UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended August 31, 2021
or
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number 001-35813
ORAMED PHARMACEUTICALS
INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
|
|
98-0376008
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
|
|
1185 Avenue of the Americas, Third Floor, New York, NY
|
|
10036
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
844-967-2633
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
|
|
Trading symbol
|
|
Name of each exchange on which registered
|
Common Stock, par value $0.012
|
|
ORMP
|
|
The Nasdaq Capital Market, Tel Aviv Stock Exchange
|
Securities registered pursuant to Section 12(g) of the Act:
None.
(Title of class)
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant:
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Date File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
|
☐
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☒
|
Smaller reporting company
|
☒
|
|
Emerging growth company
|
☐
|
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the voting and non-voting
common equity held by non-affiliates as of the last business day of the registrant’s most recently completed second fiscal quarter
was $227,769,778, based on a price of $8.91, being the last price at which the shares of the registrant’s common stock were sold
on The Nasdaq Capital Market prior to the end of the most recently completed second fiscal quarter.
Indicate the number of shares outstanding of each
of the registrant’s classes of common stock, as of the latest practicable date: 38,086,020 shares of common stock issued and outstanding
as of November 24, 2021.
ORAMED PHARMACEUTICALS INC.
FORM 10-K
(FOR THE FISCAL YEAR ENDED AUGUST 31, 2021)
TABLE OF CONTENTS
As used in this Annual Report
on Form 10-K, the terms “we,” “us,” “our,” the “Company,” and “Oramed” mean
Oramed Pharmaceuticals Inc. and our wholly-owned subsidiaries, Oramed Ltd. an Israeli corporation, and Oramed HK Limited, a Hong Kong
corporation, unless otherwise indicated. All dollar amounts refer to U.S. dollars unless otherwise indicated.
On August 31, 2021, the exchange
rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS 3.207 to $1.00. Unless indicated
otherwise by the context, statements in this Annual Report on Form 10-K that provide the dollar equivalent of NIS amounts or provide the
NIS equivalent of dollar amounts are based on such exchange rate.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
The statements contained
in this Annual Report on Form 10-K that are not historical facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,”
“intends,” “plans,” “planned expenditures,” “believes,” “seeks,” “estimates”
and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent
an all-inclusive means of identifying forward-looking statements as denoted in this Annual Report on Form 10-K. Additionally, statements
concerning future matters are forward-looking statements. We remind readers that forward-looking statements are merely predictions and
therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results,
performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance,
levels of activity, or our achievements, or industry results, expressed or implied by such forward-looking statements. Such forward-looking
statements appear in Item 1–- “Business” and Item 7–- “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” as well as elsewhere in this Annual Report on Form 10-K and include, among other statements,
statements regarding the following:
|
●
|
the expected development and potential benefits from our products in treating diabetes;
|
|
|
|
|
●
|
the prospects of entering into additional license agreements, or other partnerships or forms of cooperation with other companies or medical institutions;
|
|
|
|
|
●
|
future milestones, conditions and royalties under the license agreement with Hefei Tianhui Incubator of Technologies Co., Ltd., or HTIT;
|
|
|
|
|
●
|
expected timing of a clinical
study for the potential Oravax Medical Inc., or Oravax, vaccine and its potential to protect against the coronavirus, or COVID-19, pandemic;
|
|
|
|
|
●
|
our consideration of ways
in which our shareholders could benefit more directly from Oravax, including the potential issuance of some of our shares in Oravax to
our shareholders as a dividend;
|
|
|
|
|
●
|
our research and development plans, including pre-clinical and clinical trials plans and the timing of enrollment, obtaining results and conclusion of trials, including without limitation, our expectation that we will initiate two six-month Phase III clinical trials, and our expectation to file a Biologics License Application, or BLA, thereafter;
|
|
|
|
|
●
|
our belief that our technology has the potential to deliver medications and vaccines orally that today can only be delivered via injection;
|
|
|
|
|
●
|
the competitive ability of our technology based product efficacy, safety, patient convenience, reliability, value and patent position;
|
|
|
|
|
●
|
the potential market demand for our products;
|
|
●
|
our expectation that in the upcoming year our research and development expenses will continue to be our major expenditure;
|
|
|
|
|
●
|
our expectations regarding our short- and long-term capital requirements;
|
|
|
|
|
●
|
our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses;
|
|
●
|
information with respect to any other plans and strategies for our business; and
|
|
|
|
|
●
|
our expectations regarding the impact of the coronavirus, or COVID-19, pandemic, including on our clinical trials and operations.
|
Although forward-looking
statements in this Annual Report on Form 10-K reflect the good faith judgment of our management, such statements can only be based on
facts and factors known by us at the time of such statements. Consequently, forward-looking statements are inherently subject to risks
and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the
forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation,
those discussed herein, including those risks described in Item 1A. “Risk Factors”, and expressed from time to time in our
other filings with the Securities and Exchange Commission, or SEC. In addition, historic results of scientific research, clinical and
preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions. Also, historic
results referred to in this Annual Report on Form 10-K could be interpreted differently in light of additional research, clinical and
preclinical trials results. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of
the date of this Annual Report on Form 10-K. Except as required by law, we undertake no obligation to revise or update any forward-looking
statements in order to reflect any event or circumstance that may arise after the date of this Annual Report on Form 10-K. Readers are
urged to carefully review and consider the various disclosures made throughout the entirety of this Annual Report on Form 10-K which attempt
to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
PART I
ITEM 1. BUSINESS.
DESCRIPTION OF BUSINESS
Research and Development
We are a pharmaceutical company
currently engaged in the research and development of innovative pharmaceutical solutions, including an oral insulin capsule to be used
for the treatment of individuals with diabetes, and the use of orally ingestible capsules or pills for delivery of other polypeptides.
We utilize Clinical Research Organizations, or CROs, to conduct our clinical studies.
Through our research and development
efforts, we have successfully developed an oral dosage form intended to withstand the harsh environment of the stomach and intestines
and effectively deliver active insulin or other proteins, such as Glucagon-like peptide-1, or GLP-1, leptin, and others. The excipients
in the formulation are not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest.
We plan to continue to conduct clinical trials to show the effectiveness of our technology.
Oral insulin:
Our proprietary flagship product, an orally ingestible insulin capsule, or ORMD-0801, allows insulin to travel from the gastrointestinal
tract via the portal vein to the bloodstream, revolutionizing the manner in which insulin is delivered. It enables the passage in a more
physiological manner than current delivery methods of insulin.
FDA Guidance: In August
2017, the U.S. Food and Drug Administration, or FDA, instructed us that the regulatory pathway for the submission of ORMD-0801 would be
a BLA. If approved the BLA pathway would grant us 12 years of marketing exclusivity for ORMD-0801, from the approval date, and an additional
six months of exclusivity may be granted to us if the product also receives approval for use in pediatric patients.
Phase IIb Study: In
May 2018, we initiated a three-month dose-ranging Phase IIb clinical trial of ORMD-0801 (Cohort A). This placebo controlled, randomized,
90-day treatment clinical trial was conducted on 269 type 2 diabetic, or T2D, patients in multiple centers throughout the United States
pursuant to an Investigational New Drug application, or IND, with the FDA. The primary endpoints of the trial were to assess the safety
and evaluate the effect of ORMD-0801 on HbA1c levels over a 90-day treatment period. Secondary endpoints of the trial included measurements
of fasting plasma glucose, or FPG, post-prandial glucose, or PPG levels, during a mixed-meal tolerance test, or MMTT, and weight. In
May 2019, we initiated an extension of this protocol for approximately 75 T2D patients, who were dosed using a lower dosage of insulin
(Cohort B).
Cohort A:
In November 2019, we announced positive results from the initial cohort of the Phase IIb trial. Patients randomized in the trial to once-daily
ORMD-0801 achieved a statistically significant (p-value 0.036) reduction from baseline in HbA1c of 0.60% (0.54% with placebo adjustment).
This 0.54% reduction in HbA1c is clinically meaningful. Treatment with ORMD-0801 demonstrated an excellent safety profile, with no serious
drug-related adverse events and with no increased frequency of hypoglycemic episodes when compared to placebo. In addition, during this
90-day trial, no weight gain was observed. In the initial cohort, 269 U.S.-based patients were enrolled and treated with a dose-increasing
approach: 16 mg initial dose, titrated to 24 mg per dose, and then titrated to 32 mg per dose. Patients were randomized into three groups
to assess dosing frequency: once-daily (32 mg per day), twice-daily (64 mg per day), thrice daily (96 mg per day). There was a corresponding
placebo for each treatment arm. Two hundred nine (209) patients completed treatment to the 12-week endpoint and were included in the data
analysis (24 subjects did not complete the full 12 weeks of treatment). The twice-daily arms achieved statistically significant (p-value
0.042) reductions from baseline in HbA1c of 0.59% (0.53% with placebo adjustment). The thrice-daily arm did not meet statistical significance
(p-value 0.093). In addition, due to evidence of treatment-by-center interaction, two sites (36 patients (13.4% of enrolled subjects))
were excluded from the statistical analysis as they showed results opposite from the rest of the statistically significant results. Our
internal investigation as well as an independent investigation did not find a cause for such discrepancy.
Cohort B:
In February 2020, we announced positive topline data from the second and final cohort of the Phase IIb trial with a different regimen
across three daily dose ranges (8 mg, 16 mg, 32 mg). Patients randomized in the trial treated with 8 mg of ORMD-0801 once-daily achieved
a statistically significant (p-value 0.028) observed mean reduction of 1.29% from baseline and a least square mean reduction of 0.95%
from baseline, or 0.81% adjusted for placebo. Patients who had HbA1c readings above 9% at baseline and received 8 mg of oral insulin once-daily
experienced a 1.26% reduction in HbA1c by week 12. Treatment with ORMD-0801 at all doses demonstrated an excellent safety profile, with
no serious drug-related adverse events and with no increased frequency of hypoglycemic episodes or weight gain compared to placebo. The
primary efficacy endpoint was a reduction in HbA1c at week 12.
Phase III Study:
Based on guidance received from the FDA as part of the end-of-phase II meeting process for our oral insulin candidate, ORMD-0801, we have
submitted to the FDA the protocols for our upcoming pivotal Phase III studies. In line with the FDA’s expectations and recommendations,
we intend to conduct two Phase III studies concurrently in patients with T2D. These studies involve about 1,125 patients to provide evidence
of ORMD-0801’s safety and efficacy in T2D patients over a treatment period of 6 to 12 months. A geographically diverse patient population
will be recruited from multiple sites throughout the United States, Europe, and Israel. Our Phase III study will be composed from 2 protocols:
ORA-D-013-1:
This study will treat T2D patients with inadequate glycaemic control who are currently on 2 or 3 oral glucose-lowering agents. This U.S.
study will recruit 675 patients from at least 75 clinical sites located throughout the U.S. Patients will be randomized 1:1:1 in this
double-dummy study into cohorts of: 8 mg ORMD-0801 once-daily at night and placebo 45 minutes before breakfast; 8 mg ORMD-0801 twice-daily,
at night and 45 minutes before breakfast; and placebo twice-daily, at night and 45 minutes before breakfast. The primary endpoint of the
study is to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary
efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. We initiated this trial in December 2020.
In November 2021, we announced that 75% of the 675 patients were enrolled and randomized.
ORA-D-013-2:
This study will include T2D patients with inadequate glycaemic control who are managing their condition with either diet alone or with
diet and metformin monotherapy. A total of 450 patients will be recruited through 36 sites in the U.S. and 25 sites in Western Europe
and Israel. Patients will be randomized 1:1 into two cohorts dosed with: 8 mg ORMD-0801 at night; and placebo at night. The primary endpoint
is to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycaemic control as assessed by HbA1c over a 26-week treatment
period, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. We initiated this
trial in the U.S. in March 2021. In August 2021, we announced that over 25% of the 450 patients were enrolled and randomized.
We expect to receive the efficacy
data from the trials after patients have completed the first 6 months of treatment. Safety will be further monitored as patients will
be exposed to the drug over an additional 6 months (total 12 months). The trial’s topline results are expected in 2022 and we anticipate
filing a BLA with the FDA in 2023. A BLA would grant us 12 years of marketing exclusivity from the date of approval in the U.S.
NASH trial: In June
2020, we presented topline data of 8 patients from an open-label trial that assessed the safety, tolerability, and early effects of 16
mg ORMD-0801 (2x8 mg capsules) on liver fat in T2D, patients with nonalcoholic steatohepatitis, or NASH. The 12-week dosing had no serious
adverse events and it induced an observed mean 6.9±6.8% reduction in liver fat content (p-value: 0.035), and the relative reduction
of 30%, as measured by MRI-derived proton density fat fraction, or MRI-PDFF. In parallel, concentrations of gamma-glutamyltransferase
(GGT), a key marker of chronic hepatitis, were significantly lower after 12 weeks of treatment as compared to baseline (-14.6±13.1
U/L; p value: 0.008).
In September 2020, we initiated an open label clinical
trial of our oral insulin capsule, ORMD-0801, for the treatment of NASH. This 10 patient multi-center trial is comprised of three clinical
sites in Belgium. The trial will measure change and percent change in MRI-PDFF from baseline to week 12.
In December 2020, we initiated a double blind,
placebo controlled clinical trial of our oral insulin capsule, ORMD-0801, for the treatment of NASH. This 30 patient multi-center trial
is comprised of five clinical sites: three in the U.S. and two in Israel. The trial will measure change and percent change in MRI-PDFF
from baseline to week 12. In September 2021, we announced that over 50% of the patients were enrolled and randomized.
Oral Glucagon-Like Peptide-1: Oral
Glucagon-Like Peptide-1, or GLP-1, is an incretin hormone, which stimulates the secretion of insulin from the pancreas. In addition to
our flagship product, the ORMD-0801 insulin capsule, we use our technology for an orally ingestible GLP-1 capsule, or ORMD-0901.
In February 2019, we completed a Phase I pharmacokinetic
trial to evaluate the safety and pharmacokinetics of ORMD-0901 compared to placebo in healthy volunteers. We initiated a follow-on trial
in T2D patients, in June 2021 in the U.S. under an IND submitted to the FDA.
The following table gives
an overview of the above described primary R&D pipeline:
Our clinical trials are planned
in order to substantiate our results as well as for purposes of making future filings for drug approval. We also plan to conduct further
research and development by deploying our proprietary drug delivery technology for the delivery of other polypeptides in addition to insulin,
and to develop other innovative pharmaceutical products.
Oral Vaccine
On March 18, 2021, we entered into a license agreement,
or the Oravax License Agreement, with Oravax. For more information about the Oravax License Agreement, please see below under “Out-Licensed
Technology”.
Oravax, Oramed’s 63% owned joint venture
combines our proprietary POD™ oral delivery technology and the novel vaccine technology of Premas Biotech Pvt. Ltd., or Premas.
We are considering ways in which our shareholders could benefit more directly from Oravax, including potentially issuing some of our shares
in Oravax to our shareholders as a dividend, which would make Oravax a publicly held company that may in turn apply for listing on a stock
exchange.
A single dose of Oravax’s oral vaccine produced
a significant antibody response in a preclinical in-vivo study. Oravax’s novel vaccine technology may be a candidate for
protection against COVID-19 and its variants due to triple antigen targeting, easier distribution and ease of administration.
On October 29, 2021, we announced Oravax’s
oral COVID-19 vaccine has received clearance from the South African Health Products Regulatory Authority to initiate Phase I trial and
subsequently to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine.
Other Products
We are developing a new drug
candidate, a weight loss treatment in the form of an oral leptin capsule. During the third quarter of the 2020 calendar year, we finalized
a proof of concept single-dose trial for this candidate to evaluate its pharmacokinetics and pharmacodynamics (glucagon reduction) in
10 type 1 adult diabetic patients without any safety issues. Patients who received leptin on average had a decrease in glucose as compared
to the placebo group during the first 30-180 minutes following dosing. At different time periods, the leptin treated patients on average
had glucagon values that were either lower than or similar to, those in the placebo group. We are currently in the middle of a second
study of 15 type 1 adult diabetic patients who serve as both the active and placebo arms in this study, with anticipated results in the
fourth quarter of the 2021 calendar year.
Raw Materials
Our oral insulin capsule is
currently manufactured by Fidelio Healthcare, a diversified European Contract Development and Manufacturing Organization (CDMO) in the
pharmaceutical and healthcare industries.
In July 2010, Oramed Ltd.
entered into the Manufacturing and Supply Agreement, or MSA, with Sanofi-Aventis Deutschland GMBH, or Sanofi-Aventis. According to the
MSA, Sanofi-Aventis will supply Oramed Ltd. with specified quantities of recombinant human insulin to be used for clinical trials.
We purchase, pursuant to separate
agreements with third parties, the raw materials required for the manufacturing of our oral capsule. We generally depend upon a limited
number of suppliers for the raw materials. Although alternative sources of supply for these materials are generally available, we could
incur significant costs and disruptions if we need to change suppliers. The termination of our relationships with our suppliers or the
failure of these suppliers to meet our requirements for raw materials on a timely and cost-effective basis could have a material adverse
effect on our business, prospects, financial condition and results of operations.
Market Overview
Diabetes is a disease in which
the body does not produce or properly use insulin. Insulin is a hormone that causes sugar to be absorbed into cells, where the sugar is
converted into energy needed for daily life. The cause of diabetes is attributed both to genetics (type 1 diabetes, or T1D) and, most
often, to environmental factors such as obesity and lack of exercise (T2D). According to the International Diabetes Federation, or IDF,
an estimated 463 million adults (20-79 years) worldwide suffered from diabetes in 2019 and the IDF projects this number will increase
to 700 million by 2045. Also, according to the IDF, in 2019, an estimated 4.2 million people died from diabetes. According to the American
Diabetes Association, or ADA, in the United States there were approximately 34.2 million people with diabetes, or 10.5% of the United
States population in 2018. Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and amputation. The latest report
of the ADA that analyzed the economic costs of diabetes in the U.S in 2017 indicates that the total cost of diagnosed diabetes in the
United States in 2017 was $327 billion.
Intellectual Property
We own a portfolio of patents
and patent applications covering our technologies, and we are aggressively protecting these technology developments on a worldwide basis.
Leadership
Management:
We are led by an experienced management team knowledgeable in the treatment of diabetes. Our Chief Scientific Officer, Miriam Kidron,
PhD, is a recognized pharmacologist and a biochemist and the innovator primarily responsible for our oral insulin technology development
and know-how.
Scientific Advisory
Board: Our management team has access to our internationally recognized Scientific Advisory Board whose members are thought-leaders
in their respective areas. The Scientific Advisory Board is comprised of Dr. Roy Eldor, Dr. Ele Ferrannini, Dr. Alexander Fleming, Dr.
Avram Hershko, Dr. Harold Jacob, Dr. Julio Rosenstock and Dr. Jay Skyler.
Strategy
We plan to ultimately seek
a strategic commercial partner, or partners, with extensive experience in the development, commercialization, and marketing of insulin
applications and/or other orally digestible drugs. We anticipate such partner or partners would be responsible for, or substantially support,
late-stage clinical trials (Phase III) to increase the likelihood of obtaining regulatory approvals and registrations in the appropriate
markets in a timely manner. We further anticipate that such partner, or partners, would also be responsible for sales, marketing and support
of our products in these markets. Such planned strategic partnership, or partnerships, may provide a marketing and sales infrastructure
for our products as well as financial and operational support for global clinical trials, post marketing studies, label expansions and
other regulatory requirements concerning future clinical development. In 2015, we successfully executed this strategy when we, Oramed
Ltd. and HTIT entered into a Technology License Agreement pursuant to which we granted HTIT an exclusive commercialization license in
the territory of the People’s Republic of China, Macau and Hong Kong, or the Territory, related to our oral insulin capsule, ORMD-0801.
Any future strategic partner, or partners, may also provide capital and expertise that would enable the partnership to develop new oral
dosage forms for other polypeptides. While our strategy is to partner with an appropriate party, no assurance can be given that we will
in fact be able to reach an agreeable partnership with any third party. Under certain circumstances, we may determine to develop one or
more of our oral dosage forms on our own, either world-wide or in select territories.
In line with our strategy,
we have entered into a joint venture focused on the development of novel oral COVID-19 vaccines, based on our proprietary oral delivery
technology and our partners’ novel vaccine technology.
In addition to developing
our own oral dosage form drug portfolio, we are, on an on-going basis, considering in-licensing and other means of obtaining additional
technologies to complement and/or expand our current product portfolio. Our goal is to create a well-balanced product portfolio that will
enhance and complement our existing drug portfolio.
Potential Material Impact of COVID-19
The COVID-19 pandemic has
negatively impacted the global economy, disrupted consumer spending and global supply chains and created significant volatility and disruption
of financial markets. Although to date the COVID-19 pandemic has not had a material adverse effect on us, the COVID-19 pandemic may have
a material adverse effect on our business and financial performance in the future. The extent of the impact of the COVID-19 pandemic,
including our ability to execute our business strategies as planned, will depend on future developments, including the duration and severity
of the pandemic, which are highly uncertain and cannot be predicted.
Although, as of the date of
this Annual Report on Form 10-K, we do not expect any material impact on our long-term activity, the extent to which COVID-19 impacts
our business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may
emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others.
Patents and Licenses
We maintain a proactive intellectual
property strategy, which includes patent filings in multiple jurisdictions, including the United States and other commercially significant
markets. We hold 36 patent applications currently pending, with respect to various compositions, methods of production and oral administration
of proteins and exenatide. Expiration dates for pending patents, if granted, will fall between 2026 and 2039.
We hold 87 patents, one of
which was issued during the fiscal year ended August 31, 2021, or fiscal 2021, including patents issued by the United States, Swiss, German,
French, U.K., Italian, Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian, Canadian, Hong
Kong, Chinese, European and Indian patent offices that cover a part of our technology, which allows for the oral delivery of proteins;
patents issued by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands,
Norwegian, Spanish, Swedish, Swiss, U.K., Israeli, New Zealand, South African, Russian and Japanese patent offices that cover part of
our technology for the oral delivery of exenatide; and patents issued by the European, Austrian, Belgian, Denmark, French, German, Irish,
Italian, Luxembourg, Monaco, Netherlands, Norway, Spanish, Swedish, Swiss, U.K. and Japanese patent offices for treating diabetes.
Consistent with our strategy
to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding foreign
counterparts of such applications. We believe that our success will depend on our ability to obtain patent protection for our intellectual
property.
Our patent strategy is as
follows:
|
●
|
Aggressively protect all current and future technological developments to assure strong and broad protection by filing patents and/or continuations in part as appropriate,
|
|
|
|
|
●
|
Protect technological developments at various levels, in a complementary manner, including the base technology, as well as specific applications of the technology, and
|
|
|
|
|
●
|
Establish comprehensive coverage in the United States and in all relevant foreign markets in anticipation of future commercialization opportunities.
|
We also rely on trade secrets
and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. Our policy is to require our employees, consultants,
contractors, manufacturers, outside scientific collaborators and sponsored researchers, our board of directors, or our Board, technical
review board and other advisors, to execute confidentiality agreements upon the commencement of employment or consulting relationships
with us. These agreements provide that all confidential information developed or made known to the individual during the course of the
individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances.
We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information.
In the case of employees, consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering
services to us shall be assigned to us as the exclusive property of the Company. There can be no assurance, however, that all persons
who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate
remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed
by competitors.
Out-Licensed Technology
ENTERA BIO
In June 2010, Oramed Ltd.
entered into a joint venture agreement with D.N.A Biomedical Solutions Ltd., or D.N.A, for the establishment of Entera Bio Ltd., or Entera.
Under the terms of a license
agreement, as amended, that was entered into between Oramed Ltd. and Entera in August 2010, we out-licensed technology to Entera, on an
exclusive basis, for the development of oral delivery drugs for certain indications to be agreed upon between the parties. The out-licensed
technology differs from our main delivery technology that is used for oral insulin and GLP-1 analog and is subject to different patent
applications. Entera’s initial development effort is for an oral formulation for the treatment of osteoporosis. In March 2011, we
entered into a patent transfer agreement, or the Patent Transfer Agreement, to replace the original license agreement pursuant to which
Oramed Ltd. assigned to Entera all of its right, title and interest in and to the patent application that it had licensed to Entera in
August 2010. Under this agreement, Oramed Ltd. is entitled to receive from Entera royalties of 3% of Entera’s net revenues and a
license back of that patent application for use in respect of diabetes and influenza.
In March 2011, we also consummated
a transaction with D.N.A, whereby we sold to D.N.A 47% of Entera’s outstanding share capital on an undiluted basis, retaining a
3% interest as of March 2011. In consideration for the shares sold to D.N.A, we received, among other payments, ordinary shares of D.N.A.
The D.N.A ordinary shares are traded on the Tel Aviv Stock Exchange and its quoted price is subject to market fluctuations, and may, at
times, have a price below the value on the date we acquired such shares. In addition, the ordinary shares of D.N.A have historically experienced
low trading volume; as a result, there is no guarantee that we will be able to resell the ordinary shares of D.N.A at the prevailing market
prices. During the years ended August 31, 2021, 2020 and 2019, we did not sell any of the D.N.A ordinary shares. As of August 31, 2021,
we held approximately 1.7% of D.N.A’s outstanding ordinary shares.
On December 11, 2018, Entera
announced that it had entered into a research collaboration and license agreement, or the Amgen License, with Amgen Inc. related to research
of inflammatory disease and other serious illnesses. As reported by Entera, under the terms of the Amgen License, Entera will receive
a modest initial technology access fee from Amgen and will be responsible for preclinical development at Amgen’s expense. Entera
will be eligible to receive up to $270,000,000 in aggregate payments, as well as tiered royalties up to mid-single digits, upon achievement
of various clinical and commercial milestones if Amgen decides to move all of these programs forward. To the extent the Amgen License
results in net revenues as defined in the Patent Transfer Agreement, Oramed Ltd. will be entitled to the aforementioned royalties.
HTIT
On November 30, 2015, we,
Oramed Ltd. and HTIT entered into a Technology License Agreement, or TLA, and on December 21, 2015, these parties entered into an Amended
and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016, or the License Agreement.
According to the License Agreement, we granted HTIT an exclusive commercialization license in the Territory, related to our oral insulin
capsule, ORMD-0801, or the Product. Pursuant to the License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization
and regulatory activities with respect to our subsidiary’s technology and ORMD-0801 capsule, and will pay (i) royalties of 10% on
net sales of the related commercialized products to be sold by HTIT in the Territory, or Royalties, and (ii) an aggregate of $37.5 million,
of which $3 million was payable immediately, $8 million will be paid subject to our entry into certain agreements with certain third parties,
and $26.5 million will be payable upon achievement of certain milestones and conditions. In the event that we will not meet certain conditions,
the Royalties rate may be reduced to a minimum of 8%. Following the final expiration of our patents covering the technology in the Territory
in 2033, the Royalties rate may be reduced, under certain circumstances, to 5%. The royalty payment obligation shall apply during the
period of time beginning upon the first commercial sale of the Product in the Territory, and ending upon the later of (i) the expiration
of the last-to-expire licensed patents in the Territory; and (ii) 15 years after the first commercial sale of the Product in the Territory,
or the Royalty Term. The License Agreement shall remain in effect until the expiration of the Royalty Term. The License Agreement contains
customary termination provisions. Through August 31, 2021, we received aggregate milestone payments of $20.5 million out of the aggregate
amount of $37.5 million.
On August 21, 2020, we received
a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. We wholly dispute said claims and we are in discussions
with HTIT in an attempt to reach a mutually agreeable solution.
Oravax License
On March 18, 2021, we entered into the Oravax License
Agreement with Oravax, pursuant to which we will grant to Oravax an exclusive, worldwide license , or the License, under our rights in
certain patents and related intellectual property in which Oravax will receive certain rights relating to our proprietary oral delivery
technology to further develop, manufacture and commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas’s
proprietary vaccine technology involving a triple antigen virus like particle, or the Oravax Product, which was previously owned by Cystron
Biotech LLC, or Cystron, and later acquired by Akers Biosciences Inc., or Akers.
In consideration for the grant
of the License, the Oravax License Agreement provides that we will receive (i) royalties equal to 7.5% on net sales, as defined in the
Oravax License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related to the License during
the term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based consideration received
by Oravax from a permitted sublicensee and (iii) other payments ranging between $25 million to $100 million, based on certain sales milestones
being achieved by Oravax. The parties further agreed to establish a development and steering committee, which will consist of three members,
of which two members will be appointed by us, that will oversee the ongoing research, development, clinical and regulatory activity with
respect to the Oravax Product. In addition, we agreed to buy and Oravax agreed to issue to us 1,890,000 shares of common stock of Oravax,
representing 63% of the common stock of Oravax for the aggregate amount of $1.5 million. Akers agreed to contribute to Oravax $1.5 million
in cash and substantially all of the assets of Cystron, including a license agreement to Premas’s novel vaccine technology. Nadav
Kidron, the Company’s President and Chief Executive Officer, was one of the former members of Cystron. See note 12 to the financial
statements.
Government Regulation
The Drug Development
Process
Regulatory requirements for
the approval of new drugs vary from one country to another. In order to obtain approval to market our drug portfolio, we need to go through
a different regulatory process in each country in which we apply for such approval. In some cases, information gathered during the approval
process in one country can be used as supporting information for the approval process in another country. As a strategic decision, we
decided to first explore the FDA regulatory pathway. The following is a summary of the FDA’s requirements.
The FDA requires that pharmaceutical
and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or introduction
to the general public. Clinical testing, known as clinical trials or clinical studies, is either conducted internally by life science,
pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.
The process of conducting
clinical studies is highly regulated by the FDA, as well as by other governmental and professional bodies. Below we describe the principal
framework in which clinical studies are conducted, as well as describe a number of the parties involved in these studies.
Protocols. Before commencing
human clinical studies, the sponsor of a new drug or therapeutic product must submit an IND application to the FDA. The application contains,
among other documents, what is known in the industry as a protocol. A protocol is the blueprint for each drug study. The protocol sets
forth, among other things, the following:
|
●
|
Who must be recruited as qualified participants,
|
|
|
|
|
●
|
How often to administer the drug or product,
|
|
|
|
|
●
|
What tests to perform on the participants, and
|
|
|
|
|
●
|
What dosage of the drug or amount of the product to give to the participants.
|
Institutional Review Board.
An institutional review board is an independent committee of professionals and lay persons which reviews clinical research studies involving
human beings and is required to adhere to guidelines issued by the FDA. The institutional review board does not report to the FDA, but
its records are audited by the FDA. Its members are not appointed by the FDA. All clinical studies must be approved by an institutional
review board. The institutional review board’s role is to protect the rights of the participants in the clinical studies. It approves
the protocols to be used, the advertisements which the company or CRO conducting the study proposes to use to recruit participants, and
the form of consent which the participants will be required to sign prior to their participation in the clinical studies.
Clinical Trials. Human clinical
studies or testing of a potential product are generally done in three stages known as Phase I through Phase III testing. The names of
the phases are derived from the regulations of the FDA. Generally, there are multiple studies conducted in each phase.
Phase I. Phase I studies involve
testing a drug or product on a limited number of healthy or patient participants, typically 24 to 100 people at a time. Phase I studies
determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body. This phase lasts an average
of six months to a year.
Phase II. Phase II
trials involve testing of no more than 300 participants at a time who may suffer from the targeted disease or condition. Phase II
testing typically lasts an average of one to two years. In Phase II, the drug is tested to determine its safety and effectiveness
for treating a specific illness or condition. Phase II testing also involves determining acceptable dosage levels of the drug. Phase
II studies may be split into Phase IIa and Phase IIb sub-studies. Phase IIa studies may be conducted with patient volunteers and are
exploratory (non-pivotal) studies, typically designed to evaluate clinical efficacy or biological activity. Phase IIb studies are
conducted with patients defined to evaluate definite dose range and evaluate efficacy. If Phase II studies show that a new drug has
an acceptable range of safety risks and probable effectiveness, a company will generally continue to review the substance in Phase
III studies.
Phase III. Phase III studies
involve testing large numbers of participants, typically several hundred to several thousand persons. The purpose is to verify effectiveness
and long-term safety on a large scale. These studies generally last two to three years. Phase III studies are conducted at multiple locations
or sites. Like the other phases, Phase III requires the site to keep detailed records of data collected and procedures performed.
Biological License Application.
The results of the clinical trials for a biological product are submitted to the FDA as part of a BLA. Following the completion of Phase
III studies, assuming the sponsor of a potential product in the United States believes it has sufficient information to support the safety
and effectiveness of its product, the sponsor will generally submit a BLA to the FDA requesting that the product be approved for marketing.
The application is a comprehensive, multi-volume filing that includes the results of all clinical studies, information about the drug’s
composition, and the sponsor’s plans for producing, packaging and labeling the product. The FDA’s review of an application
can take a few months to many years, with the average review lasting 18 months. Once approved, drugs and other products may be marketed
in the United States, subject to any conditions imposed by the FDA. Approval of a BLA provides 12 years of exclusivity in the U.S. market.
Phase IV. The FDA may require
that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as Phase IV studies,
is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness. In recent years, the FDA
has increased its reliance on these trials. Phase IV studies usually involve thousands of participants. Phase IV studies also may be initiated
by the company sponsoring the new drug to gain broader market value for an approved drug.
Similar to the U.S., a European
sponsor of a biological product may submit a Marketing Approval Application to the EMA for the registration of the product. The approval
process in Europe consists of several stages, which together are summed up to 210 days from the time of submission of the application
(net, without periods in which the sponsor provides answers to questions raised by the agency) following which, a Marketing Approval may
be granted. During the approval process, the sponsor’s manufacturing facilities will be audited in order to assess Good Manufacturing
Practice compliance.
The drug approval process
is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the
illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials.
Other Regulations
Various federal, state and
local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals,
the environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous substances,
including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities.
They include, among others, the U.S. Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act,
the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions
on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation.
The compliance with these and other laws, regulations and recommendations can be time-consuming and involve substantial costs. In addition,
the extent of governmental regulation which might result from future legislation or administrative action cannot be accurately predicted
and may have a material adverse effect on our business, financial condition, results of operations and prospects.
Competition
Competition in General
Competition in the area of
biomedical and pharmaceutical research and development is intense and significantly depends on scientific and technological factors. These
factors include the availability of patent and other protection for technology and products, the ability to commercialize technological
developments and the ability to obtain regulatory approval for testing, manufacturing and marketing. Our competitors include major pharmaceutical,
medical products, chemical and specialized biotechnology companies, many of which have financial, technical and marketing resources significantly
greater than ours. In addition, many biotechnology companies have formed collaborations with large, established companies to support research,
development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other
public and private research organizations are also conducting research activities and seeking patent protection and may commercialize
products on their own or through joint ventures. We are aware of certain other products manufactured or under development by competitors
that are used for the treatment of the diseases and health conditions that we have targeted for product development. We can provide no
assurance that developments by others will not render our technology obsolete or noncompetitive, that we will be able to keep pace with
new technological developments or that our technology will be able to supplant established products and methodologies in the therapeutic
areas that are targeted by us. The foregoing factors could have a material adverse effect on our business, prospects, financial condition
and results of operations. These companies, as well as academic institutions, governmental agencies and private research organizations,
also compete with us in recruiting and retaining highly qualified scientific personnel and consultants.
Competition within our sector
is increasing, so we will encounter competition from existing firms that offer competitive solutions in diabetes treatment solutions.
These competitive companies could develop products that are superior to, or have greater market acceptance, than the products being developed
by us. We will have to compete against other biotechnology and pharmaceutical companies with greater market recognition and greater financial,
marketing and other resources.
Our competition will be determined
in part by the potential indications for which our technology is developed and ultimately approved by regulatory authorities. In addition,
the first product to reach the market in a therapeutic or preventive area is often at a significant competitive advantage relative to
later entrants to the market. Accordingly, the relative speed with which we, or our potential corporate partners, can develop products,
complete the clinical trials and approval processes and supply commercial quantities of the products to the market are expected to be
important competitive factors. Our competitive position will also depend on our ability to attract and retain qualified scientific and
other personnel, develop effective proprietary products, develop and implement production and marketing plans, obtain and maintain patent
protection and secure adequate capital resources. We expect our technology, if approved for sale, to compete primarily on the basis of
product efficacy, safety, patient convenience, reliability, value and patent position.
Competition for Our
Oral Insulin Capsule
We anticipate the oral insulin
capsule to be a competitive diabetes drug because of its anticipated efficacy and safety profile. The following are some of the treatment
options for T1D and T2D patients:
|
●
|
A combination of diet, exercise and oral medication which improve the body’s response to insulin or cause the body to produce more insulin.
|
Scientific Advisory Board
We maintain a Scientific Advisory
Board consisting of internationally recognized scientists who advise us on scientific and technical aspects of our business. The Scientific
Advisory Board meets periodically to review specific projects and to assess the value of new technologies and developments to us. In addition,
individual members of the Scientific Advisory Board meet with us periodically to provide advice in their particular areas of expertise.
The Scientific Advisory Board consists of the following members, information with respect to whom is set forth below: Dr. Roy Eldor, Professor
Ele Ferrannini, Dr. Alexander Fleming, Professor Avram Hershko, Dr. Harold Jacob, Dr. Julio Rosenstock and Dr. Jay Skyler.
Dr. Roy Eldor, MD,
PhD, joined the Oramed Scientific Advisory Board in July 2016. He is an endocrinologist, internist and researcher with over twenty
years of clinical and scientific experience. He is currently Director of the Diabetes Unit at the Institute of Endocrinology, Metabolism& Hypertension, Tel-Aviv Sourasky Medical Center. Prior to that, Dr. Eldor served as Principal Scientist at Merck Research Laboratories,
Clinical Research–- Diabetes & Endocrinology, Rahway, New Jersey. He has previously served as a senior physician in internal
medicine at the Diabetes Unit in Hadassah Hebrew University Hospital, Jerusalem, Israel; and the Diabetes Division at the University of
Texas Health Science Center in San Antonio, Texas (under the guidance of Dr. R.A. DeFronzo). Dr. Eldor is a recognized expert, with over
50 peer reviewed papers and book chapters, and has been a guest speaker at numerous international forums.
Professor Ele Ferrannini,
MD, joined the Oramed Scientific Advisory Board in February 2007. He is a past President to the European Association for the
Study of Diabetes, which supports scientists, physicians and students from all over the world who are interested in diabetes and related
subjects in Europe, and performs functions similar to that of the ADA in the United States. Professor Ferrannini has worked with various
institutions including the Department of Clinical & Experimental Medicine, University of Pisa School of Medicine, and CNR (National
Research Council) Institute of Clinical Physiology, Pisa, Italy; and the Diabetes Division, Department of Medicine, University of Texas
Health Science Center at San Antonio, Texas. He has also had extensive training in internal medicine and endocrinology, and has specialized
in diabetes studies. Professor Ferrannini has received a Certificate of the Educational Council for Foreign Medical Graduates from the
University of Bologna, and with cum laude honors completed a subspecialty in Diabetes and Metabolic Diseases at the University of Torino.
He has published over 500 original papers and 50 book chapters and he is a “highly cited researcher,” according to the Institute
for Scientific Information.
Dr. Alexander Fleming,
MD an endocrinologist, is Founder and Executive Chairman of Kinexum, a strategic advisory firm. At the FDA from 1986 to 1998,
he served as a supervisory medical officer in the Division of Metabolism and Endocrine Drug Products and was responsible for landmark
approvals of the first statin, metformin, and other endocrine and metabolic therapies. He also represented the FDA at the World Health
Organization and on multiple expert working groups of the International Conference on Harmonization (ICH). Dr. Fleming coined the term,
Metabesity, which refers to the constellation of major chronic diseases and the aging process itself, all which share common metabolic
root causes and potential preventive therapies. He organized the first Congress on Metabesity in London in October 2017, followed by annual
conferences. Dr. Fleming founded in 2020 the not-for-profit Kitalys Institute as a means of producing Metabesity conferences and advancing
interventions of any kind that can improve health and healthspan.
Professor Avram Hershko,
MD, PhD, joined the Oramed Scientific Advisory Board in July 2008. He earned his MD degree (1965) and PhD degree (1969) from the
Hebrew University-Hadassah Medical School of Jerusalem. Professor Hershko served as a physician in the Israel Defense Forces from 1965
to 1967. After a post-doctoral fellowship with Gordon Tomkins at the University of San Francisco (1969-72), he joined the faculty
of the Haifa Technion becoming a professor in 1980. He is now Distinguished Professor in the Unit of Biochemistry in the B. Rappaport
Faculty of Medicine of the Technion. Professor Hershko’s main research interests concern the mechanisms by which cellular proteins
are degraded, a formerly neglected field of study. Professor Hershko and his colleagues showed that cellular proteins are degraded by
a highly selective proteolytic system. This system tags proteins for destruction by linkage to a protein called ubiquitin, which had previously
been identified in many tissues, but whose function was previously unknown. Subsequent work by Professor Hershko and many other laboratories
has shown that the ubiquitin system has a vital role in controlling a wide range of cellular processes, such as the regulation of cell
division, signal transduction and DNA repair. Professor Hershko was awarded the Nobel Prize in Chemistry (2004) jointly with his former
PhD student Aaron Ciechanover and their colleague Irwin Rose. His many honors include the Israel Prize for Biochemistry (1994), the Gairdner
Award (1999), the Lasker Prize for Basic Medical Research (2000), the Wolf Prize for Medicine (2001) and the Louisa Gross Horwitz Award
(2001). Professor Hershko is a member of the Israel Academy of Sciences (2000) and a Foreign Associate of the U.S. Academy of Sciences
(2003).
Dr. Harold Jacob, MD,
joined the Oramed Scientific Advisory Board in November 2016. Since 1998, Dr. Jacob has served as the president of Medical Instrument
Development Inc., a company which provides a range of support and consulting services to start-up and early stage companies as well as
patenting its own proprietary medical devices. Since 2011, Dr. Jacob has also served as an attending physician at Hadassah University
Medical Center, where he has served as the director of the gastrointestinal endoscopy unit since September 2013. Dr. Jacob has advised
a spectrum of companies in the past and he served as a consultant and then as the Director of Medical Affairs at Given Imaging Ltd., from
1997 to 2003, a company that developed the first swallowable wireless pill camera for inspection of the intestine. He has licensed patents
to a number of companies including Kimberly-Clark Corporation. Since 2014, Dr. Jacob has served as the Chief Medical Officer and a director
of NanoVibronix, Inc., a medical device company using surface acoustics to prevent catheter acquired infection as well as other applications,
where he served as Chief Executive Officer from 2004 to 2014. He practiced clinical gastroenterology in New York and served as Chief of
Gastroenterology at St. John’s Episcopal Hospital and South Nassau Communities Hospital from 1986 to 1995, and was a Clinical Assistant
Professor of Medicine at SUNY from 1983 to 1990. Dr. Jacob founded and served as Editor in Chief of Endoscopy Review and has authored
numerous publications in the field of gastroenterology.
Dr. Julio Rosenstock,
MD, joined the Oramed Scientific Advisory Board in January 2020. Dr. Rosenstock is Director of the Dallas Diabetes Research Center
at Medical City, and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, Dallas. He is board certified
in Internal Medicine, and Endocrinology and Metabolism. His clinical and research activities have focused on exploring novel agents and
therapeutic strategies to improve glycemic control. Over the last 30 years, he has participated in hundreds of clinical trials and has
had an active role in the development of new diabetes oral agents, incretin-related therapies and insulin formulations, acting often as
a lead clinical investigator and scientific advisor. Dr. Rosenstock has been the author or co-author of 338 peer-reviewed manuscripts
(H-index 105) and several hundred scientific abstracts. He has also contributed to 13 book chapters on various topics in the field of
diabetes. He is currently an Associate Editor of Diabetes Care.
Dr. Jay Skyler, MD,
MCAP, joined the Oramed Scientific Advisory Board in January 2020. Dr. Skyler is Professor of Medicine, Pediatrics, & Psychology
in the Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Miami Leonard M. Miller School of Medicine.
He previously held the position of Director of the Division of Endocrinology, Diabetes& Metabolism. In addition, Dr. Skyler is Deputy
Director of Clinical Research and Academic Programs at the Diabetes Research Institute, and an Adjunct Professor of Pediatrics at the
Barbara Davis Center for Childhood Diabetes, University of Colorado at Denver. Dr. Skyler’s research focuses on the clinical aspects
of diabetes, specifically the conduct of randomized controlled clinical trials. From 1993 until 2015, he was Chairman of the NIH (NIDDK)-sponsored
Diabetes Prevention Trial–- Type 1 (DPT-1) and its successor Type 1 Diabetes TrialNet, a nationwide (and global) network conducting
clinical trials to prevent T1D.
Employees
We have been successful in
retaining experienced personnel involved in our research and development program. In addition, we believe we have successfully recruited
the clinical/regulatory, quality assurance and other personnel needed to advance through clinical studies or have engaged the services
of experts in the field for these requirements. As of August 31, 2021, we have contracted with thirteen individuals for employment or
consulting arrangements. Of our staff, five are senior management, four are engaged in research and development work, and the remaining
four are involved in administration work.
Additional Information
Additional information about
us is contained on our Internet website at www.oramed.com. Information on our website is not incorporated by reference into this report.
On our website, under “Investors”, “SEC Filings”, we make available free of charge our Annual Reports on Form
10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section
13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after we electronically
file such material with, or furnish it to, the U.S. Securities and Exchange Commission, or the SEC. Reports filed with the SEC are made
available on its website at www.sec.gov. The following Corporate Governance documents are also posted on our website: Code of Ethics,
Whistleblowing Policy and the Charters for each of the Audit Committee, Compensation Committee and Nominating Committee of our Board.
ITEM 1A. RISK FACTORS.
An investment in our
securities involves a high degree of risk. You should consider carefully the following information about these risks, together with the
other information contained in this Annual Report on Form 10-K before making an investment decision. Our business, prospects, financial
condition and results of operations may be materially and adversely affected as a result of any of the following risks. The value of
our securities could decline as a result of any of these risks. You could lose all or part of your investment in our securities. Some
of the statements in “Item 1A. Risk Factors” are forward-looking statements. The following risk factors are not the only
risk factors facing the Company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may
also affect our business, prospects, financial condition and results of operations.
Risks Related to Our Business
We continue, and in the
future expect, to incur losses.
Successful completion of our
development programs and our transition to normal operations are dependent upon obtaining necessary regulatory approvals from the FDA
prior to selling our products within the United States, and foreign regulatory approvals must be obtained to sell our products internationally.
There can be no assurance that we will receive regulatory approval of any of our product candidates, and a substantial amount of time
may pass before we achieve a level of revenues adequate to support our operations. We also expect to incur substantial expenditures in
connection with the regulatory approval process for each of our product candidates during their respective developmental periods. Obtaining
marketing approval will be directly dependent on our ability to implement the necessary regulatory steps required to obtain marketing
approval in the United States and in other countries. We cannot predict the outcome of these activities.
Based on our current cash
resources and commitments, we believe we will be able to maintain our current planned development activities and the corresponding level
of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior to such
time. If there are unexpected increases in our operating expenses, we may need to seek additional financing during the next 12 months.
We will need substantial
additional capital in order to satisfy our business objectives.
To date, we have financed
our operations principally through offerings of securities and we will require substantial additional financing at various intervals in
order to continue our research and development programs, including significant requirements for operating expenses including intellectual
property protection and enforcement, for pursuit of regulatory approvals, and for commercialization of our products. We can provide no
assurance that additional funding will be available on a timely basis, on terms acceptable to us, or at all. In the event that we are
unable to obtain such financing, we will not be able to fully develop and commercialize our technology. Our future capital requirements
will depend upon many factors, including:
|
●
|
Continued scientific progress in our research and development programs,
|
|
|
|
|
●
|
Costs and timing of conducting clinical trials and seeking regulatory approvals and patent prosecutions,
|
|
|
|
|
●
|
Competing technological and market developments,
|
|
●
|
Our ability to establish additional collaborative relationships, and
|
|
|
|
|
●
|
Effects of commercialization activities and facility expansions if and as required.
|
If we cannot secure adequate
financing when needed, we may be required to delay, scale back or eliminate one or more of our research and development programs or to
enter into license or other arrangements with third parties to commercialize products or technologies that we would otherwise seek to
develop ourselves and commercialize ourselves. In such event, our business, prospects, financial condition and results of operations may
be adversely affected as we may be required to scale-back, eliminate, or delay development efforts or product introductions or enter into
royalty, sales or other agreements with third parties in order to commercialize our products.
We have a history of losses
and can provide no assurance as to our future operating results.
We do not have sufficient revenues
from our research and development activities to fully support our operations. Consequently, we have incurred net losses and negative cash
flows since inception. We currently have only licensing revenues and no product revenues, and may not succeed in developing or commercializing
any products which could generate product revenues. We do not expect to have any products on the market for several years. In addition,
development of our product candidates requires a process of pre-clinical and clinical testing, during which our products could fail. We
may not be able to enter into agreements with one or more companies experienced in the manufacturing and marketing of therapeutic drugs
and, to the extent that we are unable to do so, we will not be able to market our product candidates. Eventual profitability will depend
on our success in developing, manufacturing, and marketing our product candidates. As of August 31, 2021, August 31, 2020 and August 31,
2019, we had working capital of $88,658,000, $35,975,000 and $28,016,000, respectively, and stockholders’ equity of $116,517,000,
$32,879,000 and $19,393,000, respectively. During fiscal 2021 and the fiscal years ended August 31, 2020, or fiscal 2020, and 2019, we
generated revenues of $2,703,000, $2,710,000 and $2,703,000, respectively. For the period from our inception on April 12, 2002 through
August 31, 2021, fiscal 2021, fiscal 2020 and fiscal 2019, we incurred net losses of $114,852,000, $22,238,000, $11,511,000 and $14,355,000,
respectively. We may never achieve profitability and expect to incur net losses in the foreseeable future. See “Item 7. Management’s
Discussion and Analysis of Financial Condition and Results of Operations.”
We rely upon patents to
protect our technology.
The patent position of biopharmaceutical
and biotechnology firms is generally uncertain and involves complex legal and factual questions. We do not know whether any of our current
or future patent applications will result in the issuance of any patents. Even issued patents may be challenged, invalidated or circumvented.
Patents may not provide a competitive advantage or afford protection against competitors with similar technology. Competitors or potential
competitors may have filed applications for, or may have received patents and may obtain additional and proprietary rights to compounds
or processes used by or competitive with ours. In addition, laws of certain foreign countries do not protect intellectual property rights
to the same extent as do the laws of the United States.
Patent litigation is becoming
widespread in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to form strategic
alliances, conduct clinical testing or manufacture and market any products under development. If challenged, our patents may not be held
valid. We could also become involved in interference proceedings in connection with one or more of our patents or patent applications
to determine priority of invention. If we become involved in any litigation, interference or other administrative proceedings, we will
likely incur substantial expenses and the efforts of our technical and management personnel will be significantly diverted. In addition,
an adverse determination could subject us to significant liabilities or require us to seek licenses that may not be available on favorable
terms, if at all. We may be restricted or prevented from manufacturing and selling our products in the event of an adverse determination
in a judicial or administrative proceeding or if we fail to obtain necessary licenses.
We may be unable to protect
our intellectual property rights and we may be liable for infringing the intellectual property rights of others.
Our ability to compete effectively
will depend on our ability to maintain the proprietary nature of our technologies. We currently hold several pending patent applications
in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan and China for our technologies covering oral administration of insulin
and other proteins and oral administration of exenatide and proteins and 87 patents issued by the United States, Australian, Canadian,
Chinese, Israeli, Japanese, New Zealand, South African, Russian, European, Hong Kong, Swiss, German, Spanish, French, United Kingdom,
Italian, Indian, Austrian, Belgian, Irish, Swedish, Denmark, Luxembourg, Monaco, Norway and Netherlands patent offices for our technologies
covering oral administration of insulin and other proteins, or for our technologies covering oral administration of exenatide, or for
methods and compositions for treating diabetes. Further, we intend to rely on a combination of trade secrets and non-disclosure and other
contractual agreements and technical measures to protect our rights in our technology. We intend to depend upon confidentiality agreements
with our officers, directors, employees, consultants, and subcontractors, as well as collaborative partners, to maintain the proprietary
nature of our technology. These measures may not afford us sufficient or complete protection, and others may independently develop technology
similar to ours, otherwise avoid our confidentiality agreements, or produce patents that would materially and adversely affect our business,
prospects, financial condition and results of operations. We believe that our technology is not subject to any infringement actions based
upon the patents of any third parties; however, our technology may in the future be found to infringe upon the rights of others. Others
may assert infringement claims against us or against companies to which we have licensed our technology, and if we should be found to
infringe upon their patents, or otherwise impermissibly utilize their intellectual property, our ability to continue to use our technology
could be materially restricted or prohibited. If this event occurs, we may be required to obtain licenses from the holders of this intellectual
property, enter into royalty agreements, or redesign our products so as not to utilize this intellectual property, each of which may prove
to be uneconomical or otherwise impossible. Licenses or royalty agreements required in order for us to use this technology may not be
available on terms acceptable to us, or at all. These claims could result in litigation, which could materially adversely affect our business,
prospects, financial condition and results of operations. Further, we may need to indemnify companies to which we licensed our technology
in the event that such technology is found to infringe upon the rights of others.
Our commercial success will
also depend significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Patent
applications are, in many cases, maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent
literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications are
filed. In the event of infringement or violation of another party’s patent, we may be prevented from pursuing product development
or commercialization. See “Item 1. Business—Description of Business—Patents and Licenses.”
At present, our success
depends primarily on the successful commercialization of our oral insulin capsule.
The successful commercialization
of our oral insulin capsule is crucial for our success. At present, our principal product is the oral insulin capsule. Our oral insulin
capsule is in a clinical development stage and faces a variety of risks and uncertainties. Principally, these risks include the following:
|
●
|
Future clinical trial results may show that the oral insulin capsule is not well tolerated by recipients at its effective doses or is not efficacious as compared to placebo,
|
|
|
|
|
●
|
Future clinical trial results may be inconsistent with previous preliminary testing results and data from our earlier studies may be inconsistent with clinical data,
|
|
|
|
|
●
|
Even if our oral insulin capsule is shown to be safe and effective for its intended purposes, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities or at reasonable prices,
|
|
|
|
|
●
|
Our ability to complete the development and commercialization of the oral insulin capsule for our intended use is significantly dependent upon our ability to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and the manufacturing, marketing and distribution of, the oral insulin capsule on a worldwide basis,
|
|
|
|
|
●
|
Even if our oral insulin capsule is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no guarantee that there will be market acceptance of our product, and
|
|
|
|
|
●
|
Our competitors may develop therapeutics or other treatments which are superior or less costly than our own with the result that our products, even if they are successfully developed, manufactured and approved, may not generate significant revenues.
|
If we are unsuccessful in
dealing with any of these risks, or if we are unable to successfully commercialize our oral insulin capsule for some other reason, it
would likely seriously harm our business.
We have limited experience
in conducting clinical trials.
Clinical trials must meet
FDA and foreign regulatory requirements. We have limited experience in designing, conducting and managing the preclinical studies and
clinical trials necessary to obtain regulatory approval for our product candidates in any country. We have entered into agreements with
Integrium LLC and other consultants to assist us in designing, conducting and managing our various clinical trials in the United States,
Europe and Israel. Any failure of Integrium LLC or any other consultant to fulfill their obligations could result in significant additional
costs as well as delays in designing, consulting and completing clinical trials on our products.
Our clinical trials may
encounter delays, suspensions or other problems.
We may encounter problems
in clinical trials that may cause us or the FDA or foreign regulatory agencies to delay, suspend or terminate our clinical trials at any
phase. These problems could include the possibility that we may not be able to conduct clinical trials at our preferred sites, enroll
a sufficient number of patients for our clinical trials at one or more sites or begin or successfully complete clinical trials in a timely
fashion, if at all. Furthermore, we, the FDA or foreign regulatory agencies may suspend clinical trials at any time if we or they believe
the subjects participating in the trials are being exposed to unacceptable health risks or if we or they find deficiencies in the clinical
trial process or conduct of the investigation. If clinical trials of any of the product candidates fail, we will not be able to market
the product candidate which is the subject of the failed clinical trials. The FDA and foreign regulatory agencies could also require additional
clinical trials, which would result in increased costs and significant development delays. Our failure to adequately demonstrate the safety
and effectiveness of a pharmaceutical product candidate under development could delay or prevent regulatory approval of the product candidate
and could have a material adverse effect on our business, prospects, financial condition and results of operations. Finally, the COVID-19
pandemic has impacted clinical trials broadly. We may experience delays in site initiation and patient enrollment, failures to comply
with study protocols, delays in the manufacture of our product candidates for clinical testing and other difficulties in starting or competing
our clinical trials.
Clinical trials of our
products conducted by third parties may encounter delays, suspensions or other problems and are outside of our control.
Third parties who conduct
clinical trials of our products may encounter problems that may cause delays, suspensions or other problems at any phase. These problems
could include the possibility that they may not be able to conduct clinical trials at their preferred sites, enroll a sufficient number
of patients for their clinical trials at one or more sites or begin or successfully complete clinical trials in a timely fashion, if at
all. In addition, these third parties are not controlled by us and may conduct these trials in a manner in which we disagree or which
may prove to be unsuccessful. Furthermore, domestic or foreign regulatory agencies may suspend clinical trials at any time if they believe
the subjects participating in the trials are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial
process or conduct of the investigation. If such clinical trials conducted by third parties fail, it could have a material adverse effect
on our business, prospects, financial condition and results of operations.
We can provide no assurance
that our products will obtain regulatory approval or that the results of clinical studies will be favorable.
The testing, marketing and
manufacturing of any of our products will require the approval of the FDA or regulatory agencies of other countries. We have completed
certain non-FDA clinical trials and pre-clinical trials for our products. In addition, we have completed a Phase IIb clinical trial in
patients with T2D under an IND with the FDA and we have completed Phase IIa clinical trials of ORMD-0801 in patients with T1D, under an
IND with the FDA. However, success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be
successful. Even within a clinical trial there might be discrepancies from statistically significant data, as occurred at two of the sites
in the initial cohort of our Phase IIb trial, which we excluded while we investigate such discrepancies. For example, a number of companies
in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials.
We cannot predict with
any certainty the amount of time necessary to obtain regulatory approvals, including from the FDA or other foreign regulatory authorities,
and whether any such approvals will ultimately be granted. In any event, review and approval by the regulatory bodies is anticipated to
take a number of years. Preclinical and clinical trials may reveal that one or more of our products are ineffective or unsafe, in which
event further development of such products could be seriously delayed or terminated. Moreover, obtaining approval for certain products
may require the testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining
necessary regulatory approvals of any proposed product and failure to receive such approvals would have an adverse effect on the product’s
potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible
that a product may be found to be ineffective or unsafe due to conditions or facts which arise after development has been completed and
regulatory approvals have been obtained. In this event we may be required to withdraw such product from the market. See “Item 1.
Business—Description of Business—Government Regulation.”
We are dependent upon third
party suppliers of our raw materials.
We are dependent on outside
vendors for our entire supply of the oral insulin and GLP-1 capsules and do not currently have any long-term agreements in place for the
supply of oral insulin or GLP-1 capsules. While we believe that there are numerous sources of supply available, if the third party suppliers
were to cease production, including as a result of the COVID-19 pandemic, or otherwise fail to supply us with quality raw materials in
sufficient quantities on a timely basis and we were unable to contract on acceptable terms for these services with alternative suppliers,
our ability to produce our products and to conduct testing and clinical trials would be materially adversely affected.
Our future revenues from
HTIT are dependent upon third party suppliers and Chinese regulatory approvals.
Our future revenues from HTIT
are dependent upon the achievement of certain milestones and conditions, and the success of HTIT to implement our technology and to manufacture
the oral insulin capsule. Our future revenues from HTIT are also dependent upon the ability of third parties to scale-up one of our oral
capsule ingredients and to scale-up the manufacturing process of our capsules. Our future revenues from royalties from HTIT are further
dependent upon the granting of regulatory approvals in the Territory. Accordingly, if any of the foregoing does not occur, we may not
be successful in receiving future revenues from HTIT and may not succeed with our business plans in China.
If we do not resolve our
dispute with HTIT favorably, we may need to reverse deferred revenue of up to $2 million and may not receive an additional $4 million
in royalties.
On August 21, 2020, we received
a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. We estimate this obligation to be between $2
million and $6 million. While we wholly dispute said claims and have been engaged in discussions and exchanges with HTIT in an attempt
to clarify and resolve disagreements between the parties regarding milestone payments and work plan implementation, we may be subsequently
required to repay to HTIT up to $2 million, which has been received and has been included in our deferred revenue in each of the consolidated
balance sheets fiscal years ended August 31, 2021 and 2020. In addition, we may not receive an additional $4 million in Royalties if HTIT
is entitled to the full disputed amount of $6 million.
We are highly dependent
upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our products.
Our long-term strategy is
to ultimately seek a strategic commercial partner, or partners, such as large pharmaceutical companies, with extensive experience in the
development, commercialization, and marketing of insulin applications and/or other orally digestible drugs. Although Phase III clinical
trials for our oral insulin candidate, ORMD-0801 will start without a partner, if we engage such a partner, we anticipate such partner
or partners would be responsible for, or substantially support, late stage clinical trials, and sales and marketing of our oral insulin
capsule and other products. Such planned strategic partnership, or partnerships, may provide a marketing and sales infrastructure for
our products as well as financial and operational support for global clinical trials, post marketing studies, label expansions and other
regulatory requirements concerning future clinical development in the United States and elsewhere. While our strategy is to partner with
an appropriate party for our expected Phase III clinical trials, no assurance can be given that any third party would be interested in
partnering with us. We currently lack the resources to manufacture any of our product candidates on a large scale and we have no sales,
marketing or distribution capabilities. In the event we are not able to enter into a collaborative agreement with a partner, or partners,
on commercially reasonable terms, or at all, we may be unable to commercialize our products, which would have a material adverse effect
upon our business, prospects, financial condition and results of operations.
The biotechnology and biopharmaceutical
industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more
substantial enterprises.
The biotechnology and biopharmaceutical
industries are characterized by rapid technological developments and a high degree of competition. As a result, our products could become
obsolete before we recoup any portion of our related research and development and commercialization expenses. These industries are highly
competitive, and this competition comes both from biotechnology firms and from major pharmaceutical and chemical companies. Many of these
companies have substantially greater financial, marketing and human resources than we do (including, in some cases, substantially greater
experience in clinical testing, manufacturing and marketing of pharmaceutical products). We also experience competition in the development
of our products from universities and other research institutions and compete with others in acquiring technology from such universities
and institutions. In addition, certain of our products may be subject to competition from products developed using other technologies.
See “Item 1. Business—Description of Business—Competition.”
We have limited senior
management resources and may be required to obtain more resources to manage our growth.
We expect the expansion of
our business to place a significant strain on our limited managerial, operational and financial resources. We will be required to expand
our operational and financial systems significantly and to expand, train and manage our work force in order to manage the expansion of
our operations. Our failure to fully integrate our new employees into our operations could have a material adverse effect on our business,
prospects, financial condition and results of operations. Our ability to attract and retain highly skilled personnel is critical to our
operations and expansion. We face competition for these types of personnel from other technology companies and more established organizations,
many of which have significantly larger operations and greater financial, technical, human and other resources than we have. We may not
be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms or at all. If we are not successful
in attracting and retaining these personnel, our business, prospects, financial condition and results of operations will be materially
adversely affected. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
“Item 1. Business—Description of Business—Strategy” and “—Employees.”
We depend upon our senior
management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage.
We currently depend upon the
efforts and abilities of our senior executives, as well as the services of several key consultants and other key personnel, including
Dr. Miriam Kidron, our Chief Scientific Officer. The loss or unavailability of the services of any of these individuals for any significant
period of time could have a material adverse effect on our business, prospects, financial condition and results of operations. We do not
maintain “key man” life insurance policies for any of our senior executives. In addition, recruiting and retaining qualified
scientific personnel to perform future research and development work will be critical to our success. There is currently a shortage of
employees with expertise in developing, manufacturing and commercialization of products and related clinical and regulatory affairs, and
this shortage is likely to continue. Competition for skilled personnel is intense and turnover rates are high. Our ability to attract
and retain qualified personnel may be limited. Our inability to attract and retain qualified skilled personnel would have a material adverse
effect on our business, prospects, financial condition and results of operations.
Our existing and any future
joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we expect from these arrangements.
We are currently party to a joint venture, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize
assets to or in this joint venture or other joint ventures that we may enter.
Our participation in our existing joint venture
is subject to risks, including the following:
|
●
|
We share approval rights over certain major decisions affecting the ownership or operation of the joint venture and any assets owned by the joint venture;
|
|
●
|
We may need to contribute additional capital in order to preserve, maintain or grow the joint venture and its investments;
|
|
●
|
Our joint venture investors may have economic or other business interests or goals that are inconsistent with our business interests or goals and that could affect our ability to fully benefit from the assets owned by the joint venture;
|
|
●
|
Our joint venture investors may be subject to different laws or regulations than us, which could create conflicts of interest;
|
|
●
|
Our joint venture has license and other agreements with other investors, which we are not party to and have no control over;
|
|
●
|
Our ability to sell our interest in, or sell additional assets to, the joint venture or the joint venture’s ability to sell additional interests of, or assets owned by, the joint venture when we so desire are subject to the approval rights of the other joint venture investors under the terms of the agreements governing the joint venture; and
|
|
●
|
Disagreements with our joint venture investors could result in litigation
or arbitration that could be expensive and distracting to management and could delay important decisions.
|
Any
of the foregoing risks could have a material adverse effect on our business, financial condition and results of operations. Further,
these, similar, enhanced or additional risks, including possible risks of the other joint venture investors having licensed assets to
the joint venture, may apply to any future additional or amended joint ventures that we may enter into.
Healthcare policy changes,
including pending legislation recently adopted and further proposals still pending to reform the U.S. healthcare system, may harm our
future business.
Healthcare costs have risen
significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to
keep these costs down. Certain proposals, if passed, would impose limitations on the prices we will be able to charge for the products
that we are developing, or the amounts of reimbursement available for these products from governmental agencies or third-party payors.
These limitations could in turn reduce the amount of revenues that we will be able to generate in the future from sales of our products
and licenses of our technology.
In 2010, the federal government
enacted healthcare reform legislation that has significantly impacted the pharmaceutical industry. In addition to requiring most individuals
to have health insurance and establishing new regulations on health plans, this legislation requires discounts under the Medicare drug
benefit program and increased rebates on drugs covered by Medicaid. In addition, the legislation imposes an annual fee, which has increased
annually, on sales by branded pharmaceutical manufacturers. There can be no assurance that our business will not be materially adversely
affected by these increased rebates, fees and other provisions. In addition, these and other initiatives in the United States may continue
the pressure on drug pricing, especially under the Medicare and Medicaid programs, and may also increase regulatory burdens and operating
costs. The announcement or adoption of any such initiative could have an adverse effect on potential revenues from any product that we
may successfully develop. An expansion in government’s role in the U.S. healthcare industry may lower the future revenues for the
products we are developing and adversely affect our future business, possibly materially.
In September 2017, members
of the U.S. Congress introduced legislation with the announced intention to repeal and replace major provisions of the Patient Protection
and Affordable Care Act, or the ACA. In addition to those efforts, on October 12, 2017, an executive order was issued that modified certain
aspects of the ACA. Various litigation to invalidate parts of the ACA are pending in court and, despite an upcoming change in presidential
administration, attempts to repeal or to repeal and replace the ACA may continue. In addition, various other healthcare reform proposals
have also emerged at the federal and state level. We cannot predict what healthcare initiatives, if any, will be implemented at the federal
or state level, or the effect any future legislation or regulation will have on us.
We are exposed to fluctuations
in currency exchange rates.
A considerable amount of our
expenses are generated in dollars or in dollar-linked currencies, but a significant portion of our expenses such as some clinical studies
and payroll costs are generated in other currencies such as NIS and Euro. Most of the time, our non-dollar assets are not totally offset
by non-dollar liabilities. Due to the foregoing and to the fact that our financial results are measured in dollars, our results could
be adversely affected as a result of a strengthening or weakening of the dollar compared to these other currencies. During the fiscal
years ended August 31, 2016, 2017, 2019, 2020 and 2021, the dollar depreciated in relation to the NIS, which raised the dollar cost of
our Israeli based operations and adversely affected our financial results, while during the fiscal year ended August 31, 2018 the dollar
increased in relation to the NIS, which reduced the dollar cost of our Israeli based operations costs. In addition, our results could
also be adversely affected if we are unable to guard against currency fluctuations in the future. Although we may in the future decide
to undertake foreign exchange hedging transactions to cover a portion of our foreign currency exchange exposure, we currently do not hedge
our exposure to foreign currency exchange risks. These transactions, however, may not adequately protect us from future currency fluctuations
and, even if they do protect us, may involve operational or financing costs we would not otherwise incur.
The COVID-19 pandemic,
or any other pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business and operations.
The spread of COVID-19 may
result in the inability of our suppliers to deliver supplies to us on a timely basis. In addition, health professionals may reduce staffing
and reduce or postpone meetings with clients in response to the spread of an infectious disease. Though we have not yet experienced such
events, if they would occur, they could result in a period of business disruption, and in reduced operations, any of which could materially
affect our business, financial condition and results of operations. Although, as of the date of this Annual Report on Form 10-K, we do
not expect any material impact on our long-term activity, the extent to which COVID-19 impacts our business will depend on future developments,
which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and
the actions to contain COVID-19 or treat its impact, among others. We are actively monitoring the pandemic and we are taking any necessary
measures to respond to the situation in cooperation with the various stakeholders.
The outbreak of COVID-19
may materially and adversely affect our clinical trial operations and our financial results.
The outbreak of COVID-19 originated
in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States, Israel and several European
countries where we expected to initiate clinical trials. The extent to which COVID-19 may impact our clinical trial operations will depend
on future developments, which are still uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the severity
of COVID-19, or the effectiveness of actions to contain and treat for COVID-19. The continued spread of COVID-19 globally could adversely
impact our clinical trial operations in the United States, Israel and in Europe, including our ability to recruit and retain patients
and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs
in their geography or due to government or institutional quarantines or stay-at-home measures.
Moreover, COVID-19 may also
affect employees of third-party contract research organizations located in affected geographies that we rely upon to carry out such enrollments
and trials. Any negative impact COVID-19 has to patient enrollment or treatment could cause costly delays to clinical trial activities,
which could adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating
expenses, and have a material adverse effect on our financial results.
Risks Related to our Common Stock
Future sales of our common
stock by our existing stockholders could adversely affect our stock price.
The market price of our common
stock could decline as a result of sales of a large number of shares of our common stock in the market, or the perception that these sales
could occur. These sales also might make it more difficult for us to sell equity securities in the future at a time and at a price that
we deem appropriate. As of November 24, 2021, we had outstanding 38,086,020 shares of common stock, a large majority of which are freely
tradable. Giving effect to the exercise in full of all of our outstanding warrants, options and restricted stock units, or RSUs, including
those currently unexercisable or unvested, we would have outstanding 41,151,814 shares of common stock.
Our issuance of warrants,
options and RSUs to investors, employees and consultants may have a negative effect on the trading prices of our common stock as well
as a dilutive effect.
We have issued and may continue
to issue warrants, options, RSUs and convertible notes at, above or below the current market price. As of November 24, 2021, we had outstanding
warrants and options exercisable for 1,056,405 shares of common stock at a weighted average exercise price of $5.91. We also had outstanding
RSUs exercisable for 364,635 shares of common stock at a total exercise price of $900. In addition to the dilutive effect of a large number
of shares of common stock and a low exercise price for the warrants and options, there is a potential that a large number of underlying
shares of common stock may be sold in the open market at any given time, which could place downward pressure on the trading of our common
stock.
Because we will not pay
cash dividends in the foreseeable future, investors may have to sell shares of our common stock in order to realize their investment.
We have not paid any cash
dividends on our common stock and do not intend to pay cash dividends in the foreseeable future. We intend to retain future earnings,
if any, for reinvestment in the development and expansion of our business. Any credit agreements which we may enter into with institutional
lenders or otherwise may restrict our ability to pay dividends. Whether we pay cash dividends in the future will be at the discretion
of our Board and will be dependent upon our financial condition, results of operations, capital requirements and any other factors that
our Board decides is relevant.
Because certain of our
stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder
approval.
As of November 24, 2021, our
directors, executive officers and principal affiliated stockholders beneficially own approximately 7.0%
of our outstanding shares of common stock, excluding shares issuable upon the exercise of options, warrants and RSUs. As a result, these
stockholders, should they act together, may have the ability to control the outcome of matters submitted to our stockholders for approval,
including the election of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, these
stockholders, should they act together, may have the ability to control our management and affairs. Accordingly, this concentration of
ownership might harm the market price of our common stock by:
|
●
|
Delaying, deferring or preventing a change in corporate control,
|
|
●
|
Impeding a merger, consolidation, takeover or other business combination involving us, or
|
|
●
|
Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
|
Risks Related to Conducting Business in Israel
We are affected by the
political, economic and military risks of having operations in Israel.
We have operations in the
State of Israel, and we are directly affected by political, economic and security conditions in that country. Since the establishment
of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors and a state of hostility,
varying in degree and intensity, has led to security and economic problems for Israel. In addition, acts of terrorism, armed conflicts
or political instability in the region could negatively affect local business conditions and harm our results of operations. We cannot
predict the effect on the region of any diplomatic initiatives or political developments involving Israel or the Palestinians or other
countries and territories in the Middle East. Recent political events, including political uprisings, social unrest and regime change,
in various countries in the Middle East and North Africa have weakened the stability of those countries and territories, which could result
in extremists coming to power. In addition, Iran has threatened to attack Israel and is widely believed to be developing nuclear weapons.
Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon.
This situation has escalated in the past and may potentially escalate in the future to violent events which may affect Israel and us.
Our business, prospects, financial condition and results of operations could be materially adversely affected if major hostilities involving
Israel should occur or if trade between Israel and its current trading partners is interrupted or curtailed.
All adult male permanent residents
of Israel, unless exempt, may be required to perform military reserve duty annually. Additionally, all such residents are subject to being
called to active duty at any time under emergency circumstances. Some of our officers, directors and employees currently are or in the
future may be obligated to perform annual military reserve duty. We can provide no assurance that such requirements will not have a material
adverse effect on our business, prospects, financial condition and results of operations in the future, particularly if emergency circumstances
occur.
Because we received grants
from the Israel Innovation Authority of the Israeli Ministry of Economy & Industry we are subject to ongoing restrictions.
We received royalty-bearing
grants from the Israel Innovation Authority of the Israeli Ministry of Economy & Industry, or IIA, for research and development programs
that meet specified criteria. We did not recognize any grants in fiscals 2021, 2020 and 2019. We do not expect to receive further grants
from the IIA in the future. The terms of the IIA grants limit our ability to transfer know-how developed under an approved research and
development program outside of Israel, regardless of whether the royalties were fully paid.
It may be difficult to
enforce a U.S. judgment against us or our officers and directors and to assert U.S. securities laws claims in Israel.
Almost all of our directors
and officers are nationals and/or residents of countries other than the United States. As a result, service of process upon us, our Israeli
subsidiary and our directors and officers, may be difficult to obtain within the United States. Furthermore, because the majority of our
assets and investments, and most of our directors and officers are located outside the United States, it may be difficult for investors
to enforce within the United States any judgments obtained against us or any such officers or directors. Additionally, it may be difficult
to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation
of U.S. securities laws because Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli
court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to such claim. If U.S. law is found to
be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain
matters of procedure will also be governed by Israeli law.
Subject to specified time
limitations and legal procedures, under the rules of private international law currently prevailing in Israel, Israeli courts may enforce
a U.S. judgment in a civil matter, including a judgment based upon the civil liability provisions of the U.S. securities laws, as well
as a monetary or compensatory judgment in a non-civil matter, provided that the following key conditions are met:
|
●
|
subject to limited exceptions, the judgment is final and non-appealable;
|
|
●
|
the judgment was given by a court competent under the laws of the state in which the court is located and is otherwise enforceable in such state;
|
|
●
|
the judgment was rendered by a court competent under the rules of private international law applicable in Israel;
|
|
●
|
the laws of the state in which the judgment was given provides for the enforcement of judgments of Israeli courts;
|
|
●
|
adequate service of process has been effected and the defendant has had a reasonable opportunity to present its arguments and evidence;
|
|
●
|
the judgment and its enforcement are not contrary to the law, public policy, security or sovereignty of the State of Israel;
|
|
●
|
the judgment was not obtained by fraud and does not conflict with any other valid judgment in the same matter between the same parties; and
|
|
●
|
an action between the same parties in the same matter was not pending in any Israeli court at the time the lawsuit was instituted in the U.S. court.
|
If any of these conditions are not met,
Israeli courts will likely not enforce the applicable U.S. judgment.
General Risk Factors
Changes to tax laws could
have a negative effect on us or our stockholders.
At any time, the U.S. federal
or state income tax laws, or the administrative interpretations of those laws, may be amended. Federal and state tax laws are constantly
under review by persons involved in the legislative process, the U.S. Internal Revenue Service, the U.S. Department of the Treasury and
state taxing authorities. Changes to the tax laws, regulations and administrative interpretations, which may have retroactive application,
could adversely affect us. Our stockholders are encouraged to consult with their tax advisors about the potential effects that changes
in law may have on them and their ownership of our securities.
As the market price of
our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common stock when you want or
at prices you find attractive.
The price of our common stock
is currently listed on Nasdaq and on the Tel Aviv Stock Exchange and constantly changes. In recent years, the stock market in general
has experienced extreme price and volume fluctuations. We expect that the market price of our common stock will continue to fluctuate.
These fluctuations may result from a variety of factors, many of which are beyond our control. These factors include:
|
●
|
Clinical trial results and the timing of the release of such results,
|
|
●
|
The amount of cash resources and our ability to obtain additional funding,
|
|
●
|
Announcements of research activities, business developments, technological innovations or new products by us or our competitors,
|
|
●
|
Entering into or terminating strategic relationships,
|
|
●
|
Changes in government regulation,
|
|
●
|
The impact of the recent outbreak of COVID-19 on our business or on the economy generally,
|
|
●
|
Departure of key personnel,
|
|
●
|
Disputes concerning patents or proprietary rights,
|
|
●
|
Changes in expense level,
|
|
●
|
Future sales of our equity or equity-related securities,
|
|
●
|
Public concern regarding the safety, efficacy or other aspects of the products or methodologies being developed,
|
|
●
|
Activities of various interest groups or organizations,
|
|
●
|
Status of the investment markets.
|
Future sales of common
stock or the issuance of securities senior to our common stock or convertible into, or exchangeable or exercisable for, our common stock
could materially adversely affect the trading price of our common stock, and our ability to raise funds in new equity offerings.
Future sales of substantial
amounts of our common stock, including pursuant to our New Equity Distribution Agreement (as defined below), or other equity-related securities
in the public market or privately, or the perception that such sales could occur, could adversely affect prevailing trading prices of
our common stock and could impair our ability to raise capital through future offerings of equity or other equity-related securities.
We anticipate that we will need to raise capital through offerings of equity and equity related securities. We can make no prediction
as to the effect, if any, that future sales of shares of our common stock or equity-related securities, or the availability of shares
of common stock for future sale, will have on the trading price of our common stock.
Our stockholders may experience
significant dilution as a result of any additional financing using our equity securities.
To the extent that we raise
additional funds by issuing equity securities, including pursuant to our New Equity Distribution Agreement (as defined below), our stockholders
may experience significant dilution.
Our management will have
significant flexibility in using the net proceeds of any offering of securities.
We intend generally to use
the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and product development activities,
and for general corporate purposes, including general working capital purposes. Our management will have significant flexibility in applying
the net proceeds of any such offering. The actual amounts and timing of expenditures will vary significantly depending on a number of
factors, including the amount of cash used in our operations and our research and development efforts. Management’s failure to use
these funds effectively would have an adverse effect on the value of our common stock and could make it more difficult and costly to raise
funds in the future.
Delaware law could discourage
a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely
affect existing stockholders.
The Delaware General Corporation
Law contains provisions that may have the effect of making more difficult or delaying attempts by others to obtain control of the Company,
even when these attempts may be in the best interests of stockholders. Delaware law imposes conditions on certain business combination
transactions with “interested stockholders.” These provisions and others that could be adopted in the future could deter unsolicited
takeovers or delay or prevent changes in our control or management, including transactions in which stockholders might otherwise receive
a premium for their shares of common stock over then current market prices. These provisions may also limit the ability of stockholders
to approve transactions that they may deem to be in their best interests.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
Not applicable.
ITEM 2. PROPERTIES.
We believe that our existing
facilities are suitable and adequate to meet our current business requirements. In the event that we should require additional or alternative
facilities, we believe that such facilities can be obtained on short notice at competitive rates.
ITEM 3. LEGAL PROCEEDINGS.
From time to time we may become
subject to litigation incidental to our business. We are not currently a party to any material legal proceedings.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Price for our Common Stock
Our common stock is traded
on Nasdaq and on the Tel Aviv Stock Exchange, in each case under the symbol “ORMP.”
Holders
As of November 24, 2021, there
were 38,086,020 shares of our common stock issued and outstanding held of record by approximately 34 registered stockholders. We believe
that a significant number of stockholders hold their shares of our common stock in brokerage accounts and registered in the name of stock
depositories and are therefore not included in the number of stockholders of record.
Unregistered Sales of Equity Securities and
Use of Proceeds
No unregistered sales of equity
securities were made during the three months ended August 31, 2021.
ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and
analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements
and the related notes included elsewhere herein and in our consolidated financial statements.
In addition to our consolidated
financial statements, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our
actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute
to these differences include those discussed below and elsewhere in this Annual Report on Form 10-K, particularly in “Cautionary
Statement Regarding Forward-Looking Statements” and “Item 1A. Risk Factors.”
Overview of Operations
We are a pharmaceutical company
currently engaged in the research and development of innovative pharmaceutical solutions, including an orally ingestible insulin capsule
to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules or pills for delivery of other polypeptides.
An overview of our current clinical studies can be found in “Item 1. Business–- Research and Development.”
Results of Operations
Critical accounting
policies
Our significant accounting
policies are more fully described in the notes to our accompanying consolidated financial statements. We believe that the accounting policies
below are critical for one to fully understand and evaluate our financial condition and results of operations.
The discussion and analysis
of our financial condition and results of operations is based on our consolidated financial statements, which we prepared in accordance
with U.S. generally accepted accounting principles, or GAAP. The preparation of our consolidated financial statements requires us to make
estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of the consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. On an
ongoing basis, we evaluate such estimates and judgments. We base our estimates on historical experience and on various other factors that
we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of
assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions.
Valuation of options
and warrants: We grant options to purchase shares of our common stock to employees and consultants and have and may in the future
issue warrants in connection with some of our financings and to certain other consultants.
We account for share-based
payments to employees, directors and consultants in accordance with the guidance that requires awards classified as equity awards to be
accounted for using the grant-date fair value method. The fair value of share-based payment transactions is based on the Black Scholes
option-pricing model or Monte Carlo model when appropriate and is recognized as an expense over the vesting period.
We elected to recognize compensation
cost for awards to employees, directors and consultants that have a graded vesting schedule using the accelerated method based on the
multiple-option award approach.
Revenue recognition:
Revenue is recognized when delivery has occurred, evidence of an arrangement exists, title and risks and rewards for the products are
transferred to the customer and collection is reasonably assured.
Under Accounting Standards
Codification, or ASC, 605 (which was the authoritative revenue recognition guidance applied for all periods prior to September 1, 2018)
given our continuing involvement through the expected product submission in June 2023, amounts received relating to the License Agreement
were recognized over the period from which we were entitled to the respective payment, and the expected product submission date using
a time-based model approach over the periods that the fees were earned.
However, under ASC 606, we
are required to recognize the total transaction price (which includes consideration related to milestones once the criteria for recognition
have been satisfied) using the input method over the period the performance obligation is fulfilled. Accordingly, once the consideration
associated with a milestone is included in the transaction price, incremental revenue is recognized immediately based on the period of
time that has elapsed towards complete satisfaction of the performance obligation.
Since the customer benefits
from the services as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using
the input method. The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates
the straight line attribution. The Company used significant judgment when it determined the product submission date.
Under ASC 606, the consideration
that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future
events, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included
in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related
to milestones of which the occurrence is not considered the most likely outcome.
The Company then evaluates
if any of the variable consideration determined in the first step is constrained by including in the transaction price variable consideration
to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty
associated with the variable consideration is subsequently resolved. The Company used significant judgment when it determined the first
step of variable consideration.
Comparison of Fiscal
2021 to Fiscal 2020
The following table summarizes
certain statements of operations data for us for the twelve month periods ended August 31, 2021 and 2020:
|
|
Year ended
August 31,
|
|
Operating Data:
|
|
2021
|
|
|
2020
|
|
|
|
(dollar amounts in thousands, except per share data)
|
|
Revenues
|
|
$
|
2,703
|
|
|
$
|
2,710
|
|
Cost of revenues
|
|
|
-
|
|
|
|
-
|
|
Research and development expenses
|
|
|
20,989
|
|
|
|
10,235
|
|
General and administrative expenses
|
|
|
5,937
|
|
|
|
4,232
|
|
Financial income, net
|
|
|
1,234
|
|
|
|
246
|
|
Loss before taxes on income
|
|
|
22,989
|
|
|
|
11,511
|
|
Taxes on income
|
|
|
-
|
|
|
|
-
|
|
Net loss for the year
|
|
|
22,989
|
|
|
|
11,511
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Company’s shareholders
|
|
|
22,238
|
|
|
|
11,511
|
|
Net loss attributable to non-controlling interest
|
|
|
751
|
|
|
|
-
|
|
Net loss for the year
|
|
|
22,989
|
|
|
|
11,511
|
|
|
|
|
|
|
|
|
|
|
Loss per common share – basic and diluted
|
|
$
|
0.78
|
|
|
$
|
0.56
|
|
Weighted average common shares outstanding
|
|
|
28,469,068
|
|
|
|
20,532,347
|
|
Revenues
Revenues consist of proceeds
related to the License Agreement that are recognized over the period from which the Company is entitled to the respective payments and
through June 2023.
Revenues for fiscal 2021 totaled
$2,703,000, consistent with $2,710,000 for fiscal 2020.
Cost of revenues
Cost of revenues consists
of royalties related to the License Agreement that will be paid over the term of the License Agreement in accordance with revenue recognition
accounting and the Law for the Encouragement of Industrial Research, Development and Technological Innovation, 1984, as amended, including
any regulations or tracks promulgated thereunder, or the R&D Law.
There were no cost of revenues
for fiscal 2021 and 2020.
Research and development
expenses
Research and development expenses
include costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits,
costs of materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials,
clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development. All costs associated with
research and development are expensed as incurred.
Clinical trial costs are a
significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial
portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators and other third-party
service providers to assist us with the execution of our clinical studies.
Clinical activities which
relate principally to clinical sites and other administrative functions to manage our clinical trials are performed primarily by CROs.
CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening
and preparation, pre-study visits, training and program management.
Clinical trial and pre-clinical
trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase of materials, cost
of manufacturing of the oral insulin and exenatide capsules, payments for patient recruitment and treatment, as well as salaries and related
expenses of research and development staff.
From August 2009 to March
2014, Oramed Ltd. was awarded five government grants amounting to a total net amount of NIS 8 million (approximately $2,194,000 during
such period) from the IIA. We used the funds to support further research and development and clinical studies of our oral insulin capsule
and oral GLP-1 analog during the period from February 2009 to December 2014. The five grants are subject to repayment according to the
terms determined by the IIA and applicable law. See “—Government grants” below.
Research and development
expenses for fiscal 2021 increased by 105% to $20,989,000 from $10,235,000 for fiscal 2020. The increase is primarily due to an increase
in expenses related to our Phase III clinical trial in addition to expenses related to the in process research and development costs related
to Oravax, partially offset by a decrease in expenses related to our Phase II clinical trial. During fiscal 2021, stock-based compensation
costs totaled $1,120,000, as compared to $458,000 during fiscal 2020. The increase is mainly attributable to new grants in fiscal 2021.
Government grants
The Government of Israel encourages
research and development projects through the IIA, pursuant to the R&D Law. Under the R&D Law, a research and development plan
that meets specified criteria is generally eligible for a grant of up to 50% of certain approved research and development expenditures.
Each plan must be approved by the IIA.
In fiscals 2021 and 2020,
we did not recognize any research and development grants. As of August 31, 2021, our liability to pay royalties to the IIA was $243,000.
Under the terms of the grants
we received from the IIA, we are obligated to pay royalties of 3% on all revenues derived from the sale of the products developed pursuant
to the funded plans, including revenues from licensed ancillary services. Royalties are generally payable up to a maximum amount equaling
100% of the grants received (dollar linked) with the addition of interest at an annual rate based on the LIBOR rate.
The R&D Law generally
requires that a product developed under a program be manufactured in Israel. However, when applying for a grant, the applicant may declare
that part of the manufacturing will be performed outside of Israel or by non-Israeli residents and if the IIA is convinced that performing
some of the manufacturing abroad is essential for the execution of the program, it may still approve the grant. This declaration will
be a significant factor in the determination of the IIA as to whether to approve a program and the amount and other terms of the benefits
to be granted. If a company wants to increase the volume of manufacturing outside of Israel after the grant has been approved, it may
transfer up to 10% of the company’s approved Israeli manufacturing volume, measured on an aggregate basis, outside of Israel after
first notifying the IIA thereof (provided that the IIA does not object to such transfer within 30 days). In addition, upon the approval
of the IIA, a portion greater than 10% of the manufacturing volume may be performed outside of Israel. In any case of transfer of manufacturing
out of Israel, the grant recipient is required to pay royalties at an increased rate, which may be substantial, and the aggregate repayment
amount is increased up to 120%, 150% or 300% of the grant, depending on the portion of the total manufacturing volume that is performed
outside of Israel. The approval we received from the IIA for the License Agreement was subject to payment of increased royalties and an
increased ceiling, all in accordance with the provisions of the R&D Law. The R&D Law further permits the IIA, among other things,
to approve the transfer of manufacturing rights outside of Israel in exchange for the import of different manufacturing into Israel as
a substitute, in lieu of the increased royalties.
The R&D Law also provides
that know-how developed under an approved research and development program may not be transferred or licensed to third parties in Israel
without the approval of the research committee. Such approval is not required for the sale or export of any products resulting from such
research or development. The R&D Law further provides that the know-how developed under an approved research and development program
may not be transferred or licensed to any third parties outside Israel absent IIA approval which may be granted in certain circumstances
as follows: (a) the grant recipient pays to the IIA a portion of the sale or license price paid in consideration for the purchase or license
of such IIA-funded know-how or the price paid in consideration for the sale of the grant recipient itself, as the case may be, in accordance
with certain formulas included in the R&D Law; (b) the grant recipient receives know-how from a third party in exchange for its IIA-funded
know-how; or (c) such transfer of IIA-funded know-how is made in the context of IIA approved research and development cooperation projects
or consortia.
The R&D Law imposes reporting
requirements with respect to certain changes in the ownership of a grant recipient. The R&D Law requires the grant recipient to notify
the IIA of any change in control of the recipient or a change in the holdings of the means of control of the recipient that results in
a non-Israeli entity becoming an interested party in the recipient, and requires the new non-Israeli interested party to undertake to
the IIA to comply with the R&D Law. In addition, the rules of the IIA may require the provision of additional information or representations
in respect of certain such events. For this purpose, “control” is defined as the ability to direct the activities of a company
other than any ability arising solely from serving as an officer or director of the company. A person is presumed to have control if such
person holds 50% or more of the means of control of a company. “Means of control” refers to voting rights or the right to
appoint directors or the chief executive officer. An “interested party” of a company includes a holder of 5% or more of its
outstanding share capital or voting rights, its chief executive officer and directors, someone who has the right to appoint its chief
executive officer or at least one director, and a company with respect to which any of the foregoing interested parties holds 25% or more
of the outstanding share capital or voting rights or has the right to appoint 25% or more of the directors.
Failure to meet the R&D
Law’s requirements may subject us to mandatory repayment of grants received by us (together with interest and penalties), as well
as expose us to criminal proceedings. In addition, the Israeli government may from time to time audit sales of products which it claims
incorporate technology funded through IIA programs which may lead to additional royalties being payable on additional products.
General and administrative
expenses
General and administrative
expenses include the salaries and related expenses of our management, consulting costs, legal and professional fees, travel expenses,
business development costs, insurance expenses and other general costs.
General and administrative
expenses increased by 40% from $4,232,000 for fiscal 2020 to $5,937,000 for fiscal 2021. The increase in costs incurred related to general
and administrative activities during fiscal 2021, is primarily attributable to an increase in stock-based compensation costs, an increase
in costs related to the directors and officers insurance policy and an increase in legal expenses, partially offset by a decrease in public
and investor relations expenses. During fiscal 2021, as part of our general and administrative expenses, we incurred expenses of $1,575,000
related to stock-based compensation costs, as compared to an expense of $714,000 during fiscal 2020. The increase is mainly attributable
to new grants during fiscal 2021.
Financial income, net
Net financial income, was $1,234,000
for fiscal 2021 as compared to net financial income of $246,000 for fiscal 2020. The increase is mainly attributable to an increase in
the fair market value of some investments.
Taxes on income
No taxes on income were recognized
for fiscal 2021 and 2020.
Fiscal 2020 compared with Fiscal 2019
For a discussion of fiscal
2020 compared with fiscal 2019, see Management’s Discussion and Analysis of Financial Condition and Results of Operations included
in our Annual Report on Form 10-K for the fiscal year ended August 31, 2020.
Liquidity and Capital Resources
From our inception through
August 31, 2021, we have incurred losses in an aggregate amount of $114,852,000. During that period we have financed our operations through
several private placements of our common stock, as well as public offerings of our common stock, raising a total of $181,492,000, net
of transaction costs. During that period we also received cash consideration of $27,300,000 from the exercise of warrants and options.
We will seek to obtain additional financing through similar sources in the future as needed. As of August 31, 2021, we had $77,245,000
of available cash, $11,044,000 of short term deposits, $25,016,000 of long term deposits and $12,543,000 of marketable securities.
Management continues to evaluate
various financing alternatives for funding future research and development activities and general and administrative expenses through
fundraising in the public or private equity markets. Although there is no assurance that we will be successful with those initiatives,
management believes that it will be able to secure the necessary financing as a result of future third party investments. Based on our
current cash resources and commitments, we believe we will be able to maintain our current planned development activities and the corresponding
level of expenditures for at least the next 12 months.
As of August 31, 2021, our
total current assets were $95,337,000 and our total current liabilities were $6,679,000. On August 31, 2021, we had a working capital
surplus of $88,658,000 and an accumulated loss of $114,852,000. As of August 31, 2020, our total current assets were $40,511,000 and our
total current liabilities were $4,536,000. On August 31, 2020, we had a working capital surplus of $35,975,000 and an accumulated loss
of $92,614,000. The increase in working capital surplus from August 31, 2020 to August 31, 2021 was primarily due to an increase in cash
and cash equivalents.
During fiscal 2021, cash and
cash equivalents increased to $77,245,000 from $19,296,000 as of August 31, 2020, which is due to the reasons described below.
Operating activities used cash
of $21,181,000 in fiscal 2021 compared to $12,440,000 used in fiscal 2020. Cash used in operating activities in fiscal 2021 and 2020 primarily
consisted of net loss resulting from research and development and general and administrative expenses.
Investing activities used cash
of $23,764,000 in fiscal 2021, as compared to $4,626,000 provided by investing activities in fiscal 2020. Cash used in investing activities
in fiscal 2021 consisted primarily of the acquisition of short-term and long-term investments, and acquisition of short-term and long-term
marketable securities, partially offset by proceeds from short-term investments and proceeds from the sale of marketable securities.
Financing activities provided
cash of $102,892,000 in fiscal 2021, as compared to $23,786,000 in fiscal 2020. Cash provided by financing activities during fiscal 2021
consisted of proceeds from our issuance of common stock and proceeds from exercise of warrants and options. Our primary financing activities
since the beginning of fiscal 2021 were as follows:
|
●
|
During fiscal 2021, 3,175,645 warrants were exercised and 103,782 options were exercised and resulted in the issuance of 3,253,334 shares of common stock. Out of these exercised options, 24,646 options were exercised for cash and 79,136 via cashless method. The cash consideration received for the exercise of options was $125,593. During fiscal 2020, no warrants were exercised and 12,253 options were exercised for cash and resulted in the issuance of 12,253 shares of common stock. The cash consideration received for the exercise of options was $12,253.
|
|
|
|
|
●
|
On December 1, 2020, we entered into an Equity Distribution Agreement,
or the New Sales Agreement, pursuant to which we could, from time to time and at our option, issue and sell shares of our common stock
having an aggregate offering price of up to $40,000,000 through a sales agent, subject to certain terms and conditions. Any shares sold
were to be sold pursuant to our effective shelf registration statement on Form S-3 including a prospectus dated February 10, 2020 as supplemented
by a prospectus supplement dated December 1, 2020. We paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale
of any shares sold through the sales agent under the New Sales Agreement. As of August 31, 2021, 4,061,956 shares were issued under the
New Sales Agreement for aggregate net proceeds of $38,799,000.
|
|
|
|
|
●
|
On June 16, 2021, we entered into an Equity Distribution Agreement,
or the Equity Distribution Agreement, pursuant to which we could, from time to time and at our option, issue and sell shares of our common
stock having an aggregate offering price of up to $28,000,000 through a sales agent, subject to certain terms and conditions. Any shares
sold were to be sold pursuant to our effective shelf registration statement on Form S-3 including a prospectus and prospectus supplement,
each dated February 10, 2020 (which superseded a prior registration statement, prospectus and prospectus supplement that related to shares
sold under the Equity Distribution Agreement). We paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of
any shares sold through the sales agent under the Equity Distribution Agreement. As of August 31, 2021, 1,823,287 shares were issued under
the Equity Distribution Agreement for aggregate net proceeds of $27,119,000.
|
|
|
|
|
●
|
On July 15, 2021, we entered into an additional Equity Distribution
Agreement, or the New Equity Distribution Agreement, pursuant to which we may, from time to time and at our option, issue and sell shares
of our common stock having an aggregate offering price of up to $100,000,000 through a sales agent, subject to certain terms and conditions.
Any shares sold was sold pursuant to our effective shelf registration statement on Form S-3 including a prospectus and prospectus supplement,
each dated July 15, 2021. We paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through
the sales agent under the New Equity Distribution Agreement. As of August 31, 2021 and through November 24, 2021, 208,451 and 273,997
shares were respectively issued under the New Equity Distribution Agreement for aggregate net proceeds of $3,884,000 and $5,129,000 respectively.
|
|
●
|
On
November 3, 2021, we entered into a Securities Purchase Agreement with several institutional and accredited investors, pursuant to which
we agreed to sell, in a registered direct offering, 2,000,000 shares of our common stock for an aggregate offering price of $50,000,000
to the Purchasers. The net proceeds from this offering were approximately $46,375,000.
|
Planned Expenditures
We invest heavily in research
and development, and we expect that in the upcoming years our research and development expenses, net, will continue to be our major operating
expense. We have expected obligations with respect to an aggregate of approximately $31 million of clinical research obligations over
the next three years.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK.
We are exposed to a variety
of risks, including changes in interest rates, foreign currency exchange rates, changes in the value of our marketable securities and
inflation.
As of August 31, 2021, we
had $77.2 million in cash and cash equivalents, $36 million in short term and long term bank deposits and $12.5 million in marketable
securities.
We aim to preserve our financial
assets, maintain adequate liquidity and maximize return while minimizing exposure to market risks. Such policy further provides that we
should hold most of our current assets in bank deposits. As of today, the currency of our financial assets is mainly in U.S. dollars.
Marketable securities
We own 1,701,357 common shares
of D.N.A, 117,000 ordinary shares of Entera which are presented in our financial statements as marketable
securities. Marketable securities are presented at fair value and their realization is subject to certain limitations if sold through
the market, and we are therefore exposed to market risk. There is no assurance that at the time of sale of the marketable securities the
price per share will be the same or higher, nor that we will be able to sell all of the securities at once given the volume of securities
we hold. Entera shares are traded on Nasdaq in U.S. dollars, while D.N.A shares are traded on the Tel Aviv Stock Exchange and the D.N.A
shares’ price is denominated in NIS. We are also exposed to changes in the market price of the Entera and D.N.A shares, as well
as to exchange rates fluctuations in the NIS currency compared to the U.S. dollar with respect to the D.N.A shares.
Interest Rate Risk
We invest a major portion
of our cash surplus in bank deposits in banks in Israel. Since the bank deposits typically carry fixed interest rates, financial income
over the holding period is not sensitive to changes in interest rates, but only the fair value of these instruments. However, our interest
gains from future deposits may decline in the future as a result of changes in the financial markets. In any event, given the historic
low levels of the interest rate, we estimate that a further decline in the interest rate we are receiving will not result in a material
adverse effect to our business.
Foreign Currency Exchange Risk and Inflation
A significant portion of
our expenditures, including salaries, clinical research expenses, consultants’ fees and office expenses relate to our operations
in Israel. The cost of those Israeli operations, as expressed in U.S. dollars, is influenced by the extent to which any increase in the
rate of inflation in Israel is not offset (or is offset on a lagging basis) by a devaluation of the NIS in relation to the U.S. dollar.
If the U.S. dollar declines in value in relation to the NIS, it will become more expensive for us to fund our operations in Israel. In
addition, as of August 31, 2021, we own net balances in NIS of approximately $1,287,000. Assuming a 10% appreciation of the NIS against
the U.S. dollar, we would experience exchange rate gain of approximately $143,000, while assuming a 10% devaluation of the NIS against
the U.S. dollar, we would experience an exchange rate loss of approximately $117,000.
The exchange rate of the
U.S. dollar to the NIS, based on exchange rates published by the Bank of Israel, was as follows:
|
|
Year Ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
2019
|
|
Average rate for period
|
|
|
3.292
|
|
|
|
3.490
|
|
|
|
3.623
|
|
Rate at period-end
|
|
|
3.207
|
|
|
|
3.362
|
|
|
|
3.535
|
|
We do not use any currency
hedging transactions of options or forwards to decrease the risk of financial exposure from fluctuations in the exchange rate of the U.S.
dollar against the NIS.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY
DATA.
See Item 15 of this Annual
Report on Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures
Our management, including
our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of August
31, 2021. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and
procedures are effective.
Management’s Annual Report on Internal
Control over Financial Reporting
Our management, under the
supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal
control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act. The Company’s
internal control over financial reporting is defined as a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. Internal control over financial
reporting includes policies and procedures that:
|
●
|
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;
|
|
●
|
provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
|
●
|
provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.
|
Under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness
of our internal control over financial reporting as of August 31, 2021 based on the current framework for Internal Control-Integrated
Framework (2013) set forth by The Committee of Sponsoring Organizations of the Treadway Commission.
Based on this evaluation,
our management concluded that the Company’s internal control over financial reporting was effective as of August 31, 2021 at a reasonable
assurance level.
Changes in Internal Control over Financial
Reporting
There were no changes in our
internal control over financial reporting that occurred during the quarter ended August 31, 2021 that have materially affected, or are
reasonable likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
Not applicable.
ITEM 9C. DISCLOSURE REGARDING FOREIGN
JURISDICTIONS THAT PREVENT INSPECTIONS.
Not applicable.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND
CORPORATE GOVERNANCE.
Set forth below is certain
information with respect to the individuals who are our directors and executive officers.
Name
|
|
Age
|
|
|
Position
|
Nadav Kidron
|
|
|
47
|
|
|
President, Chief Executive Officer and Director
|
|
|
|
|
|
|
|
Miriam Kidron
|
|
|
81
|
|
|
Chief Scientific Officer and Director
|
|
|
|
|
|
|
|
David Silberman
|
|
|
38
|
|
|
Chief Financial Officer, Treasurer and Secretary
|
|
|
|
|
|
|
|
Joshua Hexter
|
|
|
51
|
|
|
Chief Operating & Business Officer
|
|
|
|
|
|
|
|
Michael Rabinowitz
|
|
|
56
|
|
|
Chief Commercial Officer
|
|
|
|
|
|
|
|
Aviad Friedman
|
|
|
50
|
|
|
Director
|
|
|
|
|
|
|
|
Arie Mayer
|
|
|
66
|
|
|
Director
|
|
|
|
|
|
|
|
Kevin Rakin
|
|
|
61
|
|
|
Chairman, Director
|
|
|
|
|
|
|
|
Leonard Sank
|
|
|
57
|
|
|
Director
|
Dr. Miriam Kidron is Mr. Nadav
Kidron’s mother. There are no other directors or officers of the Company who are related by blood or marriage.
Business Experience
The following is a brief account
of the education and business experience during at least the past five years of each director and our executive officers who are not also
directors, indicating the principal occupation during that period, and the name and principal business of the organization in which such
occupation and employment were carried out.
Mr. Nadav Kidron was
appointed President, Chief Executive Officer and a director in March 2006. He is also a director of Israel
Advanced Technology Industries organization, and until 2016 was a director of Entera Bio Ltd. In 2009, he was a fellow at the Merage Foundation
for U.S.-Israel Trade Programs for executives in the life sciences field. From 2003 to 2006, he was the managing director of the Institute
of Advanced Jewish Studies at Bar Ilan University. From 2001 to 2003, he was a legal intern at Wine, Mishaiker & Ernstoff Law Offices
in Jerusalem, Israel. Mr. Kidron holds an LL.B. and an International MBA from Bar Ilan University, Israel, and is a member of the Israel
Bar Association.
We believe that Mr. Kidron’s
qualifications to serve on our Board include his familiarity with the Company as its founder, his experience in capital markets, as well
as his knowledge and familiarity with corporate management.
Dr. Miriam Kidron
was appointed Chief Scientific Officer and a director in March 2006. Dr. Kidron is a pharmacologist and a
biochemist with a Ph.D. in biochemistry. From 1990 to 2007, Dr. Kidron was a senior researcher in the Diabetes Unit at Hadassah University
Hospital in Jerusalem, Israel. During 2003 and 2004, Dr. Kidron served as a consultant to Emisphere Technologies Inc., a company that
specializes in developing broad-based proprietary drug delivery platforms. Dr. Kidron was formerly a visiting professor at the Medical
School at the University of Toronto (Canada), and is a member of the American, European and Israeli Diabetes Associations. Dr. Kidron
is a recipient of the Bern Schlanger Award.
We believe that Dr. Kidron’s
qualifications to serve on our Board include her expertise in the Company’s technology, as it is based on her research, as well
as her experience and relevant education in the fields of pharmacology and diabetes.
Mr. David Silberman
was appointed Chief Financial Officer, Treasurer and Secretary effective July 2021. Prior to his appointment, from April
2018 until May 2021, Mr. Silberman served as a Corporate Financial Planning and Analysis associate director and director at Teva Pharmaceutical
Industries Ltd., a global pharmaceutical company, committed to helping patients around the world to access affordable medicines and benefit
from innovations to improve their health. From 2014 to 2018, Mr. Silberman served as Global Internal Audit Senior Manager at Teva Pharmaceutical
Industries Ltd.. From 2009 to 2014, Mr. Silberman provided internal audit and risk management services in the advisory department of Grant
Thornton Fahn Kanne Control Management. From January 2009 until June 2009, Mr. Silberman worked in the audit department of KPMG, a certified
public accounting firm. Mr. Silberman holds a DCG and a DSCG degrees from the French Ministry of higher study and research and is a certified
public accountant in Israel.
Mr. Joshua Hexter
was appointed Chief Operating & Business Officer, effective September 2019. Prior to his appointment, Mr. Hexter served
as Chief Business Officer at BrainsWay Ltd. (Nasdaq/TASE: BWAY) from 2018 to 2019, a commercial stage medical device company focused on
the development and sale of non-invasive neuromodulation products. From 2013 to 2018, Mr. Hexter served as Chief Operating Officer and
VP Business Development of the Company and from 2007 to 2013, Mr. Hexter was a Director or Executive Director of BioLineRx Ltd. (Nasdaq/TASE:
BLRX), a biopharmaceutical development company dedicated to identifying, in-licensing and developing innovative therapeutic candidates.
Prior to his employment with BioLineRx, Mr. Hexter was a member of the board of directors and Chief Executive Officer of Biosensor Systems
Design, Inc., a company developing market-driven biosensors. Mr. Hexter holds a bachelor’s degree from the University of Wisconsin
and a master’s degree in management from Boston University.
Mr. Michael Rabinowitz
was appointed Chief Commercial Officer, effective August 1, 2021. Prior to his appointment, from June 1993 until
February 2021, Mr. Rabinowitz served in various marketing, sales, business development, and financial leadership roles at the global biopharmaceutical
company Merck & Co., where he launched and marketed products in over 30 countries across several disease areas, including launching
billion-dollar oral agents in diabetes and managing a global business. Mr. Rabinowitz holds a Masters’ Degree from The Carlson School
of Management, University of Minnesota. He has also participated in executive health care programs at the Harvard Business School.
Mr. Aviad Friedman
became a director in August 2016. Mr. Friedman is an international businessman and since July 2021, he has been acting as
Director General of Israel’s Housing Ministry. From 2007 to 2021, he was Chief Executive Officer of Most Properties 1998 Ltd.. Mr.
Friedman was the first Director General of Israel’s Ministry of Diaspora Affairs and served as personal advisor to Prime Minister
Ariel Sharon from 2001 to 2005. Mr. Friedman served as Chief Operating Officer of one of Israel’s premier newspapers, Ma’ariv
from 2003 to 2007, and has more than 15 years of experience serving on boards of public and private companies including Maayan Ventures,
Capital Point, Rosetta Green Ltd and Aerodrome Groupe Ltd. Mr. Friedman additionally served as an investor and consultant at Rhythmia
Medical Inc. from 2007, and was actively involved in the sale of the company to Boston Scientific in 2012. Mr. Friedman holds a bachelor’s
degree and master’s degree with honors in Public Administration from Bar-Ilan University.
We believe that Mr. Friedman’s
qualifications to serve on our Board include his experience in serving as a director of public and private companies as well as his knowledge
and familiarity with corporate finance.
Dr. Arie Mayer
became a director in December 2019. Dr. Mayer, is currently the Managing Director and Chairman of the Board of Sigma-Aldrich
Israel Ltd. and has held that position since January 2010. Dr. Mayer has held various roles with Sigma-Aldrich Israel Ltd. since 1995
and was instrumental in introducing and developing the Cell Culture and Molecular Biology business for Sigma Aldrich Israel Ltd. Dr. Mayer
holds a Bachelor of Science degree in chemistry from Hebrew University and a Ph.D. in biochemistry from Israel Institute of Technology.
We believe that Dr. Mayer’s
qualifications to serve on our Board include his experience as an executive in the biotechnology industry, as well as his experience and
relevant education in the fields of chemistry and biochemistry.
Mr. Kevin Rakin
became a director in August 2016 and Chairman of the Board in July 2017. Mr. Rakin is a co-founder and partner at Quantum
Si Incorporated (formerly HighCape Partners), a growth equity life sciences fund where he has served since 2013. From June 2011 to November
2012, Mr. Rakin was the President of Regenerative Medicine at Shire plc, or Shire, a leading specialty biopharmaceutical company. Prior
to joining Shire, Mr. Rakin served as the Chairman and Chief Executive Officer of Advanced BioHealing, Inc. from 2007 until its acquisition
by Shire for $750 million in June 2011. Mr. Rakin currently serves on the boards of Quantum-Si Inc. (Nasdaq: QSI), Aziyo Biologics Inc.
(Nasdaq: AZYO) and Nyxoah SA (Nasdaq: NYXH) as well as a number of private companies. Mr. Rakin holds an MBA from Columbia University
and received his graduate and undergraduate degrees in Commerce from the University of Cape Town, South Africa.
We believe that Mr. Rakin’s
qualifications to serve on our Board include his extensive experience as an executive in the biotechnology industry, as well as his service
in positions in various companies as a chief executive officer, chief financial officer and president and his involvement in public and
private financings and mergers and acquisitions in the biotechnology industry.
Mr. Leonard Sank
became a director in October 2007. Mr. Sank is a South African entrepreneur and businessman, whose interests lie in entrepreneurial
endeavors and initiatives, with over 25 years’ experience of playing significant leadership roles in developing businesses. Mr.
Sank serves on the boards of a few national businesses and local non-profit charity organizations in Cape Town, where he resides.
We believe that Mr. Sank’s
qualifications to serve on our Board include his years of experience in development stage businesses, as well as his experience serving
as a director of many entities.
Board of Directors
There are no agreements with
respect to the election of directors. Each director is elected for a period of one year at our annual meeting of stockholders and serves
until the next such meeting and until his or her successor is duly elected or until his or her earlier resignation or removal. The Board
may also appoint additional directors. A director so chosen or appointed will hold office until the next annual meeting of stockholders
and until his or her successor is duly elected and qualified or until his or her earlier resignation or removal. The Board has determined
that Aviad Friedman, Arie Mayer, Kevin Rakin and Leonard Sank are independent as defined under the rules promulgated by Nasdaq.
We have determined that each
of the directors is qualified to serve as a director of the Company based on a review of the experience, qualifications, attributes and
skills of each director. In reaching this determination, we have considered a variety of criteria, including, among other things: character
and integrity; ability to review critically, evaluate, question and discuss information provided, to exercise effective business judgment
and to interact effectively with the other directors; and willingness and ability to commit the time necessary to perform the duties of
a director.
Board Meeting Attendance
During fiscal 2021, our
Board held 15 meetings and took actions by written consent on 13 occasions. Board members are encouraged to attend our annual
meetings of stockholders.
All of our directors, except
Mr. Gao Xiaoming, whose term as a director expired on August 30, 2021, attended at least 75% of the aggregate number of meetings of the
Board and the committees that were held during the period such director served on the Board.
Committees
Audit Committee and Audit
Committee Financial Expert
The members of our Audit Committee
are Aviad Friedman, Arie Mayer and Kevin Rakin. Our Board has determined that Aviad Friedman is an “audit committee financial expert”
as set forth in Item 407(d)(5) of Regulation S-K and that all members of the Audit Committee are “independent” as defined
by the rules of the SEC and the Nasdaq rules and regulations. The Audit Committee operates under a written charter that is posted on the
“Investors” section of our website, www.oramed.com. The primary responsibilities of our Audit Committee include:
|
●
|
Overseeing the accounting and financial reporting processes of the Company and the audits of the financial statements of the Company;
|
|
●
|
Appointing, compensating and retaining our registered independent public accounting firm;
|
|
●
|
Overseeing the work performed by any outside accounting firm;
|
|
●
|
Assisting the Board in fulfilling its responsibilities by reviewing: (i) the financial reports provided by us to the SEC, our stockholders or to the general public and (ii) our internal financial and accounting controls; and
|
|
●
|
Recommending, establishing and monitoring procedures designed to improve the quality and reliability of the disclosure of our financial condition and results of operations.
|
Compensation Committee
The members of our Compensation
Committee are Aviad Friedman, Kevin Rakin and Leonard Sank. The Board has determined that all of the members of the Compensation Committee
are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations. The Compensation Committee operates
under a written charter that is posted on the “Investors” section of our website, www.oramed.com. The primary responsibilities
of our Compensation Committee include:
|
●
|
Reviewing, negotiating and approving, or recommending for approval by our Board the salaries and incentive compensation of our executive officers;
|
|
●
|
Administering our equity based plans and making recommendations to our Board with respect to our incentive-compensation plans and equity-based plans; and
|
|
●
|
Making recommendations to our Board with respect to director compensation.
|
Nominating Committee
The members of our Nominating Committee are Arie Mayer and Kevin Rakin.
The Board has determined that all of the members of the Nominating Committee are “independent” as defined by the rules of
the SEC and Nasdaq rules and regulations. The Nominating Committee operates under a written charter that is posted on the “Investors”
section of our website, www.oramed.com . The primary responsibilities of our Nominating Committee include:
|
●
|
Overseeing the composition and size of the Board, developing qualification criteria for Board members and actively seeking, interviewing and screening individuals qualified to become Board members for recommendation to the Board;
|
|
●
|
Recommending the composition of the Board for each annual meeting of stockholders; and
|
|
●
|
Reviewing periodically with the Chairman of the Board and the Chief Executive Officer the succession plans relating to positions held by directors, and making recommendations to the Board with respect to the selection and development of individuals to occupy those positions.
|
Delinquent Section 16(a) Reports
Based solely upon a review
of Forms 3, 4 and 5, and amendments thereto, furnished to us during fiscal 2021, we believe that during fiscal 2021, our executive officers,
directors and all persons who own more than ten percent of a registered class of our equity securities complied with all Section 16(a)
filing requirements, except: (a) Avraham Gabay, our former Chief Financial Officer, failed to timely file a Form 4 reporting his February
3, 2021 acquisition of options to purchase 40,000 shares of our common stock. Mr. Gabay filed a Form 4 reporting this transaction on February
8, 2021, (b) Joshua Hexter, our Chief Operating & Business Officer, failed to timely file a Form 4 reporting his February 3, 2021
acquisition of options to purchase 50,000 shares of our common stock. Mr. Hexter filed a Form 4 reporting this transaction on February
8, 2021, (c) Nadav Kidron, our President, Chief Executive Officer and one of our directors, failed to timely file a Form 4 reporting his
February 3, 2021 acquisition of options to purchase 150,000 shares of our common stock. Mr. Kidron filed a Form 4 reporting this transaction
on February 8, 2021 and (d) Miriam Kidron, our Chief Scientific Officer and one of our directors, failed to timely file a Form 4 reporting
her February 3, 2021 acquisition of options to purchase 100,000 shares of our common stock. Ms. Kidron filed a Form 4 reporting this transaction
on February 8, 2021.
Code of Ethics
We have adopted a Code of
Ethics and Business Conduct for our senior officers, directors and employees. A copy of the Code of Ethics and Business Conduct is located
at our website at www.oramed.com. We intend to satisfy the disclosure requirement regarding any amendment to, or a waiver from, a provision
of the Code of Ethics that applies to our Chief Executive Officer, or CEO, Chief Financial Officer or controller, or persons performing
similar functions and that relates to the Code of Ethics by posting such information on our website, www.oramed.com.
ITEM 11. EXECUTIVE COMPENSATION.
Compensation Discussion and Analysis
This section explains the
policies and decisions that shape our executive compensation program, including its specific objectives and elements, as it relates to
our “named executive officers,” or NEOs. Our NEOs for fiscal 2021 are those four individuals listed in the “Summary
Compensation Table” below. The Compensation Committee believes that our executive compensation is appropriately designed to incentivize
our named executive officers to work for our long-term prosperity, is reasonable in comparison with the levels of compensation provided
by comparable companies and reflects a reasonable cost. We believe our named executive officers are critical to the achievement of our
corporate goals, through which we can drive stockholder value.
The Compensation Committee
of our Board is comprised solely of independent directors as defined by Nasdaq and non-employee directors as defined by Rule 16b-3 under
the Exchange Act. The Compensation Committee has the authority and responsibility to review and approve the compensation of our CEO and
other executive officers. Other information concerning the structure, roles and responsibilities of our Compensation Committee is set
forth in “Board Meetings and Committees—Compensation Committee” section.
Our executive compensation
program and our NEOs’ compensation packages are designed around the following objectives:
|
●
|
attract, hire, and retain talented and experienced executives;
|
|
●
|
motivate, reward and retain executives whose knowledge, skills and performance are critical to our success;
|
|
●
|
ensure fairness among the executive management team via recognizing the contributions of each executive to our success;
|
|
●
|
focus executive behavior on achievement of our corporate objectives and strategy; and
|
|
●
|
align the interests of management and stockholders by providing management with longer-term incentives through equity ownership.
|
The Compensation Committee
reviews the allocation of compensation components regularly to ensure alignment with strategic and operating goals, competitive market
practices and legislative changes. The Compensation Committee does not apply a specific formula to determine the allocation between cash
and non-cash forms of compensation. Certain compensation components, such as base salaries, benefits and perquisites, are intended primarily
to attract, hire, and retain well-qualified executives. Other compensation elements, such as long-term incentive opportunities, are designed
to motivate and reward performance. Long-term incentives are intended to reward NEOs for our long-term performance and executing our business
strategy, and to strongly align NEOs’ interests with those of stockholders.
With respect to equity compensation,
the Compensation Committee makes awards to executives under our 2019 Stock Incentive Plan, as amended and restated, or the 2019 Plan.
Executive compensation is paid or granted based on such matters as the Compensation Committee deems appropriate, including our financial
and operating performance and the alignment of the interests of the executive officers and our stockholders.
Elements of Compensation
Our executive officer compensation
program is comprised of: (i) base salary or monthly compensation; (ii) discretionary bonus; (iii) long-term equity incentive compensation
in the form of stock option grants; and (iv) benefits and perquisites.
In establishing overall executive
compensation levels and making specific compensation decisions for our NEOs in fiscal 2021, the Compensation Committee considered a number
of criteria, including the executive’s position, scope of responsibilities, prior base salary and annual incentive awards and expected
contribution.
Generally, our Compensation
Committee reviews and, as appropriate, approves compensation arrangements for the NEOs from time to time but not less than once each year.
The Compensation Committee also takes into consideration the CEO’s recommendations for executive compensation of the other NEOs.
The CEO generally presents these recommendations at the time of our Compensation Committee’s review of executive compensation arrangements.
Base Salary
The Compensation Committee
performs a review of base salaries and monthly compensation for our NEOs from time to time as appropriate. In determining salaries, the
Compensation Committee members also take into consideration the scope of the NEOs’ responsibilities and independent third-party
market data, such as compensation surveys to industry, individual experience and performance and contribution to our clinical, regulatory,
commercial and operational performance. None of the factors above has a dominant weight in determining the compensation of our named executive
officers, and our Compensation Committee considers the factors as a whole when considering such compensation. In addition, our Compensation
Committee uses comparative data regarding compensation paid by peer companies in order to obtain a general understanding of current trends
in compensation practices and ranges of amounts being awarded by other public companies, and not as part of an analysis or a formula.
We believe that a competitive
base salary and monthly compensation is a necessary element of any compensation program that is designed to attract and retain talented
and experienced executives. We also believe that attractive base salaries can motivate and reward executives for their overall performance.
Base salary and monthly compensation are established in part based on the individual experience, skills and expected contributions to
our performance, as well as such executive’s performance during the prior year. Generally, we believe that executives’ base
salaries should be targeted near the median of the range of salaries for executives in similar positions with similar responsibilities,
experience and performance at comparable companies. Compensation adjustments are made occasionally based on changes in an executive’s
level of responsibility, company progress or on changed local and specific executive employment market conditions.
In fiscal 2021, our Compensation
Committee increased the base salary of one of our NEOs by 15% as it deemed this to be a reasonable rate based on, among other factors,
such NEO’s increased responsibilities and time passed since the last salary increase.
Performance Based Bonus
Our NEOs are eligible to
receive discretionary annual bonuses based upon performance. The amount of annual bonus to our NEOs is based on various factors, including,
among others, the achievement of scientific and business goals and our financial and operational performance. The Compensation Committee
takes into account the overall performance of the individuals, as well as the overall performance of the Company over the period being
reviewed and the recommendation of management. For any given year, the compensation objectives vary, but relate generally to strategic
factors such as developments in our clinical path, the execution of a license agreement for the commercialization of product candidates,
the establishment of key strategic collaborations, the build-up of our pipeline and financial factors such as capital raising. Bonuses
are awarded generally based on corporate performance, with adjustments made within a range for individual performance, at the discretion
of the Compensation Committee. The Compensation Committee determines, on a discretionary basis, the size of the entire bonus pool and
the amount of the actual award to each NEO. The overall payment is also based on historic compensation of the NEOs.
We believe that annual bonuses
payable based on the achievement of short-term corporate goals incentivize our NEOs to create stockholder value and attain short-term
performance objectives.
Long-Term Equity Incentive Compensation
Long-term incentive compensation
allows the NEOs to share in any appreciation in the value of our common stock. The Compensation Committee believes that stock participation
aligns executive officers’ interests with those of our stockholders. Equity incentive awards are generally made at the commencement
of employment and following a significant change in job responsibilities, or to meet other special retention or performance objectives.
The amounts of the awards are designed to reward past performance and create incentives to meet long-term objectives. Awards are made
at a level expected to be competitive within the biotechnology industry, as well as with Israeli-based companies. Awards are made on a
discretionary basis and not pursuant to specific criteria set out in advance. In determining the amount of each grant, the Compensation
Committee also takes into account the number of shares held by the executive prior to the grant. The vesting schedule for NEOs generally
provides for annual installments for new grants, though the Compensation Committee also utilizes quarterly vesting from time to time,
as well as performance-based vesting. The Compensation Committee believes that time-based vesting encourages recipients to build stockholder
value over a long period of time and that performance-based vesting encourages recipients to achieve goals that benefit the Company.
Benefits and Perquisites
Generally, benefits available
to NEOs are available to all employees on similar terms and include welfare benefits, paid time-off, life and disability insurance and
other customary or mandatory social benefits in Israel. We provide our NEOs with a phone and a company car, which are customary benefits
in Israel to managers and officers.
We do not believe that the
benefits and perquisites described above deviate materially from the customary practice for compensation of executive officers by other
companies similar in size and stage of development in Israel. These benefits represent a relatively small portion of the executive officers’
total compensation.
The Company pays for certain
direct costs, related taxes and expenses incurred in connection with the relocation of our CEO to United States. During fiscal 2021, such
relocation expenses totaled approximately $377,000, and included mainly payments intended to reflect the difference in the cost of living
between Israel and the United States, relocation expenses, accommodation allowances, education allowances, health insurance and related
taxes.
Say-on-Pay Vote
Our stockholders
approved, on an advisory basis, our executive compensation program at our annual meeting of stockholders held on August 3, 2020. We did
not seek or receive any specific feedback from our stockholders concerning our executive compensation program during the past fiscal year.
The Compensation Committee did not specifically rely on the results of the prior vote in making any compensation-related decisions during
fiscal 2021.
REPORT OF THE COMPENSATION COMMITTEE
The Compensation Committee
has reviewed and discussed the foregoing Compensation Discussion and Analysis required by Item 402(b) of Regulation S-K with our management
and, based on such review and discussions, the Compensation Committee recommended to our Board that the Compensation Discussion and Analysis
be included in this Annual Report on Form 10-K and in our proxy statement relating to our next annual meeting of stockholders.
|
Compensation Committee Members:
|
|
|
|
Aviad Friedman
|
|
Kevin Rakin
|
|
Leonard Sank
|
SUMMARY COMPENSATION TABLE
The following table sets forth the compensation
earned by our NEOs for fiscals 2021, 2020 and 2019.
Name and Principal Position
|
|
Year
(1)
|
|
|
Salary
($)
(2)
|
|
|
Bonus
($)
(2)(3)
|
|
|
RSUs Awards
($)
(4)
|
|
|
Option Awards
($)
(4)(5)
|
|
|
All Other
Compensation
($)
(2)(6)
|
|
|
Total
($)
|
|
Nadav Kidron
|
|
|
2021
|
|
|
|
465,982
|
|
|
|
300,000
|
|
|
|
1,995,666
|
|
|
|
876,693
|
|
|
|
382,240
|
|
|
|
4,020,581
|
|
President and CEO and director(7)
|
|
|
2020
|
|
|
|
439,076
|
|
|
|
220,582
|
|
|
|
-
|
|
|
|
569,062
|
|
|
|
539,131
|
|
|
|
1,767,851
|
|
|
|
|
2019
|
|
|
|
419,460
|
|
|
|
224,975
|
|
|
|
-
|
|
|
|
398,910
|
|
|
|
507,750
|
|
|
|
1,551,095
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Miriam Kidron
|
|
|
2021
|
|
|
|
319,868
|
|
|
|
86,000
|
|
|
|
1,330,451
|
|
|
|
584,462
|
|
|
|
14,193
|
|
|
|
2,334,974
|
|
Chief Scientific Officer and director(8)
|
|
|
2020
|
|
|
|
305,840
|
|
|
|
70,000
|
|
|
|
-
|
|
|
|
299,506
|
|
|
|
13,354
|
|
|
|
688,700
|
|
|
|
|
2019
|
|
|
|
267,386
|
|
|
|
123,149
|
|
|
|
-
|
|
|
|
211,128
|
|
|
|
14,503
|
|
|
|
616,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avraham Gabay
|
|
|
2021
|
|
|
|
156,113
|
|
|
|
60,000
|
|
|
|
532,174
|
|
|
|
233,785
|
|
|
|
43,616
|
|
|
|
1,025,688
|
|
Former Chief Financial Officer(9)
|
|
|
2020
|
|
|
|
130,554
|
|
|
|
15,951
|
|
|
|
-
|
|
|
|
-
|
|
|
|
44,912
|
|
|
|
191,418
|
|
|
|
|
2019
|
|
|
|
32,122
|
|
|
|
-
|
|
|
|
-
|
|
|
|
73,928
|
|
|
|
9,441
|
|
|
|
115,491
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Silberman
|
|
|
2021
|
|
|
|
27,762
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
4,376
|
|
|
|
32,138
|
|
Chief Financial Officer(10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joshua Hexter
|
|
|
2021
|
|
|
|
206,223
|
|
|
|
60,000
|
|
|
|
665,215
|
|
|
|
292,231
|
|
|
|
60,720
|
|
|
|
1,284,389
|
|
Chief Operating & Business Officer(11)
|
|
|
2020
|
|
|
|
190,801
|
|
|
|
12,169
|
|
|
|
-
|
|
|
|
351,128
|
|
|
|
54,735
|
|
|
|
608,833
|
|
|
|
|
2019
|
|
|
|
52,848
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
9,022
|
|
|
|
61,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Rabinowitz
|
|
|
2021
|
|
|
|
30,015
|
|
|
|
-
|
|
|
|
986,352
|
|
|
|
860,416
|
|
|
|
-
|
|
|
|
1,876,783
|
|
Chief Commercial Officer(12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
The information is provided for each fiscal year, which begins on September 1 and ends on August 31.
|
(2)
|
Amounts paid for Salary, Bonus and All Other Compensation were originally denominated in NIS and were translated into U.S. Dollars at the then current exchange rate for each payment.
|
(3)
|
Bonuses were granted at the discretion of the Compensation Committee.
|
(4)
|
For RSU awards, the amounts reflect the grant date fair value, as calculated pursuant to FASB ASC Topic 718. The assumptions used to determine the fair value of the RSU awards are set forth in Note 8 to our audited consolidated financial statements included in this Annual Report on Form 10-K. Our NEOs will not realize the value of these awards in cash unless and until the awards vest and the underlying shares are issued and subsequently sold.
|
|
|
(5)
|
The amounts reflect the grant date fair value, as calculated pursuant to FASB ASC Topic 718, of these option awards. The assumptions used to determine the fair value of the option awards are set forth in Note 8 to our audited consolidated financial statements included in this Annual Report on Form 10-K. Our NEOs will not realize the value of these awards in cash unless and until these awards are exercised and the underlying shares subsequently sold.
|
(6)
|
Amounts exclude the fair market value of the options that were re-granted on September 11, 2019, as it was offset by the negative amount created by the cancelled options (that is, it was accounted for as a modification under FASB ASC Topic 718, and no incremental compensation expense was recorded). For more information about the regrant see Note 7(a) to our audited consolidated financial statements included in this Annual Report on Form 10-K. For more information about the regrant fair market value see “Grants of Plan-Based Awards” below.
|
(6)
|
See “All Other Compensation Table” below.
|
(7)
|
Mr. Kidron receives certain compensation from Oramed Ltd. through KNRY, Ltd., an Israeli entity owned by Dr. Miriam Kidron, or KNRY. See “—Employment and Consulting Agreements” below.
|
(8)
|
Dr. Kidron receives compensation from Oramed Ltd. through KNRY. See “—Employment and Consulting Agreements” below.
|
(9)
|
Mr. Gabay resigned from his positions, effective July 4, 2021.
|
(10)
|
Mr. Silberman was appointed as Chief Financial Officer, effective July 5, 2021.
|
|
|
(11)
|
Mr. Hexter was appointed Chief Operating & Business Officer, effective September 19, 2019. From 2013 to 2018, Mr. Hexter served as Chief Operating Officer and VP Business Development of the Company.
|
|
|
(12)
|
Mr. Rabinowitz was appointed as Chief Commercial Officer, effective August 1, 2021.
|
All Other Compensation Table
The “All Other Compensation”
amounts set forth in the Summary Compensation Table above consist of the following:
Name
|
|
Year
|
|
|
Automobile-
Related Expenses
($)
|
|
|
Manager’s
Insurance*
($)
|
|
|
Education
Fund*
($)
|
|
|
Relocation Expenses**
($)
|
|
|
Total
($)
|
|
Nadav Kidron
|
|
|
2021
|
|
|
|
4,926
|
|
|
|
-
|
|
|
|
-
|
|
|
|
377,314
|
|
|
|
382,240
|
|
|
|
|
2020
|
|
|
|
23,438
|
|
|
|
-
|
|
|
|
-
|
|
|
|
515,693
|
|
|
|
539,131
|
|
|
|
|
2019
|
|
|
|
21,090
|
|
|
|
-
|
|
|
|
-
|
|
|
|
486,660
|
|
|
|
507,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Miriam Kidron
|
|
|
2021
|
|
|
|
14,193
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
14,193
|
|
|
|
|
2020
|
|
|
|
13,354
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
13,354
|
|
|
|
|
2019
|
|
|
|
14,503
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
14,503
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avraham Gabay
|
|
|
2021
|
|
|
|
14,223
|
|
|
|
19,222
|
|
|
|
10,171
|
|
|
|
-
|
|
|
|
43,616
|
|
|
|
|
2020
|
|
|
|
16,625
|
|
|
|
18,606
|
|
|
|
9,681
|
|
|
|
-
|
|
|
|
44,912
|
|
|
|
|
2019
|
|
|
|
2,808
|
|
|
|
4,405
|
|
|
|
2,228
|
|
|
|
-
|
|
|
|
9,441
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Silberman
|
|
|
2021
|
|
|
|
-
|
|
|
|
3,527
|
|
|
|
849
|
|
|
|
-
|
|
|
|
4,376
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joshua Hexter
|
|
|
2021
|
|
|
|
18,163
|
|
|
|
28,327
|
|
|
|
14,230
|
|
|
|
-
|
|
|
|
60,720
|
|
|
|
|
2020
|
|
|
|
13,685
|
|
|
|
26,820
|
|
|
|
14,230
|
|
|
|
-
|
|
|
|
54,735
|
|
|
|
|
2019
|
|
|
|
4,409
|
|
|
|
1,985
|
|
|
|
2,628
|
|
|
|
-
|
|
|
|
9,022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Rabinowitz
|
|
|
2021
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
*
|
Manager’s insurance and education funds are customary benefits provided to employees based in Israel. Manager’s insurance is a combination of severance savings (in accordance with Israeli law), defined contribution tax-qualified pension savings and disability insurance premiums. An education fund is a savings fund of pre-tax contributions to be used after a specified period of time for educational or other permitted purposes.
|
**
|
Relocation expenses represents additional compensation for the period during which Mr. Kidron was in the United States. These expenses mainly include relocation expenses, supplemental living expenses, accommodation allowances, education allowances, health insurance and related costs.
|
Employment and Consulting Agreements
On July 1, 2008, Oramed Ltd.
entered into a consulting agreement with KNRY, whereby Mr. Nadav Kidron, through KNRY, provides services as President and Chief Executive
Officer of both the Company and Oramed Ltd., or the Nadav Kidron Consulting Agreement. Additionally, on July 1, 2008, Oramed Ltd. entered
into a consulting agreement with KNRY whereby Dr. Miriam Kidron, through KNRY, provides services as Chief Scientific Officer of both the
Company and Oramed Ltd., or the Miriam Kidron Consulting Agreement. We refer to the Miriam Kidron Consulting Agreement and Nadav Kidron
Consulting Agreement collectively as the Consulting Agreements.
The Consulting Agreements
are both terminable by either party upon 140 days prior written notice. The Consulting Agreements, as amended, provide that KNRY will
be reimbursed for reasonable expenses incurred in connection with performance of the Consulting Agreements and that Nadav Kidron receives
a monthly consulting fee of NIS 127,570 and Miriam Kidron receives a monthly consulting fee of NIS 92,522. Pursuant to the Consulting
Agreements, KNRY, Nadav Kidron and Miriam Kidron each agree that during the term of the Consulting Agreements and for a 12-month period
thereafter, none of them will compete with Oramed Ltd. nor solicit employees of Oramed Ltd. Starting September 1, 2021, Nadav Kidron receives
a monthly consulting fee of NIS 146,705 and Miriam Kidron receives a monthly consulting fee of NIS 106,400.
We, through Oramed Ltd., have
entered into an employment agreement with David Silberman as of May 23, 2021, pursuant to which Mr. Silberman was appointed as Chief Financial
Officer, Treasurer and Secretary of the Company and Oramed Ltd., effective July 5, 2021. In accordance with the employment agreement,
as amended, Mr. Silberman’s current gross monthly salary is NIS 37,500. In addition, Mr. Silberman is provided with a cellular phone
and a company car allowance pursuant to the terms of his agreement. Starting September 1, 2021, Mr. Silberman’s gross monthly salary
is NIS 43,125.
We, through Oramed Ltd.,
have entered into an employment agreement with Joshua Hexter as of August 18, 2019, pursuant to which Mr. Hexter was appointed as Chief
Operating & Business Officer of the Company and Oramed Ltd., effective September 19, 2019. In accordance with the employment agreement,
as amended, Mr. Hexter’s current gross monthly salary is NIS 56,000. In addition, Mr. Hexter is provided with a cellular phone and
a company car pursuant to the terms of his agreement. Starting September 1, 2021, Mr. Hexter’s gross monthly salary is NIS 64,400.
We, through Oramed Inc., have
entered into an employment agreement with Michael Rabinowitz as of July 25, 2021, pursuant to which Mr. Rabinowitz was appointed as Chief
Commercial Officer of the Company, effective August 1, 2021. In accordance with the employment agreement, as amended, Mr. Rabinowitz’s
current gross monthly salary is $27,500. In addition, Mr. Rabinowitz is entitled to a monthly reimbursement of his cell phones expenses
and medical and dental benefits up to a certain amount per year.
We have entered into indemnification
agreements with our directors and officers pursuant to which we agreed to indemnify each director and officer for any liability he or
she may incur by reason of the fact that he or she serves as our director or officer, to the maximum extent permitted by law.
Potential Payments upon
Termination or Change-in-Control
We have no plans or arrangements
in respect of remuneration received or that may be received by our named executive officers to compensate such officers in the event of
termination of employment (as a result of resignation, retirement, change-in- control) or a change of responsibilities following a change-in-control.
Pension, Retirement or Similar Benefit Plans
We have no arrangements or
plans under which we provide pension, retirement or similar benefits for directors or executive officers. Our directors and executive
officers may receive stock options, RSUs or restricted shares at the discretion of our Compensation Committee in the future.
GRANTS OF PLAN-BASED AWARDS
The following table shows grants of plan-based
equity awards made to our NEOs during fiscal 2021. Mr. Silberman received no awards during fiscal 2021.
Name
|
|
Grant Date
|
|
|
Options Awards:
Number of
Securities
Underlying
Options
(#)
|
|
|
All Other
Stock Awards:
Number of
Securities
Underlying
RSUs
(#)
|
|
|
Grant Date
Fair Value of
Stock Awards
($)
|
|
Nadav Kidron(1)
|
|
02/03/2021
|
|
|
|
150,000
|
|
|
|
-
|
|
|
|
876,693
|
|
Nadav Kidron(2)
|
|
02/03/2021
|
|
|
|
-
|
|
|
|
300,000
|
|
|
|
1,995,666
|
|
Miriam Kidron(3)
|
|
02/03/2021
|
|
|
|
100,000
|
|
|
|
-
|
|
|
|
584,462
|
|
Miriam Kidron(4)
|
|
02/03/2021
|
|
|
|
-
|
|
|
|
200,000
|
|
|
|
1,330,451
|
|
Avraham Gabay(5)
|
|
02/03/2021
|
|
|
|
40,000
|
|
|
|
-
|
|
|
|
233,785
|
|
Avraham Gabay(6)
|
|
02/03/2021
|
|
|
|
-
|
|
|
|
80,000
|
|
|
|
532,174
|
|
Joshua Hexter(7)
|
|
02/03/2021
|
|
|
|
50,000
|
|
|
|
-
|
|
|
|
292,231
|
|
Joshua Hexter(8)
|
|
02/03/2021
|
|
|
|
-
|
|
|
|
100,000
|
|
|
|
665,215
|
|
Michael Rabinowitz(9)
|
|
08/04/2021
|
|
|
|
100,000
|
|
|
|
-
|
|
|
|
860,416
|
|
Michael Rabinowitz(10)
|
|
08/04/2021
|
|
|
|
-
|
|
|
|
100,000
|
|
|
|
986,352
|
|
(1)
|
These options were granted under our 2019 Plan and shall vest in four equal installments of 37,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
|
|
|
(2)
|
These RSUs were granted under our 2019 Plan and shall vest as follows: 100,000 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 100,000 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period and 100,000 upon achievement of a certain licensing agreement as specified by the Board of Directors.
|
|
|
(3)
|
These options were granted under our 2019 Plan and shall vest in four equal installments of 25,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
|
|
|
(4)
|
These RSUs were granted under our 2019 Plan and shall vest as follows: 66,667 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 66,667 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 66,666 upon achievement of a certain licensing agreement as specified by the Board of Directors.
|
|
|
(5)
|
These options were granted under our 2019 Plan and shall vest in four equal installments of 10,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
|
|
|
(6)
|
These RSUs were granted under our 2019 Plan and shall vest as follows: 26,666 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 26,667 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 26,667 upon achievement of a certain licensing agreement as specified by the Board of Directors.
|
(7)
|
These options were granted under our 2019 Plan and shall vest in four equal installments of 12,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
|
|
|
(8)
|
These RSUs were granted under our 2019 Plan and shall vest as follows: 33,333 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 33,333 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 33,334 upon achievement of a certain licensing agreement as specified by the Board of Directors.
|
|
|
(9)
|
These options were granted under our 2019 Plan. 12,500 shall vest on December 31, 2021, 25,000 on each of December 31, 2022, December 31, 2023 and December 31, 2024 and 12,500 on August 4, 2025.
|
|
|
(10)
|
These RSUs were granted under our 2019 Plan and shall vest as follows: 33,333 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 33,333 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 33,334 upon achievement of a certain licensing agreement as specified by the Board of Directors.
|
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
The following table sets forth
information concerning stock options and stock awards held by the NEOs as of August 31, 2021.
|
|
|
Option Awards
|
|
|
|
Stock Awards
|
Name
|
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
|
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
|
|
|
Option
Exercise
Price
($)
|
|
|
|
Option
Expiration
Date
|
|
|
|
Number of
shares that
have not
vested
(#)
|
|
|
|
Market
value of
shares that
have not
vested
($)
|
|
Nadav Kidron
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,000
|
(1)
|
|
|
-
|
|
|
|
4.08
|
|
|
|
8/8/22
|
|
|
|
|
|
|
|
|
|
|
|
|
47,134
|
(2)
|
|
|
-
|
|
|
|
12.45
|
|
|
|
4/9/24
|
|
|
|
|
|
|
|
|
|
|
|
|
49,000
|
(3)
|
|
|
-
|
|
|
|
7.77
|
|
|
|
6/30/27
|
|
|
|
|
|
|
|
|
|
|
|
|
72,750
|
(4)
|
|
|
24,250
|
(4)
|
|
|
8.14
|
|
|
|
1/31/28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98,250
|
(10)
|
|
|
98,250
|
(10)(13)
|
|
|
3.16
|
|
|
|
2/26/29
|
|
|
|
|
|
|
|
|
|
|
|
|
47,500
|
(15)
|
|
|
142,500
|
(15)
|
|
|
4.80
|
|
|
|
1/8/30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000
|
(17)
|
|
|
10.40
|
|
|
|
2/3/31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,000
|
(7)(8)(21)
|
|
|
3,936,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Miriam Kidron
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,000
|
(1)
|
|
|
-
|
|
|
|
4.08
|
|
|
|
8/8/22
|
|
|
|
|
|
|
|
|
|
|
|
|
47,134
|
(2)
|
|
|
-
|
|
|
|
12.45
|
|
|
|
4/9/24
|
|
|
|
|
|
|
|
|
|
|
|
|
69,999
|
(5)
|
|
|
-
|
|
|
|
7.77
|
|
|
|
6/30/27
|
|
|
|
|
|
|
|
|
|
|
|
|
35,250
|
(6)
|
|
|
11,750
|
(6)
|
|
|
8.14
|
|
|
|
1/31/28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,000
|
(11)
|
|
|
52,000
|
(11)(13)
|
|
|
3.16
|
|
|
|
2/26/29
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
(16)
|
|
|
75,000
|
(16)
|
|
|
4.80
|
|
|
|
1/8/30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000
|
(18)
|
|
|
10.40
|
|
|
|
2/3/31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
133,334
|
(9)(22)
|
|
|
2,624,013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avraham Gabay
|
|
|
-
|
(12)
|
|
|
18,500
|
(12)(13)
|
|
|
3.55
|
|
|
|
6/17/29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
(19)
|
|
|
10.40
|
|
|
|
2/3/31
|
|
|
|
|
(26)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joshua Hexter
|
|
|
50,000
|
(14)
|
|
|
150,000
|
(14)
|
|
|
3.69
|
|
|
|
9/11/29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
66,667
|
(23)
|
|
|
1,312,007
|
|
|
|
|
|
|
|
|
50,000
|
(20)
|
|
|
10.40
|
|
|
|
2/3/31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Rabinowitz
|
|
|
100,000
|
(24)
|
|
|
100,000
|
(24)
|
|
|
15.10
|
|
|
|
8/4/31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000
|
(25)
|
|
|
1,968,000
|
|
(1)
|
On August 8, 2012, 72,000 options were granted to each of Nadav Kidron and Miriam Kidron under the Second Amended and Restated 2008 Stock Incentive Plan, or the 2008 Plan, at an exercise price of $4.08 per share; 21,000 of such options vested immediately on the date of grant and the remainder vested in seventeen equal monthly installments, commencing on August 31, 2012. The options have an expiration date of August 8, 2022.
|
(2)
|
On April 9, 2014, 47,134 options were granted to each of Nadav Kidron and Miriam Kidron under the 2008 Plan at an exercise price of $12.45 per share; 15,710 of such options vested on April 30, 2014 and the remainder vested in eight equal monthly installments, commencing on May 31, 2014. The options have an expiration date of April 9, 2024.
|
(3)
|
On June 30, 2017, 147,000 options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $7.77 per share; 49,000 of such options vested on December 31, 2017 and the remainder vest in two equal installments of 49,000 on each of December 31, 2018 and December 31, 2019, subject to the Company share price reaching the target of $9.50 and $12.50 per share, respectively. The options expire on June 30, 2027. As of August 31, 2021, 98,000 options were forfeited.
|
|
|
(4)
|
On January 31, 2018,
97,000 options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $8.14 per share; 72,250 of such options
vested on each of January 1, 2019, January 1, 2020 and January 1, 2021 and the remainder of 24,250 shall vest on January 1, 2022.
The options expire on January 31, 2028.
|
(5)
|
On June 30, 2017, 69,999 options were granted to Miriam Kidron under the 2008 Plan at an exercise price of $7.77 per share; Such options vested in 3 equal installments of 23,333 on each of December 31, 2017, December 31, 2018 and December 31, 2019. The options have an expiration date of June 30, 2027.
|
(6)
|
On January 31, 2018, 47,000 options were granted to Miriam Kidron under the 2008 Plan at an exercise price of $8.14 per share; 35,250 of such options vested in three equal installments of 11,750 on each of January 1, 2019, January 1, 2020 and January 1, 2021 and the remainder of 11,750 shall vest on January 1, 2022. The options expire on January 31, 2028.
|
(7)
|
On November 13, 2014, 9,788 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. The RSUs vested in two equal installments, each of 4,894 shares, on November 30 and December 31, 2014. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
|
(8)
|
On February 23, 2015, 79,848 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. The RSUs vested in 23 installments consisting of one installment of 6,654 shares on February 28, 2015 and 22 equal monthly installments of 3,327 shares each, commencing March 31, 2015. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
|
(9)
|
On June 30, 2017, 75,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Miriam Kidron. The RSUs vested immediately, have an exercise price of $0.012 per share of common stock and expire on June 30, 2027.
|
(10)
|
On February 26, 2019, 196,500 options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $3.16 per share; 98,250 of such option vested on December 31, 2019 and December 31, 2020 and the remainder shall vest in two equal installments of 49,125 on each of December 31, 2021 and December 31, 2022. The options expire on February 26, 2029. For additional information please see note 13 below.
|
(11)
|
On February 26, 2019, 104,000 options were granted to Miriam Kidron under the 2008 Plan at an exercise price of $3.16 per share; 52,000 of such option vested on December 31, 2019 and December 31, 2020 and the remainder shall vest in two equal installments of 26,000 on each of December 31, 2021 and December 31, 2022. The options expire on February 26, 2029. For additional information please see note 13 below.
|
(12)
|
On June 17, 2019, 33,146 options were granted to Avraham Gabay under the 2008 Plan at an exercise price of $3.55 per share; 5,396 of the options vested on December 31, 2019 and the remining options shall vest in 3 equal installments of 9,250 on each of December 31, 2020, December 31, 2021 and December 31, 2022. The options expire on June 17, 2029. For additional information please see note 13 below.
|
(13)
|
On September 11, 2019, the options in this table were canceled and re-granted under the 2019 Plan in the same amounts and under the same terms as the original grants.
|
(14)
|
On September 11, 2019, 200,000 options were granted to Joshua Hexter under the 2019 Plan at an exercise price of $3.69 per share; 100,000 of such options shall vest in 16 equal installments of 6,250 on the first day of every three month period beginning November 1, 2019 and the remaining 100,000 shall vest upon achievement of certain performance conditions, such as consummating licensing agreements and entering into R&D collaboration agreements. The options expire on September 11, 2029.
|
(15)
|
On January 8, 2020, 190,000 options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $4.80 per share. 47,500 of the options vested on December 31, 2020 and the remainder shall vest in three equal installments of 47,500 on each of December 31, 2021, December 31, 2022 and December 31, 2023. The options expire on January 8, 2030.
|
(16)
|
On January 8, 2020, 100,000 options were granted to Miriam Kidron under the 2019 Plan at an exercise price of $4.80 per share. 25,000 of the options vested on December 31, 2020 and the remainder shall vest in three equal installments of 25,000 on each of December 31, 2021, December 31, 2022 and December 31, 2023. The options expire on January 8, 2030.
|
|
|
(17)
|
On February 3, 2021, 150,000 options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 37,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
|
|
|
(18)
|
On February 3, 2021, 100,000 options were granted to Miriam Kidron under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 25,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
|
|
|
(19)
|
On February 3, 2021, 40,000 options were granted to Avraham Gabay under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 10,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
|
|
|
(20)
|
On February 3, 2021, 50,000 options were granted to Joshua Hexter under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 12,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
|
|
|
(21)
|
On February 3, 2021, 300,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. 100,000 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 100,000 shares shall vest upon our common stock achieving a specified price per share, and 100,000 shall vest upon our achievement of certain business objectives. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
|
|
|
(22)
|
On February 3, 2021, 200,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Miriam Kidron. 66,666 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 66,667 shares shall vest upon our common stock achieving a specified price per share, and 66,667 shall vest upon our achievement of certain business objectives. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
|
|
|
(23)
|
On February 3, 2021, 100,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Joshua Hexter. 33,333 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 33,333 shares shall vest upon our common stock achieving a specified price per share, and 33,334 shall vest upon our achievement of certain business objectives. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
|
|
|
(24)
|
On August 4, 2021, 100,000 options were granted to Michael Rabinowitz under the 2019 Plan at an exercise price of $15.10 per share. The options shall vest as follows: 12,500 on December 31, 2021, three equal annual installments of 25,000 on each of December 31, 2022, 2023 and 2024 and 12,500 on August 4, 2025. The options expire on August 4, 2031.
|
|
|
(25)
|
On August 4, 2021, 100,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Michael Rabinowitz. 66,666 shares shall vest upon our common stock achieving a specified price per share, and 33,334 shall vest upon our achievement of certain business objectives.
|
|
|
(26)
|
Mr. Gabay resigned from his positions, effective July 4, 2021. Following his resignation, 39,250 options and 53,334 RSUs were forfeited.
|
Compensation Committee Interlocks and Insider Participation
During fiscal 2021, Mr. Aviad Friedman, Mr. Kevin
Rakin and Mr. Leonard Sank served as the members of our Compensation Committee. None of the members of our Compensation Committee is,
or has been, an officer or employee of ours.
During the last year, none
of our NEOs served as: (1) a member of the compensation committee (or other committee of the Board performing equivalent functions or,
in the absence of any such committee, the entire board of directors) of another entity, one of whose executive officers served on the
compensation committee; (2) a director of another entity, one of whose executive officers served on the compensation committee; or (3)
a member of the compensation committee (or other committee of the board of directors performing equivalent functions or, in the absence
of any such committee, the entire board of directors) of another entity, one of whose executive officers served as a director on our Board.
DIRECTOR COMPENSATION
The following table provides
information regarding compensation earned by, awarded or paid to each person for serving as a director who is not an executive officer
during fiscal 2021:
Name of Director
|
|
Fees
Earned or
Paid in
Cash
($)
|
|
|
Stock
Awards
(2) (3)
($)
|
|
|
Option
Awards
(2)
(3) ($)
|
|
|
All Other
Compensation
($)
|
|
|
Total
($)
|
|
Nadav Kidron(1)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Miriam Kidron(1)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Aviad Friedman
|
|
|
20,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
20,000
|
|
Arie Mayer
|
|
|
20,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
20,000
|
|
Kevin Rakin
|
|
|
20,000
|
|
|
|
217,764
|
|
|
|
98,048
|
|
|
|
-
|
|
|
|
335,812
|
|
Leonard Sank
|
|
|
20,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
20,000
|
|
Gao Xiaoming(4)
|
|
|
20,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
20,000
|
|
(1)
|
Please refer to the Summary Compensation Table for executive compensation with respect to the named individual.
|
(2)
|
As of August 31, 2021, our
non-employee directors then in office held options to purchase shares of our common stock and RSUs as follows:
|
Name of Director
|
|
Aggregate Number
of Shares
Underlying
Stock
Awards
|
|
|
Aggregate Number
of Shares
Underlying
Option
Awards
|
|
Aviad Friedman
|
|
|
-
|
|
|
|
40,857
|
|
Arie Mayer
|
|
|
-
|
|
|
|
20,000
|
|
Kevin Rakin
|
|
|
30,000
|
|
|
|
28,334
|
|
Leonard Sank
|
|
|
-
|
|
|
|
69,867
|
|
Gao Xiaoming
|
|
|
-
|
|
|
|
6,666
|
|
(3)
|
The amounts reflect the grant date fair value, as calculated pursuant to FASB ASC Topic 718, of these option awards. The assumptions used to determine the fair value of the option awards are set forth in Note 8 to our audited consolidated financial statements included in this Annual Report on Form 10-K. Our directors will not realize the value of these awards in cash unless and until these awards are exercised and the underlying shares subsequently sold.
|
|
|
(4)
|
Gao Xiaoming’s term as a director expired on August 30, 2021.
|
Our directors are entitled
to reimbursement for reasonable travel and other out-of-pocket expenses incurred in connection with attendance at meetings of our Board.
Each independent director is entitled to receive as remuneration for his or her service as a member of the Board a sum equal to $20,000
per annum, to be paid quarterly after the close of each quarter. Our executive officers did not receive additional compensation for service
as directors. The Board may award special remuneration to any director undertaking any special services on behalf of us other than services
ordinarily required of a director.
Other than as described above,
we have no present formal plan for compensating our directors for their service in their capacity as directors. Other than indicated above,
no director received and/or accrued any compensation for his services as a director, including committee participation and/or special
assignments during fiscal 2021.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Stock Option Plans
Our Board adopted the 2008
Plan and the 2019 Plan in order to attract and retain quality personnel.
The 2008 Plan, which is no
longer utilized for new grants, provided for the grant of stock options, restricted stock, RSUs, and stock appreciation rights, collectively
referred to as “awards”. Under the 2008 Plan, as amended, 2,400,000 shares were reserved for the grant of awards. As of August
31, 2021, options with respect to 2,287,989 shares had been granted, of which 275,673 had been forfeited, 254,697 had been exercised and
1,166,586 have expired. As of August 31, 2021, 525,824 RSUs had been granted, of which 164,636 have vested and the shares of common stock
underlying those RSUs have not been issued and 34,118 have been forfeited.
The 2019 Plan provides for
the grant of stock options, restricted stock, RSUs, and stock appreciation rights, collectively referred to as “awards.” Under
the 2019 Plan, 1,000,000 shares were initially reserved for the grant of awards. On June 29, 2020, and August 3, 2020, respectively, our
Board and stockholders approved to amend and restate the 2019 Plan, the principal change being an increase in the number of shares of
common stock available under the 2019 Plan from 1,000,000 shares to 3,000,000 shares. Stock options granted under the 2019 Plan may be
either incentive stock options under the provisions of Section 422 of the Code, or non-qualified stock options. Under the 2019 Plan, as
amended, 3,000,000 shares are reserved for the grant of awards, which may be issued at the discretion of our Board from time to time.
As of August 31, 2021, options with respect to 1,454,646 shares have been granted, of which 52,584 had been forfeited, 31,312 had been
exercised and none of them were expired. As of August 31, 2021, 810,000 RSUs had been granted, of which 236,665 have vested and the shares
of common stock underlying those RSUs have not been issued and 53,334 have been forfeited. Since the Company had granted options during
the time after the 2008 Plan allegedly terminated, and out of an abundance of caution, the Company canceled these grants and re-granted
certain of the options under 2019 Plan in the same amounts and under the same terms as the original grants.
The following table sets forth
additional information with respect to our equity compensation plans as of August 31, 2021:
Plan category
|
|
Number
of securities to be issued upon exercise of outstanding options, RSUs and rights (a)
|
|
|
Weight-
average exercise price of outstanding options, RSUs and rights (b)
|
|
|
Number
of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(c)
|
|
Equity compensation plans approved by security holders
|
|
|
2,883,085
|
|
|
$
|
4.57
|
|
|
|
841,272
|
|
Equity compensation plans not approved by security holders
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
Total
|
|
|
2,883,085
|
|
|
$
|
4.57
|
|
|
|
841,272
|
|
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth
certain information regarding the beneficial ownership of our common stock as of November 24, 2021 by: (1) each person who is known by
us to own beneficially more than 5% of our common stock; (2) each director; (3) each of our NEOs listed above under “Summary Compensation
Table”; and (4) all of our directors and current executive officers as a group. On such date, we had 38,086,020 shares of common
stock outstanding.
As used in the table below
and elsewhere in this form, the term “beneficial ownership” with respect to a security consists of sole or shared voting power,
including the power to vote or direct the vote, and/or sole or shared investment power, including the power to dispose or direct the disposition,
with respect to the security through any contract, arrangement, understanding, relationship, or otherwise, including a right to acquire
such power(s) during the next 60 days following November 24, 2021. Inclusion of shares in the table does not, however, constitute an admission
that the named stockholder is a direct or indirect beneficial owner of those shares. Unless otherwise indicated, (1) each person or entity
named in the table has sole voting power and investment power (or shares that power with that person’s spouse) with respect to all
shares of common stock listed as owned by that person or entity and (2) the address of each of the individuals named below is: c/o Oramed
Pharmaceuticals Inc., 1185 Avenue of the Americas, Third Floor, New York, NY 10036.
Name and Address of Beneficial Owner
|
|
Number of
Shares
|
|
|
Percentage
of Shares
Beneficially
Owned
|
|
Nadav Kidron #+
|
|
|
1,601,821
|
(1)
|
|
|
4.1
|
%
|
Miriam Kidron #+
|
|
|
530,799
|
(2)
|
|
|
1.4
|
%
|
Aviad Friedman #
|
|
|
34,190
|
(3)
|
|
|
*
|
|
Avraham Gabay+
|
|
|
-
|
(4)
|
|
|
*
|
|
David Silberman+
|
|
|
-
|
|
|
|
*
|
|
Joshua Hexter+
|
|
|
172,083
|
(5)
|
|
|
*
|
|
Michael Rabinowitz+
|
|
|
66,666
|
(6)
|
|
|
*
|
|
Arie Mayer #
|
|
|
16,333
|
(7)
|
|
|
*
|
|
Kevin Rakin #
|
|
|
68,671
|
(8)
|
|
|
*
|
|
Leonard Sank #
|
|
|
202,089
|
(9)
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
All current executive officers and directors, as a group (nine persons)
|
|
|
2,692,652
|
(10)
|
|
|
7.0
|
%
|
(1)
|
Includes 545,009 shares of common stock issuable upon the exercise of outstanding stock options and 189,636 shares of Common Stock underlying vested RSUs that are issuable upon request. Mr. Nadav’s beneficial ownership includes the 218,603 shares of common stock held by Xiaopeng Li, a former director of the Company, over which he holds a proxy.
|
|
|
(2)
|
Includes 389,133 shares of common stock issuable upon the exercise of outstanding stock options and 141,666 shares of Common Stock underlying vested RSUs that are issuable upon request.
|
(3)
|
Includes 34,190 shares of common stock issuable upon the exercise of outstanding stock options.
|
(4)
|
Mr. Gabay resigned from his positions, effective July 4, 2021.
|
(5)
|
Includes 68,750 shares of common stock issuable upon the exercise of outstanding stock options.
|
(6)
|
Includes 33,333 shares of common stock issuable upon the exercise of outstanding stock options and 33,333 shares of Common Stock underlying vested RSUs that are issuable upon request.
|
|
|
(7)
|
Includes 13,333 shares of common stock issuable upon the exercise of outstanding stock options.
|
(8)
|
Includes 11,667 shares of common stock issuable upon the exercise of outstanding stock options
|
(9)
|
Includes 63,200 shares of common stock issuable upon the exercise of outstanding stock.
|
(10)
|
Includes 1,158,615 shares of Common Stock issuable upon the exercise of options beneficially owned by the referenced persons and 364,635 shares of Common Stock underlying vested RSUs that are issuable upon request.
|
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
During fiscals 2021 and 2020,
except for compensation arrangements described elsewhere herein, we did not participate in any transaction, and we are not currently participating
in any proposed transaction, or series of transactions, in which the amount involved exceeded the lesser of $120,000 or one percent of
the average of our total assets at year end for the last two completed fiscal years, and in which, to our knowledge, any of our directors,
officers, five percent beneficial security holders, or any member of the immediate family of the foregoing persons had, or will have,
a direct or indirect material interest.
Our policy is to enter into
transactions with related persons on terms that, on the whole, are no less favorable than those available from unaffiliated third parties.
Based on our experience in the business sectors in which we operate and the terms of our transactions with unaffiliated third parties,
we believe that all of the transactions described below met this policy standard at the time they occurred. All related person transactions
are approved by our Board.
On November 30, 2015, we,
our Israeli subsidiary and HTIT entered into a Technology License Agreement, which was further amended, according to which we granted
HTIT an exclusive commercialization license in the Territory related to our oral insulin capsule, ORMD-0801. Pursuant to this license
agreement, HTIT will conduct certain pre-commercialization and regulatory activities with respect to our subsidiary’s technology
related to the ORMD-0801 capsule, and will pay certain royalties and an aggregate of approximately $37.5 million. On November 30, 2015,
we also entered into a securities purchase agreement with HTIT, pursuant to which, among other things, Mr. Kidron would serve as proxy
and attorney in fact of HTIT, with full power of substitution, to cast on behalf of HTIT all votes that HTIT is entitled to cast with
respect to the Purchased Shares at any and all meetings of our stockholders to consent or dissent to any action taken without a meeting
and to vote all the Purchased Shares held by HTIT in any manner Mr. Kidron deemed appropriate except for matters related to our activities
in the People’s Republic of China, on which Mr. Kidron would consult with HTIT before taking any action as proxy. On August 19,
2021, the proxy was revoked in accordance with its terms by HTIT.
The Board has determined that
Aviad Friedman, Arie Mayer, Kevin Rakin and Leonard Sank are independent as defined under the rules promulgated by Nasdaq.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
The aggregate fees billed
by Kesselman & Kesselman, independent registered public accounting firm, and member firm of PricewaterhouseCoopers International Limited,
for services rendered to us during fiscals 2021 and 2020:
|
|
2021
|
|
|
2020
|
|
Audit Fees(1)
|
|
$
|
90,000
|
|
|
$
|
95,000
|
|
Audit-Related Fees(2)
|
|
|
47,500
|
|
|
|
101,000
|
|
Tax Fees(3)
|
|
|
1,400
|
|
|
|
2,000
|
|
All Other Fees
|
|
|
-
|
|
|
|
-
|
|
Total Fees
|
|
$
|
138,900
|
|
|
$
|
198,000
|
|
(1)
|
Amount represents fees paid for professional services for the audit of our consolidated annual financial statements, review of our interim condensed consolidated financial statements included in quarterly reports and services that are normally provided by our independent registered public accounting firm in connection with statutory and regulatory filings or engagements.
|
(2)
|
Represents fees paid for services rendered in connection with our February 2020 public offering of common stock for fiscal 2020 and at-the-market offering related fees.
|
(3)
|
Represents fees paid for tax consulting services.
|
SEC rules require that before
the independent registered public accounting firm are engaged by us to render any auditing or permitted non-audit related service, the
engagement be: (1) pre-approved by our Audit Committee; or (2) entered into pursuant to pre-approval policies and procedures established
by the Audit Committee, provided the policies and procedures are detailed as to the particular service, the Audit Committee is informed
of each service, and such policies and procedures do not include delegation of the Audit Committee’s responsibilities to management.
The Audit Committee pre-approves
all services provided by our independent registered public accounting firm. All of the above services and fees were reviewed and approved
by the Audit Committee before the services were rendered.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
|
(a)
|
Index to Financial Statements
|
The following consolidated financial
statements are filed as part of this Annual Report on Form 10-K:
________________
Report of Independent Registered Public Accounting
Firm
To the Board of Directors and Stockholders of Oramed Pharmaceuticals
Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance
sheets of Oramed Pharmaceuticals Inc. and its subsidiaries (the “Company”) as of August 31, 2021 and 2020, and the related
consolidated statements of loss, changes in stockholders’ equity and cash flows for the years then ended, including the related
notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements
present fairly, in all material respects, the financial position of the Company as of August 31, 2021 and 2020, and the results of its
operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States
of America.
Basis for Opinion
These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements
based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial
statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are
matters arising from the current period audit of the consolidated financial statements that
were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material
to the consolidated financial statements and (ii) involved our especially challenging, subjective,
or complex judgments. We determined there are no critical audit matters.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International
Limited
Tel Aviv, Israel
November 24, 2021
We have served as the Company’s auditor since 2008.
Kesselman& Kesselman, Trade Tower, 25 Hamered Street, Tel-Aviv 6812508, Israel,
P.O Box 50005 Tel-Aviv 6150001 Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
ORAMED PHARMACEUTICALS INC.
CONSOLIDATED BALANCE SHEETS
In thousands (except share and per share data)
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
ASSETS
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
77,245
|
|
|
$
|
19,296
|
|
Short-term deposits (note 2)
|
|
|
11,044
|
|
|
|
11,060
|
|
Marketable securities (note 3)
|
|
|
5,851
|
|
|
|
9,544
|
|
Prepaid expenses and other current assets
|
|
|
1,197
|
|
|
|
611
|
|
Total current assets
|
|
|
95,337
|
|
|
|
40,511
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM ASSETS:
|
|
|
|
|
|
|
|
|
Long-term deposits (note 4)
|
|
|
25,016
|
|
|
|
2
|
|
Marketable securities (note 3)
|
|
|
6,692
|
|
|
|
3,928
|
|
Amounts funded in respect of employee rights upon retirement
|
|
|
24
|
|
|
|
18
|
|
Property and equipment, net
|
|
|
397
|
|
|
|
99
|
|
Operating lease right of use assets
|
|
|
533
|
|
|
|
75
|
|
Total long-term assets
|
|
|
32,662
|
|
|
|
4,122
|
|
Total assets
|
|
$
|
127,999
|
|
|
$
|
44,633
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses (note 5)
|
|
$
|
3,792
|
|
|
$
|
1,699
|
|
Deferred revenues
|
|
|
2,703
|
|
|
|
2,703
|
|
Payable to related parties (note 11c)
|
|
|
54
|
|
|
|
90
|
|
Operating lease liabilities
|
|
|
130
|
|
|
|
44
|
|
Total current liabilities
|
|
|
6,679
|
|
|
|
4,536
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES:
|
|
|
|
|
|
|
|
|
Long-term deferred revenues
|
|
|
4,244
|
|
|
|
6,947
|
|
Employee rights upon retirement
|
|
|
21
|
|
|
|
18
|
|
Provision for uncertain tax position (note 10f)
|
|
|
11
|
|
|
|
11
|
|
Operating lease liabilities
|
|
|
403
|
|
|
|
31
|
|
Other liabilities
|
|
|
124
|
|
|
|
211
|
|
Total long-term liabilities
|
|
|
4,803
|
|
|
|
7,218
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
(note 6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS’ :
|
|
|
|
|
|
|
|
|
Common stock, $ 0.012 par value (60,000,000 authorized shares as of August 31, 2021 and August 31, 2020; 35,293,889 and 23,675,530 shares issued and outstanding as of August 31, 2021 and 2020, respectively)
|
|
|
424
|
|
|
|
284
|
|
Additional paid-in capital
|
|
|
230,201
|
|
|
|
125,209
|
|
Accumulated deficit
|
|
|
(114,852
|
)
|
|
|
(92,614
|
)
|
Total stockholders’ equity
|
|
|
115,773
|
|
|
|
32,879
|
|
Non-controlling interests
|
|
|
744
|
|
|
|
-
|
|
Total
equity
|
|
|
116,517
|
|
|
|
32,879
|
|
Total
liabilities and equity
|
|
$
|
127,999
|
|
|
$
|
44,633
|
|
The accompanying notes are an integral part
of the financial statements.
ORAMED PHARMACEUTICALS
INC.
CONSOLIDATED STATEMENTS OF LOSS
In thousands (except share and per share data)
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
REVENUES
|
|
$
|
2,703
|
|
|
$
|
2,710
|
|
RESEARCH AND DEVELOPMENT EXPENSES
|
|
|
20,989
|
|
|
|
10,235
|
|
GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
5,937
|
|
|
|
4,232
|
|
OPERATING LOSS
|
|
|
24,223
|
|
|
|
11,757
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL
INCOME (note 9a)
|
|
|
1,242
|
|
|
|
690
|
|
FINANCIAL
EXPENSES (note 9b)
|
|
|
8
|
|
|
|
444
|
|
NET LOSS
|
|
$
|
22,989
|
|
|
$
|
11,511
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO:
|
|
|
|
|
|
|
|
|
COMPANY’S SHAREHOLDERS
|
|
|
22,238
|
|
|
|
11,511
|
|
NON-CONTROLLING INTERESTS
|
|
|
751
|
|
|
|
-
|
|
NET LOSS
|
|
|
22,989
|
|
|
|
11,511
|
|
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK
|
|
$
|
0.78
|
|
|
$
|
0.56
|
|
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK
|
|
|
28,469,068
|
|
|
|
20,532,347
|
|
The accompanying notes are an integral part
of the financial statements.
ORAMED PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
in thousands
|
|
Attributable to Company’s Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Total
|
|
|
Non-
|
|
|
|
|
|
|
Common Stock
|
|
|
paid-in
|
|
|
Accumulated
|
|
|
stockholders’
|
|
|
controlling
|
|
|
Total
|
|
|
|
Shares
|
|
|
$
|
|
|
capital
|
|
|
deficit
|
|
|
equity
|
|
|
interests
|
|
|
Equity
|
|
|
|
In thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE AS OF SEPTEMBER 1, 2019
|
|
|
17,383
|
|
|
|
208
|
|
|
|
100,288
|
|
|
|
(81,103
|
)
|
|
|
19,393
|
|
|
|
-
|
|
|
|
19,393
|
|
SHARES ISSUED FOR SERVICES
|
|
|
10
|
|
|
|
*
|
|
|
|
38
|
|
|
|
|
|
|
|
38
|
|
|
|
|
|
|
|
38
|
|
ISSUANCE OF COMMON STOCK, NET
|
|
|
6,270
|
|
|
|
75
|
|
|
|
23,698
|
|
|
|
|
|
|
|
23,773
|
|
|
|
|
|
|
|
23,773
|
|
EXERCISE OF WARRANTS AND OPTIONS
|
|
|
12
|
|
|
|
1
|
|
|
|
12
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
13
|
|
STOCK-BASED COMPENSATION
|
|
|
-
|
|
|
|
-
|
|
|
|
1,173
|
|
|
|
|
|
|
|
1,173
|
|
|
|
|
|
|
|
1,173
|
|
NET LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,511
|
)
|
|
|
(11,511
|
)
|
|
|
|
|
|
|
(11,511
|
)
|
BALANCE AS OF AUGUST 31, 2020
|
|
|
23,675
|
|
|
|
284
|
|
|
|
125,209
|
|
|
|
(92,614
|
)
|
|
|
32,879
|
|
|
|
|
|
|
|
32,879
|
|
ISSUANCE OF COMMON STOCK, NET
|
|
|
8,467
|
|
|
|
102
|
|
|
|
79,881
|
|
|
|
|
|
|
|
79,983
|
|
|
|
|
|
|
|
79,983
|
|
EXERCISE OF WARRANTS AND OPTIONS
|
|
|
3,151
|
|
|
|
38
|
|
|
|
21,371
|
|
|
|
|
|
|
|
21,409
|
|
|
|
|
|
|
|
21,409
|
|
STOCK-BASED COMPENSATION
|
|
|
-
|
|
|
|
-
|
|
|
|
2,695
|
|
|
|
|
|
|
|
2,695
|
|
|
|
|
|
|
|
2,695
|
|
ASSET ACQUISITION TRANSACTION
|
|
|
|
|
|
|
|
|
|
|
1,045
|
|
|
|
|
|
|
|
1,045
|
|
|
|
(751
|
)
|
|
|
294
|
|
NET LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(22,238
|
)
|
|
|
(22,238
|
)
|
|
|
1,495
|
|
|
|
(20,743
|
)
|
BALANCE AS OF AUGUST 31, 2021
|
|
|
35,293
|
|
|
|
424
|
|
|
|
230,201
|
|
|
|
(114,852
|
)
|
|
|
115,773
|
|
|
|
744
|
|
|
|
116,517
|
|
* Represents an amount of less than $1.
The accompanying notes are an integral part
of the financial statements
ORAMED PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
In thousands
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(22,989
|
)
|
|
$
|
(11,511
|
)
|
Adjustments required to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
77
|
|
|
|
7
|
|
Non-cash expense for acquired In-Process Research & Development (or IPR&D)
|
|
|
1,040
|
|
|
|
-
|
|
Exchange differences and interest on deposits and held to maturity bonds
|
|
|
187
|
|
|
|
546
|
|
Changes in fair value of investments
|
|
|
(876
|
)
|
|
|
1,173
|
|
Stock-based compensation
|
|
|
2,695
|
|
|
|
465
|
|
Shares issued for services
|
|
|
-
|
|
|
|
38
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
(586
|
)
|
|
|
431
|
|
Accounts payable, accrued expenses and related parties
|
|
|
2,060
|
|
|
|
(816
|
)
|
Deferred revenues
|
|
|
(2,703
|
)
|
|
|
(2,710
|
)
|
Liability for employee rights upon retirement
|
|
|
3
|
|
|
|
(4
|
)
|
Other liabilities
|
|
|
(89
|
)
|
|
|
(59
|
)
|
Total net cash used in operating activities
|
|
|
(21,181
|
)
|
|
|
(12,440
|
)
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(375
|
)
|
|
|
(82
|
)
|
Investment in short-term deposits
|
|
|
(18,460
|
)
|
|
|
(27,204
|
)
|
Purchase of mutual funds
|
|
|
-
|
|
|
|
(3,750
|
)
|
Investment in long-term deposits
|
|
|
(25,000
|
)
|
|
|
-
|
|
Proceeds from sale of mutual funds
|
|
|
3,765
|
|
|
|
-
|
|
Purchase of held to maturity securities
|
|
|
(10,362
|
)
|
|
|
(8,428
|
)
|
Proceeds from redemption of short-term deposits
|
|
|
18,460
|
|
|
|
40,891
|
|
Proceeds from maturity of held to maturity securities
|
|
|
8,209
|
|
|
|
3,200
|
|
Funds in respect of employee rights upon retirement
|
|
|
(1
|
)
|
|
|
(1
|
)
|
Total net cash provided by (used in) investing activities
|
|
|
(23,764
|
)
|
|
|
4,626
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs
|
|
|
79,983
|
|
|
|
23,773
|
|
Proceeds from exercise of warrants and options
|
|
|
21,409
|
|
|
|
13
|
|
Transaction with non-controlling interests
|
|
|
1,500
|
|
|
|
|
|
Total net cash provided by financing activities
|
|
|
102,892
|
|
|
|
23,786
|
|
EFFECT OF EXCHANGE RATE CHANGES ON CASH
|
|
|
2
|
|
|
|
(5
|
)
|
INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
57,949
|
|
|
|
15,967
|
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
|
|
|
19,296
|
|
|
|
3,329
|
|
CASH AND CASH EQUIVALENTS AT END OF YEAR
|
|
$
|
77,245
|
|
|
$
|
19,296
|
|
|
|
|
|
|
|
|
|
|
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS:
|
|
|
|
|
|
|
|
|
Interest received
|
|
$
|
563
|
|
|
$
|
1,313
|
|
(B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:
|
|
|
|
|
|
|
|
|
Recognition of operating lease right of use assets and liabilities
|
|
|
582
|
|
|
|
-
|
|
(C) ASSET ACQUISITION TRANSACTION (see note 12):
|
|
|
|
|
|
|
|
|
IPR&D
|
|
|
1,040
|
|
|
|
-
|
|
Transaction with non-controlling interests
|
|
|
1,500
|
|
|
|
-
|
|
Additional paid in capital
|
|
|
(1,045
|
)
|
|
|
-
|
|
Non-controlling interests
|
|
|
(1,495
|
)
|
|
|
-
|
|
The accompanying notes are an integral part
of the financial statements
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:
|
1)
|
Incorporation and operations
|
Oramed Pharmaceuticals Inc. (collectively
with its subsidiaries, the “Company”, unless the context indicates otherwise) was incorporated on April 12, 2002, under the
laws of the State of Nevada. From incorporation until March 3, 2006, the Company was an exploration stage company engaged in the acquisition
and exploration of mineral properties. On February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development
Ltd. to acquire the provisional patent related to orally ingestible insulin capsule to be used for the treatment of individuals with diabetes.
On May 14, 2007, the Company incorporated
a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development.
On March 11, 2011, the Company was
reincorporated from the State of Nevada to the State of Delaware.
On July 30, 2019, the Company’s
subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of August
31, 2021, the Hong Kong Subsidiary has no operation.
On November 30, 2015, the Company entered
into a Technology License Agreement (the “TLA”), with Hefei Tianhui Incubation of Technologies Co. Ltd. (“HTIT”)
and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended by the
parties on June 3, 2016 and July 24, 2016 (the “License Agreement”). See note 6b.
On March 18, 2021, the Company entered
into a license agreement (the “Oravax License Agreement”) and into the Stockholders Agreement (as defined below) with Oravax
Medical Inc. (“Oravax”). According to the Stockholders Agreement, Oravax issued 1,890,000 shares of its capital stock to the
Company, representing 63% of the issued and outstanding share capital of Oravax, on a fully diluted basis, as of the date of issuance.
See note 12.
|
2)
|
Development and liquidity risks
|
The Company is engaged in research
and development in the biotechnology field for innovative pharmaceutical solutions, including an orally ingestible insulin capsule to
be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules for delivery of other polypeptides,
and has not generated significant revenues from its operations. Based on the Company’s current cash resources and commitments, the
Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for
at least the next 12 months, although no assurance can be given that the Company will not need additional funds prior to such time. If
there are unexpected increases in its operating expenses, the Company may need to seek additional financing during the next 12 months.
Successful completion of the Company’s development programs and its transition to normal operations is dependent upon obtaining
necessary regulatory approvals from the U.S. Food and Drug Administration prior to selling its products within the United States, obtaining
foreign regulatory approvals to sell its products internationally, or entering into licensing agreements with third parties. There can
be no assurance that the Company will receive regulatory approval of any of its product candidates, and a substantial amount of time may
pass before the Company achieves a level of revenues adequate to support its operations, if at all. The Company also expects to incur
substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective
developmental periods. Obtaining marketing approval will be directly dependent on the Company’s ability to implement the necessary
regulatory steps required to obtain marketing approval in the United States and in other countries. The Company cannot predict the outcome
of these activities.
In addition to the foregoing, based
on the Company’s current assessment, the Company does not expect any material impact on its development timeline and its liquidity
due to the worldwide spread of the COVID-19 virus. However, the Company is continuing to assess the effect on its operation by monitoring
the spread of COVID-19 and the actions implemented by the governments to combat the virus throughout the world.
The consolidated financial statements
have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
|
c.
|
Use of estimates in the preparation of financial statements
|
The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the financial statements date and the reported expenses during
the reporting periods. Actual results could differ from those estimates.
As applicable to these consolidated financial
statements, the most significant estimates and assumptions relate to stock-based compensation, expectation of milestone payments and to
the expected product submission date for revenue recognition purposes.
The currency of the primary economic environment
in which the operations of the Company and its Subsidiaries are conducted is the U.S. dollar (“$” or “dollar”).
Therefore, the functional currency of the Company and its subsidiaries is the dollar.
Transactions and balances originally denominated
in dollars are presented at their original amounts. Balances in foreign currencies are translated into dollars using historical and current
exchange rates for non-monetary and monetary balances, respectively. For foreign transactions and other items reflected in the statements
of operations, the following exchange rates are used: (1) for transactions - exchange rates at transaction dates or average rates and
(2) for other items (derived from non-monetary balance sheet items such as depreciation) - historical exchange rates. The resulting transaction
gains or losses are carried to financial income or expenses, as appropriate.
|
e.
|
Principles of consolidation
|
The consolidated financial statements
include the accounts of the Company and its subsidiaries. All inter-company transactions and balances have been eliminated in consolidation.
The Company considers all short-term,
highly liquid investments, which include short-term deposits with original maturities of three months or less from the date of purchase
that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents.
|
g.
|
Fair value measurement:
|
The Company measures fair value and discloses
fair value measurements for financial assets. Fair value is based on the price that would be received to sell an asset in an orderly transaction
between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the
guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three
broad levels, which are described as follows:
|
Level 1:
|
Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
|
|
|
|
|
Level 2:
|
Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
|
|
|
|
|
Level 3:
|
Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
|
|
|
August 31, 2021
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Fair Value
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
D.N.A
|
|
|
701
|
|
|
|
-
|
|
|
|
-
|
|
|
|
701
|
|
Entera
|
|
|
571
|
|
|
|
-
|
|
|
|
-
|
|
|
|
571
|
|
|
|
|
1,272
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,272
|
|
|
|
August 31,
2020
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Fair Value
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
D.N.A
|
|
|
246
|
|
|
|
-
|
|
|
|
-
|
|
|
|
246
|
|
Entera
|
|
|
150
|
|
|
|
-
|
|
|
|
-
|
|
|
|
150
|
|
Mutual Funds
|
|
|
3,298
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,298
|
|
|
|
|
3,694
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,694
|
|
As of August 31, 2021, the assets measured at fair value are comprised
of equity securities (Level 1). The fair value of held to maturity bonds as presented in note 3 was based on a Level 2 measurement.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
As of August 31, 2021, the carrying amounts of cash equivalents,
short-term deposits and accounts payable approximate their fair values due to the short-term maturities of these instruments.
As of August 31, 2021, the carrying amounts of long-term deposits
approximate their fair values due to the stated interest rates which approximate market rates.
The amounts funded in respect of employee
rights are stated at cash surrender value which approximates its fair value.
Other than items related to the asset
acquisition transaction of Oravax (see note 12), there were no Level 3 items measured at fair value for the fiscal 2021.
The Company classified the available
for sale securities (investments in equity securities of D.N.A Biomedical Solutions Ltd. (“D.N.A”), Entera Bio Ltd. (“Entera”)
and other mutual funds) to financial assets measured at fair value through profit or loss.
|
2)
|
Held to maturity securities
|
All debt securities are classified
as held-to-maturity because the Company has the positive intent and ability to hold the securities to maturity. Held-to-maturity securities
are stated at amortized cost, adjusted for amortization of premiums and accretion of discounts to maturity. On a continuous basis, management
assesses whether there are any indicators that the value of the Company’s marketable securities may be impaired, which includes
reviewing the underlying cause of any decline in value and the estimated recovery period, as well as the severity and duration of the
decline. In the Company’s evaluation, the Company considers its ability and intent to hold these investments for a reasonable period
of time sufficient for the Company to recover its cost basis. A marketable security is impaired if the fair value of the security is less
than the carrying value of the security and such difference is deemed to be other-than temporary. To the extent impairment has occurred,
the loss shall be measured as the excess of the carrying amount of the security over the estimated fair value of the security.
|
i.
|
Concentration of credit risks
|
Financial instruments that subject the
Company to credit risk consist primarily of cash and cash equivalents, short and long-term deposits and marketable securities which are
deposited in major financial institutions. The Company is of the opinion that the credit risk in respect of these balances is remote.
Deferred taxes are determined utilizing
the asset and liability method based on the estimated future tax effects of differences between the financial accounting and tax bases
of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect
when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available
evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full
valuation allowance with respect to its deferred tax assets. See note 10.
Regarding the Israeli subsidiary, the
recognition is prohibited for deferred tax liabilities or assets that arise from differences between the financial reporting and tax bases
of assets and liabilities that are measured from the local currency into dollars using historical exchange rates, and that result from
changes in exchange rates or indexing for tax purposes. Consequently, the abovementioned differences were not reflected in the computation
of deferred tax assets and liabilities.
Until fiscal 2019, the Israeli subsidiary
has measured its results for tax purposes in nominal terms in NIS. In order to avoid unfavorable tax implications derived from the fluctuations
in the exchange rate, the Israeli subsidiary's results for tax purposes are measured is U.S. dollars starting from fiscal 2020.
Taxes that would apply in the event
of disposal of investments in the Israeli subsidiary have not been taken into account in computing deferred taxes, as it is the Company’s
intention to hold this investment, not to realize it.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
|
2.
|
Uncertainty in income tax
|
The Company follows a two-step approach
to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if
the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit. The second step
is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. Such liabilities
are classified as long-term, unless the liability is expected to be resolved within twelve months from the balance sheet date. The Company’s
policy is to include interest and penalties related to unrecognized tax benefits within income tax expenses.
The License Agreement and the SPA (as
defined below) were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500
between the License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock
(less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28,
2015, and $38,883 was allocated to the License Agreement.
Under Accounting Standard Codification,
or ASC 606, the Company identified a single performance obligation in the agreement and determined that the license and services are not
distinct as the license and services are highly dependent on each other. In other words, HTIT cannot benefit from the license without
the related services, and vice versa.
Since the customer benefits from the services
as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using the input method.
The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates the straight-line
attribution. The Company used significant judgment when it determined the product submission date.
Under ASC 606, the consideration that
the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events,
are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the
transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones
of which the occurrence is not considered the most likely outcome.
The Company then evaluates if any of the
variable consideration determined in the first step is constrained by including in the transaction price variable consideration to the
extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty
associated with the variable consideration is subsequently resolved. The Company used significant judgment when it determined the
first step of variable consideration.
The potential future royalty consideration
is also considered a form of variable consideration under ASC 606 as it is based on a percentage of potential future sales of the Company’s
products. However, the Company applies the sales-based royalty exception and accordingly will recognize the sales-based royalty amounts
when the related sale has occurred. To date, the Company has not recognized any royalty-related revenue.
Amounts that were allocated to the License
Agreement as of August 31, 2021 aggregated $22,382, all of which was received through the balance sheet date. Through August 31, 2021,
the Company recognized revenue associated with this agreement in the aggregate amount of $15,435 (of which $2,703 was recognized in the
twelve-months period ended August 31, 2021), and deferred the remaining amount of $6,947, which is presented as a contract liability on
the condensed consolidated balance sheet.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
|
l.
|
Research and development
|
Research and development expenses include
costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits, the
cost of supplies, the cost of services provided by outside contractors, including services related to the Company’s clinical trials,
clinical trial expenses and the full cost of manufacturing drug for use in research and preclinical development. All costs associated
with research and development are expensed as incurred.
Clinical trial costs are a significant
component of research and development expenses and include costs associated with third-party contractors. The Company outsources a substantial
portion of its clinical trial activities, utilizing external entities such as Clinical Research Organizations (“CROs”), independent
clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical studies. For
each clinical trial that the Company conducts, clinical trial costs are expensed immediately.
|
m.
|
Stock-based compensation
|
Equity awards granted to employees
are accounted for using the grant date fair value method. The grant date fair value is determined as follows: for stock options and
restricted stock units (“RSUs”) with an exercise price using the Black Scholes pricing model, for stock options and RSUs
with market conditions using a Monte Carlo model and for RSUs with service conditions based on the grant date share price. The fair
value of share based payment awards is recognized as an expense over the requisite service period. The expected term is the length
of time until the expected dates of exercising the award and is estimated using the simplified method due to insufficient specific
historical information of employees’ exercise behavior, unless the award includes a market condition, in which case the
contractual term is used. The volatility is based on a historical volatility, by statistical analysis of the weekly share price for
past periods. The Company elected to recognize compensation cost for awards granted to employees that have a graded vesting schedule
using the accelerated method based on the multiple-option award approach. For awards with only market conditions, compensation
expense is not reversed if the market conditions are not satisfied.
The Company elects to account for forfeitures
as they occur.
Basic and diluted net loss per common
share are computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding for each
period. Outstanding stock options, warrants and RSUs have been excluded from the calculation of the diluted loss per share because all
such securities are anti-dilutive for all periods presented. The weighted average number of stock options, warrants and RSUs excluded
from the calculation of diluted net loss was 5,042,299 and 5,025,723 for the years ended August 31, 2021 and 2020, respectively.
When determining whether a transaction gives rise to an acquisition
of a business or asset group, the Company applies a screening test to determine whether substantially all of the fair value of the gross
assets acquired in the transaction is concentrated in a single identifiable asset or group of similar identifiable assets. If so, then
the assets are not considered a business and the transaction is accounted for as an asset acquisition.
When a transaction is accounted for as an asset acquisition,
an IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project.
Otherwise, amounts allocated to IPR&D that have no alternative use are expensed.
The Company has elected an accounting
policy to measure non-controlling interests in an asset acquisition at fair value on the date of acquisition.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
The Company leases real estate and cars
for use in its operations, which are classified as operating leases. In addition to rent, the leases may require the Company to pay directly
for fees, insurance, maintenance and other operating expenses.
The Company determines if an arrangement
is a lease at inception. Operating leases are included in operating lease right of use assets and operating lease liabilities in the consolidated
balance sheets. Right of use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and
lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities
are recognized at the commencement date based on the present value of lease payments over the lease term. The Company uses its incremental
borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. Lease
expenses are recognized on a straight-line basis over the lease term.
The Company elected the short-term lease
recognition exemption for all leases with a term shorter than 12 months. This means that for those leases, the Company does not recognize
ROU assets or lease liabilities but recognizes lease expenses over the lease term on a straight line basis. The Company also elected the
practical expedient to not separate lease and non-lease components for all of its leases.
Lease terms will include options to extend
or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate
the lease.
The Company’s lease agreements have
remaining lease terms ranging from 1 year to 4 years. Some of these agreements include options to extend the leases for up to an additional
5 years and some include options to terminate the leases immediately. See also note 6h.
|
q.
|
Recently issued Accounting Pronouncements, not yet adopted
|
In
June 2016, the Financial Accounting Standards Board issued ASU 2016-13 “Financial
Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the
current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a
broader range of reasonable and supportable information to inform credit loss estimates. The guidance will be effective for the
fiscal year beginning after December 15, 2022, including interim periods within that year. The adoption of this guidance is not
expected to have a significant impact on the Company’s consolidated financial statements.
NOTE 2 - SHORT-TERM DEPOSITS:
Composition:
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
Annual interest rate
|
|
|
Amount
|
|
|
Annual
interest rate
|
|
|
Amount
|
|
Dollar deposits
|
|
|
0.73-0.82
|
%
|
|
$
|
11,044
|
|
|
|
0.85-1.60
|
%
|
|
$
|
11,060
|
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 3 - MARKETABLE SECURITIES:
The Company’s marketable securities
include investments in equity securities of D.N.A, Entera, mutual funds and in held to maturity bonds.
Composition:
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Short-term:
|
|
|
|
|
|
|
D.N.A (see b below)
|
|
$
|
701
|
|
|
$
|
246
|
|
Entera (see c below)
|
|
|
571
|
|
|
|
150
|
|
Held to maturity bonds (see d below)
|
|
|
4,579
|
|
|
|
5,369
|
|
Preferred equity
|
|
|
-
|
|
|
|
481
|
|
Mutual funds*
|
|
|
-
|
|
|
|
3,298
|
|
|
|
$
|
5,851
|
|
|
$
|
9,544
|
|
|
|
|
|
|
|
|
|
|
Long-term:
|
|
|
|
|
|
|
|
|
Held to maturity bonds (see d below)
|
|
$
|
6,692
|
|
|
$
|
3,928
|
|
|
|
$
|
12,543
|
|
|
$
|
13,472
|
|
*
|
Mutual funds include equity funds only
|
The D.N.A ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted
prices of the securities on the measurement date.
During the years ended August 31, 2021
and 2020, the Company did not sell any of the D.N.A ordinary shares. As of August 31, 2021, the Company owns approximately 1.7% of D.N.A’s
outstanding ordinary shares.
The cost of the securities as of August
31, 2021 and 2020 was $595.
Entera ordinary shares have been traded
on The Nasdaq Capital Market since June 28, 2018. The Company measures the investment at fair value from such date. The cost of the securities
as of August 31, 2021 and 2020 was $1.
|
d.
|
Held to maturity bonds
|
The amortized cost and estimated fair
value of held-to-maturity securities at August 31, 2021, are as follows:
|
|
August 31, 2021
|
|
|
|
Amortized
cost
|
|
|
Gross
unrealized
gains (losses)
|
|
|
Estimated
fair value
|
|
|
Average
yield to
maturity
rate
|
|
Short-term:
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial bonds
|
|
$
|
4,463
|
|
|
$
|
(98
|
)
|
|
$
|
4,365
|
|
|
|
1.73
|
%
|
Accrued interest
|
|
|
116
|
|
|
|
-
|
|
|
|
116
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
|
|
|
6,692
|
|
|
|
610
|
|
|
|
7,302
|
|
|
|
1.08
|
%
|
|
|
$
|
11,271
|
|
|
$
|
512
|
|
|
$
|
11,783
|
|
|
|
|
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 3 - MARKETABLE
SECURITIES (continued):
The amortized cost and estimated fair value of held-to-maturity securities at August 31, 2020, are as follows:
|
|
August 31, 2020
|
|
|
|
Amortized
cost
|
|
|
Gross
unrealized
gains (losses)
|
|
|
Estimated
fair value
|
|
|
Average
yield to
maturity
rate
|
|
Short-term:
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial bonds
|
|
$
|
5,295
|
|
|
$
|
(29
|
)
|
|
$
|
5,266
|
|
|
|
2.26
|
%
|
Accrued interest
|
|
|
74
|
|
|
|
-
|
|
|
|
74
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
|
|
|
3,928
|
|
|
|
56
|
|
|
|
3,984
|
|
|
|
2.20
|
%
|
|
|
$
|
9,297
|
|
|
$
|
27
|
|
|
$
|
9,324
|
|
|
|
|
|
Held to maturity securities which will
mature during the 12 months from the balance sheet date are included in short-term marketable securities. Held to maturity securities
with maturity dates of more than one year are considered long-term marketable securities.
NOTE 4 - LONG-TERM DEPOSITS:
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Composition:
|
|
|
|
|
|
|
Long-term deposits*
|
|
$
|
25,014
|
|
|
|
-
|
|
Lease car deposits
|
|
$
|
2
|
|
|
|
2
|
|
|
|
$
|
25,016
|
|
|
$
|
2
|
|
|
*
|
Long term deposits include one deposit of $25,000 with an
annual interest rate of 0.93% and a maturity date of August 10, 2023.
|
NOTE 5 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Composition:
|
|
|
|
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Accounts payable
|
|
$
|
2,606
|
|
|
$
|
594
|
|
Payroll and related accruals
|
|
|
324
|
|
|
|
54
|
|
Institutions
|
|
|
39
|
|
|
|
19
|
|
Accrued liabilities
|
|
|
823
|
|
|
|
1,032
|
|
|
|
$
|
3,792
|
|
|
$
|
1,699
|
|
NOTE 6 - COMMITMENTS:
|
a.
|
In March 2011, the Subsidiary sold shares of its investee company, Entera, to D.N.A, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration for the shares sold to D.N.A, the Company received, among other payments, ordinary shares of D.N.A (see also note 3).
|
As part of this agreement, the Subsidiary
entered into a patent transfer agreement (the “Patent Transfer Agreement”) according to which the Subsidiary assigned to Entera
all of its right, title and interest in and to a certain patent application related to the oral administration of proteins that it has
licensed to Entera since August 2010. Under this agreement, the Subsidiary is entitled to receive from Entera royalties of 3% of Entera’s
net revenues (as defined in the agreement) and a license back of that patent application for use in respect of diabetes and influenza.
As of August 31, 2021, Entera had not yet realized any revenues and had not paid any royalties to the Subsidiary. On December 11, 2018,
Entera announced that it had entered into a research collaboration and license agreement (the “Amgen License”) with Amgen
related to research of inflammatory disease and other serious illnesses. As reported by Entera, under the terms of the Amgen License,
Entera will receive a modest initial technology access fee from Amgen and will be responsible for preclinical development at Amgen’s
expense. Entera will be eligible to receive up to $270,000 in aggregate payments, as well as tiered royalties up to mid-single digits,
upon achievement of various clinical and commercial milestones if Amgen decides to move all of these programs forward. Amgen is responsible
for clinical development, manufacturing and commercialization of any of the resulting programs. To the extent the Amgen License results
in net revenues as defined in the Patent Transfer Agreement, the Subsidiary will be entitled to the aforementioned royalties.
In addition, as part of a consulting agreement
with a third party, dated February 15, 2011, the Subsidiary is obliged to pay this third party royalties of 8% of the net royalties received
in respect of the patent that was sold to Entera in March 2011.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 6 - COMMITMENTS (continued):
|
b.
|
According to the License Agreement, the Company granted HTIT an exclusive commercialization license in the territory of the People’s Republic of China, Macau and Hong Kong (the “Territory”), related to the Company’s oral insulin capsule, ORMD-0801 (the “Product”). Pursuant to the License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities with respect to the Subsidiary’s technology and ORMD-0801 capsule, and will pay to the Subsidiary (i) royalties of 10% on net sales of the related commercialized products to be sold by HTIT in the Territory (“Royalties”), and (ii) an aggregate of $37,500, of which $3,000 was payable immediately, $8,000 will be paid subject to the Company entering into certain agreements with certain third parties, and $26,500 will be paid upon achievement of certain milestones and conditions. In the event that the Company does not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the final expiration of the Company’s patents covering the technology in the Territory in 2033, the Royalties rate may be reduced, under certain circumstances, to 5%.
The royalty payment obligation shall apply during the period of time beginning upon the first commercial sale of the Product in the Territory, and ending upon the later of (i) the expiration of the last-to-expire licensed patents in the Territory; and (ii) 15 years after the first commercial sale of the Product in the Territory (the “Royalty Term”).
The License Agreement shall remain in effect until the expiration of the Royalty Term. The License Agreement contains customary termination provisions.
Among others, the Company’s involvement through the product submission date will include consultancy for the pre-commercialization activities in the Territory, as well as advisory services to HTIT on an ongoing basis.
As of August 31, 2021, the Company has received milestone payments in an aggregate amount of $20,500 as follows: the initial payment of $3,000 was received in January 2016. Following the achievement of certain milestones, the second and third payments of $6,500 and $4,000, respectively, were received in July 2016, the fourth milestone payment of $4,000 was received in October 2016 and the fifth milestone payment of $3,000 was received in January 2019.
On August 21, 2020, the Company received a letter
from HTIT, disputing certain pending payment obligations of HTIT under the TLA. The payment obligation being disputed is $6,000, out of
which only an amount of $2,000 has been received and has been included in Deferred revenue in each of the consolidated balance sheets
as of the fiscal years ended August 31, 2021, and 2020. The Company wholly disputes the claims made by HTIT and has been engaged in discussions
and exchanges with HTIT in an attempt to clarify and resolve disagreements between the parties regarding milestone payments and work plan
implementation.
In addition, on November 30, 2015, the Company entered into a Stock Purchase Agreement with HTIT (the “SPA”). According to the SPA, the Company issued 1,155,367 shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015.
The License Agreement and the SPA were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28, 2015, and $38,883 was allocated to the License Agreement. The Company determined that revenues are recognized over time through the expected product submission date in June 2023.
In July 2015, according to the letter of intent signed between the parties or their affiliates, HTIT’s affiliate paid the Subsidiary a non-refundable amount of $500 as a no-shop fee. The no-shop fee was deferred and the related revenue is recognized over the estimated term of the License Agreement.
For the Company’s revenue recognition policy see note 1k.
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 6 - COMMITMENTS (continued):
|
c.
|
On December 18, 2017, the Subsidiary entered into an agreement with a vendor for the process development and production of one of its oral capsule ingredients in the amount of $2,905 that will be paid over the term of the engagement and based on the achievement of certain development milestones, of which $1,592 was recognized in research and development expenses through August 31, 2021.
|
|
d.
|
On September 2, 2020 (effective as of January 15, 2020),
the Subsidiary entered into a CRO Services Agreement with a third party to retain it as a CRO for the Subsidiary’s Phase III clinical
trial for its oral insulin. As consideration for its services, the Subsidiary will pay the CRO a total amount of $21,589 during the term
of the engagement and based on achievement of certain milestones, of which $7,663 was recognized in research and development expenses
through August 31, 2021.
|
|
e.
|
On September 16, 2020 (effective as of January 15, 2020), the Subsidiary entered into a CRO Services Agreement with a third party to retain it as a CRO for the Subsidiary’s Phase III clinical trial for its oral insulin. As consideration for its services, the Subsidiary will pay the CRO a total amount of $12,343 during the term of the engagement and based on achievement of certain milestones, of which $2,935 was recognized in research and development expenses through August 31, 2021.
|
|
f.
|
Grants from the Israel Innovation Authority (“IIA”)
|
Under the terms of the Company’s
funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling
100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on LIBOR.
At the time the grants were received,
successful development of the related projects was not assured. The total amount that was received through August 31, 2021 was $2,207
($2,505 including LIBOR). All grants were received before fiscal 2020 and recorded as a reduction of Research and development expenses
at that time. As of August 31, 2021, the liability to the IIA was $243.
The royalty expenses which are related
to the funded project were recognized in cost of revenues in the relevant periods.
|
g.
|
Grants from the European Commission (“EC”)
|
During fiscal 2020, the Company received
an aggregate payment of €50 from the EC under The European Innovation Council Accelerator (previously known as SME Instrument) of
the European Innovation Programme Horizon 2020.
As of August 31, 2021, all amounts were
recognized in the Company’s profit and loss statement.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 6 - COMMITMENTS (continued):
On August 2, 2020, the Subsidiary entered
into a lease agreement for its facilities in Israel. The lease agreement is for a period of 60 months commencing September 1, 2020. The
Subsidiary has the option to extend the period for another 60 months. The annual lease payment, including management fees, as of August
31, 2021 is approximately NIS 435,000 ($136). As security for its obligation under this lease agreement, the Company provided a bank guarantee
in an amount equal to three monthly lease payments.
The total expenses related to leases were
$124 and $56 as of August 31, 2021 and 2020 respectively.
The right-of-use asset and lease liability
are initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that
rate cannot be readily determined, the Company’s incremental borrowing rate based on the information available at the date of adoption
in determining the present value of the lease payments. The Company’s incremental borrowing rate is estimated to approximate the
interest rate on similar terms and payments and in economic environments where the leased asset is located.
The Company has various operating leases
for office space and vehicles that expire through 2025. Below is a summary of the Company’s operating right-of-use assets and operating
lease liabilities as of August 31, 2021 and 2020:
|
|
August 31,
2021
|
|
August 31,
2020
|
|
Operating right-of-use assets
|
|
$
|
533
|
|
$
|
75
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities, current
|
|
|
130
|
|
|
44
|
|
Operating lease liabilities long-term
|
|
|
403
|
|
|
31
|
|
Total operating lease liabilities
|
|
$
|
533
|
|
$
|
75
|
|
|
|
|
|
|
|
|
|
Weighted Average of Remaining Lease Term
|
|
|
|
|
|
|
|
Operating leases
|
|
|
3.88
|
|
|
1.74
|
|
|
|
|
|
|
|
|
|
Weighted Average Discount Rate
|
|
|
|
|
|
|
|
Operating leases
|
|
|
3.00
|
%
|
|
3.00
|
%
|
Minimum lease payments for the Company’s right-of-use assets
over the remaining lease periods as of August 31, 2021 are as follows:
|
|
August 31,
2021
|
|
|
|
|
|
2022
|
|
$
|
156
|
|
2023
|
|
|
138
|
|
2024
|
|
|
136
|
|
2025
|
|
|
136
|
|
Total undiscounted lease payments
|
|
|
565
|
|
Less: Interest*
|
|
|
(32
|
)
|
Present value of lease liabilities
|
|
$
|
533
|
|
*
|
Future lease payments were discounted by 3% interest rate.
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 7 - STOCKHOLDERS’ EQUITY:
The following are the significant capital
stock transactions that took place during the years ended August 31, 2021 and 2020:
|
a.
|
In August 2019, the Company became aware of a shareholder derivative claim and putative class action alleging, among other things, that the Second Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”) may have terminated in 2018. However, the Company disputed these claims and believes that the 2008 Plan does not terminate until 2026 and any suggestion to the contrary is not well-founded. For the sake of clarity and out of an abundance of caution, the Company adopted a new option plan, which was approved at its 2019 shareholder meeting. Such 2019 Stock Incentive Plan, as amended and restated (the “2019 Plan”) originally allowed the Company to grant up to 1,000,000 options. Since the Company had granted options during the time after the old plan allegedly terminated, and out of an abundance of caution, the Company canceled these grants and reissued the options under the new option plan in the same amounts and under the same terms as the original grants. The cancelation and grants were approved by the Company’s board on September 11, 2019. Out of the available options under the 2019 Plan, the Company granted 563,646 to replace the options under dispute as mentioned above. The cancellation of the award accompanied by the concurrent grant of a replacement award was accounted for as modification of the terms of the cancelled award. Since the replacement award was given under the same terms as the cancelled award, no incremental compensation cost was recognized. On August 3, 2020, the stockholders of the Company adopted the amended and restated 2019 Plan which increased the shares available to grant under the plan by an additional 2,000,000 to 3,000,000 options.
|
|
b.
|
On September 5, 2019, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”), pursuant to which the Company could, from time to time and at the Company’s option, issue and sell shares of Company common stock having an aggregate offering price of up to $15,000, through a sales agent, subject to certain terms and conditions. Any shares sold were to be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus and prospectus supplement, each dated February 10, 2020 (which superseded a prior registration statement, prospectus and prospectus supplement that related to shares sold under the Sales Agreement). The Company paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the Sales Agreement. As of August 31, 2021, 3,212,621 shares were issued under the Sales Agreement for aggregate net proceeds of $14,397.
|
|
c.
|
On February 27, 2020, the Company entered into an underwriting agreement (“Agreement”) with National Securities Corporation (“Underwriter”), in connection with a public offering (“Offering”) of 5,250,000 shares of the Company’s common stock, at an offering price of $4.00 per share. Under the terms of the Agreement, the Company granted the Underwriter a 45-day option to purchase from the Company up to an additional 787,500 shares of common stock at the public offering price (“Over-Allotment Option”). In connection with the Offering, the Company also agreed to issue to the Underwriter, or its designees, warrants (“Underwriter’s Warrants”), to purchase up to an aggregate of 7% of the shares of common stock sold in the Offering (including any additional shares sold during the 45-day option period), at an exercise price of $4.80 per share. The Underwriter’s Warrants issued in the Offering will be exercisable at any time and from time to time, in whole or in part, commencing six months from issuance for a period of three years from the date of issuance. The closing of the sale of the Offering occurred on March 2, 2020. On April 9, 2020, the Company issued 180,561 shares of Common Stock and 12,640 Underwriter’s Warrants pursuant to a partial exercise by the Underwriter of the Over-Allotment Option (“Partial Over-Allotment Option Exercise”). The net proceeds to the Company from the Offering, including from the Partial Over-Allotment Option Exercise, after deducting the underwriting discount and the Company’s estimated Offering expenses were $19,894.
|
|
d.
|
On December 1, 2020, the Company entered into a new equity distribution
agreement (the “New Sales Agreement”), pursuant to which the Company could, from time to time and at the Company’s option,
issue and sell shares of Company common stock having an aggregate offering price of up to $40,000, through a sales agent, subject to certain
terms and conditions. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3
including a prospectus dated February 10, 2020 as supplemented by a prospectus supplement dated December 1, 2020. The Company paid the
sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the New Sales
Agreement. As of August 31, 2021, 4,061,956 shares were issued under the New Sales Agreement for aggregate net proceeds of $38,799.
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 7 - STOCKHOLDERS’ EQUITY (continued):
|
e.
|
On June 16, 2021, the Company entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Canaccord Genuity LLC, as agent (“Canaccord Genuity”), pursuant to which the Company could issue and sell shares of its common stock having an aggregate offering price of up to $28,000 from time to time through Canaccord Genuity. The Equity Distribution Agreement replaced the New Sales Agreement, once it had been exhausted. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated February 10, 2020 and prospectus supplement dated June 16, 2021. The Company paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the Equity Distribution Agreement. As of August 31, 2021, 1,823,287 shares were issued under the Equity Distribution Agreement for aggregate net proceeds of $27,119.
|
|
f.
|
On July 15, 2021, the Company entered into a new equity distribution
agreement (the “New Equity Distribution Agreement”) with Canaccord Genuity, pursuant to which the Company may issue and sell
shares of its common stock having an aggregate offering price of up to $100,000 from time to time through Canaccord Genuity. The New Equity
Distribution Agreement replaced the Equity Distribution Agreement, once it had been exhausted. Any shares sold will be sold pursuant to
the Company’s effective shelf registration statement on Form S-3 including a prospectus dated July 15, 2021. The Company paid the
sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the New Equity
Distribution Agreement. As of August 31, 2021 and through November 24, 2021, 208,451 and 273,997 shares were respectively issued under
the New Equity Distribution Agreement for aggregate net proceeds of $3,884.
|
|
g.
|
As of August 31, 2021, the Company had outstanding warrants exercisable commencing January 6, 2019 for 232,175 shares of common stock at exercise prices ranging from $4.13 to $7.8125 per share and expiring from January 6, 2022 to April 15, 2029.
|
The following table presents the warrant
activity for the years ended August 31, 2021 and 2020:
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
Warrants
|
|
|
Weighted-
Average
Exercise
Price
|
|
|
Warrants
|
|
|
Weighted-
Average
Exercise
Price
|
|
Warrants outstanding at beginning of year
|
|
|
3,407,820
|
|
|
$
|
6.98
|
|
|
|
3,007,680
|
|
|
$
|
7.27
|
|
Issued
|
|
|
-
|
|
|
$
|
-
|
|
|
|
400,140
|
|
|
$
|
4.77
|
|
Exercised
|
|
|
3,175,645
|
|
|
$
|
7.07
|
|
|
|
-
|
|
|
$
|
-
|
|
Expired
|
|
|
-
|
|
|
$
|
-
|
|
|
|
-
|
|
|
$
|
-
|
|
Warrants outstanding at end of year
|
|
|
232,175
|
|
|
$
|
5.57
|
|
|
|
3,407,820
|
|
|
$
|
6.98
|
|
Warrants exercisable at end of year
|
|
|
232,175
|
|
|
$
|
5.57
|
|
|
|
3,407,820
|
|
|
$
|
6.98
|
|
NOTE 8 - STOCK-BASED COMPENSATION:
The Company makes awards only under
the 2019 Plan, under which, the Company had reserved a pool of 3,000,000 shares of the Company’s common stock which may be issued
at the discretion of the Company’s Board of Directors from time to time. Under this 2019 Plan, each option or RSU is exercisable
into one share of common stock of the Company. The options may be exercised after vesting and in accordance with vesting schedules which
will be determined by the Board of Directors for each grant. The maximum term of the options and RSUs is 10 years.
The following are the significant stock
options and RSUs transactions with employees, board members and non-employees made during the years ended August 31, 2021 and 2020:
|
a.
|
On September 11, 2019, the Company granted options to its Chief Operating
and Business Officer to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $3.69 per share
(equivalent to the closing price of the Company’s common stock on the date of grant). The options shall vest in 16 equal installments
of 6,250 on the first day of every three months period beginning November 1, 2019. As of August 31, 2021, 50,000 of such options are vested.
The options expire on September 11, 2029. The fair value of all these options on the date of grant was $224, using the Black Scholes option-pricing
model and was based on the following assumptions: stock price of $3.69; dividend yield of 0% for all years; expected volatility of 65.60%;
risk-free interest rates of 1.89%; and expected term of 6.14 years.
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
|
b.
|
On September 11, 2019, the Company granted options to its Chief Operating
and Business Officer to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $3.69 per share
(equivalent to the closing price of the Company’s common stock on the date of grant). The options shall vest in four installments
upon achievement of certain performance conditions. As of August 31, 2021, no such options are vested. The options expire on September
11, 2029. The fair value of all these options on the date of grant was $127, using the Black Scholes option-pricing model and was based
on the following assumptions: stock price of $3.69; dividend yield of 0% for all years; expected volatility of 67.96%; risk-free interest
rates of 1.68%; expected term of 6.91 years; and the probability that such performance conditions will occur.
|
|
c.
|
On January 8, 2020, the Company granted options to its directors to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $4.80 per share (equivalent to the closing price of the Company’s common stock on the date of grant). The options shall vest in three equal installments on each of December 31, 2020, December 31, 2021 and December 31, 2022. As of August 31, 2021, 33,330 of such options are vested. The options expire on January 8, 2030. The fair value of all these options on the date of grant was $278, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $4.80; dividend yield of 0% for all years; expected volatility of 62.55%; risk-free interest rates of 1.67%; and expected term of 5.99.
|
|
d.
|
On January 8, 2020, the Company granted options
to purchase an aggregate of 290,000 shares of common stock of the Company at an exercise price of $4.80 per share (equivalent to the closing
price of the Company’s common stock on the date of grant) as follows: 190,000 to the Company’s Chief Executive Officer, or
CEO, and 100,000 to the Company’s Chief Scientific Officer, or CSO. The options shall vest in four equal annual installments, on
each of December 31, 2020, 2021, 2022 and 2023. As of August 31, 2021, 72,500 of such options are vested. These options expire on January
8, 2030. The fair value of all these options on the date of grant was $868, using the Black Scholes option-pricing model and was based
on the following assumptions: stock price of $4.80; dividend yield of 0% for all years; expected volatility of 67.87%; risk-free interest
rates of 1.67%; and expected term of 6.24 years.
|
|
e.
|
On February 3, 2021, the Company granted options
to purchase an aggregate of 340,000 shares of common stock of the Company at an exercise price of $10.40 per share (equivalent to the
closing price of the Company’s common stock on the date of grant) as follows: 150,000 to the CEO, 100,000 to the CSO, 40,000 to
the Company’s former Chief Financial Officer and 50,000 to the Company’s Chief Operating & Business Officer. The options
shall vest in four equal annual installments, on each of December 31, 2021, 2022, 2023 and 2024. These options expire on February 3, 2031.
The fair value of all these options on the date of grant was $1,987, using the Black Scholes option-pricing model and was based on the
following assumptions: stock price of $10.40; dividend yield of 0% for all years; expected volatility of 61.07%; risk-free interest rates
of 0.64%; and expected term of 6.21 years.
On February 3, 2021, the Company granted a total of 680,000 RSUs as
follows: 300,000 to the CEO, 200,000 to the CSO, 80,000 to the Company’s former Chief Financial Officer and 100,000 to the Company’s
Chief Operating and Business Officer. These RSUs were granted under the Company’s 2019 Plan and shall vest as follows: 226,666 shall
vest upon the Company’s common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 226,667
shall vest upon the Company’s common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and
226,667 upon achievement of a certain licensing agreement as specified by the Board of Directors. The total fair value of these RSUs on
the date of the grant was $4,511, using the Monte-Carlo model.
|
|
f.
|
On February 17, 2021, the Company granted options
to purchase an aggregate of 15,000 shares of common stock of the Company at an exercise price of $11.33 per share (equivalent to the closing
price of the Company’s common stock on the date of grant) to the chairman of the Board of Directors. The options shall vest in three
equal annual installments, on each of December 31, 2021, 2022 and 2023. These options expire on February 17, 2031. The fair value of all
these options on the date of grant was $98, using the Black Scholes option-pricing model and was based on the following assumptions: stock
price of $11.33; dividend yield of 0% for all years; expected volatility of 64.39%; risk-free interest rates of 0.76%; and expected term
of 5.94 years.
On February 17, 2021, the Company granted a total of 30,000 RSUs to
the chairman of the Board of Directors. These RSUs were granted under the Company’s 2019 Plan and shall vest as follows: 10,000
shall vest upon the Company’s common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 10,000
shall vest upon the Company’s common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and
10,000 upon achievement of a certain licensing agreement as specified by the Board of Directors. The total fair value of these RSUs on
the date of the grant was $217, using the Monte-Carlo model.
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
|
g.
|
On August 4, 2021, the Company granted options to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $15.10 per share (equivalent to the closing price of the Company’s common stock on the date of grant) to the Chief Commercial Officer. The options shall vest as follows: 12,500 on December 31, 2021, three equal annual installments of 25,000 on each of December 31, 2022, 2023 and 2024 and 12,500 on August 4, 2025. These options expire on August 4, 2031. The fair value of all these options on the date of grant was $860, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $15.10; dividend yield of 0% for all years; expected volatility of 61.98%; risk-free interest rates of 0.82%; and expected term of 6.17 years.
On August 4, 2021, the Company granted a total of 100,000 RSUs to the Chief Commercial Officer. These RSUs were granted under the Company’s 2019 Plan and shall vest as follows: 33,333 shall vest upon the Company’s common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 33,333 shall vest upon the Company’s common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 33,334 upon achievement of a certain licensing agreement as specified by the Board of Directors. The total fair value of these RSUs on the date of the grant was $985, using the Monte-Carlo model.
|
|
h.
|
Options to employees, directors and non-employees
|
The fair value of each option grant is
estimated on the date of grant using the Black Scholes option-pricing model or Monte Carlo model with the following range of assumptions:
|
|
For options granted
in the year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Expected option life (years)
|
|
|
5.94-6.21
|
|
|
|
5.74-6.24
|
|
Expected stock price volatility (%)
|
|
|
61.07-64.39
|
|
|
|
57.77-68.14
|
|
Risk free interest rate (%)
|
|
|
0.64-0.82
|
|
|
|
1.67-1.89
|
|
Expected dividend yield (%)
|
|
|
0.0
|
|
|
|
0.0
|
|
A summary of the status of the stock options
granted to employees and directors as of August 31, 2021 and 2020, and changes during the years ended on those dates, is presented below:
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
Options outstanding at beginning of year
|
|
|
1,597,149
|
|
|
|
5.47
|
|
|
|
1,264,645
|
|
|
|
6.11
|
|
Changes during the year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
455,000
|
|
|
|
11.46
|
|
|
|
943,646
|
|
|
|
3.98
|
|
Forfeited
|
|
|
(52,584
|
)
|
|
|
7.78
|
|
|
|
(392,646
|
)
|
|
|
3.79
|
|
Expired
|
|
|
-
|
|
|
|
-
|
|
|
|
(206,243
|
)
|
|
|
6.02
|
|
Exercised
|
|
|
(93,782
|
)
|
|
|
6.42
|
|
|
|
(12,253
|
|
|
|
1.00
|
|
Options outstanding at end of year
|
|
|
1,905,783
|
|
|
|
6.79
|
|
|
|
1,597,149
|
|
|
|
5.47
|
|
Options exercisable at end of year
|
|
|
859,447
|
|
|
|
|
|
|
|
687,024
|
|
|
|
|
|
Weighted average fair value of options granted during the year
|
|
$
|
6.47
|
|
|
|
|
|
|
$
|
2.79
|
|
|
|
|
|
Expenses recognized in respect of stock
options granted to employees and directors, for the years ended August 31, 2021 and 2020 were $1,409 and $1,086, respectively.
The total intrinsic value of employees’
options exercised during the year ended August 31, 2021 was $1,287 and $27 during the year ended August 31, 2020.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
The following table presents summary information
concerning the options granted to employees and directors outstanding as of August 31, 2021:
Exercise
prices
|
|
Number outstanding
|
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
|
Weighted
average
exercise
price
|
|
$
|
|
|
|
|
Years
|
|
|
$
|
|
1.00 to 6.00
|
|
|
1,064,084
|
|
|
|
7.01
|
|
|
|
3.98
|
|
6.23 to 9.12
|
|
|
306,781
|
|
|
|
6.11
|
|
|
|
7.94
|
|
10.40 to 15.10
|
|
|
534,918
|
|
|
|
8.12
|
|
|
|
11.73
|
|
|
|
|
1,905,783
|
|
|
|
7.18
|
|
|
|
6.79
|
|
859,447 options granted to employees and
directors that were outstanding as of August 31, 2021 were also exercisable as of August 31, 2021, compared to 687,024 as of August 31,
2020.
As of August 31, 2021, there were $2,598
of unrecognized compensation costs related to non-vested options previously granted to employees and directors. The unrecognized compensation
costs are expected to be recognized over a weighted average period of 1.3 years.
A summary of the status of the stock options
granted to non-employees outstanding as of August 31, 2021 and 2020, and changes during the years ended on those dates, is presented below:
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
Options outstanding at beginning of year
|
|
|
103,152
|
|
|
|
6.64
|
|
|
|
47,152
|
|
|
|
9.51
|
|
Changes during the year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
|
|
56,000
|
|
|
|
4.21
|
|
Exercised
|
|
|
(10,000
|
)
|
|
|
7.36
|
|
|
|
-
|
|
|
|
-
|
|
Forfeited
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Expired
|
|
|
(37,152
|
)
|
|
|
6.00
|
|
|
|
-
|
|
|
|
-
|
|
Options outstanding at end of year
|
|
|
56,000
|
|
|
|
4.22
|
|
|
|
103,152
|
|
|
|
6.64
|
|
Options exercisable at end of year
|
|
|
46,000
|
|
|
|
4.03
|
|
|
|
65,152
|
|
|
|
5.58
|
|
Weighted average fair value of options granted during the year
|
|
$
|
-
|
|
|
|
|
|
|
$
|
2.47
|
|
|
|
|
|
The Company recorded stock-based compensation
of $22 and $87 during the years ended August 31, 2021 and 2020, respectively, related to non-employees’ awards.
10,000 options were exercised by non-employees
during the year ended August 31, 2021 for a total intrinsic value of $100 while no options were exercised by non-employees during the
year ended August 31, 2020.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
The following table presents summary information
concerning the options granted to non-employees outstanding as of August 31, 2021:
Range of
exercise
prices
|
|
|
Number outstanding
|
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
|
Weighted
Average
Exercise
Price
|
|
$
|
|
|
|
|
|
Years
|
|
|
$
|
|
|
3.74-5.08
|
|
|
|
56,000
|
|
|
|
8.30
|
|
|
|
4.22
|
|
46,000 options granted to non-employees
that were outstanding as of August 31, 2021, were also exercisable as of August 31, 2021.
As of August 31, 2021, there were $2 of
unrecognized compensation costs related to non-vested options previously granted to non-employees. The unrecognized compensation costs
are expected to be recognized over a weighted average period of 0.17 years.
|
i.
|
Restricted stock units
|
The following table summarizes the activities
for unvested RSUs granted to employees and directors for the years ended August 31, 2021 and 2020:
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
Number of RSUs
|
|
Vested and unissued at the beginning of period
|
|
|
164,636
|
|
|
|
164,636
|
|
Granted
|
|
|
810,000
|
|
|
|
-
|
|
Forfeited
|
|
|
(53,334
|
)
|
|
|
-
|
|
Outstanding at the end of the period
|
|
|
921,302
|
|
|
|
164,636
|
|
Vested
|
|
|
236,665
|
|
|
|
-
|
|
Vested and unissued
|
|
|
401,301
|
|
|
|
164,636
|
|
The Company recorded compensation expenses
related to RSUs of $1,265 for the year ended August 31, 2021. During the year ended August 31, 2020, the Company did not record expense
or income related to RSUs.
As of August 31, 2021, there were unrecognized compensation costs of $4,201 related to RSUs. The unrecognized compensation costs are expected
to be recognized over a weighted average period of 1.06 years.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 9 - FINANCIAL INCOME AND EXPENSES
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Income from interest on deposits
|
|
$
|
130
|
|
|
$
|
552
|
|
Income from interest on corporate bonds
|
|
|
217
|
|
|
|
138
|
|
Gain from securities, net
|
|
|
6
|
|
|
|
-
|
|
Revaluation of securities, net
|
|
|
889
|
|
|
|
-
|
|
|
|
$
|
1,242
|
|
|
$
|
690
|
|
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Exchange rate differences, net
|
|
$
|
2
|
|
|
$
|
6
|
|
Bank and broker commissions
|
|
|
5
|
|
|
|
6
|
|
Loss from securities, net
|
|
|
-
|
|
|
|
432
|
|
Other
|
|
|
1
|
|
|
|
-
|
|
|
|
$
|
8
|
|
|
$
|
444
|
|
NOTE 10 - TAXES ON INCOME:
Taxes on income included in the consolidated
statements of operations represent current taxes due to taxable income of the Company and its Israeli subsidiary.
|
a.
|
Corporate taxation in the U.S.
|
The applicable corporate tax rate for
the Company is 21%.
As of August 31, 2021, the Company has
an accumulated tax loss carryforward of approximately $19,159 (as of August 31, 2020, $15,880). Under U.S. tax laws, subject to certain
limitations, carryforward tax losses originating in tax years beginning after January 1, 2018, have no expiration date, but they are limited
to 80% of the company’s taxable income in any given tax year. Carryforward tax losses originating in tax years beginning prior to January
1, 2018, expire 20 years after the year in which incurred. In the case of the Company, subject to potential limitations in accordance
with the relevant law, the net loss carryforward will expire in the years 2027 through 2039.
|
b.
|
Corporate taxation in Israel:
|
The Subsidiary is taxed in accordance
with Israeli tax laws. The corporate tax rate applicable to 2021 and 2020 is 23%.
As of August 31, 2021, the Subsidiary
has an accumulated tax loss carryforward of approximately $73,762 (as of August 31, 2020, approximately $57,900). Under the Israeli tax
laws, carryforward tax losses have no expiration date.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - TAXES ON INCOME (continued):
|
c.
|
Deferred income taxes:
|
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
In respect of:
|
|
|
|
|
|
|
Net operating loss carryforward
|
|
$
|
21,196
|
|
|
$
|
16,652
|
|
Research and development expenses
|
|
|
3,877
|
|
|
|
2,740
|
|
Less - valuation allowance
|
|
|
(25,073
|
)
|
|
|
(19,392
|
)
|
Net deferred tax assets
|
|
$
|
-
|
|
|
$
|
-
|
|
Deferred taxes are determined based on
temporary differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates
and laws that will be in effect when the differences are expected to reverse.
Realization of deferred tax assets is
dependent upon sufficient future taxable income during the period that deductible temporary differences and carryforwards are expected
to be available to reduce taxable income. As the achievement of required future taxable income is uncertain, the Company recorded a full
valuation allowance.
|
d.
|
Loss before taxes on income and income taxes included in the income statements of operations:
|
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Loss before taxes on income:
|
|
|
|
|
|
|
U.S.
|
|
$
|
5,307
|
|
|
$
|
2,868
|
|
Outside U.S.
|
|
|
17,682
|
|
|
|
8,643
|
|
|
|
$
|
22,989
|
|
|
$
|
11,511
|
|
Taxes on income (tax benefit):
|
|
|
|
|
|
|
|
|
Current:
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
-
|
|
|
|
-
|
|
Outside U.S.
|
|
|
-
|
|
|
|
-
|
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
e.
|
Reconciliation of the statutory tax benefit to effective tax expense
|
Following is a reconciliation of the theoretical
tax expense, assuming all income is taxed at the regular tax rates applicable to companies in the United States, and the actual tax expense:
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Loss before income taxes as reported in the consolidated statement of comprehensive loss
|
|
$
|
(22,989
|
)
|
|
$
|
(11,511
|
)
|
|
|
|
|
|
|
|
|
|
Statutory tax benefit
|
|
|
(4,828
|
)
|
|
|
(2,417
|
)
|
Increase in income taxes resulting from:
|
|
|
|
|
|
|
|
|
Change in the balance of the valuation allowance for deferred tax
|
|
|
4,872
|
|
|
|
3,154
|
|
Disallowable deductions
|
|
|
310
|
|
|
|
135
|
|
Influence of different tax rate applicable to the Subsidiary and changes in tax rates from previous years
|
|
|
(354
|
)
|
|
|
(872
|
)
|
Withholding tax, see note 10d above
|
|
|
-
|
|
|
|
-
|
|
Uncertain tax position
|
|
|
-
|
|
|
|
-
|
|
Taxes on income for the reported year
|
|
$
|
-
|
|
|
$
|
-
|
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - TAXES ON INCOME (continued):
|
f.
|
Uncertainty in Income Taxes
|
ASC Topic 740, “Income Taxes”
requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each tax
position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate of the effective tax
rate and consequently, affect the operating results of the Company. The Company recognizes interest and penalties related to its tax contingencies
as income tax expense.
The following table summarizes the activity
of the Company unrecognized tax benefits:
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Balance at Beginning of Year
|
|
$
|
11
|
|
|
$
|
11
|
|
Decrease in uncertain tax positions for the current year
|
|
|
-
|
|
|
|
-
|
|
Balance at End of Year
|
|
$
|
11
|
|
|
$
|
11
|
|
The Company does not expect unrecognized
tax expenses to change significantly over the next 12 months.
The Company is subject to U.S. Federal
income tax examinations for the tax years of 2016 through 2018.
The Subsidiary is subject to Israeli income
tax examinations for the tax years of 2014 through 2019.
|
g.
|
Valuation Allowance Rollforward
|
|
|
Year ended
August 31,
|
|
|
|
Balance at beginning of period
|
|
|
Additions
|
|
|
Balance at end of period
|
|
Allowance in respect of carryforward tax losses:
|
|
|
|
|
|
|
|
|
|
Year ended August 31, 2021
|
|
$
|
19,392
|
|
|
$
|
5,681
|
|
|
$
|
25,073
|
|
Year ended August 31, 2020
|
|
|
16,238
|
|
|
|
3,154
|
|
|
|
19,392
|
|
NOTE 11 - RELATED PARTIES - TRANSACTIONS:
|
a.
|
During each of the fiscal years of 2021 and 2020, the Company paid to directors $100 and $95, respectively, as directors’ fees.
|
|
b.
|
On July 1, 2008, the Subsidiary entered into two consulting agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the CSO, whereby the CEO and the CSO, through KNRY, provide services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either party upon 140 days, prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the Consulting Agreements and that the monthly consulting fee paid to the CEO and the CSO is NIS 127,570 ($40) and NIS 92,522 ($29), respectively.
Starting September 1, 2021, the CEO receives a monthly consulting fee of NIS 146,705 ($46) and the CSO receives a monthly consulting fee of NIS 106,400 ($33)
|
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE
11 - RELATED PARTIES - TRANSACTIONS (continued):
In addition to the Consulting Agreements,
based on a relocation cost analysis, the Company pays for certain direct costs, related taxes and expenses incurred in connection with
the relocation of the CEO to New York. During fiscal 2021 and 2020, such relocation expenses totaled $377 and $516, respectively.
|
c.
|
Balances with related parties:
|
|
|
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
Accounts payable and accrued expenses - KNRY
|
|
$
|
54
|
|
|
$
|
90
|
|
|
d.
|
Expenses to related parties:
|
|
|
Year ended
August 31,
|
|
|
|
2021
|
|
|
2020
|
|
KNRY
|
|
$
|
872
|
|
|
$
|
766
|
|
Nadav Kidron (CEO)
|
|
$
|
687
|
|
|
|
801
|
|
NOTE 12 - ASSET ACQUISITION TRANSACTION
On March 18, 2021, the Company entered into the
Oravax License Agreement and into the Stockholders Agreement (as defined below) with Oravax. On that date, Oravax’s assets were
(1) in process research and development of COVID-19 vaccine technology; and (2) $1,500 received in cash. According to the Stockholders
Agreement, Oravax issued 1,890,000 shares of its capital stock to the Company, representing 63% of the issued and outstanding share capital
of Oravax, on a fully diluted basis, as of the date of issuance. Consequently, the Company is consolidating Oravax in its consolidated
financial statements as from the inception of Oravax. In addition, under the terms of the Oravax License Agreement, the Company has licensed
out to Oravax certain patent rights, know-how and information related to the Company’s oral drug delivery technology with respect
to the combination with the COVID-19 vaccine technology (the “Licensed IP”).
In consideration for the grant of the License,
the Oravax License Agreement provides that the Company will receive (i) royalties equal to 7.5% on net sales, as defined in the Oravax
License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related to the License during the
term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based consideration received by Oravax
from a permitted sublicensee and (iii) other payments ranging between $25,000 to $100,000, based on certain sales milestones being achieved
by Oravax. The parties further agreed to establish a development and steering committee, which will consist of three members, of which
two members will be appointed by the Company, that will oversee the ongoing research, development, clinical and regulatory activity with
respect to the Oravax Product. Akers Biosciences Inc. (“Akers”) contributed Oravax $1,500 in cash and a license agreement
to the Oravax Product which includes a maximum of 2.5% royalties of all net sales.
Concurrently with the execution and delivery of
the Oravax License Agreement, the Company entered into a Stockholders Agreement (the “Stockholders Agreement”), with Akers,
Premas Biotech Pvt. Ltd. (“Premas”), Cutter Mill Capital LLC (“Cutter Mill”), and Run Ridge LLC (“Run Ridge”),
entities controlled by Michael Vasinikovich and Craig Schwabe, former members of Cystron, and collectively with Akers, Premas, Cutter
Mill and Run Ridge, the Stockholders Parties. Pursuant to the Stockholders Agreement, among other things, the Company will have the right
to appoint two out of the three members to the board of directors of Oravax (the “Oravax Board”), one of which is the Company’s
Chief Executive Officer who will serve as the chairman of the Oravax Board, conditioned upon the Company maintaining certain ownership
thresholds. Akers will have the right, until the third anniversary of the Stockholders Agreement effective date, to appoint one member
to the Oravax Board. Oravax’s common stock held by the Stockholders Parties will be subject to certain transfer restrictions. In
addition, the Stockholders Parties will have certain rights of participation in future financings as well as rights of first refusal and
co-sale related to future potential transactions.
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 12 - ASSET ACQUISITION TRANSACTION
(continued):
According to ASC 805, the transaction was accounted
for as an asset acquisition. No gain or loss was recognized on the transfer of the cash or the Licensed IP to Oravax while the Company
retained control of those assets. The Company has recognized an increase in non-controlling interests of $1,495 based on the carrying
amount of the contributed assets and, according to the Company’s accounting policy, the fair value of Oravax excluding the contributed
assets. Any difference between the fair value of consideration paid and the increase in the non-controlling interests’ carrying
amount was recognized in equity. As a result of the acquisition, the Company recognized IPR&D expense in the amount of $1,040.
NOTE 13 - SUBSEQUENT EVENTS
|
a.
|
On September 1, 2021, the Company granted options
to its Chief Financial Officer to purchase an aggregate of 50,000 shares of common stock of the Company at an exercise price of $20.19
per share. The options shall vest in four equal installments of 12,500 options on each of June 27, 2022, June 27, 2023, June 27, 2024
and June 27, 2025. In addition, The Company granted 50,000 RSUs that shall vest as follows:
33,333 if the closing price per share of the Company’s common
stock will be at least $25 for at least 20 days out of any 30-trading day period; and
|
|
1.
|
If the first condition is met anytime before June 27, 2022, then the RSUs will vest in three equal installments (on June 27, 2022,
June 27, 2023 and June 27, 2024).
|
|
|
|
|
2.
|
If the first condition is met anytime between June 27, 2022 and June 27, 2023, then 1/3 of the RSUs will vest immediately, and the
remainder will vest in two equal installments (on June 27, 2023 and June 27, 2024).
|
|
|
|
|
3.
|
If the first condition is met anytime between June 27, 2023 and June 27, 2024, then 2/3 of the RSUs will vest immediately, and the
remaining 1/3 will vest on June 27, 2024).
|
|
|
|
|
4.
|
If the first condition is met anytime after June 27, 2024, then the RSUs will vest immediately.
|
|
|
16,667 upon achievement of a certain licensing agreement as specified by the Board of Directors; and
|
|
1.
|
If the first condition is met anytime before June 27, 2022, then the RSUs will vest in three equal installments (on June 27, 2022, June 27, 2023 and June 27, 2024).
|
|
|
|
|
2.
|
If the first condition is met anytime between June 27, 2022 and June 27, 2023, then 1/3 of the RSUs will vest immediately, and the remainder will vest in two equal installments (on June 27, 2023 and June 27, 2024).
|
|
|
|
|
3.
|
If the first condition is met anytime between June 27, 2023 and June 27, 2024, then 2/3 of the RSUs will vest immediately, and the remaining 1/3 will vest on June 27, 2024).
|
|
|
|
|
4.
|
If the first condition is met anytime after June 27, 2024, then the RSUs will vest immediately.
|
These options and RSUs expire on September 1, 2031.
The total value of the options and RSUs is $1,572.
|
b.
|
On September 1, 2021, the Company entered into a controlled equity offering agreement, or the Cantor Equity Distribution Agreement,
with Cantor Fitzgerald & Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may issue and sell shares
of its common stock having an aggregate offering price of up to $100,000 from time to time through Cantor Fitzgerald. As of November 24,
2021, 565,120 shares issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $12,298.
|
|
c.
|
On November 3, 2021, the Company entered into a securities purchase
agreement with several institutional and accredited investors, or the Purchasers, pursuant to which the Company agreed to sell, in a registered
direct offering, or the Offering, an aggregate of 2,000,000 shares of the Company’s common stock, or the Shares, to the Purchasers
for an offering price of $25 per Share. The closing of the sale of the Shares occurred on November 5, 2021. The net proceeds to the Company
from the Offering, after deducting the placement agent’s fees and expenses and the Company’s estimated Offering expenses,
were approximately $46,375.
|
All other schedules for which provision is made
in the applicable accounting regulations of the SEC are not required under the related instructions, or are inapplicable, and therefore
have been omitted.
3.1
|
|
Composite Copy of Certificate of Incorporation, as amended as of January 22, 2013, corrected February 8, 2013, as amended as of July 25, 2014, corrected September 5, 2017 and as further amended as of August 3, 2020 (incorporated by reference from our annual report on Form 10-K filed November 24, 2020)
|
|
|
|
3.3
|
|
Second Amended and Restated By-laws (incorporated by reference from our current report on Form 8-K filed July 15, 2021).
|
|
|
|
4.1
|
|
Specimen Common Stock Certificate (incorporated by reference from our registration statement on Form S-1 filed February 1, 2013).
|
|
|
|
4.2
|
|
Form of Common Stock Purchase Warrant (incorporated by reference from our current report on Form 8-K filed July 5, 2018).
|
|
|
|
4.3
|
|
Form of Underwriter’s Warrant (incorporated by reference from our current report on Form 8-K filed February 28, 2020).
|
|
|
|
4.4
|
|
Description of Securities (incorporated by reference from our annual report on Form 10-K filed November 24, 2020).
|
|
|
|
10.1+
|
|
Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our current report on Form 8-K filed July 2, 2008).
|
|
|
|
10.2+
|
|
Amendment, dated July 13, 2013, to Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008 for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
|
|
|
|
10.3+
|
|
Amendment, dated November 13, 2014, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron and Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
|
10.4+
|
|
Amendment, dated July 21, 2015, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2015).
|
|
|
|
10.5+
|
|
Amendment, dated June 27, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
|
|
|
|
10.6+
|
|
Amendment, dated November 28, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our quarterly report on Form 10-Q filed January 11, 2017).
|
|
|
|
10.7+*
|
|
Amendment, dated September 19, 2021, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron.
|
|
|
|
10.8+
|
|
Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our current report on Form 8-K filed July 2, 2008).
|
|
|
|
10.9+
|
|
Amendment, dated July 13, 2013, to Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008 for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
|
|
|
|
10.10+
|
|
Amendment, dated July 21, 2015, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2015).
|
|
|
|
10.11+
|
|
Amendment, dated June 27, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
|
|
|
|
10.12+
|
|
Amendment, dated June 30, 2017, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 29, 2017).
|
|
|
|
10.13+
|
|
Amendment, dated January 10, 2020, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our quarterly report on Form 10-Q filed April 6, 2020).
|
|
|
|
10.14+*
|
|
Amendment, dated September 19, 2021, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron.
|
|
|
|
10.15+
|
|
Oramed Pharmaceuticals Inc. Second Amended and Restated 2008 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed August 4, 2016).
|
|
|
|
10.16+
|
|
Form of Restricted Stock Unit Notice and Restricted Stock Unit Agreement (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
|
10.17+
|
|
Form of Restricted Stock Unit Notice and Restricted Stock Unit Agreement between the Company and the CSO or CEO (incorporated by reference from our annual report on Form 10-K filed November 29, 2017).
|
|
|
|
10.18+
|
|
Form of Notice of Stock Option Award and Stock Option Award Agreement (incorporated by reference from our current report on Form 8-K filed July 2, 2008).
|
|
|
|
10.19+
|
|
Oramed Pharmaceuticals Inc. 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed August 6, 2019).
|
|
|
|
10.20+
|
|
Oramed Pharmaceuticals Inc. Amended and Restated 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed June 30, 2020).
|
|
|
|
10.21+
|
|
Form of Notice of Stock Option Award and Stock Option Award Agreement (incorporated by reference from our annual report on Form 10-K filed November 27, 2019).
|
|
|
|
10.22+
|
|
Employment Agreement, dated May 16, 2019, by and between Oramed Ltd. and Avraham Gabay (incorporated by reference from our current report on Form 8-K filed May 16, 2019).
|
|
|
|
10.23+
|
|
First Amendment, dated December 19, 2019, to Employment Agreement, entered into as of May 16, 2019, by and between Oramed Ltd. and Avraham Gabay (incorporated by reference from our quarterly report on Form 10-Q filed January 9, 2020).
|
|
|
|
10.24+*
|
|
Employment Agreement, dated July 25, 2021, by and between the Company and Michael Rabinowitz.
|
|
|
|
10.25+
|
|
Employment Agreement, dated May 23, 2021, by and between Oramed Ltd. and David Silberman (incorporated by reference from our quarterly report on Form 10-Q filed July 14, 2021).
|
|
|
|
10.26+*
|
|
First Amendment, dated September 19, 2021, to Employment Agreement, by and between Oramed Ltd. and David Silberman.
|
|
|
|
10.27+
|
|
Clinical Trial Agreement, dated September 11, 2011, between Oramed Ltd., Hadasit Medical Research Services and Development Ltd., Miriam Kidron and Daniel Schurr (incorporated by reference from our annual report on Form 10-K/A filed December 21, 2012).
|
|
|
|
10.28+
|
|
Clinical Trial Agreement, dated July 8, 2009, between Oramed Ltd., Hadasit Medical Research Services and Development Ltd., Miriam Kidron and Itamar Raz (incorporated by reference from our current report on Form 8-K filed July 9, 2009).
|
|
|
|
10.29
|
|
Agreement, dated January 7, 2009, between Oramed Pharmaceuticals Inc. and Hadasit Medical Research Services and Development Ltd. (incorporated by reference from our current report on Form 8-K filed January 7, 2009).
|
|
|
|
10.30
|
|
Patent Transfer Agreement, dated February 22, 2011, between Oramed Ltd. and Entera Bio Ltd. (incorporated by reference from our registration statement on Form S-1 filed March 25, 2011).
|
10.31+*
|
|
Representative Form of Indemnification Agreements between Oramed Pharmaceuticals Inc. and each of our directors and officers.
|
|
|
|
10.32+
|
|
Employment Agreement, dated August 18, 2019, between Oramed Ltd. and Joshua Hexter (incorporated by reference from our annual report on Form 10-K filed November 27, 2019).
|
|
|
|
10.33+*
|
|
First Amendment, dated September 19, 2021, to Employment Agreement, by and between Oramed Ltd. and Joshua Hexter.
|
|
|
|
10.34
|
|
Amended and Restated Technology License Agreement, dated December 21, 2015, between Hefei Tianhui Incubator of Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been granted for portions of this document. Incorporated by reference from our quarterly report on Form 10-Q filed January 13, 2016).
|
|
|
|
10.35
|
|
Amendment to the Amended and Restated Technology License Agreement, dated June 3, 2016, between Hefei Tianhui Incubator of Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been requested for portions of this document. The confidential portions will be omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
|
|
|
|
10.36
|
|
Amendment to the Amended and Restated Technology License Agreement, dated July 24, 2016, between Hefei Tianhui Incubator of Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been requested for portions of this document. The confidential portions will be omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
|
|
|
|
10.37
|
|
Service Agreement, dated as of June 3, 2016, between Oramed Ltd. and XERTECS GmbH (Confidential treatment has been granted for portions of this document. The confidential portions have been omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
|
|
|
|
10.38
|
|
General Technical Agreement between Oramed Ltd. and Premas Biotech Pvt. Ltd., dated July 24, 2016 (Confidential treatment has been granted for portions of this document. The confidential portions have been omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
|
10.39
|
|
Equity Distribution Agreement, dated July 15, 2021, by and between the Company and Canaccord Genuity LLC (incorporated by reference from our current report on Form 8-K filed July 15, 2021).
|
|
|
|
10.40
|
|
Equity Distribution Agreement, dated September 1, 2021, by and between the Company and Cantor Fitzgerald & Co. (incorporated by reference from our current report on Form 8-K filed September 1, 2021).
|
|
|
|
10.41
|
|
Clinical Research Organization Services Agreement, dated February 14, 2018 and effective as of November 1, 2017, between Oramed Ltd. and Integrium, LLC (Confidential treatment has been granted for portions of this document. The confidential portions have been omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission.) (incorporated by reference from our quarterly report on Form 10-Q filed April 9, 2018).
|
10.42
|
|
Amendment #1 to Clinical Research Organization Services Agreement Protocol # ORA-D-015 between Oramed, Inc. and Integrium, LLC (incorporated by reference from our quarterly report on Form 10-Q filed July 10, 2019).
|
|
|
|
10.43
|
|
Amendment #2 to Clinical Research Organization Services Agreement Protocol # ORA-D-015 between Oramed, Inc. and Integrium, LLC (incorporated by reference from our quarterly report on Form 10-Q filed July 10, 2019).
|
|
|
|
10.44
|
|
Clinical Research Organization Services Agreement, dated September 2, 2020 and effective as of January 15, 2020, between Oramed Ltd. and Integrium, LLC (incorporated by reference from our Form 8-K filed September 9, 2020).
|
|
|
|
10.45
|
|
Clinical Research Organization Services Agreement, dated September 16, 2020 and effective as of January 15, 2020, between Oramed Ltd. and Integrium, LLC (incorporated by reference from our Form 8-K filed September 18, 2020).
|
|
|
|
10.46
|
|
License Agreement, dated as of March 18, 2021, between the Company, Oramed Ltd. and Oravax Medical Inc. (incorporated by reference from our Form 8-K filed March 19, 2021).
|
|
|
|
10.47
|
|
Stockholders Agreement, dated as of March 18, 2021, between Oramed Pharmaceuticals Inc., Akers Biosciences Inc., Premas Biotech PVT Ltd., Cutter Mill Capital LLC, and Run Ridge LLC. (incorporated by reference from our Form 8-K filed March 19, 2021).
|
|
|
|
21.1*
|
|
Subsidiaries.
|
|
|
|
23.1*
|
|
Consent of Kesselman & Kesselman, Independent Registered Public Accounting Firm.
|
|
|
|
31.1*
|
|
Certification Statement of the Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
|
|
|
|
31.2*
|
|
Certification Statement of the Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
|
|
|
|
32.1**
|
|
Certification Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350.
|
|
|
|
32.2**
|
|
Certification Statement of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
|
|
|
|
101.1*
|
|
The following financial
statements from the Company’s annual report on Form 10-K for the year ended August 31, 2021, formatted in XBRL (eXtensible
Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Loss, (iii) Consolidated Statements
of Changes in Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows and (v) the Notes to Consolidated Financial
Statements, tagged as blocks of text and in detail.
|
|
|
|
104.1*
|
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
|
+
|
Management
contract or compensation plan.
|
ITEM 16. FORM 10-K SUMMARY.
None.
SIGNATURES
Pursuant to the requirements
of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
ORAMED PHARMACEUTICALS INC.
|
|
|
|
/s/ NADAV KIDRON
|
|
Nadav Kidron,
|
|
President and Chief Executive Officer
|
|
|
|
Date: November 24, 2021
|
Pursuant to the requirements
of the Securities and Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and
in the capacities and on the dates indicated.
|
/s/ NADAV KIDRON
|
|
November 24, 2021
|
|
Nadav Kidron,
|
|
|
|
President and Chief Executive Officer and Director
|
|
|
|
(principal executive officer)
|
|
|
|
|
|
|
|
/s/ DAVID SILBERMAN
|
|
November 24, 2021
|
|
David Silberman,
|
|
|
|
Chief Financial Officer
|
|
|
|
(principal financial and accounting officer)
|
|
|
|
|
|
|
|
/s/ AVIAD FRIEDMAN
|
|
November 24, 2021
|
|
Aviad Friedman,
|
|
|
|
Director
|
|
|
|
|
|
|
|
/s/ MIRIAM KIDRON
|
|
November 24, 2021
|
|
Miriam Kidron,
|
|
|
|
Director
|
|
|
|
|
|
|
|
/s/ ARIE MAYER
|
|
November 24, 2021
|
|
Arie Mayer,
|
|
|
|
Director
|
|
|
|
|
|
|
|
/s/ KEVIN RAKIN
|
|
November 24, 2021
|
|
Kevin Rakin,
|
|
|
|
Director
|
|
|
|
|
|
|
|
/s/ LEONARD SANK
|
|
November 24, 2021
|
|
Leonard Sank,
|
|
|
|
Director
|
|
|
Mutual funds include equity funds only
Long term deposits include one deposit of $25,000 with an annual interest rate of 0.93% and a maturity date of August 10, 2023.
Future lease payments were discounted by 3% interest rate.
false
844
--08-31
FY
0001176309
967-2633
0001176309
2020-09-01
2021-08-31
0001176309
2021-11-24
0001176309
2021-02-28
0001176309
2021-08-31
0001176309
2020-08-31
0001176309
2019-09-01
2020-08-31
0001176309
us-gaap:CommonStockMember
2019-08-31
0001176309
us-gaap:AdditionalPaidInCapitalMember
2019-08-31
0001176309
us-gaap:RetainedEarningsMember
2019-08-31
0001176309
ormp:TotalStockholdersEquityMember
2019-08-31
0001176309
us-gaap:NoncontrollingInterestMember
2019-08-31
0001176309
2019-08-31
0001176309
us-gaap:CommonStockMember
2019-09-01
2020-08-31
0001176309
us-gaap:AdditionalPaidInCapitalMember
2019-09-01
2020-08-31
0001176309
us-gaap:RetainedEarningsMember
2019-09-01
2020-08-31
0001176309
ormp:TotalStockholdersEquityMember
2019-09-01
2020-08-31
0001176309
us-gaap:NoncontrollingInterestMember
2019-09-01
2020-08-31
0001176309
us-gaap:CommonStockMember
2020-08-31
0001176309
us-gaap:AdditionalPaidInCapitalMember
2020-08-31
0001176309
us-gaap:RetainedEarningsMember
2020-08-31
0001176309
ormp:TotalStockholdersEquityMember
2020-08-31
0001176309
us-gaap:NoncontrollingInterestMember
2020-08-31
0001176309
us-gaap:CommonStockMember
2020-09-01
2021-08-31
0001176309
us-gaap:AdditionalPaidInCapitalMember
2020-09-01
2021-08-31
0001176309
ormp:TotalStockholdersEquityMember
2020-09-01
2021-08-31
0001176309
us-gaap:NoncontrollingInterestMember
2020-09-01
2021-08-31
0001176309
us-gaap:RetainedEarningsMember
2020-09-01
2021-08-31
0001176309
us-gaap:CommonStockMember
2021-08-31
0001176309
us-gaap:AdditionalPaidInCapitalMember
2021-08-31
0001176309
us-gaap:RetainedEarningsMember
2021-08-31
0001176309
ormp:TotalStockholdersEquityMember
2021-08-31
0001176309
us-gaap:NoncontrollingInterestMember
2021-08-31
0001176309
srt:SubsidiariesMember
2021-03-18
0001176309
ormp:LicenseAgreementMember
2015-12-01
2015-12-28
0001176309
ormp:StockPurchaseAgreementMember
2015-12-01
2015-12-28
0001176309
srt:MinimumMember
2021-08-31
0001176309
srt:MaximumMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
ormp:DNAMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
ormp:DNAMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
ormp:DNAMember
2021-08-31
0001176309
ormp:DNAMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
ormp:EnteraMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
ormp:EnteraMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
ormp:EnteraMember
2021-08-31
0001176309
ormp:EnteraMember
2021-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
2021-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
2021-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
2021-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
ormp:DNAMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
ormp:DNAMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
ormp:DNAMember
2020-08-31
0001176309
ormp:DNAMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
ormp:EnteraMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
ormp:EnteraMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
ormp:EnteraMember
2020-08-31
0001176309
ormp:EnteraMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
ormp:MutualFundsMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
ormp:MutualFundsMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
ormp:MutualFundsMember
2020-08-31
0001176309
ormp:MutualFundsMember
2020-08-31
0001176309
us-gaap:FairValueInputsLevel1Member
2020-08-31
0001176309
us-gaap:FairValueInputsLevel2Member
2020-08-31
0001176309
us-gaap:FairValueInputsLevel3Member
2020-08-31
0001176309
srt:MinimumMember
2020-08-31
0001176309
srt:MaximumMember
2020-08-31
0001176309
us-gaap:ShortTermDebtMember
ormp:CommercialBondsMember
2021-08-31
0001176309
us-gaap:ShortTermDebtMember
ormp:CommercialBondsMember
2020-09-01
2021-08-31
0001176309
us-gaap:ShortTermDebtMember
ormp:AccruedInterestMember
2021-08-31
0001176309
us-gaap:LongTermDebtMember
2021-08-31
0001176309
us-gaap:LongTermDebtMember
2020-09-01
2021-08-31
0001176309
us-gaap:ShortTermDebtMember
ormp:CommercialBondsMember
2020-08-31
0001176309
us-gaap:ShortTermDebtMember
ormp:CommercialBondsMember
2019-09-01
2020-08-31
0001176309
us-gaap:ShortTermDebtMember
ormp:AccruedInterestMember
2020-08-31
0001176309
us-gaap:LongTermDebtMember
2020-08-31
0001176309
us-gaap:LongTermDebtMember
2019-09-01
2020-08-31
0001176309
ormp:EnteraBioMember
ormp:DnaBiomedicalSolutionsMember
2011-03-27
2011-03-31
0001176309
ormp:EnteraBioMember
ormp:DnaBiomedicalSolutionsMember
2011-03-31
0001176309
2018-12-01
2018-12-11
0001176309
ormp:EnteraBioMember
ormp:DnaBiomedicalSolutionsMember
2011-02-15
0001176309
us-gaap:RoyaltyMember
2020-09-01
2021-08-31
0001176309
2016-01-01
2016-01-31
0001176309
ormp:MilestoneTwoMember
2016-07-01
2016-07-31
0001176309
ormp:MilestonesThreeMember
2016-07-01
2016-07-31
0001176309
ormp:MilestoneFourMember
2016-10-01
2016-10-01
0001176309
ormp:MilestoneFiveMember
2019-01-01
2019-01-31
0001176309
2020-08-01
2020-08-21
0001176309
2021-08-21
0001176309
2015-11-01
2015-11-30
0001176309
2015-12-28
2015-12-28
0001176309
2015-07-01
2015-07-31
0001176309
ormp:VendorOneMember
2017-12-01
2017-12-18
0001176309
ormp:VendorTwoMember
2020-09-01
2020-09-02
0001176309
ormp:VendorThreeMember
2020-09-13
2020-09-16
0001176309
ormp:IsraelInnovationAuthorityMember
2021-08-31
0001176309
srt:MinimumMember
ormp:IsraelInnovationAuthorityMember
2021-08-31
0001176309
srt:MaximumMember
ormp:IsraelInnovationAuthorityMember
2021-08-31
0001176309
us-gaap:LondonInterbankOfferedRateLIBORMember
2021-08-31
0001176309
srt:OfficeBuildingMember
2020-08-01
2020-08-02
0001176309
2019-09-01
2020-08-02
0001176309
2020-08-02
0001176309
2019-08-01
2019-08-31
0001176309
srt:MinimumMember
2020-08-03
0001176309
srt:MaximumMember
2020-08-03
0001176309
ormp:SaleAgreementMember
2019-09-01
2019-09-05
0001176309
ormp:SaleAgreementMember
2021-08-31
0001176309
ormp:SaleAgreementMember
2020-09-01
2021-08-31
0001176309
2020-02-01
2020-02-27
0001176309
ormp:NewSalesAgreementMember
2020-11-27
2020-12-01
0001176309
ormp:NewSalesAgreementMember
2021-08-31
0001176309
ormp:NewSalesAgreementMember
2020-09-01
2021-08-31
0001176309
ormp:EmployeesAndBoardMembersMember
2021-06-01
2021-06-16
0001176309
ormp:EquityDistributionAgreementMember
2020-09-01
2021-08-31
0001176309
ormp:NewEquityDistributionAgreementMember
2021-07-01
2021-07-15
0001176309
ormp:NewEquityDistributionAgreementMember
2021-08-31
0001176309
us-gaap:SubsequentEventMember
2021-11-24
0001176309
ormp:NewEquityDistributionAgreementMember
2020-09-01
2021-08-31
0001176309
ormp:AmendedAndRestatedTwoZeroOneNineStockIncentivePlanMember
2021-08-31
0001176309
ormp:AmendedAndRestatedTwoZeroOneNineStockIncentivePlanMember
2020-09-01
2021-08-31
0001176309
ormp:EmployeesBoardMembersAndNonemployeesMember
2019-09-02
2019-09-11
0001176309
2019-09-02
2019-09-11
0001176309
ormp:EmployeesBoardMembersAndNonemployeesMember
2019-09-11
0001176309
srt:ChiefOperatingOfficerMember
2019-09-02
2019-09-11
0001176309
srt:ChiefOperatingOfficerMember
2019-09-11
0001176309
2020-01-01
2020-01-08
0001176309
srt:DirectorMember
us-gaap:CommonStockMember
2020-01-08
0001176309
2020-01-08
0001176309
us-gaap:CommonStockMember
2020-01-01
2020-01-08
0001176309
srt:DirectorMember
2020-01-01
2020-01-08
0001176309
srt:ChiefExecutiveOfficerMember
2020-01-01
2020-01-08
0001176309
ormp:ChiefScientificOfficerMember
2020-01-01
2020-01-08
0001176309
srt:DirectorMember
2020-01-08
0001176309
us-gaap:CommonStockMember
2021-02-01
2021-02-03
0001176309
2021-02-01
2021-02-03
0001176309
srt:ChiefExecutiveOfficerMember
2021-02-01
2021-02-03
0001176309
ormp:ChiefScientificOfficerMember
2021-02-01
2021-02-03
0001176309
srt:ChiefFinancialOfficerMember
2021-02-01
2021-02-03
0001176309
2021-02-03
0001176309
us-gaap:RestrictedStockUnitsRSUMember
2021-02-01
2021-02-03
0001176309
ormp:AmendedAndRestatedTwoZeroOneNineStockIncentivePlanMember
2021-02-01
2021-02-03
0001176309
srt:DirectorMember
us-gaap:CommonStockMember
2021-02-01
2021-02-03
0001176309
2021-02-01
2021-02-17
0001176309
2021-02-17
0001176309
us-gaap:RestrictedStockUnitsRSUMember
2021-02-01
2021-02-17
0001176309
ormp:AmendedAndRestatedTwoZeroOneNineStockIncentivePlanMember
2021-02-01
2021-02-17
0001176309
us-gaap:CommonStockMember
2021-02-01
2021-02-17
0001176309
srt:DirectorMember
us-gaap:CommonStockMember
2021-02-01
2021-02-17
0001176309
2021-08-01
2021-08-04
0001176309
2021-08-04
0001176309
us-gaap:RestrictedStockUnitsRSUMember
2021-08-01
2021-08-04
0001176309
ormp:AmendedAndRestatedTwoZeroOneNineStockIncentivePlanMember
2021-08-01
2021-08-04
0001176309
us-gaap:CommonStockMember
2021-08-01
2021-08-04
0001176309
srt:DirectorMember
us-gaap:CommonStockMember
2021-08-01
2021-08-04
0001176309
ormp:EmployeesAndDirectorsMember
2020-09-01
2021-08-31
0001176309
ormp:EmployeesAndDirectorsMember
2019-09-01
2020-08-31
0001176309
ormp:EmployeesAndDirectorsMember
2021-08-31
0001176309
ormp:EmployeesBoardMembersAndNonemployeesMember
2020-09-01
2021-08-31
0001176309
ormp:NonEmployeesMember
2020-09-01
2021-08-31
0001176309
us-gaap:RestrictedStockUnitsRSUMember
2020-09-01
2021-08-31
0001176309
srt:MinimumMember
us-gaap:StockOptionMember
2020-09-01
2021-08-31
0001176309
srt:MaximumMember
us-gaap:StockOptionMember
2020-09-01
2021-08-31
0001176309
srt:MinimumMember
us-gaap:StockOptionMember
2019-09-01
2020-08-31
0001176309
srt:MaximumMember
us-gaap:StockOptionMember
2019-09-01
2020-08-31
0001176309
us-gaap:StockOptionMember
2020-09-01
2021-08-31
0001176309
us-gaap:StockOptionMember
2019-09-01
2020-08-31
0001176309
ormp:EmployeesAndDirectorsMember
ormp:ExercisePriceRangeOneMember
2021-08-31
0001176309
ormp:EmployeesAndDirectorsMember
ormp:ExercisePriceRangeOneMember
2020-09-01
2021-08-31
0001176309
ormp:EmployeesAndDirectorsMember
ormp:ExercisePriceRangeTwoMember
2021-08-31
0001176309
ormp:EmployeesAndDirectorsMember
ormp:ExercisePriceRangeTwoMember
2020-09-01
2021-08-31
0001176309
ormp:EmployeesAndDirectorsMember
2021-08-31
0001176309
ormp:EmployeesAndDirectorsMember
2020-09-01
2021-08-31
0001176309
us-gaap:StockCompensationPlanMember
2020-08-31
0001176309
us-gaap:StockCompensationPlanMember
2019-08-31
0001176309
us-gaap:StockCompensationPlanMember
2020-09-01
2021-08-31
0001176309
us-gaap:StockCompensationPlanMember
2019-09-01
2020-08-31
0001176309
us-gaap:StockCompensationPlanMember
2021-08-31
0001176309
ormp:NonEmployeesMember
2021-08-31
0001176309
ormp:NonEmployeesMember
2020-09-01
2021-08-31
0001176309
us-gaap:DomesticCountryMember
2020-09-01
2021-08-31
0001176309
us-gaap:DomesticCountryMember
2021-08-31
0001176309
us-gaap:DomesticCountryMember
2020-08-31
0001176309
us-gaap:IsraelTaxAuthorityMember
2020-09-01
2021-08-31
0001176309
us-gaap:IsraelTaxAuthorityMember
2019-09-01
2020-08-31
0001176309
us-gaap:IsraelTaxAuthorityMember
2021-08-31
0001176309
us-gaap:IsraelTaxAuthorityMember
2020-08-31
0001176309
srt:ChiefExecutiveOfficerMember
2008-06-15
2008-07-01
0001176309
srt:ChiefExecutiveOfficerMember
2021-08-15
2021-09-01
0001176309
srt:ChiefExecutiveOfficerMember
2020-09-01
2021-08-31
0001176309
srt:ChiefExecutiveOfficerMember
2019-09-01
2020-08-31
0001176309
ormp:KnryMember
2021-08-31
0001176309
ormp:KnryMember
2020-08-31
0001176309
ormp:KnryMember
2020-09-01
2021-08-31
0001176309
ormp:KnryMember
2019-09-01
2020-08-31
0001176309
ormp:NadavKidronCEOMember
2020-09-01
2021-08-31
0001176309
ormp:NadavKidronCEOMember
2019-09-01
2020-08-31
0001176309
2021-03-01
2021-03-18
0001176309
ormp:OravaxMember
2020-09-01
2021-08-31
0001176309
ormp:OravaxLicenseAgreementMember
2021-08-31
0001176309
us-gaap:SubsequentEventMember
2021-09-01
0001176309
us-gaap:SubsequentEventMember
2021-08-15
2021-09-01
0001176309
us-gaap:RestrictedStockUnitsRSUMember
2021-08-15
2021-09-01
0001176309
srt:BoardOfDirectorsChairmanMember
us-gaap:SubsequentEventMember
2021-08-15
2021-09-01
0001176309
us-gaap:SubsequentEventMember
2020-08-15
2021-09-01
0001176309
srt:ScenarioForecastMember
us-gaap:SubsequentEventMember
2021-11-24
0001176309
srt:ScenarioForecastMember
us-gaap:SubsequentEventMember
2021-11-24
2021-11-24
0001176309
srt:ScenarioForecastMember
us-gaap:SubsequentEventMember
2021-11-03
0001176309
srt:ScenarioForecastMember
us-gaap:SubsequentEventMember
2021-10-01
2021-11-03
xbrli:shares
iso4217:USD
iso4217:USD
xbrli:shares
xbrli:pure