Attached files
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EX-31.1 - SECTION 302 CEO CFO CERTIFICATE - SYMBOLLON CORP | section302ceocfocert.htm |
EX-32.1 - SECTION 906 CEO CFO CERTIFICATE - SYMBOLLON CORP | section906ceocfocert.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
[x]
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934 FOR
THE QUARTERLY PERIOD
ENDED
SEPTEMBER 30,
2009
[
] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934 FOR THE TRANSITION
PERIOD FROM _______ TO
________
Commission
file number 0-22872
SYMBOLLON
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
36-3463683
|
|
(State
of incorporation)
|
(I.R.S.
employer identification no.)
|
99
West Street, Suite J
Medfield,
Massachusetts
|
02052
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(508)
242-7500
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the issuer: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act during the past 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
__
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large-accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
(Do not
check if a smaller reporting company)
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes __ No _X_
As of
November 13, 2009, 27,473,340 shares of Class A Common Stock of the issuer were
outstanding.
1
SYMBOLLON
PHARMACEUTICALS, INC.
INDEX
PAGE
|
|
PART
I. FINANCIAL INFORMATION
|
|
Item
1. Financial
Statements
|
|
Condensed Balance Sheets –
September 30, 2009
|
|
(unaudited) and December 31,
2008
|
3
|
Unaudited Condensed
Statements of Operations
|
|
– For the three and nine
months ended
|
|
September 30, 2009 and
2008
|
5
|
Unaudited Condensed
Statements of Cash Flows
|
|
- For the nine months ended
September 30, 2009 and 2008
|
6
|
|
|
Notes to the Unaudited
Condensed Financial Statements
|
7
|
Item
2. Management’s
Discussion and Analysis
|
|
Of Financial Conditions and
Results of Operation
|
15
|
Item
3. Quantitative
and Qualitative Disclosures
|
|
About Market
Risk
|
18
|
Item
4T. Controls and
Procedures
|
18
|
PART
II. OTHER INFORMATION
|
|
Item
1. Legal
Proceedings
|
19
|
Item
1A. Risk
Factors
|
19
|
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
19
|
Item
3.
Defaults Upon Senior
Securities
|
19
|
Item
4.
Submission of Matters to a Vote of Security
Holders
|
19
|
Item
5. Other
Information
|
19
|
Item
6. Exhibits
|
19
|
SIGNATURES
|
19
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EXHIBIT
INDEX
|
E-1
|
2
Symbollon
Pharmaceuticals, Inc.
|
||||||||
Condensed
Balance Sheets
|
||||||||
September
30,
2009
(unaudited)
|
December
31,
2008
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash and cash
equivalents
|
$ | 9,266 | $ | 66,242 | ||||
Inventory
|
- | 30,085 | ||||||
Prepaid expenses
|
5,198 | 21,263 | ||||||
Total current
assets
|
14,464 | 117,590 | ||||||
Equipment and leasehold
improvements, net of
accumulated
depreciation and amortization
|
875 | 1,627 | ||||||
Other
assets:
|
||||||||
Patent and trademark costs, net of
accumulated amortization
|
188,531 | 206,216 | ||||||
Deposit
|
- | 2,364 | ||||||
$ | 203,870 | $ | 327,797 |
3
Symbollon
Pharmaceuticals, Inc.
|
||||||||
Condensed
Balance Sheets
(Continued)
|
||||||||
September
30,
2009
(unaudited)
|
December
31,
2008
|
|||||||
Liabilities
and Stockholders’ Equity (Deficit)
|
||||||||
Current
liabilities:
|
||||||||
Accounts payable
|
$ | 97,601 | $ | 63,014 | ||||
Accrued payroll
expenses
|
57,348 | - | ||||||
Accrued clinical development
expenses
|
112,763 | 112,765 | ||||||
Total current
liabilities
|
267,712 | 175,779 | ||||||
Stockholders’ equity
(deficit):
|
||||||||
Common stock, Class A, par value
$.001 per share, 93,750,000 shares
authorized, 27,473,340
and 16,473,340 shares issued and outstanding
as of September 30,
2009 and December 31, 2008, respectively
|
27,473 | 16,473 | ||||||
Convertible common stock, Class B,
par value $.001
per share, 1,250,000
shares authorized and unissued
|
- | - | ||||||
Preferred stock, par value $.001
per share, 5,000,000 shares
authorized and
unissued
|
- | - | ||||||
Additional paid-in
capital
|
21,673,436 | 21,526,658 | ||||||
Accumulated
deficit
|
(21,764,751 | ) | (21,391,113 | ) | ||||
Total stockholders’ equity
(deficit)
|
(63,842 | ) | 152,018 | |||||
$ | 203,870 | $ | 327,797 | |||||
See
accompanying notes to condensed financial statements.
|
4
Symbollon
Pharmaceuticals, Inc.
|
||||||||||||||||
Condensed
Statements of Operations
(unaudited)
|
||||||||||||||||
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Revenue:
|
||||||||||||||||
Net
product sales
|
$ | 30,701 | $ | - | $ | 32,272 | $ | - | ||||||||
Total
revenues
|
30,701 | - | 32,272 | - | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Cost
of goods sold
|
30,722 | - | 31,440 | - | ||||||||||||
Research and
development
|
- | 9,442 | - | 487,050 | ||||||||||||
General and
administrative
|
216,192 | 149,667 | 374,557 | 1,059,454 | ||||||||||||
Total operating
expenses
|
246,914 | 159,109 | 405,997 | 1,546,504 | ||||||||||||
Loss
from operations
|
(216,213 | ) | (159,109 | ) | (373,725 | ) | (1,546,504 | ) | ||||||||
Interest
income
|
- | 1,637 | 85 | 10,295 | ||||||||||||
Net
loss
|
$ | (216,213 | ) | $ | (157,472 | ) | $ | (373,640 | ) | $ | (1,536,209 | ) | ||||
Net
loss per share of common stock
|
||||||||||||||||
– basic and
diluted
|
$ | (.01 | ) | $ | (.01 | ) | $ | (.02 | ) | $ | (.09 | ) | ||||
Weighted
average number of common shares
outstanding
– basic and
diluted
|
27,473,340 | 16,473,340 | 20,180,300 | 16,298,687 | ||||||||||||
See
accompanying notes to condensed financial statements.
|
5
Symbollon
Pharmaceuticals, Inc.
|
||||||||
Condensed
Statements of Cash Flows
(unaudited)
|
||||||||
Nine
Months Ended
September
30,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (373,640 | ) | $ | (1,536,209 | ) | ||
Adjustments to reconcile net loss
to net cash used in
operating
activities:
|
||||||||
Stock-based
compensation
|
47,777 | 797,224 | ||||||
Issuance of securities for
services rendered
|
110,000 | 30,800 | ||||||
Depreciation and
amortization
|
18,438 | 26,157 | ||||||
Changes in operating assets and
liabilities:
|
||||||||
Inventory
|
30,085 | - | ||||||
Prepaid expenses
|
16,065 | 10,851 | ||||||
Rent Deposit
|
2,364 | - | ||||||
Accounts payable and other
current liabilities
|
91,933 | (209,330 | ) | |||||
Net cash
used in operating activities
|
(56,976 | ) | (880,507 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Patent and trademark cost
additions
|
- | (21,979 | ) | |||||
Net cash used
in investing activities
|
- | (21,979 | ) | |||||
Net
decrease in cash and cash equivalents
|
(56,976 | ) | (902,486 | ) | ||||
Cash and cash
equivalents, beginning of period
|
66,242 | 1,102,381 | ||||||
Cash and cash
equivalents, end of period
|
$ | 9,266 | $ | 199,895 | ||||
Supplemental
information:
There were no payments made for
interest or income taxes during the nine months ended September 30, 2009
or 2008.
|
||||||||
See
accompanying notes to condensed financial statements.
|
6
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
1. Description
of
Business and
Basis of
Presentation
|
Symbollon
Pharmaceuticals, Inc. (formerly Symbollon Corporation) was formed to
develop and commercialize proprietary iodine-based products for infection
control and treatment in biomedical and bioagricultural
industries.
The
success of future operations is subject to a number of risks similar to
those of other companies in the same stage of
development. Principal among these risks are the Company’s
cumulative operating losses, no assurance of profitable future operations,
early state of market development, competition from substitute products or
larger companies, dependence on key personnel and the uncertainty of
additional future financing as needed.
Our
financial statements for the interim period ended September 30, 2009 have
been prepared in conformity with accounting principles generally accepted
in the United States of America, which contemplate continuation of our
Company as a going concern. We had a net loss of $1,784,105 and
$373,640 and negative cash flows from operations of $1,019,600 and $56,976
for the year ended December 31, 2008 and nine months ended September 30,
2009, respectively. At September 30, 2009, we also had an
accumulated deficit of $21,764,751 and negative working capital of
$253,248. These factors raise substantial doubt as to our
ability to continue as a going concern. These financial
statements do not include any adjustments relating to the recoverability
and classification of recorded asset amounts, or amounts and
classification of liabilities that might be necessary should the Company
be unable to continue as a going concern and, therefore, be required to
realize the Company’s assets and discharge our liabilities in other than
the normal course of operations.
The
ability of the Company to continue as a going concern is dependent upon
the Company’s ability to receive continued financial support from the
Company’s creditors, stockholders and external investors and to increase
sales of IoGen, our dietary supplement marketed to promote breast health
for women. Management is actively seeking equity and debt
financing from external investors, and is attempting to increase sales of
IoGen. The Company is also pursuing other strategic options,
including possible sales or licenses of its technology or a sale or merger
of the Company. In December 2008, the Company transferred
certain intellectual property in exchange for an equity stake in BioCide
Pharma, Inc., a start-up company, and the assumption of approximately
$18,000 in debt. On June 30, 2009, Symbollon Pharmaceuticals,
Inc. signed a distribution agreement with Integra Labs, Inc. granting
Integra the exclusive right to distribute IoGen in countries allowing
over-the-counter sales of the product. Under the agreement,
Integra will assume all manufacturing, sales and marketing
responsibilities for the product. Integra purchased Symbollon’s
existing inventory of IoGen at cost. Integra shall pay
Symbollon a royalty on all sales of IoGen.
Failure
to either obtain the support of additional external investors to finance
the Company’s operations, increase sales of IoGen or execute our other
strategic options will cause us to cease operations in the near
future.
|
7
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
2. Summary
of
Significant
Accounting
Policies
|
The
accompanying unaudited financial statements do not contain all of the
disclosures required by generally accepted accounting principles and
should be read in conjunction with the financial statements and related
notes included in our Form 10-K for the year ended December 31, 2008 filed
with the Securities and Exchange Commission.
In
the opinion of management, the financial statements reflect all
adjustments, all of which are of a normal recurring nature, to fairly
present our financial position, results of operations and cash
flows. The results of operations for the nine-month period
ended September 30, 2009 are not necessarily indicative of the results to
be expected for the full year.
The
accounting policies that management believes are most critical to aid in
fully understanding and evaluating our reported financial results include
the following:
|
Use of
Estimates
|
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from
those estimates.
|
Cash and Cash
Equivalents
|
Cash
and cash equivalents include short-term, highly liquid investments with
maturities of less than three months when acquired.
|
Concentration of
Credit Risks
|
In
2008, the Company launched IoGen as a dietary supplement for the promotion
of female breast health. In June 2009, the Company entered into
a distribution agreement with Integra Labs. Under the agreement
Integra will pay a royalty on all IoGen sales. The Company had
no accounts receivables as of September 30, 2009.
|
Inventory
|
Inventory
is stated at the lower of cost (determined on a first-in, first-out basis)
or market.
|
Long-Lived
Assets
|
Long-lived
assets, such as intangible assets and property and equipment, are
evaluated for impairment when events or changes in circumstances indicate
that the carrying amount of the assets may not be recoverable through the
estimated undiscounted future cash flows from the use of these
assets. When any such impairment exists, the related assets are
written down to fair value. The Company does not believe that
any of its long-lived assets are impaired at September 30,
2009.
|
8
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
2. Summary
of
Significant
Accounting
Policies
(Continued)
|
|
Depreciation and
Amortization
|
Equipment
is stated at cost and is depreciated over its estimated useful life
(ranging from 5-7 years) using the straight-line method.
|
Intangible
Assets
|
Intangible
assets subject to amortization consist of patents and trademarks that have
estimated useful lives ranging from 9-17 years and a remaining weighted
average useful life of 7.2 years. Costs related to patent
applications are capitalized as incurred and are amortized once the patent
application is accepted or are expensed if the application is rejected or
there are other circumstances that indicate that the asset is impaired (as
described above).
|
Income Taxes
|
The
Company follows the liability method of accounting for income taxes, as
set forth in the Financial Accounting Standards Board (“FASB”)
guidance. Under this method, deferred tax liabilities and
assets are recognized for the expected future tax consequences of
temporary differences between the carrying amount and the tax basis of
assets and liabilities. The Company records a valuation
allowance against deferred tax assets unless it is more likely than not
that such asset will be realized in future periods.
|
Fair value of
Financial
Instruments
|
The
carrying amounts of cash and cash equivalents, other current assets and
accounts payable approximate fair value based on their short-term
maturities.
|
Equity
Investment
|
On
December 8, 2008, the Company acquired 625,000 shares of common stock in
BioCide Pharma, Inc., a start-up venture, in exchange for a transfer of
certain patent rights and assumption of liabilities. The
Company will account for this investment on the equity
method. At September 30, 2009, the Company’s investment had no
recorded value.
|
Revenue
Recognition
|
The
Company recognizes revenue from its product sales and licensing
arrangements in accordance with SEC Staff Accounting Bulletin No. 104,
“Revenue Recognition.” Under these guidelines, revenue is
recognized when persuasive evidence of an arrangement exists, delivery has
occurred or services rendered, the price is fixed or determinable and
payment is reasonably assured.
|
9
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
2. Summary
of
Significant
Accounting
Policies
(Continued)
|
|
Research and
Development
|
Research
and development costs are expensed as incurred.
|
Stock-Based
Compensation
|
The
Company accounts for share-based compensation based on the option's fair
value and the vesting period of the award.
|
Loss Per Share
|
Basic
earnings per share excludes the effect of any dilutive options, warrants
or convertible securities and is computed by dividing the net earnings
available to common shareholders by the weighted average number of common
shares outstanding for the period. Diluted earnings per share
is computed by dividing the net earnings available to common shareholders
by the sum of the weighted average number of common shares and common
share equivalents computed using the average market price for the period
under the treasury stock method.
|
Adoption of
Warrant
Accounting
|
In
June 2008, FASB issued guidance for determining whether an equity-linked
financial instrument (or embedded feature) is indexed to an entity’s own
stock. This guidance applies to any freestanding financial instrument or
embedded feature that has all the characteristics of a derivative. This
guidance is effective for fiscal years beginning after December 15,
2008. We have concluded that adoption of this guidance does not
have a material impact on the Company’s financial
statements.
|
10
Symbollon
Pharmaceuticals, Inc.
|
Notes
to Condensed Financial Statements
(unaudited)
|
3. Stockholders’
Equity
|
|
Capital Stock
|
The
Company has authorized 93,750,000 shares of Class A common stock,
1,250,000 shares of Class B common stock and 5,000,000 shares of
preferred stock. The Class A and Class B common stock
are substantially identical except that holders of Class A common
stock have the right to cast one vote for each share held and the
Class B shareholders have the right to cast five votes for each share
held. As of September 30, 2009 and December 31, 2008,
there were no shares of Class B common stock issued and
outstanding. The preferred stock may be issued in series, and
shares of each series will have such rights and preferences as are fixed
by the Company’s Board of Directors. As of September 30, 2009
and December 31, 2008, there were no shares of preferred stock issued
and outstanding.
|
Issuance of Common
Stock and Common
Stock Purchase
Warrants
|
On
January 18, 2008, the Company entered into a services agreement with The
Number One Corporation. In accordance with the services
agreement, and as partial consideration for the services provided by the
vendor, the Company agreed to issue 40,000 shares of Class A common stock
upon execution of the agreement. The Company has determined the
fair value of the shares to be $30,800 which was recognized as an expense
in general and administrative expenses in the accompanying statement of
operations for the nine month periods ended September 30,
2008. No expense related to these shares was recognized for the
nine month period ended September 30, 2009.
On
February 7, 2008, the Company issued 900,000 and 375,000 restricted shares
to its executive officers, Merrs. Desjourdy and Kessler,
respectively. The shares were initially to vest one-third each
of the next three anniversaries of the grant date. On May 16,
2008, the Company fully vested the shares as part of the termination of
the executive officers’ employment agreements. The Company
recorded $637,500 of stock-based compensation for the nine month period
ended September 30, 2008, with $450,000 and $187,500 included in general
and administrative expenses and in research and development costs,
respectively. No expense related to these shares was recognized
for the nine month period ended September 30, 2009.
On
June 29, 2009, the Company issued 10,000,000 shares to its executive
officer, Mr. Desjourdy. The Company recorded $100,000 of
stock-based compensation for the three and nine month periods ended
September 30, 2009 in accordance with applicable FASB
guidance.
At
September 30, 2009, warrants to purchase 7,293,732 shares of common stock
are outstanding.
|
11
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
4. Stock
Plans
|
The
Company has adopted two stock plans: a stock option plan and a nonemployee
directors’ stock option plan.
The
stock option plan provides for the grant of incentive stock options,
nonqualified stock options and stock appreciation rights. The
stock option plan expired on August 4, 2008 with options to purchase
1,225,000 shares outstanding at September 30, 2009. No future
grants may be made under this plan.
The
nonemployee directors’ stock option plan provides for the grant of
nonstatutory stock options automatically on January 1 of each
calendar year. The Company has reserved 500,000 shares for
issuance under the plan. Each outside director shall be granted
an option to purchase 10,000 shares of Class A common stock at fair
market value, vesting 50% on each of the first two anniversaries of the
grant. The nonemployee directors’ stock option plan expires on
the first business day of 2017. There are 400,000 shares
available for future grant or purchase under this plan.
The
Company issued stock options to its employees and outside directors
pursuant to stockholder approved stock option plans. Option
awards are generally granted with an exercise price equal to the market
price of the Company’s stock at the date of grant. Employee
option awards generally vest over three years from the date of grant, and
outside directors option awards generally vest over two years from the
date of grant. All option awards generally have 10-year
contractual terms. The Company attributes stock-based
compensation cost to operations using the straight-line method over the
applicable vesting period.
The
Company recorded $115,926 and $54,016 of stock-based compensation in
general and administrative expenses for the three month periods ended
September 30, 2009 and 2008, respectively. The Company recorded
$147,778 and $159,724 of stock-based compensation in general and
administrative expenses for the nine month periods ended September 30,
2009 and 2008, respectively. As of September 30, 2009, the
unrecognized stock-based compensation cost related to
non-vested stock awards was $18,430. This amount will be
recognized in operations over a weighted average period of 3
months.
|
12
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
4. Stock
Plans
(Continued)
|
The
following table summarizes the Company’s stock option information as of
and for the nine month period ended September 30,
2009:
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
(1)
|
|
Outstanding
at December 31, 2008
|
1,345,000
|
$ 0.90
|
||
Options
granted
|
40,000
|
$ 0.01
|
||
Options
expired
|
(7,500)
|
$ 1.60
|
||
Outstanding
at September 30, 2009
|
1,377,500
|
$ 0.87
|
7.3
|
$800
|
Exercisable
at September 30, 2009
|
1,197,500
|
$ 0.93
|
7.0
|
$0
|
(1) The
intrinsic value of a stock option is the amount by which the current
market value of the underlying stock exceeds the option exercise
price.
|
No
stock options wre granted during the three month periods ended September
30, 2009 and 2008. For the nine month periods ended September
30, 2009 and 2008, the Company granted options for 40,000 and 180,000
shares exercisable between $0.01 and $0.65 per share. The
weighted-average grant date fair value of stock options granted during the
nine month periods ended September 30, 2009 and 2008 was $0.01 and $0.39
per share, respectively. No stock options were exercised during
the nine month periods ended September 30, 2009 or 2008.
The
fair value of each option granted was estimated on the date of grant using
the Black-Scholes option-pricing model with the following
assumptions:
|
Nine
Months Ended
September
30,
|
|||
2009
|
2008
|
||
Weighted-average
expected stock-price volatility
|
143%
|
88%
|
|
Weighted-average
expected option life
|
6
years
|
6
years
|
|
Average risk-free interest rate
|
1.72%
|
2.79-3.28%
|
|
Average dividend yield
|
0.0%
|
0.0%
|
13
Symbollon
Pharmaceuticals, Inc.
|
|
Notes
to Condensed Financial Statements
(unaudited)
|
|
4. Stock
Plans
(Continued)
|
The
dividend yield of zero is based on the fact that the Company has never
paid cash dividends and has no present intention to pay cash
dividends. Expected volatility is based on the historical
volatility of the Company’s common stock over the period commensurate with
the expected life of the options. The risk-free interest rate
is the U.S. Treasury Strips rate on the date of grant. The
expected life was calculated using the method outlined in SEC Staff
Accounting Bulletin Topic 14.D.2, “Expected Terms,” as the Company’s
historical experience does not provide a reasonable basis for the expected
term of the option. Based on the recent history and current
expectations, the Company has not adjusted the calculated value of the
options for the nine month periods ended September 30, 2009 to reflect a
forfeiture rate.
|
5. Loss
Per Share
|
The
Company’s basic and diluted net loss per share of common stock for the
three and nine month periods ended September 30, 2009 and 2008 is
computed by dividing the net loss by the weighted average number of common
shares outstanding during the period.
The
following table summarizes securities that were outstanding as of
September 30, 2009 and 2008 but not included in the calculation of
diluted net loss per share because such shares are
antidilutive:
|
September
30,
|
2009
|
2008
|
Stock
options
|
1,377,500
|
1,645,000
|
Stock
warrants
|
7,293,732
|
7,929,193
|
6. Distribution
Agreement
|
On
June 30, 2009, Symbollon Pharmaceuticals, Inc. signed a distribution
agreement with Integra Labs, Inc. granting Integra the exclusive right to
distribute Symbollon’s IoGen in countries allowing over-the-counter sales
of the product. Under the agreement, Integra will assume all
manufacturing, sales and marketing responsibilities for the
product. Integra purchased Symbollon’s existing inventory of
IoGen at cost. Integra shall pay Symbollon a royalty on all
sales of IoGen. The initial term of the agreement is for five
years, subject to the achievement of certain milestones and minimum sales
requirements. Pursuant to the agreement, the parties intend to
identify other OTC product opportunities for Symbollon’s iodine technology
which would be distributed by Integra.
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14
Item 2. Management's Discussion and Analysis
of Financial Condition and Results of Operation
The following discussion contains
forward-looking statements which involve risks and uncertainties. See
“Forward Looking Statements” below and “Risk Factors” in the Annual Report on
Form 10-K for the year ended December 31, 2008.
Overview
We are a specialty pharmaceutical
company. We have a formulation iodine-based proprietary technology
that has potential product applications in the areas of infection control and
women’s healthcare. In 1995, we launched our first commercial
product, IodoZyme. Through March 31, 2007, it generated approximately
$2.8 million in sales. IodoZyme is no longer being sold.
Since 2000, we have concentrated our
product development efforts on the proposed product application for the
treatment of fibrocystic breast disease. In March 2008, we
discontinued clinical development of the proposed product, IoGen, and decided to
commercialize IoGen as a dietary supplement to promote breast
health. We launched commercial sale of IoGen in November
2008. We do not have adequate cash reserves to continue base
operations. In order for us to continue our operations, we must raise
additional resources, increase sales of IoGen or sell the Company or some of our
assets. If we cannot secure additional resources, adequately increase
sales of IoGen or sell some or all of our assets before existing resources are
exhausted, we will have to cease operations.
Going
Concern
Our financial statements for the
interim period ended September 30, 2009 have been prepared in conformity with
accounting principles generally accepted in the United States of America, which
contemplate continuation of our company as a going concern. We had a
net loss of $1,784,105 and $373,640 and negative cash flows from operations of
$1,019,600 and $56,976 for the year ended December 31, 2008 and nine months
ended September 30, 2009, respectively. At September 30, 2009, we
also had an accumulated deficit of $21,764,751 and negative working capital of
$253,248. We do not have adequate cash resources to continue our base
operation. These factors raise substantial doubt as to our ability to
continue as a going concern.
The
application of the going concern concept is dependent upon the Company’s ability
to receive continued financial support from the Company’s creditors,
stockholders and external investors and to increase sales of IoGen, our dietary
supplement marketing to promote breast health for women. Management
is actively seeking equity and debt financing from external investors, and is
attempting to increase sales of IoGen. The Company is also pursuing
other strategic options, including possible sales or licenses of its technology
or a sale or merger of the Company. There can be no assurance that
management's efforts will be successful. Failure to either obtain the
support of additional external investors to finance the Company’s operations,
increase sales of IoGen or execute our other strategic options will cause us to
cease operations in the near future.
15
Forward-Looking
Statements
In
addition to the historical information contained herein, this Quarterly Report
on Form 10-Q contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but not limited to
statements concerning plans, objectives, goals, strategies, prospects, revenues,
liquidity and capital resources, financial needs and future performance, costs
and expenditures. Such statements may be identified or qualified,
without limitation, by words such as "likely", "will", "suggests", "may",
"would", "could", "should", "expects", "anticipates", "estimates", "plans",
"projects", "believes", or similar expressions (and variants of such words or
expressions). Investors are cautioned that forward-looking statements
are inherently uncertain. Actual performance, achievements and
results may differ materially from those expressed, projected or suggested in
the forward-looking statements due to certain risks and uncertainties,
including, but not limited to, uncertainty about our ability to continue as a
going concern, our ability to raise any additional financing in light of the
IoGen failure, history (and expectation) of losses, uncertainty associated with
preclinical and clinical testing, market acceptance, intense competition, lack
of marketing experience, materials incompatibility, hazardous materials, and the
other risks and uncertainties described or discussed in the section "Risk
Factors" in the Annual Report on Form 10-K for the year ended December 31,
2008. The forward-looking statements contained herein represent our
judgment as of the date of this Quarterly Report on Form 10-Q, and we caution
readers not to place undue reliance on such statements.
Results
of Operations
Symbollon's net loss for the
three-month period ended September 30, 2009 was $216,213, reflecting an increase
of $58,741 from a net loss of $157,472 in the comparable 2008
period. Symbollon's net loss for the nine-month period ended
September 30, 2009 was $373,640, reflecting a decrease of $1,162,569 from a net
loss of $1,536,209 in the comparable 2008 period. The increased loss
for the three-month period resulted primarily from increase stock-based employee
compensation, partially offset by decreased clinical development
expenses. The decreased loss for the nine-month period resulted
primarily from decreased clinical development expenses related to the clinical
trials of IoGen, employee salaries and consulting and other third party
expenses. We expect to continue to incur operating losses for the
foreseeable future.
Product revenues from sales of IoGen
(our dietary supplement for breast health) for the three and nine-month periods
ended September 30, 2009 were $30,701 and $32,272,
respectively. IoGen was launched for commercial sale in November
2008, and thus, there were no product revenues from sales of IoGen for the three
and nine-month periods ended September 30, 2008. Cost of goods sold
for IoGen were $30,722 and $31,440 for the three and nine-month periods ended
September 30, 2009, respectively.
16
Research
and development expense for the three-month period ended September 30, 2009 was
$0, reflecting a decrease of $9,442 from the research and development expenses
in the comparable 2008 period. Research and development expense for
the nine-month period ended September 30, 2009 was $0, reflecting a decrease of
$487,050 from the research and development expenses in the comparable 2008
period. The decrease resulted from cessation of our research and
development efforts, including the IoGen clinical trials. We do not
anticipate incurring further research and development expenses, unless and
until, additional resources are secured by us.
General and administrative expenses for
the three-month period ended September 30, 2009 were $216,192, reflecting an
increase of $66,525 from the general and administrative expenses in the
comparable 2008 period. General and administrative expenses for the
nine-month period ended September 30, 2009 were $374,557, reflecting a decrease
of $684,897 from the general and administrative expenses in the comparable 2008
period. The decrease in the general and administrative expenses was
primarily due to decreased employee salaries and consulting and other third
party expenses. We anticipate that general and administrative
expenses will decrease from current levels as we limit, or cease, activities
over the remainder of 2009.
Our
interest income for the three-month period ended September 30, 2009 was $0,
reflecting a decrease of $1,637 from the interest income in the comparable 2008
period. Our interest income for the nine-month period ended September
30, 2008 was $85, reflecting a decrease of $10,295 from the interest income in
the comparable 2008 period. The decrease resulted from a decrease in
available funds for investment and in interest rates available on invested
funds.
Financial
Condition, Liquidity and Capital Resources
We have
funded our activities primarily through proceeds from private and public
placements of equity securities. During 1999, we sold 836,685 shares
of common stock, together with warrants for a like number of shares, in a
private placement, realizing net proceeds of approximately
$1,356,000. During 2000, we received net proceeds of approximately
$1,761,000 from the exercise of 586,910 warrants issued as part of the 1999
private placement. During 2004, we sold 1,261,692 shares of common
stock, together with 630,846 warrants, in a private placement, for net proceeds
of approximately $634,000 in cash and approximately $186,000 in prepaid services
for manufacturing, consulting and clinical trial expenses. During
2005, we sold 1,642,795 shares of Class A Common Stock for gross proceeds of
$853,957 (aggregate net proceeds were $800,585) in an offering exclusively to
foreign investors pursuant to Regulation S. From December 2005
through March 2006, we issued 615,461 shares of Class A common stock and a like
number of warrants for $332,775 in cash and prepaid consulting services upon
exercise of privately placed warrants. In June and August 2006, we
sold 1,366,500 shares of common stock, together with warrants for a like number
of shares, in a private placement, realizing net proceeds of approximately
$1,342,340. In December 2006 and January 2007, Symbollon raised net
aggregate proceeds of $2,368,038 in a private placement of 3,213,632 shares of
its Class A common stock and warrants for 2,410,224 shares. From
September through December 2007, Symbollon raised net proceeds of $1,704,350 in
a private placement of 2,573,086 shares of its Class A common stock and a like
number of warrants.
17
We continued to incur operating losses
and have incurred a cumulative loss through September 30, 2009 of
$21,764,751. We also continue to have negative cash flow from
operations of $56,976 for the nine months ended September 30,
2009. As of September 30, 2009, we had negative working capital of
$253,248. We do not have the necessary liquidity and capital
resources to sustain operations. We are actively seeking equity and
debt financing from external investors, and are attempting to increase sales of
IoGen. Any funding we do raise may be dilutive to existing
stockholders. We are also pursuing other strategic options,
including possible sales or licenses of our technology or a sale or
merger. There can be no assurance that our efforts will be
successful. Failure to either obtain the support of additional
external investors to finance the Company’s operations, increase sales of IoGen
or execute our other strategic options will cause us to cease operations in the
near future.
The report of our independent
registered public accountants on our financial statements for the
year ended December 31, 2008 contains an explanatory paragraph, which indicates
that we have incurred recurring losses and negative cash flows from operations
that raises substantial doubt about our ability to continue as a going
concern. This report is not viewed favorably by analysts or investors
and may make it more difficult for us to raise additional debt or equity
financing needed to continue our operations.
We have
no other material capital expenditures planned during fiscal 2009. At
December 31, 2008, we had a net operating loss carryforward for federal income
tax purposes of approximately $18,171,000 expiring at various dates through 2028
(from which, however, we may never receive a benefit).
Item 3. Quantitative an Qualitative
Disclosures About Market Risk
Not applicable.
Item 4T. Controls and
Procedures
Evaluation
of Disclosure Controls and Procedures
The Company’s management carried out an
evaluation, with the participation of its Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the Company’s disclosure controls and
procedures as of September 30, 2009. Based upon that evaluation, in
light of the absence of any segregation of duties, the Company’s Chief Executive
Officer and Chief Financial Officer concluded that the Company’s disclosure
controls and procedures were not effective to ensure that information required
to be disclosed by the Company in reports that the Company files or submits
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is
recorded, processed, summarized and reported, within the time periods specified
in the rules and forms of the Securities and Exchange Commission.
Changes
in Internal Control Over Financial Reporting
There has
not been any change in the Company’s internal control over financial reporting
in connection with the evaluation required by Rule 13a-15(d) under the
Exchange Act that occurred during the quarter ended September 30, 2009 that has
materially affected, or is reasonably likely to materially affect, the Company’s
internal control over financial reporting. The material weakness in
our internal control over financial reporting described in our Annual Report on
Form 10-K for the year ended December 31, 2008 (absence of adequate segregation
of duties) continues unremediated, due to our limited resources and
employees.
18
Part II -
Other Information
Item
1. Legal Proceedings
To the best knowledge of the officers
and directors, the Company is not a party to any legal proceeding or
litigation.
Item
1A. Risk Factors
As a “smaller reporting company”
defined by Item 10 of Regulation S-K, the Company is not required to provide
this information.
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
None.
Item
5. Other Information
On
October 1, 2009, the Company issued stock options to purchase 500,000 shares of
Class A common stock to each of its four non-employee directors. The
options will vested one-half each of the next two anniversaries of the grant
date. The Company also revised the previous June 2009 stock grant to
its executive officer by fully vesting such shares.
Item
6. Exhibits
See Index to Exhibits on page
E-1.
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.
SYMBOLLON
PHARMACEUTICALS, INC.
|
|
Date:
November 16,
2009
|
By:
/s/ Paul C.
Desjourdy____________________
|
Paul
C. Desjourdy, President/CEO/CFO and authorized
signatory
|
19
EXHIBIT
INDEX
Exhibit
Number
|
Exhibit
Description
|
31.1
|
Certification
of Paul C. Desjourdy, the Chief Executive Officer and Chief Financial
Officer of the Company, required by Securities Exchange Act Rule 13a-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
32.1
|
Certification
of Paul C. Desjourdy, the Chief Executive Officer and Chief Financial
Officer of the Company, required by Securities Exchange Act Rule 13a-14(b)
and 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
|
E-1