UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC. 20549
FORM 10-Q/A
Amendment No. 1
(Mark One)
x | Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 for the Quarterly Period ended June 30, 2012 |
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 A-100, Miami, Florida | 33137 | |
(Address of principal executive offices) | (Zip code) |
Registrants telephone number, including area code: (305) 575-4600
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 ¨
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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ | 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 ¨ No x
48,797,755 shares of the Companys common stock, par value $0.001 per share, were outstanding as of August 10, 2012.
Explanatory Note
This Amendment No. 1 on Form 10-Q/A amends the Quarterly Report on Form 10-Q of SafeStitch Medical, Inc. for the quarter ended June 30, 2012 filed on August 14, 2012 (the Form 10-Q) for the sole purpose of furnishing the interactive data files as Exhibit 101 in accordance with Rule 405(a)(2) of Regulation S-T.
No other changes have been made to the Form 10-Q. This Form 10-Q/A speaks as of the original filing date of the Form 10-Q, does not reflect events that may have occurred subsequent to the original filing date, and does not modify or update in any way disclosures made in the Form 10-Q.
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS
Exhibit No. |
Description | |
31.1* | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act | |
31.2* | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act | |
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 | |
101.INS ** | XBRL Instance Document | |
101.SCH ** | XBRL Taxonomy Extension Schema Document | |
101.CAL ** | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF ** | XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB ** | XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE ** | XBRL Taxonomy Extension Presentation Linkbase Document |
* | Previously filed or furnished with the Quarterly Report on Form 10-Q of SafeStitch Medical, Inc. for the quarter ended June 30, 2012 filed on August 14, 2012. |
** | Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Act of 1934 and otherwise not subject to liability under those sections. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SAFESTITCH MEDICAL, INC. | ||||||
Date: August 30, 2012 | By: | /s/ James J. Martin | ||||
James J. Martin | ||||||
Chief Financial Officer | ||||||
(Duly Authorized Officer and | ||||||
Principal Accounting Officer) |
EXHIBIT INDEX
Exhibit No. |
Description | |
31.1* | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act | |
31.2* | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act | |
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 | |
101.INS ** | XBRL Instance Document | |
101.SCH ** | XBRL Taxonomy Extension Schema Document | |
101.CAL ** | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF ** | XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB ** | XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE ** | XBRL Taxonomy Extension Presentation Linkbase Document |
* | Previously filed or furnished with the Quarterly Report on Form 10-Q of SafeStitch Medical, Inc. for the quarter ended June 30, 2012 filed on August 14, 2012. |
** | Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Act of 1934 and otherwise not subject to liability under those sections. |
Basic and Diluted Net Loss Per Share (Details)
|
3 Months Ended | 6 Months Ended |
---|---|---|
Jun. 30, 2012
|
Jun. 30, 2011
|
|
Summary of Potential Common Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 3,150,021 | 2,435,188 |
Basic and Diluted Net Loss Per Share (Textual) [Abstract] | ||
Weighted average outstanding common shares | 0 | 0 |
Stock Options [Member]
|
||
Summary of Potential Common Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 2,344,500 | 1,629,667 |
Stock Warrants [Member]
|
||
Summary of Potential Common Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 805,521 | 805,521 |
Summary of Significant Accounting Policies (Details Textual) (USD $)
|
3 Months Ended | 6 Months Ended | 81 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2012
|
Jun. 30, 2011
|
Jun. 30, 2012
|
Jun. 30, 2011
|
Jun. 30, 2012
|
|
Summary of Significant Accounting Policies (Textual) [Abstract] | |||||
Inventory Balance | $ 1,646,000 | $ 1,646,000 | $ 1,646,000 | ||
Components | 972,000 | 972,000 | 972,000 | ||
Finished units | 671,000 | 671,000 | 671,000 | ||
Standard mesh | 3,000 | 3,000 | 3,000 | ||
Selling, General and Administrative costs and expenses | 1,068,000 | 467,000 | 1,981,000 | 1,121,000 | 10,977,000 |
Advertising and Promotional costs and expense | $ 45,000 | $ 0 | $ 83,000 | $ 9,000 |
Certain Relationships and Related Party Transactions (Details Textual) (USD $)
|
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2012
|
Jun. 30, 2011
|
Jun. 30, 2012
|
Jun. 30, 2011
|
Dec. 31, 2011
|
|
Certain Relationships And Related Party Transactions (Textual) [Abstract] | |||||
Credit facility | $ 4,000,000 | $ 4,000,000 | |||
Lease period for office space | 5 years | ||||
Percentage of annual rent increase of lease | 4.50% | ||||
Current rental payments under the lease | 19,000 | ||||
Reduction in selling general and administrative costs and expenses | 52,000 | 78,000 | 103,000 | 154,000 | |
Aggregate account receivable from NIMS | 35,000 | 35,000 | 66,000 | ||
Mr. Spragens and The Frost Group [Member]
|
|||||
Certain Relationships And Related Party Transactions (Textual) [Abstract] | |||||
Credit facility | 4,000,000 | 4,000,000 | |||
Miami [Member]
|
|||||
Certain Relationships And Related Party Transactions (Textual) [Abstract] | |||||
Current rental payments under the lease | $ 69,000 | $ 47,000 | $ 126,000 | $ 94,000 |
Summary of Significant Accounting Policies
|
6 Months Ended |
---|---|
Jun. 30, 2012
|
|
Summary of Significant Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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. Use of estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) 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. Cash and cash equivalents. We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company holds cash and cash equivalent balances in banks and other financial institutions, and includes overnight repurchase agreements collateralizing its depository bank accounts (sweep accounts) in its cash balances. Balances in excess of Federal Deposit Insurance Corporation (“FDIC”) limitations may not be insured. Allowances for Doubtful Accounts. The Company provides an allowance for receivables it believes it may not collect in full. Receivables are written off when they are deemed to be uncollectible and all collection attempts have ceased. The amount of bad debt recorded each period and the resulting adequacy of the allowance for doubtful accounts at the end of each period are determined using a combination of customer-by-customer analysis of the Company’s accounts receivable each period and subjective assessments of the Company’s future bad debt exposure. Inventories. Inventories are stated at lower of cost or market using the weighted average cost method and are evaluated for impairment when conditions exist that suggests impairment may be necessary. The $1.6 million inventory balance at June 30, 2012 consists of $972,000 in components, $671,000 in finished units of the AMID HFD and $3,000 in standard mesh. Scrap materials and quality testing costs are included in Cost of Goods Sold (“COGS”), as incurred. Provisions for potentially obsolete or slow-moving inventory are made based on management’s analysis of inventory levels, obsolescence and future sales forecasts. 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. Revenue Recognition. Revenue from product sales is recognized when persuasive evidence of an arrangement exists, the goods are shipped and title has transferred, the price is fixed or determinable, and the collection of the sales proceeds is reasonably assured.
Advertising Costs. The Company expenses all costs of advertising as incurred. Advertising and promotional costs are included in selling, general and administrative costs and expenses for all periods presented, and totaled $45,000 and $83,000, respectively, for the three and six months ended June 30, 2012. Advertising and promotional costs and expenses totaled $0 and $9,000, respectively, for the three and six months ended June 30, 2011. Research and development. Research and development costs principally represent salaries of the Company’s medical and biomechanical engineering professionals, material and shop costs associated with manufacturing product prototypes and payments to third parties for clinical trials and additional product development and testing. 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. Stock-based compensation. The Company accounts for all share-based payments to employees and directors, based on their grant date fair values. Compensation for share-based payments to non-employees is based on the fair value at the measurement date, which is generally the performance completion date. The fair value is initially measured at the grant date and subsequently measured at each reporting period until the final measurement date. 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. Stock-based compensation is included in general and administrative costs and expenses for all periods presented. Therapeutic discovery project tax credit. The Company records the therapeutic discovery project tax credit on an accrual basis when the credit is considered realized, which is generally when approved by the government agency. Such credit is reported as other income in the accompanying financial statements. Fair value of financial instruments. The carrying amounts of cash and cash equivalents, accounts payable, accrued expenses and notes payable approximate fair value based on their short-term maturity. Related party receivables and stockholder loans are carried at cost. 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, 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). 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, and, as a result, no statement of comprehensive income (loss) has been included in the condensed consolidated financial statements.
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