(1,256
|
)
|
|
|
2,568
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
|
61
|
|
|
|
60
|
|
|
|
24
|
|
|
|
6
|
|
|
|
6
|
|
Finance costs
|
|
|
(35
|
)
|
|
|
(15
|
)
|
|
|
(7
|
)
|
|
|
(7
|
)
|
|
|
(10
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income (costs), net
|
|
|
26
|
|
|
|
45
|
|
|
|
17
|
|
|
|
(1
|
)
|
|
|
(4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (losses) from investment in associate
|
|
|
(845
|
)
|
|
|
569
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before taxes on income
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,564
|
|
tax benefit
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) for the year
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that might be classified to profit or loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
108
|
|
|
|
114
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Reclassification of foreign currency translation adjustments to Other gains, net
|
|
|
(221
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Total other comprehensive income
|
|
|
(113
|
)
|
|
|
114
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year
|
|
|
(3,826
|
)
|
|
|
(1,628
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) for the year attributable to:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
|
(2,476
|
)
|
|
|
(1,390
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,587
|
|
Non-controlling interests
|
|
|
(1,237
|
)
|
|
|
(352
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year attributable to:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
|
(2,589
|
)
|
|
|
(1,276
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,587
|
|
Non-controlling interests
|
|
|
(1,237
|
)
|
|
|
(352
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,826
|
)
|
|
|
(1,628
|
)
|
|
|
(1,207
|
)
|
|
|
(1,257
|
)
|
|
|
2,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings (loss) per share (in US dollars)
|
|
|
(0.011
|
)
|
|
|
(0.006
|
)
|
|
|
(0.006
|
)
|
|
|
(0.011
|
)
|
|
|
0.044
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of issued ordinary shares
|
|
|
223,605,181
|
|
|
|
217,689,926
|
|
|
|
201,825,645
|
|
|
|
113,397,846
|
|
|
|
58,561,065
|
|
* Including
reduced expenses which result from forfeiture of shares that were contingent on the performance of the former chairman and former
CEO.
Consolidated Statements of Financial Position Data:
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
2010
|
|
|
2009
|
|
|
|
U.S Dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and bank deposits
|
|
|
4,165
|
|
|
|
3,312
|
|
|
|
1,495
|
|
|
|
1,066
|
|
|
|
412
|
|
Working capital
|
|
|
3,870
|
|
|
|
2,143
|
|
|
|
955
|
|
|
|
259
|
|
|
|
(151
|
)
|
Total assets
|
|
|
8,015
|
|
|
|
11,086
|
|
|
|
4,073
|
|
|
|
3,797
|
|
|
|
715
|
|
Long term liabilities
|
|
|
11
|
|
|
|
13
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Total shareholders' equity
|
|
|
6,265
|
|
|
|
7,353
|
|
|
|
3,444
|
|
|
|
2,834
|
|
|
|
7
|
|
Non-controlling interests
|
|
|
520
|
|
|
|
2,071
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
B.
|
Capitalization And Indebtedness
|
Not applicable.
|
C.
|
Reasons For Offer And Use Of Proceeds
|
Not applicable.
Before you invest
in our ordinary shares or American Depositary Receipts, you should understand the high degree of risk involved. You should carefully
consider the risks described below and other information in this report, including our financial statements and related notes included
elsewhere in this report, before you decide to purchase our ordinary shares or ADRs. If any of the following risks actually occur,
our business, financial condition and operating results could be adversely affected. As a result, the trading price of our ordinary
shares or ADRs could decline and you could lose part or all of your investment.
Risks Related to Our Business
We have incurred substantial operating
losses since our inception. We expect to continue to incur losses in the future in our drug development activity and may incur
losses in our medical device activity and may never become profitable.
You should consider
our prospects in light of the risks and difficulties frequently encountered by development stage companies. We have incurred operating
losses since our inception and expect to continue to incur operating losses for the foreseeable future. As of December 31, 2013,
we had an accumulated accounting deficit of approximately $146 million. We have not yet commercialized any of our drug candidates
or technologies and cannot be sure we will ever be able to do so. Even if we commercialize one or more of our drug candidates or
technologies, we may not become profitable. Our ability to achieve profitability depends on a number of factors, including our
ability to complete our development efforts, consummate out-licensing agreements, obtain regulatory approval for our drug candidates
and technologies and successfully commercialize them.
In addition, in July
2012 we acquired the control over InterCure Ltd. (“InterCure”), a public company whose shares are traded on the Tel-Aviv
Stock Exchange and which develops a home therapeutic device for non-medicinal and non-invasive treatment of various diseases such
as hypertension, heart failure, sleeplessness and mental stress and markets and sells a home therapeutic device for hypertension.
As of the date hereof, we hold approximately 54.72% of the issued and outstanding shares of InterCure. In the year ended December
31, 2013, InterCure's revenues amounted to approximately $2,369,000 and losses attributable to the investment in InterCure amounted
to approximately $2,600,000 (including InterCure’s operating losses, as well as losses recorded by the Company for amortization
of identifiable intangible assets in the amount of approximately $292,000 and impairment of said intangible assets in the amount
of approximately $1,729,000). InterCure has had recurring losses and presently does not have sufficient cash and other resources
to meet its future plans beyond July 2015.
If our competitors develop and market
products that are less expensive, more effective or safer than our products, our revenues and results may be harmed and our commercial
opportunities may be reduced or eliminated.
The pharmaceutical
industry is highly competitive. Our commercial opportunities may be reduced or eliminated if our competitors develop and market
products that are less expensive, more effective or safer than our products. Other companies have drug candidates in various stages
of pre-clinical or clinical development to treat diseases for which we are also seeking to discover and develop drug candidates.
Some of these potential competing drugs are already commercialized or are further advanced in development than our drug candidates
and may be commercialized earlier. Even if we are successful in developing safe, effective drugs, our products may not compete
successfully with products produced by our competitors, who may be able to market their drugs more effectively.
Our competitors include
pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In
addition, companies that are active in different but related fields present substantial competition for us. Many of our competitors
have significantly greater capital resources, larger research and development staffs and facilities and greater experience in drug
development, regulation, manufacturing and marketing than we do. These organizations also compete with us to recruit qualified
personnel, attract partners for joint ventures or other collaborations, and license technologies that are competitive with ours.
As a result, our competitors may be able to more easily develop products that could render our technologies or our drug candidates
obsolete or noncompetitive. Development of new drugs, medical technologies and competitive medical devices may damage the demand
for our products without any certainty that we will successfully and effectively contend with those competitors.
Development of new
drugs, medical technologies and competitive medical devices may damage the demand for our products without any certainty that we
will successfully and effectively contend with those competitors.
If we lose our key personnel or are
unable to attract and retain additional personnel, our business could be harmed.
As of the date hereof,
XTL had three full-time employees and three part-time service providers (one of whom is an officer). As of the same date InterCure
had six full-time employees and service providers and two part-time service providers.
To successfully develop
our drug candidates and technologies, we must be able to attract and retain highly skilled personnel, including consultants and
employees. The retention of their services cannot be guaranteed.
Our failure to retain
and/or recruit such professionals might impair our performance and materially affect our technological and product development
capabilities and our product marketing ability.
Any acquisitions or in-licensing
transactions we make may dilute your equity or require a significant amount of our available cash and may not be scientifically
or commercially successful.
As part of our business
strategy, we may effect acquisitions or in-licensing transactions to obtain additional businesses, products, technologies, capabilities
and personnel. If we complete one or more such transactions in which the consideration includes our ordinary shares or other securities,
your equity in may be significantly diluted. If we complete one or more such transactions in which the consideration includes cash,
we may be required to use a substantial portion of our available cash.
Acquisitions and in-licensing
transactions also involve a number of operational risks, including:
|
·
|
difficulty and expense of assimilating the operations, technology or personnel of the business;
|
|
·
|
our inability to attract and retain management, key personnel and other employees necessary to
conduct the business;
|
|
·
|
our inability to maintain relationships with key third parties, such as alliance partners, associated
with the business;
|
|
·
|
exposure to legal claims for activities of the business prior to the acquisition;
|
|
·
|
the diversion of our management’s attention from our other drug development and medical device
businesses; and
|
|
·
|
the potential impairment of substantial goodwill and write-off of in-process research and development
costs, adversely affecting our reported results of operations.
|
In addition, the basis
for completing the acquisition or in-licensing could prove to be unsuccessful as the drugs or processes involved could fail to
be scientifically or commercially viable. We may also be required to pay third parties substantial transaction fees, in the form
of cash or ordinary shares, in connection with such transactions.
If any of these risks
occur, it could have an adverse effect on both the business we acquire or in-license and our existing operations.
We face product liability risks and
may not be able to obtain adequate insurance.
The use of our drug
candidates and technologies in clinical trials, and the sale of any approved products (drugs or medical devices), exposes us to
liability claims. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities
or be required to cease clinical trials of our drug candidates and technologies or limit commercialization of any approved products.
We believe that we
will be able to obtain sufficient product liability insurance coverage for our planned clinical trials. We intend to expand our
insurance coverage to include the commercial sale of any approved products if marketing approval is obtained; however, insurance
coverage is becoming increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost. We may not
be able to obtain additional insurance coverage that will be adequate to cover product liability risks that may arise. Regardless
of merit or eventual outcome, product liability claims may result in:
|
·
|
decreased demand for a product;
|
|
·
|
damage to our reputation;
|
|
·
|
inability to continue to develop a drug candidate or technology;
|
|
·
|
withdrawal of clinical trial volunteers; and
|
Consequently, a product
liability claim or product recall may result in material losses.
Risks related to our drug development
business
If we are unable to successfully
complete our clinical trial programs for our drug candidates, or if such clinical trials take longer to complete than we project,
our ability to execute our current business strategy will be adversely affected.
Whether or not and
how quickly we complete clinical trials depends in part upon the rate at which we are able to engage clinical trial sites and,
thereafter, the rate of enrollment of patients, and the rate at which we are able to collect, clean, lock and analyze the clinical
trial database. Patient enrollment is a function of many factors, including the size of the patient population, the proximity of
patients to clinical sites, the eligibility criteria for the study, the existence of competitive clinical trials, and whether existing
or new drugs are approved for the indication we are studying. We are aware that other companies are planning clinical trials that
will seek to enroll patients with the same diseases and stages as we are studying. If we experience delays in identifying and contracting
with sites and/or in patient enrollment in our clinical trial programs, we may incur additional costs and delays in our development
programs, and may not be able to complete our clinical trials on a cost-effective or timely basis.
If third parties on which we will
have to rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory
approval for or commercialize our products.
We will have to depend
on independent clinical investigators, and other third-party service providers to conduct the clinical trials of our drug candidates
and technologies. We also may, from time to time, engage a clinical research organization for the execution of our clinical trials.
We will rely heavily on these parties for successful execution of our clinical trials, but we will not control many aspects of
their activities. Nonetheless, we are responsible for confirming that each of our clinical trials is conducted in accordance with
the general investigational plan and protocol. Our reliance on these third parties that we do not control does not relieve us of
our responsibility to comply with the regulations and standards of the Food and Drug Administration (“FDA”) and/or
other foreign regulatory agencies/authorities relating to good clinical practices. Third parties may not complete activities on
schedule or may not conduct our clinical trials in accordance with regulatory requirements or the applicable trial’s plans
and protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval
and commercialization of our products, or could result in enforcement action against us.
Our international clinical trials
may be delayed or otherwise adversely impacted by social, political and economic factors affecting the particular foreign country.
We may conduct clinical
trials in different geographical locations. Our ability to successfully initiate, enroll and complete a clinical trial in any of
these countries, or in any future foreign country in which we may initiate a clinical trial, are subject to numerous risks unique
to conducting business in foreign countries, including:
|
·
|
difficulty in establishing or managing relationships with clinical research organizations and physicians;
|
|
·
|
different standards for the conduct of clinical trials and/or health care reimbursement;
|
|
·
|
our inability to locate qualified local consultants, physicians, and partners;
|
|
·
|
the potential burden of complying with a variety of foreign laws, medical standards and regulatory
requirements, including the regulation of
|
|
·
|
pharmaceutical products and treatment; and
|
|
·
|
general geopolitical risks, such as political and economic instability, and changes in diplomatic
and trade relations.
|
Any disruption to our
international clinical trial program could significantly delay our product development efforts.
If the clinical data related to our
drug candidates and technologies do not confirm positive early clinical data or preclinical data, our corporate strategy and financial
results will be adversely impacted.
Our drug candidates
and technologies are ready to enter into clinical stages. Specifically, our lead product candidates, hCDR1 and Recombinant Human
Erythropoietin (rHuEPO) are each planned for and/or ready for a Phase 2 clinical study. In order for our candidates to proceed
to later stage clinical testing or marketing approval, they must show positive clinical and/or preclinical data.
Preliminary results
of pre-clinical, clinical observations or clinical tests do not necessarily predict the final results, and promising results in
pre-clinical, clinical observations or early clinical testing might not be obtained in later clinical trials. Drug candidates in
the later stages of clinical development may fail to show the desired safety and efficacy traits despite having progressed through
initial clinical testing. Any negative results from future tests may prevent us from proceeding to later stage clinical testing
or marketing approval, which would materially impact our corporate strategy, and our financial results may be adversely impacted.
We have limited experience in conducting
and managing clinical trials necessary to obtain regulatory approvals. If our drug candidates and technologies do not receive the
necessary regulatory approvals, we will be unable to commercialize our products.
We have not received,
and may never receive, regulatory approval for commercial sale for hCDR1, rHuEPO or SAM-101. We currently do not have any drug
candidates pending approval with the FDA or with regulatory authorities of other countries. We will need to conduct significant
additional research and human testing before we can apply for product approval with the FDA or with regulatory authorities of other
countries. In order to obtain FDA approval to market a new drug product, we or our potential partners must demonstrate proof of
safety and efficacy in humans. To meet these requirements, we and/or our potential partners will have to conduct “adequate
and well-controlled” clinical trials.
Clinical development
is a long, expensive and uncertain process. Clinical trials are very difficult to design and implement, in part because they are
subject to rigorous regulatory requirements. Satisfaction of regulatory requirements typically depends on the nature, complexity
and novelty of the product and requires the expenditure of substantial resources. The commencement and rate of completion of clinical
trials may be delayed by many factors, including:
|
·
|
obtaining regulatory approvals to commence a clinical trial;
|
|
·
|
reaching agreement on acceptable terms with prospective CROs, and trial sites, the terms of which
can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
|
·
|
slower than expected rates of patient recruitment due to narrow screening requirements and competing
clinical studies;
|
|
·
|
the inability of patients to meet protocol requirements imposed by the FDA or other regulatory
authorities;
|
|
·
|
the need or desire to modify our manufacturing process;
|
|
·
|
delays, suspension, or termination of the clinical trials due to the institutional review board
responsible for overseeing the study at a particular study site; and
|
|
·
|
government or regulatory delays or “clinical holds” requiring suspension or termination
of the trials.
|
Following the completion
of a clinical trial, regulators may not interpret data obtained from pre-clinical and clinical tests of our drug candidates and
technologies the same way that we do, which could delay, limit or prevent our receipt of regulatory approval. In addition, the
designs of any clinical trials may not be reviewed or approved by the FDA prior to their commencement, and consequently the FDA
could determine that the parameters of any studies are insufficient to demonstrate proof of safety and efficacy in humans. Failure
to approve a completed study could also result from several other factors, including unforeseen safety issues, the determination
of dosing, low rates of patient recruitment, the inability to monitor patients adequately during or after treatment, the inability
or unwillingness of medical investigators to follow our clinical protocols, and the lack of effectiveness of the trials.
Additionally, the regulators
could determine that the studies indicate the drugs may have serious side effects. In the US, this is called a black box warning,
which is a type of warning that appears on the package insert for prescription drugs indicating that they may cause serious adverse
effects. A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening
adverse effects.
If the clinical trials
fail to satisfy the criteria required, the FDA and/or other regulatory agencies/authorities may request additional information,
including additional clinical data, before approval of marketing a product. Negative or inconclusive results or medical events
during a clinical trial could also cause us to delay or terminate our development efforts. If we experience delays in the testing
or approval process, or if we need to perform more or larger clinical trials than originally planned, our financial results and
the commercial prospects for our drug candidates and technologies may be materially impaired.
Clinical trials have
a high risk of failure. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered
significant setbacks in clinical trials, even after achieving promising results in earlier trials. It may take us many years to
complete the testing of our drug candidates and technologies, and failure can occur at any stage of this process.
Even if regulatory
approval is obtained, our products and their manufacture will be subject to continual review, and there can be no assurance that
such approval will not be subsequently withdrawn or restricted. Changes in applicable legislation or regulatory policies, or discovery
of problems with the products or their manufacture, may result in the imposition of regulatory restrictions, including withdrawal
of the product from the market, or result in increased costs to us.
Because all of our proprietary drug
candidates and technologies are licensed to us by third parties, termination of these license agreements could prevent us from
developing our drug candidates.
We do not own any of
our drug candidates and technologies. We have licensed the rights, patent or otherwise, to our drug candidates from third parties.
We have licensed hCDR1, a phase 2 clinical stage asset for the treatment of Systemic Lupus Erythematosus (“SLE”) from
Yeda Research and Development Company Ltd. (“Yeda”). We licensed a use patent for the use of Recombinant Human Erythropoietin
(rHuEPO) for the prolongation of Multiple Myeloma patients’ survival and improvement of their quality of life from Bio-Gal
Ltd., or Bio-Gal, who in turn licensed it from Mor Research Applications Ltd., an Israeli corporation and licensing arm of Kupat
Holim Clalit, one of the largest HMOs in Israel (“Mor”) and Yeda. We have licensed a patent on SAM-101 for the treatment
of psychotic disorders from MinoGuard Ltd., or MinoGuard, who in turn licensed it from Mor.
These license agreements
require us to meet development or financing milestones and impose development and commercialization due diligence requirements
on us. In addition, under these agreements, we must pay royalties on sales of products resulting from licensed drugs and technologies
and pay the patent filing, prosecution and maintenance costs related to the licenses. While we have the right to defend patent
rights related to our licensed drug candidates and technologies, we are not obligated to do so. In the event that we decide to
defend our licensed patent rights, we will be obligated to cover all of the expenses associated with that effort. If we do not
meet our obligations in a timely manner, or if we otherwise breach the terms of our agreements, our licensors could terminate the
agreements, and we would lose the rights to our drug candidates and technologies. From time to time, in the ordinary course of
business, we may have disagreements with our licensors or collaborators regarding the terms of our agreements or ownership of proprietary
rights, which could lead to delays in the research, development, collaboration and commercialization of our drug candidates, or
could require or result in litigation or arbitration, which could be time-consuming and expensive.
If we do not establish or maintain
drug development and marketing arrangements with third parties, we may be unable to commercialize our drug candidates and technologies
into products.
We are an emerging
company and do not possess all of the capabilities to fully commercialize our drug candidates and technologies on our own. From
time to time, we may need to contract with third parties to:
|
·
|
assist us in developing, testing and obtaining regulatory approval for some of our compounds and
technologies;
|
|
·
|
manufacture our drug candidates; and
|
|
·
|
market and distribute our products.
|
We can provide no assurance
that we will be able to successfully enter into agreements with such third-parties on terms that are acceptable to us. If we are
unable to successfully contract with third parties for these services when needed, or if existing arrangements for these services
are terminated, whether or not through our actions, or if such third parties do not fully perform under these arrangements, we
may have to delay, scale back or end one or more of our drug development programs or seek to develop or commercialize our drug
candidates and technologies independently, which could result in delays. Further, such failure could result in the termination
of license rights to one or more of our drug candidates and technologies. Moreover, if these development or marketing agreements
take the form of a partnership or strategic alliance, such arrangements may provide our collaborators with significant discretion
in determining the efforts and resources that they will apply to the development and commercialization of our products. Accordingly,
to the extent that we rely on third parties to research, develop or commercialize our products, we may be unable to control whether
such products will be scientifically or commercially successful.
Even if we or our collaborative/strategic
partners or potential collaborative/strategic partners receive approval to market our drug candidates, if our products fail to
achieve market acceptance, we will never record meaningful revenues.
Even if our products
are approved for sale, they may not be commercially successful in the marketplace. Market acceptance of our product candidates
will depend on a number of factors, including:
|
·
|
perceptions by members of the health care community, including physicians, of the safety and efficacy
of our products;
|
|
·
|
the rates of adoption of our products by medical practitioners and the target populations for our
products;
|
|
·
|
the potential advantages that our products offer over existing treatment methods or other products
that may be developed;
|
|
·
|
the cost-effectiveness of our products relative to competing products including potential generic
competition;
|
|
·
|
the availability of government or third-party pay or reimbursement for our products;
|
|
·
|
the side effects of our products which may lead to unfavorable publicity concerning our products
or similar products; and
|
|
·
|
the effectiveness of our and/or partners' sales, marketing and distribution efforts.
|
Specifically, each
of hCDR1, rHuEPO or SAM-101, if successfully developed and commercially launched for the treatment of SLE, Multiple Myeloma or
Schizophrenia, respectively, will compete with both currently marketed and new products marketed by other companies. Health care
providers may not accept or utilize any of our product candidates. Physicians and other prescribers may not be inclined to prescribe
our products unless our products bring clear and demonstrable advantages over other products currently marketed for the same indications.
Because we expect sales of our products to generate substantially all of our revenues in the long-term, the failure of our products
to find market acceptance would harm our business and could require us to seek additional financing or other sources of revenue.
If the third parties upon whom we rely to manufacture
our products do not successfully manufacture our products, our business will be harmed.
We do not currently
have the ability to manufacture the compounds that we need to conduct our clinical trials and, therefore, rely upon, and intend
to continue to rely upon, certain manufacturers to produce and supply our drug candidates for use in clinical trials and for future
sales. In order to commercialize our products, such products will need to be manufactured in commercial quantities while adhering
to all regulatory and other local requirements, all at an acceptable cost. We may not be able to enter into future third-party
contract manufacturing agreements on acceptable terms, if at all.
If our contract manufacturers
or other third parties fail to deliver our product candidates for clinical use on a timely basis, with sufficient quality, and
at commercially reasonable prices, and we fail to find replacement manufacturers or sources, we may be required to delay or suspend
clinical trials or otherwise discontinue development and production of our drug candidates.
Our contract manufacturers
will be required to produce our clinical drug candidates under strict compliance with current Good Manufacturing Practices, or
cGMP, in order to meet acceptable regulatory standards for our clinical trials. If such standards change, the ability of contract
manufacturers to produce our drug candidates on the schedule we require for our clinical trials may be affected. In addition, contract
manufacturers may not perform their obligations under their agreements with us or may discontinue their business before the time
required by us to successfully produce and market our drug candidates. Any difficulties or delays in our contractors’ manufacturing
and supply of drug candidates could increase our costs, cause us to lose revenue or make us postpone or cancel clinical trials.
In addition, our contract
manufacturers will be subject to ongoing periodic, unannounced inspections by the FDA and corresponding foreign or local governmental
agencies to ensure strict compliance with, among other things, cGMP, in addition to other governmental regulations and corresponding
foreign standards. We will not have control over, other than by contract, third-party manufacturers’ compliance with these
regulations and standards. No assurance can be given that our third-party manufacturers will comply with these regulations or other
regulatory requirements now or in the future.
In the event that we
are unable to obtain or retain third-party manufacturers, we will not be able to commercialize our products as planned. If third-party
manufacturers fail to deliver the required quantities of our products on a timely basis and at commercially reasonable prices,
our ability to develop and deliver products on a timely and competitive basis may be adversely impacted and our business, financial
condition or results of operations will be materially harmed.
Risks related to our Medical Device business:
InterCure's products
are manufactured by a single manufacturer, which has limited production capacity. In the case of a sharp increase in demand for
InterCure's products, it may take a few months to adjust the production capacity to demand.
As of the date hereof,
InterCure meets all its production needs through subcontractors and particularly a major subcontractor in China which has been
manufacturing the RESPeRATE Ultra versions since November 2008. In 2013, InterCure manufactured an average of less than 1,000 product
units a month. The Chinese production line's monthly manufacturing capacity is about 10,000. In the event of increased demand,
it may take a few months to increase the manufacturing capacity. The time needed to prepare for increased production mainly depends
on the ability of the component suppliers to respond to increased order volumes and the availability of components with variable
manufacturing technology.
There is no certainty as to whether
we will be capable of developing additional medical device applications based on InterCure's intellectual property.
Based on its intellectual
property and the technologies it developed, InterCure aims to develop additional products in the future in order to broaden its
product offering. It is uncertain whether InterCure will be capable of fulfilling the technological, clinical and regulatory or
other requirements applicable during the process of developing new products. Additionally, there is no certainty that InterCure
will have the required financing resources available to fund such development.
Failure or delay in submission or
revoking the approvals, permits and licenses required for marketing our medical devices products may significantly damage our results
of operations and financial condition.
Marketing InterCure
products worldwide is subject to receiving and maintaining the validity of the permits and regulatory accreditation from a variety
of international bodies such as the FDA. InterCure has already received regulatory approvals for marketing its products in the
US, Europe, Canada, South Korea and Israel. Processes for receiving certification and permits, as mentioned, for marketing in additional
territories, specifically in Japan, and the receipt of approvals and permits for marketing future InterCure products, to the extent
required, is an intensive and costly process that stretches over a period of between three months to several years. Changes in
legislation and/or the policies of the regulatory bodies or new legislation may delay the process of receiving the required permits,
a delay that may cause the Company additional expenses or result in revoking the existing ones. Additionally, there is no certainty
that InterCure will receive the permits required for marketing its future products. Should InterCure fail to receive the aforementioned
certificates and permits or existing certificates or permits be revoked, there may be an adverse impact on our results of operations
and financial condition.
Risks Related to Our Financial
Condition
The Company's revenues from operations
derive from InterCure's business, and are not sufficient at this stage to support the financing of our entire operations. We fund
our operations from our own capital and from external sources by way of issuing equity securities. If we need to raise additional
capital and are unable to do so on terms favorable to us, or at all, we may not be able to continue our operations.
The Company has incurred
continuing losses and its entire income at this stage originates from InterCure. The Company depends on external financing resources
to continue its activities. The actual amount of cash that the Company will need to fund its operations is subject to many factors,
including, but not limited to, the timing, design and conduct of the clinical trials of our existing drug candidates, any future
projects which may be in-licensed or any other business development activities. For example, changing circumstances and/or in-licenses
of new technologies may cause us to consume capital significantly faster than we currently anticipate, and we may need to spend
more money than currently expected because of circumstances beyond our control
.
The Company will incur
additional losses in 2014 from research and development activities and from current operations which will be reflected in negative
cash flows from operating activities. Accordingly, in order to complete the clinical trials to bring a product to market, the Company
will be required to raise additional cash through the issuance of equity securities. However, if the Company is not able to raise
additional capital at acceptable terms, the Company may be required to sell tradable securities held by it or reduce operations
or sell or out-license to third parties some or all of its technologies. If the Company is unable to raise capital, the Company
will be required to delay some of its planned research and development activities as well as curtail or discontinue operations.
InterCure has had recurring losses and presently does not have sufficient cash and other resources to meet its future plans beyond
July 2015.
If InterCure is unsuccessful in raising additional financing, it may need to curtail or discontinue operations.
The financial condition
of our drug development business depends on a number of factors, some of which are beyond our control. These factors include, among
other things:
|
·
|
the progress of our planned research activities;
|
|
·
|
the accuracy of our financial forecasts;
|
|
·
|
the number and scope of our planned development programs;
|
|
·
|
our ability to establish and maintain current and new licensing or acquisition arrangements;
|
|
·
|
our ability to achieve our milestones under our licensing arrangements;
|
|
·
|
the costs involved in enforcing patent claims and other intellectual property rights;
|
|
·
|
the costs and timing of the clinical trials according to regulatory requirements;
|
|
·
|
rHuEPO patent expiration in 2019 and failure to obtain orphan drug designation in Europe;
|
|
·
|
hCDR1 patent expiration in 2024 and failure to obtain patent term extension or obtain data exclusivity
in the US and Europe;
|
|
·
|
SAM-101 patent expiration in 2027; and
|
|
·
|
The costs and timing of regulatory approvals.
|
The financial condition
of our medical device business depends on a number of factors, some of which are beyond our control. These factors include, among
other things:
|
·
|
Maintaining InterCure's patents;
|
|
·
|
Technological advantage - since the hypertension market is very large and plays host to numerous
multinational pharmaceutical companies, any new entity interested in entering and operating in the market will need, among other
things, a proven technological advantage that separates it from competitors;
|
|
·
|
Recognition by the medical community;
|
|
·
|
Obtaining regulatory approvals from the FDA in the US or the CE Mark in Europe;
|
|
·
|
Branding - An important parameter in deciding whether to acquire a therapeutic device is consumer
confidence that the product is efficient and safe;
|
|
·
|
Our ability to set up a marketing, advertising and sales system for effectively increasing activity;
|
|
·
|
The grant of a reimbursement code by an insurer or healthcare authority that offer participation
in the cost of purchase of our products.
|
The global capital
markets have been experiencing extreme volatility and disruption for the last several years. Given recent market conditions, additional
financing may not be available to us when we need it. In order to complete the clinical trials to bring a product to market we
will need to raise additional capital. However we may be unable to do so on terms favorable to us, or at all, and we may be required
to cease or reduce our operating activities or sell or license to third parties some or all of our technologies. If we raise additional
funds by selling ordinary shares, ADRs, or other securities, the ownership interests of our shareholders will be diluted. If we
need to raise additional funds through the sale or license of our drug candidates or technology, we may be unable to do so on terms
favorable to us or at all.
Risks Related to Our Intellectual
Property
If we are unable to adequately protect
our intellectual property, third parties may be able to use our technology, which could adversely affect our ability to compete
in the market.
Our commercial success
will depend in part on our ability and the ability of our licensors to obtain and maintain patent protection on our drug products
and technologies and successfully defend these patents and technologies against third-party challenges. As part of our business
strategy, our policy is to actively file patent applications in the US and internationally to cover methods of use, new chemical
compounds, pharmaceutical compositions and dosing of the compounds and composition and improvements in each of these. Because of
the extensive time required for development, testing and regulatory review of a potential product, it is possible that before we
commercialize any of our products, any related patent may expire or remain in force for only a short period following commercialization,
thus reducing any advantage of the patent.
The patent positions
of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. No consistent
policy regarding the breadth of claims allowed in biotechnology patents has emerged to date. Accordingly, the patents we use may
not be sufficiently broad to prevent others from practicing our technologies or from developing competing products. Furthermore,
others may independently develop similar or alternative technologies or design around our patented technologies. The patents we
use may be challenged or invalidated or may fail to provide us with any competitive advantage.
Generally, patent applications
in the US are maintained in secrecy for a period of at least 18 months. Since publication of discoveries in the scientific or patent
literature often lag behind actual discoveries, we are not certain that we were the first to make the inventions covered by each
of our pending patent applications or that we were the first to file those patent applications. We cannot predict the breadth of
claims allowed in biotechnology and pharmaceutical patents, or their enforceability. Third parties or competitors may challenge
or circumvent our patents or patent applications, if issued. If our competitors prepare and file patent applications in the US
that claim compounds or technology also claimed by us, we may be required to challenge competing patent rights, which could result
in substantial cost, even if the eventual outcome is favorable to us. While we have the right to defend patent rights related to
the licensed drug candidates and technologies, we are not obligated to do so. In the event that we decide to defend our licensed
patent rights, we will be obligated to cover all of the expenses associated with that effort.
We also rely on trade
secrets to protect technology where we believe patent protection is not appropriate or obtainable. Trade secrets are difficult
to protect. While we require our employees, collaborators and consultants to enter into confidentiality agreements, this may not
be sufficient to protect our trade secrets or other proprietary information adequately. In addition, we share ownership and publication
rights to data relating to some of our drug candidates and technologies with our research collaborators and scientific advisors.
If we cannot maintain the confidentiality of this information, our ability to protect our proprietary information will be at risk.
Litigation or
third-party claims of intellectual property infringement could require us to spend substantial time, money and other resources
defending such claims and adversely affect our ability to develop and commercialize our products.
Third parties may assert
that we are using their proprietary technology without authorization. In addition, third parties may have or obtain patents in
the future and claim that our products infringe their patents. If we are required to defend against patent suits brought by third
parties, or if we sue third parties to protect our patent rights, we may be required to pay substantial litigation costs, and our
management’s attention may be diverted from operating our business. In addition, any legal action against our licensors or
us that seeks damages or an injunction of our commercial activities relating to the affected products could subject us to monetary
liability and require our licensors or us to obtain a license to continue to use the affected technologies. We cannot predict whether
our licensors or we would prevail in any of these types of actions or that any required license would be made available on commercially
acceptable terms, if at all. In addition, any legal action against us that seeks damages or an injunction relating to the affected
activities could subject us to monetary liability and/or require us to discontinue the affected technologies or obtain a license
to continue use thereof.
In addition, there
can be no assurance that our patents or patent applications or those licensed to us will not become involved in opposition or revocation
proceedings instituted by third parties. If such proceedings were initiated against one or more of our patents, or those licensed
to us, the defense of such rights could involve substantial costs and the outcome could not be predicted.
Competitors or potential
competitors may have filed applications for, may have been granted patents for, or may obtain additional patents and proprietary
rights that may relate to compounds or technologies competitive with ours. If patents are granted to other parties that contain
claims having a scope that is interpreted to cover any of our products (including the manufacture thereof), there can be no assurance
that we will be able to obtain licenses to such patents at reasonable cost, if at all, or be able to develop or obtain alternative
technology.
Risks Related to Our ADRs
Our ADRs are traded in small volumes,
limiting your ability to sell your ADRs that represent ordinary shares at a desirable price, if at all.
The trading volume
of our ADRs has historically been low. Even if the trading volume of our ADRs increases, we can give no assurance that it will
be maintained or will result in a desirable stock price. As a result of this low trading volume, it may be difficult to identify
buyers to whom you can sell your ADRs in desirable volume and you may be unable to sell your ADRs at an established market price,
at a price that is favorable to you, or at all. A low volume market also limits your ability to sell large blocks of our ADRs at
a desirable or stable price at any one time. You should be prepared to own our ADRs indefinitely.
Our stock price can be volatile,
which increases the risk of litigation and may result in a significant decline in the value of your investment.
The trading price of
the ADRs representing our ordinary shares is likely to be highly volatile and subject to wide fluctuations in price in response
various factors, many of which are beyond our control. These factors include:
|
·
|
developments concerning our drug candidates or medical devices;
|
|
·
|
announcements of technological innovations by us or our competitors;
|
|
·
|
introductions or announcements of new products by us or our competitors;
|
|
·
|
developments in the markets of the field of activities and changes in customer attributes;
|
|
·
|
announcements by us of significant acquisitions, in/out license transactions, strategic partnerships,
joint ventures or capital commitments;
|
|
·
|
changes in financial estimates by securities analysts;
|
|
·
|
actual or anticipated variations in interim operating results and near-term working capital as
well as failure to raise required funds for the continued development and operations of the company;
|
|
·
|
expiration or termination of licenses, patents, research contracts or other collaboration agreements;
|
|
·
|
conditions or trends in the regulatory climate and the biotechnology and pharmaceutical industries;
|
|
·
|
failure to obtain orphan drug designation status for the relevant drug candidates in the relevant
regions;
|
|
·
|
increase in costs and lengthy timing of the clinical trials according to regulatory requirements;
|
|
·
|
failure to increase awareness to our non-medicinal non-invasive therapy and its benefits;
|
|
·
|
changes in reimbursement policy by governments or insurers in markets we operate or may operate
in the future;
|
|
·
|
any changes in the regulatory environment relating to the Company's products may impact our ability
to market and sell our products;
|
|
·
|
failure to obtain renewal of the required licenses for marketing and sales of the Company's products
in the main markets in which the Company's products are sold;
|
|
·
|
changes in the market valuations of similar companies; and
|
|
·
|
additions or departures of key personnel.
|
In addition, equity
markets in general, and the market for biotechnology and life sciences companies in particular, have experienced extreme price
and volume fluctuations that have often been unrelated or disproportionate to the operating performance of companies traded in
those markets. These broad market and industry factors may materially affect the market price of our ADRs, regardless of our development
and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities
class-action litigation has often been instituted against that company. Such litigation, if instituted against us, could cause
us to incur substantial costs to defend such claims and divert management’s attention and resources even if we prevail in
the litigation, all of which could seriously harm our business.
Future issuances or sales of our
ADRs could depress the market for our ADRs.
Future issuances of
a substantial number of our ADRs, or the perception by the market that those issuances could occur, could cause the market price
of our ordinary shares or ADRs to decline or could make it more difficult for us to raise funds through the sale of equity in the
future. Also, if we make one or more significant acquisitions in which the consideration includes ordinary shares or other securities,
your portion of shareholders’ equity in us may be significantly diluted.
Concentration of ownership of our
ordinary shares among our principal stockholders may prevent new investors from influencing significant corporate decisions.
There are three shareholders
(Mr. Alexander Rabinovitch, Mr. David Bassa and Mr. Shalom Manova), who each hold more than 5% of our outstanding ordinary shares
(approximately 34.34% cumulative, as of the date hereof). As a result, these persons, either acting alone or together, may have
the ability to significantly influence the outcome of all matters submitted to our shareholders for approval, including the election
and removal of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, such persons,
acting alone or together, may have the ability to effectively control our management and affairs. Accordingly, this concentration
of ownership may depress the market price of our ADRs.
Notwithstanding the
aforesaid, in connection with Section 239 of the Israeli Companies Law that focuses on the number of votes required to appoint
external directors, and in connection with Section 121(c) of the Israeli Companies Law that focuses on the number of votes required
to authorize the Chairman of the Board in a company to act also as the Chief Executive Officer of such company, the Company will
deem these three shareholders as controlling shareholders in the Company, for as long as such individuals are interested parties
in the Company. In addition, any contractual arrangement as detailed in Section 270 (4) of the Israeli Companies Law with any of
these three shareholders and/or their relatives will be presented for approval in accordance with the provisions of Section 275
of the Israeli Companies Law. In all of these situations, the Company will consider any of these three parties, who are not part
of the transaction presented for approval, as individual interested parties in such transaction so that their vote will not be
included in the quorum comprising a majority (50%) of the votes who are not interested parties in such transaction.
Our ordinary shares and ADRs trade
on more than one market, and this may result in price variations and regulatory compliance issues.
ADRs representing our
ordinary shares are quoted on the Nasdaq Capital Market (“Nasdaq”) and our ordinary shares are traded on the TASE.
Trading in our securities on these markets is made in different currencies and at different times, including as a result of different
time zones, different trading days and different public holidays in the US and Israel. Consequently, the effective trading prices
of our shares on these two markets may differ. Any decrease in the trading price of our securities on one of these markets could
cause a decrease in the trading price of our securities on the other market.
Holders of our ordinary shares or
ADRs who are US citizens or residents may be required to pay additional income taxes
There is a risk that
we will be classified as a passive foreign investment company, or PFIC, for certain tax years. If we are classified as a PFIC,
a US holder of our ordinary shares or ADRs representing our ordinary shares will be subject to special federal income tax rules
that determine the amount of federal income tax imposed on income derived with respect to the PFIC shares. We will be a PFIC if
either 75% or more of our gross income in a tax year is passive income or the average percentage of our assets (by value) that
produce or are held for the production of passive income in a tax year is at least 50%. The risk that we will be classified as
a PFIC arises because cash balances, even if held as working capital, are considered to be assets that produce passive income.
Therefore, any determination of PFIC status will depend upon the sources of our income and the relative values of passive and non-passive
assets, including goodwill. A determination as to a corporation’s status as a PFIC must be made annually. We believe that
we were likely not a PFIC for the taxable years ended December 31, 2009, 2010, 2011 and 2012. Although such a determination is
fundamentally factual in nature and generally cannot be made until the close of the applicable taxable year, based on our current
operations, we believe that we were likely not a PFIC for the taxable year ended December 31, 2013, but we may be a PFIC in subsequent
years. Although we may not be a PFIC in any one year, the PFIC taint remains with respect to those years in which we were or are
a PFIC and the special PFIC taxation regime will continue to apply.
In view of the complexity
of the issues regarding our treatment as a PFIC, US shareholders are urged to consult their own tax advisors for guidance as to
our status as a PFIC.
Provisions of Israeli corporate law
may delay, prevent or affect a potential acquisition of all or a significant portion of our shares or assets and thereby depress
the price of our ADRs and ordinary shares.
We are incorporated
in the State of Israel. Israeli corporate law regulates acquisitions of shares through tender offers. It requires special approvals
for transactions involving significant shareholders and regulates other matters that may be relevant to these types of transactions.
These provisions of Israeli law may delay or prevent an acquisition, or make it less desirable to a potential acquirer and therefore
depress the price of our shares. Further, Israeli tax considerations may make potential transactions undesirable to us or to some
of our shareholders.
Israeli corporate law
provides that an acquisition of shares in a public company must be made by means of a tender offer if, as a result of such acquisition,
the purchaser would become a 25% or greater shareholder of the company. This rule does not apply if there is already another 25%
or greater shareholder of the company. Similarly, Israeli corporate law provides that an acquisition of shares in a public company
must be made by means of a tender offer if, as a result of the acquisition, the purchaser's shareholdings would entitle the purchaser
to over 45% of the shares in the company, unless there is a shareholder with 45% or more of the shares in the company. These requirements
do not apply if, in general, the acquisition (1) was made in a private placement that received the approval of the company’s
shareholders, (2) was from a 25% or greater shareholder of the company which resulted in the purchaser becoming a 25% or greater
shareholder of the company, or (3) was from a 45% or greater shareholder of the company which resulted in the acquirer becoming
a 45% or greater shareholder of the company. These rules do not apply if the acquisition is made by way of a merger.
Finally, in general,
Israeli tax law treats specified acquisitions less favorably than does US tax law.
Our ADR holders are not shareholders
and do not have shareholder rights.
The Bank of New York
Mellon, as depositary, executes and delivers our ADRs on our behalf. Each ADR is a certificate evidencing a specific number of
ADRs. Our ADR holders will not be treated as shareholders and do not have the rights of shareholders. The depositary will be the
holder of the shares underlying our ADRs. Holders of our ADRs will have ADR holder rights. A deposit agreement among us, the depositary
and our ADR holders, and the beneficial owners of ADRs, sets out ADR holder rights as well as the rights and obligations of the
depositary. New York law governs the deposit agreement and the ADRs. Our shareholders have shareholder rights prescribed by Israeli
law. Israeli law and our Articles of Association, or Articles, govern such shareholder rights. Our ADR holders do not have the
same voting rights as our shareholders. Shareholders are entitled to our notices of general meetings and to attend and vote at
our general meetings of shareholders. At a general meeting, every shareholder present (in person or by proxy, attorney or representative)
and entitled to vote has one vote on a show of hands. Every shareholder present (in person or by proxy, attorney or representative)
and entitled to vote has one vote per fully paid ordinary share on a poll. This is subject to any other rights or restrictions
which may be attached to any shares. Our ADR holders may instruct the depositary to vote the ordinary shares underlying their ADRs,
but only if we ask the depositary to ask for their instructions. If we do not ask the depositary to ask for their instructions,
our ADR holders are not entitled to receive our notices of general meeting or instruct the depositary how to vote. Our ADR holders
will not be entitled to attend and vote at a general meeting unless they withdraw the ordinary shares from the depository. However,
our ADR holders may not know about the meeting far enough in advance to withdraw the ordinary shares. If we ask for our ADR holders’
instructions, the depositary will notify our ADR holders of the upcoming vote and arrange to deliver our voting materials and form
of notice to them. The depositary will try, as far as is practical, subject to the provisions of the deposit agreement, to vote
the shares as our ADR holders instruct. The depositary will not vote or attempt to exercise the right to vote other than in accordance
with the instructions of the ADR holders. We cannot assure our ADR holders that they will receive the voting materials in time
to ensure that they can instruct the depositary to vote their shares. In addition, there may be other circumstances in which our
ADR holders may not be able to exercise voting rights.
Our ADR holders do
not have the same rights to receive dividends or other distributions as our shareholders. Subject to any special rights or restrictions
attached to a share, the directors may determine that a dividend will be payable on a share and fix the amount, the time for payment
and the method for payment (although we have never declared or paid any cash dividends on our ordinary stock and we do not anticipate
paying any cash dividends in the foreseeable future). Dividends and other distributions payable to our shareholders with respect
to our ordinary shares generally will be payable directly to them. Any dividends or distributions payable with respect to ordinary
shares will be paid to the depositary, which has agreed to pay to our ADR holders the cash dividends or other distributions it
or the custodian receives on shares or other deposited securities, after deducting its fees and expenses. Our ADR holders will
receive these distributions in proportion to the number of shares their ADRs represent. In addition, there may be certain circumstances
in which the depositary may not pay to our ADR holders amounts distributed by us as a dividend or distribution.
There are circumstances where it
may be unlawful or impractical to make distributions to the holders of our ADRs.
The deposit agreement
with the depositary allows the depositary to distribute foreign currency only to those ADR holders to whom it is possible to do
so. If a distribution is payable by us in New Israeli Shekels, the depositary will hold the foreign currency it cannot convert
for the account of the ADR holders who have not been paid. It will not invest the foreign currency and it will not be liable for
any interest. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, our ADR holders
may lose some of the value of the distribution.
The depositary is not
responsible if it decides that it is unlawful or impractical to make a distribution available to any ADR holders. This means that
our ADR holders may not receive the distributions we make on our shares or any value for them if it is illegal or impractical for
the depository to make such distributions available to them.
Risks Relating to Operations in
Israel
Conditions in the Middle East and
in Israel may harm our operations.
Our headquarters and
some of our planned clinical sites and suppliers are located in Israel. Political, economic and military conditions in Israel directly
affect our operations. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between
Israel and its Arab neighbors, as well as incidents of civil unrest, military conflicts and terrorist actions. There has been a
significant increase in violence since September 2000, which has continued with varying levels of severity through to the present.
This state of hostility has caused security and economic problems for Israel. To date, Israel is facing political tension in its
relationships with Iran and other Arab neighbor countries. Specifically, the hostilities along Israel’s border with the Gaza
Strip have increased, escalating to wide scale military operations by Israel in December 2008 and November 2012 and continuous
rocket attacks into the south and center of Israel. In addition, recently in some Arab countries in the Middle East and North Africa
there have been violent uprisings against the regimes in these countries. Consequently, there is a concern for the stability in
the region which may affect the political and security situation in Israel. We cannot ensure that the political and security situation
will not impact our business. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its
present trading partners could adversely affect our operations and could make it more difficult for us to raise capital.
Our commercial insurance
does not cover losses that may occur as a result of events associated with the security situation in the Middle East. Although
the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts
of war, we cannot assure you that this government coverage will be maintained. Any losses or damages incurred by us could have
a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect
business conditions and could harm our results of operations.
Further, the State
of Israel and Israeli companies have been subjected to an economic boycott. Several countries still restrict business with the
State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our operating results,
financial condition or the expansion of our business.
Our results of operations may be
adversely affected by inflation and foreign currency fluctuations.
We have generated most
of our revenues and hold most of our cash, cash equivalents, bank deposits and marketable securities in US dollars. Until 2008,
a substantial amount of our operating expenses were in US dollars (approximately 96% in 2008). In 2009 the Company’s head
office moved back to Israel, and thus the portion of our expenses in New Israeli Shekels (“NIS”) and our cash held
in NIS has increased, mainly due to payment to Israeli employees and suppliers. As a result, we could be exposed to the risk that
the US dollar will be devalued against the NIS or other currencies, and consequentially our financial results could be harmed.
To protect against currency fluctuations we may decide to hold a significant portion of our cash, cash equivalents, bank deposits
and marketable securities in NIS, as well as to enter into currency hedging transactions. These measures, however, may not adequately
protect us from the adverse effects of inflation in Israel. In addition, we are exposed to the risk that the rate of inflation
in Israel will exceed the rate of devaluation of the New Israeli Shekel in relation to the US dollar or that the timing of any
devaluation may lag behind inflation in Israel.
Our results of operations may be
adversely affected by changes in tax policy by the Israeli government.
The income of the Company
is subject to corporate tax at the regular rate; the guidance of the amendment to the Income Tax Ordinance, 2005 from August 2008
prescribes a gradual reduction in the corporate tax rates and the resulting corporate tax rates starting 2008 are as follows: 2008
- 27%, 2009 - 26% and 2010 and thereafter - 25%.
On July 14, 2009,
the “Knesset” (Israeli Parliament) passed the Law for Economic Efficiency (Amended Legislation for Implementing the
Economic Plan for 2009 and 2010), 2009, which prescribes, among other things, an additional gradual reduction in the corporate
tax rates starting 2011 to the following tax rates: 2011 - 24%, 2012 - 23%, 2013 - 22%, 2014 - 21%, 2015 - 20%, 2016 and thereafter
- 18%.
On December 6, 2011
the reduction in the corporate tax rates outlined above was revoked by the Knesset and it was also resolved that the corporate
tax rate will be 25% for the tax year 2012 and thereafter.
On August 5, 2013,
the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for 2013-2014), 2013 (the “Law”)
was published in the Government's records. Among other things, the Law prescribes from the 2014 tax year and thereafter, an increase
in the Israeli corporate tax rate to 26.5% (instead of 25%).
We cannot guarantee
that there will be no additional changes in the corporate tax rate in the future that may adversely affect our results of operations
and financial condition.
It may be difficult to enforce a
US judgment against us, our officers or our directors or to assert US securities law claims in Israel.
Service of process
upon us, since we are incorporated in Israel, and upon our directors and officers and our Israeli auditors, most of whom reside
outside the US, may be difficult to obtain within the US. In addition, because substantially all of our assets and most of our
directors and officers are located outside the US, any judgment obtained in the US against us or any of our directors and officers
may not be collectible within the US. There is a doubt as to the enforceability of civil liabilities under the Securities Act or
the Exchange Act pursuant to original actions instituted in Israel. Subject to particular time limitations and provided certain
conditions are met, executory judgments of a US court for monetary damages in civil matters may be enforced by an Israeli court.
ITEM 4. INFORMATION ON THE COMPANY
A.
History and Development of XTL
We are a biopharmaceutical
company engaged in the acquisition and development of pharmaceutical products for the treatment of unmet medical needs, currently
for the treatment of SLE, Multiple Myeloma and Schizophrenia. Also, through InterCure, we research, develop, market and sell home
therapeutic devices for non-medicinal and non-invasive treatment of various diseases such as hypertension, heart failure, sleeplessness
and mental stress.
Recent Developments
License for hCDR1
On January 7, 2014,
the Company entered into a licensing agreement with Yeda to research, develop and commercialize hCDR1, a Phase II-ready asset for
the treatment of SLE, among other indications. Lupus is a debilitating disease affecting approximately five million people worldwide,
according to the Lupus Foundation of America. hCDR1 is a peptide, short chains of amino acid monomers, and acts as a disease-specific
treatment to modify the SLE-related autoimmune process. It does so by specific upstream immunomodulation through the generation
of regulatory T cells, reducing inflammation and resuming immune balance. More than 40 peer-reviewed papers have been published
on hCDR1.
Prior to being licensed
to the Company by Yeda, hCDR1 was licensed to Teva Pharmaceutical Industries Ltd. (“Teva”), who performed two placebo
controlled Phase I trials and a placebo controlled Phase II trial (the “PRELUDE trial”). The studies consisted of over
400 patients, demonstrating that hCDR1 is well tolerated by patients and has a favorable safety profile. The PRELUDE trial did
not achieve its primary efficacy endpoint based on the SLEDAI scale, resulting in Teva returning the asset to Yeda. However, the
PRELUDE trial showed encouraging results in its secondary clinical endpoint, the BILAG index, and, in fact, the 0.5 mg weekly dose
showed a substantial effect. Multiple post-hoc analyses also showed impressive results for this dose using the BILAG index. It
is currently planned by the Company that such dose will be the focus of the clinical development plan moving forward. Following
Teva’s return of the program to Yeda, the FDA directed that the primary endpoint in future trials for Lupus therapies, including
those for hCDR1, should be based on either the BILAG index or the SLE Responder Index (SRI). Given the FDA’s recommendation
and the positive findings from the PRELUDE trial (which showed a substantial effect in the BILAG index), the Company intends to
initiate a new Phase II clinical trial, which will include the 0.5 mg (and a 0.25 mg) weekly dose of hCDR1.
Investment in Proteologics
On September 11, 2013,
the Company entered into an agreement for the purchase of another 14.13% of the shares of Proteologics from Aurum Ventures MKI
Ltd. (“Aurum”) in consideration for the issuance of 3,031,299 shares of NIS 0.1 par value each of the Company to Aurum.
On September 12, 2013, the Company signed an agreement with Zmiha Investment House Ltd. (“Zmiha”) for the sale of its
entire investment in Proteologics, representing 44.95% of Proteologics' issued and outstanding share capital as of the date of
the agreement in consideration of approximately $ 3.4 million (approximately NIS 12 million). According to the agreement, on the
consummation date, the Company received an amount of approximately $ 2.7 million (approximately NIS 9.6 million) and the balance
is held in escrow until the completion of an inspection process by an inspector and the execution of a stay of proceedings pursuant
to section 350 to the Companies Law. As of the date hereof, the entire consideration has been delivered to the Company.
Agreement with Giboov Ltd., a Provider of Online Marketing
and Sales Services
On January 20, 2014,
InterCure announced that it had entered into an agreement with Giboov to terminate the Strategic Service Agreement, effective as
of January 31, 2014. Consequently, all 20,185,184 non-marketable stock options for the purchase of InterCure shares, which were
granted to Giboov under the Strategic Service Agreement, expired on March 1, 2014. Following said expiration, Giboov holds no such
non-marketable stock options.
Agreement with Universal McCann Israel, Ltd., a Provider
of Online Marketing and Sales Services
On January 23, 2014,
InterCure announced that it had retained the services of Universal McCann Israel, Ltd. (“McCann”) to provide professional
services relating to the promotion and marketing of InterCure’s products via the internet for a period of three years effective
February 1, 2014. According to the new agreement, InterCure will pay McCann a monthly fee in exchange for online marketing services,
ranging between $8,000 and $13,000, and contingent upon achievement of sales targets.
Relisting our ADRs
On June 1, 2012,
the Company filed an application for relisting its ADRs on The Nasdaq Stock Exchange. On July 10, 2013, the Company received a
notice from Nasdaq stating that the admission committee had approved the Company's application to relist its ADRs for trading on
the Nasdaq Capital Market. Accordingly, on July 15, 2013, the Company's ADRs began trading on Nasdaq under the ticker symbol “XTLB”.
Company Information and History
Our legal and commercial
name is XTL Biopharmaceuticals Ltd. We were established as a private company limited by shares under the laws of the State of Israel
on March 9, 1993, under the name Xenograft Technologies Ltd. We re-registered as a public company on June 7, 1993, in Israel, and
changed our name to XTL Biopharmaceuticals Ltd. on July 3, 1995. We commenced operations to use and commercialize technology developed
at the Weizmann Institute, in Rehovot, Israel. Until 1999, our therapeutic focus was on the development of human monoclonal antibodies
to treat viral, autoimmune and oncological diseases. Our first therapeutic programs focused on antibodies against the hepatitis
B virus, interferon – γ and the Hepatitis C virus.
In January 2007, XTL
Development, Inc., our wholly-owned subsidiary (“XTL Development”), signed an agreement with DOV Pharmaceutical, Inc.
(“DOV”), to in-license the worldwide rights for Bicifadine, a serotonin and norepinephrine reuptake inhibitor (“SNRI”)
(the “Bicifadine transaction”). XTL Development was developing Bicifadine for the treatment of diabetic neuropathic
pain, a chronic condition resulting from damage to peripheral nerves. In November 2008, we announced that the Phase 2b clinical
trial failed to meet its primary and secondary endpoints, and as a result we ceased development of Bicifadine for diabetic neuropathic
pain, and all rights under the agreement reverted to DOV. Since the failure of the Bicifadine phase 2b clinical trial, XTL Development
has ceased the prosecution and maintenance of those patents relating to Bicifadine, in coordination with DOV. In March 2010, the
agreement was formally terminated.
In 2008, we signed
an agreement to out-license the DOS program to Presidio, a specialty pharmaceutical company focused on the discovery, in-licensing,
development and commercialization of novel therapeutics for viral infections, including HIV and HCV. Under the terms of the license
agreement, Presidio became responsible for all further development and commercialization activities and costs relating to our DOS
program. In accordance with the terms of the license agreement, we received a $5.94 million, non-refundable, upfront payment in
cash from Presidio and were to receive up to an additional $59 million upon reaching certain development and commercialization
milestones. In addition, we were to receive royalties on direct product sales by Presidio, and a percentage of Presidio’s
income if the DOS program is sublicensed by Presidio to a third party. On August 22, 2012, Presidio requested to terminate its
engagement with us effective as of August 24, 2012. Following a notice of the termination of the agreement, Presidio's entire DOS
technology (including all the patents maintained by Presidio) reverted back to the Company. The Company intends to assess opportunities
to maximize the value of the DOS technology but has no plans for continued development of the program.
In March 2009 we signed
an asset purchase agreement to acquire the rights to develop rHuEPO for the treatment of Multiple Myeloma in exchange for the issuance
of ordinary shares of XTL representing approximately 69.44% of our then issued and outstanding ordinary share capital. Under the
agreement we are obligated to pay 1% royalties on net sales of rHuEPO, as well as a fixed royalty payment in the total amount of
$350,000 upon the success of Phase 2. Such payment of $350,000 mentioned above shall be made to Yeda upon the earlier of (i) six
months from the successful completion of Phase 2 or (ii) the completion of a successful fundraising by XTL at any time after the
completion of Phase 2 of at least $2 million.
On March 24, 2011,
we entered into a Memorandum of Understanding with MinoGuard, pursuant to which we shall acquire the exclusive rights to SAM-101
by obtaining an exclusive license to use MinoGuard's entire technology. SAM-101 is based on a combination of anti-psychotic drugs
with minocycline, a recognized medicinal compound. On November 30, 2011, we received a worldwide exclusive license from MinoGuard
under which we shall develop and commercialize MinoGuard's technology for the treatment of psychotic disorders focusing on schizophrenia.
Under the agreement, we are to conduct clinical trials, develop, register, market, distribute and sell the drugs that will emerge
from MinoGuard's technology, with no limitations for a specific disorder. In consideration, we shall pay MinoGuard accumulated
clinical development and marketing approvals milestone-based payments of approximately $2.5 million. In addition, we will pay MinoGuard
royalty-based payments on products that are based on the technology, equal to 3.5% of its net sales and/or percentage from the
Company third-party out–license receipts in the range of 7.5%-20% according to the clinical phase of the drug at the time
of an out-license transaction. It should be noted that the Company has the sole discretion to pay any of the above amounts
in cash or by way of issuing ordinary shares of the Company to MinoGuard. In addition to the above payments, and in accordance
with the above agreement, as of June 30, 2013, XTL had not commenced a phase 2 clinical trial, had paid MinoGuard an annual license
fee, by way of the issuance of 175,633 ordinary shares of the Company, representing a value of $45,000, for the 12 month period
between July 1, 2013 and June 30, 2014. Such annual payments will increase by $90,000 per annum, up to $675,000 for the eighth
year of license.
On January 7, 2014,
the Company entered into a licensing agreement with Yeda to research, develop and commercialize hCDR1, a Phase II-ready asset for
the treatment of SLE, among other indications. Lupus is a debilitating disease affecting approximately five million people worldwide,
according to the Lupus Foundation of America. hCDR1 is a peptide, short chains of amino acid monomers, and acts as a disease-specific
treatment to modify the SLE-related autoimmune process. It does so by specific upstream immunomodulation through the generation
of regulatory T cells, reducing inflammation and resuming immune balance. More than 40 peer-reviewed papers have been published
on hCDR1.
Our ADRs are traded
on the Nasdaq Capital Market under the symbol “XTLB.” Our ordinary shares are traded on the TASE under the symbol “XTL.”
We operate under the laws of the State of Israel under the Israeli Companies Law, and in the US, the Securities Act and the Exchange
Act.
Our principal offices
are located at Herzliya Business Park, 85 Medinat Hayehudim Street, Building G, PO Box 4033, Herzliya 46140, Israel, and our telephone
number is +972-9-955-7080. XTL Biopharmaceuticals, Inc., our wholly-owned US subsidiary and agent for service of process in the
US, can be reached at XTL Biopharmaceuticals, Inc c/o Corporation Trust Company, Corporation Trust Center, 1209 N. Orange Street,
Wilmington, Delaware 19801, or by telephone at (800) 677-3394. Our primary internet address is www.xtlbio.com. None of the information
on our website is incorporated by reference herein.
B. Business Overview
Introduction
We are a biopharmaceutical
company engaged in the acquisition and development of pharmaceutical drugs for the treatment of unmet medical needs, currently
for the treatment of SLE, Multiple Myeloma and Schizophrenia.
Our lead program is
hCDR1, a Phase II-ready asset for the treatment of SLE. Only one new treatment, Benlysta, has been approved in the last 50 years
for SLE. Lupus is a chronic autoimmune disease involving many systems in the human body, including joints, kidneys, the central
nervous system, heart, the hematological system and others. The biologic basis of the disease is a defect in the immune (defense)
system, leading to production of self (auto) antibodies, attacking the normal organs and causing irreversible damage. According
to the Lupus Foundation of America, at least 1.5 million Americans have the disease (more than 5 million worldwide) with more than
16,000 new cases diagnosed each year. The majority of patients are women of childbearing years.
hCDR1, is a peptide
that is administered subcutaneously and acts as a disease-specific treatment to modify the SLE-related autoimmune process by specific
upstream immunomodulation through the generation of regulatory T cells, reducing inflammation and resuming immune balance. More
than 40 peer-reviewed papers have been published on hCDR1. Two placebo controlled Phase I trials and a placebo controlled Phase
II trial, the PRELUDE trial, were conducted by Teva, which had previously in-licensed hCDR1 from Yeda. The studies consisted of
over 400 patients, demonstrating that hCDR1 is well tolerated by patients and has a favorable safety profile. The PRELUDE trial
did not achieve its primary efficacy endpoint based on the SLEDAI scale, resulting in Teva returning the asset to Yeda. However,
the PRELUDE trial showed encouraging results in its secondary clinical endpoint, the BILAG index, and, in fact, the 0.5 mg weekly
dose showed a substantial effect. Multiple post-hoc analyses also showed impressive results for this dose using the BILAG index.
Such dose will be the focus of the clinical development plan moving forward. Subsequent to Teva’s return of the program to
Yeda, the FDA directed that the primary endpoint in future trials for Lupus therapies, including those for hCDR1, should be based
on either the BILAG index or the SLE Responder Index (SRI). Given the FDA's recommendation and the positive findings from the PRELUDE
trial (which showed a substantial effect in the BILAG index), XTL intends to initiate a new Phase II clinical trial, which will
include the 0.5 mg (and a 0.25 mg) weekly dose of hCDR1.
Our second
compound is rHuEPO, which we intend to develop for the extension of survival of patients with advanced/end-stage Multiple Myeloma.
Erythropoietin
(“EPO”) is a glycoprotein hormone produced mainly by the kidney. It is the major growth regulator of the erythroid
lineage. EPO stimulates erythropoiesis, the production of red blood cells, by binding to its receptor (“EPO-R”) on
the surface of erythroid progenitor cells, promoting their proliferation and differentiation and maintaining their viability. Over
the last decade, several reports have indicated that the action of EPO is not restricted to the erythroid compartment, but may
have additional biological, and consequently potential therapeutic properties, broadly beyond erythropoiesis. Erythropoietin is
available as a therapeutic agent produced by recombinant DNA technology in mammalian cell culture. rHuEPO is used in clinical practice
for the treatment of various anemias including anemia of kidney disease and cancer-related anemia.
Currently incurable,
Multiple Myeloma is a severe plasma cell malignancy characterized by the accumulation and proliferation of clonal plasma cells
in the marrow, leading to the gradual replacement of normal hematopoiesis. The course of the disease is progressive, and various
complications occur, until death. This devastating disease affects the bone marrow, bones, kidneys, heart and other vital organs.
It is characterized by pain, recurrent infections, anemia and pathological fractures. In the course of the disease, many patients
become gradually disabled and bed-ridden.
The median overall
survival duration today with chemotherapy and other novel treatments is about five years. These treatments have severe side effects,
including the suppression of the immune system, susceptibility to infections, nausea, vomiting and bleeding disorders.
A clinical observation
confirmed the high success rate of rHuEPO in treating the anemia in patients with Multiple Myeloma. Six patients with very poor
prognostic features of Multiple Myeloma, whose expected survival was less than six months continued treatment with rHuEPO beyond
the initial designed 12 week period, and they lived for 45–133 months cumulatively with the Multiple Myeloma diagnosis and
38–94 months with rHuEPO (with a good quality of life).
Our third program,
SAM-101, is based on the technology we in-licensed from MinoGuard - the development of combination drugs for psychotic diseases,
with focus on Schizophrenia. MinoGuard completed a phase 2a study on SAM-101 in accordance with the Helsinki guidelines under the
Shalvata Medical Center in Israel, which was a unique proprietary combination of antipsychotic drugs and a known medicinal compound
(minocycline). Schizophrenia is a chronic disorder that requires lifelong medication. While most of the available drugs are effective
in remitting Schizophrenia’s “positive symptoms” (hallucinations, delusions, agitation), even the best available
drug is only partially effective in remitting several of the most disturbing features of the disease, referred to as “negative
symptoms” (apathy, poverty of speech, emotional withdrawal, depression) and severe cognitive impairment. This deficiency
results in schizophrenic patients’ poor quality of life. In addition, noncompliance results in aggravation in symptoms, which
frequently causes lengthy hospitalization periods.
Following in-vivo studies
demonstrating the efficacy of minocycline treatment in a Schizophrenia murine mode, MinoGuard demonstrated in a successful phase
2a clinical study that the combination of atypical antipsychotic drugs and minocycline improves treatment efficacy and reduces
side effects associated with current therapy as compared to antipsychotic treatment alone. Two independent clinical research groups
in Manchester, UK and Japan have replicated these results, further supporting MinoGuard's hypothesis.
We also have some activity
in the medical device field through our subsidiary InterCure, which operates as a medical device company and manufactures and sells
personal therapeutic devices. InterCure's main field of activity since its establishment is the research and development of technologies
and devices for the non-medicinal non-invasive treatment of chronic diseases, including hypertension, congestive cardiac failure,
insomnia and stress. The Company’s products include RESPeRATE®, a non-drug and non-invasive hypertension treatment device.
The RESPeRATE product
harnesses the natural power of breathing to lower blood pressure. High blood pressure is generally caused by your blood vessels
tightening up and narrowing, this then causes your heart to pump harder. RESPeRATE's unique breathing exercise relaxes constricted
blood vessels to reduce high blood pressure.
Our Strategy
Our objective is to
be a leading biopharmaceutical company engaged in the acquisition and development of pharmaceutical products for the treatment
of unmet clinical needs, currently for the treatment of SLE, Multiple Myeloma and Schizophrenia. We continuously identify and in-license
therapeutic candidates in order to maximize our potential for commercial success.
Under our current strategy
with respect to our pharmaceutical and biopharmaceutical products, we plan to:
|
·
|
initiate an international, prospective phase 2 clinical study intended to assess the safety and
efficacy of hCDR1 when given to patients with SLE;
|
|
·
|
initiate a prospective phase 2 clinical study intended to assess the safety and efficacy of rHuEPO
when given to patients with advanced Multiple Myeloma;
|
|
·
|
following the initiation of the clinical studies for our two lead compounds and necessary formulation
work on SAM-101, initiate a prospective clinical study intended to assess the safety and efficacy of the combination drug when
given to patients with Schizophrenia;
|
|
·
|
continually build our pipeline of therapeutic candidates, and
|
|
·
|
develop collaborations with large pharmaceutical companies to sublicense/develop, and market our
hCDR1, rHuEPO and SAM-101 programs.
|
With regard to our
medical device business, we plan to maximize the value of our asset and focus on our core business.
Products Under Development
hCDR1 for the treatment of Systemic
Lupus Erythematosus
Market Opportunity
hCDR1 is a Phase II-ready
asset for the treatment of SLE. Lupus is a debilitating disease affecting approximately five million people worldwide. hCDR1 is
a peptide, is given by subcutaneous administration, and acts as a disease-specific treatment to modify the SLE-related autoimmune
process. It does so by specific upstream immunomodulation through the generation of regulatory T cells, reducing inflammation and
resuming immune balance. The approval of GlaxoSmithKline’s Benlysta in 2011, the first product to gain marketing approval
for patients with SLE in more than 50 years, paved the way for the introduction of new disease-modifying therapies and reignited
the interest of pharmaceutical developers in this therapy area. GlobalData estimates the drug sales for SLE in 2012 were over $473
million across the seven major markets covered in its forecast: US, France, Germany, Italy, Spain, UK and Japan. By the end of
the forecast period of 2022, sales are estimated to grow to over $1.1 billion with a CAGR of 9.36%. This growth will be driven
by improved uptake of Benlysta, and the introduction of new biological therapies and the overall increase in prevalent cases of
SLE, mainly due to the increasing population in these markets.
Regarding products
in the pipeline, there are five advanced biological therapies. Eli Lilly, Anthera Pharmaceuticals and Merck Serono are developing
anti-BLyS therapies to directly compete with Benlysta (also an anti-BLyS therapy). All new anti-BLyS therapies are being developed
for subcutaneous administration. Benlysta is currently given intravenously, even though GSK is currently developing a version for
subcutaneous administration. UCB and ImmuPharma are developing biologic drugs with novel MOAs (UCB’s drug is an antibody
which is given intravenously). In addition, Bristol-Myers Squibb is developing its RA drug Orencia for the treatment of patients
with Lupus Nephritis.
Development Status
Prior to being licensed
to the Company by Yeda, hCDR1 was licensed to Teva which performed two placebo controlled Phase I trials and a placebo controlled
Phase II trial (the “PRELUDE trial”). The Phase I and Phase II studies consisted of over 400 patients, demonstrating
that hCDR1 is well tolerated by patients and has a favorable safety profile. The PRELUDE trial did not achieve its primary efficacy
endpoint based on the SLEDAI scale, resulting in Teva returning the asset to Yeda. However, the PRELUDE trial showed encouraging
results in its secondary clinical endpoint, the BILAG index, and, in fact, the 0.5 mg weekly dose showed a substantial effect.
Multiple post-hoc analyses also showed impressive results for this dose using the BILAG index. It is currently planned by the Company
that such dose will be the focus of the clinical development plan moving forward. Subsequent to Teva’s return of the program
to Yeda, the FDA directed that the primary endpoint in future trials for Lupus therapies, including those for hCDR1, should be
based on either the BILAG index or the SRI. Given the FDA’s recommendation and the positive findings from the PRELUDE trial
(which showed a substantial effect in the BILAG index), the Company intends to initiate a new Phase II clinical trial, which will
include the 0.5 mg (and a 0.25 mg) weekly dose of hCDR1.
rHuEPO for the treatment of Multiple
Myeloma
Market Opportunity
We intend to develop
the use of rHuEPO for the prolongation of Multiple Myeloma patients’ survival. In the United States alone, there are approximately
74,800 people living with Multiple Myeloma. Multiple Myeloma is the second most prevalent blood cancer representing approximately
1% of all cancers in white US residents and 2% of all cancers in African Americans. The average age at diagnosis is 65-70 and it
is also more common in men than women, and in African Americans than Caucasians.
Erythropoietin, a glycoprotein
hormone produced mainly by the kidney, is the major growth regulator of the erythroid lineage. EPO stimulates erythropoiesis by
binding to its receptor on the surface of erythroid progenitor cells, promoting their proliferation and differentiation and maintaining
their viability. The cloning of the EPO gene led to the introduction of rHuEPO into clinical practice for the treatment of various
anemias including anemia of kidney disease and cancer-related anemia.
Over the last decade,
several reports have indicated that the action of EPO is not restricted to the erythroid compartment, but may have additional biological,
and consequently potential therapeutic properties, broadly beyond erythropoiesis. A clinical observation confirmed the high success
rate of rHuEPO in treating the anemia in patients with Multiple Myeloma. Six patients continued treatment with rHuEPO beyond the
initial designed 12 week period with very poor prognostic features of Multiple Myeloma, whose expected survival was less than six
months, and they lived for 45–133 months cumulatively with the Multiple Myeloma diagnosis and 38–94 months with rHuEPO
(with a good quality of life).
Development Status
As of the date hereof,
the Company is in stages of planning and preparing for the implementation of a phase 2 clinical trial of rHuEPO for treating Multiple
Myeloma patients. As part of those preparations, the Company conducted a study which consists of collecting preliminary data on
the existence of specific proteins in the blood of a group of Multiple Myeloma patients. The data which was collected in the framework
of the preliminary study will be combined, as necessary, in planning and preparing for the implementation of the phase 2 clinical
trial which the Company expects to obtain the approval to commence in the second half of 2014.
We plan on performing
a prospective, multi-center, double blind, placebo controlled phase 2 study intended to demonstrate its effects on survival, biological
markers related to the disease, immune improvements and quality of life. We have begun regulatory work and have held preliminary
discussions with potential clinical sites and third party vendors for the planned study.
Given that we intend
to develop a new indication for rHuEPO, which is already approved for other uses, and we intend to use a commercially available
rHuEPO as part of the study, and the fact that the pre-clinical and phase 1 phases are intended to assess drug toxicity and safety,
we may be exempted from carrying out these steps and the drug development process may begin with a Phase 2 clinical trial.
SAM-101 for Schizophrenia
Market Opportunity
SAM-101 is our third
program in order of priority, and while development may not start in the near-term, we intend to develop a patent-protected combination
of minocycline and antipsychotic drugs for the treatment of Schizophrenia. According to the US National Institute of Mental Health
(NIMH), Schizophrenia affects 1.1% of the adult population.
Schizophrenia is a
chronic disorder that requires lifelong medication. While most of the available drugs are effective in remitting schizophrenia’s
“positive symptoms” (hallucinations, delusions, agitation), even the best available drug is only partially effective
in remitting several of the most disturbing features of the disease, known as “negative symptoms” (apathy, poverty
of speech, emotional withdrawal, depression) and severe cognitive impairment. SAM-101 is expected to overcome major limitations
of currently available treatments for schizophrenia by providing an effective treatment, affecting both negative and positive symptoms
as well as cognition, therefore preventing further deterioration in schizophrenic patients. In addition, SAM-101 showed lower side
effects in the clinical trial mentioned below, which is expected to allow for higher compliance and improved patient quality of
life.
The global Schizophrenia
market in 2010 reached $6.4 billion. The market declined thereafter owing to the launch of generic versions of the leading antipsychotics
– risperidone, olanzapine, quetiapine and ziprasidone, in 2011. According to Datamonitor, pipeline products in phase 3 and
2 clinical trials are not expected to drive market growth, since most of them offer no or little significant advantage over current
medications, which will shortly become generic. Nevertheless, a number of new companies will enter the Schizophrenia market during
the upcoming years. Combination therapies are recognized for clinical advantages including facilitated patient compliance and convenience,
along with increased efficacy. Such developments play a key role in terms of pharmaceutical market contenders’ business strategy,
allowing for extended exclusivity rights.
Development Status
We in-licensed SAM-101
after it successfully completed a Phase 2a prospective, randomized, double-blind, placebo-controlled clinical trial conducted on
about 70 schizophrenics in accordance with the Helsinki guidelines under the Shalvata Medical Center in Israel. The trial met its
endpoints showing that SAM-101 maintains the positive symptoms of the disease as well as the patients’ cognitive state, stabilizes
the negative symptoms (social parameters and patient cognition) and reduces weight gain side effects among patients all as compared
to placebo.
Following in-vivo studies
demonstrating the efficacy of minocycline treatment in a Schizophrenia murine mode, MinoGuard demonstrated in a successful phase
2a clinical study that the combination of atypical antipsychotic drugs and minocycline maintains treatment efficacy and reduces
side effects associated with current therapy as compared to antipsychotic treatment alone. At least two independent clinical research
groups (Manchester, UK and Japan) have replicated these results, further supporting MinoGuard's hypothesis.
Since minocycline and
antipsychotics have been approved in the United States, a combination of the two should be eligible for market approval using the
505(b)(2) route. This allows the FDA to rely on their own previous finding of safety and efficacy of the active pharmaceutical
ingredients for the purposes of marketing approval of SAM-101.
Subject to prioritizing
our drug development activities and some formulation work in creating a fixed dose combination, we plan to perform a multi-center
phase 2 clinical trial under the FDA, using our proprietary combination, in order to confirm the scope of work required for a new
drug application, or NDA, and to identify the specific requirements for filing an Investigational New Drug, or IND, application
with the FDA.
Revenues
To date, we have not
received approval for the sale of any of our drug candidates in any market and, therefore, have not generated any commercial revenues
from the sales of our drug candidates. The table below shows our consolidated revenues by geographic market in 2013 for our medical
device business operated through InterCure:
|
|
Year ended
December 31,
2013
|
|
|
|
Audited
|
|
|
|
U.S dollars in
thousands
|
|
|
|
|
|
United States
|
|
|
2,076
|
|
United Kingdom
|
|
|
278
|
|
Israel
|
|
|
15
|
|
|
|
|
|
|
Total
|
|
|
2,369
|
|
Purchasing and Raw Materials
Since 2003, InterCure
has been manufacturing the RESPeRATE device (and its different versions) on a turnkey basis by an independent subcontractor (the
“Subcontractor”). InterCure orders some of the device's raw materials for the Subcontractor from time to time, mainly
the more expensive ones, or negotiates with suppliers of raw materials due to profit considerations and offsets the price paid
by it to the Subcontractor.
Intellectual Property and Patent
General
Patents and other proprietary
rights are very important to the development of our business. We will be able to protect our proprietary technologies from unauthorized
use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively
maintained as trade secrets. It is our intention to seek and maintain patent and trade secret protection for our drug candidates
and our proprietary technologies. As part of our business strategy, our policy is to file patent applications in the US and internationally
to cover methods of use, new chemical compounds, pharmaceutical compositions and dosing of the compounds and compositions and improvements
in each of these. We also rely on trade secret information, technical know-how, innovation and agreements with third parties to
continuously expand and protect our competitive position. Because of the extensive time required for development, testing and regulatory
review of a potential product, it is possible that before we commercialize any of our products, any related patent may expire or
remain in existence for only a short period following commercialization, thus reducing any commercial advantage or financial value
attributable to the patent.
Generally, patent applications
in the US are maintained in secrecy for a period of at least 18 months. Since publication of discoveries in the scientific
or patent literature often lag behind actual discoveries, we are not certain that we were the first to make the inventions covered
by each of our pending patent applications or that we were the first to file those patent applications. The patent positions of
biotechnology and pharmaceutical companies are highly uncertain and involve complex legal and factual questions. Therefore, we
cannot predict the breadth of claims allowed in biotechnology and pharmaceutical patents, or their enforceability. To date, there
has been no consistent policy regarding the breadth of claims allowed in biotechnology patents. Third parties or competitors may
challenge or circumvent our patents or patent applications, if issued. Granted patents can be challenged and ruled invalid at any
time, therefore the grant of a patent is not of itself sufficient to demonstrate our entitlement to a proprietary right. The disallowance
of a claim or invalidation of a patent in any one territory can have adverse commercial consequences in other territories.
If our competitors
prepare and file patent applications in the US that claim technology also claimed by us, we may choose to challenge competing patent
rights, which could result in substantial cost, even if the eventual outcome is favorable to us. While we have the right to defend
patent rights related to our licensed drug candidates and technologies, we are not obligated to do so. In the event that we decide
to defend our licensed patent rights, we will be obligated to cover all of the expenses associated with that effort.
If a patent is issued
to a third party containing one or more preclusive or conflicting claims, and those claims are ultimately determined to be valid
and enforceable, we may be required to obtain a license under such patent or to develop or obtain alternative technology. In the
event of a litigation involving a third party claim, an adverse outcome in the litigation could subject us to significant liabilities
to such third party, require us to seek a license for the disputed rights from such third party, and/or require us to cease use
of the technology. Further, our breach of an existing license or failure to obtain a license to technology required to commercialize
our products may seriously harm our business. We also may need to commence litigation to enforce any patents issued to us or to
determine the scope, validity and/or enforceability of third-party proprietary rights. Litigation would involve substantial costs.
hCDR1 for the treatment of SLE
The basic patent family
(WO 2002/067848) covers the active pharmaceutical agent, the Edratide peptide. The patent has been granted in a large number of
jurisdictions: US, Europe (validated in 13 countries), Australia, Canada, Hong Kong, Hungary, India, Israel, Korea, Mexico, Norway,
and Russia. The patent expires on February 26, 2022. The basic patent for Edratide, in the US, did receive a patent term adjustment
of 213 days (to September 27, 2022). The patent family for the formulation (WO 2004/064788) covers a very specific pharmaceutical
composition comprising Edratide. It has been granted in the US, China, India, Israel, Japan, and Mexico, and is under examination
in Europe and Canada. The formulation patent expires on January 14, 2024.
rHuEPO for the treatment of Multiple
Myeloma
A main use patent,
United States Patent 6,579,525 “Pharmaceutical Compositions Comprising Erythropoietin for Treatment of Cancer,” was
filed by Mor and Yeda in Israel on April 8, 1998. The patent was granted in the United States, Europe (Austria, Belgium, France,
Germany, Great Britain, Ireland, Italy, the Netherlands, Spain, Sweden and Switzerland), Israel, Japan, Hong Kong and Canada. The
issued patent will expire in 2019 (See “Government and Industry Regulation” regarding our granted orphan drug designation).
Pursuant to our agreement with Bio-Gal, we have exclusive worldwide rights to the above patent for the use of rHuEPO in Multiple
Myeloma.
The main claims of
this US issued patent are directed to: A method for the treatment of a Multiple Myeloma patient, comprising the administration
of Erythropoietin or Recombinant Human Erythropoietin, for the inhibition of tumor growth, triggering of tumor regression or inhibition
of Multiple Myeloma cell metastasis in the said patient.
SAM-101 for the Treatment of Schizophrenia
An international patent
application entitled “Combined therapies of antipsychotic drugs and tetracyclines in the treatment of psychiatric disorders”
was filed by Mor on October 18, 2007 (International application number PCT/IL2007/001251). The patent is currently pending in National
Phase in the US, Canada, Europe, India, and Israel.
The main claims of
this patent include a pharmaceutical composition comprising as active ingredients at least one tetracycline and at least one antipsychotic
drug, the pharmaceutical composition with modified release formulation, and a method for treating a psychotic disorder comprising
administering the pharmaceutical composition to a patient in need.
The patent applications are pending as National
Phase in Israel, US, Canada, Europe, and India. The table below details the current status of the patent applications:
Countries in which
application was
filed
|
|
Filing Date
|
|
Application No.
|
|
Patent No.
|
|
Status
|
|
Expiration
Date*
|
Canada
|
|
18.10.2007
|
|
2666796
|
|
-
|
|
Filed
|
|
18.10.2027
|
Europe
|
|
18.10.2007
|
|
07827225.9
|
|
-
|
|
Examination
|
|
18.10.2027
|
India
|
|
18.10.2007
|
|
3100/DELNP/2009
|
|
-
|
|
Filed
|
|
18.10.2027
|
Israel
|
|
18.10.2007
|
|
198134
|
|
-
|
|
Examination
|
|
18.10.2027
|
PCT
|
|
29.03.2007
|
|
PCT/IL2007/000414
|
|
-
|
|
Expired
|
|
|
PCT-1
|
|
18.10.2007
|
|
PCT/IL2007/001251
|
|
-
|
|
Expired
|
|
|
US Prov.
|
|
19.10.2006
|
|
60/852646
|
|
-
|
|
Expired
|
|
|
USA
|
|
18.10.2007
|
|
13/733130
|
|
-
|
|
Examination
|
|
18.10.2027
|
* assuming that
the patent will be registered on the basis of the PCT.
Other Intellectual Property Rights
We depend upon trademarks,
trade secrets, know-how and continuing technological advances to develop and maintain our competitive position. To maintain the
confidentiality of trade secrets and proprietary information, we require our employees, scientific advisors, consultants and collaborators,
upon commencement of a relationship with us, to execute confidentiality agreements and, in the case of parties other than our research
and development collaborators, to agree to assign their inventions to us. These agreements are designed to protect our proprietary
information and to grant us ownership of technologies that are developed in connection with their relationship with us. These agreements
may not, however, provide protection for our trade secrets in the event of unauthorized disclosure of such information.
Licensing Agreements and Collaborations
hCDR1
On January 7, 2014,
the Company entered into a licensing agreement with Yeda to research, develop, and commercialize hCDR1, a Phase II-ready asset
for the treatment of SLE, among other indications. In consideration, the Company is responsible for a patent expense reimbursement
in six installments totaling approximately $400,000. The Company is required to make milestone payments of $2.2 million: $200,000
upon starting Phase III, $1 million upon U.S. Food and Drug Administration approval and $250,000 for regulatory approval in each
of China and three of the European Union’s Group of Six. In addition, the Company will pay 2-3% royalties of annual net sales
and sublicense fees of 15-20% of whatever the Company receives from any sub-licensee.
Lupus
is a debilitating disease affecting approximately five million people worldwide. hCDR1, is a peptide and acts as a disease-specific
treatment to modify the SLE-related autoimmune process. It does so by specific upstream immunomodulation through the generation
of regulatory T cells, reducing inflammation and resuming immune balance. Prior to being licensed to the Company by Yeda, hCDR1
was licensed to Teva Pharmaceutical Industries ("Teva"), which performed two placebo controlled Phase I trials and a
placebo controlled Phase II trial called the PRELUDE trial. The studies consisted of over 400 patients, demonstrating that hCDR1
is well tolerated by patients and has a favorable safety profile. The PRELUDE trial did not achieve its primary efficacy endpoint
based on the SLEDAI scale, resulting in Teva returning the asset to Yeda. However, the PRELUDE trial showed encouraging results
in its secondary clinical endpoint, the BILAG index, and, in fact, the 0.5 mg weekly dose showed a substantial effect. Multiple
post-hoc analyses also showed impressive results for this dose using the BILAG index. It is currently planned by the Company that
such dose will be the focus of the clinical development plan moving forward. Subsequent to Teva’s return of the program to
Yeda, the FDA directed that the primary endpoint in future trials for Lupus therapies, including those for hCDR1, should be based
on either the BILAG index or the SRI. Given the FDA’s recommendation and the positive findings from the PRELUDE trial (which
showed a substantial effect in the BILAG index), the Company intends to initiate a new Phase II clinical trial, which will include
the 0.5 mg (and a 0.25 mg) weekly dose of hCDR1.
We estimate that the trial will take approximately
one year to enroll patients, another year for the treatment phase, and additional time to analyze the results for a total of approximately
two and a half years. We intend to request that an interim analysis be conducted as well. We estimate the cost for development
at between $12 and $15 million.
Bio-Gal/XTEPO
In March 2009 we signed
an asset purchase agreement to acquire the rights to develop rHuEPO for the treatment of Multiple Myeloma. We are obligated to
pay 1% royalties on net sales of the product, as well as a fixed royalty payment in the total amount of $350,000 upon the successful
completion of Phase 2. Such payment of $350,000 is payable to Yeda upon the earlier of (i) six months from the successful completion
of Phase 2 or (ii) the completion of a successful fundraising by XTL at any time after the completion of the Phase 2 of at least
$2 million.
MinoGuard License
In November 2011, the
Company acquired the assets of MinoGuard by an exclusive license to use MinoGuard’s entire technology in return for royalties
on sales and milestone payments throughout the clinical development process, without any other payments. MinoGuard was founded
in 2007 in order to commercialize combination therapies for treating psychotic diseases, focusing on Schizophrenia. Under the terms
of the license agreement we shall pay MinoGuard accumulated clinical development and marketing approvals milestone-based payments
of approximately $2.5 million. In addition, we will pay MinoGuard royalty-based payments on products that are based on the technology,
equal to 3.5% of net sales and/or a percentage of our third-party out–license receipts in the range of 7.5%-20% according
to the clinical phase of the drug at the time of an out-license transaction. It should be noted that the Company has the sole
discretion to pay any of the above amounts in cash or by way of issuing of its shares to MinoGuard. In addition to the above payments,
since as of June 30, 2013, XTL had not commenced a phase 2 clinical trial, we have paid MinoGuard an annual license fee, by way
of issuance of 175,633 ordinary shares of the Company, representing a value of $45,000, for the 12 month period between July 1,
2013 and June 30, 2014. Such annual payments will increase by $90,000 per annum, up to $675,000 for the eighth year of the license.
The term of the license
commenced upon the signing of the license agreement and will be effective for an unlimited time. Upon the expiration of the last
payment obligation of XTL the license will be considered perpetual and fully paid up.
Trademarks
InterCure and InterCure
Inc. have the following registered trademarks:
Registered trademark details
|
|
International
classification
|
|
Country
|
RESPeRATE
|
|
10
|
|
Israel
|
InterCure
|
|
10
|
|
US
|
RESPeRATE
|
|
10, 42
|
|
US
|
InterCure
|
|
10, 42
|
|
EU
|
RESPeRATE
|
|
10
|
|
EU
|
RESPeRATE
|
|
10
|
|
South Korea
|
RESPeRATE
|
|
10
|
|
China
|
RESPeRATE
|
|
10
|
|
Japan
|
URL addresses
XTL maintains the www.xtlbio.com
URL address. InterCure has different registered URL addresses, including www.resperate.com, and a variety of domain suffixes, including
of the main countries in which it operates. The expenses incurred in registering URL addresses are immaterial. InterCure renews
them on an ongoing basis.
Competition
Competition in the
pharmaceutical and biotechnology industries is intense. Our competitors include pharmaceutical companies and biotechnology companies,
as well as universities and public and private research institutions. In addition, companies that are active in different but related
fields represent substantial competition for us. Many of our competitors have significantly greater capital resources, larger research
and development staffs and facilities and greater experience in drug development, regulation, manufacturing and marketing than
we do. These organizations also compete with us to recruit qualified personnel, attract partners for joint ventures or other collaborations,
and license technologies that are competitive with ours. To compete successfully in this industry we must identify novel and unique
drugs or methods of treatment and then complete the development of those drugs as treatments in advance of our competitors.
The drugs that we are
attempting to develop will have to compete with existing therapies. In addition, a large number of companies are pursuing the development
of pharmaceuticals that target the same diseases and conditions that we are targeting. Other companies have products or drug candidates
in various stages of pre-clinical or clinical development to treat diseases for which we are also seeking to discover and develop
drug candidates. Some of these potential competing drugs are further advanced in development than our drug candidates and may be
commercialized earlier.
Competing
Products for Treatment of SLE
There
is only one product that has been approved for SLE in the last 50 years, GlaxoSmithKline’s Benlysta which was approved in
2011. There are five potential biological therapies in advanced clinical development. Eli Lilly, Anthera Pharmaceuticals and Merck
Serono are developing anti-BLyS therapies to directly compete with Benlysta (also an anti-BLyS therapy). All new anti-BLyS therapies
are being developed for subcutaneous administration. Benlysta is currently given intravenously, even though GSK is currently developing
a version for subcutaneous administration. UCB and ImmuPharma are developing biologic drugs with novel Mechanism of Actions (UCB’s
drug is an antibody which is given intravenously). In addition, Bristol-Myers Squibb is developing its Rheumatoid Arthritis drug,
Orencia, for the treatment of patients with Lupus Nephritis.
Competing Products for Treatment
of Multiple Myeloma
Although there are
commercially available drugs for the treatment of Multiple Myeloma, we plan to conduct our clinical trial so that rHuEPO will be
tested and given only to patients who have been treated with and either failed treatment or need to stop taking, all standard therapy.
Thus, the drugs below are not in direct competition to our drug. However, rHuEPO may improve the current treatments and therefore
may be supplementary to them, as follows:
Thalidomide
is effective
in approximately one-third of patients (for a certain period of time) with advanced disease and is synergistic
with other agents active in Multiple Myeloma. Its exact mechanism
of action is unclear, but inhibition of angiogenesis,
modulation
of cytokines, and immunological effects are probably involved.
Thalidomide, as a single agent
or in combination with steroids, is now the standard first line treatment
for relapsed or refractory myeloma (if not
used before) and is also being used as
frontline and maintenance treatment. Newer derivatives of
thalidomide,
such as revlimid or lenalidomide (formerly CC5013), have potentially greater biological activity
and fewer adverse effects,
including teratogenicity. Preliminary
studies show a response in 30-50% of patients with refractory
disease.
Thalidomide has severe side effects such as flu-like symptoms, constipation, neuropathy and thrombophilia, and has not yet demonstrated
survival advantage.
Lenalidomide (Revlimid)
is used with dexamethasone to treat patients with Multiple Myeloma who have already had another treatment. It is a small molecular
analog of thalidomide that was originally found based on its ability to effectively inhibit tumor necrosis factor production. Lenalidomide
is 50,000 times more potent than thalidomide in inhibiting tumor necrosis factor-alpha, and has less severe adverse drug reactions.
Nonetheless, lenalidomide, like its parent compound thalidomide, causes venous thromboembolism (VTE), a potentially serious complication
with their use.
Bortezomib
(Velcade)
inhibits the proteasome, an intracellular organelle
responsible for protein disposal. The response rate to bortezomib
in extensively treated myeloma is around 50%. The drug has
recently been approved by the FDA
based
on phase 2 clinical results. The drug has several serious side effects, including neuropathy.
Carfilzomib (Kyprolis):
This is a new generation or a novel derivative of proteasome-inhibitor, i.e. the new modern “Bortezomib”. It was already
approved by the FDA as a second or third line therapy for relapsed or resistant myeloma. This was based on phase 2 clinical trials,
and trials, including in Israel, are ongoing. According to the information gained so far, it appears that some of the previously
resistant Multiple Myeloma patients to Velcade (Bortezomib) might respond to Carfilzomib. It is still too early to determine whether
the novel drug indeed prolongs life (overall survival) or only prolongs the progression-free survival.
Pomalidomide (Pomalyst)
has been approved by the FDA just recently, also for the treatment of relapsed/resistant Multiple Myeloma, as a second-third line
treatment. This agent belongs to the INIDs family of drugs, and in essence, is considered the novel lenalidomide.
It is important to
emphasize that studies with Carfilzomib and Pomalidomide are ongoing and their real role in the treatment of Multiple Myeloma has
not been completely clarified.
Traditional chemotherapy
treatment includes melphalan and prednisone, now
used sparingly because of its propensity to compromise collection
of haematopoietic stem cells, other combinations, and regimens
containing high dose corticosteroids. The latter-including
dexamethasone; vincristine, doxorubicin, and dexamethasone;
and cyclophosphamide, vincristine, doxorubicin, and
methylprednisolone -are
preferred for transplant candidates.
High
dose chemotherapy
, particularly melphalan, with autologous
haematopoietic stem cell transplantation improves
response rates
and their duration and survival compared with conventional chemotherapy.
It is now
commonly used as consolidation treatment. Unfortunately, even after haematopoietic stem cell transplantation,
relapse
is only a matter of time, although a minority of patients
seem to survive over a decade in remission
(“operational cure”). Maintenance treatment after transplantation with corticosteroids
or interferon is
often prescribed in an attempt to delay relapse. Although
this probably does prolong the duration of remission, it
is
unclear if it confers a survival benefit.
Allogeneic haematopoietic
stem cell transplantation
might potentially cure a
proportion of patients through immunologically mediated graft
versus myeloma effect. However, this procedure remains highly experimental at the present time. High mortality related to
treatment
has been a problem historically, but the use of safer preparative
regimens of reduced intensity
could improve long term results.
Competing
Products for Treatment of Schizophrenia
SAM-101, if approved,
will compete with currently available marketed atypical anti-psychotics from Eli Lilly, Johnson & Johnson, Bristol-Myers Squibb/Otsuka
Pharmaceutical Co., Ltd., Pfizer Inc., AstraZeneca and others, as well as with generic brands of typical and atypical anti-psychotics.
In addition there are a number of potentially competitive compounds under development, which include: Cariprazine, which is being
developed by Forest Laboratories, Inc.; Bifeprunox, which is being developed by Solvay Pharmaceuticals, Inc., and Lurasidone, which
is being developed by Dainippon Sumitomo Pharma Co., Ltd.
Supply and Manufacturing
We currently have no
manufacturing capabilities and do not intend to establish any such capabilities.
hCDR1 for the treatment of SLE
We believe that we
will be able to outsource production to a contract manufacturer in order to obtain sufficient inventory to satisfy the clinical
supply needs for our future development for the treatment of SLE.
rHuEPO for the treatment of Multiple
Myeloma
We believe that we
will either be able to purchase Recombinant Erythropoietin (rHuEPO) from existing pharmaceutical companies or to enter into collaborative
agreements with contract manufacturers or other third-parties to obtain sufficient inventory to satisfy the clinical supply needs
for our planned development program for the treatment of Multiple Myeloma.
SAM-101 for the Treatment of Schizophrenia
We believe that we
will either be able to purchase the selected antipsychotic and minocycline from existing pharmaceutical companies or to enter into
collaborative agreements with contract manufacturers or other third-parties to obtain sufficient inventory to satisfy the clinical
supply needs for our future development for the treatment of Schizophrenia.
General
At the time of commercial
sale, to the extent that it is possible and commercially practicable, we plan to engage a back-up supplier for each of our product
candidates. Until such time, we expect that we will rely on a single contract manufacturer to produce each of our product candidates
under cGMP regulations. Our third-party manufacturers have a limited number of facilities in which our product candidates can be
produced and will have limited experience in manufacturing our product candidates in quantities sufficient for conducting clinical
trials or for commercialization. Our third-party manufacturers will have other clients and may have other priorities that could
affect our contractor’s ability to perform the work satisfactorily and/or on a timely basis. Both of these occurrences would
be beyond our control. We anticipate that we will similarly rely on contract manufacturers for our future proprietary product candidates.
We expect to similarly
rely on contract manufacturing relationships for any products that we may in-license or acquire in the future. However, there can
be no assurance that we will be able to successfully contract with such manufacturers on terms acceptable to us, or at all.
Contract manufacturers
are subject to ongoing periodic inspections by the FDA, the US Drug Enforcement Agency and corresponding state and local agencies
to ensure strict compliance with cGMP and other state and federal regulations. We do not have control over third-party manufacturers’
compliance with these regulations and standards, other than through contractual obligations.
If we need to change
manufacturers, the FDA and corresponding foreign regulatory agencies must approve these new manufacturers in advance, which will
involve testing and additional inspections to ensure compliance with FDA regulations and standards and may require significant
lead times and delay. Furthermore, switching manufacturers may be difficult because the number of potential manufacturers is limited.
It may be difficult or impossible for us to find a replacement manufacturer quickly or on terms acceptable to us, or at all.
Government and Industry Regulation
Numerous governmental
authorities, principally the FDA and corresponding state and foreign regulatory agencies, impose substantial regulations upon the
clinical development, manufacture and marketing of our drug candidates and technologies, as well as our ongoing research and development
activities. None of our drug candidates have been approved for sale in any market in which we have marketing rights. Before marketing
in the US, any drug that we develop must undergo rigorous pre-clinical testing and clinical trials and an extensive regulatory
approval process implemented by the FDA, under the Federal Food, Drug and Cosmetic Act of 1938, as amended. The FDA regulates,
among other things, the pre-clinical and clinical testing, safety, efficacy, approval, manufacturing, record keeping, adverse event
reporting, packaging, labeling, storage, advertising, promotion, export, sale and distribution of biopharmaceutical products.
The regulatory review
and approval process is lengthy, expensive and uncertain. We are required to submit extensive pre-clinical and clinical data and
supporting information to the FDA for each indication or use to establish a drug candidate’s safety and efficacy before we
can secure FDA approval. The approval process takes many years, requires the expenditure of substantial resources and may involve
ongoing requirements for post-marketing studies or surveillance. According to the FDA, before commencing clinical trials in humans,
we must submit an IND to the FDA containing, among other things, pre-clinical data, chemistry, manufacturing and control information,
and an investigative plan. Our submission of an IND may not result in FDA authorization to commence a clinical trial.
The Company was granted
an Orphan-drug designation from the FDA in May 2011, for rHuEPO. In the US, Orphan-drug designation is granted by the FDA Office
of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients
in the US. The designation provides the drug developer with a seven-year period of US marketing exclusivity if the drug is the
first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution
to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax
credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and
waiver of Prescription Drug User Fee Act filing fees.
The Company may apply
to the European Medicines Agency in order to obtain Orphan-drug designation for its Recombinant Erythropoietin in Europe. Orphan
designation is granted by the European Medicines Agency, following a positive opinion from the Committee for Orphan Medicinal Products,
to a medicinal product that is intended for the diagnosis, prevention or treatment of a life-threatening or a chronically debilitating
condition affecting not more than five in 10,000 persons in the European Community when the application for designation is
submitted. Orphan drug designation provides the sponsor with access to the Centralized Procedure for the application for marketing
authorization, protocol assistance, up to a 100% reduction in fees related to a marketing authorization application, pre-authorization
inspection and post-authorization activities, and could provide ten years of market exclusivity in the EU, once approved for the
treatment of Multiple Myeloma.
The FDA may permit
expedited development, evaluation, and marketing of new therapies intended to treat persons with serious or life-threatening conditions
for which there is an unmet medical need under its fast track drug development programs. A sponsor can apply for fast track designation
at the time of submission of an IND, or at any time prior to receiving marketing approval of the NDA. To receive fast track designation,
an applicant must demonstrate that the drug:
|
·
|
is intended to treat a serious or life-threatening condition;
|
|
·
|
is intended to treat a serious aspect of the condition; and
|
|
·
|
has the potential to address unmet medical needs, and this potential is being evaluated in the
planned drug development program.
|
Clinical testing must
meet requirements for institutional review board oversight, informed consent and good clinical practices, and must be conducted
pursuant to an IND, unless exempted.
For purposes of NDA
approval, clinical trials are typically conducted in the following sequential phases:
|
·
|
Phase 1: The drug is administered to a small group of humans, either healthy volunteers or patients,
to test for safety, dosage tolerance, absorption, metabolism, excretion, and clinical pharmacology.
|
|
·
|
Phase 2: Studies are conducted on a larger number of patients to assess the efficacy of the product,
to ascertain dose tolerance and the optimal dose range, and to gather additional data relating to safety and potential adverse
events.
|
|
·
|
Phase 3: Studies establish safety and efficacy in an expanded patient population.
|
|
·
|
Phase 4: The FDA may require Phase 4 post-marketing studies to find out more about the drug’s
long-term risks, benefits, and optimal use, or to test the drug in different populations, such as children.
|
The length of time
necessary to complete clinical trials varies significantly and may be difficult to predict. Clinical results are frequently susceptible
to varying interpretations that may delay, limit or prevent regulatory approvals. Additional factors that can cause delay or termination
of our clinical trials, or that may increase the costs of these trials, include:
|
·
|
slow patient enrollment due to the nature of the clinical trial plan, the proximity of patients
to clinical sites, the eligibility criteria for participation in the study or other factors, and the number of sites participating
in the trial;
|
|
·
|
inadequately trained or insufficient personnel at the study site to assist in overseeing and monitoring
clinical trials or delays in approvals from a study site’s review board;
|
|
·
|
longer treatment time required to demonstrate efficacy or determine the appropriate product dose;
|
|
·
|
insufficient supply of the drug candidates;
|
|
·
|
adverse medical events or side effects in treated patients; and
|
|
·
|
ineffectiveness of the drug candidates.
|
In addition, the FDA
may place a clinical trial on hold or terminate it if it concludes that subjects are being exposed to an unacceptable health risk.
Any drug is likely to produce some toxicity or undesirable side effects when administered at sufficiently high doses and/or for
a sufficiently long period of time. Unacceptable toxicity or side effects may occur at any dose level at any time in the course
of studies designed to identify unacceptable effects of a drug candidate, known as toxicological studies, or clinical trials of
drug candidates. The appearance of any unacceptable toxicity or side effect could bring us or regulatory authorities to interrupt,
limit, delay or abort the development of any of our drug candidates and could ultimately prevent approval by the FDA or foreign
regulatory authorities for any or all targeted indications.
Before receiving FDA
approval to market a product, we must demonstrate that the product is safe and effective for its intended use by submitting to
the FDA an NDA containing the pre-clinical and clinical data that have been accumulated, together with chemistry and manufacturing
and controls specifications and information, and proposed labeling, among other things. The FDA may refuse to accept an NDA for
filing if certain content criteria are not met and, even after accepting an NDA, the FDA may often require additional information,
including clinical data, before approval of marketing a product.
As part of the approval
process, the FDA must inspect and approve each manufacturing facility. Among the conditions of approval is the requirement that
a manufacturer’s quality control and manufacturing procedures conform to cGMP. Manufacturers must expend time, money and
effort to ensure compliance with cGMP, and the FDA conducts periodic inspections to certify compliance. It may be difficult for
our manufacturers or us to comply with the applicable cGMP and other FDA regulatory requirements. If we or our contract manufacturers
fail to comply, then the FDA will not allow us to market products that have been affected by the failure.
If the FDA grants approval,
the approval will be limited to those disease states, conditions and patient populations for which the product is safe and effective,
as demonstrated through clinical studies. Further, a product may be marketed only in those dosage forms and for those indications
approved in the NDA. Certain changes to an approved NDA, including, with certain exceptions, any changes to labeling, require approval
of a supplemental application before the drug may be marketed as changed. Any products that we manufacture or distribute pursuant
to FDA approvals are subject to continuing regulation by the FDA, including compliance with cGMP and the reporting of adverse experiences
with the drugs. The nature of marketing claims that the FDA will permit us to make in the labeling and advertising of our products
will be limited to those specified in an FDA approval, and the advertising of our products will be subject to comprehensive regulation
by the FDA. Claims exceeding those that are approved will constitute a violation of the Federal Food, Drug, and Cosmetic Act. Violations
of the Federal Food, Drug, and Cosmetic Act or regulatory requirements at any time during the product development process, approval
process, or after approval may result in agency enforcement actions, including withdrawal of approval, recall, seizure of products,
injunctions, fines and/or civil or criminal penalties. Any agency enforcement action could have a material adverse effect on our
business.
Should we wish to market
our products in countries other than the US, we must receive marketing authorization from the appropriate regulatory authorities.
The requirements governing the conduct of clinical trials, marketing authorization, pricing and reimbursement vary widely from
country to country. At present, companies are typically required to apply for foreign marketing authorizations at a national level.
However, within the EU, registration procedures are available to companies wishing to market a product in more than one EU member
state. Typically, if the regulatory authority is satisfied that a company has presented adequate evidence of safety, quality and
efficacy, then the regulatory authority will grant a marketing authorization. This regulatory approval process, however, involves
risks similar or identical to the risks associated with FDA approval discussed above, and therefore we cannot guarantee that we
will be able to obtain the appropriate marketing authorization for any product in any particular country. Our current development
strategy calls for us to seek marketing authorization for our drug candidates in countries other than the United States.
Failure to comply with
applicable laws and regulations would likely have a material adverse effect on our business. In addition, laws and regulations
regarding the manufacture and sale of new drugs are subject to future changes. We cannot predict the likelihood, nature, effect
or extent of adverse governmental regulation that might arise from future legislative or administrative action.
Organizational structure
Our wholly-owned subsidiary,
XTEPO, is an Israeli privately-held company incorporated in November 2009 for the execution of the Bio-Gal transaction and which
holds the exclusive license of the use patent of the rHuEPO drug for Multiple Myeloma.
Our wholly-owned subsidiary,
XTL Biopharmaceuticals, Inc. and its wholly-owned subsidiary XTL Development, Inc., are each incorporated in Delaware. Since November
2008, these companies have not been active.
Our subsidiary, InterCure
Ltd., is an Israeli public company, incorporated in November 1994. As of the date hereof, we hold approximately 54.72% of InterCure's
issued and outstanding ordinary shares.
Property, Plant and Equipment
Since August 2010 we
lease offices of approximately 255 square meters, in Herzliya, Israel. The basic lease period is for 36 months with an option for
an additional 24-month period. In April 2013 the company signed on the additional 24 month option as per the agreement until August
2015. In addition, the Company has the right to terminate the agreement after 12 months and/or upon introducing an alternative
tenant in its place, pursuant to approval of the landlord.
InterCure's listed
domicile is at 16 Hatidhar Street, Raanana 43652 Israel, at CFO Direct Ltd. InterCure Inc. operates out of its Manhattan offices
in New York. In May 2010, InterCure Inc. signed an office lease agreement for a period of three years. In May 2013, InterCure Inc.
signed a revised lease agreement for an additional 12 months. The monthly lease fees are approximately $1,000.
To our knowledge, there
are no environmental issues that affect our use of the properties that we lease.
ITEM 4A. UNRESOLVED STAFF COMMENTS
None.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the
following discussion and analysis in conjunction with our audited consolidated financial statements, including the related notes,
prepared in accordance with IFRS (International Financial Reporting Standards) for the years ended December 31, 2013, 2012 and
2011, and as of December 31, 2013 and 2012, contained in “Item 18. Financial Statements” and with any other selected
financial data included elsewhere in this annual report or incorporated by reference herein.
Selected Financial Data
-
The tables below present
selected financial data for the fiscal years ended as of December 31, 2013, 2012 and 2011 and as of December 31, 2013 and 2012.
We have derived this selected financial data from our audited consolidated financial statements, included elsewhere in this report
and prepared in accordance with IFRS issued by the IASB. You should read the selected financial data in conjunction with “Item
3. Key Information” and “Item 8. Financial Information” and “Item 18. Financial Statements.”
Consolidated Statements of Comprehensive Income:
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S dollars in thousands (except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
2,369
|
|
|
|
938
|
|
|
|
-
|
|
Cost of sales
|
|
|
(741
|
)
|
|
|
(380
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
1,628
|
|
|
|
558
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs
|
|
|
(113
|
)
|
|
|
(99
|
)
|
|
|
(158
|
)
|
Selling and marketing expenses
|
|
|
(1,691
|
)
|
|
|
(848
|
)
|
|
|
-
|
|
General and administrative expenses
|
|
|
(2,048
|
)
|
|
|
(2,769
|
)
|
|
|
(1,078
|
)
|
Impairment of intangible assets
|
|
|
(1,729
|
)
|
|
|
-
|
|
|
|
-
|
|
Other gains, net
|
|
|
1,059
|
|
|
|
802
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(2,894
|
)
|
|
|
(2,356
|
)
|
|
|
(1,224
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
|
61
|
|
|
|
60
|
|
|
|
24
|
|
Finance expenses
|
|
|
(35
|
)
|
|
|
(15
|
)
|
|
|
(7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income, net
|
|
|
26
|
|
|
|
45
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (losses) from investment in associate
|
|
|
(845
|
)
|
|
|
569
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that might be classified to profit or loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
108
|
|
|
|
114
|
|
|
|
-
|
|
Reclassification of foreign currency translation adjustments to Other gains, net
|
|
|
(221
|
)
|
|
|
-
|
|
|
|
-
|
|
Total other comprehensive income (loss)
|
|
|
(113
|
)
|
|
|
114
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year
|
|
|
(3,826
|
)
|
|
|
(1,628
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year attributable to:
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
|
(2,476
|
)
|
|
|
(1,390
|
)
|
|
|
(1,207
|
)
|
Non-controlling interests
|
|
|
(1,237
|
)
|
|
|
(352
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year attributable to:
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
|
(2,589
|
)
|
|
|
(1,276
|
)
|
|
|
(1,207
|
)
|
Non-controlling interests
|
|
|
(1,237
|
)
|
|
|
(352
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,826
|
)
|
|
|
(1,628
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (in US dollars)
|
|
|
(0.011
|
)
|
|
|
(0.006
|
)
|
|
|
(0.006
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of issued ordinary shares
|
|
|
223,605,181
|
|
|
|
217,689,926
|
|
|
|
201,825,645
|
|
Consolidated Statements of Financial Position Data:
|
|
As of December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and bank deposits
|
|
|
4,165
|
|
|
|
3,312
|
|
|
|
1,495
|
|
Working capital
|
|
|
3,870
|
|
|
|
2,143
|
|
|
|
955
|
|
Total assets
|
|
|
8,015
|
|
|
|
11,086
|
|
|
|
4,073
|
|
Long term liabilities
|
|
|
11
|
|
|
|
13
|
|
|
|
-
|
|
Total shareholders' equity
|
|
|
6,265
|
|
|
|
7,353
|
|
|
|
3,444
|
|
Non-controlling interests
|
|
|
520
|
|
|
|
2,071
|
|
|
|
-
|
|
Overview
We are a biopharmaceutical
company engaged in the acquisition and development of pharmaceutical products for the treatment of unmet medical needs, particularly
the treatment of SLE, Multiple Myeloma and Schizophrenia. Also, through our consolidated subsidiary, InterCure, we develop a home
therapeutic device for non-medicinal and non-invasive treatment of various diseases such as hypertension, heart failure, sleeplessness
and mental stress and market and sell a home therapeutic device for hypertension. To date, our revenues were generated only from
the medical device activity (since July 25, 2012) and we have not received approval for the sale of any of our drug candidates
in any market and, therefore, have not generated any commercial revenues from the sales of our drug candidates.
We were established
as a corporation under the laws of Israel in 1993, and commenced operations to use and commercialize technology developed at the
Weizmann Institute, in Rehovot, Israel. Since commencing operations, our activities have been primarily devoted to developing our
technologies and drug candidates, acquiring pre-clinical and clinical-stage compounds, raising capital, purchasing assets for our
facilities, and recruiting personnel. We are a development stage company. We have had no drug product sales to date and the sales
of our medical devices are as yet insufficient to generate operating income. Our major sources of working capital have been proceeds
from various private placements of equity securities, option and warrant exercises, our initial public offering, our placing and
open offer transaction, and private investments in public equities.
We have incurred negative
cash flow from operations each year since our inception and we anticipate incurring negative cash flows from operating activities
for the foreseeable future. We have spent, and expect to continue to spend, substantial amounts in connection with implementing
our business strategy, including our planned product development efforts, our clinical trials, our marketing efforts of our medical
devices and potential in-licensing and acquisition opportunities.
We started to generate
revenues in medical device activity in 2012 through our subsidiary, InterCure which we acquired on July 25, 2012 (InterCure has
been generating revenues for the sale of medical devices since 2000). Cost of sales is related to the sale of medical devices.
Our research and development
expenses in 2013, 2012 and 2011 primarily consisted of expenses related to the preparations for the rHuEPO drug clinical trial
development plan. As part of the preparations, the Company conducted research which includes collection of data relating to the
level of specific proteins in the blood of a group of patients with Multiple Myeloma, which will assist in focusing the Phase 2
clinical trial protocol. This collected research data will be integrated in the Phase 2 clinical trial. The costs of such
preparations comprise of, among other things, costs in connection with medical regulation, patent registration costs, medical consulting
costs and payments to medical centers. Additionally, we had expenses for the amortization of the exclusive right to examine a medical
technology in the field of the immune system in 2010 and 2011.
Our selling and marketing
expenses, which are wholly derived from our medical device operation through InterCure, consist primarily of advertising, mainly
direct/online advertising, salaries, sales promotions and fees. We expense our selling and marketing expenses as incurred.
Our general and administrative
expenses consist primarily of salaries, consultant fees, and related expenses for executive, finance and other administrative personnel,
professional fees, director fees and other corporate expenses, including investor relations, business development costs and facilities
related expenses. We expense our general and administrative expenses as incurred.
Our results of operations
include non-cash compensation expense as a result of the grants of XTL and InterCure stock options. Compensation expense for awards
of options granted to employees and directors represents the fair value of the award (measured using the Black-Scholes valuation
model) recorded over the respective vesting periods of the individual stock options. We expect a decrease in the non-cash compensation
in the future, primarily due to the fact that most expenses related to options granted in 2012 are recorded using the graded vesting
method (see details below).
For awards of options
and warrants to consultants and other third-parties, according to IFRS 2, the treatment of such options and warrants is the same
as employee options compensation expense (see note 2p to the consolidated financial statements). We record compensation expense
based on the fair value of the award at the grant date according to the Black-Scholes valuation model. According to the IFRS 2,
in non-performance-based options, the Company recognizes options expenses using the graded vesting method (accelerated amortization).
Graded vesting means that portions of a single option grant will vest on several dates, equal to the number of tranches. The Company
treats each tranche as a separate share option grant; because each tranche has a different vesting period, and hence the fair value
of each tranche is different. Therefore, under this method the compensation cost amortization is accelerated to earlier periods
in the overall vesting period.
Our planned clinical
trials will be lengthy and expensive. Even if these trials show that our drug candidates are effective in treating certain indications,
there is no guarantee that we will be able to record commercial sales of any of our product candidates in the near future or generate
licensing revenues from upfront payments associated with out-licensing transactions. In addition, we expect losses in our drug
development activity to continue as we continue to fund development of our drug candidates. As we continue our development efforts,
we may enter into additional third-party collaborative agreements and may incur additional expenses, such as licensing fees and
milestone payments. As a result, our periodical results may fluctuate and a period-by-period comparison of our operating results
may not be a meaningful indication of our future performance.
On November 21, 2012
we acquired from Teva its entire stake in Proteologics representing 31.35% of the share capital of Proteologics, which is accounted
for using the Equity method of accounting in accordance with International Accounting Standard 28
Investment in Associates
.
In 2012, Proteologics contributed to our results of operations a loss in the amount of approximately $144,000 which was offset
by a gain on bargain purchase in the amount of approximately $713,000, included in "Earnings from investment in associate"
in our statement of comprehensive income. In 2013, Proteologics' contribution to our results of operations amounted to approximately
$845,000, which was offset by a gain from the sale of our investment in Proteologics, effective on September 17, 2013, in the amount
of $1,051,000.
Results of Operations
Years Ended December 31, 2013 and 2012
Revenues.
Sales
for the years ended December 31, 2013 and 2012 totaled approximately $2,369,000 and $938,000, respectively, originating from the
subsidiary InterCure whose financial statements were consolidated starting July 25, 2012. The majority of InterCure's sales are
generated in the U.S., which for the year ended December 31, 2013, totaled approximately $2,076,000. From the date of consummation
of the transaction (July 25, 2012) through December 31, 2012, sales in the U.S. totaled approximately $766,000.
Cost of Sales
.
Cost of sales for the years ended December 31, 2013 and 2012, originating entirely from InterCure, totaled approximately $741,000
and $380,000, respectively (or $529,000 and $225,000, respectively, excluding the amortization of identifiable intangible assets
and other purchase price allocation (“PPA”) adjustments).
Gross profit.
Gross profit derives entirely from InterCure whose average gross margin excluding amortization of identifiable intangible assets
ranges between 76% and 78%. The percentage of gross profit out of revenues is affected by the mix of direct/online sales which
provide relatively higher gross profit margins and sales by resellers which generally provide lower gross profit margins. For the
years ended December 31, 2013 and 2012, gross margin (including amortization of identifiable intangible assets related to technology
and other PPA adjustments totaling approximately $212,000 and $155,000) was 69% and 60%, respectively. Difference in gross margin
between 2013 and 2012 is due to amortization of identifiable intangible assets and other PPA adjustments in 2012, as gross margin
in the same periods, excluding such adjustments was approximately 78% and 76%, respectively.
Research and Development
Expenses
. Research and development expenses in the years ended December 31, 2013 and 2012 totaled approximately $113,000 and
$99,000, respectively. Research and development expenses are comprised mainly of expenses related to preparations for initiating
the phase 2 clinical trials of the rHuEPO drug designed to treat cancer patients with Multiple Myeloma and include, among other
things, research costs incurred in tracing blood proteins in Multiple Myeloma patients, costs in connection with medical regulation,
clinical insurance costs and other medical consulting costs. The increase in expenses in 2013 compared to 2012 is mainly due to
expenses related to the Company's rHuEPO and SAM-101 drugs. Research and development expenses in InterCure for the year ended December
31, 2013 totaled approximately $30,000, and are mainly employee-related expenses. Research and development expenses relating to
InterCure from the date of consummation of the transaction through December 31, 2012 were immaterial.
Selling and Marketing
Expenses.
Selling and marketing expenses in the years ended December 31, 2013 and 2012 totaled approximately $1,691,000 and
$848,000, respectively, originating entirely from InterCure whose financial statements were consolidated as of July 25, 2012. Selling
and marketing expenses in the years ended December 31, 2013 and 2012 include advertising expenses (mainly direct/online advertising
expenses) totaling approximately $1,067,000 and $415,000, respectively, expenses relating to a service agreement with Giboov of
approximately $300,000 and $77,000, respectively, and share-based payment expenses of $132,000 for options granted to Giboov in
2012, which were fully reversed in 2013 due to termination of the Giboov agreement.
General and Administrative
Expenses
. General and administrative expenses for the years ended December 31, 2013 and 2012 totaled approximately $2,048,000
and $2,769,000, respectively (approximately $1,329,000 and $2,448,000 without InterCure). The decrease in 2013 compared to 2012
(without InterCure) is mainly due to a $1.1 million decrease in share-based payments to directors, service providers and employees,
originating from lower stock option grants in 2013, as well as reversal of expenses due to forfeitures of stock options by a Director
who resigned from the Company. General and administrative expenses attributable to InterCure for the year ended December 31, 2013
totaled approximately $719,000. For the period from July 25, 2012 through December 31, 2012, such expenses incurred by InterCure
totaled approximately $321,000 and consisted mainly of salary expenses, professional service fees, rent expenses, insurance costs
and share-based payments to directors and employees.
Impairment of intangible
assets
. Impairment of intangible assets originates from identifiable intangible assets recognized in the purchase of InterCure
on July 25, 2012. As the Company identified indicators of impairment with regard to InterCure, namely a significant decline in
InterCure's share price on the TASE, it hired the services of an external expert in order to establish whether or not such an impairment
charge should be recorded. The total impairment loss in the approximate amount of $1,729,000 was allocated pro rata to the Technology
and Brand Name assets in the amounts of approximately $1,372,000 and $357,000, respectively.
Other gains (losses),
net.
Other gains in the year ended December 31, 2013 totaled approximately $1,059,000, primarily originating from a gain from
the sale of the Company's investment in Proteologics which totaled approximately $1,051,000. In the year ended December 31, 2012,
the other gains in the amount of $802,000 were mainly due to a bargain purchase in connection with the InterCure transaction totaling
$795,000. Bargain purchase gain is the excess of the fair value of the investment acquired over the fair value of the consideration
provided for such purchase in accordance with IFRS 3R, "Business Combinations (Revised)" ("IFRS3R"), as further
detailed below.
Finance income,
net
. Finance income, net for the years ended December 31, 2013 and 2012 totaled approximately $26,000 and $45,000, respectively.
The decrease in finance income in 2013 compared to 2012 derives mainly from lower interest income on short-term bank deposits whose
carrying amount during 2012 was significantly higher compared to 2013 as a result of the capital raising completed by the Company
in March 2012 in a private placement and from the exercise of warrants (series 2) in the period. This decrease was partially offset
by an increase in finance income from exchange rate differences, owing to larger NIS-denominated balances originating from proceeds
from the sale of the investment in Proteologics.
Earnings (losses)
from investment in associate.
Earnings (losses) from investment in associate totaling approximately ($845,000) and $569,000
in the years ended December 31, 2013 and 2012, respectively, arose from the Company's investment in Proteologics which was accounted
for according to the equity method. During 2013, the Company recognized such losses due to operational losses in Proteologics.
From the acquisition date of November 21, 2012 through December 31, 2012, the Company's share in Proteologics' losses totaled approximately
$144,000. On the date of acquisition, the Company recorded a gain from a bargain purchase totaling approximately $713,000.
“Income Taxes”
We had no income tax expense for the years ended December 31, 2013 and 2012 due to losses incurred and we did not recognize any
deferred tax benefits, since it is not "more likely than not" that we will be able to generate profits in the future
to realize the deferred taxes.
Years Ended December 31, 2012 and 2011
Revenues.
Sales
in the year ended December 31, 2012 totaled approximately $938,000, originating from the subsidiary InterCure whose financial statements
were consolidated starting July 25, 2012. InterCure's main sales are in the U.S. and the UK, which totaled approximately $766,000
and $167,000 respectively, from the date of consummation of the transaction (July 25, 2012) through December 31, 2012. We had no
sales in 2011.
InterCure's sales in
the year ended December 31, 2012 (including sales prior the acquisition by us in July 25, 2012) totaled approximately $2,267,000,
compared to approximately $3,171,000 in the year ended December 31, 2011.
Cost of Sales
.
Cost of sales for the year ended December 31, 2012 totaled approximately $380,000 (or $225,000 excluding the amortization of identifiable
intangible assets and other PPA adjustments). We had no cost of sales for the year ended December 31, 2011 as we did not generate
revenues in that year.
Gross profit.
Gross profit derives entirely from InterCure whose average gross margin ranges between 74% and 78%. The percentage of gross profit
out of revenues is affected by the mix of direct/online sales which provide relatively higher gross profit margins and sales by
resellers which generally provide lower gross profit margins. The gross profit for the year ended December 31, 2012 (including
amortization of identifiable intangible assets related to technology and other PPA totaling approximately $ 155,000) was 60%.
The gross margin in the period, excluding the amortization of identifiable intangible assets related to technology and other PPA
adjustments, was approximately 76%. We had no gross profit for the year ended December 31, 2011 as we did not generate revenues
in that year.
Research and Development
Costs
. Research and development expenses in the year ended December 31, 2012 totaled approximately $99,000, compared to approximately
$158,000 in 2011. Research and development expenses are comprised mainly from expenses related to preparations for initiating the
phase 2 clinical trial of the rHuEPO drug designed to treat cancer patients with Multiple Myeloma and include, among others, research
costs incurred in tracing blood proteins in Multiple Myeloma patients, costs in connection with medical regulation, clinical insurance
costs and other medical consulting costs. The decrease in expenses compared to last year is mainly due to the termination of the
exclusive right to examine a medical technology relating to the immune system in late 2011. Research and development expenses relating
to InterCure from the date of consummation of the transaction through December 31, 2012 were immaterial.
Selling and Marketing
Expenses.
Sales and marketing expenses in the year ended December 31, 2012 totaled approximately $848,000, originating entirely
from InterCure whose financial statements were consolidated with ours as of July 25, 2012. We measure "average contribution"
as the ratio between gross profit less direct/online advertising expenses divided by direct/online advertising expenses. Selling
and marketing expenses include advertising expenses totaling approximately $415,000 (mainly direct/online advertising expenses)
and gross profit amounted to approximately $713,000 (net of amortization of identifiable intangible assets and other PPA), resulting
in an average contribution of 72%. Selling and marketing expenses also include expenses relating to a service agreement signed
with Giboov of approximately $77,000 and share-based payment of $132,000 for options granted to Giboov. We had no sales and marketing
expenses in 2011.
General and Administrative
Expenses
. General and administrative expenses for the year ended December 31, 2012 totaled approximately $2,769,000 compared
to approximately $1,078,000 for the year ended December 31, 2011. The increase is mainly due to an increase in share-based payments
to directors, service providers and employees and expenses related to service providers including, among others, legal, professional
and technological consulting fees in connection with the InterCure transaction and filing an application for relisting the ADRs
on Nasdaq indicated above. General and administrative expenses attributable to InterCure for the period from the date of consummation
of the transaction through December 31, 2012 totaled approximately $321,000 and consist mainly of salary expenses, professional
service fees, rent expenses, insurance costs and share-based payments to directors and employees.
Other gains (losses),
net.
Other gains in the year ended December 31, 2012 totaled approximately $802,000, primarily originating from a gain from
a bargain purchase in connection with the InterCure transaction totaling $795,000. Bargain purchase gain is the excess of the fair
value of the investment acquired over the fair value of the consideration provided for such purchase in accordance with IFRS 3R,
"Business Combinations (Revised)" ("IFRS3R"), as further detailed below. In the year ended December 31,
2011, we derived other gains totaling approximately $12,000.
Finance income,
net
. Finance income, net for the years ended December 31, 2012 and 2011 totaled approximately $45,000 and $17,000, respectively.
The increase in finance income in 2012 compared to 2011 derives mainly from interest income on short-term bank deposits whose carrying
amount during 2012 was significantly higher compared to 2011 as a result of the capital raising we completed in March 2012 in a
private placement and from the exercise of warrants (series 2) in the period.
Earnings from investment
in associate.
Earnings from investment in associate totaling approximately $569,000 for the year ended December 31, 2012, arise
from our investment in Proteologics which is accounted for according to the equity method. As at December 31, 2012, we held approximately
31.24% of Proteologics' issued and outstanding share capital. On the date of acquisition, we recorded a gain from a bargain purchase
totaling approximately $713,000. From the acquisition date November 21, 2012 through December 31, 2012, our share in Proteologics'
losses totaled approximately $144,000. There were no earnings from investment in associate in 2011.
“Income Taxes”
We had
no income tax expense for the years ended December 31, 2012 and 2011 due to losses incurred and we did not recognize any deferred
tax benefits, since it is not "more likely than not" that we will be able to generate profits in the future to realize
the deferred taxes.
Critical Accounting Policies
Basis of presentation
of the financial statements.
The financial statements of the Company and its subsidiaries ("the Group") as of December
31, 2013 and for each of the three years in the period ended December 31, 2013 have been prepared in accordance with International
Financial Reporting Standards which are standards and interpretations issued by the International Accounting Standards Board ("IFRS").
The significant accounting
policies described below are consistent with those of all periods presented, unless indicated otherwise.
The preparation of
financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires the Company’s
management to exercise its judgment in the process of applying the Group's accounting policies. The areas that involve judgment
which has significant effect or complexity or where assumptions and estimates are significant to the consolidated financial statements
are disclosed in Note 3 to the annual consolidated financial statements. Actual results could significantly differ from the estimates
and assumptions used by the Group's management.
The Company analyzes
the expenses recognized in the statement of comprehensive income by classification based on the function of expense.
We define critical
accounting policies as those that are reflective of significant judgments and uncertainties and which may potentially result in
materially different results under different assumptions and conditions. In applying these critical accounting policies, our management
uses its judgment to determine the appropriate assumptions to be used in making certain estimates. These estimates are subject
to an inherent degree of uncertainty. Our critical accounting policies include the following:
Subsidiaries consolidation and business
combinations
The consolidated financial
statements include the accounts of the Company and entities controlled by the Company. Control exists when the Company has the
power over the investee, has exposure, or rights, to variable returns from involvement in the investee, and has the ability to
use its power over the investee to affect its returns.
The Company examines
whether it controls another entity even when it does not hold more than 50% of the voting rights, but can control the entity's
financial and operating policies by de-facto control. De-facto control can be created under circumstances in which the ratio of
the Company's voting rights in the entity to the percentage and dispersion of the holdings of the other shareholders grants the
Company the power to control the entity's financial and operating policies.
Subsidiaries are fully
consolidated starting from the date on which control therein is attained by the Company. Their consolidation ceases when such control
is discontinued.
The Company's accounting
treatment of business combinations uses the acquisition method. The consideration transferred for the acquisition of a subsidiary
(the “Acquiree”) is calculated as the total of fair values of the assets transferred by the Company, the liabilities
incurred against the Acquiree's previous owners and the equity rights issued by the Company. The transferred consideration includes
the fair value of each asset or liability arising from a contingent consideration arrangement. The acquisition related costs are
recognized in profit or loss as incurred. Identifiable assets acquired and liabilities and contingent liabilities assumed by the
Company in a business combination (excluding certain exceptions prescribed in IFRS 3R, "Business Combinations (Revised)"
(“IFRS3R”) are initially measured at fair value on the acquisition date. For each business combination, the Company
decides whether to recognize non-controlling interests in the Acquiree which represent existing ownership rights and entitle their
holders to a relative portion of the entity's net assets upon liquidation at their fair value or at the relative portion of the
existing ownership instruments in amounts recognized for the Acquiree's net identifiable assets. This decision is individually
made for each business combination. All the other components of non-controlling interests are measured at fair value on the acquisition
date unless another measurement basis is required by IFRS.
The excess of the overall
amount of the transferred consideration, the amount of any non-controlling interests in the Acquiree, and the fair value of any
previous equity rights in the Acquiree on the acquisition date in excess of the net amount of identifiable assets acquired and
liabilities assumed on the acquisition date, all measured as above, is recognized as goodwill.
In the event that the
net amount of identifiable assets acquired and liabilities assumed on the acquisition date exceeds the overall amount of the transferred
consideration, the amount of any non-controlling interests in the Acquiree, and the fair value of any previous equity rights in
the Acquiree on the acquisition date as discussed above, the difference is recognized directly in profit or loss on the acquisition
date.
Intercompany balances
and transactions, including revenues, expenses and dividends in respect of transactions between the Group companies, are eliminated.
Gains and losses arising from intra-group transactions that have been recognized as assets (such as inventories and property, plant
and equipment) are also eliminated. Such intra-group losses may point to the impairment of assets which is tested and accounted
for as specified in g below.
Transactions with non-controlling interests which do not
result in loss of control
Transactions with non-controlling
interests in subsidiaries which do not result in loss of control in the subsidiaries are accounted for as transactions with owners.
In these transactions, the difference between the fair value of any consideration paid or received and the amount of adjustment
of the non-controlling interests to reflect the changes in their relative rights in the subsidiaries is directly recognized in
equity and attributed to the equity holders of the parent.
Associate
An associate is an
entity over which the Group exercises significant influence, but not control, which is usually expressed in holding 20%-50% of
the voting rights. The investment in an associate is presented using the equity method of accounting. According to the equity method
of accounting, the investment is initially recognized at cost and its carrying amount varies to the extent that the Group recognizes
its share of the associate's earnings or losses from the acquisition date.
The Group's share in
the earnings or losses of associates after the acquisition date is carried to profit or loss and its share in the other comprehensive
income movements after the acquisition date is carried to other comprehensive income against the carrying amount of the investment.
Intangible assets
|
1.
|
Brand name and technology
|
Brand name and technology acquired
in a business combination are recognized at fair value on the acquisition date. Brand name and technology have a finite useful
life and are presented at cost net of accumulated amortization and impairment losses. The amortization is calculated using the
straight-line method over the expected useful life (9-10 years).
Acquired licenses to use computer
software are capitalized based on costs incurred in acquiring the specific software and preparing it for use. These costs are amortized
using the straight-line method over the estimated useful life (five years). Costs relating to computer software upkeep are recognized
as expenses as incurred.
|
3.
|
Exclusive technology testing right
|
An acquired exclusive immune
system technology testing right has a finite life of 15 months in effect from September 1, 2010 and is amortized using the straight-line
method over its useful life. On November 30, 2011, the amortization of this right was concluded. See details in Note 14d to the
consolidated financial statements.
|
4.
|
Unamortized intangible assets (licenses and patent rights)
|
The amortization of an asset
on a straight-line basis over its useful life begins when the development procedure is completed and the asset is available for
use. These assets are reviewed for impairment once a year or whenever there are indicators of a possible impairment, in accordance
with the provisions of IAS 36, "Impairment of Assets".
|
5.
|
Research and development
|
Research expenditures are recognized
as expenses when incurred. Costs arising from development projects are recognized as intangible assets when the following criteria
are met:
|
·
|
it is technically feasible to complete the intangible asset so that it will be available for use;
|
|
·
|
management intends to complete the intangible asset and use or sell it;
|
|
·
|
there is an ability to use or sell the intangible asset;
|
|
·
|
it can be demonstrated how the intangible asset will generate probable future economic benefits;
|
|
·
|
adequate technical, financial and other resources to complete the development and to use or sell
the intangible asset are available; and
|
|
·
|
the expenditure attributable to the intangible asset during its development can be reliably measured.
|
Other development expenditures
that do not meet these criteria are recognized as an expense when incurred. Development costs that were previously recognized as
an expense are not recognized as an asset in a later period. During the reporting period, the Group did not capitalize development
costs to intangible assets.
Impairment of non-financial assets
Intangible assets which
are not yet available for use are not depreciated and impairment in their respect is tested every year. Depreciable assets are
reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An
impairment loss is recognized for the amount by which the asset's carrying amount exceeds its recoverable amount. The recoverable
amount is the higher of an asset's fair value less costs to sell and value in use. For the purposes of assessing impairment, assets
are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). Non-financial
assets that sustained impairment are reviewed for possible reversal of the impairment at each date of the statement of financial
position.
As for testing impairment of acquired intangible
assets, see
intangible assets
above.
Inventories
Inventories are measured
at the lower of cost and net realizable value. The cost of inventories comprises costs of purchase and costs incurred in bringing
the inventories to their present location and condition. Net realizable value is the estimated selling price in the ordinary course
of business less the estimated costs of completion and the estimated selling costs. The Company periodically evaluates the condition
and age of inventories and makes provisions for slow moving inventories accordingly.
Cost of inventories
is determined as follows:
Raw materials - at
cost of purchase using the "first-in, first-out" method.
Purchased merchandise
and products - using the "first-in, first-out" method.
Share capital
The Company's Ordinary
shares are classified as share capital. Incremental costs directly attributable to the issuance of new shares or options are shown
in equity as a deduction, net of tax, from the issuance proceeds.
When we purchase Company
shares (treasury shares), the consideration paid, including incremental costs directly attributable to the purchase (less the effect
of taxes on income), is deducted from the equity attributable to equity holders of the parent until the shares are eliminated or
reissued. When these shares are reissued in subsequent periods, the consideration received, less incremental costs directly attributable
to the transaction and less the effect of taxes on income, is included in equity with allocation to the equity attributable to
equity holders of the parent and non-controlling interests.
Share-based payment
We operate a number
of share-based payment plans to employees and to other service providers who render services that are similar to employees' services
that are settled with the Company’s equity instruments. In this framework, we grant employees, from time to time, and at
our sole discretion, options to purchase our common shares. The fair value of services received from employees in consideration
of the grant of options is recognized as an expense in the statement of comprehensive income (loss) and correspondingly carried
to equity. The total amount recognized as an expense over the vesting term of the options (the term over which all pre-established
vesting conditions are expected to be satisfied) is determined by reference to the fair value of the options granted at grant date,
except the effect of any non-market vesting conditions.
Non-market vesting
conditions are included in the assumptions used in estimating the number of options that are expected to vest. The total expense
is recognized over the vesting period, which is the period over which all of the specified vesting conditions of the share-based
payment arrangement are to be satisfied.
In each reporting date,
the Company revises its estimates of the number of options that are expected to vest based on the non-market vesting conditions
and recognizes the impact of the revision to original estimates, if any, in the statement of comprehensive income (loss) with a
corresponding adjustment in equity.
When the options are
exercised, the Company issues new shares. The proceeds net of any directly attributable transaction costs are credited to share
capital (nominal value) and share premium.
Share-based payment
transactions in which the Company acquired assets as consideration for the Company's equity instruments are measured at the value
of the assets acquired.
Provisions
A provision in accordance
with IAS 37 is recognized when we have a present obligation (legal or constructive) as a result of past events, likely to be required
to use economic resources to settle the obligation and can be reliably estimated. The group recognizes a provision for warranty
when the product is sold to the customer or when the service is provided to the customer. Initial recognition is based on past
experience. The estimated provision is re-tested every year.
Revenue recognition
Revenues are recognized
in profit or loss when the revenues can be measured reliably, it is probable that the economic benefits associated with the transaction
will flow to the Company, and the costs incurred or to be incurred in respect of the transaction can be measured reliably. Revenues
are measured at the fair value of the consideration received less any trade discounts, volume rebates and returns.
Following are the specific
revenue recognition criteria which must be met before revenue is recognized:
Revenues from sale
of goods to retail customers:
Revenues from the sale
of goods are recognized when all the significant risks and rewards of ownership of the goods have passed to the buyer and the seller
no longer retains continuing managerial involvement. The delivery date to the customer is usually the date on which ownership passes.
Revenues from sale
of goods to distributors:
InterCure sells its
products to distributors as well. Revenues from such sales are recognized when InterCure or its subsidiaries deliver the goods
to the distributor, when sales channel and selling price are at the distributor's sole discretion, and when there are no ongoing
obligations to prevent the distributor from receiving the goods. Revenue is only recognized when goods were delivered to the designated
site, risks of loss and damage are transferred to the distributor and distributor had received the goods in accordance with the
sales agreement, conditions for receipt of goods had expired or InterCure holds objective evidence that goods receipt criteria
had been met.
Sales do not include a finance component,
as they are made with a 60 days credit period, considered as consistent with the market in which InterCure operates.
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS
Estimates and judgments
are continually evaluated and are based on historical experience and other factors, including expectations of future events that
are believed to be reasonable under the circumstances.
|
1.
|
Critical accounting estimates and assumptions
|
The Company makes estimates
and assumptions concerning the future. The resulting accounting estimates will seldom equal the related actual results. The estimates
and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities
within the next financial year are addressed below.
|
(i)
|
In determining the fair value of assets acquired in share-based payment transactions and in testing
impairment of these research and development assets, the Company's management is required to estimate, among other things, the
probable endpoints of trials conducted by the Company, the commercial technical feasibility of the development and the resulting
economic benefits. Actual results and estimates to be made in the future may significantly differ from current estimates.
|
|
(ii)
|
The Company is required to determine at the end of each reporting period whether there is any indication
that an asset may be impaired. If indicators for impairment are identified, the Company estimates the assets' recoverable amount,
which is the higher of an asset's fair value less costs to sell and its value-in-use. The value-in-use calculations require management
to make estimates of the projected future cash flows. Determining the estimates of the future cash flows is based on management’s
past experience and best estimate for the economic conditions that will exist over the remaining useful economic life of the asset.
|
|
·
|
Share-based payments - in evaluating the fair value and the recognition method of share-based payment,
the Company's management is required to estimate, among other things, different parameters included in the computation of the fair
value of the options and the Company's results and the number of options that will vest. Actual results and estimates to be made
in the future may significantly differ from current estimates.
|
|
2.
|
Judgments that have a critical effect on the adoption of the entity's accounting policies
|
|
·
|
The existence of control over InterCure - the Company’s management has estimated the degree
of effect it has in InterCure and has determined that it is able to govern InterCure's financial and operating policies. As of
the date hereof, the Company holds approximately 54.72% of InterCure's issued and outstanding share capital.
|
Impact of Inflation and Currency Fluctuations
We generate most of
our revenues and hold most of our cash, cash equivalents and bank deposits in US dollars. While a substantial amount of our operating
expenses are in US dollars, we incur a portion of our expenses in New Israeli Shekels. In addition, we also pay for some of our
services and supplies in the local currencies of our suppliers. As a result, we are exposed to the risk that the US dollar will
be devalued against the New Israeli Shekel or other currencies, and as a result our financial results could be harmed if we are
unable to protect against currency fluctuations in Israel or other countries in which services and supplies are obtained in the
future. Accordingly, we may enter into currency hedging transactions to decrease the risk of financial exposure from fluctuations
in the exchange rates of currencies. The Company's treasury's risk management policy, excluding InterCure, is to hold NIS-denominated
cash and cash equivalents and short-term deposits in the amount of the anticipated NIS-denominated liabilities for nine to twelve
consecutive months from time to time in line with the directives of the Company's Board. InterCure focuses on actions to reduce
to a minimum the negative effects arising from this risk and therefore holds cash and cash equivalents in currencies in which it
operates, in accordance with management's assessments. These measures, however, may not adequately protect us from the adverse
effects of inflation in Israel. In addition, we are exposed to the risk that the rate of inflation in Israel will exceed the rate
of devaluation of the New Israeli Shekel in relation to the US Dollar or that the timing of any devaluation may lag behind inflation
in Israel. Future activities may lead us to perform a clinical trial in Israel, which may lead us to reassess our use of the US
dollar as our functional currency.
As of December 31,
2013, if our functional currency had weakened by 10% against the NIS with all other variables remaining constant, post-tax loss
for the year would have been approximately $157,000 higher (2012 - post-tax loss approximately $89,000 lower; 2011 - post-tax loss
approximately $30,000 higher), mainly as a result of exchange rate changes on translation of other accounts receivable, net and
exchange rate changes on NIS-denominated cash and cash equivalents and short-term deposits. Loss was more sensitive to fluctuations
in the exchange rate in relation to the NIS in 2013 than in 2012 mainly due to an increase in NIS-denominated cash and receivable
balances related to proceeds from the sale of the Company’s investment in Proteologics, late in the third quarter of 2013.
Governmental Economic, Fiscal, Monetary
or Political Policies that Materially Affected or Could Materially Affect Our Operations
The income of the Company
is subject to corporate tax at the regular rate; the guidance of the amendment to the Israeli Income Tax Ordinance, 2005 from August
2005 prescribes a gradual reduction in the corporate tax rates and the resulting corporate tax rates starting 2009 are as follows:
2009 - 26% and 2010 and thereafter - 25%.
On July 14, 2009,
the “Knesset” (Israeli Parliament) passed the Law for Economic Efficiency (Amended Legislation for Implementing the
Economic Plan for 2009 and 2010), 2009, which prescribes, among other things, an additional gradual reduction in the corporate
tax rates starting 2011 to the following tax rates: 2011 - 24%, 2012 - 23%, 2013 - 22%, 2014 - 21%, 2015 - 20%, 2016 and thereafter
- 18%.
In December 2011, following
the enactment of the Law for the Changing the Tax Burden (Legislative Amendments), 2011 (hereafter - "Tax Burden Distribution
Law"), the phased reduction in the corporate tax was eliminated, and corporate tax rate in 2012 and thereafter was set to
25%.
On August 5, 2013,
the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for 2013-2014), 2013 (the “Law”)
was published in the Government's records. The Law prescribes, among other things, from the 2014 tax year and thereafter, an increase
in the Israeli corporate tax rate to 26.5% (instead of 25%).
As of December 31,
2013, XTL Biopharmaceuticals Ltd. did not have any taxable income, except for a capital gain from the sale of the investment in
Proteologics, which was offset against capital loss carryforwards and current operating losses. As of December 31, 2013, our net
operating loss carry forwards for Israeli tax purposes registered on behalf of XTL Biopharmaceuticals Ltd. amounted to approximately
$28 million. Under Israeli law, these net-operating losses may be carried forward indefinitely and offset within XTL Biopharmaceuticals
Ltd only, against future taxable income, including capital gains from the sale of assets used in the business, with no expiration
date. Also, InterCure has carryforward business losses and capital losses which total approximately $17 million as of December
31, 2013.
In order to obtain
tax exemption for the share swap transaction with Bio-Gal pursuant to Sections 104 and 103 of the Israeli Income Tax Ordinance
(Revised), 1961, we signed an agreement with the Israeli Tax Authority on July 15, 2010. Below is the summary of the principal
conditions for the share swap and the transfer of the intangible asset:
|
1.
|
The balance of the Company's business losses and capital losses for tax purposes was reduced to
approximately NIS 80 million (approximately $ 23 million) and approximately NIS 0.7 million (approximately $ 0.2
million), respectively. This item is not to derogate from the Tax Assessing Officer's authority to establish that the balance of
losses is actually lower than the abovementioned amounts.
|
|
2.
|
Any losses incurred by the Company prior to the share swap, after their reduction as discussed
in paragraph 1 above, will not be offset against any income originating from Xtepo (the transferred company) or against a capital
gain from the sale of shares of Xtepo.
|
|
3.
|
Xtepo shareholders will not be allowed to sell their shares in the Company for a period of two
years from the end of the year of completion of the transaction (“the Lock-up Period”), subject to any changes in legislation.
|
|
4.
|
The Company and Xtepo both undertake to maintain their main economic activity as it was prior to
the transaction during the Lock-up Period.
|
|
5.
|
The Company will not be permitted to sell its holdings in Xtepo for the duration of the Lock-up
Period.
|
The Lock-up
Period ended on December 31, 2012.
It is indicated that
the guidance to Sections 104 and 103 to the Israeli Income Tax Ordinance, which deal with restructuring and mergers, impose statutory
limitations and various conditions on the entities participating in the change in structure/merger, among other things, restrictions
on dilution of holdings from raising by a prospectus or by private placements. The summary of the principles detailed above does
not constitute a substitute to the overall articles.
Additionally, on January
1, 2013, Xtepo shareholders decided to engage in a new voluntary lock-up agreement ("New Lock-Up Agreement") for an additional
period of 3 years ("New Restriction Period"), according to which selling restrictions shall apply to the shares held
by them. Hereunder are the principle restrictions regarding the quantities eligible for sale during the agreement period:
|
1.
|
During the first year of the New Restriction Period (starting on January 1, 2013 up to December
31, 2013) 15% of the total shares held by Xtepo shareholders shall be eligible for sale in a manner that every month each shareholder
shall be entitled to sell up to 1.25% (15%*1/12) of the total restricted shares.
|
|
2.
|
During the second year of the New Restriction Period (starting on January 1, 2014 up to December
31, 2014) shares that constitute 25% of the total amount of shares held by Xtepo shareholders shall be eligible for sale in a manner
that every month each shareholder shall be entitled to sell up to 2.08333% (25%*1/12) of the total restricted shares.
|
|
3.
|
During the third year of the New Restriction Period (starting on January 1, 2015 up to December
31, 2015) the remaining shares held by Xtepo shareholders shall be eligible for sale in a manner that every month each shareholder
shall be entitled to sell up to 5% (60%*1/12) of the total restricted shares.
|
The New Lock-up Agreement
terminates upon the occurrence of one of the following events: (1) the end of the New Restriction Period as defined above; (2)
the shareholders receipt of written notification from the Trustee that the Trustee wishes to terminate their position under the
New Lock-Up Agreement within 30 days, and the Company has not found a replacement trustee within the said period; or (3) a majority
of the shareholders who are party to the New Lock-Up Agreement agree to terminate the agreement.
Since April 7, 2009,
we have not had a “permanent establishment” or activity in the US, and our subsidiaries do not perform any activities
in the US. Our board of directors consists of a majority of Israeli residents and our management is domiciled in Israel.
B. Liquidity and Capital Resources
We have financed our
operations from inception primarily through various private placement transactions, our initial public offering, a placing and
open offer transaction, option and warrant exercises, and private investments in public equities. As of December 31, 2013, we had
received net proceeds of approximately $80.2 million from various private placement transactions, including net proceeds of approximately
$1.5 million from the Bio-Gal transaction in August 2010, net proceeds of approximately $45.7 million from our initial public offering
in September 2000, net proceeds of approximately $15.4 million from the 2004 placing and open offer transaction, net proceeds of
approximately $1.75 million from our public offering on TASE in March 2011 and proceeds of approximately $4.0 million from the
exercise of options and warrants.
As of December 31,
2013, we had approximately $4.2 million in cash, cash equivalents, and short-term bank deposits (approximately $3.9 million excluding
cash in InterCure), an increase of $0.9 million ($1.6 million excluding cash in InterCure) from December 31, 2012.
Cash flows used in
operating activities for the year ended December 31, 2013 totaled approximately $2.5 million, compared to cash flows used in operating
activities of approximately $1.5 million for the year ended December 31, 2012. InterCure's share in the cash flows used in operating
activities in the years ended December 31, 2013 and 2012 totaled approximately $1 million and $0.4 million, respectively. The increase
in cash used in operating activities (excluding InterCure) compared to the corresponding period last year mainly arises from payments
made in the period to professional service providers and the payment of bonuses to officers.
Cash flows provided
by (used in) investing activities in the year ended December 31, 2013 totaled approximately $3.3 million compared to cash flows
provided by (used in) investing activities of approximately $1.2 million in the previous year. The changes between the periods
mostly reflect the sale of the investment in an associate and the movement in short-term deposits in the periods.
Cash flows provided
by financing activities in the year ended December 31, 2013 totaled approximately $0.3 million, originating from the sale of treasury
shares by InterCure and the exercise of warrants (series 2) and non-marketable options in the period. Cash flows provided by financing
activities in the year ended December 31, 2012 totaled approximately $4.2 million, originating from the private placement of March
2012 and the exercise of warrants (series 2).
Continuation of our
current operations is dependent upon the generation of revenues including revenues from our medical device activity through our
consolidated subsidiary InterCure, or additional financial resources through agreements for the monetization of our rHuEPO for
Multiple Myeloma, SAM-101 for Schizophrenia, hCDR1 for Lupus or through external financing. The Company has no revenues from drug
development operations at this stage and it is dependent on external financing sources. The Company has incurred continuing losses
and its entire income at this stage originates from InterCure, a subsidiary which was consolidated for the first time in the 2012
financial statements (following the completion of the transaction of July 2012, see also Note 5 to the consolidated financial statements
for the year ended December 31, 2013). In the opinion of the Company's management and based on its business plans, the balances
of cash and cash equivalents with the balances of short-term deposits will enable the Company to fund its activities through at
least the fourth quarter of 2015. However, the actual amount of cash the Company will need to fund its operations is subject to
many factors, including, but not limited to, the timing, design and execution of the clinical trials of its existing drug candidates,
any future projects which may be in-licensed or any other business development activities. For example, changing circumstances
and/or acquisition of new technologies may cause the Company to consume capital significantly faster than management's current
anticipation and the Company may need to spend more money than currently expected because of, among other things, circumstances
beyond its control. InterCure has had recurring losses and presently does not have sufficient cash and other resources to meet
its future plans beyond July 2015.
If InterCure is unsuccessful in raising additional financing, it may need to curtail
or discontinue operations.
The Company will incur
additional losses in 2014 from research and development activities, examination of additional technologies and from current operation
which will be reflected in negative cash flows from operating activities. Accordingly, in order to complete the clinical trials
to bring a product to market, the Company will be required to raise additional cash in the future through the issuance of securities.
However, if the Company is not able to raise additional capital at acceptable terms, the Company may be required to exercise tradable
securities held by it or reduce operations or sell or out-license to third parties some or all of its technologies.
C. Research and Development, Patents
and Licenses
Research and development
costs in 2013, 2012 and 2011 substantially derived from costs related to the preparations for the rHuEPO drug clinical trial development
plan. As part of those preparations, the Company conducted a study which consists of collecting preliminary data on the existence
of specific proteins in the blood of a group of Multiple Myeloma patients. The Company has expanded the study to additional centers
in order to collect additional data beyond the original study plan. The data which was collected in the framework of the preliminary
study will be combined, as necessary, in planning and preparing for the implementation of the phase 2 clinical trial which the
Company expects to obtain the approval to commence it in the second half of 2014. The costs of such preparations comprise
of, among other things, costs in connection with medical regulation, patent registration costs, medical consulting costs and payments
to medical centers. Additionally, we had amortization expenses of the exclusive right to examine a medical technology in the field
of the immune system in 2011.
hCDR1 for the Treatment of SLE
The Company intends
to initiate a new Phase II clinical trial, which will include the 0.5 mg (and a 0.25 mg) weekly dose. We estimate that the trial
will take one year to enroll patients, another year to conduct treatment, and additional time to analyze the results for a total
of approximately two and a half years. We estimate the cost for that period at between $12 and $15 million.
rHuEPO for the Treatment of Multiple Myeloma
According to the clinical
trial’s preliminary plan received as part of the Bio-Gal transaction, we are planning on performing a prospective, multi-center,
double blind, placebo controlled, phase 2 study intended to assess safety of rHuEPO when given to patients with advanced Multiple
Myeloma and demonstrate its effects on survival, biological markers related to the disease, immune improvements and quality of
life. We intend to receive approval to commence such trial in the second half of 2014 and we expect it to last two-and-a-half years
and its cost is estimated at approximately $2.0 million. We have not yet submitted the preliminary plan, which may be updated,
to the authorities and/or the applicable IRB.
While we have begun
preliminary discussions with potential clinical sites and third party vendors for the planned study, we have not yet determined
the final size and scope of the study, and as a result, we cannot certify the above estimations regarding the clinical trial period
and cost to complete the study.
SAM-101 for the Treatment of Schizophrenia
According to the preliminary
development plan received as part of the MinoGuard transaction, we plan to perform a multi-center phase 2b clinical trial under
the FDA, using our proprietary combination. This preliminary plan is subject to changes in accordance with our regulatory advisors
and the FDA/other regulatory agencies, requirements.
The information above
provides estimates regarding the costs associated with the current estimated range of time that will be necessary to complete the
development phase for
hCDR1
for the treatment of SLE, rHuEPO for the treatment of
Multiple Myeloma and develop SAM-101 for the treatment of Schizophrenia.
The following table
sets forth the research and development costs for the years 2013, 2012 and 2011 including all costs related to the clinical-stage
projects, our pre-clinical activities, and all other research and development. We started preparations for rHuEPO clinical development
in the last quarter of 2010 (after the completion of the Bio-Gal transaction on August 2010). We in-licensed SAM-101 in November
2011 and we estimate that we will incur significant costs on its development in the upcoming years. Whether or not and how quickly
we commence and complete development of our clinical stage projects is dependent on a variety of factors, including the rate at
which we are able to engage clinical trial sites and the rate of enrollment of patients. As such, the costs associated with the
development of our drug candidates will probably increase significantly.
|
|
Research and development Expenses in thousand US$
|
|
|
|
Years ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
hCDR1
|
|
|
9
|
|
|
|
-
|
|
|
|
-
|
|
rHuEPO
|
|
|
58
|
|
|
|
93
|
|
|
|
70
|
|
SAM-101
|
|
|
16
|
|
|
|
-
|
|
|
|
-
|
|
Anti TNF (Yeda Option)
|
|
|
-
|
|
|
|
-
|
|
|
|
88
|
|
Other (RESPeRATE, through InterCure)
|
|
|
30
|
|
|
|
6
|
|
|
|
-
|
|
Total Research and Development
|
|
|
113
|
|
|
|
99
|
|
|
|
158
|
|
D. Trend Information
Please see “Item
5. Operating and Financial Review and Prospects” and “Item 4. Information on the Company” for trend information.
E. Off-Balance Sheet Arrangements
We have not entered
into any transactions with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivative
instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other
obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit
risk support.
F. Tabular disclosure of contractual
Obligations
As of December 31,
2013, we had known contractual obligations, commitments and contingencies of approximately $154,000 which relate to our offices
and vehicle operating lease obligations, of which approximately $94,000 is due within the next year, with the remaining balance
due as per the schedule below.
According to certain
vehicle operating lease agreements, we have the sole right to terminate these agreements with 1-2 months paid notice. We also had
the sole right to extend the office lease period by additional 24 months. In April 2013 we notified our offices' landlord that
we wished to extend the lease agreement, according to the option given to us. The table below reflects our obligations under the
extension of the lease period.
We do not carry any
contractual obligations, commitments or contingencies relates to research and development operation.
|
|
Payment due by period as of December 31, 2013 (in thousands of US$)
|
|
Contractual obligations
|
|
Total
|
|
|
Less than
1 year
|
|
|
1-3
years
|
|
|
3-5
years
|
|
|
More than
5 years
|
|
Operating lease obligations
|
|
|
154
|
|
|
|
94
|
|
|
|
60
|
|
|
|
-
|
|
|
|
-
|
|
Total
|
|
|
154
|
|
|
|
94
|
|
|
|
60
|
|
|
|
-
|
|
|
|
-
|
|
Pursuant to our asset
purchase agreement to acquire the rights to develop rHuEPO for the treatment of Multiple Myeloma from Bio-Gal Ltd., we are obligated
to pay 1% royalties on net sales of the product, as well as a fixed royalty payment in the total amount of $350,000 upon the successful
completion of Phase 2. The payment of $350,000 is to be made to Yeda upon the earlier of (i) six months from the successful completion
of Phase 2 or (ii) the completion of a successful fundraising by XTL at any time after the completion of the Phase 2 in an amount
of at least $2 million.
According to the agreement
with MinoGuard we are obligated to pay milestone payments to MinoGuard of up to $2.5 million based on development and marketing
milestones as well as a 3.5% royalty of our net sales of the product and 7.5%-20% from our third-party out-license receipts, depending
on the phase of the drug at the time of an out-license transaction. It should be noted we have the sole discretion to pay any of
the above amounts in cash or through an issuance of our shares to MinoGuard.
According to our strategic collaboration master agreement with
the Institute and Mor, we are obligated to pay the Institute for the services provided by them the cost basis related to the Institute's
activity in the framework of any project plus an additional 10% of the total royalties to which Mor is entitled pursuant to its
agreements with the Company in connection with each technology for which rights were granted to the Company.
Item 6. Directors,
Senior Management and Employees
|
A.
|
Directors and Senior Management
|
|
B.
|
The following sets forth information with respect to our directors and executive officers as of the date hereof.
|
Name
|
|
Age
|
|
Position
|
Amit Yonay
|
|
44
|
|
Chairman of the Board of Directors
|
Dafna Cohen
|
|
44
|
|
Non-Executive and External Director
|
Jaron Diament
|
|
46
|
|
Non-Executive and External Director
|
Marc Allouche
|
|
40
|
|
Non-Executive Director
|
David Bassa
|
|
52
|
|
Non-Executive Director
|
Josh Levine
|
|
49
|
|
Chief Executive Officer
|
David Kestenbaum
|
|
49
|
|
Chief Financial Officer
|
Prof. Moshe Mittelman
|
|
61
|
|
Medical Director
|
Amit Yonay has served
as a director of our company since March 2009. Mr. Yonay has also served as the Chairman of the Board of Directors of InterCure
Ltd. since July 2012. Since 2007, he has been actively involved in independent investments primarily in the real estate and capital
markets with an emphasis toward distressed asset opportunities. From 2000 to January 2007, Mr. Yonay served as the Head Israeli
Sell-Side Analyst with ING Financial Markets (NYSE: ING, Euronext: INGA) in Israel. Mr. Yonay received a BSc in Electrical Engineering
from Binghamton University and a MBA from Tel Aviv University in Finance and International Business.
Dafna Cohen has served
as a director of our company since March 2009. From 2010 until 2011, she served as director of Global Treasury at Mediamind Technologies
(NASDAQ: MDMD). From 2005 to 2009 she served as Director of Investment and Treasurer of Emblaze Ltd. (LSE: BLZ). From 2000 to December
2004, Ms. Cohen was an Investment Manager for Leumi Partners. From 1994-2000, Ms. Cohen worked in the derivatives sector of Bank
Leumi. In addition, Ms. Cohen serves as a director of Formula Systems Ltd (Nasdaq: FORTY, TASE: FORTY) since November 2009. Ms.
Cohen has served as a Director at Europort (TASE: ERPT.B1) since January 2012. From March 2011 to July 2012 Ms. Cohen was a director
of Inventech Central (TASE: IVTC). Ms. Cohen received a BA in economics and political science and a MBA in finance and accounting
from Hebrew University, Jerusalem.
Jaron Diament has served
as a director of our company since March 2009. He has served as the Chief Executive Officer of Tagor Capital Ltd., a public real
estate investment company (TASE: TGCP), and a board member of all of its non-Israel real estate investments since December 2009.
From September 2006 to December 2009, Mr. Diament served as Chief Financial Officer of Tagor Capital Ltd. In addition, Mr. Diament
has served as an external director of Mega Or Holdings Ltd. (TASE: MGOR) since September 2007 and served as an independent director
in Jobookit Holdings Ltd. (TASE: JBKT) from May 2011 until July 2012. Mr. Diament received a BA in economics and accounting from
Tel Aviv University.
Marc Allouche has served
as a director of our company since March 2009. He is the founder and managing partner of NFI Blue Consulting, an investment banking
& business advisory firm. NFI focuses on creating and advising Israel-related investment and business opportunities on a world
wide scale, with particular expertise on the Israel-Europe axis, and this notably within two asset classes: private equity and
real estate. Previously, he served as the head of the Alternative Investments Division of Harel Insurance Investments & Financial
Services Ltd., from 2008 to 2009, focusing on private equity and real estate investments. From 2006 to 2007, Mr. Allouche served
as Executive Vice President of investments & strategic development of SGPA, a French private equity group and, concurrently,
was CEO of one of its portfolio companies, operating in the retail sector in France, for turnaround purposes. From 2002 to 2005,
Mr. Allouche was founder and managing director of the Private Equity Advisory Group of Russel Bedford International, in charge
of international corporate finance, transaction services and restructuring advisory services. From 2000 to 2001, Mr. Allouche served
as Vice President at Nessuah Zannex Venture Capital Company Ltd., in strategic alliance with US Bancorp Piper Jaffray, managing
a life sciences venture capital fund and, concurrently, was also managing director of one of its med-tech portfolio companies for
turnaround purposes. From 1998 to 2000, Mr. Allouche was involved in the creation and the management of the Technology Group of
KPMG International - Somekh Chaikin in Israel, a corporate finance division dedicated to high-tech and biotech companies. From
1996 to 1998, Mr. Allouche was a Senior Consultant at the Audit and the Transaction Services divisions of Price Waterhouse in Paris.
Mr. Allouche received a BA in economics and a MBA with a major in corporate finance and accounting from Dauphine University, Paris.
He is also a Chartered Public Accountant in France.
David Bassa has served
as a director of our company since November 2013. He is the CEO and co-founder of Sela Software Ltd., a leading knowledge center
and software house for the high-tech and IT industry, since 1990. In 2000, Mr. Bassa founded Bio-Gal, a biopharmaceuticals company
which subsequently merged into XTL, for the purpose of developing Erythropoietin (EPO) for the treatment of Multiple Myeloma. Mr.
Bassa graduated with a B.A in Economics from Bar-Ilan University and an M.Sc in Computer Science studies (without thesis), also
from Bar-Ilan University. Mr. Bassa was twice awarded the President Excellency Award (1981, 2002) and managed the Israeli branch
of the international AIESEC organization, of which he is a Hall of Fame member.
Josh Levine was appointed
Chief Executive Officer of XTL in October 2013. Mr. Levine was the Chief Executive Officer of Proteologics Ltd. (TASE: PRTL) from
January 2011 until October 2013. Previously, from September 2008 until September 2010, he was Chairman of the Board of Proteologics
Ltd. Concurrently, he was Senior Director at Teva Innovative Ventures responsible for, among other things, business development
as well as alliance management for the unit. He had also held several executive positions within venture capital funds and boutique
investment banks. Previously, he was a corporate attorney at a large New York City law firm. Mr. Levine holds a JD degree from
Columbia University Law School and a BA degree in Chemistry from Yeshiva University.
David Kestenbaum was
appointed Chief Financial Officer of our Company in January 2014. Before joining XTL, he served as CFO of Zenith Solar Ltd., a
start-up company involved in the development and deployment of innovative solar energy technology from 2010 to 2012. Prior positions
include Finance Director of Colbar Lifescience Ltd., a medical device/biotech company and division of Johnson and Johnson (NYSE:JNJ)
from 2007 to 2010, CFO of ZAG Industries Ltd., a division of The Stanleyworks (NYSE:SWK) from 2003 to 2007, and CFO and other senior
financial positions at affiliates of Unilever NV (NYSE: UN) in the US and Israel. He worked in public accounting at PriceWaterhouseCoopers
in NY from 1986 to 1990. Mr. Kestenbaum is a US Certified Public Accountant and holds a BSc in Accounting from Yeshiva University
(NY), and a MBA in Finance and International Business from Columbia University (NY).
Prof. Moshe Mittelman has
served as the Medical Director of our company since August 2010. He is also a Hematology consultant and Director of the Department
of Medicine at the Tel Aviv Sourasky (Ichilov) Medical Center, Israel. Since 1997, Moshe has been Clinical Associate Professor
of Medicine at the Sackler School of Medicine, Tel Aviv University. A well-known hematologist focusing on cancer and erythropoietin
(EPO) research, Prof. Mittelman was one of the first hematologists to apply rHuEPO in the clinical practice, which allowed him
to make the pioneering observation of prolonged survival in Multiple Myeloma rHuEPO-treated patients. This led to extensive research
both in the lab as well as with patients, showing previously unrecognized immune effects to EPO. This research project has resulted
in a series of scientific papers published in prestigious journals. Prof. Mittelman is also a well-known speaker in international
conferences. Prof. Mittelman’s work led to the founding of Bio-Gal, Ltd. which has now merged with XTL. Prof. Mittelman has
also served as President of the Israel Society of Internal Medicine, Secretary of the Israel Society of Hematology and a Hematology
Consultant for the Israel Ministry of Health. Prof. Mittelman is also a consultant to various biotech companies. From 2008-2010,
he served as a member of the national committee of the Health Basket in Israel. From 2007 until 2013, Prof. Mittelman served as
a director of Gaon Holdings Ltd. (TASE: GAON), a public holding company.
Employment Agreements
Joshua Levine
We have an agreement
dated as of September 11, 2013, as amended on January 30, 2014, between the Company and Mr. Joshua Levine, our Chief Executive
Officer (“CEO”). The agreement shall take effect from the date of approval at the Company's general meeting of shareholders
on March 10, 2014, and will continue for a three-year term as of that date. Mr. Levine commenced his term as CEO on October 15,
2013 and will be entitled to a monthly gross base salary of NIS 40,000 (NIS 480,000 annually), which shall be paid retroactively,
effective from said commencement date. Either party may terminate the agreement upon three months’ advance written notice
during the first year of the agreement and 4 months’ advance written notice thereafter.
Upon the successful
completion of cash fund raising of at least US$3 million in a public offering or private placement of equity securities, including
securities convertible or exercisable into equity of the Company or any entity under its control (which for this purpose means
ownership by the Company of greater than 50% of the outstanding voting securities), as long as Mr. Levine is appointed as such
entity's CEO, during the thirty six month period from the date of the agreement, the Company will pay Mr. Levine a bonus equal
to 1% of the above the fund raising amount, up to a maximum aggregate amount of US$200,000 in any calendar year. In the event
the Company or any of its wholly-owned subsidiaries or any entity under its control, as long as Mr. Levine is appointed as such
entity's CEO, receives payment in connection with any collaboration or other transaction relating to their respective products
or technologies, excluding payments made to finance specific research and development activity and royalty payments, Mr. Levine
shall be entitled to payment of 1% of the cash actually received by the Company in such transaction, up to an aggregate maximum
amount of US$200,000 in any calendar year. In the event the Company or any of its wholly-owned subsidiaries or any entity under
its control, as long as Mr. Levine is appointed as such entity's CEO, receives payment in connection with payments made to finance
specific research and development activity, Mr. Levine shall be entitled to receive payment of 0.5% of such funding actually received
by the Company up to an aggregate maximum of US$200,000 in any calendar year and per single research and development funding.
The aggregate of all such bonuses paid to Mr. Levine in any calendar year cannot exceed US$300,000.
In consideration for
his service as the Company's CEO, Mr. Levine will be entitled to benefits such as convalescence pay, managers’ insurance,
a study fund and a Company vehicle. He will also be entitled to an allotment of 1,500,000 non-marketable stock options, without
charge, exercisable into 1,500,000 ordinary shares of the Company, NIS 0.1 par value each, subject to the adjustments specified
in the Company's option plan (the "Options"). Assuming that the full amount of options is exercised, the shares deriving
from the said exercise will constitute 0.64% of the issued and paid up capital, and 0.58% on a fully diluted basis. It should
be noted that Mr. Levine does not hold any securities of the Company. The exercise price of 600,000 of the Options is NIS 0.60
each, non-linked, reflecting a price higher than the average share price in the 30 days preceding the date of the Board of Directors'
resolution. The exercise price of 900,000 of the Options is NIS 0.90 each. Mr. Levine will be entitled to receive the Options
and exercise them within a maximum period of 120 months from the date of allotment, subject to the terms and conditions contained
herein, and based on a maturity period of 36 months, such that 1/12 of the Options granted to him will mature at the end of each
consecutive calendar quarter following the grant date. Following the lapse of 36 months, all the Options may be exercised by him,
subject to Mr. Levine continuing to serve in his position as CEO during that period.
Ronen Twito
On December 30, 2013,
the Company received notification from Mr. Ronen Twito that he wished to cease his service as the Company’s CFO and Deputy
CEO. Mr. Twito’s employment with the Company ends on April 5, 2014.
David Kestenbaum
We have an agreement
dated as of January 9, 2014, effective as of January 5, 2014, between the Company and Mr. David Kestenbaum, our Chief Financial
Officer (“CFO”). At a time to be determined by the CEO and at the CEO’s discretion, Mr. Kestenbaum shall be
responsible for the financial and accounting management of the Company. The agreement shall remain in effect for a three-year
term as of the effective date. Mr. Kestenbaum is entitled to a monthly gross base salary of NIS 33,000 (NIS 396,000 annually).
The agreement may be terminated by either party without cause at any time upon 60 days’ prior written notice.
Upon the successful
completion of fund raising of at least US$ 3 million in a public offering or private placement of equity securities, including
securities convertible or exercisable into equity by the Company within a period of three years as of the effective date and,
as long as Mr. Kestenbaum is employed by the Company as CFO, Mr. Kestenbaum shall be granted with a one-time bonus payment equal
to 0.6% of the funds raised, and up to maximum aggregate payment of US$120,000 per year. Upon the successful completion of a transaction
made by the Company or any of its fully owned subsidiaries or any entity in its control receives payment in connection with any
collaboration or other transaction relating to their respective products or technologies, excluding payments made to finance specific
research and development activity and royalty payment, as long as the Mr. Kestenbaum is employed by the Company as CFO, Mr. Kestenbaum
shall be granted with a one-time payment equal to 0.5% of the transaction amount actually received by the Company in such Transaction,
whether as upfront payments, milestone payments or payments of any other form, and up to maximum aggregate payment of US$100,000
per year. Upon the successful completion of a research and development funding in the Company, Mr. Kestenbaum shall be granted
a one-time bonus payment equal to 0.4% of the funding amount, and up to a maximum aggregate payment of US$75,000 per year. The
aggregate of all such bonuses paid to Mr. Kestenbaum in any calendar year cannot exceed US$150,000.
Mr. Kestenbaum is
entitled to pension and severance benefits, managers’ insurance as commonly acceptable for office holders and use of a Company
car. There is a non-compete clause surviving one year after the termination for any reason of his employment. Mr. Kestenbaum shall
be issued 750,000 options to purchase 750,000 ordinary shares of the Company of nominal value of NIS 0.1 each, available through
the Company's ESOP, at an exercise price of NIS 0.5328 per share. The Options shall vest and become exercisable on a quarterly
basis, over a period of 36 months thereafter for as long as Mr. Kestenbaum’s employment with the Company has not terminated.
David Grossman
On September 11, 2013,
the Company's Board received notification from Mr. David Grossman that he wished to terminate his position as the Company’s
CEO. A non-complete clause for a period of one year survives Mr. Grossman’s termination. On November 7, 2013, the Company
was notified of Mr. David Grossman's resignation from the Company's Board. On November 10, 2013, InterCure reported that on November
7, 2013, Mr. David Grossman announced the termination of his tenure as director of InterCure. Mr. Grossman’s employment
with the Company ended on February 15, 2014.
Moshe Mittelman
We have an agreement
dated July 12, 2010, and effective as of August 27, 2010, with Prof. Moshe Mittelman, our Medical Director. Prof. Mittelman is
entitled to a monthly fee of $2,500. His entitlement began 90 days after the date of completion of the Bio-Gal transaction, i.e.,
November 3, 2010. The agreement is limited to the date of successful completion of the phase 2 clinical trial of rHuEPO. A “successful
completion of the phase 2 clinical trial” is defined as: six (6) months after the trial of rHuEPO on the last patient in
accordance with trial protocol, or on an earlier date if XTL notifies Yeda of XTL’s desire to discontinue the trial. In
August 2010, our Board of Directors approved the agreement as well as the grant of options to Prof. Mittelman to purchase a total
of 640,000 ordinary shares at an exercise price of NIS 0.1 per share. These options were vested over a twenty four-month period,
on a monthly basis, commencing from August 27, 2010.
The aggregate compensation
paid by us to all persons who served as directors or officers for the year 2013 (9 persons) was approximately $0.6 million. This
amount includes payments of approximately $0.1 million made for social security, pension, disability insurance and health insurance
premiums, severance accruals, payments made in lieu of statutory severance, payments for continuing education plans, payments
made for the redemption of accrued vacation, and amounts expended by us for automobiles made available to our officers.
This
amount also includes a bonus payment totaling approximately $35,000 to Mr. Ronen Twito, the former CFO and Deputy CEO of the Company,
based on agreements signed with him regarding fundraising during the period.
All members of our
Board of Directors who are not our employees are reimbursed for their expenses for each meeting attended. Our directors are eligible
to receive share options under our share option plans. Non-executive directors do not receive any remuneration from us other than
their fees for services as members of the board, additional fees if they serve on committees of the board and expense reimbursement.
In March 2012, we
granted to our external directors, Mr. Diament Jaron and Ms. Dafna Cohen, 150,000 options each to purchase our ordinary shares
of NIS 0.1 par value, pursuant to the shareholder meeting of March 19, 2012, exercisable at an exercise price of NIS 0.58633 (which
is the average of the three-day closing price on TASE prior to the issuance). 33% of the options are vested and the remaining
67% shall vest and be exercisable on a monthly basis, commencing from the date of the mentioned shareholders meeting, for the
duration of two years.
In March 2009, pursuant
to a shareholders’ meeting, the monetary compensation was set for each of Mr. Grossman, Mr. Shweiger, Mr. Allouche, Mr.
Yonay, Mr. Diament and Ms. Cohen as follows: annual consideration of $10,000 (to be paid in 4 equal quarterly payments), payments
of $375 for attendance at each board or committee meeting in person or held by teleconference, $187.5 for unanimous board resolutions
and reimbursement of reasonable out-of-pocket expenses. Mr. Grossman served as the Company's Chief Executive Officer from February
11, 2009 until his effective resignation in October 2013 and was entitled to a compensation package as detailed above in the Employment
Agreements paragraph, and therefore was not entitled to a director’s fee.
We granted to three
of our directors, Mr. Yonay, Mr. Shweiger (former director) and Mr. Allouche, 150,000 options each, to purchase our ordinary shares
of NIS 0.1 par value, pursuant to the shareholder meeting of March 2, 2010, exercisable at an exercise price of NIS 0.298 (which
is the average of the three-day closing price on TASE prior to the issuance). 33% of the options are vested and the remaining
67% shall vest and be exercisable on a monthly basis, commencing from March 2, 2010, for the duration of two years. On November
22, 2010, Mr. Shweiger ceased his directorship in the Company and therefore 63,747 of the total options granted to him were forfeited.
Upon his departure, Mr. Shweiger exercised the vested 86,253 options. As of the date hereof, all options granted to Mr. Yonay
and Mr. Allouche have vested, and have yet to be exercised. Vested options may be exercised until March 1, 2020.
On September 3, 2012,
in a special meeting of InterCure's shareholders, 75,000 share options to purchase 75,000 InterCure ordinary shares were allocated
to Mr. Yonay. The exercise price of these share options is NIS 0.54. These options shall vest over a three-year period on a quarterly
basis (12 quarters), commencing the effective date for as long as Mr. Yonay’s directorship in InterCure is not terminated.
For further details
regarding share options granted to our employees, directors and service providers, see Note 20 to the consolidated financial statements
for the year ended December 31, 2013.
In accordance with
the requirements of Israeli Law, we determine our directors’ compensation in the following manner:
|
·
|
first,
our compensation committee reviews the proposal for compensation.
|
|
·
|
second,
provided that the compensation committee approves the proposed compensation, the proposal
is then submitted to our Board of Directors for review, except that a director who is
the beneficiary of the proposed compensation does not participate in any discussion or
voting with respect to such proposal; and
|
|
·
|
finally,
if our Board of Directors approves the proposal, it must then submit its recommendation
to our shareholders, which is usually done in connection with our shareholders’
general meeting.
|
The approval of a
majority of the shareholders voting at a duly convened shareholders meeting is required to implement any such compensation proposal.
Election of Directors and Terms of Office
Our Board of Directors
currently consists of five members, including our non-executive Chairman. Other than our two external directors, our directors
are elected by an ordinary resolution at the annual general meeting of our shareholders. The nomination of our directors is proposed
by a nomination committee of our Board of Directors, whose proposal is then approved by the board. The current members of the
nomination committee are Amit Yonay (chairman of the nomination committee), Jaron Diament (chairman of the audit committee) and
Dafna Cohen. Our board, following receipt of a proposal of the nomination committee, has the authority to add additional directors
up to the maximum number of 12 directors allowed under our Articles. Such directors appointed by the board serve until the next
annual general meeting of the shareholders. Unless they resign before the end of their term or are removed in accordance with
our Articles, all of our directors, other than our external directors, will serve as directors until our next annual general meeting
of shareholders. In July 2011, at an annual general meeting of our shareholders, Amit Yonay, Marc Allouche, and David Grossman
were re-elected to serve as directors of our company. Dafna Cohen and Jaron Diament were elected to serve as external directors
of our company at the March 2009 extraordinary general meeting. Dafna Cohen and Jaron Diament are serving as external directors
pursuant to the provisions of the Israeli Companies Law for a three-year term ending in March 2012. On March 19, 2012 at an annual
general meeting of our shareholders, Amit Yonay, Marc Allouche and David Grossman were re-elected to serve as directors of our
company until the next shareholders meeting and our external directors, Dafna Cohen and Jaron Diament, were re-elected to serve
as external directors of our company for an additional period of three years. After this date, the external directors term of
service may be renewed for an additional three-year term. On November 7, 2013, David Grossman resigned from his position as a
director and Mr. David Bassa was appointed in his stead.
None of our directors
or officers has any family relationship with any other director or officer.
Our Articles permit
us to maintain directors' and officers’ liability insurance and to indemnify our directors and officers for actions performed
on behalf of us, subject to specified limitations. We maintain a directors and officers insurance policy which covers the liability
of our directors and officers as allowed under Israeli Companies Law.
There are no service
contracts or similar arrangements with any director that provide for benefits upon termination of a directorship.
External and Independent Directors
The Israeli Companies
Law requires Israeli companies with shares that have been offered to the public either in or outside of Israel to appoint two
external directors. No person may be appointed as an external director if that person or that person’s relative, partner,
employer or any entity under the person’s control, has or had, on or within the two years preceding the date of that person's
appointment to serve as an external director, any affiliation with the company or any entity controlling, controlled by or under
common control with the company. The term affiliation includes:
|
·
|
an
employment relationship;
|
|
·
|
a
business or professional relationship maintained on a regular basis;
|
|
·
|
service
as an office holder, other than service as an officer for a period of not more than three
months, during which the company first offered shares to the public.
|
No person may serve
as an external director if that person’s position or business activities create, or may create, a conflict of interest with
that person's responsibilities as an external director or may otherwise interfere with his/her ability to serve as an external
director. If, at the time external directors are to be appointed, all current members of the Board of Directors are of the same
gender, then at least one external director must be of the other gender. A director in one company shall not be appointed as an
external director in another company if at that time a director of the other company serves as an external director in the first
company. In addition, no person may be appointed as an external director if he/she is a member or employee of the Israeli Security
Authority, and also not if he/she is a member of the Board of Directors or an employee of a stock exchange in Israel.
External directors
are to be elected by a majority vote at a shareholders' meeting, provided that either:
|
·
|
the
majority of shares voted at the meeting, including at least one-half of the shares held
by non-controlling shareholders or other shareholders who have a personal interest in
such election voted at the meeting, vote in favor of election of the director, with abstaining
votes not being counted in this vote; or
|
|
·
|
the
total number of shares held by non-controlling shareholders voted against the election
of the director does not exceed two percent of the aggregate voting rights in the company.
|
The initial term of
an external director is three years and may be extended for two additional three-year terms. An external director may be removed
only by the same percentage of shareholders as is required for their election, or by a court, and then only if such external director
ceases to meet the statutory qualifications for their appointment or violates his or her duty of loyalty to the company. Both
external directors must serve on every committee that is empowered to exercise one of the functions of the Board of Directors.
An external director
is entitled to compensation as provided in regulations adopted under the Israeli Companies Law and is otherwise prohibited from
receiving any other compensation, directly or indirectly, in connection with service provided as an external director.
Dafna Cohen and Jaron
Diament serve as external directors pursuant to the provisions of the Israeli Companies Law. They both serve on our audit committee,
our committee for the approval of financial statements, our nomination committee and our compensation committee.
Audit Committee
The Israeli Companies
Law requires public companies to appoint an audit committee. The responsibilities of the audit committee include identifying irregularities
in the management of the company’s business and approving related party transactions as required by law. An audit committee
must consist of at least three directors, including all of its external directors. The chairman of the Board of Directors, any
director employed by or otherwise providing services to the company, and a controlling shareholder or any relative of a controlling
shareholder, may not serve as members of the audit committee. An audit committee may not approve an action or a transaction with
a controlling shareholder, or with an office holder, unless at the time of approval two external directors are serving as members
of the audit committee and at least one of the external directors was present at the meeting in which an approval was granted.
Our audit committee
is currently comprised of three independent non-executive directors. The audit committee is chaired by Jaron Diament, who serves
as the audit committee financial expert, with Dafna Cohen and Marc Allouche as members. The audit committee meets at least four
times a year and monitors the adequacy of our internal controls, accounting policies and financial reporting. It regularly reviews
the results of the ongoing risk self-assessment process, which we undertake, and our interim and annual reports prior to their
submission for approval by the full Board of Directors. The audit committee oversees the activities of the internal auditor, sets
its annual tasks and goals and reviews its reports. The audit committee reviews the objectivity and independence of the external
auditors and also considers the scope of their work and fees.
We have adopted a
written charter for our audit committee, setting forth its responsibilities as outlined by the regulations of the SEC. In addition,
our audit committee has adopted procedures for the receipt, retention and treatment of complaints we may receive regarding accounting,
internal accounting controls, or auditing matters and the submission by our employees of concerns regarding questionable accounting
or auditing matters. In addition, SEC rules mandate that the audit committee of a listed issuer consist of at least three members,
all of whom must be independent, as such term is defined by rules and regulations promulgated by the SEC. We are in compliance
with the independence requirements of the SEC rules.
Financial Statement Examination
Committee
The Israeli Companies
Law regulations require each public company to appoint a committee that examines the financial statements (the “Committee”)
which shall be compounded from at least three (3) members, of which the majority among them shall be independent directors and
the Committee's Chairman shall be an external director. The Committee's duties are, among other things, to examine the Company's
financial statements and to recommend and report to the board of directors of the Company regarding any problem or defect found
in such financial statements.
In addition to the
above-said, all of the Committee's members must meet the following requirements:
|
·
|
All
members shall be members of the board of directors of the Company.
|
|
·
|
At
least one of the Committee's members shall have financial and accounting expertise and
the rest of the Committee's members must have the ability to read and understand financial
statements.
|
The Company is in
full compliance with the requirements outlined above.
According to a resolution
of our Board of Directors, the Audit Committee has been assigned the responsibilities and duties of a financial statements examination
committee, as permitted under relevant regulations promulgated under the Companies Law. From time to time as necessary and required
to approve our financial statements, the Audit Committee holds separate meetings, prior to the scheduled meetings of the entire
Board of Directors, regarding financial statement approval. The function of a financial statements examination committee is to
discuss and provide recommendations to its board of directors (including the report of any deficiency found) with respect to the
following issues: (i) estimations and assessments made in connection with the preparation of financial statements; (ii) internal
controls related to the financial statements; (iii) completeness and propriety of the disclosure in the financial statements;
(iv) the accounting policies adopted and the accounting treatments implemented in material matters of the Company; (v) value evaluations,
including the assumptions and assessments on which evaluations are based and the supporting data in the financial statements.
Our independent auditors and our internal auditors are invited to attend all meetings of the Audit Committee when it is acting
in the role of the financial statements examination committee.
Compensation Committee
Amendment no. 20 to
the Companies Law was published on November 12, 2012 and became effective on December 12, 2012 ("Amendment no. 20").
In general, Amendment no. 20 requires public companies to appoint a compensation committee and to adopt a compensation policy
with respect to its officers (the "Compensation Policy"). In addition, Amendment no. 20 addresses the corporate approval
process required for a public company's engagement with its officers (with specific reference to a director, a non-director officer,
a chief executive officer and controlling shareholders and their relatives who are employed by the company).
The compensation committee
shall be nominated by the board of directors and be comprised of its members. The compensation committee must consist of at least
three members. All of the external directors must serve on the compensation committee and constitute a majority of its members.
The remaining members of the compensation committee must be directors who qualify to serve as members of the audit committee (including
the fact that they are independent) and their compensation should be identical to the compensation paid to the external directors
of the company. The approval of the compensation committee is required in order to approve terms of office and/or employment of
office holders. The Company's Compensation Policy was duly approved on November 19, 2013.
Similar to the rules
that apply to the audit committee, the compensation committee may not include the chairman of the board, or any director employed
by the company, by a controlling shareholder or by any entity controlled by a controlling shareholder, or any director providing
services to the company, to a controlling shareholder or to any entity controlled by a controlling shareholder on a regular basis,
or any director whose primary income is dependent on a controlling shareholder, and may not include a controlling shareholder
or any of its relatives. Individuals who are not permitted to be compensation committee members may not participate in the committee’s
meetings other than to present a particular issue; provided, however, that an employee that is not a controlling shareholder or
relative may participate in the committee’s discussions, but not in any vote, and the company’s legal counsel and
corporate secretary may participate in the committee’s discussions and votes if requested by the committee.
The roles of the compensation
committee are, among other things, to: (i) recommend to the board of directors the Compensation Policy for office holders and
recommend to the board once every three years the extension of a Compensation Policy that had been approved for a period of more
than three years; (ii) recommend to the directors any update of the Compensation Policy, from time to time, and examine its implementation;
(iii) decide whether to approve the terms of office and of employment of office holders that require approval of the compensation
committee; and (iv) decide, in certain circumstances, whether to exempt the approval of terms of office of a chief executive officer
from the requirement of shareholder approval.
The Compensation Policy
requires the approval of the general meeting of shareholders with a “Special Majority”, which requires a majority
of the shareholders of the company who are not either a controlling shareholder or an "interested party" in the proposed
resolution, or the shareholders holding less than 2% of the voting power in the company voted against the proposed resolution
at such meeting. However, under special circumstances, the board of directors may approve the Compensation Policy without shareholder
approval, if the compensation committee and thereafter the board of directors decided, based on substantiated reasons after they
have reviewed the compensation policy again, that the Compensation Policy is in the best interest of the company.
Amendment no. 20 details
the considerations that should be taken into account in determining the Compensation Policy and certain issues which the Compensation
Policy should include.
Mr. Jaron Diament
is the chairman of our compensation committee. Mr. Marc Allouche and Mrs. Dafna Cohen serve as the other members of our compensation
committee.
Approval of Compensation to Our
Officers
The Israeli Companies
Law prescribes that compensation to officers must be approved by a company’s board of directors.
As detailed above,
our compensation committee consists of three independent directors: Mr. Jaron Diament, Mr. Marc Allouche and Mrs. Dafna Cohen.
The responsibilities of the compensation committee are to set our overall policy on executive remuneration and to decide the specific
remuneration, benefits and terms of employment for directors, officers and the Chief Executive Officer.
The objectives of
the compensation committee’s policies are that such individuals should receive compensation which is appropriate given their
performance, level of responsibility and experience. Compensation packages should also allow us to attract and retain executives
of the necessary caliber while, at the same time, motivating them to achieve the highest level of corporate performance in line
with the best interests of shareholders. In order to determine the elements and level of remuneration appropriate to each executive
director, the compensation committee reviews surveys on executive pay, obtains external professional advice and considers individual
performance.
Internal Auditor
Under the Israeli
Companies Law, the board of directors must appoint an internal auditor, nominated by the audit committee. The role of the internal
auditor is to examine, among other matters, whether the company's actions comply with the law and orderly business procedure.
Under the Israeli Companies Law, an internal auditor may not be:
|
·
|
a
person (or a relative of a person) who holds more than 5% of the company’s shares;
|
|
·
|
a
person (or a relative of a person) who has the power to appoint a director or the general
manager of the company;
|
|
·
|
an
executive officer or director of the company; or
|
|
·
|
a
member of the company’s independent accounting firm.
|
We comply with the
requirement of the Israeli Companies Law relating to internal auditors. Our internal auditors examine whether our various activities
comply with the law and orderly business procedure.
As of the date hereof,
the Company had three full-time employees, and three part-time service providers (one of whom is an officer). As of the same date
InterCure had five full-time employees and service providers and one part-time service provider. We and our Israeli employees
are subject, by an extension order of the Israeli Ministry of Welfare, to certain provisions of collective bargaining agreements
between the Histadrut, the General Federation of Labor Unions in Israel and the Coordination Bureau of Economic Organizations,
including the Industrialists Associations. These provisions principally address cost of living increases, recreation pay, travel
expenses, vacation pay and other conditions of employment. We provide our employees with benefits and working conditions equal
to or above the required minimum. Other than those provisions, our employees are not represented by a labor union.
For the years ended
December 31, 2013, 2012 and 2011, the number of our full-time employees engaged in the specified activities, by geographic location,
are presented in the table below.
|
|
Years ended December
31,
|
|
|
|
2013*
|
|
|
2012*
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
Israel
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
US
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Israel
|
|
|
3
|
|
|
|
-
|
|
|
|
-
|
|
US
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
4
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial and general management
|
|
|
|
|
|
|
|
|
|
|
|
|
Israel
|
|
|
7
|
|
|
|
3
|
|
|
|
3
|
|
US
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
8
|
|
|
|
3
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
12
|
|
|
|
3
|
|
|
|
3
|
|
Average number of full-time employees
|
|
|
12
|
|
|
|
3
|
|
|
|
3
|
|
* Includes the employees in InterCure,
which was consolidated for the first time since July 25, 2012. The average number was calculated based on InterCure's employees
during the full year.
E. Share Ownership
The following table sets forth certain
information as of March 31, 2014, regarding the beneficial ownership of our directors and executive officers.
|
|
Amount and nature of beneficial ownership
|
|
|
|
|
|
|
Ordinary
shares
beneficially
owned
excluding
options
|
|
|
Options
1
exercisable
within
60 days of
March 31,
2014
|
|
|
Total
ordinary
shares
beneficially
owned
including
options
|
|
|
Percent of
ordinary shares
beneficially
owned
|
|
Amit Yonay
Chairman
of the Board
|
|
|
—
|
|
|
|
150,000
2
|
|
|
|
150,000
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marc Allouche
Director
|
|
|
—
|
|
|
|
150,000
2
|
|
|
|
150,000
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dafna Cohen
External
Director
|
|
|
—
|
|
|
|
150,000
3
|
|
|
|
150,000
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaron Diament
External
Director
|
|
|
—
|
|
|
|
150,000
3
|
|
|
|
150,000
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Bassa
Director
|
|
|
21,705,987
|
|
|
|
—
|
|
|
|
21,705,987
|
|
|
|
8.45
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Josh Levine
Chief Executive
Officer
|
|
|
—
|
|
|
|
250,000
4
|
|
|
|
250,000
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Kestenbaum
Chief
Financial Officer
|
|
|
—
|
|
|
|
62,500
5
|
|
|
|
62,500
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Moshe Mittelman
Medical
Director
|
|
|
5,562,715
|
|
|
|
640,000
6
|
|
|
|
6,202,715
|
|
|
|
2.46
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All directors and executive officers as a group (8 persons)
|
|
|
27,268,702
|
|
|
|
1,740,000
|
|
|
|
29,008,702
|
|
|
|
11.1
|
%
|
|
(1)
|
Options to purchase ordinary shares
|
|
(2)
|
150,000 options at an exercise price
of NIS 0.298 per ordinary share of NIS 0.1 par value, exercisable until March 1, 2020.
|
|
(3)
|
150,000 options at an exercise price
of NIS 0.58633 per ordinary share of NIS 0.1 par value, exercisable until March 18, 2022.
|
|
(4)
|
100,000 options at an exercise price
of NIS 0.6 per ordinary share of NIS 0.1 par value, and 150,000 options at an exercise
price of NIS 0.9 per ordinary share of NIS 0.1 par value, all exercisable until January
29, 2024.
|
|
(5)
|
62,500 options at an exercise price
of NIS 0.5328 per ordinary share of NIS 0.1 par value, exercisable until December 29,
2023.
|
|
(6)
|
640,000 warrants (series 2) at an
exercise price of NIS 0.1 per ordinary share of NIS 0.1 par value, exercisable until
August 26, 2020.
|
|
*
|
Represents less than 1% of ordinary
shares outstanding.
|
Share Option Plans
We maintain the following
share option plans for our and our subsidiary’s employees, directors and consultants. In addition to the discussion below,
see Note 20 of our consolidated financial statements for the year ended December 31, 2013.
Our Board of Directors
administers our share option plans and has the authority to designate all terms of the options granted under our plans including
the grantees, exercise prices, grant dates, vesting schedules and expiration dates, which may be no more than ten years after
the grant date. Options may not be granted with an exercise price of less than the fair market value of our ordinary shares on
the date of grant, unless otherwise determined by our Board of Directors.
As of December 31,
2013, we have granted to employees, directors and consultants options that are outstanding to purchase up to 8,038,000 ordinary
shares of NIS 0.1 par value, pursuant to two share option plans and pursuant to certain grants apart from these plans also discussed
below under Non-Plan Share Options.
2001 Share Option Plan
Under a share option
plan established in 2001, referred to as the 2001 Plan, we granted options during 2001-2011, at an exercise price between $0.0198
and $4.655 per ordinary share of NIS 0.1 par value. Up to 2,200,000 options of NIS 0.1 par value were available to be granted
under the 2001 Plan. On July 29, 2009, the option pool was increased by 5,000,000 unissued additional ordinary shares of NIS 0.1
par value, as well as forfeited and expired options that reverted to the pool due to departure of employees. As of December 31,
2013, 60,000 options were outstanding. Options granted to Israeli employees were in accordance with section 102 of the Tax Ordinance,
under the capital gains option set out in section 102(b)(2) of the ordinance. The options are non-transferable.
The option term is
for a period of ten years from the grant date. The options were granted for no consideration. The options vest over a three or
two year period. As of December 31, 2013, 60,000 options were fully vested. On May 2, 2011, the 2001 Share Option Plan expired
and no options may be granted under this plan.
2011 Share Option Plan
On August 29, 2011,
the Company's Board of Directors approved the adoption of an employee stock option scheme for the grant of options exercisable
into shares of the Company according to section 102 to the Israeli Tax Ordinance ("2011 Plan"), and to maintain up to
10 million shares in the framework of the 2011 Plan, for options allocation to employees, directors and Company consultants.
The 2011 Plan shall
be subject to section 102 of the Israeli Tax Ordinance. According to the Capital Gain Track, which was adopted by the Company
and the abovementioned section 102, the Company is not entitled to receive a tax deduction that relates to remuneration paid to
its employees, including amounts recorded as salary benefit in the Company's accounts for options granted to employees in the
framework of the 2011 Plan, except the yield benefit component, if available, that was determined on the grant date. The terms
of the options which will be granted according to the 2011 Plan, including option period, exercise price, vesting period and exercise
period, shall be determined by the Company's Board of Directors on the date of the actual allocation. As of December 31, 2013,
we have granted 7,858,000 share options under the 2011 Plan at an exercise price between $0.15 and $0.36 per ordinary share of
NIS 0.1 par value.
Non-Plan Share Options
In addition to the
options granted under our share option plans, there are 120,000 of NIS 0.1 par value outstanding options as of December 31, 2013,
which were granted to consultants and a member of our Scientific Advisory Board, not under an option plan during 2011. The options
were granted at an exercise price of $0.15. As of December 31, 2013, 120,000 options of NIS 0.1 par value were fully vested.
For further details
regarding share options granted to our employees, directors and service providers, see Note 20 to the consolidated financial statements
for the year ended December 31, 2013.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
As of December 31, 2013,
there were 1,978,930 ADRs outstanding, held by 4 record holders, whose holdings represented approximately 16.99%
of the total outstanding ordinary shares, of which 2 record holders were in the US.
The following table
sets forth the number of our ordinary shares owned by any person known to us to be the beneficial owner of 5% or more of our ordinary
shares as of the date hereof. The information in this table is based on 232,894,900 outstanding ordinary shares as of such date.
The number of Ordinary Shares beneficially owned by a person includes Ordinary Shares subject to options held by that person that
were currently exercisable. None of the holders of the Ordinary Shares listed in this table have voting rights different from
other holders of the Ordinary Shares.
Name
|
|
Number of shares owned
|
|
|
Percent of ordinary shares
|
|
Alexander Rabinovitch
(1)(2)(3)
|
|
|
41,139,256
|
|
|
|
17.66
|
%
|
David Bassa
(2)
|
|
|
21,705,987
|
|
|
|
9.32
|
%
|
Shalom Manova
(2)
|
|
|
17,136,242
|
|
|
|
7.36
|
%
|
|
(1)
|
22,152,007 of our ordinary shares
are held through Green Forest Ltd., which to the best of our knowledge is held jointly
by Alexander Rabinovitch and Sagit Rabinovitch.
|
|
(2)
|
Alexander Rabinovitch, David
Bassa and Shalom Manova hold our shares since August 3, 2010 as part of the completion
of the Bio-Gal transaction.
|
|
(3)
|
In addition to his holding as
stated in the table above, Mr. Alexander Rabinovitch, through Green Forest Ltd., holds
573,750 warrants (series 2). Each warrant (series 2) is exercisable into one ordinary
share of NIS 0.1 par value from the date of registration for trade on the Tel-Aviv Stock
Exchange (March 9, 2011) until October 28, 2014, at an exercise price equal to NIS 1.0
per share, linked to the US dollar. On a fully diluted basis, assuming exercise of all
outstanding warrants, the total holding shall represent 16.21% of the share capital of
the Company.
|
|
B.
|
Related Party Transactions
|
To our knowledge,
there are no related party transactions existing as of March 31, 2014.
Item 8. Financial
Information
Consolidated Statements and Other Financial Information
Our audited consolidated
financial statements appear in this annual report on Form 20-F. See “Item 18. Financial Statements.”
Legal Proceedings
Neither we nor our
subsidiaries are a party to, and our property is not the subject of, any material pending legal proceedings.
Dividend Distributions
We have never declared
or paid any cash dividends on our ordinary shares and do not anticipate paying any such cash dividends in the foreseeable future.
Any future determination to pay dividends will be at the discretion of our Board of Directors. Cash dividends may be paid by an
Israeli company only out of retained earnings as calculated under Israeli law. We currently have no retained earnings and do not
expect to have any retained earnings in the foreseeable future.
Significant Changes
On
February 21, 2013 and after the reporting date, the Company's special general meeting of shareholders and the general meeting
of holders of warrants (series 2) of the Company decided to extend the exercise period of said warrants from February 27, 2013
to December 31, 2013. This decision is subject to the approval of the District Court pursuant to Section 350 to the Israeli Companies
Law, 1999. On March 12, 2013 the Court approved the decision to extend the exercise price of the warrants. On January 14, 2014,
the general meeting of shareholders and the general meeting of holders of warrants (series 2) of the Company
resolved
to approve the extension of the term of warrants (series 2) of the Company until October 28, 2014, in accordance with the request
for a settlement filed with and granted by the Tel-Aviv-Jaffa district court.
ITEM 9. THE OFFER AND LISTING
Markets and Share Price History
On June 1, 2012,
the Company filed an application for relisting its ADRs on The Nasdaq Stock Exchange. On July 10, 2013, the Company received a
notice from Nasdaq stating that the admission committee had approved the Company's application to relist its ADRs for trading
on the Nasdaq Capital Market. Accordingly, on July 15, 2013, the Company's ADRs began trading on Nasdaq under the ticker symbol
“XTLB”.
American Depositary Shares
The following table
presents, for the periods indicated, the high and low market closing prices for our ADRs as reported on the Nasdaq Stock Market
from September 1, 2005 until April 16, 2009, on the Pink Sheets from April 17, 2009 until July 14, 2013, and on Nasdaq from July
15, 2013 to the present. For convenience of the readers of this report, the data below was adjusted so that all the quotes of
our ADRs price would represent the current ADR-NIS 0.1 par value ordinary share ratio, meaning 1:20.
|
|
US Dollar
|
|
|
|
High
|
|
|
Low
|
|
Last Six Calendar Months
|
|
|
|
|
|
|
|
|
March 2014 (until March 28, 2014)
|
|
|
4.01
|
|
|
|
3.55
|
|
February 2014
|
|
|
4.30
|
|
|
|
3.43
|
|
January 2014
|
|
|
3.80
|
|
|
|
2.73
|
|
December 2013
|
|
|
4.00
|
|
|
|
2.24
|
|
November 2013
|
|
|
5.37
|
|
|
|
3.80
|
|
October 2013
|
|
|
5.49
|
|
|
|
4.93
|
|
Financial Quarters During the Past Two Full
Fiscal Years
|
|
|
|
|
|
|
|
|
First Quarter of 2014 (until March 28, 2014)
|
|
|
4.30
|
|
|
|
2.73
|
|
Fourth Quarter of 2013
|
|
|
5.49
|
|
|
|
2.24
|
|
Third Quarter of 2013
|
|
|
7.00
|
|
|
|
5.28
|
|
Second Quarter of 2013
|
|
|
6.35
|
|
|
|
4.95
|
|
First Quarter of 2013
|
|
|
7.42
|
|
|
|
5.80
|
|
Fourth Quarter of 2012
|
|
|
7.80
|
|
|
|
5.66
|
|
Third Quarter of 2012
|
|
|
8.50
|
|
|
|
5.15
|
|
Second Quarter of 2012
|
|
|
6.90
|
|
|
|
4.7
|
|
First Quarter of 2012
|
|
|
6.95
|
|
|
|
3.00
|
|
Full Five Financial Years
|
|
|
|
|
|
|
|
|
2013
|
|
|
7.42
|
|
|
|
2.24
|
|
2012
|
|
|
8.50
|
|
|
|
3.00
|
|
2011
|
|
|
5.40
|
|
|
|
2.00
|
|
2010
|
|
|
4.70
|
|
|
|
0.55
|
|
2009
|
|
|
3.10
|
|
|
|
0.55
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth, for the
periods indicated, the high and low closing prices of the NIS 0.1 par value ordinary shares (after the 1:5 share consolidation
which was resolved on June 22, 2009) on the Tel-Aviv Stock Exchange. For comparative purposes only, we have also provided such
figures translated into US Dollars at an exchange rate of 3.498 New Israeli Shekel per US Dollar, as of March 28, 2014 according
to the Bank of Israel.
|
|
New Israeli Shekel
|
|
|
US Dollar
|
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
|
Low
|
|
Last Six Calendar Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 2014 (until March 28, 2014)
|
|
|
0.725
|
|
|
|
0.590
|
|
|
|
0.207
|
|
|
|
0.169
|
|
February 2014
|
|
|
0.733
|
|
|
|
0.584
|
|
|
|
0.210
|
|
|
|
0.167
|
|
January 2014
|
|
|
0.640
|
|
|
|
0.469
|
|
|
|
0.183
|
|
|
|
0.134
|
|
December 2013
|
|
|
0.651
|
|
|
|
0.383
|
|
|
|
0.186
|
|
|
|
0.109
|
|
November 2013
|
|
|
0.857
|
|
|
|
0.652
|
|
|
|
0.245
|
|
|
|
0.186
|
|
October 2013
|
|
|
0.974
|
|
|
|
0.866
|
|
|
|
0.278
|
|
|
|
0.248
|
|
Financial Quarters During the Past Two Full Fiscal Years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter of 2014 (until March 28, 2014)
|
|
|
0.733
|
|
|
|
0.469
|
|
|
|
0.210
|
|
|
|
0.134
|
|
Fourth Quarter of 2013
|
|
|
0.974
|
|
|
|
0.383
|
|
|
|
0.278
|
|
|
|
0.109
|
|
Third Quarter of 2013
|
|
|
1.259
|
|
|
|
0.978
|
|
|
|
0.360
|
|
|
|
0.280
|
|
Second Quarter of 2013
|
|
|
1.143
|
|
|
|
0.905
|
|
|
|
0.327
|
|
|
|
0.259
|
|
First Quarter of 2013
|
|
|
1.348
|
|
|
|
1.079
|
|
|
|
0.385
|
|
|
|
0.308
|
|
Fourth Quarter of 2012
|
|
|
1.439
|
|
|
|
1.118
|
|
|
|
0.411
|
|
|
|
0.320
|
|
Third Quarter of 2012
|
|
|
1.675
|
|
|
|
0.989
|
|
|
|
0.479
|
|
|
|
0.283
|
|
Second Quarter of 2012
|
|
|
1.218
|
|
|
|
0.858
|
|
|
|
0.348
|
|
|
|
0.245
|
|
First Quarter of 2012
|
|
|
1.230
|
|
|
|
0.521
|
|
|
|
0.352
|
|
|
|
0.149
|
|
Full Five Financial Years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013
|
|
|
1.348
|
|
|
|
0.383
|
|
|
|
0.385
|
|
|
|
0.109
|
|
2012
|
|
|
1.675
|
|
|
|
0.521
|
|
|
|
0.479
|
|
|
|
0.149
|
|
2011
|
|
|
0.950
|
|
|
|
0.414
|
|
|
|
0.272
|
|
|
|
0.118
|
|
2010
|
|
|
0.681
|
|
|
|
0.193
|
|
|
|
0.195
|
|
|
|
0.055
|
|
2009
|
|
|
0.594
|
|
|
|
0.020
|
|
|
|
0.170
|
|
|
|
0.006
|
|
ITEM 10. ADDITIONAL INFORMATION
Memorandum and Articles of Association
Objects and Purposes of the Company
Pursuant to Part B, Section 3 of our Articles
of Association, we may undertake any lawful activity.
Powers and Obligations of the Directors
Pursuant to the Israeli
Companies Law and our Articles of Association, a director is not permitted to vote on a proposal, arrangement or contract in which
he or she has a personal interest. Also, the directors may not vote on compensation to themselves or any members of their body,
as that term is defined under Israeli law, without the approval of our audit committee and our shareholders at a general meeting.
The power of our directors to enter into borrowing arrangements on our behalf is limited to the same extent as any other transaction
by us.
The Israeli Companies
Law codifies the fiduciary duties that office holders, including directors and executive officers, owe to a company. An office
holder’s fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care generally requires an office
holder to act with the same level of care as a reasonable office holder in the same position would employ under the same circumstances.
The duty of loyalty includes avoiding any conflict of interest between the office holder’s position in the company and such
person’s personal affairs, avoiding any competition with the company, avoiding exploiting any corporate opportunity of the
company in order to receive personal advantage for such person or others, and revealing to the company any information or documents
relating to the company’s affairs which the office holder has received due to his or her position as an office holder.
Indemnification of Directors and Officers; Limitations
on Liability
Israeli law permits
a company to insure an office holder in respect of liabilities incurred by him or her as a result of an act or omission in the
capacity of an office holder for:
|
·
|
a
breach of the office holder’s duty of care to the company or to another person;
|
|
·
|
a
breach of the office holder’s fiduciary duty to the company, provided that he or
she acted in good faith and had reasonable cause to believe that the act would not prejudice
the company; and
|
|
·
|
a
financial liability imposed upon the office holder in favor of another person.
|
Moreover, a company
can indemnify an office holder for any of the following obligations or expenses incurred in connection with the acts or omissions
of such person in his or her capacity as an office holder:
|
·
|
monetary
liability imposed upon him or her in favor of a third party by a judgment, including
a settlement or an arbitral award confirmed by the court; and
|
|
·
|
reasonable
litigation expenses, including attorneys’ fees, actually incurred by the office
holder or imposed upon him or her by a court, in a proceeding brought against him or
her by or on behalf of the company or by a third party, or in a criminal action in which
he or she was acquitted, or in a criminal action which does not require criminal intent
in which he or she was convicted; furthermore, a company can, with a limited exception,
exculpate an office holder in advance, in whole or in part, from liability for damages
sustained by a breach of duty of care to the company.
|
Our Articles of Association
allow for insurance, exculpation and indemnification of office holders to the fullest extent permitted by law. We have entered
into indemnification, insurance and exculpation agreements with our directors and executive officers, following shareholder approval
of these agreements. We have directors’ and officers’ liability insurance covering our officers and directors for
a claim imposed upon them as a result of an action carried out while serving as an officer or director, for (a) the breach of
duty of care towards us or towards another person, (b) the breach of fiduciary duty towards us, provided that the officer or director
acted in good faith and had reasonable grounds to assume that the action would not harm our interests, and (c) a monetary liability
imposed upon him in favor of a third party.
Approval of Related Party
Transactions under the Israeli Companies Law
Fiduciary
duties of the office holders
The Israeli Companies
Law imposes a duty of care and a duty of loyalty on all office holders of a company. The duty of care of an office holder is based
on the duty of care set forth in connection with the tort of negligence under the Israeli Torts Ordinance (New Version) 5728-1968.
This duty of care requires an office holder to act with the degree of proficiency with which a reasonable office holder in the
same position would have acted under the same circumstances. The duty of care includes a duty to use reasonable means, in light
of the circumstances, to obtain:
|
·
|
information
on the advisability of a given action brought for his or her approval or performed by
virtue of his or her position; and
|
|
·
|
All
other important information pertaining to these actions.
|
The duty of loyalty
requires an office holder to act in good faith and for the benefit of the company, and includes the duty to:
|
·
|
refrain
from any act involving a conflict of interest between the performance of his or her duties
in the company and his or her other duties or personal affairs;
|
|
·
|
refrain
from any activity that is competitive with the business of the company;
|
|
·
|
refrain
from exploiting any business opportunity of the company for the purpose of gaining a
personal advantage for himself or herself or others; and
|
|
·
|
disclose
to the company any information or documents relating to the company’s affairs which
the office holder received as a result of his or her position as an office holder.
|
We
may approve an act performed in breach of the duty of loyalty of an office holder provided that the office holder acted in good
faith, the act or its approval does not harm the company, and the office holder discloses his or her personal interest, as described
below.
Disclosure
of personal interests of an office holder and approval of acts and transactions
The
Israeli Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she may
have and all related material information or documents relating to any existing or proposed transaction by the company. An interested
office holder’s disclosure must be made promptly and in any event no later than the first meeting of the board of directors
at which the transaction is considered. An office holder is not obligated to disclose such information if the personal interest
of the office holder derives solely from the personal interest of his or her relative in a transaction that is not considered
as an extraordinary transaction.
The
term personal interest is defined under the Israeli Companies Law to include the personal interest of a person in an action or
in the business of a company, including the personal interest of such person’s relative or the interest of any corporation
in which the person is an interested party, but excluding a personal interest stemming solely from the fact of holding shares
in the company. A personal interest furthermore includes the personal interest of a person for whom the office holder holds a
voting proxy or the interest of the office holder with respect to his or her vote on behalf of the shareholder for whom he or
she holds a proxy even if such shareholder itself has no personal interest in the approval of the matter. An office holder is
not, however, obligated to disclose a personal interest if it derives solely from the personal interest of his or her relative
in a transaction that is not considered an extraordinary transaction.
Under
the Israeli Companies Law, an extraordinary transaction which requires approval is defined any of the following:
|
·
|
a
transaction other than in the ordinary course of business;
|
|
·
|
a
transaction that is not on market terms; or
|
|
·
|
a
transaction that may have a material impact on the company’s profitability, assets
or liabilities.
|
Under the Israeli
Companies Law, once an office holder has complied with the disclosure requirement described above, a company may approve a transaction
between the company and the office holder or a third party in which the office holder has a personal interest, or approve an action
by the office holder that would otherwise be deemed a breach of duty of loyalty. However, a company may not approve a transaction
or action that is adverse to the company’s interest or that is not performed by the office holder in good faith.
Under
the Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder, a transaction
with a third party in which the office holder has a personal interest, and an action of an office holder that would otherwise
be deemed a breach of duty of loyalty requires approval by the board of directors. Our Articles of Association do not provide
otherwise. If the transaction or action considered is (i) an extraordinary transaction, (ii) an action of an office holder that
would otherwise be deemed a breach of duty of loyalty and may have a material impact on a company’s profitability, assets
or liabilities, (iii) an undertaking to indemnify or insure an office holder who is not a director, or (iv) for matters considered
an undertaking concerning the terms of compensation of an office holder who is not a director, including, an undertaking to indemnify
or insure such office holder, then approval by the audit committee is required prior to approval by the board of directors. Arrangements
regarding the compensation, indemnification or insurance of a director require the approval of the audit committee, board of directors
and shareholders, in that order.
A
director who has a personal interest in a matter that is considered at a meeting of the board of directors or the audit committee
may generally not be present at the meeting or vote on the matter, unless a majority of the directors or members of the audit
committee have a personal interest in the matter or the chairman of the audit committee or board of directors, as applicable,
determines that he or she should be present to present the transaction that is subject to approval. If a majority of the directors
have a personal interest in the matter, such matter would also require approval of the shareholders of the company.
Disclosure
of personal interests of a controlling shareholder and approval of transactions
Under
the Israeli Companies Law and a recent amendment thereto, the disclosure requirements that apply to an office holder also apply
to a controlling shareholder of a public company. See “Audit Committee” for a definition of controlling shareholder.
Extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, including
a private placement in which a controlling shareholder has a personal interest, as well as transactions for the provision of services
whether directly or indirectly by a controlling shareholder or his or her relative, or a company such controlling shareholder
controls, and transactions concerning the terms of engagement of a controlling shareholder or a controlling shareholder’s
relative, whether as an office holder or an employee, require the approval of the audit committee, the board of directors and
a majority of the shares voted by the shareholders of the company participating and voting on the matter in a shareholders’
meeting. In addition, such shareholder approval must fulfill one of the following requirements:
|
·
|
at
least a majority of the shares held by shareholders who have no personal interest in
the transaction and are voting at the meeting must be voted in favor of approving the
transaction, excluding abstentions; or
|
|
·
|
the
shares voted by shareholders who have no personal interest in the transaction who vote
against the transaction represent no more than 2% of the voting rights in the company.
|
To
the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval is
required once every three years, unless the audit committee determines that the duration of the transaction is reasonable given
the circumstances related thereto.
Duties of
shareholders
Under
the Israeli Companies Law, a shareholder has a duty to refrain from abusing its power in the company and to act in good faith
and in an acceptable manner in exercising its rights and performing its obligations to the company and other shareholders, including,
among other things, voting at general meetings of shareholders on the following matters:
|
·
|
an
amendment to the articles of association;
|
|
·
|
an
increase in the company’s authorized share capital;
|
|
·
|
an
increase in the company’s authorized share capital; and
|
|
·
|
the
approval of related party transactions and acts of office holders that require shareholder
approval.
|
A
shareholder also has a general duty to refrain from discriminating against other shareholders.
The
remedies generally available upon a breach of contract will also apply to a breach of the above mentioned duties, and in the event
of discrimination against other shareholders, additional remedies are available to the injured shareholder.
In
addition, any controlling shareholder, any shareholder that knows that its vote can determine the outcome of a shareholder vote
and any shareholder that, under a company’s articles of association, has the power to appoint or prevent the appointment
of an office holder, or has another power with respect to a company, is under a duty to act with fairness towards the company.
The Israeli Companies Law does not describe the substance of this duty except to state that the remedies generally available upon
a breach of contract will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s
position in the company into account.
ORDINARY SHARES
Rights Attached to Ordinary Shares
Through March 18,
2009, our authorized share capital was NIS 10,000,000 consisting of 500,000,000 ordinary shares, par value NIS 0.02 per share.
On March 18, 2009, pursuant to a shareholder’s meeting, the share capital of our company was consolidated and re-divided
so that each five (5) shares of NIS 0.02 nominal value was consolidated into one (1) share of NIS 0.1 nominal value so that following
such consolidation and re-division, our authorized share capital consisted of 100,000,000 ordinary shares, par value NIS 0.10
per share. In addition, the authorized share capital of our company was increased from NIS 10,000,000 to NIS 70,000,000 divided
into 700,000,000 ordinary shares, NIS 0.10 nominal value. The share consolidation was effected in June 22, 2009.
Holders of ordinary
shares have one vote per share, and are entitled to participate equally in the payment of dividends and share distributions and,
in the event of our liquidation, in the distribution of assets after satisfaction of liabilities to creditors. No preferred shares
are currently authorized. All outstanding ordinary shares are validly issued and fully paid.
Transfer of Shares
Fully paid ordinary
shares are issued in registered form and may be freely transferred under our Articles of Association unless the transfer is restricted
or prohibited by another instrument or applicable securities laws.
Dividend and Liquidation Rights
We may declare a dividend
to be paid to the holders of ordinary shares according to their rights and interests in our profits. In the event of our liquidation,
after satisfaction of liabilities to creditors, our assets will be distributed to the holders of ordinary shares in proportion
to the nominal value of their holdings.
This right may be
affected by the grant of preferential dividend or distribution rights, to the holders of a class of shares with preferential rights
that may be authorized in the future. Under the Israeli Companies Law, the declaration of a dividend does not require the approval
of the shareholders of the company, unless the company's articles of association require otherwise. Our Articles provide that
the Board of Directors may declare and distribute dividends without the approval of the shareholders.
Annual and Extraordinary General
Meetings
We must hold our annual
general meeting of shareholders each year no later than 15 months from the last annual meeting, at a time and place determined
by the Board of Directors, upon at least 21 days’ prior notice to our shareholders, to which we need to add an additional
three days for notices sent outside of Israel. A special meeting may be convened by request of two directors, 25% of the directors
then in office, one or more shareholders holding at least 5% of our issued share capital and at least 1% of our issued voting
rights, or one or more shareholders holding at least 5% of our issued voting rights. Notice of a general meeting must set forth
the date, time and place of the meeting. Such notice must be given at least 21 days but not more than 45 days prior to the general
meeting. The quorum required for a meeting of shareholders consists of at least two shareholders present in person or by proxy
who hold or represent between them at least one-third of the voting rights in the company. A meeting adjourned for lack of a quorum
generally is adjourned to the same day in the following week at the same time and place (with no need for any notice to the shareholders)
or until such other later time if such time is specified in the original notice convening the general meeting, or if we serve
notice to the shareholders no less than seven days before the date fixed for the adjourned meeting. If at an adjourned meeting
there is no quorum present half an hour after the time set for the meeting, any number participating in the meeting shall represent
a quorum and shall be entitled to discuss the matters set down on the agenda for the original meeting. All shareholders who are
registered in our registrar on the record date, or who will provide us with proof of ownership on that date as applicable to the
relevant registered shareholder, are entitled to participate in a general meeting and may vote as described in “Voting Rights”
and “Voting by Proxy and in Other Manners,” below.
Voting Rights
Our ordinary shares
do not have cumulative voting rights in the election of directors. As a result, the holders of ordinary shares that represent
more than 50% of the voting power represented at a shareholders meeting in which a quorum is present have the power to elect all
of our directors, except the external directors whose election requires a special majority.
Holders of ordinary
shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders. Shareholders may vote in
person or by proxy. These voting rights may be affected by the grant of any special voting rights to the holders of a class of
shares with preferential rights that may be authorized in the future.
Under the Israeli
Companies Law, unless otherwise provided in the Articles of Association or by applicable law, all resolutions of the shareholders
require a simple majority. Our Articles of Association provide that all decisions may be made by a simple majority. See “–Approval
of Certain Transactions” above for certain duties of shareholders towards the company.
Voting by Proxy and in Other Manners
Our Articles of Association
enable a shareholder to appoint a proxy, who need not be a shareholder, to vote at any shareholders meeting. We require that the
appointment of a proxy be in writing signed by the person making the appointment or by an attorney authorized for this purpose,
and if the person making the appointment is a corporation, by a person or persons authorized to bind the corporation. In the document
appointing a proxy, each shareholder may specify how the proxy should vote on any matter presented at a shareholders meeting.
The document appointing the proxy shall be deposited in our offices or at such other address as shall be specified in the notice
of the meeting not less than 48 hours before the time of the meeting at which the person specified in the appointment is due to
vote.
The Israeli Companies
Law and our Articles of Association do not permit resolutions of the shareholders to be adopted by way of written consent, for
as long as our ordinary shares are publicly traded.
Limitations on the Rights to Own
Securities
The ownership or voting
of ordinary shares by non-residents of Israel is not restricted in any way by our Articles of Association or the laws of the State
of Israel, except that nationals of countries which are, or have been, in a state of war with Israel may not be recognized as
owners of ordinary shares.
Anti-Takeover Provisions under Israeli
Law
The Israeli Companies
Law permits merger transactions with the approval of each party’s board of directors and shareholders. In accordance with
the Israeli Companies Law, a merger may be approved at a shareholders meeting by a majority of the voting power represented at
the meeting, in person or by proxy, and voting on that resolution. In determining whether the required majority has approved the
merger, shares held by the other party to the merger, any person holding at least 25% of the outstanding voting shares or means
of appointing the board of directors of the other party to the merger, or the relatives or companies controlled by these persons,
are excluded from the vote.
Under the Israeli
Companies Law, a merging company must inform its creditors of the proposed merger. Any creditor of a party to the merger may seek
a court order blocking the merger, if there is a reasonable concern that the surviving company will not be able to satisfy all
of the obligations of the parties to the merger. Moreover, a merger may not be completed until at least 30 days have passed from
the time the merger was approved in a general meeting of each of the merging companies, and at least 50 days have passed from
the time that a merger proposal was filed with the Israeli Registrar of Companies.
Israeli corporate
law provides that an acquisition of shares in a public company must be made by means of a tender offer if, as a result of such
acquisition, the purchaser would become a 25% or greater shareholder of the company. This rule does not apply if there is already
another shareholder with 25% or greater shares in the company. Similarly, Israeli corporate law provides that an acquisition of
shares in a public company must be made by means of a tender offer if, as a result of the acquisition, the purchaser's shareholdings
would entitle the purchaser to over 45% of the shares in the company, unless there is a shareholder with 45% or more of the shares
in the company. These requirements do not apply if, in general, the acquisition (1) was made in a private placement that received
the approval of the company’s shareholders; (2) was from a 25% or greater shareholder of the company which resulted in the
purchaser becoming a 25% or greater shareholder of the company, or (3) was from a 45% or greater shareholder of the company which
resulted in the acquirer becoming a 45% or greater shareholder of the company. These rules do not apply if the acquisition is
made by way of a merger. Regulations promulgated under the Israeli Companies Law provide that these tender offer requirements
do not apply to companies whose shares are listed for trading external of Israel if, according to the law in the country in which
the shares are traded, including the rules and regulations of the stock exchange or which the shares are traded, either:
|
·
|
there
is a limitation on acquisition of any level of control of the company; or
|
|
·
|
the
acquisition of any level of control requires the purchaser to do so by means of a tender
offer to the public.
|
The Israeli Companies
Law provides specific rules and procedures for the acquisition of shares held by minority shareholders, if the majority shareholder
holds more than 90% of the outstanding shares. If, as a result of an acquisition of shares, the purchaser will hold more than
90% of a company’s outstanding shares, the acquisition must be made by means of a tender offer for all of the outstanding
shares. If less than 5% of the outstanding shares are not tendered in the tender offer, all the shares that the purchaser offered
to purchase will be transferred to it. The Israeli Companies Law provides for appraisal rights if any shareholder files a request
in court within three months following the consummation of a full tender offer. If more than 5% of the outstanding shares are
not tendered in the tender offer, then the purchaser may not acquire shares in the tender offer that will cause his shareholding
to exceed 90% of the outstanding shares of the company. Israeli tax law treats specified acquisitions, including a stock-for-stock
swap between an Israeli company and a foreign company, less favorably than does US tax law. These laws may have the effect of
delaying or deterring a change in control of us, thereby limiting the opportunity for shareholders to receive a premium for their
shares and possibly affecting the price that some investors are willing to pay for our securities.
Rights of Shareholders
Under the Israeli
Companies Law, our shareholders have the right to inspect certain documents and registers including the minutes of general meetings,
the register of shareholders and the register of substantial shareholders, any document held by us that relates to an act or transaction
requiring the consent of the general meeting as stated above under “Approval of Certain Transactions,” our Articles
of Association and our financial statements, and any other document which we are required to file under the Israeli Companies
Law or under any law with the Registrar of Companies or the Israeli Securities Authority, and is available for public inspection
at the Registrar of Companies or the Securities Authority, as the case may be.
If the document required
for inspection by one of our shareholders relates to an act or transaction requiring the consent of the general meeting as stated
above, we may refuse the request of the shareholder if in our opinion the request was not made in good faith, the documents requested
contain a commercial secret or a patent, or disclosure of the documents could prejudice our good in some other way.
The Israeli Companies
Law provides that with the approval of the court any of our shareholders or directors may file a derivative action on our behalf
if the court finds the action is a priori, to our benefit, and the person demanding the action is acting in good faith. The demand
to take action can be filed with the court only after it is serviced to us, and we decline or omit to act in accordance to this
demand.
Enforceability of Civil Liabilities
We are incorporated
in Israel and most of our directors and officers and the Israeli experts named in this report reside outside the US. Service of
process upon them may be difficult to effect within the US. Furthermore, because substantially all of our assets, and those of
our non-US directors and officers and the Israeli experts named herein, are located outside the US, any judgment obtained in the
US against us or any of these persons may not be collectible within the US.
We have been informed
by our legal counsel in Israel, Kantor & Co., that there is doubt as to the enforceability of civil liabilities under the
Securities Act or the Exchange Act, pursuant to original actions instituted in Israel. However, subject to particular time limitations,
executory judgments of a US court for monetary damages in civil matters may be enforced by an Israeli court, provided that:
|
·
|
the
judgment was obtained after due process before a court of competent jurisdiction, that
recognizes and enforces similar judgments of Israeli courts, and the court had authority
according to the rules of private international law currently prevailing in Israel;
|
|
·
|
adequate
service of process was effected and the defendant had a reasonable opportunity to be
heard;
|
|
·
|
the
judgment is not contrary to the law, public policy, security or sovereignty of the State
of Israel and its enforcement is not contrary to the laws governing enforcement of judgments;
|
|
·
|
the
judgment was not obtained by fraud and does not conflict with any other valid judgment
in the same matter between the same parties;
|
|
·
|
the
judgment is no longer appealable; and
|
|
·
|
an
action between the same parties in the same matter is not pending in any Israeli court
at the time the lawsuit is instituted in the foreign court.
|
We have irrevocably
appointed XTL Biopharmaceuticals, Inc., our US subsidiary, as our agent to receive service of process in any action against us
in any US federal court or the courts of the State of New York.
Foreign judgments
enforced by Israeli courts generally will be payable in Israeli currency. The usual practice in an action before an Israeli court
to recover an amount in a non-Israeli currency is for the Israeli court to render judgment for the equivalent amount in Israeli
currency at the rate of exchange in force on the date of the judgment. Under existing Israeli law, a foreign judgment payable
in foreign currency may be paid in Israeli currency at the rate of exchange for the foreign currency published on the day before
date of payment. Current Israeli exchange control regulations also permit a judgment debtor to make payment in foreign currency.
Pending collection, the amount of the judgment of an Israeli court stated in Israeli currency ordinarily may be linked to Israel’s
consumer price index plus interest at the annual statutory rate set by Israeli regulations prevailing at that time. Judgment creditors
must bear the risk of unfavorable exchange rates.
AMERICAN DEPOSITARY RECEIPTS
We have issued and
deposited ordinary shares with Bank Hapoalim B.M., The Bank of New York’s custodian in Tel Aviv, Israel. The Bank of New
York in turn issued American Depositary Receipts, or ADRs, representing American Depositary Shares, or ADSs. One ADR represents
an ownership interest in twenty of our ordinary shares. Each ADR also represents securities, cash or other property deposited
with The Bank of New York but not distributed to ADR holders. The Bank of New York’s Corporate Trust Office is located at
101 Barclay Street, New York, NY 10286, U.S.A. Their principal executive office is located at One Wall Street, New York, NY 10286,
U.S.A.
You may hold ADRs
either directly or indirectly through your broker or other financial institution. If you hold ADRs directly, you are an ADR holder.
This description assumes you hold your ADRs directly. If you hold the ADRs indirectly, you must rely on the procedures of your
broker or other financial institution to assert the rights of ADR holders described in this section. You should consult with your
broker or financial institution to find out what those procedures are.
Because The Bank of
New York will actually hold the ordinary shares, you must rely on it to exercise the rights of a shareholder. The obligations
of The Bank of New York are set out in a deposit agreement among us, The Bank of New York and you, as an ADR holder. The agreement
and the ADRs are generally governed by New York law.
The following is a
summary of the agreement. Because it is a summary, it does not contain all the information that may be important to you. For more
complete information, you should read the entire agreement and the ADR. Directions on how to obtain copies of these are provided
in the section entitled “Where You Can Find More Information.”
Share Dividends and Other Distributions
The Bank of New York
has agreed to pay to you the cash dividends or other distributions it or the custodian receives on shares or other deposited securities
after deducting its fees and expenses. You will receive these distributions in proportion to the number of shares your ADRs represent.
Cash.
The Bank
of New York will convert any cash dividend or other cash distribution we pay on the shares into U.S. dollars, if it can do so
on a reasonable basis and can transfer the U.S. dollars to the U.S. If that is not possible or if any approval from any government
or agency thereof is needed and cannot be obtained, the agreement allows The Bank of New York to distribute the foreign currency
only to those ADR holders to whom it is possible to do so. It will hold the foreign currency it cannot convert for the account
of the ADR holders who have not been paid. It will not invest the foreign currency and it will not be liable for the interest.
Before making a distribution,
any withholding taxes that must be paid under U.S. law will be deducted. The Bank of New York will distribute only whole U.S.
dollars and cents and will round fractional cents to the nearest whole cent. If the exchange rates fluctuate during a time when
The Bank of New York cannot convert the foreign currency, you may lose some or all of the value of the distribution.
Shares.
The
Bank of New York may distribute new ADRs representing any shares we may distribute as a dividend or free distribution, if we furnish
it promptly with satisfactory evidence that it is legal to do so. The Bank of New York will only distribute whole ADRs. It will
sell shares which would require it to use a fractional ADR and distribute the net proceeds in the same way as it does with cash.
If The Bank of New York does not distribute additional ADRs, each ADR will also represent the new shares.
Rights to receive
additional shares
. If we offer holders of our ordinary shares any rights to subscribe for additional shares or any other rights,
The Bank of New York may make these rights available to you. We must first instruct The Bank of New York to do so and furnish
it with satisfactory evidence that it is legal to do so. If we do not furnish this evidence and/or give these instructions, and
The Bank of New York decides it is practical to sell the rights, The Bank of New York will sell the rights and distribute the
proceeds, in the same way as it does with cash. The Bank of New York may allow rights that are not distributed or sold to lapse.
In that case, you will receive no value for them. If The Bank of New York makes rights available to you, upon instruction from
you, it will exercise the rights and purchase the shares on your behalf. The Bank of New York will then deposit the shares and
issue ADRs to you. It will only exercise rights if you pay it the exercise price and any other charges the rights require you
to pay.
U.S. securities laws
may restrict the sale, deposit, cancellation and transfer of the ADRs issued after exercise of rights. For example, you may not
be able to trade the ADRs freely in the U.S. In this case, The Bank of New York may issue the ADRs under a separate restricted
deposit agreement which will contain the same provisions as the agreement, except for the changes needed to put the restrictions
in place.
Other Distributions
.
The Bank of New York will send to you anything else we distribute on deposited securities by any means it thinks is legal, fair
and practical. If it cannot make the distribution in that way, The Bank of New York has a choice. It may decide to sell what we
distributed and distribute the net proceeds in the same way as it does with cash or it may decide to hold what we distributed,
in which case the ADRs will also represent the newly distributed property.
The Bank of New York
is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADR holders. We have
no obligation to register ADRs, shares, rights or other securities under the Securities Act. We also have no obligation to take
any other action to permit the distribution of ADRs, shares, rights or anything else to ADR holders. This means that you may not
receive the distribution we make on our shares or any value for them if it is illegal or impractical for us to make them available
to you.
Deposit, Withdrawal and Cancellation
The Bank of New York
will issue ADRs if you or your broker deposit shares or evidence of rights to receive shares with the custodian upon payment of
its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees. The Bank of New York will
register the appropriate number of ADRs in the names you request and will deliver the ADRs at its office to the persons you request.
You may turn in your
ADRs at The Bank of New York’s office. Upon payment of its fees and expenses and of any taxes or charges, such as stamp
taxes or stock transfer taxes or fees, The Bank of New York will deliver (1) the underlying shares to an account designated by
you and (2) any other deposited securities underlying the ADR at the office of the custodian; or, at your request, risk and expense,
The Bank of New York will deliver the deposited securities at its office.
Voting Rights
You may instruct The
Bank of New York to vote the shares underlying your ADRs but only if we ask The Bank of New York to ask for your instructions.
Otherwise, you won’t be able to exercise your right to vote unless you withdraw the shares. However, you may not know about
the meeting enough in advance to withdraw the shares.
If we ask for your
instructions, The Bank of New York will notify you of the upcoming vote and arrange to deliver our voting materials to you. The
materials will (1) describe the matters to be voted on and (2) explain how you, on a certain date, may instruct The Bank of New
York to vote the shares or other deposited securities underlying your ADRs as you direct. For instructions to be valid, The Bank
of New York must receive them on or before the date specified. The Bank of New York will try, as far as practical, subject to
Israeli law and the provisions of our Articles of Association, to vote or to have its agents vote the shares or other deposited
securities as you instruct. The Bank of New York will only vote or attempt to vote as you instruct. However, if The Bank of New
York does not receive your voting instructions, it will deem you to have instructed it to give a discretionary proxy to vote the
shares underlying your ADRs to a person designated by us provided that no such instruction shall be deemed given and no such discretionary
proxy shall be given with respect to any matter as to which we inform The Bank of New York that (x) we do not wish such proxy
given, (y) substantial opposition exists, (z) such matter materially affects the rights of the holders of the shares underlying
the ADRs.
We cannot assure you
that you will receive the voting materials in time to ensure that you can instruct The Bank of New York to vote your shares. In
addition, The Bank of New York and its agents are not responsible for failing to carry out voting instructions or for the manner
of carrying out voting instructions. This means that you may not be able to exercise your right to vote and there may be nothing
you can do if your shares are not voted as you requested.
Rights of Non-Israeli Shareholders
to Vote
Our ADRs may be freely
held and traded pursuant to the General Permit and the Currency Control Law. The ownership or voting of ADRs by non-residents
of Israel are not restricted in any way by our Articles of Association or by the laws of the State of Israel.
Fees and Expenses
ADR holders must pay:
|
|
For:
|
$5.00 (or less) per 100 ADRs
(or portion thereof)
|
|
Each issuance of an ADR, including as a result of a
distribution of shares or rights or other property.
Each cancellation of an ADR, including if the agreement
terminates.
|
$0.05 (or less) per ADR
|
|
Any cash payment.
|
Registration or Transfer Fees
|
|
Transfer and registration of shares on the share register
of the Foreign Registrar from your name to the name of The Bank of New York or its agent when you deposit or withdraw
shares.
|
Expenses of The Bank of New York
|
|
Conversion of foreign currency to U.S. dollars.
Cable, telex and facsimile transmission expenses.
Servicing of shares or deposited securities.
|
$0.02 (or less) per ADR per calendar year (if the depositary
has not collected any cash distribution fee during that year)
|
|
Depositary services.
|
Taxes and other governmental charges
|
|
As necessary The Bank of New York or the Custodian
have to pay on any ADR or share underlying an ADR, for example, stock transfer taxes, stamp duty or withholding taxes.
|
A fee equivalent to the fee that would be payable if securities distributed to you had been
ordinary shares and the ordinary shares had been deposited for issuance of ADRs
|
|
Distribution of securities distributed to holders of deposited securities which are distributed
by the depositary to ADR holders.
|
Payment of Taxes
You will be responsible
for any taxes or other governmental charges payable on your ADRs or on the deposited securities underlying your ADRs. The Bank
of New York may refuse to transfer your ADRs or allow you to withdraw the deposited securities underlying your ADRs until such
taxes or other charges are paid. It may apply payments owed to you or sell deposited securities underlying your ADRs to pay any
taxes owed and you will remain liable for any deficiency. If it sells deposited securities, it will, if appropriate, reduce the
number of ADRs to reflect the sale and pay to you any proceeds, or send to you any property, remaining after it has paid the taxes.
Reclassifications, Recapitalizations and Mergers
If we:
|
|
Then:
|
Change the nominal or par value of our shares;
|
|
The cash, shares or other securities received by The
Bank of New York
will become deposited securities. Each ADR will automatically
represent its equal share of the new deposited securities. The Bank of New York may, and will if we ask it to, distribute
some or all of the cash, shares or other securities it received. It may also issue new ADRs or ask you to surrender your
outstanding ADRs in exchange for new ADRs, identifying the new deposited securities.
|
Reclassify, split up or consolidate any of the deposited
securities;
|
|
Distribute securities on the shares that are not distributed
to you; or
|
|
|
Recapitalize, reorganize, merge, liquidate, sell all
or substantially all of
our assets, or takes any similar action.
|
|
|
Amendment and Termination
We may agree with
The Bank of New York to amend the agreement and the ADRs without your consent for any reason. If the amendment adds or increases
fees or charges, except for taxes and other governmental charges or registration fees, cable, telex or facsimile transmission
costs, delivery costs or other such expenses, or prejudices an important right of ADR holders, it will only become effective thirty
days after The Bank of New York notifies you of the amendment. At the time an amendment becomes effective, you are considered,
by continuing to hold your ADR, to agree to the amendment and to be bound by the ADRs and the agreement is amended.
The Bank of New York
will terminate the agreement if we ask it to do so. The Bank of New York may also terminate the agreement if The Bank of New York
has told us that it would like to resign and we have not appointed a new depositary bank within ninety days. In both cases, The
Bank of New York must notify you at least ninety days before termination.
After termination,
The Bank of New York and its agents will be required to do only the following under the agreement: (1) advise you that the agreement
is terminated, and (2) collect distributions on the deposited securities and deliver shares and other deposited securities upon
cancellation of ADRs. After termination, The Bank of New York will, if practical, sell any remaining deposited securities by public
or private sale. After that, The Bank of New York will hold the proceeds of the sale, as well as any other cash it is holding
under the agreement for the pro rata benefit of the ADR holders that have not surrendered their ADRs. It will not invest the money
and will have no liability for interest. The Bank of New York’s only obligations will be to account for the proceeds of
the sale and other cash. After termination our only obligations will be with respect to indemnification and to pay certain amounts
to The Bank of New York.
Limitations on Obligations and Liability
to ADR Holders
The agreement expressly
limits our obligations and the obligations of The Bank of New York, and it limits our liability and the liability of The Bank
of New York. We and The Bank of New York:
|
·
|
are
only obligated to take the actions specifically set forth in the agreement without negligence
or bad faith;
|
|
·
|
are
not liable if either is prevented or delayed by law or circumstances beyond their control
from performing their obligations under the agreement;
|
|
·
|
are
not liable if either exercises discretion permitted under the agreement;
|
|
·
|
have
no obligation to become involved in a lawsuit or other proceeding related to the ADRs
or the agreement on your behalf or on behalf of any other party; and
|
|
·
|
may
rely upon any documents they believe in good faith to be genuine and to have been signed
or presented by the proper party.
|
In the agreement,
we and The Bank of New York agree to indemnify each other under certain circumstances.
Requirements for Depositary Actions
Before The Bank of
New York will issue or register transfer of an ADR, make a distribution on an ADR, or make a withdrawal of shares, The Bank of
New York may require payment of stock transfer or other taxes or other governmental charges and transfer or registration fees
charged by third parties for the:
|
·
|
transfer
of any shares or other deposited securities;
|
|
·
|
production
of satisfactory proof of the identity and genuineness of any signature or other information
it deems necessary, and
|
|
·
|
compliance
with regulations it may establish, from time to time, consistent with the agreement,
including presentation of transfer documents.
|
The Bank of New York
may refuse to deliver, transfer, or register transfers of ADRs generally when the books of The Bank of New York or our books are
closed, or at any time if The Bank of New York or we think it advisable to do so. You have the right to cancel your ADRs and withdraw
the underlying shares at any time except:
|
·
|
when
temporary delays arise because: (1) The Bank of New York or we have closed its transfer
books; (2) the transfer of shares is blocked to permit voting at a shareholders’
meeting; or (3) we are paying a dividend on the shares; or
|
|
·
|
when
it is necessary to prohibit withdrawals in order to comply with any laws or governmental
regulations that apply to ADRs or to the withdrawal of shares or other deposited securities.
|
This right of withdrawal
may not be limited by any other provision of the agreement.
Pre-Release of ADRs
In certain circumstances,
subject to the provisions of the agreement, The Bank of New York may issue ADRs before deposit of the underlying shares. This
is called a pre-release of the ADR. The Bank of New York may also deliver shares upon cancellation of pre-released ADRs (even
if the ADRs are cancelled before the pre-release transaction has been closed out). A pre-release is closed out as soon as the
underlying shares are delivered to The Bank of New York. The Bank of New York may receive ADRs instead of shares to close out
a pre-release. The Bank of New York may pre-release ADRs only under the following conditions: (1) before or at the time of the
pre-release, the person to whom the pre-release is being made must represent to The Bank of New York in writing that it or its
customer owns the shares or ADRs to be deposited; (2) the pre-release must be fully collateralized with cash or other collateral
that The Bank of New York considers appropriate; and (3) The Bank of New York must be able to close out the pre-release on not
more than five business days’ notice. In addition, The Bank of New York will limit the number of ADRs that may be outstanding
at any time as a result of prerelease, although The Bank of New York may disregard the limit from time to time, if it thinks it
is appropriate to do so.
Inspection of Books of the Depositary
Under the terms of
the agreement, holders of ADRs may inspect the transfer books of the depositary at any reasonable time, provided that such inspection
shall not be for the purpose of communicating with holders of ADRs in the interest of a business or object other than either our
business or a matter related to the deposit agreement or ADRs.
Book-Entry Only Issuance - The Depository
Trust Company
The Depository Trust
Company, or DTC, New York, New York, will act as securities depository for the ADRs. The ADRs will be represented by one global
security that will be deposited with and registered in the name of Cede & Co. (DTC’s partnership nominee), or such other
name as may be requested by an authorized representative of DTC. This means that we will not issue certificates to you for the
ADRs. One global security will be issued to DTC, which will keep a computerized record of its participants (for example, your
broker) whose clients have purchased the ADRs. Each participant will then keep a record of its clients. Unless it is exchanged
in whole or in part for a certificated security, a global security may not be transferred. However, DTC, its nominees, and their
successors may transfer a global security as a whole to one another. Beneficial interests in the global security will be shown
on, and transfers of the global security will be made only through, records maintained by DTC and its participants.
DTC is a limited-purpose
trust company organized under the New York Banking Law, a “banking organization” within the meaning of the New York
Banking Law, a member of the United States Federal Reserve System, a “clearing corporation” within the meaning of
the New York Uniform Commercial Code and a “clearing agency” registered under the provisions of Section 17A of
the Exchange Act . DTC holds securities that its participants (direct participants) deposit with DTC. DTC also records the settlement
among direct participants of securities transactions, such as transfers and pledges, in deposited securities through computerized
records for direct participant’s accounts. This eliminates the need to exchange certificates. Direct participants include
securities brokers and dealers, banks, trust companies, clearing corporations and certain other organizations.
DTC’s book-entry
system is also used by other organizations such as securities brokers and dealers, banks and trust companies that work through
a direct participant. The rules that apply to DTC and its participants are on file with the SEC.
DTC is a wholly-owned
subsidiary of The Depository Trust & Clearing Corporation, or DTCC. DTCC is, in turn, owned by a number of DTC’s direct
participants and by the New York Stock Exchange, Inc., the American Stock Exchange, Inc. and the National Association
of Securities Dealers, Inc.
When you purchase
ADRs through the DTC system, the purchases must be made by or through a direct participant, who will receive credit for the ADRs
on DTC’s records. Since you actually own the ADRs, you are the beneficial owner and your ownership interest will only be
recorded on the direct (or indirect) participants’ records. DTC has no knowledge of your individual ownership of the ADRs.
DTC’s records only show the identity of the direct participants and the amount of ADRs held by or through them. You will
not receive a written confirmation of your purchase or sale or any periodic account statement directly from DTC. You will receive
these from your direct (or indirect) participant. Thus the direct (or indirect) participants are responsible for keeping accurate
account of the holdings of their customers like you.
We will wire dividend
payments to DTC’s nominee, and we will treat DTC’s nominee as the owner of the global security for all purposes. Accordingly,
we will have no direct responsibility or liability to pay amounts due on the global security to you or any other beneficial owners
in the global security.
Any redemption notices
will be sent by us directly to DTC, who will in turn inform the direct participants, who will then contact you as a beneficial
holder.
It is DTC’s
current practice, upon receipt of any payment of dividends or liquidation amount, to credit direct participants’ accounts
on the payment date based on their holdings of beneficial interests in the global securities as shown on DTC’s records.
In addition, it is DTC’s current practice to assign any consenting or voting rights to direct participants whose accounts
are credited with preferred securities on a record date, by using an omnibus proxy. Payments by participants to owners of beneficial
interests in the global securities, and voting by participants, will be based on the customary practices between the participants
and owners of beneficial interests, as is the case with the ADRs held for the account of customers registered in “street
name.” However, payments will be the responsibility of the participants and not of DTC or us.
ADRs represented by
a global security will be exchangeable for certificated securities with the same terms in authorized denominations only if:
|
·
|
DTC
is unwilling or unable to continue as depositary or if DTC ceases to be a clearing agency
registered under applicable law and a successor depositary is not appointed by us within
90 days; or
|
|
·
|
we
determine not to require all of the ADRs to be represented by a global security.
|
If the book-entry
only system is discontinued, the transfer agent will keep the registration books for the ADRs at its corporate office.
The information in
this section concerning DTC and DTC’s book-entry system has been obtained from sources we believe to be reliable, but we
take no responsibility for the accuracy thereof.
Material Contracts
Bio-Gal Ltd.
On March 18, 2009,
we announced that we had entered into an asset purchase agreement with Bio-Gal Ltd. (“Bio-Gal”), a Gibraltar private
company, for the rights to a use patent on Recombinant Erythropoietin (“rHuEPO”) for the prolongation of Multiple
Myeloma patients’ survival and improvement of their quality of life. On December 31, 2009, we amended the asset purchase
agreement with Bio-Gal, so that XTL could acquire XTEPO Ltd., a special purpose company that was established by Bio-Gal’s
shareholders who received from Bio-Gal all of Bio-Gal’s rights on rHuEPO and raised approximately $1.5 million. We intend
to develop rHuEPO for the prolongation of Multiple Myeloma patients’ survival and improvement of their quality of life.
Multiple Myeloma is a severe and incurable malignant hematological cancer of plasma cells. In accordance with the terms of the
amended asset purchase agreement, we issued to XTEPO’s shareholders ordinary shares representing approximately 69.44% of
our then issued and outstanding ordinary share capital. In addition, the parties agreed to cancel a $10 million cash milestone
payment to Bio-Gal upon the successful completion of a Phase 2 clinical trial, which was under the original asset purchase agreement.
We are obligated to pay 1% royalties on net sales of the product, as well as a fixed royalty payment in the total amount of $350,000
upon the successful completion of Phase 2. Such payment of $350,000 mentioned above shall be made to Yeda Research and Development
Company Ltd. (“Yeda”) upon the earlier of (i) six months from the successful completion of the Phase 2 or (ii) the
completion of a successful fundraising by XTL or XTEPO at any time after the completion of the Phase 2 of at least $2 million.
On August 3, 2010, the Bio-Gal transaction was completed according to the outline signed by the parties to the agreement on December
31, 2009, after all the prerequisites had been met, including, among other things, the signing of an agreement with the Israeli
Tax Authority regarding the tax exemption granted to the share swap transaction pursuant to article 104 and 103 to the Israeli
tax ordinance (Revised), 1961. (See note 14c to the consolidated financial statements: Intangible Asset).
MinoGuard Ltd.
On March 24, 2011,
we entered into a Memorandum of Understanding with MinoGuard, pursuant to which we shall acquire the exclusive rights to SAM-101
by obtaining an exclusive license to use MinoGuard's entire technology. SAM-101 is based on a combination of anti-psychotic drugs
with minocycline, a recognized medicinal compound. On November 30, 2011, we received a worldwide exclusive license from MinoGuard
under which we shall develop and commercialize MinoGuard's technology for the treatment of psychotic disorders focusing on Schizophrenia.
Under the agreement, we are to conduct clinical trials, develop, register, market, distribute and sell the drugs that will emerge
from MinoGuard's technology, with no limitations for a specific disorder. In consideration, we shall pay MinoGuard accumulated
clinical development and marketing approvals milestone-based payments of approximately $2.5 million. In addition, we will pay
MinoGuard royalty-based payments on products that are based on the technology, equal to 3.5% of its net sales and/or percentage
from the Company third-party out–license receipts in the range of 7.5%-20% according to the clinical phase of the drug at
the time of an out-license transaction. It should be noted that the Company has the sole discretion to pay any of the above amounts
in cash or by way of issuing ordinary shares of the Company to MinoGuard. In addition to the above payments, and in accordance
with the above agreement, since as of June 30, 2013, XTL had not commenced a phase 2 clinical trial, we have paid MinoGuard an
annual license fee, by way of the issuance of 175,633 ordinary shares of the Company, representing a value of $45,000, for the
12 month period between July 1, 2013 and June 30, 2014. Such annual payments will increase by $90,000 per annum, up to $675,000
for the eighth year of license.
The term of the license
commenced upon the signing of the license agreement will be an unlimited period. Upon the expiration of the last payment obligation
of XTL the license will be considered perpetual and fully paid up.
The license may be
terminated by either XTL without cause upon 30 days’ notice, or by the licensor for no commercial progress in the event
that by the date of June 30, 2013 commencement of phase 2 clinical trial with respect to the licensed product has not occurred,
we have not entered into a Sublicense Agreement with a substantial third party or we have not paid the annual license fee.
hCDR1
On January 7, 2014,
the Company entered into a licensing agreement with Yeda to research, develop, and commercialize hCDR1, a Phase II-ready asset
for the treatment of SLE, among other indications. In consideration, the Company is responsible for a patent expense reimbursement
in six installments totaling approximately $400,000. The Company is required to make milestone payments of $2.2 million: $200,000
upon starting Phase III, $1 million upon U.S. Food and Drug Administration approval and $250,000 for regulatory approval in each
of China and three of the European Union’s Group of Six. In addition, the Company will pay 2-3% royalties of annual net
sales and sublicense fees of 15-20% of whatever the Company receives from any sub-licensee.
Lupus is a debilitating
disease affecting approximately five million people worldwide. hCDR1, is a peptide and acts as a disease-specific treatment to
modify the SLE-related autoimmune process. It does so by specific upstream immunomodulation through the generation of regulatory
T cells, reducing inflammation and resuming immune balance. Prior to being licensed to the Company by Yeda, hCDR1 was licensed
to Teva Pharmaceutical Industries ("Teva"), which performed two placebo controlled Phase I trials and a placebo controlled
Phase II trial called the PRELUDE trial. The studies consisted of over 400 patients, demonstrating that hCDR1 is well tolerated
by patients and has a favorable safety profile. The PRELUDE trial did not achieve its primary efficacy endpoint based on the SLEDAI
scale, resulting in Teva returning the asset to Yeda. However, the PRELUDE trial showed encouraging results in its secondary clinical
endpoint, the BILAG index, and, in fact, the 0.5 mg weekly dose showed a substantial effect. Multiple post-hoc analyses also showed
impressive results for this dose using the BILAG index. It is currently planned by the Company that such dose will be the focus
of the clinical development plan moving forward. Subsequent to Teva’s return of the program to Yeda, the FDA directed that
the primary endpoint in future trials for Lupus therapies, including those for hCDR1, should be based on either the BILAG index
or the SRI. Given the FDA’s recommendation and the positive findings from the PRELUDE trial (which showed a substantial
effect in the BILAG index), the Company intends to initiate a new Phase II clinical trial, which will include the 0.5 mg (and
a 0.25 mg) weekly dose of hCDR1. We estimate that the trial will take one year to enroll patients, another year to conduct treatment,
and additional time to analyze the results for a total of approximately two and a half years. We estimate the cost for that period
at between $12 and $15 million.
InterCure Ltd.
On June 13, 2012,
we entered into an agreement with InterCure under which, subject to carry out a contemplated debt settlement before the transaction,
InterCure will convert all of its debts into Ordinary shares of InterCure based on the distribution mechanism determined in conjunction
with its debtors (including its employees). The Company will acquire control over InterCure in consideration for investing in
InterCure an aggregate amount of approximately $ 2.7 million, subject to adjustments, as detailed below. Also, in addition
to the Company's investment in InterCure, Medica Fund will invest approximately $ 630,000 in InterCure (subject to adjustments).
InterCure is a public
company whose shares are traded on the TASE and which develops a home therapeutic device for non-medicinal and non-invasive treatment
of various diseases such as hypertension, heart failure, sleeplessness and mental stress and markets and sells a home therapeutic
device for hypertension.
The transaction was
consummated on July 25, 2012. The Company acquired 16,839,532 Ordinary shares of InterCure with no par value in consideration
of a private placement of 7,165,662 Ordinary shares of the Company of NIS 0.1 par value each whose value on the date of signing
the agreement, measured based on the quoted market price of the Company's shares on the TASE, approximated $2.2 million (the market
value of such shares on the InterCure closing date was approximately $2.47 million), which represented a pre-money valuation of
InterCure of $1.75 million, after all of InterCure's debts were converted as described above ("InterCure's adjusted value").
In addition, the Company
provided InterCure an amount of approximately $150,000 in cash on the basis of InterCure's adjusted value. After effecting the
above allocation, the Company held about 50.79% of the issued and outstanding share capital of InterCure. The investment of Medica
Fund on the date of closing on the basis of InterCure's adjusted value amounted to approximately $460,000.
Further, the Company
and Medica Fund provided InterCure a loan of $500,000 (the Company's share is $ 330,000) for a period of up to ten months
at an overall interest rate of 15%. The Company and Medica Fund have the right to convert the loan into an additional 11,546,507
shares of InterCure (the Company's share is 7,620,695 shares) which will constitute, upon conversion and assuming full dilution
on the date of closing, approximately 24.47% of the issued and outstanding share capital of InterCure (the Company's share in
the convertible loan is 16.15% of the issued and outstanding share capital of InterCure). On August 6, 2012, Medica Fund converted
the loan it provided InterCure into shares and its stake in InterCure rose to approximately 23.69% of the issued and outstanding
share capital of InterCure (about 18.61% on a fully diluted basis, as of the date of the loan's conversion). On May 16, 2013,
the Company converted the loan it provided InterCure into 7.620,695 ordinary shares of Intercure, as predetermined in the acquisition
agreement. Following said conversion, and as of the date of this report, the Company holds approximately 54.72% of InterCure's
issued and outstanding share capital (36.69% on a fully diluted basis).
In October 2012, InterCure
granted 20,185,184 performance contingent options (exercisable into 20,185,184 Ordinary shares with no par value) to Giboov (see
details below).
Agreement with Giboov Ltd., a Provider
of Online Marketing and Sales Services
On September 24, 2012,
InterCure announced the signing of a three-year non-exclusive strategic service agreement with Giboov, a private company wholly-owned
by Messrs. Shay Ben-Yitzhak and Avner Yassur, for the provision of online marketing and sales services of InterCure's products.
In the context of
the strategic agreement, Giboov will be allocated up to 20,185,184 unlisted stock options that are exercisable into shares of
InterCure for an exercise price (dividend adjusted) of NIS 0.54 per stock option which will vest according to Giboov's compliance
with annual sales targets. In the context of the strategic agreement, Giboov's shareholders were given a put option to sell to
InterCure Giboov's entire share capital for a period of 18 months from the effective date of the strategic agreement. On the date
of signing the strategic agreement, InterCure was granted a call option to purchase Giboov's entire share capital for a period
of one year from the effective date of the strategic agreement. The agreement's allocation items were approved by the general
meeting of InterCure's shareholders on October 28, 2012. InterCure will be able to cancel the agreement if Giboov fails to meet
the sales targets prescribed in the strategic agreement effective from March 2014 or in the event of a material breach of the
agreement, fraud, damage etc. For further details regarding the agreement with Giboov, see note 18(a) to the consolidated financial
statements.
On January 20, 2014,
InterCure announced that it had entered into an agreement with Giboov to terminate the Strategic Service Agreement, effective
as of January 31, 2014. Consequently, all 20,185,184 non-marketable stock options for the purchase of InterCure shares, which
were granted to Giboov under the Strategic Service Agreement, had expired on March 1, 2014. Following said expiration, Giboov
holds no such non-marketable stock options.
Agreement with Universal McCann Israel, Ltd., a Provider
of Online Marketing and Sales Services
On January 23, 2014,
InterCure announced that it has agreed to retain the services of Universal McCann Israel, Ltd. (“
McCann
”) in
which McCann will provide professional services relating to the promotion and marketing of InterCure’s products via the
internet for a period of three years effective February 1, 2014. According to the new agreement, InterCure shall pay McCann a
monthly fee in exchange for online marketing services, ranging between $8,000 and $13,000, and contingent upon achievement of
sales targets.
Manufacturing agreement with a subcontractor
As of the date of
this report, the Chinese manufacturer of the device is the exclusive supplier of the Ultra versions. The Chinese manufacturer
is a company registered in Hong Kong which holds manufacturing plants in Shenzhen, China. According to the turnkey manufacturing
agreement, the entire manufacturing process is performed by the Chinese manufacturer, including the purchase of raw materials
and components from suppliers, and the supply of a finished product to InterCure. The Chinese manufacturer is restricted to entering
into engagements with suppliers approved by InterCure only and is in charge of supervising the quality of the raw materials and
components supplied by it in accordance with InterCure's specifications. The Chinese manufacturer manufactures according to order
forecasts delivered by InterCure from time to time and is committed to providing InterCure reasonable advance notice if any shortage
of raw materials and/or components is expected in the market or in a specific supplier. The timeframe in which the Chinese manufacturer
can respond to increased device demands and increased manufacturing is derived from the rate of the change in demand.
Proteologics
On November 21, 2012,
in an off-market transaction, we purchased from Teva 4,620,356 Ordinary shares of NIS 1.0 par value each of Proteologics,
representing Teva's entire stake in Proteologics and approximately 31.35% of Proteologics' issued and outstanding share capital,
for approximately NIS 6.5 million (approximately $ 1.7 million). Proteologics is a public company whose shares are listed
on the TASE and is engaged in the discovery and development of drugs comprised of various components of the UBIQUITIN system, which
was discovered by Dr. Avram Hershko and Dr. Aaron Ciechanover, both 2004 Nobel Prize laureates in Chemistry for the discovery of
the UBIQUITIN system.
On August 22, 2013,
Proteologics’ board of directors resolved to terminate Proteologics’ operations effective immediately.
On September 11, 2013,
the Company entered into an agreement for the purchase of another 14.13% of the shares of Proteologics from Aurum Ventures MKI
Ltd. (“Aurum”) in consideration for the issuance of 3,031,299 shares of NIS 0.1 par value each of the Company to Aurum.
On September 12, 2013, the Company signed an agreement with Zmiha Investment House Ltd. (“Zmiha”) for the sale of its
entire investment in Proteologics, representing 44.95% of Proteologics' issued and outstanding share capital as of the date of
the agreement in consideration of approximately $ 3.4 million (approximately NIS 12 million). According to the agreement,
on the consummation date, the Company received an amount of approximately $ 2.7 million (approximately NIS 9.6 million)
and the balance is held in escrow until the completion of an inspection process by an inspector and the execution of a stay of
proceeding pursuant to Section 350 to the Israeli Companies Law in Proteologics. As of the date of this report the entire considerations
has been delivered to the Company and no amount remains in escrow.
Exchange Controls
Under Israeli Law,
Israeli non-residents who purchase ordinary shares with certain non-Israeli currencies (including dollars) may freely repatriate
in such non-Israeli currencies all amounts received in Israeli currency in respect of the ordinary shares, whether as a dividend,
as a liquidating distribution, or as proceeds from any sale in Israel of the ordinary shares, provided in each case that any applicable
Israeli income tax is paid or withheld on such amounts. The conversion into the non-Israeli currency must be made at the rate of
exchange prevailing at the time of conversion.
Taxation
The following discussion
summarizes certain Israeli and US federal income tax consequences that may be material to the holders of our ordinary shares and
ADRs, respectively, but is not intended, and should not be construed, as legal or professional tax advice and does not exhaust
all possible tax considerations that may be relevant to holders of our ordinary shares. This discussion is based on existing law,
judicial authorities and administrative interpretations, all of which are subject to change or differing interpretations, possibly
with retroactive effect. This summary does not purport to be a complete analysis of all potential tax consequences of owning our
ordinary shares. In particular, this discussion does not take into account the specific circumstances of any particular holder
or holders who may be subject to special rules, such as tax-exempt entities, broker-dealers, shareholders subject to Alternative
Minimum Tax, shareholders that actually or constructively own 10% or more of our voting securities, shareholders that hold ordinary
shares or ADRs as part of straddle or hedging or conversion transaction, traders in securities that elect mark to market, banks
and other financial institutions or partnerships or other passthrough entities.
We urge shareholders
to consult their own tax advisors as to the potential US, Israeli, or other tax consequences of the purchase, ownership and disposition
of ordinary shares and ADRs, including, in particular, the effect of any foreign, state or local taxes. For purposes of the entire
Taxation discussion, we refer to ordinary shares and ADRs collectively as ordinary shares.
Israeli Tax Considerations
The following discussion
refers to the current tax law applicable to companies in Israel, with special reference to its effect on us. This discussion also
includes specified Israeli tax consequences to holders of our ordinary shares and Israeli Government programs benefiting us.
Corporate Tax Rate
The income of the Company is subject to
corporate tax at the regular rate; the guidance of the amendment to the Income Tax Ordinance, 2005 from August 2008 prescribes
a gradual reduction in the corporate tax rates and the resulting corporate tax rates starting 2008 are as follows: 2008 - 27%,
2009 - 26% and 2010 and thereafter - 25%.
On July 14, 2009, the “Knesset”
(Israeli Parliament) passed the Law for Economic Efficiency (Amended Legislation for Implementing the Economic Plan for 2009 and
2010), 2009, which prescribes, among other things, an additional gradual reduction in the corporate tax rates starting 2011 to
the following tax rates: 2011 - 24%, 2012 - 23%, 2013 - 22%, 2014 - 21%, 2015 - 20%, 2016 and thereafter - 18%.
In December 2011, following the enactment
of the Law for the Changing the Tax Burden (Legislative Amendments), 2011 (hereafter - "Tax Burden Distribution Law"),
the phased reduction in the corporate tax was eliminated, and the corporate tax rate in 2012 and thereafter was set to 25%.
On August 5, 2013,
the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for 2013-2014), 2013 (the “Law”)
was published in the Government's records. Among other things, the Law prescribes from the 2014 tax year and thereafter, an increase
in the Israeli corporate tax rate to 26.5% (instead of 25%).
Capital gains in the
hands of the Company and its Israeli subsidiaries are taxable according to the corporate tax rate applicable in the tax year.
Tax Benefits for Research and Development
Israeli tax law allows,
under specific conditions, a tax deduction in the year incurred for expenditures, including capital expenditures, relating to scientific
research and development projects, if the expenditures are approved by the relevant Israeli government ministry, determined by
the field of research, and the research and development is for the promotion of the company and is carried out by or on behalf
of the company seeking the deduction. Expenditures not so approved are deductible over a three-year period. In the past, expenditures
that were made out of proceeds made available to us through government grants were automatically deducted during a one year period.
Israeli Estate and Gift Taxes
Israel does not currently
impose taxes on inheritance or bona fide gifts. For transfers of assets by inheritance or gift that would normally be subject to
capital gains tax or land appreciation tax, the recipient’s tax cost basis and date of purchase are generally deemed to be
the same as those for the transferor of the property.
Capital Gains Tax on Sales of our Ordinary Shares by Both
Residents and Non-Residents of Israel
Israeli law generally
imposes a capital gains tax on the sale of capital assets located in Israel, including shares in Israeli resident companies, by
both residents and non-residents of Israel, unless a specific exemption is available or unless a treaty between Israel and the
country of the non-resident provides otherwise. The law distinguishes between the inflationary surplus and the real gain. The inflationary
surplus is the portion of the total capital gain, which is equivalent to the increase of the relevant asset’s purchase price
attributable to the increase in the Israeli consumer price index from the date of purchase to the date of sale. The real gain is
the excess of the total capital gain over the inflationary surplus. A non-resident that invests in taxable assets with foreign
currency may elect to calculate the inflationary amount by using such foreign currency.
Non-Israeli residents
will be exempt from Israeli capital gains tax on any gains derived from the sale of shares publicly traded on a stock exchange
recognized by the Israeli Ministry of Finance (including the Tel-Aviv Stock Exchange and Nasdaq), provided such shareholders did
not acquire their shares prior to an initial public offering and that such capital gains are not derived by a permanent establishment
of the foreign resident in Israel. Notwithstanding the foregoing, dealers in securities in Israel are taxed at the regular tax
rates applicable to business income. However, Non-Israeli corporations will not be entitled to such exemption if an Israeli resident
(1) has a controlling interest of 25% or more in such non-Israeli corporation, or (2) is the beneficiary of, or is entitled to,
25% or more of the revenue or profits of such non-Israeli corporation, whether directly or indirectly. In any event, the provisions
of the tax reform shall not affect the exemption from capital gains tax for gains accrued before January 1, 2003, as described
in the previous paragraph.
The capital gains tax
imposed on Israeli tax resident individuals on the sale of securities was 20%. With respect to an Israeli tax resident individual
who is a “substantial shareholder” on the date of sale of the securities or at any time during the 12 months preceding
such sale, the capital gains tax rate was increased to 25%. In December 2011, following the enactment of the Tax Burden Distribution
Law, the tax rates mentioned above were increased to 25% and 30%, respectively, from 2012 and thereafter. A “substantial
shareholder” is defined as someone who alone, or together with another person, holds, directly or indirectly, at least 10%
in one or all of any of the means of control in the corporation. With respect to Israeli tax resident corporate investors, capital
gains tax at the regular corporate rate will be imposed on such taxpayers on the sale of traded shares.
In addition, pursuant
to the Convention Between the Government of the United States of America and the Government of Israel with Respect to Taxes on
Income, as amended (the “United States- Israel Tax Treaty”), the sale, exchange or disposition of ordinary shares by
a person who qualifies as a resident of the US within the meaning of the United States-Israel Tax Treaty and who is entitled to
claim the benefits afforded to such person by the United States- Israel Tax Treaty (a “Treaty United States Resident”)
generally will not be subject to the Israeli capital gains tax unless such Treaty United States Resident holds, directly or indirectly,
shares representing 10% or more of our voting power during any part of the twelve- month period preceding such sale, exchange or
disposition, subject to certain conditions or if the capital gains from such sale are considered as business income attributable
to a permanent establishment of the US resident in Israel. However, under the United States-Israel Tax Treaty, such “Treaty
United States Resident” would be permitted to claim a credit for such taxes against the US federal income tax imposed with
respect to such sale, exchange or disposition, subject to the limitations in US laws applicable to foreign tax credits.
Taxation of Dividends
Non-residents of Israel
are subject to income tax on income accrued or derived from sources in Israel.
The tax rate imposed
on dividends distributed by an Israeli company to Israeli tax resident individuals or to non-Israeli residents was set at a rate
of 20%. With respect to “substantial shareholders,” as defined above, the applicable tax rate was 25%. In December
2011, following the enactment of the Tax Burden Distribution Law, the tax rates mentioned above were increased to 25% and 30%,
respectively, from 2012 and thereafter. The taxation of dividends distributed by an Israeli company to another Israeli corporate
tax resident is generally exempt from tax.
In any case, dividends
distributed from the taxable income attributable to an Approved Enterprise (as defined above), to both Israeli tax residents and
non-Israeli residents remains subject to a 15% tax rate.
Notwithstanding, dividends
distributed by an Israeli company to Israeli tax resident individuals or to non-Israeli residents were subject to a 20% withholding
tax, which was increased to 25% from 2012 and thereafter, following the enactment of the Tax Burden Distribution Law (15% in the
case of dividends distributed from the taxable income attributable to an Approved Enterprise), unless a lower rate is provided
in a treaty between Israel and the shareholder’s country of residence. Dividends distributed by an Israeli company to another
Israeli tax resident company are generally exempt, unless such dividends are distributed from taxable income attributable to an
Approved Enterprise, in which case such dividends are taxed at a rate of 15%, or unless such dividends are distributed from income
that was not sourced in Israel, in which case such dividends are taxed at a rate of 25%.
Under the US-Israel
Tax Treaty, the maximum Israeli tax and withholding tax on dividends paid to a holder of ordinary shares who is a resident of the
US is generally 25%, but is reduced to 12.5% if the dividends are paid to a corporation that holds in excess of 10% of the voting
rights of a company during the company’s taxable year preceding the distribution of the dividend and the portion of the company’s
taxable year in which the dividend was distributed. Dividends of an Israeli company derived from the income of an Approved Enterprise
will still be subject to a 15% dividend withholding tax; if the dividend is attributable partly to income derived from an Approved
Enterprise, and partly to other sources of income, the withholding rate will be a blended rate reflecting the relative portions
of the two types of income. A non-resident of Israel who has dividend income derived from or accrued in Israel, from which tax
was withheld at the source, is generally exempt from the duty to file tax returns in Israel in respect of such income, provided
such income was not derived from a business conducted in Israel by the taxpayer.
US Federal Income Tax Considerations
TO ENSURE COMPLIANCE
WITH US TREASURY DEPARTMENT CIRCULAR 230, PROSPECTIVE HOLDERS OF ORDINARY SHARES ARE HEREBY NOTIFIED THAT: (A) ANY DISCUSSION
OF US FEDERAL TAX ISSUES IN THIS MEMORANDUM IS NOT INTENDED OR WRITTEN TO BE RELIED UPON, AND CANNOT BE RELIED UPON, BY HOLDERS
OF ORDINARY SHARES FOR THE PURPOSE OF AVOIDING PENALTIES THAT MAY BE IMPOSED ON SUCH HOLDERS UNDER THE INTERNAL REVENUE CODE OF 1986,
AS AMENDED (THE “CODE”); (B) SUCH DISCUSSION IS WRITTEN IN CONNECTION WITH THE PROMOTION OR MARKETING OF THE TRANSACTIONS
OR MATTERS ADDRESSED HEREIN; AND (C) PROSPECTIVE HOLDERS OF ORDINARY SHARES SHOULD SEEK ADVICE BASED ON THEIR PARTICULAR CIRCUMSTANCES
FROM AN INDEPENDENT TAX ADVISOR.
The following discussion
applies only to a holder of our ordinary shares who qualifies as a “US holder”. For purposes of this discussion a “US
holder” is a beneficial owner of our ordinary shares that is for US federal income tax purposes:
|
·
|
an individual who is a US citizen or US resident alien;
|
|
·
|
a corporation (or other entity taxable as a corporation for US federal income tax purposes) that
was created or organized under the laws of the US, any state thereof or the District of Columbia;
|
|
·
|
an estate whose income is subject to US federal income taxation regardless of its source; or
|
|
·
|
a trust (i) if a US court is able to exercise primary supervision over the administration
of the trust and one or more “United States persons” (as defined in the Code) have the authority to control all substantial
decisions of the trust, or (ii) if the trust has a valid election in effect under applicable Treasury Regulations to be treated
as a “United States person.”
|
This discussion is
based on current provisions of the Internal Revenue Code of 1986, as amended, which we refer to as the Code, current and proposed
Treasury regulations promulgated under the Code, and administrative and judicial decisions as of the date of this report, all of
which are subject to change or differing interpretation, possibly on a retroactive basis. This discussion does not address any
aspect of state, local or non-US tax laws. Except where noted, this discussion addresses only those holders who hold our shares
as capital assets. This discussion does not purport to be a comprehensive description of all of the tax considerations that may
be relevant to US holders entitled to special treatment under US federal income tax laws, for example, financial institutions,
insurance companies, tax-exempt organizations and broker/dealers, and it does not address all aspects of US federal income taxation
that may be relevant to any particular shareholder based on the shareholder's individual circumstances. In particular, this discussion
does not address the potential application of the alternative minimum tax, or the special US federal income tax rules applicable
in special circumstances, including to US holders who:
|
·
|
have elected mark-to-market accounting;
|
|
·
|
hold our ordinary shares as part of a straddle, hedge or conversion transaction with other investments;
|
|
·
|
own directly, indirectly or by attribution at least 10% of our voting power;
|
|
·
|
are tax exempt entities;
|
|
·
|
are persons who acquire shares in connection with employment or other performance of services;
and
|
|
·
|
have a functional currency that is not the US dollar.
|
Additionally, this
discussion does not consider the tax treatment of partnerships or persons who hold ordinary shares through a partnership or other
pass-through entity or the possible application of US federal gift or estate taxes.
Each
prospective shareholder is urged to consult its tax advisor regarding the particular tax consequences to such holder of ownership
and disposition of our shares, as well as any tax consequences that may arise under the laws of any other relevant foreign, state,
local, or other taxing jurisdiction
.
Taxation of Distributions Paid on
Ordinary Shares
Subject to the description
of the passive foreign investment company rules below, a US holder will be required to include in gross income as ordinary income
from sources outside of the US the amount of any distribution paid on ordinary shares, including any Israeli taxes withheld from
the amount paid, to the extent the distribution is paid out of our current or accumulated earnings and profits as determined for
US federal income tax purposes. Distributions in excess of these earnings and profits will be applied against and will reduce the
US holder’s basis in the ordinary shares and, to the extent in excess of this basis, will be treated as gain from the sale
or exchange of ordinary shares.
Certain dividend income
may be eligible for a reduced rate of taxation. Dividend income will be taxed to a non-corporate holder at the applicable long-term
capital gains rate if the dividend is received from a “qualified foreign corporation,” and the shareholder of such
foreign corporation holds such stock for more than 60 days during the 121 day period that begins on the date that is 60 days before
the ex-dividend date for the stock. The holding period is tolled for any days on which the shareholder has reduced his risk of
loss with respect to the stock. A “qualified foreign corporation” is either a corporation that is eligible for the
benefits of a comprehensive income tax treaty with the US or a corporation whose stock, the shares of which are with respect to
any dividend paid by such corporation, is readily tradable on an established securities market in the United States (including,
for this purpose, ADRs traded on a securities market in the United States with respect to the foreign corporation’s shares).
However, a foreign corporation will not be treated as a “qualified foreign corporation” if it is a passive foreign
investment company (as discussed below) for the year in which the dividend was paid or the preceding year. Distributions of current
or accumulated earnings and profits paid in foreign currency to a US holder will be includible in the income of a US holder in
a US dollar amount calculated by reference to the exchange rate in effect on the day the distribution is received by the US holder
(or, in the case of ADRs, on the day the distribution is received by the depository). A US holder that receives a foreign currency
distribution and converts the foreign currency into US dollars subsequent to receipt will have foreign exchange gain or loss based
on any appreciation or depreciation in the value of the foreign currency against the US dollar, which will generally be US source
ordinary income or loss.
As described above,
we will generally be required to withhold Israeli income tax from any dividends paid to holders who are not resident in Israel.
See “- Israeli Tax Considerations—Taxation of Dividends” above. If a US holder receives a dividend from us that
is subject to Israeli withholding, the following would apply:
|
·
|
You must include the gross amount of the dividend, not reduced by the amount of Israeli tax withheld,
in your US taxable income.
|
|
·
|
You may be able to claim the Israeli tax withheld as a foreign tax credit against your US income
tax liability. However, to the extent that 25% or more of our gross income from all sources was effectively connected with the
conduct of a trade or business in the US (or treated as effectively connected, with limited exceptions) for a three-year period
ending with the close of the taxable year preceding the year in which the dividends are declared, a portion of this dividend will
be treated as US source income, possibly reducing the allowable foreign tax.
|
|
·
|
The foreign tax credit is subject to significant and complex limitations. Generally, the credit
can offset only the part of your US tax attributable to your net foreign source passive income. Additionally, if we pay dividends
at a time when 50% or more of our stock is owned by US persons, you may be required to treat the part of the dividend attributable
to US source earnings and profits as US source income, possibly reducing the allowable credit.
|
|
·
|
A US holder will be denied a foreign tax credit with respect to Israeli income tax withheld from
dividends received on the ordinary shares to the extent the US holder has not held the ordinary shares for at least 16 days of
the 31-day period beginning on the date which is 15 days before the ex-dividend date or, alternatively, to the extent the US holder
is under an obligation to make related payments with respect to substantially similar or related property. Any days during which
a US holder has substantially diminished its risk of loss on the ordinary shares are not counted toward meeting the 16-day holding
period required by the statute.
|
|
·
|
If you do not elect to claim foreign taxes as a credit, you will be entitled to deduct the Israeli
income tax withheld from your XTL dividends in determining your taxable income.
|
|
·
|
Individuals who do not claim itemized deductions, but instead utilize the standard deduction, may
not claim a deduction for the amount of the Israeli income taxes withheld.
|
|
·
|
If you are a US corporation holding our stock, the general rule is that you cannot claim the dividends-received
deduction with respect to our dividends. There is an exception to this rule if you own at least 10% of our ordinary shares (by
vote) and certain conditions are met.
|
Special rules, described
below, apply if we are a passive foreign investment company.
Taxation of the Disposition of Ordinary
Shares
Subject to the description
of the passive foreign investment company rules below, upon the sale, exchange or other disposition of our ordinary shares, a US
holder will recognize capital gain or loss in an amount equal to the difference between the US holder's basis in the ordinary shares,
which is usually the cost of those shares, and the amount realized on the disposition. Capital gain from the sale, exchange or
other disposition of ordinary shares held more than one year is long-term capital gain and is eligible for a reduced rate of taxation
for non-corporate holders. In general, gain realized by a US holder on a sale, exchange or other disposition of ordinary shares
generally will be treated as US source income for US foreign tax credit purposes. A loss realized by a US holder on the sale, exchange
or other disposition of ordinary shares is generally allocated to US source income. However, regulations require the loss to be
allocated to foreign source income to the extent certain dividends were received by the taxpayer within the 24-month period preceding
the date on which the taxpayer recognized the loss. The deductibility of a loss realized on the sale, exchange or other disposition
of ordinary shares is subject to limitations for both corporate and individual shareholders.
A US holder that uses
the cash method of accounting calculates the US dollar value of the proceeds received from a sale of ordinary shares as of the
date that the sale settles, and will generally have no additional foreign currency gain or loss on the sale, while a US holder
that uses the accrual method of accounting is required to calculate the value of the proceeds of the sale as of the trade date
and may therefore realize foreign currency gain or loss, unless the US holder has elected to use the settlement date to determine
its proceeds of sale for purposes of calculating this foreign currency gain or loss. In addition, a US holder that receives foreign
currency upon disposition of our ordinary shares and converts the foreign currency into US dollars subsequent to receipt will have
foreign exchange gain or loss based on any appreciation or depreciation in the value of the foreign currency against the US dollar,
which will generally be US source ordinary income or loss.
Tax Consequences if We are a Passive
Foreign Investment Company
Special federal income
tax rules apply to the timing and character of income received by a US holder of a PFIC. We will be a PFIC if either 75% or more
of our gross income in a tax year is passive income or the average percentage of our assets (by value) that produce or are held
for the production of passive income in a tax year is at least 50%. The IRS has indicated that cash balances, even if held as working
capital, are considered to be assets that produce passive income. Therefore, any determination of PFIC status will depend upon
the sources of our income, and the relative values of passive and non- passive assets, including goodwill. Furthermore, because
the goodwill of a publicly-traded corporation is largely a function of the trading price of its shares, the valuation of that goodwill
is subject to significant change throughout each year. A determination as to a corporation’s status as a PFIC must be made
annually. We believe that we were likely not a PFIC for the taxable years ended December 31, 2012, 2011, 2010 and 2009. Although
such a determination is fundamentally factual in nature and generally cannot be made until the close of the applicable taxable
year, based on our current operations, we believe that we were likely not classified as a PFIC for the taxable year ended December
31, 2013. Notwithstanding the above, we may be a PFIC in subsequent years. In addition, even though we may not be a PFIC in any
one particular year, if we have qualified as a PFIC in a prior year, the special PFIC tax regime will continue to apply.
If we are classified
as a PFIC, a special tax regime would apply to both (a) any “excess distribution” by us (generally, the US holder's
ratable share of distributions in any year that are greater than 125% of the average annual distributions received by such US holder
in the three preceding years or its holding period, if shorter) and (b) any gain recognized on the sale or other disposition of
your ordinary shares. Under this special regime, any excess distribution and recognized gain would be treated as ordinary income
and the federal income tax on such ordinary income would be determined as follows: (i) the amount of the excess distribution or
gain would be allocated ratably over the US holder's holding period for our ordinary shares; (ii) US federal income tax would be
determined for the amounts allocated to the first year in the holding period in which we were classified as a PFIC and for all
subsequent years (except the year in which the excess distribution was received or the sale occurred) by applying the highest applicable
tax rate in effect in the year to which the income was allocated; (iii) an interest charge would beadded to this tax, calculated
by applying the underpayment interest rate to the tax for each year determined under the preceding sentence from the due date of
the income tax return for such year to the due date of the return for the year in which the excess distribution or sale occurs;
and (iv) amounts allocated to a year prior to the first year in the US holder’s holding period in which we were classified
as a PFIC or to the year in which the excess distribution or the disposition occurred would be taxed as ordinary income but without
the imposition of an interest charge.
A US holder may generally
avoid the PFIC “excess distribution” regime by electing to treat his PFIC shares as a “qualified electing fund.”
If a US holder elects to treat PFIC shares as a qualified electing fund, also known as a “QEF Election,” the US holder
must include annually in gross income (for each year in which PFIC status is met) his
pro rata
share of the PFIC’s
ordinary earnings and net capital gains, whether or not such amounts are actually distributed to the US holder. A US holder may
make a QEF Election with respect to a PFIC for any taxable year in which he was a shareholder. A QEF Election is effective for
the year in which the election is made and all subsequent taxable years of the US holder. Procedures exist for both retroactive
elections and the filing of protective statements. A US holder making the QEF Election must make the election on or before the
due date, as extended, for the filing of the US holder's income tax return for the first taxable year to which the election will
apply.
A QEF Election is made
on a shareholder-by-shareholder basis. A US holder must make a QEF Election by completing Form 8621, Return by a Shareholder
of a Passive Foreign Investment Company or Qualified Electing Fund, and attaching it to the holder’s timely filed US federal
income tax return. As a prerequisite to the validity of a US holder’s QEF Election, we will be required tocomply with certain
record-keeping and reporting requirements. While we historically have and plan to continue to comply with such requirements, if,
in the future, meeting those record-keeping and reporting requirements becomes onerous, we may decide, in our sole discretion,
that such compliance is impractical and will so notify US holders.
Alternatively, a US
holder may also generally avoid the PFIC regime by making a so-called “mark-to-market” election. Such an election may
be made by a US holder with respect to ordinary shares owned at the close of such holder's taxable year, provided that we are a
PFIC and the ordinary shares are considered “marketable stock.” The ordinary shares will be marketable stock if they
are regularly traded on a national securities exchange that is registered with the Securities and Exchange Commission, or the national
market system established pursuant to section 11A of the Securities and Exchange Act of 1934, or an equivalent regulated and supervised
foreign securities exchange.
If a US holder were
to make a mark-to-market election with respect to ordinary shares, such holder generally will be required to include in its annual
gross income the excess of the fair market value of the PFIC shares at year-end over such shareholder’s adjusted tax basis
in the ordinary shares. Such amounts will be taxable to the US holder as ordinary income, and will increase the holder’s
tax basis in the ordinary shares. Alternatively, if in any year, a United States holder’s tax basis exceeds the fair market
value of the ordinary shares at year-end, then the US holder generally may take an ordinary loss deduction to the extent of the
aggregate amount of ordinary income inclusions for prior years not previously recovered through loss deductions and any loss deductions
taken will reduce the shareholder’s tax basis in the ordinary shares. Gains from an actual sale or other disposition of the
ordinary shares with a “mark-to-market” election will be treated as ordinary income, and any losses incurred on an
actual sale or other disposition of the ordinary shares will be treated as an ordinary loss to the extent of any prior “unreversed
inclusions” as defined in Section 1296(d) of the Code.
The mark-to-market
election is made on a shareholder-by-shareholder basis. The mark-to-market election is made by completing Form 8621, Return by
a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund, and attaching it to the holder’s timely
filed US federal income tax return for the year of election. Such election is effective for the taxable year for which made and
all subsequent years until either (a) the ordinary shares cease to be marketable stock or (b) the election is revoked with the
consent of the IRS.
In view of the
complexity of the issues regarding our treatment as a PFIC, US shareholders are urged to consult their own tax advisors for guidance
as to our status as a PFIC.
Information Reporting and Back-Up
Withholding
US holders generally
are subject to information reporting requirements with respect to dividends paid in the US on ordinary shares. Existing regulations
impose information reporting and back-up withholding on dividends paid in the US on ordinary shares and on proceeds from the disposition
of ordinary shares unless the US holder provides IRS Form W-9 or otherwise establishes an exemption..
Prospective investors
should consult their tax advisors concerning the effect, if any, of these Treasury regulations on an investment in ordinary shares.
Back-up withholding is not an additional tax. The amount of any back-up withholding will be allowed as a credit against a holder's
US federal income tax liability and may entitle the holder to a refund, provided that specified required information is furnished
to the IRS on a timely basis.
US Federal Income Tax Consequences
for XTL
As of April 7, 2009,
we did not have a “permanent establishment” in the US. Our board of directors consists of a majority of Israeli residents
and our CEO is domiciled in Israel. However, for the period we did have a “permanent establishment” in the US, any
income attributable to such US permanent establishment would be subject to US corporate income tax in the same manner as if we
were a US corporation. The maximum US corporate income tax rate (not including applicable state and local tax rates) is currently
at 35%. In addition, if we had income attributable to the permanent establishment in the US, we may be subject to an additional
branch profits tax of 30% on our US effectively connected earnings and profits, subject to adjustment, for that taxable year if
certain conditions occur, unless we qualified for the reduced 12.5% US branch profits tax rate pursuant to the United States-Israel
tax treaty. We would be potentially able to credit any foreign taxes that may become due in the future against its US tax liability
in connection with income attributable to its US permanent establishment and subject to both US and foreign income tax.
As of December 31,
2013, we did not earn any taxable income for US federal tax purposes and we have not had a permanent establishment in the US since
2009. If we eventually earn taxable income attributable to a US permanent establishment, we would be able to utilize accumulated
loss carryforwards to offset such income only to the extent these carryforwards were attributable to our US permanent establishment.
As of December 31, 2013, the net operating tax losses (“NOL”) of the US subsidiaries amounted to approximately
$20 million. These losses of the U.S. subsidiaries expire through 2029, are limited in use, and it is probable that they will be
even significantly further reduced due to tax laws that apply in cases where "change of control" of sufficient equity
of certain shareholders occurs, which is we believe to have occurred in connection with the Bio-Gal transaction. See “Item
10 Financial Information -Material Contracts”). These losses may be subject to further limitations in the case of future
offerings or capital raises that result in additional “change of control” equity shifts.
The above comments
are intended as a general guide to the current position. Any person who is in any doubt as to his or her taxation position, and
who requires more detailed information than the general outline above or who is subject to tax in a jurisdiction other than the
United States should consult professional advisers.
Documents on Display
We voluntarily file
reports and other information with the SEC under the Exchange Act and the regulations thereunder applicable to foreign private
issuers. You may inspect and copy reports and other information filed by us with the SEC at the SEC’s public reference facilities
described below. Although as a foreign private issuer we are not required to file periodic information as frequently or as promptly
as US companies, we generally announce publicly our interim and year-end results promptly on a voluntary basis and will file that
periodic information with the SEC under cover of Form 6-K. As a foreign private issuer, we are also exempt from the rules under
the Exchange Act prescribing the furnishing and content of proxy statements, and our officers, directors and principal shareholders
are exempt from the reporting and other provisions in Section 16 of the Exchange Act.
You may read and
copy any document we file or furnish with the SEC at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference facilities. You can
review our SEC filings and the registration statement by accessing the SEC’s internet site at
http://www.sec.gov
.
We also maintain
a website at
http://www.xtlbio.com
, but information contained on our website does not constitute a part of this report
and is not incorporated by reference into this report.
Item
11. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk.
The primary objective of our investment activities is to preserve principal while maximizing our income from investments and minimizing
our market risk. We invest in bank deposits in accordance with our investment policy. As of December 31, 2013, our portfolio of
financial instruments consists of cash and cash equivalents, short-term bank deposits with multiple institutions. The average duration
of all of our investments held as of December 31, 2013, was less than one year. Due to the short-term nature of these investments,
we believe we have no material exposure to interest rate risk arising from our investments.
Foreign Currency
and Inflation Risk.
We generate most of our revenues and hold most of our cash, cash equivalents and bank deposits in US dollars.
While a substantial amount of our operating expenses are in US dollars, we incur a portion of our expenses in New Israeli Shekels.
In addition, we also pay for some of our services and supplies in the local currencies of our suppliers, as our head office is
located in Israel. As a result, we are exposed to the risk that the US dollar will be devalued against the New Israeli Shekel or
other currencies, and as a result our financial results could be harmed if we are unable to guard against currency fluctuations
in Israel or other countries in which services and supplies are obtained in the future. Accordingly, we may enter into currency
hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of currencies. The Company's
treasury risk management policy, excluding InterCure, is to hold NIS-denominated cash and cash equivalents and short-term deposits
in the amount of the anticipated NIS-denominated liabilities for nine to twelve consecutive months from time to time and this in
line with the directives of the Company's Board. InterCure focuses on actions to minimize the negative effects arising from this
risk and therefore holds cash and cash equivalents in currencies in which it operates, in accordance with management's assessments.
These measures, however, may not adequately protect us from the adverse effects of inflation in Israel. In addition, we are exposed
to the risk that the rate of inflation in Israel will exceed the rate of devaluation of the New Israeli Shekel in relation to the
dollar or that the timing of any devaluation may lag behind inflation in Israel.
As of December 31,
2013, if the Group's functional currency had weakened by 10% against the NIS with all other variables remaining constant, post-tax
loss for the year would have been approximately $157,000 thousand lower (2012 - post-tax loss approximately $ 89 thousand
lower; 2011 - post-tax loss approximately $ 30 thousand higher), mainly as a result of exchange rate changes on translation
of other accounts receivable, net and exchange rate changes on NIS-denominated cash and cash equivalents and short-term deposits.
Loss was more sensitive to fluctuations in the exchange rate in relation to the NIS in 2013 than in 2012 mainly due to an increase
in NIS-denominated cash and receivable balances related to proceeds from the sale of the Company’s investment in Proteologics,
late in the third quarter of 2013.
Credit Risk
.
Credit risks are managed at the Group level. The Group has no significant concentrations of credit risk. The Group has a policy
to ensure collection through sales of its products to wholesalers with an appropriate credit history and through retail sales in
cash or by credit card.
The Group extends a
30-day term to its customers. The Group regularly monitors the credit extended to its customers and their general financial condition
but does not require collateral as security for these receivables. The Group provides an allowance for doubtful accounts based
on the factors that affect the credit risk of certain customers, past experience and other information. Credit risks arise from
cash and cash equivalents, restricted bank deposits as well as outstanding receivables.
The Group, excluding
InterCure, engages with banks and financial institutions which are independently rated at least A.
Liquidity Risk.
Cash flow forecasting is performed by the Group's management both in the entities of the Group and aggregated by the Group.
The Group's management monitors rolling forecasts of the Group's liquidity requirements to ensure it has sufficient cash to meet
operations. The Group currently does not use credit facilities. Forecasting takes into consideration several factors such as raising
capital to finance operations and certain liquidity ratios that the Group strives to achieve.
Surplus cash held to
finance operating activities is invested in interest bearing current accounts, time deposits and other similar channels. These
channels were chosen by reference to their appropriate maturities or liquidity to provide sufficient cash balances to the Group
as determined by the abovementioned forecasts.
As of December 31, 2013 and 2012, the
maturity of the Group's financial liabilities is less than one year from each of the reporting dates.
Item
12. Description of Securities Other than Equity Securities
Not applicable.
PART III
Item
17. Financial Statements
We have elected to
furnish financial statements and related information specified in Item 18.
Item
18. Financial Statements
XTL BIOPHARMACEUTICALS
LTD.
CONSOLIDATED FINANCIAL
STATEMENTS
AS OF DECEMBER
31, 2013
INDEX
|
Page
|
|
|
Auditors' Report
|
F-2
|
|
|
Consolidated Financial Statements -
in U.S. dollars:
|
|
|
|
Statements of
Financial Position
|
F-3 - F-4
|
|
|
Statements of
Comprehensive loss
|
F-5
|
|
|
Statements of
Changes in Equity
|
F-6 - F-7
|
|
|
Statements of
Cash Flows
|
F-8 - F-10
|
|
|
Notes to Financial
Statements
|
F-11 - F-89
|
- - - - - - - - - - - -
Report of Independent Registered
Public Accounting Firm
XTL BIOPHARMACEUTICALS LTD.
We have audited the consolidated Statements
of Financial Position of XTL Biopharmaceuticals Ltd. (hereafter - the "Company") and its subsidiaries as of December
31, 2013 and 2012, and the related consolidated statements of Comprehensive Income (Loss), changes in equity and cash flows for
each of the three years ended December 31, 2013. These financial statements are the responsibility of the Company's Board of Directors
and management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance
with the standards of the Public Company Accounting Oversight Board (United States of America). Those standards require that we
plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.
An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An
audit also includes assessing the accounting principles used and significant estimates made by the Company's Board of Directors
and management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the consolidated financial
statements referred to above, present fairly, in all material respects, the consolidated financial position of the Company and
its subsidiaries as of December 31, 2013 and 2012, and the consolidated comprehensive income (loss), changes in equity and cash
flows for each of the three years ended December 31, 2013, in conformity with International Financial Reporting Standards
("IFRS") as issued by the International Accounting Standards Board ("IASB").
As discussed in Note 1 to the financial
statements, the Company's 54.72% owned subsidiary, InterCure Ltd., has had recurring losses and presently does not have sufficient
cash and other resources to meet its future plans beyond July 2015.
If the subsidiary is unsuccessful in raising
additional financing, it may need to curtail or discontinue operations. See Note 11 for InterCure's summarized consolidated balance
sheet as of December 31, 2013 and its summarized consolidated income statements and cash flow for the year then ended.
Tel-Aviv, Israel
|
Kesselman & Kesselman
|
March 31, 2014
|
Certified Public Accountants (lsr.)
|
|
A member firm of PricewaterhouseCoopers International Limited
|
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|
|
|
|
December 31,
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
|
Note
|
|
U.S. dollars in thousands
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
6
|
|
|
2,887
|
|
|
|
1,696
|
|
Short-term deposits
|
|
7
|
|
|
1,278
|
|
|
|
1,616
|
|
Trade receivables
|
|
8
|
|
|
126
|
|
|
|
76
|
|
Other accounts receivable
|
|
9
|
|
|
473
|
|
|
|
153
|
|
Restricted deposits
|
|
|
|
|
23
|
|
|
|
22
|
|
Inventories
|
|
10
|
|
|
302
|
|
|
|
229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,089
|
|
|
|
3,792
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
Investment in associate
|
|
12
|
|
|
-
|
|
|
|
2,336
|
|
Property, plant and equipment, net
|
|
13
|
|
|
61
|
|
|
|
72
|
|
Intangible assets, net
|
|
14
|
|
|
2,865
|
|
|
|
4,886
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,926
|
|
|
|
7,294
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
|
8,015
|
|
|
|
11,086
|
|
The accompanying notes are an integral
part of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|
|
|
|
December 31,
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
|
Note
|
|
U.S. dollars in thousands
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
15
|
|
|
615
|
|
|
|
743
|
|
Other accounts payable
|
|
16
|
|
|
604
|
|
|
|
906
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,219
|
|
|
|
1,649
|
|
NON-CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
Employee benefit liabilities
|
|
|
|
|
11
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
|
|
|
|
13
|
|
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:
|
|
19
|
|
|
|
|
|
|
|
|
Share capital - ordinary shares of NIS
0.01 par value: authorized – December 31, 2012 and 2013 – 700,000,000 shares; issued and outstanding:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2012 – **222,306,007
|
|
|
|
|
|
|
|
|
|
|
December 31, 2013 – **226,826,957
|
|
|
|
|
6,093
|
|
|
|
5,997
|
|
Share premium and options
|
|
|
|
|
148,327
|
|
|
|
147,475
|
|
Accumulated deficit
|
|
|
|
|
(146,073
|
)
|
|
|
(143,560
|
)
|
Treasury shares, at cost:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2012 – 7,165,662
|
|
|
|
|
|
|
|
|
|
|
December 31, 2013 – 6,067,943
|
|
|
|
|
(2,091
|
)
|
|
|
(2,469
|
)
|
Currency translation differences
|
|
|
|
|
-
|
|
|
|
114
|
|
Reserve from transactions with
non-controlling interests
|
|
|
|
|
9
|
|
|
|
(204
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,265
|
|
|
|
7,353
|
|
Non-controlling interests
|
|
|
|
|
520
|
|
|
|
2,071
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
|
|
6,785
|
|
|
|
9,424
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
|
|
|
8,015
|
|
|
|
11,086
|
|
** Net of treasury shares
The accompanying notes are an integral
part of the consolidated financial statements.
|
|
|
|
|
Amit Yonay
|
|
Josh Levine
|
|
David Kestenbaum
|
Chairman of the Board
|
|
Chief Executive Officer
|
|
Chief Financial Officer
|
Date of approval of the financial statements
by the Company's Board: March 31, 2014.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
|
|
|
|
Year ended December
31,
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
Note
|
|
U.S. dollars in thousands
(except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
2,369
|
|
|
|
938
|
|
|
|
-
|
|
Cost of sales
|
|
21
|
|
|
(741
|
)
|
|
|
(380
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
1,628
|
|
|
|
558
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
22
|
|
|
(113
|
)
|
|
|
(99
|
)
|
|
|
(158
|
)
|
Selling and marketing expenses
|
|
23
|
|
|
(1,691
|
)
|
|
|
(848
|
)
|
|
|
-
|
|
General and administrative expenses
|
|
24
|
|
|
(2,048
|
)
|
|
|
(2,769
|
)
|
|
|
(1,078
|
)
|
Impairment of intangible assets
|
|
14
|
|
|
(1,729
|
)
|
|
|
-
|
|
|
|
-
|
|
Other gains, net
|
|
25
|
|
|
1,059
|
|
|
|
802
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
|
(2,894
|
)
|
|
|
(2,356
|
)
|
|
|
(1,224
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
26
|
|
|
61
|
|
|
|
60
|
|
|
|
24
|
|
Finance expenses
|
|
26
|
|
|
(35
|
)
|
|
|
(15
|
)
|
|
|
(7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income, net
|
|
|
|
|
26
|
|
|
|
45
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from investment
in associate
|
|
12
|
|
|
(845
|
)
|
|
|
569
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that might be classified to profit or loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
|
|
108
|
|
|
|
114
|
|
|
|
|
|
Reclassification of foreign currency
translation adjustments to Other gains, net
|
|
|
|
|
(221
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income
(loss)
|
|
|
|
|
(113
|
)
|
|
|
114
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for
the year
|
|
|
|
|
(3,826
|
)
|
|
|
(1,628
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year attributable to:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
|
|
|
(2,476
|
)
|
|
|
(1,390
|
)
|
|
|
(1,207
|
)
|
Non-controlling interests
|
|
|
|
|
(1,237
|
)
|
|
|
(352
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year attributable
to:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
|
|
|
(2,589
|
)
|
|
|
(1,276
|
)
|
|
|
(1,207
|
)
|
Non-controlling interests
|
|
|
|
|
(1,237
|
)
|
|
|
(352
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,826
|
)
|
|
|
(1,628
|
)
|
|
|
(1,207
|
)
|
Basic and diluted loss per share
(in U.S. dollars)
|
|
28
|
|
|
(0.011
|
)
|
|
|
(0.006
|
)
|
|
|
(0.006
|
)
|
The accompanying notes are an integral
part of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY
|
|
|
Attributable
to equity holders of the Company
|
|
|
|
|
|
|
|
|
|
Share
capital
|
|
|
Share
premium
and options
|
|
|
Accumulated
deficit
|
|
|
Treasury
shares
|
|
|
Foreign
currency
translation
adjustments
of foreign
operations
|
|
|
Reserve
from
transactions
with
non-
controlling
interests
|
|
|
Total
|
|
|
Non-
controlling
interests
|
|
|
Total
equity
|
|
|
|
U.S.
dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as
of January 1, 2013
|
|
|
5,997
|
|
|
|
147,475
|
|
|
|
(143,560
|
)
|
|
|
(2,469
|
)
|
|
|
114
|
|
|
|
(204
|
)
|
|
|
7,353
|
|
|
|
2,071
|
|
|
|
9,424
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,476
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,476
|
)
|
|
|
(1,237
|
)
|
|
|
(3,713
|
)
|
Other
comprehensive income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(113
|
)
|
|
|
-
|
|
|
|
(113
|
)
|
|
|
-
|
|
|
|
(113
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,476
|
)
|
|
|
-
|
|
|
|
(113
|
)
|
|
|
-
|
|
|
|
(2,589
|
)
|
|
|
(1,237
|
)
|
|
|
(3,826
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment to
employees and others
|
|
|
-
|
|
|
|
-
|
|
|
|
(7
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(7
|
)
|
|
|
(58
|
)
|
|
|
(65
|
)
|
Issuance of shares and
warrants
|
|
|
90
|
|
|
|
876
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
966
|
|
|
|
-
|
|
|
|
966
|
|
Exercise of options in
associate
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
(1
|
)
|
Sale of treasury shares
|
|
|
-
|
|
|
|
(52
|
)
|
|
|
-
|
|
|
|
378
|
|
|
|
-
|
|
|
|
-
|
|
|
|
326
|
|
|
|
(43
|
)
|
|
|
283
|
|
Conversion of convertible
loan into capital in subsidiary
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
213
|
|
|
|
213
|
|
|
|
(213
|
)
|
|
|
-
|
|
Other
|
|
|
-
|
|
|
|
-
|
|
|
|
(30
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(30
|
)
|
|
|
-
|
|
|
|
(30
|
)
|
Exercise
of warrants into shares
|
|
|
6
|
|
|
|
28
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
34
|
|
|
|
-
|
|
|
|
34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2013
|
|
|
6,093
|
|
|
|
148,327
|
|
|
|
(146,073
|
)
|
|
|
(2,091
|
)
|
|
|
-
|
|
|
|
9
|
|
|
|
6,265
|
|
|
|
520
|
|
|
|
6,785
|
|
The accompanying notes are an integral
part of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY
|
|
|
Attributable
to equity holders of the Company
|
|
|
|
|
|
|
|
|
|
Share
capital
|
|
|
Share
premium
and options
|
|
|
Accumulated
deficit
|
|
|
Treasury
shares
|
|
|
Foreign
currency
translation
adjustments
of foreign
operations
|
|
|
Reserve
from
transactions
with
non-
controlling
interests
|
|
|
Total
|
|
|
Non-
controlling
interests
|
|
|
Total
equity
|
|
|
|
U.S.
dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as
of January 1, 2012
|
|
|
5,335
|
|
|
|
141,385
|
|
|
|
(143,276
|
)
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
3,444
|
|
|
|
-
|
|
|
|
3,444
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,390
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,390
|
)
|
|
|
(352
|
)
|
|
|
(1,742
|
)
|
Other
comprehensive income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
114
|
|
|
|
-
|
|
|
|
114
|
|
|
|
-
|
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,390
|
)
|
|
|
-
|
|
|
|
114
|
|
|
|
-
|
|
|
|
(1,276
|
)
|
|
|
(352
|
)
|
|
|
(1,628
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment to
employees and others
|
|
|
-
|
|
|
|
-
|
|
|
|
1,106
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,106
|
|
|
|
193
|
|
|
|
1,299
|
|
Issuance of shares for
business combination
|
|
|
176
|
|
|
|
2,293
|
|
|
|
-
|
|
|
|
(2,469
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,858
|
|
|
|
1,858
|
|
Issuance of shares and
options
|
|
|
309
|
|
|
|
2,109
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,418
|
|
|
|
-
|
|
|
|
2,418
|
|
Conversion of convertible
loan into capital in subsidiary
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(204
|
)
|
|
|
(204
|
)
|
|
|
372
|
|
|
|
168
|
|
Exercise
of warrants into shares
|
|
|
177
|
|
|
|
1,688
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,865
|
|
|
|
-
|
|
|
|
1,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2012
|
|
|
5,997
|
|
|
|
147,475
|
|
|
|
(143,560
|
)
|
|
|
(2,469
|
)
|
|
|
114
|
|
|
|
(204
|
)
|
|
|
7,353
|
|
|
|
2,071
|
|
|
|
9,424
|
|
|
|
Attributable
to equity holders of the Company
|
|
|
|
|
|
|
|
|
|
Share
capital
|
|
|
Share
premium
and options
|
|
|
Accumulated
deficit
|
|
|
Treasury
shares
|
|
|
Foreign
currency
translation
adjustments
of foreign
operations
|
|
|
Reserve
from
transactions
with
non-
controlling
interests
|
|
|
Total
|
|
|
Non-
controlling
interests
|
|
|
Total
equity
|
|
|
|
U.S.
dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as
of January 1, 2011
|
|
|
4,993
|
|
|
|
139,983
|
|
|
|
(142,142
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,834
|
|
|
|
-
|
|
|
|
2,834
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss for
the year
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,207
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,207
|
)
|
|
|
-
|
|
|
|
(1,207
|
)
|
Issuance of shares and
options
|
|
|
342
|
|
|
|
1,399
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,741
|
|
|
|
-
|
|
|
|
1,741
|
|
Share-based payment to
employees and others
|
|
|
-
|
|
|
|
-
|
|
|
|
73
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
73
|
|
|
|
-
|
|
|
|
73
|
|
Exercise
of stock options into shares
|
|
|
*
|
|
|
|
3
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2011
|
|
|
5,335
|
|
|
|
141,385
|
|
|
|
(143,276
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,444
|
|
|
|
-
|
|
|
|
3,444
|
|
The accompanying notes are an integral part
of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
Year ended December
31,
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
Note
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
Adjustments to reconcile loss
to net cash provided by (used in) operating activities (a)
|
|
|
|
|
1,214
|
|
|
|
236
|
|
|
|
(105
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
|
|
(2,499
|
)
|
|
|
(1,506
|
)
|
|
|
(1,312
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of subsidiary, less cash received (d)
|
|
5
|
|
|
-
|
|
|
|
733
|
|
|
|
-
|
|
Investment in associate
|
|
12
|
|
|
-
|
|
|
|
(1,658
|
)
|
|
|
-
|
|
Sale of investment in associate
|
|
|
|
|
3,054
|
|
|
|
|
|
|
|
|
|
Decrease in restricted deposit
|
|
|
|
|
-
|
|
|
|
1
|
|
|
|
25
|
|
Decrease (increase) in short-term bank deposits
|
|
|
|
|
366
|
|
|
|
(170
|
)
|
|
|
(1,377
|
)
|
Purchase of property, plant and equipment
|
|
13
|
|
|
(84
|
)
|
|
|
(6
|
)
|
|
|
(12
|
)
|
Purchase of intangible assets
|
|
14
|
|
|
-
|
|
|
|
(80
|
)
|
|
|
-
|
|
Other investments
|
|
|
|
|
-
|
|
|
|
(29
|
)
|
|
|
(8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used) in
investing activities
|
|
|
|
|
3,336
|
|
|
|
(1,209
|
)
|
|
|
(1,372
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of shares and options
|
|
19
|
|
|
-
|
|
|
|
2,418
|
|
|
|
1,741
|
|
Exercise of warrants and options into shares
|
|
19
|
|
|
34
|
|
|
|
1,865
|
|
|
|
3
|
|
Sale of treasury shares
|
|
|
|
|
283
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing
activities
|
|
|
|
|
317
|
|
|
|
4,283
|
|
|
|
1,744
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
|
|
1,154
|
|
|
|
1,568
|
|
|
|
(940
|
)
|
Gains (losses) from exchange rate differences on cash
and cash equivalents
|
|
|
|
|
37
|
|
|
|
5
|
|
|
|
(3
|
)
|
Cash and cash equivalents at beginning
of year
|
|
|
|
|
1,696
|
|
|
|
123
|
|
|
|
1,066
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of year
|
|
|
|
|
2,887
|
|
|
|
1,696
|
|
|
|
123
|
|
The accompanying notes are an integral
part of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED STATEMENT OF CASH FLOWS
|
|
|
|
|
|
|
Year ended December
31,
|
|
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
Note
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
Adjustments
to reconcile loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income and expenses not involving cash flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
13, 14
|
|
|
313
|
|
|
|
136
|
|
|
|
94
|
|
|
|
Loss from disposal of property, plant and equipment
|
|
25
|
|
|
2
|
|
|
|
2
|
|
|
|
3
|
|
|
|
Share-based payment transactions to employees and others
|
|
20
|
|
|
(65
|
)
|
|
|
1,299
|
|
|
|
73
|
|
|
|
Revaluation of short-term deposits
|
|
|
|
|
(29
|
)
|
|
|
(75
|
)
|
|
|
5
|
|
|
|
Exchange rate differences on operating activities
|
|
|
|
|
(37
|
)
|
|
|
(5
|
)
|
|
|
3
|
|
|
|
Gain from bargain purchase
|
|
5
|
|
|
-
|
|
|
|
(795
|
)
|
|
|
-
|
|
|
|
Change in employee benefit liabilities, net
|
|
|
|
|
(2
|
)
|
|
|
2
|
|
|
|
-
|
|
|
|
Loss (gain) from change in holding rate in associate
|
|
12
|
|
|
(10
|
)
|
|
|
5
|
|
|
|
-
|
|
|
|
Earnings from investment in associate
|
|
12
|
|
|
845
|
|
|
|
(569
|
)
|
|
|
-
|
|
|
|
Impairment of intangible assets
|
|
14
|
|
|
1,729
|
|
|
|
-
|
|
|
|
-
|
|
|
|
Gain from sale of investment in
associate
|
|
|
|
|
(1,051
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,695
|
|
|
|
-
|
|
|
|
178
|
|
|
|
Changes in operating asset and liability items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in trade receivables
|
|
8
|
|
|
(50
|
)
|
|
|
3
|
|
|
|
-
|
|
|
|
Decrease (increase) in other accounts receivable and
income taxes receivable
|
|
9
|
|
|
30
|
|
|
|
(23
|
)
|
|
|
42
|
|
|
|
Increase in inventories
|
|
10
|
|
|
(73
|
)
|
|
|
(44
|
)
|
|
|
-
|
|
|
|
Increase (decrease) in trade payables
|
|
15
|
|
|
(86
|
)
|
|
|
199
|
|
|
|
(109
|
)
|
|
|
Increase (decrease) in other accounts
payable
|
|
16
|
|
|
(302
|
)
|
|
|
101
|
|
|
|
(216
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(481
|
)
|
|
|
236
|
|
|
|
(283
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,214
|
|
|
|
236
|
|
|
|
(105
|
)
|
The accompanying notes are an integral
part of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
CONSOLIDATED STATEMENT OF CASH FLOWS
|
|
|
|
|
Year ended December
31,
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(b)
|
|
Additional
information on cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest received
|
|
|
24
|
|
|
|
40
|
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c)
|
|
Non-cash transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property, plant
and equipment on suppliers' credit
|
|
|
-
|
|
|
|
73
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of treasury shares
to subsidiary
|
|
|
-
|
|
|
|
2,469
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible loan
into capital in subsidiary
|
|
|
377
|
|
|
|
168
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment to third
party
|
|
|
49
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allotment of shares to Aurum
|
|
|
913
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivables from sale of investment
in associate
|
|
|
297
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(d)
|
|
Acquisition of newly consolidated
subsidiary (see Note 5):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital (excluding cash and cash equivalents)
|
|
|
-
|
|
|
|
517
|
|
|
|
-
|
|
|
|
Property, plant and equipment
|
|
|
-
|
|
|
|
(51
|
)
|
|
|
-
|
|
|
|
Intangible assets
|
|
|
-
|
|
|
|
(2,397
|
)
|
|
|
-
|
|
|
|
Gain from bargain purchase
|
|
|
-
|
|
|
|
795
|
|
|
|
-
|
|
|
|
Non-current liabilities
|
|
|
-
|
|
|
|
11
|
|
|
|
-
|
|
|
|
Non-controlling interests
|
|
|
-
|
|
|
|
1,858
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
733
|
|
|
|
-
|
|
The accompanying notes are an integral
part of the consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
|
a.
|
A general description of the
Company and its activity:
|
XTL Biopharmaceuticals Ltd.
(the “
Company
”) is engaged in the development of therapeutics for the treatment of unmet medical needs. The
Company was incorporated under the Israeli Companies Law on March 9, 1993. The registered office of the Company is located
at 85 Medinat Hayehudim Street, Herzliya 46766. The Company owns 54.72% of the issued and outstanding capital of InterCure Ltd.
(“
InterCure
”), a public company whose shares are traded on the Tel-Aviv Stock Exchange (“
TASE
”).
The Company also owns 100% of Xtepo Ltd. (“
Xtepo
”) and owns 100% of a U.S. company, XTL Biopharmaceuticals
Inc. (“
XTL Inc.
”), which was incorporated in 1999 under the laws of the State of Delaware, USA.
The Company's American Depository
Receipts (“
ADRs
”) are traded on the NASDAQ Capital Market and its securities are traded on the TASE.
On January 7, 2014, the Company
signed a licensing agreement with Yeda to develop hCDR1, a Phase II-ready asset for the treatment of Systemic Lupus Erythematosus
(“
SLE
”). The terms of the licensing agreement include, among other things, expense reimbursement for patent
expenses, certain milestone payments to Yeda, low single-digit royalties based on net sales, and additional customary royalties
to the Office of the Chief Scientist. For additional information, see Note 31 below.
On November 21, 2012, the
Company acquired approximately 31.35% of the shares of Proteologics Ltd. (“
Proteologics
”), a public company
whose shares are traded on the TASE in consideration of approximately NIS 6.5 million (approximately $ 1.7 million)
paid in cash. On September 12, 2013, the Company sold its entire investment in Proteologics (representing 44.95% of Proteologics
issued and outstanding capital at the time) in consideration of approximately $ 3.4 million after having acquired an additional
14.13% of Proteologics' shares on September 11, 2013. See also Note 12 below.
On July 25, 2012, the Company
completed the acquisition of approximately 50.79% of the issued and outstanding share capital of InterCure Ltd., a public company
whose shares are traded on the TASE and is engaged in the research, development, marketing and sale of home medical devices for
the non-medicinal and non-invasive treatment of various diseases such as hypertension, congestive cardiac failure, insomnia and
stress. In the context of the acquisition, the Company provided InterCure a loan that was convertible into shares of InterCure.
On May 16, 2013, the Company informed InterCure of its decision to convert the entire convertible loan which had been extended
by the Company in the context of the acquisition into 7,620,695 Ordinary shares of InterCure as predetermined in the acquisition
agreement. Following said conversion and as of December 31, 2013, the Company holds approximately 54.72% of InterCure's issued
and outstanding share capital.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
As of the date of the report,
the Company is in the planning stages for the implementation of a phase 2 clinical trial of the recombinant EPO (“
rHuEPO
”)
drug for treating Multiple Myeloma patients. As part of said preparations, the Company has conducted a study which consists of
collecting preliminary data on the existence of specific proteins in the blood of a group of Multiple Myeloma patients and is
preparing market analyses and regulatory activities. The data collected in the preliminary study will be combined in the plans
and preparations for the implementation of the phase 2 clinical trial, as needed. Based on the Company's current business plans
and estimates, the approval for commencing the clinical trial is expected to be obtained during the middle to second half of 2014.
On November 30, 2011, the
Company completed the MinoGuard transaction in which it acquired the activity of MinoGuard Ltd. (“
MinoGuard
”),
founded by Mor Research Applications Ltd. (“
Mor
”) by way of receiving an exclusive license to use MinoGuard's
entire technology, including the SAM-101, a combination drug for treating psychotic diseases, focusing on schizophrenia, in return
for sales royalties and milestone payments to be made over the clinical development period. The drug is based on a combination
of existing antipsychotic drugs and a recognized medicinal compound (Minocycline). See also Note 18a(4) below.
The Company has patent rights
and other assets in the field of treating hepatitis C (DOS program) transferred to Presidio Pharmaceuticals Inc. (“
Presidio
”)
and returned by Presidio to the Company in August 2012 (see more information in Note 18a to the annual consolidated financial
statements for 2012). The Company intends to examine renewing the activity in the field of hepatitis C and/or locate strategic
partners for the continued development and marketing of drugs for treating hepatitis C based on the DOS technology.
As of December 31, 2013, the
Company has the following subsidiaries:
InterCure - a publicly traded
company on the TASE. InterCure has two subsidiaries - InterCure Inc., incorporated in the U.S., and InterCure UK (inactive), incorporated
in the UK.
Xtepo Ltd. (“
Xtepo
”)
- a private company incorporated in Israel in November 2009 which holds a license for the exclusive use of the patent for rHuEPO
drug for treating Multiple Myeloma patients.
XTL Biopharmaceuticals Inc.
(“
XTL Inc.
”) which was engaged in development of therapeutics and business development in the medical realm.
XTL Inc. has a wholly-owned subsidiary - XTL Development Inc. (“
XTL Development
”), which was incorporated in
2007 under the laws of the State of Delaware, USA. As of the date of the approval of the financial statements, XTL Inc. and XTL
Development are inactive.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
|
b.
|
The Company has incurred continuing
losses and depends on outside financing resources to continue its activities. The Company's
only source of income at this stage originates from InterCure, a subsidiary in which
control was acquired on July 25, 2012. Based on existing business plans, the Company's
management estimates that its outstanding cash and cash equivalent balances, including
short-term deposits, will allow the Company to finance its activities at least until
the fourth quarter of 2015 (independently of InterCure, which is 54.72% held). However,
the amount of cash which the Company will need in practice to finance its activities
depends on numerous factors which include, but are not limited to, the timing, planning
and execution of clinical trials of existing drugs and future projects which the Company
might acquire or other business development activities such as acquiring new technologies
and/or changes in circumstances which are liable to cause significant expenses to the
Company in excess of management's current and known expectations as of the date of these
financial statements and which will require the Company to reallocate funds against plans,
also due to circumstances beyond its control.
|
The Company expects to incur
additional losses in 2014 arising from research and development activities, testing additional technologies and operating activities,
which will be reflected in negative cash flows from operating activities. Accordingly, in order to perform the clinical trials
aimed at developing a product until obtaining its marketing approval, the Company will be forced to raise additional funds in
the future by issuing securities. Should the Company fail to raise additional capital in the future under standard terms, it will
be required to dispose of marketable securities held by it or minimize its activities or sell or grant a sublicense to third parties
to use all or part of its technologies.
InterCure has noted in its
consolidated financial statements for the year ended December 31, 2013, that there is a substantial doubt regarding its ability
to continue as a going concern. As of December 31, 2013, the Company has impaired its assets accordingly. See Note 14f below
with regard to the impairment. The financial statements of the Company include no further adjustments of the value of assets
and liabilities, if any, that will apply if InterCure is unable to continue operating as a going concern. InterCure's management
believes that it has sufficient cash and other resources to meet its future plans through July 2015. InterCure's summarized consolidated
balance sheet as of December 31, 2013 and its income and cash flow statements for the year then ended are included in Note 11
below.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
|
|
a.
|
Basis of presentation of the
financial statements:
|
|
1.
|
The consolidated financial statements
of the Company ("the financial statements") have been prepared in accordance
with International Financial Reporting Standards (IFRSs), as issued by the International
Accounting Standards Board (IASB).
|
The consolidated
financial statements have been prepared under the historical cost convention, as adjusted for defined benefit plans.
The preparation
of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires the
Group's management to exercise its judgment in the process of applying the Group's accounting policies. The areas that involve
judgment which have significant effect or complexity or where assumptions and estimates are significant to the consolidated financial
statements are disclosed in Note 3. Actual results could significantly differ from the estimates and assumptions used by the Group's
management.
|
2.
|
The Group analyzes the expenses
recognized in the statement of comprehensive income by classification based on the function
of expense.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
b.
|
Consolidated financial statements:
|
|
1.
|
Subsidiaries and business combinations:
|
The consolidated
financial statements include the accounts of the Company and entities controlled by the Company. Control exists when the Company
has the power over the investee; has exposure, or rights, to variable returns from involvement in the investee; and has the ability
to use its power over the investee to affect its returns.
The Company
examines whether it controls another entity even when it does not hold more than 50% of the voting rights, but can control the
entity's financial and operating policies by de-facto control. De-facto control can be created under circumstances in which the
ratio of the Company's voting rights in the entity to the percentage and dispersion of the holdings of the other shareholders
grants the Company the power to control the entity's financial and operating policies.
Subsidiaries
are fully consolidated starting from the date on which control therein is attained by the Company. Their consolidation ceases
when such control is discontinued.
The Company's
accounting treatment of business combinations uses the acquisition method. The consideration transferred for the acquisition of
a subsidiary (the “
Acquiree
”) is calculated as the total of fair values of the assets transferred by the Company,
the liabilities incurred to the Group against the Acquiree's previous owners and the equity rights issued by the Company. The
transferred consideration includes the fair value of each asset or liability arising from a contingent consideration arrangement.
The acquisition related costs are recognized in profit or loss as incurred. Identifiable assets acquired and liabilities and contingent
liabilities assumed by the Company in a business combination (excluding certain exceptions prescribed in IFRS 3R, "Business
Combinations (Revised)" (“
IFRS3R
”) are initially measured at fair value on the acquisition date. For each
business combination, the Company decides whether to recognize non-controlling interests in the Acquiree which represent existing
ownership rights and entitle their holders to a relative portion of the entity's net assets upon liquidation at their fair value
or at the relative portion of the existing ownership instruments in amounts recognized for the Acquiree's net identifiable assets.
This decision is individually made for each business combination. All the other components of non-controlling interests are measured
at fair value on the acquisition date unless another measurement basis is required by IFRS.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
The excess
of the overall amount of the transferred consideration, the amount of any non-controlling interests in the Acquiree, and the fair
value of any previous equity rights in the Acquiree on the acquisition date in excess of the net amount of identifiable assets
acquired and liabilities assumed on the acquisition date, all measured as above, is recognized as goodwill.
In the event
that the net amount of identifiable assets acquired and liabilities assumed on the acquisition date exceeds the overall amount
of the transferred consideration, the amount of any non-controlling interests in the Acquiree, and the fair value of any previous
equity rights in the Acquiree on the acquisition date as discussed above, the difference is recognized directly in profit or loss
on the acquisition date.
Intra-group
balances and transactions, including revenues, expenses and dividends in respect of transactions between the Group companies,
are eliminated. Gains and losses arising from intra-group transactions that have been recognized as assets (such as inventories
and property, plant and equipment) are also eliminated. Such intra-group losses may point to the impairment of assets which is
tested and accounted for as specified in g below.
|
2.
|
Transactions with non-controlling
interests which do not result in loss of control:
|
Transactions
with non-controlling interests in subsidiaries which do not result in loss of control in the subsidiaries are accounted for as
transactions with owners. In these transactions, the difference between the fair value of any consideration paid or received and
the amount of adjustment of the non-controlling interests to reflect the changes in their relative rights in the subsidiaries
is directly recognized in equity and attributed to the equity holders of the parent.
An associate
is an entity over which the Group exercises significant influence, but not control, which is usually expressed in holding 20%-50%
of the voting rights. The investment in an associate is presented using the equity method of accounting. According to the equity
method of accounting, the investment is initially recognized at cost and its carrying amount varies to the extent that the Group
recognizes its share of the associate's earnings or losses from the acquisition date.
The Group's
share in the earnings or losses of associates after the acquisition date is carried to profit or loss and its share in the other
comprehensive income movements after the acquisition date is carried to other comprehensive income against the carrying amount
of the investment.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
Each reporting date, the Group
determines if there are indicators of impairment in the investment in the associate. In such case, the Group calculates the amount
of the impairment as the difference between the recoverable amount of the investment in the associate (the higher of the value
in use and the fair value less selling costs) and its carrying amount and recognizes the amount of impairment in profit or loss
in the line item of "equity in earnings (losses) in associates".
In 2013, the Company sold
its investment in Proteologics. For further details, see Note 12 below.
|
c.
|
Translation of balances and transactions
in foreign currency:
|
|
1.
|
Functional currency and presentation
currency:
|
Items included
in the financial statements of each of the Group's entities are measured using the currency of the primary economic environment
in which the entity operates (the "
Functional Currency
"). The consolidated financial statements are presented
in U.S. dollars, which is the Functional Currency of each of the Group's entities and the Company's presentation currency.
Below are
the changes in the reporting periods in the exchange rate of the U.S. dollar in relation to the NIS:
|
|
Change in the
|
|
|
|
exchange rate
|
|
Year ended
|
|
of U.S. $ 1
|
|
|
|
%
|
|
|
|
|
|
December 31, 2013
|
|
|
(7.02
|
)
|
December 31, 2012
|
|
|
(2.30
|
)
|
December 31, 2011
|
|
|
7.66
|
|
|
|
Exchange rate
|
|
As of
|
|
of U.S. $ 1
|
|
|
|
NIS
|
|
|
|
|
|
December 31, 2013
|
|
|
3.471
|
|
December 31, 2012
|
|
|
3.733
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
2.
|
Transactions and balances:
|
Transactions
in a currency other than the Functional Currency ("foreign currency") are translated into the Functional Currency using
the exchange rates at the dates of the transactions. After initial recognition, monetary assets and liabilities denominated in
foreign currency are translated at the end of each reporting period into the Functional Currency at the exchange rate at that
date. Exchange differences are recognized in the statement of comprehensive income in the line item finance income (expenses).
Non-monetary assets and liabilities denominated in foreign currency and measured at cost are translated at the exchange rate at
the date of the transaction.
|
3.
|
Translation of the financial
statements of the Group companies:
|
The operating
results and financial position of all the Group companies (none of whose functional currency is the currency of a hyperinflationary
economy), including companies accounted for at equity, whose functional currency differs from the presentation currency (Proteologics'
functional currency is NIS), are translated into the presentation currency as follows:
|
a)
|
Assets and liabilities at each
statement of financial position date are translated at the closing rate on the statement
of financial position date;
|
|
b)
|
Revenues and expenses at each
statement of comprehensive income date are translated at the average exchange rates for
the period (unless this average is not a reasonable approximation of the cumulative effect
of exchange rates on the transaction dates in which case the revenues and expenses are
translated at the exchange rate on the transaction date);
|
|
c)
|
All resulting exchange rate
differences are recognized in other comprehensive income.
|
Upon consolidation
of the financial statements, exchange rate differences arising from translating the net investment in foreign operations and from
loans and other currency instruments which are designated as investment hedges are carried to other comprehensive income. Upon
the disposal of part of or an entire foreign operation, the exchange rate differences carried to other comprehensive income are
recognized in profit or loss as part of the gain or loss from the disposal.
Goodwill
and fair value adjustments arising from the acquisition of a foreign operation are accounted for as the foreign operation's assets
and liabilities and translated at the closing rate. Exchange rate differences arising from such translation are carried to other
comprehensive income.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
e.
|
Property, plant and equipment:
|
Items of
property, plant and equipment are measured at cost with the addition of direct acquisition costs, less accumulated depreciation,
less accumulated impairment losses and excluding day-to-day servicing expenses.
Depreciation of property,
plant and equipment is calculated on a straight-line basis to reduce their cost to their residual value over their useful life
as follows:
|
|
%
|
|
|
|
Computers
|
|
33
|
Office furniture and equipment
|
|
6 - 15
|
Production molds
|
|
20
|
The useful
life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for
prospectively as a change in accounting estimate.
Depreciation
of an asset ceases at the earlier of the date that the asset is classified as held for sale and the date that the asset is derecognized.
An asset is derecognized on disposal or when no further economic benefits are expected from its use. The gain or loss arising
from derecognition of the asset (determined as the difference between the net disposal proceeds and the carrying amount in the
financial statements) is included when the asset is derecognized in "other gains (losses), net" in the consolidated
statements of comprehensive income.
An asset's
carrying amount is written down immediately to its recoverable amount if the asset's carrying amount is greater than its estimated
recoverable amount (see g below).
|
1.
|
Brand name and technology:
|
Brand name
and technology acquired in a business combination are recognized at fair value on the acquisition date. Brand name and technology
have a finite useful life and are presented at cost net of accumulated amortization and impairment losses. The amortization is
calculated using the straight-line method over the expected useful life (9-10 years).
Acquired
licenses to use computer software are capitalized based on costs incurred in acquiring the specific software and preparing it
for use. These costs are amortized using the straight-line method over the estimated useful life (five years). Costs relating
to computer software upkeep are recognized as expenses as incurred.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
3.
|
Exclusive technology testing
right:
|
An acquired
exclusive immune system technology testing right has a finite life of 15 months in effect from September 1, 2010 and is amortized
using the straight-line method over its useful life. On November 30, 2011, the amortization of this right was concluded. See details
in Note 14d below.
|
4.
|
Unamortized intangible assets
(licenses and patent rights):
|
The amortization
of an asset on a straight-line basis over its useful life begins when the development procedure is completed and the asset is
available for use. These assets are reviewed for impairment once a year or whenever there are indicators of a possible impairment,
in accordance with the provisions of IAS 36, "Impairment of Assets".
|
5.
|
Research and development:
|
Research
expenditures are recognized as expenses when incurred. Costs arising from development projects are recognized as intangible assets
when the following criteria are met:
|
-
|
it is technically feasible to
complete the intangible asset so that it will be available for use;
|
|
-
|
management intends to complete
the intangible asset and use or sell it;
|
|
-
|
there is an ability to use or
sell the intangible asset;
|
|
-
|
it can be demonstrated how the
intangible asset will generate probable future economic benefits;
|
|
-
|
adequate technical, financial
and other resources to complete the development and to use or sell the intangible asset
are available; and
|
|
-
|
the expenditure attributable
to the intangible asset during its development can be reliably measured.
|
Other development
expenditures that do not meet these criteria are recognized as an expense when incurred. Development costs that were previously
recognized as an expense are not recognized as an asset in a later period. During the reporting period, the Group did not capitalize
development costs to intangible assets.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
g.
|
Impairment
of non-financial assets:
|
Intangible
assets which are not yet available for use are not depreciated and impairment in their respect is tested every year. Depreciable
assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
An impairment loss is recognized for the amount by which the asset's carrying amount exceeds its recoverable amount. The recoverable
amount is the higher of an asset's fair value less costs to sell and value in use. For the purposes of assessing impairment, assets
are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). Non-financial
assets that sustained impairment are reviewed for possible reversal of the impairment at each date of the statement of financial
position.
The Group
classifies its financial assets into the loans and receivables category. The classification depends on the purpose for which the
financial assets were acquired. The Group's management determines the classification of its financial assets at initial recognition.
Loans
and receivables:
Loans and
receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They
are included in current assets, except for maturities greater than 12 months after the date of the statement of financial position.
The Group's loans and receivables are included in the line items: "trade receivables", "other accounts receivable",
"cash and cash equivalents", "short-term deposits" and "restricted deposits" in the statement of
financial position.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
2.
|
Recognition
and measurement:
|
Regular
purchases and sales of financial assets are recognized in the books of the Group companies on the transaction settlement date
which is the date on which the asset is transferred to the Group or transferred by the Group. Investments are initially recognized
at fair value plus transaction costs for all financial assets not carried at fair value through profit or loss. Loans and receivables
are subsequently carried at amortized cost using the effective interest method.
|
3.
|
Impairment
of financial assets:
|
Financial
assets carried at amortized cost:
The Group
assesses at the date of each statement of financial position whether there is objective evidence that a financial asset or group
of financial assets is impaired. A financial asset or a group of financial assets is impaired and impairment losses are incurred
only if there is objective evidence of impairment as a result of one or more events that occurred after the initial recognition
of the asset ("a loss event") and that loss event (or events) has an impact on the estimated future cash flows of the
financial asset or group of financial assets that can be reliably estimated.
Inventories are measured at
the lower of cost and net realizable value. The cost of inventories comprises costs of purchase and costs incurred in bringing
the inventories to their present location and condition. Net realizable value is the estimated selling price in the ordinary course
of business less the estimated costs of completion and the estimated selling costs. The Group periodically evaluates the condition
and age of inventories and makes provisions for slow moving inventories accordingly.
Cost of inventories is determined
as follows:
Raw materials - at cost of
purchase using the "first-in, first-out" method.
Purchased merchandise and
products - using the "first-in, first-out" method.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
The balance of trade receivables
relates to amounts receivable from the Group's customers for goods sold or services rendered in the ordinary course of business.
Trade receivables are initially recognized at fair value and subsequently measured at amortized cost based on the effective interest
method, less an allowance for doubtful accounts.
Allowance for doubtful
accounts:
The allowance for doubtful
accounts is determined in respect of specific debts whose collection, in the opinion of the Group's management, is doubtful. The
Group's also recognizes a provision for groups of customers that are collectively assessed for impairment based on their credit
risk characteristics. Impaired debts are derecognized when they are assessed as uncollectible.
|
k.
|
Cash and cash
equivalents:
|
Cash and
cash equivalents include cash at hand and short-term bank deposits with original maturities of three months or less, that are
not restricted as to withdrawal or use, and are therefore considered to be cash equivalents.
The Company's
Ordinary shares are classified as share capital. Incremental costs directly attributable to the issuance of new shares or options
are shown in equity as a deduction, net of tax, from the issuance proceeds.
When Group
companies purchase Company shares (treasury shares), the consideration paid, including incremental costs directly attributable
to the purchase (less the effect of taxes on income), is deducted from the equity attributable to equity holders of the parent
until the shares are eliminated or reissued. When these shares are reissued in subsequent periods, the consideration received,
less incremental costs directly attributable to the transaction and less the effect of taxes on income, is included in equity
attributable to equity holders of the parent.
Trade payables
are the Group's obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers.
Trade payables are initially recognized at fair value and subsequently measured at amortized cost using the effective interest
method.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
Taxes on
income in profit or loss comprise current and deferred taxes. Current or deferred tax results are recognized in profit or loss,
except to the extent that the tax arises from items which are recognized directly in other comprehensive income or in equity.
In such cases, the tax effect is also recognized in the relevant item.
The current
tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted by the reporting date
as well as adjustments required in connection with the tax liability in respect of prior years.
Deferred
taxes are computed in respect of temporary differences between the carrying amounts in the financial statements and the amounts
attributed for tax purposes.
Deferred
tax balances are measured at the tax rate that is expected to apply when the taxes are taken to the statement of comprehensive
income (loss), to other comprehensive income or equity based on tax laws that have been enacted or substantively enacted by the
reporting date. The amount for deferred taxes in the statement of comprehensive income (loss) represents the changes in said balances
during the reported period, except for items attributable to other comprehensive income or equity.
Deferred
tax assets are reviewed at the end of each reporting period and reduced to the extent that it is not probable that they will be
utilized. Also, temporary differences (such as carryforward losses) for which deferred tax assets have not been recognized are
reassessed and deferred tax assets are recognized to the extent that their utilization has become probable. Any resulting reduction
or recognition is recognized in the line item "taxes on income".
Taxes that
would apply in the event of the sale of investments in investees have not been taken into account in computing the deferred taxes,
as long as the sale of the investments in investees is not expected in the foreseeable future. Also, deferred taxes that would
apply in the event of distribution of earnings by investees as dividend have not been taken into account in computing the deferred
taxes, since the distribution of dividend does not involve an additional tax liability or since it is the Company's policy not
to initiate distribution of dividend that triggers an additional tax liability.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
Deferred
tax assets and deferred tax liabilities are offset if there is a legally enforceable right to set off a current tax asset against
a current tax liability and the deferred taxes relate to the same taxpayer and the same taxation authority.
A deferred
tax asset has not been recognized in the Group's accounts because the availability of taxable income in the future is not probable.
|
1.
|
Employment
benefits for retirement compensation/pension:
|
A Defined
contribution plan (Section 14) is a post-employment employee benefit plan under which the Company pays fixed contributions into
a separate and independent entity so that the Company has no legal or constructive obligation to pay further contributions if
the fund does not hold sufficient assets to pay all employees the benefits relating to employee service in the current and prior
periods. A defined benefit plan is a post-employment employee benefit plan that is not a defined contribution plan.
The Group
operates various pension plans. The plans are generally funded through payments to insurance companies or trustee-administered
funds. Said pension plans qualify for the criteria of defined contribution plan, as above, based on their terms.
According
to the labor laws and employment agreements in Israel and according to the Group's practice, the Group is obligated to pay compensation
to employees who are dismissed and, under certain circumstances, to employees who retire. The Group's liability to pay retirement
compensation for certain employees is accounted for as a defined benefit plan and for the remaining employees it is accounted
for as a defined contribution plan.
According
to the liabilities of the Group companies to employees under defined benefit plans, the amounts of the benefits to be received
by employees eligible for severance pay upon retirement are based on the number of years of employment and latest salary.
The liabilities
of the Group companies for the remaining employees under defined contribution plans consist of making fixed contributions in a
separate and independent entity whereby the Group companies have no legal or constructive liability to make additional contributions
in the event that the fund's assets are insufficient for paying all employees the benefits for their services in the current period
and in previous periods.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
The total
accrued severance pay presented in the statement of financial position is the present value of the defined benefit liability as
of the statement of financial position date, less the fair value of the plan assets. The defined benefit liability is measured
on an annual basis by an actuary using the Projected Unit Credit Method.
The present
value of the liability is determined by discounting the expected future cash flows (after taking into account expected salary
increase rates), based on interest rates of Government bonds denominated in the currency in which the benefits will be paid and
whose maturity period approximates the accrued severance pay period.
According
to IAS 19,
Employee Benefits
, the discount rate used to calculate the actuarial obligation is determined by using market
returns of high quality corporate debentures on the statement of financial position date. However, according to IAS 19, in countries
which do not have a deep market for such debentures, the market returns of Government bonds on the statement of financial position
date will be used instead.
Remeasurement
gains and losses arising from experience adjustments and changes in actuarial assumptions are charged or credited to equity
in other comprehensive income
in the period in which they
arise. Interest costs in respect of the defined benefit plan
are
charged or credited to finance costs.
An Amendment
to IAS 19,
Employee benefits
, became effective on January 1, 2013. The amendment replaces interest costs and expected returns
on plan assets with a net interest amount that is calculated by applying the discount rate to the net defined benefit liability
(assets). The initial implementation of the amendment did not have a material effect on the Company's financial statements
As abovementioned,
the Group buys insurance policies and makes payments to pension and compensation funds to finance its obligations under defined
contribution plans. The Group has no further payment obligations once the contributions have been paid. The contributions are
recognized as employee benefit expenses concurrently with the services rendered by the employees. Prepaid contributions are recognized
as an asset to the extent that a cash refund or reduction in the future payments is available.
|
2.
|
Vacation and
recreation benefits:
|
According to the Law, an employee
is entitled to paid annual leave and sick leave on an annual basis. The entitlement is based on the number of years of service.
The Company recognizes an obligation and expense for paid annual leave and sick leave based on the benefit accumulated for each
employee.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
The Group operates a number
of share-based payment plans to employees and to other service providers who render services that are similar to employees' services
that are settled with the Group's equity instruments. In this framework, the Group grants employees, from time to time, and, at
its discretion, options to purchase shares of the Group companies. The fair value of services received from employees in consideration
of the grant of options is recognized as an expense in the statement of comprehensive income (loss) and correspondingly carried
to equity. The total amount recognized as an expense over the vesting term of the options (the term over which all pre-established
vesting conditions are expected to be satisfied) is determined by reference to the fair value of the options granted at grant
date, except the effect of any non-market vesting conditions.
Non-market vesting conditions
are included in the assumptions used in estimating the number of options that are expected to vest. The total expense is recognized
over the vesting period, which is the period over which all of the specified vesting conditions of the share-based payment arrangement
are to be satisfied.
In each reporting date, the
Company revises its estimates of the number of options that are expected to vest based on the non-market vesting conditions and
recognizes the impact of the revision to original estimates, if any, in the statement of comprehensive income (loss) with a corresponding
adjustment in equity.
When the options are exercised,
the Company issues new shares. The proceeds net of any directly attributable transaction costs are credited to share capital (nominal
value) and share premium.
Share-based payment transactions
in which the Company acquired assets as consideration for the Company's equity instruments are measured at the value of the assets
acquired (see Note 14d below).
A provision in accordance
to IAS 37 is recognized when the Group has a present obligation (legal or constructive) as a result of event occurred in the past,
probable to be required to use economic resources to settle the obligation and can be reliably estimated. The group recognizes
a provision for warranty when the product is sold to the customer or when the service is provided to the customer. Initial recognition
is based on past experience. The estimated provision is re-tested every year.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
Revenues
are recognized in profit or loss when the revenues can be measured reliably, it is probable that the economic benefits associated
with the transaction will flow to the Company and the costs incurred or to be incurred in respect of the transaction can be measured
reliably. Revenues are measured at the fair value of the consideration received less any trade discounts, volume rebates and returns.
Following
are the specific revenue recognition criteria which must be met before revenue is recognized:
Revenues from sale of goods
to retail customers:
Revenues
from the sale of goods are recognized when all the significant risks and rewards of ownership of the goods have passed to the
buyer and the seller no longer retains continuing managerial involvement. The delivery date to the customer is usually the date
on which ownership passes.
Revenues
from sale of goods to distributors:
InterCure
sells its products to distributors as well. Revenues from such sales are recognized when InterCure or its subsidiaries deliver
the goods to the distributor, when sales channel and selling price are at the distributor's sole discretion, and when there are
no ongoing obligations to prevent the distributor from receiving the goods. Revenue is only recognized when goods were delivered
to the designated site, risks of loss and damage are transferred to the distributor and distributor had received the goods in
accordance with the sales agreement, conditions for receipt of goods had expired or InterCure holds objective evidence that goods
receipt criteria had been met.
Sales do
not include a finance component, as they are made with a 60 days credit period, considered as consistent with the market in which
InterCure operates.
Leases in which a significant
portion of the risks and rewards of ownership are retained by the lessor are classified as operating leases. Payments made under
operating leases are charged to the statement of comprehensive income (loss) on a straight-line basis over the period of the lease.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
Basic loss per share is calculated
by dividing the income or loss attributable to equity holders of the Company by the weighted average number of Ordinary shares
outstanding during the period, less Company shares held by a subsidiary.
In calculating diluted loss
per share, in addition to the average of Ordinary shares used for calculating basic loss, the weighted average number of shares
that will be issued assuming that all the potentially dilutive shares are converted into shares is also taken into consideration.
Potential shares are taken into account as above only when their effect is dilutive (reduces the earnings or increases the loss
per share).
|
u.
|
New and amended IFRS standards
and IFRIC interpretations:
|
Standards
and amendments and interpretations that have been issued and are effective as from January 1 2013:
|
1.
|
IFRS 10, "Consolidated
Financial Statements" ("IFRS 10"):
|
IFRS 10 supersedes
all existing guidance on the control and consolidation of financial statements in IAS 27, "Consolidated and Separate Financial
Statements" ("IAS 27") and SIC 12, "Consolidation - Special Purpose Entities". IFRS 10 redefines "control".
The new definition focuses on the requirement that power and variable returns should exist in order for control to exist. "Power"
is the current ability to direct the activities which significantly affect the returns. IFRS 10 contains, inter alia, guidance
relating to differentiating between participating rights and protective rights as well as guidance relating to cases where an
investor is acting on behalf of another party or on behalf of a group of parties (agent/principal relationships). The core principle
whereby a consolidated entity presents the accounts of a parent company and its subsidiaries as a single entity remains unchanged
as well as the mechanics of consolidation. The Group will adopt IFRS 10 for the first time for the annual period commencing on
January 1, 2013. The adoption of IFRS 10 is not expected to have a material impact on the Group's consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
2.
|
IFRS 12, "Disclosure of
Interests in Other Entities" ("IFRS 12"):
|
IFRS 12 prescribes disclosure
requirements addressing accounting issues prescribed in IFRS 10 and IFRS 11, "Joint Arrangements" ("IFRS 11")
and supersedes the existing disclosure requirements in IAS 28. The disclosure requirements prescribed in IFRS 12 include: significant
judgments and assumptions; rights in subsidiaries; rights in joint arrangements and in associates; and rights in structured entities
not consolidated in the financial statements. The Group will adopt IFRS 12 for the first time for the annual period commencing
on January 1, 2013. The initial adoption of IFRS 12 expanded certain disclosures in the Group's consolidated financial statements
regarding its rights in other entities.
|
3.
|
IFRS 13, "Fair Value Measurement"
("IFRS 13"):
|
IFRS 13 focuses on improving
the consistency and minimizing the complexity of fair value measurements by providing an accurate definition of the term "fair
value" and offering a single source of guidance for the measurement of fair value and for the disclosure requirements of
fair value measurement to be used by all the various IFRS standards. The requirements prescribed in IFRS 13 do not expand the
use of fair value accounting but do provide guidance as to its adoption in cases where its use is required or allowed by other
IFRS standards.
The initial adoption of IFRS
13 did not to have a material effect on the Group's consolidated financial statements.
|
4.
|
IAS 19 (Revised 2011), "Employee
Benefits" ("IAS 19R"):
|
IAS 19R introduces significant
changes in the manner of recognizing and measuring defined benefit plans and benefits in respect of employee dismissal and provides
new disclosure requirements for all types of employees benefits within the scope of IAS 19 as follows:
|
-
|
The remeasurement of the net
defined benefit liability (formerly - actuarial gains and losses) will be recognized
in other comprehensive income and not in profit or loss.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
-
|
Income from the plan assets is
recognized in profit or loss based on the discount rate used to measure the employee
benefit liabilities. The return on plan assets excluding the aforementioned income recognized
in profit or loss is included in the remeasurement of the net defined benefit liability.
|
The adoption of IAS 19R did
not have a material impact on the financial statements.
|
5.
|
IFRS 9, "Financial Instruments"
("IFRS 9")
|
IFRS 9
Financial instruments
,
is the first standard issued as part of a wider project to replace IAS 39. IFRS 9 retains but simplifies the mixed measurement
model and establishes two primary measurement categories for financial assets: amortized cost and fair value. The basis of classification
depends on the entity’s business model and the contractual cash flow characteristics of the financial asset. The guidance
in IAS 39 on impairment of financial assets and hedge accounting continues to apply. 2013 amendments to IFRS 9 have removed the
previous mandatory effective date of January 1, 2015, but the standard is available for immediate application. The Group is yet
to assess the full impact of the standard.
|
6.
|
IAS 1 (Revised), "Presentation
of Financial Statements" ("IAS 1R"):
|
IAS 1R modifies the manner
of disclosure of items of other comprehensive income in the statement of comprehensive income according to the following principles:
|
-
|
The items presented in other
comprehensive income should be separated into two groups based on whether they can be
reclassified in the future to profit or loss. Accordingly, items which cannot be reclassified
in the future to profit or loss will be presented separately from the re-classifiable
items.
|
|
-
|
Entities that choose to present
the items of other comprehensive income before the respective tax will be required to
separately present the tax effect of each of the abovementioned groups.
|
The Group has adopted IAS
1R for the first time for the annual period commencing on January 1, 2013 retrospectively for all reported periods. Since all
of the Group's items of other comprehensive income may be reclassified in the future to profit or loss, the initial adoption of
IAS 1R is expected to have a material impact on the Group's consolidated financial statements.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 3:-
|
CRITICAL ACCOUNTING
ESTIMATES AND JUDGMENTS
|
Estimates and judgments are
continually evaluated and are based on historical experience and other factors, including expectations of future events that are
believed to be reasonable under the circumstances.
|
a.
|
Critical accounting estimates
and assumptions:
|
The Group makes estimates
and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual
results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of
assets and liabilities within the next financial year are addressed below.
|
(i)
|
In determining the fair value
of assets acquired in share-based payment transactions and in testing impairment of these
research and development assets, the Company's management is required to estimate, among
other things, the probable endpoints of trials conducted by the Company, the commercial
technical feasibility of the development and the resulting economic benefits. Actual
results and estimates to be made in the future may significantly differ from current
estimates.
|
|
(ii)
|
The Group is required to determine
at the end of each reporting period whether there is any indication that an asset may
be impaired. If indicators for impairment are identified, the Group estimates the assets'
recoverable amount, which is the higher of an asset's fair value less costs to sell and
its value-in-use. The value-in-use calculations require management to make estimates
of the projected future cash flows. Determining the estimates of the future cash flows
is based on management past experience and best estimate for the economic conditions
that will exist over the remaining useful economic life of the CGU.
|
|
2.
|
Share-based payments - in evaluating
the fair value and the recognition method of share-based payment, the Company's management
is required to estimate, among others, different parameters included in the computation
of the fair value of the options and the Company's results and the number of options
that will vest. Actual results and estimates to be made in the future may significantly
differ from current estimates.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 3:-
|
CRITICAL ACCOUNTING
ESTIMATES AND JUDGMENTS (Cont.)
|
|
b.
|
Judgments that have a critical
effect on the adoption of the entity's accounting policies:
|
The existence of
effective control over InterCure – as of December 31, 2013, and effective as of May 16, 2013, the Company holds 54.72%
of InterCure's issued and outstanding share capital, following the conversion of the loan granted to InterCure into 7,620,695
shares of InterCure. In the reporting period ended December 31, 2012, the Group's management had estimated the degree of
effect it had in InterCure and had determined that it was able to govern InterCure's financial and operating policies despite
holding less than 50% of InterCure's issued and outstanding share capital at the time, through de-facto control, this
following an examination of InterCure's entire equity instruments. This conclusion was reached mainly since the Company was
able to convert the aforementioned loan into shares of InterCure, a conversion which will have conferred the Company a stake
of approximately 54.72% of InterCure's issued and outstanding share capital.
NOTE 4:-
|
FINANCIAL INSTRUMENTS
AND FINANCIAL RISK MANAGEMENT
|
|
a.
|
Financial risk
management:
|
|
1.
|
Financial
risk factors:
|
The Group's activities expose
it to a variety of financial risks: market risks (including currency risks and price risk), credit risk and liquidity risk. The
Group's overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse
effects on the Group's financial performance.
Risk management is carried
out by the Group's management under policies approved by the Board. The Group's treasury identifies, evaluates and defines financial
risks. The Board provides written principles for overall risk management, as well as written policies covering specific areas,
such as foreign exchange risk, interest rate risk and investment of excess liquidity.
Foreign currency exchange
rate risk:
The Group operates internationally
and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the NIS. Foreign exchange
risk arises from assets and liabilities denominated in currency that is other than the functional currency.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 4:-
|
FINANCIAL INSTRUMENTS
AND FINANCIAL RISK MANAGEMENT (Cont.)
|
The Group's management has
set up a policy to require Group companies to manage their foreign exchange risk against their functional currency. The Group
companies are required to hedge their entire foreign exchange risk exposure. To manage their foreign exchange risk arising from
future commercial transactions and recognized assets and liabilities, the Group uses short-term deposits denominated in foreign
currency. Foreign exchange risk arises when future commercial transactions or recognized assets or liabilities are measured and
denominated in a currency that is not the entity's functional currency.
The Company treasury's risk
management policy, excluding InterCure, is to hold NIS-denominated cash and cash equivalents and short-term deposits in the amount
of the anticipated NIS-denominated liabilities for nine to twelve consecutive months from time to time and this in line with the
directives of the Company's Board. InterCure focuses on actions to reduce to a minimum the negative effects arising from this
risk and therefore holds cash and cash equivalents in currencies in which it operates, in accordance with management's assessments.
As of December 31, 2013,
if the Group's functional currency had weakened by 10% against the NIS with all other variables remaining constant, post-tax loss
for the year would have been $ 157 thousand lower (2012 - post-tax loss approximately $ 89 thousand lower; 2011 - post-tax
loss approximately $ 30 thousand lower), mainly as a result of exchange rate changes on translation of other accounts receivable,
net and exchange rate changes on NIS-denominated cash and cash equivalents and short-term deposits. Loss was more sensitive to
movement in the exchange rate in relation to the NIS in 2012 than in 2011 mainly because of the increased amount of the NIS-denominated
balances in the items of cash, receivables and payables of the Group.
Credit risks are managed
at the Group level. The Group has no significant concentrations of credit risk. The Group has a policy to ensure collection through
sales of its products to wholesalers with an appropriate credit history and through retail sales in cash or by credit card.
The Group extends a 30-day
term to its customers. The Group regularly monitors the credit extended to its customers and their general financial condition
but does not require collateral as security for these receivables. The Group provides an allowance for doubtful accounts based
on the factors that affect the credit risk of certain customers, past experience and other information. Credit risks arise from
cash and cash equivalents, restricted bank deposits as well as outstanding receivables.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 4:
|
FINANCIAL INSTRUMENTS
AND FINANCIAL RISK MANAGEMENT (Cont.)
|
The Group engages with banks
and financial institutions which are independently rated A at least.
See Note 4b(2) for further
disclosure on credit risk.
Cash flow forecasting is
performed by the Group's management both in the entities of the Group and aggregated by the Group. The Group's management monitors
rolling forecasts of the Group's liquidity requirements to ensure it has sufficient cash to meet operations. The Group does not
use borrowing credit facilities. These forecasting takes into consideration several factors such as raising capital to finance
operations and certain liquidity ratios that the Group strives to achieve.
As for InterCure's ability
to meet its operational cash requirements, see Note 1b above.
Surplus cash held to finance
operating activities is invested in interest bearing current accounts, time deposits and other solid channels. These channels
were chosen by reference to their appropriate maturities or liquidity to provide sufficient cash balances to the Group as determined
by the abovementioned forecasts.
As of December 31, 2013
and 2012, the maturity of the Group's financial liabilities is less than one year from each of the reporting dates.
The Group's objectives when
managing capital are to ensure the Group's ability to continue as a going concern in order to provide returns on investments for
shareholders and benefits for other interested parties and to maintain an optimal capital structure to reduce the cost of capital.
In order to maintain or adjust
the capital structure, the Group may take a variety of measures such as issue new shares or sell assets to reduce liabilities
(see also Note 1b).
|
b.
|
Financial instruments:
|
|
1.
|
Financial
instruments by category:
|
As of December 31, 2013
and 2012, all financial assets were classified in the category of loans and receivables. Likewise, all financial liabilities as
of such dates were classified in the category of other financial liabilities at amortized cost.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 4:-
|
FINANCIAL INSTRUMENTS
AND FINANCIAL RISK MANAGEMENT (Cont.)
|
|
2.
|
Credit quality
of financial assets:
|
The credit quality of financial
assets can be assessed by reference to external credit ratings (if available).
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
Cash at banks, short-term deposits and restricted deposits:
|
|
|
|
|
|
|
|
|
AA+
|
|
|
819
|
|
|
|
1,822
|
|
AA
|
|
|
3,185
|
|
|
|
1,265
|
|
AA-
|
|
|
3
|
|
|
|
3
|
|
A
|
|
|
180
|
|
|
|
-
|
|
A-
|
|
|
-
|
|
|
|
242
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,187
|
|
|
|
3,332
|
|
Cash not in banks
|
|
|
1
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,188
|
|
|
|
3,334
|
|
|
3.
|
Concentration
of credit risks:
|
The majority of the Group's
sales are conducted in the U.S. and the UK to a large number of customers. Accordingly, the balances of the Group's trade receivables
do not represent a significant concentration of credit risk as of December 31, 2013.
NOTE 5:-
|
BUSINESS COMBINATIONS AND CONSOLIDATED COMPANIES
|
On June 13,
2012, the Company entered into an agreement in principle with InterCure, according to which, subject to carrying out the debt
settlement pursuant to Article 350 of the Israeli Companies Law, 1999 (the "
Settlement
") before the transaction,
in which InterCure will convert all its debts into Ordinary shares of InterCure based on the distribution mechanism determined
with all its debtors (including its employees). Once the Settlement was consummated, the Company acquired the control over InterCure
in consideration for investing an aggregate amount of approximately $ 2.7 million, partly in cash and partly by the issuance
of Company shares. Also, besides the Company's investment in InterCure, a third party ("
Medica Fund
") will invest
in InterCure an amount of approximately $ 630 thousand.
As part of
the prerequisites underlying the agreement, InterCure undertook to be free of any net debts and/or monetary liabilities on the
date of closing of the transaction as well as any contingent liabilities, excluding an amount of up to $ 150 thousand in
net liabilities.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 5:-
|
BUSINESS COMBINATIONS AND CONSOLIDATED COMPANIES (Cont.)
|
On July 25,
2012, the transaction was completed after all the prerequisites had been met and the Company acquired 16,839,532 Ordinary shares
of InterCure with no par value, in consideration of a private placement of 7,165,662 Ordinary shares of the Company of NIS 0.1
par value each, whose value on the date of signing the agreement, measured according to the quoted market price of the Company's
shares on the Tel-Aviv Stock Exchange, was approximately $ 2.2 million, and which represents a value of InterCure of $ 1.75
million before the money, but after all of InterCure's debts were converted as described above ("
InterCure's Adjusted
Value
"). The fair value of the Company's shares on the date of consummation of the transaction was approximately $
2,469 thousand. In the year ended December 31, 2013, InterCure sold 1,097,719 shares of the Company for an aggregate amount of
approximately $ 283 thousand. In addition, the Company provided InterCure an amount of approximately $ 150 thousand in cash
on the basis of InterCure's Adjusted Value. After affecting the above allocation, the Company held approximately 50.79% of the
issued and outstanding share capital of InterCure. The investment of Medica Fund on the date of closing on the basis of InterCure's
Adjusted Value amounted to approximately $ 460 thousand.
Further,
the Company and Medica Fund provided InterCure a loan of $ 500 thousand (the Company's share is $ 330 thousand) for
a period of up to ten months at an overall interest rate of 15%. The Company and Medica Fund have the right to convert the loan
into an additional 11,546,507 shares of InterCure (the Company's share was 7,620,695 shares) which would constitute, upon conversion
and assuming full dilution on the date of closing, approximately 24.47% of the issued and outstanding share capital of InterCure
(the Company's share in the convertible loan was 16.15% of the issued and outstanding share capital of InterCure). On August 6,
2012, Medica Fund converted the loan it provided InterCure into shares.
On May 16,
2013, the Company informed InterCure of its decision to convert the entire convertible loan which had been extended by the Company
in the context of the acquisition into 7,620,695 ordinary shares of InterCure, as predetermined in the acquisition agreement.
Following said conversion, and as of the date of the approval of the financial statements, the Company holds approximately 54.72%
of InterCure's issued and outstanding share capital.
On October
28, 2012, InterCure allocated 20,185,184 performance-based stock options exercisable into 20,185,184 Ordinary shares with no par
value to Giboov Ltd. ("
Giboov
"). For additional information, see Note 18a below.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 5:-
|
BUSINESS COMBINATIONS AND CONSOLIDATED COMPANIES (Cont.)
|
The table
below summarizes the consideration paid for the Company's share in InterCure, the amounts recognized in the consolidated financial
statements for the assets acquired and liabilities assumed and the fair value on the date of acquisition (July 25, 2012) of non-controlling
interests:
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
Consideration:
|
|
|
|
|
Cash
|
|
|
*) 479
|
|
Fair value of Company shares issued in the acquisition
|
|
|
**) 2,469
|
|
|
|
|
|
|
Total consideration transferred
|
|
|
2,948
|
|
|
|
|
|
|
Amounts recognized for identifiable assets acquired and liabilities assumed:
|
|
|
|
|
Current assets (including a convertible loan of $ 330 thousand extended to InterCure by the Company)
|
|
|
1,538
|
|
Treasury shares
|
|
|
2,469
|
|
Property, plant and equipment
|
|
|
51
|
|
Intangible assets
|
|
|
***) 2,397
|
|
Current liabilities
|
|
|
(843
|
)
|
Employee benefit liabilities
|
|
|
(11
|
)
|
|
|
|
|
|
Total net identifiable assets
|
|
|
5,601
|
|
Non-controlling interests at fair value
|
|
|
(1,858
|
)
|
Gain from bargain purchase
|
|
|
(795
|
)
|
|
|
|
|
|
|
|
|
2,948
|
|
|
*)
|
Includes an amount of $ 330
thousand transferred by the Company against a convertible loan, as explained above.
|
|
**)
|
The fair value as of the date
of completion of the transaction, July 25, 2012 (see below).
|
|
***)
|
Including technology in the
amount of $ 1,909 thousand ($ 238 as of December 31, 2013) and brand name in the
amount of $ 488 thousand ($ 62 as of December 31, 2013) thousand which are amortized
using the straight-line method over periods of nine and ten years, respectively.
|
The fair value of the Company's
Ordinary shares which were issued as part of the consideration in the transaction to acquire InterCure was measured on the basis
of the quoted share price in an active market (the Tel-Aviv Stock Exchange) as of the date of closing, after weighing in the fact
that shares granted to InterCure are restricted for periods between 0.5 and 1.25 years, by virtue of the provisions of the Israeli
Securities Law, 1968 and the Israeli Securities Regulations (Details with regard to Sections 15A to 15C of the Law), 2000.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 5:-
|
BUSINESS COMBINATIONS AND CONSOLIDATED COMPANIES (Cont.)
|
The Group
elected to measure non-controlling interests at fair value as of the date of business combination. The fair value of non-controlling
interests was measured by quoting the price for InterCure share on July 26, 2012, the first trading day on the Tel-Aviv Stock
Exchange after the date of closing with the addition of the equity component of the loan Medica Fund provided InterCure.
The fair
value of trade receivables and other accounts receivable is $ 159 thousand. This amount includes a trade receivable balance
with a fair value of $ 79 thousand. The gross contractual amount of the trade receivable balance is $ 175 thousand,
of which an amount of $ 96 thousand was expected to be uncollectible.
The revenues
included in the consolidated statement of comprehensive loss from the acquisition date arising from the consolidation of InterCure's
results totaled approximately $ 938 thousand for the year ended December 31, 2012. Moreover, the consolidation of InterCure's
results has increased the loss by $ 649 thousand (including amortization of excess cost on the acquisition in the amount
of $ 176 thousand) for the year then ended.
Had InterCure's
accounts been consolidated from January 1, 2012, the consolidated statement of comprehensive loss would have included revenues
of $ 2,267 thousand and an increase in income of $ 11,628 thousand for the year ended December 31, 2012 (including income
from the debt refinancing of $ 12,404 thousand).
The Company's
statement of comprehensive loss for the year ended December 31, 2012 included transaction related costs totaling approximately
$ 30 thousand presented in general and administrative expenses.
NOTE 6:-
|
CASH AND CASH EQUIVALENTS
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Cash in banks and on hand
|
|
|
1,010
|
|
|
|
1,178
|
|
Bank deposits for periods of three months or less
|
|
|
1,877
|
|
|
|
518
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,887
|
|
|
|
1,696
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 6:-
|
CASH AND CASH EQUIVALENTS
(Cont.)
|
The currencies in which the
cash and cash equivalents are denominated or linked to are:
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
U.S. dollars
|
|
|
2,199
|
|
|
|
862
|
|
NIS (not linked to the Israeli CPI)
|
|
|
680
|
|
|
|
833
|
|
Other currencies
|
|
|
8
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,887
|
|
|
|
1,696
|
|
NOTE 7:-
|
SHORT-TERM DEPOSITS
|
|
a.
|
The currencies in which the short-term deposits are denominated:
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
U.S. dollars
|
|
|
500
|
|
|
|
1,008
|
|
NIS (not linked to the Israeli CPI)
|
|
|
778
|
|
|
|
608
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,278
|
|
|
|
1,616
|
|
|
b.
|
The U.S. dollar-denominated deposits
earn annual interest at the average rate of 0.85%. The NIS-denominated deposits earn
annual interest at the average rate of 1.01%.
|
The carrying amount of short-term
deposits is a reasonable approximation of the fair value because the effect of discounting is immaterial.
|
c.
|
In addition, the Company has
a restricted deposit in connection with its office lease agreement. As of December 31,
2013 and 2012, the restricted deposit balance was $ 23 thousand and $ 22 thousand, respectively.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 8:-
|
TRADE RECEIVABLES
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Open debts
|
|
|
90
|
|
|
|
52
|
|
Credit cards
|
|
|
42
|
|
|
|
30
|
|
Less - allowance for doubtful accounts
|
|
|
(6
|
)
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
126
|
|
|
|
76
|
|
The Group's sales (through
InterCure) are made both directly to consumers and through resellers and retail chains. Direct sales to consumers are made using
credit cards on the date of order. The credit term to resellers is up to 60 days.
Impaired debts are accounted
for through recording an allowance for doubtful accounts.
The movement in the allowance
for doubtful accounts is as follows:
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
Balance at July 25, 2012
|
|
|
96
|
|
|
|
|
|
|
Charge for the year
|
|
|
12
|
|
Derecognition of bad debts
|
|
|
(102
|
)
|
|
|
|
|
|
Balance at January 1, 2013
|
|
|
6
|
|
|
|
|
|
|
Balance at December 31, 2013
|
|
|
6
|
|
An analysis
of past due but not impaired trade receivables (allowance for doubtful accounts), trade receivables, net, with reference to reporting
date:
|
|
Undue
balances
(without
arrears)
|
|
|
Overdue
balances of
60-90 days
|
|
|
Overdue
balances of
90-120 days
|
|
|
Total
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2013
|
|
|
94
|
|
|
|
8
|
|
|
|
24
|
|
|
|
126
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2012
|
|
|
64
|
|
|
|
12
|
|
|
|
-
|
|
|
|
76
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 9:-
|
OTHER ACCOUNTS RECEIVABLE
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Government authorities
|
|
|
67
|
|
|
|
56
|
|
Prepaid expenses
|
|
|
106
|
|
|
|
47
|
|
Receivables due to sale of investment in Proteologics
|
|
|
297
|
|
|
|
-
|
|
Other receivables
|
|
|
3
|
|
|
|
50
|
|
|
|
|
|
|
|
|
|
|
|
|
|
473
|
|
|
|
153
|
|
|
b.
|
The currencies in which other
accounts receivable which are monetary items are denominated or to which they are linked
are as follows:
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
U.S. dollars
|
|
|
-
|
|
|
|
13
|
|
NIS
|
|
|
367
|
|
|
|
93
|
|
|
|
|
|
|
|
|
|
|
|
|
|
367
|
|
|
|
106
|
|
|
|
The carrying amount of other accounts
receivable is a reasonable approximation of the fair value because the effect of discounting
is immaterial.
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Raw and auxiliary materials
|
|
|
52
|
|
|
|
42
|
|
Finished goods
|
|
|
250
|
|
|
|
187
|
|
|
|
|
|
|
|
|
|
|
|
|
|
302
|
|
|
|
229
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 11:-
|
ADDITIONAL INFORMATION
ABOUT INVESTMENT IN INVESTEES
|
Name and country of
incorporation of subsidiary
|
|
Date
|
|
|
Equity
interests and
voting rights
|
|
|
Scope of
investments
in investee
(in $ 000)
|
|
|
Stock Exchange
data *)
|
|
Dividends
received or
receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
Xtepo Ltd., incorporated in Israel
|
|
|
31.12.13
|
|
|
|
100
|
%
|
|
|
3,862
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
31.12.12
|
|
|
|
100
|
%
|
|
|
3,919
|
|
|
-
|
|
|
-
|
|
2
|
|
XTL Biopharmaceuticals Inc., incorporated in Delaware
|
|
|
31.12.13
|
|
|
|
100
|
%
|
|
|
(144
|
)
|
|
-
|
|
|
-
|
|
|
|
|
|
|
31.12.12
|
|
|
|
100
|
%
|
|
|
(163
|
)
|
|
-
|
|
|
-
|
|
3
|
|
InterCure Ltd., incorporated in Israel
|
|
|
31.12.13
|
|
|
|
54.72
|
%
|
|
|
2,144
|
|
|
TASE, value of shares as of 31.12.13 - $ 754 thousand
|
|
|
-
|
|
|
|
|
|
|
31.12.12
|
|
|
|
45.41
|
%
|
|
|
2,916
|
|
|
TASE, value of shares as of 31.12.12 - $ 2,016 thousand
|
|
|
-
|
|
4
|
|
Proteologics Ltd., incorporated in Israel
|
|
|
31.12.13
|
|
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
31.12.12
|
|
|
|
31.24
|
%
|
|
|
2,336
|
|
|
TASE, value of shares as of 31.12.12 - $ 1,045 thousand
|
|
|
-
|
|
|
*)
|
The data relates to the value
of the shares held by the Company as of December 31, 2013.
|
The total non-controlling interest
as of December 31, 2013 and 2012 is $ 523 and $ 2,071, respectively, and is attributable entirely to InterCure.
Set out below is the summarized
financial information for InterCure as of December 31, 2012 and 2013 and for the respective years then ended:
|
a.
|
InterCure Ltd. – Summarized consolidated balance
sheet *)
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Current assets**
|
|
|
1,623
|
|
|
|
3,703
|
|
Current liabilities
|
|
|
634
|
|
|
|
1,243
|
|
|
|
|
|
|
|
|
|
|
Total current net assets
|
|
|
989
|
|
|
|
2,460
|
|
|
|
|
|
|
|
|
|
|
Non-current assets***
|
|
|
440
|
|
|
|
2,470
|
|
Non-current liabilities
|
|
|
11
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
Total non-current net assets
|
|
|
429
|
|
|
|
2,457
|
|
|
|
|
|
|
|
|
|
|
Net assets
|
|
|
1,418
|
|
|
|
4,917
|
|
|
**
|
Including treasury shares of the Company, presented at
fair value.
|
|
***
|
Including intangible assets, net, recognized in the Company's
purchase of InterCure.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER
31, 2013
|
NOTE 11:-
|
ADDITIONAL INFORMATION
ABOUT INVESTMENT IN INVESTEES (Cont.)
|
|
b.
|
InterCure Ltd. - Summarized consolidated income statement
*)
|
|
|
Year ended
December 31,
2013
|
|
|
July 25, 2012 –
December 31,
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
2,369
|
|
|
|
938
|
|
Profit (loss) before income tax**
|
|
|
(3,887
|
)
|
|
|
(649
|
)
|
Income tax income (expense)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Post-tax profit (loss) from continuing operations
|
|
|
(3,887
|
)
|
|
|
(649
|
)
|
|
|
|
|
|
|
|
|
|
Other comprehensive gain (loss)
|
|
|
73
|
|
|
|
(73
|
)
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
(3,814
|
)
|
|
|
(722
|
)
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss allocated to non-controlling interests
|
|
|
(1,787
|
)
|
|
|
(392
|
)
|
|
**
|
Including amortization and impairment
of intangible assets, net, recognized in the Company's purchase of InterCure.
|
|
c.
|
InterCure Ltd. - Summarized consolidated cash flows
*)
|
|
|
December 31,
2013
|
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(955
|
)
|
|
|
|
|
|
Net cash generated from investing activities
|
|
|
209
|
|
|
|
|
|
|
Net cash generated from (used in) financing activities
|
|
|
-
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents
|
|
|
(746
|
)
|
|
|
|
|
|
Cash and cash equivalents at beginning of year
|
|
|
966
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
|
220
|
|
|
*)
|
The information above is the amount before inter-company
eliminations.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 12:-
|
INVESTMENT IN ASSOCIATE
|
|
a.
|
On November 21, 2012, in an off-market transaction, the Company acquired from Teva Pharmaceutical
Industries Ltd. ("
Teva
") 4,620,356 Ordinary shares of NIS 1.0 par value each of Proteologics, representing
Teva's entire stake in Proteologics - approximately 31.35% of Proteologics' issued and outstanding share capital (as of the acquisition
date) - in consideration of approximately NIS 6.5 million (approximately $ 1.7 million).
|
|
|
Proteologics is a public company traded on the TASE which at the time of the acquisition of its
shares by XTL, was engaged in the discovery and development of drugs operating on various components of the Ubiquitin system.
|
|
|
On August 22, 2013, Proteologics’ board of directors resolved to terminate Proteologics’
operations effective immediately.
|
On September 12, 2013, the
Company signed an agreement with Zmiha Investment House Ltd. ("
Zmiha
") for the sale of its entire investment in
Proteologics, representing 44.95% of Proteologics' issued and outstanding share capital as of the date of the agreement, after
having purchased an additional 14.13% of the shares of Proteologics from Aurum Ventures MKI Ltd. ("
Aurum
") on
September 11, 2013, in consideration for the issuance of 3,031,299 shares of NIS 0.1 par value each of the Company to Aurum.
Consideration for the sale to Zmiha totaled approximately $ 3.4 million (approximately NIS 12 million). According to the agreement,
on the consummation date, the Company received an amount of approximately $ 2.7 million (approximately NIS 9.6 million)
with the balance to be held in escrow until the completion of an inspection process by an inspector and the execution of a stay
of proceedings pursuant to section 350 to the Companies Law in Proteologics. As of the reporting date, the majority of the consideration
has been delivered to the Company and an amount of approximately $ 0.3 million (approximately NIS 1 million) remains
in escrow according to the agreement. The agreement was effective as of September 17, 2013. As a result, as of December 31, 2013,
the Company no longer holds any shares of Proteologics. On February 7, 2014, the remaining amount held in escrow payable to the
Company with regard to the sale of its investment in Proteologics, totaling approximately $ 0.3 million, was transferred to the
Company.
b. The amounts recognized
in the consolidated statements of financial position are as follows:
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
Investment in Proteologics
|
|
|
-
|
|
|
|
2,336
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 12:-
|
INVESTMENT IN ASSOCIATE (Cont.)
|
|
c.
|
The amounts recognized in the income statement are as
follows:
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Equity gains (losses)
|
|
|
(845
|
)
|
|
|
569
|
|
Gain due to exercise of options in associate
|
|
|
10
|
|
|
|
-
|
|
Capital gain from sale of investment
|
|
|
1,051
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
216
|
|
|
|
569
|
|
|
d.
|
The movement in the investment in 2013:
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
Balance as of January 1, 2013
|
|
|
2,336
|
|
|
|
|
|
|
Equity losses
|
|
|
(845
|
)
|
Gain due to exercise of options in associate
|
|
|
10
|
|
Foreign currency translation adjustments of foreign operations
|
|
|
108
|
|
Purchase of shares from Aurum
|
|
|
913
|
|
Disposal of investment
|
|
|
(2,522
|
)
|
|
|
|
|
|
Balance as of December 31, 2013
|
|
|
-
|
|
|
e.
|
Data of the Company's share in the results of Proteologics
in the period from the acquisition date through December 31, 2012 and the Company's share in Proteologics' assets and liabilities
as of December 31, 2012:
|
|
|
As of December 31, 2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
Assets *)
|
|
|
2,994
|
|
|
|
|
|
|
Liabilities *)
|
|
|
(403
|
)
|
|
|
|
|
|
Revenues
|
|
|
(64
|
)
|
|
|
|
|
|
Loss *)
|
|
|
(144
|
)
|
|
*)
|
Including balances/adjustments
of excess cost.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 12:-
|
INVESTMENT IN ASSOCIATE (Cont.)
|
As of December 31, 2013, the
Company no longer holds any shares of Proteologics. As of December 31, 2012, the fair value of the Company's ownership rights in
Proteologics, based on the quoted market price of the Company's shares on that date, totaled approximately $ 1,045 thousand,
an amount lower than the net cash of Proteologics at the time. The Company's management, based on a purchase price allocation performed
by an outside appraiser, estimated that market value did not represent the economic value of Proteologics as of the transaction
date, November 21, 2012.
|
NOTE 13:-
|
PROPERTY, PLANT AND EQUIPMENT
|
|
a.
|
Composition and movement:
|
|
|
The composition of property, plant and equipment and accumulated depreciation, by major classes,
and the movement therein in 2013 are:
|
|
|
Office
furniture and
equipment
|
|
|
Computers
|
|
|
Production
molds
|
|
|
Total
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2013
|
|
|
38
|
|
|
|
83
|
|
|
|
51
|
|
|
|
172
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
-
|
|
|
|
11
|
|
|
|
-
|
|
|
|
11
|
|
Disposals during the year
|
|
|
(14
|
)
|
|
|
(8
|
)
|
|
|
-
|
|
|
|
(22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2013
|
|
|
24
|
|
|
|
86
|
|
|
|
51
|
|
|
|
161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2013
|
|
|
15
|
|
|
|
75
|
|
|
|
10
|
|
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
2
|
|
|
|
8
|
|
|
|
10
|
|
|
|
20
|
|
Disposals during the year
|
|
|
(12
|
)
|
|
|
(8
|
)
|
|
|
-
|
|
|
|
(20
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2013
|
|
|
5
|
|
|
|
75
|
|
|
|
20
|
|
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciated cost at December 31, 2013
|
|
|
19
|
|
|
|
11
|
|
|
|
31
|
|
|
|
61
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 13:-
|
PROPERTY, PLANT AND EQUIPMENT (Cont.)
|
|
|
The composition of property, plant and equipment and accumulated depreciation, by major classes,
and the movement therein in 2012 are:
|
|
|
Office
furniture and
equipment
|
|
|
Computers
|
|
|
Production
molds
|
|
|
Total
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2012
|
|
|
49
|
|
|
|
81
|
|
|
|
-
|
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
-
|
|
|
|
6
|
|
|
|
-
|
|
|
|
6
|
|
Disposals during the year
|
|
|
(11
|
)
|
|
|
(4
|
)
|
|
|
-
|
|
|
|
(15
|
)
|
Initially consolidated company
|
|
|
-
|
|
|
|
-
|
|
|
|
51
|
|
|
|
51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2012
|
|
|
38
|
|
|
|
83
|
|
|
|
51
|
|
|
|
172
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2012
|
|
|
22
|
|
|
|
76
|
|
|
|
-
|
|
|
|
98
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
2
|
|
|
|
3
|
|
|
|
10
|
|
|
|
15
|
|
Disposals during the year
|
|
|
(9
|
)
|
|
|
(4
|
)
|
|
|
-
|
|
|
|
(13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2012
|
|
|
15
|
|
|
|
75
|
|
|
|
10
|
|
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciated cost at December 31, 2012
|
|
|
23
|
|
|
|
8
|
|
|
|
41
|
|
|
|
72
|
|
|
b.
|
Additional information:
|
In 2013, 2012 and 2011, depreciation
of property, plant and equipment was charged to general and administrative expenses.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 14:-
|
INTANGIBLE
ASSETS
|
|
a.
|
Composition and movement:
|
|
|
The composition of intangible assets and accumulated amortization, by major classes, and the movement
therein in 2013 are:
|
|
|
Licenses
and patent
rights
|
|
|
Technology
|
|
|
Brand
name
|
|
|
Software
|
|
|
Total
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2013
|
|
|
2,457
|
|
|
|
1,909
|
|
|
|
488
|
|
|
|
153
|
|
|
|
5,007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2013
|
|
|
2,457
|
|
|
|
1,909
|
|
|
|
488
|
|
|
|
153
|
|
|
|
5,007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2013
|
|
|
-
|
|
|
|
92
|
|
|
|
21
|
|
|
|
8
|
|
|
|
121
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
-
|
|
|
|
212
|
|
|
|
49
|
|
|
|
31
|
|
|
|
292
|
|
Impairment
|
|
|
-
|
|
|
|
1,372
|
|
|
|
357
|
|
|
|
-
|
|
|
|
1,729
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2013
|
|
|
-
|
|
|
|
1,676
|
|
|
|
427
|
|
|
|
39
|
|
|
|
2,142
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized cost at December 31, 2013
|
|
|
2,457
|
|
|
|
233
|
|
|
|
61
|
|
|
|
114
|
|
|
|
2,865
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 14:-
|
INTANGIBLE ASSETS (Cont.)
|
|
|
The composition of intangible assets and accumulated amortization, by major classes, and the movement
therein in 2012 are:
|
|
|
Licenses
and patent
rights
|
|
|
Technology
|
|
|
Brand
name
|
|
|
Software
|
|
|
Total
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2012
|
|
|
2,457
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,457
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
153
|
|
|
|
153
|
|
Initially consolidated company
|
|
|
-
|
|
|
|
1,909
|
|
|
|
488
|
|
|
|
-
|
|
|
|
2,397
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2012
|
|
|
2,457
|
|
|
|
1,909
|
|
|
|
488
|
|
|
|
153
|
|
|
|
5,007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2012
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions during the year
|
|
|
-
|
|
|
|
92
|
|
|
|
21
|
|
|
|
8
|
|
|
|
121
|
|
Initially consolidated company
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2012
|
|
|
-
|
|
|
|
92
|
|
|
|
21
|
|
|
|
8
|
|
|
|
121
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized cost at December 31, 2012
|
|
|
2,457
|
|
|
|
1,817
|
|
|
|
467
|
|
|
|
145
|
|
|
|
4,886
|
|
|
b.
|
Amortization expenses:
|
Amortization
expenses of intangible assets are classified in profit or loss as follows:
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
212
|
|
|
|
92
|
|
Selling and marketing expenses
|
|
|
80
|
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
292
|
|
|
|
121
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 14:-
|
INTANGIBLE ASSETS (Cont.)
|
|
c.
|
On August 3, 2010, the Company completed the share swap transaction with the shareholders of Bio-Gal
Ltd. (the “
Transaction
”) in which the Company acquired 100% of the shares of Xtepo, which for the Transaction
purposes held an exclusive license to use the patented recombinant EPO (rHuEPO) drug for treating Multiple Myeloma and also held
cash totaling approximately $ 1.5 million on the date of completion of the transaction, in return for the allocation of 133,063,688
Ordinary shares of NIS 0.1 par value each, representing approximately 69.44% of the Company's issued and outstanding share
capital after completion of the Transaction.
|
Following the closing of the
Transaction, the Company recognized in its accounts an intangible asset representing the license for the exclusive use of the patent
for the rHuEPO drug for Multiple Myeloma as well as every clinical study and accumulated knowhow underlying the patent in a total
of approximately $ 2,265 thousand (excluding transaction costs of approximately $ 187 thousand), based on its fair value
as of the date of closing of the Transaction according to an independent external valuation.
On May 29, 2011, the Company
received the approval of the FDA, a subdivision of the U.S. Health and Human Services, for orphan drug status for the rHuEPO drug
which is patented by the Company until 2019. An "orphan drug" is defined as a drug for treating diseases that affect
a relatively small number of people. In the U.S., an "orphan drug" is defined as a disease affecting fewer than 200,000
people a year. To encourage the development of drugs for these diseases, the different regulatory authorities grant benefits and
incentives to developers. The main standard benefit of orphan drugs in the U.S. is receiving seven years marketing exclusivity
from the date of marketing approval by the FDA, as far as the FDA gives such approval. Other benefits are local U.S. tax credits
for research and development expenses and waiver of FDA filing fees.
According to the guidance of
IAS 38, this asset is not systematically amortized and the Company reviews the asset for impairment once a year or more frequently
if indicators show that the asset may be impaired.
In December 2013, the Company
tested the asset for impairment with the assistance of a consultant in accordance
with the guidance of IAS 36. According to the valuation performed, there is no need to reduce the value of the asset in relation
to its carrying amount. Since there are no similar transactions according to which the fair value of the patent can be determined,
the value of the patent was determined by the value in use on the basis of the discounted future cash flow method for the years
2014 to 2027. The discount period was determined on the basis of the estimated schedules to perform the clinical trials in order
to approve the drug for marketing and under the limitation of the patent years and the orphan drug designation as above.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 14:-
|
INTANGIBLE ASSETS (Cont.)
|
The key assumptions used by
the external expert in measuring value-in-use as of December 31, 2013 are: life of phase 2 and 3 clinical trials of 3 and
3.5 years, respectively, expected penetration levels from 10% in
202
1 to 55% in 2025-2027
out of an estimate of 60,756 new cases of Multiple Myeloma diagnosed each year, royalties at the rate of 12.5% and (pre-tax) discount
rate of 26%.
|
d.
|
On September 1, 2010, the Company
and Yeda Research and Development Co. Ltd. (“
Yeda
”) entered into a
license agreement of an exclusive right to examine a medical technology in the field
of the immune system, comprising two proteins through which target molecules are examined
and may serve as a basis for the development of therapeutics for diseases relating to
the immune system, such as acute Hepatitis, rheumatoid arthritis,
Crohn's
disease, psoriasis etc. Under the agreement, the Company purchased this exclusive right
to examine the medical technology for a 15-month period ("the right") in consideration
of $ 120 thousand (the “
Option Fee
”) payable by the Company in
the following manner and at the earlier of: (i) in the event of raising by a public prospectus
more than $ 2 million, the Company is obligated to settle the payment to Yeda in
cash; or (ii) if 12 months after the date of closing of the agreement an amount of more
than $ 2 million is not raised, the liability to Yeda can be satisfied, at the Company's
election and after obtaining Yeda's approval to the timing, in cash or by issuance of
Company stock options with an equivalent value. The Company's option to purchase said
technology expired on November 30, 2011 and the Company elected not to exercise
the option.
|
|
|
On July 11, 2013, the Company and
Yeda entered into an amendment to the license agreement, according to which the Company
shall pay Yeda an amount of $ 120 thousand in the following manner: (a) $ 30 thousand
in cash, payable as of the date of the amendment, and (b) an additional amount of $ 90
thousand shall be paid by the Company to Yeda upon the earlier of: (a) a capital raise
in the amount of $ 2 million and (b) upon the consummation of a transaction relating
to the Company's Erythropoetin technology with any third party, which includes the receipt
by the Company of a consideration of at least $ 2 million.
|
In the years
ended December 31, 2011 and 2010, the Company recognized in its accounts amortization expenses of $ 88 thousand and $ 32
thousand, respectively relating to the right to examine a medical technology over the option period. These expenses were recorded
in the item of research and development expenses.
|
e.
|
On November 30, 2011, the Company completed the MinoGuard transaction according to which the Company
acquired the activity of MinoGuard Ltd. (“
MinoGuard
”), founded by Mor Research Applications Ltd. (“
Mor
”),
by obtaining an exclusive license to MinoGuard's entire technology, including the SAM-101 drug (combined drug to treat mental disorders
focusing on schizophrenia) in return for royalties on sales and milestone payments to be provided throughout the clinical development
process with no additional consideration. The drug is based on a combination of existing antipsychotic drugs and a known medicinal
compound (Minocycline). For more details of the engagement with MinoGuard, see Note 18a(4) below.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 14:-
|
INTANGIBLE ASSETS (Cont.)
|
|
f.
|
As for intangible assets recognized for the first time after the completion of the InterCure transaction,
as presented in Note 5 above, and due to a significant decline in InterCure's share price as quoted on the TASE, the Company hired
the services of an external independent expert in order to establish whether or not an impairment exist in connection with the
Technology and Brand Name assets recognized in the purchase price allocation study of InterCure.
|
|
|
The recoverable amount was assessed by management with the assistance of a consultant. In
light of recent developments in InterCure, namely conclusions
reached by its management and board of directors regarding its ability
to continue operating as a going concern, several scenarios were taken into account by the expert. Each scenario was
assigned a different weight in order to accommodate all
scenarios into a weighted-average discounted cash flow. Such scenarios were as
follows:
|
|
(i)
|
The Liquidation scenario, under which the realizable value of InterCure's net operational assets
was estimated, was assigned a weighting of 60%.
|
|
(ii)
|
The Going concern scenario, establishing the value-in-use of InterCure's operations using the discounted
cash flow method, was assigned a weighting of 40%. The value-in-use calculations use pre-tax cash flow projections covering an
eight-year period and using extrapolation with specific adjustments expected until 2021, and a pre-tax discount rate of 33.3%.
The value-in-use calculations included all factors in nominal terms.
|
|
|
The impairment test was based on assessments of financial performance and future strategies in
light of current and expected market and economic conditions. Trends in the economic and financial environment, competition and
regulatory authorities' decisions, or changes in competitors’ behavior in response to the economic environment may affect
the estimate of recoverable amounts in future periods.
|
|
|
For the purpose of the impairment test, InterCure was considered the lowest level for which there
are separately identifiable cash flows – a Cash Generating Unit (“
CGU
”). Upon examination, the expert
concluded that an impairment exists, and that InterCure's recoverable amount stands at $ 300 thousand. The impairment loss in the
amount of $1,729 was recognized in loss from operations, and allocated between said intangible assets of the CGU pro rata, based
on their respective carrying amounts (net of amortization), in the following amounts:
|
|
(a)
|
Technology – $ 1,372 thousand;
|
|
(b)
|
Brand Name – $ 357 thousand.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Open accounts
|
|
|
455
|
|
|
|
596
|
|
Checks payable
|
|
|
160
|
|
|
|
147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
615
|
|
|
|
743
|
|
The carrying amount of trade
payables is a reasonable approximation of their fair value because the effect of discounting is immaterial.
|
b.
|
The carrying amount of trade payables is denominated in the following currencies:
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
U.S. dollars
|
|
|
405
|
|
|
|
515
|
|
NIS (not linked to the Israeli CPI)
|
|
|
208
|
|
|
|
224
|
|
Others
|
|
|
2
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
615
|
|
|
|
743
|
|
|
NOTE 16:-
|
OTHER ACCOUNTS PAYABLE
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
Employees, consultants and payroll accruals
|
|
|
199
|
|
|
|
443
|
|
Provision for returns
|
|
|
45
|
|
|
|
32
|
|
Deferred revenue
|
|
|
35
|
|
|
|
-
|
|
Authorities
|
|
|
86
|
|
|
|
144
|
|
Accrued expenses
|
|
|
239
|
|
|
|
280
|
|
Other
|
|
|
-
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
604
|
|
|
|
906
|
|
The carrying amount of other
accounts payable is a reasonable approximation of their fair value because the effect of discounting is immaterial.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 16:-
|
OTHER ACCOUNTS PAYABLE (Cont.)
|
|
b.
|
The carrying amount of other accounts payable is denominated in the following currencies:
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
U.S. dollars
|
|
|
405
|
|
|
|
477
|
|
NIS (not linked to the Israeli CPI)
|
|
|
105
|
|
|
|
429
|
|
Other
|
|
|
94
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
604
|
|
|
|
906
|
|
|
NOTE 17:-
|
EMPLOYEE BENEFIT LIABILITIES
|
|
a.
|
According to the effective labor laws and employment agreements in Israel and overseas, the Company
and the subsidiaries are obligated to pay compensation and/or pension to employees who are dismissed and, under certain circumstances,
to employees who retire.
|
|
b.
|
The Company's obligation for pension payment in Israel and the Company's obligation for compensation
payments to employees in Israel for whom the applicable obligation is pursuant to section 14 to the Severance Pay Law, are covered
by fixed contributions into defined contribution plans. The amounts contributed as above are not reflected in the statements of
financial position. In 2013, section 14 to the Severance Pay Law applied to most of the Company's employees.
|
The amount
recognized as an expense for defined contribution plans in 2013, 2012 and 2011 was $ 26 thousand, $ 23 thousand and $ 22
thousand, respectively.
|
c.
|
A member of the Group in Israel has an obligation to pay severance to an employee which represents
a defined benefit plan. The Group member has severance pay funds and executive insurance policies in which it deposits funds in
respect of this obligation. The amount of accrued severance pay, net included in the statements of financial position as of December
31, 2013 and 2012 reflects the difference between the accrued severance pay and the severance pay funds.
|
Since as
of December 31, 2013, section 14 to the Severance Pay Law applies to most of the Company's employees, as above, pursuant to
which they are covered by fixed contributions to defined contribution plans, no contributions to defined benefit plans are expected
for the year ending December 31, 2014.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
a.
|
Royalty and contingent milestone payments:
|
|
1.
|
On September 14, 2012, InterCure entered into a strategic service agreement with Giboov Ltd. (“
Giboov
”)
for a period of three years according to which online marketing and sale services were to be provided to InterCure.
|
As per
the agreement, in addition to periodic payments made to Giboov, and based on Giboov's achievement of said sales targets, it will
be allocated up to 20,185,184 non-marketable stock options that are exercisable into InterCure shares, for an exercise (dividend
adjusted) price equivalent to NIS 0.54 per stock option.
On October 28, 2012, the Company's
general meeting approved the Company's engagement in the strategic service agreement with Giboov, including the allocation of stock
options and the items of the strategic agreement relating to said allocation.
The expenses in respect of
the grant were recorded similarly to share-based payment to employees, pursuant to the provisions of IFRS 2. The fair value of
all performance-based stock options according to the Monte Carlo model pursuant to IFRS 2 as of the date of approval by InterCure's
special meeting approximates $ 2,169 thousand. The maximum stock option exercise term is five years from the date of allocation.
After the reporting period,
on January 20, 2014, InterCure announced it had entered in an agreement with Giboov to terminate the Strategic Service Agreement,
effective as of January 31, 2014 (the “
Arrangement
”). According to the Arrangement, all 20,185,184 non-marketable
stock options for the purchase of InterCure shares which were granted to Giboov under the Strategic Service Agreement expired on
March 1, 2014, resulting in a reversal in 2013 of the expenses recognized in 2012 in the amount of $ 132. Following said expiration,
Giboov holds no such non-marketable stock options.
Further, on January 23, 2014,
InterCure announced that it has agreed to retain the services of Universal McCann Israel, Ltd. (“
McCann
”) in
which McCann will provide professional services relating to the promotion and marketing of InterCure’s products via the internet
for a period of three years effective February 1, 2014. According to the new agreement, InterCure shall pay McCann a monthly fee
in exchange for online marketing services, ranging between $ 8 thousand and $ 13 thousand, and contingent upon achievement of sales
targets.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
|
2.
|
On March 14, 2012, the Company signed a strategic collaboration master agreement with Clalit
Health Services - Clalit Research Institute Ltd. ("the Institute") and Mor Research Applications Ltd. (“
Mor
”)
according to which the Institute provides the Company the right to receive data which are based on the Institute's database in
connection with technologies that stem from inventions and patents of Clalit Health Services' physicians, in projects whose content
shall be agreed upon by the Company, the Institute and Mor in advance and in writing.
|
|
|
In consideration for the above, the Company shall pay the Institute the cost basis related to the
Institute's activity in the framework of any project plus an additional 10% of the total royalties to which Mor is entitled pursuant
to its agreements with the Company in connection with each technology where rights were granted to the Company.
|
|
|
This agreement may be terminated by giving a written and advance notice of 180 days by any of the
parties on condition that all joint active projects have reached their end. As of the date of the approval of the financial statements,
the Company has no active projects with the Institute.
|
|
3.
|
On November 30, 2011, the Company completed the MinoGuard transaction according to which an exclusive
license to the SAM-101 drug (combined drug to treat mental disorders focusing on schizophrenia) was transferred to the Company.
According to the terms of the agreement with MinoGuard, the Company will act to conduct clinical trials, develop, register, market,
distribute and sell the drug candidates that will emerge from the technology, with no limitations to a specific disorder.
|
In return
for the receipt of the license, as above, the Company will pay MinoGuard cumulative milestone payments throughout the research
and development and the approval of the drug in an aggregate of $ 2.5 million. In addition, the Company will make royalty
payments to MinoGuard of 3.5% on sales of products derived from the license and/or a percentage of the Company's net income of
any third-party sublicense in the range of 7.5% to 20% depending on the clinical phase of the drug at the time of the above sublicense
transaction.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
|
|
In addition to the above payments, if the Company does not commence a phase 2 clinical trial by
June 30, 2013 (the agreement states that receipt of an approval to commence such trial or continuance of the clinical trials that
were conducted/will be conducted by MinoGuard and/or its researchers, shall be deemed commencement of phase 2 clinical trial for
this matter), the Company will then pay MinoGuard an annual license fee of $ 45 thousand for the first payment and its cost
will increase by $ 90 thousand per year (should the trial not commence) up to $ 675 thousand for the eighth year of license.
The Company can pay any of the above amounts in cash or by issuance of securities to MinoGuard, at its sole discretion. In accordance
with the agreement, and since as of June 30, 2013, the Company had not commenced a phase 2 clinical trial, it has paid MinoGuard
an annual license fee, by way of issuance of 175,633 ordinary shares of the Company, representing a value of $45,000, for the 12
month period between July 1, 2013 and June 30, 2014.
|
The licensed
technology transferred to the Company is protected by a registered patent through 2027. If the Company does not commence a phase
2 clinical trial (as described above) within 9.5 years from the date of the license agreement, the license will expire.
|
4.
|
On November 2, 2011, the Company entered into a term sheet by which it will acquire a technology
(“
NiCure
” or the “
Technology
”) from Mor Research Applications Ltd., the Technology Transfer
Office of Clalit Health Services, by obtaining an exclusive license to use the entire technology in return for royalties on sales
and milestone payments throughout the clinical development process. The agreement that will be signed by the parties is subject
to, among others, the completion of a due diligence study, examination of the regulatory environment for the continued development
of the technology and the approval of the Company's Board.
|
|
|
The technology mentioned above
is based on the local administration of renin-angiotensin inhibitors (a known drug for
the treatment of hypertension, "Enalaprilat") and is a novel treatment for
the symptoms of cartilage-related diseases (such as Osteoarthritis). The therapy focuses
on increasing or replenishing the level of glycoaminoglycans (GAGs) in the synovial fluid
and cartilage, thereby relieving or even reversing symptoms of such diseases. Moreover,
the same technology can be used to treat skin wrinkles.
|
|
|
According to estimates of the
scientists who have invented this technology, the technology may enter a phase 2 clinical
trial for the continuance of the clinical development based on this technology, as the
drug mentioned above was approved for the treatment of reducing hypertension and is being
provided to patients for already 20 years.
|
|
|
As of the date of the approval
of the financial statements, the transaction has not been closed and the Company is considering
the adapting of this project to its business plan.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
|
5.
|
As stated in Note 14c above,
on August 3, 2010, the Company closed the Bio-Gal Transaction. According to this
agreement, the Company is obligated to pay 1% royalties on net sales of the product and
$ 350 thousand upon the successful completion of a phase 2 clinical trial. The payment
conditions for the above amount are at the earlier of occurrence of the following events:
|
|
(i)
|
Raising at least $ 2 million by the Company or Xtepo after a successful completion of a phase
2 clinical trial;
|
|
(ii)
|
Six months after the successful completion of a phase 2 clinical trial.
|
|
6.
|
In January 2007, a subsidiary committed to pay advisory fees to a third party in connection with
the DOV transaction. In October 2008, in furtherance to the above commitment, the Company and the subsidiary entered into an agreement
with the third party according to which the advisory fees will be based on share appreciation rights in the Company as follows:
|
|
(i)
|
3% of the Company's fully diluted shares as of the date of the transaction, representing 1,659,945
shares exercisable one year after the date of the transaction;
|
|
(ii)
|
7% of the Company's fully diluted shares as of the date of the transaction, representing 3,873,204
shares vesting on the occurrence of certain events which represent a "milestone event."
|
Payment of
the share appreciation rights can be satisfied, at the Company's election, in cash or by issuance of the Company's shares. Upon
the exercise of share appreciation rights by the issuance of shares, the payment will be equal to the difference between the market
value (the greater of the share price on the exercise date or the average share price in the preceding five days) and $ 1.7.
The share appreciation rights expire on January 15, 2017.
Share appreciation
rights in the amount equivalent to 3% are exercisable, as stated above, and presented in equity in accordance with IFRS 2 whereas
share appreciation rights in the amount equivalent to 7%, as stated above, expired in March 2010 with the termination of the Company's
license agreement with DOV for the Bicifadine drug.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
|
7.
|
During September 2005, the Company acquired from VivoQuest patent rights and other assets (DOS
program), covering a proprietary compound library, which includes hepatitis C compounds, laboratory equipment and employment agreements
with research and development employees in consideration of approximately $ 1,939 thousand (including transaction costs of
$ 148 thousand), of which an amount of $ 1,391 thousand was paid by issuance of Ordinary shares of the Company. According
to the agreement with VivoQuest, the Company is obligated to contingent milestone payments triggered by certain regulatory and
sales targets, totaling as of the reporting date $ 34 million, of which $ 25 million due upon regulatory approval or
actual product sales, and payable in cash or issuance of shares at the Company's election. No contingent consideration has been
paid pursuant to the license agreement as of December 31, 2013 because none of the milestones have been achieved. The Company
is also obligated to make royalty payments to VivoQuest on future product sales.
|
In March 2008, the Company
signed an agreement (as revised in August 2008) to sell the DOS program development rights to the U.S. Presidio in consideration
of $ 5.94 million in cash. Under this agreement, Presidio becomes responsible for all further development and commercialization
activities relating to the DOS program. Presidio is also obligated to pay the Company up to $ 59 million upon reaching certain
milestones and royalty payments ranging from 1% to 10% on product sales by Presidio. Presidio is also obligated to pay the Company
for any milestone consideration owed to VivoQuest pursuant to the VivoQuest license agreement.
On August 22, 2012, Presidio
requested to terminate the engagement with the Company in effect from August 24, 2012. Following the announcement of the termination
of the agreement, the entire DOS technology (including all patents kept by Presidio) was returned to the Company within 90 days
from the date of said announcement pursuant to the agreement.
The Company intends to examine
the renewal of activity in the field of Hepatitis C and/or locate strategic partners for the continued development and marketing
of drugs for treating Hepatitis C based on the DOS technology.
|
1.
|
On January 15, 2004, a subsidiary, InterCure, received the Israeli Chief Scientist's letter of
approval for developing a medical device for treating patients with congestive heart failure (“
CHF
”) which included
participation in R&D expenses in the amount of $ 200 thousand. According to the agreement with the Chief Scientist, InterCure
will be obligated to pay royalties at a rate of 3%-5% of sales of products which are the result of the R&D activity funded
by the Chief Scientist up to the amount of funding provided, linked to the exchange rate of the U.S. dollar with the addition of
interest at the rate of Libor.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
As of December 31, 2013, InterCure
has not yet commenced making sales of products combining the technology for treating CHF and therefore has not paid any royalties
for this technology.
|
2.
|
On February 12, 2010, InterCure
Inc., a subsidiary of InterCure, entered into a marketing collaboration agreement (the
“
Agreement
”) with Omron Healthcare Inc., a U.S. subsidiary of the
Omron Healthcare Group headquartered in Japan (“
Omron
”), which is
a leading global supplier of home blood pressure monitors. According to the agreement,
Omron and InterCure Inc. will co-develop consumer and medical marketing strategies for
increasing the sales of the RESPeRATE, a non-drug, non-invasive hypertension treatment
and blood pressure monitoring device. The agreement includes, among others, an item which
grants Omron a right of first offer to acquire InterCure's activity if any offer is made
by a third party.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
|
3.
|
Obtaining approval for insurance indemnification in the UK - InterCure filed a motion for setting
insurance indemnification amounts in the context of the British healthcare system. On November 17, 2011, InterCure announced that
the British Department of Health had approved its motion regarding product insurance indemnification as part of the British healthcare
services. Accordingly, InterCure signed several distribution agreements in the UK. On February 1, 2012, InterCure began selling
the relevant product such that British patients who had been previously required to pay approximately £ 200 out of their
own pocket to buy the product may now receive it at no charge or for a symbolic participation fee when producing a signed physician's
prescription. In order to allow sales in the context of the UK drug tariff, InterCure has been preparing in the last few months
to implement a plan for leveraging the approval in order to increase the device sales, taking into consideration its limited resources.
The plan consisted of preparing an inventory of devices, setting up the appropriate logistic channels for marketing the device
and investing in a public relations and advertising campaign to create awareness to the new manner of purchasing the device under
the UK drug tariff. In the context of the marketing efforts, InterCure entered into an engagement with a public relations entity
specializing in the medical field in the UK and contacted the relevant professional associations.
|
The British Hypertension
Society opinion:
On June 7, 2012, InterCure
announced that it had obtained an opinion from the British Hypertension Society (the “
Society
”) of April 2012
(the “
Opinion
”) which studied the InterCure's developed and sold RESPeRATE device for treating hypertension
(the “
Device
”), as included in the UK drug tariff. In the Opinion, the Society stated that several clinical
trials that had been performed on the Device over timeframes that do not exceed nine weeks indicate that the use of the Device
has a significant effect of lowering both systolic and diastolic blood pressure, yet the Society believes that in view of the relatively
small degree of the decreases and the relatively short effect of the trials, more trials must be conducted for longer timeframes
for the Society to be able to recommend the Device.
InterCure stated that it believes
that the opinion is based on a solitary article which analyzed the results of trials using a problematic methodology which does
not address the direct effect of the treatment on the patient. Consequently, the article's conclusions contradict the conclusions
of several other independent articles which have recently reviewed the results of device trials and concluded that it is an efficient
means of treating hypertension. InterCure aims to act to establish a dialog with the Society which might yield its reassessment
of the Device.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
On January 21, 2013, InterCure
announced that the examination conducted as part of the process of concluding the engagement with Mr. Erez Gavish, InterCure's
former CEO (“
Mr. Gavish
”), revealed several issues which require inspection in connection with InterCure's
actions during Mr. Gavish's term as CEO, including the legal validity granted to the License Agreement of October 2011 signed
between InterCure and Yazmonit. InterCure's board of directors appointed a committee which included an external attorney hired
for this purpose and another director in InterCure in order to investigate the issue and provide InterCure's board of directors
with its conclusions. In addition, a notice was delivered to Mr. Gavish and Dr. Gavish on the establishment of said committee
which summoned the two to provide explanations regarding the issues under inspection and requested that they inform any of their
future potential partners or investors of the inspection of the legal validity of the License Agreement.
On April 7, 2013, InterCure
announced that an originating summons had been filed by Yazmonit against it, with the Tel-Aviv-Jaffa district court (the “
Court
”),
according to which the Court was asked to render a verdict which declares that the License Agreement had been approved and signed
and the rights therein had been conferred and transferred by the respondent to the petitioner as required by law. Moreover, on
May 13, 2013, InterCure filed a petition with the Court for dismissing the originating summons in limine, and assigning the motion
to a standard legal procedure. On July 17, 2013, InterCure announced that it had reached a settlement with Mr. Gavish and Dr.
Gavish in connection with the amendment of the License Agreement. According to the amendment, Yazmonit will not be able to market
its products under InterCure's RESPeRATE
TM
trademark and brand name.
|
c.
|
Operating lease commitments:
|
|
1.
|
As of December 31, 2013, the
Company leases two vehicles under an operating lease. The lease agreements expire in
2014. Vehicle lease expense for the years ended December 31, 2013, 2012 and 2011 were
$ 29 thousand, $ 33 thousand and $ 32 thousand, respectively. The lease
fees are stated in NIS and are linked to the Israeli CPI. Expected lease fees for 2014
under the lease fees as of December 31, 2013 are approximately $ 4 thousand.
|
|
2.
|
The Company entered into an operating lease agreement on the offices it uses. The agreement is
in effect until August 2015. The lease fees are stated in NIS and are linked to the Israeli CPI. To secure the lease, the Company
provided a bank guarantee which is secured by a restricted NIS deposit of approximately $ 23 thousand.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 18:-
|
COMMITMENTS (Cont.)
|
The expected lease fees and
management fees for subsequent years under the prevailing lease fees as of December 31, 2013 are as follows:
|
|
U.S. dollars
in thousands
|
|
|
|
|
|
2014
|
|
|
94
|
|
2015
|
|
|
60
|
|
The Company entered into agreements
with three subtenants to lease an office space for approximately $ 57 thousand a year. The agreements are in effect until
April-November 2014 with a renewal option for some of the subtenants until August 2015.
|
3.
|
In May 2010, a subsidiary, InterCure Inc., signed an agreement for the lease of offices for a period
of three years. In May 2013, InterCure Inc. signed a revised lease agreement for an additional 12 months. The monthly lease fees
are approximately $ 1 thousand.
|
|
NOTE 19:-
|
SHARE CAPITAL, RESERVES AND RETAINED EARNINGS
|
|
|
Number
of shares
|
|
|
Amount
|
|
|
|
Authorized
|
|
|
Issued
and
outstanding
|
|
|
Authorized
|
|
|
Issued
and
outstanding
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
|
|
In
thousands
|
|
|
NIS
in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary
shares of NIS 0.1 *
|
|
|
700,000
|
|
|
|
700,000
|
|
|
|
**232,895
|
|
|
|
**229,472
|
|
|
|
70,000
|
|
|
|
70,000
|
|
|
|
**23,289
|
|
|
|
**22,947
|
|
|
*
|
Traded on the TASE. The Company's ADRs are traded on the NASDAQ in the U.S. The share price was
NIS 0.514 as of December 31, 2013.
|
|
**
|
Including 6,067,943 and 7,165,662 treasury shares held by InterCure as of December 31, 2013 and
2012, respectively, as 1,097,719 shares were sold by InterCure in 2013.
|
|
b.
|
Ordinary shares confer upon their holders voting rights and right to participate in the shareholders'
meeting, right to receive dividends and the right to participate in the excess of assets upon liquidation of the Company.
|
|
c.
|
On August 3, 2010, upon the closing of the Bio-Gal Transaction, 133,063,688 Ordinary shares
of NIS 0.1 par value each were allocated to Xtepo's shareholders in return for 100% of the shares of Xtepo which, before closing,
held a license for the exclusive use of the patent for the rHuEPO drug for Multiple Myeloma and approximately $ 1.5 million
in its account.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 19:-
|
SHARE CAPITAL, RESERVES AND RETAINED EARNINGS (Cont.)
|
|
d.
|
On March 7, 2011, the Company
raised by public issuance on the TASE 12,305,000 Ordinary shares of NIS 0.1 par
value each, 6,152,500 warrants (series 1) and 18,457,500 warrants (series 2) for immediate
overall proceeds of approximately NIS 6.3 million (approximately $ 1.75 million)
net of issuance expenses of approximately $ 68 thousand.
|
The warrants (series 1) were
exercisable into Ordinary shares of NIS 0.1 par value each from the date of registration for trade on the TASE (March 9,
2011) to November 27, 2011 for an exercise increment of NIS 0.7 per share, linked to the U.S. dollar. On July 21,
2011, a shareholder in the Company exercised 15,544 warrants (series 1) into 15,544 Ordinary shares of NIS 0.1 par value
each for an overall exercise increment of approximately $ 3 thousand. The remaining warrants (series 1) expired on November 27,
2011.
The warrants (series 2) were
originally exercisable into Ordinary shares of NIS 0.1 par value each from the date of registration for trade on the TASE
(March 9, 2011) to February 27, 2013 for an exercise increment of NIS 1 per share, linked to the U.S. dollar (as
of December 31, 2013, the exercise increment was approximately NIS 0.96 per warrant). For details on extensions of term of
the warrants (series 2), see Note 19j and Note 31 below.
|
e.
|
On March 22, 2011, 4,666,667
unlisted warrants which had been issued in 2006 under a private placement to American
investors expired.
|
|
f.
|
On March 18, 2012, the Company's
Board approved a private placement to institutional and private investors (foreign as
well as Israeli) for the total of approximately $ 2.4 million (approximately NIS 9.1
million) net of issuance expenses of approximately $ 19 thousand. According to the
private placement, the Company allocated 11,560,362 Ordinary shares of the Company of
NIS 0.1 par value each, 3,853,454 warrants (series A) and 1,926,727 warrants (series
B).
|
|
|
The warrants (series A) were exercisable
into Ordinary shares of NIS 0.1 par value each from the date of allocation (March 18,
2012) to September 17, 2012 for an exercise increment of NIS 1.046 per share,
linked to the U.S. dollar. See more details in i below.
|
|
|
The warrants (series B) are exercisable
into Ordinary shares of NIS 0.1 par value each from the date of allocation (March 18,
2012) to March 17, 2015 for an exercise increment of NIS 1.124 per share, linked
to the U.S. dollar.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 19:-
|
SHARE CAPITAL, RESERVES AND RETAINED EARNINGS (Cont.)
|
|
h.
|
On June 1, 2012, the Company
applied for the relisting of its ADRs on the NASDAQ (after the ADRs had been delisted
from trade on the NASDAQ in July 2009), subject to compliance with all the criteria reviewed
by the NASDAQ admissions committee, including minimum ADR price (according to the various
listing criteria). On September 24, 2012, the Company's Board approved a change in the
number of shares underlying the ADRs such that 20 Ordinary shares of the Company will
constitute a single ADR, this in order to support the Company's compliance with the NASDAQ's
ADR listing conditions. The record date of change in the ADR ratio is October 4, 2012.
On July 10, 2013, the Company's management received a notice from NASDAQ representatives
stating that the admission committee had approved the Company's application to relist
its ADRs for trading on the NASDAQ Capital Market. Accordingly, on July 15, 2013, the
Company's ADRs began trading on NASDAQ.
|
|
i.
|
In the context of the consummation
of the InterCure acquisition transaction, the Company purchased 16,839,532 Ordinary shares
of InterCure with no par value in return for the allocation, by private placement, of
7,165,662 Ordinary shares of NIS 0.1 par value each of the Company.
|
|
j.
|
In the year ended December 31,
2012, the Company's warrants (series 2) holders exercised 6,145,095 warrants (series
2) into 6,145,095 ordinary shares of NIS 0.1 par value each for an average exercise
increment of approximately NIS 1.06 per warrant, for the overall proceeds of approximately
$1,703 thousand (approximately NIS 6.5 million). In the year ended December 31, 2013,
the Company's warrant (series 2) holders exercised 86,299 warrants (series 2) into 86,299
ordinary shares of NIS 0.1 par value each for an average exercise increment of approximately
NIS 1 per warrant, for the overall proceeds of approximately $ 25 thousand. For
additional information, see Note 31 below.
|
|
k.
|
In the year ended December 31,
2012, the Company's warrants (series A) holders exercised 560,000 warrants (series A)
into 560,000 Ordinary shares of NIS 0.1 par value each for an average exercise increment
of approximately NIS 1.09 per warrant, for the overall proceeds of approximately
$ 155 thousand (approximately NIS 0.6 million). On September 17, 2012, in accordance
with the terms of the private placement of March 2012, the remaining unexercised 3,293,454
warrants (series A) of the Company expired.
|
|
l.
|
On September 11, 2013, the Company
issued Aurum a total of 3,031,299 Ordinary shares of the Company of NIS 0.1 par value
each. For additional details, see Note 12 above.
|
|
m.
|
On September 12, 2013, the Company
issued MinoGuard a total of 175,633 Ordinary shares of the Company of NIS 0.1 par value
each. For additional details, see Note 18a(4).
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT
|
|
a.
|
Share-based payment in the Company:
|
On August 29, 2011, the Company's
Board approved the adoption of an employee share option plan for the grant of options exercisable into shares of the Company in
accordance with section 102 to the Israeli Tax Ordinance (the "
2011 Plan
") in lieu of the option plan established
in 2001 (the "
2001 Plan
") which ended after 10 years, and the holding of up to 10 million shares in the framework
of the 2011 Plan, for option allocation to Company employees, directors and consultants.
In May 2011,
after 10 years, the 2001 Plan ended and, accordingly, since that date no new options can be granted under this plan. In August
2011, the 2011 Plan was approved (see details above). As of December 31, 2013, the remaining number of options available for
grant under the 2011 Plan is 6,024,500 options.
The 2011 Plan shall be subject
to the directives determined for this purpose in section 102 to the Income Tax Ordinance. Under the capital track which was adopted
by the Company and the abovementioned directives, the Company is not entitled to receive a tax deduction that relates to remuneration
paid to employees, including amounts recorded as salary benefit in the Company's accounts for options granted to employees in the
framework of the plan, except the yield benefit component, if available, that was determined on the grant date.
The terms of the options which
will be granted according to the 2011 Plan, including the option period, exercise price, vesting period and exercise period shall
be determined by the Company's Board on the date of the actual allocation.
Below is
information about share-based payments granted to the Group's directors, employees and service providers during the reported years
in accordance with the 2001 and 2011 Plans pursuant to section 102 to the Income Tax Ordinance and options granted without a plan
in accordance with section 3i to the Income Tax Ordinance:
|
1.
|
In July 2009, the Company's Board approved the allocation of 1,400,000 unlisted stock options to
the Company's former CFO which are exercisable into 1,400,000 Ordinary shares of NIS 0.1 par value each for an exercise increment
of NIS 0.075 per stock option. The fair value of all stock options using the Black-Scholes model on the date the Board accepted
the decision was approximately $ 148 thousand. The option exercise term is for a maximum period of 120 months from the grant
date, such that 33.33% of the stock options are exercisable immediately and the remaining 66.67% stock options are exercisable
in equal rates every month from the grant date for a three-year period.
|
|
|
The value of each option is based on the following inputs: expected dividend of 0%, expected standard
deviation of 175%, risk-free interest rate of 3.85% and expected life of five years. The volatility is based on the historical
volatility of the Company's share for comparative periods that commensurate with the expected term of the option.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
Likewise,
the Company is committed to supplement the difference between the par value of the share and the exercise price in this plan on
the actual exercise date by allocating amounts from share premium to share capital. For additional information, see note 20a(15)
below.
|
2.
|
On January 18, 2010, the Company's Board approved to grant 450,000 share options to directors
in the Company to purchase 450,000 Ordinary shares of NIS 0.1 par value each at an exercise price equal to NIS 0.298
per share. On March 2, 2010, the annual meeting of shareholders approved to grant options to the directors. Pursuant to the
guidance of IFRS 2, the fair value of all share options on the date of approval by the annual meeting, using the Black-Scholes
model was approximately $ 36 thousand. The option term is for a period of 10 years from the grant date. 33% of the options
are exercisable immediately and the remaining share options are exercisable in 24 tranches every month over a two-year period.
On November 22, 2010, one of the optionees discontinued serving as a director and, accordingly, the 63,747 options granted
to him have been forfeited.
|
The value
of each option is based on the following inputs: expected dividend of 0%, expected standard deviation of 175%, risk-free interest
rate of 3.9%-4.3% and expected life of five to six years.
|
3.
|
On January 18, 2010, the Company's Board approved to grant 1,610,000 share options to the
Company's former CEO to purchase 1,610,000 Ordinary shares of NIS 0.1 par value each at an exercise price equal to NIS 0.075
per share. On March 2, 2010, the annual meeting of shareholders approved to grant options to the Company's CEO with approval
of his employment terms, subject to the closing of Bio-Gal Transaction (whose closing occurred on August 3, 2010). Pursuant
to the guidance of IFRS 2, the fair value of all share options on the date of approval by the annual meeting, using the Black-Scholes
model was approximately $ 133 thousand. The option term is for a period of 10 years from the grant date. 33% of the options
are exercisable immediately and the remaining options are exercisable in 24 tranches every month over a two-year period.
|
The value
of each option is based on the following inputs: expected dividend of 0%, expected standard deviation of 175%, risk-free interest
rate of 3.87%-4.11% and expected life of five to six years. Likewise, the Company is committed to supplement the difference between
the par value of the share and the exercise price in this plan on the actual exercise date by allocating amounts from share premium
to share capital. For additional information, see note 20a(14) below.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
|
4.
|
On January 26, 2010, the Company's Board approved
to grant 100,000 stock options to an employee in the Company to purchase 100,000 Ordinary shares of NIS 0.1 par value each
at an exercise price of NIS 0.1 per share. Pursuant to the guidance of IFRS 2, the fair value of all stock options on the
date of the Board resolution using the Black-Scholes model was approximately $ 10 thousand. The exercise period of the stock
options is a maximum of ten years from the grant date. The stock options vest in twelve equal portions each quarter over a period
of three years from the grant date. The value of each option is based on the following inputs: expected dividend of 0%, expected
standard deviation of 175%, risk-free interest rate of 4.3% and expected life of five to six years. On June 30, 2013, all 100,000
stock options were exercised for approximately $ 7 thousand.
|
|
5.
|
On August 27, 2010, the Company's Board approved the employment agreement of Professor Moshe Mittelman
as a senior officer - Medical Director of the development plan of the rHuEPO drug designed to treat multiple myeloma. It also approved
the allocation of 640,000 share options (unlisted) to purchase 640,000 Ordinary shares of NIS 0.1 par value each at an exercise
price equal to NIS 0.1 per share. The fair value of all share options on the date the Board accepted the decision using the
Black-Scholes model was approximately $ 50 thousand. The option term is for a period of 10 years from the grant date. The
options are exercisable in equal monthly tranches over a 24-month period.
|
Also, upon
the commencement of a phase 2 clinical trial (first-in-man), 50% of the unvested options (until the date of the commencement of
the said trial) of Prof. Mittelman shall vest immediately. In addition, upon the termination by the Company (with no cause) of
the Prof. Mittelman's employment agreement, 25% of Prof. Mittelman's unvested options (until the date of the said termination)
shall vest immediately.
The value of each option is
based on the following inputs: expected dividend of 0%, expected standard deviation of 160%, risk-free interest rate of 3.54%-3.68%
and expected life of five to six years.
|
6.
|
On June 1, 2011, the Company's Board approved to allocate to the Company's external consultant
options that are exercisable into 120,000 Ordinary shares of the Company of NIS 0.1 par value each at an exercise price equal
to NIS 0.572 per share. According to the provisions of IFRS 2, the fair value of all options on the grant date using the Black-Scholes
model was approximately $ 19 thousand. The option term is for a period of 10 years from the grant date. The options are exercisable
on a straight-line basis every month of the grant date over a 30-month period.
|
The value of each option is
based on the following inputs: expected dividend of 0%, expected standard deviation of 155%, risk-free interest rate of 4.83% and
expected life of 6.25 years.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
|
7.
|
On March 19, 2012, in the context
of the annual meeting of shareholders, 300,000 options were allocated to external directors
in the Company that are exercisable into 300,000 Ordinary shares of NIS 0.1 par
value each for an exercise increment of NIS 0.58633 per option. The fair value of
all the options according to the Black-Scholes model pursuant to IFRS 2 as of the date
of approval by the Company's general meeting was approximately $ 79 thousand. The
exercise period of the options is a maximum of ten years from the allocation date. 33%
of the options vested immediately upon allocation and the remaining options vest in 24
equal portions each month over a period of two years from the allocation date. The value
of each option is based on the following assumptions: expected dividend rate of 0%, expected
standard deviation of 153%, risk-free interest rate of 4.08% and expected life until
exercise of six years.
|
|
8.
|
On April 12, 2012, the Company's
Board approved the allocation of 1,810,000 stock options which are exercisable into 1,810,000
Ordinary shares of NIS 0.1 par value each of the Company for an exercise increment
of NIS 0.9 per stock option as follows: 1,710,000 stock options to the Company's
former Deputy CEO and CFO and 100,000 stock options to Company employees. The fair value
of all the stock options according to the Black-Scholes model pursuant to IFRS 2 as of
the date of grant (the date of the Company's Board's decision) was approximately $ 399
thousand. The exercise period of the stock options is a maximum of ten years from the
grant date. The stock options vest in 12 equal portions each quarter over a period of
three years from the grant date. The value of each stock option is based on the following
assumptions: expected dividend rate of 0%, expected standard deviation of 153.85%, risk-free
interest rates of 3.67%-4.22% and expected life until exercise of 5-6.5 years. On June
30, 2013, an employee exercised 30,000 stock options of the 90,000 stock options granted
to him, for approximately $ 2 thousand. The remaining 60,000 stock options granted to
the employee, which had not yet vested at the time, were forfeited. For additional information,
see note 20a(14) and (15) below.
|
|
9.
|
On May 29, 2012, in the context
of a special meeting of shareholders, 4,408,000 stock options were allocated to a director
in the Company (the "Director") which were exercisable into 4,408,000 Ordinary
shares of NIS 0.1 par value each of the Company for an exercise increment of NIS 0.9
per stock option. The fair value of all the stock options according to the Black-Scholes
model pursuant to IFRS 2 as of the date of approval by the Company's special meeting
was approximately $ 1,255 thousand. The exercise period of the stock options is
a maximum of ten years from the grant date. The stock options vest in twelve equal portions
each quarter over a period of three years from the grant date. The value of each stock
option is based on the following assumptions: expected dividend rate of 0%, expected
standard deviation of 154.09%, risk-free interest rates of 3.90%-4.16% and expected life
until exercise of 5-6.5 years. On August 19, 2013, the Director resigned from his position,
pursuant to which 2,938,668 stock options, which had not yet vested as of the date of
resignation, were forfeited. The remaining 1,469,332 vested stock options were not exercised
within the required period of 90 days from the resignation date, and had accordingly
expired on November 17, 2013.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
In addition, 1,500,000 stock
options were allocated to the Company's former CEO which are exercisable into 1,500,000 Ordinary shares of NIS 0.1 par value
each of the Company for an exercise increment of NIS 0.9 per stock option. The fair value of all the stock options according
to the Black-Scholes model pursuant to IFRS 2 as of the date of approval by the Company's special meeting was approximately $ 427
thousand. The exercise period of the stock options is a maximum of ten years from the grant date. The stock options vest in twelve
equal portions each quarter over a period of three years from the grant date. The value of each stock option is based on the following
assumptions: expected dividend rate of 0%, expected standard deviation of 154.09%, risk-free interest rates of 3.90%-4.16% and
expected life until exercise of 5-6.5 years. For additional information, see note 20a(14) below.
|
10.
|
On December 30, 2012, the Company's Board approved the allocation of 258,000 stock options to medical
consultants in the Company which are exercisable into 258,000 Ordinary shares of NIS 0.1 par value each of the Company for
an exercise increment of NIS 1.2837 per stock option. The fair value of all the stock options according to the Black-Scholes
model pursuant to IFRS 2 as of the date of grant (the date of the Company's Board's decision) was approximately $ 83 thousand.
The exercise period of the stock options is a maximum of ten years from the grant date. The stock options vest in eight equal portions
each quarter over a period of two years from the grant date. The value of each stock option is based on the following assumptions:
expected dividend rate of 0%, expected standard deviation of 154.49%, risk-free interest rates of 2.60%-2.87% and expected life
until exercise of 5-6 years.
|
|
11.
|
On September 11, 2013, the Company's Board received notice from the former CEO of the Company that
he wished to terminate his position as CEO. Accordingly, and in the lapse of the prior notice period stipulated in the former CEO's
employment agreement, on February 15, 2013, 750,000 stock options formerly granted to him, and that had not yet vested as of the
day of his effective termination, were forfeited. As of the date of the financial statements, the remaining vested 2,360,000 stock
options were not yet exercised.
|
|
12.
|
On December 30, 2013, the Company's Board approved the allocation of 880,000 stock options to the
new CFO and an employee of the Company, exercisable into 880,000 Ordinary shares of NIS 0.1 par value each of the Company, for
an exercise increment of NIS 0.5328 per stock option. The fair value of all the stock options according to the Black-Scholes model
pursuant to IFRS 2 as of the date of grant (the date of the Company's Board's decision) was approximately $ 120 thousand.
The exercise period of the stock options is a maximum of ten years from the grant date. The stock options vest in twelve equal
portions each quarter over a period of three years from the grant date. The value of each stock option is based on the following
assumptions: expected dividend rate of 0%, expected standard deviation of 117.86%, risk-free interest rates of 3.98% and expected
life until exercise of 5-6.5 years.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
|
13.
|
On January 30, 2014, the Company's Board approved the allocation of 1,500,000 stock options to
the new CEO of the Company, exercisable into 1,500,000 Ordinary shares of NIS 0.1 par value each of the Company, as follows: 600,000
stock options are exercisable into 600,000 Ordinary shares of the Company for an exercise increment of NIS 0.6 per stock option,
and an additional 900,000 stock options are exercisable into 900,000 Ordinary shares of the Company for an exercise increment of
NIS 0.9 per stock option. The fair value of all the stock options according to the Black-Scholes model pursuant to IFRS 2 as of
the date of grant (the date of the Company's Board's decision) was approximately $ 244 thousand. The exercise period of the
stock options is a maximum of ten years from the grant date. The stock options vest in twelve equal portions each quarter over
a period of three years from the grant date. The value of each stock option is based on the following assumptions: expected dividend
rate of 0%, expected standard deviation of 154.49%, risk-free interest rates of 2.60%-2.87% and expected life until exercise of
5-6.5 years. For additional information, see Note 31 below.
|
|
14.
|
On December 30, 2013, the Company's Board received notice from the former CFO and Deputy CEO of
the Company, Mr. Ronen Twito, that he wished to terminate his employment with the Company. Accordingly, on December 30, 2013, the
Company's Board approved the appointment and employment terms of Mr. David Kestenbaum as CFO of the Company effective from January
5, 2014. Mr. Twito's employment with the Company shall terminate at the end of the three-month notice period stipulated in his
employment agreement.
|
Following Mr. Twito's notice,
and in the lapse of the prior notice period stipulated in his employment agreement, on April 5, 2014, 570,000 stock options formerly
granted to him, and that will not yet vest as of the same day, shall be forfeited. The remaining vested 2,550,000 stock options
are exercisable for a 90 day period from the date of Mr. Twito's termination of employment.
Ordinary
shares allocated upon the exercise of options in all grants will have identical rights to Ordinary shares of the Company immediately
after their allocation.
On January 29, 2012,
39,000 options which had been issued in 1997 to a former service provider expired.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
Movements
in the number of share options and their related weighted average exercise prices (in dollars) are as follows:
|
|
Year
ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at beginning of year
|
|
|
12,506,000
|
|
|
|
0.18
|
|
|
|
4,269,000
|
|
|
|
0.08
|
|
|
|
4,149,000
|
|
|
|
0.07
|
|
Granted
|
|
|
130,000
|
|
|
|
0.22
|
|
|
|
8,276,000
|
|
|
|
0.24
|
|
|
|
120,000
|
|
|
|
0.15
|
|
Exercised *)
|
|
|
(130,000
|
)
|
|
|
0.08
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Expired
|
|
|
(1,469,332
|
)
|
|
|
0.26
|
|
|
|
(39,000
|
)
|
|
|
2.69
|
|
|
|
-
|
|
|
|
-
|
|
Forfeited
|
|
|
(2,998,668
|
)
|
|
|
0.26
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end
of year
|
|
|
8,038,000
|
|
|
|
0.15
|
|
|
|
12,506,000
|
|
|
|
0.18
|
|
|
|
4,269,000
|
|
|
|
0.07
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end
of year
|
|
|
6,084,845
|
|
|
|
0.11
|
|
|
|
5,635,001
|
|
|
|
0.13
|
|
|
|
3,692,725
|
|
|
|
0.08
|
|
*) No
options were exercised in 2011-2012.
Below is
information about the exercise price (in dollars) and the remaining contractual life (in years) for options outstanding at end
of year:
December
31, 2013
|
|
|
December
31, 2012
|
|
Options
outstanding at
end of year
|
|
|
Range
of
exercise prices
|
|
|
Weighted
average
remaining
contractual
life
|
|
|
Options
outstanding at
end of year
|
|
|
Range
of
exercise prices
|
|
|
Weighted
average
remaining
contractual
life
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,978,000
|
|
|
|
0
- 0.500
|
|
|
|
4.2
|
|
|
|
12,446,000
|
|
|
|
0
- 0.500
|
|
|
|
8.6
|
|
|
60,000
|
|
|
|
1.500
- 2.499
|
|
|
|
4.0
|
|
|
|
60,000
|
|
|
|
1.500
- 2.499
|
|
|
|
5.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,038,000
|
|
|
|
|
|
|
|
|
|
|
|
12,506,000
|
|
|
|
|
|
|
|
8.6
|
|
Net expenses
recognized in the Company's statements of comprehensive loss for the years ended December 31, 2013, 2012 and 2011 for grant of
options to employees were $ (7) thousand, $ 1,106 thousand and $ 73 thousand, respectively.
These plans
are administered in accordance with the principles set forth in this issue in section 102 to the Income Tax Ordinance.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
According
to the track which was adopted by the Company (capital track) and these principles, the Company is not entitled to receive a tax
deduction that relates to remuneration paid to its employees, including amounts recorded as salary benefit in the Company's accounts
for options granted to employees in the framework of the plan, except the yield benefit component, if available, that was determined
on the grant date.
As for share-based
payment under the Yeda transaction, see Note 14d above.
|
b.
|
Share-based payment in a subsidiary:
|
|
1.
|
On July 25, 2012, 1,484,551 stock options were allocated to InterCure's then CEO, Mr. Erez Gavish,
which are exercisable into 1,484,551 Ordinary shares of InterCure with no par value for an exercise increment of NIS 0.54
per stock option based on the share price of InterCure as determined in the debt refinancing. The fair value of all the stock options
according to the Black-Scholes model pursuant to IFRS 2 as of the date of grant was approximately $ 132 thousand.
|
|
|
On November 28, 2012, Mr. Erez Gavish notified InterCure's board of directors of his intention
not to extend his term as CEO of InterCure. Mr. Ronen Twito, the Deputy CEO and CFO of InterCure at the time, was appointed as
interim CEO of InterCure effective immediately. Mr. Gavish continued to be employed by InterCure until the conclusion of the agreement
period on January 25, 2013.
|
Following the conclusion of
the term of Mr. Gavish on January 25, 2013, 1,237,126 stock options were forfeited and 247,425 stock options became exercisable
for a period of 90 days from the date of conclusion of term until April 24, 2013. If these stock options are not exercised until
said date, they will expire.
In addition, on the same date,
1,000,000 stock options were allocated to InterCure's Deputy CEO and CFO which are exercisable into 1,000,000 Ordinary shares of
InterCure with no par value for an exercise increment of NIS 0.54 per stock option, based on InterCure's share price as determined
in the debt refinancing. The fair value of all the stock options according to the Black-Scholes model pursuant to IFRS 2 as of
the date of grant was approximately $ 88 thousand. The exercise period of the stock options granted to the Deputy CEO and
CFO is a maximum of ten years from the grant date. The stock options vest in 12 equal portions each quarter over a period of three
years from the grant date. The value of each stock option is based on the following assumptions: expected dividend rate of 0%,
expected standard deviation of 90.76%, risk-free interest rates of 3.39%-3.68% and expected life until exercise of 5-6.5 years.
For additional information as to the replacement of Mr. Twito as CEO of InterCure, see Note 20b(5) below.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED
PAYMENT (Cont.)
|
On August 15, 2013, following
the approval of the board of directors of
InterCure of June 26, 2013, the general meeting
of InterCure's shareholders approved a change in the terms of the options previously granted to Mr. Twito, who at the time acted
also as the Company's CFO and Deputy CEO. Such changes included the reduction of exercise increment of the InterCure stock options
granted to him as well as the acceleration of vesting of 347,222 such stock option. The total economic value of the change in the
option terms as above according to the Black-Scholes model, pursuant to the provisions of IFRS 2 as of the date of InterCure's
board of directors' approval, approximates $ 12 thousand.
|
2.
|
On September 3, 2012, in a special meeting of InterCure's shareholders, 75,000 stock options were
allocated to each of four directors in InterCure which are exercisable into 300,000 Ordinary shares of InterCure with no par value
for an exercise increment of NIS 0.54 per stock option. The fair value of all the stock options according to the Black-Scholes
model pursuant to IFRS 2 as of the date of the approval of InterCure's special meeting was approximately $ 26 thousand. The
exercise period of the stock options is a maximum of ten years from the grant date. The stock options vest in 12 equal portions
each quarter over a period of three years from the grant date. The value of each stock option is based on the following assumptions:
expected dividend rate of 0%, expected standard deviation of 87.27%, risk-free interest rates of 3.06%-3.53% and expected life
until exercise of 5-6.5 years.
|
|
3.
|
On December 13, 2012, 100,000 stock options were allocated InterCure's controller and financial
manager which are exercisable into 100,000 Ordinary shares of InterCure with no par value for an exercise increment of NIS 0.54
per stock option.
|
The fair value of all the stock
options according to the Black-Scholes model pursuant to IFRS 2 as of the date of grant was approximately $ 10 thousand. The
exercise period of the stock options is a maximum of ten years from the grant date. The stock options vest in 12 equal portions
each quarter over a period of three years from the grant date. The value of each stock option is based on the following assumptions:
expected dividend rate of 0%, expected standard deviation of
90.38
%, risk-free interest rates
of 2.74%-3.16% and expected life until exercise of 5-6.5 years.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 20:-
|
SHARE-BASED PAYMENT (Cont.)
|
|
4.
|
On March 21, 2013, Prof. Reuven Tzimlichman was appointed to InterCure's medical director. In the
consulting agreement of Prof. Tzimlichman it was stated that he will provide InterCure consulting services in the field of research
and development, intellectual property management and medical regulation. The agreement provides the grant of 130,000 share options
to Prof. Tzimlichman, exercisable into 130,000 ordinary shares at an exercise price of NIS 0.54 per share. The vesting period of
the shares was set to three years when 1/12 of the options shall vest at the end of each quarter. Alternately, if as a result of
the signing between InterCure and a medical institution (such as HMO) for the sale of its products through the medical institution,
InterCure's products will be sold in excess of $ 175,000, than 30% of the unvested options at that time shall vest.
|
The value of each option is
based on the following inputs: expected dividend of 0%, expected standard deviation of 92.21%, risk-free interest rates of 2.76%-3.21%
and expected life of 5-6.5 years.
|
5.
|
On June 26, 2013, Mr. Ofer Gilboa ("
Mr. Gilboa
") was appointed as CEO of InterCure
in lieu of Mr. Ronen Twito, the interim CEO. According to the employment agreement with Mr. Gilboa, he will be granted 650,000
stock options which are exercisable into Ordinary shares of InterCure at an exercise price of NIS 0.23 per stock option. The
stock options vest over a period of three years whereby 1/12 of stock options will vest at the end of each quarter. The fair value
of all of the stock options using the Black-Scholes model pursuant to the provisions of IFRS 2 as of the date of approval by the
board of directors of InterCure was approximately $ 19 thousand. The exercise period is for a maximum of ten years from the
allocation date. The value of each option is based on the following inputs: expected dividend rate of 0%, expected standard deviation
rate of 5.41%, risk-free interest rate of 1% and expected life of 5-6.5 years. Also according to the employment agreement, if InterCure's
revenues exceed $ 5 million and the EBITDA is not less than $ 1 million, Mr. Gilboa will be entitled to a bonus of $ 25
thousand. It was also determined that Mr. Gilboa will be entitled to a bonus of 1% of any capital raising round in InterCure over
a period of 36 months from the commencement of his tenure, provided that the investments are made by third parties that are unrelated
to InterCure, and up to a maximum bonus of $ 100 thousand.
|
On November 27, 2013, InterCure
announced the resignation of Mr. Gilboa as its CEO. Mr. Gilboa's term will effectively end following a two-month notice period,
on January 26, 2014.
For details regarding the appointment
of a new CEO in InterCure, see Note 31 below.
|
6.
|
As for performance-based stock options granted to Giboov, see Note 18a above.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of finished goods
|
|
|
422
|
|
|
|
244
|
|
|
|
-
|
|
Storage and transport
|
|
|
180
|
|
|
|
49
|
|
|
|
-
|
|
Changes in inventory of finished goods
|
|
|
(73
|
)
|
|
|
(22
|
)
|
|
|
-
|
|
Depreciation and amortization
|
|
|
212
|
|
|
|
92
|
|
|
|
-
|
|
Commissions
|
|
|
-
|
|
|
|
17
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
741
|
|
|
|
380
|
|
|
|
-
|
|
|
NOTE 22:-
|
RESEARCH AND DEVELOPMENT EXPENSES
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Salaries and expenses relating to employees and service providers
|
|
|
47
|
|
|
|
30
|
|
|
|
26
|
|
Expenses relating to options to employees and service providers
|
|
|
6
|
|
|
|
3
|
|
|
|
20
|
|
Professional consulting
|
|
|
43
|
|
|
|
28
|
|
|
|
9
|
|
Medical centers
|
|
|
-
|
|
|
|
23
|
|
|
|
-
|
|
Depreciation and amortization
|
|
|
-
|
|
|
|
-
|
|
|
|
88
|
|
Other
|
|
|
17
|
|
|
|
15
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
113
|
|
|
|
99
|
|
|
|
158
|
|
|
NOTE 23:-
|
SELLING AND MARKETING EXPENSES
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Advertising and public relations
|
|
|
1,435
|
|
|
|
512
|
|
|
|
-
|
|
Salaries and related expenses
|
|
|
155
|
|
|
|
123
|
|
|
|
-
|
|
Rent and maintenance
|
|
|
65
|
|
|
|
52
|
|
|
|
-
|
|
Share-based payment
|
|
|
(132
|
)
|
|
|
132
|
|
|
|
-
|
|
Depreciation and amortization
|
|
|
80
|
|
|
|
29
|
|
|
|
-
|
|
Commissions
|
|
|
61
|
|
|
|
-
|
|
|
|
-
|
|
Others
|
|
|
27
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,691
|
|
|
|
848
|
|
|
|
-
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 24:-
|
GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Salaries and expenses relating to employees and service providers
|
|
|
673
|
|
|
|
586
|
|
|
|
421
|
|
Expenses relating to options to employees and service providers
|
|
|
62
|
|
|
|
1,164
|
|
|
|
53
|
|
Patents and fees
|
|
|
188
|
|
|
|
55
|
|
|
|
25
|
|
Directors' fees
|
|
|
79
|
|
|
|
75
|
|
|
|
63
|
|
Foreign services, public relation and travel
|
|
|
10
|
|
|
|
4
|
|
|
|
2
|
|
Rent and office maintenance
|
|
|
87
|
|
|
|
113
|
|
|
|
115
|
|
Vehicle maintenance
|
|
|
51
|
|
|
|
44
|
|
|
|
44
|
|
Insurance
|
|
|
70
|
|
|
|
56
|
|
|
|
57
|
|
Professional services
|
|
|
715
|
|
|
|
546
|
|
|
|
233
|
|
Depreciation and amortization
|
|
|
20
|
|
|
|
15
|
|
|
|
6
|
|
Allowance for doubtful accounts
|
|
|
-
|
|
|
|
12
|
|
|
|
-
|
|
Other
|
|
|
93
|
|
|
|
99
|
|
|
|
59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,048
|
|
|
|
2,769
|
|
|
|
1,078
|
|
|
NOTE 25:-
|
OTHER GAINS, NET
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Gain from bargain purchase
|
|
|
-
|
|
|
|
795
|
|
|
|
-
|
|
Gain from sale of investment in associate (a)
|
|
|
1,051
|
|
|
|
-
|
|
|
|
-
|
|
Loss from disposal of property, plant and equipment
|
|
|
(2
|
)
|
|
|
(2
|
)
|
|
|
(3
|
)
|
Gain (loss) from decrease in holding rate in associate
|
|
|
10
|
|
|
|
(5
|
)
|
|
|
-
|
|
Other
|
|
|
-
|
|
|
|
14
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,059
|
|
|
|
802
|
|
|
|
12
|
|
|
a.
|
Gain from sale of investment in associate:
|
|
|
U.S. dollars
in thousands
|
|
|
|
|
|
Consideration
|
|
|
3,369
|
|
Balance as of September 17, 2013
|
|
|
(2,522
|
)
|
Transaction-related expenses
|
|
|
(17
|
)
|
Reclassification to Other gains, net due to sale of investment
|
|
|
221
|
|
|
|
|
|
|
|
|
|
1,051
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 26:-
|
FINANCE INCOME, NET
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
Finance expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bank account management fees and commissions
|
|
|
35
|
|
|
|
15
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total finance expenses
|
|
|
35
|
|
|
|
15
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income on bank deposits
|
|
|
10
|
|
|
|
43
|
|
|
|
24
|
|
Exchange rate differences
|
|
|
51
|
|
|
|
17
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total finance income
|
|
|
61
|
|
|
|
60
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income, net
|
|
|
26
|
|
|
|
45
|
|
|
|
17
|
|
|
NOTE 27:-
|
TAXES ON INCOME
|
|
1.
|
Since the 2008 tax year, the results for tax purposes of the Company and its Israeli subsidiaries
are measured in nominal values. Until the end of the 2007 tax year, the results for tax purposes of the Company were adjusted for
the changes in the Israeli CPI pursuant to the Income Tax (Inflationary Adjustments) Law, 1985 ("the inflationary adjustments
law"). According to the transition provisions of the scope of the inflationary adjustments law, it is determined that adjustments
to the Israeli CPI relating to carryforward tax losses, deduction for depreciation and real loss from sale of a depreciable asset
or security continue to apply until the end of the 2007 tax year and starting that date they will no longer apply.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 27:-
|
TAXES ON INCOME (Cont.)
|
The income
of the Company and its Israeli subsidiaries is subject to corporate tax at the regular rate; the guidance of the amendment to the
Income Tax Ordinance, 2005 from August 2005 and the provisions of the Law for Economic Efficiency (Amended Legislation for Implementing
the Economic Plan for 2009 and 2010) of July 2009 prescribe a gradual reduction in the corporate tax rates and the resulting corporate
tax rates starting from the 2011 tax year and thereafter are as follows: 2011 - 24%, 2012 - 23%, 2013 - 22%, 2014 - 21%, 2015 -
20%, 2016 and thereafter - 18%.
On December 6,
2011, the Law for Tax Burden Reform (Legislative Amendments), 2011 was published in the records (the "
2011 Amendment
"),
which prescribes a halt in the scheduled reduction in the corporate tax rate as in the 2009 amendment, as above, and an increase
in the corporate tax rate to 25% in 2012 and thereafter.
On August
5, 2013, the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for 2013-2014), 2013 (the
"
Law
") was published in the Government's records. Among other things, the Law prescribes from the 2014 tax year
and thereafter, an increase in the Israeli corporate tax rate to 26.5% (instead of 25%).
Capital gains
generated by the Company and its Israeli subsidiaries are taxable according to the corporate tax rate applicable in the tax year.
The tax rates
applicable to subsidiaries whose place of incorporation is the U.S. are (progressive) corporate tax of 35% with the addition of
State tax and local tax at rates which vary according to the State and city in which the subsidiaries conduct their business affairs.
As a rule,
intragroup transactions between the Company and the foreign subsidiaries are subject to the guidance and reporting of the Income
Tax Regulations (Determination of Market Conditions), 2006.
|
c.
|
Carryforward tax losses and real loss on sale of marketable securities:
|
Deferred
tax assets for carryforward tax losses are recognized to the extent that the realization of the related tax benefit through future
taxable income is probable.
As stated
in Note 14c above, on August 3, 2010, the Bio-Gal Transaction was completed after all the prerequisites had been met including,
inter alia, the signing of an agreement with the Tax Authority regarding the tax exemption granted to the share swap transaction
pursuant to sections 104 and 103 to the Income tax Ordinance (New Version), 1961.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 27:-
|
TAXES ON INCOME (Cont.)
|
Below is
the summary of principle conditions of the agreement signed with the Tax Authority:
|
1.
|
The balance of the Company's business losses and capital losses for tax purposes was reduced to
approximately NIS 80 million (approximately $ 23 million) and approximately NIS 0.7 million (approximately $ 0.2
million), respectively. This item is not to derogate from the Tax Assessing Officer's authority to establish that the balance of
losses is lower than the abovementioned amounts.
|
|
2.
|
Any losses incurred to the Company prior to the share swap, after their reduction as discussed
in 1 above, will not be offset against any income originating from Xtepo (the transferred company) or against a capital gain from
the sale of shares of Xtepo.
|
|
3.
|
Xtepo shareholders will not be allowed to sell their shares in the Company for a period of two
years from the end of the year of completion of the transaction ("the lock-up period"), subject to any changes in legislation.
|
|
4.
|
The Company and Xtepo undertake to maintain their main economic activity as it was prior to the
transaction during the lock-up period.
|
|
5.
|
The Company will not be permitted to sell its holdings in Xtepo for the duration of the lock-up
period.
|
The Company's
carryforward tax losses as of December 31, 2013 and 2012, after giving effect to the agreement with the Tax Authority in connection
with the Bio-Gal Transaction, as above, totaled approximately $ 28 million and $ 26, respectively. The carryforward tax losses
of the U.S. subsidiaries, XTL Inc. and XTL Development, as of December 31, 2013 totaled approximately $ 20 million (approximately
$ 20 million as of December 31, 2012). These losses of the U.S. subsidiaries are limited in use and it is probable that they
will be even significantly reduced due to state tax laws that deal in cases of "change of control" which is the outcome
of the carrying out the Bio-Gal Transaction as above. The Company does not recognize deferred taxes for tax losses because their
utilization in the foreseeable future is not probable.
InterCure
has carryforward business losses and capital losses which total approximately $ 17 million as of December 31, 2013.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 27:-
|
TAXES ON INCOME (Cont.)
|
InterCure
Inc. has carryforward business losses and capital losses which total approximately $ 24 million as of December 31, 2013. It
should be noted that following the composition of creditors agreed upon in July 2012 (see Note 5 above) in which the control over
InterCure was changed, the utilization of said losses is limited and they are expected to be significantly reduced according to
internal U.S. laws.
Carryforward
capital losses on securities which were not offset (including carryforward losses on securities that were reversed after January 1,
2006) and other carryforward capital losses total approximately $ 0.2 million as of December 31, 2013 after giving effect
to the agreement with the Tax Authority in connection with the Bio-Gal Transaction, as above. These losses may be used only against
capital gains (including, since 2006, against gains on marketable securities).
A real loss
for tax purposes from sale of securities through December 31, 2005 which was not offset by December 31, 2013 totals approximately
$ 14 thousand. This loss is deductible in the coming years only against real gains on marketable securities, if available
in these years.
The Company
did not recognize deferred taxes for carryforward losses, as well as capital losses and real losses, because their utilization
in the foreseeable future is not probable.
|
d.
|
Below is the reconciliation between the "theoretical" tax expense, assuming that all
the income were taxed at the regular tax rate applicable to companies in Israel (see a(2) above) and the taxes recorded in the
statements of comprehensive income in the reporting year:
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 27:-
|
TAXES ON INCOME (Cont.)
|
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes on income, as reported in the statements of comprehensive loss
|
|
|
(3,713
|
)
|
|
|
(1,742
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Theoretical tax saving on this loss
|
|
|
(928
|
)
|
|
|
(436
|
)
|
|
|
(290
|
)
|
Increase (decrease) in taxes resulting from different tax rates for foreign subsidiaries
|
|
|
(154
|
)
|
|
|
(40
|
)
|
|
|
(3
|
)
|
Expenses not deductible for tax purposes
|
|
|
628
|
|
|
|
277
|
|
|
|
18
|
|
Tax exempt income
|
|
|
-
|
|
|
|
(341
|
)
|
|
|
-
|
|
Utilization of taxable losses for which no deferred taxes were recognized
|
|
|
(55
|
)
|
|
|
(5
|
)
|
|
|
-
|
|
Effect of lower tax rates on capital gains
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Increase in taxes resulting mainly from taxable losses in the reported year for which no deferred taxes were recognized
|
|
|
509
|
|
|
|
545
|
|
|
|
275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax benefit
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
3.
|
Since the balance of carryforward tax losses exceeds other temporary differences (net), and considering
that the Company does not expect that it will have sufficient income in the future to allow the losses to be used in the foreseeable
future, in 2013, the Company did not record deferred taxes on these losses.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 27:-
|
TAXES ON INCOME (Cont.)
|
The Company filed self-assessments
that are deemed final through the 2008 tax year. The subsidiary, Xtepo, has not received tax assessments since its incorporation
in November 2009. The U.S. subsidiaries, XTL Inc. and XTL Development, filed self-assessments that are deemed final through the
2008 tax year. However, the IRS may examine the tax reports for the years in which the U.S. subsidiaries claimed tax refunds for
operating losses offset against taxes paid in the past for tax years 2003 to 2005. This examination is limited to the amount of
tax refunds that the Company received ($ 72 thousand in 2003-2004 and $ 77 thousand in 2005). InterCure has received
final tax assessments through 2007.
Basic loss per share is calculated
by dividing loss attributable to equity holders of the parent by the weighted average number of issued Ordinary shares, excluding
ordinary shares held by a subsidiary, which are accounted for as treasury shares. As for the years ended December 31, 2013, 2012
and 2011, there were no dilutive effect potential shares.
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to equity holders of the parent (U.S. dollars in thousands)
|
|
|
(2,476
|
)
|
|
|
(1,390
|
)
|
|
|
(1,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of issued Ordinary shares
|
|
|
223,605,181
|
|
|
|
217,689,926
|
|
|
|
201,825,645
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (in U.S. dollars)
|
|
|
(0.011
|
)
|
|
|
(0.006
|
)
|
|
|
(0.006
|
)
|
|
NOTE 29:-
|
TRANSACTIONS AND BALANCES WITH RELATED PARTIES
|
"Related party" -
as the term is defined in IAS 24,
"Related Party Disclosures"
("
IAS 24
").
The Company's key management
personnel who are included, along with other factors, in the definition of related party, as above in IAS 24, includes directors
and members of the executive committee.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 29:-
|
TRANSACTIONS AND BALANCES WITH RELATED PARTIES (Cont.)
|
Compensation
to key management personnel:
The compensation to key management
personnel for employee services provided to the Group is shown below:
|
|
Year ended December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
Salaries, management and consulting fees and other short-term benefits *)
|
|
|
698
|
|
|
|
643
|
|
|
|
493
|
|
Share-based payments, net **)
|
|
|
(10
|
)
|
|
|
1,148
|
|
|
|
59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
688
|
|
|
|
1,791
|
|
|
|
552
|
|
|
*)
|
In 2013 and 2012, includes grants to senior officers based on agreements signed with them in a
total of approximately $ 35 thousand and $ 90 thousand, respectively.
|
|
**)
|
In 2013 – includes share-based payments expenses less a reversal of expenses due to forfeiture
of stock options in the amount of $ 647 thousand.
|
As of December 31, 2013 and
2012, the Group's balances with related parties total approximately $ 134 thousand (of which $ 105 thousand linked to
the NIS) and $ 323 thousand (of which $ 267 thousand linked to the NIS), respectively.
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 30:
|
SEGMENT INFORMATION
|
The Group's management has established
operating segments in accordance with reports reviewed by the Chief Operating Decision Maker (“
CODM
”) and which
are used to make strategic decisions. Until July 25, 2012, the Company had a single operating segment - drug development. Effective
from said date, following the acquisition of InterCure, the CODM reviews the business activities both according to the nature of
the activity and the geographical location of the activity. With respect to the nature of the activity, the CODM reviews the operating
results of the drug development activity and of the medical device activity. From a geographical standpoint, the CODM reviews the
performance of sales of medical devices in the U.S., the UK and the rest of the world.
|
a.
|
Segment reporting data for the years ended December 31, 2013 and December 31, 2012:
|
|
|
Year
ended December 31, 2013
|
|
|
|
Medical
devices
|
|
|
Drug
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
UK
|
|
|
Israel
|
|
|
development
|
|
|
Adjustments
|
|
|
Total
|
|
|
|
U.S.
dollars in thousands
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
External customers
|
|
|
2,076
|
|
|
|
278
|
|
|
|
15
|
|
|
|
-
|
|
|
|
|
|
|
|
2,369
|
|
Inter-segment revenues
|
|
|
-
|
|
|
|
-
|
|
|
|
1,041
|
|
|
|
-
|
|
|
|
(1,041
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues
|
|
|
2,076
|
|
|
|
278
|
|
|
|
1,056
|
|
|
|
-
|
|
|
|
(1,041
|
)
|
|
|
2,369
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment results before
current amortization of intangible assets identified in the acquisition
|
|
|
128
|
|
|
|
24
|
|
|
|
1
|
|
|
|
(385
|
)
|
|
|
-
|
|
|
|
(232
|
)
|
Current amortization of
intangible assets identified in the acquisition
|
|
|
(231
|
)
|
|
|
(29
|
)
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(261
|
)
|
Impairment of intangible
assets
|
|
|
(1,532
|
)
|
|
|
(189
|
)
|
|
|
(8
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,729
|
)
|
Segment
results
|
|
|
(1,635
|
)
|
|
|
(194
|
)
|
|
|
(8
|
)
|
|
|
(385
|
)
|
|
|
-
|
|
|
|
(2,222
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated joint expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,731
|
)
|
Other gains, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,059
|
|
Finance income (expense),
net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26
|
|
Earnings
from investment in associate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(845
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before taxes on income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,713
|
)
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 30:
|
SEGMENT INFORMATION (Cont.)
|
|
|
Year
ended December 31, 2012
|
|
|
|
Medical
devices
|
|
|
Drug
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
UK
|
|
|
Israel
|
|
|
development
|
|
|
Adjustments
|
|
|
Total
|
|
|
|
U.S.
dollars in thousands
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
External customers
|
|
|
766
|
|
|
|
167
|
|
|
|
5
|
|
|
|
-
|
|
|
|
-
|
|
|
|
938
|
|
Inter-segment revenues
|
|
|
-
|
|
|
|
-
|
|
|
|
583
|
|
|
|
-
|
|
|
|
(583
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues
|
|
|
766
|
|
|
|
167
|
|
|
|
588
|
|
|
|
-
|
|
|
|
(583
|
)
|
|
|
938
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment results before
current amortization of intangible assets identified in the acquisition
|
|
|
(21
|
)
|
|
|
(31
|
)
|
|
|
2
|
|
|
|
(388
|
)
|
|
|
-
|
|
|
|
(438
|
)
|
Current amortization of
intangible assets identified in the acquisition
|
|
|
(91
|
)
|
|
|
(22
|
)
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(114
|
)
|
Segment
results
|
|
|
(112
|
)
|
|
|
(53
|
)
|
|
|
1
|
|
|
|
(388
|
)
|
|
|
-
|
|
|
|
(552
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated joint expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,606
|
)
|
Other gains, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
802
|
|
Finance income (expense),
net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
Earnings
from investment in associate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
569
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before taxes on income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,742
|
)
|
|
b.
|
Additional information:
|
|
|
December
31, 2013
|
|
|
|
Medical
devices
|
|
|
Drug
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
UK
|
|
|
Israel
|
|
|
development
|
|
|
Adjustments
|
|
|
Total
|
|
|
|
U.S.
dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment
assets
|
|
|
279
|
|
|
|
130
|
|
|
|
2
|
|
|
|
2,457
|
|
|
|
-
|
|
|
|
2,868
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
consolidated assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment
liabilities
|
|
|
2
|
|
|
|
369
|
|
|
|
-
|
|
|
|
11
|
|
|
|
|
|
|
|
382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
848
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
consolidated liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,230
|
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 30:
|
SEGMENT INFORMATION (Cont.)
|
|
|
December
31, 2012
|
|
|
|
Medical
devices
|
|
|
Drug
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
UK
|
|
|
Israel
|
|
|
development
|
|
|
Adjustments
|
|
|
Total
|
|
|
|
U.S.
dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment
assets
|
|
|
37
|
|
|
|
51
|
|
|
|
-
|
|
|
|
2,457
|
|
|
|
-
|
|
|
|
2,545
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
consolidated assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment
liabilities
|
|
|
454
|
|
|
|
-
|
|
|
|
-
|
|
|
|
22
|
|
|
|
-
|
|
|
|
476
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,186
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
consolidated liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,662
|
|
|
NOTE 31:
|
EVENTS AFTER THE REPORTING DATE
|
|
a.
|
On January 5, 2014, InterCure announced it shall appoint Mr. Alon Dulzin (“
Mr. Dulzin
”)
as its new CEO, effective as of January 6, 2014. According to the employment agreement with Mr. Dulzin, he will be granted 650,000
stock options which are exercisable into Ordinary shares of InterCure. Mr. Dulzin's employment terms were approved by a general
meeting of shareholders of InterCure, held on March 5, 2014.
|
|
b.
|
On January 7, 2014, the Company signed a licensing agreement with Yeda to develop hCDR1, a Phase
II-ready asset for the treatment of Systemic Lupus Erythematosus (“
SLE
”). The terms of the licensing agreement
include, among other things, expense reimbursement for patent expenses, certain milestone payments to Yeda, low single-digit royalties
based on net sales, and additional customary royalties to the Office of the Chief Scientist.
|
|
c.
|
On January 13, 2014, the extraordinary general meetings of shareholders of warrant (series 2) holders
of the Company resolved to extend the exercise period of warrants (series 2) of the Company from December 31, 2013 to October 28,
2014, subject to the approval of the Tel-Aviv-Jaffa district court (the “
Court
”), pursuant to Section 350 to
the Israeli Companies Law, 1999. On January 28, 2014, the Court approved the decision to extend the exercise period of the warrants.
|
|
d.
|
On January 14, 2014, the general meeting of shareholders and the general meeting of holders of
warrants (series 2) of the Company resolved to approve the extension of the term of warrants (series 2) of the Company from December
31, 2013 to October 28, 2014, in accordance with the request for a settlement filed with and granted by the Tel-Aviv-Jaffa district
court.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2013
|
|
NOTE 31:
|
EVENTS AFTER THE REPORTING DATE (Cont.)
|
|
e.
|
On March 17, 2014, the Company's extraordinary general
meeting of shareholders of the Company decided to approve the terms of an employment agreement between the Company and Mr. Joshua
Levine, pursuant to which Mr. Levine will serve as the Company's CEO in a fulltime position, in accordance with the resolution
of the Company’s Compensation Committee and Board of Directors dated January 30, 2014 and in accordance with the Israeli
Companies Law – 1999. For additional details, see also Note 20a(13) above.
|
- - - - - - - - - - - -
Item
19. Exhibits
The following exhibits are filed as part
of this annual report:
Item
19. Exhibits
The following exhibits are filed as part
of this annual report:
Exhibit
Number
|
Description
|
3.1
|
Articles of Association (incorporated by reference from an exhibit to the first amendment to Form 20-F, filed with the SEC on August 10, 2005)
|
4.1
|
Form of Share Certificate (including both Hebrew and English translations) (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on March 23, 2007) >
|
4.2
|
Form of American Depositary Receipt (included in Exhibit 4.3)
|
4.3
|
Form of Deposit Agreement, by and between XTL Biopharmaceuticals Ltd., The Bank of New York, as Depositary, and each holder and beneficial owner of American Depositary Receipts issued thereunder (incorporated by reference from an exhibit to the First Amendment to the Form 20-F, filed with the SEC on August 10, 2005)
|
10.1
|
2001 Share Option Plan dated February 28, 2001 (incorporated by reference from an exhibit to the Form 20-F, filed on with the SEC on July 14, 2005)
|
10.2
|
License Agreement Between XTL Biopharmaceuticals Ltd. and VivoQuest, Inc., dated August 17, 2005 (incorporated by reference from an exhibit to the second amendment to Form 20-F, filed with the SEC on August 23, 2005)
|
10.3
|
Asset Purchase Agreement Between XTL Biopharmaceuticals Ltd. and VivoQuest, Inc., dated August 17, 2005 (incorporated by reference from an exhibit to the second amendment to Form 20-F, filed with the SEC on August 23, 2005)
|
10.4
|
Research and License Agreement Between Yeda Research and Development Company Ltd., Mor Research Applications Ltd., Biogal Ltd. (under its previous name Haverfield Ltd.) and Biogal Advanced Biotechnology Ltd. dated January 7, 2002 (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on April 6, 2009) >
|
10.5
|
Amendment to Research and License Agreement Between Yeda Research and Development Company Ltd., Mor Research Applications Ltd., Haverfield Ltd. and Biogal Advanced Biotechnology Ltd. effective as of April 1, 2008 (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on April 6, 2009) >
|
10.6
|
Employment Agreement, dated as of January 18, 2010, between XTL Biopharmaceuticals Ltd. and David Grossman (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on June 30, 2010)
|
10.7
|
Employment Agreement, dated as of July 29, 2009, between XTL Biopharmaceuticals Ltd. and Ronen Twito (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on June 30, 2010)
|
10.8
|
Consulting Agreement, dated as of August 27, 2010, between XTL Biopharmaceuticals Ltd. and Moshe Mittelman (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on May 31, 2011)
|
10.9
|
Option to License Agreement, dated as of September 1, 2010, between XTL Biopharmaceuticals Ltd. and Yeda Research and Development Company Limited (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on May 31, 2011)
|
10.10
|
License Agreement, dated as of November 30, 2011, between XTL Biopharmaceuticals Ltd. and MinoGuard Ltd. (incorporated by reference from an exhibit to the first amendment to Form 20-F, filed with the SEC on March 30, 2012)
>
|
10.11
|
A translation from Hebrew of strategic service agreement, dated as of September 24, 2012, between InterCure Ltd. and Giboov Ltd. (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on April 25, 2013)
|
10.12
|
Share Purchase Agreement, dated as of November 21, 2012, between XTL Biopharmaceuticals Ltd. and Teva Pharmaceutical Industries Ltd. (incorporated by reference from an exhibit to the Form 20-F, filed with the SEC on April 25, 2013)
|
10.13
|
License Agreement dated January 7, 2014, by and between Yeda Research and Development Company Limited and XTL Biopharmaceuticals Ltd.
|
10.14
|
Consolidated Financial Statements of Proteologics Ltd. for the nine months ended September 30, 2013
|
21.1
|
List of Subsidiaries
|
23.1
|
Consent of Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Ltd.
|
23.2
|
Consent of Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Ltd.
|
31.1
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
32.1
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 USC. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
> Confidential treatment has been requested with respect
to the omitted portions of this exhibit.