ASENSUS SURGICAL, INC. - Quarter Report: 2008 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC. 20549
FORM
10-Q
(Mark
One)
x
|
Quarterly
Report Pursuant to Section 13 or 15 (d) of the Securities Exchange
Act of
1934 for the Quarterly Period ended March
31, 2008
|
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 0-19437
SAFESTITCH
MEDICAL, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
11-2962080
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
employer identification no.)
|
4400
Biscayne Blvd., Suite 670, Miami, Florida
|
33137
|
|
(Address
of principal executive offices)
|
(Zip
code)
|
Registrant’s
telephone number, including area code: (305)
575-6000
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
x No
o
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 Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes
o No
x
16,093,016
shares of the Company’s common stock, par value $0.001 per share, were
outstanding as of May 12, 2008.
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
TABLE
OF CONTENTS FOR FORM 10-Q
PART
I. FINANCIAL INFORMATION
|
|
|
|
|
|
ITEM 1.
|
FINANCIAL
STATEMENTS
|
3
|
|
|
|
Condensed
Consolidated Balance Sheets as of March 31, 2008 (unaudited) and
December
31, 2007
|
3
|
|
Condensed
Consolidated Statements of Operations for the Three Months ended
March 31,
2008 and 2007, and for the period from September 15, 2005 (inception)
to
March 31, 2008 (unaudited)
|
4
|
|
Condensed
Consolidated Statements of Stockholders’ Equity for the period from
September 15, 2005 (inception) through March 31, 2008
|
5
|
|
Condensed
Consolidated Statements of Cash Flows for the Three Months ended
March 31,
2008 and 2007, and for the period from September 15, 2005 (inception)
to
March 31, 2008 (unaudited)
|
6
|
|
Notes
to unaudited condensed consolidated financial statements
|
7
|
|
ITEM 2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
15
|
ITEM 3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
|
19
|
ITEM 4T.
|
CONTROLS
AND PROCEDURES
|
19
|
PART
II. OTHER INFORMATION
|
||
|
|
|
ITEM 1.
|
LEGAL
PROCEEDINGS
|
20
|
ITEM 1A.
|
RISK
FACTORS
|
20
|
ITEM 2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
20
|
ITEM 3.
|
DEFAULTS
UPON SENIOR SECURITIES
|
20
|
ITEM 4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
20
|
ITEM 5.
|
OTHER
INFORMATION
|
20
|
ITEM 6.
|
EXHIBITS
|
20
|
SIGNATURES
|
21
|
2
(A
Developmental Stage Company)
(in
000s,
except share and per share data)
March 31,
|
December 31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
658
|
$
|
631
|
|||
Prepaid
expenses
|
102
|
99
|
|||||
Total
Current Assets
|
760
|
730
|
|||||
FIXED
ASSETS
|
|||||||
Property
and equipment, net
|
186
|
196
|
|||||
OTHER
ASSETS
|
|||||||
Security
deposits
|
56
|
56
|
|||||
Deferred
financing costs, net
|
1,489
|
1,702
|
|||||
Total
Other Assets
|
1,545
|
1,758
|
|||||
LONG-TERM
INVESTMENT, net of valuation adjustment of $1,754
|
-
|
-
|
|||||
TOTAL
ASSETS
|
$
|
2,491
|
$
|
2,684
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable and accrued liabilities
|
$
|
365
|
$
|
253
|
|||
Total
Current Liabilities
|
365
|
253
|
|||||
Stockholder
loans
|
1,010
|
10
|
|||||
Commitments
and contingencies (Note 9)
|
|||||||
STOCKHOLDERS’
EQUITY
|
|||||||
Preferred
Stock, $.01 par value per share, 25,000,000 shares authorized,
no shares
issued and outstanding
|
-
|
-
|
|||||
Common
Stock, $.001 par value per share, 225,000,000 shares authorized,16,093,016
shares issued and outstanding
|
16
|
16
|
|||||
Additional
Paid-in Capital
|
6,721
|
6,582
|
|||||
Deficit
accumulated during the development stage
|
(5,621
|
)
|
(4,177
|
)
|
|||
Total
Stockholders’ Equity
|
1,116
|
2,421
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
2,491
|
$
|
2,684
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
3
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
(in
000s,
except share and per share amounts)
Three Months Ended
March 31,
|
September 15,
2005
(Inception) to
|
|||||||||
2008
|
2007
|
March 31, 2008
|
||||||||
REVENUES
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
COSTS
AND EXPENSES
|
||||||||||
Research and
development
|
814
|
366
|
3,719
|
|||||||
General
and administrative
|
416
|
38
|
1,437
|
|||||||
Total
Costs and Expenses
|
1,230
|
404
|
5,156
|
|||||||
LOSS
FROM OPERATIONS
|
(1,230
|
)
|
(404
|
)
|
(5,156
|
)
|
||||
INTEREST
INCOME
|
5
|
4
|
58
|
|||||||
AMORTIZATION
OF FINANCE COSTS
|
(213
|
)
|
-
|
(496
|
)
|
|||||
INTEREST
EXPENSE
|
(6
|
)
|
-
|
(27
|
)
|
|||||
LOSS
BEFORE TAX
|
(1,444
|
)
|
(400
|
)
|
(5,621
|
)
|
||||
PROVISION
FOR INCOME TAX
|
-
|
-
|
-
|
|||||||
NET
LOSS
|
$
|
(1,444
|
)
|
$
|
(400
|
)
|
$
|
(5,621
|
)
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND DILUTED
|
16,093,016
|
11,256,369
|
||||||||
NET
LOSS PER BASIC AND DILUTED SHARE
|
$
|
(0.09
|
)
|
$
|
(0.04
|
)
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
4
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE PERIOD SEPTEMBER 15, 2005 (INCEPTION) THROUGH MARCH 31,
2008
(in
000s)
Preferred Stock
|
Common Stock
|
Additional
Paid-in
|
Deficit
Accumulated
During the
Development
|
|||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stage
|
Total
|
||||||||||||||||
Inception –
September 15, 2005
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||||
Capital
contributed
|
-
|
-
|
-
|
-
|
1
|
-
|
1
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(76
|
)
|
(76
|
)
|
|||||||||||||
Balance
at December 31, 2005
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
1
|
$
|
(76
|
)
|
$
|
(75
|
)
|
||||||||
Capital
contributed
|
-
|
-
|
11,256
|
11
|
1,493
|
-
|
1,504
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(1,060
|
)
|
(1,060
|
)
|
|||||||||||||
Balance
at December 31, 2006
|
-
|
$
|
-
|
11,256
|
$
|
11
|
$
|
1,494
|
$
|
(1,136
|
)
|
$
|
369
|
|||||||||
|
||||||||||||||||||||||
Exercise
of options (CTS)-September 23, 2007 at $0.79 per share
|
-
|
-
|
42
|
-
|
35
|
-
|
35
|
|||||||||||||||
Stock-based
compensation-September 4, 2007
|
-
|
-
|
-
|
-
|
77
|
-
|
77
|
|||||||||||||||
Issuance
of shares in recapitalization - September 4, 2007 at $0.64 per
share
|
-
|
-
|
4,795
|
5
|
3,078
|
-
|
3,083
|
|||||||||||||||
SafeStitch
expenses associated with recapitalization
|
-
|
-
|
-
|
-
|
(156
|
)
|
-
|
(156
|
)
|
|||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
-
|
65
|
-
|
65
|
|||||||||||||||
Warrants
issued in connection with credit facility-September 4, 2007 at $2.46
per
share
|
-
|
-
|
-
|
-
|
1,985
|
-
|
1,985
|
|||||||||||||||
Rule
16 payment received
|
-
|
-
|
-
|
-
|
4
|
-
|
4
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(3,041
|
)
|
(3,041
|
)
|
|||||||||||||
Balance
at December 31, 2007
|
-
|
$
|
-
|
16,093
|
$
|
16
|
$
|
6,582
|
$
|
(4,177
|
)
|
$
|
2,421
|
|||||||||
Stock-based
compensation
|
-
|
-
|
-
|
-
|
139
|
-
|
139
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(1,444
|
)
|
(1,444
|
)
|
|||||||||||||
Balance
at March 31, 2008 - Unaudited
|
-
|
$
|
-
|
16,093
|
$
|
16
|
$
|
6,721
|
$
|
(5,621
|
)
|
$
|
1,116
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
5
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
(in
000s)
Three
Months Ended
March
31,
|
September
15,
2005
(Inception)
to
March
|
|||||||||
2008
|
2007
|
31,
2008
|
||||||||
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(1,444
|
)
|
$
|
(400
|
)
|
$
|
(5,621
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Amortization
of deferred finance costs
|
213
|
-
|
496
|
|||||||
Stock-based
compensation expense
|
139
|
-
|
281
|
|||||||
Depreciation
and amortization
|
13
|
-
|
17
|
|||||||
(Increase)
in other current assets
|
(3
|
)
|
-
|
(82
|
)
|
|||||
(Increase)
in other assets
|
-
|
-
|
(56
|
)
|
||||||
Increase
(Decrease) in accounts payable and accrued liabilities
|
112
|
30
|
80
|
|||||||
NET
CASH USED IN OPERATING ACTIVITIES
|
(970
|
)
|
(370
|
)
|
(4,885
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Purchase
of equipment
|
(3
|
)
|
-
|
(203
|
)
|
|||||
Payment
received under Rule 16b
|
-
|
-
|
4
|
|||||||
NET
CASH USED IN INVESTING ACTIVITIES
|
(3
|
)
|
-
|
(199
|
)
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||||
Net
cash provided in connection with the acquisition of SafeStitch
LLC
|
-
|
-
|
3,192
|
|||||||
Capital
contributions
|
-
|
-
|
1,505
|
|||||||
Stockholder
loans
|
1,000
|
-
|
1,010
|
|||||||
Exercise
of options
|
-
|
-
|
35
|
|||||||
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
1,000
|
-
|
5,742
|
|||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
27
|
(370
|
)
|
658
|
||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
631
|
546
|
-
|
|||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
658
|
$
|
176
|
$
|
658
|
||||
Supplemental
disclosure of non cash activities:
|
||||||||||
Stockholder
loans contributed to capital
|
$
|
74
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
6
SAFESTITCH
Medical, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – BASIS OF PRESENTATION AND LIQUIDITY
The
condensed consolidated balance sheet as of December 31, 2007, which has
been derived from audited financial statements, and the unaudited condensed
consolidated interim financial statements of SafeStitch Medical, Inc.
(“SafeStitch” or the “Company”) have been prepared in accordance with accounting
principles generally accepted in the United States for interim financial
information and the instructions to the quarterly report on Form 10-Q and
Rule 10-01 of Regulation S-X. Accordingly, they do not include all of
the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management,
all
adjustments (consisting of normal recurring accruals) considered necessary
for a
fair presentation have been included. These condensed financial statements
should be read in conjunction with the audited consolidated financial statements
and notes thereto for the year ended December 31, 2007 included in the Company’s
annual report on form 10-KSB, as amended, filed with the Securities Exchange
Commission on April 24, 2008.
SafeStitch
is a developmental stage medical device company focused on the development
of
medical devices that manipulate tissues for obesity, gastroesophageal reflux
disease (“GERD”), Barrett’s Esophagus, esophageal obstructions, upper
gastrointestinal bleeding, hernia formation and other intraperitoneal
abnormalities through endoscopic and minimally invasive surgery.
Cellular
Technical Services Company, Inc. (“Cellular”), a non-operating public company,
was incorporated in 1988 as NCS Ventures Corp. under the laws of the State
of
Delaware. On July 25, 2007 Cellular entered into a Share Transfer, Exchange
and
Contribution Agreement (the “Share Exchange”) with SafeStitch LLC, a limited
liability company formed in Virginia on September 15, 2005. On September 4,
2007, Cellular acquired all of the members’ equity of SafeStitch LLC in exchange
for 11,256,369 shares of its common stock, which represented a majority of
outstanding shares after the date of acquisition. For accounting purposes,
the
acquisition has been treated as a recapitalization of SafeStitch LLC, with
SafeStitch LLC as the acquirer (reverse acquisition). The historical financial
statements prior to September 4, 2007 are those of SafeStitch LLC, which began
operations on September 15, 2005. The accompanying financial statements give
retroactive effect to the recapitalization as if it had occurred on September
15, 2005 (inception). Effective January 8, 2008, Cellular changed its name
to
SafeStitch Medical, Inc. and increased the aggregate number of shares of capital
stock that may be issued from 35,000,000 to 250,000,000, comprised of
225,000,000 shares of common stock, par value $0.001 per share, and 25,000,000
shares of preferred stock, par value $0.01 per share.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. For the period from September 15, 2005
(inception) through March 31, 2008, the Company has accumulated a
deficit of $5,621,000 and has not generated positive cash flows from operations.
The Company has been dependent upon equity financing and loans from stockholders
to meet its obligations and sustain operations. The Company’s efforts have been
principally devoted to developing its technologies and commercializing its
products. Based upon its current cash position; its budget for business
operations through December 31, 2008; its $4.0 million line of credit from
The Frost Group LLC and the Company’s President and CEO, Jeffrey G. Spragens,
and by monitoring its discretionary expenditures, management believes that
the
Company will be able to fund operations without revenues or additional financing
only through December 31, 2008. Although the Company plans to secure
additional funds through the issuance of equity and/or debt, no assurance can
be
given that additional financing will be available to the Company on acceptable
terms, or at all. The Company’s ability to continue as a going concern is
ultimately dependent upon achieving profitable operations and generating
sufficient cash flows from operations to meet future obligations.
NOTE
2
– SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Consolidation.
The
condensed consolidated financial statements include the accounts of the Company
and its wholly-owned subsidiaries Isis Tele-Communications, Inc., which has
no
current operations, and SafeStitch LLC. All inter-company accounts and
transactions have been eliminated in consolidation.
Cash
and cash equivalents.
We
consider all highly liquid investments purchased with an original maturity
of
three months or less to be cash equivalents.
7
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Property
and equipment.
Property
and equipment are carried at cost less accumulated depreciation. Major additions
and improvements are capitalized, while maintenance and repairs that do not
extend the lives of assets are expensed. Gain or loss, if any, on the
disposition of fixed assets is recognized currently in operations. Depreciation
is calculated primarily on a straight-line basis over estimated useful lives
of
the assets.
Research
and development.
Substantially all of the Company’s research and development activities are
currently outsourced. Research and development costs principally represent
costs
associated with conducting clinical trials and manufacturing product prototypes.
All research and development costs are charged to expense as incurred.
Patent
costs.
Costs
incurred in connection with acquiring patent rights and the protection of
proprietary technologies are charged to expense as incurred.
Use
of estimates.
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions, such as useful lives of property and equipment,
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 expenses during the reporting period. Actual results
could differ from those estimates.
Stock-based
compensation.
The
Company follows Statement of Financial Accounting Standards (“SFAS”) No. 123R,
“Share
Based Payment”
(“SFAS
123R”), which requires all share-based payments, including grants of stock
options, to be recognized in the income statement as an operating expense,
based
on their fair values. All stock-based compensation is included in general and
administrative expenses.
Fair
value of financial instruments.
The
Company follows SFAS No. 157, “Fair
Value Measurements”
(“SFAS
157”), which defines fair value, establishes a framework for measuring fair
value and requires additional disclosures about fair value measurements. The
carrying amounts of cash, accounts payable, and accrued expenses approximate
fair value based on their short-term maturity.
Long-Term
investments.
In
accordance with SFAS No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets,”
the
Company reviews the carrying values of its long-lived assets for possible
impairment whenever events or changes in circumstances indicate that the
carrying amounts of the assets may not be recoverable. Any long-lived assets
held for disposal are reported at the lower of their carrying amounts or fair
value less costs to sell.
Income
taxes.
The
Company follows the liability method of accounting for income taxes, as set
forth in SFAS No. 109, “Accounting
for Income Taxes”
(“SFAS
109”). SFAS 109 prescribes an asset and liability approach, which requires the
recognition of deferred tax liabilities and assets for the expected future
tax
consequences of temporary differences between the carrying amounts and the
tax
bases of the assets and liabilities. The Company’s policy is to record a
valuation allowance against deferred tax assets, when the deferred tax asset
is
not recoverable. The Company considers estimated future taxable income or loss
and other available evidence when assessing the need for its deferred tax
valuation allowance.
Comprehensive
income (loss).
SFAS No.
130, “Reporting
Comprehensive Income (Loss),”
requires
companies to classify items of other comprehensive income (loss) in a financial
statement. Comprehensive income (loss) is defined as the change in equity of
a
business enterprise during a period from transactions and other events and
circumstances from non-owner sources. The Company’s comprehensive net loss is
equal to its net loss for all periods presented.
8
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
3 – PROPERTY AND EQUIPMENT
Machinery
and equipment consist of the following:
March
31, 2008
|
Estimated
Useful lives
|
||||||
Machinery
and equipment
|
$
|
162,000
|
5
years
|
||||
Furniture
and fixtures
|
41,000
|
5
years
|
|||||
Accumulated
depreciation and amortization
|
(17,000
|
)
|
|||||
Property
and equipment, net
|
$
|
186,000
|
Depreciation
of fixed assets utilized in research and development activities is included
in
research and development expense. All other depreciation is included in general
and administrative expense. Depreciation and amortization expense was $13,000
for the three months ended March 31, 2008. There was no depreciation expense
in
the corresponding 2007 period.
NOTE
4 –
LONG-TERM INVESTMENT
In
November 1999, Cellular invested in a one-year, $1.0 million 10% convertible
note of KSI, Inc. (“KSI”) and also received warrants to purchase KSI common
stock. All of the outstanding stock of KSI was acquired by TruePosition, Inc.,
a
majority owned subsidiary of Liberty Media Corporation, (“Liberty Media”) in
August 2000. Prior to the acquisition, the convertible note was exchanged for
KSI common stock. The Company exercised the KSI warrants and purchased
additional KSI common stock for approximately $754,000. Cellular’s investment in
KSI common stock was exchanged for TruePosition common stock on the date of
the
acquisition. The Company currently holds 191,118 shares of TruePosition common
stock, and accounts for the investment in TruePosition using the cost method.
In
December 2002, Cellular received certain valuation information from
TruePosition, indicating a range of values for TruePosition. Based upon its
review of available information and communications with Liberty Media, Cellular
concluded there had been an other-than-temporary decline in estimated fair
value
of its investment, and reduced the recorded carrying value of this investment
from its cost basis of $1,754,000 to zero, representing its best estimate of
the
then-current fair value of Cellular’s investment in the net equity of
TruePosition. TruePosition’s operations have required significant infusions of
cash by Liberty Media to date, and have not generated significant revenues.
The
Company’s investment in TruePosition common stock has been diluted by these
advances, which were converted to preferred stock in late 2002. In August 2007,
the Company and Cellular were informed that Liberty TP Acquisition, Inc., which
held an aggregate of no less than 90% of TruePosition’s outstanding capital
stock, was being merged into TruePosition. Pursuant to the terms of the merger,
TruePosition’s minority stockholders, including the Company, were entitled to
receive $3.5116 in cash in exchange for each share held. This merger is the
subject of an appraisal action and securities litigation to which the Company
is
a party (see Note 9). It is possible that the Company may receive proceeds
from
the merger, the litigation or other disposition of this investment, but no
such
amount can be estimated at this time.
NOTE
5 –
STOCK-BASED COMPENSATION
The
Company’s 1996 Stock Option Plan (the “1996 Plan”) authorized the grant of both
incentive (“ISO”) and non-qualified stock options up to a maximum of 335,000
shares of the Company’s common stock to employees (including officers and
directors who are employees) of and consultants to SafeStitch. The exercise
price, term and vesting provision of each option grant is fixed by the
compensation committee of the Board of Directors (the “Compensation Committee”)
with the provision that the exercise price of an ISO may not be less than the
fair market value of the Company’s common stock on the date of grant, and the
term of an ISO may not exceed ten years. The Company has not granted any options
under the 1996 Plan since December 31, 2005. The 1996 Plan has expired and
no
new options may be granted under the 1996 Plan.
As
of the
date of the Share Exchange, all options issued to former officers and directors
under the 1996 Plan with exercise prices in excess of the then-current share
price of the Company’s common stock were cancelled in exchange for the issuance
of 2,000 shares of the Company’s common stock per person, for an aggregate
issuance of 6,000 shares of the Company’s common stock. The Company recognized
compensation expense of $77,000 on the date of the Share Exchange for the fair
value of the 6,000 shares issued.
9
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On
November 13, 2007, the Board of Directors and a majority of the stockholders
of
the Company approved the SafeStitch Medical, Inc. 2007 Incentive Compensation
Plan (the “2007 Plan”). Under the 2007 Plan, which is administered by the
Compensation Committee, the Company is allowed to grant stock options, stock
appreciation rights, restricted stock and/or deferred stock to employees,
officers, directors, consultants and vendors up to an aggregate of 2,000,000
shares of the Company’s common stock, which are fully reserved for future
issuance. The exercise price of stock options or stock appreciation rights
may
not be less than the fair market value of Company’s shares at the date of grant
and, within any 12 month period, no person can receive stock options or stock
appreciation rights for more than one million shares. Additionally, no stock
options or stock appreciation rights granted under the plan may have a term
exceeding ten years.
The
Company granted 148,500 options under the 2007 Plan during the three months
ended March 31, 2008. The exercise prices of the options granted ranged from
$3.00 to $3.10 per share. The Company determined the estimated aggregate fair
value of these options on the grant dates to be $300,000, and stock option
compensation expense related to these grants was $125,000 for the three months
ended March 31, 2008. Total stock-based compensation recorded for the three
months ended March 31, 2008 was $139,000. All stock-based compensation is
included in general and administrative expense. The fair values of options
granted are estimated on the date of their grant using the Black-Scholes option
pricing model based on the assumptions included in the table below. The fair
value of the Company’s stock option awards is expensed over the vesting life of
the underlying stock options using the graded vesting method, with each tranche
of vesting options valued separately. Expected volatility is based on the
historical volatility of the Company’s stock. Due to the short period of time
the Company has been publicly traded since the Share Exchange, the historical
volatilities of similar publicly traded entities are reviewed to validate the
Company’s expected volatility assumption. The risk-free interest rate for
periods within the contractual life of the stock option award is based on the
yield of US Treasury bonds on the date the stock option award is granted with
a
maturity equal to the expected term of the stock option award granted. The
expected life of stock option awards granted is based upon the “simplified”
method for “plain vanilla” options contained in SEC Staff Accounting Bulletin
No. 107, as amended by SEC Staff Accounting Bulletin No. 110. Forfeiture rates
are based on management’s estimates. During the three months ended March 31,
2007, the Company granted no stock option awards. The fair value of each option
granted during the three months ended March 31, 2008 was estimated using the
following assumptions.
Expected
volatility
|
88.31%
- 94.46%
|
Expected
dividend yield
|
0.00%
|
Risk-free
interest rate
|
1.96% –
2.61%
|
Expected
life
|
3.5 –
5.5 years
|
Forfeiture
rate
|
2.50%
|
The
following summarizes the Company’s stock option activity for the three months
ended March 31, 2008:
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding at December 31, 2007
|
88,667
|
$
|
2.60
|
9.96
|
|||||||||
Granted
|
148,500
|
$
|
3.06
|
6.97
|
|||||||||
Exercised
|
-
|
-
|
-
|
||||||||||
Canceled
or expired
|
-
|
-
|
-
|
||||||||||
Outstanding
at March 31, 2008
|
237,167
|
$
|
2.89
|
7.90
|
$
|
35,467
|
|||||||
Exercisable
at March 31, 2008
|
87,667
|
$
|
2.97
|
7.59
|
$
|
8,867
|
|||||||
Vested
and expected to vest at March 31, 2008
|
232,107
|
$
|
2.89
|
7.92
|
$
|
35,467
|
10
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Of
the
148,500 options granted during the first quarter of the Company’s 2008 fiscal
year, 44% of such options were vested as of March 31, 2008. A summary of the
status of the Company’s non-vested options and changes during the three months
ended March 31, 2008 is presented below.
Stock Options
|
Weighted Average Grant
Date Fair Value
|
||||||
Non-Vested at December 31,
2007
|
66,500
|
$
|
2.21
|
||||
Options
Granted
|
148,500
|
2.02
|
|||||
Options
Vested
|
(65,500
|
)
|
1.88
|
||||
Non-Vested
at March 31, 2008
|
149,500
|
$
|
2.16
|
At
March
31, 2008, there was $283,000 of total unrecognized compensation cost related
to
non-vested employee and director share-based compensation arrangements granted
under the 2007 Plan. That cost is expected to be recognized over a
weighted-average period of 1.35 years.
No
options were exercised during the three months ended March 31, 2008.
NOTE
6 –
CREDIT FACILITY
In
connection with the acquisition of SafeStitch LLC, the Company entered into
a
Note and Security Agreement (the “Credit Facility”) with both the Frost Group,
LLC (the “Frost Group”) and Jeffrey G. Spragens, the Company’s Chief Executive
Officer and President and a director. The Frost Group is a Florida limited
liability company whose members include Frost Gamma Investments Trust, a trust
controlled by Dr. Phillip Frost, the largest beneficial holder of the issued
and
outstanding shares of the Company’s common stock, Dr. Jane H. Hsiao, the
Company’s Chairman of the Board, and Steven D. Rubin, a director. The Credit
Facility provides for $4.0 million in total available borrowings, consisting
of
$3.9 million from The Frost Group and $100,000 from Mr. Spragens. The Credit
Facility has a term of 28 months, which expires in December 2009. Outstanding
borrowings under the Credit Facility bear interest at a 10% annual rate.
The
Company granted a security interest in all present and subsequently acquired
collateral in order to secure prompt, full and complete payment of the amounts
due under the Credit Facility. The collateral includes all assets of the
Company, inclusive of intellectual property (patents, patent rights, trademarks,
service marks, etc.).
In
connection with the Credit Facility, the Company granted warrants to purchase
an
aggregate of 805,521 shares of its common stock to The Frost Group and Mr.
Spragens. The fair value of the warrants was determined to be $1,985,000 on
the
grant date based on the Black-Scholes valuation model using the following
assumptions: expected volatility of 82%, dividend yield of 0%, risk-free
interest rate of 4.88% and expected life of 10 years. The fair value of the
warrants was recorded as deferred financing costs and will be amortized over
the
life of the Credit Facility. The Company recorded amortization expense of
$213,000 related to these deferred financing costs for the three months ended
March 31, 2008.
As
of
March 31, 2008, $1.0 million was outstanding under the Credit Facility, and
the
Company recognized $6,000 of interest expense related to the outstanding
borrowings during the three months ended March 31, 2008.
NOTE
7 –
CAPITAL TRANSACTIONS:
As
described in Note 1, on September 4, 2007, the Company acquired all of the
members’ equity of SafeStitch LLC in exchange for the issuance of 11,256,369
shares of its common stock. For accounting purposes the transaction has been
treated as a recapitalization of SafeStitch LLC whereby all membership interests
of SafeStitch LLC were eliminated, ordinary shares received in exchange were
recorded at par value and the difference between membership interest and the
value of the ordinary shares received was recorded as additional paid-in capital
to effect the transaction as of the beginning of the year. Additionally, as
of
the date of the transaction, net assets of Cellular, its ordinary shares and
additional paid-in capital were recorded to reflect the transaction. SafeStitch
LLC incurred $156,000 of transaction expenses, which were recorded as a
reduction of additional paid-in capital.
11
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
8 – BASIC AND DILUTED NET LOSS PER SHARE:
Basic
net
loss per common share is computed by dividing net loss by the weighted average
number of common shares outstanding during the period. Diluted net loss per
common share is computed giving effect to all dilutive potential common shares
that were outstanding during the period. Diluted potential common shares consist
of incremental shares issuable upon exercise of stock options and warrants.
In
computing diluted net loss per share for the three months ended March 31, 2008
and 2007, no adjustment has been made to the weighted average outstanding common
shares as the assumed exercise of outstanding options and warrants is
anti-dilutive.
Potential
common shares not included in calculating diluted net loss per share are as
follows:
March 31, 2008
|
March 31, 2007
|
||||||
Stock
options
|
237,167
|
173,000
|
|||||
Stock
warrants
|
805,521
|
-
|
|||||
Total
|
1,042,688
|
173,000
|
NOTE
9 –
COMMITMENTS AND CONTINGENCIES
The
Company is obligated under various operating lease agreements for office space.
Generally, the lease agreements require the payment of base rent plus
escalations for increases in building operating costs and real estate taxes.
Rental expense under operating leases amounted to $48,000 and $3,000 for the
three months ended March 31, 2008 and 2007, respectively.
The
Company is presently a plaintiff in a securities fraud and appraisal action
in
respect of its ownership of 191,118 shares of common stock of TruePosition,
Inc., a Delaware corporation (“TruePosition”), which was filed November 13, 2007
in the United States District Court for the District of Connecticut. SafeStitch
and other plaintiffs seek damages and other relief totaling $80 million. In
August 2007, the Company was informed that Liberty TP Acquisition, Inc., which
held an aggregate of no less than 90% of TruePosition’s outstanding capital
stock, was being merged into TruePosition. Pursuant to the terms of the merger,
TruePosition’s minority stockholders, including the Company, became entitled to
receive $3.5116 in cash in exchange for each share held, which the Company
and
certain other minority stockholders considered insufficient compensation. The
Company and other minority stockholders brought forth the aforementioned
securities fraud and appraisal action, and on August 10, 2007, the Company
entered into a joint shareholder litigation governance and funding agreement
(the “Funding Agreement”) with such other stockholders. Under the Funding
Agreement, the Company agrees to fund a portion of the litigation expenses
in
connection with the appraisal and securities fraud action. The Company has
contributed approximately $45,000 to date, and management anticipates that
the
Company will be called upon to fund additional amounts during the 2008 fiscal
year. The Company may elect to terminate its participation in the Funding
Agreement, whereby the Company would no longer be required to contribute funds;
however, the Company would lose all rights under the Funding Agreement,
including access to any additional work-product created after the date of
termination. Additionally, the Company’s portion of any proceeds from a
favorable disposition of the litigation may be reduced if the Company terminates
its participation. The outcome of this litigation is not now known, nor can
it
be reasonably predicted at this time.
NOTE
10 –
NEW ACCOUNTING PRONOUNCEMENTS
Effective
January 1, 2008, the Company adopted SFAS No. 157, “Fair
Value Measurements”
(“SFAS
157”), which defines fair value, establishes a framework for measuring fair
value and requires additional disclosures about fair value measurements. In
February 2008, the FASB delayed the effective date of SFAS 157 for one year
for
all nonfinancial assets and nonfinancial liabilities, except for those items
that are recognized or disclosed at fair value in the financial statements
on a
recurring basis. Management has determined that the adoption of SFAS 157 did
not
have a material effect on the Company’s consolidated financial statements.
12
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Effective
January 1, 2008, the Company adopted SFAS No. 159, “The
Fair Value Option for Financial Assets and Financial Liabilities- including
an
amendment of FASB Statement 115”
(“SFAS
159”). This statement provides companies with an option to report selected
financial assets and liabilities at fair value. As of March 31, 2008, the
Company has not elected to use the fair value option allowed by SFAS 159.
Management has determined that the adoption of SFAS 159 did not have a material
effect on the Company’s consolidated financial position, results of operations,
cash flows or financial statement disclosures.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling
Interests in Consolidated Financial
Statements-an amendment of ARB No. 51” (“SFAS
160”). SFAS 160 establishes accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. It clarifies that a noncontrolling interest in a subsidiary is
an
ownership interest in the consolidated entity that should be reported as equity
in the consolidated financial statements. SFAS No. 160 will be effective for
the
Company in its fiscal year beginning January 1, 2009. The Company is currently
evaluating the impact of SFAS No. 160 on its consolidated financial position
and
results of operations.
In
December 2007, the FASB issued SFAS No. 141 R “Business
Combinations”
(“SFAS
141R”). SFAS 141R establishes principles and requirements for how the acquirer
of a business recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree. SFAS 141R also provides guidance for recognizing
and
measuring the goodwill acquired in a business combination and determines what
information to disclose to enable users of the financial statements to evaluate
the nature and financial effects of a business combination. SFAS 141R will
be
effective for the Company in its fiscal year beginning January 1, 2009. While
the Company has not yet evaluated the impact, if any, that SFAS 141R will have
on its consolidated financial position and results of operations, the Company
will be required to expense costs related to any acquisitions consummated after
December 31, 2008.
In
December 2007, the FASB ratified the consensus reached on Emerging Issues Task
Force Issue No. 07-1, “Accounting
for Collaborative Arrangements Related to the Development and Commercialization
of Intellectual Property”
(“EITF
07-1”). EITF 07-1 defines collaborative arrangements and establishes
reporting requirements for transactions between participants
in a
collaborative arrangement and between participants in the arrangement and third
parties. EITF 07-1 will be effective for the Company’s fiscal year
beginning January 1, 2009. The Company is currently evaluating the
potential impact of this standard on its financial statements.
NOTE
11 –
AGREEMENT WITH CREIGHTON UNIVERSITY
On
May
26, 2006, SafeStitch entered into an exclusive license and development agreement
(the “License Agreement”) with Creighton University granting the Company a
worldwide exclusive (even as to the university) license, with rights to
sublicense, to all the Company’s product candidates and associated know-how,
including the exclusive right to manufacture, use and sell the product
candidates.
Pursuant
to the License Agreement, the Company is obligated to pay Creighton University,
on a quarterly basis, a royalty of 1.5% of the revenue collected worldwide
from
the sale of any product licensed under the License Agreement, less certain
amounts including, without limitation, chargebacks, credits, taxes, duties
and
discounts or rebates. The License Agreement does not provide for minimum
royalties. Also pursuant to the License Agreement, the Company has agreed to
invest, in the aggregate, at least $2.5 million over 36 months, beginning May
26, 2006, towards development of any licensed product. This $2.5 million
investment obligation excludes the first $150,000 of costs related to the
prosecution of patents, which the Company invested outside of the License
Agreement. The Company is further obligated to pay to Creighton University
an
amount equal to 20 percent of certain of the Company’s research and development
expenditures as reimbursement for the use of Creighton University’s
facilities.
13
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Failure
to comply with the payment obligations above will result in all rights in the
licensed patents and know-how reverting back to Creighton University. As of
December 31, 2007, the Company had satisfied the $2.5 million investment
obligation described above. Pursuant to the License Agreement, SafeStitch is
entitled to exercise its own business judgment and sole and absolute discretion
over the marketing, sale, distribution, promotion and other commercial
exploitation of any licensed products, provided that, if the Company has not
commercially exploited or commenced development of a licensed patent and its
associated know-how by the seventh anniversary of the later of the date of
the
License Agreement or the date such technology is disclosed to and accepted
by
SafeStitch, then the licensed patent and associated know-how shall revert back
to the university, with no rights retained by the Company, and the university
will have the right to seek a third party with whom to commercialize such patent
and associated know-how, unless the Company purchases one or more one-year
extensions.
NOTE
12 –
INCOME TAXES
The
Company accounts for income taxes using the asset and liability method described
in SFAS No. 109, “Accounting
For 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. All of the
Company’s deferred tax assets have been fully reserved by a valuation allowance
due to management's uncertainty regarding the future profitability of the
Company.
The
Company has adopted the provisions of FASB interpretation No. 48 (“FIN 48”)
“Accounting
for Uncertainty in Income Taxes, an interpretation of FASB Statement No.
109.”
The
Company has recognized no adjustment for uncertain tax provisions. SafeStitch
recognizes interest and penalties related to uncertain tax positions in general
and administrative expense, however no such provisions for accrued interest
and
penalties related to uncertain tax positions have been recorded as of March
31,
2008.
The
tax
years 2003 through 2007 remain open to examination by the major tax
jurisdictions in which the Company operates.
14
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
This
Quarterly Report on Form 10-Q contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”),
Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),
and Section 21E of the Securities Exchange Act of 1934, as amended, (the
“Exchange Act”), about our expectations, beliefs or intentions regarding our
product development efforts, business, financial condition, results of
operations, strategies or prospects. You can identify forward-looking statements
by the fact that these statements do not relate strictly to historical or
current matters. Rather, forward-looking statements relate to anticipated or
expected events, activities, trends or results as of the date they are made.
Because forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that could
cause our actual results to differ materially from any future results expressed
or implied by the forward-looking statements. Many factors could cause our
actual operations or results to differ materially from the operations and
results anticipated in forward-looking statements. These factors include, but
are not limited to: our ability to obtain additional funding to continue our
operations; our ability to successfully develop, clinically test and
commercialize our product candidates; the timing and outcome of the regulatory
review process for our product candidates; changes in the regulatory
environments of the United States and other countries in which we intend to
operate; our ability to attract and retain key management and scientific
personnel; competition; our ability to successfully prepare file, prosecute,
maintain, defend and enforce patent claims and other intellectual property
rights; our ability to successfully transition from a research and development
company to a marketing, sales and distribution concern, and our ability to
identify and pursue development of additional product candidates, as well as
the
factors contained in “Item 1A - Risk Factors” of our Annual Report on Form
10-KSB, as amended. We do not undertake any obligation to update forward-looking
statements. We intend that all forward-looking statements be subject to the
safe
harbor provisions of PSLRA. These forward-looking statements are only
predictions and reflect our views as of the date they are made with respect
to
future events and financial performance.
Overview
We
are a
developmental stage medical device company focused on the development of medical
devices that manipulate tissues for endoscopic and minimally invasive surgery
for the treatment of obesity, gastroesophageal reflux disease (“GERD”),
Barrett’s Esophagus, esophageal obstructions, upper gastrointestinal bleeding,
hernia formation and other intraperitoneal abnormalities. We have utilized
our
expertise in intraperitoneal surgery to test certain of our devices in
in
vivo and
ex
vivo
animal
trials and ex
vivo
human
trials, and with certain products, in limited in
vivo
human
trials, and we intend to rapidly, efficiently and safely move into clinical
trials for our devices that are utilized in surgery for the treatment of
obesity, GERD and esophageal obstructions and for the treatment and diagnosis
of
Barrett’s Esophagus. Clinical trials for certain product candidates are
anticipated to begin in 2008.
On
September 4, 2007, we completed the acquisition of SafeStitch LLC pursuant
to a
Share Transfer, Exchange and Contribution Agreement, dated as of July 25, 2007
(referred to as the “Share Exchange Agreement”), by and among us, SafeStitch LLC
and the members of SafeStitch LLC. At the closing of the transaction
contemplated by the Share Exchange Agreement (the “Share Exchange”), we issued
an aggregate of 11,256,369 shares of our common stock to the former members
of
SafeStitch LLC in exchange for all of their membership interests in SafeStitch
LLC. We also granted warrants to purchase a total of 805,521 shares of our
common stock to The Frost Group, LLC and Jeffrey G. Spragens in connection
with
a line of credit of up to $4 million that was provided to us simultaneously
with
the closing by The Frost Group, LLC and Jeffrey G. Spragens. The warrants have
a
ten year term and an assumed exercise price of $0.25 per share of common stock.
Dr. Phillip Frost has a controlling interest in The Frost Group LLC and is
the
largest beneficial holder of our common stock. Dr. Jane Hsiao and Steven D.
Rubin, two of our directors, are also members of The Frost Group, LLC. Jeffrey
G. Spragens is our Chief Executive Officer and President and a director. Frost
Gamma Investments Trust, Dr. Phillip Frost, Dr. Jane Hsiao, Steven D. Rubin
and
Jeffrey G. Spragens were also beneficial owners of membership interests in
SafeStitch LLC. We incurred customary acquisition related costs in connection
with the Share Exchange.
In
January 2008, we changed our name from Cellular Technical Services Company,
Inc.
to SafeStitch Medical, Inc., and, on February 11, 2008, our trading symbol
on
the OTCBB changed from “CTSC” to “SFES”. We intend to apply for the listing of
our common stock on the American Stock Exchange during our 2008 fiscal
year.
15
Critical
Accounting Policies and Estimates
The
discussion and analysis of our financial condition and results of operations
set
forth below under “Results of Operations,” “Liquidity” and “Capital Resources”
should be read in conjunction with our financial statements and notes thereto
appearing elsewhere in this Form 10-Q. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses, and related disclosure
of
contingent assets and liabilities. On an on-going basis, we evaluate our
estimates, including those related to investments, including the carrying value
of our long term investments, property and equipment, contingencies and
litigation. We base our estimates on historical experience and on various other
assumptions that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
A
more detailed discussion on the application of these and other accounting
policies can be found in Note B in the Notes to the Consolidated Financial
Statements set forth in Item 7 of our Annual Report on Form 10-KSB, as amended,
for the year ended December 31, 2007. Actual results may differ from these
estimates.
Accounting
Treatment
Our
acquisition of SafeStitch LLC in accordance with the Share Exchange Agreement
has been accounted for as a recapitalization of SafeStitch LLC, and SafeStitch
LLC is treated as the continuing reporting entity. The transaction is not
accounted for as a business combination because we did not have an operating
business. The transaction was instead accounted for as a recapitalization of
SafeStitch and the issuance of stock by SafeStitch (represented by our
outstanding shares of common stock) at the book values of our assets and
liabilities, which approximates fair value with no goodwill or other intangibles
recorded.
Treatment
of Warrants and Options
SafeStitch
LLC did not have any outstanding warrants or options and no warrants or options
were assumed by Cellular as a result of the Share Exchange, except warrants
issued in connection with the $4 million line of credit described
above.
Recent
Accounting Pronouncements
Effective
January 1, 2008, we adopted SFAS No. 157, “Fair
Value Measurements”
(“SFAS
157”), which defines fair value, establishes a framework for measuring fair
value and requires additional disclosures about fair value measurements. In
February 2008, the FASB delayed the effective date of SFAS 157 for one year
for
all nonfinancial assets and nonfinancial liabilities, except for those items
that are recognized or disclosed at fair value in the financial statements
on a
recurring basis. We have determined that the adoption of SFAS 157 did not have
a
material effect on our consolidated financial statements.
Effective
January 1, 2008, we adopted SFAS No. 159, “The
Fair Value Option for Financial Assets and Financial Liabilities- including
an
amendment of FASB Statement 115”
(“SFAS
159”). This statement provides companies with an option to report selected
financial assets and liabilities at fair value. As of March 31, 2008, we elected
not to use the fair value option allowed by SFAS 159. We have determined that
the adoption of SFAS 159 did not have a material effect on our consolidated
financial position, results of operations, cash flows or financial statement
disclosures.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling
Interests in Consolidated Financial
Statements-an amendment of ARB No. 51” (“SFAS
160”). SFAS 160 establishes accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. It clarifies that a noncontrolling interest in a subsidiary is
an
ownership interest in the consolidated entity that should be reported as equity
in the consolidated financial statements. SFAS No. 160 will be effective for
our
fiscal year beginning January 1, 2009. We are currently evaluating the impact
of
SFAS No. 160 on our financial statements.
16
In
December 2007, the FASB issued SFAS No. 141 R “Business
Combinations”
(“SFAS
141R”), which establishes principles and requirements for how the acquirer of a
business recognizes and measures in its financial statements the identifiable
assets acquired, the liabilities assumed and any noncontrolling
interest
in the acquiree. SFAS 141R also provides guidance for recognizing and measuring
the goodwill acquired in a business combination and determines what information
to disclose to enable users of the financial statements to evaluate the nature
and financial effects of a business combination. SFAS 141R will be effective
for
our fiscal year beginning January 1, 2009. While we have not yet evaluated
the
impact, if any, that SFAS 141R will have on our financial statements, we will
be
required to expense costs related to any acquisitions consummated after December
31, 2008.
In
December 2007, the FASB ratified the consensus reached on Emerging Issues Task
Force Issue No. 07-1, “Accounting
for Collaborative Arrangements Related to the Development and Commercialization
of Intellectual Property”
(“EITF
07-1”). EITF 07-1 defines collaborative arrangements and establishes
reporting requirements for transactions between participants
in a
collaborative arrangement and between participants in the arrangement and third
parties. EITF 07-1 will be effective for our fiscal year beginning January
1, 2009. We are currently evaluating the potential impact of this standard
on our financial statements.
Results
of Operations
At
March
31, 2008, we had an accumulated deficit of $5.6 million. This deficit included
losses of $1,444,000 and $400,000 for the three months ended March 31, 2008
and
2007, respectively. Since we do not generate revenue from any of our product
candidates, we expect to continue to generate losses in connection with the
clinical development of our products and development activities relating to
our
technologies. These research and development activities are budgeted to expand
over time and will require further resources if we are to be successful. As
a
result, we believe our operating losses are likely to be substantial over the
next several years.
Three
Months ended March 31, 2008
Compared to Three Months Ended March 31, 2007
Research
and development expenses were $814,000 for the three months ended March 31,
2008, as compared to $366,000 for the first quarter of 2007. This $448,000
increase was primarily due to an increase in the amount of research being
performed as we moved further into our research activities, the addition of
research personnel and the establishment of our Miami prototype development
facility. We expect research and development expenses to continue to increase
as
we enter into the more advanced stages of animal and human clinical trials
for
our product candidates.
General
and administrative costs were $416,000 for three months ended March 31, 2008,
as
compared to $38,000 for the first quarter of 2007. This $378,000 increase was
primarily related to the increase in administrative staffing and operating
costs
and approximately $139,000 in stock-based compensation. General and
administrative expense consists primarily of salaries and other related costs
for persons serving as our executive, finance, accounting and administration
personnel. Other general and administrative expense includes all of our
stock-based compensation expense, facility-related costs not otherwise included
in research and development expense, and professional fees for legal and
accounting services. We expect that our general and administrative expense
will
increase as we add additional personnel and continue to comply with the
reporting and other obligations applicable to public companies.
Interest
income increased from $4,000 in the first three months of 2007 to $5,000 in
the
first three months of 2008 due to an increase in our average cash balance as
a
result of advances under the $4 million credit facility with the Frost Group
LLC
and Jeffery Spragens (the “Credit Facility,” see Note 6 to the unaudited
condensed consolidated financial statements). Interest expense also increased
from $0 in the first quarter of 2007 to $6,000 in the first quarter of 2008
due
to the accrual of interest on amounts outstanding under the Credit
Facility.
Liquidity
As
a
result of our significant research and development expenditures and the lack
of
any approved products to generate product sales revenue, we have not been
profitable and have generated operating losses since inception. Additionally,
we
may be called upon to contribute additional funds in connection with our
involvement as a plaintiff in the TruePosition litigation for so long as we
stay
involved in the litigation. We do not expect to generate any revenues until
at
least the fourth quarter of 2008. Our ability to continue as a going concern
is
ultimately dependent upon achieving profitable operations and generating
sufficient cash flows from operations to meet future obligations. We have funded
our operations to date primarily with proceeds from the private placement of
stock and credit facilities available to us, and our management believes that,
absent any reductions of our discretionary expenditures, our cash balance as
of
March 31, 2008 of approximately $0.6 million, together with the $3.0 million
remaining under our line of credit will be sufficient to fund our cash flow
requirements only through the end of 2008. Our management has currently budgeted
cash expenditures of approximately $3.6 million for the remainder of our 2008
fiscal year, which is expected to fund the final development of three of our
product candidates, as well as continuing research and development on our
gastroplasty (GERD and obesity) and Barrett’s devices. Even if we are able to
bring certain products to market prior to the end of 2008, we plan to raise
additional capital through the issuance of equity and/or debt. There can be
no
assurance that such additional external funding will be available on terms
acceptable to us or at all.
17
Plan
of Operations 2008
Through
the end of our 2008 fiscal year, we plan the following, although there is no
assurance all of it will be completed:
· |
FDA
Registration and initial marketing and commercialization of standard
and
airway bite blocks.
|
· |
Continued
product development of gastroplasty device for obesity and GERD
procedures.
|
· |
Manufacturing
of gastroplasty devices for clinical trials and engineering (performance,
validation) testing.
|
· |
Feasibility
trial of gastroplasty device and commencement of multicenter US and
international trials.
|
· |
Continued
product development of Barrett’s Excision
Device.
|
· |
Final
product development, FDA approval and initial marketing and
commercialization of smart dilator.
|
· |
Institutional
Review Board (IRB) clinical evaluation trials for standard and airway
bite
blocks and smart dilator.
|
· |
Early
development efforts on hernia device and NOTES devices, for which
we have
existing intellectual property and
licenses.
|
Capital
Resources
We
expect
to incur losses from operations for the foreseeable future. We also expect
to
incur increasing research and development expenses, including expenses related
to the hiring of personnel and additional clinical trials. We expect that
general and administrative expenses will also increase as we expand our finance
and administrative staff, add infrastructure and incur additional costs related
to being a public company, including the costs of directors’ and officers’
insurance, investor relations programs and increased professional fees. We
believe that our existing cash and cash equivalents and the $3.0 million
remaining under the credit facility available to us will be sufficient to enable
us to fund our operating expenses and capital expenditure requirements only
through the end of 2008. We have based this estimate on assumptions and the
above-described Plan of Operations that are subject to change and may prove
to
be wrong, and we may be required to use our available capital resources sooner
than we currently expect. Because of the numerous risks and uncertainties
associated with the development and commercialization of our product candidates,
we are unable to estimate the amounts of increased capital outlays and operating
expenditures associated with our current and anticipated clinical
trials.
Our
future capital requirements will depend on many factors, including the progress
and results of our clinical trials, the duration and cost of discovery and
preclinical development, and laboratory testing and clinical trials for our
product candidates, the timing and outcome of regulatory review of our product
candidates, the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims and other intellectual property rights,
the number and development requirements of other product candidates that we
pursue and the costs of commercialization activities, including product
marketing, sales and distribution. We expect to finance some of our future
cash
needs through public or private equity offerings, debt financings or corporate
collaboration and licensing arrangements. We currently do not have any binding
commitments for such additional external funding. We may need to raise
additional funds more quickly if one or more of our assumptions prove to be
incorrect or if we choose to expand our product development efforts more rapidly
than we presently anticipate. We may also decide to raise additional funds
even
before we need them if the conditions for raising capital are favorable. The
sale of additional equity or debt securities will likely result in dilution
to
our stockholders. The incurrence of additional indebtedness would also likely
result in increased fixed obligations and covenants that could restrict our
operations. Additional equity or debt financing, grants or corporate
collaboration and licensing arrangements may not be available to us on
acceptable terms, or at all. If adequate funds are not available, we may be
required to delay, reduce the scope of or eliminate our research and development
programs, reduce our planned commercialization efforts or obtain funds through
arrangements with collaborators or others that may require us to relinquish
rights to certain product candidates that we might otherwise seek to develop
or
commercialize independently.
18
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
Not
required for smaller reporting companies as defined in
Rule
12b-2 of the Exchange Act.
Item
4T. Controls and Procedures.
We
maintain a system of disclosure controls and procedures that is designed to
provide reasonable assurance that information we are required to disclose in
the
reports we file or submit under the Exchange Act, is accumulated and
communicated to management in a timely manner. Our Chief Executive Officer
and
Chief Financial Officer have evaluated this system of disclosure controls and
procedures as of the end of the period covered by this quarterly report, and
believe that the system is not operating effectively to ensure appropriate
disclosure. This conclusion was based on the following:
Our
Chief
Executive Officer and Chief Financial Officer conducted evaluations of our
systems of internal control over financial reporting and disclosure control
for
the year ended December 31, 2007 and concluded at that time that our system
of
internal controls was not operating effectively primarily because we did not
maintain a
sufficient complement of personnel with the appropriate level of knowledge,
experience and training in the application of accounting principles generally
accepted in the U.S. (referred to as GAAP) and in internal control over
financial reporting commensurate with our financial reporting obligations under
the Exchange Act. We did not maintain effective controls over the presentation
of our consolidated financial statements and related disclosures in preparing
our consolidated financial statements. There
were no significant changes in our internal control over financial reporting
between the aforementioned evaluation and the end of the most recent fiscal
quarter that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting. Furthermore, in reviewing
our 10-KSB after its filing, we determined that certain information required
to
be included in the Form 10-KSB was in error, including the calculation and
presentation of basic and diluted earnings (loss) per common share, resulting
in
the filing of an amended annual report on Form 10-KSB/A on April 24, 2008.
As
of the
date of this filing, we began implementing changes approved by the Audit
Committee of the Board of Directors, including the hiring of a new Chief
Financial Officer and the addition of other personnel with the appropriate
knowledge of GAAP and the financial reporting requirements of the Exchange
Act.
19
PART
II. OTHER INFORMATION
There
have been no material changes to legal proceedings since the filing of our
annual report for the year ended December 31, 2007 on Form 10-KSB, as
amended.
Item
1A. Risk Factors.
There
have been no material changes in our risk factors since the filing of our annual
report for the year ended December 31, 2007 on Form 10-KSB, as
amended.
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.
None.
Item
6. Exhibits.
|
|
Exhibits:
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Rule
13a-14(a)/15d-14(a)
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Rule
13a-14(a)/15d-14(a)
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
20
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned thereunto
duly
authorized.
SAFESTITCH
MEDICAL, INC.
|
||
Date:
May 12, 2008
|
By:
|
/s/
Jeffrey G. Spragens
|
|
|
Jeffrey
G. Spragens
|
|
|
President
and Chief Executive Officer
|
|
||
Date:
May 12, 2008
|
By:
|
/s/
Adam S. Jackson
|
|
|
Adam
S. Jackson
|
|
|
Chief
Financial Officer
|
21