UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2012
Commission file number: 1-33818
ENTEROMEDICS INC.
(Exact name of registrant as specified in its charter)
Delaware | 48-1293684 | |
(State or other jurisdiction of incorporation) |
(IRS Employer Identification No.) |
2800 Patton Road, St. Paul, Minnesota 55113
(Address of principal executive offices, including zip code)
(651) 634-3003
(Registrants 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 x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, 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 | ¨ (Do not check if a smaller reporting entity) | 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
As of October 31, 2012, 41,701,594 shares of the registrants Common Stock were outstanding.
PART I FINANCIAL INFORMATION | ||||||
Item 1. |
Condensed Consolidated Financial Statements (unaudited) | 3 | ||||
Condensed Consolidated Balance Sheets at September 30, 2012 and December 31, 2011 |
3 | |||||
4 | ||||||
4 | ||||||
5 | ||||||
6 | ||||||
Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations | 13 | ||||
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk | 19 | ||||
Item 4. |
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. |
Mine Safety Disclosures | 20 | ||||
Item 5. |
Other Information | 20 | ||||
Item 6. |
Exhibits | 20 | ||||
21 |
Registered Trademarks and Trademark Applications: In the United States we have registered trademarks for VBLOC®, ENTEROMEDICS® and MAESTRO®, each registered with the United States Patent and Trademark Office. In addition, some or all of the marks VBLOC, MAESTRO and ENTEROMEDICS are the subject of either a trademark registration or application for registration in Australia, Brazil, China, the European Community, Saudi Arabia and Switzerland. The trademarks VBLOC, ENTEROMEDICS and MAESTRO SYSTEM ORCHESTRATING OBESITY SOLUTIONS are registered in Mexico. The trademarks VBLOC, ENTEROMEDICS and MAESTRO SYSTEM ORCHESTRATING OBESITY SOLUTIONS are the subject of pending trademark applications in the United Arab Emirates. This form 10-Q contains other trade names and trademarks and service marks of EnteroMedics and of other companies.
2
PART I FINANCIAL INFORMATION
ITEM 1. | CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
ENTEROMEDICS INC.
(A development stage company)
Condensed Consolidated Balance Sheets
(Unaudited)
September 30, 2012 |
December 31, 2011 |
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ASSETS | ||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 27,214,739 | $ | 28,487,688 | ||||
Restricted cash |
200,000 | 200,000 | ||||||
Short-term investments available for sale |
| 1,005,411 | ||||||
Accounts receivable |
52,649 | | ||||||
Inventory |
1,611,339 | 1,068,623 | ||||||
Prepaid expenses and other current assets |
558,419 | 804,799 | ||||||
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Total current assets |
29,637,146 | 31,566,521 | ||||||
Property and equipment, net |
629,811 | 630,354 | ||||||
Other assets |
456,494 | 288,980 | ||||||
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Total assets |
$ | 30,723,451 | $ | 32,485,855 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
Current liabilities: |
||||||||
Current portion of notes payable |
$ | 2,000,000 | $ | 2,307,162 | ||||
Accounts payable |
292,690 | 434,436 | ||||||
Accrued expenses |
3,470,524 | 6,373,370 | ||||||
Accrued interest payable |
515,051 | 448,821 | ||||||
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Total current liabilities |
6,278,265 | 9,563,789 | ||||||
Notes payable, less current portion (net discounts of $366,598 and $216,711 at September 30, 2012 and December 31, 2011, respectively) |
7,633,402 | 2,881,161 | ||||||
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Total liabilities |
13,911,667 | 12,444,950 | ||||||
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Commitments and contingencies (note 3) |
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Stockholders equity: |
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Common stock, $0.01 par value; 125,000,000 shares authorized; 41,560,615 and 36,752,746 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively |
415,606 | 367,527 | ||||||
Additional paid-in capital |
209,541,873 | 196,384,995 | ||||||
Accumulated other comprehensive income |
| 692 | ||||||
Deficit accumulated during development stage |
(193,145,695 | ) | (176,712,309 | ) | ||||
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Total stockholders equity |
16,811,784 | 20,040,905 | ||||||
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Total liabilities and stockholders equity |
$ | 30,723,451 | $ | 32,485,855 | ||||
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See accompanying notes to condensed consolidated financial statements.
3
ENTEROMEDICS INC.
(A development stage company)
Condensed Consolidated Statements of Operations
(Unaudited)
Three months ended September 30, | Nine months ended September 30, | Period from December 19, 2002 (inception) to September 30, |
||||||||||||||||||
2012 | 2011 | 2012 | 2011 | 2012 | ||||||||||||||||
Sales |
$ | | $ | | $ | 311,493 | $ | | $ | 311,493 | ||||||||||
Cost of goods sold |
| | 231,520 | | 231,520 | |||||||||||||||
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Gross profit |
| | 79,973 | | 79,973 | |||||||||||||||
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Operating expenses: |
||||||||||||||||||||
Research and development |
2,580,653 | 4,778,967 | 7,521,177 | 10,882,384 | 124,302,751 | |||||||||||||||
Selling, general and administrative |
2,991,817 | 2,354,501 | 8,347,481 | 6,488,749 | 56,516,451 | |||||||||||||||
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Total operating expenses |
5,572,470 | 7,133,468 | 15,868,658 | 17,371,133 | 180,819,202 | |||||||||||||||
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Operating loss |
(5,572,470 | ) | (7,133,468 | ) | (15,788,685 | ) | (17,371,133 | ) | (180,739,229 | ) | ||||||||||
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Other income (expense): |
||||||||||||||||||||
Interest income |
3,193 | 2,303 | 7,353 | 10,634 | 4,043,616 | |||||||||||||||
Interest expense |
(263,713 | ) | (167,794 | ) | (636,607 | ) | (563,656 | ) | (12,199,377 | ) | ||||||||||
Change in value of warrant liability |
| | | | (3,840,622 | ) | ||||||||||||||
Other, net |
(13,850 | ) | 847 | (15,447 | ) | (17,080 | ) | (279,115 | ) | |||||||||||
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Net loss |
$ | (5,846,840 | ) | $ | (7,298,112 | ) | $ | (16,433,386 | ) | $ | (17,941,235 | ) | $ | (193,014,727 | ) | |||||
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Net loss per sharebasic and diluted |
$ | (0.14 | ) | $ | (0.26 | ) | $ | (0.42 | ) | $ | (0.64 | ) | ||||||||
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Shares used to compute basic and diluted net loss per share |
40,984,216 | 28,209,522 | 38,810,762 | 27,999,412 | ||||||||||||||||
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See accompanying notes to condensed consolidated financial statements.
ENTEROMEDICS INC.
(A development stage company)
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
Three months ended September 30, | Nine months ended September 30, | Period from December 19, 2002 (inception) to September 30, |
||||||||||||||||||
2012 | 2011 | 2012 | 2011 | 2012 | ||||||||||||||||
Net loss |
$ | (5,846,840 | ) | $ | (7,298,112 | ) | $ | (16,433,386 | ) | $ | (17,941,235 | ) | $ | (193,014,727 | ) | |||||
Change in unrealized gain (loss) on available for sale investments |
(116 | ) | (174 | ) | (692 | ) | (174 | ) | | |||||||||||
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Comprehensive loss |
$ | (5,846,956 | ) | $ | (7,298,286 | ) | $ | (16,434,078 | ) | $ | (17,941,409 | ) | $ | (193,014,727 | ) | |||||
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See accompanying notes to condensed consolidated financial statements.
4
ENTEROMEDICS INC.
(A development stage company)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine months ended September 30, | Period from December 19, 2002 (inception) to September 30, |
|||||||||||
2012 | 2011 | 2012 | ||||||||||
Cash flows from operating activities: |
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Net loss |
$ | (16,433,386 | ) | $ | (17,941,235 | ) | $ | (193,014,727 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation |
177,587 | 223,590 | 2,437,625 | |||||||||
Loss on sale of equipment |
4,241 | 1,269 | 78,368 | |||||||||
Stock-based compensation |
2,739,319 | 2,092,058 | 17,202,485 | |||||||||
Amortization of commitment fees, debt issuance costs and original issue discount |
152,932 | 180,672 | 4,039,555 | |||||||||
Amortization of short-term investment premium or discount |
4,719 | 1,408 | (300,071 | ) | ||||||||
Change in value of warrant liability |
| | 3,840,622 | |||||||||
Change in operating assets and liabilities: |
||||||||||||
Accounts receivable |
(52,649 | ) | | (52,649 | ) | |||||||
Inventory |
(542,716 | ) | | (1,611,339 | ) | |||||||
Prepaid expenses and other current assets |
246,380 | (279,825 | ) | (558,419 | ) | |||||||
Other assets |
(182,984 | ) | 50,824 | (420,317 | ) | |||||||
Accounts payable |
(271,228 | ) | 323,609 | 29,912 | ||||||||
Accrued expenses |
(2,902,846 | ) | 801,664 | 3,470,524 | ||||||||
Accrued interest payable |
66,230 | 23,438 | 680,873 | |||||||||
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Net cash used in operating activities |
(16,994,401 | ) | (14,522,528 | ) | (164,177,558 | ) | ||||||
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Cash flows from investing activities: |
||||||||||||
Decrease (increase) in restricted cash |
| 6,327,031 | (200,000 | ) | ||||||||
Purchases of short-term investments available for sale |
| (5,007,980 | ) | (19,890,213 | ) | |||||||
Maturities of short-term investments available for sale |
1,000,000 | 2,000,000 | 19,854,414 | |||||||||
Purchases of short-term investments held to maturity |
| | (22,414,130 | ) | ||||||||
Maturities of short-term investments held to maturity |
| | 22,750,000 | |||||||||
Purchases of property and equipment |
(51,803 | ) | (239,044 | ) | (2,883,025 | ) | ||||||
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Net cash provided by (used in) investing activities |
948,197 | 3,080,007 | (2,782,954 | ) | ||||||||
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Cash flows from financing activities: |
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Proceeds from stock options exercised |
| 2,164 | 203,018 | |||||||||
Proceeds from warrants exercised |
5,546,160 | 119,912 | 5,863,501 | |||||||||
Proceeds from sale of common stock and warrants for purchase of common stock |
5,050,000 | 14,520,000 | 119,404,439 | |||||||||
Common stock financing costs |
(367,871 | ) | (1,234,300 | ) | (9,846,301 | ) | ||||||
Payment to shareholders for fractional shares upon reverse stock split |
| | (355 | ) | ||||||||
Proceeds from sale of Series A, B and C convertible preferred stock |
| | 63,766,564 | |||||||||
Series A, B and C convertible preferred stock financing costs |
| | (1,658,662 | ) | ||||||||
Proceeds from notes payable and convertible notes payable |
5,347,807 | | 47,993,774 | |||||||||
Repayments on notes payable |
(752,841 | ) | (367,188 | ) | (31,178,928 | ) | ||||||
Debt issuance costs |
(50,000 | ) | | (371,799 | ) | |||||||
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Net cash provided by financing activities |
14,773,255 | 13,040,588 | 194,175,251 | |||||||||
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Net (decrease) increase in cash and cash equivalents |
(1,272,949 | ) | 1,598,067 | 27,214,739 | ||||||||
Cash and cash equivalents: |
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Beginning of period |
28,487,688 | 30,840,560 | | |||||||||
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End of period |
$ | 27,214,739 | $ | 32,438,627 | $ | 27,214,739 | ||||||
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Supplemental disclosure: |
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Interest paid |
$ | 417,445 | $ | 359,505 | $ | 7,470,345 | ||||||
Noncash investing and financing activities: |
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Cancellation of Alpha Medical, Inc. Series A convertible preferred stock and common stock |
$ | | $ | | $ | (661,674 | ) | |||||
Issuance of Beta Medical, Inc. Series A convertible preferred stock in exchange for Alpha Medical, Inc. Series A convertible preferred stock and common stock |
| | 661,674 | |||||||||
Value of warrants issued with debt and for debt commitment |
237,349 | | 4,070,532 | |||||||||
Value of warrants issued with sale of common and preferred stock offerings |
| | 1,684,832 | |||||||||
Cashless exercise of warrants |
| | 5,244,778 | |||||||||
Conversion of notes and interest payable to Series B and C convertible preferred shares |
| | 6,980,668 | |||||||||
Options issued for deferred compensation |
| | 10,898 | |||||||||
Common stock issued to Mayo Foundation and for deferred compensation |
| | 1,770,904 | |||||||||
Reclassification of warrant liability |
| | 2,932,766 | |||||||||
Conversion of convertible preferred stock to common stock |
| | 51,132 |
See accompanying notes to condensed consolidated financial statements.
5
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(1) Summary of Significant Accounting Policies
Description of Business
EnteroMedics Inc. (formerly Beta Medical, Inc.) (the Company) is developing medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders. The Company was incorporated in the state of Minnesota on December 19, 2002 and was reincorporated in Delaware on July 22, 2004. The Company is in the development stage and since inception has devoted substantially all of its resources to recruiting personnel, developing its product technology, obtaining patents to protect its intellectual property and raising capital, and only recently has derived revenues from its primary business activity. The Company is headquartered in St. Paul, Minnesota. In January 2006, the Company established EnteroMedics Europe Sárl, a wholly-owned subsidiary located in Switzerland.
Since inception, the Company has incurred losses through September 30, 2012 totaling approximately $193.0 million and has not generated positive cash flows from operations. The Company expects such losses to continue into the foreseeable future as it continues to develop and commercialize its technologies. The Company may need to obtain additional financing and there can be no assurance that the Company will be successful in obtaining additional financing on favorable terms, or at all. If adequate funds are not available, the Company may have to delay development or commercialization of products or license to third parties the rights to commercialize products or technologies that the Company would otherwise seek to commercialize.
Basis of Presentation
The Company has prepared the accompanying condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America. The Companys fiscal year ends on December 31.
The accompanying condensed consolidated financial statements and notes thereto are unaudited. In the opinion of the Companys management, these statements include all adjustments, which are of a normal recurring nature, necessary to present a fair presentation. Interim results are not necessarily indicative of results for a full year. The condensed consolidated balance sheet as of December 31, 2011 was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America. The information included in this Form 10-Q should be read in conjunction with the Companys Annual Report on Form 10-K for the year ended December 31, 2011.
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 that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All significant intercompany balances and transactions have been eliminated in consolidation.
Fair Value of Financial Instruments
Carrying amounts of certain of the Companys financial instruments, including cash and cash equivalents, restricted cash, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their short maturities. The fair value of the Companys long-term debt is approximately $9.9 million as of September 30, 2012 based on the present value of estimated future cash flows using a discount rate commensurate with borrowing rates available to the Company. If measured at fair value in the condensed consolidated financial statements, long-term debt (including the current portion) would be classified as Level 2 in the fair value hierarchy.
6
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
The Companys assets that are measured at fair value on a recurring basis are classified within Level 1 or Level 2 of the fair value hierarchy. The Company does not hold any assets that are measured at fair value using Level 3 inputs. The types of instruments the Company invests in that are valued based on quoted market prices in active markets include U.S. treasury securities. Such instruments are classified by the Company within Level 1 of the fair value hierarchy. U.S. treasuries are valued using unadjusted quoted prices for identical assets in active markets that the Company can access.
The types of instruments the Company invests in that are valued based on quoted prices in less active markets, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency include U.S. agency securities, commercial paper, U.S. corporate bonds and municipal obligations. Such instruments are classified by the Company within Level 2 of the fair value hierarchy. The Company values these types of assets using consensus pricing or a weighted average price, which is based on multiple pricing sources received from a variety of industry standard data providers (e.g. Bloomberg), security master files from large financial institutions, and other third-party sources. The multiple prices obtained are then used as inputs into a distribution-curve-based algorithm to determine the daily market price.
The Company did not hold any short-term investments as of September 30, 2012.
Restricted Cash
The Company had $200,000 in a cash collateral money market account as of September 30, 2012 and December 31, 2011. Pursuant to the Lease Agreement the Company entered into with Roseville Properties Management Company in July 2008, the Company was required to deliver to Roseville Properties an irrevocable, unconditional, standby letter of credit in the amount of $200,000 on the second anniversary of the commencement of lease payments. The standby letter of credit is to be maintained through October 1, 2013. The irrevocable standby letter of credit was issued by Silicon Valley Bank, who required the Company to set up a restricted cash collateral money market account to fully secure the standby letter of credit.
Inventory
The Company accounts for inventory at the lower of cost or market and records any long-term inventory as other assets in the condensed consolidated balance sheets.
Comprehensive Loss
Comprehensive loss is defined as the change in equity of a company during a period from transactions and other events and circumstances excluding transactions resulting from investment owners and distributions to owners. The difference from reported net loss for the three and nine months ended September 30, 2012 and 2011 related entirely to changes in unrealized gains (losses) on available for sale investments.
Revenue Recognition
The Company recognizes revenue when persuasive evidence of an arrangement exists, title or risk of loss has passed, the selling price is fixed or determinable and collection is reasonably assured. The Company sells products internationally through distributors and recognizes revenue upon sale to the distributor as these sales are considered to be final and no right of return or price protection exists. Terms of sales to international distributors are generally EXW, reflecting that goods are shipped ex works, in which risk of loss is assumed by the distributor at the shipping point. The Company does not provide for rights of return to customers on product sales and therefore does not record a provision for returns.
Research and Development Expenses
Research and development expenses are charged to expense as incurred. Research and development expenses include, but are not limited to, product development, clinical trial expenses, including supplies and devices, regulatory expenses, payroll and other personnel expenses, materials and consulting costs.
Derivative Instruments
The Company accounts for outstanding warrants that are not indexed to the Companys stock or warrants issued when the Company has insufficient authorized and unissued stock available to share settle the outstanding warrants as derivative instruments, which require that the warrants be classified as a liability and measured at fair value with changes in fair value recognized currently in earnings and recorded separately in the condensed consolidated statements of operations.
7
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is based on the weighted-average common shares outstanding during the period plus dilutive potential common shares calculated using the treasury stock method. Such potentially dilutive shares are excluded when the effect would be to reduce a net loss per share. The Companys potential dilutive shares, which include outstanding common stock options, unvested common shares subject to repurchase and warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.
The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2012 and 2011:
Three months
ended September 30, |
Nine months
ended September 30, |
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2012 | 2011 | 2012 | 2011 | |||||||||||||
Numerator: |
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Net loss |
$ | (5,846,840 | ) | $ | (7,298,112 | ) | $ | (16,433,386 | ) | $ | (17,941,235 | ) | ||||
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Denominator for basic and diluted net loss per share: |
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Weighted-average common shares outstanding |
40,984,216 | 28,209,522 | 38,810,762 | 27,999,412 | ||||||||||||
Weighted-average unvested common shares subject to repurchase |
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Denominator for net loss per common sharebasic and diluted |
40,984,216 | 28,209,522 | 38,810,762 | 27,999,412 | ||||||||||||
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Net loss per sharebasic and diluted |
$ | (0.14 | ) | $ | (0.26 | ) | $ | (0.42 | ) | $ | (0.64 | ) | ||||
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The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented:
September 30, | ||||||||
2012 | 2011 | |||||||
Stock options outstanding |
7,879,730 | 2,799,908 | ||||||
Warrants to purchase common stock |
21,493,883 | 23,927,766 |
Recently Issued Accounting Standards
In June 2011, the Financial Accounting Standards Board issued guidance on the presentation of comprehensive income in financial statements. Entities are required to present total comprehensive income either in a single, continuous statement of comprehensive income or in two separate, but consecutive, statements. The Company adopted this standard during the first quarter of 2012 and presents net loss and other comprehensive loss in two separate, but consecutive, statements. The adoption of this standard did not have a material effect on the Companys financial statement disclosures.
There have been no other significant changes in recent accounting pronouncements during the nine months ended September 30, 2012 as compared to the recent accounting pronouncements described in the Companys Annual Report on Form 10-K for the year ended December 31, 2011.
(2) Inventory
From inception until December 2011, inventory related purchases had been used for research and development related activities and had accordingly been expensed as incurred. In December 2011, the Company began receiving Australian
8
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
Register of Therapeutic Goods (ARTG) listings for components of the Maestro Rechargeable System from the Australian Therapeutic Goods Administration (TGA), with the final components being listed on the ARTG in January 2012. As a result, the Company determined certain assets were recoverable as inventory beginning in December 2011. The Company accounts for inventory at the lower of cost or market and records any long-term inventory as other assets in the condensed consolidated balance sheets. There was approximately $373,000 and $228,000 of long-term inventory as of September 30, 2012 and December 31, 2011, respectively.
Current inventory consists of the following as of:
September 30, 2012 |
December 31, 2011 |
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Raw materials |
$ | 361,539 | $ | 376,580 | ||||
Work-in-process |
1,221,434 | 692,043 | ||||||
Finished goods |
28,366 | | ||||||
|
|
|
|
|||||
Inventory |
$ | 1,611,339 | $ | 1,068,623 | ||||
|
|
|
|
(3) Commitments and Contingencies
The Company rents its office, warehouse and laboratory facilities under an operating lease, which expires on September 30, 2015. At September 30, 2012, future minimum payments under the lease are as follows:
Years ending December 31: |
||||
Remaining three months in 2012 |
$ | 71,058 | ||
2013 |
285,656 | |||
2014 |
291,369 | |||
2015 |
221,789 | |||
|
|
|||
$ | 869,872 | |||
|
|
The Company is exposed to product liability claims that are inherent in the testing, production, marketing and sale of medical devices. Management believes any losses that may occur from these matters are adequately covered by insurance, and the ultimate outcome of these matters will not have a material effect on the Companys financial position or results of operations. The Company is not currently a party to any litigation and is not aware of any pending or threatened litigation that could have a material adverse effect on the Companys business, operating results or financial condition.
(4) Notes Payable
On November 18, 2008 the Company entered into a Loan and Security Agreement (the Prior Loan Agreement) with Silicon Valley Bank (SVB), Venture Lending & Leasing V, Inc. (a private equity fund under the management of Western Technology Investment (WTI)) and Compass Horizon Funding Company LLC (Horizon and, collectively with SVB and WTI, the Lenders), in an aggregate principal amount of up to $20.0 million. On November 21, 2008, SVB and WTI each funded a term loan in the aggregate principal amount of $10.0 million and $5.0 million, respectively. The additional $5.0 million term loan was automatically funded by Horizon on April 28, 2009 when the trading price of the Companys common stock on the NASDAQ Global Market exceeded a target amount specified in the Prior Loan Agreement. On December 1, 2009, the Company repaid the outstanding principal amount due to WTI and Horizon pursuant to the Prior Loan Agreement.
During 2010 and 2011, the Company and SVB entered into four amendments to the Prior Loan Agreement, which modified the payment terms, annual interest rate and financial covenants. A brief summary of the four amendments is provided below.
On February 8, 2010, the Company and SVB entered into the First Amendment to the Prior Loan Agreement, which reduced the annual interest rate from 11.0% to a fixed annual rate of 10.0%, payable monthly, revised the liquidity financial covenant and added a New Capital Transaction covenant.
9
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
On July 8, 2010, the Company and SVB entered into a Second Amendment to the Prior Loan Agreement, which modified the repayment terms of the loan such that interest only payments were required through December 31, 2010 followed by 30 equal payments of principal and interest, increased the annual interest rate from 10.0% to a fixed annual rate of 11.0%, payable monthly, revised the liquidity financial covenant and added additional New Capital Transaction requirements. On July 8, 2010, per the terms of the Second Amendment to the Prior Loan Agreement, SVB was issued a warrant to purchase 150,642 shares of the Companys common stock with an exercise price of $2.10 per share.
On November 4, 2010, the Company and SVB entered into a Third Amendment (the Third Amendment) to the Prior Loan Agreement, which modified the New Capital Transaction covenant, suspended the liquidity financial covenant and required the Company to maintain a blocked cash collateral account with funds equal to the principal balance outstanding.
On March 3, 2011, the Company entered into a Fourth Amendment (the Fourth Amendment) to the Prior Loan Agreement with SVB. The Fourth Amendment modified the repayment terms of the term loan such that beginning April 1, 2011 through September 30, 2011, the Company was required to make interest only monthly payments on the term loan. Then, beginning on October 1, 2011, the remaining balance due on the term loan started to amortize over 30 equal payments of principal and interest, payable monthly. In addition, the Fourth Amendment amended the interest rate due effective March 1, 2011 on the remaining principal amount of the term loan from 11.0% to a fixed annual rate of 6.25%, payable monthly. The Fourth Amendment reinstated the liquidity financial covenant and eliminated SVBs springing lien on the Companys intellectual property, the New Capital Transactions requirement and the requirement of the Third Amendment to maintain a blocked cash collateral account with funds equal to the principal balance outstanding.
On April 16, 2012, the Company entered into a new Loan and Security Agreement (the Loan Agreement) with SVB, pursuant to which SVB agreed to make term loans to the Company in an aggregate principal amount of up to $20.0 million ($10.0 million of which has not and may not be funded unless the Company meets the primary endpoints of the ReCharge trial as well as certain financial objectives for 2012 prior to February 15, 2013), on the terms and conditions set forth in the Loan Agreement. The Loan Agreement amends and restates the Prior Loan Agreement, as amended.
Pursuant to the Loan Agreement, a term loan was funded in the aggregate principal amount of $10.0 million on April 23, 2012, a portion of which was used to repay in full the outstanding debt of approximately $4.7 million. The term loan requires interest only payments monthly through March 31, 2013 followed by 30 equal payments of principal in the amount of $333,333 plus accrued interest beginning on April 1, 2013 and ending on September 1, 2015, payable monthly. Amounts borrowed under the Loan Agreement bear interest at a fixed annual rate equal to 8.0%. The final payment fee from the Prior Loan Agreement will be due on September 1, 2015. The Company may voluntarily prepay the term loan in full, but not in part, and any voluntary or mandatory prepayment is subject to applicable prepayment premiums and will also include the final payment fee. The Company is required to comply with certain financial covenants that require the Company to generate certain minimum amounts of revenue from the sale of its Maestro System and to implant certain minimum numbers of Maestro Systems during cumulative quarterly measurement periods beginning with the period ended March 31, 2013 and ending with the period ended June 30, 2015. If the Company fails to meet the financial covenants, the term loan will be in default.
The Company has granted SVB a security interest in all of the Companys assets, excluding intellectual property except with respect to all license, royalty fees and other revenues and income arising out of or relating to any of the intellectual property and all proceeds of the intellectual property. The Company also has entered into a negative pledge arrangement with SVB pursuant to which it has agreed not to encumber any of its intellectual property without SVBs prior written consent. If the Company does not meet the primary endpoints of the ReCharge trial or does not fully disclose the results of the trial to the public prior to February 15, 2013, it will be required to place the lesser of $7.5 million or the outstanding principal balance in a restricted account at SVB.
Pursuant to the Loan Agreement, on April 16, 2012, the Company issued SVB a warrant to purchase 106,746 shares of common stock, exercisable for ten years from the date of grant, at an exercise price of $2.34 per share.
Scheduled debt principal payments are as follows as of September 30, 2012:
Years Ending December 31: |
||||
Remaining three months in 2012 |
$ | | ||
2013 |
3,000,000 | |||
2014 |
4,000,000 | |||
2015 |
3,000,000 | |||
|
|
|||
10,000,000 | ||||
Less: Original issue discount |
(366,598 | ) | ||
|
|
|||
Notes payable, net |
$ | 9,633,402 | ||
|
|
10
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
(5) Stock-based Compensation
The fair value method of accounting for share-based payments is applied to all share-based payment awards issued to employees and where appropriate, nonemployees, unless another source of literature applies. When determining the measurement date of a nonemployees share-based payment award, the Company measures the stock options at fair value and remeasures such stock options to the current fair value until the performance date has been reached.
Based on the application of these standards, stock-based compensation expense for stock-based awards under the Companys Amended and Restated 2003 Stock Incentive Plan for the three and nine months ended September 30, 2012 and 2011 was allocated to operating expenses and employees and nonemployees as follows:
Three months
ended September 30, |
Nine months
ended September 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Research and development |
$ | 319,964 | $ | 208,942 | $ | 606,994 | $ | 680,431 | ||||||||
Selling, general and administrative |
1,008,747 | 488,821 | 2,132,325 | 1,411,627 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 1,328,711 | $ | 697,763 | $ | 2,739,319 | $ | 2,092,058 | ||||||||
|
|
|
|
|
|
|
|
Three months
ended September 30, |
Nine months
ended September 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Employees |
$ | 1,326,311 | $ | 682,733 | $ | 2,687,253 | $ | 2,060,581 | ||||||||
Nonemployees |
2,400 | 15,030 | 52,066 | 31,477 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 1,328,711 | $ | 697,763 | $ | 2,739,319 | $ | 2,092,058 | ||||||||
|
|
|
|
|
|
|
|
As of September 30, 2012 there was approximately $17.5 million of total unrecognized compensation costs, net of estimated forfeitures, related to employee unvested stock option awards granted after January 1, 2006, which are expected to be recognized over a weighted-average period of 3.45 years.
The estimated grant-date fair values of the stock options were calculated using the Black-Scholes valuation model, based on the following assumptions for the three and nine months ended September 30, 2012 and 2011:
Employees | Employees | |||||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Risk-free interest rates |
0.90%-0.97 | % | 1.20%-2.16 | % | 0.90%-1.09 | % | 1.20%-2.68 | % | ||||||||
Expected life |
6.25 years | 6.25 years | 6.00-6.25 years | 5.42-6.25 years | ||||||||||||
Expected dividends |
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Expected volatility |
137.58%-138.38 | % | 116.75%-119.35 | % | 123.18%-141.05 | % | 116.75%-124.40 | % |
11
EnteroMedics Inc.
(A development stage company)
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
Nonemployees | Nonemployees | |||||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Risk-free interest rates |
0.33 | % | 0.66%-1.91 | % | 0.24%-2.05 | % | 0.66%-3.45 | % | ||||||||
Expected life |
2.76 years | 3.75-9.95 years | 2.00-9.25 years | 3.75-9.95 years | ||||||||||||
Expected dividends |
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Expected volatility |
80.13 | % | 116.40%-120.50 | % | 80.13%-139.80 | % | 116.40%-123.80 | % |
Option activity under the Companys Amended and Restated 2003 Stock Incentive Plan for the nine months ended September 30, 2012 was as follows:
Shares Available For Grant |
Outstanding Options | |||||||||||
Number of Shares |
Weighted-Average Exercise Price |
|||||||||||
Balance, December 31, 2011 |
763,829 | 3,470,908 | $ | 3.17 | ||||||||
Shares reserved |
8,000,000 | | | |||||||||
Options granted |
(4,462,873 | ) | 4,462,873 | 3.35 | ||||||||
Options exercised |
| | | |||||||||
Options cancelled |
54,051 | (54,051 | ) | 2.28 | ||||||||
|
|
|
|
|||||||||
Balance, September 30, 2012 |
4,355,007 | 7,879,730 | 3.28 | |||||||||
|
|
|
|
(6) Stock Sales
On April 16, 2012, the Company entered into a securities purchase agreement with a current investor for the sale of 2,271,705 shares of its common stock in a registered direct offering, at a purchase price of $2.223 per share. On April 20, 2012, the offering closed and the Company received gross proceeds of $5.0 million before deducting estimated offering expenses.
(7) Subsequent Events
On October 4, 2012, the Company entered into a Common Stock Purchase Agreement (the Purchase Agreement) with Terrapin Opportunity, L.P. (Terrapin) pursuant to which the Company may sell up to the lesser of $45.0 million of its common stock or 8,312,122 shares of its common stock over an approximately 24-month period pursuant to the terms of the Purchase Agreement. The Company is not obligated to utilize any portion of the facility and generally remains free to enter into and consummate other equity and debt financing transactions.
The Company will determine, at its sole discretion, the timing, the dollar amount and the price per share of each draw under this facility, subject to certain conditions. When and if the Company elects to utilize the facility by delivery of a draw down notice to Terrapin, the Company will issue shares to Terrapin at a discount ranging from 4.00% to 6.80% to the volume weighted average price of the Companys common stock over a preceding period of trading days (a Draw Down Period). The Purchase Agreement also provides that from time to time, at the Companys sole discretion, it may grant Terrapin an option to purchase additional shares of the Companys common stock during each Draw Down Period for an amount of shares specified by the Company based on the trading price of its common stock. Upon Terrapins exercise of such an option, the Company will sell to Terrapin the shares subject to the option at a price equal to the greater of (i) the daily volume weighted average price of the Companys common stock on the day Terrapin notifies the Company of its election to exercise its option or (ii) the threshold price for the option determined by the Company, in each case less a discount ranging from 4.00% to 6.80%.
Terrapin is not required to purchase any shares at a pre-discounted purchase price below $1.25 per share, or any shares that would cause it to hold over 9.9% of the Companys common stock. Any shares sold under this facility will be sold pursuant to a shelf registration statement declared effective by the U.S. Securities and Exchange Commission on August 29, 2012. Subject to earlier termination under certain conditions, the Purchase Agreement will terminate on November 1, 2014.
12
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The following discussion should be read in conjunction with the condensed consolidated financial statements and notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q.
Except for the historical information contained herein, the matters discussed in this Managements Discussion and Analysis of Financial Condition and Results of Operations, are forward-looking statements that involve risks and uncertainties. In some cases, these statements may be identified by terminology such as may, will, should, expects, could, intends, might, plans, anticipates, believes, estimates, predicts, potential, or continue, or the negative of such terms and other comparable terminology. These statements involve known and unknown risks and uncertainties that may cause our results, level of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Factors that may cause or contribute to such differences include, among others, those discussed in Part I, Item 1A, Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2011. Except as may be required by law, we undertake no obligation to update any forward-looking statement to reflect events after the date of this report.
Overview
We are a development stage medical device company with approvals to commercially launch our product in Australia, the European Economic Area and other countries that recognize the European CE Mark. We are focused on the design and development of devices that use neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders. Our proprietary neuroblocking technology, which we refer to as VBLOC therapy, is designed to intermittently block the vagus nerve using high frequency, low energy, electrical impulses. We have a limited operating history and currently, we only have regulatory approval to sell our product in Australia, the European Economic Area and other countries that recognize the European CE Mark and do not have any other source of revenue. Our initial product is the Maestro System, which uses VBLOC therapy to affect metabolic regulatory control, limit the expansion of the stomach, help control hunger sensations between meals, reduce the frequency and intensity of stomach contractions and produce a feeling of early and prolonged fullness. We were formerly known as Beta Medical, Inc. and were incorporated in Minnesota on December 19, 2002. We later reincorporated in Delaware on July 22, 2004. Since inception, we have devoted substantially all of our resources to the development and commercialization of our Maestro System.
Based on our understanding of vagal nerve function and nerve blocking from our preclinical studies and the results of our clinical trials, we believe the Maestro System may offer obese patients a minimally-invasive treatment that has the potential to result in significant and sustained weight loss. We believe that our Maestro System will allow bariatric surgeons to help obese patients who are concerned about the risks and complications associated with currently available restrictive and malabsorptive surgical procedures. In addition, data from our VBLOC-DM2 ENABLE trial outside the United States demonstrate that VBLOC therapy may hold promise in improving obesity-related co-morbidities such as diabetes and hypertension. We are conducting, or plan to conduct, further studies in each of these co-morbidities to assess VBLOC therapys potential in addressing multiple indications.
We continue to evaluate the Maestro System in human clinical trials in the United States, Australia, Mexico, Norway and Switzerland. To date, we have not observed any mortality related to our device or any unanticipated adverse device effects in these clinical trials. We have also not observed any long-term problematic clinical side effects in any patients, including in those patients who have been using the Maestro System for more than one year.
In October 2010, we received an unconditional Investigational Device Exemption (IDE) Supplement approval from the U.S. Food and Drug Administration (FDA) to conduct a randomized, double-blind, parallel-group, multicenter pivotal clinical trial, called the ReCharge trial, testing the effectiveness and safety of VBLOC therapy utilizing our second generation Maestro Rechargeable (RC) System. Enrollment and implantation in the ReCharge trial was completed in December 2011 in 233 patients at 10 centers. All patients in the study received an implanted device and were randomized in a 2:1 allocation to treatment or control groups. The control group received a non-functional device during the study period. All patients are expected to participate in a weight management counseling program. The primary endpoints of efficacy and safety will be evaluated at 12 months, or around December 2012. Assuming we achieve favorable results, we plan to use data from the trial to support a premarket approval (PMA) application for the Maestro Rechargeable System. If the FDA grants us approval, we anticipate we will be able to commercialize the Maestro Rechargeable System in the United States in 2014.
If we obtain FDA approval of our Maestro Rechargeable System we intend to market our products in the United States through a direct sales force supported by field technical and marketing managers who provide training, technical and other support services to our customers. Outside the United States we intend to use direct, dealer and distributor sales models as the
13
targeted geography best dictates. To date, we have relied on third-party manufacturers and suppliers for the production of our Maestro System. We currently anticipate that we will continue to rely on third-party manufacturers and suppliers for the production of the Maestro System.
We obtained European CE Mark approval for our Maestro Rechargeable System in March 2011. In January 2012, the final Maestro Rechargeable System components were listed on the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA). We have been working closely with our Australian distributor, Device Technologies Australia Pty Limited, to bring the Maestro Rechargeable System to the Australian market through a controlled commercial launch and made our first commercial shipment of the Maestro ReChargeable System to Device Technologies Australia Pty Limited in March 2012. We also entered into an exclusive, multi-year agreement with Bader Sultan & Brothers Co. W.L.L. for commercialization and distribution of the Maestro ReChargeable System in the Gulf Coast Countries, including Saudi Arabia, Kuwait, Bahrain, Qatar and the United Arab Emirates and made our first commercial shipments to Bader Sultan & Brothers Co. W.L.L. during the second quarter of 2012. We continue to explore additional select international markets to commercialize the Maestro Rechargeable System, including Europe. The method of assessing conformity with applicable regulatory requirements varies depending on the class of the device, but for our Maestro System (which is considered an Active Implantable Medical Device (AIMD) in Australia and the European Economic Area, and falls into Class III within the United States), the method involves a combination of self-assessment by the manufacturer of the safety and performance of the device, and a third-party assessment by a Notified Body, usually of the design of the device and of the manufacturers quality system. We use DEKRA Certification B.V. (formerly known as KEMA Quality) in the Netherlands as the Notified Body for our CE marking approval process.
We have only recently begun to generate revenue from the sale of products, and we have incurred net losses in each year since our inception. As of September 30, 2012, we had experienced net losses during the development stage of $193.0 million. Although we recently received ARTG listings to sell our Maestro Rechargeable System in Australia and European CE Mark to sell our Maestro Rechargeable System in the European Economic Area and other countries that recognize the European CE Mark, resulting in our first commercial sales in 2012, we expect to incur significant sales and marketing expenses prior to recording sufficient revenue to offset these expenses. We expect our general and administrative expenses to increase as we continue to add the infrastructure necessary to support our initial commercial sales, operate as a public company and develop our intellectual property portfolio. For these reasons, we expect to continue to incur significant and increasing operating losses for the next several years. We have financed our operations to date principally through the sale of capital stock, debt financing and interest earned on investments.
Financial Overview
Revenue
We have received the European CE Mark for our Maestro Rechargeable System, which enables commercialization in the European Economic Area and other countries that recognize the European CE Mark. In January 2012, the final Maestro Rechargeable System components were listed on the ARTG by the Australian TGA and we have been working closely with Device Technologies Australia Pty Limited to bring the Maestro Rechargeable System to the Australian market through a controlled commercial launch and made our first commercial shipment of the Maestro ReChargeable System to Device Technologies Australia Pty Limited in March 2012. We also entered into an exclusive, multi-year agreement with Bader Sultan & Brothers Co. W.L.L. for commercialization and distribution of the Maestro ReChargeable System in the Gulf Coast Countries, including Saudi Arabia, Kuwait, Bahrain, Qatar and the United Arab Emirates and made our first commercial shipments to Bader Sultan & Brothers Co. W.L.L. during the second quarter of 2012. For the nine months ended September 30, 2012, we recognized $311,000 in revenue.
In the United States, we completed enrollment and device implantation in our ReCharge pivotal trial for obesity in December 2011. The primary endpoints of efficacy and safety will be evaluated at 12 months, or around December 2012. Assuming we achieve favorable results, we plan to use data from that trial to pursue a PMA from the FDA to allow us to commence sales in the United States. If the FDA grants us approval, we anticipate we will be able to commercialize the Maestro Rechargeable System in the United States in 2014. Any revenue from initial sales of a new product in the United States or internationally is difficult to predict and in any event will only modestly reduce our continued losses resulting from our research and development and other activities.
Research and Development Expenses
Our research and development expenses primarily consist of engineering, product development and clinical and regulatory expenses, incurred in the development of our Maestro System. Research and development expenses also include employee compensation, including stock-based compensation, consulting services, outside services, materials, supplies, including those related to our various clinical trials, depreciation and travel. We expense research and development costs as
14
they are incurred. From inception through September 30, 2012, we have incurred a total of $124.3 million in research and development expenses. With the completion of enrollment and device implantation in our ReCharge pivotal trial for obesity in late 2011, we expect research and development expenditures to decrease in 2012 as we turn our primary focus to supporting this new clinical trial in addition to the continued follow-up on existing trials, such as VBLOC-DM2 ENABLE and EMPOWER.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses consist primarily of compensation for executive, finance, market development and administrative personnel, including stock-based compensation. Other significant expenses include costs associated with attending medical conferences, professional fees for legal, including legal services associated with our efforts to obtain and maintain broad protection for the intellectual property related to our products, and accounting services, cash management fees, consulting fees and travel expenses. From inception through September 30, 2012, we have incurred $56.5 million in selling, general and administrative expenses. We expect selling, general and administrative expenses to increase modestly in 2012 as we continue a controlled commercial launch in Australia, the Gulf Coast Countries of the Middle East and possibly other select international markets.
Results of Operations
Comparison of the Three Months Ended September 30, 2012 and 2011
Sales and Cost of Goods Sold. There were no sales for the three months ended September 30, 2012 and 2011. We began a controlled commercial launch of the Maestro ReChargeable System in Australia and the Gulf Coast Countries of the Middle East with our first commercial shipments occurring in the first quarter of 2012. Our distributors had enough inventory from prior quarters to continue to provide adequate supply during the third quarter to support the early stages of this controlled launch process.
Research and Development Expenses. Research and development expenses were $2.6 million for the three months ended September 30, 2012, compared to $4.8 million for the three months ended September 30, 2011. The decrease of $2.2 million, or 46.0%, is primarily due to decreases of $1.5 million and $590,000 in professional services and device costs, respectively. Both are the result of our ReCharge pivotal trial for obesity which began to ramp up in early 2011 with the first enrollments and device implantations occurring late in the first quarter of 2011. Ongoing costs in 2012 are for follow-up visits, which are significantly less than the implantation costs.
Selling, General and Administrative Expenses. Selling, general and administrative expenses were $3.0 million for the three months ended September 30, 2012, compared to $2.4 million for the three months ended September 30, 2011. The increase of $637,000, or 27.1%, is primarily due to an increase of $745,000 in compensation and benefits, including $533,000 in stock based compensation, partially offset by a decrease of $74,000 in travel expense. The increase in compensation and benefits, including stock based compensation, is the result of increased staff to support international commercialization efforts as well as a stock option grant made to management on July 10, 2012.
Interest Expense. Interest expense was $264,000 for the three months ended September 30, 2012, compared to $168,000 for the three months ended September 30, 2011. The increase of $96,000, or 57.2%, was the result of an increase in the gross principal balance outstanding from approximately $6.0 million on September 30, 2011 to $10.0 million on September 30, 2012 which was the result of the April 2012 modification to the loan agreement that also increased our annual interest rate from 6.25% to 8.00% effective April 23, 2012 with interest only payments through March 31, 2013.
Comparison of the Nine months Ended September 30, 2012 and 2011
Sales. Sales were $311,000 for the nine months ended September 30, 2012, compared to no sales for the nine months ended September 30, 2011. The $311,000 of sales for the nine months ended September 30, 2012 are the result of beginning a controlled commercial launch of the Maestro ReChargeable System in Australia and the Gulf Coast Countries of the Middle East with our first commercial shipments occurring in the first quarter of 2012.
Cost of Goods Sold. Cost of goods sold were $232,000 for the nine months ended September 30, 2012, compared to no cost of goods sold for the nine months ended September 30, 2011. Gross margin was 25.7% for the nine months ended September 30, 2012.
Research and Development Expenses. Research and development expenses were $7.5 million for the nine months ended September 30, 2012, compared to $10.9 million for the nine months ended September 30, 2011. The decrease of $3.4 million, or 30.9%, is primarily due to decreases of $1.6 million and $1.6 million in device costs and professional services, respectively. The decreases in device costs and professional services are primarily the result of the completion of enrollments and device implantation in our ReCharge pivotal trial for obesity in late 2011. Ongoing costs in 2012 are for follow-up visits, which are significantly less than the implantation costs.
15
Selling, General and Administrative Expenses. Selling, general and administrative expenses were $8.3 million for the nine months ended September 30, 2012, compared to $6.5 million for the nine months ended September 30, 2011. The increase of $1.9 million, or 28.6%, is primarily due to an increase of $1.4 million in compensation and benefits, including $700,000 in stock based compensation, and an increase of $449,000 in professional services. The increase in compensation and benefits, including stock based compensation, is the result of increased staff to support international commercialization efforts as well as a stock option grant made to management on July 10, 2012. The increase in professional services is also the result of international commercialization efforts.
Interest Expense. Interest expense was $637,000 for the nine months ended September 30, 2012, compared to $564,000 for the nine months ended September 30, 2011, an increase of $73,000, or 12.9%. Loan modifications occurred in March 2011 and April 2012. The March 2011 loan modification reduced the interest rate from 11.00% to 6.25% with interest only payments through September 30, 2011. The principal balance was approximately $6.0 million at the time of the modification. The April 2012 loan modification increased the interest rate from 6.25% to 8.00% effective April 23, 2012 with interest only payments through March 31, 2013. The April 2012 loan modification resulted in the principal balance increasing from $4.7 million to $10.0 million.
Liquidity and Capital Resources
We have incurred losses since our inception in December 2002 and, as of September 30, 2012, we had experienced net losses during the development stage of $193.0 million. We have financed our operations to date principally through the sale of capital stock, debt financing and interest earned on investments. Through December 31, 2011, we had received net proceeds of $173.8 million from the sale of common stock and preferred stock, including $39.1 million from our initial public offering in November 2007 and $71.5 million from public, private placement and registered direct offerings from 2009 through 2011. In addition, through December 31, 2011 we had received $35.8 million in debt financing, $746,000 to finance equipment purchases and $35.0 million to finance working capital. On April 20, 2012, we completed the sale of 2,271,705 shares of common stock in a registered direct offering at a purchase price of $2.223 per share. We received gross proceeds of $5.0 million before deducting estimated offering expenses. We have also received approximately $5.5 million from the exercise of common stock warrants during the nine months ended September 30, 2012.
As of September 30, 2012, we had $27.4 million in cash, cash equivalents and restricted cash. Of this amount $22.9 million was invested in short-term money market funds that are not considered to be bank deposits and are not insured or guaranteed by the federal deposit insurance company or other government agency. These money market funds seek to preserve the value of the investment at $1.00 per share; however, it is possible to lose money investing in these funds. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. At times, such deposits may be in excess of insured limits. We have not experienced any losses on our deposits of cash and cash equivalents. We believe that our cash, cash equivalents and restricted cash balance of approximately $27.4 million as of September 30, 2012, and any interest income we earn on these balances, will be sufficient to meet our anticipated cash requirements (including scheduled or potentially accelerated debt obligations) well into 2013, assuming our planned commercialization and we do not receive any other additional funds.
On April 16, 2012, we entered into a new loan agreement with SVB pursuant to which SVB agreed to make term loans to us in an aggregate principal amount of up to $20.0 million ($10.0 million of which has not and may not be funded unless we meet the primary endpoints of the ReCharge trial as well as certain financial objectives for 2012 prior to February 15, 2013). Pursuant to the loan agreement, a term loan was funded in the aggregate principal amount of $10.0 million on April 23, 2012, a portion of which was used to repay in full the outstanding debt of approximately $4.7 million. The new term loan requires interest only payments monthly through March 31, 2013 followed by 30 equal payments of principal in the amount of $333,333 plus accrued interest beginning on April 1, 2013 and ending on September 1, 2015, payable monthly. Amounts borrowed under the new loan agreement bear interest at a fixed annual rate equal to 8.0%. See Note 4 to our condensed consolidated financial statements included in Part I, Item 1, of this Quarterly Report on Form 10-Q for a more detailed description of the new loan agreement.
On October 4, 2012, we entered into a Common Stock Purchase Agreement (the Purchase Agreement) with Terrapin Opportunity, L.P. (Terrapin) under which we may sell up to the lesser of $45.0 million of common stock or 8,312,122 shares of our common stock over an approximately 24-month period pursuant to the terms of the Purchase Agreement. We are not obligated to utilize any portion of the facility and we generally remain free to enter into and consummate other equity and debt financing transactions. We will determine, at our sole discretion, the timing, the dollar amount and the price per share of each draw under this facility, subject to certain conditions. When and if we elect to use the facility, we will issue shares to Terrapin at a discount ranging from 4.00% to 6.80% to the volume weighted average price of our common stock over a preceding period of trading days. Terrapin is not required to purchase any shares at a pre-discounted purchase price below $1.25 per share, or any shares that would cause it to hold over 9.9% of our common stock. Any shares sold under this facility will be sold pursuant to a shelf registration statement declared effective by the U.S Securities and Exchange Commission (SEC) on August 29, 2012. Subject to earlier termination under certain conditions, the Purchase Agreement will terminate on November 1, 2014.
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Net Cash Used in Operating Activities
Net cash used in operating activities was $17.0 million and $14.5 million for the nine months ended September 30, 2012 and 2011, respectively. Net cash used in operating activities primarily reflects the net loss for those periods, which was partially offset by depreciation and amortization, stock-based compensation and changes in operating assets and liabilities. The increase of $2.5 million is primarily due to a decrease in accrued expenses as payments related to 2011 ReCharge trial activity began to be paid during the nine months ended September 30, 2012.
Net Cash Provided by (Used in) Investing Activities
Net cash provided by investing activities was $948,000 and $3.1 million for the nine months ended September 30, 2012 and 2011, respectively. Net cash provided by investing activities for the nine months ended September 30, 2012 was primarily attributable to $1.0 million in maturities of short-term investments available for sale. Net cash provided by investing activities for the nine months ended September 30, 2011 was primarily attributable to a $6.3 million decrease in the restricted cash balance as a result of the Fourth Amendment to the SVB loan agreement and $2.0 million in maturities of short-term investments available for sale offset by $5.0 million in purchases of short-term investments available for sale and $239,000 of property and equipment purchases.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $14.7 million and $13.0 million for the nine months ended September 30, 2012 and 2011, respectively. Net cash provided by financing activities for the nine months ended September 30, 2012 was primarily the result of $5.3 million in net proceeds from the initial term loan funded pursuant to the new loan agreement entered into on April 16, 2012 with SVB, net proceeds of $4.7 million from the April 16, 2012 registered direct offering and $5.5 million from the exercise of common stock warrants. These increases were partially offset by principal repayments of $753,000 on our note payable. Net cash provided by financing activities for the nine months ended September 30, 2011 was primarily attributable to the completion of a public offering that resulted in gross proceeds of $14.5 million for the issuance of common stock and common stock warrants, offset by $1.2 million in financing costs incurred through September 30, 2011, partially offset by repayments on our note payable of $367,000.
Operating Capital and Capital Expenditure Requirements
We have only recently begun to generate revenue from the sale of products. We obtained European CE Mark approval for our Maestro Rechargeable System in March 2011. In January 2012, the final Maestro Rechargeable System components were listed on the ARTG by the TGA. We have been working closely with our Australian distributor, Device Technologies Australia Pty Limited, to bring the Maestro Rechargeable System to the Australian market through a controlled commercial launch and made our first commercial shipment of the Maestro ReChargeable System to Device Technologies Australia Pty Limited in March 2012. We also entered into an exclusive, multi-year agreement with Bader Sultan & Brothers Co. W.L.L. for commercialization and distribution of the Maestro ReChargeable System in the Gulf Coast Countries, including Saudi Arabia, Kuwait, Bahrain, Qatar and the United Arab Emirates and began commercial shipments to Bader Sultan & Brothers Co. W.L.L. during the second quarter of 2012. We continue to explore additional select international markets to commercialize the Maestro Rechargeable System, including Europe. In the United States, we completed enrollment and device implantation in our ReCharge pivotal trial for obesity in December 2011. The primary endpoints of efficacy and safety will be evaluated at 12 months, or around December 2012. Assuming we achieve favorable results, we plan to use data from that trial to pursue a PMA from the FDA to allow us to commence sales in the United States. If the FDA grants us approval, we anticipate we will be able to commercialize the Maestro Rechargeable System in the United States in 2014. We anticipate that we will continue to incur substantial net losses for the next several years as we develop our products, prepare for the potential commercial launch of our Maestro Rechargeable System, develop the corporate infrastructure required to sell our products, operate as a publicly-traded company and pursue additional applications for our technology platform.
We believe that our cash, cash equivalents and restricted cash balance of approximately $27.4 million as of September 30, 2012, and any interest income we earn on these balances, will be sufficient to meet our anticipated cash requirements (including scheduled or potentially accelerated debt obligations) well into 2013, assuming our planned commercialization and we do not receive any other additional funds. If our available cash, cash equivalents and restricted cash balances are insufficient to satisfy our liquidity requirements, we may seek additional funding through our existing issuer managed equity financing facility with Terrapin, sell additional equity or debt securities or enter into a credit facility. Obtaining funds through our existing issuer managed equity financing facility or through the sale of additional equity and debt securities may result in dilution to our stockholders. If we raise additional funds through the issuance of debt securities, these securities could have rights senior to those of our common stock and could
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contain covenants that would restrict our operations. We may require additional capital beyond our currently forecasted amounts. Any such required additional capital may not be available on reasonable terms, if at all. If we are unable to obtain additional financing, we may be required to reduce the scope of, delay, or eliminate some or all of, our planned research, development and commercialization activities, which could materially harm our business.
Our forecast of the period of time through which our financial resources will be adequate to support our operations, the costs to complete development of products and the cost to commercialize our products are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in Part I, Item 1A, Risk Factors, of our Annual Report on Form 10-K for the year ended December 31, 2011. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
Because of the numerous risks and uncertainties associated with the development of medical devices, such as our Maestro System, we are unable to estimate the exact amounts of capital outlays and operating expenditures necessary to complete the development of the products and successfully deliver a commercial product to the market. Our future capital requirements will depend on many factors, including but not limited to the following:
| the scope, rate of progress, results and cost of our clinical trials and other research and development activities; |
| the cost and timing of regulatory approvals; |
| the cost and timing of establishing sales, marketing and distribution capabilities; |
| the cost of any recalls or other field actions required either by us or by regulatory bodies in those countries in which we market our products; |
| the cost of establishing clinical and commercial supplies of our Maestro System and any products that we may develop; |
| the rate of market acceptance of our Maestro System and VBLOC therapy and any other product candidates; |
| the cost of filing and prosecuting patent applications and defending and enforcing our patent and other intellectual property rights; |
| the cost of defending, in litigation or otherwise, any claims that we infringe third-party patent or other intellectual property rights; |
| the effect of competing products and market developments; |
| the cost of explanting clinical devices; |
| the terms and timing of any collaborative, licensing or other arrangements that we may establish; |
| any revenue generated by sales of our Maestro System or our future products; and |
| the extent to which we invest in products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions. |
Critical Accounting Policies and Estimates
We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the United States. In doing so, we have to make estimates and assumptions that affect our reported amounts of assets, liabilities and expenses, as well as related disclosure of contingent assets and liabilities. In many cases, we could reasonably have used different accounting policies and estimates. In some cases, changes in the accounting estimates are reasonably likely to occur from period to period. Accordingly, actual results could differ materially from our estimates. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations will be affected. We base our estimates on past experiences and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis.
Our significant accounting policies are fully described in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC.
Contractual Obligations
During the nine months ended September 30, 2012, there were no material changes to our contractual obligation disclosures as set forth under the caption, Contractual Obligations in Part II, Item 7, Managements Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2011.
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The following table summarizes our contractual obligations as of September 30, 2012 and the effect those obligations are expected to have on our financial condition and liquidity position in future periods:
Payments Due By Period | ||||||||||||||||||||
Contractual Obligations |
Total | Less Than
1 Year |
1-3 Years | 3-5 Years | More than 5 Years |
|||||||||||||||
Operating lease |
$ | 869,872 | $ | 284,235 | $ | 585,637 | $ | | $ | | ||||||||||
Long-term debt, including interest |
11,952,074 | 2,776,963 | 9,175,111 | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total contractual cash obligations |
$ | 12,821,946 | $ | 3,061,198 | $ | 9,760,748 | $ | | $ | | ||||||||||
|
|
|
|
|
|
|
|
|
|
The table above reflects only payment obligations that are fixed and determinable. Our operating lease commitments relate to our corporate headquarters in St. Paul, Minnesota.
Off-Balance Sheet Arrangements
As of September 30, 2012, we did not have any off-balance sheet arrangements.
Recent Accounting Pronouncements
In June 2011, the Financial Accounting Standards Board issued guidance on the presentation of comprehensive income in financial statements. Entities are required to present total comprehensive income either in a single, continuous statement of comprehensive income or in two separate, but consecutive, statements. We adopted this standard during the first quarter of 2012 and present net loss and other comprehensive loss in two separate, but consecutive, statements. The adoption of this standard did not have a material effect on our financial statement disclosures.
There were no other significant changes in recent accounting pronouncements during the nine months ended September 30, 2012 as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the year ended December 31, 2011.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Our exposure to market risk is confined to our cash, cash equivalents and restricted cash. As of September 30, 2012, we had approximately $27.4 million in cash, cash equivalents and restricted cash. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. To achieve our goals, we may maintain a portfolio of cash equivalents and investments in a variety of securities of high credit quality. The securities in our investment portfolio, if any, are not leveraged, are classified as either available for sale or held-to-maturity and are, due to their very short-term nature, subject to minimal interest rate risk. We currently do not hedge interest rate exposure. Because of the short-term maturities of our cash equivalents, we do not believe that an increase in market rates would have any material negative impact on the value of our investment portfolio. We have no investments denominated in foreign currencies and therefore our investments are not subject to foreign currency exchange risk.
ITEM 4. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), defines the term disclosure controls and procedures as those controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms and that such information is accumulated and communicated to the companys management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on their evaluation as of September 30, 2012, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms.
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Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 1. | LEGAL PROCEEDINGS |
We are not currently a party to any litigation and we are not aware of any pending or threatened litigation against us that could have a material adverse effect on our business, operating results or financial condition. The medical device industry in which we operate is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, we may be involved in various legal proceedings from time to time.
ITEM 1A. | RISK FACTORS |
There have been no material changes during the nine months ended September 30, 2012 to the risk factors set forth in Part I, Item 1A, Risk Factors, of our Annual Report on Form 10-K for the year ended December 31, 2011.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Unregistered Sales of Equity Securities
As previously described in our Current Report on Form 8-K filed April 17, 2012, on April 16, 2012, we entered into a new Loan and Security Agreement with Silicon Valley Bank. As required by the new agreement, on April 16, 2012, we issued a warrant to Silicon Valley Bank to purchase 106,746 shares of our common stock with an exercise price of $2.34 per share and a ten year exercise period. See Note 4 to our condensed consolidated financial statements included in Part I, Item 1, of this Quarterly Report on Form 10-Q for more detail about the loan agreement. The sale and issuance of this warrant was deemed to be exempt from registration under the Securities Act of 1933 (the Securities Act) by virtue of Section 4(2) of the Securities Act, as a transaction by an issuer not involving any public offering.
Uses of Proceeds from Sale of Registered Securities
None.
Purchases of Equity Securities
None.
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
ITEM 4. | MINE SAFETY DISCLOSURES |
Not applicable.
ITEM 5. | OTHER INFORMATION |
None.
ITEM 6. | EXHIBITS |
The list of exhibits on the accompanying Exhibit Index are filed or incorporated by reference (as stated therein) as part of this Quarterly Report on Form 10-Q.
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Pursuant to the requirements of Section 13 or 15(d) 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.
ENTEROMEDICS INC. | ||
BY: | /S/ MARK B. KNUDSON, PH.D. | |
Mark B. Knudson, Ph.D. | ||
President and Chief Executive Officer (Principal Executive Officer) | ||
BY: | /S/ GREG S. LEA | |
Greg S. Lea | ||
Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) |
Dated: November 8, 2012
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EXHIBIT INDEX
Exhibit Number |
Description of Document | |
3.1* | Fifth Amended and Restated Certificate of Incorporation of the Company and all amendments thereto. | |
3.2 | Amended and Restated Bylaws of the Company, as currently in effect. (Incorporated herein by reference to Exhibit 3.4 to Amendment No. 1 to the Companys Registration Statement on Form S-1 filed on July 6, 2007 (File No. 333-143265)). | |
4.1 | Amended and Restated Investors Rights Agreement, dated as of July 6, 2006, by and between the Company and the parties named therein. (Incorporated herein by reference to Exhibit 4.2 to the Companys Registration Statement on Form S-1 filed on May 25, 2007 (File No. 333-143265)). | |
10.1 | Distribution Agreement, dated as of February 21, 2012, by and between Bader Sultan & Brothers Co. W.L.L. and the Company. (Incorporated herein by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q filed on May 10, 2012 (File No. 1-33818)). | |
10.2 | Securities Purchase Agreement, dated as of April 16, 2012, between the Company and the purchasers identified on Schedule A thereto. (Incorporated herein by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on April 17, 2012 (File No. 1-33818)). | |
10.3 | Loan and Security Agreement, dated April 16, 2012, between the Company and Silicon Valley Bank. (Incorporated herein by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q/A filed on August 3, 2012 (File No. 1-33818)). | |
10.4 | Form of Warrant to purchase stock under Loan and Security Agreement, dated April 16, 2012, between the Company and Silicon Valley Bank. (Incorporated herein by reference to Exhibit 10.4 to the Companys Quarterly Report on Form 10-Q filed on May 10, 2012 (File No. 1-33818)). | |
10.5 | Amendment No. 3, effective as of February 3, 2012, to License Agreement between Mayo Foundation for Medical Education and Research and the Company. (Incorporated herein by reference to Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q filed on August 8, 2012 (File No. 1-33818)). | |
10.6 | Amendment No. 1, effective as of July 10, 2012, to Distribution Agreement by and between Device Technologies Australia Pty Limited and the Company. (Incorporated herein by reference to Exhibit 10.6 to the Companys Quarterly Report on Form 10-Q filed on August 8, 2012 (File No. 1-33818)). | |
10.7 | Form of 2012 Senior Management Non-Incentive Stock Option Agreement pursuant to the 2003 Stock Incentive Plan. (Incorporated herein by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on July 13, 2012 (File No. 1-33818)). | |
10.8 | Amended and Restated 2003 Stock Incentive Plan. (Incorporated herein by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on September 28, 2012 (File No. 1-33818)). | |
10.9 | Common Stock Purchase Agreement, dated as of October 4, 2012, by and between Terrapin Opportunity, L.P. and the Company. (Incorporated herein by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on October 4, 2012 (File No. 1-33818)). | |
31.1* | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2* | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1* | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2* | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
101* | Financial statements from the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2012, formatted in Extensible Business Reporting Language: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations, (iii) the Condensed Consolidated Statements of Comprehensive Loss, (iv) the Condensed Consolidated Statements of Cash flows and (v) the Notes to Condensed Consolidated Financial Statements. |
* | Filed herewith. |
| Indicates management contract or compensation plan or agreement. |
22
Exhibit 3.1
FIFTH AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
ENTEROMEDICS INC.
EnteroMedics Inc., a corporation organized and existing under the General Corporation Law of the State of Delaware (as amended from time to time, the General Corporation Law), does hereby certify as follows:
FIRST: The name of the corporation is EnteroMedics Inc. and the name under which the corporation was originally incorporated is EnteroMedics Inc.
SECOND: The date of filing the original Certificate of Incorporation of this corporation with the Secretary of State of the State of Delaware was July 22, 2004.
THIRD: This Fifth Amended and Restated Certificate of Incorporation, having been duly adopted in accordance with Sections 242 and 245 of the General Corporation Law and by the written consent of a majority of the stockholders of this corporation in accordance with Section 228 of the General Corporation Law, restates and integrates and further amends the provisions of the original Certificate of Incorporation as amended or supplemented heretofore. As so restated and integrated and further amended, the Fifth Amended and Restated Certificate of Incorporation of the corporation (the Amended and Restated Certificate of Incorporation) reads as follows:
ARTICLE I
NAME
The name of the corporation (hereinafter called the Corporation) is EnteroMedics Inc.
ARTICLE II
REGISTERED OFFICE
The address of the registered office of the Corporation in the State of Delaware is 1209 Orange Street in the City of Wilmington, County of New Castle, and the name of the registered agent of the Corporation in the State of Delaware at such address is The Corporation Trust Company.
ARTICLE III
PURPOSE
The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law.
ARTICLE IV
CAPITAL STOCK
1. Authorized Stock. The Corporation is authorized to issue two classes of shares to be designated respectively Preferred Stock, par value $0.01 per share, and Common Stock, par value $0.01 per share. The total number of shares of Preferred Stock authorized is 5,000,000. The total number of shares of Common Stock authorized is 50,000,000.
2. Common Stock.
All shares of Common Stock shall be identical and shall entitle the holders thereof to the same rights and privileges. Subject to the rights of the holders of any series of Preferred Stock, and subject to any other provisions of this Amended and Restated Certificate of Incorporation, holders of Common Stock shall be entitled to receive such dividends and other distributions in cash, stock of any corporation or property of the Corporation as may be declared thereon by the Board of Directors from time to time out of assets or funds of the Corporation legally available therefor. When and as dividends are declared on the Common Stock, whether payable in cash, in property or in securities of the Corporation, the holders of the Common Stock shall be entitled to share equally, share for share, in such dividends.
Upon any liquidation, dissolution or winding-up of the Corporation, whether voluntary or involuntary, after the payment in full of all amounts to which the holders of each series, if any, of the Preferred Stock shall be entitled, the remaining assets of the Corporation to be distributed ratably to the holders of the stock of the Corporation shall be distributed ratably among the holders of the shares of Common Stock, together with the holders of the shares of any class of stock on a parity with the Common Stock. For purposes of this paragraph, unless otherwise provided with respect to any series of Preferred Stock, the voluntary sale, conveyance, lease, exchange or transfer (for cash, shares of stock, securities or other consideration) of all or substantially all of the assets of the Corporation or a consolidation or merger of the Corporation with one or more other corporations (whether or not the Corporation is the corporation surviving such consolidation or merger) shall not be deemed to be a liquidation, dissolution or winding up, either voluntary or involuntary.
The holders of shares of the Common Stock shall be entitled to vote on all matters to be voted on by the stockholders of the Corporation; provided, however, that, except as otherwise required by law, holders of Common Stock shall not be entitled to vote on any amendment to this Amended and Restated Certificate of Incorporation (including any certificate of designation filed with respect to any series of Preferred Stock) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon by law or pursuant to this Amended and Restated Certificate of Incorporation (including any certificate of designation filed with respect to any series of Preferred Stock). On all matters to be voted on by the holders of the Common Stock, the holders shall be entitled to one vote in person or by proxy for each share thereof held of record.
Subject to the rights of the holders of any series of Preferred Stock, stockholders of the Corporation shall not have any preemptive rights to subscribe for, purchase or receive any part of any new or additional issue of stock of the Corporation and no stockholder will be entitled to cumulate votes at any election of directors.
3. Preferred Stock. The Board of Directors is authorized, subject to limitations prescribed by law, to provide by resolution or resolutions for the issuance of shares of Preferred Stock from time to time in one or more series, and, by filing a certificate pursuant to the applicable law of the State of Delaware (each a Preferred Stock Designation), to establish the number of shares to be included in each such series, and to fix the voting powers (if any), designations, powers, preferences, and relative, participating, optional or other rights, if any, of the shares of each such series, and any qualifications, limitations and restrictions thereof. The shares of Preferred Stock of any one series shall be identical with each other in all respects except as to the dates from and after which dividends thereon shall cumulate, if cumulative.
The authority of the Board of Directors with respect to each series shall include, but not be limited to, determination of the following:
(a) the designation of the series, which may be by distinguishing number, letter or title;
(b) the number of the shares of the series, which number the Board of Directors may thereafter (except where otherwise provided in the Preferred Stock Designation) increase or decrease (but not below the number of shares of such series then outstanding);
(c) whether dividends, if any, shall be cumulative or noncumulative and the dividend rate of the series;
(d) the dates at which dividends, if any, shall be payable;
(e) the redemption rights and price or prices, if any, for shares of the series;
(f) the terms and amount of any sinking fund provided for the purchase or redemption of shares of the series;
(g) the amounts payable on, and the preferences, if any, of shares of the series in the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Corporation;
(h) whether the shares of the series shall be convertible or exchangeable into shares of any other class or series, or any other security, of the Corporation or any other corporation, and, if so, the specification of such other class or series or of such other security, the conversion price or prices or exchange rate or rates, any adjustments thereof, the date or dates at which such shares shall be convertible or exchangeable and all other terms and conditions upon which such conversion or exchange may be made;
(i) restrictions on the issuance of shares of the same series or of any other class or series;
(j) the voting rights, if any, of the holders of shares of the series; and
(k) such other powers, preferences and relative, participating, optional and other special rights, and the qualifications, limitations and restrictions thereof as the Board of Directors shall determine.
ARTICLE V
BYLAWS
In furtherance and not in limitation of the powers conferred by statute and except as provided herein or in the bylaws, the Board of Directors shall have the power to adopt, amend, repeal or otherwise alter, from time to time, the bylaws without any action on the part of the stockholders in accordance with the bylaws; provided, however, that any bylaws made by the Board of Directors and any and all powers conferred by any of said bylaws may be amended, altered or repealed by the affirmative vote of the holders of at least a majority of the voting power of the then outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors (Voting Stock), voting together as a single class.
ARTICLE VI
LIMITATION OF DIRECTORS LIABILITY; INDEMNIFICATION
A director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for any breach of the directors duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involved intentional misconduct or a knowing violation of law, (iii) under Section 174 of the General Corporation Law, or (iv) for any transaction from which the director derived an improper personal benefit. Each person who is or was a director or officer of the Corporation, and each person who
serves or served at the request of the Corporation as a director or officer of another enterprise, shall be indemnified by the Corporation in accordance with, and to the fullest extent authorized by, the General Corporation Law.
If the General Corporation Law is hereafter amended to authorize the further elimination or limitation of the liability of a director, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law as so amended.
Any repeal or modification of the foregoing provisions of this Article VI by the stockholders of the Corporation shall not adversely affect any right or protection of a director of the Corporation existing at the time of such repeal or modification with respect to acts or omissions occurring prior to such repeal or modification.
ARTICLE VII
ELECTION OF DIRECTORS
The election of directors need not be by written ballot unless the bylaws of the Corporation shall so provide.
ARTICLE VIII
BOARD OF DIRECTORS
1. Business and Quorum. The business of the Corporation shall be managed by or under the direction of the Board of Directors. A majority of the whole Board of Directors shall constitute a quorum for the transaction of business. Any director may tender his resignation at any time.
2. Number; Classes and Term. Subject to the rights of holders of any series of Preferred Stock to elect directors, the number of directors of the Corporation shall be established exclusively by the Board of Directors. Subject to the rights of the holders of any series of Preferred Stock to elect additional directors under specified circumstances, the Board of Directors shall be divided into three classes designated as Class I, Class II and Class III, respectively. The terms of office of the Class I directors shall expire and Class I directors shall be elected for a full term of three years at the annual meeting of stockholders in 2008. The term office of the Class II directors shall expire and Class II directors shall be elected for a full term of three years at the annual meeting of stockholders in 2009. The term of office for the Class III directors shall expire and Class III directors shall be elected for a full term of three years at the annual meeting in 2010. At each succeeding annual meeting of stockholders, directors shall be elected for a full term of three years to succeed the directors of the class whose terms expire at such annual meeting. The Board of Directors is authorized to assign members of the Board of Directors already in office to Class I, Class II or Class III.
Notwithstanding the foregoing provisions of this section, each director shall serve until his successor is duly elected and qualified or until his death, resignation or removal. No decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director. If the number of directors is hereafter changed, any increase or decrease shall be apportioned among the classes so as to maintain the number of directors in each class as nearly equal as possible, except as may be expressly provided as to any directors who may be elected by the holders of any series of Preferred Stock.
3. Removal of Directors. Subject to the rights of the holders of any series of Preferred Stock then outstanding, any director, or the entire Board of Directors, may be removed from office at any time, only for cause, and only by the affirmative vote of the holders of at least a majority of the Voting Stock.
4. Vacancies. Subject to the rights of the holders of any series of Preferred Stock then outstanding, newly created directorships resulting from any increase in the authorized number of directors or any vacancies in the Board of Directors resulting from death, resignation, retirement, disqualification, or other cause may be filled only by a majority vote of the directors then in office, though less than a quorum, and shall not be filled by the stockholders, with the director so elected to serve for the remainder of the term of the director being replaced or, in the case of an additional director, for the remainder of the term of the class to which the director has been assigned. No decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director.
ARTICLE IX
STOCKHOLDER ACTION BY WRITTEN CONSENT
Action shall be taken by the stockholders of the Corporation only at annual or special meetings of the stockholders, and stockholders may not act by written consent. Special meetings of the stockholders, for any purpose or purposes prescribed in the notice of the meeting, may be called by (a) the Board of Directors pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exist any vacancies in previously authorized directorships at the time any such resolution is presented to the Board for adoption) or (b) the Chairman of the Board, and shall be held at such place, on such date, and at such time as they shall fix. Business transacted at special meetings shall be confined to the purpose or purposes stated in the notice.
ARTICLE X
AMENDMENT
The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Amended and Restated Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon stockholders herein are granted subject to this reservation; provided, however, that no Preferred Stock Designation shall be amended after the issuance of any shares of the series of Preferred Stock created thereby, except in accordance with the terms of such Preferred Stock Designation and the requirements of applicable law.
IN WITNESS WHEREOF, EnteroMedics Inc. has caused this Amended and Restated Certificate to be signed by Mark B. Knudson, its Chief Executive Officer, this 20th day of November, 2007.
By: | /s/ Mark B. Knudson | |
Name: | Mark B. Knudson | |
Title: | Chief Executive Officer |
CERTIFICATE OF AMENDMENT
TO THE
FIFTH AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
ENTEROMEDICS INC.
I, Greg S. Lea, certify that:
1. The following resolution was duly adopted and approved by the board of directors of EnteroMedics Inc. (the Corporation) at a meeting of the board of directors held on May 5, 2009, in accordance with the applicable provisions of Section 242 of the General Corporation Law of the State of Delaware:
RESOLVED, that Article IV, Section 1 of the Fifth Amended and Restated Certificate of Incorporation of EnteroMedics Inc. is hereby amended and restated to read in full as follows:
1. Authorized Stock. The Corporation is authorized to issue two classes of shares to be designated respectively Preferred Stock, par value $0.01 per share, and Common Stock, par value $0.01 per share. The total number of shares of Preferred Stock authorized is 5,000,000. The total number of shares of Common Stock authorized is 85,000,000.
2. The foregoing amendment was duly adopted by the stockholders of the Corporation in accordance with Section 242 of the General Corporation Law of the State of Delaware on July 2, 2009 at a Special Meeting of the Stockholders of the Corporation, and such resolution has not been subsequently modified or rescinded.
Dated: July 2, 2009
/s/ Greg S. Lea |
Greg S. Lea |
Senior Vice President, |
Chief Financial Officer and Secretary |
CERTIFICATE OF AMENDMENT
TO THE
FIFTH AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
ENTEROMEDICS INC.
I, Greg S. Lea, certify that:
1. The following resolution was duly adopted and approved by the Board of Directors of EnteroMedics Inc. (the Corporation) by unanimous written consent effective as of June 24, 2010, in accordance with the applicable provisions of Section 242 of the General Corporation Law of the State of Delaware.
RESOLVED, that Article IV of the Fifth Amended and Restated Certificate of Incorporation of the Company shall be amended to add a new Section 4 (the Amendment) to read in full as follows:
4. Reverse Stock Split. At the close of the trading market on the filing date hereof with the Delaware Secretary of State, the issued and outstanding shares of the Corporations Common Stock shall be reverse split, and each six (6) shares thereof, as determined by the Board of Directors, shall be deemed exchanged for one (1) share of the Corporations Common Stock without any further action by the holder thereof. Any resulting fractional shares will be rounded up to a whole share.
2. The foregoing amendment was duly adopted by the stockholders of the Corporation in accordance with Section 242 of the General Corporation Law of the State of Delaware on May 6, 2010 at the Annual Meeting of the Stockholders of the Corporation, and such resolution has not been subsequently modified or rescinded.
Dated: July 9, 2010
/s/ Greg S. Lea |
Greg S. Lea |
Senior Vice President, |
Chief Financial Officer and Secretary |
ENTEROMEDICS INC.
CERTIFICATE OF DESIGNATIONS
FOR
SERIES A NONVOTING CONVERTIBLE PREFERRED STOCK
(PURSUANT TO DELAWARE GENERAL CORPORATION LAW,
SECTION 151(G))
The undersigned, being the Chief Financial Officer, Vice President and Secretary of EnteroMedics Inc. (the Corporation), a corporation organized and existing under the Delaware General Corporation Law, in accordance with the provisions of the Delaware General Corporation Law, Section 151(g), do hereby certify that:
Pursuant to the authority vested in the Board of Directors of the Corporation by the Fifth Amended and Restated Certificate of Incorporation of the Corporation, the Board of Directors of the Corporation on September 9, 2010, in accordance with the Delaware General Corporation Law, Section 151, duly adopted the following resolution establishing a series of 3,600,000 shares of the Corporations Preferred Stock, to be designated as its Series A NonVoting Convertible Preferred Stock:
RESOLVED, that pursuant to the authority vested in the Board of Directors of the Corporation (the Board of Directors) by the Fifth Amended and Restated Certificate of Incorporation of the Corporation, the Board of Directors hereby establishes a series of Series A NonVoting Convertible Preferred Stock of the Corporation and hereby states the number of shares and fixes the powers, designations, preferences and relative, participating, optional and other rights, and the qualifications, limitations and restrictions thereof, of such series of shares as follows:
SERIES A NONVOTING CONVERTIBLE PREFERRED STOCK
Section 1. Designation; Number of Shares. The shares of such series shall be designated as Series A NonVoting Convertible Preferred Stock (the Convertible Preferred Stock), and the number of shares constituting the Convertible Preferred Stock shall be 3,600,000. Such number of shares may be decreased by resolution of the Board of Directors adopted and filed pursuant to the Delaware General Corporation Law, Section 151(g), or any successor provision; provided, that no such decrease shall reduce the number of authorized shares of Convertible Preferred Stock to a number less than the number of shares then outstanding plus the number of shares reserved for issuance upon the exercise of outstanding options, warrants, convertible or exchangeable securities or other rights to acquire shares of Convertible Preferred Stock.
Section 2. Stated Capital. The amount to be represented in the stated capital of the Corporation for each share of Convertible Preferred Stock shall be $0.01.
Section 3. Rank. The Convertible Preferred Stock shall rank prior to all of the Corporations Common Stock, par value $0.01 per share (the Common Stock), now outstanding or hereafter issued, as to distributions of assets upon the liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary.
Section 4. Dividends. So long as any shares of Convertible Preferred Stock remain outstanding, if the Corporation makes any dividend or distribution of cash, securities (including, but not limited to, rights, warrants, options or evidences of indebtedness) or properties or assets on shares of Common Stock, then the Corporation shall simultaneously declare and pay a dividend or distribution on shares of Convertible Preferred Stock in the amount of dividends or distributions that would be made with respect to shares of Convertible Preferred Stock if such shares were converted into shares of Common Stock on the record date for such dividend or distribution (or if no record date is established, at the date such dividend or distribution is declared).
Section 5. Liquidation Preference. In the event of a liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary, the holders of Convertible Preferred Stock shall be entitled to receive out of the assets of the Corporation, whether such assets constitute stated capital or surplus of any nature, an amount equal to the dividends accumulated and unpaid thereon to the date of final distribution to such holders, whether or not declared, without interest, plus a sum equal to $2.58 per share, and no more, before any payment shall be made or any assets distributed to the holders of Common Stock or any other capital stock of the Corporation ranking junior as to liquidation rights to the Convertible Preferred Stock (such Common Stock and other capital stock being referred to herein collectively as Junior Liquidation Stock. After payment in full of the liquidation preference of the shares of the Convertible Preferred Stock, the entire remaining assets and funds of the Corporation legally available for distribution, if any, shall be distributed among the holders of the Common Stock and the Convertible Preferred Stock in proportion to the shares of Common Stock then held by them and the shares of Common Stock which they then have the right to acquire upon conversion of the shares of Convertible Preferred Stock then held by them. A merger or consolidation (other than one in which stockholders of the Corporation own a majority by voting power of the outstanding shares of the surviving or acquiring corporation) and a sale, lease, transfer, exclusive license or other disposition of all or substantially all of the assets of the Corporation shall be deemed a liquidation, dissolution or winding up of the Corporation for purposes of this Section 5, thereby triggering payment of the liquidation preferences described above, unless the holders of 75% of the Convertible Preferred Stock elect otherwise.
Section 6. No Redemption. The shares of Convertible Preferred Stock shall not be redeemable.
Section 7. Conversion.
(a) Conversion at Option of Holders.
(i) Subject to the limitation set forth in Section 7(e), holders of Convertible Preferred Stock may, at their option upon surrender of the certificates therefor, convert any or all of their shares of Convertible Preferred Stock into fully paid and nonassessable shares of Common Stock (and such other securities and property as they may be entitled to, as hereinafter provided) at any time after issuance thereof. Each share of Convertible Preferred Stock shall be convertible at the office of any transfer agent for the Convertible Preferred Stock, and at such other office or offices, if any, as the Board of Directors may designate, into that number of fully paid and nonassessable shares of Common Stock as shall be equal to the Conversion Rate, determined as hereinafter provided, in effect at the time of conversion. Shares of Convertible Preferred Stock may initially be converted into full shares of Common Stock as is determined by dividing (A) the Original Issue Price by (B) the sum of the Original Issue Price plus the Conversion Price, subject to adjustment from time to time as provided in Section 8 (such conversion rate, as so adjusted from time to time, being referred to herein as the Conversion Rate). Original Issue Price means $1.72. Conversion Price means $0.125 multiplied by the sum of the number of shares of Common Stock issuable under the converting holders Conversion Warrant (as defined in that certain Securities Purchase Agreement,
dated as of the date hereof, between the Corporation and the investors purchasing Convertible Preferred Stock pursuant thereto (the Securities Purchase Agreement) divided by the number of Convertible Preferred Stock held by such converting holder. Upon conversion, no adjustment or payment shall be made in respect of accumulated and unpaid dividends on the Convertible Preferred Stock surrendered for conversion.
(ii) The right of holders of Convertible Preferred Stock to convert their shares shall be exercised by surrendering for such purpose to the Corporation or its agent, as provided above, certificates representing shares to be converted, duly endorsed in blank or accompanied by proper instruments of transfer. The Corporation shall not be required to pay any tax which may be payable in respect of any transfer involved in the issue and delivery of Common Stock or other securities or property upon conversion of Convertible Preferred Stock in a name other than that of the holder of the shares of Convertible Preferred Stock being converted, nor shall the Corporation shall be required to issue or deliver any such shares or other securities or property unless and until the person or persons requesting the issuance thereof shall have paid to the Corporation the amount of any such tax or shall have established to the satisfaction of the Corporation that such tax has been paid.
(b) Mandatory Conversion. Subject to the limitation set forth in Section 7(e), each share of Convertible Preferred Stock shall be automatically converted into shares of Common Stock at the then effective Conversion Rate (i) upon the date on which at least 75% of the outstanding shares of Convertible Preferred Stock elect such conversion or (ii) upon the closing of an offering of equity securities for the account of the Corporation (other than by sale of the Convertible Preferred Stock pursuant to the Securities Purchase Agreement), provided that the aggregate gross proceeds to the Corporation are $15 million or more (net of underwriting commissions and expenses) (an Equity Offering), provided further that the Convertible Preferred Stock shall not be deemed to have converted until immediately after the closing of the Equity Offering.
(c) A number of shares of the authorized but unissued Common Stock sufficient to provide for the conversion of the Convertible Preferred Stock outstanding upon the basis hereinbefore provided shall at all times be reserved by the Corporation, free from preemptive rights, for such conversion, subject to the provisions of the next paragraph. If the Corporation shall issue any securities or make any change in its capital structure which would change the number of shares of Common Stock into which each share of the Convertible Preferred Stock shall be convertible as herein provided, the Corporation shall at the same time also make proper provision so that thereafter there shall be a sufficient number of shares of Common Stock authorized and reserved, free from preemptive rights, for conversion of the outstanding Convertible Preferred Stock on the new basis. The Corporation shall comply with all securities laws regulating the offer and delivery of shares of Common Stock upon conversion of the Convertible Preferred Stock.
(d) Upon the surrender of certificates representing shares of Convertible Preferred Stock to be converted, duly endorsed or accompanied by proper instruments of transfer as provided above, the person converting such shares shall be deemed to be the holder of record of the Common Stock issuable upon such conversion, and all rights with respect to the shares surrendered shall forthwith terminate except the right to receive the Common Stock or other securities, cash or other assets as herein provided.
(e) Notwithstanding any other provision of this Section 7, no stockholder of the Corporations capital stock shall be permitted to convert an amount of Convertible Preferred Stock that would result in such stockholder owning more than 19.99% of the Common Stock outstanding after such conversion.
Section 8. Adjustments to Conversion Rate.
(a) Notwithstanding anything in this Section 8 to the contrary, no change in the Conversion Rate shall be made until the cumulative effect of the adjustments called for by this Section 8 since the date of
the last change in the Conversion Rate would change the Conversion Rate by more than 3%. However, once the cumulative effect would result in such a change, then the Conversion Rate shall be changed to reflect all adjustments called for by this Section 8 and not previously made. Subject to the foregoing, the Conversion Rate shall be adjusted from time to time as follows:
(i) In case the Corporation shall (A) pay a dividend or make a distribution on its Common Stock in shares of its capital stock, (B) subdivide its outstanding Common Stock into a greater number of shares, (C) combine the shares of its outstanding Common Stock into a smaller number of shares or (D) issue by reclassification of its Common Stock any shares of its capital stock, then in each such case the Conversion Rate in effect immediately prior thereto shall be proportionately adjusted so that the holder of any Convertible Preferred Stock thereafter surrendered for conversion shall be entitled to receive, to the extent permitted by applicable law, the number and kind of shares of capital stock of the Corporation which such holder would have owned or have been entitled to receive after the happening of such event had such Convertible Preferred Stock been converted immediately prior to the record date for such event (or if no record date is established in connection with such event, the effective date for such action). An adjustment pursuant to this subparagraph (a)(ii) shall become effective immediately after the record date in the case of a stock dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or reclassification.
(b) Except as otherwise provided above in this Section 8, no adjustment in the Conversion Rate shall be made in respect of any conversion for share distributions or dividends theretofore declared and paid or payable on the Common Stock.
(c) Whenever the Conversion Rate is adjusted as herein provided, the Corporation shall send to each transfer agent for the Convertible Preferred Stock and the Common Stock, and to the NASDAQ Capital Market, a statement signed by the Chairman of the Board of Directors, the President or any Vice President of the Corporation and by its Treasurer or its Secretary stating the adjusted Conversion Rate determined as provided in this Section 8; and any adjustment so evidenced, given in good faith, shall be binding upon all stockholders and upon the Corporation. Whenever the Conversion Rate is adjusted, the Corporation shall give notice by mail at the time of, and together with, the next dividend payment to the holders of record of Convertible Preferred Stock, setting forth the adjustment and the new Conversion Rate and Conversion Price. Notwithstanding the foregoing notice provisions, failure by the Corporation to give such notice or a defect in such notice shall not affect the binding nature of such corporate action of the Corporation.
(d) Whenever the Corporation shall propose to take any of the actions specified in subparagraphs (a)(i) or (a)(ii) of this Section 8 which would result in any adjustment in the Conversion Rate, the Corporation shall cause a notice to be mailed at least 30 days prior to the date on which the books of the Corporation will close or on which a record will be taken for such action to the holders of record of the outstanding Convertible Preferred Stock on the date of such notice. Such notice shall specify the action proposed to be taken by the Corporation and the date as of which holders of record of the Common Stock shall participate in any such actions or be entitled to exchange their Common Stock for securities or other property, as the case may be. Failure by the Corporation to give such notice or any defect in such notice shall not affect the validity of the transaction.
Section 9. Convertible Preferred Stock Not Redeemable at Option of Holders or Exchangeable; No Sinking Fund. The Convertible Preferred Stock shall not be redeemable upon the request of holders thereof or exchangable for other capital stock or indebtedness of the Corporation or other property. The shares of Convertible Preferred Stock shall not be subject to the operation of a purchase, retirement or sinking fund.
Section 10. Voting Rights. The holders of Convertible Preferred Stock shall not have any voting rights except as set forth below in Section 11 or as otherwise from time to time required by law.
Section 11. Certain Actions Not to be Taken Without Vote of Holders of Convertible Preferred Stock. So long as 10% of the shares of Convertible Preferred Stock are outstanding, in addition to any other vote or approval required under the Fifth Amended and Restated Certificate of Incorporation of the Corporation or the Amended and Restated Bylaws of the Corporation, the Corporation will not, without the written consent of the holders of at least 75% of the Convertible Preferred Stock, either directly or by amendment, merger, consolidation or otherwise (i) create or authorize the creation of or issue any other security convertible into or exercisable for any equity security, having rights, preferences or privileges senior to or on parity with the Convertible Preferred Stock, or increase the authorized number of shares of Convertible Preferred Stock or (ii) purchase or redeem or pay any dividend on any capital stock prior to the Convertible Preferred Stock other than stock repurchased from former employees or consultants in connection with the cessation of their employment or services, as the case may be, at the lower of fair market value or cost, other than as approved by the Board of Directors.
Section 12. Outstanding Shares. For purposes of this Certificate of Designations, all shares of Convertible Preferred Stock shall be deemed outstanding except for (a) shares of Convertible Preferred Stock held of record or beneficially by the Corporation or any subsidiary of the Corporation; (b) from the date of surrender of certificates representing Convertible Preferred Stock for conversion pursuant to Section 7, all shares of Convertible Preferred Stock which have been converted into Common Stock or other securities or property pursuant to Section 7.
IN WITNESS WHEREOF, the Corporation has caused this certificate to be signed by Gregory S. Lea, its Chief Financial Officer, Senior Vice President and Secretary, this 29th day of September, 2010.
ENTEROMEDICS INC. |
/s/ Greg S. Lea |
Greg S. Lea |
Senior Vice President, |
Chief Financial Officer and Secretary |
CERTIFICATE OF AMENDMENT
TO THE
FIFTH AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
ENTEROMEDICS INC.
I, Greg S. Lea, certify that:
1. The following resolution was duly adopted and approved by the board of directors of EnteroMedics Inc. (the Corporation) at a meeting of the board of directors held on February 15, 2012, in accordance with the applicable provisions of Section 242 of the General Corporation Law of the State of Delaware:
RESOLVED, that Article IV, Section 1 of the Fifth Amended and Restated Certificate of Incorporation of EnteroMedics Inc. is hereby amended and restated to read in full as follows:
1. Authorized Stock. The Corporation is authorized to issue two classes of shares to be designated respectively Preferred Stock, par value $0.01 per share, and Common Stock, par value $0.01 per share. The total number of shares of Preferred Stock authorized is 5,000,000. The total number of shares of Common Stock authorized is 125,000,000.
2. The foregoing amendment was duly adopted by the stockholders of the Corporation in accordance with Section 242 of the General Corporation Law of the State of Delaware on May 9, 2012 at an Annual Meeting of the Stockholders of the Corporation, and such resolution has not been subsequently modified or rescinded.
Dated: May 9, 2012
/s/ Greg S. Lea |
Greg S. Lea |
Senior Vice President, |
Chief Financial Officer and Secretary |
CERTIFICATE OF ELIMINATION
OF
SERIES A NON-VOTING CONVERTIBLE PREFERRED STOCK
OF
ENTEROMEDICS INC.
EnteroMedics Inc., a corporation organized and existing under the General Corporation Law of the State of Delaware (the Company),
DOES HEREBY CERTIFY:
FIRST: That at a meeting of the Board of Directors of the Company, resolutions were duly adopted setting forth the proposed elimination of the Series A Non-Voting Convertible Preferred Stock as set forth herein:
RESOLVED, that no shares of the Series A Non-Voting Convertible Preferred Stock are outstanding and none will be issued.
FURTHER RESOLVED, that a Certificate of Elimination be executed, which shall have the effect when filed in Delaware of eliminating from the Companys Fifth Amended and Restated Certificate of Incorporation, as amended, all reference to the Series A Non-Voting Convertible Preferred Stock.
SECOND: That the Certificate of Designations with respect to the above Series A Non-Voting Convertible Preferred Stock was filed in the office of the Secretary of State of Delaware on September 29, 2010. None of the authorized shares of the Series A Non-Voting Convertible Preferred Stock are outstanding and none will be issued.
THIRD: That in accordance with the provisions of Section 151 of the General Corporation Law of the State of Delaware, the Fifth Amended and Restated Certificate of Incorporation, as amended, is hereby amended to eliminate all reference to the Series A Non-Voting Convertible Preferred Stock.
IN WITNESS WHEREOF, the Company has caused this certificate to be signed by Greg S. Lea, its Senior Vice President and Chief Financial Officer, this 13th day of September, 2012.
ENTEROMEDICS INC. | ||
By: | /s/ Greg S. Lea | |
Greg S. Lea | ||
Senior Vice President and Chief Financial Officer |
Exhibit 31.1
CERTIFICATION
I, Mark B. Knudson, Ph.D., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of EnteroMedics Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
/S/ MARK B. KNUDSON, PH.D. |
Mark B. Knudson, Ph.D. |
President and Chief Executive Officer |
Date: November 8, 2012
Exhibit 31.2
CERTIFICATION
I, Greg S. Lea, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of EnteroMedics Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
/S/ GREG S. LEA |
Greg S. Lea |
Senior Vice President and Chief Financial Officer |
Date: November 8, 2012
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Mark B. Knudson, Ph.D., in his capacity as Chief Executive Officer of EnteroMedics Inc., hereby certifies that, to the best of his knowledge:
1. | The Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 to which this Certification is attached as Exhibit 32.1 (the Report) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and the results of operations of EnteroMedics Inc. as of, and for, the periods covered by the Report. |
By: | /S/ MARK B. KNUDSON, PH.D. | |
Mark B. Knudson, Ph.D. | ||
President and Chief Executive Officer |
Date: November 8, 2012
Exhibit 32.2
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Greg S. Lea, in his capacity as Chief Financial Officer of EnteroMedics Inc., hereby certifies that, to the best of his knowledge:
1. | The Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 to which this Certification is attached as Exhibit 32.2 (the Report) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and the results of operations of EnteroMedics Inc. as of, and for, the periods covered by the Report. |
By: | /S/ GREG S. LEA | |
Greg S. Lea | ||
Senior Vice President and Chief Financial Officer |
Date: November 8, 2012