Attached files
file | filename |
---|---|
EX-10.3 - Pathfinder Cell Therapy, Inc. | v165041_ex10-3.htm |
EX-31.1 - Pathfinder Cell Therapy, Inc. | v165041_ex31-1.htm |
EX-32.1 - Pathfinder Cell Therapy, Inc. | v165041_ex32-1.htm |
EX-10.2 - Pathfinder Cell Therapy, Inc. | v165041_ex10-2.htm |
EX-10.1 - Pathfinder Cell Therapy, Inc. | v165041_ex10-1.htm |
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
þQUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the quarterly period ended
September 30, 2009
OR
¨ 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: 0-20580
SYNTHEMED,
INC.
(Exact name
of registrant as specified in its charter)
Delaware
|
14-1745197
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
200
Middlesex Essex Turnpike, Suite 210
|
08830
|
Iselin,
New Jersey
|
(Zip
Code)
|
(Address
of principal executive offices)
|
(732)
404-1117
(Issuer’s telephone number, including
area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 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 þ No
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files).
Yes ¨ 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.
Large accelerated filer o
|
Accelerated filer o
|
Non-accelerated filer o
(Do not check if a smaller
reporting company)
|
Smaller reporting company þ
|
Indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act)
Yes ¨ No
þ
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date.
Common
Stock, $.001 Par Value – 104,809,940 shares outstanding at October 31,
2009
SYNTHEMED, INC.
INDEX
Page
|
|||
Part I -
|
FINANCIAL
INFORMATION
|
||
Item 1.
|
Financial
Statements
|
||
Condensed
Statements of Operations (unaudited) for the three-month and nine-month
periods ended September 30, 2008 and 2009
|
3
|
||
Condensed
Balance Sheets as of December 31, 2008 and September 30, 2009
(unaudited)
|
4
|
||
Condensed
Statements of Cash Flows (unaudited) for the nine-month periods ended
September 30, 2008 and 2009
|
5
|
||
Notes
to Condensed Financial Statements (unaudited)
|
6
|
||
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
|
Item 4T.
|
Controls
and Procedures
|
18
|
|
Part II -
|
OTHER
INFORMATION
|
||
Item 2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
19
|
|
Item 6.
|
Exhibits
|
19
|
|
Signature
|
19
|
2
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
SYNTHEMED,
INC.
CONDENSED
STATEMENTS OF OPERATIONS
(unaudited)
(In thousands, except per share data)
|
||||||||||||||||
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2008
|
2009
|
2008
|
2009
|
|||||||||||||
Revenue
|
||||||||||||||||
Product
sales
|
$ | 44 | $ | 92 | $ | 123 | $ | 252 | ||||||||
Revenue
|
44 | 92 | 123 | 252 | ||||||||||||
Cost
of goods sold
|
13 | 59 | 71 | 120 | ||||||||||||
Gross
profit
|
31 | 33 | 52 | 132 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
316 | 491 | 1,165 | 1,158 | ||||||||||||
General
and administrative
|
408 | 300 | 1,461 | 1,133 | ||||||||||||
Sales
and marketing
|
344 | 316 | 975 | 1,097 | ||||||||||||
Operating
expenses
|
1,068 | 1,107 | 3,601 | 3,388 | ||||||||||||
(Loss)
from operations
|
(1,037 | ) | (1,074 | ) | (3,549 | ) | (3,256 | ) | ||||||||
Other
income/(expense):
|
||||||||||||||||
Interest
income
|
1 | 1 | 20 | 20 | ||||||||||||
Interest
expense
|
(1 | ) | (1 | ) | (2 | ) | (2 | ) | ||||||||
Reversal
of liabilities
|
5 | |||||||||||||||
Other
income/(expense)
|
- | - | 23 | 18 | ||||||||||||
Net
loss
|
$ | (1,037 | ) | $ | (1,074 | ) | $ | (3,526 | ) | $ | (3,238 | ) | ||||
Net
loss per common share-basic and diluted
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.04 | ) | $ | (0.03 | ) | ||||
Weighted
average shares outstanding
|
87,899 | 99,802 | 87,703 | 99,479 |
See Notes
to Condensed Financial Statements
3
SYNTHEMED,
INC.
CONDENSED
BALANCE SHEETS
(In thousands, except per share data)
|
||||||||
December 31, September 30,
|
||||||||
2008
|
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 2,944 | $ | 960 | ||||
Accounts
receivable, net
|
36 | 28 | ||||||
Inventory,
net
|
199 | 163 | ||||||
Prepaid
expenses and deposits
|
78 | 124 | ||||||
Total
current assets
|
3,257 | 1,275 | ||||||
Machinery,
equipment and software, less accumulated depreciation
|
74 | 32 | ||||||
TOTAL
|
$ | 3,331 | $ | 1,307 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 208 | $ | 101 | ||||
Accrued
expenses
|
212 | 179 | ||||||
Insurance
note payable
|
8 | 47 | ||||||
Total
current liabilities
|
428 | 327 | ||||||
Contingencies
|
||||||||
Stockholders'
equity:
|
||||||||
Preferred
stock, $.01 par value; shares authorized - 5,000; issued and
outstanding - none
|
||||||||
Common
stock, $.001 par value; shares authorized - 150,000 issued and
outstanding - 98,746 and 104,747
|
99 | 105 | ||||||
Additional
paid-in capital
|
59,976 | 61,285 | ||||||
Accumulated
deficit
|
(57,172 | ) | (60,410 | ) | ||||
Total
stockholders' equity
|
2,903 | 980 | ||||||
TOTAL
|
$ | 3,331 | $ | 1,307 |
See Notes
to Condensed Financial Statements
4
SYNTHEMED,
INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(unaudited)
(In
thousands, except for share data)
|
||||||||
Nine
Months Ended
|
||||||||
September
30,
|
||||||||
2008
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (3,526 | ) | $ | (3,238 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
46 | 42 | ||||||
Amortization
of acquired technology
|
21 | |||||||
Reversal
of liabilities
|
(5 | ) | ||||||
Stock
based compensation
|
630 | 386 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
(Increase)
decrease in accounts receivable
|
(18 | ) | 8 | |||||
(Increase)
decrease in inventory
|
(142 | ) | 36 | |||||
(Increase)
in prepaid expenses
|
(37 | ) | (46 | ) | ||||
(Decrease)
in accounts payable
|
(108 | ) | (107 | ) | ||||
(Decrease)
in accrued expenses
|
(61 | ) | (17 | ) | ||||
Net
cash used in operating activities
|
(3,200 | ) | (2,936 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Net
proceeds from the issuance of common stock
|
3,684 | 903 | ||||||
Net
proceeds from insurance note payable
|
60 | 39 | ||||||
Proceeds
from exercise of stock options and warrants
|
148 | 10 | ||||||
Net
cash provided by financing activities
|
3,892 | 952 | ||||||
Net
increase (decrease) in cash and cash equivalents
|
692 | (1,984 | ) | |||||
Cash
and cash equivalents at beginning of period
|
2,991 | 2,944 | ||||||
Cash
and cash equivalents at end of period
|
$ | 3,683 | $ | 960 | ||||
Supplementary
disclosure of non-cash operating activities:
|
||||||||
Issuance
of 445,250 common shares in settlement of a liability
|
$ | - | $ | 75 |
See Notes
to Condensed Financial Statements
5
SYNTHEMED,
INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
A)
|
Basis of Presentation
and Going
Concern
|
The
accompanying condensed financial statements of SyntheMed, Inc. (the “Company”)
do not include all of the information and footnote disclosures normally included
in financial statements prepared in accordance with U.S. generally accepted
accounting principles; but, in the opinion of management, contain all
adjustments (which consist of only normal recurring adjustments) necessary for a
fair presentation of such financial information. Results of
operations and cash flows for interim periods are not necessarily indicative of
those to be achieved for full fiscal years. These condensed financial statements
have been presented on a going concern basis and do not include any adjustments
that might be necessary if the Company is unable to continue as a going concern.
The balance of cash and cash equivalents as of September 30, 2009 may not be
sufficient to meet the Company’s anticipated cash requirements through 2009,
based on management’s present plan of operation. As a result, the Company is
seeking to raise additional capital to meet short-term requirements.
Insufficient funds have required the Company to delay, scale back or eliminate
some of its operations including research and development programs and certain
commercialization activities and may require the Company to license or sell to
third parties certain products or technologies that management would otherwise
seek to commercialize independently. The Company does not have sufficient cash
resources, either on hand or anticipated from operations, to fund the additional
clinical studies required for the adult cardiac surgery indication for
REPEL-CV®
Bioresorbable Adhesion Barrier (“REPEL-CV”). Therefore, the Company is pursuing
strategic and other arrangements. No assurance can be given that additional
financing or strategic arrangements will be available on acceptable terms or at
all. Under these circumstances there are substantial doubts about the Company’s
ability to continue as a going concern. These condensed financial statements do
not include any adjustments relating to the recoverability and classification of
the carrying amount of recorded assets and liabilities that might be necessary
if the Company is unable to continue as a going concern. These condensed
financial statements should be read in conjunction with the Company’s audited
financial statements for the year ended December 31, 2008 included in our Annual
Report on Form 10-K filed with the Securities and Exchange Commission. The
report of our independent registered public accounting firm contained in our
2008 Annual Report on Form 10-K, also contains an explanatory paragraph
referring to an uncertainty concerning our ability to continue as a going
concern.
B)
|
Cash and Cash
Equivalents
|
The
Company considers all highly liquid investments purchased with a maturity of
three months or less to be cash equivalents. The Company deposits cash and cash
equivalents with high credit quality financial institutions and believe any
amounts in excess of insurance limitations to be at minimal
risk. Cash and cash equivalents held in these accounts are insured by
the Federal Deposit Insurance Corporation up to a maximum of $250,000 through
December 31, 2013, and $100,000 thereafter.
C)
|
Accounts
Receivable
|
Accounts
receivable are stated at estimated net realizable value. Management evaluates
the need for an allowance for doubtful accounts based on a combination of
historical experience, aging analysis and information on specific accounts. In
cases where management is aware of circumstances that may impair a specific
customer’s ability to meet its financial obligations, management records a
specific allowance against amounts due and reduces the net recognized receivable
to the amount that we believe will be collected. For all other customers, the
Company maintains a reserve that considers the total receivables outstanding,
historical collection rates and economic trends. Account balances are written
off when collection efforts have been exhausted and the potential for recovery
is considered remote. At September 30, 2009 and December 31, 2008, the allowance
for doubtful accounts was $29,000 and $14,000, respectively.
D)
|
Inventory
|
Inventory
is stated at the lower of cost or market, as determined by the first-in,
first-out method. The Company maintains an allowance for potentially slow moving
and obsolete inventories. Management reviews on-hand inventory for potential
slow moving and obsolete amounts and estimate the level of inventory reserve
accordingly. The Company’s allowance for slow moving and obsolete inventories
includes an allowance for on-hand finished goods inventory which is within six
months of the expiration date.
6
December 31,
|
September 30,
|
|||||||
2008
|
2009
|
|||||||
Raw
materials
|
$ | 139,000 | $ | 125,000 | ||||
Work
in process
|
33,000 | 14,000 | ||||||
Finished
goods
|
73,000 | 31,000 | ||||||
245,000 | 170,000 | |||||||
Slow
moving and obsolete inventories
|
(46,000 | ) | (7,000 | ) | ||||
$ | 199,000 | $ | 163,000 |
During
the nine months ended September 30, 2009, management has disposed
of $26,000 of slow moving and obsolete inventory.
The
production of the Company’s inventory is outsourced to third party facilities
located in Ohio, Minnesota and Prince Edward Island, Canada.
E)
|
Stock
Based Compensation Plans
|
At
September 30, 2009, the Company has three stock-based compensation plans: the
2000 Non-Qualified Stock Option Plan, under which the Company is authorized to
issue non-qualified stock options to purchase up to an aggregate of 1,000,000
shares of common stock; the 2001 Non-Qualified Stock Option Plan, under which
the Company is authorized to issue non-qualified stock options to purchase up to
an aggregate of 10,000,000 shares of common stock; and the 2006 Stock Option
Plan, under which the Company is authorized to issue incentive stock options and
non-qualified stock options to purchase up to an aggregate of 5,000,000 shares
of common stock. At September 30, 2009, there were 694,000 options available for
grant under these plans. The exercise price is determined by the
Compensation Committee of the Board of Directors at the time of the granting of
an option. Options vest over a period not greater than five years, and expire no
later than ten years from the date of grant.
The
Company follows the FASB ASC 718 “Compensation – Stock Compensation” which
requires all share-based payments to employees, including grants of employee
stock options, to be recognized as compensation expense over the requisite
service period (generally the vesting period) in the financial statements based
on their fair values. For options with graded vesting, the Company values the
stock option grants and recognize compensation expense as if each vesting
portion of the award was a separate award. The impact of forfeitures that may
occur prior to vesting is also estimated and considered in the amount of expense
recognized. In addition, the realization of tax benefits in excess of amounts
recognized for financial reporting purposes will be recognized in the cash flow
statement as a financing activity rather than as an operating
activity.
No tax
benefits were attributed to the stock-based compensation expense because a
valuation allowance was maintained for substantially all net deferred tax
assets. The Company elected to adopt the alternative method of calculating the
historical pool of windfall tax benefits . This is a simplified method to
determine the pool of windfall tax benefits that is used in determining the tax
effects of stock compensation in the results of operations and cash flow
reporting for awards that were outstanding as of the adoption of ASC
718.
The
Company uses the Black-Scholes option pricing model to determine the weighted
average fair value of options. The fair value of options at date of grant and
the assumptions utilized to determine such values are indicated in the following
table:
7
|
Nine Months Ended
September 30,
|
|||||||
2008
|
2009
|
|||||||
Weighted
average fair value at date of grant for options granted during the
period
|
$ | 0.42 | $ | 0.18 | ||||
Risk-free
interest rates
|
2.05% -2.79 | % | 1.16%- 2.0 | % | ||||
Expected
option life in years
|
7-10 | 8-10 | ||||||
Expected
forfeiture rate
|
0 | % | 0 | % | ||||
Actual
vesting terms in years
|
1-3 | 2 | ||||||
Expected
stock price volatility
|
94.1 | % | 98.0 | % | ||||
Expected
dividend yield
|
-0- | -0- |
The
following summarizes the activities of the Company’s stock options for the nine
months ended September 30, 2009 (shares in thousands):
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Number
of shares under option plans:
|
|||||||||||||
Outstanding
at January 1, 2009
|
13,818 | $ | 0.44 |
5.5
Years
|
|||||||||
Granted
|
1,470 | 0.18 |
9.5
Years
|
||||||||||
Exercised
|
(833 | )* | 0.13 | ||||||||||
Canceled,
expired or forfeited
|
(785 | ) | 0.42 | ||||||||||
Outstanding
at September 30, 2009
|
13,670 | $ | 0.42 |
5.9 Years
|
$ | 654,000 | |||||||
Vested
and expected to vest after September 30, 2009
|
11,355 | $ | 0.42 |
5.5 Years
|
$ | 509,000 |
*
Includes 783,000 options that were exercised on a cashless, net exercise basis
that resulted in the issuance of 506,000 shares of common stock and the
forfeiture of all rights to the remaining 277,000 shares otherwise issuable upon
exercise of such options.
The
following summarizes the activities of the Company’s stock options that have not
vested as of September 30, 2009 (shares in thousands):
Shares
|
Weighted Average
Exercise Price
|
|||||||
Nonvested
at January 1, 2009
|
2,130 | $ | 0.60 | |||||
Granted
|
1,470 | 0.18 | ||||||
Canceled,
expired or forfeited
|
(547 | ) | 0.42 | |||||
Vested
|
(738 | ) | 0.31 | |||||
Nonvested
at September 30, 2009
|
2,315 | $ | 0.43 |
As of
September 30, 2009, there was approximately $152,000 of unrecognized stock
compensation related to unvested awards (net of estimated forfeitures) expected
to be recognized over the next 22 months.
8
The
Company granted 1,440,000 and 1,470,000 options in the nine-month periods ended
September 30, 2008 and 2009, respectively. Of the 1,470,000 options granted
during the period ended September 30, 2009, 360,000 vested immediately, 100,000
vest one year from the date of grant, 100,000 vest two years from the date of
grant and 910,000 vest upon the achievement of certain performance criteria
during 2009. The Company has recorded a charge of $11,000, $88,000 and $55,000
in research and development, general and administrative and sales and marketing
expense, respectively, for the fair value of the options granted for the nine
months ended September 30, 2009. Of the 1,440,000 options
granted during the period ended September 30, 2008, 585,000 vested immediately,
215,000 vest one year, 40,000 options vest two years and 40,000 options vest
three years from the date of grant, respectively and 560,000 were scheduled to
vest upon the achievement of certain performance criteria, of which, 60,000
options were subsequently cancelled. The Company recorded a charge of $92,000,
$407,000 and $131,000 in research and development, general and administrative
and sales and marketing expense, respectively, for the fair value of the options
granted for the nine months ended September 30, 2008.
Under ASC
718 forfeitures are estimated at the time of valuation and reduce expense
ratably over the vesting period. This estimate is adjusted periodically based on
the extent to which actual forfeitures differ, or are expected to differ, from
the previous estimate.
At
September 30, 2009, the Company had 1,760,000 options outstanding which vest
upon the achievement of certain performance criteria including FDA-related
milestones associated with REPEL-CV and other product development programs,
certain sales and marketing activities, new product and business development
initiatives, financing activities and market based criteria. The
performance-based options have a term of 10 years from date of grant and an
exercise price range of $0.10 to $1.00. Of these options, 100,000 relate to the
achievement of certain FDA-related milestones and the Company has recorded an
estimated expense of $36,000 in research and development for these options,
910,000 relate to specific performance criteria including FDA-related milestones
associated with REPEL-CV and other product development programs, certain sales
and marketing activities, new product and business development initiatives,
financing activities, regulatory and administrative activities and the Company
has recorded an estimated charge of $11,000, $19,000 and $9,000 in research and
development, general and administrative and sales and marketing expense,
respectively, for these options and 750,000 relate to market condition criteria
for the Company’s common stock and recorded an estimated charge of $68,000 in
general and administrative expense for these options. The Company has valued
these market condition options utilizing the Black-Scholes option pricing model
rather than the preferable Lattice method due to the subjectivity of the Lattice
method’s assumptions when compared to the Black-Scholes pricing model and the
estimated immaterial difference between the two methods given the short term
vesting requirements of one and two years. At each reporting period for the
performance based grants only, management re-evaluates the probability that the
vesting contingency will be satisfied and adjusts the fair value charge
accordingly.
F)
|
Acquired
Technology
|
In March
2003, the Company purchased certain polymer technology from Phairson Medical,
Ltd., a private medical technology company based in the United Kingdom, for
approximately 6,896,000 shares of the Company’s restricted common
stock. These assets comprise a series of United States and foreign
patent applications as well as scientific and clinical
documentation. In connection with this transaction, the Company
recorded $344,000 as the fair value of this technology which includes (i)
$330,000, representing the deemed value of the shares issued (approximately
$0.0478 per share) paid by investors in the contemporaneous private placement of
Series C Convertible Preferred Stock and related warrants; (ii) $11,000 in
transaction-related costs and (iii) $3,000 representing the fair value of the
options issued as a finder’s fee. A useful life of five years was
assigned to the acquired technology considering the stage of product
development, the estimated period during which patent protection could be
enforced, which would go well beyond five years from the acquisition date, the
development cycle time for medical devices of the type envisioned by us based on
such technology, as well as potential technology obsolescence over time. For the
nine month period ended September 30, 2008, the Company recorded amortization of
$21,000 in research and development relating to these assets; no comparable
expense was recorded for the nine month period ended September 30, 2009, as
these assets were fully amortized as of April 30, 2008.
G)
|
Insurance
Note Payable
|
In March
2009, the Company entered into two short term financing agreements for product
liability and directors and officers liability insurance premiums totaling
$160,000, payable in monthly installments including interest of $6,700 and
$7,000, respectively. The monthly installments are due through December 2009 and
January 2010, respectively and carry interest of 4.9% per
annum.
9
H)
|
Net
Loss Per Common Share
|
Basic and
diluted net loss per common share is computed using the weighted average number
of shares outstanding during each period, which excludes 31,405,000 potential
common shares issuable upon the exercise of outstanding options and warrants
since their inclusion would have been be anti-dilutive.
I)
|
Exercise
of Options
|
For the
nine month period ended September 30, 2009, a total of 556,000 shares were
issued from the exercise of options. The Company received proceeds of
approximately $10,000 from the exercise of options, resulting in the issuance of
50,000 shares of the Company’s common stock. In addition, 783,000 were
exercised using a cashless, net exercise feature that resulted in the issuance
of 506,000 shares of common stock and the forfeiture of all rights to the
remaining 277,000 shares otherwise issuable upon exercise of such
options.
J)
|
Common
Stock
|
On
September 30, 2009, the Company raised $1,000,000 in gross proceeds from the
sale of 5,000,000 units, each consisting of one share of common stock and one
warrant to purchase one share of common stock, at a purchase price of $.20 per
unit. The warrants are exercisable for shares at a price of $.20 per share, and
are scheduled to expire on September 30, 2013. In connection with the
financing, the Company paid a placement agent a commission of $70,000 in cash,
representing 7% of the gross proceeds raised, and warrants to purchase an
aggregate of 350,000 shares of common stock, representing 7% of the number of
units sold in the financing. The agent warrants are identical to the investor
warrants. The Company also reimbursed the agent for certain
financing-related expenses totaling $27,000 including legal fees. One of the
Company’s directors, Mr. Joerg Gruber, is Chairman and a director of the
placement agent.
In
accordance with interim measures previously adopted by the Company’s Board of
Directors under which 65% of the cash portion of performance bonuses and Board
fees would be payable in shares, (i) effective February 6, 2009, the Company
granted an aggregate of 282,750 shares of common stock to certain of the
Company’s officers and other employees in full satisfaction of $42,000 in
aggregate performance bonus compensation for 2008 otherwise payable at that time
in cash to such individuals and (ii) effective April 1, 2009, the
Company granted an aggregate of 54,166 shares of common stock to the Company’s
non-employee directors in full satisfaction of $16,250 in aggregate Board fees
otherwise payable at that time in cash to such directors and attributable to the
first quarter of 2009 and (iii) effective July 1, 2009 the
Company granted an aggregate of 108,334 shares of common stock to the Company’s
non-employee directors in full satisfaction of $16,250 in aggregate Board fees
otherwise payable at that time in cash to such directors and attributable to the
second quarter of 2009. In each case, the shares were valued
at fair market value on the date of grant, as reflected by the prior trading
day's closing price. The transactions were not registered under the Securities
Act of 1933, in reliance on the exemption provided by Section 4(2)
thereunder.
On
September 30, 2008, the Company raised $4,000,000 in gross proceeds from the
sale of 10,000,000 units, each consisting of one share of common stock and one
warrant to purchase one share of common stock, at a purchase price of $.40 per
unit. The warrants are exercisable for shares at a price of $.50 per share, and
are scheduled to expire on September 30, 2011. In connection with the
financing, the Company paid a placement agent a commission of $280,000 in cash,
representing 7% of the gross proceeds raised, and warrants to purchase an
aggregate of 700,000 shares of common stock, representing 7% of the number of
shares sold in the financing. The agent warrants are identical to the investor
warrants, except that the agent warrants expire on September 30, 2012.
The Company also reimbursed the agent for certain financing-related expenses
totaling $36,000 including legal fees. One of the Company’s directors, Mr. Joerg
Gruber, is Chairman and a director of the placement agent.
K)
|
Newly
Adopted Accounting Pronouncements
|
In
June 2009, the Financial Accounting Standards Board (“FASB”) issued
guidance now codified under Accounting Standards Codification (“ASC”) Topic
105-10, which establishes the FASB Accounting Standards Codification (the
“Codification”) as the source of authoritative accounting principles recognized
by the FASB to be applied in the preparation of financial statements in
conformity with GAAP. ASC Topic 105-10 explicitly recognizes rules and
interpretive releases of the Securities and Exchange Commission (“SEC”) under
federal securities laws as authoritative GAAP for SEC registrants. Upon
adoption of this guidance under ASC Topic 105-10, the Codification superseded
all then-existing non-SEC accounting and reporting standards. All other
non-grandfathered non-SEC accounting literature not included in the Codification
became non-authoritative. The guidance under ASC Topic 105-10 became
effective for the Company as of September 30, 2009. References made
to authoritative FASB guidance throughout this document have been updated to the
applicable Codification section.
10
On
October 10, 2008, the FASB issued FASB ASC 820-10-35 (Previously known as: (FSP
FAS 157-3, “Determining the Fair Value of a Financial Asset in a Market That Is
Not Active.”) which was effective upon issuance, including periods for which
financial statements have not been issued. It clarified the application of FASB
ASC 820-10 in an inactive market and provided an illustrative example to
demonstrate how the fair value of a financial asset is determined when the
market for that financial asset is inactive. The adoption of this FSP did not
have a material impact on the Company’s financial position and results of
operations.
In
April 2009, the FASB issued FASB ASC 820-10-65 (Previously known as: FSP
157-4 “Determining Fair Value When the Volume and Level of Activity for the
Asset or Liability Have Significantly Decreased and Identifying Transactions
That Are Not Orderly”). Based on the guidance, if an entity determines that the
level of activity for an asset or liability has significantly decreased and that
a transaction is not orderly, further analysis of transactions or quoted prices
is needed, and a significant adjustment to the transaction or quoted prices may
be necessary to estimate fair value in accordance with Statement of Financial
Accounting Standards FASB ASC 820-10 (Prior authoritative literature: (SFAS)
No. 157 “Fair Value Measurements”). This FSP is to be applied prospectively
and is effective for interim and annual periods ending after June 15, 2009
with early adoption permitted for periods ending after March 15, 2009. The
company adopted this FSP for its quarter ended June 30, 2009. The adoption
has no impact on the Company’s financial statements.
In 2008,
the FASB issued FASB ASC 815-40 (Previously known as: EITF 07-05, Determining
whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own
Stock). FASB ASC 815-40 provides guidance on determining what types of
instruments or embedded features in an instrument held by a reporting entity can
be considered indexed to its own stock for the purpose of evaluating the first
criteria of the scope exception in FASB ASC 810-10-15 (Prior authoritative
literature: paragraph 11(a) of SFAS 133). The adoption of FASB ASC 815-40
effective January 1, 2009 did not have any impact on the Company’s financial
statements.
In April
2009, the FASB issued FASB ASC 805-10-05 (Previously known as: Statement No.
141(R)-1 "Accounting for Assets Acquired and Liabilities Assumed in a Business
Combination That Arises from Contingencies"). For business combinations, the
standard requires the acquirer to recognize at fair value an asset acquired or
liability assumed from a contingency if the acquisition date fair value can be
determined during the measurement period. The adoption of FASB ASC 805-10-05 as
of January 1, 2009 did not have an impact on the Company's financial position
and results of operations, however it may have a material impact in the future
which can not currently be determined.
In
April 2009, the FASB issued FASB ASC 825-10-50 (Previously known as: FASB
Staff Position No. FAS 107-1) and FASB ASC 270-10-05 (Prior authoritative
literature: APB 28-1, “Interim Disclosures about Fair Value of Financial
Instruments,”) which requires disclosures about fair value of financial
instruments for interim reporting periods of publicly traded companies as well
as in annual financial statements. This Staff Position is effective for interim
reporting periods ending after June 15, 2009, with early adoption permitted
for periods ending after March 15, 2009. The Company will adopt this
pronouncement as of July 1, 2009 and did not have a material impact on the
financial statements.
In May
2009, the FASB issued FASB ASC 855-10 (Previously known as:
SFAS No. 165, “Subsequent Events”) FASB ASC 855-10 establishes general
standards for accounting for and disclosure of events that occur after the
balance sheet date but before financial statements are available to be issued
(“subsequent events”). More specifically, FASB ASC 855-10 sets forth the period
after the balance sheet date during which management of a reporting entity
should evaluate events or transactions that may occur for potential recognition
in the financial statements, identifies the circumstances under which an entity
should recognize events or transactions occurring after the balance sheet date
in its financial statements and the disclosures that should be made about events
or transactions that occur after the balance sheet date. FASB ASC 855-10
provides largely the same guidance on subsequent events which previously existed
only in auditing literature. The guidance under ASC Topic 855-10 became
effective for the Company as of June 30, 2009.
11
L)
|
Recent
Accounting Pronouncements
|
In June
2009, the FASB has issued SFAS No. 167, Amendments to FASB Interpretation
No 46(R). SFAS No. 167 amends certain requirements of FASB Interpretation
No. 46 (revised December 2003), Consolidation of Variable Interest
Entities, to improve financial reporting by enterprises involved with variable
interest entities and to provide more relevant and reliable information to users
of financial statements. SFAS No. 167 becomes effective for the Company in
2010 and has currently not been codified in the ASC. The Company does not
expect that the adoption of SFAS No. 167 will have a material impact on the
Company’s financial statements.
In
October 2009, the FASB issued new guidance for revenue recognition with
multiple deliverables, which is effective for revenue arrangements entered into
or materially modified in fiscal years beginning on or after June 15, 2010,
although early adoption is permitted. This guidance eliminates the residual
method under the current guidance and replaces it with the “relative selling
price” method when allocating revenue in a multiple deliverable arrangement. The
selling price for each deliverable shall be determined using vendor specific
objective evidence of selling price, if it exists, otherwise third-party
evidence of selling price shall be used. If neither exists for a deliverable,
the vendor shall use its best estimate of the selling price for that
deliverable. After adoption, this guidance will also require expanded
qualitative and quantitative disclosures. The Company is currently assessing the
impact of adoption on its financial position and results of
operations.
M)
|
Income
Taxes
|
The
Company accounts for income taxes using the asset and liability method described
in FASB ASC 740-10
(Previously known as: SFAS No. 109), Income Taxes, the objective of which
is to establish deferred tax assets and liabilities for the temporary
differences between the financial reporting and the tax bases of the Company’s
assets and liabilities at enacted tax rates expected to be in effect when such
amounts are realized or settled. A valuation allowance related to deferred tax
assets is recorded when it is more likely than not that some portion or all of
the deferred tax assets will not be realized. At September 30, 2009, the Company
had a deferred tax asset which was fully reserved by a valuation allowance to
reduce the deferred tax asset to the amount that is expected to be
realized.
The
Company follows FASB
ASC 740-10-25 (Previously known as: Financial Accounting Standards Board
interpretation No. 48 Accounting for Uncertainty in Income Taxes) an
interpretation of FASB ASC 740-10-25
on January 1, 2007. As a result of the implementation of FASB ASC 740-10-25,
the Company recognized no adjustment for unrecognized tax
provisions.
The
Company recognizes interest and penalties related to uncertain tax positions in
general and administrative expense. As of September 30, 2009, the Company has
not recorded any provisions for accrued interest and penalties related to
uncertain tax positions.
By
statute, tax years 2005 through 2008 remain open to examination by the major
taxing jurisdictions to which the Company is subject.
N)
|
Reversal
of Liabilities
|
For the
nine month period ended September 30, 2008, the Company reversed liabilities of
$5,000 primarily relating to trade transactions with former vendors. The
underlying transactions occurred during or before March 31, 2002 and, as of the
date of reversal, there had been no communication with the parties regarding the
transactions since that time. Accordingly, based on advice of legal counsel, the
Company believes that any claim for these amounts made at or subsequent to the
time of reversal, would be barred by applicable statutes of limitations. No liabilities were
reversed for the nine month period ended September 30,
2009.
12
O)
|
Revenue
Recognition Policy
|
The
Company recognizes revenue when the amounts become fixed and determinable, when
product is shipped to customers and receipt of payment is reasonably assured.
Terms of sale are “f.o.b. shipping point” with the customer covering all costs
of shipment and insurance. All sales are final with no right of return except
for defective product.
P)
|
Retirement
Plan
|
In March
2007, the Company adopted a defined contribution retirement plan which qualifies
under section 401(k) of the Internal Revenue Code. The plan allows all
employees, upon commencement of employment, to voluntarily contribute amounts
not exceeding the maximum allowed under the Internal Revenue Code. The Company
is obligated to make a matching contribution equal to 100% of the salary
deferral contributions made up to the first 4% of total compensation. During the
nine months ended September 30, 2008 and 2009, the Company made matching
contributions to the plan in the amount of $17,000 and $29,000,
respectively.
Q)
|
Shareholders
Rights Plan
|
On April
25, 2008, the Company’s Board of Directors approved the adoption of a
shareholder rights plan. The Board of Directors has declared a dividend
distribution of one right for each share of our common stock outstanding as of
the close of business on June 2, 2008. Initially, the rights will be represented
by common stock certificates, will not be traded separately from the common
stock and will not be exercisable. The rights generally will become exercisable
following any person becoming an “acquiring person” by acquiring, or commencing
a tender offer to acquire, beneficial ownership of 15% or more of the
outstanding shares of the Company’s common stock. If a person becomes an
“acquiring person,” each holder of a right, other than the acquirer, would be
entitled to receive, upon payment of the then purchase price, a number of shares
of our common stock or other securities having a value equal to twice the
purchase price. If the Company is acquired in a merger or other business
combination transaction after any such event, each holder of a right, other than
the acquirer, would be entitled to receive, upon payment of the then purchase
price, shares of the acquiring company having a value equal to twice the
purchase price. The rights are scheduled to expire on June 2, 2018 unless
earlier redeemed, terminated or exchanged in accordance with the terms of the
shareholder rights plan.
R)
|
Nature
of Business
|
Commencing
in the quarter ended June 30, 2009, the
Company began selling REPEL-CV in the United States. The following table
summarizes the Company’s Revenues and Long-Lived Assets for the three and nine
months ended September 30, 2008 and 2009, respectively (in
thousands):
13
Geographic
Information
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
As of September 30,
|
||||||||||||||||||||||
2008
|
2009
|
2008
|
2009
|
2008
|
2009
|
|||||||||||||||||||
Revenues
|
Revenues
|
Long-Lived Assets
|
||||||||||||||||||||||
United
States
|
$ | - | $ | 45 | $ | - | $ | 85 | $ | 89 | $ | 32 | ||||||||||||
Saudi
Arabia
|
- | 11 | - | 35 | - | - | ||||||||||||||||||
Italy
|
36 | - | 69 | 24 | - | - | ||||||||||||||||||
Czech
Republic
|
- | 5 | 10 | 25 | - | - | ||||||||||||||||||
Turkey
|
- | - | 29 | - | - | - | ||||||||||||||||||
Romania
|
- | - | - | 13 | - | - | ||||||||||||||||||
Dubai
|
- | 10 | - | 10 | - | - | ||||||||||||||||||
Australia
|
- | 7 | - | 7 | - | - | ||||||||||||||||||
France
|
- | 7 | - | 21 | - | - | ||||||||||||||||||
Canada
|
6 | - | 7 | - | - | - | ||||||||||||||||||
Other
countries
|
2 | 7 | 8 | 32 | - | - | ||||||||||||||||||
$ | 44 | $ | 92 | $ | 123 | $ | 252 | $ | 89 | $ | 32 |
S)
|
Subsequent
Events
|
The
Company’s non-employee directors are entitled to cash compensation for their
service as directors, payable quarterly. In accordance with interim
cash conserving measures previously adopted by the Company’s Board of Directors
that stipulates that such quarterly cash compensation would be paid 35% in cash
and the balance in shares, effective October 1, 2009 the Company granted an
aggregate of 62,500 shares of common stock to the Company’s non-employee
directors in full satisfaction of $16,250 in aggregate Board fees otherwise
payable at that time in cash to such directors and attributable to the third
quarter of 2009. The shares were valued at fair market value on
September 30, the last trading day of the quarter, as reflected by the closing
price on that day.
The
Company has performed an evaluation of subsequent events through November 6,
2009, which is the day the financial statements were filed.
Item
2. Management's Discussion and Analysis of Financial Condition
and Results of Operations.
Certain
statements in this Report under this Item 2 and elsewhere constitute
“forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995, including, without limitation, statements
regarding future cash requirements, the success of any pending or proposed
clinical trial and the timing or ability to achieve necessary regulatory
approvals. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the actual results,
performance or achievements of our Company, or industry results, to be
materially different from any future results, performance, or achievements
expressed or implied by such forward-looking statements. Such risks
and uncertainties include but are not limited to (i) potential adverse
developments regarding our efforts to obtain and maintain required FDA and other
approvals including, without limitation, approval by the FDA of an expanded
indication of REPEL-CV to include adult cardiac surgery patients; (ii) potential
inability to secure funding as and when needed or to engage in a strategic
transaction to support our activities and (iii) unanticipated delays associated
with manufacturing and marketing activities. Reference is made to our
Annual Report on Form 10-K for the year ended December 31, 2008 for a
description of some of these risks and uncertainties. Without
limiting the foregoing, the words “anticipates”, “plans”, “intends”, “expects”
and similar expressions are intended to identify such forward-looking statements
that speak only as of the date hereof. We undertake no obligation to
publicly release the results of any revisions to these forward- looking
statements that may be made to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
14
The
discussion and analysis of our financial condition and results of operations set
forth below under “Results of Operations” and “Liquidity and Capital Resources”
should be read in conjunction with our financial statements and notes thereto
appearing elsewhere herein.
General
We are a
biomaterials company engaged in the development and commercialization of
innovative and cost-effective medical devices for therapeutic
applications. Our products and product candidates, all of which are
based on our proprietary, bioresorbable polymer technology, are primarily
surgical implants designed to prevent or reduce the formation of adhesions (scar
tissue) following a broad range of surgical procedures. Our
commercialization efforts are currently focused on our lead product, REPEL-CV®
Bioresorbable Adhesion Barrier (“REPEL-CV”), for use in cardiac
surgery. REPEL-CV is a bioresorbable film designed to be placed over
the surface of the heart at the conclusion of surgery to reduce the formation of
post-operative adhesions.
In
November 2008, we received 510(k) clearance to market from the FDA for
SinusShield™, a bioresorbable film intended to reduce adhesions and act as a
space-occupying stent in nasal and sinus surgical procedures. SinusShield was
developed utilizing the same polymer film used in REPEL-CV. We are continuing to
explore a marketing/distribution relationship with prospective companies who
focus on the ear, nose and throat (“ENT”) surgical market.
In March
2009, the US Food and Drug Administration (“FDA”) approved REPEL-CV for use in
reducing the severity of post-operative adhesions in pediatric patients who are
likely to require reoperation via sternotomy. The approval was consistent
with the earlier recommendation, in September 2007, of the FDA’s Circulatory
System Devices Advisory Panel (“Advisory Panel”), which also recommended the
development of additional clinical data as a basis for expanding the indicated
use to include adult patients. As stipulated in the approval, we are required to
conduct a post-approval safety study in pediatric patients.
In July
2009, a separate Advisory Panel met to provide general guidance to the FDA on
the clinical requirements for anti-adhesion products in cardiac surgery as well
as, during a closed session, to comment on clinical study protocols we submitted
in support of the adult indication. In August 2009, we reached an understanding
with the FDA regarding the additional clinical data requirements for the adult
indication. Clearance to commence these clinical studies is subject
to submission to and approval by the FDA of an Investigational Device Exemption
(“IDE”) application. We do not have sufficient cash resources, either
on hand or anticipated from operations, to fund these clinical
studies. Therefore, we are pursuing strategic and other
arrangements.
During
the third quarter, we further expanded our international distribution network
through the approvals by regulatory authorities in Brazil and the Russian
Federation to market REPEL-CV for use in all patients who undergo open heart
surgery and have begun marketing the product in these countries through
independent distributors. In April 2009, we initiated the marketing of REPEL-CV
in the United States through a direct sales force comprised of both Company and
independent sales representatives. REPEL-CV has been available for sale in the
European Union and certain Southeast Asian and Middle Eastern markets since
receipt, in August 2006, of CE Mark approval for use in adult and pediatric
cardiac surgery patients. In the international markets, product sales are
generated through a network of independent distributors, all of whom are
experienced in selling devices and medical equipment for use by cardiac
surgeons. We are continuing to expand and upgrade our international
distribution network.
Results
of Operations
Revenue
for the three and nine months ended September 30, 2009 was $92,000 and $252,000,
respectively, compared to $44,000 and $123,000 for the comparable prior year
periods, representing increases of 109.1% or $48,000 for the three month period
and 104.9% or $129,000 for the nine month period. The increases in revenue are
primarily attributable to our launch of REPEL-CV in the United States in April
2009 and from initial stocking orders from new international distributors. The
recent FDA approval of REPEL-CV for use in pediatric patients who are likely to
require reoperation via sternotomy, coupled with the expansion of our
international distribution network, should result in increased revenue in future
periods.
15
During
the three and nine month periods ended September 30, 2009, sales revenue in the
United States were $45,000 and $85,000 which represented 48.9% and 33.7% of
total revenue for the respective periods. For more detail on geographic
breakdown, see Note
R of Notes to Condensed Financial Statements.
Cost of
goods sold was $59,000 and $120,000 for the three and nine months ended
September 30, 2009, respectively, compared to $13,000 and $71,000 for the
comparable prior year periods, representing an increase of 353.8% or $46,000 for
the three month period and an increase of 69% or $49,000 for the nine month
period. The increase in cost of goods sold for the three month period is mainly
attributable to a charge of $28,000 in the current year period for a failed
inventory production run in addition to the costs associated with higher current
year sales. The increase in cost of goods sold for the nine month
period is primarily attributable to factors mentioned in the previous comment as
well as the inclusion of certain raw material costs in the current year period
that had been included in product development expense in the prior year period.
Had these raw material costs been included in the prior year period, cost of
goods sold for that period would have increased by $3,000. As of December 31, 2008,
the finished goods inventory produced from this raw material was fully
depleted.
The
following table illustrates the effect on cost of goods sold and gross profit if
the cost of these raw materials of $3,000 had been included in finished goods
inventory for the nine months ended September 30, 2008 (in
thousands):
Nine Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30, 2008
Proforma
|
September 30, 2009
Actual
|
|||||||||||||||
Reported
Net Sales
|
$ | 123 | 100 | % | $ | 252 | 100 | % | ||||||||
COGS
|
74 | 60 | % | 120 | 48 | % | ||||||||||
Gross
Profit
|
$ | 49 | 40 | % | $ | 132 | 52 | % |
For the nine
months ended September 30, 2009, $23,000 of costs for these raw materials is
included in the cost of goods sold.
Cost
of goods sold reflects raw material costs and the cost of processing and
packaging REPEL-CV into saleable form.
We
incurred research and development expenses of $491,000 and $1,158,000 for the
three and nine months ended September 30, 2009, respectively, compared to
$316,000 and $1,165,000 for the comparable prior year periods, an increase of
55.4% or $175,000 for the three month period and a decrease of 0.6% or $7,000
for the nine month period. The increase for the three month period is primarily
attributable to an increase of $134,000 in regulatory costs, increased
stock-based compensation expense of $20,000, and higher new product development
costs of $24,000.
General
and administrative expenses totaled $300,000 and $1,133,000 for the three and
nine months ended September 30, 2009, respectively, compared to $408,000 and
$1,461,000 for the comparable prior year periods, a decrease of 26.5% or
$108,000 for the three month period and a decrease of 22.5% or $328,000 for the
nine month period. The decrease for the three month period is primarily
attributable to lower stock-based compensation expense of $67,000 and reduced
legal fees of $31,000. The decrease for the nine month period is primarily
attributable to reductions in stock-based compensation expense of $196,000,
compensation expense of $61,000, legal fees of $44,000, and director fees,
investor relations and insurance expenses totaling $49,000.
We
incurred sales and marketing expenses of $316,000 and $1,097,000 for the three
and nine months ended September 30, 2009, respectively, compared to $344,000 and
$975,000 for the comparable prior year periods, a decrease of 8.1% or $28,000
for the three month period and an increase of 12.5% or $122,000 for the nine
month period. The decrease for the three month period is primarily attributable
to decreases totaling $85,000 in consulting expenses, recruiting fees and
meeting expenses, partially offset by increased compensation-related and travel
expenses totaling $52,000 primarily related to the launch of REPEL-CV in the
United States. The increase for the nine month period is primarily attributable
to increases totaling $203,000 in compensation-related expenses, recruiting
fees, travel expenses, training expenses and samples expense primarily related
to the launch of REPEL-CV in the United States, partially offset by a decrease
in consulting expenses of $92,000. We anticipate future increases in sales and
marketing expenses as we increase penetration into the United States market and
continue to pursue broader international distribution.
16
Interest
income totaled $1,000 and $20,000 for the three and nine months ended September
30, 2009, respectively, compared to $1,000 and $20,000 for the comparable prior
year periods.
Interest
expense totaled $1,000 and $2,000 for the three and nine months ended September
30, 2009, respectively, compared to $1,000 and $2,000 for the comparable prior
year periods.
We
realized other income from the reversal of liabilities of $5,000 for the nine
months ended September 30, 2008; there were no comparable transactions for the
nine months ended September 30, 2009. The reversal of liabilities related to
trade and other payables which had been due and payable for at least six years
as of the date of reversal. The reversals were made due to the passage of time
and our belief, at the time of the respective reversals, that the underlying
claims would be barred by applicable statutes of limitations if recovery actions
were asserted. We do not anticipate reversing any of the remaining liabilities
in the foreseeable future.
Our net
loss was $1,074,000 and $3,238,000 for the three and nine months ended September
30, 2009, respectively, compared to $1,037,000 and $3,526,000 for the comparable
prior year periods, an increase of 3.6% or $37,000 for the three month period
and a decrease of 8.2% or $288,000 for the nine month period. The changes are
primarily attributable to the factors mentioned above. We expect to incur losses
for the foreseeable future.
Liquidity
and Capital Resources
At
September 30, 2009, we had cash and cash equivalents of $960,000, compared to
$3,683,000 at September 30, 2008.
At
September 30, 2009, we had working capital of $948,000, compared to $3,664,000
at September 30, 2008.
Net cash
used in operating activities was $2,936,000 for the nine months ended September
30, 2009, compared to $3,200,000 for the comparable prior year
period. Net cash used in operating activities for the current year
period was primarily comprised of a net loss of $3,238,000, decreases totaling
$108,000 in accounts payable and accrued expenses, partially offset by the
impact of $412,000 in non-cash charges, primarily for stock-based compensation
and depreciation expenses. Net cash used in operating activities for the prior
year period was primarily comprised of a net loss of $3,526,000, increases
totaling $160,000 in inventory and accounts receivable, decreases totaling
$169,000 in accounts payable and accrued expenses and a decrease of $23,000 in
prepaid expenses, partially offset by the impact of $692,000 in stock-based
compensation and other non-cash expenses.
Net cash
provided from financing activities for the nine months ended September 30, 2009
was $952,000 compared to $3,892,000 for the prior year period. The current year
amount was comprised of $903,000 from the sale of common stock and warrants and
$39,000 of net proceeds from a insurance note payable for the financing of our
product liability and directors and officers insurance premiums and $10,000 from
the exercise of stock options; the prior year amount was comprised of $3,684,000
of net proceeds from the sale of common stock and warrants, a similar insurance
note payable of $60,000 and $148,000 from the from the exercise of stock
options. (See Note G of Notes to Condensed Financial Statements.)
The
balance of cash and cash equivalents as of September 30, 2009 may not be
sufficient to meet our anticipated cash requirements through 2009, based on our
present plan of operation. As a result, we are seeking to raise
additional capital to meet our short-term requirements. Insufficient
funds has required us to delay, scale back or eliminate some of our operations
including research and development programs and certain commercialization
activities and may require us to license or sell to third parties certain
products or technologies that we would otherwise seek to commercialize
independently. We do not have sufficient cash resources, either on hand or
anticipated from operations, to fund the additional clinical studies required
for the REPEL-CV adult indication. Therefore, we are pursuing strategic and
other arrangements. No assurance can be given that additional financing or
strategic arrangements will be available on acceptable terms or at all. Under
these circumstances there are substantial doubts about our ability to continue
as a going concern. The report of our independent registered public accounting
firm contained in our 2008 Annual Report on Form 10-K, also contains an
explanatory paragraph referring to an uncertainty concerning our ability to
continue as a going concern.
17
As of
September 30, 2009, we had employment agreements with five individuals that
expire as follows: two in September 2010, one in March 2010, one in May 2010 and
one in October 2012. Pursuant to these agreements, our commitment regarding cash
severance benefits aggregates $675,000 at September 30, 2009. We have also
entered into change of control agreements with our three executive officers
pursuant to which, upon the occurrence of events described therein, we could
become obligated, in addition to certain other benefits, to pay either 150% or
200%, depending on the executive, of such executives’ annual base salaries plus
the greater of the prior year’s cash bonus or current year’s target
bonus. Any severance payments under the employment agreements would
offset amounts required to be paid under the change of control
agreements.
Item
4T. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our Chief
Executive Officer who is also our Chief Financial Officer, after
evaluating the effectiveness of our "disclosure controls
and procedures" (as defined in the Securities Exchange Act of 1934 Rule
13a-15(e); collectively, “Disclosure Controls”) as of the end of the period
covered by this quarterly report (the "Evaluation Date")
has concluded that as of the Evaluation Date, our Disclosure Controls were
effective to provide reasonable assurance that information required to be
disclosed in our reports filed or submitted under the Securities Exchange Act of
1934 is recorded, processed, summarized and reported within the time periods
specified by the SEC, and that material information relating to our company and
any consolidated subsidiaries is made known to management, including our Chief
Executive Officer and Chief Financial Officer, particularly during the period
when our periodic reports are being prepared to allow timely decisions regarding
required disclosure.
Changes
in Internal Control Over Financial Reporting
In
connection with the evaluation referred to in the
foregoing paragraph, we have identified no change in our internal
control over financial reporting that occurred during the quarter ended
September 30, 2009, that has materially affected, or is reasonably
likely to materially affect, our internal control over financial
reporting.
Inherent
Limitations on Effectiveness of Controls
Our
management, including the chief executive officer and chief financial officer
who are the same person, does not expect that our Disclosure Controls or our
internal control over financial reporting will prevent or detect all error and
all fraud. A control system, no matter how well designed and operated, can
provide only reasonable, not absolute, assurance that the control system’s
objectives will be met. The design of a control system must reflect the fact
that there are resource constraints, and the benefits of controls must be
considered relative to their costs. Further, because of the inherent limitations
in all control systems, no evaluation of controls can provide absolute assurance
that misstatements due to error or fraud will not occur or that all control
issues and instances of fraud, if any, within the company have been detected.
These inherent limitations include the realities that judgments in
decision-making can be faulty and that breakdowns can occur because of simple
error or mistake. Controls can also be circumvented by the individual acts of
some persons, by collusion of two or more people, or by management override of
the controls. The design of any system of controls is based in part on certain
assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential
future conditions. Projections of any evaluation of controls effectiveness to
future periods are subject to risks. Over time, controls may become inadequate
because of changes in conditions or deterioration in the degree of compliance
with policies or procedures.
18
PART
II - OTHER INFORMATION
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds
|
Our non-employee directors are entitled
to cash compensation for their service as directors, payable
quarterly. In accordance with interim cash conserving measures
previously adopted by our Board of Directors that stipulates that such quarterly
cash compensation would be paid 35% in cash and the balance in shares, effective
October 1, 2009 we granted an aggregate of 62,500 shares of common stock to our
non-employee directors in full satisfaction of $16,250 in aggregate board fees
otherwise payable at that time in cash to such directors and attributable to the
third quarter of 2009. The shares were valued at fair market value on
September 30, the last trading day of the quarter, as reflected in the closing
price on that day.
The transactions were not registered under the Securities Act of 1933, in
reliance on the exemption provided by Section 4(2)
thereunder.
Item
6.
|
Exhibits
|
|
10.1
|
Form
of Subscription Agreement for investors in the September 2009 unit
placement (including form of investor warrant), pursuant to which an
aggregate of 5,000,000 units were
sold.
|
|
10.2
|
Agency
Agreement dated September 30, 2009 between SyntheMed, Inc. and Clubb
Capital Limited, as placement
agent.
|
|
10.3
|
Broker
warrant issued for 350,000 shares to the placement agent in connection
with the September 2009 placement.
|
|
31.1
|
Certification
of Principal Executive Officer and Principal Financial Officer Pursuant to
Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Principal Executive Officer and Principal Financial Officer Pursuant to
18 U.S.C.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
SIGNATURE
In accordance with 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.
SyntheMed,
Inc.
|
|||
By:
|
/s/ Robert P. Hickey
|
||
Robert
P. Hickey
|
|||
President,
CEO and CFO
|
|||
Date: November
6, 2009
|
19
EXHIBIT
INDEX
ITEM
|
10.1
|
Form
of Subscription Agreement for investors in the September 2009 unit
placement (including form of investor warrant), pursuant to which an
aggregate of 5,000,000 units were
sold.
|
|
10.2
|
Agency
Agreement dated September 30, 2009 between SyntheMed, Inc. and Clubb
Capital Limited, as placement
agent.
|
|
10.3
|
Broker
warrant issued for 350,000 shares to the placement agent in connection
with the September 2009 placement.
|
|
31.1
|
Certification
of Principal Executive Officer and Principal Financial Officer Pursuant to
Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Principal Executive Officer and Principal Financial Officer Pursuant to
18 U.S.C.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
20