DMK PHARMACEUTICALS Corp - Quarter Report: 2008 June (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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For
the quarterly period ended June 30, 2008
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OR
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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For
the transition period from
to
Commission
File Number: 0-26372
CELLEGY
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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82-0429727
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(State
or other jurisdiction of
incorporation
or organization)
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(I.R.S.
Employer
Identification
Number)
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128
Grandview Road, Boyertown, PA 19512
(Address
of principal executive offices, including zip code)
215-529-6084
(Registrant’s
telephone number, including area code)
2085
Quaker Point Drive, Quakertown , Pa 18951
(Former
address of principal executive offices, including zip 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 ý 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 ¨
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 o No ý
The
number of shares outstanding of the registrant’s common stock at June 30, 2008
was 29,834,796.
CELLEGY
PHARMACEUTICALS, INC.
CONTENTS
OF QUARTERLY REPORT ON FORM 10-Q
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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:
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Condensed
Consolidated Balance Sheets
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3
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Condensed
Consolidated Statements of Operations
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4
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Condensed
Consolidated Statements of Cash Flows
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5
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Notes
to Condensed Consolidated Financial Statements
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6
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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12
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Item
3.
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Quantitative
and Qualitative Disclosure of Market Risk
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16
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Item
4.
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Controls
and Procedures
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16
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PART
II
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OTHER
INFORMATION
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Item
1.
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Legal
Proceedings
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17
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Item
1A.
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Risk
Factors
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17
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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22
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Item
3.
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Defaults
Upon Senior Securities
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22
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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22
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Item
5.
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Other
Information
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23
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Item
6.
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Exhibits
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23
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Signatures
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24
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2
PART
I - FINANCIAL INFORMATION
Financial
Statements
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Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands)
(Unaudited)
June
30, 2008
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December
31, 2007
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Assets
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|||||||
Current
assets:
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|||||||
Cash
and cash equivalents
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$
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635
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$
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1,827
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|||
Prepaid
expenses and other current assets
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61
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267
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|||||
Total
current assets
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696
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2,094
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|||||
Note
receivable
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500
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-
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|||||
Interest
receivable
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19
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-
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|||||
Total
assets
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$
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1,215
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$
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2,094
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Liabilities
and Stockholders' Equity
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|||||||
Current
liabilities:
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|||||||
Accounts
payable
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$
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23
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$
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-
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|||
Accrued
expenses and other current liabilities
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239
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396
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|||||
Total
current liabilities
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262
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396
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Note
payable
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636
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507
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|||||
Derivative
instruments
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1
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1
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Total
liabilities
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899
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904
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Stockholders'
equity:
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Common
stock
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3
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3
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Additional
paid-in capital
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125,767
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125,753
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Accumulated
deficit
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(125,454
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)
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(124,566
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)
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Total
stockholders' equity
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316
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1,190
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Total
liabilities and stockholders' equity
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$
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1,215
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$
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2,094
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The
accompanying notes are an integral part of these condensed consolidated
financial statements.
3
Cellegy
Pharmaceuticals, Inc
(Amounts
in thousands, except per share data)
(Unaudited)
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Three
Months Ended
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Six
Months Ended
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June
30,
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June
30,
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||||||||
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2008
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2007
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2008
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2007
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|||||
Costs
and expenses:
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|||||||||||||
Research
and development
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$
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-
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$
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15
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$
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3
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$
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21
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|||||
Selling,
general and administrative
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335
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426
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798
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942
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|||||||||
Total
costs and expenses
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335
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441
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801
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963
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Operating
loss
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(335
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)
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(441
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)
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(801
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)
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(963
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)
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Other
income (expenses):
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Interest
and other income
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14
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23
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42
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56
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Interest
and other expense
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(68
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)
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(51
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)
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(129
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)
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(94
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)
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Derivative
revaluation
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-
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3
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-
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(3
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)
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Total
other income (expenses)
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(54
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)
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(25
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)
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(87
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)
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(41
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)
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Net
loss
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$
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(389
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)
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$
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(466
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)
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$
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(888
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)
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$
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(1,004
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)
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Basic
and diluted loss per common share:
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$
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(0.01
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)
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$
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(0.02
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)
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$
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(0.03
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)
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$
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(0.03
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)
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Weighted
average number of common shares
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used
in per share calculations:
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Basic
and diluted
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29,835
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29,835
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29,835
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29,835
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The
accompanying notes are an integral part of these condensed consolidated
financial statements.
4
Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands)
(Unaudited)
Six
Months Ended June 30,
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2008
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2007
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|||||
Operating
activities
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Net
loss
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$
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(888
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)
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$
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(1,004
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)
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Adjustments
to reconcile net loss from continuing
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operations
to net cash used in operating activities:
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Equity
compensation expense
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14 |
24
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Derivative
revaluation
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-
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3
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Interest
accretion on note payable
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129
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82
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Forgiveness
of debt
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- | (5 |
)
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Changes
in operating and Liabilities:
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Prepaid
expenses and other current assets
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206
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169
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Accounts receivable
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-
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58
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Interest
on long term note receivable
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(19
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) | - | ||||
Accounts
payable
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23
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(162
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) | ||||
Accrued
expenses and other current liabilities
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(157
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)
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(408
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)
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Net
cash used in operating activities
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(692
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)
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(1,243
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)
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Investing
activity:
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|||||||
Issuance
or long term note receivable
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(500 |
)
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- | ||||
Net
cash used in investing activity
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(500 |
)
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- | ||||
Financing
activity:
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|||||||
Repayment
of note payable
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-
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(40
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) | ||||
Net
cash used in financing activity
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-
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(40
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)
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Net
decrease in cash and cash equivalents
|
(1,192
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)
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(1,283
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)
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Cash
and cash equivalents, beginning of period
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1,827
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3,804
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|||
Cash
and cash equivalents, end of period
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$
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635 |
$
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2,521 |
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
5
Cellegy
Pharmaceuticals, Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note
1:
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Basis
of Presentation
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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 Article
10 of Regulation S-X promulgated by the Securities and Exchange
Commission. 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 Cellegy
Pharmaceuticals, Inc. (“Cellegy” or “the Company”) 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
Cellegy’s Annual Report on Form 10-K for the year ended December 31,
2007.
Liquidity
and Capital Resources
Cellegy’s
operations currently relate primarily to
the management of intellectual property rights of its Biosyn subsidiary and
the
administration of the clinical and regulatory affairs of its Savvy Phase 3
contraception trial. While the Savvy Phase 3 contraception trial in the United
States is ongoing, Cellegy is not directly involved with the conduct and funding
thereof and, due to the cessation of the HIV Phase 3 trials in 2005 and 2006,
it
is uncertain whether Savvy will be commercialized or whether Cellegy will ever
realize revenues there from. We therefore expect negative cash flows to continue
for the foreseeable future. Cellegy believes that it presently has enough
financial resources to continue operations as they currently exist until
approximately September 30, 2008, absent unforeseen significant additional
expenses; however, it does not have the technological nor the financial assets
necessary to fund the expenditures that would be required to conduct the future
clinical and regulatory work necessary to commercialize Savvy or other product
candidates without additional funding.
On
February 12, 2008, Cellegy entered into a definitive merger agreement (the
“Merger Agreement”) providing for the acquisition of Cellegy by Adamis
Pharmaceuticals Corporation (“Adamis”). Adamis is a privately held specialty
pharmaceuticals company that is engaged in the research, development and
commercialization of products for the prevention of viral infections, including
influenza. Adamis
currently markets and sells a line of prescription product for a variety of
allergy, respiratory disease and pediatric conditions and has other devices
and
drug candidates in its product pipeline. Adamis previously owned an independent
contract packager of pharmaceutical and nutraceutical products. Adamis completed
the sale of that business in July, 2008. The merger transaction was
unanimously approved by the boards of directors of both companies and is
anticipated to close during 2008, subject to the filing of a registration
statement and proxy statement with the Securities and Exchange Commission
(“SEC”), the approval of Adamis’ and Cellegy’s respective stockholders at
stockholder meetings following distribution of a definitive proxy statement,
and
other customary closing conditions. Holders of approximately 40% of Cellegy’s
outstanding common stock have entered into voting agreements pursuant to which
they agreed to vote their shares in favor of the transaction. The combined
company expects to continue to be publicly traded after completion of the
merger, although under a different corporate name.
If
the
merger is consummated, each Adamis stockholder will receive, in exchange for
each share of Adamis common stock held by such stockholder immediately before
the closing, one share of Cellegy common stock (post-reverse stock split and
excluding in all cases dissenting shares). If the transaction is approved by
Cellegy’s stockholders, before the closing Cellegy will implement a reverse
stock split of its common stock so that the outstanding Cellegy shares will
be
converted into a number of shares equal to the sum of (i) 3,000,000 plus (ii)
the amount of Cellegy’s net working capital as of the end of the month
immediately preceding the month in which the closing occurs divided by .50.
Based on several assumptions that are subject to change, including, without
limitation, the number of shares of Cellegy common stock outstanding immediately
before the merger and the amount of Cellegy’s current assets and liabilities as
of the end of the month immediately prior to the closing, Cellegy estimates
that
the reverse stock split will be approximately 10 to 1. The actual amounts and
percentages will depend on many factors, and actual amounts and percentages
could be higher or lower.
In
addition, the Merger Agreement contains certain termination rights for both
Cellegy and Adamis, and further provides that, upon termination of the merger
agreement under specified circumstances, either party may be required to pay
the
other party a termination fee of $150,000. Both parties have the right to
terminate the Merger Agreement if the merger is not consummated by (i) August
31, 2008, if the SEC does not review the registration statement and (ii)
September 30, 2008, if the SEC does review the registration statement, so long
as the terminating party is not in breach of the Merger Agreement and such
breach is a principal failure of the merger to occur by such date. Cellegy
and Adamis are engaged in discussions concerning extensions of those
dates.
6
In
connection with the signing of the Merger Agreement, Cellegy also issued to
Adamis an unsecured convertible promissory note (the “Promissory Note”) pursuant
to which Cellegy agreed to lend Adamis $500,000 to provide additional funds
to
Adamis during the pendency of the merger transaction. Any principal outstanding
under the Promissory Note accrues interest at 10% per annum. The Promissory
Note
becomes immediately due and payable in the event that the Merger Agreement
is
terminated by Adamis or Cellegy for certain specified reasons or on the later
of
(i) the sixteen month anniversary of the issue date of the Promissory Note
or
(ii) the date that is two business days following the first date on which
certain other notes issued by Adamis to a third party have been repaid in full.
If the Promissory Note is outstanding as of the closing of the merger
transaction, the Promissory Note will not be repaid, but will convert into
shares of Adamis stock and these shares will be immediately cancelled. Cellegy
will receive no additional shares. The terms of the Promissory Note provide
Cellegy with no collateralized interest in the assets of Adamis. In the event
the merger is not consummated with Adamis, Cellegy bears the risk of collecting
the Promissory Note and therefore is subject to the risks and uncertainties
of
being in the position of an unsecured creditor. While the Company feels that
it
is more likely than not that the merger will be consummated, in the event it
is
not, Cellegy will have no ability to attach a claim to Adamis’
assets.
There
is
no assurance that the Company will be able to close the transaction with Adamis.
If the proposed merger transaction with Adamis is still pending and Cellegy
requires additional cash resources to complete the transaction, Cellegy
and Adamis are engaged in discussions concerning an agreement for Adamis
to provide funding sufficient to permit the merger to be completed,
although there can be no assurance that such funding will be
available.
Should
Cellegy be unable to secure the additional shareholder votes necessary to
approve the transaction with Adamis or otherwise be unable to close the
transaction, the Company may choose to pursue liquidation or voluntarily file
bankruptcy proceedings. If Cellegy files for bankruptcy protection, Cellegy
will
most likely not be able to raise any type of funding from any source. In that
event, the creditors of Cellegy would have first claim on the value of the
assets of Cellegy which, other than remaining cash, would most likely be
liquidated in a bankruptcy sale. Cellegy can give no assurance as to the
magnitude of the net proceeds of such sale and whether such proceeds would
be
sufficient to satisfy Cellegy’s obligations to its creditors, let alone to
permit any distribution to its equity holders. The condensed consolidated
financial statements do not include any adjustments that might result from
the
outcome of this uncertainty. Any failure to dispel any continuing doubts about
our ability to continue as a going concern could negatively affect the market
price of our common stock and could otherwise have a material adverse effect
on
our business, financial condition and results of operations. These factors
raise
substantial doubt about our ability to continue as a going concern.
Note
2:
|
Basis
and Diluted Net Loss per Common
Share
|
Basic
net
loss per common share is computed using the weighted average number of common
shares outstanding during the period. Diluted net loss per common share
incorporates the incremental shares issued upon the assumed exercise of stock
options and warrants, when dilutive. There is no difference between basic and
diluted net loss per common share, as presented in the condensed consolidated
statements of operations, because all options and warrants are anti-dilutive.
The total number of shares that had their impact excluded was (in
thousands):
Three
Months Ended
|
|||||||
June
30,
|
|||||||
2008
|
|
2007
|
|
||||
Options
|
1,333
|
1,363
|
|||||
Warrants
|
2,115
|
2,115
|
|||||
Total
number of shares excluded
|
3,448
|
3,478
|
7
Note
3:
|
Stock-Based
Compensation
|
In
the
condensed consolidated statement of operations in the second quarter of 2008
and
2007, the Company recorded stock based compensation expenses of $2,902 and
$22,971, respectively.
2005
Equity Incentive Plan (“2005 Plan”)
Options
Outstanding
|
|
|
Options
Exercisable
|
|
||||||||||||||||||
Number
of Options
|
|
|
Weighted
Average Remaining Contractual Life
|
|
|
Weighted
Average Exercise Price
|
|
|
Aggregate
Intrinsic Value
|
|
|
Number
of Options
|
|
|
Weighted
Average Remaining Contractual Life
|
|
|
Weighted
Average Exercise Price
|
|
|
Aggregate
Intrinsic Value
|
|
48,000
|
7.49
Years
|
$
|
1.34
|
$
|
-
|
32,000
|
7.49
Years
|
$
|
1.34
|
$
|
-
|
There
were no grants, cancellations or exercises of options under the 2005 Plan during
the quarter ended June 30, 2008. None of the options vested in the quarter
ended
June 30, 2008.
1995
Equity Incentive Plan (“Prior Plan”)
Options
Outstanding and Exercisable
|
|
|||||||||
Number
of Options
|
|
|
Weighted
Average Remaining Contractual Life
|
|
|
Weighted
Average Exercise Price
|
|
|
Aggregate
Intrinsic Value
|
|
204,944
|
5.93
Years
|
$
|
2.66
|
$
|
-
|
There
were no cancellations during the period, or exercises of options under
the Prior Plan during the quarter ended June 30, 2008. 38,958 options vested
under the Prior Plan during quarter ended June 30, 2008. No future options
may
be granted under the Prior Plan.
Directors’
Stock Option Plan (“Director’s Plan”)
Options
Outstanding and Exercisable
|
|
|||||||||
Number
of Options |
|
|
Weighted
Average Remaining Contractual Life
|
|
|
Weighted
Average Exercise Price
|
|
|
Aggregate
Intrinsic Value
|
|
84,000
|
4.75
Years
|
$
|
4.35
|
$
|
-
|
There
were 8,000 options cancelled during the quarter ended June 30, 2008. There
were
no exercises or vesting of options under the Director’s Plan during the period.
No future options may be granted under the Directors’ Plan.
Non-Plan
Options
In
November 2003, the Company granted an initial stock option to Mr. Richard C.
Williams, upon his appointment as Chairman of the Board, to purchase 1,000,000
shares of common stock. 400,000 and 600,000 options have exercise prices of
$2.89 and $5.00 per share, respectively. The options were vested and exercisable
in full on the grant date, although a portion of the option covering up to
600,000 shares initially and declining over time is subject to cancellation
if
they have not been exercised in the event that Mr. Williams voluntarily resigns
as Chairman and as director within certain future time periods. As of June
30,
2008 none of these options have been exercised and none are subject to
cancellation.
8
Biosyn
Options
In
October 2004, in conjunction with its acquisition of Biosyn, Cellegy issued
stock options to certain Biosyn option holders to purchase 236,635 shares of
Cellegy common stock. All options issued were immediately vested and
exercisable.
During
the quarter ended June 30, 2008, there were no exercises under Biosyn options
plan; however, 514 options were cancelled during this period. The following
table summarizes information about stock options outstanding and exercisable
related to Biosyn option grants at June 30, 2008:
Options
Outstanding and Exercisable
|
||||||||||
Number
of Options
|
|
|
Weighted
Average Remaining Contractual Life
|
|
|
Weighted
Average Exercise Price
|
|
|
Aggregate
Intrinsic Value
|
|
4,283
|
5.56
Years
|
$
|
0.29
|
$
|
-
|
Shares
Reserved
As
of
June 30, 2008, the Company has reserved shares of common stock for issuance
upon
exercise as follows:
Biosyn
options
|
4,283
|
|||
Director's
Plan
|
84,000
|
|||
Warrants
|
2,114,593
|
|||
Nonplan
options
|
1,000,000
|
|||
1995
Equity Incentive Plan
|
204,944
|
|||
2005
Equity Incentive Plan
|
1,000,000
|
|||
Total
|
4,407,820
|
Warrants
Warrant
Shares
|
Exercise
Price Per Share
|
Date
Issued
|
Expiration
Date
|
||||||||||
June
2004 PIPE
|
604,000
|
$
|
4.62
|
July
27, 2004
|
July
27, 2009
|
||||||||
Biosyn
warrants
|
81,869
|
5.84
- 17.52
|
October
22, 2004
|
2013
- 2014
|
|||||||||
May
2005 PIPE
|
|||||||||||||
Series
A
|
714,362
|
2.25
|
May
13, 2005
|
May
13, 2010
|
|||||||||
Series
B
|
714,362
|
2.50
|
May
13, 2005
|
May
13, 2010
|
|||||||||
Total
|
2,114,593
|
Note
4:
|
Recent
Accounting Pronouncements
|
SFAS No. 157,
Fair Value Measurements
9
SFAS No. 157, “Fair
Value Measurements”
(“SFAS 157”), has been issued by the Financial Accounting Standards Board
(the “FASB”). This new standard provides guidance for using fair value to
measure assets and liabilities. SFAS 157 applies whenever other standards
require (or permit) assets or liabilities to be measured at fair value but
does
not expand the use of fair value in any new circumstances. Currently, over
40
accounting standards within GAAP require (or permit) entities to measure assets
and liabilities at fair value. The standard clarifies that for items that are
not actively traded, such as certain kinds of derivatives, fair value should
reflect the price in a transaction with a market participant, including an
adjustment for risk, not just the Company’s mark-to-model value. SFAS 157
also requires expanded disclosure of the effect on earnings for items measured
using unobservable data. Under SFAS 157, fair value refers to the price
that would be received to sell an asset or paid to transfer a liability in
an
orderly transaction between market participants in the market in which the
reporting entity transacts. In this standard, FASB clarified the principle
that
fair value should be based on the assumptions market participants would use
when
pricing the asset or liability. In support of this principle, SFAS 157
establishes a fair value hierarchy that prioritizes the information used to
develop those assumptions. The fair value hierarchy gives the highest priority
to quoted prices in active markets and the lowest priority to unobservable
data,
for example, the reporting entity’s own data. Under the standard, fair value
measurements would be separately disclosed by level within the fair value
hierarchy.
The
FASB
agreed to defer the effective date of SFAS 157 for all non-financial assets
and liabilities, except those that are recognized or disclosed at fair value
in
the financial statements on a recurring basis. The FASB again rejected the
proposal of a full one-year deferral of the effective date of SFAS 157.
SFAS 157 was issued in September 2006, and is effective for financial
statements issued for fiscal years beginning after November 15, 2007 and
interim periods within those fiscal years. Accordingly, the Company adopted
this
statement on October 1, 2007 for assets and liabilities not subject to the
deferral and will adopt this statement October 1, 2008, for all other
assets and liabilities. There was no impact upon the Company’s financial
statements resulting from the adoption of this pronouncement.
SFAS No. 141
(Revised 2007), Business Combinations
On
December 4, 2007, the FASB issued SFAS No. 141 (Revised 2007),
“Business
Combinations”
(“SFAS 141R”). Under SFAS 141R, 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 141R will
change the accounting treatment for certain specific items including:
·
|
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 and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired
contingencies;
|
·
|
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 generally be 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 141R
also includes a substantial number of new disclosure requirements.
SFAS 141R 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 is currently assessing the impact of this
statement.
SFAS No. 160,
“Non-controlling Interests in Consolidated Financial Statements — An
Amendment of ARB No. 51”
10
On
December 4, 2007, the FASB issued SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements — An Amendment of ARB
No. 51”
(“SFAS 160”). SFAS 160 establishes new accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the
recognition of a non-controlling interest (minority interest) as equity in
the
consolidated financial statements and separate from the parent’s equity. The
amount of net income attributable to the non-controlling interest will be
included in consolidated net income on the face of the income statement.
SFAS 160 clarifies that changes in a parent’s ownership interest in a
subsidiary that do not result in deconsolidation are equity transactions if
the
parent retains its controlling financial interest. In addition, this statement
requires that a parent recognize a gain or loss in net income when a subsidiary
is deconsolidated. Such gain or loss will be measured using the fair value
of
the non-controlling equity investment on the deconsolidation date. SFAS 160
also includes expanded disclosure requirements regarding the interests of the
parent and its non-controlling interest. SFAS 160 is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after
December 15, 2008. Earlier adoption is prohibited. The Company believes
that this pronouncement will have no effect on its financial
statements.
Note
5:
|
Prepaid
Expenses and Other Current
Assets
|
Prepaid
expenses and other current assets consist of the following (in
thousands):
June
30,
|
|
December
31,
|
|
||||
|
|
2008
|
|
2007
|
|||
Prepaid
insurance
|
$
|
53
|
$
|
134
|
|||
Security
deposits
|
8
|
8
|
|||||
Retention
compensation
|
-
|
120
|
|||||
Other
|
-
|
5
|
|||||
$
|
61
|
$
|
267
|
Note
6:
|
Accrued
Expenses and Other Current
Liabilities
|
The
Company accrues for goods and services received but for which billings have
not
been received. Accrued expenses and other current liabilities consist of the
following (in thousands):
June
30,
|
|
December
31,
|
|
||||
|
|
2008
|
|
2007
|
|||
Accrued
legal fees
|
$
|
18
|
$
|
29
|
|||
Accrued
compensation
|
61
|
30
|
|||||
Accrued
retention
|
102
|
139
|
|||||
Accrued
accounting and consulting fees
|
33
|
125
|
|||||
Insurance
payable
|
11
|
13
|
|||||
Other
|
14
|
60
|
|||||
Total
|
$
|
239
|
$
|
396
|
Accrued
retention of approximately $102,000 represents the unamortized portion of
approximately $139,000 in retention payments offered and accepted by employees
in 2007. The retention payments are to be paid if the employee maintains his
or
her employment with the Company through the retention period indicated in the
individual’s retention agreement. The retention payment was in lieu of all other
severance or similar payments that the Company may have been obligated to make
under any other existing agreement, arrangement or understanding, but would
be
in addition to any accrued salary and vacation earned through the end of the
respective retention period. As of June 30, 2008, the retention periods have
been satisfied.
11
Note
7:
|
Note
Payable
|
Ben
Franklin Note
Biosyn
issued a note to Ben Franklin Technology Center of Southeastern Pennsylvania
(“Ben Franklin Note”) in October 1992, in connection with funding the
development of a compound to prevent the transmission of Acquired
Immunodeficiency Disease (“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% applied to future revenues of Biosyn, if any,
until the principal balance of $777,902 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. There is
no
obligation to repay the amounts in the absence of future Biosyn revenues. The
Company is accreting the discount of $572,902 using the interest rate method
over the discount period of five years, which was estimated in connection with
the note’s valuation at the time of the acquisition. At June 30, 2008, the
outstanding balance of the note is $636,189.
Note
8:
|
Derivative
Instrument
|
The
warrants issued in connection with the May 2005 PIPE financing are revalued
at
the end of each reporting period as long as they remain outstanding. The
estimated fair value of all warrants, using the Black-Scholes valuation model,
recorded as derivative instruments liability at June 30, 2008 and December
31,
2007 was approximately $1,200. Any change in the estimated fair value of the
warrants has been recorded as other income and expense in the condensed
consolidated statement of operations. For the three and six months ended June
30, 2008, the Company recognized no income or expense related to derivative
revaluation. For the three and six months ended June 30, 2007, the Company
recognized income of $2,707 and expense of $3,173, respectively, from derivative
revaluation.
Note
9:
|
Note
Receivable
|
In
connection with the signing of the Merger Agreement with Adamis, Cellegy issued
to Adamis an unsecured convertible promissory note in the amount of $500,000
to
provide additional funds to Adamis during the pendency of the merger
transaction. Principal outstanding under the Promissory Note accrues interest
at
10% per annum. The Promissory Note becomes immediately due and payable in the
event that the Merger Agreement is terminated by Adamis or Cellegy for certain
specified reasons or on the later of (i) the sixteen month anniversary of the
issue date of the Promissory Note or (ii) the date that is two business days
following the first date on which certain other notes issued by Adamis to a
third party have been repaid in full. If the Promissory Note is outstanding
as
of the closing of the merger transaction, the Promissory Note will not be
repaid, but will convert into shares of Adamis stock, and these shares will
be
immediately cancelled. Cellegy will receive no additional shares. Due to the
uncertainty surrounding the timing of closing the merger transaction with
Adamis, if the transaction closes at all, the Company has shown the Promissory
Note and its related interest income accrual as long term.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
The
following discussion of our financial condition and results of operations should
be read in conjunction with the financial statements and notes to those
statements included elsewhere in this Quarterly Report on Form 10-Q and our
most recent audited financial statements included in our Annual Report on
Form 10-K previously filed with the SEC. This discussion may contain
forward-looking statements that involve substantial risks and uncertainties.
These forward-looking statements are not historical facts, but are based on
current expectations, estimates and projections about our industry, our beliefs
and our assumptions. Words such as “believes,” “anticipates,” “expects,”
“intends” and similar expressions are intended to identify forward-looking
statements, but are not the exclusive means of identifying such statements.
These forward-looking statements are not guarantees of future performance and
concern matters that could subsequently differ materially from those described
in the forward-looking statements. Actual events or results may also differ
materially from those discussed in this Quarterly Report on Form 10-Q.
These risks and uncertainties include those described in “Management’s
Discussion and Analysis of Financial Condition and Results of Operations -
Factors That May Affect Future Operating Results” and elsewhere in this
Quarterly Report on Form 10-Q. Except as required by law, we undertake no
obligation to revise any forward-looking statements in order to reflect events
or circumstances that may arise after the date of this Quarterly Report on
Form 10-Q.
12
General
Cellegy
Pharmaceuticals is a specialty biopharmaceutical company. The Company’s
operations currently relate primarily to the ownership of its intellectual
property rights relating to the Biosyn product candidate.
Results
of Operations
Revenues.
The
Company had no revenues for the three and six month periods ended June 30,
2008
and 2007 and does not expect to recognize revenue in the foreseeable future.
Biosyn
benefits indirectly from agency funding paid to third party contractors in
support of its ongoing Phase 3 clinical trials. These payments from the funding
agencies are made directly to the service providers, not to Biosyn. Under the
terms of certain of its funding agreements, Biosyn has been granted the right
to
commercialize products supported by the funding in developed and developing
countries, and is obligated to make its commercialized products, if any,
available in developing countries, as well as to public sector agencies in
developed countries at prices reasonably above cost or at a reasonable royalty
rate.
Research
and Development Expenses. Cellegy's research and development expenses
in the three month period ended June 30, 2008 were de minimis. For the six
month
period ending June 30, 2008, the Company incurred research and development
expenses of approximately $3,000. In
the
three and six month periods ending June 30, 2007, the Company incurred research
and development expenses of approximately $15,000 and $21,000, respectively.
Selling,
General and Administrative Expenses.
Selling, general and administrative expenses for the three and six month periods
ending June 30, 2008 were approximately $335,000 and $798,000, respectively.
Selling, general and administrative expenses for the three and six month periods
ending June 30, 2007 were approximately $426,000 and $942,000. Selling, general
and administrative expenses consist primarily of legal fees incurred in
connection with merger activities, accounting and audit fees, regulatory
expenses and salaries. The reduction in 2008 expense levels compared to the
comparable periods in 2007 is primarily a result of reduced levels of
operations.
Other
Income (Expenses).
Interest and other income for the three and six month periods ending June 30,
2008 was approximately $14,000 and $42,000, respectively, as compared to
approximately $23,000 and $56,000 for the comparable periods in 2007. Interest
and other income consists primarily of interest income earned in connection
with
bank deposits and the note receivable with Adamis. The decrease in interest
income was primarily due to the decline in the Company’s cash deposits.
Interest
and other expense for the three and six month periods ending June 30, 2008
was
approximately $68,000 and $129,000, respectively, as compared to approximately
$51,000 and $94,000 for the comparable periods in 2007. Interest expense for
the
three and six month periods ending June 30, 2008 was approximately $68,000
and
$129,000, respectively, as compared to $47,000 and $89,000 for the comparable
periods in 2007. The increase in interest expense in the current periods is
due
primarily to the increased interest accretion of the note payable to Ben
Franklin.
Liquidity
and Capital Resources
Our
cash
and cash equivalents were approximately $635,000 and $1,827,000 at June 30,
2008
and December 31, 2007, respectively. Cash and cash equivalents decreased
approximately $1,192,000 during the six month period ending June 30, 2008 due
to
our $500,000 loan to Adamis in connection with the proposed merger, related
merger expenses and operating expenses incurred in connection with Cellegy’s
present level of operations.
13
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 Cellegy’s future business alternatives as described below, which may
preclude Cellegy from realizing the value of certain assets during their future
course of business.
Cellegy’s
operations currently relate primarily to the management of intellectual property
rights of its Biosyn subsidiary and the administration of the clinical and
regulatory affairs of its Savvy Phase 3 contraception trial. While the Savvy
Phase 3 contraception trial in the United States is ongoing, Cellegy is not
directly involved with the conduct and funding thereof and, due to the cessation
of the HIV Phase 3 trials in 2005 and 2006, it is uncertain whether Savvy will
be commercialized or whether Cellegy will ever realize revenues there from.
We
therefore expect negative cash flows to continue for the foreseeable future.
Cellegy believes that it presently has enough financial resources to continue
operations as they currently exist until approximately September 30, 2008,
absent unforeseen significant additional expenses; however, it does not have
the
technological nor the financial assets necessary to fund the expenditures that
would be required to conduct the future clinical and regulatory work necessary
to commercialize Savvy or other product candidates without additional
funding.
On
February 12, 2008, Cellegy entered into a definitive merger agreement providing
for the acquisition of Cellegy by Adamis Pharmaceuticals Corporation. In
connection with the signing of the Merger Agreement, Cellegy issued to Adamis
an
unsecured convertible promissory note pursuant to which Cellegy agreed to lend
Adamis $500,000 to provide funds to Adamis during the pendency of the merger
transaction. Any principal outstanding under the Promissory Note accrues
interest at 10% per annum. The Promissory Note becomes immediately due and
payable in the event that the Merger Agreement is terminated by Adamis or
Cellegy for certain specified reasons or on the later of (i) the sixteen month
anniversary of the issue date of the Promissory Note or (ii) the date that
is
two business days following the first date on which certain other notes issued
by Adamis to a third party have been repaid in full. If the Promissory Note
is
outstanding as of the closing of the merger transaction, the Promissory Note
will not be repaid but will convert into shares of Adamis stock, and these
shares will be immediately cancelled. Cellegy will receive no additional shares.
There
is
no assurance that Cellegy will be able to close the transaction with Adamis.
If
the proposed merger transaction with Adamis is still pending and Cellegy
requires additional cash resources to complete the transaction, Cellegy
and Adamis are engaged in discussions concerning an agreement for Adamis to
provide funding sufficient to permit the merger to be completed, although
there can be no assurance that such funding will be available.
If
the
merger with Adamis is not completed, Cellegy’s board of directors will be
required to explore alternatives for Cellegy’s business and assets. These
alternatives might include seeking the dissolution and liquidation of Cellegy,
merging or combining with another company, or initiating bankruptcy proceedings.
There can be no assurance that any third party will be interested in merging
with Cellegy or acquiring the remaining assets of Cellegy or would agree to
a
price and other terms that we would deem adequate. Although Cellegy may try
to
pursue an alternative strategic transaction, it will likely have very limited
cash resources, and if no such alternate transaction can be negotiated and
completed within a reasonable period of time will likely be forced to file
for
federal bankruptcy protection. If Cellegy files for bankruptcy protection,
Cellegy will most likely not be able to raise any type of funding from any
source. In that event, the creditors of Cellegy would have first claim on the
value of the assets of Cellegy which, other than remaining cash, would most
likely be liquidated in a bankruptcy sale. Cellegy can give no assurance as
to
the magnitude of the net proceeds of such sale and whether such proceeds would
be sufficient to satisfy Cellegy’s obligations to its creditors, let alone to
permit any distribution to its equity holders. These factors, among others,
raise substantial doubt about our ability to continue as a going
concern.
The
condensed consolidated financial statements do not include any adjustments
that
might result from the outcome of this uncertainty. Any failure to dispel any
continuing doubts about our ability to continue as a going concern could
adversely affect our ability to enter into business combination or other
agreements, therefore making it more difficult to obtain required financing
on
favorable terms or at all. Such an outcome may negatively affect the market
price of our common stock and could otherwise have a material adverse effect
on
our business, financial condition and results of operations.
14
Recent
Accounting Pronouncements
SFAS No. 157,
Fair Value Measurements
SFAS No. 157, “Fair
Value Measurements”
(“SFAS 157”), has been issued by the Financial Accounting Standards Board
(the “FASB”). This new standard provides guidance for using fair value to
measure assets and liabilities. SFAS 157 applies whenever other standards
require (or permit) assets or liabilities to be measured at fair value but
does
not expand the use of fair value in any new circumstances. Currently, over
40
accounting standards within GAAP require (or permit) entities to measure assets
and liabilities at fair value. The standard clarifies that for items that are
not actively traded, such as certain kinds of derivatives, fair value should
reflect the price in a transaction with a market participant, including an
adjustment for risk, not just the Company’s mark-to-model value. SFAS 157
also requires expanded disclosure of the effect on earnings for items measured
using unobservable data. Under SFAS 157, fair value refers to the price
that would be received to sell an asset or paid to transfer a liability in
an
orderly transaction between market participants in the market in which the
reporting entity transacts. In this standard, FASB clarified the principle
that
fair value should be based on the assumptions market participants would use
when
pricing the asset or liability. In support of this principle, SFAS 157
establishes a fair value hierarchy that prioritizes the information used to
develop those assumptions. The fair value hierarchy gives the highest priority
to quoted prices in active markets and the lowest priority to unobservable
data,
for example, the reporting entity’s own data. Under the standard, fair value
measurements would be separately disclosed by level within the fair value
hierarchy.
The
FASB
agreed to defer the effective date of SFAS 157 for all non-financial assets
and liabilities, except those that are recognized or disclosed at fair value
in
the financial statements on a recurring basis. The FASB again rejected the
proposal of a full one-year deferral of the effective date of SFAS 157.
SFAS 157 was issued in September 2006, and is effective for financial
statements issued for fiscal years beginning after November 15, 2007 and
interim periods within those fiscal years. Accordingly, the Company will adopt
this statement on October 1, 2007 for assets and liabilities not subject to
the deferral and October 1, 2008, for all other assets and liabilities. The
Company is currently assessing the impact of this statement.
SFAS No. 141
(Revised 2007), Business Combinations
On
December 4, 2007, the FASB issued SFAS No. 141 (Revised 2007),
“Business
Combinations”
(“SFAS 141R”). Under SFAS 141R, 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 141R will
change the accounting treatment for certain specific items
including:
·
|
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 and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired
contingencies;
|
·
|
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 generally be 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 141R
also includes a substantial number of new disclosure requirements.
SFAS 141R 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 is currently assessing the impact of this
statement.
15
SFAS No. 160,
“Non-controlling Interests in Consolidated Financial Statements — An
Amendment of ARB No. 51”
On
December 4, 2007, the FASB issued SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements — An Amendment of ARB
No. 51”
(“SFAS 160”). SFAS 160 establishes new accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the
recognition of a non-controlling interest (minority interest) as equity in
the
consolidated financial statements and separate from the parent’s equity. The
amount of net income attributable to the non-controlling interest will be
included in consolidated net income on the face of the income statement.
SFAS 160 clarifies that changes in a parent’s ownership interest in a
subsidiary that do not result in deconsolidation are equity transactions if
the
parent retains its controlling financial interest. In addition, this statement
requires that a parent recognize a gain or loss in net income when a subsidiary
is deconsolidated. Such gain or loss will be measured using the fair value
of
the non-controlling equity investment on the deconsolidation date. SFAS 160
also includes expanded disclosure requirements regarding the interests of the
parent and its non-controlling interest. SFAS 160 is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after
December 15, 2008. Earlier adoption is prohibited. The Company believes
that this pronouncement will have no effect on its financial
statements.
Critical
Accounting Policies and Estimates
Our
critical accounting policies and estimates were discussed in our Annual Report
on Form 10-K for the year ended December 31, 2007. No changes in those
policies and estimates have occurred during the six months ended June 30,
2008.
ITEM
3.
|
Quantitative
and Qualitative Disclosure of Market Risk
|
Cellegy
invests its excess cash in short-term, investment grade, fixed income securities
under an investment policy. All of our securities owned as of June 30, 2008,
were in money market funds and are classified as cash equivalents. We believe
that potential near-term losses in future earnings, fair values or cash flows
related to our investment portfolio are not significant. We currently do not
hedge interest rate exposure. If market interest rates were to increase or
decrease, the fair value of our portfolio would not be significantly
affected.
We
are
incurring market risk associated with the issuance of warrants to the May 2005
PIPE investors to purchase approximately 1.4 million shares of our common stock.
We will continue to calculate the fair value at the end of each quarter and
record the change in valuation to other income or expense until the
warrants are exercised or expired. We are incurring risk associated with
increases or decreases in the market price of our common stock, which will
directly impact the fair value calculation and the non-cash charge or credit
recorded to the statement of operations in future quarters.
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)).
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.
16
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
Legal
Proceedings
|
None
ITEM
1A.
|
Risk
Factors
|
Several
of the risk factors below relate to risks and uncertainties associated with
Cellegy’s ongoing business. As noted below, there is substantial doubt about our
ability to continue as a going concern, absent completion of the proposed
business combination transaction with Adamis.
There
is no assurance that the Company will be able to close the merger transaction
with Adamis.
There
is
no assurance that Cellegy will be able to close the transaction with Adamis.
If
the proposed merger transaction with Adamis is still pending and Cellegy
requires additional cash resources to complete the transaction, Cellegy
and Adamis are engaged in discussions concerning an agreement for Adamis
to provide funding sufficient to permit the merger to be completed,
although there can be no assurance that such funding will be
available.
If
the
merger with Adamis is not completed for any reason, Cellegy’s board of directors
will be required to explore alternatives for Cellegy’s business and assets.
These alternatives might include seeking the dissolution and liquidation of
Cellegy, merging or combining with another company, or initiating bankruptcy
proceedings. There can be no assurance that any third party will be interested
in merging with Cellegy or acquiring the remaining assets of Cellegy or would
agree to a price and other terms that we would deem adequate. Although Cellegy
may try to pursue an alternative strategic transaction, it will likely have
very
limited cash resources, and if no such alternate transaction can be negotiated
and completed within a reasonable period of time will likely be forced to file
for federal bankruptcy protection. If Cellegy files for bankruptcy protection,
Cellegy will most likely not be able to raise any type of funding from any
source. In that event, the creditors of Cellegy would have first claim on the
value of the assets of Cellegy which, other than remaining cash, would most
likely be liquidated in a bankruptcy sale. Cellegy can give no assurance as
to
the magnitude of the net proceeds of such sale and whether such proceeds would
be sufficient to satisfy Cellegy’s obligations to its creditors, let alone to
permit any distribution to its equity holders. These factors, among others,
raise substantial doubt about our ability to continue as a going
concern.
The
Company’s cash resources are diminishing.
We
have
incurred accumulated losses since our inception and accumulated negative cash
flows from operations that raise substantial doubt about our ability to continue
as a going concern. We expect negative cash flows to continue for the
foreseeable future. The Company believes that it has enough financial resources
to continue operations as they currently exist until approximately September
30,
2008, absent significant unforeseen additional expenses; however, it does not
have the technological resources or the financial assets necessary to fund
the
expenditures that would be required to conduct the future clinical and
regulatory work necessary to commercialize Savvy without additional funding.
Without additional funds from financing, sales of assets, intellectual property
or technologies, or from a business combination or a similar transaction, we
will exhaust our resources and will be unable to continue operations, and our
accumulated deficit will continue to increase as we continue to incur losses.
These factors raise substantial doubt about our ability to continue as a going
concern.
17
We
have received a “going concern” opinion from our independent registered public
accounting firm, which may negatively impact our
business.
Our
audit
opinions from our independent registered public accounting firm regarding the
consolidated financial statements for the years ended December 31, 2007 and
2006
include an explanatory paragraph indicating that there is substantial doubt
about the Company’s ability to continue as a going concern. Doubts concerning
our ability to continue as a going concern could adversely affect our ability
to
enter into business combination or other agreements, therefore making it more
difficult to obtain required financing on favorable terms or at all. Such an
outcome may negatively affect the market price of our common stock and could
otherwise have a material adverse effect on our business, financial condition
and results of operations.
We
are subject to regulation by regulatory authorities including the FDA, which
could delay or prevent marketing of our products. Unexpected regulatory outcomes
could adversely affect our business and stock price.
Cellegy’s
remaining product candidate is subject to extensive regulation by governmental
regulatory authorities in the United States and in other countries. Before
we
obtain regulatory approval for the commercial sale of any potential drug
products, we must demonstrate through pre-clinical studies and clinical trials
that the product is safe and efficacious for use in the clinical indication
for
which approval is sought. The timing of new drug application (“NDA”)
submissions, the outcome of reviews by the FDA and the initiation and completion
of other clinical trials are subject to uncertainty, change and unforeseen
delays. Under the Prescription Drug User Fee Act (“PDUFA”), the FDA establishes
a target date to complete its review of an NDA. Although the FDA attempts to
respond by the relevant PDUFA date to companies that file NDAs, there is no
obligation on the FDA’s part to do so. In addition, extensive current
pre-clinical and clinical testing requirements and the current regulatory
approval process of the FDA in the United States and of certain foreign
regulatory authorities, or new government regulations, could prevent or delay
regulatory approval of our product candidate.
The
process of developing and obtaining approval for a new pharmaceutical product
within this regulatory framework requires a number of years and substantial
expenditures. There can be no assurance that necessary approvals will be
obtained in a timely manner, if at all. Delays in clinical trials or obtaining
regulatory approvals could delay receipt of revenues from product sales,
increase our expenditures relating to obtaining approvals, jeopardize corporate
partnership arrangements that we might enter into with third parties regarding
particular products, or cause a decline in our stock price. If we fail to comply
with applicable regulatory requirements, we could be subject to a wide variety
of serious administrative or judicially imposed sanctions and penalties, any
of
which could result in significant financial penalties that could reduce our
available cash, delay introduction of products resulting in deferral or
elimination of revenues from product sales, and could result in a decline in
our
stock price.
Clinical
trial results are very difficult to predict in advance, and the clinical trial
process is subject to delays. Failure of one or more clinical trials or delays
in trial completion could adversely affect our business and our stock
price.
Results
of pre-clinical studies and early clinical trials may not be good predictors
of
results that will be obtained in later-stage clinical trials. We cannot provide
any assurance that the current Phase 3 clinical trial relating to Savvy will
demonstrate the results required to continue advanced trial development and
allow us to seek marketing approval for our product candidate. Because of the
independent and blind nature of certain human clinical testing, there will
be
extended periods during the testing process when we will have only limited,
or
no, access to information about the status or results of the tests. Cellegy
and
other pharmaceutical companies have believed that their product
candidates performed satisfactorily in early tests, only to find their
performance in later tests, including Phase 3 clinical trials, to be inadequate
or unsatisfactory, or that FDA Advisory Committees have declined to recommend
approval of the drugs, or that the FDA itself refused approval, with the result
that stock prices have fallen precipitously.
18
Clinical
trials can be extremely costly. Certain costs relating to the Phase 3 trials
for
the Savvy product for contraception and, when they were conducted, for the
reduction in the transmission of HIV, and other clinical and preclinical
development costs for Savvy, were funded directly by certain grant and contract
commitments from several governmental and non-governmental organizations
(“NGOs”). Nevertheless, current or future clinical trials could require
substantial additional funding. There can be no assurance that funding from
governmental agencies and NGOs will continue to be available, and any other
Phase 3 trials that Cellegy may commence in the future relating to its products
could involve the expenditure of several million dollars through the completion
of the clinical trials. In addition, delays in the clinical trial process can
be
extremely costly in terms of lost sales opportunities and increased clinical
trial costs. The speed with which we complete our clinical trials and our
regulatory submissions, including NDAs, will depend on several factors,
including the following:
·
|
the
rate of patient enrollment, which is affected by the size of the
patient
population, the proximity of patients to clinical sites, the difficulty
of
the entry criteria for the study and the nature of the
protocol;
|
·
|
the
timely completion of clinical site protocol approval and obtaining
informed consent from subjects;
|
·
|
analysis
of data obtained from preclinical and clinical
activities;
|
·
|
changes
in policies or staff personnel at regulatory agencies during the
lengthy
drug application review; and
|
·
|
the
availability of experienced staff to conduct and monitor clinical
studies,
internally or through Contract Research Organizations
(“CRO”).
|
Adverse
events in our clinical trials section may force us to stop development of our
product candidate or prevent regulatory approval of our product candidate,
which
could materially harm our business.
Patients
participating in the clinical trial of our product candidate may experience
serious adverse health events. A serious adverse health event includes death,
a
life-threatening condition, hospitalization, disability, congenital anomaly,
or
a condition requiring intervention to prevent permanent impairment or damage.
The occurrence of any of these events could interrupt, delay or halt clinical
trials of our product candidate and could result in the FDA, or other regulatory
authorities, denying approval of our product candidate for any or all targeted
indications. An institutional review board or independent data safety monitoring
board, the FDA, other regulatory authorities or we, may suspend or terminate
clinical trials at any time. Our product candidate may prove not to be safe
for
human use. Any delay in the regulatory approval of our product candidate could
increase our product development costs and allow our competitors additional
time
to develop or market competing products.
Due
to our reliance on contract research organizations or other third-parties to
assist us in conducting clinical trials, we are unable to directly control
all
aspects of our clinical trials.
We
have
relied on CROs and other third parties to conduct our clinical trials. As a
result, we have had and will continue to have less control over the conduct
of
the clinical trials, the timing and completion of the trials and the management
of data developed through the trial than would be the case if we were relying
entirely upon our own staff. Communicating with CROs can also be challenging,
potentially leading to difficulties in coordinating activities. CROs
may:
·
|
have
staffing difficulties;
|
·
|
experience
regulatory compliance issues;
|
·
|
undergo
changes in priorities or may become financially distressed;
or
|
·
|
not
be able to properly control payments to government agencies or clinical
sites, particularly in less developed
countries.
|
These
factors may adversely affect their ability to conduct trials relating to our
product candidate. We may experience unexpected cost increases or experience
problems with the timeliness or quality of the work of the CRO. If we must
replace these CROs or any other third party contractor, trials may have to
be
suspended until we find another CRO that offers comparable services. The time
that it takes us to find alternative organizations may cause a delay in the
commercialization of our product candidate or may cause us to incur significant
expenses. Although we do not now intend to replace our CROs, such a change
would
make it difficult to find a replacement organization to conduct our trials
in an
acceptable manner and at an acceptable cost. Any delay in or inability to
complete clinical trials could significantly compromise our ability to secure
regulatory approval of product candidates, thereby limiting our ability to
generate product revenue resulting in a decrease in our stock
price.
19
The
type and scope of the patent coverage we have may limit the commercial success
of our products.
Cellegy’s
success depends, in part, on our ability to obtain patent protection for our
products and methods, both in the United States and in other countries. No
assurance can be given that any additional patents will be issued to us, that
the protection of any patents that may be issued in the future will be
significant, or that current or future patents will be held valid if
subsequently challenged.
The
patent position of companies engaged in businesses such as Cellegy’s business
generally is uncertain and involves complex, legal and factual questions. There
is a substantial backlog of patent applications at the United States Patent
and
Trademark Office. Patents in the United States are issued to the party that
is
first to invent the claimed invention. There can be no assurance that any patent
applications relating to Cellegy’s product candidate or methods will be
issued as patents, or, if issued, that the patents will not be challenged,
invalidated or circumvented or that the rights granted there under will provide
a competitive advantage.
In
addition, many other organizations are engaged in research and product
development efforts that may overlap with Cellegy’s product candidate. Such
organizations may currently have, or may obtain in the future, legally blocking
proprietary rights, including patent rights, in one or more products or methods
under development or consideration by Cellegy. These rights may prevent us
from
commercializing technology, or may require Cellegy to obtain a license from
the
organizations to use the technology. Cellegy may not be able to obtain any
such
licenses that may be required on reasonable financial terms, if at all, and
cannot be sure that the patents underlying any such licenses will be valid
or
enforceable. Moreover, the laws of certain foreign countries do not protect
intellectual property rights relating to United States patents as extensively
as
those rights are protected in the United States. The issuance of a patent in
one
country does not assure the issuance of a patent with similar claims in another
country, and claim interpretation and infringement laws vary among countries;
therefore, the extent of any patent protection is uncertain and may vary in
different countries. As with other companies in the pharmaceutical industry,
we
are subject to the risk that persons located in other countries will engage
in
development, marketing or sales activities of products that would infringe
our
patent rights if such activities were conducted in the United
States.
We
have limited sales and marketing experience.
We
may
market products, if any are successfully developed and approved and if we obtain
sufficient funding, through a direct sales force in the United States. Cellegy
has very limited experience in sales, marketing or distribution. To market
these
products directly, we may seek to establish a direct sales force in the United
States or obtain the assistance of a marketing partner. However, Cellegy does
not presently have the financial capability or the experience to successfully
establish a direct sales force, marketing or distribution operations, which
could delay or prevent the successful commercialization of our products and
could reduce the ultimate profitability for Cellegy of such products if we
needed to rely on a third party marketing partner to commercialize the
products.
If
medical doctors do not prescribe our products or the medical profession does
not
accept our products, our product sales and business would be adversely
affected.
Our
business is dependent on market acceptance of our products by physicians,
healthcare providers, patients and the medical community. Medical doctors’
willingness to prescribe our products depends on many factors,
including:
·
|
perceived
efficacy of our products;
|
·
|
convenience
and ease of administration;
|
·
|
prevalence
and severity of adverse side effects in both clinical trials and
commercial use;
|
·
|
availability
of alternative treatments;
|
·
|
cost
effectiveness;
|
·
|
effectiveness
of our marketing strategy and the pricing of our
products;
|
·
|
publicity
concerning our products or competing products;
and
|
·
|
our
ability to obtain third-party coverage or
reimbursement.
|
20
Even
if
we receive regulatory approval and satisfy the above criteria, physicians may
not prescribe our products if we do not promote our products effectively.
Factors that could affect our success in marketing our products
include:
·
|
the
experience, skill and effectiveness of the sales force and our sales
managers;
|
·
|
the
effectiveness of our production, distribution and marketing
capabilities;
|
·
|
the
success of competing products; and
|
·
|
the
availability and extent of reimbursement from third-party
payers.
|
Failure
of our product candidate to achieve market acceptance would limit our ability
to
generate revenue and could harm our business.
We
have very limited staffing and will continue to be dependent upon key
personnel.
Our
success is dependent upon the efforts of a small management team and staff.
We
do not have key man life insurance policies covering any of our executive
officers or key employees. If key individuals leave Cellegy, we could be
adversely affected if suitable replacement personnel are not quickly recruited.
There is competition for qualified personnel in all functional areas, which
makes it difficult to attract and retain the qualified personnel necessary
for
the development and growth of our business. Our future success depends upon
our
ability to continue to attract and retain qualified scientific, clinical and
administrative personnel.
Our
corporate compliance programs cannot guarantee that we are in compliance with
all potentially applicable regulations.
The
development, manufacturing, pricing, sales, and reimbursement of our product,
together with our general operations, are subject to extensive regulation by
federal, state and other authorities within the United States and numerous
entities outside of the United States. We are a small company and we rely
heavily on third parties to conduct many important functions. We also have
significantly fewer employees than many other companies that have the same
or
fewer product candidates in late stage clinical development. In addition, as
a
publicly traded company we are subject to significant regulations, including
the
Sarbanes-Oxley Act of 2002. While we have developed and instituted a corporate
compliance program and continue to update the program in response to newly
implemented or changing regulatory requirements, we cannot assure you that
we
are now or will be in compliance with all such applicable laws and regulations.
If we fail to comply with any of these regulations, we could be subject to
a
range of regulatory actions, including suspension or termination of clinical
trials, or manufacturing processes, significant fines, or other sanctions or
litigation. Failure to comply with potentially applicable laws and regulations
could also lead to the imposition of fines, cause the value of our common stock
to decline, and impede our ability to raise capital or lead to the de-listing
of
our stock.
Risks
Relating to Our Industry
We
face intense competition from larger companies, and in the future Cellegy may
not have the resources required to develop innovative products. Cellegy’s
products are subject to competition from existing
products.
The
pharmaceutical industry is subject to rapid and significant technological
change. Cellegy is much smaller in terms of size and resources than many of
its
competitors in the United States and abroad, which include, among others, major
pharmaceutical, chemical, consumer product, specialty pharmaceutical and
biotechnology companies, universities and other research institutions. Cellegy’s
competitors may succeed in developing technologies and products that are safer
and more effective than any product or product candidates that we may develop
and could render Cellegy’s technology and potential products obsolete and
noncompetitive. Many of these competitors have substantially greater financial
and technical resources, clinical production and marketing capabilities and
regulatory experience. In addition, any Cellegy products will likely be subject
to competition from existing products. As a result, any future Cellegy products
may never be able to compete successfully with existing products or with
innovative products under development by other organizations.
21
We
are subject to the risk of clinical trial and product liability
lawsuits.
The
testing of human health care product candidates entails an inherent risk of
allegations of clinical trial liability, while the marketing and sale of
approved products entails an inherent risk of allegations of product liability.
We are subject to the risk that substantial liability claims from the testing
or
marketing of pharmaceutical products could be asserted against us in the future.
There
can
be no assurance that Cellegy will be able to obtain or maintain insurance on
acceptable terms, particularly in overseas locations, for clinical and
commercial activities or that any insurance obtained will provide adequate
protection against potential liabilities. Moreover, our current and future
coverages may not be adequate to protect us from all of the liabilities that
we
may incur. If losses from liability claims exceed our insurance coverage, we
may
incur substantial liabilities that exceed our financial resources. In addition,
a product or clinical trial liability action against us would be expensive
and
time-consuming to defend, even if we ultimately prevail. If we are required
to
pay a claim, we may not have sufficient financial resources and our business
and
results of operations may be harmed.
Our
stock price could be volatile.
Our
stock
price has from time to time experienced significant price and volume
fluctuations. Since becoming a public company, our stock price has fluctuated
due to overall market conditions and due to matters or events more specific
to
Cellegy. Events or announcements that could significantly impact our stock
price
include:
·
|
Publicity
or announcements regarding regulatory developments relating to our
products;
|
·
|
Clinical
trial results, particularly the outcome of more advanced studies;
or
negative responses from both domestic and foreign regulatory authorities
with regard to the approvability of our product
candidate;
|
·
|
Period-to-period
fluctuations in our financial results, including our cash and cash
equivalents balance, operating expenses or cash burn
rate;
|
·
|
Common
stock sales in the public market by one or more of our larger
stockholders, officers or
directors;
|
·
|
A
negative outcome in any litigation or potential legal proceedings;
or
|
·
|
Other
potentially negative financial announcements including: a review
of any of
our filings by the SEC, changes in accounting treatment or restatement
of
previously reported financial results or delays in our filings with
the
SEC.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds
|
None
Defaults
Upon Senior Securities
|
None
Submission
of Matters to a Vote of Security
Holders
|
None
22
ITEM
5.
|
Other
Information
|
None
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
|
23
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:
|
July
22, 2008
|
|
|
/s/
Richard C. Williams
|
|
|
|
Richard
C. Williams
|
|||
|
|
Chairman
and Interim Chief Executive Officer
|
|||
|
|
|
|||
|
|
|
|||
Date:
|
July
22, 2008
|
|
|
/s/
Robert J. Caso
|
|
|
|
Robert
J. Caso
|
|||
|
|
Vice
President, Finance and Chief Financial
Officer
|
24