DMK PHARMACEUTICALS Corp - Quarter Report: 2006 September (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 September 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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2085
B Quaker Pointe Drive, Quakertown, Pa 18951
(Address
of principal executive offices, including zip code)
215-529-6084
(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 October 30,
2006 was 29,834,796.
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1
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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
|
5
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Notes
to Condensed Consolidated Financial Statements
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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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24
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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
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PART
I - FINANCIAL INFORMATION
Cellegy
Pharmaceuticals, Inc.
(a
development stage company)
(Amounts
in thousands)
(Unaudited)
September
30, 2006
|
December
31, 2005
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
830
|
$
|
2,251
|
|||
Short-term
investments
|
-
|
11
|
|||||
Accounts
receivable
|
105
|
1,085
|
|||||
Inventory
|
-
|
352
|
|||||
Prepaid
expenses and other current assets
|
310
|
1,077
|
|||||
Total
current assets
|
1,245
|
4,776
|
|||||
Property
and equipment, net
|
-
|
496
|
|||||
Goodwill
|
-
|
982
|
|||||
Intangible
assets, net
|
-
|
196
|
|||||
Other
assets
|
-
|
-
|
|||||
Total
assets
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$
|
1,245
|
$
|
6,450
|
|||
Liabilities
and Stockholders' Deficit
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,374
|
$
|
1,756
|
|||
Accrued
expenses and other current liabilities
|
818
|
2,402
|
|||||
Current
portion of notes payable
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6,880
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4,976
|
|||||
Current
portion of deferred revenue
|
336
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303
|
|||||
Total
current liabilities
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9,408
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9,437
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|||||
Notes
payable
|
-
|
213
|
|||||
Derivative
instruments
|
22
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193
|
|||||
Deferred
revenue
|
3,350
|
3,084
|
|||||
Total
liabilities
|
12,780
|
12,927
|
|||||
Stockholders'
deficit:
|
|||||||
Common
stock
|
3
|
3
|
|||||
Additional
Paid-in Capital
|
125,669
|
125,548
|
|||||
Accumulated
other comprehensive income
|
406
|
284
|
|||||
Deficit
accumulated during the development stage
|
(137,613
|
)
|
(132,312
|
)
|
|||
Total
stockholders' deficit
|
(11,535
|
)
|
(6,477
|
)
|
|||
Total
liabilities and stockholders' deficit
|
$
|
1,245
|
$
|
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)
Period
from
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||||||||||||||||
June
26, 1989
|
||||||||||||||||
Three
Months Ended
|
Nine
Months Ended
|
(inception)
to
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||||||||||||||
September
30,
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September
30,
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September
30,
|
||||||||||||||
2006
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2005
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2006
|
2005
|
2006
|
||||||||||||
Revenues:
|
||||||||||||||||
Licensing
and contract revenue from affiliates
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
1,145
|
||||||
Licensing,
milestone and development funding
|
73
|
229
|
452
|
6,988
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10,949
|
|||||||||||
Grants
|
99
|
1,252
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1,926
|
3,420
|
7,910
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|||||||||||
Product
sales
|
-
|
257
|
257
|
397
|
5,828
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|||||||||||
Total
revenues
|
172
|
1,738
|
2,635
|
10,804
|
25,832
|
|||||||||||
Costs
and expenses:
|
||||||||||||||||
Cost
of product sales
|
-
|
197
|
257
|
241
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1,945
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|||||||||||
Research
and development
|
338
|
1,816
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2,244
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6,855
|
92,207
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|||||||||||
Selling,
general and administrative
|
955
|
2,471
|
4,526
|
6,764
|
50,624
|
|||||||||||
Equipment
FMV adjustment
|
276
|
-
|
276
|
-
|
276
|
|||||||||||
Acquired
in-process technology
|
-
|
-
|
-
|
-
|
22,332
|
|||||||||||
Total
costs and expenses
|
1,569
|
4,484
|
7,303
|
13,860
|
167,384
|
|||||||||||
Operating
income (loss)
|
(1,397
|
)
|
(2,746
|
)
|
(4,668
|
)
|
(3,054
|
)
|
(141,552
|
)
|
||||||
Interest
and other income
|
99
|
17
|
114
|
121
|
7,144
|
|||||||||||
Interest
and other expense
|
(487
|
)
|
(217
|
)
|
(924
|
)
|
(478
|
)
|
(3,082
|
)
|
||||||
Derivative
revaluation
|
145
|
79
|
170
|
243
|
1,250
|
|||||||||||
Net
income income (loss)
|
(1,640
|
)
|
(2,867
|
)
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(5,308
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)
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(3,169
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)
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(136,240
|
)
|
||||||
Non-cash
Preferred Dividends
|
-
|
-
|
-
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-
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(1,449
|
)
|
||||||||||
Net
income (loss) from continuing operations applicable
to common stockholders
|
(1,640
|
)
|
(2,867
|
)
|
(5,308
|
)
|
(3,169
|
)
|
(137,689
|
)
|
||||||
Discontinued
operations (Note 14)
|
||||||||||||||||
Profit
(loss) from discontinued operations
|
-
|
74
|
7
|
124
|
76
|
|||||||||||
Net
income (loss) applicable to common shareholders
|
$
|
(1,640
|
)
|
$
|
(2,793
|
)
|
$
|
(5,301
|
)
|
$
|
(3,044
|
)
|
$
|
(137,613
|
)
|
|
From
continuing operations
|
$
|
(0.05
|
)
|
$
|
(0.10
|
)
|
$
|
(0.18
|
)
|
$
|
(0.11
|
)
|
||||
From
discontinued operations
|
-
|
-
|
-
|
-
|
||||||||||||
Basic
income (loss) per common share:
|
$
|
(0.05
|
)
|
$
|
(0.10
|
)
|
$
|
(0.18
|
)
|
$
|
(0.11
|
)
|
||||
From
continuing operations
|
$
|
(0.05
|
)
|
$
|
(0.10
|
)
|
$
|
(0.18
|
)
|
$
|
(0.11
|
)
|
||||
From
discontinued operations
|
-
|
-
|
-
|
-
|
||||||||||||
Diluted
income (loss) per common share:
|
$
|
(0.05
|
)
|
$
|
(0.10
|
)
|
$
|
(0.18
|
)
|
$
|
(0.11
|
)
|
||||
|
||||||||||||||||
Weighted
average number of common shares used in
per share calculations:
|
||||||||||||||||
Basic
|
29,833
|
29,832
|
29,832
|
28,048
|
||||||||||||
Diluted
|
29,833
|
29,832
|
29,832
|
28,048
|
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)
Period
from
|
||||||||||
June
26, 1989
|
||||||||||
Nine
Months Ended
|
(inception)
to
|
|||||||||
September
30,
|
September
30,
|
|||||||||
2006
|
|
2005
|
2006
|
|||||||
Operating
activities
|
||||||||||
Net
loss
|
$
|
(5,301
|
)
|
$
|
(3,044
|
)
|
$
|
(136,164
|
)
|
|
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
|
35
|
114
|
234
|
|||||||
Depreciation
expense
|
122
|
319
|
3,499
|
|||||||
Intangible
assets amortization
|
196
|
286
|
2,120
|
|||||||
Loss
(gain) on sale of fixed assets
|
375
|
615
|
1,987
|
|||||||
Equity
compensation expense
|
121
|
2
|
2,421
|
|||||||
Derivative
re-evaluation
|
(170
|
)
|
(242
|
)
|
(1,250
|
)
|
||||
Interest
accretion on notes payable
|
574
|
351
|
1,106
|
|||||||
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
|
2,065
|
(196
|
)
|
1,157
|
||||||
Accounts
receivable
|
980
|
(203
|
)
|
124
|
||||||
Other
assets
|
(1,013
|
)
|
1
|
(712
|
)
|
|||||
Accounts
payable
|
(401
|
)
|
107
|
73
|
||||||
Accrued
expenses and other current liabilities
|
(1,566
|
)
|
(818
|
)
|
(2,404
|
)
|
||||
Other
long term liabilities
|
75
|
(448
|
)
|
40
|
||||||
Deferred
revenue
|
298
|
(9,036
|
)
|
1,224
|
||||||
Net
cash used in operating activities
|
(3,610
|
)
|
(12,192
|
)
|
(99,830
|
)
|
||||
Investing
activities:
|
||||||||||
Purchases
of property and equipment
|
-
|
(170
|
)
|
(5,507
|
)
|
|||||
Purchases
of investments
|
-
|
-
|
(98,921
|
)
|
||||||
Sale
of investments
|
11
|
-
|
43,521
|
|||||||
Maturity
of investments
|
-
|
-
|
55,305
|
|||||||
Proceeds
from restricted cash
|
-
|
227
|
614
|
|||||||
Proceeds
from sale of property
|
-
|
-
|
238
|
|||||||
Proceeds
from sale of subsidiary
|
1,013
|
-
|
1,013
|
|||||||
Acquisition
of Vaxis and Quay and Biosyn
|
-
|
-
|
(816
|
)
|
||||||
Net
cash provided by (used in) investing activities
|
1,024
|
57
|
(4,553
|
)
|
||||||
Financing
activities:
|
||||||||||
Proceeds
from notes payable
|
-
|
-
|
8,047
|
|||||||
Issuance
of notes payable
|
2,000
|
-
|
6,444
|
|||||||
Repayment
of notes payable
|
(958
|
)
|
-
|
(7,569
|
)
|
|||||
Net
proceeds from issuance of common stock
|
-
|
5,747
|
86,843
|
|||||||
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
|
1,042
|
5,747
|
104,829
|
|||||||
Effect
of exchange rate changes on cash
|
123
|
(12
|
)
|
384
|
||||||
Net
increase (decrease) in cash and cash equivalents
|
(1,421
|
)
|
(6,400
|
)
|
830
|
|||||
Cash
and cash equivalents, beginning of period
|
2,251
|
8,705
|
-
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
830
|
$
|
2,305
|
$
|
830
|
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)
Period
from
|
||||||||||
June
26, 1989
|
||||||||||
Nine
Months Ended
|
(inception)
to
|
|||||||||
September
30,
|
September
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
|
|||||||
Interest
expense amortization for long-term obligations
|
575
|
607
|
1,371
|
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
(“SEC”). Accordingly, certain information and footnote disclosures normally
included in annual financial statements have been condensed or omitted. In
the
opinion of management, the accompanying unaudited interim condensed consolidated
financial statements reflect all adjustments (including normal recurring
adjustments and the elimination of intercompany accounts) considered necessary
for a fair statement of all periods presented. The results of 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. The
year-end condensed consolidated balance sheet data was derived from audited
financial statements, but does not include all disclosures required by
accounting principles generally accepted in the United States of
America. 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, 2005.
As
more
fully described below and subject to stockholder approval, the Company has
entered into an agreement to sell substantially all its intellectual property.
As such, the Company concluded it may not realize the value of its remaining
assets during the normal course of business. As
a
result, the Company has written down its remaining assets to fair market value,
resulting in a charge in the third quarter of approximately $276,000 to
write down of idle fixtures and equipment.
Due to
the contingent nature of the proposed transaction, the Company has not reflected
the results of the sale in the financial statements presented herein. To the
extent the Company has made certain cash payments or has incurred certain
additional liabilities or expenses related to the proposed transaction, such
has
been reflected in the accompanying financial statements.
The
intellectual property included in the proposed transaction with ProStrakan
has
no book value since the accounting regulations generally require that the costs
incurred in connection with the research or development of such be charged
to
income at the time these costs were incurred.
Liquidity
and Capital Resources
If
the
proposed transaction with ProStrakan, described in Note 2, is approved by its
shareholders, the Company intends to use the proceeds from the sale to satisfy
its existing obligations and to provide working capital. The $9.0 million
purchase price will be reduced by (i) amounts owed by the Company to ProStrakan
to repay a $2.0 million principal amount promissory note (plus accrued but
unpaid interest) reflecting a secured loan made by ProStrakan to Cellegy in
late
September 2006, (ii) amounts advanced on or before the closing date by
ProStrakan to the Company or paid by ProStrakan on the Company’s behalf to third
parties, including governmental agents, patent agents and other service
providers, relating to the assets proposed to be sold to ProStrakan, (iii)
transaction fees and expenses in connection with the proposed transaction,
(iv)
$2,500,000 to be paid to PDI, Inc. (“PDI”) at the closing of the ProStrakan
transaction in full satisfaction (in addition to amounts previously paid to
PDI,
including a $500,000 payment made in late September 2006) of the Company’s
obligations under its previous agreements with PDI, and (v) $250,000 to be
paid
to Neptune Pharmaceutical Corporation at the closing of the transaction with
ProStrakan in full satisfaction of the Company’s obligations under its previous
agreements with Neptune. In addition, as of September 30, 2006, the Company
had
other creditor obligations of approximately $1.7 million.
The
proposed transaction with ProStrakan is a taxable event, however the Company
believes that the expected taxable gain from the transaction will be offset
by
the application of its capitalized research expenses. The Company may also
use
its net operating tax loss carryforwards to reduce the taxable gain from the
transaction, however due to the limitation of net operating loss carryforwards
under the federal alternative minimum tax system, any portion of the taxable
gain reduced by net operating loss carryforwards may be subject to the federal
alternative minimum income tax. Both the Company’s past elections to capitalize
research expenses and the availability and amount of net operating loss
carryforwards are subject to audit and adjustment by the Internal Revenue
Service. In the event that the Internal Revenue Service adjusts either the
Company’s election to capitalize research expenses or its reported net operating
loss carryforwards, the Company may incur tax liability from the
transaction.
-
7
-
The
Company currently expects to have approximately $3.0 million remaining to fund
its working capital requirements
after the closing, but this amount could vary depending on a number of factors,
such as overall transaction costs and expenses and the amount of our obligations
to creditors.
There
is
no assurance that the proposed transaction will be approved by the shareholders.
If the proposed transaction is not approved by the shareholders, a significant
portion of the Company’s liabilities would become immediately due and payable,
including the notes due PDI and ProStrakan. In this event, the Company would
most likely be unable to meet its obligations to its creditors.
The
Company would be required to pay the $2.0 million loan from ProStrakan and
other
amounts owed under the note and security agreements with ProStrakan. If the
Company does not pay amounts owed under the note when due, ProStrakan could
declare the note in default and take possession of the collateral, which
consists of substantially all of the intellectual property rights that are
subject to the transaction. As permitted by the provisions of the Uniform
Commercial Code, ProStrakan could then sell or otherwise dispose of the
collateral, apply the proceeds to repayment of the note (and other amounts
that
the Company owes to ProStrakan under the loan and security agreements), and
the
Company would be entitled to any remaining proceeds from the sale. In addition,
the Company would likely owe ProStrakan the $500,000 termination payment under
the provisions of the asset purchase agreement. Moreover, the Company’s
obligations under its original promissory notes to PDI, approximately $5.3
million, would become due and payable, and PDI would be entitled to
foreclose on the collateral securing the Company's obligations to
PDI. Also, the Company would continue to have unpaid obligations to other
creditors. The Company currently does not have any independent sources of
funding to satisfy these obligations, and the Company likely would be required
to file for protection under the bankruptcy laws. If the transaction with
ProStrakan was not completed but adequate funding was available to satisfy
all
of the foregoing obligations as well as other obligations to our creditors,
the
Company might explore other strategic alternatives, including a sale of our
assets to, or a business combination with, another party, or the Company might
attempt to pursue other business opportunities and investments unrelated to
its
current business.
Even
if
funds are obtained to continue operations, failure to obtain adequate additional
funds would require us to further delay development or commercialization of
certain products, to license to third parties the rights to commercialize
certain products that the Company would otherwise seek to commercialize
internally or to reduce resources devoted to product development. The Company’s
current outlook with respect to its going concern status could adversely affect
the Company’s 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 the common stock and could
otherwise have a material adverse effect on the Company’s business, financial
condition and results of operations. The Company estimates that its current
cash
balance is sufficient to carry it through November, 2006.
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: Proposed Sale of Assets to ProStrakan
Subject
to the terms and conditions of the proposed Asset Purchase Agreement with
ProStrakan (“APA”), the Company has agreed to sell to ProStrakan all of its
right, title and interest in and to the assets used in connection with or
relating to the research, development and commercialization of
nitroglycerin/nitric oxide and other related pharmacological products for pain
management applications and testosterone gels for treatment of male
hypogonadism, and for certain female sexual dysfunction conditions, as currently
conducted and as currently proposed to be conducted by Cellegy, including those
assets relating to Cellegy’s nitroglycerin/nitric oxide and related
pharmacological products marketed under the name Rectogesic® and proposed to be
marketed under the name Cellegesic® and Cellegy’s testosterone gels marketed
under the name Tostrex™ and proposed to be marketed under the names Tostran™ or
Fortigel™ and Cellegy’s product candidate Tostrelle, other than the assets to be
retained below. Collectively, the assets to be sold are hereinafter referred
to
as the “Acquired Assets.”
-
8
-
The
Acquired Assets include: all U.S. and foreign patents and patent applications,
trademarks and trademark applications, service marks, all authorizations,
registrations, filings, permits, licenses, franchises, orders, approvals,
concessions, consents and other regulatory approvals and any related
intellectual property relating to the Acquired Assets, together with all related
know-how, information, techniques, methodologies, modifications, improvements,
works of authorship, procedures, processes, designs and data (whether or not
protectable under patent, copyright, trade secrecy or similar laws); assignment
of certain contracts, primarily consisting of distribution agreements with
third
party distributors in certain foreign countries relating to the Acquired Assets
and all books and records relating to the Acquired Assets.
In
addition Cellegy has agreed to assign to ProStrakan certain agreements relating
to the Acquired Assets including non-disclosure, confidentiality and inventions
assignment agreements or contracts with all former and current employees and
consultants of Cellegy to the extent related to the Acquired Assets; and foreign
distribution agreements relating to the Acquired Assets.
If
the
proposed transaction is completed, the Company will retain the following: all
intellectual property and related assets relating to the Biosyn products; books
and records of Cellegy not relating to the Acquired Assets being sold;
equipment, furniture, fixtures, computers, and other personal property; certain
contracts; all interests in leases and real properties and cash, cash
equivalents and trade receivables.
Assumed
Liabilities
Subject
to and upon the terms and conditions of the APA, ProStrakan will assume the
obligations under certain agreements being assigned relating to the Acquired
Assets and obligations after the closing relating to the conduct of the Acquired
Assets after the closing, but will not assume any other Cellegy
liabilities.
Purchase
Price
ProStrakan
has agreed to purchase the Acquired Assets for a purchase price of $9.0 million
in cash, subject to adjustment as provided in the APA. ProStrakan may deduct
from the purchase price the $2.0 million previously advanced as well as certain
other expenses incurred by ProStrakan in conjunction with the
transaction.
Cellegy
also has indemnity obligations to ProStrakan pursuant to the indemnification
provisions of the APA, and if Cellegy were obligated to pay amounts to
ProStrakan pursuant to those provisions, that would reduce the net amount to
Cellegy resulting from the transaction.
The
APA
is subject to stockholder approval and in October, 2006 the Company filed
preliminary and definitive proxy statements on Schedule 14A with the SEC
relating to a special meeting of the shareholders to vote on the proposed
transaction to be held November 22, 2006.
Other
Agreements Relating to the Proposed Transaction
Agreements
with PDI, Inc. The
Company is a party to several agreements with PDI, all dated April 11, 2005
(the
“Settlement Agreements”), including: Settlement Agreement and Release;
Nonnegotiable Convertible Senior Note, in the original principal amount of
$3,500,000: Security Agreement; and Secured Promissory Note, in the original
principal amount of $3,000,000. The Company’s obligations under the Secured
Promissory Note and the Security Agreement are secured by a security interest
in
favor of PDI in the “Pledged Collateral,” as defined in the Security
Agreement.
In
an
agreement dated September 20, 2006 (the “New Note”), the Company agreed to pay
PDI an aggregate amount of $3.0 million (the “Payoff Amount”), as follows: (i)
no later than four business days after the Company enters into any agreement
pursuant to which all or any material portion of the assets of the Company
relating to Cellegesic, Rectogesic, Tostrex, Tostrelle and/or Fortigel are
proposed to be sold, which includes the APA with ProStrakan, the sum of
$500,000, as a nonrefundable prepayment of a portion of the outstanding unpaid
principal and accrued interest on the Secured Note; and (ii) no later than
two
business days after the consummation of any such transaction, the sum of $2.5
million. PDI agreed that it will accept receipt of the Payoff Amount as payment
in full of all obligations owing under the Settlement Agreements
(“Obligations”).
-
9
-
Upon
the
receipt by PDI of the Payoff Amount, all of the Obligations will be deemed
paid
in full; all of the security interests and liens created under the Settlement
Agreements in favor of PDI terminate and are released; all other obligations
of
the Company owing to PDI under the Settlement Agreements or any related
agreement, instrument or other document are released and discharged and each
of
the Settlement Agreements terminates and is null and void and of no further
force or effect without any further action of the parties. Effective upon
receipt of the Payoff Amount, the Company and PDI release each other for any
past claims relating to the Settlement Agreements.
In
the
agreement the Company makes a number of representations to PDI concerning the
material terms of the proposed transaction with ProStrakan, and agrees that
PDI
has the right to declare the agreement null and void (and will retain the
initial $500,000 payment) should those representations be materially false
or
inaccurate. All of the Settlement Agreements will continue to be enforceable
by
PDI and remain in full force and effect until such time as PDI receives from
the
Company the entire Payoff Amount.
PDI
agreed that it will not convert any portion of the Convertible Note prior to
December 31, 2006, provided that this obligation will immediately terminate
in
the event that (i) the Company fails to comply with obligations pursuant to
the
agreement, or (ii) PDI determines that the Company has failed to disclose to
PDI
any information that could be material to PDI’s determination to enter into the
PDI agreement. If the closing of the APA does not occur by December 31, 2006,
then the letter agreement will terminate and be of no further force or effect,
and PDI is entitled to retain the initial payoff as discussed
above.
PDI
and
the Company also agreed to release each other and related parties from any
claims or liabilities arising before the date of their agreement arising out
of
or relating to any of the Settlement Agreements, other than as a result of
the
released person’s gross negligence or willful misconduct. PDI’s release is
effective only upon receipt of the full Payoff Amount.
Agreement
with Neptune Pharmaceutical Corporation. The
Company is a party to an asset purchase agreement dated December 31, 1997
with Neptune Pharmaceutical Corporation (“Neptune”), and certain related
agreements dated January 12, 1998, pursuant to which the Company acquired
certain patents and intellectual property rights relating to Cellegesic and
Rectogesic. The agreement calls for a series of payments, which may be paid
in
part in shares of common stock, upon successful completion of various
development milestones.
The
Company and Stephen R. Gorfine, M.D., representative of the former shareholders
of Neptune, have entered into a Termination Agreement and Release of Claims
dated as of September 22, 2006. The termination agreement provides that upon
execution of the APA with ProStrakan (or similar such agreements), the Company
will pay Neptune $125,000, and that upon the closing of the transactions
contemplated by the APA, the Company will pay Neptune an additional $125,000.
In
consideration of these payments, and effective upon the second payment, Neptune
has agreed that all payment, performance, and other obligations and covenants
of
the Company under the original asset purchase agreement between Neptune and
the
Company will be fully satisfied and terminated in their entirety, and that
no
further payments will be owed to Neptune.
Accounting
Treatment
If
the
sale of assets to ProStrakan is approved by the Company’s stockholders, Cellegy
will recognize a gain equal to the net proceeds (the sum of the purchase price
less the expenses relating to the sale) and the value of the liabilities assumed
by ProStrakan less the net book value of the assets sold and the fair value
of
the indemnification liability retained. The Company will also record income
to
the extent that its indebtedness to PDI is reduced under its renegotiated
obligations therewith, as discussed above, and will also credit the balance
of
its deferred revenue to income since such revenue relates to past license
agreements with ProStrakan that will no longer be in force subsequent to the
transaction, if approved.
-
10
-
Note
3: 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.
Total comprehensive income (loss) during the three and nine months ended
September 30, 2006 and 2005 consisted of (in thousands):
Three
Months
|
Nine
Months Ended
|
||||||||||||
Ended
September 30,
|
September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Net
income (loss) after discontinued operations
|
$
|
(1,640
|
)
|
$
|
(2,793
|
)
|
$
|
(5,301
|
)
|
$
|
(3,044
|
)
|
|
Change
in FCT adjustments
|
-
|
5
|
123
|
(12
|
)
|
||||||||
Comprehensive
income (loss)
|
$
|
(1,640
|
)
|
$
|
(2,788
|
)
|
$
|
(5,178
|
)
|
$
|
(3,056
|
)
|
Note
4: 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
|
Nine
Months Ended
|
||||||||||||
Ended
September 30,
|
September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Options
|
4,357
|
4,722
|
|
2,222
|
4,106
|
||||||||
Warrants
|
2,375
|
2,375
|
2,375
|
2,375
|
|||||||||
Total
number of shares excluded
|
6,732
|
7,097
|
|
4,597
|
6,481
|
Excluded
also are 2,121,212 shares that would be issuable upon conversion of the PDI
Notes (see also Note 12).
Note
5: Stock-Based Compensation
The
Company’s stockholders 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 September 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. Options granted
to directors or officers will automatically vest upon a triggering event such
as
certain kinds of merger transactions or certain transactions involving sale
of
all or substantially all of the assets of the Company. The Company believes
tht
approval of the APA by its stockholders constitutes a triggering event and,
as
such, will require that the affected options be re measured as of the date
of
the event.
-
11
-
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 and the stockholders subsequently approved increases in the number
of
shares available under the Directors’ Plan. 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 third quarter of 2006 and the third
quarter of 2005 for stock options were $38,000 and $0, respectively. For the
nine months ended September 30, 2006 and 2005 compensation expense related
to
stock options was $121,000 and $0, respectively. There is no impact on earnings
per share for the third quarter of 2006. Of the $38,000 of stock option
compensation expense recognized in the third quarter of fiscal 2006, $34,000
was
a component of selling, general and administrative expenses and $4,000 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 September 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 $0.15 as of September 30, 2006. Those options
with exercise prices above $0.15 have no intrinsic value. However, the options
granted in October 2004, in connection with Biosyn acquisition have an aggregate
intrinsic value of $899 (see Biosyn options table).
The
fair
value of each option calculated during the third 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
|
||||
September
30,
|
||||
2005
|
||||
Expected
life in years
|
3.2
|
|||
Expected
volatility
|
76.0
|
%
|
||
Risk-free
interest rate
|
4.1
|
%
|
||
Dividend
yield
|
0
|
%
|
The
status of the Company’s stock option plans at September 30, 2006, is summarized
below:
-
12
-
2005
Equity Incentive Plan
Weighted
|
|||||||
Shares
Under
|
Average
|
||||||
Option
|
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
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
-
|
-
|
|||||
Exercised
|
-
|
-
|
|||||
Balance
at September 30, 2006
|
48,000
|
$
|
1.34
|
The
following table summarizes those stock options outstanding related to the 2005
Plan at September 30, 2006:
Options
Outstanding
|
||||||||||
Weighted
|
Weighted
|
|||||||||
Average
|
Average
|
|||||||||
Number
of
|
Remaining
|
|||||||||
Range
of Exercise Prices
|
Options
|
Contract
Life
|
Exercise
Price
|
|||||||
$1.34
|
48,000
|
9.00
years
|
$
|
1.34
|
There
were no options exercisable under the 2005 Plan as of September 30, 2006. None
of the options vested in the quarter ended September 30, 2006.
-
13
-
Prior
Plan
Weighted
|
|||||||
Shares
Under
|
Average
|
||||||
Option
|
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
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
(1,095,348
|
)
|
(4.80
|
)
|
|||
Exercised
|
-
|
-
|
|||||
Balance
at September 30, 2006
|
824,246
|
$
|
4.86
|
The
following table summarizes those stock-options outstanding and exercisable
related to the Prior Plan at September 30, 2006:
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||
Average
|
Average
|
Average
|
Average
|
Average
|
|||||||||||||||
Range
of Exercise
|
Number
of
|
Remaining
|
Exercise
|
Number
of
|
Remaining
|
Exercise
|
|||||||||||||
Prices
|
Options
|
Contractual
Life
|
Price
|
Options
|
Contractual
Life
|
Price
|
|||||||||||||
$1.35
- $2.03
|
227,479
|
7.64
years
|
$
|
1.77
|
156,212
|
6.55
years
|
$
|
1.42
|
|||||||||||
$2.89
- $3.88
|
199,767
|
5.92
years
|
3.27
|
160,851
|
5.21
years
|
3.36
|
|||||||||||||
$4.38
- $6.50
|
180,500
|
3.67
years
|
5.47
|
169,250
|
3.14
years
|
5.55
|
|||||||||||||
$7.00
- $8.81
|
197,250
|
3.54
years
|
8.48
|
197,250
|
3.29
years
|
8.48
|
|||||||||||||
$15.00
|
19,250
|
5.01
years
|
15.00
|
19,250
|
4.76
years
|
15.00
|
|||||||||||||
Total
|
824,246
|
5.06
years
|
4.86
|
702,813
|
4.46
years
|
5.29
|
No
future
options may be offered under the Prior Plan. In the quarter ended September
30,
2006 there were 250 options vesting with a total fair value of $26.
-
14
-
Directors’
Stock Option Plan
Weighted
|
|||||||
Shares
|
Average
|
||||||
Under
|
Exercise
|
||||||
Option
|
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
|
||||
Granted
|
-
|
-
|
|||||
Canceled
|
(20,000
|
)
|
(4.30
|
)
|
|||
Exercised
|
-
|
-
|
|||||
Balance
at September 30, 2006
|
285,500
|
$
|
4.67
|
The
following table summarizes those stock options outstanding and exercisable
related to the Directors’ Plan at September 30, 2006:
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||
Average
|
Average
|
Average
|
Average
|
Average
|
|||||||||||||||
Range
of Exercise
|
Number
of
|
Remaining
|
Exercise
|
Number
of
|
Remaining
|
Exercise
|
|||||||||||||
Prices
|
Options
|
Contractual
Life
|
Price
|
Options
|
Contractual
Life
|
Price
|
|||||||||||||
$1.34
- $3.25
|
35,000
|
4.85
years
|
$
|
2.62
|
35,000
|
3.04
years
|
$
|
2.62
|
|||||||||||
$4.30
- $5.50
|
234,500
|
3.48
years
|
4.85
|
218,500
|
3.16
years
|
4.89
|
|||||||||||||
$6.50
- $8.50
|
16,000
|
2.36
years
|
6.50
|
16,000
|
2.36
years
|
6.50
|
|||||||||||||
Total
|
285,500
|
3.37
years
|
4.67
|
269,500
|
4.69
years
|
4.75
|
As
of
September 30, 2006, there were no options available for future grants under
the
Directors’ Plan. During the quarter ending September 30, 2006, no options
vested.
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 September 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 94,879 were
cancelled. For the nine months ended September 30, 2006, 3,171 options were
exercised and no options have been canceled.
-
15
-
The
following table summarizes information about stock options outstanding and
exercisable related to Biosyn option grants at September 30,
2006:
Options
Outstanding and Exercisable
|
|||||||||||||
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Range
of Exercise
|
Number
of
|
Remaining
|
Exercise
|
Intrinsic
|
|||||||||
Prices
|
Options
|
Contractual
Life
|
Price
|
Value
|
|||||||||
$0.06
|
9,816
|
2.64
years
|
$
|
0.06
|
$
|
899
|
|||||||
$0.29
|
23,401
|
8.14
years
|
0.29
|
-
|
|||||||||
$1.46
- $6.83
|
8,564
|
9.05
years
|
1.46
|
-
|
|||||||||
$8.76
|
3,855
|
6.63
years
|
8.76
|
-
|
|||||||||
$14.60
- $21.02
|
18,503
|
3.61
years
|
18.68
|
-
|
|||||||||
Total
|
64,139
|
6.02
years
|
6.23
|
$
|
899
|
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 September 30,
2006, there was $135,000 of total unrecognized compensation cost related to
non-vested options, which is expected to be recognized over a remaining
weighted-average vesting period of 1.25 years.
Warrants
The
Company has the following warrants outstanding to purchase common stock as
of
September 30, 2006:
Exercise
|
|||||||||||||
Warrant
|
Price
Per
|
Expiration
|
|||||||||||
Shares
|
Share
|
Date
Issued
|
Date
|
||||||||||
June
2004 PIPE Financing
|
260,000
|
$
|
4.62
|
July
27,
2004
|
July
27,
2009
|
||||||||
Biosyn
warrants
|
80,757
|
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
|
2,029,481
|
Shares
Reserved
As
of
September 30, 2006, the Company has reserved shares of common stock for issuance
as follows:
Biosyn
options
|
64,139
|
|||
Director's
Plan
|
285,500
|
|||
Warrants
|
2,029,481
|
|||
Non-plan
options
|
1,000,000
|
|||
Neptune
agreement
|
1,080,082
|
|||
Kingsbridge
SSO
|
3,493,601
|
|||
1995
Equity Incentive Plan
|
824,246
|
|||
2005
Equity Incentive Plan
|
952,000
|
|||
Total
|
9,729,049
|
-
16
-
Note
6: 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 nine months periods ended September 30, 2006
of
$172,000 and $2,635,000, 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):
Three
Months
Ended
|
Nine
Months Ended
|
||||||||||||
September
30,
|
September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
North
America Pharmaceuticals
|
$
|
99
|
$
|
1,252
|
$
|
1,926
|
$
|
3,420
|
|||||
Europe
Pharmaceuticals
|
73
|
486
|
709
|
7,384
|
|||||||||
Revenue
from continuing operations
|
$
|
172
|
$
|
1,738
|
$
|
2,635
|
$
|
10,804
|
Operating
Income (loss) by geographic region is as follows (in
thousands):
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
Operating
Income (Loss)
|
September
30,
|
September
30,
|
|||||||||||
2006
|
2005
|
2006
|
|
2005
|
|||||||||
North
America Pharmaceuticals
|
$
|
(501
|
)
|
$
|
(712
|
)
|
$
|
(1,784
|
)
|
$
|
(2,423
|
)
|
|
Europe
Pharmaceuticals
|
(1,139
|
)
|
(2,155
|
)
|
(3,524
|
)
|
(741
|
)
|
|||||
Operating
income (loss) from continuing operations
|
$
|
(1,640
|
)
|
$
|
(2,867
|
)
|
$
|
(5,308
|
)
|
$
|
(3,164
|
)
|
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):
Period
Ended
|
|||||||
Assets
|
September
30,
|
||||||
2006
|
2005
|
||||||
North
America
|
$
|
1,246
|
$
|
6,459
|
Note
7: 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 nine 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.
-
17
-
As
a
result of the adoption of SFAS 123R, the Company’s net loss for the quarter
ended September 30, 2006, was $38,000 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
|
Nine
Months Ended
|
||||||
Ended
September
|
September
30, 2005
|
||||||
Net
loss, as reported
|
$
|
(2,793
|
)
|
$
|
(3,044
|
)
|
|
Deduct:
Stock-based employee compensation costs determined under the
fair value
method
|
(35
|
)
|
(301
|
)
|
|||
Net
loss, pro forma
|
$
|
(2,828
|
)
|
$
|
(3,345
|
)
|
|
Basic
and diluted net income (loss) per share:
|
|||||||
As
reported
|
$
|
(0.09
|
)
|
$
|
(0.11
|
)
|
|
Pro
forma
|
(0.09
|
)
|
(0.12
|
)
|
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
July
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
statements.
In
September 2006, the Securities and Exchange Commission (SEC) issued
Staff Accounting Bulletin No. 108, Considering the Effects of Prior
Year Misstatements when Quantifying Misstatements in Current Year Financial
Statements (SAB 108), which will be effective for the year ended
December 31, 2006. The objective of SAB 108 is to eliminate diversity in
practice surrounding how public companies quantify financial statement
misstatements. SAB 108 requires quantification of financial statement
misstatements based on the effects of the misstatements on the consolidated
statement of income and the consolidated balance sheet and related financial
statement disclosures. The adoption of SAB 108 is not expected to have an impact
on the Company’s financial position or results of operations.
In
September 2006, the FASB issued Statement No. 157, Fair Value
Measurements (FAS 157), which will be effective January 1, 2008. This
Statement clarifies the definition of fair value, establishes a framework for
measuring fair value, and expands the disclosures on fair value measurements.
The effect of adoption of FAS 157 on the Company’s financial position and
results of operations is not expected to be material.
-
18
-
Note
8: Accounts Receivable
At
September 30, 2006 and December 31, 2005 accounts receivable consist of the
following (in thousands):
Period
Ended
|
|||||||
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
Unbilled
grant receivable
|
$
|
-
|
$
|
760
|
|||
Trade
receivables
|
62
|
265
|
|||||
Other
receivables
|
43
|
60
|
|||||
Total
|
$
|
105
|
$
|
1,085
|
Note
9: Prepaid Expenses and Other Current Assets
At
September 30, 2006 and December 31, 2005 this account includes the following
(in
thousands):
Period
Ended
|
|||||||
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
Prepaid
insurance
|
$
|
287
|
$
|
196
|
|||
Prepaid
rent
|
8
|
35
|
|||||
Prepaid
compensation
|
-
|
803
|
|||||
Inventory
|
-
|
351
|
|||||
Other
|
15
|
44
|
|||||
Total
|
$
|
310
|
$
|
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 were paid if the employee maintained his or her
employment with the Company through the retention period indicated in the
individual’s offer letter. 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 date of
termination. The retention periods terminated on dates between January 15,
2006
and June 30, 2006.
Inventories
are valued at the lower of cost or market.
-
19
-
Note
10: 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
|
|||||||
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
Clinical
expenses
|
$
|
23
|
$
|
642
|
|||
Legal
fees
|
57
|
61
|
|||||
Insurance
|
249
|
||||||
Neptune
Pharmaceutical agreement
|
125
|
-
|
|||||
Retention
and severance pay
|
-
|
1,039
|
|||||
Consulting
fees
|
5
|
46
|
|||||
Kingsbridge
contract penalty
|
266
|
-
|
|||||
Other
|
93
|
614
|
|||||
Total
|
$
|
818
|
$
|
2,402
|
The
Neptune Pharmaceutical agreement amount of $125,000 represents the outstanding
balance on a termination agreement to Stephen Gorfine, M.D. that was accepted
by
Neptune and Cellegy on September 25, 2006. (See Note 2)
Note
11: 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 September 30, 2006
total current and long-term deferred revenue of $3,686,000 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. As further discussed in Note 2, the
Company will credit the balance of its deferred revenue to income since such
revenue relates to past license agreements with ProStrakan be terminated and,
as
a result, all milestones will be considered satisfied.
Note
12: Notes Payable
Notes
payable at September 30, 2006 include two non-interest bearing notes issued
in
April 2005 by Cellegy to PDI pursuant to a lawsuit settlement in April 2005,
a
note issued by Biosyn to Ben Franklin Technology Center of Southeastern
Pennsylvania (“Ben Franklin”) in October, 1992 and a note issued by ProStrakan
in September, 2006 in connection with the Company’s proposed sale of assets (See
Note 2). The notes have been recorded at their total net present
value.
PDI
Notes
The
terms
of the notes issued to PDI are as follows:
a.)
The
$3.0
million secured promissory note has an outstanding balance and a net present
value of $1.8 million at September 30, 2006 and is payable on October 12, 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 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%.
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.
-
20
-
b.)
The
$3.5
million non-negotiable senior convertible debenture stated at its net present
value of $2.8 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 stock 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 indebtedness 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.
c.)
In an
agreement dated September 20, 2006, the Company agreed to pay PDI an aggregate
amount of $3.0 million (the “Payoff Amount”), as follows: (i) no later than four
business days after the Company enters into and agreement to sell all or a
material portion of its assets relating to Cellegesic, Rectogesic, Tostrex,
Tostrelle and/or Fortigel, which includes the APA with ProStrakan, the sum
of
$500,000, as a nonrefundable prepayment of a portion of the outstanding unpaid
principal and accrued interest on the Secured Note; and (ii) no later than
two
business days after the consummation of any such asset sale transaction, the
sum
of $2.5 million. PDI agreed that, effective upon receipt of the Payoff Amount,
it will accept the Payoff Amount as payment in full of all obligations owing
under the Settlement Agreements (“Obligations”). The Company remitted $500,000
to PDI on September 28, 2006 and has recorded the payment against its existing
obligation. If the proposed transaction is not approved by Cellegy’s
stockholders, the face value of the New Note of $3.0 million will revert to
the
amounts owed under the original settlement, less the $500,000 that had been
paid
as part of the renegotiated settlement, or approximately $5.3 million as of
September 30, 2006.
Upon
the
receipt by PDI of the Payoff Amount, all of the Obligations will be deemed
paid
in full; all of the security interests and liens created under the Settlement
Agreements in favor of PDI terminate and are released; all other obligations
of
the Company owing to PDI under the Settlement Agreements or any related
agreement, instrument or other document are released and discharged and each
of
the Settlement Agreements terminates and is null and void and of no further
force or effect without any further action of the parties. Effective upon
receipt of the Payoff Amount, the Company and PDI release each other for any
past claims relating to the Settlement Agreements.
In
the
agreement the Company makes a number of representations to PDI concerning the
material terms of the proposed transaction with ProStrakan, and agrees that
PDI
has the right to declare the agreement null and void (and will retain the
initial $500,000 payment) should those representations be materially false
or
inaccurate. All of the Settlement Agreements will continue to be enforceable
by
PDI and remain in full force and effect until such time as PDI receives from
the
Company the entire Payoff Amount.
PDI
agreed that it will not convert any portion of the Convertible Note prior to
December 31, 2006, provided that this obligation will immediately terminate
in
the event that (i) the Company fails to comply with obligations pursuant to
the
agreement, or (ii) PDI determines that the Company has failed to disclose to
PDI
any information that could be material to PDI’s determination to enter into the
PDI agreement. If the closing of the APA does not occur by December 31, 2006,
then the letter agreement will terminate and be of no further force or effect,
and PDI is entitled to retain the initial payoff as discussed
above.
PDI
and
the Company also agreed to release each other and related parties from any
claims or liabilities arising before the date of their agreement arising out
of
or relating to any of the Settlement Agreements, other than as a result of
the
released person’s gross negligence or willful misconduct. PDI’s release is
effective only upon receipt of the full Payoff Amount.
Since
the
closing of the APA is contingent upon approval by the Company’s stockholders, no
adjustments to the Company’s financial statements have been made reflecting the
terms of the New Note. If the APA is approved by the stockholders in the
timeframe specified under the New Note, the Company will record an ordinary
gain
to the extent the existing notes exceed the amount of the New Note. There is
no
assurance that the proposed transaction will be approved by the
stockholders.
-
21
-
ProStrakan
Note
At
the
same time that Cellegy and ProStrakan signed the APA, ProStrakan made a loan
to
Cellegy of $2.0 million, evidenced by a secured promissory note (the “ProStrakan
Note”). The note has a maturity date of November 30, 2006 or, if the SEC reviews
the Company’s proxy statement, December 21, 2006, or such later date as the
parties mutually agree in writing. Interest on the unpaid principal amount
of
the ProStrakan Note accrues at a rate of 6% per annum and overdue amounts bear
interest at an annual rate of 3% per annum, in addition to the basic interest
rate. Accrued unpaid interest is due and payable on the maturity date or, if
earlier, on the date of any prepayment of the note. Amounts payable by Cellegy
under the ProStrakan Note shall be made by Cellegy without set-off or
counterclaim and free and clear of any other restrictions or provisions. The
Company has also agreed to indemnify ProStrakan from all losses and expenses
it
incurs in connection with or by reason of (i) the failure of any of our
obligations under the loan documents to be legal, valid and binding obligations
of Cellegy, or (ii) any investigation, litigation or proceeding (including
any
insolvency proceeding) relating to the note or any of the other loan documents.
Additionally, the Company has agreed that it will not assert against ProStrakan
any claim on any theory of liability for special, indirect, consequential or
punitive damages relating to the transactions contemplated by the loan documents
except in the event of a finding of ProStrakan’s gross negligence or willful
misconduct.
The
Company has also made certain representations and warranties to ProStrakan,
including that the ProStrakan Note constitutes a valid, binding and enforceable
obligation of Cellegy and that the Company will not create, incur, assume or
permit or suffer to exist any liens or other encumbrances on the collateral
securing the Company’s obligations under the ProStrakan Note.
Events
of
default under the ProStrakan Note include: default on the payment when due
under
the ProStrakan Note of any principal, interest or other obligation; default
in
the observance in any of the Company’s obligations under the ProStrakan Note and
such default continues unremedied for more than five days after notice from
ProStrakan; any representation or warranty of Cellegy under the loan documents
is untrue or incorrect in any material respect when made or deemed made; entry
into an agreement by Cellegy to sell or otherwise transfer all or substantially
all of the Company’s property or the patent collateral securing our obligations
under the ProStrakan Note; or the stockholders and directors of Cellegy shall
not have approved the asset sale transaction on or before the dates specified
in
the APA. The ProStrakan Note also contains certain other events of default
including the failure of Cellegy to pay its debts when they become due, or
its
inability to remedy such a situation.
If
any
default or event of default by virtue of an insolvency proceeding as described
above shall at any time occur, the entire outstanding principal amount of the
ProStrakan Note and all other Cellegy obligations under the loan documents
automatically become immediately due and payable. Cellegy has agreed to pay
all
of ProStrakan’s costs and expenses involved in any action to enforce the
provisions of the ProStrakan Note.
Ben
Franklin Note
The
Ben
Franklin note has a face value of $778,000 and net present value of $288,000
at
September 30, 2006. The note has no scheduled repayment term.
Payment is based on 3% of Biosyn’s revenues excluding income recorded pursuant
to research and development grants.
At
September 30, 2006, future minimum payments on the notes were payable as follows
(in thousands):
2006
|
$
|
3,842
|
||
2007
|
-
|
|||
2008
|
3,500
|
|||
2009
and thereafter
|
778
|
|||
Total
payments
|
8,120
|
|||
Less:
Amount representing discount
|
(1,240
|
)
|
||
Net
present value of notes at September 30, 2006
|
$
|
6,880
|
If
the
APA is approved by the Company’s stockholders, the future minimum payments on
the notes payable would be $4.5 million in 2006 and $778,000 in 2009 and
thereafter.
-
22
-
Note
13: 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 September 30, 2006 and December 31, 2005
was
$23,000 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 nine months ended September 30, 2006, the Company recognized $145,000
income and $170,000 income, respectively from derivative
revaluation.
Note
14: Discontinued Operations
On
April
11, 2006, pursuant to a share purchase agreement (“SPA”) between 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 $1.3 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 September
30,
|
Nine
Months Ended September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Net
revenue
|
$
|
-
|
$
|
214
|
$
|
166
|
$
|
502
|
|||||
Cost
of revenues
|
40
|
$
|
27
|
79
|
|||||||||
Gross
Profit
|
-
|
174
|
139
|
423
|
|||||||||
R&D
expenses
|
-
|
-
|
-
|
22
|
|||||||||
S,
G & A expenses
|
-
|
104
|
65
|
287
|
|||||||||
Operating
income
|
-
|
70
|
75
|
114
|
|||||||||
Interest
income
|
-
|
4
|
2
|
10
|
|||||||||
Interest
expense
|
-
|
-
|
-
|
-
|
|||||||||
Gain(loss)
on disposal
|
-
|
-
|
(69
|
)
|
-
|
||||||||
Income(loss)
from discontinued operations
|
$
|
-
|
$
|
74
|
$
|
7
|
$
|
124
|
Note
15: Subsequent Events
Proxy
Filing
In
October, 2006 the Company filed preliminary and definitive proxy statements
on
Schedule 14A with the SEC relating to a special meeting of the shareholders
to
vote on the proposed transaction to be held November 22, 2006 at the Company’s
office in Quakertown, Pa. (See Note 2)
-
23
-
Relocation
of the Company’s Headquarters
On
October 1, 2006, the Company relocated its headquarters from Huntingdon Valley,
Pennsylvania to Quakertown, Pennsylvania and also closed its Brisbane,
California offices.
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-hal`f 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.
-
24
-
On
April
25, 2006, the Cardiovascular Renal Drugs Advisory Committee (the “Committee”) of
the U.S. 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 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.
|
2. |
A
majority of the Committee agreed that the quadratic model was
the proper
analysis for the purpose of
decision-making.
|
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.”
|
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.
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.
On
August
28, 2006, the Company announced that Family Health International planned to
stop
the Savvy®
(C31G
vaginal gel) Phase 3 trial being conducted in Nigeria to determine whether
Savvy
is safe and effective for reducing women’s risk of acquiring HIV infection. The
trial was part of an international effort to evaluate microbicides as a tool
to
reduce the risk of HIV infection in people at high risk. The decision followed
a
recommendation during a meeting of the study’s external, independent Data
Monitoring Committee (“DMC”). After reviewing the study data to date, DMC
members concluded that the Nigeria trial was unlikely to provide convincing
evidence that Savvy protects against HIV. Without obvious signals of
effectiveness in the interim data, the study would be unlikely to detect a
reduction in the HIV risk if it were to continue. The Savvy trial in Nigeria
began screening volunteers in September 2004 and completed planned enrollment
with 2,152 women in June, 2006. The Savvy Phase 3 contraception study being
conducted in the U.S. is ongoing.
On
September 26, 2006, the Company entered into an asset purchase agreement with
ProStrakan to sell substantially all of the Company’s intellectual property and
other assets relating to Cellegesic, Rectogesic, Tostrex, Fortigel and
Tostrelle. In October 2006, the Company filed a preliminary and subsequently
a
final proxy statement relating to a special meeting of stockholders scheduled
to
be held November 22, 2006, to consider and vote on the proposed transaction
with
ProStrakan. See Note 2 above for further information, as well as the definitive
proxy statement filed with the SEC.
Results
of Operations
As
more
fully explained in Note 1, “Basis of Presentation” and Note 2, “Proposed Sale of
Assets to ProStrakan”, the Company has entered into an agreement to sell
substantially all its intellectual property and has written down its remaining
assets to fair market value, as the Company believes it may not realize the
value of its remaining assets during the normal course of business.
The
operations of Cellegy Australia, for the three and nine month periods ended
September 30, 2005 and for the nine month period ended September 30, 2006 are
shown as discontinued operations due to the disposition of Cellegy Australia
in
April of 2006.
Revenues.
The Company had revenues of $172,000 and $1,738,000 for the three months ended
September 30, 2006 and 2005, respectively. For the corresponding nine
month periods, revenues were $2,635,000 and $10,804,000,
respectively.
-
25
-
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 $73,000 and $229,000 for the three months ended
September 30, 2006 and 2005, respectively, consisting primarily of revenues
related to its marketing arrangements with ProStrakan. Licensing revenues for
the corresponding nine month periods were $452,000 in 2006 and $6,988,000 in
2005. Approximately $6.5 million of the 2005 revenues consist of deferred
revenues recognized in connection with the Company’s settlement with PDI.
Grant
Revenues.
Grant
revenues were $99,000 and $1,252,000 for the three months ended September 30,
2006 and 2005, respectively. Due to the cessation of the Nigeria HIV clinical
trial in August 2006, the Company is no longer conducting research in the
HIV/microbicidal field. The grant funding supporting such research for CVN
and
UC-781 was discontinued in the third quarter and the laboratory was shut down
and certain employees were laid off effective September 30, 2006. The Company
will record no further grant revenue. Grant revenues for the respective nine
month periods were $1,926,000 and $3,420,000 and decreased due to a decline
in
laboratory research activities in 2006 for CVN and UC-781 product
candidates.
Product
Sales.
The Company had no product sales for the three months ended September 30,
2006 and $257,000 for the three months ended September 30, 2005, which consisted
primarily of Rectogesic related inventory sales to ProStrakan. Sales for the
nine month period of the current year consist primarily of in process and other
inventory purchases by ProStrakan in conjunction with their acquisition of
the
European marketing rights to Rectogesic in late 2005.
Research
and Development Expenses.
The Company has significantly curtailed its research activities due to capital
shortages. The Company is also no longer pursuing its primary HIV/microbicidal
product candidate, Savvy, due to the cessation of the Nigeria HIV clinical
trial
in August, 2006 and has terminated further research for CVN and UC-781 product
candidates. The Savvy Phase 3 contraception study being conducted in the U.S.
is
ongoing.
The
Company has been seeking buyers or licensees for its HIV/microbicidal technology
in exchange for funding. There can be no assurance that the Company will find
suitable terms or arrangements, if any, in connection with its sale or
out-licensing of its technology and research programs.
For
the
three months ended September 30, 2006 and 2005, research and development
expenses were $340,000 and $1,816,000, respectively. The decrease of $1,476,000
is comprised of a $1.1 million decrease in clinical manufacturing, testing
and
professional fees related to the Company’s HIV research, and a decrease in
personnel and related costs of $263,000 due
to
research and development staff reductions.
Research
and development expenses were $2,246,000 and $6,855,000 for
the
nine month periods ended September 30, 2006 and 2005, respectively. The decrease
of $4,609,000 is due primarily to a reduction in salaries of $1.0 million due
to
staffing reductions and reductions in clinical manufacturing, testing and
professional fees of $2.8 million attributable to the reduction in research
activities. Additionally, the balance of the decrease is due to reductions
in
amortization expense from past write downs of intangible assets and to loss
on
disposal of assets in the prior year.
Selling,
General and Administrative Expenses.
Selling, general and administrative (“SG&A”) expenses during the three
months ended September 30, 2006 and 2005 were $1,229,000 and $2,471,000,
respectively. The decrease in SG&A of $1,242,000 is
due
primarily to staff reductions of $790,000, office expenses of $254,000, and
reductions in professional fees of $507,000.
For
the
nine month periods ended September 30, 2006 and 2005, SG&A expenses were
$4,800,000 and $6,764,000, respectively. The decrease includes reductions in
legal and accounting fees of $1.5 million due
to
lower litigation and financing expenses and
decreases in salary and office expenses of approximately $1.2 million. SG&A
expenses for 2005 include the receipt of a $1.1 million payment for the
Company’s early vacation of its previous headquarters.
-
26
-
Equipment
fair market value adjustments. During the third quarter of 2006, the
Company recorded a charge in the third quarter of approximately $276,000
relating to the write down of idle fixtures and equipment since its research
activities have been greatly scaled back.
Interest
and Other Income.
Interest income declined in 2006 due to the decrease in the Company’s interest
bearing cash balances. Additionally, 2005 includes income from the rental of
facilities whereas in 2006 there is no such activity. Results for 2006 also
include the sale of approximately $81,000 of Pennsylvania research tax credits
in the third quarter.
Interest
and Other Expense.
Interest expense for the nine month period in 2006 increased $226,000 primarily
due to interest expense related to the PDI notes. The Company also included
in
other expense $250,000 in connection with its renegotiation of its agreement
with Neptune.
Derivative
Revaluation. Derivative
revaluation expense decreased in 2006 due to the downward fluctuation in the
Company’s stock price during 2006.
Liquidity
and Capital Resources
The
Company estimates that its current cash balances are sufficient to carry it
through November 2006; however the Company has significant current unpaid
liabilities. If the proposed transaction with ProStrakan is not approved by
the
stockholders, a significant portion of these liabilities would become
immediately due and payable, including the notes due PDI and
ProStrakan.
Cash
and
cash equivalents were $830,000 at September 30, 2006, as
compared with $2,251,000 at December 31, 2005. Cash used in operations
during the nine month period of 2006 was $3,610,000 as compared to $12,192,000
during the same period in the prior year. Operating activities during 2005
included the recognition of $6.5 million in PDI deferred revenue and a cash
payment to PDI of $2.0 million upon settlement of the PDI litigation. In 2006,
the Company divested its Australian business unit which generated approximately
$1.0 million in investing activity proceeds.
Financing
activities in 2006 include the issuance of a $2.0 million note to ProStrakan
in
connection with the proposed sale of the Company’s assets. The Company also made
approximately $959,000 in payments against the notes due PDI. 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.
At
September 30, 2006, we had a deficit accumulated during the development stage
from continuing operations of $137.6 million, negative cash flows from
operations of $99.8 million, and cash and cash equivalents of $828,000. There
is
no assurance that the proposed transaction with ProStrakan will be approved
by
the shareholders. If the proposed transaction is not approved by the
shareholders, the Company would be unable to meet its obligations to its
creditors. The Company would be required to pay the $2.0 million loan from
ProStrakan and other amounts owed under the note and security agreements with
ProStrakan. If the Company did not pay amounts owed under the note when due,
ProStrakan could declare the note in default and take possession of the
collateral, which consists of substantially all of the intellectual property
rights that are subject to the transaction. ProStrakan could then sell or
otherwise dispose of the collateral, apply the proceeds to repayment of the
note
and the Company would be entitled to any remaining proceeds from the sale.
In
addition, the Company would likely owe ProStrakan a $500,000 termination payment
under the provisions of the asset purchase agreement. In addition, the Company’s
obligations under its original promissory notes due PDI of approximately $5.3
million would become due and payable, and PDI would be entitled to
foreclose on the collateral securing the Company's obligations to PDI. Also,
the
Company would continue to have unpaid obligations to other creditors. The
Company currently does not have any independent sources of funding to satisfy
these obligations, and the Company likely would be required to file for
protection under the bankruptcy laws. If the proposed transaction with
ProStrakan is not completed but adequate funding was available to satisfy all
of
the foregoing obligations as well as other obligations to our creditors, the
Company might explore other strategic alternatives, including a sale of our
assets to, or a business combination with another party, or the Company might
attempt to pursue other business opportunities and investments unrelated to
its
current business.
-
27
-
The
proposed transaction with ProStrakan is a taxable event; however the Company
believes that the expected taxable gain from the transaction will be offset
by
the application of its capitalized research expenses. The Company may also
use
its net operating tax loss carryforwards to reduce the taxable gain from the
transaction, however due to the limitation of net operating loss carryforwards
under the federal alternative minimum tax system, any portion of the taxable
gain reduced by net operating loss carryforwards may be subject to the federal
alternative minimum income tax. Both the Company’s past elections to capitalize
research expenses and the availability and amount of net operating loss
carryforwards are subject to audit and adjustment by the Internal Revenue
Service. In the event that the Internal Revenue Service adjusts either the
Company’s election to capitalize research expenses or the Company’s reported net
operating loss carryforwards, we may incur tax liability from the
transaction
Even
if
funds are obtained to continue operations, failure to obtain adequate additional
funds would require us to further delays in the development or commercialization
of certain products, to license to third parties the rights to commercialize
certain products that the Company would otherwise seek to commercialize
internally or to reduce resources devoted to product development. The Company’s
current outlook with respect to its going concern status could adversely affect
the Company’s 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 the common stock and could
otherwise have a material adverse effect on the Company’s 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.
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, for the three
months ended June 30, 2006 was $40,000 and for the three months ended September
30, 2006 was $38,000. 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 nine 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.
-
28
-
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
policies have occurred during the nine months ended September 30, 2006. The
Company has made certain adjustments to estimates concerning the realizability
of certain assets in the third quarter of 2006 and has made appropriate
adjustments reflective thereof. Specifically, due to the scale back of its
research activities, the Company recorded a charge in the third quarter of
approximately $276,000 relating to the write down of idle fixtures and
equipment.
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 investments are classified as
available-for-sale. All of our securities owned as of September 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
September 30, 2006 our investment portfolio consisted of approximately $830,000
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 forth quarter of 2006
from the September 30, 2006 value, and all other inputs into the Black-Scholes
model remained constant, we would record approximately $7,000 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.
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 September 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.
PART
II - OTHER INFORMATION
ITEM
1. Legal Proceedings
None
-
29
-
ITEM
1A. Risk Factors
We
have entered into an agreement to sell substantially all our assets to a third
party.
We
have
recently entered an agreement to sell substantially all our assets to ProStrakan
Group Ltd, plc (“ProStrakan”). See Note 2 above and our definitive proxy
statement filed with the SEC on Schedule 14A relating to the proposed
transaction for further information concerning the transaction and the risks
associated therewith.
We
have a history of losses..
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 September 30, 2006,
was
approximately $137.6 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 November
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.
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 and
have
recently entered into an agreement to sell substantially all its assets. As
such, the accompanying interim financial statements have been prepared assuming
the Company may not continue as a going concern and therefore may not realize
the value of its assets during the normal course of business. As a result,
the
Company has written down its remaining assets to fair market value. The
Company’s current outlook with respect to its going concern status could
adversely affect the Company’s 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 its common
stock and could otherwise have a material adverse effect on the Company’s
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 September
30,
2006, Cellegy had approximately $830,000 in cash and cash equivalents. Cellegy
has no current source of significant ongoing revenues or capital beyond its
existing cash balance.
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;
|
·
|
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;
|
-
30
-
·
|
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 November 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.
Our
common stock may be less liquid after the transaction, and you may find it
more
difficult to dispose of your shares.
Our
common stock is currently traded on the OTC Bulletin Board under the symbol
“CLGY.” Following the completion of the proposed transaction, we expect that the
common stock will continue to be traded on the OTC Bulletin Board. However,
it
is not possible to predict the trading price of our common stock following
the
closing of the sale to ProStrakan. It is likely that there will only be limited
trading volume in our common stock following the closing of the sale to
ProStrakan. Accordingly, you may find it more difficult to dispose of your
shares of common stock and you may not be able to sell some or all of your
shares of common stock when and at such times as you desire.
-
31
-
The
failure to complete the proposed transaction with ProStrakan will likely result
in a decrease in the market value of our common stock and will create
substantial doubt as to our ability to continue as an ongoing business.
The
proposed sale of assets to ProStrakan is subject to a number of contingencies,
including approval by our stockholders and other customary closing conditions.
We cannot predict whether we will succeed in obtaining the approval of our
stockholders. As a result, we cannot assure you that the transaction will be
completed. If our stockholders fail to approve the proposal to sell the assets
to ProStrakan at the special meeting or if the sale of the assets is not
completed for any other reason, the market price of our common stock would
likely decline, and there would be substantial doubt as to our ability to
continue as an ongoing concern.
Whether
or not the asset sale is completed, Cellegy may not be able to pay or provide
for the payment of all of its liabilities and obligations.
If
the
sale is not completed, it is likely that Cellegy will file for or be forced
to
resort to bankruptcy protection. In this event, it is extremely unlikely that
Cellegy would be able to pay, or provide for the payment of, its liabilities
and
obligations, and therefore there would be no assets available for distribution
to Cellegy's stockholders unless additional debt or equity funding was provided
after the bankruptcy filing or the assets proposed to be sold to ProStrakan
were
sold to a third party as part of the bankruptcy proceeding. Even if the parties
complete the asset sale, the cash payment received at the closing, together
with
Cellegy's other assets, may not be sufficient to pay, or provide for the payment
of, all of Cellegy's known and unknown liabilities and obligations. If the
proceeds from the asset sale together with Cellegy's other assets were
insufficient to pay or provide for the payment of Cellegy's liabilities and
other obligations, it is likely that Cellegy could be required to file for
or be
forced to resort to bankruptcy protection.
Failure
to complete the asset sale could cause Cellegy’s stock price to
decline.
If
the
asset sale is not completed, Cellegy's stock price may decline due to any or
all
of the following potential consequences:
·
|
Cellegy
may not be able to dispose of its assets for values equaling or exceeding
those currently estimated by Cellegy; in particular, the assets that
are
the subject of the asset sale will likely be substantially diminished
in
value;
|
·
|
Cellegy
may file for or be forced into bankruptcy;
and
|
·
|
Cellegy's
costs related to the asset sale, such as required payments to ProStrakan,
legal, accounting and financial advisor fees, must be paid even if
the
asset sale is not completed.
|
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.
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.
-
32
-
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.
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
None
ITEM
3. Defaults Upon Senior Securities
None
ITEM
4. Submission of Matters to a Vote of Security Holders
In
October, 2006 the Company filed preliminary and definitive proxy statements
on
Schedule 14A with the SEC relating to a special meeting of the shareholders
to
vote on the proposed asset sale transaction with ProStrakan, to be held
November 22, 2006 at the Company’s office in Quakertown, Pa.
ITEM
5. Other Information
None
ITEM
6. Exhibits
a)
Exhibits
2.1
|
Asset
Purchase Agreement dated September 26, 2006, between the Registrant
and
Strakan International Limited.(1)
|
10.1
|
Termination
Agreement and Release of Claims dated as of September 22, 2006, by
and
between the Registrant and Stephen R. Gorfine, M.D., as
representative.(1)
|
-
33
-
10.2
|
Letter
agreement dated September 20, 2006, between the Registrant and PDI,
Inc.(1)
|
10.3
|
Promissory Note dated September 26, 2006, in favor of Straken International Limitied. |
10.4
|
Patent Collateral Assignment and Security Agreement Dated September 26, 2006, between the Registrant and Strakan International Limited. |
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
|
(1)
Incorporated by reference to Exhibits filed with the Registrant's Schedule
14A,
which includes a Report on Form 8-K, filed September 27, 2006, with the
Securities and Exchange Commission.
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: November
14, 2006
|
/s/ Richard
C. Williams
|
|
Richard
C. Williams
Chairman
and Interim Chief Executive Officer
|
Date: November
14, 2006
|
/s/ Robert
J. Caso
|
|
Robert
J. Caso
Vice
President, Finance and Chief Financial Officer
|
||
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34
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