Item 1. Interim Consolidated Financial
Statements
.
The
information in this report for the six months ended December 31, 2012, is
unaudited but includes all adjustments (consisting only of normal recurring
accruals, unless otherwise indicated) which Molecular Pharmacology (USA)
Limited ("
Molecular USA
" or the "
Company
") considers necessary for a fair presentation
of the financial position, results of operations, changes in stockholders'
deficiency and cash flows for those periods.
The
interim consolidated financial statements should be read in conjunction with
Molecular USA's consolidated financial statements and the notes thereto
contained in Molecular USA's Audited Financial Statements for the year ended
June 30, 2012, in the Form 10K filed with the SEC on August 22, 2012.
Interim
results are not necessarily indicative of results for the full fiscal year.
The
unaudited interim consolidated financial statements start on the next page.
1
Molecular Pharmacology (USA)
Limited
(A Development Stage Company)
Interim Consolidated
Financial Statements
(Expressed
in U.S. Dollars)
(Unaudited)
31 December 2012
2
Molecular Pharmacology (USA) Limited
(A Development Stage
Company)
Interim Consolidated Balance Sheets
(Expressed in U.S. Dollars)
|
|
As at
31
December
2012
|
|
As at
30 June
2012
(Audited)
|
|
|
$
|
|
$
|
Assets
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
Cash and cash equivalents
|
|
5,994
|
|
2,572
|
Amounts receivable
|
|
7,521
|
|
5,110
|
|
|
|
|
|
|
|
13,515
|
|
7,682
|
|
|
|
|
|
Equipment
(Note
4)
|
|
166
|
|
1,159
|
|
|
|
|
|
|
|
13,681
|
|
8,841
|
Liabilities
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
Accounts payable and accrued liabilities (Note 5)
|
|
7,184
|
|
19,252
|
|
|
|
|
|
Due to related parties
(Note
6)
|
|
2,220,112
|
|
2,069,448
|
|
|
|
|
|
|
|
2,227,296
|
|
2,088,700
|
|
|
|
|
|
Stockholders’ deficiency
|
|
|
|
|
Capital stock
(Note
7)
|
|
|
|
|
Authorized
|
|
|
|
|
300,000,000 common
shares, par value $0.001
|
|
|
|
|
Issued and outstanding
|
|
|
|
|
31 December 2012 – 111,553,740 common shares, par value $0.001
|
|
|
|
|
30 June 2012 –
111,553,740 common shares, par value $0.001
|
|
111,554
|
|
111,554
|
Additional paid-in capital
|
|
106,707
|
|
106,707
|
Cumulative translation adjustment
|
|
(478,835)
|
|
(446,072)
|
Deficit, accumulated during the development
stage
|
|
(1,954,041)
|
|
(1,852,048)
|
|
|
|
|
|
|
|
(2,213,615)
|
|
(2,079,859)
|
|
|
|
|
|
|
|
13,681
|
|
8,841
|
Nature and Continuance of Operations
(Note 1)
On behalf of the Board:
/s/ Jeffery Edwards
Director
Jeffery Edwards
The accompanying notes are an integral part
of these interim consolidated financial statements.
3
Molecular Pharmacology (USA) Limited
(A
Development Stage Company)
Interim Consolidated Statements of Operations
(Expressed in U.S. Dollars)
(Unaudited)
|
For the
period
from
the date of
inception on
14 July
2004
to
31
December
2012
|
|
For the
three
month
period
ended
31
December
2012
|
|
For the
three
month
period
ended
31
December
2011
|
|
For the
six
month
period
ended
31
December
2012
|
|
For the
six
month
period
ended
31
December
2011
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
Advertising and promotion
|
23,739
|
|
-
|
|
-
|
|
-
|
|
-
|
Amortization (Note 4)
|
6,861
|
|
84
|
|
112
|
|
170
|
|
225
|
Analysis
|
33,947
|
|
-
|
|
-
|
|
-
|
|
-
|
Consulting (Note 6)
|
1,354,259
|
|
30,638
|
|
41,669
|
|
64,118
|
|
60,133
|
Office and miscellaneous (Note 6)
|
234,313
|
|
6,786
|
|
6,128
|
|
15,780
|
|
10,573
|
Professional fees
|
379,326
|
|
10,566
|
|
6,563
|
|
19,743
|
|
10,813
|
Public relations
|
3,656
|
|
-
|
|
-
|
|
-
|
|
-
|
Rent (Note 6)
|
27,759
|
|
-
|
|
-
|
|
-
|
|
-
|
Salaries and benefits
|
44,464
|
|
-
|
|
-
|
|
-
|
|
-
|
Transfer agent and filing fees
|
17,172
|
|
-
|
|
-
|
|
-
|
|
-
|
Travel
|
111,693
|
|
-
|
|
-
|
|
359
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net loss before other items
|
(2,237,189)
|
|
(48,074)
|
|
(54,472)
|
|
(100,170)
|
|
(81,744)
|
|
|
|
|
|
|
|
|
|
|
Other items
|
|
|
|
|
|
|
|
|
|
Export market development grants
|
69,629
|
|
-
|
|
-
|
|
-
|
|
-
|
Loss on write-off of equipment
|
(823)
|
|
(823)
|
|
-
|
|
(823)
|
|
-
|
Interest income
|
2,322
|
|
-
|
|
-
|
|
-
|
|
-
|
Research and development tax refund
|
213,020
|
|
-
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period
|
(1,953,041)
|
|
(48,897)
|
|
(54,472)
|
|
(100,993)
|
|
(81,744)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
(0.001)
|
|
(0.001)
|
|
(0.001)
|
|
(0.001)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used in
per share calculations
|
|
111,553,740
|
|
111,553,740
|
|
111,553,740
|
|
111,553,740
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
Net loss for the period
|
(1,953,041)
|
|
(48,897)
|
|
(54,472)
|
|
(100,993)
|
|
(81,744)
|
Foreign currency translation adjustment
|
(478,835)
|
|
(1,829)
|
|
(94,964)
|
|
(32,763)
|
|
63,604
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period
|
(2,431,876)
|
|
(50,726)
|
|
(149,436)
|
|
(133,756)
|
|
(18,140)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted comprehensive loss per common
share
|
|
(0.001)
|
|
(0.001)
|
|
(0.001)
|
|
(0.001)
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part
of these interim consolidated financial statements.
4
Molecular Pharmacology (USA)
Limited
(A Development Stage
Company)
Interim
Consolidated Statements of Cash Flows
(Expressed in U.S. Dollars)
(Unaudited)
|
For the
period
from
the
date of inception on
14 July
2004
to
31
December
2012
|
|
For the
three
month
period
ended
31
December
2012
|
|
For the
three
month
period
ended
31
December
2011
|
|
For the
six
month
period
ended
31
December
2012
|
|
For the
six
month
period
ended
31
December
2011
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in operating activities
|
|
|
|
|
|
|
|
|
|
Net loss for the period
|
(1,953,041)
|
|
(48,897)
|
|
(54,472)
|
|
(100,993)
|
|
(81,744)
|
Adjustments to reconcile net
loss to cash used by operating activities
|
|
|
|
|
|
|
|
|
|
Amortization
|
6,861
|
|
84
|
|
112
|
|
170
|
|
225
|
Write-down of
intangible assets
|
1,278
|
|
-
|
|
-
|
|
-
|
|
-
|
Write-off of equipment
|
823
|
|
823
|
|
-
|
|
823
|
|
-
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
Increase in amounts
receivable
|
(5,295)
|
|
(673)
|
|
(1,791)
|
|
(2,411)
|
|
(2,427)
|
Increase in prepaid
expenses
|
-
|
|
-
|
|
(1,376)
|
|
-
|
|
(1,376)
|
Decrease in accounts payable and
accrued liabilities
|
(40,233)
|
|
(11,116)
|
|
(3,719)
|
|
(12,068)
|
|
(6,662)
|
|
(1,989,607)
|
|
(59,779)
|
|
(61,246)
|
|
(114,479)
|
|
(91,984)
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
Purchase of equipment
|
(7,850)
|
|
-
|
|
-
|
|
-
|
|
-
|
Purchase of intangible assets
|
(1,278)
|
|
-
|
|
-
|
|
-
|
|
-
|
Cash acquired on the purchase of Molecular Pharmacology (USA) Limited
|
37,163
|
|
-
|
|
-
|
|
-
|
|
-
|
|
28,035
|
|
-
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
Common shares issued for cash
|
234,497
|
|
-
|
|
-
|
|
-
|
|
-
|
Increase in due to related parties
|
2,211,904
|
|
56,159
|
|
155,225
|
|
150,664
|
|
29,739
|
|
2,446,401
|
|
56,159
|
|
155,225
|
|
150,664
|
|
29,739
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash
|
(478,835)
|
|
(1,829)
|
|
(94,964)
|
|
(32,763)
|
|
63,604
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
5,994
|
|
(5,449)
|
|
(985)
|
|
3,422
|
|
1,359
|
Cash and cash equivalents, beginning of period
|
-
|
|
11,443
|
|
11,019
|
|
2,572
|
|
8,675
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
5,994
|
|
5,994
|
|
10,034
|
|
5,994
|
|
10,034
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures with Respect to Cash
Flows
(Note 10)
The accompanying notes are an integral part
of these interim consolidated financial statements.
5
Molecular Pharmacology (USA)
Limited
(A Development Stage
Company)
Interim Consolidated Statements of Changes in Stockholders’ Deficiency
(Expressed in U.S. Dollars)
(Unaudited)
|
Number of common shares issued
|
|
Capital stock
|
|
Additional paid-in capital
|
|
Deficit, accumulated during the development stage
|
|
Cumulative translation adjustment
|
|
Stockholders' deficiency
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
Balance at 14
July 2004 (inception)
|
294
|
|
-
|
|
1
|
|
-
|
|
-
|
|
1
|
Net loss
for the period
|
-
|
|
-
|
|
-
|
|
(128,488)
|
|
-
|
|
(128,488)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(6,536)
|
|
(6,536)
|
Balance at 31
October 2004
|
294
|
|
-
|
|
1
|
|
(128,488)
|
|
(6,536)
|
|
(135,023)
|
Common
shares issued for cash - January 2005
|
87,999,706
|
|
88,000
|
|
146,496
|
|
-
|
|
-
|
|
234,496
|
Net loss
for the year
|
-
|
|
-
|
|
-
|
|
(387,667)
|
|
-
|
|
(387,667)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(161)
|
|
(161)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 31
October 2005
|
88,000,000
|
|
88,000
|
|
146,497
|
|
(516,155)
|
|
(6,697)
|
|
(288,355)
|
Acquisition of Molecular
Pharmacology (USA) Limited - Recapitalization May 2006
|
43,553,740
|
|
43,554
|
|
(59,790)
|
|
-
|
|
-
|
|
(16,236)
|
Cancellation of common shares - July
2006
|
(20,000,000)
|
|
(20,000)
|
|
20,000
|
|
-
|
|
-
|
|
-
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(508,260)
|
|
-
|
|
(508,260)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(16,222)
|
|
(16,222)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 31
October 2006
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,024,415)
|
|
(22,919)
|
|
(829,073)
|
Net loss for the period
|
-
|
|
-
|
|
-
|
|
(377,131)
|
|
-
|
|
(377,131)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(105,436)
|
|
(105,436)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30
June 2007
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,401,546)
|
|
(128,355)
|
|
(1,311,640)
|
Net income for the year
|
-
|
|
-
|
|
-
|
|
62,296
|
|
-
|
|
62,296
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(166,483)
|
|
(166,483)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30
June 2008
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,339,250)
|
|
(294,838)
|
|
(1,415,827)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(94,336)
|
|
-
|
|
(94,336)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
219,034
|
|
219,034
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30
June 2009
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,433,586)
|
|
(75,804)
|
|
(1,291,129)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(117,220)
|
|
-
|
|
(117,220)
|
Cumulative
translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(78,521)
|
|
(78,521)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30
June 2010
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,550,806)
|
|
(154,325)
|
|
(1,486,870)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(121,860)
|
|
-
|
|
(121,860)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(357,962)
|
|
(357,962)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30
June 2011
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,672,666)
|
|
(512,287)
|
|
(1,966,692)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(179,382)
|
|
-
|
|
(179,382)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
66,215
|
|
66,215
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30
June 2012
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,852,048)
|
|
(446,072)
|
|
(2,079,859)
|
Net loss for the period
|
-
|
|
-
|
|
-
|
|
(100,993)
|
|
-
|
|
(100,993)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(33.763)
|
|
(32,763)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 31 December 2012
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,953,041)
|
|
(478,835)
|
|
(2,213,615)
|
The accompanying
notes are an integral part of these interim consolidated financial statements.
6
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
1.
Nature and Continuance of Operations
Molecular Pharmacology (USA)
Limited (the "Company") was incorporated in the state of Nevada on 1 May
2002 under the name Blue Hawk Ventures, Inc. The Company changed its name to
Molecular Pharmacology (USA) Limited on 29 August 2005. At the same time, the Company completed
a four for one forward split of its issued and outstanding share capital and
altered its authorized share capital to 300,000,000 shares of common stock with
a par value of $0.001 per share.
The Company is a development
stage enterprise, as defined in
Accounting Standards Codification
(the "Codification" or
"ASC") 915-10, "
Development Stage Entities
".
The Company is devoting all of its present efforts to securing and establishing
a new business and its current planned principle operations have not
commenced. Accordingly, no revenue
has been derived during the organization period.
Up until the fall of 2005, the
Company was in the business of mineral exploration and development of a mineral
property. The Company allowed the
option on its mineral claim to lapse in the fall of 2005.
On 13 October 2005, the
Company acquired the exclusive distribution rights to distribute, market,
promote, detail, advertise and sell certain "Licensed Products"
through Molecular Pharmacology Pty. Ltd. (formerly Molecular Pharmacology
Limited) ("MPLA") (Note 9).
MPLA was incorporated under the laws of Australia and converted to a
proprietary company on 29 October 2009.
MPLA is a wholly owned subsidiary company of PharmaNet Group Limited
("PharmaNet"), an
Australian company listed on the Australian Stock Exchange.
Since then, the Company has
engaged in organizational and start up activities, including developing a new
business plan, recruiting new directors, scientific advisors and key
scientists, making arrangements for laboratory facilities and office space and
raising additional capital. The
Company has generated no revenue from product sales. The Company does not have any
pharmaceutical products currently available for sale, and none are expected to
be commercially available for some time, if at all. The Licensed Products must first undergo
pre-clinical and human clinical testing in the United States before they may be
sold commercially.
The Company completed a
share purchase agreement on 8 May 2006 with PharmaNet (the "Purchase
Agreement"). Under the terms
of the Purchase Agreement the Company acquired 100% of the issued and
outstanding shares of MPLA. The
Company, in exchange for 100% of the issued and outstanding shares of MPLA,
issued PharmaNet an aggregate total of 88,000,000 common shares of the Company
on the closing of the transaction.
The issuance of 88,000,000 common shares of the Company constituted an
acquisition of control of the Company by PharmaNet. The transaction has been accounted for
as a recapitalization of the Company (Note 2).
MPLA was incorporated on 14
July 2004 under the laws of Australia. The accompanying interim consolidated
financial statements are the historical financial statements of MPLA.
On 15 March 2007, the Board
of Directors approved a change in the Company
'
s financial year end from 31 October to 30
June. The decision to change the fiscal year end was intended to assist the
financial community in its analysis of the business and in comparing the
Company’s financial results to others in the industry, and to synchronize
the Company’s fiscal reporting with MPLA.
7
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
The Company’s interim consolidated financial statements as at 31
December 2012 and for the six month period then ended have been prepared on a
going concern basis, which contemplates the realization of assets and
settlement of liabilities and commitments in the normal course of
business. The Company has a net
loss of $100,993 for the six month period ended 31 December 2012 (31 December
2011 – $81,744, cumulative - $1,953,041) and has working capital of $6,331
at 31 December 2012 (30 June 2012 –
working capital deficit of $11,570).
Management cannot provide
assurance that the Company will ultimately achieve profitable operations or
become cash flow positive, or raise additional debt and/or equity capital. Management believes that the Company’s
capital resources should be adequate to continue operating and maintaining its
business strategy during the fiscal year ending 30 June 2013. However, if the Company is unable to
raise additional capital in the near future, due to the Company’s
liquidity problems, management expects that the Company will need to curtail
operations, liquidate assets, seek additional capital on less favorable terms
and/or pursue other remedial measures.
These interim consolidated financial statements do not include any
adjustments related to the recoverability and classification of assets or the
amounts and classification of liabilities that might be necessary should the
Company be unable to continue as a going concern.
At 31 December 2012, the
Company has suffered losses from development stage activities to date. Although management is currently
attempting to implement its business plan, and is seeking additional sources of
equity or debt financing, there is no assurance these activities will be
successful. These factors raise
substantial doubt about the ability of the Company to continue as a going
concern. The interim consolidated financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
2.
Significant Accounting Policies
The
following is a summary of significant accounting policies used in the
preparation of these interim consolidated financial statements.
Basis of presentation
These interim consolidated
financial statements have been prepared in accordance with accounting
principles
generally
accepted in the United
States of America ("U.S. GAAP") applicable
for a development stage company for financial information and are expressed in
U.S. dollars.
Principles of consolidation
These interim consolidated
financial statements include the accounts of MPLA since its incorporation on 14
July 2004
and the
Company since the reverse acquisition on 8 May 2006 (Note 1). All intercompany balances and
transactions have been eliminated.
Cash and cash equivalents
Cash
and cash equivalents include highly liquid investments with original maturities
of three months or less.
8
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
Segments of an
enterprise and related information
ASC 280, "
Segment Reporting
"
establishes
guidance for the way that public companies report information about operating
segments in annual financial statements and requires reporting of selected
information about operating segments in interim financial statements issued to
the public. It also establishes
standards for disclosures regarding products and services, geographic areas and
major customers. ASC 280 defines
operating segments as components of a company about which separate financial
information is available that is evaluated regularly by the chief operating
decision maker in deciding how to allocate resources and in assessing
performance.
Foreign currency
translation
The Company’s functional and reporting currency is U.S.
dollars.
The interim
consolidated financial statements of the Company are translated to U.S. dollars
in accordance with ASC
830, "
Foreign Currency Matters
". Assets and
liabilities denominated in foreign currencies are translated using the exchange
rate prevailing at the balance sheet date.
Revenue and expenses are translated at average rates of exchange
prevailing during the period. Translation adjustments resulting from this process
are charged or credited to other comprehensive income
.
The
Company has not, to the date of these interim consolidated financial
statements, entered into derivative instruments to offset the impact of foreign
currency fluctuations.
Equipment
Equipment
is recorded at cost and amortization is provided over its estimated economic
life at the rate of 15% declining balance.
Income taxes
Deferred income taxes are reported for timing
differences between items of income or expense reported in the interim
consolidated financial statements and those reported for income tax purposes in
accordance with ASC 740,
"Income Taxes"
,
which requires the use of the asset/liability method of accounting for income
taxes. Deferred income taxes and
tax benefits are recognized for the future tax consequences attributable to
differences between the financial statement carrying amounts of existing assets
and liabilities and their respective tax bases, and for tax losses and credit
carry-forwards. Deferred tax assets
and liabilities are measured using enacted tax rates expected to apply to taxable
income in the years in which those temporary differences are expected to be
recovered or settled. The Company
provides for deferred taxes for the estimated future tax effects attributable
to temporary differences and carry-forwards when realization is more likely
than not.
Comprehensive income (loss)
ASC 220, "
Comprehensive Income
", establishes
standards for the reporting and disclosure of comprehensive income (loss) and
its components in the financial statements. As at 31 December 2012, the Company has
items that represent a comprehensive loss and, therefore, has included a
schedule of comprehensive loss in the interim consolidated financial
statements.
9
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
Basic and diluted net income (loss) per share
The Company computes net income
(loss) per share in accordance with ASC
260, "
Earnings per Share
". ASC 260 requires presentation of both
basic and diluted earnings per share ("EPS") on the face of the
income statement. Basic EPS is
computed by dividing net income (loss) available to common shareholders
(numerator) by the weighted average number of shares outstanding (denominator)
during the period. Diluted EPS
gives effect to all potentially dilutive common shares outstanding during the
period using the treasury stock method and convertible preferred stock using
the if-converted method. In
computing diluted EPS, the average stock price for the period is used in
determining the number of shares assumed to be purchased from the exercise of
stock options or warrants. Diluted
EPS excludes all potentially dilutive shares if their effect is anti-dilutive.
Stock-based compensation
Effective 1 January 2006,
the Company adopted the provisions of ASC 718, "
Compensation
– Stock Compensation
", which establishes accounting for
equity instruments exchanged for employee services. Under the provisions of ASC
718, stock-based compensation cost is measured at the grant date, based on the
calculated fair value of the award, and is recognized as an expense over the
employees’ requisite service period (generally the vesting period of the
equity grant). The Company adopted ASC 718 using the modified prospective
method, which requires the Company to record compensation expense over the
vesting period for all awards granted after the date of adoption, and for the
unvested portion of previously granted awards that remain outstanding at the
date of adoption. Accordingly, the financial statements for the periods
prior to 1 January 2006 have not been restated to reflect the fair value method
of expensing share-based compensation. The adoption of ASC 718 does not
change the way the Company accounts for share-based payments to non-employees,
with guidance provided by ASC 505-50, "
Equity-Based
Payments to Non-Employees
".
Comparative figures
Certain comparative figures
have been adjusted to conform to the current period’s presentation.
3.
Changes in Accounting Policies
In December 2011, the Financial
Accounting Standards Board ("FASB") issued Accounting Standards
Update ("ASU") No. 2011-12,
"Comprehensive
Income"
. This ASU
effectively defers the changes in ASU No. 2011-05,
"Presentation
of Comprehensive Income"
that relate to the presentation of
reclassification adjustments out of accumulated other comprehensive
income. ASU No. 2011-12 should be
applied retrospectively and is effective for fiscal years, and interim periods
within those years, beginning after 15 December 2011. As ASU No. 2011-12 relates only to the
presentation of Comprehensive Income, the adoption of this update did not have
a material effect on the Company’s interim consolidated financial
statements.
10
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
In June 2011, the FASB issued
ASU No. 2011-05,
"Presentation of Comprehensive
Income"
. This ASU
presents an entity with the option to present the total of comprehensive
income, the components of net income, and the component of other comprehensive
income either in a single continuous statement of comprehensive income or in
two separate but consecutive statements.
In both choices, an entity is required to present each component of
other comprehensive income along with a total for other comprehensive income,
and a total amount for comprehensive income. This update eliminates the option to
present the components of other comprehensive income as part of the statement
of changes in stockholders’ equity (deficiency). The amendments in this update do not change
the items that must be reported in other comprehensive income or when an item
of other comprehensive income must be reclassified to net income. ASU No. 2011-05 should be applied
retrospectively and is effective for fiscal years, and interim periods within
those years, beginning after 15 December 2011. As ASU No. 2011-05 relates only to the
presentation of comprehensive income, the adoption of this update did not have
a material effect on the Company’s interim consolidated financial
statements.
In May 2011, the FASB issued
ASU No. 2011-04,
"Fair Value Measurement"
to amend the accounting and disclosure requirements on fair value
measurements. This ASU limits the
highest-and-best-use measure to nonfinancial assets, permits certain financial
assets and liabilities with offsetting positions in market or counterparty
credit risks to be measured at a net basis, and provides guidance on the
applicability of premiums and discounts.
Additionally, this update expands the disclosure on Level 3 inputs by
requiring quantitative disclosure of the unobservable inputs and assumptions,
as well as description of the valuation processes and the sensitivity of the
fair value to changes in unobservable inputs. ASU No. 2011-04 is to be applied
prospectively and is effective during interim and annual periods beginning
after 15 December 2011. The
adoption of this update did not have a material effect on the Company’s interim
consolidated financial statements.
4.
Equipment
|
|
|
Accumulated amortization
|
|
Net Book Value
|
|
|
Cost
|
|
As at
31
December
2012
|
|
As at
30 June
2012
(Audited)
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
|
Office equipment
|
|
864
|
|
698
|
|
166
|
|
1,159
|
During the six month
period ended 31 December 2012, the total additions to equipment were $Nil (31
December 2011 – $Nil) and equipment with a net book value of $823 was
written off (31 December 2011 - $Nil).
5.
Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities are
non-interest bearing, unsecured and have settlement dates within one year.
11
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
6.
Due
to Related Parties and Related Party Transactions
As at 31 December 2012, the amount due to related parties includes
$1,000 payable to a director of the Company (30 June 2012
–
$1,000). This balance is non-interest bearing,
unsecured and has no fixed terms of repayment.
As at 31 December 2012, the amount due to related parties includes
$2,598 payable to a company owned by a director of the Company or an officer of
PharmaNet (30 June 2012
–
$22,846). This
balance is non-interest bearing, unsecured and has no fixed terms of repayment.
As at 31 December 2012, the amount due to related parties includes
$1,062 payable to a company owned by a director of the Company or an officer of
PharmaNet (30 June 2012
–
$1,101). This
balance is non-interest bearing, unsecured and has no fixed terms of repayment.
As at 31 December 2012, the amount due to related parties includes
$Nil payable to a company owned by a director of the Company or an officer of
Pharmanet (30 June 2012 - $7,741).
This balance is non-interest bearing, unsecured and has no fixed terms
of repayment.
As at 31 December 2012, the amount due to related parties includes
$2,215,452 payable to PharmaNet (30 June 2012
–
$2,036,760). This balance is non-interest bearing,
unsecured and has no fixed terms of repayment.
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting fees of $18,015 (
31 December 2011
– $27,141; cumulative - $880,611).
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting and/or administrative fees of $13,558 (
31
December 2011
–
$9,772; cumulative - $56,904) by the Company.
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting fees of $44,285 (31 December 2011 - $32,992; cumulative -
$65,570) by the Company.
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued office and miscellaneous expenses of $Nil (31 December 2011 - $Nil;
cumulative - $4,481) by the Company.
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting fees of $Nil (31 December 2011 – $Nil; cumulative
– $41,928) by the Company.
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued office and miscellaneous expenses of $Nil (
31 December
2011
–
$Nil; cumulative
–
$80,468) by the Company.
12
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
During the six month period ended 31 December 2012, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued rental fees of $Nil (
31 December 2011
– $Nil; cumulative – $12,987) by the Company.
Transactions comprising the amount due to PharmaNet are as
follows:
|
|
For the
six month
period
ended
31
December
2012
|
|
For the
year
ended
30 June
2012
(Audited)
|
|
|
$
|
|
$
|
|
|
|
|
|
Opening balance, beginning of period
|
|
2,036,760
|
|
1,896,625
|
Funds
transferred to the Company by PharmaNet
|
|
147,546
|
|
170,790
|
Expenses paid by PharmaNet on behalf of the
Company
|
|
85
|
|
33,852
|
Foreign
currency translation adjustment
|
|
31,061
|
|
(64,507)
|
|
|
|
|
|
Balances, end of period
|
|
2,215,452
|
|
2,036,760
|
The average amount due to PharmaNet for the six month period ended
31 December 2012 was $2,106,502 (30 June 2012 - $1,816,134).
7.
Capital
Stock
Authorized
The total authorized capital is 300,000,000 common
shares with a par value of $0.001 per common share.
Issued
and outstanding
The total issued and outstanding capital stock is 111,553,740
common shares with a par value of $0.001 per common share.
13
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
8.
Income
Taxes
Income
tax expense differs
from the amount that would result from applying the federal income tax rate to
earnings before income taxes. These
differences result from the following items:
|
|
|
|
For the
six month
period
ended
31
December
2012
|
|
For the
three month
period
ended
31
December
2011
|
|
|
|
|
$
|
|
$
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
|
(100,993)
|
|
(81,744)
|
|
|
|
|
|
|
|
Federal income tax rates
|
|
|
|
34.0%
|
|
34.0%
|
|
|
|
|
|
|
|
Income
tax recovery based on the above rates
|
|
|
|
(34,338)
|
|
(27,793)
|
|
|
|
|
|
|
|
Increase
(decrease) due to:
|
|
|
|
|
|
|
Difference
between U.S. and foreign tax rates
|
|
|
|
3,254
|
|
2,837
|
Change in
valuation allowance
|
|
|
|
37,579
|
|
12,368
|
Foreign
exchange and other
|
|
|
|
(6,495)
|
|
12,588
|
|
|
|
|
|
|
|
Income tax expense
|
|
|
|
-
|
|
-
|
The
composition of the Company’s deferred tax assets as at 31 December 2012
and 30 June 2012 are as follows:
|
|
As at
31
December
2012
|
|
As at
30 June
2012
(Audited)
|
|
|
$
|
|
$
|
|
|
|
|
|
Net income tax operating loss
carryforward
|
|
2,224,109
|
|
2,101,601
|
|
|
|
|
|
Deferred
tax assets
|
|
698,327
|
|
660,748
|
Less:
Valuation allowance
|
|
(698,327)
|
|
(660,748)
|
|
|
|
|
|
Net
deferred tax asset
|
|
-
|
|
-
|
14
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
The
Company has non-capital
loss carry-forwards of approximately $2,224,109 that may be available for tax
purposes. The loss carry-forwards
are all in respect to U.S. and Australian operations and expire as follows:
|
$
|
|
|
2022
|
20,402
|
2023
|
46,992
|
2024
|
27,717
|
2025
|
14,187
|
2026
|
261,311
|
2027
|
111,155
|
2028
|
75,463
|
2029
|
57,882
|
2030
|
48,765
|
2031
|
43,836
|
2032
|
49,005
|
2033
|
20,640
|
No expiry
|
1,446,754
|
|
|
|
2,224,109
|
A
full
valuation allowance has been recorded against the potential deferred tax assets
associated with all the loss carry-forwards as their utilization is not
considered more likely than not at this time.
9.
Distribution
Agreement
The
Company has the exclusive distribution rights,
through MPLA, to distribute, market, promote, detail, advertise and sell
certain Licensed Products, with metallo-polypeptide analgesic as an active
ingredient, in the United States (excluding its territories and possessions)
(Note 1). If, and when necessary,
the Company will obtain all necessary regulatory approvals for the Licensed Products
and incorporate the Licensed Products in the United States.
15
Molecular Pharmacology (USA) Limited
(A Development Stage Company)
Notes to
Interim Consolidated Financial Statements
(Expressed in
U.S. Dollars)
(Unaudited)
31 December 2012
10.
Supplemental
Disclosures with Respect to Cash Flows
|
|
For the
period from
the date of inception on
14 July 2004
to
31 December
2012
|
For the
three
month
period
ended
31 December
2012
|
For the
three
month
period
ended
31 December
2011
|
For the
six
month
period
ended
31 December
2012
|
For the
six
month
period
ended
31 December
2011
|
|
|
|
$
|
|
$
|
|
$
|
$
|
$
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period
for interest
|
|
|
-
|
|
-
|
|
-
|
-
|
-
|
Cash paid during the period
for income taxes
|
|
|
-
|
|
-
|
|
-
|
-
|
-
|
Common shares issued
on acquisition of MPLA
|
|
|
16,236
|
|
-
|
|
-
|
-
|
-
|
Amounts receivable
acquired on recapitalization of the Company
|
|
|
2,226
|
|
-
|
|
-
|
-
|
-
|
Accounts payable
assumed on recapitalization of the Company
|
|
|
54,624
|
|
-
|
|
-
|
-
|
-
|
Due to related party
assumed on recapitalization of the Company
|
|
|
1,000
|
|
-
|
|
-
|
-
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
Molecular Pharmacology (USA) Limited
(A Development Stage Company)
Notes to
Interim Consolidated Financial Statements
(Expressed in
U.S. Dollars)
(Unaudited)
31 December 2012
11.
Segmented
Information
Details
on a geographic basis as at and for the six month period ended 31 December 2012
are as follows:
|
|
Australia
|
|
U.S.A.
|
|
Total
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
Assets
|
|
13,681
|
|
-
|
|
13,681
|
|
|
|
|
|
|
|
Loss for the period
|
|
(80,353)
|
|
(20,640)
|
|
(100,993)
|
Details on a geographic basis as at and for the
year ended 30 June 2012 are as follows:
|
|
Australia
|
|
U.S.A.
|
|
Total
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
Assets
|
|
8,841
|
|
-
|
|
8,841
|
|
|
|
|
|
|
|
Loss for the year
|
|
(130,377)
|
|
(49,005)
|
|
(179,382)
|
Details on a geographic basis as at and for the
six month period ended 31 December 2011 are as follows:
|
|
Australia
|
|
U.S.A.
|
|
Total
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
Assets
|
|
20,450
|
|
1,376
|
|
21,826
|
|
|
|
|
|
|
|
Loss for the period
|
|
(70,931)
|
|
(10,813)
|
|
(81,744)
|
12.
Financial Instruments
The
carrying values of cash and cash equivalents and accounts payable approximate
fair value due to the short term maturity of these financial instruments.
Credit
Risk
Financial instruments that
potentially subject the Company to credit risk consists of cash and cash
equivalents. The Company
deposits cash and cash equivalents with high credit
quality financial institutions as determined by rating agencies. As a result, credit risk is considered
insignificant.
Currency Risk
The Company’s
subsidiary i
s located in Australia. As a result, a significant portion of the
Company’s assets, liabilities and expenses were
denominated in the Australian dollar and were therefore subject to fluctuation
in exchange rates.
17
Molecular
Pharmacology (USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31
December 2012
The Company’s
objective in managing its foreign currency risk is to minimize its net
exposures to foreign currency cash flows by holding most of its cash and cash
equivalents in Australian dollars.
The Company monitors and forecasts the values of net foreign currency
cash flow and balance sheet exposures and from time to time could authorize the
use of derivative financial instruments such as forward foreign exchange
contracts to economically hedge a portion of foreign currency fluctuations.
If the Australian dollar had
weakened (strengthened) against the U.S. dollar, with all other variables held
constant, by 100 basis points (1%) at period end, the impact on net loss and
other comprehensive loss would have been $22,056 higher ($22,056 lower).
The Company has not, to the
date of these interim consolidated financial statements, entered into
derivative instruments to offset the impact of foreign currency fluctuations.
Interest
Rate Risk
The Company has non-interest
paying cash balances and no interest-bearing debt. Its management’s
opinion that the Company is not exposed to significant interest risk arising
from these financial instruments.
Liquidity
Risk
Liquidity risk is the risk
that an entity will encounter difficulty in meeting obligations associated with
its financial liabilities. The
Company is reliant upon PharmaNet as its sole source of cash. The Company has received financing from
PharmaNet in the past; however, there is no assurance that it will be able to do
so in the future.
18
Item 2. Management's Discussion and
Analysi
s of Financial Condition and Results of Operations.
THE FOLLOWING ANALYSIS OF THE RESULTS OF
OPERATIONS AND FINANCIAL CONDITION OF MOLECULAR USA FOR THE SECOND QUARTER PERIOD
ENDED DECEMBER 31, 2012 AND SHOULD BE READ IN CONJUNCTION WITH MOLECULAR
USA’S INTERIM CONSOLIDATED FINANCIAL STATEMENTS, INCLUDING THE NOTES
THERETO CONTAINED ELSEWHERE IN THE FORM 10-Q.
Our interim consolidated financial statements are
stated in United States Dollars and are prepared in accordance with United
States Generally Accepted Accounting Principles.
Overview
We were incorporated in the state of Nevada on
May 1, 2002. Up until the fall of 2005, Molecular USA was in the business of
mineral exploration and development of a mineral property.
On
October 13, 2005, Molecular USA entered into a distribution and supply
agreement with Molecular
Pharmacology Pty. Ltd. (formerly Molecular
Pharmacology Limited)("
MPLA
"). MPLA is incorporated under the laws of
Australia and at the time was a wholly owned subsidiary company of PharmaNet
Group Limited, an Australian company listed on the Australian Stock
Exchange. Under the terms of
the distribution and supply agreement, Molecular USA received the exclusive
distribution rights to distribute, market, promote, detail, advertise and sell
certain "
Licensed Products
", as
defined in the agreement, with metallo-polypeptide analgesic as an active
ingredient, in the United States (excluding its territories and
possessions).
On May 9, 2006, Molecular USA announced that it
has acquired 100% of the issued and outstanding share capital of MPLA. The transaction was originally announced
by Molecular USA in a press release dated November 29, 2005 and was
subsequently approved by a majority of the stockholders of the Company at a
stockholders meeting held on April 21, 2006. As a result of the transaction,
PharmaNet Group Limited ("
PharmaNet
"),
the former parent company of MPLA, now controls approximately 79% of Molecular
USA's issued and outstanding share capital. The transaction between the parties
closed in escrow with an effective closing date of May 8, 2006. The business of
MPLA is now the business of Molecular USA.
Our Current Business
Molecular USA through its wholly owned subsidiary
MPLA is in the business of developing and commercializing a new analgesic and
anti-inflammatory molecule known as Tripeptofen. Tripeptofen is likely to
appear in a new group of products suitable for the treatment of common
every-day pain. As an analgesic and anti-inflammatory drug, Tripeptofen is
unusual due to its rapid speed of action and its topical or rub-on
application.
The majority of over-the-counter anti-pain and
anti-inflammatory products sold for the treatment of acute localized pain are based
on non-steroidal anti-inflammatory drugs or NSAIDs. The majority of such
products are slow acting and provide only mild pain relief.
The NSAID group has come under additional
pressure and increasing medical alarm, as many drugs in this class have been
found to set-back the recovery of certain conditions and treatments for which
they were marketed. Moreover, NSAIDs are associated with severe
gastro-intestinal side-effects. This has left a niche in an industry
under-served by new products and ingredients.
MPLA's business strategy is to exploit the fast
and locally acting, low side effects, and recovery-enhancing properties of its
new drug group and to market this as a new ingredient, enabling pharmaceutical
companies to develop and market effective and safer products suited to a broad
range of common everyday pain.
19
Licensed Products
Molecular USA has exclusive distribution rights
to distribute, market, promote, advertise and sell certain "
Licensed
Products
",
with metallo-polypeptide analgesic and anti-inflammatory activity as an active
ingredient, in the United States (excluding its territories and possessions)
from its wholly owned subsidiary company MPLA.
The Licensed Products include all products in all
dosage forms, formulations, line extensions and package configurations using or
otherwise incorporating any aspect or production method of metallo-polypeptide
analgesic and anti-inflammatory activity as an active ingredient marketed by
MPLA or its affiliates under the trade name Tripeptofen or any other trade
names or trademarks used by MPLA relating to the product and any improvements
to such formulations or dosages as may hereafter be distributed by MPLA or its
affiliates in the territory during the term of the distribution and supply
agreement between Molecular USA and MPLA for the topical application for human
use only, and specifically excludes:
·
dermatological
or cosmetic use, or tissue repair or tissue regeneration effect;
·
any use or
application of the Licensed Product in non-human groups or species; and
·
Thermalife
cream, presently owned by PharmaNet, the parent company of MPLA.
All Licensed Products must first obtain
regulatory clearance in the United States before they may be marketed and sold
by Molecular USA in that territory. Regulatory approval, commencement of the
Master Drug File ("
MDF
") and
market approval are the focus of an ongoing program expected to continue over
the next 18 to 24 months.
MPLA has an exclusive license from Cambridge
Scientific Pty Ltd. of Australia. This license is restricted to a "field
of use" defined in the license documentation. Cambridge Scientific Pty
Ltd. may grant other licenses to third parties outside the "field of
use" the subject of the licenses granted to MPLA.
Patents &
Trademarks
Molecular USA and its subsidiary MPLA, regard
their intellectual property rights, such as copyrights, trademarks, trade
secrets, practices and tools, as important to the success of their company. To
protect their intellectual property rights, Molecular USA relies on a
combination of patent, trademark and copyright law, trade secret protection,
confidentiality agreements and other contractual arrangements with their
employees, affiliates, clients, strategic partners, acquisition targets and
others. Effective patent,
trademark, copyright and trade secret protection may not be available in every
country in which the combined company intends to offer its products. The steps
taken by Molecular USA and MPLA to protect their intellectual property rights
may not be adequate. Third parties may infringe or misappropriate the combined
company's intellectual property rights or the combined company may not be able
to detect unauthorized use and take appropriate steps to enforce its rights. In
addition, other parties may assert infringement claims against the combined
company. Such claims, regardless of merit, could result in the expenditure of
significant financial and managerial resources. Further, an increasing number
of patents are being issued to third parties regarding these processes. Future
patents may limit the combined company's ability to use processes covered by
such patents or expose the combined company to claims of patent infringement or
otherwise require the combined company to seek to obtain related licenses. Such
licenses may not be available on acceptable terms. The failure to obtain such
licenses on acceptable terms could have a negative effect on the combined
company's business.
To protect their
intellectual property rights, MPLA relies on a combination of license and
patent applications held by
Cambridge
Scientific Pty Ltd which includes "Analgesic and
Anti-Inflammatory Composition" comprising USA patent application in
completion plus PCT Provisional Specification having the same name designated
as Serial No. 11/059580.
These patent applications
embody all the current Analgesic and Anti-inflammatory assets. MPLA will also
rely on the exclusive nature of its license, trademark and copyright law, trade
secret protection, confidentiality agreements and other contractual
arrangements as it may execute from time to time.
Management of Molecular USA and MPLA believes that MPLA's products,
trademarks, and other proprietary rights do not infringe on the proprietary
rights of third parties.
20
Marketing
Molecular USA plans to market its Licensed
Products, when approved, through existing pharmaceutical distributors and by
collaborative dealings with major companies active in the United States and
Europe.
In addition, Molecular USA plans to explore
opportunities for direct sales, out-licensing and the integration of the
company’s proprietary anti-inflammatory and analgesic components in
products already distributed through various international markets.
Molecular USA expects that these activities may
even help fund the development costs of the Licensed Products in the United
States.
Manufacturing &
Supply
Molecular USA and MPLA have no manufacturing
facilities. MPLA is required to supply Molecular USA with all Licensed Products
under the distribution and supply agreement entered into by the parties in
October 2005. It is likely MPLA will enter into arrangements with various Good
Manufacturing Practice ("
GMP
") certified
formulation and manufacturers of the Licensed Products for clinical trial and
sales purposes. These formulations and the manufacturing facilities must comply
with regulations and current good laboratory practices (or CGLPs), and current
GMPs, enforced by the Food and Drug Administration ("
FDA
").
Molecular
USA plans to
continue MPLA's practice to outsource formulation and manufacturing for its
clinical trials and potential commercialization after the acquisition of MPLA
by Molecular USA.
Molecular USA has not entered into any supply
agreements.
Competition
Molecular USA and MPLA compete in the segment of
the pharmaceutical market that treats pain and inflammation, which is highly
competitive. We face significant competition from most pharmaceutical companies
as well as biotechnology companies that are also researching and selling products
designed to treat pain and inflammation. Many of our competitors have
significantly greater financial, manufacturing, marketing and product
development resources than we do. Large pharmaceutical companies in particular
have extensive experience in clinical testing and in obtaining regulatory
approvals for drugs. These companies also have significantly greater research
capabilities than we do. In addition, many universities and private and public
research institutes are active in neurological research, some in direct
competition with us. These companies, as well as academic institutions,
governmental agencies and other public and private organizations conducting
research, also compete with Molecular USA and MPLA in recruiting and retaining
highly qualified scientific personnel and consultants and may establish
collaborative arrangements with competitors of Molecular USA.
Molecular USA's competition will be determined in
part by the potential indications for which the MPLA's products are developed
and ultimately approved by regulatory authorities.
Molecular USA knows of other companies and
institutions dedicated to the development of anti-pain and anti-inflammatory
pharmaceuticals similar to those being developed by MPLA and licensed to
Molecular USA. Many of Molecular USA's competitors, existing or potential, have
substantially greater financial and technical resources and therefore may be in
a better position to develop, manufacture and market pharmaceutical products.
Many of these competitors are also more experienced with regard to preclinical
testing, human clinical trials and obtaining regulatory approvals. The current
or future existence of competitive products may also adversely affect the
marketability of Molecular USA's products.
Governmental Regulation
FDA Regulation
. Pharmaceutical products are subject to
extensive pre- and post-marketing regulation by the FDA, including regulations
that govern the testing, manufacturing, safety, efficacy, labeling, storage,
record-keeping, advertising and promotion of the products under the Federal
Food, Drug and Cosmetic Act and the Public Health Services Act, and by
comparable agencies in most foreign countries. The process required by the FDA
before a new drug may be marketed in the U.S. generally involves the following:
completion of pre-clinical laboratory and animal testing; submission of an
investigational new drug application ("
IND
"), which must
21
become effective before clinical trials may
begin; performance of adequate and well controlled human clinical trials to
establish the safety and efficacy of the proposed drug’s intended use;
and approval by the FDA of a New Drug Application ("
NDA
").
The activities required before a pharmaceutical
agent may be marketed in the United States begin with pre-clinical testing. Pre-clinical tests include laboratory
evaluation of potential products and animal studies to assess the potential
safety and efficacy of the product and its formulations. The results of these
studies and other information must be submitted to the FDA as part of an IND
application, which must be reviewed and approved by the FDA before proposed
clinical testing can begin. Clinical trials involve the administration of the
investigational new drug to healthy volunteers or to patients under the supervision
of a qualified principal investigator. Clinical trials are conducted in
accordance with Good Clinical Practices under protocols that detail the
objectives of the study, the parameters to be used to monitor safety and the
efficacy criteria to be evaluated. Each protocol must be submitted to the FDA
as part of the IND application. Further, each clinical study must be conducted
under the auspices of an independent institutional review board. The
institutional review board will consider, among other things, ethical factors
and the safety of human subjects.
Typically, human clinical trials are conducted in
three phases that may overlap. In Phase 1, clinical trials are conducted with a
small number of subjects to determine the early safety profile and pharmacology
of the new therapy. In Phase 2, clinical trials are conducted with groups of
patients afflicted with a specific disease in order to determine preliminary
efficacy, optimal dosages and expanded evidence of safety. In Phase 3, large
scale, multicenter, comparative clinical trials are conducted with patients
afflicted with a target disease in order to provide enough data for the
statistical proof of efficacy and safety required by the FDA and others.
The results of the pre-clinical and clinical
testing, together with chemistry and manufacturing information, are submitted
to the FDA in the form of an NDA for a pharmaceutical product in order to
obtain approval to commence commercial sales. In responding to an NDA, the FDA
may grant marketing approvals, request additional information or further
research, or deny the application if it determines that the application does
not satisfy its regulatory approval criteria. Patient-specific therapies may be
subject to additional risk with respect to the regulatory review process. FDA
approval for a pharmaceutical product may not be granted on a timely basis, if
at all, or if granted may not cover all the clinical indications for which
approval is sought or may contain significant limitations in the form of warnings,
precautions or contraindications with respect to conditions of use.
Satisfaction of FDA premarket approval
requirements for new drugs typically takes several years, and the actual time
required may vary substantially based upon the type, complexity and novelty of
the product or targeted disease. Government regulation may delay or prevent
marketing of potential products for a considerable period of time and impose
costly procedures upon our activities. Success in early stage clinical trials
or with prior versions of products does not assure success in later stage
clinical trials. Data obtained from clinical activities are not always
conclusive and may be susceptible to varying interpretations that could delay,
limit or prevent regulatory approval.
22
Once approved, the FDA may withdraw the product
approval if compliance with pre- and post-marketing regulatory standards is not
maintained or if problems occur after the product reaches the marketplace. In
addition, the FDA may require post-marketing studies, referred to as Phase 4
studies, to monitor the effect of an approved product, and may limit further
marketing of the product based on the results of these post-market studies. The
FDA has broad post-market regulatory and enforcement powers, including the
ability to levy fines and civil penalties, suspend or delay issuance of
approvals, seize or recall products, or withdraw approvals.
Facilities used to manufacture drugs are subject
to periodic inspection by the FDA, Drug Enforcement Agency and other authorities
where applicable, and must comply with the FDA’s Current Good
Manufacturing regulations. Failure to comply with the statutory and regulatory
requirements subjects the manufacturer to possible legal or regulatory action,
such as suspension of manufacturing, seizure of product or voluntary recall of
a product. Adverse experiences with the product must be reported to the FDA and
could result in the imposition of market restriction through labeling changes
or in product removal. Product approvals may be withdrawn if compliance with
regulatory requirements is not maintained or if problems concerning safety or
efficacy of the product occur following approval.
With respect to post-market product advertising
and promotion, the FDA imposes a number of complex regulations on entities that
advertise and promote pharmaceuticals, which include, among other things,
standards and regulations relating to direct-to-consumer advertising, off-label
promotion, industry sponsored scientific and educational activities, and
promotional activities involving the Internet. The FDA has very broad
enforcement authority under the Federal Food, Drug and Cosmetic Act, and
failure to abide by these regulations can result in penalties including the
issuance of a warning letter directing the entity to correct deviations from
FDA standards, a requirement that future advertising and promotional materials
be pre-cleared by the FDA, and state and federal civil and criminal
investigations and prosecutions.
Research facilities are subject to various laws
and regulations regarding laboratory practices, the experimental use of
animals, and the use and disposal of hazardous or potentially hazardous
substances in connection with the research in question. In each of these areas, as above, the
government has broad regulatory and enforcement powers, including the ability
to levy fines and civil penalties, suspend or delay issuance of approvals,
seize or recall products, and withdraw approvals, any one or more of which
could have a material adverse effect upon us.
Other Government Regulations
. In addition to laws and regulations
enforced by the FDA, research of Molecular USA’s products in the United
States are subject to regulation under National Institutes of Health
guidelines, as well as under the Controlled Substances Act, the Occupational
Safety and Health Act, the Environmental Protection Act, the Toxic Substances
Control Act, the Resource Conservation and Recovery Act and other present and
potential future federal, state or local laws and regulations, as research and
development of its products involves the controlled use of hazardous materials,
chemicals, viruses and various radioactive compounds.
In addition to regulations in the United States,
Molecular USA’s products are subject to a variety of foreign regulations
governing clinical trials and commercial sales and distribution of its Licensed
Products. Whether or not Molecular USA obtains FDA approval for a product,
Molecular USA or its subsidiaries must obtain approval of a product by the
comparable regulatory authorities of foreign countries before it can commence
clinical trials or marketing of the product in those countries. The approval
process varies from country to country, and the time may be longer or shorter
than that required for FDA approval. The requirements governing the conduct of
clinical trials, product licensing, pricing and reimbursement vary greatly from
country to country.
23
Sarbanes-Oxley Act of 2002
. On July 30, 2002, President Bush signed
into law the Sarbanes-Oxley Act of 2002 ("
SOA
").
SOA imposes a wide variety of new requirements on both U.S. and non-U.S.
companies, that file or are required to file periodic reports with the
Securities and Exchange Commission (the "
SEC
")
under the Securities Exchange Act of 1934. Many of these new requirements will
affect Molecular USA and its board of directors. For instance, under SOA
Molecular USA is required to:
·
form an audit committee in compliance with
the SOA;
·
have Molecular USA's chief executive officer
and chief financial officer certify its financial statements;
·
ensure Molecular USA's directors and senior
officers forfeit all bonuses or other incentive-based compensation and profits
received from the sale of Molecular USA's securities in the twelve month period
following initial publication of any of Molecular USA's financial statements
that later require restatement;
·
disclose any off-balance sheet transactions
as required by the SOA;
·
prohibit all personal loans to directors and
officers;
·
insure directors, officers and 10% holders
file their Forms 4's within two days of a transaction;
·
adopt a code of ethics and file a Form 8-K
whenever there is a change or waiver of this code; and
·
insure Molecular USA's auditor is
independent as defined by the SOA.
The SOA has required us to review our current
procedures and policies to determine whether they comply with the SOA and the
new regulations promulgated thereunder. We will continue to monitor our
compliance with all future regulations that are adopted under the SOA and will
take whatever actions are necessary to ensure that we are in compliance.
Environmental Compliance
The nature of Molecular USA's and MPLA's business does not require special environmental or local
government approval. Molecular USA
and MPLA are compliant with all environmental laws. The cost of such compliance
is minimal for the company.
Employees
Molecular USA currently has no employees and
instead relies on outside contractors.
Immediate Business
Plans
The Company, through its subsidiary MPLA, plans
to continue to pursue the various levels of the international regulatory
approval processes. Applications and product opportunities for Tripeptofen are
believed to be broad and cover a range of commercial fields, each with distinct
pre-market requirements. The international drug development team, global
resources and local know-how will allow MPLA to seek the most time and cost
effective regulatory pathways for each product and market sector.
On commercial development, MPLA will focus on
consolidating the regulatory pathway work in order to prioritize the path to
market. Jeff Edwards will work to set-out the strategies designed to maximize
the multi-jurisdictional capabilities of MPLA's development teams.
Results of Operation
For the quarter
ended December 31, 2012.
24
Rev
enues
REVENUE
- Molecular USA has
not generated any revenues for the quarter ended December 31, 2012, or since
inception.
COMMON
STOCK
– Molecular USA has not
issued any shares during the most recent quarter. As of the date of February 8,
2012, Molecular USA has 111,553,740 common shares issued and outstanding.
Expenses
SUMMARY
– Total expenses were $100,170 for the
six month period ended December 31, 2012.
Expenses had increased during this past six month period as compared to
the six month period ended December 31, 2011 – $81,744. A total of $2,237,189
in expenses has been incurred by Molecular USA since inception on July 14, 2004 through to December 31, 2012. The increase in costs over this six month period has
occurred as the result of Molecular USA’s wholly owned subsidiary increase
in its consulting fees. The costs
can be subdivided into the following categories.
-
Office Expenses and Rent
: $15,780 in
office expenses (for administrative costs) were incurred for the six month
period ended December 31, 2012, as compared to $10,573
for the six month period ended December 31, 2011, while a total of $234,313
was incurred in the period from inception on July
14, 2004 to December 31, 2012. All contributed expenses are reported as
contributed costs with a corresponding credit to additional paid-in
capital.
-
Consulting and Analysis
Costs
: Molecular USA relies on consultants and other third parties to
conduct the majority of its research. For the six month period ended December
31, 2012, $64,118 in consulting and analysis expenses were incurred as
compared to $60,133 during the six month period ended December
31, 2011. We have incurred a total of $1,354,259
in consulting and analyst fees since our inception on July 14, 2004 to December
31, 2012.
-
Advertising and Promotion
Fees
: Molecular USA has spent no money in this area this year. During the six month period ended December 31, 2012, we spent $Nil on
advertising and public relations and $Nil for six month period ended December
31, 2011. A total of $23,739 has
been incurred in this area during the period from inception on July 14, 2004 to December 31, 2012.
-
Professional Fees
: Molecular USA
incurred $19,743 in professional fees for the six month period ended on December
31, 2012, as compared to $10,813
for the six month period ended December 31, 2011. From inception to December 31, 2012 we have incurred
a total of $379,326 professional fees mainly spent on legal and accounting
matters.
-
Travel Costs
: Molecular USA
incurred $359 in travel costs for the six month period ended December 31,
2012, as compared to $Nil for the six month period ended December 31, 2011 and $111,693 has been incurred in the period
from inception on July 14, 2004 to December
31, 2012.
-
Salaries and Benefit
Costs
: Molecular USA and its subsidiary rely primarily on outside
consultants and not salaried employees. As a result, Molecular USA incurred
$Nil in salaries and benefits for the six month period ended December 31,
2012 and $Nil in salaries and benefits during the six month period ended December,
2011. For the period July 14, 2004 (inception) through December 31, 2012, Molecular USA
has spent a total of $44,464 on salaries and benefits.
Molecular USA
continues to carefully control its expenses and overall costs as it moves
forward with the development of its new business plan. Molecular USA does not
have any employees and engages personnel through outside
consulting contracts or agreements or other such arrangements.
Income Tax Provision
: We have losses carried forward for income tax purpose to December 31,
2012. There are no current or
deferred tax expenses for the six
month period ended December 31, 2012, due to our loss position. We have fully reserved for any benefits
of these losses. The deferred tax
consequences of temporary differences in reporting items for financial
statement and income tax purposes are recognized as appropriate.
Liquidity and Capital
Resources
During the six month period ended December 31, 2012, Molecular USA satisfied
its working capital needs by borrowing cash from its parent company PharmaNet. As December 31, 2012, the Company had
cash and cash equivalents on hand in the amount of $5,994 ($2,572–
June 30, 2012) and current payable and accrued liabilities of $7,184 ($19,252 – June 30, 2012). As December 31, 2012, Molecular USA
currently owes its parent company PharmaNet, $2,215,452, an additional $4,660
to other related parties, and $7,184 to non-related parties. Given the proposed business activities
of Molecular USA and its subsidiary, management does not expect that the
current level of cash on hand will be sufficient to fund its operation for the
next twelve month period.
25
To achieve our goals and objectives for the next
12 months, we plan to raise additional capital through private placements of
our equity securities and future financing from our majority shareholder PharmaNet.
We plan to use any additional funds that we might
be successful in raising for development, as well as for strategic acquisition
of existing businesses that complement our market niche, and general working
capital purposes.
If we are unsuccessful in obtaining new capital,
our ability to seek and consummate strategic acquisitions to build our company internationally
and to expand of our business development and marketing programs could be
adversely affected.
Off-Balance Sheet
Arrangement
As of December
31, 2012,
Molecular USA did not have any
off-balance sheet arrangements.
Research and Development
Since the acquisition of MPLA, Molecular USA has maintained
MPLA’s research and development program to:
-
Refine and prove-up its proprietary active
ingredients and to commence the processes that will lead to the issue of a Master
Drug File registration of its products;
-
Define the mode of action and potential of
Tripeptofen in both in vitro, animal and human studies;
-
Gain Australian regulatory and marketing
approval;
-
Gain European regulatory approval; and
-
Commence application for American regulatory
approval.
MPLA is in the business of developing and
commercializing a new analgesic and anti-inflammatory molecule known as
Tripeptofen. Tripeptofen is likely to appear in a new group of products
suitable for the treatment of common every-day pain. As an analgesic and
anti-inflammatory drug, Tripeptofen is unusual due to its rapid speed of action
and its topical or rub-on application.
On April 19, 2006, Molecular USA announced the filing of a new patent,
Tissue Disruption Treatment and Composition for Use (US Patent number
11218382). The patent describes a proprietary process for the manufacture of
topical biological secondary injury mediators (B-SIMs) that should have local,
rather than systemic, effects and may be significantly less expensive to
manufacture than conventional B-SIMs. MPLA is developing its B-SIMs to stop the
tissue disruption that occurs after injury by suppressing the body's reactions,
such as inflammation and damage/death of otherwise uninjured cells that are triggered
in response to primary injury.
The first conditions targeted by MPLA will be the
musculoskeletal injuries. The use
of a B-SIM in these markets represents a new approach to one of the
world’s largest over the counter drug markets and includes indications
such as joint inflammation, musculoskeletal pain, overuse and strain injuries,
burns and even surgical and cosmetic procedures. MPLA’s proprietary, industrially
scalable peptide-ligand bond exchange (PLBE) B-SIM manufacturing process
involves the disassociation of proteins, rather than the far more costly
process of assembling B-SIMs one sequence at a time. The patent was lodged in
the name of Cambridge Scientific Pty Ltd; however, Molecular USA holds the
worldwide exclusive license to manufacture, commercialize, market and
distribute topical anti-inflammatory and analgesic products based on the
proprietary MPL-TL compound.
26
Molecular USA is still working on the projections
regarding the necessary expenditure and time frame involved in pursuing this
research and development program.
Any such program will also be subject to Molecular USA raising the
necessary funds to advance such a program.
Capital Expenditure
Commitments
Capital expenditures for the six month period
ended December 31, 2012, amounted to $Nil. Molecular USA does not anticipate
any significant purchase or sale of equipment over the next 12 months.
Changes in Accounting
Policies
In December 2011, the Financial Accounting Standards Board ("
FASB
") issued Accounting Standards
Update ("
ASU
") No.
2011-12, "
Comprehensive Income
".
This ASU effectively defers the changes in ASU No. 2011-05, "
Presentation of Comprehensive Income
"
that relate to the presentation of reclassification adjustments out of
accumulated other comprehensive income. ASU No. 2011-12 should be applied
retrospectively and is effective for fiscal years, and interim periods within
those years, beginning after December 15, 2011. As ASU No. 2011-12 relates only
to the presentation of Comprehensive Income, the adoption of this update did
not have a material effect on the Company's interim consolidated financial
statements.
In June 2011, the
FASB issued ASU No. 2011-05,
"Presentation of
Comprehensive Income"
.
This ASU presents an entity with the option to present the total of comprehensive
income, the components of net income, and the component of other comprehensive
income either in a single continuous statement of comprehensive income or in
two separate but consecutive statements.
In both choices, an entity is required to present each component of
other comprehensive income along with a
total
for other comprehensive income, and a total amount for comprehensive
income. This update eliminates the
option to present the components of other comprehensive income as part of the
statement of changes in stockholders’ equity/deficit. The amendments in this update do not
change the items that must be reported in other comprehensive income or when an
item of other comprehensive income must be reclassified to net income. ASU No. 2011-05 should be applied
retrospectively and is effective for fiscal years, and interim periods within
those years, beginning after 15 December 2011. As ASU No. 2011-05 relates only to the
presentation of Comprehensive Income, the adoption of this update did not have
a material effect on the Company’s interim consolidated financial
statements.
In May 2011, the
FASB issued ASU No. 2011-04,
"Fair Value
Measurement"
to amend the accounting and disclosure
requirements on fair
value
measurements. This ASU limits the
highest-and-best-use measure to nonfinancial assets, permits certain financial
assets and liabilities with offsetting positions in market or counterparty
credit risks to be measured at a net basis, and provides guidance on the
applicability of premiums and discounts.
Additionally, this update expands the disclosure on Level 3 inputs by
requiring quantitative disclosure of the unobservable inputs and assumptions,
as well as description of the valuation processes and the sensitivity of the
fair value to changes in unobservable inputs. ASU No. 2011-04 is to be applied
prospectively and is effective during interim and annual periods beginning
after 15 December 2011. The adoption
of this update did not have a material effect on the Company’s interim
consolidated financial statements.
27
Critical Accounting Policies and Estimates
Our quarterly interim consolidated financial
statements and accompanying notes are prepared in accordance with generally
accepted accounting principles used in the United States. Preparing financial statements requires
management to make estimates and assumptions that affect the reported amounts
of assets, liabilities, revenue, and expenses. These estimates and assumptions
are affected by management's application of accounting policies. We believe that understanding the basis
and nature of the estimates and assumptions involved with the following aspects
of our interim consolidated financial statements is critical to an
understanding of our financials.
Stock-based
compensation
Effective
January 1, 2006, the Company adopted the provisions of ASC 718,
"Compensation – Stock Compensation"
, which
establishes accounting for equity instruments exchanged for employee services.
Under the provisions of ASC 718, stock-based compensation cost is measured at
the grant date, based on the calculated fair value of the award, and is
recognized as an expense over the employees’ requisite service period
(generally the vesting period of the equity grant). The Company adopted ASC 718
using the modified prospective method, which requires the Company to record
compensation expense over the vesting period for all awards granted after the
date of adoption, and for the unvested portion of previously granted awards
that remain outstanding at the date of adoption. Accordingly, the financial statements
for the periods prior to January 1, 2006 have not been restated to reflect the
fair value method of expensing share-based compensation. The adoption of ASC 718 does not change
the way the Company accounts for share-based payments to non-employees, with
guidance provided by ASC 505-50,
"Equity-Based
Payments to Non-Employees".