Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | Apr. 29, 2016 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ETRM | |
Entity Registrant Name | EnteroMedics Inc | |
Entity Central Index Key | 1,371,217 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 9,254,451 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 11,153,525 | $ 7,927,240 |
Accounts receivable | 55,000 | 57,928 |
Inventory | 1,868,206 | 1,686,324 |
Prepaid expenses and other current assets | 873,531 | 831,495 |
Total current assets | 13,950,262 | 10,502,987 |
Property and equipment, net | 298,447 | 326,296 |
Other assets | 606,291 | 757,802 |
Total assets | 14,855,000 | 11,587,085 |
Current liabilities: | ||
Current portion of convertible notes payable | 5,639,752 | 717,391 |
Accounts payable | 261,447 | 172,050 |
Accrued expenses | 3,483,280 | 3,595,415 |
Accrued interest payable | 1,172 | |
Total current liabilities | 9,384,479 | 4,486,028 |
Convertible notes payable, less current portion (net of discounts of $533,110 and $149,340 at March 31, 2016 and December 31, 2015, respectively) | 5,116,248 | 549,791 |
Common stock warrant liability | 1,613,560 | 2,877,817 |
Total liabilities | $ 16,114,287 | $ 7,913,636 |
Commitments and contingencies (note 5) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value; 150,000,000 and 13,333,333 shares authorized at March 31, 2016 and December 31, 2015, respectively; 8,499,651 and 7,163,820 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | $ 84,997 | $ 71,638 |
Additional paid-in capital | 283,645,016 | 281,182,349 |
Accumulated deficit | (284,989,300) | (277,580,538) |
Total stockholders' (deficit) equity | (1,259,287) | 3,673,449 |
Total liabilities and stockholders' equity | $ 14,855,000 | $ 11,587,085 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Convertible notes payable, less current portion, discounts | $ 533,110 | $ 149,340 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 150,000,000 | 13,333,333 |
Common stock, shares issued | 8,499,651 | 7,163,820 |
Common stock, shares outstanding | 8,499,651 | 7,163,820 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Sales | $ 72,000 | |
Cost of goods sold | 40,135 | |
Gross profit | 31,865 | |
Operating expenses: | ||
Selling, general and administrative | 6,141,177 | $ 4,727,519 |
Research and development | 1,432,381 | 2,236,606 |
Total operating expenses | 7,573,558 | 6,964,125 |
Operating loss | (7,541,693) | (6,964,125) |
Other income (expense): | ||
Interest income | 1,691 | 867 |
Interest expense | (1,149,294) | (214,546) |
Change in value of convertible notes payable | (499,568) | |
Change in value of warrant liability | 1,779,414 | |
Other, net | 688 | 3,781 |
Net loss | $ (7,408,762) | $ (7,174,023) |
Net loss per share - basic and diluted | $ (0.94) | $ (1.48) |
Shares used to compute basic and diluted net loss per share | 7,840,992 | 4,849,061 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Net loss | $ (7,408,762) | $ (7,174,023) |
Comprehensive loss | $ (7,408,762) | $ (7,174,023) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (7,408,762) | $ (7,174,023) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 39,393 | 48,651 |
Stock-based compensation | 1,092,488 | 1,372,076 |
Amortization of commitment fees, debt issuance costs and original issue discount | 815,421 | 165,291 |
Change in value of convertible notes payable | 499,568 | |
Change in value of warrant liability | (1,779,414) | |
Change in operating assets and liabilities: | ||
Accounts receivable | 2,928 | 1,334 |
Inventory | (181,882) | (145,778) |
Prepaid expenses and other current assets | (42,036) | (41,313) |
Other assets | (87,520) | (138,417) |
Accounts payable | 89,397 | (347,163) |
Accrued expenses | (112,135) | 642,993 |
Accrued interest payable | 174,148 | (4,302) |
Net cash used in operating activities | (6,898,406) | (5,620,651) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (11,544) | (18,656) |
Net cash used in investing activities | (11,544) | (18,656) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock and warrants for purchase of common stock | 6,651,931 | |
Common stock financing costs | (14,000) | (199,557) |
Proceeds from convertible notes payable | 11,000,000 | |
Repayments on convertible notes payable | (404,762) | |
Repayments on notes payable | (1,000,000) | |
Debt issuance costs | (445,003) | |
Net cash provided by financing activities | 10,136,235 | 5,452,374 |
Net increase (decrease) in cash and cash equivalents | 3,226,285 | (186,933) |
Cash and cash equivalents: | ||
Beginning of period | 7,927,240 | 11,619,167 |
End of period | 11,153,525 | 11,432,234 |
Supplemental disclosure: | ||
Cash paid for interest | 163,152 | $ 53,556 |
Noncash investing and financing activities: | ||
Conversion of convertible notes and interest payable | $ 1,397,538 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Significant Accounting Policies | (1) Summary of Significant Accounting Policies Description of Business EnteroMedics Inc. (the Company) develops and sells implantable systems 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 headquartered in St. Paul, Minnesota. In January 2006, the Company established EnteroMedics Europe Sárl, a wholly-owned subsidiary located in Switzerland. The Company’s board of directors and stockholders approved a 1-for-15 reverse split (the Reverse Stock Split) of the Company’s outstanding common stock that became effective after trading on January 6, 2016. The Reverse Stock Split did not change the par value of the Company’s stock or the number of preferred shares authorized by the Company’s Fifth Amended and Restated Certificate of Incorporation. An amendment to the Certificate of Incorporation was also approved in connection with the Reverse Stock Split to increase the number of shares of the Company’s common stock authorized for issuance to 150 million shares, effective immediately after the Reverse Stock Split on January 6, 2016. All share and per share amounts have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented. Risks and Uncertainties The Company is focused on the design and development of medical devices that use neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders and currently has approvals to commercially launch the Maestro Rechargeable System in the United States and in Australia, the European Economic Area and other countries that recognize the European CE Mark. The Company 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 has recently commenced commercial operations in the United States deriving revenues from its primary business activity in 2015. The Company’s products require approval from the U.S. Food and Drug Administration (FDA) or corresponding foreign regulatory agencies prior to commercial sales. The Company received FDA approval on January 14, 2015 for vBloc Therapy, delivered via the Maestro Rechargeable System, and has begun a controlled commercial launch at select centers in the United States. The Maestro Rechargeable System has also received CE Mark and is listed on the Australian Register of Therapeutic Goods (ARTG). The medical device industry is characterized by frequent and extensive litigation and administrative proceedings over patent and other intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often difficult to predict, and the outcome may be uncertain until the court has entered final judgment and all appeals are exhausted. The Company’s competitors may assert that its products or the use of the Company’s products are covered by U.S. or foreign patents held by them. The Company’s activities are subject to significant risks and uncertainties, including the ability 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 Company’s fiscal year ends on December 31. The accompanying condensed consolidated financial statements and notes thereto are unaudited. In the opinion of the Company’s 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, 2015 was derived from audited consolidated 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2015. 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 intercompany transactions and accounts have been eliminated in consolidation. Fair Value of Financial Instruments Carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their short maturities. The Company’s common stock warrants are required to be reported at fair value and the Company has elected to report its senior amortizing convertible notes at fair value. The fair values of common stock warrants and investments in debt and equity securities, if any, are disclosed in Note 3. The fair value of the Company’s senior amortizing convertible notes is disclosed in Notes 3 and 7. Common Stock Warrant Liability Common stock warrants that were issued in connection with the July 8, 2015 public offering and the November 9, 2015 and January 11, 2016 senior amortizing convertible notes are classified as a liability in the condensed consolidated balance sheets, as the common stock warrants issued provide for certain anti-dilution protections in the event shares of common stock or securities convertible into shares of common stock are issued below the then-existing exercise price. The fair value of these common stock warrants is re-measured at each financial reporting period and immediately before exercise, with any changes in fair value being recognized as a component of other income (expense) in the condensed consolidated statements of operations. Cash and Cash Equivalents The Company considers highly liquid investments generally with maturities of 90 days or less when purchased to be cash equivalents. Cash equivalents are stated at cost, which approximates market value. The Company’s cash equivalents are primarily in money market funds and certificates of deposit. The Company deposits its cash and cash equivalents in high-quality credit institutions. Short-Term Investments The Company considers all investments with maturities greater than three months and less than one year at the time of purchase as short-term investments and classifies them as either available for sale or held to maturity. The Company also considers certain investments with maturities greater than one year but which are also held for liquidity purposes and are available for sale as short-term investments. Available-for-sale securities are carried at fair value based on quoted market prices, with the unrealized gains and losses included in other comprehensive income within stockholders’ equity in the condensed consolidated balance sheets. Realized gains and losses and declines in value judged to be other than temporary on available-for-sale securities are included in interest and other income. Interest and dividends on securities classified as available for sale are included in interest income. The cost of securities sold is based on the specific identification method. Short-term investments in debt securities which the Company has the positive intent and ability to hold to maturity are reported at cost, adjusted for premiums and discounts that are recognized in interest income, using the interest method, over the period to maturity. Unrealized losses on held-to-maturity securities reflecting a decline in value determined to be other than temporary are charged to income. 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. Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives of five to seven years for furniture and equipment and three to five years for computer hardware and software. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Upon retirement or sale, the cost and related accumulated depreciation or amortization are removed from the condensed consolidated balance sheets and the resulting gain or loss is reflected in the condensed consolidated statements of operations. Repairs and maintenance are expensed as incurred. Impairment of Long-Lived Assets The Company evaluates its long-lived assets for impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or estimates of future discounted cash flows. The Company has not identified any such impairment losses to date. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance for deferred income tax assets is recorded when it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The Company has provided a full valuation allowance against the gross deferred tax assets. The Company’s policy is to classify interest and penalties related to income taxes as income tax expense in the condensed consolidated statements of operations. Medical Device Excise Tax On January 14, 2015, the Company received FDA approval for vBloc Therapy, delivered via the Maestro Rechargeable System, and starting in the second quarter of 2015 revenues were generated from sales in the United States. As a result, the Company is now required to pay a quarterly Medical Device Tax which is a part of the Affordable Care Act, which imposes a 2.3% excise tax on the sale of certain medical devices by device manufactures, producers or importers. The excise tax was effective on sales of devices made after December 31, 2012. The Company records the Medical Device Tax as an operating expense in the condensed consolidated statements of operations. A moratorium was placed on the Medical Device Tax for 2016 and 2017. 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. There was no difference from reported net loss for the three months ended March 31, 2016 and 2015. Revenue Recognition Revenue is recognized 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. Products are sold through direct sales or medical device distributors and revenue is recognized upon sale to a bariatric center of excellence or a medical device distributor when 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. A provision for returns is recorded only if product sales provide for a right of return. No provision for returns was recorded for the three months ended March 31, 2016 and 2015, as the product sales recorded did not provide for rights of return. 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, devices, explants and revisions, quality assurance, regulatory expenses, payroll and other personnel expenses, materials and consulting costs. 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 Company’s potential dilutive shares, which include outstanding common stock options 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 months ended March 31, 2016 and 2015: Three months ended March 31, 2016 2015 Numerator: Net loss $ (7,408,762 ) $ (7,174,023 ) Denominator for basic and diluted net loss per share: Weighted-average common shares outstanding 7,840,992 4,849,061 Net loss per share—basic and diluted $ (0.94 ) $ (1.48 ) 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: March 31, 2016 2015 Stock options outstanding 1,953,859 948,675 Warrants to purchase common stock 4,476,839 1,613,133 Recently Issued or Adopted Accounting Standards In March 2016, the Financial Accounting Standards Board (FASB) issued Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (Accounting Standards Update No. 2016-09 (ASU 2016-09)) In May 2014, FASB issued Revenue from Contracts with Customers, Topic 606 (Accounting Standards Update No. 2014-09 (ASU 2014-09)) There have been no other significant changes in recent accounting pronouncements during the three months ended March 31, 2016 as compared to the recent accounting pronouncements described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. |
Liquidity and Management's Plan
Liquidity and Management's Plans | 3 Months Ended |
Mar. 31, 2016 | |
Liquidity and Management's Plans | (2) Liquidity and Management’s Plans The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has financed its operations to date principally through the sale of equity securities, debt financing and interest earned on investments. As of March 31, 2016, the Company had $11.2 million of cash and cash equivalents to fund its anticipated operations through 2016. On November 4, 2015, the Company entered into a securities purchase agreement (the Purchase Agreement) with institutional investors to issue $25.0 million of senior amortizing convertible notes (the Notes) along with the accompanying warrants. $1.5 million of the Notes was funded at the first closing on November 9, 2015. An additional $11.0 million of the Notes was funded at the second closing on January 11, 2016. Pursuant to an amendment to the Purchase Agreement (the Amendment) entered into on May 2, 2016, the remaining $12.5 million will be funded at two separate closings, with $6.25 million of the Notes funded on May 2, 2016 and the remaining $6.25 million to be funded at a later date. Additionally, the Company has agreed that it will not, for a period of one year after the first closing, issue any further securities, other than certain excluded securities. The Company’s anticipated operations include plans that consider the controlled commercial launch of vBloc Therapy, delivered via the Maestro Rechargeable System, which was approved by the FDA on January 14, 2015. The Company believes that it has the flexibility to manage the growth of its expenditures and operations. |
Short-term Investments and Fair
Short-term Investments and Fair Value Measurements | 3 Months Ended |
Mar. 31, 2016 | |
Short-term Investments and Fair Value Measurements | (3) Short-term Investments and Fair Value Measurements Fair value of financial assets and liabilities is defined as the price that would be received to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date. A fair value hierarchy has been established that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below: • Level 1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. • Level 2—Quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active or model-derived valuations for which all significant inputs are observable, either directly or indirectly. • Level 3—Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable. The Company’s 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 may include U.S. treasury securities and money market funds. 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 the Company’s 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 classified as available for sale or held to maturity as of March 31, 2016 and December 31, 2015. The fair value of the Company’s common stock warrant liability is calculated using a Black-Scholes valuation model and is classified as Level 2 in the fair value hierarchy. The common stock warrants issued July 8, 2015 had a fair value of $1,198,689 and $2,759,583 on March 31, 2016 and December 31, 2015, respectively. The common stock warrants issued November 9, 2015 had a fair value of $75,670 and $118,234 on March 31, 2016 and December 31, 2015, respectively. The common stock warrants issued January 11, 2016 had a fair value of $339,201 and $515,157 on March 31, 2016 and January 11, 2016, respectively. The fair value was calculated using the following assumptions: July 2015 Warrants November 2015 Warrants January 2016 Warrants March 31, 2016 December 31, 2015 March 31, 2016 December 31, 2015 March 31, 2016 January 11, 2016 Risk-free interest rates 0.87 % 1.31 % 1.21 % 1.76 % 1.21 % 1.58 % Expected life 33 months 36 months 55 months 58 months 57 months 60 months Expected dividends 0 % 0 % 0 % 0 % 0 % 0 % Expected volatility 91.15 % 97.94 % 91.42 % 86.27 % 90.04 % 85.90 % The following table summarizes fair value measurements of the senior amortizing convertible notes and the common stock warrants issued in 2015 and during the three months ended March 31, 2016 by level at March 31, 2016: Level 1 Level 2 Level 3 Total Senior amortizing convertible notes $ — $ — $ 10,756,000 $ 10,756,000 Common stock warrants — 1,613,560 — 1,613,560 Total $ — $ 1,613,560 $ 10,756,000 $ 12,369,560 As of March 31, 2016, the Company converted $1,507,042 of senior amortizing convertible notes principal and interest into shares of common stock. There was a $499,568 loss resulting from the senior amortizing convertible notes recognized in the condensed consolidated statements of operations for the three months ended March 31, 2016. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2016 | |
Inventory | (4) Inventory From the Company’s inception, 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 ARTG listings for components of the Maestro Rechargeable System from the Australian Therapeutic Goods Administration, 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 $606,000 and $519,000 of long-term inventory, primarily consisting of raw materials, as of March 31, 2016 and December 31, 2015, respectively. Current inventory consists of the following as of: March 31, 2016 December 31, 2015 Raw materials $ 527,471 $ 576,898 Work-in-process 1,296,525 1,066,345 Finished goods 44,210 43,081 Inventory $ 1,868,206 $ 1,686,324 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies | (5) Commitments and Contingencies Operating Lease The Company rents its office, warehouse and laboratory facilities under an operating lease, which was originally set to expire on September 30, 2015. On August 25, 2015, the Company entered into an amendment extending the term of the operating lease for three years until September 30, 2018, with monthly base rent ranging from $18,925 to $20,345. Total rent expense recognized for each of the three month periods ended March 31, 2016 and 2015 was $58,905 and $67,718, respectively. At March 31, 2016, future minimum payments under the lease are as follows: Year ending December 31: Remaining nine months in 2016 $ 172,457 2017 237,749 2018 183,103 $ 593,309 Product Liability Claims 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 Company’s 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 Company’s business, operating results or financial condition. Clinical Trials The Company is evaluating the Maestro System in human clinical trials, including the EMPOWER trial and ReCharge trial. Both of these clinical trials require patients to be followed out to 60 months. The Company is required to pay for patient follow up visits only to the extent they occur. In the event a patient does not attend a follow up visit, the Company has no financial obligation. The Company is also required to pay for explants or revisions, including potential conversions of ReCharge control devices to active devices, should a patient request or be required to have one during the course of the clinical trials. The Company has no financial obligation unless an explant, revision or conversion is requested or required. Clinical trial costs are expensed as incurred. |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2016 | |
Notes Payable | (6) Notes Payable On April 16, 2012, the Company entered into a Loan and Security Agreement (the Loan Agreement) with Silicon Valley Bank (SVB) pursuant to which SVB agreed to make term loans in an aggregate principal amount of up to $20.0 million ($10.0 million of which was not available as the Company did not meet the predefined primary efficacy measures of the ReCharge trial and did not meet certain financial objectives for 2012), on the terms and conditions set forth in the Loan Agreement. 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 outstanding debt of approximately $4.7 million. The term loan required 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 bore interest at a fixed annual rate equal to 8.0%. The Company entered into a First Amendment (the First Amendment) to the Loan Agreement on May 9, 2013 pursuant to which the Company and SVB agreed to new financial covenants. The First Amendment eliminated the financial covenants that required the Company to generate certain minimum amounts of revenue from the sale of its Maestro Rechargeable System and to implant certain minimum numbers of Maestro Rechargeable Systems during cumulative quarterly measurement periods beginning with the period ended March 31, 2013 and ending with the period ended June 30, 2015. It also removed SVB’s ability to require the Company to maintain a restricted cash balance of $7.5 million in an SVB account as a result of the Company not meeting the predefined primary efficacy measures of the ReCharge trial. The First Amendment added two new financial covenants, one of which required the Company to receive cumulative aggregate net proceeds of at least $5.0 million by November 15, 2013 and $10.0 million by April 15, 2014 from new capital transactions, both of which were fulfilled. The second financial covenant required the Company to maintain a liquidity ratio (unrestricted cash divided by outstanding debt) of at least 1.25:1.00 until it received FDA approval for the Maestro Rechargeable System on January 14, 2015, at which point it was reduced to 0.75:1.00. The First Amendment did not change the interest rate or the amortization structure. A 5.0% final payment fee of $500,000 was due and paid on September 1, 2015. The Company also paid SVB a $187,000 success fee as a result of receiving FDA approval for the Maestro Rechargeable System. The Company had granted SVB a security interest in all of the Company’s 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 had entered into a negative pledge arrangement with SVB pursuant to which it had agreed not to encumber any of its intellectual property without SVB’s prior written consent. Pursuant to the Loan Agreement, on April 16, 2012, the Company issued SVB a warrant to purchase 7,116 shares of common stock, exercisable for ten years from the date of grant, at an exercise price of $35.10 per share. The final payment related to the Loan Agreement, as amended, was paid on September 1, 2015. |
Senior Amortizing Convertible N
Senior Amortizing Convertible Notes | 3 Months Ended |
Mar. 31, 2016 | |
Senior Amortizing Convertible Notes | (7) Senior Amortizing Convertible Notes On November 4, 2015, the Company entered into the Purchase Agreement to issue and sell to four institutional investors 7% senior amortizing convertible notes due 2017 that are convertible into shares of the Company’s common stock at a price equal to $4.35 per share with an aggregate principal amount of $25.0 million. Each Note was sold with a warrant to purchase a share of common stock (the Warrants) with an exercise price of $4.65 per share. The Company issued and sold Notes and Warrants for aggregate total proceeds of $12.5 million in two separate closings through March 31, 2016 and pursuant to the Amendment, issued and sold Notes and Warrants for aggregate total proceeds of $6.25 million in the third closing, which occurred on May 2, 2016. The Company will issue and sell Notes and Warrants for aggregate total proceeds of $6.25 million in the fourth and final closing. Description of the Notes The Notes are payable in monthly installments, accrue interest at a rate of 7.0% per annum from the date of issuance and will mature 24 months after the First Closing (defined below), unless converted or redeemed earlier. The Notes may be repaid, at the Company’s election, in either cash or shares of the Company’s common stock at a discount to the then-current market price. The Notes are also convertible from time to time, at the election of the holders, into shares of the Company’s common stock at an initial conversion price of $4.35 per share. The conversion price was adjusted to $1.09 per share on January 29, 2016, the 16 th The holder of each Note has the right to convert any portion of such Note unless the holder, together with its affiliates, beneficially owns in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the conversion, as such percentage ownership is determined in accordance with the terms of the Notes. However, any holder may increase or decrease such percentage to any other percentage, but in no event above 9.99%, provided that any increase of such percentage will not be effective until 61 days after providing notice to the Company. The Company has determined that the conversion feature in the Notes requires bifurcation and liability classification and measurement, at fair value, and requires evaluation at each reporting period. Under Accounting Standards Codification (ASC) 825, Financial Instruments, the FASB provides an alternative to bifurcation and companies may instead elect fair value measurement for the entire instrument, including the debt and conversion feature. The Company has elected the fair value alternative in order to simplify its accounting and reporting of the Notes upon issuance. The fair value of the Warrants is recorded as a discount to the Notes and amortized to interest expense following the effective interest rate method over the term of the Notes. The first of the four closings (the First Closing) occurred on November 9, 2015. At the First Closing, the Company issued and sold Notes with an aggregate principal amount of $1.5 million, along with Warrants exercisable for 117,520 shares. The fair value of the Warrants issued on November 9, 2015 was determined to be $169,000 using a Black-Scholes valuation model and the following assumptions: (1) dividend yield of 0%; (2) expected volatility of 84.85%; (3) weighted average risk –free interest rate of 1.75%; and (4) expected life of 5.0 years. The second of the four closings (the Second Closing) occurred on January 11, 2016 after the Company received approval of the offering by the Company’s stockholders and the satisfaction of certain customary closing conditions. At the Second Closing, the Company issued and sold Notes with an aggregate principal amount of $11.0 million, along with Warrants exercisable for 861,842 shares. The fair value of the Warrants issued on January 11, 2016 was determined to be $515,000 using a Black-Scholes valuation model and the following assumptions: (1) dividend yield of 0%; (2) expected volatility of 85.90%; (3) weighted average risk –free interest rate of 1.58%; and (4) expected life of 5.0 years. The third of the four closings (the Third Closing) occurred on May 2, 2016 after the Company entered into the Amendment. At the Third Closing, the Company issued and sold Notes with an aggregate principal amount of $6.25 million, along with Warrants exercisable for 489,684 shares. At the final of the four closings (the Fourth Closing) the Company will issue and sell Notes with an aggregate principal amount of $6.25 million, along with Warrants exercisable for 489,682 shares. On March 31, 2016 and December 31, 2015, the fair value of the outstanding Notes from the First Closing was determined to be $1.2 million and $1.3 million, respectively. On March 31, 2016 and January 11, 2016, the fair value of the outstanding Notes from the Second Closing was determined to be $9.5 million and $9.9 million, respectively. The fair values were calculated using a Binomial Lattice model and the following assumptions: November 2015 Notes January 2016 Notes March 31, 2016 December 31, 2015 March 31, 2016 January 11, 2016 Risk-free interest rates 0.68 % 1.11 % 0.68 % 1.01 % Expected life 1.61 years 1.86 years 1.61 years 1.83 years Expected dividends 0 % 0 % 0 % 0 % Expected volatility 65.0 % 57.5 % 65.0 % 60.0 % Fair value per share of common stock $ 0.97 $ 1.95 $ 0.97 $ 1.33 The following table summarizes the installment amounts and additional conversions by the holders of the Notes issued at the First Closing through March 31, 2016: Principal Interest Total Common Shares Installment amount at December 31, 2015 $ 65,217 $ 23,651 $ 88,868 56,967 Holder conversions during the quarter ended December 31, 2015 18,261 2,375 20,636 13,228 Balance December 31, 2015 83,478 26,026 109,504 70,195 Installment amount at February 29, 2016 65,217 23,681 88,898 91,953 Installment amount at March 31, 2016 65,217 14,827 80,044 88,960 Holder conversions during the quarter ended March 31, 2016 104,784 12,762 117,546 106,684 Balance, March 31, 2016 $ 318,696 $ 77,296 $ 395,992 357,792 The following table summarizes the installment amounts and additional conversions by the holders of the Notes issued at the Second Closing through March 31, 2016: Principal Interest Total Common Shares Installment amount at March 2, 2016 $ 404,762 $ 149,300 $ 554,062 * Holder conversions during the quarter ended March 31, 2016 987,000 124,050 1,111,050 1,048,167 Balance, March 31, 2016 $ 1,391,762 $ 273,350 $ 1,665,112 1,048,167 * Cash payments Description of the Warrants Each Warrant is exercisable immediately and for a period of 60 months from the date of the issuance of the Warrant. The Warrants entitle the holders of the Warrants to purchase, in aggregate, 1,958,728 shares of the Company’s common stock upon the completion of the Fourth Closing, subject to certain adjustments. The Warrants are initially exercisable at an exercise price equal to $4.65, subject to adjustment on the eighteen month anniversary of issuance, and certain other adjustments. The exercise price and number of shares of common stock issuable on the exercise of the Warrants is subject to adjustment upon the issuance of any shares of common stock or securities convertible into shares of common stock below the then-existing exercise price, with certain exceptions, and in the event of any stock split, reverse stock split, recapitalization, reorganization or similar transaction. The holder of each Warrant does not have the right to exercise any portion of such Warrant if the holder, together with its affiliates, beneficially owns in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants. However, any holder may increase or decrease such percentage to any other percentage, but in no event above 9.99%, provided that any increase of such percentage will not be effective until 61 days after providing notice to the Company. The exercise price of the Warrants issued November 9, 2015 was reduced to $1.09 per share on January 29, 2016, the 16 th |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Stock-based Compensation | (8) 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 nonemployee’s 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 Company’s Amended and Restated 2003 Stock Incentive Plan (the Plan) and inducement grants for the three months ended March 31, 2016 and 2015 was allocated to operating expenses and employees and nonemployees as follows: Three months ended March 31, 2016 2015 Selling, general and administrative $ 839,777 $ 1,036,446 Research and development 252,711 335,630 Total $ 1,092,488 $ 1,372,076 Three months ended March 31, 2016 2015 Employees $ 1,090,192 $ 1,387,924 Nonemployees 2,296 (15,848 ) Total $ 1,092,488 $ 1,372,076 As of March 31, 2016 there was approximately $5.1 million of total unrecognized compensation costs, net of estimated forfeitures, related to employee unvested stock option awards, which are expected to be recognized over a weighted-average period of 2.57 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 months ended March 31, 2016 and 2015: Employees Three months ended March 31, 2016 2015 Risk-free interest rates 1.16%-1.64% 1.65%-1.80% Expected life 5.00-6.25 years 6.25 years Expected dividends 0% 0% Expected volatility 88.43%-92.24% 110.32%-111.77% Nonemployees Three months ended March 31, 2016 2015 Risk-free interest rates 1.11% 0.03%-1.77% Expected life 4.39 years 0.25-8.51 years Expected dividends 0% 0% Expected volatility 92.41% 37.36%-131.49% Option activity under the Plan for the three months ended March 31, 2016 was as follows: Outstanding Options Shares Available For Grant Number of Shares Weighted- Average Exercise Price Balance, December 31, 2015 296,579 1,018,752 $ 32.83 Shares reserved — — — Options granted (53,333 ) 53,333 1.07 Options exercised — — — Options cancelled 14,893 (14,893 ) 5.10 Balance, March 31, 2016 258,139 1,057,192 $ 31.62 In addition to the stock options granted pursuant to the Plan, the Company has also granted inducement stock options in connection with the appointments of Mr. Gladney to the position of President and Chief Executive Officer on October 28, 2015, Mr. Ansari to the position of Senior Vice President (SVP) of Sales on January 6, 2016, Mr. Delange to the position of SVP of Operations and Business Development on January 18, 2016 and Mr. Hickey to the position of SVP of Marketing and Reimbursement on January 18, 2016. Mr. Gladney was granted an option to purchase 516,666 shares of the Company’s common stock as an inducement grant, with an exercise price of $3.75 per share, the closing price of the Company’s common stock on October 28, 2015. Mr. Delange was granted an option to purchase 166,667 shares of the Company’s common stock as an inducement grant, with an exercise price of $1.38 per share, the closing price of the Company’s common stock on January 18, 2016. Mr. Ansari was granted an option to purchase 106,667 shares of the Company’s common stock as an inducement grant, with an exercise price of $1.31 per share, the closing price of the Company’s common stock on January 19, 2016. Mr. Hickey was granted an option to purchase 106,667 shares of the Company’s common stock as an inducement grant, with an exercise price of $1.32 per share, the closing price of the Company’s common stock on January 22, 2016. Each of the inducement grants will vest as follows: 25% of the shares will vest as of one year from the date of the officer’s employment agreement, and the remaining 75% of the shares will then vest in equal 2.0833% installments each month thereafter for 36 months. |
Stock Sales
Stock Sales | 3 Months Ended |
Mar. 31, 2016 | |
Stock Sales | (9) Stock Sales Sales Agreement—July 2015 On July 8, 2015, the Company closed a public offering, where it sold 2,133,333 units at an aggregate price of $7.50 per unit, for gross proceeds of $16.0 million before deducting estimated offering expenses of approximately $1.4 million, of which $532,000 was assigned to the warrants issued with each unit sold and was recognized immediately as interest expense in the condensed consolidated statements of operations as the warrants are exercisable upon issuance. Each unit consisted of: (A)(i) one share of common stock or (ii) one pre-funded Series C warrant to purchase one share of common stock at an exercise price equal to $7.50 per share (Series C Warrant); and (B) one Series A warrant to purchase one share of common stock at an exercise price initially equal to $9.00 per share (Series A Warrant). Each purchaser of a unit could elect to receive a Series C Warrant in lieu of a share of common stock. No Series C Warrants were issued. The Series A Warrants are exercisable for a period of 42 months from the closing date of the public offering. The exercise price and number of shares of common stock issuable on the exercise of the Series A Warrants are subject to adjustment upon the issuance of any shares of common stock or securities convertible into shares of common stock below the then-existing exercise price, with certain exceptions, and in the event of any stock split, reverse stock split, recapitalization, reorganization or similar transaction. The holder of the Series A Warrant does not have the right to exercise any portion of the Series A Warrant if the holder, together with its affiliates, would, subject to certain limited exceptions, beneficially own in excess of 9.99% of the Company’s common stock outstanding immediately after the exercise or 4.99% as may be elected by the purchaser. The exercise price of the Series A Warrants issued July 8, 2015 was reduced to $2.40 per share on November 9, 2015 as a result of the issuance of the Notes and was further reduced to $1.50 per share on December 31, 2015, $0.97 per share on January 29, 2016 and $0.88 on March 30, 2016 after installment payments on the Notes were made. Sales Agreement—June 2014 On June 13, 2014, the Company entered into a sales agreement with Cowen and Company, LLC (Cowen) to sell shares of the Company’s common stock having aggregate gross sales proceeds of up to $25.0 million, from time to time, through an ATM under which Cowen will act as the Company’s sales agent (the Cowen ATM). The Company will determine, at its sole discretion, the timing and number of shares to be sold under the Cowen ATM. The Company will pay Cowen a commission for its services in acting as agent in the sale of common stock equal to 3.0% of the gross sales price per share of all shares sold through it as agent under the sales agreement. As of March 31, 2016, the Company had sold 367,903 shares under the Cowen ATM at a weighted-average selling price of $20.60 per share for gross proceeds of $7.6 million before deducting offering expenses. There have been no shares sold under the Cowen ATM subsequent to March 31, 2016 through May 10, 2016. The Company is restricted from issuing shares under the Cowen ATM until November 9, 2016 per the terms of the Notes (see Notes 2 and 7). |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Description of Business | Description of Business EnteroMedics Inc. (the Company) develops and sells implantable systems 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 headquartered in St. Paul, Minnesota. In January 2006, the Company established EnteroMedics Europe Sárl, a wholly-owned subsidiary located in Switzerland. The Company’s board of directors and stockholders approved a 1-for-15 reverse split (the Reverse Stock Split) of the Company’s outstanding common stock that became effective after trading on January 6, 2016. The Reverse Stock Split did not change the par value of the Company’s stock or the number of preferred shares authorized by the Company’s Fifth Amended and Restated Certificate of Incorporation. An amendment to the Certificate of Incorporation was also approved in connection with the Reverse Stock Split to increase the number of shares of the Company’s common stock authorized for issuance to 150 million shares, effective immediately after the Reverse Stock Split on January 6, 2016. All share and per share amounts have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented. |
Risks and Uncertainties | Risks and Uncertainties The Company is focused on the design and development of medical devices that use neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders and currently has approvals to commercially launch the Maestro Rechargeable System in the United States and in Australia, the European Economic Area and other countries that recognize the European CE Mark. The Company 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 has recently commenced commercial operations in the United States deriving revenues from its primary business activity in 2015. The Company’s products require approval from the U.S. Food and Drug Administration (FDA) or corresponding foreign regulatory agencies prior to commercial sales. The Company received FDA approval on January 14, 2015 for vBloc Therapy, delivered via the Maestro Rechargeable System, and has begun a controlled commercial launch at select centers in the United States. The Maestro Rechargeable System has also received CE Mark and is listed on the Australian Register of Therapeutic Goods (ARTG). The medical device industry is characterized by frequent and extensive litigation and administrative proceedings over patent and other intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often difficult to predict, and the outcome may be uncertain until the court has entered final judgment and all appeals are exhausted. The Company’s competitors may assert that its products or the use of the Company’s products are covered by U.S. or foreign patents held by them. The Company’s activities are subject to significant risks and uncertainties, including the ability 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 | 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 Company’s fiscal year ends on December 31. The accompanying condensed consolidated financial statements and notes thereto are unaudited. In the opinion of the Company’s 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, 2015 was derived from audited consolidated 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2015. |
Use of Estimates | 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 | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany transactions and accounts have been eliminated in consolidation. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their short maturities. The Company’s common stock warrants are required to be reported at fair value and the Company has elected to report its senior amortizing convertible notes at fair value. The fair values of common stock warrants and investments in debt and equity securities, if any, are disclosed in Note 3. The fair value of the Company’s senior amortizing convertible notes is disclosed in Notes 3 and 7. |
Common Stock Warrant Liability | Common Stock Warrant Liability Common stock warrants that were issued in connection with the July 8, 2015 public offering and the November 9, 2015 and January 11, 2016 senior amortizing convertible notes are classified as a liability in the condensed consolidated balance sheets, as the common stock warrants issued provide for certain anti-dilution protections in the event shares of common stock or securities convertible into shares of common stock are issued below the then-existing exercise price. The fair value of these common stock warrants is re-measured at each financial reporting period and immediately before exercise, with any changes in fair value being recognized as a component of other income (expense) in the condensed consolidated statements of operations. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers highly liquid investments generally with maturities of 90 days or less when purchased to be cash equivalents. Cash equivalents are stated at cost, which approximates market value. The Company’s cash equivalents are primarily in money market funds and certificates of deposit. The Company deposits its cash and cash equivalents in high-quality credit institutions. |
Short-Term Investments | Short-Term Investments The Company considers all investments with maturities greater than three months and less than one year at the time of purchase as short-term investments and classifies them as either available for sale or held to maturity. The Company also considers certain investments with maturities greater than one year but which are also held for liquidity purposes and are available for sale as short-term investments. Available-for-sale securities are carried at fair value based on quoted market prices, with the unrealized gains and losses included in other comprehensive income within stockholders’ equity in the condensed consolidated balance sheets. Realized gains and losses and declines in value judged to be other than temporary on available-for-sale securities are included in interest and other income. Interest and dividends on securities classified as available for sale are included in interest income. The cost of securities sold is based on the specific identification method. Short-term investments in debt securities which the Company has the positive intent and ability to hold to maturity are reported at cost, adjusted for premiums and discounts that are recognized in interest income, using the interest method, over the period to maturity. Unrealized losses on held-to-maturity securities reflecting a decline in value determined to be other than temporary are charged to income. |
Inventory | 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. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives of five to seven years for furniture and equipment and three to five years for computer hardware and software. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Upon retirement or sale, the cost and related accumulated depreciation or amortization are removed from the condensed consolidated balance sheets and the resulting gain or loss is reflected in the condensed consolidated statements of operations. Repairs and maintenance are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates its long-lived assets for impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or estimates of future discounted cash flows. The Company has not identified any such impairment losses to date. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance for deferred income tax assets is recorded when it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The Company has provided a full valuation allowance against the gross deferred tax assets. The Company’s policy is to classify interest and penalties related to income taxes as income tax expense in the condensed consolidated statements of operations. |
Medical Device Excise Tax | Medical Device Excise Tax On January 14, 2015, the Company received FDA approval for vBloc Therapy, delivered via the Maestro Rechargeable System, and starting in the second quarter of 2015 revenues were generated from sales in the United States. As a result, the Company is now required to pay a quarterly Medical Device Tax which is a part of the Affordable Care Act, which imposes a 2.3% excise tax on the sale of certain medical devices by device manufactures, producers or importers. The excise tax was effective on sales of devices made after December 31, 2012. The Company records the Medical Device Tax as an operating expense in the condensed consolidated statements of operations. A moratorium was placed on the Medical Device Tax for 2016 and 2017. |
Comprehensive Loss | 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. There was no difference from reported net loss for the three months ended March 31, 2016 and 2015. |
Revenue Recognition | Revenue Recognition Revenue is recognized 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. Products are sold through direct sales or medical device distributors and revenue is recognized upon sale to a bariatric center of excellence or a medical device distributor when 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. A provision for returns is recorded only if product sales provide for a right of return. No provision for returns was recorded for the three months ended March 31, 2016 and 2015, as the product sales recorded did not provide for rights of return. |
Research and Development Expenses | 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, devices, explants and revisions, quality assurance, regulatory expenses, payroll and other personnel expenses, materials and consulting costs. |
Net Loss Per Share | 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 Company’s potential dilutive shares, which include outstanding common stock options 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 months ended March 31, 2016 and 2015: Three months ended March 31, 2016 2015 Numerator: Net loss $ (7,408,762 ) $ (7,174,023 ) Denominator for basic and diluted net loss per share: Weighted-average common shares outstanding 7,840,992 4,849,061 Net loss per share—basic and diluted $ (0.94 ) $ (1.48 ) 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: March 31, 2016 2015 Stock options outstanding 1,953,859 948,675 Warrants to purchase common stock 4,476,839 1,613,133 |
Recently Issued or Adopted Accounting Standards | Recently Issued or Adopted Accounting Standards In March 2016, the Financial Accounting Standards Board (FASB) issued Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (Accounting Standards Update No. 2016-09 (ASU 2016-09)) In May 2014, FASB issued Revenue from Contracts with Customers, Topic 606 (Accounting Standards Update No. 2014-09 (ASU 2014-09)) There have been no other significant changes in recent accounting pronouncements during the three months ended March 31, 2016 as compared to the recent accounting pronouncements described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Computation of Basic and Diluted Net Loss per Share | The following table sets forth the computation of basic and diluted net loss per share for the three months ended March 31, 2016 and 2015: Three months ended March 31, 2016 2015 Numerator: Net loss $ (7,408,762 ) $ (7,174,023 ) Denominator for basic and diluted net loss per share: Weighted-average common shares outstanding 7,840,992 4,849,061 Net loss per share—basic and diluted $ (0.94 ) $ (1.48 ) |
Antidilutive Securities | 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: March 31, 2016 2015 Stock options outstanding 1,953,859 948,675 Warrants to purchase common stock 4,476,839 1,613,133 |
Short-term Investments and Fa18
Short-term Investments and Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Fair Value Measurements of Senior Amortizing Convertible Notes and Common Stock Warrants | The following table summarizes fair value measurements of the senior amortizing convertible notes and the common stock warrants issued in 2015 and during the three months ended March 31, 2016 by level at March 31, 2016: Level 1 Level 2 Level 3 Total Senior amortizing convertible notes $ — $ — $ 10,756,000 $ 10,756,000 Common stock warrants — 1,613,560 — 1,613,560 Total $ — $ 1,613,560 $ 10,756,000 $ 12,369,560 |
Warrant Liability | |
Schedule Of Assumption used to Calculate Fair Value | The fair value was calculated using the following assumptions: July 2015 Warrants November 2015 Warrants January 2016 Warrants March 31, 2016 December 31, 2015 March 31, 2016 December 31, 2015 March 31, 2016 January 11, 2016 Risk-free interest rates 0.87 % 1.31 % 1.21 % 1.76 % 1.21 % 1.58 % Expected life 33 months 36 months 55 months 58 months 57 months 60 months Expected dividends 0 % 0 % 0 % 0 % 0 % 0 % Expected volatility 91.15 % 97.94 % 91.42 % 86.27 % 90.04 % 85.90 % |
Senior Amortizing Convertible Notes | |
Schedule Of Assumption used to Calculate Fair Value | The fair values were calculated using a Binomial Lattice model and the following assumptions: November 2015 Notes January 2016 Notes March 31, 2016 December 31, 2015 March 31, 2016 January 11, 2016 Risk-free interest rates 0.68 % 1.11 % 0.68 % 1.01 % Expected life 1.61 years 1.86 years 1.61 years 1.83 years Expected dividends 0 % 0 % 0 % 0 % Expected volatility 65.0 % 57.5 % 65.0 % 60.0 % Fair value per share of common stock $ 0.97 $ 1.95 $ 0.97 $ 1.33 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Current Inventory | Current inventory consists of the following as of: March 31, 2016 December 31, 2015 Raw materials $ 527,471 $ 576,898 Work-in-process 1,296,525 1,066,345 Finished goods 44,210 43,081 Inventory $ 1,868,206 $ 1,686,324 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Future Minimum Payments under Lease | At March 31, 2016, future minimum payments under the lease are as follows: Year ending December 31: Remaining nine months in 2016 $ 172,457 2017 237,749 2018 183,103 $ 593,309 |
Senior Amortizing Convertible21
Senior Amortizing Convertible Notes (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Installment Amounts and Additional Conversions | The following table summarizes the installment amounts and additional conversions by the holders of the Notes issued at the First Closing through March 31, 2016: Principal Interest Total Common Shares Installment amount at December 31, 2015 $ 65,217 $ 23,651 $ 88,868 56,967 Holder conversions during the quarter ended December 31, 2015 18,261 2,375 20,636 13,228 Balance December 31, 2015 83,478 26,026 109,504 70,195 Installment amount at February 29, 2016 65,217 23,681 88,898 91,953 Installment amount at March 31, 2016 65,217 14,827 80,044 88,960 Holder conversions during the quarter ended March 31, 2016 104,784 12,762 117,546 106,684 Balance, March 31, 2016 $ 318,696 $ 77,296 $ 395,992 357,792 The following table summarizes the installment amounts and additional conversions by the holders of the Notes issued at the Second Closing through March 31, 2016: Principal Interest Total Common Shares Installment amount at March 2, 2016 $ 404,762 $ 149,300 $ 554,062 * Holder conversions during the quarter ended March 31, 2016 987,000 124,050 1,111,050 1,048,167 Balance, March 31, 2016 $ 1,391,762 $ 273,350 $ 1,665,112 1,048,167 * Cash payments |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Operating Expenses and Employee and Nonemployees | Based on the application of these standards, stock-based compensation expense for stock-based awards under the Company’s Amended and Restated 2003 Stock Incentive Plan (the Plan) and inducement grants for the three months ended March 31, 2016 and 2015 was allocated to operating expenses and employees and nonemployees as follows: Three months ended March 31, 2016 2015 Selling, general and administrative $ 839,777 $ 1,036,446 Research and development 252,711 335,630 Total $ 1,092,488 $ 1,372,076 Three months ended March 31, 2016 2015 Employees $ 1,090,192 $ 1,387,924 Nonemployees 2,296 (15,848 ) Total $ 1,092,488 $ 1,372,076 |
Stock Option Valuation Assumptions | 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 months ended March 31, 2016 and 2015: Employees Three months ended March 31, 2016 2015 Risk-free interest rates 1.16%-1.64% 1.65%-1.80% Expected life 5.00-6.25 years 6.25 years Expected dividends 0% 0% Expected volatility 88.43%-92.24% 110.32%-111.77% Nonemployees Three months ended March 31, 2016 2015 Risk-free interest rates 1.11% 0.03%-1.77% Expected life 4.39 years 0.25-8.51 years Expected dividends 0% 0% Expected volatility 92.41% 37.36%-131.49% |
Summary of Stock Option Activity | Option activity under the Plan for the three months ended March 31, 2016 was as follows: Outstanding Options Shares Available For Grant Number of Shares Weighted- Average Exercise Price Balance, December 31, 2015 296,579 1,018,752 $ 32.83 Shares reserved — — — Options granted (53,333 ) 53,333 1.07 Options exercised — — — Options cancelled 14,893 (14,893 ) 5.10 Balance, March 31, 2016 258,139 1,057,192 $ 31.62 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | ||
Mar. 31, 2016USD ($)shares | Jan. 06, 2016shares | Dec. 31, 2015shares | |
Schedule Of Significant Accounting Policies [Line Items] | |||
Common stock, reverse split ratio | 0.0667 | ||
Common stock authorized for issuance | shares | 150,000,000 | 150,000,000 | 13,333,333 |
Cash equivalents maturity period | 90 days | ||
Excise tax rate on medical devices | 2.30% | ||
Provision for returns | $ | $ 0 | ||
Minimum | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Short term investment maturity period | 3 months | ||
Maximum | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Short term investment maturity period | 1 year | ||
Furniture and Fixtures | Minimum | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Property and equipment estimated useful lives | 5 years | ||
Furniture and Fixtures | Maximum | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Property and equipment estimated useful lives | 7 years | ||
Computer hardware and software | Minimum | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Property and equipment estimated useful lives | 3 years | ||
Computer hardware and software | Maximum | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Property and equipment estimated useful lives | 5 years |
Computation of Basic and Dilute
Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Numerator: | ||
Net loss | $ (7,408,762) | $ (7,174,023) |
Denominator for basic and diluted net loss per share: | ||
Weighted-average common shares outstanding | 7,840,992 | 4,849,061 |
Net loss per share-basic and diluted | $ (0.94) | $ (1.48) |
Potential Shares of Common Stoc
Potential Shares of Common Stock Not Included in Calculation of Diluted Net Loss per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Stock Option Outstanding | ||
Anti-dilutive Securities | ||
Anti-dilutive as of end of each period | 1,953,859 | 948,675 |
Warrants to purchase common stock | ||
Anti-dilutive Securities | ||
Anti-dilutive as of end of each period | 4,476,839 | 1,613,133 |
Liquidity and Management's Pl26
Liquidity and Management's Plans - Additional Information (Detail) - USD ($) | Dec. 31, 2016 | May. 02, 2016 | Mar. 31, 2016 | Jan. 11, 2016 | Dec. 31, 2015 | Nov. 09, 2015 | Nov. 04, 2015 | Mar. 31, 2015 | Dec. 31, 2014 |
Liquidity and Managements Plans [Line Items] | |||||||||
Cash and cash equivalents | $ 11,153,525 | $ 7,927,240 | $ 11,432,234 | $ 11,619,167 | |||||
Senior Amortizing Convertible Note | |||||||||
Liquidity and Managements Plans [Line Items] | |||||||||
Senior amortizing convertible notes issued | $ 25,000,000 | ||||||||
Senior Amortizing Convertible Note | First closing | |||||||||
Liquidity and Managements Plans [Line Items] | |||||||||
Senior amortizing convertible notes issued | $ 1,500,000 | ||||||||
Senior Amortizing Convertible Note | Second closing | |||||||||
Liquidity and Managements Plans [Line Items] | |||||||||
Senior amortizing convertible notes issued | $ 11,000,000 | ||||||||
Senior Amortizing Convertible Note | Subsequent Event | Amendment | |||||||||
Liquidity and Managements Plans [Line Items] | |||||||||
Senior amortizing convertible notes issued | $ 12,500,000 | ||||||||
Senior Amortizing Convertible Note | Subsequent Event | First closing | Amendment | |||||||||
Liquidity and Managements Plans [Line Items] | |||||||||
Senior amortizing convertible notes issued | $ 6,250,000 | ||||||||
Senior Amortizing Convertible Note | Scenario, Forecast | Second closing | Amendment | |||||||||
Liquidity and Managements Plans [Line Items] | |||||||||
Senior amortizing convertible notes issued | $ 6,250,000 |
Short - term Investment and Fai
Short - term Investment and Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2016 | Jan. 11, 2016 | Dec. 31, 2015 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Senior amortizing convertible notes principal and interest converted into shares of common stock | $ 1,507,042 | ||
(losses) resulting from conversion of senior amortizing convertible notes | (499,568) | ||
Common Stock | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of warrants | 1,613,560 | ||
Warrants Issued July 8, 2015 | Common Stock | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of warrants | 1,198,689 | $ 2,759,583 | |
Warrants Issued November 9, 2015 | Common Stock | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of warrants | 75,670 | $ 118,234 | |
Warrants Issued January 11, 2016 | Common Stock | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of warrants | $ 339,201 | $ 515,157 |
Series A Warrants Fair Value Ca
Series A Warrants Fair Value Calculated Using Black-Scholes Valuation Model (Detail) | Jan. 11, 2016 | Mar. 31, 2016 | Dec. 31, 2015 |
Warrants Issued July 8, 2015 | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Risk-free interest rates | 0.87% | 1.31% | |
Expected life | 33 months | 36 months | |
Expected dividends | 0.00% | 0.00% | |
Expected volatility | 91.15% | 97.94% | |
Warrants Issued November 9, 2015 | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Risk-free interest rates | 1.21% | 1.76% | |
Expected life | 55 months | 58 months | |
Expected dividends | 0.00% | 0.00% | |
Expected volatility | 91.42% | 86.27% | |
Warrants Issued January 11, 2016 | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Risk-free interest rates | 1.58% | 1.21% | |
Expected life | 60 months | 57 months | |
Expected dividends | 0.00% | 0.00% | |
Expected volatility | 85.90% | 90.04% |
Summary of Fair Value Measureme
Summary of Fair Value Measurements of Senior Amortizing Convertible Notes and Common Stock Warrants (Detail) | Mar. 31, 2016USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Senior amortizing convertible notes | $ 10,756,000 |
Total | 12,369,560 |
Common Stock | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Fair value of warrants | 1,613,560 |
Level 2 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total | 1,613,560 |
Level 2 | Common Stock | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Fair value of warrants | 1,613,560 |
Level 3 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Senior amortizing convertible notes | 10,756,000 |
Total | $ 10,756,000 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Inventory [Line Items] | ||
Long-term inventory | $ 606,000 | $ 519,000 |
Current Inventory (Detail)
Current Inventory (Detail) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Inventory [Line Items] | ||
Raw materials | $ 527,471 | $ 576,898 |
Work-in-process | 1,296,525 | 1,066,345 |
Finished goods | 44,210 | 43,081 |
Inventory | $ 1,868,206 | $ 1,686,324 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Aug. 25, 2015 | Mar. 31, 2016 | Mar. 31, 2015 |
Loss Contingencies [Line Items] | |||
Operating lease agreement expiration date | Sep. 30, 2018 | Sep. 30, 2015 | |
Operating lease agreement term | 3 years | ||
Total rent expense | $ 58,905 | $ 67,718 | |
Number of months that require patients to be followed out in clinical trials | 60 months | ||
Minimum | |||
Loss Contingencies [Line Items] | |||
Operating lease, monthly base rent | $ 18,925 | ||
Maximum | |||
Loss Contingencies [Line Items] | |||
Operating lease, monthly base rent | $ 20,345 |
Future Minimum Lease Payment (D
Future Minimum Lease Payment (Detail) | Mar. 31, 2016USD ($) |
Leases Future Minimum Payments [Line Items] | |
Remaining nine months in 2016 | $ 172,457 |
2,017 | 237,749 |
2,018 | 183,103 |
Operating Leases, Future Minimum Payments Due, Total | $ 593,309 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) | May. 09, 2013USD ($) | Apr. 23, 2012USD ($)Installment | Apr. 16, 2012USD ($)$ / sharesshares | Mar. 31, 2016USD ($) | Jan. 29, 2016$ / shares | Jan. 11, 2016$ / shares | Nov. 09, 2015shares |
Debt Instrument [Line Items] | |||||||
Amount used to repay outstanding debt | $ 4,700,000 | ||||||
Repayment of principal amount | $ 333,333 | ||||||
Loan agreement with fixed annual rate | 8.00% | ||||||
Conditional amount to be placed in restricted account at SVB | $ 7,500,000 | ||||||
Issued warrant | shares | 1,958,728 | ||||||
Exercise price | $ / shares | $ 1.09 | $ 4.65 | |||||
Silicon Valley Bank | |||||||
Debt Instrument [Line Items] | |||||||
Term loans, agreed sum | $ 20,000,000 | ||||||
Principal amount of loan | $ 10,000,000 | $ 10,000,000 | |||||
Number of installments of repayment of debt | Installment | 30 | ||||||
Issued warrant | shares | 7,116 | ||||||
Time for exercising warrant | 10 years | ||||||
Exercise price | $ / shares | $ 35.10 | ||||||
First Amendment | Silicon Valley Bank | |||||||
Debt Instrument [Line Items] | |||||||
Success fee percentage in the event the Company receives FDA approval for the Maestro Rechargeable System | 187,000 | ||||||
Final payment fee percentage | 5.00% | ||||||
Final payment fee | $ 500,000 | ||||||
First Amendment | Silicon Valley Bank | November 15, 2013 | |||||||
Debt Instrument [Line Items] | |||||||
Cumulative aggregate proceeds from new capital transactions | 5,000,000 | ||||||
First Amendment | Silicon Valley Bank | April 15, 2014 | |||||||
Debt Instrument [Line Items] | |||||||
Cumulative aggregate proceeds from new capital transactions | $ 10,000,000 | ||||||
First Amendment | Silicon Valley Bank | Until it received FDA approval for the Maestro Rechargeable System | |||||||
Debt Instrument [Line Items] | |||||||
Liquidity ratio (unrestricted cash divided by outstanding debt) | 125.00% | ||||||
First Amendment | Silicon Valley Bank | After FDA approval for the Maestro Rechargeable System | |||||||
Debt Instrument [Line Items] | |||||||
Liquidity ratio (unrestricted cash divided by outstanding debt) | 75.00% |
Senior Amortizing Convertible35
Senior Amortizing Convertible Notes - Additional Information (Detail) - USD ($) | May. 02, 2016 | Jan. 11, 2016 | Nov. 09, 2015 | Nov. 04, 2015 | Mar. 31, 2016 | Jan. 29, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | |||||||
Convertible notes, per share price | $ 4.35 | $ 4.35 | $ 1.09 | ||||
Exercise price | $ 4.65 | $ 1.09 | |||||
Convertible notes, interest rate | 7.00% | ||||||
Convertible notes, maturity period | 24 months | ||||||
Issued warrant | 1,958,728 | ||||||
Warrants issued, exercisable time period | 60 months | ||||||
Subsequent Event | |||||||
Debt Instrument [Line Items] | |||||||
Exercise price | $ 4.65 | ||||||
First closing | |||||||
Debt Instrument [Line Items] | |||||||
Fair value of outstanding Notes | $ 1,200,000 | $ 1,300,000 | |||||
Second closing | |||||||
Debt Instrument [Line Items] | |||||||
Fair value of outstanding Notes | $ 9,900,000 | 9,500,000 | |||||
Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Common stock ownership percentage required to exercise warrants | 4.99% | ||||||
Period available for the percentage to be effective | 61 days | ||||||
Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Common stock ownership percentage required to exercise warrants | 9.99% | ||||||
Senior Amortizing Convertible Note | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | $ 25,000,000 | ||||||
Exercise price | $ 4.65 | ||||||
Proceeds from issuance of debt instrument including warrants | $ 12,500,000 | ||||||
Convertible notes, interest rate | 7.00% | ||||||
Senior convertible notes, maturity year | 2,017 | ||||||
Senior Amortizing Convertible Note | Subsequent Event | Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | $ 12,500,000 | ||||||
Senior Amortizing Convertible Note | First closing | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | $ 1,500,000 | ||||||
Issued warrant | 117,520 | ||||||
Fair value of warrants | $ 169,000 | ||||||
Expected dividends | 0.00% | ||||||
Expected volatility | 84.85% | ||||||
Risk-free interest rates | 1.75% | ||||||
Expected life | 5 years | ||||||
Senior Amortizing Convertible Note | First closing | Subsequent Event | Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | 6,250,000 | ||||||
Senior Amortizing Convertible Note | Second closing | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | $ 11,000,000 | ||||||
Issued warrant | 861,842 | ||||||
Fair value of warrants | $ 515,000 | ||||||
Expected dividends | 0.00% | ||||||
Expected volatility | 85.90% | ||||||
Risk-free interest rates | 1.58% | ||||||
Expected life | 5 years | ||||||
Senior Amortizing Convertible Note | Third closing | Subsequent Event | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | $ 6,250,000 | ||||||
Issued warrant | 489,684 | ||||||
Senior Amortizing Convertible Note | Third closing | Subsequent Event | Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of debt instrument including warrants | $ 6,250,000 | ||||||
Senior Amortizing Convertible Note | Fourth closing | |||||||
Debt Instrument [Line Items] | |||||||
Senior amortizing convertible notes to be issue | 6,250,000 | ||||||
Proceeds from issuance of debt instrument including warrants | $ 6,250,000 | ||||||
Issued warrant | 489,682 |
Schedule of Fair Value Assumpti
Schedule of Fair Value Assumption Calculated Using Binomial Lattice Model (Detail) - $ / shares | Jan. 11, 2016 | Mar. 31, 2016 | Dec. 31, 2015 |
November Twenty Fifteen Notes | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Risk-free interest rates | 0.68% | 1.11% | |
Expected life | 1 year 7 months 10 days | 1 year 10 months 10 days | |
Expected dividends | 0.00% | 0.00% | |
Expected volatility | 65.00% | 57.50% | |
Fair value per share of common stock | $ 0.97 | $ 1.95 | |
January Twenty Sixteen Notes | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Risk-free interest rates | 1.01% | 0.68% | |
Expected life | 1 year 9 months 29 days | 1 year 7 months 10 days | |
Expected dividends | 0.00% | 0.00% | |
Expected volatility | 60.00% | 65.00% | |
Fair value per share of common stock | $ 1.33 | $ 0.97 |
Summary of Installment Amounts
Summary of Installment Amounts and Additional Conversions (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2016 | Dec. 31, 2015 | |
Short-term Debt [Line Items] | ||
Total | $ 1,397,538 | |
First closing | ||
Short-term Debt [Line Items] | ||
Principal | 318,696 | $ 83,478 |
Interest | 77,296 | 26,026 |
Total | $ 395,992 | $ 109,504 |
Common Shares | 357,792 | 70,195 |
Second closing | ||
Short-term Debt [Line Items] | ||
Principal | $ 1,391,762 | |
Interest | 273,350 | |
Total | $ 1,665,112 | |
Common Shares | 1,048,167 | |
Installment amount | First closing | ||
Short-term Debt [Line Items] | ||
Principal | $ 65,217 | |
Interest | 23,651 | |
Total | $ 88,868 | |
Common Shares | 56,967 | |
Installment amount | Second closing | ||
Short-term Debt [Line Items] | ||
Principal | $ 404,762 | |
Interest | 149,300 | |
Total | 554,062 | |
Installment Payments February 29, 2016 | First closing | ||
Short-term Debt [Line Items] | ||
Principal | 65,217 | |
Interest | 23,681 | |
Total | $ 88,898 | |
Common Shares | 91,953 | |
Installment Payments March 31, 2016 | First closing | ||
Short-term Debt [Line Items] | ||
Principal | $ 65,217 | |
Interest | 14,827 | |
Total | $ 80,044 | |
Common Shares | 88,960 | |
Holder Conversions | First closing | ||
Short-term Debt [Line Items] | ||
Principal | $ 104,784 | $ 18,261 |
Interest | 12,762 | 2,375 |
Total | $ 117,546 | $ 20,636 |
Common Shares | 106,684 | 13,228 |
Holder Conversions | Second closing | ||
Short-term Debt [Line Items] | ||
Principal | $ 987,000 | |
Interest | 124,050 | |
Total | $ 1,111,050 | |
Common Shares | 1,048,167 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense for Stock-Based Awards (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation | $ 1,092,488 | $ 1,372,076 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation | 839,777 | 1,036,446 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation | 252,711 | 335,630 |
Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation | 1,090,192 | 1,387,924 |
Nonemployees | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation | $ 2,296 | $ (15,848) |
Stock Options - Additional Info
Stock Options - Additional Information (Detail) $ / shares in Units, $ in Millions | 3 Months Ended |
Mar. 31, 2016USD ($)$ / sharesshares | |
Schedule Of Stock Options [Line Items] | |
Total unrecognized compensation costs related to non-vested stock options | $ | $ 5.1 |
Total unrecognized compensation costs related to non-vested stock options, weighted-average period of recognition | 2 years 6 months 26 days |
President and Chief Executive Officer | |
Schedule Of Stock Options [Line Items] | |
Award granted, shares | shares | 516,666 |
Award granted, exercise price per share | $ / shares | $ 3.75 |
Award granted, vesting installment percentage | 2.0833% |
Award vesting period | 36 months |
Senior Vice President of Operations and Business Development Mr. Delange | |
Schedule Of Stock Options [Line Items] | |
Award granted, shares | shares | 166,667 |
Award granted, exercise price per share | $ / shares | $ 1.38 |
Senior Vice President of Sales | |
Schedule Of Stock Options [Line Items] | |
Award granted, shares | shares | 106,667 |
Award granted, exercise price per share | $ / shares | $ 1.31 |
Senior Vice President of Marketing and Reimbursement | |
Schedule Of Stock Options [Line Items] | |
Award granted, shares | shares | 106,667 |
Award granted, exercise price per share | $ / shares | $ 1.32 |
Vest as of one year from the date of his employment agreement | President and Chief Executive Officer | |
Schedule Of Stock Options [Line Items] | |
Award granted, vesting percentage | 25.00% |
Vest in equal 2.0833% installments each month thereafter over the following 36 months | President and Chief Executive Officer | |
Schedule Of Stock Options [Line Items] | |
Award granted, vesting percentage | 75.00% |
Estimated Grant-Date Fair Value
Estimated Grant-Date Fair Values of Employee Stock Options (Detail) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 1.16% | 1.65% |
Risk-free interest rate, maximum | 1.64% | 1.80% |
Expected life | 6 years 3 months | |
Expected dividends | 0.00% | 0.00% |
Expected volatility factor, minimum | 88.43% | 110.32% |
Expected volatility factor, maximum | 92.24% | 111.77% |
Employees | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 5 years | |
Employees | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 6 years 3 months | |
Nonemployees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 1.11% | 0.03% |
Risk-free interest rate, maximum | 1.77% | |
Expected life | 4 years 4 months 21 days | |
Expected dividends | 0.00% | 0.00% |
Expected volatility factor, minimum | 92.41% | 37.36% |
Expected volatility factor, maximum | 131.49% | |
Nonemployees | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 3 months | |
Nonemployees | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 8 years 6 months 4 days |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) - Stock Incentive Plan 2003 | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares Available For Grant, Beginning Balance | 296,579 |
Shares Available For Grant, Shares reserved | 0 |
Shares Available For Grant, Options granted | (53,333) |
Shares Available For Grant, Options exercised | 0 |
Shares Available For Grant, Options cancelled | 14,893 |
Shares Available For Grant, Ending Balance | 258,139 |
Outstanding Options, Number of Shares, Beginning Balance | 1,018,752 |
Outstanding Options, Number of Shares, Shares reserved | 0 |
Outstanding Options, Number of Shares, Options granted | 53,333 |
Outstanding Options, Number of Shares, Options exercised | 0 |
Outstanding Options, Number of Shares, Options cancelled | (14,893) |
Outstanding Options, Number of Shares, Ending Balance | 1,057,192 |
Outstanding Options, Weighted-Average Exercise Price, Beginning Balance | $ / shares | $ 32.83 |
Outstanding Options, Weighted-Average Exercise Price, Shares reserved | $ / shares | 0 |
Outstanding Options, Weighted-Average Exercise Price, Options granted | $ / shares | 1.07 |
Outstanding Options, Weighted-Average Exercise Price, Options exercised | $ / shares | 0 |
Outstanding Options, Weighted-Average Exercise Price, Options cancelled | $ / shares | 5.10 |
Outstanding Options, Weighted-Average Exercise Price, Ending Balance | $ / shares | $ 31.62 |
Stock Sales - Additional Inform
Stock Sales - Additional Information (Detail) - USD ($) | Jul. 08, 2015 | Jun. 13, 2014 | Mar. 31, 2016 | Mar. 30, 2016 | Jan. 29, 2016 | Jan. 11, 2016 | Dec. 31, 2015 | Nov. 09, 2015 |
Class of Stock [Line Items] | ||||||||
Public offering selling units | 2,133,333 | |||||||
Shares issued, price per unit | $ 7.50 | |||||||
Gross proceeds before deducting estimate offering expenses | $ 16,000,000 | |||||||
Offering costs | $ 1,400,000 | |||||||
Exercise price | $ 1.09 | $ 4.65 | ||||||
Beneficial ownership percentage | 9.99% | |||||||
Series A Warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Exercise price | $ 9 | $ 0.88 | $ 0.97 | $ 1.50 | $ 2.40 | |||
Warrants exercisable period | 42 months | |||||||
Warrants to purchase common stock | ||||||||
Class of Stock [Line Items] | ||||||||
Offering costs | $ 532,000 | |||||||
Series C Warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Exercise price | $ 7.50 | |||||||
Warrant issued | 0 | |||||||
Cowen and Company LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Gross proceeds before deducting estimate offering expenses | $ 7,600,000 | |||||||
Commission or discount percentage on issue of shares | 3.00% | |||||||
Number of shares sold | 367,903 | |||||||
Minimum | ||||||||
Class of Stock [Line Items] | ||||||||
Beneficial ownership percentage | 4.99% | |||||||
Maximum | Cowen and Company LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Gross proceeds before deducting estimate offering expenses | $ 25,000,000 | |||||||
Weighted Average | Cowen and Company LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, price per share | $ 20.60 |