DMK PHARMACEUTICALS Corp - Quarter Report: 2007 June (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
x
|
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
|
|
For
the quarterly period ended June 30, 2007
|
|
|
OR
|
|
|
|
o
|
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the transition period
from
to
Commission
File Number: 0-26372
CELLEGY
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
82-0429727
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(I.R.S.
Employer
Identification
Number)
|
2085B
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 x 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 ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
The
number of shares outstanding of the registrant’s common stock at July 31, 2007
was 29,834,796.
CELLEGY
PHARMACEUTICALS, INC.
CONTENTS
OF QUARTERLY REPORT ON FORM 10-Q
|
|
Page
|
PART
I
|
FINANCIAL
INFORMATION
|
|
|
|
|
Item
1.
|
Financial
Statements:
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
3
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
4
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows
|
5
|
|
|
|
|
Notes
to Condensed Consolidated Financial Statements
|
6
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosure of Market Risk
|
16
|
|
|
|
Item
4.
|
Controls
and Procedures
|
16
|
|
|
|
PART
II
|
OTHER
INFORMATION
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
17
|
Item
1A.
|
Risk
Factors
|
17
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
23
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
23
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
23
|
|
|
|
Item
5.
|
Other
Information
|
23
|
|
|
|
Item
6.
|
Exhibits
|
23
|
|
Signatures
|
24
|
|
|
|
2
PART
I - FINANCIAL INFORMATION
Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands)
(Unaudited)
June
30, 2007
|
December
31, 2006
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,521
|
$
|
3,804
|
|||
Accounts
receivable
|
19
|
77
|
|||||
Prepaid
expenses and other current assets
|
95
|
264
|
|||||
Total
current assets
|
2,635
|
4,145
|
|||||
Total
assets
|
$
|
2,635
|
$
|
4,145
|
|||
|
|||||||
Liabilities
and Stockholders' Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
13
|
$
|
175
|
|||
Accrued
expenses and other current liabilities
|
128
|
536
|
|||||
Current
portion of notes payable
|
-
|
45
|
|||||
Total
current liabilities
|
141
|
756
|
|||||
Notes
payable
|
404
|
322
|
|||||
Derivative
instruments
|
7
|
4
|
|||||
Total
liabilities
|
552
|
1,082
|
|||||
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock
|
3
|
3
|
|||||
Additional
paid-in capital
|
125,723
|
125,699
|
|||||
Accumulated
deficit
|
(123,643
|
)
|
(122,639
|
)
|
|||
Total
stockholders' equity
|
2,083
|
3,063
|
|||||
Total
liabilities and stockholders' equity
|
$
|
2,635
|
$
|
4,145
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
3
Cellegy
Pharmaceuticals, Inc
(Amounts
in thousands, except per share data)
(Unaudited)
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|||||
Revenues:
|
|||||||||||||
Licensing,
milestone and development funding
|
$
|
-
|
$
|
315
|
$
|
-
|
$
|
379
|
|||||
Grants
|
-
|
912
|
-
|
1,827
|
|||||||||
Product
sales
|
-
|
-
|
-
|
257
|
|||||||||
Total
revenues
|
-
|
1,227
|
-
|
2,463
|
|||||||||
Costs
and expenses:
|
|||||||||||||
Cost
of product sales
|
-
|
-
|
-
|
257
|
|||||||||
Research
and development
|
15
|
800
|
21
|
1,906
|
|||||||||
Selling,
general and administrative
|
426
|
1,472
|
942
|
3,571
|
|||||||||
Total
costs and expenses
|
441
|
2,272
|
963
|
5,734
|
|||||||||
Operating
loss
|
(441
|
)
|
(1,045
|
)
|
(963
|
)
|
(3,271
|
)
|
|||||
Other
income (expenses):
|
|||||||||||||
Interest
and other income
|
23
|
7
|
56
|
15
|
|||||||||
Interest
and other expense
|
(51
|
)
|
(224
|
)
|
(94
|
)
|
(437
|
)
|
|||||
Derivative
revaluation
|
3
|
80
|
(3
|
)
|
25
|
||||||||
Total
other income (expenses)
|
(25
|
)
|
(137
|
)
|
(41
|
)
|
(397
|
)
|
|||||
Net
loss from continuing operations applicable to common
stockholders
|
(466
|
)
|
(1,182
|
)
|
(1,004
|
)
|
(3,668
|
)
|
|||||
Income
(loss) from discontinued operations
|
-
|
(69
|
)
|
-
|
7
|
||||||||
Net
loss applicable to common stockholders
|
$
|
(466
|
)
|
$
|
(1,251
|
)
|
$
|
(1,004
|
)
|
$
|
(3,661
|
)
|
|
|
|||||||||||||
Earnings
per common share:
|
|||||||||||||
From
continuing operations
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.12
|
)
|
|
From
discontinued operations
|
-
|
-
|
-
|
-
|
|||||||||
Basic
loss per common share:
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.12
|
)
|
|
|
|||||||||||||
From
continuing operations
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.12
|
)
|
|
From
discontinued operations
|
-
|
-
|
-
|
-
|
|||||||||
Diluted
loss per common share:
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.12
|
)
|
|
|
|||||||||||||
Weighted
average number of common shares used in per share
calculations:
|
|||||||||||||
Basic
|
29,835
|
29,833
|
29,835
|
29,832
|
|||||||||
Diluted
|
29,835
|
29,833
|
29,835
|
29,832
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
4
Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands)
(Unaudited)
|
Six
Months Ended June 30,
|
||||||
|
2007
|
2006
|
|||||
Operating
activities
|
|||||||
Net
loss
|
$
|
(1,004
|
)
|
$
|
(3,661
|
)
|
|
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activites:
|
|||||||
Bad
debt expense & other non-cash items
|
-
|
37
|
|||||
Depreciation
expense
|
-
|
81
|
|||||
Intangible
assets amortization
|
-
|
196
|
|||||
Loss
on sale of fixed assets
|
-
|
77
|
|||||
Equity
compensation expense
|
24
|
83
|
|||||
Derivative
re-evaluation
|
3
|
(26
|
)
|
||||
Interest
accretion on notes payable
|
82
|
384
|
|||||
MPI
Note debt forgiveness
|
(5
|
)
|
-
|
||||
Changes
in operating assets and liabilitites:
|
|||||||
Prepaid
expenses and other current assets
|
169
|
2,251
|
|||||
Accounts
receivable
|
58
|
365
|
|||||
Other
assets
|
-
|
(1,012
|
)
|
||||
Accounts
payable
|
(162
|
)
|
(159
|
)
|
|||
Accrued
expenses and other current liabilities
|
(408
|
)
|
(1,071
|
)
|
|||
Other
long term liabilities
|
-
|
46
|
|||||
Deferred
revenue
|
-
|
(128
|
)
|
||||
Net
cash used in operating activities
|
(1,243
|
)
|
(2,537
|
)
|
|||
Investing
activities:
|
|||||||
Sale
of investments
|
-
|
11
|
|||||
Proceeds
from sale of subsidiary
|
-
|
1,012
|
|||||
Net
cash provided by (used in) investing activities
|
-
|
1,023
|
|||||
Financing
activities:
|
|||||||
Repayment
of notes payable
|
(40
|
)
|
(209
|
)
|
|||
Net
cash provided by (used in) financing activities
|
(40
|
)
|
(209
|
)
|
|||
|
|||||||
Effect
of exchange rate changes on cash
|
-
|
123
|
|||||
|
|||||||
Net
decrease in cash and cash equivalents
|
(1,283
|
)
|
(1,600
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
3,804
|
2,251
|
|||||
Cash
and cash equivalents, end of period
|
$
|
2,521
|
$
|
651
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
5
Cellegy
Pharmaceuticals, Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note
1: Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial statements
have
been prepared in accordance with generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and Article
10 of Regulation S-X promulgated by the Securities and Exchange
Commission. Accordingly, certain information and footnote disclosures
normally included in annual financial statements have been condensed or omitted.
In the opinion of management, the accompanying 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. 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, 2006.
Liquidity
and Capital Resources
We
prepared the condensed consolidated financial statements assuming that we will
continue as a going concern, which contemplates the realization of assets and
the satisfaction of liabilities during the normal course of business. In
preparing these condensed consolidated financial statements, consideration
was
given to the Company’s future business alternatives as described below, which
may preclude the Company from realizing the value of certain assets during
their
future course of business. At June 30, 2007, the Company had cash and cash
equivalents of approximately $2.5 million.
In
2006,
the Company eliminated its direct research activities and the Company sold
a
material portion of its intellectual property. The Company’s operations
currently relate primarily to the intellectual property of its Biosyn subsidiary
and the evaluation of its remaining options and alternatives with respect to
its
future course of business. While the Savvy Phase 3 contraception trial in the
United States is ongoing, the Company is not directly involved with the conduct
and funding thereof and it is uncertain whether Savvy will be commercialized
or
whether the Company will ever realize revenues therefrom. We therefore expect
negative cash flows to continue for the foreseeable future. The Company
presently has enough financial resources to continue operations as they
currently exist for the near term, however, it does not have the technological
nor the financial assets necessary to fund the expenditures that would be
required to conduct the future clinical and regulatory work necessary to
commercialize Savvy without additional funding. Alternatives with respect to
the
Company’s remaining business and assets might include seeking to merge or
combine with another third party with greater resources and infrastructure
necessary to conduct development programs and to commercialize technology.
If a
suitable candidate cannot be found, the Company may choose to liquidate or
voluntarily file bankruptcy proceedings. Due to the uncertainty of the cash
flow
necessary to explore or implement these alternatives, there can be no assurance
that the Company will have adequate resources to continue operations for longer
than twelve (12) months.
These
factors raise substantial doubt about our ability to continue as a going
concern. There is no assurance that any of the above options will be implemented
on a timely basis or that we will be able to sell our remaining technology
or
find suitable candidates for a business combination or other transaction, if
at
all. We may be required to accept less than favorable commercial terms in any
such future arrangements. The condensed consolidated financial statements do
not
include any adjustments that might result from the outcome of this uncertainty.
Any failure to dispel any continuing doubts about our ability to continue as
a
going concern could adversely affect our ability to enter into any business
combination or other agreements, therefore making it more difficult to obtain
required financing on favorable terms or at all. Such an outcome may negatively
affect the market price of our common stock and could otherwise have a material
adverse effect on our business, financial condition and results of
operations.
6
Note
2: Accumulated Other Comprehensive Loss
Accumulated
other comprehensive loss generally represents all changes in stockholders’
equity except those resulting from investments or contributions by stockholders.
The Company’s unrealized foreign currency translation (“FCT”) adjustments
represent the only components of accumulated other comprehensive loss that
are
excluded from the Company’s net loss.
Total
comprehensive income during three and six months ended June 30, 2007 and 2006
consisted of (in thousands):
|
Three
Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|||||
Net
loss after discontinued operations
|
$
|
(466
|
)
|
$
|
(1,251
|
)
|
$
|
(1,004
|
)
|
$
|
(3,661
|
)
|
|
Change
in FCT adjustments
|
-
|
157
|
-
|
123
|
|||||||||
Comprehensive
loss
|
$
|
(466
|
)
|
$
|
(1,094
|
)
|
$
|
(1,004
|
)
|
$
|
(3,538
|
)
|
Note
3: Basic and Diluted Net Loss per Common Share
Basic
net
loss per common share is computed using the weighted average number of common
shares outstanding during the period. Diluted net loss per common share
incorporates the incremental shares issued upon the assumed exercise of stock
options and warrants, when dilutive. There is no difference between basic and
diluted net loss per common share, as presented in the statement of operations,
because all options and warrants are anti-dilutive. The total number of shares
that had their impact excluded was (in thousands):
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|||||
Options
|
1,363
|
3,659
|
1,363
|
3,289
|
|||||||||
Warrants
|
2,115
|
2,375
|
2,115
|
2,375
|
|||||||||
Total
number of shares excluded
|
3,478
|
6,034
|
3,478
|
5,664
|
2006
share amounts exclude 2,121,212 shares that would have been issuable upon
conversion of the $3.5 million nonnegotiable senior convertible debenture due
PDI, Inc. (“PDI”). This note was settled in September, 2006.
Note
4: Stock-Based Compensation
In
the
condensed consolidated statement of operations in the second quarter of 2007
and
2006, the Company recorded stock based compensation expenses of $22,971 and
$39,844, respectively.
2005
Equity Incentive Plan (“2005 Plan”)
Options
Outstanding
|
||||||||||
Weighted
Average
Number
of
Options
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
Weighted
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
|
||||
48,000
|
8.25
years
|
$
|
1.34
|
$
|
-
|
There
were no grants, cancellations or exercises of options under the 2005 Plan during
the quarter ended June 30, 2007. None of the options vested in the quarter
ended
June 30, 2007.
7
1995
Equity Incentive Plan (“Prior Plan”)
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||
Weighted
Average
Number
of
Options
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
Aggregate
Intrinsic
Value
|
Weighted
Average
Number
of
Options
|
Weighted
Average
Remaining Contractual Life
|
Weighted
Average
Exercise
Price
|
Aggregate
Intrinsic
Value
|
|||||||||||
222,944
|
|
6.43 years
|
|
3.12
|
$ |
|
- |
172,236
|
6.18
years
|
3.37
|
$ |
-
|
There
were no cancellations or exercises of options under the Prior Plan during the
quarter ended June 30, 2007. No future options may be granted under the Prior
Plan. The total fair value of the options vesting in the quarter ended June
30,
2007 was $300.
Directors’
Stock Option Plan
Options
Outstanding and Exercisable
|
||||||||||
Weighted
Average
Number
of
Options
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
|
||||||
92,000
|
|
|
5.33
years
|
|
|
4.45
|
$
|
-
|
During
the quarter ended June 30, 2007, 1,000 options expired and no options were
exercised. As of June 30, 2007, there were no options available for future
grants under the Directors’ Plan. The total fair value of the options vesting in
the quarter ended June 30, 2007 was $583.
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 and 600,000 options have exercise
prices of $2.89 and $5.00 per share, respectively. The option was vested and
exercisable in full on the grant date, although a portion of the option covering
up to 600,000 shares initially and declining over time is subject to
cancellation if they have not been exercised in the event that Mr. Williams
voluntarily resigns as Chairman and a director within certain future time
periods. As of June 30, 2007, none of these options have been
exercised.
Biosyn
Options
In
October 2004, in conjunction with its acquisition of Biosyn, Cellegy issued
stock options to certain Biosyn option holders to purchase 236,635 shares of
Cellegy common stock. All options issued were immediately vested and
exercisable.
During
the quarter ended June 30, 2007, there were no cancellations or exercises under
Biosyn options plan. The following table summarizes information about stock
options outstanding and exercisable related to Biosyn option grants at June
30,
2007:
Options
Outstanding and Exercisable
|
||||||||||
Weighted
Average
Number
of
Options
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
Weighted
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
|
||||
4,797
|
|
|
6.56
years
|
|
|
0.29
|
$
|
-
|
8
Shares
Reserved
As
of
June 30, 2007, the Company has reserved shares of common stock for issuance
as
follows:
Biosyn
options
|
4,797
|
|||
Director's
Plan
|
92,000
|
|||
Warrants
|
2,114,593
|
|||
Nonplan
options
|
1,000,000
|
|||
1995
Equity Incentive Plan
|
222,944
|
|||
2005
Equity Incentive Plan
|
998,500
|
|||
Total
|
4,432,834
|
As
of
June 30, 2007, there was $48,335 of total unrecognized compensation cost related
to non-vested options, which is expected to be recognized over a remaining
weighted-average vesting period of approximately 0.72 years.
Warrants
|
Warrant
Shares
|
Exercise
Price
Per
Share
|
|
Date
Issued
|
|
Expiration
Date
|
|||||||
June
2004 PIPE
|
604,000
|
$
|
4.62
|
July
27, 2004
|
July
27, 2009
|
||||||||
Biosyn
warrants
|
81,869
|
5.84-17.52
|
October
22, 2004
|
2008
- 2014
|
|||||||||
May
2005 PIPE
|
|||||||||||||
Series
A
|
714,362
|
2.25
|
May
13, 2005
|
May
13, 2010
|
|||||||||
Series
B
|
714,362
|
2.50
|
May
13, 2005
|
May
13, 2010
|
|||||||||
Total
|
2,114,593
|
Note
5: Segment Reporting
All
revenues during the three and six months ended June 30, 2006, were derived
from
the Company’s pharmaceutical segment.
Revenues
from external sources by major geographic area are as follows (in
thousands):
|
Three
Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|||||||||
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
Revenues
|
|||||||||||||
North
America
|
|||||||||||||
Pharmaceuticals
|
$
|
-
|
$
|
912
|
$
|
-
|
$
|
1,827
|
|||||
Europe
|
|||||||||||||
Pharmaceuticals
|
-
|
315
|
-
|
636
|
|||||||||
Revenues
from continuing operations
|
$
|
-
|
$
|
1,227
|
$
|
-
|
$
|
2,463
|
Cellegy
allocates its revenues and operating expenses to each business segment.
Management regularly assesses segment operating performance and makes decisions
on how resources are allocated based upon segment performance, with the segment
measurement of profitability being net income. The accounting policies of the
reportable segments are the same as those described in the summary of
significant accounting policies.
9
Operating
loss by geographic region is as follows (in thousands):
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|||||
Operating
Loss
|
|||||||||||||
North
America
|
|||||||||||||
Pharmaceuticals
|
$
|
(466
|
)
|
$
|
(879
|
)
|
$
|
(1,004
|
)
|
$
|
(2,721
|
)
|
|
Europe
|
|||||||||||||
Pharmaceuticals
|
-
|
(303
|
)
|
-
|
(947
|
)
|
|||||||
Net
loss from continuing operations
|
$
|
(466
|
)
|
$
|
(1,182
|
)
|
$
|
(1,004
|
)
|
$
|
(3,668
|
)
|
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):
June
30,
2007
|
|
December
31,
2006
|
|||||
Assets
|
|||||||
North
America
|
$
|
2,635
|
$
|
4,145
|
Note
6: Recent Accounting Pronouncements
In
July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for
Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109”
(“FIN 48”). FIN 48 prescribes how a company should recognize, measure,
present and disclose uncertain income tax positions. A “tax position” is a
position taken on a previously filed tax return, or expected to be taken in
a
future tax return that is reflected in the measurement of current or deferred
tax assets or liabilities for interim or annual periods. A tax position can
result in a permanent reduction of income taxes payable, a deferral of income
taxes to future periods, or a change in the expected ability to realize deferred
tax assets. A change in net assets that results from the adoption of FIN 48
is
recorded as an adjustment to retained earnings in the period of adoption.
FIN 48 is effective for fiscal years beginning after December 15, 2006. The
Company is currently evaluating the effect that the adoption of FIN 48 will
have
on its results of operations and financial position. The adoption of FIN 48
is
not expected to have a material impact on the Company’s financial
statements.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities, including an amendment of FASB
Statement No. 115.” SFAS No. 159 permits entities to choose to measure
many financial instruments and certain other items at fair value that are not
currently required to be measured at fair value. Unrealized gains and
losses on items for which the fair value option has been elected are reported
in
earnings. SFAS No. 159 does not affect any existing accounting literature
that requires certain assets and liabilities to be carried at fair value.
SFAS No. 159 is effective for fiscal years beginning after November 15,
2007. We do not expect our adoption of this new standard to have a
material impact on the Company’s financial statements.
The
Emerging Issues Task Force (“EITF”) has two issues currently under consideration
that may impact the Company. EITF 07-01, “Accounting for Collaboration
Arrangements Related to the Development and Commercialization of Intellectual
Property” , is focused on how the parties to a collaborative agreement should
account for costs incurred and revenue generated on sales to third parties,
how
sharing payments pursuant to a collaboration agreement should be presented
in
the income statement and certain related disclosure questions. EITF 07-3,
“Accounting for Non-Refundable Advance Payments for Goods or Services to Be
Used
in Future Research and Development Activities”, is focused on whether
non-refundable advance payments for goods that will be used or services that
will be performed in future research and development activities should be
accounted for as research and development costs or deferred and capitalized
until the goods have been delivered or the related services have been rendered.
The Company will continue to monitor the development of these EITF’s and
evaluate the effects on its financial statements and
disclosures.
10
Note
7: Accounts
Receivable
Accounts
receivable consists of the following (in thousands):
|
June
30,
2007
|
December
31,
2006
|
|||||
Grant
receivables
|
$
|
-
|
$
|
63
|
|||
Other
receivables
|
19
|
14
|
|||||
|
$
|
19
|
$
|
77
|
Note
8: Prepaid
Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following (in
thousands):
|
June
30,
2007
|
|
December
31,
2006
|
||||
Prepaid
insurance
|
$
|
86
|
$
|
237
|
|||
Security
deposits
|
8
|
18
|
|||||
Other
|
1
|
9
|
|||||
|
$
|
95
|
$
|
264
|
Note
9: Accrued
Expenses and Other Current Liabilities
The
Company accrues for goods and services received but for which billings have
not
been received. Accrued expenses and other current liabilities consist of the
following (in thousands):
|
June
30,
2007
|
|
December
31,
2006
|
||||
Accrued
legal fees
|
$
|
-
|
$
|
22
|
|||
Accrued
retention and severance
|
59
|
100
|
|||||
Accrued
accounting and consulting fees
|
15
|
175
|
|||||
Insurance
payable
|
3
|
164
|
|||||
Other
|
51
|
75
|
|||||
Total
|
$
|
128
|
$
|
536
|
Note
10: Notes Payable
Ben
Franklin Note
Biosyn
issued a note to Ben Franklin Technology Center of Southeastern Pennsylvania
(“Ben Franklin Note”) in October 1992, in connection with funding the
development of a compound to prevent the transmission of Acquired
Immunodeficiency Disease (“AIDS”).
The
Ben
Franklin Note was recorded at its estimated fair value of $205,000 and was
assumed by Cellegy in connection with its acquisition of Biosyn in 2004. The
repayment terms of the non-interest bearing obligation include the remittance
of
an annual fixed percentage of 3% applied to future revenues of Biosyn, if any,
until the principal balance of $777,902 is satisfied. Under the terms of the
obligation, revenues are defined to exclude the value of unrestricted research
and development funding received by Biosyn from nonprofit sources. There is
no
obligation to repay the amounts in the absence of future Biosyn revenues. The
Company is accreting the discount of $572,902 against earnings using the
interest rate method over the discount period of five years, which was estimated
in connection with the note’s valuation at the time of the acquisition. At June
30, 2007, the outstanding balance of the note is $404,153.
11
PDI
Notes
In
connection with a settlement agreement dated April 11, 2005, PDI issued two
non-interest bearing notes; a $3.0 million secured promissory note payable
on
October 12, 2006, and a $3.5 million nonnegotiable senior convertible debenture
with a maturity date of April 11, 2008 (the “PDI Notes”). The PDI Notes were
settled for $3.0 million in September 2006.
MPI
Note
In
2004,
the Company settled a dispute with MPI, Inc. (“MPI”) and agreed to pay $60,000
as full and final settlement (the “MPI note”). The MPI note had no stated
interest rate. The settlement agreement allowed the Company to take certain
credits against the MPI note based upon the cumulative amount of contracts
entered into by the Company with MPI over a thirty-month period ending in
January 2007, at which time the remaining balance was payable. During that
period, MPI credited the Company $15,300 under this provision of the agreement.
The MPI note
was
settled in March 2007, for $40,000 and the remaining balance of $4,700 was
forgiven and recorded as other income.
Note
11: Derivative Instruments.
The
warrants from the May 2005 PIPE financing and Kingsbridge SSO are revalued
at
the end of each reporting period as long as they remain outstanding. The
estimated fair value of all warrants, using the Black-Scholes valuation model,
recorded as derivative liability at June 30, 2007 and December 31, 2006 was
$6,987 and $3,987. The changes in the estimated fair value of the warrants
have
been recorded as other income and expense in the condensed consolidated
statement of operations. For the three and six months ended June 30, 2007,
the
Company recognized expense of $2,707 and income of $3,173, respectively from
derivative revaluation. The Kingsbridge warrants were cancelled January 12,
2007.
Note
12: Discontinued Operations
On
April
11, 2006, Epsilon Pharmaceuticals (“Epsilon”) purchased all of the shares of
Cellegy Australia Pty, Ltd (“Cellegy Australia”). The subsidiary was part of the
Pharmaceutical Segment for the Australian and Pacific Rim geographic areas.
The
purchase price for the shares was $1.0 million 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:
Cash
|
$
|
185,554
|
||
Inventory
|
69,427
|
|||
Accounts
Receivable
|
52,305
|
|||
Goodwill
|
955,415
|
|||
Current
liabilities
|
262,000
|
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 balance as income in the current period pursuant to SFAS No. 52,
Foreign
Currency Translation.
Below
is a summary of those results:
12
|
Three
Months
Ended
June
30,
2006
|
Six
Months
Ended
June
30,
2006
|
|||||
Net
revenue
|
$
|
-
|
$
|
166
|
|||
Cost
of revenues
|
-
|
27
|
|||||
Gross
profit
|
-
|
139
|
|||||
Selling
general and administrative expenses
|
-
|
65
|
|||||
Operating
income
|
-
|
74
|
|||||
Interest
income
|
-
|
2
|
|||||
Loss
on disposal
|
(69
|
)
|
(69
|
)
|
|||
Income
(loss) from discontinued operations
|
$
|
(69
|
)
|
$
|
7
|
The
following discussion of our financial condition and results of operations should
be read in conjunction with the financial statements and notes to those
statements included elsewhere in this Quarterly Report on Form 10-Q and our
most recent audited financial statements included in our Annual Report on
Form 10-K previously filed with the SEC. This discussion may contain
forward-looking statements that involve substantial risks and uncertainties.
These forward-looking statements are not historical facts, but are based on
current expectations, estimates and projections about our industry, our beliefs
and our assumptions. Words such as “believes,” “anticipates,” “expects,”
“intends” and similar expressions are intended to identify forward-looking
statements, but are not the exclusive means of identifying such statements.
These forward-looking statements are not guarantees of future performance and
concern matters that could subsequently differ materially from those described
in the forward-looking statements. Actual events or results may also differ
materially from those discussed in this Quarterly Report on Form 10-Q.
These risks and uncertainties include those described in “Management’s
Discussion and Analysis of Financial Condition and Results of Operations -
Factors That May Affect Future Operating Results” and elsewhere in this
Quarterly Report on Form 10-Q. Except as required by law, we undertake no
obligation to revise any forward-looking statements in order to reflect events
or circumstances that may arise after the date of this Quarterly Report on
Form 10-Q.
General
Cellegy
Pharmaceuticals is a specialty biopharmaceutical company. Following the
Company’s decision to eliminate its direct research activities and the sale of
its assets to ProStrakan in late 2006, the Company’s operations currently relate
primarily to the ownership of its intellectual property rights relating to
the
Biosyn product candidates and the evaluation of its remaining options and
alternatives with respect to its future course of business.
Results
of Operations
Revenues.
The
Company had no revenues for the three and six month periods ended June 30,
2007
and had revenues of approximately $1,227,000 and $2,463,000 for the three and
six month periods ended June 30, 2006, respectively. Six-month 2006
period-to-date revenues consist of licensing, product sales and grant revenues.
Licensing
revenues. The
Company had no licensing revenues for the three and six month periods ended
June
30, 2007. The Company recorded licensing revenues for the three and six month
periods ended June 30, 2006 of approximately $315,000 and $379,000,
respectively. Licensing revenues consist primarily of amortization of upfront
payments received from licensees in connection with the Company’s existing
licensing agreements. We expect to recognize no licensing revenues in the
foreseeable future.
13
Grant
Revenues. The
Company had no grant revenues for the three and six month periods ending June
30, 2007. Grant revenues were approximately $912,000 and $1,827,000 for the
three and six month periods ended June 30, 2006 and related primarily to the
CVN
and UC-781 product candidates. The Company has discontinued its grant funding
in
connection with the elimination of its direct research activities in 2006 and
does not expect to record grant revenues in 2007.
In
addition to the grants funding above, Biosyn benefits indirectly from agency
funding paid to third party contractors in support of its ongoing Phase 3
clinical trials. These payments from the funding agencies are made directly
to
the service providers, not to Biosyn. Under the terms of certain of its funding
agreements, Biosyn has been granted the right to commercialize products
supported by the funding in developed and developing countries, and is obligated
to make its commercialized products, if any, available in developing countries,
as well as to public sector agencies in developed countries at prices reasonably
above cost or at a reasonable royalty rate.
Product
Sales.
The Company had no product sales for the three and six month periods ended
June 30, 2007. There were no product sales for the three month period ended
June
30, 2006. Product sales for the six-month period ending June 30, 2006 of
approximately $257,000 consisted primarily of in-process and other inventory
purchases by ProStrakan in conjunction with its acquisition of the European
marketing rights to Rectogesic in late 2005. Due to the renegotiation of its
agreements with ProStrakan and the sale of the Company’s technology in 2006,
Cellegy does not currently generate product sales revenue. We expect to
recognize no product sales revenues in the foreseeable future.
Research
and Development Expenses.
In the three and six month periods ending June 30, 2007, the Company incurred
research and development expenses of approximately $15,000 and $21,000,
respectively. During the corresponding periods of 2006, research and development
expenses of approximately $800,000 and $1,906,000 were attributable primarily
to
research activities concerning the Company’s HIV product candidates. The Company
discontinued its direct research activities in 2006 and does not expect to
incur
significant research and development expenses in 2007.
Selling,
General and Administrative Expenses.
Selling, general and administrative expenses for the three and six month periods
ending June 30, 2007 were approximately $426,000 and $942,000. Selling, general
and administrative expenses for the three and six month periods ending June
30,
2006 were approximately $1,472,000 and $3,571,000, respectively.
For
the
three month period, the decrease of approximately $1,046,000 consists primarily
of approximately $431,000 decreases in salary and related expenses due to
reductions in staffing, a decrease of approximately $116,000 in rent and other
office expenses and a decrease of approximately $499,000 in legal, consulting
and other administrative expenses. For the six month period, the decrease of
approximately $2,629,000 consists primarily of approximately $1,099,000
decreases in salary and related expenses due to reductions in staffing,
decreases of approximately $996,000 in legal, consulting and other
administrative expenses and decreases of approximately $534,000 in rent and
other office expenses. Additionally, the first quarter of 2006 includes
Kingsbridge SSO financing fees of $266,000.
Other
Income (Expense).
Net other expense in the second quarters of 2007 and 2006 was approximately
$25,000 and $137,000, respectively. Net other expense for the six month period
ending June 30, 2007 and 2006 was approximately $41,000 and $397,000,
respectively. The decrease in expense was due primarily to a reduction in
interest expense due to the liquidation of the promissory notes due PDI, Inc.
in
the fourth quarter of 2006. Additionally, derivative expense decreased in 2007
due to the termination of the Kingsbridge SSO agreement and related warrants
derivative in January 2007.
Discontinued
Operations.
On April 11, 2006, Epsilon purchased all of the shares of Cellegy Australia
and
as a result, the Company reflected Cellegy Australia as a discontinued
operation. As of April 11, 2006, income from discontinued operations was
approximately $7,000.
14
Liquidity
and Capital Resources
Our
cash
and cash equivalents were approximately $2.5 million and $3.8 million at June
30, 2007 and December 31, 2006, respectively.
Cash
and
cash equivalents decreased approximately $1,283,000 in the six month period
ended June 30, 2007 due primarily to operating expenses.
We
prepared the condensed consolidated financial statements assuming that we will
continue as a going concern, which contemplates the realization of assets and
the satisfaction of liabilities during the normal course of business. In
preparing these condensed consolidated financial statements, consideration
was
given to the Company’s future business alternatives as described below, which
may preclude the Company from realizing the value of certain assets during
their
future course of business.
In
2006,
the Company eliminated its direct research activities and sold a material
portion of its intellectual property. The Company’s operations currently relate
primarily to the ownership of its intellectual property rights of its Biosyn
subsidiary and the evaluation of its remaining options and alternatives with
respect to its future course of business. While the Savvy Phase 3 contraception
trial in the United States is ongoing, the Company is not directly involved
with
the conduct and funding thereof and it is uncertain whether Savvy will be
commercialized or whether the Company will ever realize revenues therefrom.
We
therefore expect negative cash flows to continue for the foreseeable future.
The
Company presently has enough financial resources to continue operations as
they
currently exist for the near term, however, it does not have the technological
or the financial assets necessary to fund the expenditures that would be
required to conduct the future clinical and regulatory work necessary to
commercialize Savvy without additional funding. Alternatives with respect to
the
Company’s remaining business and assets might include seeking to merge or
combine with another third party with greater resources and infrastructure
necessary to conduct development programs and to commercialize technology.
If a
suitable candidate cannot be found, the Company may chose to liquidate or
voluntarily file bankruptcy proceedings. Due to the uncertainty of the cash
flow
necessary to explore or implement these alternatives, there can be no assurance
that the Company will have adequate resources to continue operations for longer
than 12 months.
These
factors raise substantial doubt about our ability to continue as a going
concern. There is no assurance that any of the above options will be implemented
on a timely basis or that we will be able to sell or license our remaining
technology or find suitable candidates for a business combination or other
transaction, if at all. We may be required to accept less than favorable
commercial terms in any such future arrangements. The condensed consolidated
financial statements do not include any adjustments that might result from
the
outcome of this uncertainty. Any failure to dispel any continuing doubts about
our ability to continue as a going concern could adversely affect our ability
to
enter into business combination or other agreements, therefore making it more
difficult to obtain required financing on favorable terms or at all. Such an
outcome may negatively affect the market price of our common stock and could
otherwise have a material adverse effect on our business, financial condition
and results of operations.
Recent
Accounting Pronouncements
In
July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for
Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109”
(“FIN 48”). FIN 48 prescribes how a company should recognize, measure,
present and disclose uncertain income tax positions. A “tax position” is a
position taken on a previously filed tax return, or expected to be taken in
a
future tax return that is reflected in the measurement of current or deferred
tax assets or liabilities for interim or annual periods. A tax position can
result in a permanent reduction of income taxes payable, a deferral of income
taxes to future periods, or a change in the expected ability to realize deferred
tax assets. A change in net assets that results from the adoption of FIN 48
is
recorded as an adjustment to retained earnings in the period of adoption.
FIN 48 is effective for fiscal years beginning after December 15, 2006. The
Company is currently evaluating the effect that the adoption of FIN 48 will
have
on its results of operations and financial position. The adoption of FIN 48
is
not expected to have a material impact on the Company’s financial
statements.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities, including an amendment of FASB
Statement No. 115.” SFAS No. 159 permits entities to choose to measure
many financial instruments and certain other items at fair value that are not
currently required to be measured at fair value. Unrealized gains and
losses on items for which the fair value option has been elected are reported
in
earnings. SFAS No. 159 does not affect any existing accounting literature
that requires certain assets and liabilities to be carried at fair value.
SFAS No. 159 is effective for fiscal years beginning after November 15,
2007. We do not expect our adoption of this new standard to have a
material impact on the Company’s financial statements.
15
The
Emerging Issues Task Force (“EITF”) has two issues currently under consideration
that may impact the Company. EITF 07-01, “Accounting for Collaboration
Arrangements Related to the Development and Commercialization of Intellectual
Property”, is focused on how the parties to a collaborative agreement should
account for costs incurred and revenue generated on sales to third parties,
how
sharing payments pursuant to a collaboration agreement should be presented
in
the income statement and certain related disclosure questions. EITF 07-3,
“Accounting for Non-Refundable Advance Payments for Goods or Services to Be
Used
in Future Research and Development Activities”, is focused on whether
non-refundable advance payments for goods that will be used or services that
will be performed in future research and development activities should be
accounted for as research and development costs or deferred and capitalized
until the goods have been delivered or the related services have been rendered.
The Company will continue to monitor the development of these EITF’s and
evaluate the effects on its financial statements and disclosures.
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, 2006. No changes in
those policies and estimates have occurred during the six months ended June
30,
2007.
ITEM
3. Quantitative and Qualitative Disclosure of Market Risk
Cellegy
invests its excess cash in short-term, investment grade, fixed income securities
under an investment policy. All of our securities owned as of June 30, 2007,
were in money market funds and are classified as cash equivalents. We believe
that potential near-term losses in future earnings, fair values or cash flows
related to our investment portfolio are not significant. We currently do not
hedge interest rate exposure. If market interest rates were to increase or
decrease, the fair value of our portfolio would not be
affected.
We
are
incurring market risk associated with the issuance of warrants to the May 2005
PIPE investors to purchase approximately 1.4 million shares of our common stock.
We will continue to calculate the fair value at the end of each quarter and
record the difference to other income or expense until the warrants are
exercised or expired. We are incurring risk associated with increases or
decreases in the market price of our common stock, which will directly impact
the fair value calculation and the non-cash charge or credit recorded to the
statement of operations in future quarters.
ITEM
4. Controls and Procedures
As
of the
end of the period covered by this report, we carried out an evaluation, under
the supervision and with the participation of our management, including our
Chief Executive Officer and Chief Financial Officer, of the effectiveness of
the
design and operation of our disclosure controls and procedures (as defined
in
Exchange Act Rules 13a-15(e) and 15d-15(e)).
Based
upon this evaluation, our Chief Executive Officer and our Chief Financial
Officer concluded that, as of the end of the period covered by this report,
our
disclosure controls and procedures were effective to ensure that information
required to be disclosed in the reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time periods
specified in the United States Securities and Exchange Commission rules and
forms.
16
During
the period covered by this report, there have been no changes in our internal
control over financial reporting that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting. A controls system, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls are met,
and no evaluation of controls can provide absolute assurance that all controls
and instances of fraud, if any, within a company have been
detected.
PART
II - OTHER INFORMATION
None
ITEM
1A. Risk Factors
We
sold substantially all of our remaining assets to a third party and have
drastically reduced the scope of our current
operations.
In
the
fourth quarter of 2006, we sold a material portion of our assets, including
intellectual property rights and related assets to ProStrakan. The Company’s
operations currently relate primarily to the ownership of the intellectual
property rights of our Biosyn subsidiary.
The
Company is considering alternatives regarding future
operations.
The
Company’s board of directors is continuing to explore alternatives for the
Company with respect to its business and assets. These alternatives might
include seeking to sell remaining assets to third parties, the possible
dissolution or liquidation of the Company, merging or combining with another
company, bankruptcy proceedings or other alternatives. There can be no assurance
that any third party will be interested in merging with the Company or acquiring
the remaining assets of the Company or would agree to a price and other terms
that we would deem adequate.
We
have a history of losses and do not expect to achieve
profitability.
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.
Without additional funds from sales of assets, intellectual property or
technologies, or from a business combination or a similar transaction, we will
exhaust our resources and will be unable to continue operations, and our
accumulated deficit will continue to increase as we continue to incur losses.
The amount of future net losses and our ability to sell our remaining assets
or
successfully enter a business combination transaction are highly
uncertain.
In
2006,
the Company eliminated its direct research activities and sold a material
portion of its intellectual property. The Company’s operations currently relate
primarily to the intellectual property relating to the product candidates of
its
Biosyn subsidiary and the evaluation of its remaining options and alternatives
with respect to its future course of business. While the Savvy Phase 3
contraception trial in the United States is ongoing, the Company is not directly
involved with the conduct and funding thereof and it is uncertain whether Savvy
will be commercialized or whether the Company will ever realize revenues
therefrom. We therefore expect negative cash flows to continue for the
foreseeable future. The Company presently has enough financial resources to
continue operations as they currently exist for the near term, however, it
does
not have the technological or the financial assets necessary to fund the
expenditures that would be required to conduct the future clinical and
regulatory work necessary to commercialize Savvy without additional funding.
Alternatives with respect to the Company’s remaining business and assets might
include seeking to merge or combine with another third party with greater
resources and infrastructure necessary to conduct development programs and
to
commercialize technology. If a suitable candidate cannot be found, the Company
may choose to liquidate or voluntarily file bankruptcy proceedings. Due to
the
uncertainty of the cash flow necessary to explore or implement these
alternatives, there can be no assurance that the Company will have adequate
resources to continue operations for longer than twelve (12)
months.
17
These
factors raise substantial doubt about our ability to continue as a going
concern. There is no assurance that any of the above options will be implemented
on a timely basis or that we will be able to sell or license our remaining
technology or find suitable candidates for a business combination or other
transaction, if at all. We may be required to accept less than favorable
commercial terms in any such future arrangements. The condensed consolidated
financial statements do not include any adjustments that might result from
the
outcome of this uncertainty. Any failure to dispel any continuing doubts about
our ability to continue as a going concern could adversely affect our ability
to
enter into business combination or other agreements, therefore making it more
difficult to obtain required financing on favorable terms or at all. Such an
outcome may negatively affect the market price of our common stock and could
otherwise have a material adverse effect on our business, financial condition
and results of operations.
We
have received a “going concern” opinion from our independent registered public
accounting firm, which may negatively impact our
business.
Our
audit
opinions from our current and prior independent registered public accounting
firms regarding the consolidated financial statements for the years ended
December 31, 2006, 2005 and 2004 include an explanatory paragraph indicating
that there is substantial doubt about the Company’s ability to continue as a
going concern. Doubts concerning our ability to continue as a going concern
could adversely affect our ability to enter into business combination or other
agreements, therefore making it more difficult to obtain required financing
on
favorable terms or at all. Such an outcome may negatively affect the market
price of our common stock and could otherwise have a material adverse effect
on
our business, financial condition and results of operations.
We
are subject to regulation by regulatory authorities including the FDA, which
could delay or prevent marketing of our products. Unexpected regulatory outcomes
could adversely affect our business and stock price.
Cellegy’s
remaining product candidates and our research and clinical activities 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 any potential drug products, we must demonstrate through
pre-clinical studies and clinical trials that the product is safe and
efficacious for use in the clinical indication for which approval is sought.
The
timing of NDA submissions, the outcome of reviews by the FDA and the initiation
and completion of other clinical trials are subject to uncertainty, change
and
unforeseen delays. Under the Prescription Drug User Fee Act (“PDUFA”), the FDA
establishes a target date to complete its review of an NDA. Although the FDA
attempts to respond by the relevant PDUFA date to companies that file NDAs,
there is no obligation on the FDA’s part to do so. In addition, extensive
current pre-clinical and clinical testing requirements and the current
regulatory approval process of the FDA in the United States and of certain
foreign regulatory authorities, or new government regulations, could prevent
or
delay regulatory approval of our product candidates.
The
process of developing and obtaining approval for a new pharmaceutical product
within this regulatory framework requires a number of years and substantial
expenditures. There can be no assurance that necessary approvals will be
obtained in a timely manner, if at all. Delays in clinical trials or obtaining
regulatory approvals could delay receipt of revenues from product sales,
increase our expenditures relating to obtaining approvals, jeopardize corporate
partnership arrangements that we might enter into with third parties regarding
particular products, or cause a decline in our stock price. If we fail to comply
with applicable regulatory requirements, we could be subject to a wide variety
of serious administrative or judicially imposed sanctions and penalties, any
of
which could result in significant financial penalties that could reduce our
available cash, delay introduction of products resulting in deferral or
elimination of revenues from product sales, and could result in a decline in
our
stock price.
18
Clinical
trial results are very difficult to predict in advance, and the clinical trial
process is subject to delays. Failure of one or more clinical trials or delays
in trial completion could adversely affect our business and our stock
price.
Results
of pre-clinical studies and early clinical trials may not be good predictors
of
results that will be obtained in later-stage clinical trials. We cannot provide
any assurance that Cellegy’s remaining clinical trial will demonstrate the
results required to continue advanced trial development and allow us to seek
marketing approval for our product candidate. Because of the independent and
blind nature of certain human clinical testing, there will be extended periods
during the testing process when we will have only limited, or no, access to
information about the status or results of the tests. Cellegy and other
pharmaceutical companies have believed that their products performed
satisfactorily in early tests, only to find their performance in later tests,
including Phase 3 clinical trials, to be inadequate or unsatisfactory, or that
FDA Advisory Committees have declined to recommend approval of the drugs, or
that the FDA itself refused approval, with the result that stock prices have
fallen precipitously. Clinical trials can be extremely costly. Certain costs
relating to the Phase 3 trials for the Savvy product for contraception and,
when
they were conducted, for the reduction in the transmission of HIV, and other
clinical and preclinical development costs for Savvy, were funded directly
by
certain grant and contract commitments from several governmental and
non-governmental organizations (“NGOs”). Nevertheless, current or future
clinical trials could require substantial additional funding. There can be
no
assurance that funding from governmental agencies and NGOs will continue to
be
available, and any other Phase 3 trials that Cellegy may commence in the future
relating to its products could involve the expenditure of several million
dollars through the completion of the clinical trials. In addition, delays
in
the clinical trial process can be extremely costly in terms of lost sales
opportunities and increased clinical trial costs. The speed with which we
complete our clinical trials and our regulatory submissions, including NDAs,
will depend on several factors, including the following:
·
|
the
rate of patient enrollment, which is affected by the size of the
patient
population, the proximity of patients to clinical sites, the difficulty
of
the entry criteria for the study and the nature of the
protocol;
|
·
|
the
timely completion of clinical site protocol approval and obtaining
informed consent from subjects;
|
·
|
analysis
of data obtained from preclinical and clinical
activities;
|
·
|
changes
in policies or staff personnel at regulatory agencies during the
lengthy
drug application review; and
|
·
|
the
availability of experienced staff to conduct and monitor clinical
studies,
internally or through Contract Research Organizations
(“CRO”).
|
Adverse
events in our clinical trials section may force us to stop development of our
product candidates or prevent regulatory approval of our product candidates,
which could materially harm our business.
Patients
participating in the clinical trial of our product candidate may experience
serious adverse health events. A serious adverse health event includes death,
a
life-threatening condition, hospitalization, disability, congenital anomaly,
or
a condition requiring intervention to prevent permanent impairment or damage.
The occurrence of any of these events could interrupt, delay or halt clinical
trials of our product candidate and could result in the FDA, or other regulatory
authorities, denying approval of our product candidate for any or all targeted
indications. An institutional review board or independent data safety monitoring
board, the FDA, other regulatory authorities or we, may suspend or terminate
clinical trials at any time. Our product candidate may prove not to be safe
for
human use. Any delay in the regulatory approval of our product candidate could
increase our product development costs and allow our competitors additional
time
to develop or market competing products.
Due
to our reliance on contract research organizations or other third-parties to
assist us in conducting clinical trials, we are unable to directly control
all
aspects of our clinical trials.
We
have
relied on CROs and other third parties to conduct our clinical trials. As a
result, we have had and will continue to have less control over the conduct
of
the clinical trials, the timing and completion of the trials and the management
of data developed through the trial than would be the case if we were relying
entirely upon our own staff. Communicating with CROs can also be challenging,
potentially leading to difficulties in coordinating activities. CROs
may:
·
|
have
staffing difficulties;
|
19
·
|
experience
regulatory compliance issues;
|
·
|
undergo
changes in priorities or may become financially distressed;
or
|
·
|
not
be able to properly control payments to government agencies or clinical
sites, particularly in less developed
countries.
|
These
factors may adversely affect their ability to conduct trials relating to our
product candidates. We may experience unexpected cost increases or experience
problems with the timeliness or quality of the work of the CRO. If we must
replace these CROs or any other third party contractor, trials may have to
be
suspended until we find another CRO that offers comparable services. The time
that it takes us to find alternative organizations may cause a delay in the
commercialization of our product candidates or may cause us to incur significant
expenses. Although we
do not
now intend to replace our CROs, such a change would make it difficult to find
a
replacement organization to conduct our trials in an acceptable manner and
at an
acceptable cost. Any delay in or inability to complete clinical trials could
significantly compromise our ability to secure regulatory approval of product
candidates, thereby limiting our ability to generate product revenue resulting
in a decrease in our stock price.
The
type and scope of the patent coverage we have may limit the commercial success
of our products.
Cellegy’s
success depends, in part, on our ability to obtain patent protection for our
products and methods, both in the United States and in other countries. No
assurance can be given that any additional patents will be issued to us, that
the protection of any patents that may be issued in the future will be
significant, or that current or future patents will be held valid if
subsequently challenged.
The
patent position of companies engaged in businesses such as Cellegy’s business
generally is uncertain and involves complex, legal and factual questions. There
is a substantial backlog of patent applications at the United States Patent
and
Trademark Office. Patents in the United States are issued to the party that
is
first to invent the claimed invention. There can be no assurance that any patent
applications relating to Cellegy’s products or methods will be issued as
patents, or, if issued, that the patents will not be challenged, invalidated
or
circumvented or that the rights granted there under will provide a competitive
advantage.
In
addition, many other organizations are engaged in research and product
development efforts that may overlap with Cellegy’s products. Such organizations
may currently have, or may obtain in the future, legally blocking proprietary
rights, including patent rights, in one or more products or methods under
development or consideration by Cellegy. These rights may prevent us from
commercializing technology, or may require Cellegy to obtain a license from
the
organizations to use the technology. Cellegy may not be able to obtain any
such
licenses that may be required on reasonable financial terms, if at all, and
cannot be sure that the patents underlying any such licenses will be valid
or
enforceable. Moreover, the laws of certain foreign countries do not protect
intellectual property rights relating to United States patents as extensively
as
those rights are protected in the United States. The issuance of a patent in
one
country does not assure the issuance of a patent with similar claims in another
country, and claim interpretation and infringement laws vary among countries;
therefore, the extent of any patent protection is uncertain and may vary in
different countries. As with other companies in the pharmaceutical industry,
we
are subject to the risk that persons located in other countries will engage
in
development, marketing or sales activities of products that would infringe
our
patent rights if such activities were conducted in the United
States.
We
have limited sales and marketing experience.
We
may
market products, if any are successfully developed and approved and if we obtain
sufficient funding, through a direct sales force in the United States. Cellegy
has very limited experience in sales, marketing or distribution. To market
these
products directly, we may seek to establish a direct sales force in the United
States or obtain the assistance of a marketing partner. However, Cellegy does
not presently have the financial capability or the experience to successfully
establish a direct sales force, marketing or distribution operations, which
could delay or prevent the successful commercialization of our products and
could reduce the ultimate profitability for Cellegy of such products if we
needed to rely on a third party marketing partner to commercialize the
products.
20
If
medical doctors do not prescribe our products or the medical profession does
not
accept our products, our product sales and business would be adversely
affected.
Our
business is dependent on market acceptance of our products by physicians,
healthcare providers, patients and the medical community. Medical doctors’
willingness to prescribe our products depends on many factors,
including:
·
|
perceived
efficacy of our products;
|
·
|
convenience
and ease of administration;
|
·
|
prevalence
and severity of adverse side effects in both clinical trials and
commercial use;
|
·
|
availability
of alternative treatments;
|
·
|
cost
effectiveness;
|
·
|
effectiveness
of our marketing strategy and the pricing of our
products;
|
·
|
publicity
concerning our products or competing products;
and
|
·
|
our
ability to obtain third-party coverage or
reimbursement.
|
Even
if
we receive regulatory approval and satisfy the above criteria, physicians may
not prescribe our products if we do not promote our products effectively.
Factors that could affect our success in marketing our products
include:
·
|
the
experience, skill and effectiveness of the sales force and our sales
managers;
|
·
|
the
effectiveness of our production, distribution and marketing
capabilities;
|
·
|
the
success of competing products; and
|
·
|
the
availability and extent of reimbursement from third-party
payers.
|
Failure
of our products or product candidates to achieve market acceptance would limit
our ability to generate revenue and could harm our business.
We
have very limited staffing and will continue to be dependent upon key
personnel.
Our
success is dependent upon the efforts of a small management team and staff.
We
do not have key man life insurance policies covering any of our executive
officers or key employees. If key individuals leave Cellegy, we could be
adversely affected if suitable replacement personnel are not quickly recruited.
There is competition for qualified personnel in all functional areas, which
makes it difficult to attract and retain the qualified personnel necessary
for
the development and growth of our business. Our future success depends upon
our
ability to continue to attract and retain qualified scientific, clinical and
administrative personnel.
Our
corporate compliance programs cannot guarantee that we are in compliance with
all potentially applicable regulations.
The
development, manufacturing, pricing, sales, and reimbursement of our products,
together with our general operations, are subject to extensive regulation by
federal, state and other authorities within the United States and numerous
entities outside of the United States. We are a small company and we rely
heavily on third parties to conduct many important functions. We also have
significantly fewer employees than many other companies that have the same
or
fewer product candidates in late stage clinical development. In addition, as
a
publicly traded company we are subject to significant regulations, including
the
Sarbanes-Oxley Act of 2002, some of which have either only recently been adopted
or are currently proposals subject to change. While we have developed and
instituted a corporate compliance program and continue to update the program
in
response to newly implemented or changing regulatory requirements, we cannot
assure you that we are now or will be in compliance with all such applicable
laws and regulations. If we fail to comply with any of these regulations, we
could be subject to a range of regulatory actions, including suspension or
termination of clinical trials, restrictions on our products or manufacturing
processes, withdrawal of products from the market, significant fines, or other
sanctions or litigation. Failure to comply with potentially applicable laws
and
regulations could also lead to the imposition of fines, cause the value of
our
common stock to decline, and impede our ability to raise capital or lead to
the
de-listing of our stock.
21
We
are
evaluating our internal controls over financial reporting to allow management
to
report on, and our independent registered public accounting firm to attest
to,
our internal controls, as required by the Sarbanes-Oxley Act. We will be
performing the system and process evaluation and testing (and any necessary
remediation) required to comply with the management certification and auditor
attestation requirements of Section 404 of the Sarbanes-Oxley Act (“Section
404”). Cellegy is considered a non-accelerated filer, and as such is required to
comply with the Section 404 requirements for its fiscal year ending December
31,
2007. While we anticipate being able to fully implement the requirements
relating to internal controls and all other aspects of Section 404 by our
compliance deadline, we cannot be certain as to the timing of completion of
our
evaluation, testing and remediation actions or the impact of the same on our
operations. If we are not able to implement the requirements of Section 404
in a timely manner or with adequate compliance, we might be subject to sanctions
or investigation by regulatory authorities, including the SEC. In addition,
we
may be required to incur a substantial financial investment to improve our
internal systems and the hiring of additional personnel or
consultants.
Risks
Relating to Our Industry
We
face intense competition from larger companies, and in the future Cellegy may
not have the resources required to develop innovative products. Cellegy’s
products are subject to competition from existing
products.
The
pharmaceutical industry is subject to rapid and significant technological
change. Cellegy is much smaller in terms of size and resources than many of
its
competitors in the United States and abroad, which include, among others, major
pharmaceutical, chemical, consumer product, specialty pharmaceutical and
biotechnology companies, universities and other research institutions. Cellegy’s
competitors may succeed in developing technologies and products that are safer
and more effective than any product or product candidates that we may develop
and could render Cellegy’s technology and potential products obsolete and
noncompetitive. Many of these competitors have substantially greater financial
and technical resources, clinical production and marketing capabilities and
regulatory experience. In addition, any Cellegy products will likely be subject
to competition from existing products. As a result, any future Cellegy products
may never be able to compete successfully with existing products or with
innovative products under development by other organizations.
We
are subject to the risk of clinical trial and product liability
lawsuits.
The
testing of human health care product candidates entails an inherent risk of
allegations of clinical trial liability, while the marketing and sale of
approved products entails an inherent risk of allegations of product liability.
We are subject to the risk that substantial liability claims from the testing
or
marketing of pharmaceutical products could be asserted against us in the future.
Cellegy has obtained clinical trial insurance coverage relating to our clinical
trials in an aggregate amount of $3 million. If any of our product candidates
are approved for marketing, we may seek additional coverage.
There
can
be no assurance that Cellegy will be able to obtain or maintain insurance on
acceptable terms, particularly in overseas locations, for clinical and
commercial activities or that any insurance obtained will provide adequate
protection against potential liabilities. Moreover, our current and future
coverages may not be adequate to protect us from all of the liabilities that
we
may incur. If losses from liability claims exceed our insurance coverage, we
may
incur substantial liabilities that exceed our financial resources. In addition,
a product or clinical trial liability action against us would be expensive
and
time-consuming to defend, even if we ultimately prevail. If we are required
to
pay a claim, we may not have sufficient financial resources and our business
and
results of operations may be harmed.
Our
stock price could be volatile.
Our
stock
price has from time to time experienced significant price and volume
fluctuations. Since becoming a public company, our stock price has fluctuated
due to overall market conditions and due to matters or events more specific
to
Cellegy. Events or announcements that could significantly impact our stock
price
include:
·
|
Publicity
or announcements regarding regulatory developments relating to our
products;
|
22
·
|
Clinical
trial results, particularly the outcome of more advanced studies;
or
negative responses from both domestic and foreign regulatory authorities
with regard to the approvability of our
products;
|
·
|
Period-to-period
fluctuations in our financial results, including our cash and cash
equivalents balance, operating expenses, cash burn rate or revenue
levels;
|
·
|
Common
stock sales in the public market by one or more of our larger
stockholders, officers or
directors;
|
·
|
A
negative outcome in any litigation or potential legal proceedings;
or
|
·
|
Other
potentially negative financial announcements including: a review
of any of
our filings by the SEC, changes in accounting treatment or restatement
of
previously reported financial results or delays in our filings with
the
SEC.
|
None
None
None
ITEM
5. Other Information
None
a)
Exhibits
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
23
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
CELLEGY
PHARMACEUTICALS, INC.
|
|
|
Date:
July 31, 2007
|
/s/
Richard C. Williams
|
|
Richard
C. Williams
|
|
Chairman
and Interim Chief Executive Officer
|
|
|
|
|
Date:
July 31, 2007
|
/s/
Robert J. Caso
|
|
Robert
J. Caso
|
|
Vice
President, Finance and Chief Financial
Officer
|
24