DMK PHARMACEUTICALS Corp - Quarter Report: 2009 June (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended June 30, 2009
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from
to
Commission
File Number: 0-26372
ADAMIS
PHARMACEUTICALS CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
|
82-0429727
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
Number)
|
2658 Del Mar Heights Rd., #555, Del
Mar, CA 19512
(Address
of principal executive offices, including zip code)
(858) 401-3984
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Sections 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 x No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definitions of “larger accelerated filer”, “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer ¨ Accelerated
filer ¨
Non-accelerated filer ¨ Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange
Act). Yes ¨ No x
CELLEGY
PHARMACEUTICALS, INC.
CONTENTS
OF QUARTERLY REPORT ON FORM 10-Q
Page
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PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements:
|
|
Condensed
Consolidated Balance Sheets
|
3
|
|
Condensed
Consolidated Statements of Operations
|
4
|
|
Condensed
Consolidated Statements of Cash Flows
|
5&6
|
|
Notes
to Condensed Consolidated Financial Statements
|
7
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
12
|
Item
3.
|
Quantitative
and Qualitative Disclosure of Market Risk
|
20
|
Item
4.
|
Controls
and Procedures
|
20
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
21
|
Item
1A.
|
Risk
Factors
|
21
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
21
|
Item
3.
|
Defaults
Upon Senior Securities
|
21
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
21
|
Item
5.
|
Other
Information
|
21
|
Item
6.
|
Exhibits
|
22
|
Signatures
|
23
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2
PART I
- FINANCIAL INFORMATION
ITEM 1: Financial
Statements
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
June
30, 2009
|
||||||||
(Unaudited)
|
March 31, 2009
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
|
$ | 9,212 | $ | 17,697 | ||||
Accounts
Receivable
|
170,786 | 136,283 | ||||||
Inventory,
Net
|
193,712 | 195,167 | ||||||
Prepaid
Expenses and Other Current Assets
|
43,442 | 4,087 | ||||||
Assets
from Discontinued Operations
|
350,000 | 350,000 | ||||||
Total
Current Assets
|
767,152 | 703,234 | ||||||
PROPERTY
AND EQUIPMENT, Net
|
27,129 | 31,726 | ||||||
DEFERRED ACQUISTION COSTS | - | 147,747 | ||||||
$ | 794,281 | $ | 882,707 | |||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
Payable
|
$ | 1,317,089 | $ | 972,522 | ||||
Accrued
Expenses
|
1,272,643 | 723,896 | ||||||
Notes
Payable to Related Parties
|
287,065 | 599,765 | ||||||
Total
Current Liabilities
|
2,876,797 | 2,296,183 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||
Preferred
Stock – Par Value $.0001; 10,000,000 Shares Authorized; Issued
and
Outstanding-None |
- | - | ||||||
Common
Stock – Par Value $.0001; 175,000,000 Shares Authorized; 39,005,685 and
36,321,685 Issued and Outstanding, Respectively
|
3,963 | 3,663 | ||||||
Additional
Paid-in Capital
|
10,781,858 | 10,763,031 | ||||||
Accumulated
Deficit
|
(12,868,337 | ) | (12,179,854 | ) | ||||
Treasury
Stock
|
- | (316 | ) | |||||
Total
Stockholders' Equity (Deficit)
|
(2,082,516 | ) | (1,413,476 | ) | ||||
$ | 794,281 | $ | 882,707 |
The
Accompanying Notes are an Integral Part of These Consolidated Financial
Statements
3
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
Three
Months Ended
|
||||||||
June
30, 2009
|
June
30, 2008
|
|||||||
(Unaudited)
|
(Unaudited)
|
|||||||
REVENUE
|
$ | 106,470 | $ | 109,142 | ||||
COST
OF GOODS SOLD
|
48,078 | 43,689 | ||||||
Gross
Margin
|
58,392 | 65,453 | ||||||
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES
|
729,627 | 1,001,974 | ||||||
RESEARCH
AND DEVELOPMENT
|
13,015 | 310,943 | ||||||
Loss
from Operations
|
(684,250 | ) | (1,247,464 | ) | ||||
OTHER
INCOME (EXPENSE)
|
||||||||
Interest
Expense
|
(4,233 | ) | (197,075 | ) | ||||
Gain
on Fixed Asset Disposal
|
- | 1,329 | ||||||
Total
Other Income (Expense)
|
(4,233 | ) | (195,746 | ) | ||||
(Loss)
from Continuing Operations
|
(688,483 | ) | (1,443,210 | ) | ||||
(Loss)
from Discontinued Operations
|
- | (2,130,711 | ) | |||||
Net
(Loss)
|
(688,483 | ) | (3,573,921 | ) | ||||
Basic
and Diluted (Loss) Per Share:
|
||||||||
Continuing
Operations
|
$ | (0.02 | ) | $ | (0.06 | ) | ||
Discontinued
Operations
|
- | (0.09 | ) | |||||
Basic
and Diluted (Loss) Per Share
|
$ | (0.02 | ) | $ | (0.15 | ) | ||
Basic
and Diluted Weighted Average Shares Outstanding
|
28,671,722 | 24,176,378 |
The
Accompanying Notes are an Integral Part of These Consolidated Financial
Statements
4
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Three
Months Ended June 30,
|
||||||||
2009
|
2008
|
|||||||
(Unaudited)
|
(Unaudited)
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
(Loss) from Continuing Operations
|
$ | (688,483 | ) | $ | (1,443,210 | ) | ||
Adjustments
to Reconcile Net (Loss) from Continuing Operations to Net Cash (Used in)
Operating Activities:
|
||||||||
Depreciation
Expense
|
4,597 | 4,675 | ||||||
Gain
on Fixed Asset Disposal
|
- | (1,329 | ) | |||||
Loan
Discount Acretion
|
- | 88,000 | ||||||
Inventory
Reserve Adjustment
|
(4,821 | ) | (20,981 | ) | ||||
Sales
Return Reserve Adjustment
|
(11,308 | ) | (137,327 | ) | ||||
Stock-Based
Compensation Expense
|
23,034 | - | ||||||
Change
in Assets and Liabilities:
|
||||||||
(Increase)
Decrease in:
|
||||||||
Accounts
Receivable
|
(34,503 | ) | (3,099 | ) | ||||
Inventory
|
6,276 | 20,248 | ||||||
Prepaid
Expenses and Other Current Assets
|
(12,992 | ) | 14,152 | |||||
Increase
(Decrease) in:
|
||||||||
Accounts
Payable
|
117,443 | 338,096 | ||||||
Accrued
Expenses
|
339,358 | 352,754 | ||||||
Net
Cash (Used in) Operating Activities from Continuing
Operations
|
(260,899 | ) | (788,021 | ) | ||||
Net
Cash (Used in) Operating Activities from Discontinued
Operations
|
- | (1,392,068 | ) | |||||
Net
Cash (Used in) Operating Activities
|
(260,899 | ) | (2,180,089 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Cash
Acquired in Cellegy Pharmaceuticals, Inc. Merger
|
65,114 | - | ||||||
Sale
of Property and Equipment
|
- | 5,001 | ||||||
Net
Cash Provided by Investing Activities from Continuing
Operations
|
65,114 | 5,001 | ||||||
Net
Cash Provided by Investing Activities from Discontinued
Operations
|
- | 98,035 | ||||||
Net
Cash Provided by Investing Activities
|
65,114 | 103,036 | ||||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Payments
of Notes Payable to Shareholders
|
- | (5,436 | ) | |||||
Proceeds
from Issuance of Common Stock
|
- | 828,740 | ||||||
Proceeds
from Issuance of Notes Payable to Related Parties
|
172,300 | - | ||||||
Proceeds
from Issuance of Notes Payable to Shareholders
|
15,000 | - | ||||||
Net
Cash Provided by Financing Activities from Continuing
Operations
|
187,300 | 823,304 | ||||||
Net
Cash Provided by Financing Activities from Discontinued
Operations
|
- | 1,273,780 | ||||||
Net
Cash Provided by Financing Activities
|
187,300 | 2,097,084 | ||||||
Increase
(Decrease) in Cash
|
(8,485 | ) | 20,031 | |||||
Cash:
|
||||||||
Beginning
|
17,697 | 541 | ||||||
Ending
|
$ | 9,212 | $ | 20,572 |
The
Accompanying Notes are an Integral Part of These Consolidated Financial
Statements
5
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Three
Months Ended June 30,
|
||||||||
2009
(Unaudited)
|
2008
(Unaudited)
|
|||||||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION
|
||||||||
Cash
Paid for Interest
|
$ | - | $ | 37,054 | ||||
SUPPLEMENTAL
DISCLOSURE OF NON-CASH FINANCING AND INVESTING
ACTIVITIES
|
||||||||
Note
Payable and Accrued Interest Converted into Equity
|
$ | 556,610 | $ | - | ||||
Deferred
Acquisition Costs Converted to Additional Paid-In Capital in Connection
with
Asset Acquisition and Recapitalization
|
$ | 147,747 | - |
The
Accompanying Notes are an Integral Part of These Consolidated Financial
Statements
6
Note
1: Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial statements have
been prepared in accordance with generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and
Articles 8 and 10 of Regulation S-X promulgated by the Securities and
Exchange Commission (“SEC”). Accordingly, certain information and footnote
disclosures normally included in annual financial statements have been condensed
or omitted. In the opinion of management, the accompanying unaudited interim
condensed consolidated financial statements reflect all adjustments (including
normal recurring adjustments and the elimination of intercompany accounts)
considered necessary for a fair statement of all periods
presented. The results of Adamis Pharmaceuticals Corporation
operations for any interim periods are not necessarily indicative of the results
of operations for any other interim period or for a full fiscal year. These
unaudited interim condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements and footnotes thereto
included in the Company’s Annual Report on Form 10-K for the year ended December
31, 2008 and Form 8-K/A as of and for the year ended March 31, 2009 filed on
July 1, 2009.
Liquidity
and Capital Resources
Our cash
and cash equivalents were $9,212 and $17,697 at June 30, 2009 and March 31,
2009, respectively.
We
prepared the condensed consolidated financial statements assuming that we will
continue as a going concern, which contemplates the realization of assets and
the satisfaction of liabilities during the normal course of business. In
preparing these condensed consolidated financial statements, consideration was
given to the Company’s future business as described below, which may preclude
the Company from realizing the value of certain assets.
The
Company has negative working capital, liabilities that exceed its assets and
significant cash flow deficiencies. Additionally, the Company will need
significant funding for future operations and the expenditures that will be
required to conduct the clinical and regulatory work to develop the merged
company’s product candidates. Management is currently seeking additional funding
to satisfy existing obligations, liabilities and future working capital needs,
to build working capital reserves and to fund its research and development
projects. There is no assurance that the Company will be successful
in obtaining the necessary funding to meet its business objectives.
Note
2: Asset Acquisition and Recapitalization
The
stockholders of Cellegy Pharmaceuticals, Inc. (“Cellegy”) and the former Adamis
Pharmaceuticals Corporation (“Old Adamis”) approved the merger transaction and
related matters at an annual meeting of Cellegy’s stockholders and at a special
meeting of Old Adamis’ stockholders each held on March 23, 2009. On April 1,
2009, Cellegy completed the merger transaction with
Old Adamis. In connection with the closing of the merger
transaction, the promissory note issued to Old Adamis converted into shares of
Old Adamis stock, and these shares were immediately cancelled.
In
connection with the consummation of the merger and pursuant to the terms of the
Merger Agreement, Cellegy changed its name from Cellegy Pharmaceuticals, Inc. to
Adamis Pharmaceuticals Corporation (“Adamis” or “the Company”), and Old Adamis
changed its corporate name to Adamis Corporation.
7
Pursuant
to the terms of the Merger Agreement, immediately before the consummation of the
merger Cellegy affected a reverse stock split of its common
stock. Pursuant to this reverse stock split, each 9.929060333 shares
of common stock of Cellegy that were issued and outstanding immediately before
the effective time of the merger was converted into one share of common stock
and any remaining fractional shares held by a stockholder (after the aggregating
fractional shares) were rounded up to the nearest whole share (the “Reverse
Split”).
As a
result, the total number of shares of Cellegy that were outstanding immediately
before the effective time of the merger were converted into approximately
3,000,000 shares of post-Reverse Split shares of common stock of the
Company. Pursuant to the terms of the Merger Agreement, at the
effective time of the merger, each share of Adamis common stock that was issued
and outstanding immediately before the effective time of the merger ceased to be
outstanding and was converted into the right to receive one share of common
stock of the Company. As a result, the Company issued approximately
43,053,970, inclusive of 6,732,285 contingent shares held in
escrow, post-Reverse Split shares of common stock to the holders of the
outstanding shares of common stock of Old Adamis before the effective time of
the merger. Old Adamis is the surviving entity as a wholly-owned subsidiary of
Cellegy.
Old
Adamis security holders owned, immediately after the closing of the merger,
approximately 93.5% of the combined company on a fully-diluted basis. Further,
Old Adamis directors constitute a majority of the combined company’s board of
directors and all members of executive management of the combined company are
from old Adamis. Therefore, Old Adamis was deemed to be the acquiring company
for accounting purposes and the merger transaction is accounted for as an asset
acquisition recapitalization in accordance with accounting principles generally
accepted in the United States. Cellegy did not meet the definition of a business
related to the combined company and did not have material assets or continuing
operations at the time of the closing of the merger. As a result, all of the
assets and liabilities of Cellegy have been reflected in the financial
statements at their respective fair market values and no goodwill or other
intangibles were recorded as part of acquisition accounting and the cost of the
merger is measured at the net liabilities acquired. Transaction costs amounting
to $147,747 were considered as part of the assets acquired and included as a
reduction of additional paid-in capital. The financial statements of the
combined entity after the merger reflect the historical results of Old Adamis
prior to the merger and do not include the historical financial results of
Cellegy prior to the completion of the merger. Stockholders’ equity and earnings
per share of the combined entity after the merger have been retroactively
restated to include the number of shares received by Old Adamis security
holders in the merger with the offset to additional paid-in
capital.
In
connection with the closing of the merger, the Company amended its certificate
of incorporation to increase the authorized number of shares of common stock
from 50,000,000 to 175,000,000 and the authorized number of shares of preferred
stock from 5,000,000 to 10,000,000.
Note
3: Stock Option Plans, Shares Reserved and Warrants
Cellegy’s stockholders approved a new
2009 Equity Incentive Plan (the “2009 Plan”), which became effective upon the
closing of the merger. The 2009 Plan provides for the grant of
incentive stock options, non-statutory stock options, restricted stock awards,
restricted stock unit awards, stock appreciation rights, performance stock
awards, and other forms of equity compensation (collectively “stock
awards”). In addition, the 2009 Plan provides for the grant of
performance cash awards. The aggregate number of shares of common
stock that may be issued initially pursuant to stock awards under the 2009 Plan
is 7,000,000 shares. The number of shares of common stock reserved
for issuance will automatically increase on January 1 of each calendar year,
from January 1, 2010 through and including January 1, 2019, by the lesser of (a)
5.0% of the total number of shares of common stock outstanding on December 31 of
the preceding calendar year or (b) a lesser number of shares of common stock
determined by the Company’s board of directors before the start of a calendar
year for which an increase applies.
The
Company granted a total of 150,000 stock options to directors upon the closing
of the merger. The options have an exercise price of $0.60 per option, which is
equal to the fair market value of the Company’s common stock on the date of the
grant. The options vest 3 years from the date of the grant, and expire on the
10th
anniversary of the options’ grant date. The Company estimated that the options
have a fair market value of $0.30 per option using the Black-Scholes valuation
model. Management’s assumptions included in the model assumed volatility of
35.4%, a risk-free interest rate of 2.7% based on the 10-year Treasury Rate at
the date of the grant and no dividends. The Company estimated a forfeiture rate
of 5.5%. The Company recorded stock based compensation expense of $23,034
related to such options for the three months ended June 30, 2009.
The
following summarizes outstanding stock options at June 30, 2009:
Number
of
Options
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
Number
of
Options
Vested
|
||||||||||
1995
Equity Incentive Plan
|
20,641 |
4.93
Years
|
$ | 31.83 | 20,641 | ||||||||
2005
Equity Incentive Plan
|
4,834 |
6.25
Years
|
$ | 13.30 | 4,834 | ||||||||
Directors’
Stock Option Plan
|
8,460 |
3.06
Years
|
$ | 44.16 | 8,460 | ||||||||
Non-Plan
Options
|
100,714 |
4.36
Years
|
|
$ | 43.82 | 100,714 | |||||||
Biosyn
Options
|
431 |
4.56
Years
|
$ | 2.90 | 431 | ||||||||
2009
Equity Incentive Plan
|
150,000 |
9.76
Years
|
$ | 0.60 | - |
The Company has reserved shares of
common stock for issuance upon exercise at June 30, 2009 as
follows:
Biosyn
Options
|
431 | |||
Director’s
Plan
|
8,460 | |||
Warrants
|
1,212,970 | |||
Non-Plan
Options
|
100,714 | |||
1995
Equity Incentive Plan
|
20,641 | |||
2005
Equity Incentive Plan
|
100,714 | |||
2009
Equity Incentive Plan
|
7,000,000 | |||
Total
Shares Reserved
|
8,443,931 |
The
following summarizes warrants outstanding at June 30, 2009:
Warrant
Shares
|
Exercise
Price Per Share
|
Date
Issued
|
Expiration
Date
|
||||||||||
June
2004 PIPE
|
60,832 | $ | 45.87 |
July
27, 2004
|
July
27, 2009
|
||||||||
Biosyn
Warrants
|
8,254 | $ | 57.97 - $173.92 |
October
22, 2004
|
|
2013
- 2014
|
|||||||
May
2005 PIPE
|
|||||||||||||
Series
A
|
71,947 | $ | 22.34 |
May
13, 2005
|
May
13, 2010
|
||||||||
Series
B
|
71,947 | $ | 24.82 |
May
13, 2005
|
May
13, 2010
|
||||||||
Old Adamis Warrants | 1,000,000 | $ | 0.50 |
November
15, 2007
|
November
15, 2012
|
||||||||
Total
Warrants
|
1,212,970 | - |
Note
4: Recent Accounting Pronouncements
On
December 4, 2007, the FASB issued SFAS No. 141 (Revised 2007),
Business Combinations
(“SFAS 141(R)”). Under SFAS 141(R), an acquiring entity will be
required to recognize all the assets acquired and liabilities assumed in a
transaction at the acquisition date fair value with limited exceptions.
SFAS 141(R) will change the accounting treatment for certain specific
items, including:
8
·
|
acquisition
costs will be generally expensed as
incurred;
|
·
|
non-controlling
interests will be valued at fair value at the acquisition
date;
|
·
|
acquired
contingent liabilities will be recorded at fair value at the acquisition
date;
|
·
|
in-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition date until the
completion or abandonment of the associated research and development
efforts;
|
·
|
restructuring
costs associated with a business combination will be generally expensed
subsequent to the acquisition
date; and
|
·
|
changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax
expense.
|
SFAS 141(R)
also includes a substantial number of new disclosure requirements.
SFAS 141(R) applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. Earlier adoption is
prohibited. The Company adopted SFAS 141(R) on April 1, 2009,
which did not have a material impact on the financial
statements.
9
Note
5: Inventory
Inventory
consists of the following:
June
30, 2009
|
March
31, 2009
|
|||||||
Respiratory
and Allergy Products
|
$ | 46,567 | $ | 52,843 | ||||
Less:
Obsolescence Reserve
|
(32,354 | ) | (37,175 | ) | ||||
Respiratory
and Allergy Products, Net
|
14,213 | 15,668 | ||||||
Pre-Launch
epi Inventory
|
179,499 | 179,499 | ||||||
Inventory,
Net
|
$ | 193,712 | $ | 195,167 |
The
Company launched the epi product in the second fiscal quarter of
2010.
Note
6: Notes Payable
Ben
Franklin Note
Biosyn (a
wholly owned subsidiary of Cellegy) issued a note payable to Ben Franklin
Technology Center of Southeastern Pennsylvania (“Ben Franklin Note”) in October
1992, in connection with funding the development of Savvy, a compound to prevent
the transmission of AIDS.
The Ben
Franklin Note was recorded at its estimated fair value of $205,000 and was
assumed by Cellegy in connection with its acquisition of Biosyn in 2004. The
repayment terms of the non-interest bearing obligation include the remittance of
an annual fixed percentage of 3.0% applied to future revenues of Biosyn, if any,
until the principal balance of $777,902 (face amount) is satisfied. Under the
terms of the obligation, revenues are defined to exclude the value of
unrestricted research and development funding received by Biosyn from nonprofit
sources. Absent a material breach of contract by Cellegy, there is no obligation
to repay the amounts in the absence of future Biosyn revenues. Cellegy accreted
the discount of $572,902 against earnings using the interest rate method
(approximately 46%) over the discount period of five years, which was estimated
in connection with the Ben Franklin Note’s valuation at the time of the
acquisition. At June 30, 2009, the outstanding balance of the note was
$777,902.
Accounting
principles generally accepted in the United States emphasize market-based
measurement through the use of valuation techniques that maximize the use of
observable or market-based inputs. The Ben Franklin Note’s peculiar
repayment terms outlined above affects its comparability with main stream market
issues and also affects its transferability. The value of the Ben
Franklin Note would also be impacted by the ability to estimate Biosyn’s
expected future revenues which in turn hinge largely upon the outcome of its
ongoing Savvy contraception trial, the results of which are currently under
review and which are not known by the Company. Given the above
factors and therefore the lack of market comparability, the Ben Franklin Note
would be valued based on Level 3 inputs. As such,
management has determined that the Ben Franklin Note will have no future cash
flows, as we do not believe the product will create a revenue stream in the
future. As a result, the Note had no fair market value at the time of the
acquisition..
10
Notes
Payable to Related Parties
The
Company had notes payable to related parties amounting to $287,065 at June 30,
2009, which bear interest at 10%. Accrued interest related to the notes was
$6,630 at June 30, 2009.
On
various dates during May – June 2009 and included in the amount above, the
Company issued promissory notes to shareholders for a total of $172,300 that
bear interest at 10% with all principal and interest due on various
maturity dates during May – June 2010.
Note
7: Subsequent Events
On August
14, 2009, the Company repurchased 756,686 shares of common stock for
treasury at a total cost of $786.
11
ITEM 2.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
This
discussion of Adamis’ financial condition and results of operations contains
certain statements that are not strictly historical and are “forward-looking”
statements within the meaning of the Private Securities Litigation Reform Act of
1995 and involve a high degree of risk and uncertainty. Actual results may
differ materially from those projected in the forward-looking statements due to
other risks and uncertainties that exist in Adamis’ operations, development
efforts and business environment, the other risks and uncertainties described in
the section entitled “Risk Factors” in the most recent Annual Report on Form
10-K filed and Form S-4 Registration Statement by Adamis with the
Securities and Exchange Commission on May 13, 2009 and February 12, 2009,
respectively, and the other risks and uncertainties described elsewhere in this
report. All forward-looking statements included in this report are based on
information available to Adamis as of the date hereof, and except as may be
required under the Securities Exchange Act of 1934 and the rules and regulations
promulgated thereunder, Adamis assumes no obligation to update any such
forward-looking statements.
Recent
Events
Merger
of Cellegy and Adamis; Change of Corporate Name
On
February 12, 2008, Cellegy Pharmaceuticals, Inc. (“Cellegy,” and Cellegy before
the effective time of the merger described below sometimes referred to as “Old
Cellegy”) entered into an Agreement and Plan of Reorganization (the agreement as
amended, referred to as the “Merger Agreement”) with Adamis Pharmaceuticals
Corporation (“Old Adamis”) and Cellegy Holdings, Inc., a wholly-owned subsidiary
of Cellegy (“Merger Sub”), providing for the acquisition of Old Cellegy by Old
Adamis shareholders. The Merger Agreement provided that Merger
Sub will merge with and into Old Adamis, with Old Adamis becoming a wholly-owned
subsidiary of Cellegy and the surviving corporation in the merger (the
“Merger”). The stockholders of Old Cellegy and Old Adamis approved
the transaction at a special meeting of Adamis stockholders held on March 23,
2009, and at an annual meeting of Old Cellegy’s stockholders held on March 23,
2009.
Effective
as of the close of business on April 1, 2009, Old Adamis and Old Cellegy
completed the Merger transaction contemplated by the Merger
Agreement. In connection with the consummation of the Merger
and pursuant to the terms of the Merger Agreement, Old Cellegy changed its name
from Cellegy Pharmaceuticals, Inc. to Adamis Pharmaceuticals
Corporation, and Old Adamis changed its corporate name to “Adamis
Corporation.”
Reverse
Stock Split of Old Cellegy Common Stock
Pursuant
to the terms of the Merger Agreement, immediately before the consummation of the
Merger Old Cellegy effected a reverse stock split of its common
stock. Pursuant to this reverse stock split, each 9.929060333
shares of common stock of Old Cellegy that were issued and outstanding
immediately before the effective time of the Merger was converted into one share
of common stock of the Company, and any remaining fractional shares held by a
record holder of shares were rounded up to the nearest whole share.
As a
result, the total number of shares of Old Cellegy that were outstanding
immediately before the effective time of the Merger were converted into
approximately 3,000,000 shares of post-reverse split shares of common stock of
the Company.
Issuance of Shares to Old Adamis
Stockholders
Pursuant
to the terms of the Merger Agreement, at the effective time of the Merger, each
share of Old Adamis common stock that was issued and outstanding immediately
before the effective time of the Merger ceased to be outstanding and was
converted into the right to receive one share of common stock of the
Company. As a result, the Company issued approximately
42,978,067 post-reverse split shares of common stock of the Company to persons
who were Old Adamis stockholders before the effective time of the Merger, and
the former Old Adamis stockholders, together with the holders of converted Old
Adamis warrants, became entitled to receive shares of Company common stock and
warrants representing in the aggregate approximately 93.5% of the outstanding
shares of Company common stock outstanding immediately after the effective time
of the Merger.
12
In
connection with the Merger, each outstanding stock option, warrant, convertible
security and other right to purchase or acquire the capital stock of Old Adamis
was assumed by the Company and became an option, warrant, convertible security
or other right to purchase or acquire shares of common stock of the Company,
with the number of shares and exercise prices proportionately adjusted based on
the exchange ratio in the Merger. Because the exchange ratio in
the Merger was one-for-one, the exercise prices and numbers of shares covered by
outstanding Old Adamis options, warrants and convertible securities that the
Company assumed in the Merger remained the same after the
Merger. As a result, an outstanding Adamis warrant to purchase
1,000,000 shares of Old Adamis common stock was assumed by the Company in the
Merger and became a warrant to purchase 1,000,000 shares of common stock of the
Company.
Increase
in Authorized Shares of Capital Stock
Also in
connection with the closing of the Merger, the Company amended its certificate
of incorporation to increase the authorized number of shares of common stock
from 50,000,000 to 175,000,000 and the authorized number of shares of preferred
stock from 5,000,000 to 10,000,000.
General
Old
Adamis currently has two wholly-owned subsidiaries: Adamis Laboratories,
Inc. (specialty pharmaceuticals), or Adamis Labs; and Adamis Viral Therapies,
Inc. (biotechnology), or Adamis Viral.
Adamis
Labs is a specialty pharmaceutical company. Adamis Labs currently has a line of
prescription products that it markets for a variety of allergy, respiratory
disease and pediatric conditions. Adamis acquired these products in April 2007
by acquiring all of the outstanding shares of Healthcare Ventures Group, a
private company that had previously acquired the products and related
intellectual property, assets and personnel from another corporation in February
2007, and subsequently renaming the company Adamis Labs. A pre-filled
epinephrine syringe product for use in the emergency treatment of extreme acute
allergic reactions, or anaphylactic shock, was launched in July
2009. An additional product candidate in its product pipeline is a
generic inhaled nasal steroid for the treatment of seasonal and perennial
allergic rhinitis.
Adamis
estimates that approximately $1 million will be required to support the
commercial launch of the epinephrine syringe product. Adamis believes
that the syringe product has the potential to compete successfully and generate
net cash inflows shortly after commercial introduction, although there can be no
assurances that this will be the case. Adamis estimates that the time
to develop the nasal steroid product candidate will be approximately 24 months
from April 2009, assuming sufficient funding and no unexpected
delays. Currently, neither manufacturing nor clinical trials have
commenced for that product candidate. Adamis estimates that
approximately $9-14 million or more must be invested to support development and
commercial introduction of the nasal steroid product
candidate. Factors that could affect the actual launch date for the
nasal steroid product candidate include the outcome of discussions with the FDA
concerning the number and kind of clinical trials that the FDA will require
before the FDA will consider regulatory approval of the product, any unexpected
difficulties in licensing or sublicensing intellectual property rights for other
components of the product such as the inhaler, any unexpected difficulties in
the ability of our suppliers to timely supply quantities for commercial launch
of the product, any unexpected delays or difficulties in assembling and
deploying an adequate sales force to market the product, and adequate funding to
support sales and marketing efforts. Significant delays in obtaining
funding to support ongoing sales efforts for the syringe product, or in the
introduction of the steroid product, could reduce revenues and income to Adamis,
require additional funding from other sources, and potentially have an adverse
effect on the ability to fund Adamis’ research and development efforts for avian
influenza and other vaccine product candidates by Adamis Viral.
13
From
inception, Adamis’ development efforts have been focused on development of its
vaccine technology, with the first product candidate expected to be a vaccine
for avian flu. Adamis formed Adamis Viral to focus on developing that vaccine
technology. As the avian flu product candidate is at an earlier stage of
development, Adamis cannot estimate with any precision the amount that will be
required to support development, clinical trials and commercial introduction of
a product, although the amounts are likely to be larger than the amounts
required to support the nasal steroid product candidate. Factors that
could affect the costs of developing such a candidate include those described
above for the steroid product candidate. Adamis Viral’s product candidates
are in the preclinical stage, and it has not generated any revenues to date.
From June 6, 2006 (date of inception) through June 30 , 2009, Adamis has spent a
total of approximately $388,000 to in-license and develop the Adamis Viral
vaccine technology. Research and development efforts will require the conduct of
both preclinical and clinical studies and significant additional funding, and
even if development and marketing efforts are successful, substantial time may
pass before significant revenues will be realized; accordingly, even if Adamis
Labs generates revenues and net income, during this period Adamis will require
additional funds for its Adamis Viral operations, the availability of which
cannot be assured. Consequently, Adamis is subject to many of the risks
associated with early stage companies, including the need for additional
financings; the uncertainty of research and development efforts resulting in
successful commercial products, as well as the marketing and customer acceptance
of such products; competition from larger organizations; reliance on the
proprietary technology of others; dependence on key personnel; uncertain patent
protection; and dependence on corporate partners and collaborators.
To
achieve successful operations of both its Adamis Viral and Adamis Labs
subsidiaries, Adamis will require additional capital to continue research and
development and marketing efforts and to make capital investments in its
operations. No assurance can be given as to the timing or ultimate success of
obtaining future funding, and there are no assurances that Adamis will be
successful, with the limited experience and resources Adamis has available at
the present time, in developing and commercializing the syringe product, an
avian flu vaccine or any other vaccine product or technology.
The
process of developing new therapeutic products is inherently complex,
time-consuming, expensive and uncertain. Adamis must make long-term investments
and commit significant resources before knowing whether its development programs
will result in products that will receive regulatory approval and achieve market
acceptance. Product candidates that may appear to be promising at all stages of
development may not reach the market for a number of reasons. Product candidates
may be found ineffective or may cause harmful side effects during clinical
trials, may take longer to progress through clinical trials than had been
anticipated, may not be able to achieve the pre-defined clinical endpoint due to
statistical anomalies even though clinical benefit may have been achieved, may
fail to receive necessary regulatory approvals, may prove impracticable to
manufacture in commercial quantities at reasonable cost and with acceptable
quality, or may fail to achieve market acceptance. For these reasons, as well as
other reasons identified under the heading “Risk Factors” in our most recent
annual report on Form 10-K, and Form S-4 Registration Statement filed February
12, 2009 with the Securities and Exchange Commission. Adamis is unable to
predict the period in which material net cash inflows from product candidates
incorporating the vaccine technology will commence.
Critical Accounting Policies and
Estimates
Adamis
has identified below some of its more significant accounting policies. For
further discussion of Adamis’ accounting policies, see Note 1 in the Notes to
the Adamis Consolidated Financial Statements.
Principles of Consolidation.
The accompanying consolidated financial statements include Adamis
Pharmaceuticals and its wholly owned subsidiaries, Adamis Labs and Adamis Viral.
All significant intercompany balances and transactions have been eliminated in
consolidation.
Use of Estimates. The
preparation of consolidated financial statements, in conformity with accounting
principles generally accepted in the United States, requires management to make
estimates, judgments and assumptions that affect the amounts reported in the
financial statements and accompanying notes. Actual results could differ from
those estimates.
Cash and Cash Equivalents.
For purposes of the consolidated statements of cash flows, Adamis considers all
highly liquid investments with original maturities at the date of purchase of
three months or less to be cash equivalents.
Accounts Receivable, Allowance for
Doubtful Accounts and Sales Returns. Trade accounts receivable are stated
net of an allowance for doubtful accounts and sales returns. Adamis estimates an
allowance based on its historical experience of the relationship between actual
bad debts and net credit sales.
14
Adamis
has established an allowance for sales returns based on management’s best
estimate of probable loss inherent in the accounts receivable balance.
Management determines the allowance based on current credit conditions,
historical experience, and other currently available information.
Registration Payment
Arrangements. Adamis accounts for registration payment arrangements under
Financial Accounting Standards Board (“FASB”) Staff Position (“FSP”) EITF
00-19-2, “Accounting for Registration Payment Arrangements,” or FSP EITF
00-19-2. FSP EITF 00-19-2 specifies that the contingent obligation to make
future payments under a registration payment arrangement should be
separately recognized and measured in accordance with SFAS No. 5, “Accounting
for Contingencies.” FSP EITF 00-19-2 was issued in December 2006. Early adoption
of FSP EITF 00-19-2 is permitted and Adamis adopted FSP EITF 00-19-2 effective
January 3, 2007.
Inventory . Inventory,
consisting of allergy and respiratory products, is recorded at the lower of cost
or market, using the weighted average method.
Property and Equipment.
Property and equipment are recorded at cost less accumulated depreciation.
Depreciation is computed using the straight-line method over the estimated
useful lives of the related assets. The cost of leasehold improvements are
amortized over the lesser of the lease term or the life of the improvement, if
shorter.
Useful
lives used to depreciate property and equipment are as follows:
Life in
Years
|
||
Office
Furniture and Equipment
|
7
|
|
Computer
Equipment and Software
|
3
|
|
Vehicles
|
3
|
Deferred Acquisition Costs.
Adamis incurred certain professional fees associated with specific potential
acquisition targets. These costs will be capitalized as part of the purchase
price paid for the acquisition.
Revenue Recognition.
Our primary customers are pharmaceutical wholesalers. In accordance with our
revenue recognition policy, revenue is recognized when title and risk of loss
are transferred to the customer, the sale price to the customer is fixed and
determinable, and collectability of the sale price is reasonably assured.
Reported revenue is net of estimated customer returns and other wholesaler fees.
Our policy regarding sales to customers is that we do not recognize revenue
from, or the cost of, such sales, where we believe the customer has more than a
demonstrably reasonable level of inventory. We make this assessment based on
historical demand, historical customer ordering patterns for purchases, business
considerations for customer purchases and estimated inventory levels. If our
actual experience proves to be different than our assumptions we would then
adjust such allowances accordingly.
We
estimate allowances for revenue dilution items using a combination of
information received from third parties, including market data, inventory
reports from our major U.S. wholesaler customers, when available, historical
information and analysis that we perform. The key assumptions used to arrive at
our best estimate of revenue dilution reserves are estimated customer inventory
levels and purchase forecasts provided. Our estimates of inventory at wholesaler
customers and in the distribution channels are subject to the inherent
limitations of estimates that rely on third-party data, as certain third-party
information may itself rely on estimates, and reflect other limitations. We
believe that such provisions are reasonably ascertainable due to the limited
number of assumptions involved and the consistency of historical
experience.
Revenues
under license and royalty agreements are recognized in the period the earnings
process is completed based on the terms of the specific agreement. Advanced
payments received under these agreements are recorded as deferred revenue at the
time the payment is received and are subsequently recognized as revenue on a
straight-line basis over the longer of the life of the agreement or the life of
the underlying patent. Royalties payable to Adamis under license agreements are
recognized as earned when the royalties are no longer refundable under the terms
defined in the agreement. To date no royalties have been paid.
15
Long Lived Assets. Adamis
periodically assesses whether there has been permanent impairment of its
long-lived assets held and used in accordance with SFAS No. 144, “Accounting for
the Impairment or Disposal of Long-Lived Assets.” SFAS No. 144 requires Adamis
to review long-lived assets for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. Recoverability of assets to be held and used is measured by
comparison of the carrying amount of the asset to future net undiscounted cash
flows expected to be generated from the use and eventual disposition of the
asset.
Research and Development
Expenses .
Adamis accounts for research and development costs in accordance with SFAS No.
2, “Accounting for Research and Development Costs” and Emerging Issues Task
Force (“EITF”) Issue No. 07-3, “Accounting for Nonrefundable Advance
Payments for Goods or Services to Be Used in Future Research and Development
Activities.” Under SFAS No. 2, research and development costs are expensed as
incurred. EITF 07-3 requires non-refundable advance payments for goods and
services to be used in future research and development activities to be recorded
as an asset and expensing the payments when the research and development
activities are performed.
Shipping and Handling Costs.
Shipping and handling costs are included in selling, general and administrative
expenses.
Advertising Costs .
Advertising costs are expensed as incurred as set forth in Statement of Position
(“SOP”) No. 93-7, “Reporting on Advertising Costs.”
Net Loss per Share. Adamis
computes net loss per share in accordance with SFAS No. 128, "Earnings per Share," under
the provisions of which basic loss per share is computed by dividing the income
attributable to holders of common stock for the period by the weighted average
number of shares of common stock outstanding during the period. Since the effect
of common stock equivalents was anti-dilutive, all such equivalents were
excluded from the calculation of weighted average shares
outstanding.
16
Income Taxes . Adamis accounts for income
taxes in accordance with SFAS No. 109, “Accounting for Income Taxes.” SFAS No.
109 requires an asset and liability approach for financial accounting and
reporting for income taxes. Under the asset and liability approach, deferred
taxes are provided for the net tax effect of temporary differences between the
carrying amount of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Valuation allowances are established
where management determines that it is more likely than not that some portion or
all of a deferred tax asset will not be realized.
On April
1, 2007, Adamis adopted the provisions of FASB Interpretation No. 48,
“Accounting for Uncertainty on Income Taxes, an Interpretation of SFAS No. 109,
Accounting for Income Taxes,” which did not have a material impact on Adamis’
liability for unrecognized tax benefits.
Discontinued Operations .
The results of operations for the year ended March 31, 2009, and the
three month period ended June 30, 2009 and the assets and liabilities
at March 31, 2009 and June 30, 2009 related to International Laboratories,
Inc. (“INL”), a formerly wholly owned subsidiary of Adamis, have been
accounted for as discontinued operations in accordance with SFAS No. 144,
“Accounting for the Impairment or Disposal of Long-Lived Assets.” There were no
operations or related assets and liabilities of INL in the accompanying
consolidated financial statements of prior periods.
Results
of Operations
Adamis’
consolidated results of operations are presented for the quarter ended June 30,
2009. Adamis acquired Adamis Labs on April 23, 2007 and, accordingly,
Adamis’ consolidated results of operations for the quarter ended June 30, 2009,
include a full quarter of Adamis Labs’.
Revenues and Cost of Sales.
Adamis had revenues of $106,000 and $109,000 for the three months ending June
30, 2009 and 2008. Cost of sales for the three months ending June 30,
2009 and 2008 were approximately $48,000 and $44,000.
Research and Development Expense.
Adamis incurred research and development expenses of approximately
$311,000 for the quarter ended June 30, 2008 and $13,000 in the three month
period ended June 30, 2009. The reduction of research and development
for the two comparative periods was caused by the completion of the prefilled
EPI syringe.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses for the three
months ending June 30, 2009 and 2008 were approximately $730,000 and $1,002,000,
respectively. Selling, general and administrative expenses consist
primarily of legal fees, accounting and audit fees, professional fees related to
Adamis’ merger with Cellegy and employee salaries. The reduction in
comparative quarter end expense levels is primarily a result of temporarily
reduced salary levels offset somewhat by professional fees and other related
expenses incurred in connection with Adamis’ merger with Cellegy.
Other Income
(Expenses). Interest and other income (expense) for the three month
period ending June 30, 2009 and 2008 was approximately $4,000 and $196,000,
respectively. Interest and other income consists primarily of
interest expense paid in connection with various notes payable.
Liquidity
and Capital Resources
For
the Quarter ending June 30, 2009 and 2008
Adamis’
cash was $9,000 and $21,000 as of June 30, 2009 and June 30, 2008,
respectively. The decrease in cash was primarily the result of selling, general
and administrative expenses, expansion of plant and merger costs, partially
offset by funds received from financing transactions and the sale of
International Laboratories.
17
Net cash
used in operating activities from continuing operations for the quarter ended
June 30, 2009 and 2008 were approximately $261,000 and $788,000, respectively.
Adamis expects net cash used in operating activities to increase going forward
as it completes product development, launches new products, engages in
additional product research and development activities and pursues additional
expansion of its sales base and other business activities. Accrued
expenses of approximately $340,000 was created by an increase in legal,
accounting and consulting expenses due to becoming a publicly traded
company.
Net cash
provided by investing activities from continuing operations was approximately
$65,000 and $5,000 for the quarters ended June 30, 2009 and
2008. Net cash used in investing activities from discontinued
operations of approximately $0 and $98,000 for the quarters ended June 30, 2009
and 2008 result from INL’s contract packaging operations which were sold in July
2008.
Net cash
provided by financing activities from continuing operations was approximately
$187,000 and $823,000 for the quarters ended June 30, 2009 and
2008. The differences between the two periods are primarily due to
the receipt of proceeds from the issuance of common stock in the June 30, 2008
quarter and the increase of debt from related parties and shareholders during
the June 30, 2009 quarter of $187,000. Net cash provided by financing activities
of discontinued operations was $0 and $1,274,000 for the three months ended June
30, 2009 and 2008, respectively.
At June
30, 2009, Adamis had no significant cash balances and substantial liabilities
and obligations. Even if development and marketing efforts are
successful, substantial time may pass before significant revenues will be
realized from the Epi syringe product or other products, and during this period
Adamis will require additional funds, the availability of which cannot be
assured. Consequently, Adamis is subject to the risks associated with early
stage companies, including the need for additional financings; the uncertainty
of research and development efforts resulting in successful commercial products,
as well as the marketing and customer acceptance of such products; competition
from larger organizations; reliance on the proprietary technology of others;
dependence on key personnel; uncertain patent protection; and dependence on
corporate partners and collaborators. To achieve successful operations, Adamis
will require additional capital to continue research and development and
marketing efforts. No assurance can be given as to the timing or ultimate
success of obtaining future funding.
We
prepared the condensed consolidated financial statements assuming that we will
continue as a going concern, which contemplates the realization of assets and
the satisfaction of liabilities during the normal course of
business. In preparing these condensed consolidated financial
statements, consideration was given to the Company’s future business
as described below, which may preclude the Company from realizing the value of
certain assets. The Company has limited cash reserves, liabilities
that exceed its assets and significant cash flow
deficiencies. Additionally, Adamis will need significant funding for
the future operations and the expenditures that will be required to conduct the
clinical and regulatory work to develop the merged company’s product
candidates. Management is currently seeking additional funding to
satisfy existing obligations, liabilities and future working capital needs, to
build working capital reserves and to fund its research and development
projects. There is no assurance that Adamis will be successful
obtaining the necessary funding to meet its business objectives.
Additional
financing will be required to support sales and marketing efforts relating to
the syringe product, product development and marketing efforts for the Adamis
Labs products, continued product research and development on its vaccine
technology, and fund any product or company acquisition opportunities, and cash
flow from the Adamis Labs’ operations are not expected to provide sufficient
cash to fund Adamis’ overall cash requirements for the foreseeable
future. Adamis’ future capital requirements will depend upon numerous
factors, including the following:
·
|
the
progress and costs of development
programs;
|
·
|
the
commercial success of new products that are
introduced;
|
·
|
patient
recruitment and enrollment in future clinical
trials;
|
18
·
|
the
scope, timing and results of pre-clinical testing and clinical
trials;
|
·
|
the
costs involved in seeking regulatory approvals for product
candidates;
|
·
|
the
costs involved in filing and pursuing patent applications and enforcing
patent claims;
|
·
|
the
establishment of collaborations and strategic
alliances;
|
·
|
the
cost of manufacturing and commercialization
activities;
|
·
|
the
results of operations;
|
·
|
the
cost, timing and outcome of regulatory
reviews;
|
·
|
the
rate of technological advances;
|
·
|
ongoing
determinations of the potential commercial success of products under
development;
|
·
|
the
level of resources devoted to sales and marketing capabilities;
and
|
·
|
the
activities of competitors.
|
To obtain
additional capital when needed, Adamis will evaluate alternative financing
sources, including, but not limited to, the issuance of equity or debt
securities, corporate alliances, joint ventures and licensing agreements;
however, there can be no assurance that funding will be available on favorable
terms, if at all. There are no assurances that Adamis will be able to
successfully develop its products under development or that its products, if
successfully developed, will generate revenues sufficient to enable it to earn a
profit. If Adamis is unable to obtain additional capital, management may be
required to explore alternatives to reduce cash used by operating activities,
including the termination of development efforts that may appear to be promising
to Adamis, the sale of certain assets and the reduction in overall operating
activities.
Off
Balance Sheet Arrangements
At June
30, 2009, Adamis did not have any off balance sheet arrangements.
Recent
Accounting Pronouncements
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations,” which establishes the principles and requirements for how an
acquirer: (1) recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, and any noncontrolling
interest in the acquiree; (2) recognizes and measures the goodwill acquired
in the business combination or a gain from a bargain purchase;
(3) determines what information to disclose to enable users of the
financial statements to evaluate the nature and financial effects of the
business combination; and (4) requires acquisition costs related to business
combinations incurred prior to acquisition to be expensed rather than deferred.
SFAS No. 141(R) replaces SFAS No. 141, “Business Combinations.” SFAS
No. 141(R) is effective in fiscal years beginning after December 15,
2008.
19
ITEM
3. Quantitative and Qualitative Disclosure of Market
Risk
Not
required.
ITEM 4. Controls
and Procedures
As of the
end of the period covered by this report, we carried out an evaluation, under
the supervision and with the participation of our management, including our
Chief Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)).
20
Based
upon this evaluation, our Chief Executive Officer and our Chief Financial
Officer concluded that, as of the end of the period covered by this report, our
disclosure controls and procedures were effective to ensure that information
required to be disclosed in the reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time periods
specified in the United States Securities and Exchange Commission rules and
forms.
During
the period covered by this report, there have been no changes in our internal
control over financial reporting that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting. A controls system, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls are met,
and no evaluation of controls can provide absolute assurance that all controls
and instances of fraud, if any, within a company have been
detected.
PART II -
OTHER INFORMATION
ITEM 1. Legal
Proceedings
None
ITEM 1A. Risk
Factors
As a
smaller reporting company, Adamis is not required under the rules of the
Securities and Exchange Commission, or SEC, to provide information under this
Item. Risks and uncertainties relating to the amount of cash and cash
equivalents at June 30, 2009 are discussed above under the heading, “Liquidity
and Capital Resources” in the Management’s Discussion and Analysis of Financial
Condition and Results of Operations” section of this Form 10-Q, and are
incorporated herein by this reference. Other material risks and
uncertainties associated with Adamis’ business have been previously disclosed in
our most recent annual report on Form 10-K, and Form S-4 Registration
Statement filed February 12, 2009 with the Securities and Exchange Commission,
included under the heading “Risk Factors,” and those disclosures are
incorporated herein by reference.
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
None
ITEM
3. Defaults Upon Senior Securities
None
ITEM 4. Submission of
Matters to a Vote of Security Holders
None
ITEM 5. Other
Information
None
21
ITEM
6. Exhibits
a)
|
Exhibits
|
10.1
|
2009
Equity Incentive Plan
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
22
SIGNATURES
Pursuant
to the requirements 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.
CELLEGY
PHARMACEUTICALS, INC.
|
|||
Date: August 19,
2009
|
/s/ Dennis J. Carlo
|
||
Dennis
J. Carlo
|
|||
Chief
Executive Officer
|
|||
Date: August
19, 2009
|
/s/ Robert O. Hopkins
|
||
Robert
O. Hopkins
|
|||
Vice
President, Finance and Chief Financial
Officer
|
23