DMK PHARMACEUTICALS Corp - Quarter Report: 2006 June (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
x
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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, 2006
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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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1800
Byberry Rd., Building 13, Huntingdon Valley, PA 19006
(Address
of principal executive offices, including zip code)
215-914-0900
(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 ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer x
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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 July
31,
2006 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 |
3
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Condensed Consolidated Statements of Operations |
4
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Condensed Consolidated Statements of Cash Flows |
5
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Notes to Condensed Consolidated Financial Statements |
7
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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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18
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Item
3.
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Quantitative
and Qualitative Disclosure of Market Risk
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22
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Item
4.
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Controls
and Procedures
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22
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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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23
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Item
1A.
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Risk
Factors
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23
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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25
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Item
3.
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Defaults
Upon Senior Securities
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25
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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25
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Item
5.
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Other
Information
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25
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Item
6.
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Exhibits
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26
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Signatures
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27
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2
PART
I - FINANCIAL INFORMATION
Cellegy
Pharmaceuticals, Inc.
(a
development stage company)
(Amounts
in thousands)
(Unaudited)
June
30,
2006
|
December
31, 2005
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
651
|
$
|
2,251
|
|||
Short-term
investments
|
-
|
11
|
|||||
Accounts
receivable
|
720
|
1,085
|
|||||
Inventory
|
-
|
352
|
|||||
Prepaid
expenses and other current assets
|
124
|
1,077
|
|||||
Total
current assets
|
1,495
|
4,776
|
|||||
Property
and equipment, net
|
338
|
496
|
|||||
Goodwill
|
-
|
982
|
|||||
Intangible
assets, net
|
-
|
196
|
|||||
Other
assets
|
-
|
-
|
|||||
Total
assets
|
$
|
1,833
|
$
|
6,450
|
|||
Liabilities
and Stockholders' Deficit
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,616
|
$
|
1,756
|
|||
Accrued
expenses and other current liabilities
|
1,313
|
2,402
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|||||
Current
portion of notes payable
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5,151
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4,976
|
|||||
Current
portion of deferred revenue
|
303
|
303
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|||||
Total
current liabilities
|
8,383
|
9,437
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|||||
Notes
payable
|
259
|
213
|
|||||
Derivative
instruments
|
167
|
193
|
|||||
Deferred
revenue
|
2,956
|
3,084
|
|||||
Total
liabilities
|
11,765
|
12,927
|
|||||
Commitments
and contingencies (Note 14)
|
|||||||
Stockholders'
deficit:
|
|||||||
Common
stock
|
3
|
3
|
|||||
Additional
Paid-in Capital
|
125,631
|
125,548
|
|||||
Accumulated
other comprehensive income
|
407
|
284
|
|||||
Deficit
accumulated during the development stage
|
(135,973
|
)
|
(132,312
|
)
|
|||
Total
stockholders' deficit
|
(9,932
|
)
|
(6,477
|
)
|
|||
Total
liabilities and stockholders' deficit
|
$
|
1,833
|
$
|
6,450
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
3
Cellegy
Pharmaceuticals, Inc
(a
development stage company)
(Amounts
in thousands, except per share data)
(Unaudited)
Three
Months Ended
June 30,
|
Six
Months Ended
June 30,
|
Period
from June 26, 1989 (inception) to June 30,
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||||||||||||||
2006
|
2005
|
2006
|
2005
|
2006
|
||||||||||||
Revenues:
|
||||||||||||||||
Licensing
and contract revenue from affiliates
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
1,145
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||||||
Licensing,
milestone and development funding
|
315
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6,519
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379
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6,759
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10,876
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|||||||||||
Grants
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912
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955
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1,827
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2,168
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7,811
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|||||||||||
Product
sales
|
-
|
139
|
257
|
139
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5,828
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|||||||||||
Total
revenues
|
1,227
|
7,613
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2,463
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9,066
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25,660
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|||||||||||
Costs
and expenses:
|
||||||||||||||||
Cost
of product sales
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-
|
44
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257
|
44
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1,945
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|||||||||||
Research
and development
|
800
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2,280
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1,906
|
5,038
|
91,868
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|||||||||||
Selling,
general and administrative
|
1,472
|
378
|
3,571
|
4,293
|
49,671
|
|||||||||||
Acquired
in-process technology
|
-
|
-
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-
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-
|
22,332
|
|||||||||||
Total
costs and expenses
|
2,272
|
2,702
|
5,734
|
9,375
|
165,816
|
|||||||||||
Operating
income (loss)
|
(1,045
|
)
|
4,911
|
(3,271
|
)
|
(309
|
)
|
(140,156
|
)
|
|||||||
Interest
and other income
|
7
|
20
|
15
|
104
|
7,046
|
|||||||||||
Interest
and other expense
|
(224
|
)
|
(241
|
)
|
(437
|
)
|
(261
|
)
|
(2,596
|
)
|
||||||
Derivative
revaluation
|
80
|
106
|
25
|
164
|
1,106
|
|||||||||||
Net
income income (loss) from continuing operations
|
(1,182
|
)
|
4,796
|
(3,668
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)
|
(302
|
)
|
(134,600
|
)
|
|||||||
Non-cash
Preferred Dividends
|
-
|
-
|
-
|
-
|
(1,449
|
)
|
||||||||||
Net
income (loss) from continuing operations applicable to common
stockholders
|
(1,182
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)
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4,796
|
(3,668
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)
|
(302
|
)
|
(136,049
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)
|
|||||||
Discontinued
operations (Note 13)
|
||||||||||||||||
Profit
(loss) from discontinued operations
|
(69
|
)
|
39
|
7
|
51
|
76
|
||||||||||
Net
income (loss) applicable to common shareholders
|
$
|
(1,251
|
)
|
$
|
4,835
|
$
|
(3,661
|
)
|
$
|
(251
|
)
|
$
|
(135,973
|
)
|
||
Basic income (loss) per common share: | ||||||||||||||||
From
continuing operations
|
$
|
(0.04
|
)
|
$
|
0.17
|
$
|
(0.12
|
) | $ |
(0.01
|
)
|
|||||
From
discontinued operations
|
-
|
|
-
|
-
|
-
|
|||||||||||
Basic
income (loss) per common share
|
$
|
(0.04
|
)
|
0.17
|
$
|
(0.12
|
)
|
$
|
(0.01
|
)
|
||||||
Diluted
income (loss) per common share:
|
||||||||||||||||
From
continuing operations
|
$
|
(0.04
|
)
|
$
|
0.16
|
$
|
(0.12
|
)
|
$
|
(0.01
|
)
|
|||||
From
discontinued operations
|
-
|
|
-
|
-
|
-
|
|||||||||||
Diluted
income (loss) per common share
|
$
|
(0.04
|
)
|
$
|
0.16
|
$
|
(0.12
|
)
|
$
|
(0.01
|
)
|
|||||
Weighted
average number of common shares used in per share
calculations:
|
||||||||||||||||
|
||||||||||||||||
Basic
|
29,833
|
28,135
|
29,832
|
27,141
|
||||||||||||
Diluted
|
29,833
|
30,103
|
29,832
|
27,141
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
4
Cellegy
Pharmaceuticals, Inc.
(a
development stage company)
(Amounts
in thousands)
(Unaudited)
Six
Months Ended June 30,
|
Period
from June 26, 1989 (inception)
|
|||||||||
2006
|
2005
|
to
June 30, 2006
|
||||||||
Operating
activities
|
||||||||||
Net
loss
|
$
|
(3,661
|
)
|
$
|
(251
|
)
|
$
|
(134,524
|
)
|
|
Adjustments
to reconcile net loss to net cash provided by
|
||||||||||
(used
in) operating activites:
|
||||||||||
Acquired
in-process technology
|
-
|
-
|
22,332
|
|||||||
Bad
debt expense & other non-cash items
|
37
|
60
|
234
|
|||||||
Depreciation
expense
|
81
|
224
|
3,459
|
|||||||
Intangible
assets amortization
|
196
|
245
|
2,120
|
|||||||
Loss
(gain) on sale of fixed assets
|
77
|
602
|
1,689
|
|||||||
Equity
compensation expense
|
83
|
1
|
2,383
|
|||||||
Derivative
re-evaluation
|
(26
|
)
|
(163
|
)
|
(1,104
|
)
|
||||
Interest
accretion on notes payable
|
384
|
172
|
915
|
|||||||
PDI
settlement
|
-
|
-
|
2,000
|
|||||||
Amortization
of discount on notes payable and deferred
financing costs
|
-
|
-
|
24
|
|||||||
Issuance
of common shares for services
|
-
|
-
|
1,041
|
|||||||
Issuance
of common stock for services rendered, interest
and Neptune milestones
|
-
|
1,318
|
||||||||
Changes
in operating assets and liabilitites:
|
||||||||||
Prepaid
expenses and other current assets
|
2,251
|
(363
|
)
|
1,344
|
||||||
Accounts
receivable
|
365
|
(108
|
)
|
(491
|
)
|
|||||
Other
assets
|
(1,012
|
)
|
-
|
(712
|
)
|
|||||
Accounts
payable
|
(159
|
)
|
(275
|
)
|
316
|
|||||
Accrued
expenses and other current liabilities
|
(1,071
|
)
|
(1,255
|
)
|
(1,910
|
)
|
||||
Other
long term liabilities
|
46
|
(273
|
)
|
12
|
||||||
Deferred
revenue
|
(128
|
)
|
(9,058
|
)
|
796
|
|||||
Net
cash used in operating activities
|
(2,537
|
)
|
(10,442
|
)
|
(98,758
|
)
|
||||
Investing
activities:
|
||||||||||
Purchases
of property and equipment
|
-
|
(70
|
)
|
(5,507
|
)
|
|||||
Purchases
of investments
|
-
|
-
|
(98,921
|
)
|
||||||
Sale
of investments
|
11
|
-
|
43,521
|
|||||||
Maturity
of investments
|
-
|
-
|
55,305
|
|||||||
Proceeds
from restricted cash
|
-
|
227
|
615
|
|||||||
Proceeds
from sale of property
|
-
|
-
|
238
|
|||||||
Proceeds
from sale of subsidiary
|
1,012
|
1,012
|
||||||||
Acquisition
of Vaxis and Quay and Biosyn
|
-
|
-
|
(816
|
)
|
||||||
Net
cash provided by (used in) investing activities
|
1,023
|
157
|
(4,553
|
)
|
||||||
Financing
activities:
|
||||||||||
Proceeds
from notes payable
|
-
|
-
|
8,047
|
|||||||
Issuance
of notes payable
|
-
|
-
|
4,444
|
|||||||
Repayment
of notes payable
|
(209
|
)
|
-
|
(6,819
|
)
|
|||||
Net
proceeds from issuance of common stock
|
-
|
5,747
|
86,842
|
|||||||
Other
assets
|
-
|
-
|
(614
|
)
|
||||||
Issuance
of convertible preferred stock, net of issuance
cost
|
-
|
-
|
11,758
|
|||||||
Deferred
financing costs
|
-
|
-
|
(80
|
)
|
||||||
Net
cash provided by (used in) financing activities
|
(209
|
)
|
5,747
|
103,578
|
||||||
Effect
of exchange rate changes on cash
|
123
|
(26
|
)
|
384
|
||||||
Net
increase (decrease) in cash and cash equivalents
|
(1,600
|
)
|
(4,564
|
)
|
651
|
|||||
Cash
and cash equivalents, beginning of period
|
2,251
|
8,709
|
-
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
651
|
$
|
4,145
|
$
|
651
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
5
Cellegy
Pharmaceuticals, Inc.
(a
development stage company)
Condensed
Consolidated Statements of Cash Flows
(Amounts
in thousands)
(Unaudited)
Six
Months Ended June
|
Period
From
June
26, 1989
(inception)
to
June
30,
|
|||||||||
2006
|
2005
|
2006
|
||||||||
Supplemental
cash flow information:
|
||||||||||
Interest
paid
|
$
|
-
|
$
|
-
|
$
|
726
|
||||
Supplemental
disclosure of non-cash transactions:
|
||||||||||
Issuance
of common stock in connection with acquired-in-process technology
|
-
|
-
|
7,350
|
|||||||
Conversion
of preferred stock to common stock
|
-
|
-
|
14,715
|
|||||||
Issuance
of common stock for notes payable
|
-
|
-
|
5,998
|
|||||||
Issuance
of warrants in connection with Kingsbridge financings
|
-
|
471
|
801
|
|||||||
Issuance
of warrants in connection with notes payable financing
|
-
|
-
|
959
|
|||||||
Issuance
of convertible preferred stock for notes payable
|
-
|
-
|
1,268
|
|||||||
Issuance
of common stock for milestone payments
|
-
|
-
|
1,500
|
|||||||
Fair
value of assets acquired net of liabilities assumed for Biosyn acquisition
|
-
|
-
|
11,856
|
|||||||
Fair
value of assets acquired net of liabilities assumed for Biosyn acquisition
|
-
|
-
|
11,856
|
|||||||
Interest
expense amortization for long-term obligations
|
437 |
204
|
1,233
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
6
Cellegy
Pharmaceuticals, Inc.
(a
development stage company)
(Unaudited)
Note
1: Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial statements
have
been prepared in accordance with generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and 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 un-audited interim condensed
consolidated financial statements reflect all adjustments (including normal
recurring adjustments and the elimination of inter-company accounts) considered
necessary for a fair statement of all periods presented. The results of
Cellegy’s 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 un-audited 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, 2005.
Liquidity
and Capital Resources
The
accompanying interim financial statements have been prepared assuming the
Company will continue as a going concern, which contemplates the realization
of
assets and satisfaction of liabilities and commitments in the normal course
of
business. However, we believe we do not have sufficient financial
resources to continue operations beyond September 2006. At June 30, 2006, the
Company had a deficit accumulated during the development stage of $136.0 million
(including discontinued operations with accumulated surplus of $0.08 million)
and recurring, negative cash flows from operations. We expect negative cash
flow
from operations to continue for the foreseeable future, with the need to
commercialize products once regulatory approvals have been obtained. These
factors raise substantial doubt about our ability to continue as a going
concern. Our plans, with regard to these matters, include raising additional
required funds through one or more of the following options, among others:
sales
of assets, including intellectual property and technologies, seeking
partnerships with other pharmaceutical companies or private foundations to
co-develop and fund our research and development efforts, pursuing additional
out-licensing arrangements with third parties, re-licensing and monetizing
in
the near term our future milestone and royalty payments expected from existing
licensees and seeking equity or debt financing. In addition, we will continue
to
implement further cost reduction programs and reduce discretionary spending,
if
necessary.
There
is
no assurance that any of the above options will be implemented on a timely
basis
or that we will be able to obtain funds required to continue operations.
Alternatively, we may be required to accept less than favorable commercial
terms
in any such future arrangements. Even if funds are obtained to continue
operations, failure to obtain adequate additional funds could require us to
delay development or commercialization of certain products, to license to third
parties the rights to commercialize certain products that we would otherwise
seek to commercialize internally or to reduce resources devoted to product
development. In addition, if we do not receive all, or a portion, of the planned
Biosyn grant funding, or if such funding is delayed, this could impact our
ability to complete our Biosyn development programs on a timely basis, if at
all. The 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
out ability to enter into collaborative relationships with business partners,
make it more difficult to obtain required financing on favorable terms or at
all, 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.
There
is
a risk that one or more of our creditors could bring lawsuits to collect amounts
to which they believe they are entitled. In the event of lawsuits of this type,
if we are unable to negotiate settlements or satisfy our obligations, we could
voluntarily file bankruptcy proceedings, or we could become the subject of
an
involuntary bankruptcy proceeding filed by one or more creditors against
us.
Note
2: Comprehensive Income (Loss)
Comprehensive
income (loss) generally represents all changes in stockholders’ deficit except
those resulting from investments or contributions by stockholders. The Company’s
unrealized foreign currency translation (“FCT”) adjustments represent the only
components of comprehensive loss that are excluded from the Company’s net
loss.
7
Cellegy
Pharmaceuticals, Inc.
(a
development stage company)
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Total
comprehensive income (loss) during the three and six months ended June 30,
2006
and 2005 consisted of (in thousands):
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Net
income (loss) after discontinued operations
|
$
|
(1,251
|
)
|
$
|
4,835
|
$
|
(3,661
|
)
|
$
|
(251
|
)
|
||
Change
in FCT adjustments
|
157
|
(18
|
)
|
123
|
(17
|
)
|
|||||||
Comprehensive
income (loss)
|
$
|
(1,094
|
)
|
$
|
4,817
|
$
|
(3,538
|
)
|
$
|
(268
|
)
|
Note
3: Basic and Diluted Net Income (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 statement 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,
|
Six
Months Ended June 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Options
|
3,659
|
197
|
3,289
|
4,494
|
|||||||||
Warrants
|
2,375
|
1,429
|
2,375
|
2,375
|
|||||||||
Total
number of shares excluded
|
6,034
|
1,626
|
5,664
|
6,869
|
Excluded
also are 2,121,212 shares that would be issuable upon conversion of the PDI
Notes in 2006 (see also Note 11).
Note
4: Stock-Based Compensation
The
Company’s stock holders approved the 2005 Equity Incentive Plan (the “2005
Plan”) at the Annual Meeting of Stockholders held September 28, 2005. The 2005
Plan replaces the 1995 Equity Incentive Plan (“Prior Plan”) which had expired.
The 2005 Plan will be administered by the Board of Directors and the Board
has
delegated administration of the Plan to the Compensation Committee. The Board
may at any time amend, alter, suspend, or discontinue the 2005 Plan without
stockholder approval, except as required by applicable law. The 2005 Plan is
not
subject to ERISA and is not qualified under Section 401(a) of the Code.
The
Company’s 2005 Plan allows for the granting of options to employees, directors
and consultants. Options granted under the 2005 Plan may either be incentive
stock options or non-qualified stock options. Incentive stock options may be
granted only to employees. The Compensation Committee determines who will
receive options or other awards under the 2005 Plan and their terms, including
the exercise price, number of shares subject to the option or award, and the
vesting and exercisability thereof. Options granted under the 2005 Plan
generally have a term of ten years from the grant date, and the exercise price
typically is equal to the closing price of the common stock on the grant date.
Options typically vest over a three-year or four-year period. Options granted
under the 2005 Plan typically expire if not exercised within 90 days from the
date on which the optionee is no longer an employee, director, or consultant.
The vesting and exercisability of options may also be accelerated upon certain
change of control events. As of June 30, 2006 there were outstanding options
to
purchase 48,000 shares under the 2005 Plan and 952,000 shares were available
for
options for other awards under the 2005 Plan.
8
The
total
number of shares reserved and available for issuance pursuant to the exercise
of
Awards under the Prior Plan is 4,850,000 shares. The Prior Plan will continue
to
govern the stock options previously granted under the Prior Plan. The terms
and
conditions of the Prior Plan are substantially the same as the ones governing
the 2005 Plan.
In
1995,
Cellegy adopted the 1995 Directors’ Stock Option Plan (the “Directors’ Plan”) to
provide for the issuance of non-qualified stock options to eligible outside
Directors. When the plan was established, Cellegy reserved 150,000 shares for
issuance. From 1996 to 2005, a total of 350,000 shares were reserved for
issuance under the Directors’ Plan. The 2005 Plan replaces the Directors’
Plan.
The
Directors’ Plan provides for the granting of initial and annual non-qualified
stock options to non-employee directors. Initial options vest over a four-year
period and subsequent annual options vest over three years. The exercise of
options granted under the “Directors’ Plan” is the fair market value of the
common stock on the grant date. Options generally expire ten years from the
grant date, and generally expire within 90 days of the date the optionee is
no
longer a director. The vesting and exercisability of options under this plan
may
also be accelerated upon certain change of control events.
The
compensation expense and related income tax benefit recognized in the
Consolidated Statement of Operations in the second quarter of 2006 and the
second quarter of 2005 for stock options were $40,000 and $0, respectively.
The
impact on earnings per share was $0.001 per share for the second quarter of
2006. Of the $40,000 of stock option compensation expense recognized in the
second quarter of fiscal 2006, $35,000 was a component of selling, general
and
administrative expenses and $5,000 was a component of research and development
expenses. None of the compensation costs were capitalized. No options were
granted under all share-based payment arrangements for the quarter ended June
30, 2006. All of the compensation expense was derived by calculating the fair
value of the unvested portion of all stock options issued after the first fiscal
year beginning after December 15, 1994.
The
Company continues to estimate the fair value of each option award on the date
of
granting using the Black-Scholes option valuation model. The company now
estimates option forfeitures based on historical data and adjusts the rate
to
expected forfeitures periodically. The adjustment of the forfeiture rate will
result in a cumulative catch-up adjustment in the period the forfeiture estimate
is changed.
Substantially
all of the options granted and vested by Cellegy are at exercise prices above
the current per share value of $0.65 as of June 30, 2006. Those options with
exercise prices above $0.65 have no intrinsic value. However, the options
granted in October 2004, in connection with Biosyn acquisition have an aggregate
intrinsic value of $14,186 (see Biosyn options table).
The
fair
value of each option calculated during the second quarter of 2005 was estimated
on the date of grant using the Black-Sholes option valuation model and
weighted-average assumptions in the following table.
Three
Months
Ended
June
|
||||||
2005
|
||||||
Expected
life in years
|
4.3
|
|||||
Expected
volatility
|
81
|
%
|
||||
Risk-free
interest rate
|
4.00
|
%
|
||||
Dividend
yield
|
0
|
%
|
The
status of the Company’s stock option plans at June 30, 2006, is summarized
below:
2005
Equity Incentive Plan
Shares
Under
Option
|
Weighted
Average
Exercise
Price
|
||||||
Balance
at December 31, 2005
|
49,500
|
$
|
1.34
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
(1,500
|
)
|
(1.39
|
)
|
|||
Exercised
|
-
|
-
|
|||||
Balance
at March 31, 2006
|
48,000
|
$
|
1.34
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
-
|
-
|
|||||
Exercised
|
-
|
-
|
|||||
Balance
at June 30, 2006
|
48,000
|
$
|
1.34
|
9
The
following table summarizes those stock options outstanding related to the 2005
Plan at June 30, 2006:
Options
Outstanding
|
||||||||
Range
of Exercise Prices
|
Weighted
Average
Number
of Options
|
Weighted
Average
Remaining
Contract
Life
|
Exercise
Price
|
|||||
$ |
1.34
|
48,000
|
9.25
years
|
$
|
1.34
|
There
were no options exercisable under the 2005 plan as of June 30, 2006. None of
the
options vested in the quarter ended June 30, 2006.
Prior
Plan
Shares
Under
Option
|
Weighted
Average
Exercise
Price
|
||||||
Balance
at December 31, 2005
|
2,238,737
|
$
|
4.67
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
(138,790
|
)
|
(5.54
|
)
|
|||
Exercised
|
-
|
-
|
|||||
Balance
at March 31, 2006
|
2,099,947
|
$
|
4.61
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
(180,353
|
)
|
(2.33
|
)
|
|||
Exercised
|
-
|
-
|
|||||
Balance
at June 30, 2006
|
1,919,594
|
$
|
4.83
|
The
following table summarizes those stock-options outstanding and exercisable
related to the Prior Plan at June 30, 2006:
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Range
of Exercise Prices
|
Weighted
Average Number of Options
|
Weighted
Average
Remaining
Contractual
|
Weighted
Average
Exercise
Price
|
Number
of
Options
|
Weighted
Average
Exercise
Price
|
|||||||||||
$1.35
- $2.03
|
435,660
|
4.3
years
|
$
|
1.79
|
364,393
|
$
|
1.80
|
|||||||||
$2.89
- $3.88
|
516,434
|
2.6
years
|
3.52
|
477,268
|
3.57
|
|||||||||||
$4.38
- $6.50
|
473,500
|
1.8
years
|
5.06
|
456,625
|
5.08
|
|||||||||||
$7.00
- $8.81
|
441,000
|
1.9
years
|
7.90
|
441,000
|
7.90
|
|||||||||||
$15.00
|
53,000
|
2.2
years
|
15.00
|
53,000
|
15.00
|
|||||||||||
Total
|
1,919,594
|
2.3
years
|
$
|
4.83
|
1,792,286
|
$
|
5.00
|
No
future
options may be offered under the Prior Plan. In the quarter ended June 30,
2006
there were 1,263 options vesting with a total fair value of
$333.
10
Directors’
Stock Option Plan
Shares
Under
Option
|
Weighted
Average
Exercise
Price
|
||||||
Balance
at December 31, 2005
|
307,500
|
$
|
4.74
|
||||
Granted
|
-
|
-
|
|||||
Exercised
|
-
|
-
|
|||||
Balance
at March 31, 2006
|
307,500
|
$
|
4.74
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
(2,000
|
)
|
(8.50
|
)
|
|||
Exercised
|
-
|
-
|
|||||
Balance
at June 30, 2006
|
305,500
|
$
|
4.72
|
The
following table summarizes those stock options outstanding and exercisable
related to the Directors’ Plan at June 30, 2006:
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Range
of Exercise Prices
|
Weighted
Average Number of Options
|
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
Number
of
Options
|
Weighted
Average
Exercise
Price
|
||||||||||
$1.34
- $3.25
|
35,000
|
4.9
years
|
$
|
2.62
|
35,000
|
$
|
2.62
|
|||||||||
$4.30
- $5.50
|
254,500
|
3.2
years
|
4.90
|
234,500
|
4.95
|
|||||||||||
$6.50
- $8.50
|
16,000
|
2.3
years
|
6.50
|
16,000
|
6.50
|
|||||||||||
Total
|
305,500
|
3.2
years
|
$
|
4.72
|
285,500
|
$
|
4.75
|
As
of
June 30, 2006, there were no options available for future grants under the
Directors’ Plan. In the quarter ended June 30, 2006 there were 16,000 options
vesting with a total fair value of $1,286.
Non-Plan
Options
In
November 2003, the Company granted an initial stock option to Mr. Richard C.
Williams, on his appointment to become Chairman of the Board, to purchase
1,000,000 shares of common stock. 400,000 of the options have an exercise price
equal to $2.89 per share, the closing price of the stock on the grant date
and
600,000 of the options have an exercise price of $5.00 per share. The option
was
vested and exercisable in full on the grant date, although a portion of the
option covering up to 600,000 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 a director within certain future time
periods. As of June 30, 2006, none of these options have been
exercised.
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 2005, 74,446 options were exercised and 99,162 were
cancelled. There were 3,171 options exercised in the quarter ended June 30,
2006
providing $445 in cash.
11
The
following table summarizes information about stock options outstanding and
exercisable related to Biosyn option grants at June 30, 2006:
Options
Outstanding and Exercisable
|
|||||||||||||
Range
of Exercise Prices
|
Number
of Options
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
Intrinsic
Value
|
|||||||||
$0.06
|
9,816
|
2.6
years
|
$
|
0.06
|
$
|
5,807
|
|||||||
$0.29
|
23,401
|
8.1
years
|
0.29 |
8,379
|
|||||||||
$1.46
- $6.83
|
8,564
|
9.1
years
|
1.46 |
-
|
|||||||||
$8.76
|
3,855
|
6.6
years
|
8.76 |
-
|
|||||||||
$14.60
- $21.02
|
18,503
|
3.6
years
|
18.68 |
-
|
|||||||||
Total
|
64,139
|
6.0
years
|
$
|
6.23
|
$
|
14,186
|
Options
outstanding under the Company’s current plans have been granted at prices which
are either equal to or above the market value of the stock on the date of grant.
Options granted under the 2005 Plan generally vest over three to four years
based on service conditions and expire no later than ten years after the grant
date. Effective January 1, 2006, the Company generally recognizes compensation
expense ratably over the vesting period (service period). As of June 30, 2006,
there was $173,000 of total unrecognized compensation cost related to non-vested
options, which is expected to be recognized over a remaining weighted-average
vesting period of 1.5 years.
Warrants
The
Company has the following warrants outstanding to purchase common stock as
of
June 30, 2006:
Warrant
Shares
|
Exercise
Price
Per
Share
|
Date
Issued
|
Expiration
Date
|
||||||||||
June
2004 PIPE Financing
|
604,000
|
$
|
4.62
|
July
27, 2004
|
July
27, 2009
|
||||||||
Biosyn
warrants
|
81,869
|
5.84-17.52
|
Oct.
22, 2004
|
2008
- 2014
|
|||||||||
Kingsbridge
SSO
|
260,000
|
5.27
|
Jan.
16, 2004
|
Jan.
16, 2009
|
|||||||||
May
2005 PIPE Financing
|
|||||||||||||
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
|
2,374,593
|
Shares
Reserved
As
of
June 30, 2006, the Company has reserved shares of common stock for issuance
as
follows:
Biosyn
options
|
64,139
|
|||
Director's
Plan
|
305,500
|
|||
Warrants
|
2,374,593
|
|||
Non-plan
options
|
1,000,000
|
|||
Neptune
agreement
|
1,080,082
|
|||
Kingsbridge
SSO
|
3,493,601
|
|||
1995
Equity Incentive Plan
|
1,919,594
|
|||
2005
Equity Incentive Plan
|
952,000
|
|||
Total
|
11,189,509
|
12
Note
5: Segment Reporting
The
Company had two business segments: pharmaceuticals and skin care. The skin
care
segment was sold in December 2005. Pharmaceuticals include primarily research
and clinical development expenses for potential prescription products to be
marketed directly by Cellegy or through corporate partners.
All
revenues during the three and six months periods ended June 30, 2006 of
$1,227,000 and $2,463,000, respectively, were derived from the Company’s
pharmaceutical segment. Current pharmaceutical revenues consist primarily of
Rectogesic® product sales in Singapore, United Kingdom and South Korea, grant
revenue from research and clinical development trials as well the ProStrakan
license revenues for Rectogesic and Tostrex® products.
Revenues
from external sources by major geographic area are as follows (in
thousands):
Revenues
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
North
America Pharmaceuticals
|
$
|
912
|
$
|
955
|
$
|
1,827
|
$
|
2,168
|
|||||
Europe
Pharmaceuticals
|
315
|
6,658
|
636
|
6,898
|
|||||||||
Revenue
from continuing operations
|
$
|
1,227
|
$
|
7,613
|
$
|
2,463
|
$
|
9,066
|
Operating
Income (loss) by geographic region is as follows (in
thousands):
Operating
Income (Loss)
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
North
America Pharmaceuticals
|
$
|
(879
|
)
|
$
|
602
|
$
|
(2,721
|
)
|
$
|
(72
|
)
|
||
Europe
Pharmaceuticals
|
(303
|
)
|
4,195
|
(947
|
)
|
(230
|
)
|
||||||
Operating
income (loss) from continuing operations
|
$
|
(1,182
|
)
|
$
|
4,796
|
$
|
(3,668
|
)
|
$
|
(302
|
)
|
All
of
the Company’s assets are related to the pharmaceutical segment and are located
in the United States.
Assets
by
major geographic region are as follows (in thousands):
Assets
|
Period
Ended June 30,
|
||||||
2006
|
2005
|
||||||
North
America
|
$
|
1,833
|
$
|
8,462
|
13
Note
6: Recent Accounting Pronouncements
Effective
January 1, 2006, the Company began recording compensation expense associated
with stock options and other forms of equity compensation in accordance with
Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based
Payment (SFAS
123R), as interpreted by SEC Staff Accounting Bulletin No. 107. Prior to January
1, 2006, the Company accounted for stock options according to the provisions
of
Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees (APB
25),
and related interpretations, and therefore no related compensation expense
was
recorded for awards granted with no intrinsic value. The Company adopted the
modified prospective transition method provided for under SFAS 123R and,
consequently, has not retroactively adjusted results from prior periods. Under
this transition method, compensation cost associated with stock options
recognized in the first six months of 2006 includes: 1) amortization related
to
the remaining unvested portion of all stock option awards granted prior to
January 1, 2006, based on the grant date fair value estimated in accordance
with
the original provisions of SFAS 123, Accounting
for Stock-Based Compensation;
and 2)
amortization related to all stock option awards granted on or subsequent to
January 1, 2006, based on the grant-date fair value estimated in accordance
with
the provisions of SFAS 123R.
As
a
result of the adoption of SFAS 123R, the Company’s net loss for the quarter
ended June 30, 2006, was $40,000 higher than under the Company’s previous
accounting method for share-based compensation.
Prior
to
the adoption of SFAS 123R, the Company presented all tax benefits resulting
from
the exercise of stock options as operating cash flows in the Condensed
Consolidated Statement of Cash Flows. SFAS 123R requires that cash flows
resulting from tax deductions in excess of the cumulative compensation cost
recognized for options exercised (excess tax benefits) be classified as
financing cash flows. The Company has sufficient net operating loss
carryforwards to generally eliminate cash payments for income taxes. Therefore,
no cash has been retained as a result of excess tax benefits relating to share
based payments made to directors and employees.
For
stock
options granted prior to the adoption of SFAS 123R, if compensation expense
for
the Company’s various stock option plans had been determined based upon
estimated fair values at the grant dates in accordance with SFAS No. 123, the
Company’s pro forma net loss and basic and diluted income per common share would
have been as follows (in thousands):
Three
Months Ended
June
30, 2005
|
Six
Months Ended June
30, 2005 |
||||||
Net
loss, as reported
|
$
|
4,835
|
$
|
(251
|
)
|
||
Deduct:
Stock-based employee compensation costs determined
under the fair value method
|
(99 | ) | (266 | ) | |||
Pro-forma
net loss
|
$
|
4,736
|
$
|
(517
|
)
|
||
Basic
net income (loss) per share:
|
|||||||
As
reported
|
$
|
0.17
|
$
|
(0.01
|
)
|
||
Pro-forma
|
$
|
0.17
|
$
|
(0.02
|
)
|
||
Diluted
net income (loss) per share:
|
|||||||
As
reported
|
$
|
0.16
|
$
|
(0.01
|
)
|
||
Pro-forma
|
$
|
0.16
|
$
|
(0.02
|
)
|
On
January 1, 2006, the Company adopted FASB Statement 154, Accounting Changes
and
Error Corrections, a replacement of APB Opinion No. 20 and FASB Statement No.
3,
which changes the requirements for the accounting for and reporting of a change
in accounting principle. There was no effect upon the Company’s financial
statements as a result of the adoption of this pronouncement.
In
June
2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes - an interpretation of FASB Statement No. 109”, which becomes
effective for fiscal years beginning December 15, 2006. The interpretation
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected
to be
taken in a tax return. The Company is currently studying this interpretation
to
determine the effect, if any, on the Company’s consolidated financial
statement.
14
Note
7: Accounts Receivable
At
June
30, 2006 and December 31, 2005 accounts receivable consist of the following
(in
thousands):
Period
Ended
|
|||||||
June
30, 2006
|
December
31, 2005
|
||||||
Unbilled
grant receivable
|
$
|
515
|
$
|
760
|
|||
Trade
receivables
|
205 | 265 | |||||
Other
receivables
|
- | 60 | |||||
Total
|
$
|
720
|
$
|
1,085
|
Note
8: Prepaid Expenses and Other Current Assets
At
June
30, 2006 and December 31, 2005 this account includes the folowing (in
thousands):
Period
Ended
|
|||||||
June
30, 2006
|
December
31, 2005
|
||||||
Prepaid
insurance
|
$
|
122
|
$
|
196
|
|||
Prepaid
rent
|
- | 35 | |||||
Prepaid
compensation
|
- | 803 | |||||
Inventory
|
- | 351 | |||||
Other
|
2 | 44 | |||||
Total
|
$
|
124
|
$
|
1,429
|
Prepaid
compensation of $803,000 represents the unamortized balance of $902,000 in
retention payments offered and accepted by employees in March and December
2005.
The retention payments would be paid if the employee maintains his or her
employment with the Company through the retention period indicated in the
individual’s offer letter. The retention payment is in lieu of all other
severance or similar payments that the Company may be obligated to make under
any other existing agreement, arrangement or understanding, but will be in
addition to any accrued salary and vacation earned through the date of
termination. The retention periods terminate on dates between January 15,
2006
and June 30, 2006.
Note
9: Accrued
Expenses and Other Current Liabilities
The
Company accrues for goods and services received but for which billings have
not
been received. Accruals for the following expenses and other current liabilities
were made for the following expenses (in thousands):
Period
Ended
|
|||||||
June
30, 2006
|
December
31, 2005
|
||||||
Clinical
expenses
|
$
|
494
|
$
|
642
|
|||
Legal
fees
|
87 | 61 | |||||
Retention
and severance pay
|
327 | 1,039 | |||||
Consulting
fees
|
14 | 46 | |||||
Kingsbridge
contract penalty
|
266 | - | |||||
Other
|
125 | 614 | |||||
Total
|
$
|
1,313
|
$
|
2,402
|
Note
10: Deferred Revenue
The
Company records upfront payments received from licensees as deferred revenue
and
amortize them to income over the life of the licensing agreement or the life
of
the product being licensed, whichever is longer. At June
30,
2006 total current and long-term deferred revenue of $3,259,000 substantially
includes the remaining unearned portion of the upfront licensing fees received
from ProStrakan for the right to store, promote, sell and/or distribute the
Company’s Tostrex and Rectogesic products.
15
Note
11: Notes Payable
Notes
payable at June 30, 2006 include two non-interest bearing notes issued in April
2005 by Cellegy to PDI pursuant to a lawsuit settlement signed by both parties
in April 2005, and the note issued by Biosyn to Ben Franklin Technology Center
of Southeastern Pennsylvania (Ben Franklin) in October 1992 for funds provided
by Ben Franklin for the development of a compound to prevent transmission of
AIDS. The notes have been recorded at their total net present value of
$5.4 million.
The
terms
of the notes issued to PDI are as follows:
a.)
The
$3.0
million secured promissory note has an outstanding balance of $2.6 million
and a
net present value of $2.5 million at June 30, 2006 and is payable in October
2006. There is no stated interest rate and no periodic payments are
required. Payment terms include payments to the extent of 50% of future
funds to be received by Cellegy as licensing fees, royalties or milestone
payments or similar payments from licensees of Cellegy’s Tostrex® (testosterone
gel) and Rectogesic® (nitroglycerin ointment) products in territories outside of
North America, 50% of licensing fees, royalties or milestone payments or similar
payments from Fortigel licensees in North American markets, and 10% of proceeds
received by Cellegy in excess of $5 million from financings. These various
payments will be made until the note is paid in full. However, no regular
periodic payments are required. The note is subject to a default interest rate
of 12%.
b.)
The
$3.5
million non-negotiable senior convertible debenture stated at its net present
value of $2.7 million has a maturity date of April 11, 2008, three years from
the PDI settlement date of April 11, 2005. There is no stated interest rate
and
no periodic payments are required. Cellegy may redeem the note at anytime before
the maturity date upon prior notice to PDI, at a redemption price equal to
the
principal amount. If Cellegy delivers such a redemption notice, PDI may convert
the note into shares of Cellegy common stocks at a price of $1.65 per share.
In
addition, after the 18th
month
anniversary of the debenture, PDI may convert the note into Cellegy common
stock
at a price of $1.65 per share. If Cellegy does redeem the note within the first
18 months, then Cellegy has agreed to file a registration statement relating
to
the possible resale of any shares issued to PDI after 18 months; approximately
2.1 million shares would be issuable upon such conversion. As long as amounts
are owed under the note, Cellegy has agreed not to incur or become responsible
for any indebted ness that ranks contractually senior or pari passu in right
of
payment to amounts outstanding under the note. Events of default under the
senior note are generally similar to events of default under the secured
note.
The
net
present value of the secured $3.0 million note will be recalculated based on
its
remaining principal whenever a payment is made by Cellegy.
The
Ben
Franklin note has a face value of $778,000 and net present value of $257,000
at
June 30, 2006. The note has no scheduled repayment term. Payment is
based on 3% of Biosyn’s revenues excluding other research and development
grants.
At
June
30, 2006, future minimum payments on the notes were payable as follows (in
thousands):
2006
|
$
|
2,592
|
||
2007
|
-
|
|||
2008
|
3,500
|
|||
2009
and thereafter
|
778
|
|||
Total
payments
|
6,870
|
|||
Less:
Amount represending discount
|
(1,460
|
)
|
||
Net
present value of notes at June 30, 2006
|
$
|
5,410
|
Note
12: Derivative Instruments
The
warrants from the May 2005 PIPE financing and Kingsbridge SSO 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 liability at June 30, 2006 and December 31, 2005 was
$167,000 and $193,000. The changes in the estimated fair value of the warrants
have been recorded as other income and expense in the income statement. For
the
three and sixth months ended June 30, 2006, the Company recognized a $80,000
income and $25,000 income, respectively from derivative revaluation.
16
Note
13: Discontinued Operations
On
April
11, 2006, pursuant to a share purchase agreement (SPA) between Cellegy
Pharmaceuticals, Inc. (Cellegy) and Epsilon Pharmaceuticals Pty Ltd (Epsilon),
an Australian company located in New South Wales, Australia, Epsilon purchased
all of the shares of Cellegy Australia Pty Ltd, a wholly-owned subsidiary of
Cellegy. The subsidiary was part of the Pharmaceutical Segment for the
Australian and Pacific Rim geographic areas. The purchase price for the shares
was $1,000,000 plus amounts equal to the liquidated value of Cellegy Australia's
cash, accounts receivable and inventory. The total amount received was
approximately $1.331 million. Below is a summary of the assets and liabilities
included in the sale (dollar amounts in thousands):
Current
assets
|
|
$
|
308
|
|
Goodwill
|
955
|
|||
Current
liabilities
|
262
|
Cellegy
recorded a pre-tax gain of approximately $88,000 reflected in gain (loss)
on
disposal. There was no income tax effect to this transaction as Cellegy had
a
full valuation on its deferred taxes and more than likely will not pay any
taxes
on the transaction.
Cellegy's
discontinued operations reflect the operating results for the disposal group
through the date of disposition and recognize the subsidiary's foreign currency
translation (FCT) balance as a loss in the current period pursuant to FAS 52
(Foreign Currency Translation). Below is a summary of those results (dollar
amounts in thousands):
Three
Months Ended June 30,
|
Six
Months Ended June 30
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Net
revenue
|
$
|
-
|
$
|
136
|
$
|
166
|
$
|
288
|
|||||
Cost
of revenues
|
18
|
$
|
27
|
39
|
|||||||||
Gross
Profit
|
-
|
118
|
139
|
249
|
|||||||||
R&D
expenses
|
-
|
3
|
-
|
22
|
|||||||||
S,
G & A expenses
|
-
|
79
|
65
|
182
|
|||||||||
Operating
income
|
-
|
36
|
75
|
45
|
|||||||||
Interest
income
|
-
|
3
|
2
|
6
|
|||||||||
Gain(loss)
on disposal
|
(69
|
)
|
|
-
|
(69
|
)
|
-
|
||||||
Income(loss)
from discontinued operations
|
$
|
(69
|
)
|
$
|
39
|
$
|
7
|
$
|
51
|
Note
14: Commitments and Contingencies
Legal
Proceedings
On
December 2, 2005, PDI filed suit in United States District Court for the
Southern District of New York requesting that the court declare that Cellegy
has
breached its obligations under the settlement agreement, order Cellegy to
specifically perform its obligations under the settlement agreement, and award
PDI damages in the amount of $6.4 million plus default interest as well as
certain other amounts.
On
July
13, 2006, PDI filed a “Stipulation of Dismissal Without Prejudice” in United
States District Court for the Southern District of New York pursuant to which
the case has been dismissed. Because the dismissal is without prejudice,
however, it is possible that PDI may reinstitute proceedings for the same claims
in the future.
Note
15: Subsequent Events
None
17
ITEM
2.
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
audited financial statements for the year ended December 31, 2005 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 Operation,” “ Risk Factors” 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.
General
Cellegy
Pharmaceuticals is a development stage specialty biopharmaceutical company
engaged in the development and commercialization primarily of prescription
drugs
targeting women’s health care conditions, including HIV prevention and sexual
dysfunction, as well as gastrointestinal conditions using proprietary topical
formulations and nitric oxide donor technologies.
Recent
Events
On
January 16, 2006 Cellegy entered into an amendment of its Exclusive License
and
Distribution Agreement dated July 9, 2004, with Strakan International Limited
(“ProStrakan”), whereby ProStrakan will assume responsibility for all of the
manufacturing and other product support functions for Tostrex in
Europe.
On
February 1, 2006, Cellegy announced that it had entered into a non-exclusive,
developing world licensing agreement with CONRAD for the collaboration on the
development of Cellegy’s entire microbicide pipeline. The agreement encompasses
the licensing of Savvy currently in Phase 3 clinical trials in the United States
and Africa; UC-781, currently in expanded Phase 1 trials in the United States
and Thailand; and Cyanovirin-N, currently in pre-clinical
development.
On
March
24, 2006, the Company announced that ProStrakan had successfully completed
the
European Union Mutual Recognition Procedure for Rectogesic. Following the
successful conclusion of the MRP process, national licenses will be sought
and
are expected to be issued in due course in the 19 additional countries (in
addition to the United Kingdom where approvals have been previously obtained)
included in the MRP submission application. Cellegy received $250,000 for this
milestone and, under its previous agreement with PDI, remitted one-half of
these
proceeds to PDI.
On
April
11, 2006, Epsilon Pharmaceuticals, acquired all of the shares of Cellegy
Australia PTY LTD (“Australia”), formerly a wholly owned subsidiary of Cellegy,
in exchange for cash totaling approximately $1.33 million.
On
April
25, 2006, the Cardiovascular Renal Drugs Advisory Committee (the “Committee”) of
the US Food and Drug Administration (“FDA”) met to review the Company’s New Drug
Application relating to Cellegesic. The Committee voted on three questions
in
connection with its review with the following results:
1. |
A
majority of the Committee agreed that the quadratic model was the
proper
analysis for the purpose of decision-making.
|
2. |
A
majority of the Committee found that, taking all three studies into
consideration, the data is compelling that there is an effect of
nitroglycerin ointment on the pain associated with anal
fissures.
|
3. |
In
its final vote, six members of the Committee voted for “Approval” of
Cellegesic and six voted “Approvable pending another study of
effectiveness.” There were no votes for “Not
Approvable.”
|
18
On
June 20, 2006, the Company amended its license agreement with ProStrakan
concerning Rectogesic. The amendment adds several countries and territories
in
Eastern Europe, including several countries and territories that were part
of
the former Soviet Union, to the territories covered by the original agreement.
As part of the amendment, ProStrakan paid to Cellegy the sum of $500,000 on
July
3, 2006, representing a prepayment of the milestone due upon approval of
Rectogesic in certain major European countries. Following the payment described
above, ProStrakan has no further payment obligations to Cellegy under the
Rectogesic license agreement. Pursuant to its previous agreements with PDI,
Cellegy remitted one-half of these proceeds to PDI.
On
July
7, 2006, the FDA issued an Approvable Letter for Cellegy’s product, Cellegesic®
(nitroglycerin ointment) indicating that before the Company's New Drug
Application ("NDA") may be approved and the product approved for marketing,
Cellegy must conduct another clinical trial to demonstrate efficacy at a level
deemed statistically significant by the agency. The letter indicated that the
agency was requiring an additional study because it believed the results of
the
three trials conducted to date did not provide substantial evidence that the
drug is effective, and provided a number of comments on the results previously
presented by Cellegy and recommendations concerning the design and protocol
of
the additional required study. The Company is presently reviewing its options
with respect to Cellegesic and is planning a meeting with the FDA.
Results
of Operations
Note
that
the operations of Cellegy Australia, for the three and six month periods ended
June 30, 2005 and 2006 are shown as discontinued operations due to the
disposition of Cellegy Australia in April of 2006.
Revenues.
The Company had revenues of $1,227,000 and $7,613,000 for the three months
ended
June 30, 2006 and 2005, respectively. For the corresponding six month
periods, revenues were $2,463,000 and $9,066,000, respectively.
Licensing
revenues. Licensing
revenue consists primarily of amortization of upfront payments received from
licensees in connection with the Company’s existing licensing agreements. The
Company recorded revenues of $315,000 and $6,519,000 for the three months ended
June 30, 2006 and 2005, respectively. The 2005 amount is comprised primarily
of
deferred revenue recognized upon the termination of the Company’s agreement with
PDI in connection with the April 2005 settlement of the companies’ respective
lawsuits.
Product
Sales.
The Company had no product sales for the three months ended June 30, 2006
and $139,000 for the three months ended June 30, 2005, which consisted primarily
of Rectogesic sales to ProStrakan in connection with its launch of the product
in the UK. Sales for the six month period of the current year include in process
and other inventory purchases by ProStrakan in conjunction with their
acquisition of the European marketing rights to Rectogesic in late 2005.
Grant
Revenues.
Grant
revenues were $912,000 and $955,000 for the three months ended June 30, 2006
and
2005, respectively. As a result of the Company’s granting of a
non-exclusive research license to CONRAD, the transfer of the grants relating
to
the UC-781 and CV-N technologies and the licensors’ transfer of the license to
CONRAD, the Company expects that grant revenues (and related expenses) will
decrease significantly over the balance of the year. Grant revenues for the
respective six month periods were $1,827,000 and $2,168,000 due to a decline
in
laboratory research activities in 2006 for CVN and UC-781 product
candidates.
The
level
of grant funding under the various grant arrangements is generally dependent
upon the amount of direct labor (primarily laboratory personnel) and direct
expenses such as supplies, testing services and other direct costs expected
to
be incurred in connection with the given program over its duration. The grant
agreements generally provide for an overhead percentage that is applied to
the
direct labor costs. These amounts, along with the amounts billed to the grantor
for direct costs comprise the total amount billed and recorded as grant revenue.
Grant agreements undergo periodic renegotiation and it is the prerogative of
granting agency or foundation to determine the level and duration of future
funding of Cellegy’s programs. There can be no assurance that Cellegy will be
able to maintain grant funding at current levels or at levels necessary to
properly fund its research programs.
In
addition to the grants funding above, 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.
19
Research
and Development Expenses.
The Company has significantly curtailed its research activities due to capital
shortages. The Company has sought and will continue to seek partners to assist
in the funding of its research programs and it may also seek to sell or
out-license its technology in exchange for funding. There can be no assurance
that the Company will find suitable terms or arrangements, if any, to fund
its
research programs.
For
the
three months ended June 30, 2006 and 2005, research and development expenses
were $800,000 and $2,280,000, respectively. The decrease is comprised of a
$770,000 decrease in professional fees, primarily clinical and consulting fees
and a decrease in personnel and related costs of $620,000 due to staff
reductions.
Research
and development expenses were $1,906,000 and $5,038,000 for
the
six month periods ended June 30, 2006 and 2005, respectively. The decrease
is
due primarily to a reduction in salaries of $771,000 due to staffing reductions
at the parent level and
reductions in clinical and related costs of $1,725,000 in connection with the
research of Savvy.
Selling,
General and Administrative Expenses.
Selling, general and administrative (“SG&A”) expenses during the three
months ended June 30, 2006 and 2005 were $1,472,000 and $378,000, respectively.
For the year 2005, SG&A includes a $1,090,000 early lease termination
payment made to the Company and offsetting expense reimbursements from the
sublet of its previous facilities.
For
the
six month periods ended June 30, 2006 and 2005, SG&A expenses were
$3,571,000 and $4,293,000, respectively. For the six month period ended June
30,
2005, SG&A expenses include a $1,090,000 gain arising from income received
for the early vacation of the Company’s previous headquarters. For the first six
months of 2006, professional fees declined $1,659,000 due to a decrease in
litigation expenses and accounting fees. The Company expects SG&A expenses
to decline for the remainder of 2006.
Other
Income (Expense).
Interest expense for the six month period in 2006 increased $226,000 primarily
due to accretion relating to the PDI notes. Interest income declined during
the
same period due to the decrease in the Company’s cash balance. Derivatives
expense decreased in 2006 due to the downward fluxuation in the Company’s stock
prices.
Liquidity
and Capital Resources
Cash
and
cash equivalents were $651,000 at June 30, 2006, as
compared with $2,251,000 at December 31, 2005. Cash used in operations
during the six month period of 2006 was $2,537,000 as compared to $10,442,000
during the same period in the prior year. Operations in 2005 included the
recognition of $6,500,000 in deferred revenue associated with the PDI
settlement. Additionally in 2005, the Company made a cash payment to PDI of
$2,000,000 upon settlement of the litigation. Other assets changed by $1,012,000
due to the April 2006 divestiture of the Company’s Australian business unit
which generated approximately $1,012,000 in investing activity proceeds.
Financing
activities in 2005 include the May 2005 private placement financing.
The
overall use of cash declined in 2006 due to a lower level of clinical research
and commercialization activity expenses, staffing reductions and reductions
in
litigation expenses and in other professional fees.
We
prepared the financial statements assuming that we will continue as a going
concern, which contemplates the realization of assets and satisfaction of
liabilities and commitments in the normal course of business. At June 30, 2006,
we had a deficit accumulated during the development stage from continuing
operations of $136.0 million, negative cash flows from operations of $98.7
million, and cash and cash equivalents of $651,000. We expect negative cash
flow
from operations to continue for the foreseeable future. At present, our revenues
from existing licensing arrangements, funding agreements and other sources
are
not sufficient to offset our ongoing operating expenses or to pay in full our
current obligations reflected in our financial statements. We believe we do
not
have sufficient financial resources to continue operations beyond September
2006, without additional funds obtained from one or more of the options
discussed below. These factors raise substantial doubt about our ability to
continue as a going concern.
Our plans, with regard to these matters, include raising additional required
funds through one or more of the following options, among others: sales of
all
or part of our assets, including intellectual property and technologies, seeking
partnerships with other pharmaceutical companies or with private foundations
to
co-develop and fund our research and development efforts, pursuing additional
out-licensing arrangements with third parties, re-licensing and monetizing
in
the near term our future milestone and royalty payments expected from existing
licensees and seeking equity or debt financing. The Company is in discussions
with third parties concerning sales of assets, intellectual property or
technologies and other options discussed above, but there is no assurance that
any of the above options will be implemented on a timely basis or that we will
be able to obtain additional funds required to continue operations. Doubts
about
our ability to continue as a going concern could adversely affect our ability
to
enter into one or more of the possible transactions described above, make it
more difficult to obtain required financing on favorable terms or at all,
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. Even if we are successful in entering into one or more of the
options described above, we may be required to accept less than favorable
commercial terms. In addition, we have made significant staff reductions and
will continue to implement further cost reduction programs and reduce
discretionary spending, if necessary.
20
Failure
to obtain required funds to continue operations could require us to seek
protection under the bankruptcy laws or be subject to an involuntary bankruptcy
proceeding filed by one or more creditors. Even if funds are obtained to
continue operations, failure to obtain adequate additional funds could require
us to delay development or commercialization of certain products, to license
to
third parties the rights to commercialize certain products that we would
otherwise seek to commercialize internally, to reduce resources devoted to
product development or to file voluntary bankruptcy proceedings or be subject
to
an involuntary bankruptcy proceeding filed by one or more creditors. There
is a
risk that one or more of our creditors could bring lawsuits to collect amounts
to which they believe they are entitled. In the event of lawsuits of this type,
if we are unable to negotiate settlements or satisfy our obligations, we could
voluntarily file bankruptcy proceedings, or we could become the subject of
an
involuntary bankruptcy proceeding filed by one or more creditors against
us.
In
addition, if we do not receive all, or a portion, of the planned Biosyn grant
funding, or if such funding is delayed, this could impact the ability to
complete development programs relating to the Biosyn products on a timely basis,
if at all. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Future
expenditures and capital requirements depend on numerous factors including,
without limitation, the progress and focus of our research and development
programs, the progress of pre-clinical and clinical testing, the time and costs
involved in obtaining regulatory approvals, the costs of filing, prosecuting,
defending and enforcing patent claims, oppositions and appeals, the timing
and
level of grant funding to support clinical programs and operations relating
to
the Biosyn products and our ability to establish new collaborative
arrangements.
Stock-Based
Compensation
Effective
January 1, 2006, the Company began recording compensation expense associated
with stock options and other forms of equity compensation in accordance with
SFAS 123R, Share-Based
Payment.
The
expense for the three months ended March 31, 2006 was $43,000 and for the three
months ended June 30, 2006 was $40,000. Prior to January 1, 2006, the Company
accounted for stock options according to the provisions of Accounting Principles
Board Opinion No. 25, Accounting
for Stock Issued to Employees, and
related interpretations, and, therefore, no related compensation expense was
recorded for awards granted with no intrinsic value. The Company adopted the
modified prospective transition method provided for under SFAS 123R and,
consequently, has not retroactively adjusted results from prior periods. Under
this transition method, compensation cost associated with stock options
recognized in the six months of fiscal 2006 includes: 1) amortization related
to
the remaining unvested portion of all stock option awards granted prior to
January 1, 2006, based on the grant date fair value estimated in accordance
with
the original provisions of SFAS No. 123; and 2) amortization related to all
stock option awards granted on or subsequent to January 1, 2006 based on the
grant-date fair value estimated in accordance with the provisions of SFAS
123R.
The
Company continues to estimate the fair value of each option award on the date
of
grant using the Black-Scholes option valuation model. The Company now estimates
option forfeitures based on historical data and adjusts the rate to expected
forfeitures periodically. The adjustment of the forfeiture rate will result
in a
cumulative catch-up adjustment in the period the forfeiture estimate is
changed.
Recent
Accounting Pronouncements
The
Company, on January 1, 2006, adopted FASB Statement 154, Accounting Changes
and
Error Corrections, a replacement of APB Opinion No. 20 and FASB Statement No.
3,
which changes the requirements for the accounting for and reporting of a change
in accounting principle. There was no effect upon the Company’s financial
statements as a result of the adoption of this pronouncement.
In
June
2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes - an interpretation of FASB Statement No. 109”, which becomes
effective for fiscal years beginning December 15, 2006. The interpretation
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected
to be
taken in a tax return. The Company is currently studying this interpretation
to
determine the effect, if any, on the Company’s consolidated financial
statement.
21
Critical
Accounting Policies and Estimates
Our
critical accounting policies and estimates were discussed in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2005. No changes in
those policies and estimates have occurred during the six months ended June
30,
2006.
Cellegy
invests its excess cash in short-term, investment grade, fixed income securities
under an investment policy. All of our investments are classified as
available-for-sale. All of our securities owned as of June 30, 2006 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.
As
of
June 30, 2006 our investment portfolio consisted of approximately $504,000
in
money market funds. 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 affected.
We
are
incurring market risk associated with the issuance of warrants to Kingsbridge
to
purchase 260,000 shares of our common stock and to the May 2005 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 difference
to other income or expense until the warrants are exercised. 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 income statement in future quarters. For
example, if our stock price increases by 20% during the third quarter of 2006
from the June 30, 2006 value, and all other inputs into the Black-Scholes model
remained constant, we would record approximately $28,000 of other expense for
the quarter ended September 30, 2006. If our stock price decreased by 20% from
its value for the same periods, we would record approximately the same amount
as
other income.
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 June 30, 2006, our disclosure controls and
procedures were effective.
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. However, following the sale of our Australian subsidiary in
April 2006, we identified certain changes and additions that we believe are
appropriate to address to improve the timeliness and review of financial,
accounting and legal issues relating to acquisition or disposition transactions,
which include earlier and more extensive involvement of the disclosure committee
of the Company and more extensive review of accounting and reporting issues
relating to such transactions. 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.
22
PART
II - OTHER INFORMATION
On
December
2, 2005, PDI filed suit in United States District Court for the Southern
District of New York requesting that the court declare that Cellegy has breached
its obligations under the settlement agreement, order Cellegy to specifically
perform its obligations under the settlement agreement, and award PDI damages
in
the amount of $6.4 million plus default interest as well as certain other
amounts.
On
July
13, 2006, PDI filed a “Stipulation of Dismissal Without Prejudice” in United
States District Court for the Southern District of New York pursuant to which
the case has been dismissed. Because the dismissal is without prejudice,
however, it is possible that PDI may reinstitute proceedings for the same claims
in the future.
ITEM
1A. Risk Factors
We
have a history of losses, and we expect losses to
continue.
We
have
incurred losses since our inception and negative cash flows from operations
that
raise substantial doubt about our ability to continue as a going concern. Our
deficit accumulated during the development stage as of June 30, 2006, was
approximately $134.6 million. Without additional funds from sales of assets,
intellectual property or technologies, new corporate collaborations, royalties
on product sales equity or debt financing, or other sources, we believe we
will
not have sufficient financial resources to continue operations beyond September,
2006. As a result of our continuing losses, we may exhaust our resources and
may
be unable to continue operations or complete the development of our products,
and our accumulated deficit will continue to increase as we continue to incur
losses. The amount of future net losses, and the time required to reach
profitability, are both highly uncertain. To achieve sustained profitable
operations, we must, among other things, successfully discover, develop, and
obtain regulatory approvals for and market pharmaceutical products. We cannot
assure you that we will ever be able to achieve or sustain
profitability.
We
have received a “going concern” opinion from our independent registered public
accounting firm, which may negatively impact our
business.
Our
audit
opinion from our independent registered public accounting firm regarding the
consolidated financial statements for the years ended December 31, 2004 and
2005, included an explanatory paragraph indicating that there is substantial
doubt about the Company’s ability to continue as a going concern. We have
incurred losses and negative cash flows from operations since inception. The
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 collaborative relationships with business partners, make it more
difficult to obtain required financing on favorable terms or at all, negatively
affect the market price of our common stock or require us to seek protection
under bankruptcy laws, and could otherwise have a material adverse effect on
our
business, financial condition and results of operations.
Our
prospects for obtaining additional financing are uncertain and failure to obtain
needed financing could affect our ability to continue operations or develop
market products.
Throughout
our history, we have consumed substantial amounts of cash. As of June 30, 2006,
Cellegy had approximately $651,000 in cash and cash equivalents. Cellegy has
no
current source of significant ongoing revenues or capital beyond existing cash,
product sales and grant funding.
The
amount of cash required to fund future expenditures and capital requirements
will depend on numerous factors including, without limitation:
· |
requirements
in support of our development
programs;
|
· |
progress
and results of pre-clinical and clinical
testing;
|
23
· |
time
and costs involved in obtaining regulatory approvals, including the
cost
of complying with additional FDA information and/or clinical trial
requirements to obtain marketing approval of our product
candidates;
|
· |
the
commercial success of our products that are approved for
marketing;
|
· |
the
costs of filing, prosecuting, defending and enforcing patent claims,
oppositions and appeals, and our other intellectual property
rights;
|
· |
future
litigation brought against the
Company;
|
· |
our
ability to establish new collaborative
arrangements;
|
· |
the
validation of a second contract manufacturing site;
and
|
· |
the
extent of expenses required to support Biosyn’s
operations.
|
In
order to complete the development, manufacturing and other pre-launch marketing
activities necessary to commercialize our products, additional financing will
be
required. Cellegy may seek other alternatives such as sales of intellectual
property or technologies, private or public equity or debt investments,
partnerships with other pharmaceutical companies to co-develop and fund our
research and development efforts, sales of technology or assets, additional
out-licensing agreements with third parties, or agreements to monetize in the
near term our future milestone and royalty payments expected from licenses.
There is no assurance that we will be able to obtain sufficient funds required
to continue operations. Failure to obtain funds to continue operations could
require us to seek protection under the bankruptcy laws or be subject to
involuntary bankruptcy proceedings.
Insufficient
funding may require us to delay, reduce or eliminate some or all of our research
and development activities, planned clinical trials, administrative programs,
personnel, outside services and facility costs; reduce the size and scope of
our
sales and marketing efforts; delay or reduce the scope of, or eliminate, one
or
more of our planned commercialization or expansion activities; seek
collaborators for our product candidates at an earlier stage than otherwise
would be desirable and on terms that are less favorable than might otherwise
be
available; or relinquish, license or otherwise dispose of rights to
technologies, product candidates or products that we would otherwise seek to
develop or commercialize ourselves on terms that are less favorable than might
otherwise be available. In addition, even if we do receive additional financing,
we may not be able to complete planned clinical trials, development,
manufacturing or marketing of any or all of our product candidates.
Cellegy
believes that available cash resources will be adequate to satisfy our capital
needs through September 2006, although failure to obtain additional funds as
described above may affect the timing of development, clinical trials or
commercialization activities relating to certain products. Funds provided from
sales of subsidiaries, assets, equity or debt financing, or other arrangements,
if obtained, would permit satisfaction of capital needs for a longer period
of
time.
We
could be forced into bankruptcy.
There
is
a risk that one or more of our creditors could bring lawsuits to collect amounts
to which they believe they are entitled. In the event of lawsuits of this type,
if we are unable to negotiate settlements or satisfy our obligations, we could
voluntarily file bankruptcy proceedings, or we could become the subject of
an
involuntary bankruptcy proceeding filed by one or more creditors against
us.
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
product candidates, Savvy, Cellegesic, Fortigel and Tostrelle and our ongoing
research and clinical activities relating to those product candidates are
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 our 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 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 Cellegy’s products.
24
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 on a timely basis, if at all. Delays in 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.
On
July
7, 2006 the U.S. Food and Drug Administration issued an Approvable Letter for
Cellegy’s product, Cellegesic, indicating that before the Company's New Drug
Application ("NDA") may be approved and the product approved for marketing,
Cellegy must conduct another clinical trial to demonstrate efficacy at a level
deemed statistically significant by the agency. The letter indicated that the
agency was requiring an additional study because it believed the results of
the
three trials conducted to date did not provide substantial evidence that the
drug is effective, and provided a number of comments on the results previously
presented by Cellegy and recommendations concerning the design and protocol
of
the additional required study.
There
is still no definitive agreement with the FDA regarding requirements for
approval of Fortigel. The FDA will require an additional Phase 3 clinical
trial. The FDA may also decide to have an Advisory Panel review the submission
of our product candidates with an uncertain outcome of such panel’s
recommendation, or take other actions having the effect of delaying or
preventing commercial introduction of our products. The FDA or other regulatory
agencies could impose requirements on future trials that could delay the
regulatory approval process for our products. Similarly, there are risks and
uncertainties associated with our female clinical trial programs for Tostrelle
and Savvy in that sufficient resources for clinical development of these product
candidates may not be available or one or both drugs may not prove to be safe
and effective by standards established by worldwide regulatory authorities.
There can be no assurance that the FDA, or other regulatory agencies, will
find
any of our trial data or other sections of our regulatory submissions sufficient
to approve any of our product candidates for marketing in the United States
or
in other overseas markets.
Sales
of
Cellegy’s products outside the United States are subject to different regulatory
requirements governing clinical trials and marketing approval. These
requirements vary widely from country to country and could delay introduction
of
Cellegy’s products in those countries. Cellegy may not be able to obtain
marketing approval for one or more of its products in any countries in addition
to those countries where approvals have already been obtained.
None
None
None
ITEM
5. Other Information
None
25
ITEM
6. Exhibits
a)
Exhibits
2.1
|
Share
Purchase Agreement dated as of March 31, 2006 by and between the
Registrant and Epsilon Pharmaceuticals Pty Ltd.
|
|
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
|
26
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CELLEGY
PHARMACEUTICALS, INC.
|
||
|
|
|
Date: August 10, 2006 | /s/ Richard C. Williams | |
Richard
C. Williams
Chairman
and Interim Chief Executive
Officer
|
Date: August 10, 2006 | /s/ Robert J. Caso | |
Robert
J. Caso
Vice
President, Finance and Chief Financial Officer
|
||
27