DMK PHARMACEUTICALS Corp - Quarter Report: 2009 September (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 September 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 92014
(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 o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate website, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulations S-T during the
preceding 12 months (or such shorter period that the registrant was required to
submit and post such files).
Yes o No o
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 o Accelerated
filer o Non-accelerated
filer o 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 o No x
There were 45,469,155 shares of common stock outstanding at November
20, 2009.
ADAMIS
PHARMACEUTICALS, INC.
CONTENTS
OF QUARTERLY REPORT ON FORM 10-Q
Page
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PART
I
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FINANCIAL
INFORMATION
|
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Item
1.
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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
|
|
12
|
||
19
|
||
19
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||
20
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||
20
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||
20
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||
20
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20
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20
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||
20
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||
21
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2
September
30,
|
||||||||
|
2009
|
March
31, 2009
|
||||||
(Unaudited)
|
||||||||
ASSETS | ||||||||
CURRENT
ASSETS
|
||||||||
Cash
|
$ | 14,655 | $ | 17,697 | ||||
Accounts
Receivable, Net
|
159,011 | 136,283 | ||||||
Inventory,
Net
|
228,281 | 195,167 | ||||||
Prepaid
Expenses and Other Current Assets
|
16,612 | 4,087 | ||||||
Related
Party Receivables
|
76,732 | — | ||||||
Assets
from Discontinued Operations
|
350,000 | 350,000 | ||||||
Total
Current Assets
|
845,291 | 703,234 | ||||||
PROPERTY
AND EQUIPMENT, Net
|
27,419 | 31,726 | ||||||
DEFERRED
ACQUISITION COSTS
|
— | 147,747 | ||||||
Total
Assets
|
$ | 872,710 | $ | 882,707 | ||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
Payable
|
$ | 1,628,302 | $ | 972,522 | ||||
Accrued
Expenses
|
1,522,859 | 723,896 | ||||||
Notes
Payable to Related Parties
|
334,565 | 599,765 | ||||||
Total
Current Liabilities
|
3,485,726 | 2,296,183 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
STOCKHOLDERS'
DEFICIT
|
||||||||
Preferred
Stock – Par Value $.0001; 20,000,000 Shares Authorized; Issued
and Outstanding-None
|
— | — | ||||||
Common
Stock – Par Value $.0001; 100,000,000 Shares
Authorized; 47,073,989 and 37,306,704 Issued, 45,972,303
and
36,990,704 Outstanding,
Respectively
|
4,708 | 3,731 | ||||||
Additional
Paid-in Capital
|
10,792,097 | 10,762,963 | ||||||
Accumulated
Deficit
|
(13,408,719 | ) | (12,179,854 | ) | ||||
Treasury
Stock at Cost - 1,101,686 and 316,000 Shares, Respectively
|
(1,102 | ) | (316 | ) | ||||
Total
Stockholders’ Deficit
|
(2,613,016 | ) | (1,413,476 | ) | ||||
$ | 872,710 | $ | 882,707 |
The
Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
3
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
|
||||||||||||||||||||
Three Months Ended |
Six
Months Ended
|
|||||||||||||||
September
30, 2009
|
September
30, 2008
|
September
30, 2009
|
September
30, 2008
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||||||
REVENUE
|
$ | 125,870 | $ | 202,339 | $ | 232,340 | $ | 311,481 | ||||||||
COST
OF GOODS SOLD
|
19,496 | 137,759 | 67,574 | 181,448 | ||||||||||||
Gross
Margin
|
106,374 | 64,580 | 164,766 | 130,033 | ||||||||||||
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES
|
552,658 | 1,333,786 | 1,282,585 | 2,335,760 | ||||||||||||
RESEARCH
AND DEVELOPMENT
|
85,548 | 25,195 | 98,563 | 336,138 | ||||||||||||
Loss
from Operations
|
(531,832 | ) | (1,294,401 | ) | (1,216,382 | ) | (2,541,865 | ) | ||||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||||||
Interest
Expense
|
(8,250 | ) | (194,631 | ) | (12,483 | ) | (391,706 | ) | ||||||||
Gain
on Sale of Asset
|
— | — | — | 1,329 | ||||||||||||
Total
Other Income (Expense)
|
(8,250 | ) | (194,631 | ) | (12,483 | ) | (390,377 | ) | ||||||||
Loss
from Continuing Operations
|
(540,082 | ) | (1,489,032 | ) | (1,228,865 | ) | (2,932,242 | ) | ||||||||
Income
from Discontinued Operations
|
— | 6,031,550 | — | 3,900,839 | ||||||||||||
Net
Income (Loss)
|
$ | (540,082 | ) | $ | 4,542,518 | $ | (1,228,865 | ) | $ | 968,597 | ||||||
Basic
and Diluted Income (Loss) Per Share:
|
||||||||||||||||
Continuing
Operations
|
$ | (0.02 | ) | $ | (0.06 | ) | $ | (0.04 | ) | $ | (0.12 | ) | ||||
Discontinued
Operations
|
— | 0.24 | — | 0.16 | ||||||||||||
Basic
and Diluted Income (Loss) Per Share
|
$ | (0.02 | ) | $ | 0.18 | $ | (0.04 | ) | $ | 0.04 | ||||||
Basic
and Diluted Weighted Average Shares Outstanding
|
29,249,925 | 24,697,594 | 28,529,015 | 24,438,410 |
The
Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
4
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
|
3 |
Six
Months Ended
|
||||||||
September
30, 2009
|
September
30, 2008
|
|||||||
|
(Unaudited)
|
(Unaudited)
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
(Loss) from Continuing Operations
|
$ | (1,228,865 | ) | $ | (2,932,242 | ) | ||
Adjustments
to Reconcile Net (Loss) from Continuing Operations to Net
|
||||||||
Cash
(Used in) Operating Activities:
|
||||||||
Depreciation
Expense
|
9,195 | 9,349 | ||||||
Consulting
Expense Paid in Common Stock
|
9,000 | — | ||||||
Gain
on Sale of Asset
|
— | (1,329 | ) | |||||
Inventory
Reserve Adjustment
|
1,733 | (22,366 | ) | |||||
Loan
Discount Accretion
|
— | 328,000 | ||||||
Beneficial
Conversion Feature Interest
|
— | (80,000 | ) | |||||
Sales
Returns Reserve Adjustment
|
1,480 | (10,681 | ) | |||||
Stock—Based
Compensation Expense
|
24,702 | — | ||||||
Change
in Assets and Liabilities:
|
||||||||
(Increase)
Decrease in:
|
||||||||
Accounts
Receivable
|
(22,728 | ) | (84,496 | ) | ||||
Inventory
|
(34,847 | ) | (90,432 | ) | ||||
Prepaid
Expenses and Other Current Assets
|
13,838 | (199,970 | ) | |||||
Increase
(Decrease) in:
|
||||||||
Accounts
Payable
|
428,656 | (281,252 | ) | |||||
Accrued
Expenses
|
577,286 | 157,927 | ||||||
Net
Cash (Used in) Operating Activities from Continuing
Operations
|
(220,550 | ) | (3,207,492 | ) | ||||
Net
Cash (Used in) Operating Activities from Discontinued
Operations
|
— | (662,603 | ) | |||||
Net
Cash (Used in) Operating Activities
|
(220,550 | ) | (3,870,095 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Cash
Acquired in Cellegy Pharmaceuticals, Inc. Acquisition
|
65,114 | — | ||||||
Loans
to Related Parties
|
(76,732 | ) | — | |||||
Purchase
of Property and Equipment
|
(4,888 | ) | ||||||
Cash
Received from Sale of International Laboratories, Inc.
|
— | 2,154,000 | ||||||
International
Laboratories, Inc. Obligation Repayments
|
— | 4,322,082 | ||||||
Sale
of Property and Equipment
|
— | 5,001 | ||||||
Net
Cash (Used in) Provided by Investing Activities from Continuing
Operations
|
(16,506 | ) | 6,481,083 | |||||
Net
Cash (Used in) Investing Activities from Discontinued
Operations
|
— | (862,122 | ) | |||||
Net
Cash Provided by (Used in) Investing Activities
|
(16,506 | ) | 5,618,961 | |||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Payments
of Notes Payable to Related Parties
|
— | (1,752,000 | ) | |||||
Proceeds
from Issuance of Notes Payable to Related Parties
|
234,800 | — | ||||||
Proceeds
from Issuance of Common Stock
|
— | 878,740 | ||||||
Purchase
of Treasury Stock
|
(786 | ) | (316 | ) | ||||
Payments
of Loans
|
— | (2,000,000 | ) | |||||
Net
Cash Provided by (Used in) Financing Activities from Continuing
Operations
|
234,014 | (2,873,576 | ) | |||||
Net
Cash Provided by Financing Activities from Discontinued
Operations
|
— | 1,829,746 | ||||||
Net
Cash (Used in) Provided by Financing Activities
|
234,014 | (1,043,830 | ) | |||||
(Decrease)
Increase in Cash
|
(3,042 | ) | 705,036 | |||||
Cash:
|
||||||||
Beginning
|
17,697 | 541 | ||||||
Ending
|
$ | 14,655 | $ | 705,577 |
The Accompanying Notes are an Integral Part of
These Unaudited Condensed Consolidated Financial Statements
5
4 |
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH
FLOWS
|
Six
Months Ended
|
||||||||
September
30, 2009
|
September
30, 2008
|
|||||||
(Unaudited)
|
(Unaudited)
|
|||||||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION
|
||||||||
Cash
Paid for Interest
|
$ | — | $ | 208,470 | ||||
SUPPLEMENTAL
DISCLOSURE OF NON-CASH FINANCING AND
|
||||||||
INVESTING
ACTIVITIES
|
||||||||
Forgiveness
of Debt to International Laboratories, Inc.
|
$ | — | $ | 570,618 | ||||
Forgiveness
of Debt and Accrued Interest to Cellegy Pharmaceuticals,
Inc.
|
$ | 556,610 | $ | — | ||||
Reduction
of Capital from Unexcercised Beneficial Conversion Feature
|
$ | — | $ | 80,000 | ||||
Release
of Shares of Common Stock From Escrow
|
$ | 673 | $ | — |
The
Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
6
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 (consists of
normal recurring adjustments) 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 $14,655 and $17,697 at September 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 market existing products and conduct the clinical and regulatory
work to develop the Company’s product candidates. Management’s plans include
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 a 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 by 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
definitive merger agreement relating to the transaction (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.
Pursuant
to the terms of the Merger Agreement, immediately before the consummation of the
merger Cellegy effected 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 were 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
7
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 44,038,989 post-Reverse Split shares of common
stock, inclusive of 6,732,285 contingent shares held in escrow, were
issuable 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. 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: Common Stock
The Company released the
remaining 6,732,285 re-purchasable holdback shares related to the HVG
Acquisition from escrow during the quarter ended September 30, 2009. The
Company’s rights of repurchase related to such shares have not expired, are
subject to certain restrictions and are still treated as contingent
consideration related to the HVG Acquisition. As a result, no purchase price
adjustment was recorded during the current period, and the shares were recorded
at par value. The shares are considered anti-dilutive during the period due to
the outstanding repurchase options. On August 14, 2009, the Company exercised
its repurchase option and repurchased 785,686 shares of common stock for
treasury at a total cost of $786 in connection with the resignation of the
former Vice President of Operations.
On September 21, 2009, the
Company issued 35,000 shares of its common stock in lieu of payment for
consulting services with a value of $9,000.
Note
4: 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 options to purchase a total of 150,000 shares of common stock to
directors upon the closing of the merger. The stock options have an exercise
price of $0.60 per share, which is equal to the fair market value of the
Company’s common stock on the date of the grant. The stock options vest over a
period of three years
8
from the
date of the grant, and expire on the 10th
anniversary of the grant date of the options. The Company estimated that the
stock options have a fair market value of $0.30 per stock 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%.
During
the period, the directors resigned from their duties. Each director had 26,388
vested stock options for a total of 79,164. The remaining 73,806 stock options
granted were cancelled during the period. The total fair market value of only
the vested stock options was recorded during the period.
In August
2009, the Company hired an officer, who was granted a stock option by the
Company to purchase up to 250,000 shares of common stock. The stock options have
an exercise price of $0.22 per share, which is equal to the fair market value of
the Company’s common stock on the date of the grant. The stock options vest over
a period of three years from the date of the grant, and expire on the 10th
anniversary of the grant date of the option. The Company estimated that the
stock option has a fair market value of $0.11 per share using the Black-Scholes
valuation model. Management’s assumptions included in the model were volatility
of 35.4%, a risk-free interest rate of 3.4% 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 $1,668 and $24,702 related
to such stock options for the three and six months ended September 30, 2009,
respectively.
In August
2009, the Company issued warrants to purchase up to 600,000 shares of common
stock to consultants retained to assist the Company in fund-raising efforts. The
warrants have an exercise price of $0.25 per share, which is equal to the fair
market value of the Company’s common stock at the date of grant. The options
have a five year term and expire on August 26, 2014.
The
following summarizes outstanding stock options at September 30,
2009:
|
Number of
Stock
Options
|
Weighted
Average
Remaining
Contractual Life
|
Weighted
Average
Exercise
Price
|
Number of
Stock
Options
Vested
|
|||||||||
1995
Equity Incentive Plan
|
20,641
|
4.68 Years
|
$
|
31.83
|
20,641
|
||||||||
2005
Equity Incentive Plan
|
4,834
|
6.00 Years
|
$
|
13.30
|
4,834
|
||||||||
Directors’
Stock Option Plan
|
7,654
|
3.91
Years
|
$
|
43.49
|
7,654
|
||||||||
Non-Plan
Stock Options
|
100,714
|
4.10
Years
|
$
|
43.82
|
100,714
|
||||||||
Biosyn
Stock Options
|
431
|
4.31
Years
|
$
|
2.90
|
431
|
||||||||
2009
Equity Incentive Plan
|
329,164
|
7.51
Years
|
$
|
0.38
|
79,164
|
The
Company has reserved shares of common stock for issuance upon exercise at
September 30, 2009 as follows:
Biosyn
Stock Options
|
431
|
|||
Director’s
Plan
|
7,654
|
|||
Warrants
|
1,752,139
|
|||
Non-Plan
Stock Options
|
100,714
|
|||
1995
Equity Incentive Plan
|
20,641
|
|||
2005
Equity Incentive Plan
|
4,838
|
|||
2009
Equity Incentive Plan
|
7,000,000
|
|||
Total
Shares Reserved
|
8,886,414
|
9
The
following summarizes warrants outstanding at September 30, 2009:
|
Warrant Shares
|
Exercise Price Per
Share
|
Date Issued
|
Expiration
Date
|
|||||||
Biosyn
Warrants
|
8,254
|
$
|
57.97
- $173.92
|
October
22, 2004
|
2013
- 2014
|
||||||
May
2005 PIPE
|
|||||||||||
Series
A
|
71,947
|
$
|
1.99
|
May
13, 2005
|
May
13, 2010
|
||||||
Series
B
|
71,947
|
$
|
2.15
|
May
13, 2005
|
May
13, 2010
|
||||||
Old
Adamis Warrants
|
1,000,000
|
$
|
0.50
|
November 15, 2007
|
November
15, 2012
|
||||||
Consultant
Warants
|
600,000
|
$
|
0.25
|
August
26, 2009
|
August
26, 2014
|
||||||
Total
Warrants
|
1,752,139
|
Note
5: Inventory
Inventory
consists of the following:
|
September 30,
2009
|
March
31, 2009
|
||||||
Respiratory
and Allergy Products
|
$
|
291,450
|
$
|
52,843
|
||||
Less:
Obsolescence Reserve
|
(63,169
|
)
|
(37,175
|
)
|
||||
Respiratory
and Allergy Products, Net
|
228,281
|
15,668
|
||||||
Pre-Launch
epi Inventory
|
—
|
179,499
|
||||||
Inventory,
Net
|
$
|
228,281
|
$
|
195,167
|
The
Company launched the epinephrine syringe product in the second fiscal quarter of
2010.
Note
6: Notes Payable
Ben
Franklin Note
Biosyn (a
wholly owned subsidiary of Old 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 Old Cellegy as an obligation 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 or other
event of default, 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 September 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 $334,565 at September
30, 2009, which bear interest at 10%. Accrued interest related to the notes was
$14,877 at September 30, 2009.
On
various dates during the three and six months ended September 30, 2009 and
included in the amount above, the Company issued promissory notes to
shareholders for a total of $47,500 and $234,800, respectively, that bear
interest at 10% with all principal and interest due on various maturity
dates during May – June 2010.
Note
7: Subsequent Events
We
evaluated all events or transactions that occurred after September 30, 2009
up through November 23, 2009, the date we filed this quarterly
report.
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 with the Securities and Exchange Commission on May 13, 2009, 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, 44,038,989 post-reverse split shares of
common stock were issuable to the holders of the outstanding shares of common
stock of Old Adamis before the effective time of the merger. As a result, 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, assuming sufficient funding to support commercial sales efforts, 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
after the company receives sufficient funding. Currently, neither
manufacturing nor clinical trials have begun for that product
candidate. Adamis estimates that approximately $6-9 million will be
invested to support the development and commercial introduction of the inhaled
nasal steroid product candidate and its two other respiratory
products. 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.
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
13
preclinical
stage, and it has not generated any revenues to date. From June 6, 2006 (date of
inception) through September 30, 2009, Adamis has spent a total of approximately
$413,000 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, 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. Generally Accepted Accounting Principles (“GAAP”)
for registration payment arrangements specifies that the contingent obligation
to make future payments under a registration payment arrangement should be
separately recognized and measured.
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.
Long
Lived Assets. Adamis periodically assesses whether there has been
permanent impairment of its long-lived assets held and used in accordance with
GAAP, which requires Adamis to review long-lived assets for
15
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. Research and development costs are expensed as
incurred. Non-refundable advance payments for goods and services to be used in
future research and development activities are 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.
Net
Loss per Share. 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.
Income
Taxes. GAAP 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.
The
Company is subject to income taxes in the U.S. federal jurisdiction and various
state jurisdictions. Tax regulations within each jurisdiction are subject to the
interpretation of the related tax laws and regulations and require significant
judgment to apply. The Company is subject to U.S. federal, state and local tax
examinations by tax authorities for all previous tax years. If the Company were
to subsequently record an unrecognized tax benefit, associated penalties and tax
related interest expense would be reported as a component of income tax
expense.
Discontinued
Operations. The results of operations for the year ended March 31,
2009, and the six month period ended September 30, 2009 and the assets
and liabilities at March 31, 2009 and September 30, 2009 related to
International Laboratories, Inc. (“INL”), a formerly wholly owned subsidiary of
Adamis, have been accounted for as discontinued. There were no operations
or related assets and liabilities of INL in the accompanying consolidated
financial statements of prior periods.
Results
of Operations
Six
Months Ended September 30, 2009 and 2008
Revenues
and Cost of Sales. Adamis had revenues of approximately $232,000 and
$311,000 for the six months ending September 30, 2009 and 2008. The
approximately $79,000 reduction in revenues for the first six months of fiscal
2010 compared to the comparable period of last year was primarily the result of
reduced sales of Aerohist, Prelone and Aero Otic, partially offset by sales of
the Pre-filled Epi Syringe product, which commenced in July
2009. Cost of sales for the six months ending September 30, 2009 and
2008 were approximately $68,000 and $181,000. The difference of
approximately $113,000 was due to an adjustment of inventory reserves with the
introduction of the Epi Syringe.
Research
and Development Expense. Adamis incurred research and development
expenses of approximately $336,000 for the six months ended September 30, 2008
and approximately $99,000 in the six month period ended September 30,
2009. The reduction of research and development for the two
comparative periods was caused by the completion of the prefilled EPI syringe
product and a reduction in research and development activities in light of
limited available funds.
16
Selling,
General and Administrative Expenses. Selling, general and administrative
expenses for the six months ending September 30, 2009 and 2008 were
approximately $1,283,000 and $2,336,000, respectively. Selling,
general and administrative expenses consist primarily of legal fees, accounting
and audit fees, professional fees and employee salaries. The
reduction in comparative six month period expense levels is primarily a result
of reduced salary levels, which the Company believes is temporary, offset
somewhat by increased professional fees and other related
expenses.
Other
Income (Expenses). Interest and other income (expense) for the six
month period ending September 30, 2009 and 2008 was approximately $(12,000) and
$(390,000), respectively. Interest and other income consists
primarily of interest expense paid in connection with various notes payable. The
increase in interest expense for the six month period ended September 30, 2008
in comparison to the same period for 2009 is due to interest from three debt
instruments that were retired in 2009.
Three
Months Ended September 30, 2009 and 2008
Revenues
and Cost of Sales. Adamis had revenues of approximately $126,000 and
$202,000, for the three months ending September 30, 2009 and
2008. The difference of $76,000 resulted from reduced sales of
Aerohist, Aero Kid and Prelone, partially offset by sales of the Pre-filled Epi
Syringe. Cost of sales for the three months ending September 30, 2009
and 2008 were approximately $19,000 and $138,000. The difference of
$119,000 was due to an adjustment of the inventory reserves with the
introduction of the Epi Syringe.
Research
and Development Expense. Adamis incurred research and development
expenses of approximately $25,000 for the three months ended September 30, 2008
and approximately $86,000 in the three month period ended September 30,
2009. The increase in research and development expenses in the second
quarter of fiscal 2010 compared to the comparable period of the prior year was
caused by the Company considering a joint venture in the development of the Epi
syringe during the second quarter of fiscal 2009. Once the Company
determined not to pursue the joint venture, higher development expenditures
resulted in the third quarter of fiscal 2010.
Selling,
General and Administrative Expenses. Selling, general and administrative
expenses for the three months ending September 30, 2009 and 2008 were
approximately $553,000 and $1,334,000, respectively. Selling, general
and administrative expenses consist primarily of legal fees, accounting and
audit fees, professional fees and employee salaries. The reduction in
expense levels for the second quarter of fiscal 2010 from the comparable period
of last year is primarily a result of reduced salary levels, which the Company
believes is temporary, offset somewhat by increased professional fees and other
related expenses.
Other
Income (Expenses). Interest and other income (expense) for the
three month period ending September 30, 2009 and 2008 were approximately
$(8,000) and $(195,000), respectively. Interest and other income
consist primarily of interest expense paid in connection with various notes
payable. The increase in interest expense for quarter ended September
30, 2008 in comparison of same period for 2009 is due to interest from three
debt instruments that were retired in 2009.
Liquidity
and Capital Resources
Adamis’ cash was
approximately $15,000 and $706,000 as of September 30, 2009 and
September 30, 2008, respectively. The decrease in cash was primarily the
result of selling, general and administrative expenses and merger costs.
Net cash
used in operating activities from continuing operations for the six months ended
September 30, 2009 and 2008 were approximately $221,000 and $3,207,000,
respectively. Adamis expects net cash used in operating activities to increase
going forward as it engages in additional product research and development
activities, pursues additional expansion of its sales base and other business
activities, assuming that it is able to obtain sufficient
funding. The increase in accrued expenses of approximately
$577,000 and the increase in accounts payable of $429,000 was created by an
increase in legal, accounting, accrued compensation and consulting expenses due
to becoming a publicly traded company and reduction of cash
reserves.
17
Net cash
provided by (used in) investing activities from continuing operations was
approximately $(17,000) and $6,481,000 for the six months ended September 30,
2009 and 2008. Results for the quarter ended September 30, 2008, were
affected by proceeds received from the sale of INL’s contract packaging
operations which were sold in July 2008.
Net cash
provided by financing activities from continuing operations was approximately
$234,000 for the six months ended September 30, 2009 and
net cash used in financing activities was approximately $2,874,000 for the six
months ended September 30, 2008. The differences between the two
periods were primarily due to the repayment of loans and related party notes
from the proceeds of the sale of INL. Net cash provided by
financing activities of discontinued operations was $0 and $1,829,000 for the
six months ended September 30, 2009 and 2008, respectively. The
increase between the two six month periods was due to proceeds from the issuance
of stock.
At
September 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; unexpected
issues with the FDA or other federal or state regulatory authorities;
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 market
existing products and conduct the clinical and regulatory work to develop the
Company’s product candidates. Management’s plans include 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 the Company’s
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; | |
●
|
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;
|
18
●
|
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 September
30, 2009, Adamis did not have any off balance sheet arrangements.
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 September 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 filed with the Securities and
Exchange Commission, included under the heading “Risk Factors,” and those
disclosures are incorporated herein by reference.
In August
2009, the Company issued warrants to purchase up to 600,000 shares of common
stock to two organizations for financial consulting and advisory
services. The warrants have a term of five years and an exercise
price of $.25 per share.
All of the above issuances were made
without any public solicitation, to a limited number of employees, consultants
and shareholders and were acquired for investment purposes only. The
securities were issued in reliance on the private placement exemption provided
by Section 4(2) of the Securities Act of 1933.
During
the quarter ended September 30, 2009, the Company repurchased 316,000 and 785,
686 shares from a former executive and a consultant, pursuant to rights of
repurchase in favor of the Company. The shares were repurchased at
$.001 cents per share. The repurchase was not part of any
program.
ITEM
3. Defaults Upon Senior Securities
|
None
|
ITEM 4.
Submission of Matters to a Vote of Security
Holders
|
None
|
ITEM
5. Other Information
|
None
|
ITEM
6. Exhibits
a)
|
Exhibits
|
|
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
|
20
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:
|
November
23, 2009
|
/s/
Dennis J. Carlo
|
|||
Dennis
J. Carlo
|
|||||
Chief
Executive Officer
|
|||||
Date:
|
November 23, 2009
|
/s/
Robert O. Hopkins
|
|||
Robert
O. Hopkins
|
|||||
Vice
President, Finance and Chief Financial
Officer
|
21