Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Feb. 27, 2015 | Jun. 30, 2014 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ETRM | ||
Entity Registrant Name | EnteroMedics Inc | ||
Entity Central Index Key | 1371217 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 73,789,178 | ||
Entity Public Float | $84,881,411 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Current assets: | ||
Cash and cash equivalents | $11,619,167 | $23,297,479 |
Accounts receivable | 2,812 | 17,742 |
Inventory | 980,519 | 1,127,941 |
Prepaid expenses and other current assets | 421,673 | 546,744 |
Total current assets | 13,024,171 | 24,989,906 |
Property and equipment, net | 481,522 | 577,095 |
Other assets | 879,905 | 820,767 |
Total assets | 14,385,598 | 26,387,768 |
Current liabilities: | ||
Current portion of notes payable (net of discounts of $23,836 at December 31, 2014) | 2,976,164 | 4,000,000 |
Accounts payable | 399,336 | 127,329 |
Accrued expenses | 3,830,766 | 4,186,060 |
Accrued interest payable | 514,937 | 526,672 |
Total current liabilities | 7,721,203 | 8,840,061 |
Notes payable, less current portion (net of discounts of $131,670 at December 31, 2013) | 2,868,330 | |
Total liabilities | 7,721,203 | 11,708,391 |
Commitments and contingencies (Note 15) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value; 200,000,000 and 125,000,000 shares authorized at December 31, 2014 and 2013, respectively; 69,570,444 and 63,551,350 shares issued and outstanding at December 31, 2014 and 2013, respectively | 695,704 | 635,514 |
Additional paid-in capital | 258,050,482 | 239,996,934 |
Accumulated deficit | -252,081,791 | -225,953,071 |
Total stockholders' equity | 6,664,395 | 14,679,377 |
Total liabilities and stockholders' equity | $14,385,598 | $26,387,768 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Current portion of notes payable, discounts | $23,836 | |
Notes payable, less current portion, discounts | $131,670 | |
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 200,000,000 | 125,000,000 |
Common stock, shares issued | 69,570,444 | 63,551,350 |
Common stock, shares outstanding | 69,570,444 | 63,551,350 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Sales | $311,493 | ||
Cost of goods sold | 231,520 | ||
Gross profit | 79,973 | ||
Operating expenses: | |||
Research and development | 11,031,619 | 11,075,493 | 10,668,044 |
Selling, general and administrative | 14,561,656 | 13,658,824 | 11,960,893 |
Total operating expenses | 25,593,275 | 24,734,317 | 22,628,937 |
Operating loss | -25,593,275 | -24,734,317 | -22,548,964 |
Other income (expense): | |||
Interest income | 3,331 | 5,717 | 9,877 |
Interest expense | -530,222 | -932,364 | -901,835 |
Other, net | -8,554 | -119,695 | -19,181 |
Net loss | ($26,128,720) | ($25,780,659) | ($23,460,103) |
Net loss per share-basic and diluted | ($0.39) | ($0.47) | ($0.59) |
Shares used to compute basic and diluted net loss per share | 67,866,427 | 55,009,916 | 39,536,500 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Loss (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Net loss | ($26,128,720) | ($25,780,659) | ($23,460,103) |
Change in unrealized gain (loss) on available for sale investments | -692 | ||
Comprehensive loss | ($26,128,720) | ($25,780,659) | ($23,460,795) |
Consolidated_Statements_of_Sto
Consolidated Statements of Stockholders' Equity (Deficit) (USD $) | Total | Common Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
USD ($) | USD ($) | Maximum | USD ($) | USD ($) | USD ($) | |
Beginning Balance at Dec. 31, 2011 | $20,040,905 | $367,527 | $196,384,995 | $692 | ($176,712,309) | |
Beginning Balance (in shares) at Dec. 31, 2011 | 36,752,746 | |||||
Net loss | -23,460,103 | -23,460,103 | ||||
Change in unrealized gain (loss) on available for sale investments | -692 | -692 | ||||
Employee stock-based compensation expense | 4,173,132 | 4,173,132 | ||||
Nonemployee stock-based compensation expense | 52,190 | 52,190 | ||||
Issuance of common stock in registered direct offering | 4,682,129 | 22,717 | 4,659,412 | |||
Issuance of common stock in registered direct offering (in shares) | 2,271,705 | |||||
Warrants issued for the purchase of shares of common stock | 237,349 | 237,349 | ||||
Exercise of common stock options | 12,666 | 53 | 12,613 | |||
Exercise of common stock options (in shares) | 5,219 | 5,219 | ||||
Exercise of stock warrants | 6,137,095 | 28,136 | 6,108,959 | |||
Exercise of stock warrants (in shares) | 2,813,600 | 2,813,600 | ||||
Ending Balance at Dec. 31, 2012 | 11,874,671 | 418,433 | 211,628,650 | -200,172,412 | ||
Ending Balance (in shares) at Dec. 31, 2012 | 41,843,270 | |||||
Net loss | -25,780,659 | -25,780,659 | ||||
Employee stock-based compensation expense | 5,788,249 | 5,788,249 | ||||
Nonemployee stock-based compensation expense | 166,679 | 166,679 | ||||
Issuance of common stock in registered public offering | 12,015,300 | 137,700 | 11,877,600 | |||
Issuance of common stock in registered public offering (in shares) | 13,770,000 | |||||
Stock issued | 10,587,117 | 79,178 | 10,507,939 | |||
Stock issued (Shares) | 7,917,755 | |||||
Exercise of stock warrants | 28,020 | 203 | 27,817 | |||
Exercise of stock warrants (in shares) | 20,325 | 20,325 | ||||
Ending Balance at Dec. 31, 2013 | 14,679,377 | 635,514 | 239,996,934 | -225,953,071 | ||
Ending Balance (in shares) at Dec. 31, 2013 | 63,551,350 | 63,551,350 | ||||
Net loss | -26,128,720 | -26,128,720 | ||||
Employee stock-based compensation expense | 6,138,384 | 6,138,384 | ||||
Nonemployee stock-based compensation expense | 181,323 | 181,323 | ||||
Stock issued | 9,551,766 | 46,908 | 9,504,858 | |||
Stock issued (Shares) | 4,690,824 | |||||
Exercise of stock warrants | 2,242,265 | 13,282 | 2,228,983 | |||
Exercise of stock warrants (in shares) | 1,328,270 | 1,328,270 | ||||
Ending Balance at Dec. 31, 2014 | $6,664,395 | $695,704 | $258,050,482 | ($252,081,791) | ||
Ending Balance (in shares) at Dec. 31, 2014 | 69,570,444 | |||||
Ending Balance (in shares) at Dec. 31, 2014 | 69,570,444 |
Consolidated_Statements_of_Sto1
Consolidated Statements of Stockholders' Equity (Deficit) (Parenthetical) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Stock issued, per share | $2.22 | ||
Issuance of common stock in registered direct offering for cash per share, financing costs | $367,871 | ||
Exercise of stock warrants (in shares) | 1,328,270 | 20,325 | 2,813,600 |
Warrants issued for the purchase of stock (in shares) | 106,746 | ||
Warrants issued, per share | $2.22 | ||
Exercise of common stock options (in shares) | 5,219 | ||
Issuance of common stock and warrants to purchase number of shares of common stock | 5,508,000 | ||
Issuance of common stock in public offering for cash per share | $0.95 | ||
Payments of stock issuance costs public offering | 1,066,200 | ||
At-The-Market | |||
Payments of stock issuance costs public offering | 284,698 | $381,981 | |
Minimum | |||
Exercise of stock warrants, per share | 1.14 | $1.14 | $1.90 |
Exercise of common stock options, per share | $1.90 | ||
Minimum | At-The-Market | |||
Stock issued, per share | 1.1 | $1.10 | |
Maximum | |||
Exercise of stock warrants, per share | 2.19 | $1.90 | $2.19 |
Exercise of common stock options, per share | $2.58 | ||
Maximum | At-The-Market | |||
Stock issued, per share | 2.54 | $2.10 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Cash flows from operating activities: | |||
Net loss | ($26,128,720) | ($25,780,659) | ($23,460,103) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 188,904 | 174,629 | 226,990 |
Loss on sale of equipment | 767 | ||
Stock-based compensation | 6,319,707 | 5,954,928 | 4,225,322 |
Amortization of commitment fees, debt issuance costs and original issue discount | 123,068 | 199,592 | 207,310 |
Amortization of short-term investment premium or discount | 4,719 | ||
Other, net | 8,030 | ||
Change in operating assets and liabilities: | |||
Accounts receivable | 14,930 | 26,634 | -52,406 |
Inventory | 147,422 | 143,266 | -202,584 |
Prepaid expenses and other current assets | 125,071 | 24,910 | 233,145 |
Other assets | -74,372 | 246,764 | -813,063 |
Accounts payable | 267,356 | 60,732 | -224,562 |
Accrued expenses | -355,294 | 512,451 | -2,699,761 |
Accrued interest payable | -11,735 | 2,994 | 74,857 |
Net cash used in operating activities | -19,383,663 | -18,425,729 | -22,479,369 |
Cash flows from investing activities: | |||
Decrease in restricted cash | 200,000 | ||
Maturities of short-term investments available for sale | 1,000,000 | ||
Purchases of property and equipment | -88,680 | -416,010 | -76,394 |
Net cash (used in) provided by investing activities | -88,680 | -216,010 | 923,606 |
Cash flows from financing activities: | |||
Proceeds from stock options exercised | 12,666 | ||
Proceeds from warrants exercised | 2,242,265 | 28,020 | 6,137,095 |
Proceeds from sale of common stock and warrants for purchase of common stock | 9,836,464 | 24,050,598 | 5,050,000 |
Common stock financing costs | -284,698 | -1,448,181 | -367,871 |
Proceeds from notes payable and convertible notes payable | 5,347,807 | ||
Repayments on notes payable | -4,000,000 | -3,000,000 | -752,841 |
Debt issuance costs | -50,000 | ||
Net cash provided by financing activities | 7,794,031 | 19,630,437 | 15,376,856 |
Net (decrease) increase in cash and cash equivalents | -11,678,312 | 988,698 | -6,178,907 |
Cash and cash equivalents: | |||
Beginning of period | 23,297,479 | 22,308,781 | 28,487,688 |
End of period | 11,619,167 | 23,297,479 | 22,308,781 |
Supplemental disclosure: | |||
Interest paid | 418,889 | 729,778 | 619,668 |
Noncash investing and financing activities: | |||
Value of warrants issued with debt and for debt commitment | $237,349 |
Formation_and_Business_of_the_
Formation and Business of the Company | 12 Months Ended | |
Dec. 31, 2014 | ||
Formation and Business of the Company | -1 | Formation and Business of the Company |
EnteroMedics Inc. (EnteroMedics or the Company) is developing implantable systems to treat obesity, metabolic diseases and other gastrointestinal disorders. The Company was incorporated in the state of Minnesota on December 19, 2002, originally as two separate legal entities, Alpha Medical, Inc. and Beta Medical, Inc., both of which were owned 100% by a common stockholder. Effective October 1, 2003, the two entities were combined and the combined entity changed its name to EnteroMedics Inc. The Company reincorporated in Delaware on July 22, 2004. 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 thus far has only derived revenues from its primary business activity in 2012. The Company is headquartered in St. Paul, Minnesota. | ||
EnteroMedics Europe Sárl (EnteroMedics Europe), a wholly owned subsidiary of the Company, was formed in January 2006. EnteroMedics Europe is a Swiss entity established as a means to conduct clinical trials in Switzerland. Upon establishment there were 20 shares of EnteroMedics Europe issued and outstanding with a par value of 1,000 Swiss Francs. EnteroMedics purchased 100% of the shares and then issued one share to a fiduciary agent. The one share is the property of EnteroMedics and is held by the fiduciary in a fiduciary capacity under terms of the Fiduciary Agreement. The functional currency of EnteroMedics Europe has been determined to be the U.S. Dollar. | ||
EnteroMedics has incurred losses through December 31, 2014 and has not generated positive cash flows from operations. The Company expects such losses to continue into the foreseeable future as it continues to develop and commercialize its technologies. The Company may need to obtain additional financing and there can be no assurance that the Company will be successful in obtaining additional financing on favorable terms, or at all. If adequate funds are not available, the Company may have to delay development or commercialization of products or license to third parties the rights to commercialize products or technologies that the Company would otherwise seek to commercialize. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Summary of Significant Accounting Policies | -2 | Summary of Significant Accounting Policies | |||||||||||
Basis of Presentation | |||||||||||||
The Company has prepared the accompanying 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. | |||||||||||||
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 consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and accounts have been eliminated in consolidation. | |||||||||||||
Concentration of Credit Risk and Other Risks and Uncertainties | |||||||||||||
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. Cash and cash equivalents are primarily deposited in demand and money market accounts. At times, such deposits may be in excess of insured limits. Investments in money market funds are not considered to be bank deposits and are not insured or guaranteed by the federal deposit insurance company or other government agency. These money market funds seek to preserve the value of the investment at $1.00 per share; however, it is possible to lose money investing in these funds. The Company has not experienced any losses on its deposits of cash and cash equivalents. | |||||||||||||
Most of the products developed by the Company 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 bariatric centers of excellence in the United States. The Maestro Rechargeable System has also received CE Mark and is listed on the Australian Register of Therapeutic Goods. | |||||||||||||
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 risk 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. | |||||||||||||
Fair Value of Financial Instruments | |||||||||||||
Carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their short maturities. The fair values of investments in debt and equity securities, if any, are disclosed in Note 4. The fair value of the Company’s debt is approximately $3.4 million as of December 31, 2014 based on the present value of estimated future cash flows using a discount rate commensurate with borrowing rates available to the Company. If measured at fair value in the consolidated financial statements, long-term debt (including the current portion) would be classified as Level 2 in the fair value hierarchy. | |||||||||||||
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. Under terms of the Company’s notes payable agreements (see Note 8), in the event of default, the lender has the right to enforce account control agreements and restrict the Company’s access to their cash and investment accounts. | |||||||||||||
Restricted Cash | |||||||||||||
The Company had $200,000 in a cash collateral money market account as of December 31, 2012. Pursuant to the Lease Agreement the Company entered into with Roseville Properties Management Company in July 2008, the Company was required to deliver to Roseville Properties an irrevocable, unconditional, standby letter of credit in the amount of $200,000 on the second anniversary of the commencement of lease payments. The irrevocable standby letter of credit was issued by Silicon Valley Bank, who required the Company to set up a restricted cash collateral money market account to fully secure the standby letter of credit. The fully secured standby letter of credit was maintained through October 1, 2013, per the terms of the lease agreement. | |||||||||||||
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 (deficit) in the 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 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 consolidated balance sheets and the resulting gain or loss is reflected in the 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 as of December 31, 2014 and 2013 (see Note 11). The Company’s policy is to classify interest and penalties related to income taxes as income tax expense in the consolidated statements of operations. | |||||||||||||
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 years ended December 31, 2014 and 2013. The difference from reported net loss for the year ended December 31, 2012 related entirely to changes in unrealized gains (losses) on available-for-sale investments. | |||||||||||||
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 internationally through distributors and revenue is recognized upon sale to the distributor as these sales are considered to be final and no right of return or price protection exists. Terms of sales to international distributors are generally EXW, reflecting that goods are shipped “ex works,” in which risk of loss is assumed by the distributor at the shipping point. We do not provide for rights of return to customers on product sales and therefore do not record a provision for returns. | |||||||||||||
Research and Development Expenses | |||||||||||||
Research and development expenses are charged to expense as incurred. Research and development expenses include, but are not limited to, product development, clinical trial expenses, including supplies, devices, explants and revisions, quality assurance, regulatory expenses, payroll and other personnel expenses, materials and consulting costs. | |||||||||||||
Patent Costs | |||||||||||||
Costs associated with the submission of a patent application are expensed as incurred given the uncertainty of the patents resulting in probable future economic benefits to the Company. Patent-related legal expenses included in general and administrative costs were $338,055, $296,575 and $278,987 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||
Derivative Instruments | |||||||||||||
The Company accounts for outstanding warrants that are not indexed to the Company’s stock or warrants issued when the Company has insufficient authorized and unissued stock available to share settle the outstanding warrants as derivative instruments, which require that the warrants be classified as a liability and measured at fair value with changes in fair value recognized currently in earnings and recorded separately in the consolidated statements of operations. The Company did not have any such instruments during the years ended December 31, 2014, 2013 and 2012. | |||||||||||||
Stock-Based Compensation | |||||||||||||
The fair value method 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. All option grants are expensed on a straight-line basis over the vesting period. | |||||||||||||
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 years ended December 31, 2014, 2013 and 2012: | |||||||||||||
Years ended | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator: | |||||||||||||
Net loss | $ | (26,128,720 | ) | $ | (25,780,659 | ) | $ | (23,460,103 | ) | ||||
Denominator for basic and diluted net loss per share: | |||||||||||||
Weighted-average common shares outstanding | 67,866,427 | 55,009,916 | 39,536,500 | ||||||||||
Net loss per share—basic and diluted | $ | (0.39 | ) | $ | (0.47 | ) | $ | (0.59 | ) | ||||
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: | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Stock options outstanding | 12,655,792 | 11,687,300 | 7,835,533 | ||||||||||
Warrants to purchase common stock | 24,199,705 | 25,550,625 | 21,216,447 | ||||||||||
Recently Issued Accounting Standards | |||||||||||||
In June 2014, the Financial Accounting Standards Board (FASB) issued Development Stage Entities, Topic 915 (Accounting Standards Update No. 2014-10 (ASU 2014-10)), which eliminates certain financial reporting requirements, with the objective of improving financial reporting by reducing the cost and complexity associated with the incremental reporting requirements for development stage entities. This guidance is effective for interim and annual reporting periods beginning after December 15, 2014; however, early application is permitted for any annual reporting period or interim period for which an entity’s financial statements have not yet been issued. The Company elected to adopt ASU 2014-10 effective with the quarter ending June 30, 2014. Therefore, the accompanying consolidated financial statements no longer present or disclose any information previously required by Topic 915. | |||||||||||||
In May 2014, FASB issued Revenue from Contracts with Customers, Topic 606 (Accounting Standards Update No. 2014-09 (ASU 2014-09)), which provides a framework for the recognition of revenue, with the objective that recognized revenues properly reflect amounts an entity is entitled to receive in exchange for goods and services. This guidance will be effective for interim and annual reporting periods beginning after December 15, 2016. The Company is currently evaluating the impact of adopting ASU 2014-09 on its consolidated financial statements. | |||||||||||||
Various other accounting standards and interpretations have been issued with 2014 effective dates and effective dates subsequent to December 31, 2014. We have evaluated the recently issued accounting pronouncements that are currently effective or will be effective in 2015 and believe that none of them have had or will have a material effect on our financial position, results of operations or cash flows. |
Liquidity_and_Managements_Plan
Liquidity and Management's Plans | 12 Months Ended | |
Dec. 31, 2014 | ||
Liquidity and Management's Plans | -3 | Liquidity and Management’s Plans |
The accompanying 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 December 31, 2014, the Company had $11.6 million of cash and cash equivalents to fund its anticipated operations for 2015 and also has an “at-the-market” equity offering program (ATM) under which it can raise additional funds by instructing Cowen and Company, LLC (Cowen), the Company’s sales agent, to sell shares of the Company’s common stock having aggregate gross sales proceeds of up to $25.0 million (the Cowen ATM), of which $17.6 million remains available as of March 13, 2015 (further described in Note 10). These 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. In order to finance these anticipated operations, including the increase in internal expenditures resulting from the controlled commercial launch noted above, the Company has raised $6.4 million in gross proceeds before deducting offering expenses from the Cowen ATM subsequent to December 31, 2014 through March 13, 2015. In addition, the Company believes that it has the ability to raise additional capital through (i) the sale of additional equity securities, including, but not limited to, the use of the Cowen ATM and the exercise of outstanding warrants; (ii) the sale of debt securities; or (iii) establishing a credit facility, and has the flexibility to manage the growth of its expenditures and expand operations. |
Shortterm_Investments_and_Fair
Short-term Investments and Fair Value Measurements | 12 Months Ended | |||
Dec. 31, 2014 | ||||
Short-term Investments and Fair Value Measurements | -4 | 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 include U.S. treasury securities. Such instruments are classified by the company within Level 1 of the fair value hierarchy. U.S. treasuries are valued using unadjusted quoted prices for identical assets in active markets that the Company can access. | ||||
The types of instruments the Company invests in that are valued based on quoted prices in less active markets, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency include 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 December 31, 2014 and 2013. |
Inventory
Inventory | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventory | -5 | Inventory | |||||||
From 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 Australian Register of Therapeutic Goods (ARTG) listings for components of the Maestro Rechargeable System from the Australian Therapeutic Goods Administration (TGA), with the final components being listed on the ARTG in January 2012. As a result, the Company determined certain assets were recoverable as inventory beginning in December 2011. The Company accounts for inventory at the lower of cost or market and records any long-term inventory as other assets in the consolidated balance sheets. There was approximately $825,000 and $794,000 of long-term inventory, primarily consisting of raw materials, as of December 31, 2014 and 2013, respectively. | |||||||||
Current inventory consists of the following as of: | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Raw materials | $ | 322,157 | $ | 385,565 | |||||
Work-in-process | 632,615 | 624,530 | |||||||
Finished goods | 25,747 | 117,846 | |||||||
Inventory | $ | 980,519 | $ | 1,127,941 | |||||
Property_and_Equipment
Property and Equipment | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property and Equipment | -6 | Property and Equipment | |||||||
Property and equipment consists of the following as of: | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Furniture and equipment | $ | 2,295,433 | $ | 2,274,633 | |||||
Computer hardware and software | 556,556 | 499,922 | |||||||
Leasehold improvements | 62,651 | 46,754 | |||||||
2,914,640 | 2,821,309 | ||||||||
Less accumulated depreciation and amortization | (2,433,118 | ) | (2,244,214 | ) | |||||
Property and equipment, net | $ | 481,522 | $ | 577,095 | |||||
Accrued_Expenses
Accrued Expenses | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Expenses | -7 | Accrued Expenses | |||||||
Accrued expenses consists of the following as of: | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Professional service related expenses | $ | 2,107,712 | $ | 2,650,163 | |||||
Payroll related expenses | 1,267,141 | 1,043,028 | |||||||
Other expenses | 455,913 | 492,869 | |||||||
Accrued expenses | $ | 3,830,766 | $ | 4,186,060 | |||||
Notes_Payable
Notes Payable | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Notes Payable | -8 | Notes Payable | |||||||
Notes payable consists of the following as of: | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Growth capital loan dated April 16, 2012 (net of discounts of $23,836 and $131,670 at December 31, 2014 and 2013, respectively) | $ | 2,976,164 | $ | 6,868,330 | |||||
Less current portion | (2,976,164 | ) | (4,000,000 | ) | |||||
Total long-term debt | $ | — | $ | 2,868,330 | |||||
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 is 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 bear interest at a fixed annual rate equal to 8.0%. A 5.0% final payment fee will be due on September 1, 2015. The Company may voluntarily prepay the term loan in full, but not in part, and any voluntary or mandatory prepayment is subject to applicable prepayment premiums and will also include the final payment fee. The Company was required to comply with certain 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 ending June 30, 2015. The Company did not meet the financial covenants for the period ended March 31, 2013 and therefore 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 ending 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 have been fulfilled through the use of the equity distribution agreement with Canaccord Genuity Inc. (see Note 10). 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. The Company is required to pay SVB a $187,000 success fee as a result of receiving FDA approval for the Maestro Rechargeable System on January 14, 2015. | |||||||||
The Company has 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 has entered into a negative pledge arrangement with SVB pursuant to which it has 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 106,746 shares of common stock, exercisable for ten years from the date of grant, at an exercise price of $2.34 per share. | |||||||||
Scheduled debt principal payments are as follows as of December 31, 2014: | |||||||||
Year ending December 31: | |||||||||
2015 | $ | 3,000,000 | |||||||
Less original issue discount | (23,836 | ) | |||||||
Notes payable, net | $ | 2,976,164 | |||||||
Preferred_Stock
Preferred Stock | 12 Months Ended | |
Dec. 31, 2014 | ||
Preferred Stock | -9 | Preferred Stock |
The Company’s Amended and Restated Certificate of Incorporation currently authorizes 5,000,000 shares of $0.01 par value preferred stock. As of December 31, 2014 and 2013, there were no shares of preferred stock issued or outstanding. |
Stock_Sales
Stock Sales | 12 Months Ended | |
Dec. 31, 2014 | ||
Stock Sales | -10 | Stock Sales |
Registered Direct Offering—April 2012 | ||
On April 16, 2012, the Company entered into a securities purchase agreement with a current investor for the sale of 2,271,705 shares of its common stock in a registered direct offering, at a purchase price of $2.22 per share. On April 20, 2012, the offering closed and the Company received gross proceeds of $5.0 million before deducting offering expenses. | ||
Public Offering—February 2013 | ||
On February 27, 2013, the Company closed a public offering, selling 13,770,000 shares of common stock, together with warrants to purchase approximately 5,508,000 shares of common stock at an aggregate price of $0.95 per share and corresponding warrant, for gross proceeds of $13.1 million before deducting offering expenses. Certain directors of the Company participated in the public offering (see Note 14). | ||
The warrants have an exercise price of $1.14 per share of common stock and are exercisable for a period of five years from February 27, 2013. Holders of the warrants are not permitted to exercise those warrants for an amount of common stock that would result in the holder owning more than 19.99% of the Company’s common stock. | ||
Equity Distribution Agreement—July 2013 | ||
On July 31, 2013, the Company entered into an equity distribution agreement with Canaccord Genuity Inc. (Canaccord) to sell shares of the Company’s common stock having aggregate gross sales proceeds of up to $20.0 million, from time to time, through an ATM under which Canaccord acted as the Company’s sales agent (the Canaccord ATM). The Company determined, at its sole discretion, the timing and number of shares sold under the Canaccord ATM. The Company paid Canaccord a commission for its services in acting as agent in the sale of common stock equal to 2.0% of the gross sales price per share of all shares sold through it as agent under the equity distribution agreement. During 2013 the Company sold 7,917,755 shares under the Canaccord ATM at a weighted-average selling price of $1.39 per share for gross proceeds of $11.0 million before deducting offering expenses. During 2014 the Company sold an additional 4,006,222 shares under the Canaccord ATM at a weighted-average selling price of $2.22 per share for gross proceeds of $8.9 million before deducting offering expenses. The equity distribution agreement with Canaccord was terminated effective June 10, 2014. As of the termination date, the Company had sold a total of 11,923,977 shares under the Canaccord ATM at a weighted-average selling price of $1.67 per share for gross proceeds of $19.9 million before deducting offering expenses. | ||
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 December 31, 2014, the Company had sold 684,602 shares under the Cowen ATM at a weighted-average selling price of $1.35 per share for gross proceeds of $927,000 before deducting offering expenses. Subsequent to December 31, 2014 through March 13, 2015, the Company has sold 4,627,934 shares under the Cowen ATM at a weighted-average selling price of $1.39 per share for gross proceeds of $6.4 million before deducting offering expenses. |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Income Taxes | -11 | Income Taxes | |||||||||||
The Company has incurred net operating losses (NOLs) since inception. The Company has not reflected any benefit of such net operating loss carryforwards in the accompanying consolidated financial statements. | |||||||||||||
The income tax expense benefit differed from the amount computed by applying the U.S. federal income tax rate of 34% to income before income taxes as a result of the following: | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Computed ‘expected’ tax benefit | 34 | % | 34 | % | 34 | % | |||||||
Other permanent adjustments | -2.3 | % | -2.3 | % | -2.2 | % | |||||||
Research and development credit | 0.3 | % | 3.5 | % | 0 | % | |||||||
Federal valuation allowance | -32 | % | -35.2 | % | -31.8 | % | |||||||
0 | % | 0 | % | 0 | % | ||||||||
The tax effect of temporary differences that give rise to significant portions of the deferred tax assets as of December 31 is presented below: | |||||||||||||
2014 | 2013 | ||||||||||||
Deferred tax assets (liabilities): | |||||||||||||
Start-up costs | $ | 8,739,000 | $ | 8,851,000 | |||||||||
Capitalized research and development costs | 30,276,000 | 24,844,000 | |||||||||||
Reserves and accruals | 6,052,000 | 4,530,000 | |||||||||||
Property and equipment | 94,000 | 105,000 | |||||||||||
Research and development credit | 1,636,000 | 1,508,000 | |||||||||||
Net operating loss carryforwards | 16,656,000 | 12,198,000 | |||||||||||
Total gross deferred tax assets | 63,453,000 | 52,036,000 | |||||||||||
Valuation allowance | (63,453,000 | ) | (52,036,000 | ) | |||||||||
Net deferred tax assets | $ | — | $ | — | |||||||||
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during periods in which those temporary differences become deductible. In addition, certain limitations imposed under the Internal Revenue Code (IRC) could further limit the Company’s realization of these deferred tax assets in the event of changes in ownership of the Company (as described below). | |||||||||||||
Based on the level of historical taxable losses and projections of future taxable income (losses) over the periods in which the deferred tax assets can be realized, management currently believes that it is more likely than not that the Company will not realize the benefits of these deductible differences. Accordingly, the Company has provided a valuation allowance against the gross deferred tax assets as of December 31, 2014 and 2013. | |||||||||||||
As of December 31, 2014, the Company has generated U.S. federal net operating loss carryforwards of approximately $91.9 million. Of this amount, approximately $44.0 million is available after the application of Section 382 limitations described below. Of the total federal net operating loss, $221,000 would result in tax benefits recorded to additional paid-in capital. The federal net operating loss carryforwards expire in the years 2022 through 2034. | |||||||||||||
The IRC imposes restrictions on the utilization of various carryforward tax attributes in the event of a change in ownership of the Company, as defined by IRC Section 382. In addition, IRC Section 382 may limit the Company’s built-in items of deduction, including capitalized start-up costs and research and development costs. During 2011, the Company completed an IRC Section 382 review and the results of this review indicate ownership changes have occurred which would cause a limitation on the utilization of carryforward attributes. The Company’s gross net operating loss carryforwards, start-up costs and research and development credits are all subject to limitation. Under these tax provisions, the limitation is applied first to any built-in losses, then to any net operating losses and then to any general business credits. The Section 382 limitation and accompanying recognized built-in loss limitation is currently estimated to result in the expiration of $48.1 million of the Company’s gross federal net operating loss carryforward, as well as a write-off of $5.9 million of capitalized start-up costs, $5.5 million of capitalized research and development costs, $1.5 million of property and equipment and $2.4 million of research and development credits. Any ownership changes since we completed the IRC Section 382 review in 2011 could result in further limitations on the utilization of carryforward attributes. | |||||||||||||
As of December 31, 2014 and 2013, there were no unrecognized tax benefits. Accordingly, a tabular reconciliation from beginning to ending periods is not provided. The Company will classify any future interest and penalties as a component of income tax expense if incurred. To date, there have been no interest or penalties charged or accrued in relation to unrecognized tax benefits. | |||||||||||||
The Company does not anticipate that the total amount of unrecognized tax benefits will change significantly in the next twelve months. | |||||||||||||
The Company is subject to U.S. federal examinations for the years 2011 forward. With limited exceptions, the Company is no longer subject to U.S. federal, state or local examinations by tax authorities for years prior to 2011. There are no U.S. federal tax examinations currently in progress. | |||||||||||||
The Company’s Minnesota Corporation Franchise Tax returns for tax years ending December 31, 2010 through December 31, 2013, are currently under review. |
Stock_Options
Stock Options | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||
Stock Options | -12 | Stock Options | |||||||||||||||||||||||
The Company has adopted the Amended and Restated 2003 Stock Incentive Plan (the Plan) that includes both incentive stock options and nonqualified stock options to be granted to employees, officers, consultants, independent contractors, directors and affiliates of the Company. At December 31, 2014 and 2013, according to the Plan, 19,800,000 and 12,300,000 shares, respectively have been authorized and reserved. The board of directors establishes the terms and conditions of all stock option grants, subject to the Plan and applicable provisions of the IRC. Incentive stock options must be granted at an exercise price not less than the fair market value of the common stock on the grant date. The options granted to participants owning more than 10% of the Company’s outstanding voting stock must be granted at an exercise price not less than 110% of fair market value of the common stock on the grant date. The options expire on the date determined by the board of directors, but may not extend more than 10 years from the grant date, while incentive stock options granted to participants owning more than 10% of the Company’s outstanding voting stock expire five years from the grant date. The vesting period for employees is generally over four years. The vesting period for nonemployees is determined based on the services being provided. | |||||||||||||||||||||||||
On May 7, 2014, the annual meeting of stockholders was held and the stockholders approved the Amended and Restated 2003 Stock Incentive Plan which authorized an additional 7,500,000 shares for issuance under the Plan. | |||||||||||||||||||||||||
Stock option activity is as follows: | |||||||||||||||||||||||||
Shares | Outstanding Options | Aggregate | |||||||||||||||||||||||
Available For | Intrinsic | ||||||||||||||||||||||||
Grant | Number of | Weighted-Average | Value | ||||||||||||||||||||||
Shares | Exercise Price | ||||||||||||||||||||||||
Balance, December 31, 2011 | 763,829 | 3,470,908 | $ | 3.17 | |||||||||||||||||||||
Shares reserved | 8,000,000 | — | — | ||||||||||||||||||||||
Options granted | (4,462,873 | ) | 4,462,873 | 3.35 | |||||||||||||||||||||
Options exercised | — | (5,219 | ) | 2.43 | |||||||||||||||||||||
Options cancelled | 93,029 | (93,029 | ) | 2.79 | |||||||||||||||||||||
Balance, December 31, 2012 | 4,393,985 | 7,835,533 | 3.28 | ||||||||||||||||||||||
Shares reserved | — | — | — | ||||||||||||||||||||||
Options granted | (4,346,000 | ) | 4,346,000 | 1.32 | |||||||||||||||||||||
Options exercised | — | — | — | ||||||||||||||||||||||
Options cancelled | 494,233 | (494,233 | ) | 3 | |||||||||||||||||||||
Balance, December 31, 2013 | 542,218 | 11,687,300 | 2.56 | $ | 3,284,696 | ||||||||||||||||||||
Shares reserved | 7,500,000 | — | — | ||||||||||||||||||||||
Options granted | (1,257,500 | ) | 1,257,500 | 1.63 | |||||||||||||||||||||
Options exercised | — | — | — | ||||||||||||||||||||||
Options cancelled | 289,008 | (289,008 | ) | 2.41 | |||||||||||||||||||||
Balance, December 31, 2014 | 7,073,726 | 12,655,792 | $ | 2.47 | $ | 519,622 | |||||||||||||||||||
The options outstanding, vested and currently exercisable by exercise price at December 31, 2014: | |||||||||||||||||||||||||
Outstanding Options and Expected to Vest | Options Exercisable and Vested | ||||||||||||||||||||||||
Exercise | Number of | Weighted-Average | Aggregate | Number of | Weighted-Average | Aggregate | |||||||||||||||||||
Price | Shares | Remaining | Intrinsic | Options | Exercise Price | Intrinsic | |||||||||||||||||||
Outstanding | Contractual Life | Value | Value | ||||||||||||||||||||||
(Years) | |||||||||||||||||||||||||
$0.01 to $2.00 | 6,310,699 | 8 | $ | 519,622 | 2,766,588 | $ | 1.52 | $ | 216,439 | ||||||||||||||||
$2.01 to $3.00 | 2,146,297 | 5.9 | — | 1,963,787 | 2.63 | — | |||||||||||||||||||
$3.01 to $5.00 | 4,085,480 | 7.4 | — | 2,529,663 | 3.41 | — | |||||||||||||||||||
$5.01 to $10.00 | 4,166 | 4.1 | — | 4,166 | 8.4 | — | |||||||||||||||||||
> $10.00 | 109,150 | 3.3 | — | 109,150 | 23.54 | — | |||||||||||||||||||
12,655,792 | $ | 519,622 | 7,373,354 | $ | 2.79 | $ | 216,439 | ||||||||||||||||||
Stock-Based Compensation for Nonemployees | |||||||||||||||||||||||||
Stock-based compensation expenses related to stock options granted to nonemployees is recognized as the stock options are earned. The Company believes that the fair value of the stock options is more reliably measurable than the fair value of the services received. The fair value of the stock options granted is calculated at each reporting date, using the Black-Scholes option-pricing model, until the award vests or there is a substantial disincentive for the nonemployee not to perform the required services. The fair value for the years ended December 31, 2014, 2013 and 2012 was calculated using the following assumptions, defined below: | |||||||||||||||||||||||||
Years Ended December 31, | |||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Risk-free interest rates | 0.08%–2.63% | 0.26%–2.98% | 0.24%–2.05% | ||||||||||||||||||||||
Expected life | 0.50 years–9.51 years | 1.50 years–9.76 years | 2.00 years–9.25 years | ||||||||||||||||||||||
Expected dividends | 0% | 0% | 0% | ||||||||||||||||||||||
Expected volatility | 56.54%–139.65% | 80.00%–143.00% | 63.48%–142.25% | ||||||||||||||||||||||
Stock-based compensation expense charged to operations on options granted to nonemployees for the years ended December 31, 2014, 2013 and 2012 was $181,323, $166,679 and $52,190, respectively. | |||||||||||||||||||||||||
Employee Stock-Based Awards | |||||||||||||||||||||||||
Compensation cost for employee stock-based awards is based on the estimated grant-date fair value and is recognized over the vesting period of the applicable award on a straight-line basis. The weighted average estimated fair value of the employee stock options granted for the years ended December 31, 2014, 2013 and 2012 was $1.42, $1.22 and $3.19 per share, respectively. | |||||||||||||||||||||||||
The Company uses the Black-Scholes pricing model to determine the fair value of stock options. The determination of the fair value of stock-based payment awards on the date of grant is affected by the Company’s stock price as well as assumptions regarding a number of complex and subjective variables. These variables include the Company’s expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rates and expected dividends. The estimated grant-date fair values of the employee stock options were calculated using the Black-Scholes valuation model, based on the following assumptions for the years ended December 31, 2014, 2013 and 2012: | |||||||||||||||||||||||||
Years Ended December 31, | |||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Risk-free interest rates | 1.73%–1.96% | 0.94%–1.33% | 0.90%–1.09% | ||||||||||||||||||||||
Expected life | 6.00 years–6.25 years | 6.00 years–6.25 years | 6.00 years–6.25 years | ||||||||||||||||||||||
Expected dividends | 0% | 0% | 0% | ||||||||||||||||||||||
Expected volatility | 118.64%–120.70% | 148.00%–149.00% | 137.58%–143.98% | ||||||||||||||||||||||
Expected Life. The expected life is based on the “simplified” method described in the SEC Staff Accounting Bulletin, Topic 14: Share-Based Payment. | |||||||||||||||||||||||||
Volatility. Since the Company was a private entity for most of 2007 and a limited amount of historical data regarding the volatility of its common stock was available, the expected volatility used for 2012 was based on both the volatility of similar entities, referred to as “guideline” companies, and the Company’s historical volatility. In evaluating similarity, the Company considered factors such as industry, stage of life cycle and size. Effective with the year ended December 31, 2013, the expected volatility was based solely on the Company’s historical volatility. | |||||||||||||||||||||||||
Risk-Free Interest Rate. The risk-free rate is based on the daily yield curve rate from the U.S. Treasury with remaining terms similar to the expected term on the options. | |||||||||||||||||||||||||
Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and, therefore, used an expected dividend yield of zero in the valuation model. | |||||||||||||||||||||||||
Forfeitures. The Company is required to estimate forfeitures at the time of grant, and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. The Company uses historical data to estimate pre-vesting option forfeitures and record stock-based compensation expense only for those awards that are expected to vest. All stock-based payment awards are amortized on a straight-line basis over the requisite service periods of the awards, which are generally the vesting periods. If the Company’s actual forfeiture rate is materially different from its estimate, the stock-based compensation expense could be significantly different from what the Company has recorded in the current period. | |||||||||||||||||||||||||
As of December 31, 2014 there was approximately $9.2 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 2.00 years. | |||||||||||||||||||||||||
There were no stock option exercises for the years ended December 31, 2014 and 2013. The aggregate intrinsic value of stock options (the amount by which the market price of the stock on the date of exercise exceeded the exercise price of the option) exercised during the year ended December 31, 2012, was $3,044. |
Warrants
Warrants | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Warrants | -13 | Warrants | |||||||
Stock warrant activity is as follows: | |||||||||
Common | Price(1) | ||||||||
Shares | |||||||||
Balance, December 31, 2011 | 23,923,301 | $ | 2.55 | ||||||
Granted(2) | 106,746 | 2.34 | |||||||
Exercised | (2,813,600 | ) | 2.18 | ||||||
Cancelled | — | — | |||||||
Balance, December 31, 2012 | 21,216,447 | 2.6 | |||||||
Granted(2) | 5,508,000 | 1.14 | |||||||
Exercised | (20,325 | ) | 1.38 | ||||||
Cancelled | (1,153,497 | ) | 9.14 | ||||||
Balance, December 31, 2013 | 25,550,625 | 1.99 | |||||||
Granted | — | — | |||||||
Exercised | (1,328,270 | ) | 1.69 | ||||||
Cancelled | (22,650 | ) | 48.56 | ||||||
Balance, December 31, 2014 | 24,199,705 | $ | 1.96 | ||||||
-1 | Represents weighted-average exercise price per share. | ||||||||
-2 | See Notes 8 and 10 for discussions relating to the issuance of warrants in 2013 and 2012. | ||||||||
At December 31, 2014 and 2013, the weighted-average remaining contractual life of outstanding warrants was 1.85 and 2.87 years, respectively. All of the warrants outstanding are currently exercisable at the option of the holder into the equivalent number of shares of common stock. |
Related_Party_Transactions
Related Party Transactions | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Related Party Transactions | -14 | Related Party Transactions | |||||||||||
Public Offerings | |||||||||||||
As discussed in Note 10, on February 27, 2013, the Company closed a public offering, selling 13,770,000 shares of common stock, together with warrants to purchase approximately 5,508,000 shares of common stock at an aggregate price of $0.95 per share and corresponding warrant. The following principal stockholder purchased shares of common stock and warrants at a price of $0.95 per share and corresponding warrant. The shares purchased, together with the proceeds, before expenses, to the Company, are shown in the table below: | |||||||||||||
Beneficial Owner | Shares | Warrants | Proceeds, before | ||||||||||
Purchased | Purchased | expenses, to the Company | |||||||||||
Anthony Jansz | 150,000 | 60,000 | $ | 142,500 | |||||||||
Anthony Jansz is a director of the Company. | |||||||||||||
Consulting Agreement—Anthony Jansz | |||||||||||||
Effective June 1, 2011, the Company entered into a four year consulting agreement with Anthony Jansz, who is a member of the board of directors. Pursuant to the agreement, in exchange for consulting services provided, Mr. Jansz was entitled to receive a consulting fee of $96,000 AUD (approximately $79,000 USD as of December 31, 2014) per year and the reimbursement of reasonable expenses. Mr. Jansz also received an option to purchase 50,000 shares of common stock at $2.76 per share that vests in 48 equal monthly installments beginning on July 1, 2011. The full grant date fair value of the option grant was approximately $108,000. | |||||||||||||
On December 20, 2012, the Company entered into an amendment, effective October 1, 2012, to the consulting agreement with Mr. Jansz. Pursuant to the amendment, during the period from October 1, 2012 until June 30, 2013, Mr. Jansz agreed to commit additional time to performing consulting services for the Company. In exchange for these additional services, Mr. Jansz was entitled to receive a consulting fee of $12,000 AUD (approximately $10,000 USD as of December 31, 2014) per month from October 1, 2012 until June 30, 2013. Mr. Jansz also received an option to purchase 75,000 shares of the Company’s common stock on January 22, 2013 at $2.65 per share, which vests as follows: (A) 16,667 of such 75,000 shares vested on January 22, 2013, the date of grant; (B) 16,667 of such 75,000 shares vested on January 22, 2014; (C) 16,666 of such 75,000 shares vested on January 22, 2015; and (D) the remaining 25,000 of such 75,000 shares would have vested upon the occurrence of both (i) the Company successfully obtaining full Australian reimbursement approval for both surgeon’s fees and hospital fees for VBLOC therapy and the Maestro Rechargeable System from the Australian Medical Services Advisory Committee prior to June 30, 2014 and (ii) the Company successfully obtaining device listing for the Maestro Rechargeable System on the Australian Prostheses List prior to June 30, 2014. The full grant date fair value of the option grant was approximately $153,000. The Company did not successfully obtain full Australian reimbursement approval for both surgeon’s fees and hospital fees for VBLOC therapy and the Maestro Rechargeable System from the Australian Medical Services Advisory Committee prior to June 30, 2014 nor a device listing for the Maestro Rechargeable System on the Australian Prostheses List prior to June 30, 2014 resulting in 25,000 shares not vesting. | |||||||||||||
The Company continued to pay Mr. Jansz a consulting fee of $12,000 AUD per month subsequent to June 30, 2013 as a result of the additional time he continued to spend providing consulting services to the Company. Mr. Jansz also received an additional option to purchase 100,000 shares of the Company’s common stock on May 31, 2013 at $1.31 per share, which vests as follows: (A) 16,667 of such 100,000 shares vested on May 31, 2013, the date of the grant; (B) 16,667 of such 100,000 shares vested on May 31, 2014; (C) 16,666 of such 100,000 shares will vest on May 31, 2015; (D) 25,000 of such 100,000 shares would have vested upon the implementation of the Australian Specialty Clinic Commercial Validation Project as evidenced by the implantation of 10 or more Maestro Rechargeable Systems in an Australian Clinic prior to December 31, 2013; and (E) the remaining 25,000 of such 100,000 shares would have vested upon the Company successfully obtaining an Item Listing for Maestro Rechargeable System implantation by December 31, 2014. The Australian Specialty Clinic Commercial Validation Project was not implemented prior to December 31, 2013 resulting in 25,000 shares not vesting and the Company did not obtain an Item Listing for Maestro Rechargeable System implantation by December 31, 2014 resulting in an additional 25,000 shares not vesting. The full grant date fair value of the option grant was approximately $103,000. | |||||||||||||
On September 25, 2014, the Company entered into Amendment No. 2, effective September 1, 2014, to the consulting agreement with Mr. Jansz. Pursuant to the amendment, during the period from October 1, 2012 until April 30, 2015, Mr. Jansz agreed to commit additional time to performing consulting services for the Company. In exchange for these additional services, Mr. Jansz is entitled to receive a consulting fee of $12,000 AUD (approximately $10,000 USD as of December 31, 2014) a month for consulting services during the period beginning on October 1, 2012 and ending on April 30, 2015. Mr. Jansz also received an additional option to purchase 25,000 shares of the Company’s common stock on October 6, 2014 at $1.14 per share, which vested upon the occurrence of both the development of a reimbursement-focused clinical trial protocol in Australia and a recommendation to the Company’s management regarding Australian commercialization. The full grant date fair value of the option grant was approximately $16,000. | |||||||||||||
Total stock-based compensation expense recorded was approximately $40,000, $126,000 and $23,000 for the years ended December 31, 2014, 2013 and 2012, respectively. In addition to the option grant, the Company paid Mr. Jansz approximately $196,000, $154,000 and $195,000 in fees and expenses for consulting services provided during the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||
Other | |||||||||||||
The Company entered into an agreement with an advisory firm to provide various consulting services. The advisory firm is partially owned by a company with whom a member of our board of directors is a partner. The Company recognized $253,000 and $146,000 in selling, general and administrative expense for the year ended December 31, 2014 and 2013, respectively, for consulting services provided by the advisory firm. |
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | -15 | Commitments and Contingencies | |||
Effective October 1, 2008 the Company entered into a seven-year non-cancelable operating lease agreement for office/warehouse space. The lease expires on September 30, 2015 with monthly base rent ranging from $19,570 to $24,643. Total rent expense recognized for each of the years ended December 31, 2014, 2013 and 2012 was $270,872. Facility related expenses are included as general and administrative costs on the consolidated statements of operations. | |||||
The following is a schedule of total future minimum lease payments due as of December 31, 2014: | |||||
Year ending December 31: | |||||
2015 | $ | 221,789 | |||
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. | |||||
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. | |||||
In 2005, EnteroMedics entered into an exclusive collaborative obesity device research and development agreement with the Mayo Foundation for Medical Education and Research (Mayo Foundation), Rochester, Minnesota. Through this agreement, EnteroMedics collaborated with a group of physicians and researchers at Mayo Clinic in the field of obesity. Under the terms of this five-year agreement, EnteroMedics and this group of Mayo specialists collectively worked toward the development of new and innovative medical devices for the treatment of obesity. The agreement also includes a similar collaboration for the development of products to address a wide variety of disorders susceptible to treatment by electrically blocking neural impulses on the vagus nerve. | |||||
The Mayo Foundation received an annual $250,000 retainer fee which commenced in 2005 and continued through January 2009. | |||||
On March 11, 2010, the Company entered into Amendment No. 1 to the agreement with the Mayo Foundation extending the Company’s collaboration with the Mayo Foundation for a period of two years. Pursuant to the amendment, the Mayo Foundation granted the Company certain royalty-bearing, worldwide exclusive and non-exclusive licenses and committed to the joint collaboration between the Company and a designated group of physicians and researchers at the Mayo Clinic for the development and testing of products for the treatment of obesity, including devices that use electrical signaling to block the vagal nerve, and for the treatment of other gastrointestinal diseases, solely using devices that use electrical signaling to block the vagal nerve. The Mayo Foundation received an annual retainer of $100,000 in 2010 and 2011. The agreement was further amended on January 15, 2011 with Amendment No. 2. Under the terms of Amendment No. 2, the annual retainer the Mayo Foundation received for 2011 was reduced to $75,000. The agreement was further amended on February 3, 2012 with Amendment No. 3. Under the terms of Amendment No. 3, beginning in 2012 the Mayo Foundation will be reimbursed for services provided at an hourly rate only. Amendment No. 3 does not provide for additional annual retainer payments. No other terms were changed by Amendment Nos. 2 or 3. The agreement was further amended on February 3, 2013 and on February 3, 2014 with Amendment Nos. 4 and 5, respectively, extending the joint collaboration between the company and a designated group of physicians and researchers at the Mayo Clinic. No other terms were changed by Amendment Nos. 4 or 5. | |||||
The Company may also be obligated to pay the Mayo Foundation, contingent upon the occurrence of certain future events, earned royalty payments, including a minimum annual royalty as defined by the agreement, as amended, for the commercial sale of products developed and patented by the Mayo Foundation, jointly patented by the Company and the Mayo Foundation, or a product where the Mayo Foundation provided know-how as defined by the agreement, as amended. If no products are patented, the minimum royalty is not due. |
Retirement_Plan
Retirement Plan | 12 Months Ended | |
Dec. 31, 2014 | ||
Retirement Plan | -16 | Retirement Plan |
The Company has a 401(k) profit-sharing plan that provides retirement benefits to employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations. The Company’s matching is at the discretion of the Company’s board of directors. For the years ended December 31, 2014, 2013 and 2012, the Company did not provide any matching of employees’ contributions. |
Quarterly_Data
Quarterly Data | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Data | -17 | Quarterly Data (unaudited) | |||||||||||||||
The following table represents certain unaudited quarterly information for each of the eight quarters in the period ended December 31, 2014. In management’s opinion, this information has been prepared on the same basis as the audited consolidated financial statements and includes all the adjustments necessary to fairly state the unaudited quarterly results of operations (in thousands, except per share data). | |||||||||||||||||
First | Second | Third | Fourth | ||||||||||||||
Quarter | Quarter | Quarter | Quarter | ||||||||||||||
2014:00:00 | |||||||||||||||||
Net loss | $ | (6,732 | ) | $ | (7,501 | ) | $ | (5,714 | ) | $ | (6,181 | ) | |||||
Basic and diluted net loss per share | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.08 | ) | $ | (0.09 | ) | |||||
2013:00:00 | |||||||||||||||||
Net loss | $ | (6,581 | ) | $ | (6,323 | ) | $ | (6,303 | ) | $ | (6,573 | ) | |||||
Basic and diluted net loss per share | $ | (0.14 | ) | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.11 | ) |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Basis of Presentation | Basis of Presentation | ||||||||||||
The Company has prepared the accompanying 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. | |||||||||||||
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 consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and accounts have been eliminated in consolidation. | |||||||||||||
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties | ||||||||||||
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. Cash and cash equivalents are primarily deposited in demand and money market accounts. At times, such deposits may be in excess of insured limits. Investments in money market funds are not considered to be bank deposits and are not insured or guaranteed by the federal deposit insurance company or other government agency. These money market funds seek to preserve the value of the investment at $1.00 per share; however, it is possible to lose money investing in these funds. The Company has not experienced any losses on its deposits of cash and cash equivalents. | |||||||||||||
Most of the products developed by the Company 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 bariatric centers of excellence in the United States. The Maestro Rechargeable System has also received CE Mark and is listed on the Australian Register of Therapeutic Goods. | |||||||||||||
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 risk 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. | |||||||||||||
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, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their short maturities. The fair values of investments in debt and equity securities, if any, are disclosed in Note 4. The fair value of the Company’s debt is approximately $3.4 million as of December 31, 2014 based on the present value of estimated future cash flows using a discount rate commensurate with borrowing rates available to the Company. If measured at fair value in the consolidated financial statements, long-term debt (including the current portion) would be classified as Level 2 in the fair value hierarchy. | |||||||||||||
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. Under terms of the Company’s notes payable agreements (see Note 8), in the event of default, the lender has the right to enforce account control agreements and restrict the Company’s access to their cash and investment accounts. | |||||||||||||
Restricted Cash | Restricted Cash | ||||||||||||
The Company had $200,000 in a cash collateral money market account as of December 31, 2012. Pursuant to the Lease Agreement the Company entered into with Roseville Properties Management Company in July 2008, the Company was required to deliver to Roseville Properties an irrevocable, unconditional, standby letter of credit in the amount of $200,000 on the second anniversary of the commencement of lease payments. The irrevocable standby letter of credit was issued by Silicon Valley Bank, who required the Company to set up a restricted cash collateral money market account to fully secure the standby letter of credit. The fully secured standby letter of credit was maintained through October 1, 2013, per the terms of the lease agreement. | |||||||||||||
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 (deficit) in the 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 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 consolidated balance sheets and the resulting gain or loss is reflected in the 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 as of December 31, 2014 and 2013 (see Note 11). The Company’s policy is to classify interest and penalties related to income taxes as income tax expense in the consolidated statements of operations. | |||||||||||||
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 years ended December 31, 2014 and 2013. The difference from reported net loss for the year ended December 31, 2012 related entirely to changes in unrealized gains (losses) on available-for-sale investments. | |||||||||||||
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 internationally through distributors and revenue is recognized upon sale to the distributor as these sales are considered to be final and no right of return or price protection exists. Terms of sales to international distributors are generally EXW, reflecting that goods are shipped “ex works,” in which risk of loss is assumed by the distributor at the shipping point. We do not provide for rights of return to customers on product sales and therefore do not record a provision for returns. | |||||||||||||
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. | |||||||||||||
Patent Costs | Patent Costs | ||||||||||||
Costs associated with the submission of a patent application are expensed as incurred given the uncertainty of the patents resulting in probable future economic benefits to the Company. Patent-related legal expenses included in general and administrative costs were $338,055, $296,575 and $278,987 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||
Derivative Instruments | Derivative Instruments | ||||||||||||
The Company accounts for outstanding warrants that are not indexed to the Company’s stock or warrants issued when the Company has insufficient authorized and unissued stock available to share settle the outstanding warrants as derivative instruments, which require that the warrants be classified as a liability and measured at fair value with changes in fair value recognized currently in earnings and recorded separately in the consolidated statements of operations. The Company did not have any such instruments during the years ended December 31, 2014, 2013 and 2012. | |||||||||||||
Stock-Based Compensation | Stock-Based Compensation | ||||||||||||
The fair value method 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. All option grants are expensed on a straight-line basis over the vesting period. | |||||||||||||
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 years ended December 31, 2014, 2013 and 2012: | |||||||||||||
Years ended | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator: | |||||||||||||
Net loss | $ | (26,128,720 | ) | $ | (25,780,659 | ) | $ | (23,460,103 | ) | ||||
Denominator for basic and diluted net loss per share: | |||||||||||||
Weighted-average common shares outstanding | 67,866,427 | 55,009,916 | 39,536,500 | ||||||||||
Net loss per share—basic and diluted | $ | (0.39 | ) | $ | (0.47 | ) | $ | (0.59 | ) | ||||
Recently Issued Accounting Standards | Recently Issued Accounting Standards | ||||||||||||
In June 2014, the Financial Accounting Standards Board (FASB) issued Development Stage Entities, Topic 915 (Accounting Standards Update No. 2014-10 (ASU 2014-10)), which eliminates certain financial reporting requirements, with the objective of improving financial reporting by reducing the cost and complexity associated with the incremental reporting requirements for development stage entities. This guidance is effective for interim and annual reporting periods beginning after December 15, 2014; however, early application is permitted for any annual reporting period or interim period for which an entity’s financial statements have not yet been issued. The Company elected to adopt ASU 2014-10 effective with the quarter ending June 30, 2014. Therefore, the accompanying consolidated financial statements no longer present or disclose any information previously required by Topic 915. | |||||||||||||
In May 2014, FASB issued Revenue from Contracts with Customers, Topic 606 (Accounting Standards Update No. 2014-09 (ASU 2014-09)), which provides a framework for the recognition of revenue, with the objective that recognized revenues properly reflect amounts an entity is entitled to receive in exchange for goods and services. This guidance will be effective for interim and annual reporting periods beginning after December 15, 2016. The Company is currently evaluating the impact of adopting ASU 2014-09 on its consolidated financial statements. | |||||||||||||
Various other accounting standards and interpretations have been issued with 2014 effective dates and effective dates subsequent to December 31, 2014. We have evaluated the recently issued accounting pronouncements that are currently effective or will be effective in 2015 and believe that none of them have had or will have a material effect on our financial position, results of operations or cash flows. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
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 years ended December 31, 2014, 2013 and 2012: | ||||||||||||
Years ended | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator: | |||||||||||||
Net loss | $ | (26,128,720 | ) | $ | (25,780,659 | ) | $ | (23,460,103 | ) | ||||
Denominator for basic and diluted net loss per share: | |||||||||||||
Weighted-average common shares outstanding | 67,866,427 | 55,009,916 | 39,536,500 | ||||||||||
Net loss per share—basic and diluted | $ | (0.39 | ) | $ | (0.47 | ) | $ | (0.59 | ) | ||||
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: | ||||||||||||
December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Stock options outstanding | 12,655,792 | 11,687,300 | 7,835,533 | ||||||||||
Warrants to purchase common stock | 24,199,705 | 25,550,625 | 21,216,447 |
Inventory_Tables
Inventory (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Current Inventory | Current inventory consists of the following as of: | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Raw materials | $ | 322,157 | $ | 385,565 | |||||
Work-in-process | 632,615 | 624,530 | |||||||
Finished goods | 25,747 | 117,846 | |||||||
Inventory | $ | 980,519 | $ | 1,127,941 | |||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property and Equipment | Property and equipment consists of the following as of: | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Furniture and equipment | $ | 2,295,433 | $ | 2,274,633 | |||||
Computer hardware and software | 556,556 | 499,922 | |||||||
Leasehold improvements | 62,651 | 46,754 | |||||||
2,914,640 | 2,821,309 | ||||||||
Less accumulated depreciation and amortization | (2,433,118 | ) | (2,244,214 | ) | |||||
Property and equipment, net | $ | 481,522 | $ | 577,095 | |||||
Accrued_Expenses_Tables
Accrued Expenses (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Expenses | Accrued expenses consists of the following as of: | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Professional service related expenses | $ | 2,107,712 | $ | 2,650,163 | |||||
Payroll related expenses | 1,267,141 | 1,043,028 | |||||||
Other expenses | 455,913 | 492,869 | |||||||
Accrued expenses | $ | 3,830,766 | $ | 4,186,060 | |||||
Notes_Payable_Tables
Notes Payable (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Notes Payable | Notes payable consists of the following as of: | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Growth capital loan dated April 16, 2012 (net of discounts of $23,836 and $131,670 at December 31, 2014 and 2013, respectively) | $ | 2,976,164 | $ | 6,868,330 | |||||
Less current portion | (2,976,164 | ) | (4,000,000 | ) | |||||
Total long-term debt | $ | — | $ | 2,868,330 | |||||
Scheduled of Debt Principal Payments | Scheduled debt principal payments are as follows as of December 31, 2014: | ||||||||
Year ending December 31: | |||||||||
2015 | $ | 3,000,000 | |||||||
Less original issue discount | (23,836 | ) | |||||||
Notes payable, net | $ | 2,976,164 | |||||||
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Tax Rate Reconciliation | The income tax expense benefit differed from the amount computed by applying the U.S. federal income tax rate of 34% to income before income taxes as a result of the following: | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Computed ‘expected’ tax benefit | 34 | % | 34 | % | 34 | % | |||||||
Other permanent adjustments | -2.3 | % | -2.3 | % | -2.2 | % | |||||||
Research and development credit | 0.3 | % | 3.5 | % | 0 | % | |||||||
Federal valuation allowance | -32 | % | -35.2 | % | -31.8 | % | |||||||
0 | % | 0 | % | 0 | % | ||||||||
Deferred Tax Assets | The tax effect of temporary differences that give rise to significant portions of the deferred tax assets as of December 31 is presented below: | ||||||||||||
2014 | 2013 | ||||||||||||
Deferred tax assets (liabilities): | |||||||||||||
Start-up costs | $ | 8,739,000 | $ | 8,851,000 | |||||||||
Capitalized research and development costs | 30,276,000 | 24,844,000 | |||||||||||
Reserves and accruals | 6,052,000 | 4,530,000 | |||||||||||
Property and equipment | 94,000 | 105,000 | |||||||||||
Research and development credit | 1,636,000 | 1,508,000 | |||||||||||
Net operating loss carryforwards | 16,656,000 | 12,198,000 | |||||||||||
Total gross deferred tax assets | 63,453,000 | 52,036,000 | |||||||||||
Valuation allowance | (63,453,000 | ) | (52,036,000 | ) | |||||||||
Net deferred tax assets | $ | — | $ | — | |||||||||
Stock_Options_Tables
Stock Options (Tables) | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||
Summary of Stock Option Activity | Stock option activity is as follows: | ||||||||||||||||||||||||
Shares | Outstanding Options | Aggregate | |||||||||||||||||||||||
Available For | Intrinsic | ||||||||||||||||||||||||
Grant | Number of | Weighted-Average | Value | ||||||||||||||||||||||
Shares | Exercise Price | ||||||||||||||||||||||||
Balance, December 31, 2011 | 763,829 | 3,470,908 | $ | 3.17 | |||||||||||||||||||||
Shares reserved | 8,000,000 | — | — | ||||||||||||||||||||||
Options granted | (4,462,873 | ) | 4,462,873 | 3.35 | |||||||||||||||||||||
Options exercised | — | (5,219 | ) | 2.43 | |||||||||||||||||||||
Options cancelled | 93,029 | (93,029 | ) | 2.79 | |||||||||||||||||||||
Balance, December 31, 2012 | 4,393,985 | 7,835,533 | 3.28 | ||||||||||||||||||||||
Shares reserved | — | — | — | ||||||||||||||||||||||
Options granted | (4,346,000 | ) | 4,346,000 | 1.32 | |||||||||||||||||||||
Options exercised | — | — | — | ||||||||||||||||||||||
Options cancelled | 494,233 | (494,233 | ) | 3 | |||||||||||||||||||||
Balance, December 31, 2013 | 542,218 | 11,687,300 | 2.56 | $ | 3,284,696 | ||||||||||||||||||||
Shares reserved | 7,500,000 | — | — | ||||||||||||||||||||||
Options granted | (1,257,500 | ) | 1,257,500 | 1.63 | |||||||||||||||||||||
Options exercised | — | — | — | ||||||||||||||||||||||
Options cancelled | 289,008 | (289,008 | ) | 2.41 | |||||||||||||||||||||
Balance, December 31, 2014 | 7,073,726 | 12,655,792 | $ | 2.47 | $ | 519,622 | |||||||||||||||||||
Options Outstanding Vested and Currently Exercisable by Exercise Price | The options outstanding, vested and currently exercisable by exercise price at December 31, 2014: | ||||||||||||||||||||||||
Outstanding Options and Expected to Vest | Options Exercisable and Vested | ||||||||||||||||||||||||
Exercise | Number of | Weighted-Average | Aggregate | Number of | Weighted-Average | Aggregate | |||||||||||||||||||
Price | Shares | Remaining | Intrinsic | Options | Exercise Price | Intrinsic | |||||||||||||||||||
Outstanding | Contractual Life | Value | Value | ||||||||||||||||||||||
(Years) | |||||||||||||||||||||||||
$0.01 to $2.00 | 6,310,699 | 8 | $ | 519,622 | 2,766,588 | $ | 1.52 | $ | 216,439 | ||||||||||||||||
$2.01 to $3.00 | 2,146,297 | 5.9 | — | 1,963,787 | 2.63 | — | |||||||||||||||||||
$3.01 to $5.00 | 4,085,480 | 7.4 | — | 2,529,663 | 3.41 | — | |||||||||||||||||||
$5.01 to $10.00 | 4,166 | 4.1 | — | 4,166 | 8.4 | — | |||||||||||||||||||
> $10.00 | 109,150 | 3.3 | — | 109,150 | 23.54 | — | |||||||||||||||||||
12,655,792 | $ | 519,622 | 7,373,354 | $ | 2.79 | $ | 216,439 | ||||||||||||||||||
Nonemployees | |||||||||||||||||||||||||
Stock Option Valuation Assumptions | The fair value for the years ended December 31, 2014, 2013 and 2012 was calculated using the following assumptions, defined below: | ||||||||||||||||||||||||
Years Ended December 31, | |||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Risk-free interest rates | 0.08%–2.63% | 0.26%–2.98% | 0.24%–2.05% | ||||||||||||||||||||||
Expected life | 0.50 years–9.51 years | 1.50 years–9.76 years | 2.00 years–9.25 years | ||||||||||||||||||||||
Expected dividends | 0% | 0% | 0% | ||||||||||||||||||||||
Expected volatility | 56.54%–139.65% | 80.00%–143.00% | 63.48%–142.25% | ||||||||||||||||||||||
Employees Stock Option Plan | |||||||||||||||||||||||||
Stock Option Valuation Assumptions | The estimated grant-date fair values of the employee stock options were calculated using the Black-Scholes valuation model, based on the following assumptions for the years ended December 31, 2014, 2013 and 2012: | ||||||||||||||||||||||||
Years Ended December 31, | |||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Risk-free interest rates | 1.73%–1.96% | 0.94%–1.33% | 0.90%–1.09% | ||||||||||||||||||||||
Expected life | 6.00 years–6.25 years | 6.00 years–6.25 years | 6.00 years–6.25 years | ||||||||||||||||||||||
Expected dividends | 0% | 0% | 0% | ||||||||||||||||||||||
Expected volatility | 118.64%–120.70% | 148.00%–149.00% | 137.58%–143.98% |
Warrants_Tables
Warrants (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Stock Warrants Activity | Stock warrant activity is as follows: | ||||||||
Common | Price(1) | ||||||||
Shares | |||||||||
Balance, December 31, 2011 | 23,923,301 | $ | 2.55 | ||||||
Granted(2) | 106,746 | 2.34 | |||||||
Exercised | (2,813,600 | ) | 2.18 | ||||||
Cancelled | — | — | |||||||
Balance, December 31, 2012 | 21,216,447 | 2.6 | |||||||
Granted(2) | 5,508,000 | 1.14 | |||||||
Exercised | (20,325 | ) | 1.38 | ||||||
Cancelled | (1,153,497 | ) | 9.14 | ||||||
Balance, December 31, 2013 | 25,550,625 | 1.99 | |||||||
Granted | — | — | |||||||
Exercised | (1,328,270 | ) | 1.69 | ||||||
Cancelled | (22,650 | ) | 48.56 | ||||||
Balance, December 31, 2014 | 24,199,705 | $ | 1.96 | ||||||
-1 | Represents weighted-average exercise price per share. | ||||||||
-2 | See Notes 8 and 10 for discussions relating to the issuance of warrants in 2013 and 2012. |
Related_Party_Transactions_Tab
Related Party Transactions (Tables) (Anthony Jansz) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Anthony Jansz | |||||||||||||
Shares Purchased by Related Parties | corresponding warrant. The shares purchased, together with the proceeds, before expenses, to the Company, are shown in the table below: | ||||||||||||
Beneficial Owner | Shares | Warrants | Proceeds, before | ||||||||||
Purchased | Purchased | expenses, to the Company | |||||||||||
Anthony Jansz | 150,000 | 60,000 | $ | 142,500 |
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Future Minimum Lease Payment | The following is a schedule of total future minimum lease payments due as of December 31, 2014: | ||||
Year ending December 31: | |||||
2015 | $ | 221,789 |
Quarterly_Data_Tables
Quarterly Data (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Information | The following table represents certain unaudited quarterly information for each of the eight quarters in the period ended December 31, 2014. In management’s opinion, this information has been prepared on the same basis as the audited consolidated financial statements and includes all the adjustments necessary to fairly state the unaudited quarterly results of operations (in thousands, except per share data). | ||||||||||||||||
First | Second | Third | Fourth | ||||||||||||||
Quarter | Quarter | Quarter | Quarter | ||||||||||||||
2014:00:00 | |||||||||||||||||
Net loss | $ | (6,732 | ) | $ | (7,501 | ) | $ | (5,714 | ) | $ | (6,181 | ) | |||||
Basic and diluted net loss per share | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.08 | ) | $ | (0.09 | ) | |||||
2013:00:00 | |||||||||||||||||
Net loss | $ | (6,581 | ) | $ | (6,323 | ) | $ | (6,303 | ) | $ | (6,573 | ) | |||||
Basic and diluted net loss per share | $ | (0.14 | ) | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.11 | ) |
Formation_and_Business_of_the_1
Formation and Business of the Company - Additional Information (Detail) | 0 Months Ended | 1 Months Ended | ||||
Apr. 16, 2012 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2014 | Jan. 31, 2006 | |
USD ($) | USD ($) | Alpha Medical, Inc. | Beta Medical, Inc. | EnteroMedics Europe | ||
CHF | ||||||
Organization And Description Of Business [Line Items] | ||||||
Ownership percentage of an entity combined to form the Company | 100.00% | 100.00% | ||||
Common stock, shares outstanding | 69,570,444 | 63,551,350 | 20 | |||
Common stock, par value | $0.01 | $0.01 | 1,000 | |||
Repurchased shares percentage | 100.00% | |||||
Stock Issued (in shares) | 2,271,705 | 1 |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Schedule Of Significant Accounting Policies [Line Items] | |||
Long-term debt | $3,400,000 | ||
Cash equivalents maturity period | 90 days | ||
Cash collateral money market | 200,000 | ||
Standby letter of credit amount | 200,000 | ||
Patent related legal expenses | 338,055 | 296,575 | 278,987 |
Derivative instruments outstanding | $0 | $0 | $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 | ||
Standby letters of credit | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Stand by letter of credit expiration date | 1-Oct-13 | ||
Money Market Funds | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Money market funds preserve the value of investment per share | $1 |
Computation_of_Basic_and_Dilut
Computation of Basic and Diluted Net Loss Per Share (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Numerator: | |||||||||||
Net loss | ($6,181,000) | ($5,714,000) | ($7,501,000) | ($6,732,000) | ($6,573,000) | ($6,303,000) | ($6,323,000) | ($6,581,000) | ($26,128,720) | ($25,780,659) | ($23,460,103) |
Denominator for basic and diluted net loss per share: | |||||||||||
Weighted-average common shares outstanding | 67,866,427 | 55,009,916 | 39,536,500 | ||||||||
Net loss per share-basic and diluted | ($0.09) | ($0.08) | ($0.11) | ($0.10) | ($0.11) | ($0.11) | ($0.11) | ($0.14) | ($0.39) | ($0.47) | ($0.59) |
Potential_Shares_of_Common_Sto
Potential Shares of Common Stock Not Included in Calculation of Diluted Net Loss per Share (Detail) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Stock Option Outstanding | |||
Anti-dilutive Securities | |||
Anti-dilutive as of end of each period | 12,655,792 | 11,687,300 | 7,835,533 |
Warrants to purchase common stock | |||
Anti-dilutive Securities | |||
Anti-dilutive as of end of each period | 24,199,705 | 25,550,625 | 21,216,447 |
Liquidity_and_Managements_Plan1
Liquidity and Management's Plans - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | |||
Feb. 27, 2013 | Apr. 20, 2012 | Dec. 31, 2013 | Jul. 31, 2013 | Dec. 31, 2014 | Mar. 13, 2015 | Mar. 13, 2015 | Jun. 13, 2014 | Dec. 31, 2012 | Dec. 31, 2011 | |
Liquidity and Managements Plans [Line Items] | ||||||||||
Cash and cash equivalents | $23,297,479 | $11,619,167 | $22,308,781 | $28,487,688 | ||||||
Gross proceeds before deducting estimate offering expenses | 13,100,000 | 5,000,000 | 11,000,000 | |||||||
Maximum | ||||||||||
Liquidity and Managements Plans [Line Items] | ||||||||||
Gross proceeds before deducting estimate offering expenses | 20,000,000 | |||||||||
Cowen and Company Llc | ||||||||||
Liquidity and Managements Plans [Line Items] | ||||||||||
Cash and cash equivalents | 11,600,000 | |||||||||
Gross proceeds before deducting estimate offering expenses | 927,000 | |||||||||
Cowen and Company Llc | Subsequent Event | ||||||||||
Liquidity and Managements Plans [Line Items] | ||||||||||
Gross proceeds before deducting estimate offering expenses | 17,600,000 | 6,400,000 | ||||||||
Cowen and Company Llc | Maximum | ||||||||||
Liquidity and Managements Plans [Line Items] | ||||||||||
Gross proceeds before deducting estimate offering expenses | $25,000,000 |
Inventory_Additional_Informati
Inventory - Additional Information (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Inventory [Line Items] | ||
Long-term inventory | $825,000 | $794,000 |
Current_Inventory_Detail
Current Inventory (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Inventory [Line Items] | ||
Raw materials | $322,157 | $385,565 |
Work-in-process | 632,615 | 624,530 |
Finished goods | 25,747 | 117,846 |
Inventory | $980,519 | $1,127,941 |
Property_and_Equipment_Detail
Property and Equipment (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment | $2,295,433 | $2,274,633 |
Computer hardware and software | 556,556 | 499,922 |
Leasehold improvements | 62,651 | 46,754 |
Property and Equipment, Gross | 2,914,640 | 2,821,309 |
Less accumulated depreciation and amortization | -2,433,118 | -2,244,214 |
Property and equipment, net | $481,522 | $577,095 |
Accrued_Expenses_Detail
Accrued Expenses (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Accrued Expenses [Line Items] | ||
Professional service related expenses | $2,107,712 | $2,650,163 |
Payroll related expenses | 1,267,141 | 1,043,028 |
Other expenses | 455,913 | 492,869 |
Accrued expenses | $3,830,766 | $4,186,060 |
Notes_Payable_Detail
Notes Payable (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Accounts Payable [Line Items] | ||
Growth capital loan dated April 16, 2012 (net of discounts of $23,836 and $131,670 at December 31, 2014 and 2013, respectively) | $2,976,164 | $6,868,330 |
Less current portion | -2,976,164 | -4,000,000 |
Total long-term debt | $2,868,330 |
Notes_Payable_Parenthetical_De
Notes Payable (Parenthetical) (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Accounts Payable [Line Items] | ||
Notes payable, discounts | $23,836 | $131,670 |
Notes_Payable_Additional_Infor
Notes Payable - Additional Information (Detail) (USD $) | 12 Months Ended | 0 Months Ended | |||
Dec. 31, 2014 | Apr. 16, 2012 | 9-May-13 | Feb. 28, 2013 | Apr. 23, 2012 | |
Debt Instrument [Line Items] | |||||
Principal amount of loan | $10,000,000 | $10,000,000 | |||
Amount used to repay outstanding debt | 4,700,000 | ||||
Repayment of principal amount | 333,333 | ||||
Loan agreement with fixed annual rate | 8.00% | ||||
Final payment fee percentage | 5.00% | ||||
Conditional amount to be placed in restricted account at SVB | 7,500,000 | ||||
Warrants exercise price | $1.14 | ||||
Silicon Valley Bank | |||||
Debt Instrument [Line Items] | |||||
Term loans, agreed sum | 20,000,000 | ||||
Number of installments of repayment of debt | 30 | ||||
Issued warrant | 106,746 | ||||
Time for exercising warrant | 10 years | ||||
Warrants exercise price | $2.34 | ||||
Silicon Valley Bank | First Amendment | |||||
Debt Instrument [Line Items] | |||||
Success fee percentage in the event the Company receives FDA approval for the Maestro Rechargeable System | 187,000 | ||||
Silicon Valley Bank | First Amendment | November 15, 2013 | |||||
Debt Instrument [Line Items] | |||||
Cumulative aggregate proceeds from new capital transactions | 5,000,000 | ||||
Silicon Valley Bank | First Amendment | April 15, 2014 | |||||
Debt Instrument [Line Items] | |||||
Cumulative aggregate proceeds from new capital transactions | $10,000,000 | ||||
Silicon Valley Bank | First Amendment | Until it receives FDA approval for the Maestro Rechargeable System | |||||
Debt Instrument [Line Items] | |||||
Liquidity ratio (unrestricted cash divided by outstanding debt) | 1.25 | ||||
Silicon Valley Bank | First Amendment | After FDA approval for the Maestro Rechargeable System | |||||
Debt Instrument [Line Items] | |||||
Liquidity ratio (unrestricted cash divided by outstanding debt) | 0.75 |
Schedule_of_Debt_Principal_Pay
Schedule of Debt Principal Payments (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Debt Instrument [Line Items] | ||
2015 | $3,000,000 | |
Less original issue discount | -23,836 | -131,670 |
Notes payable, net | $2,976,164 | $6,868,330 |
Preferred_Stock_Additional_Inf
Preferred Stock - Additional Information (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Preferred Stock [Line Items] | ||
Preferred stock, authorized | 5,000,000 | |
Preferred stock, par value | $0.01 | |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Stock_Sales_Additional_Informa
Stock Sales - Additional Information (Detail) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | |||
Feb. 27, 2013 | Apr. 20, 2012 | Apr. 16, 2012 | Feb. 28, 2013 | Dec. 31, 2013 | Jun. 10, 2014 | Dec. 31, 2014 | Mar. 13, 2015 | Mar. 13, 2015 | Jul. 31, 2013 | Jun. 13, 2014 | |
Class of Stock [Line Items] | |||||||||||
Stock Issued (in shares) | 2,271,705 | ||||||||||
Purchase price per share | $2.22 | $1.39 | |||||||||
Gross proceeds before deducting estimate offering expenses | $13,100,000 | $5,000,000 | $11,000,000 | ||||||||
Purchase price per share | $0.95 | ||||||||||
Warrants exercise price | $1.14 | ||||||||||
Warrant, exercise period | 5 years | ||||||||||
Maximum percentage of ownership restriction on warrant exercises | 19.99% | ||||||||||
Commission or discount percentage on issue of shares | 2.00% | ||||||||||
Number of shares sold | 7,917,755 | ||||||||||
Warrants to purchase common stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrant issued | 5,508,000 | ||||||||||
Canaccord Genuity Inc | |||||||||||
Class of Stock [Line Items] | |||||||||||
Purchase price per share | $1.67 | $2.22 | |||||||||
Gross proceeds before deducting estimate offering expenses | 19,900,000 | 8,900,000 | |||||||||
Number of shares sold | 11,923,977 | 4,006,222 | |||||||||
Agreement termination effective date | 10-Jun-14 | 10-Jun-14 | |||||||||
Cowen and Company Llc | |||||||||||
Class of Stock [Line Items] | |||||||||||
Purchase price per share | $1.35 | ||||||||||
Gross proceeds before deducting estimate offering expenses | 927,000 | ||||||||||
Commission or discount percentage on issue of shares | 3.00% | ||||||||||
Number of shares sold | 684,602 | ||||||||||
Cowen and Company Llc | Subsequent Event | |||||||||||
Class of Stock [Line Items] | |||||||||||
Purchase price per share | $1.39 | $1.39 | |||||||||
Gross proceeds before deducting estimate offering expenses | 17,600,000 | 6,400,000 | |||||||||
Number of shares sold | 4,627,934 | ||||||||||
Maximum | |||||||||||
Class of Stock [Line Items] | |||||||||||
Gross proceeds before deducting estimate offering expenses | 20,000,000 | ||||||||||
Maximum | Cowen and Company Llc | |||||||||||
Class of Stock [Line Items] | |||||||||||
Gross proceeds before deducting estimate offering expenses | $25,000,000 | ||||||||||
Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock Issued (in shares) | 13,770,000 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Income Taxes [Line Items] | |||
U.S. federal income tax rate | 34.00% | 34.00% | 34.00% |
U.S. federal net operating loss carryforwards amount | $91,900,000 | ||
Net operating loss carryforwards amount available for utilization | 44,000,000 | ||
Tax benefit recorded to additional paid-in capital | 221,000 | ||
Gross federal net operating loss carryforward expired amount | 48,100,000 | ||
Deferred tax asset, write-off of capitalized start-up costs | 5,900,000 | ||
Deferred tax asset, write-off of capitalized research and development costs | 5,500,000 | ||
Deferred tax asset, write-off of property and equipment | 1,500,000 | ||
Deferred tax asset, write-off of research and development credits | 2,400,000 | ||
Unrecognized tax | 0 | 0 | |
Interest or penalties charged or accrued related to unrecognized tax benefits | 0 | ||
Tax examinations | $0 | ||
Federal examinations for the years | 2011 | ||
Minimum | |||
Income Taxes [Line Items] | |||
Federal net operating loss carryforwards expiration date | 2022 | ||
Maximum | |||
Income Taxes [Line Items] | |||
Federal net operating loss carryforwards expiration date | 2034 |
Tax_Rate_Reconciliation_Detail
Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Reconciliation of Effective Income Tax Rate [Line Items] | |||
Computed 'expected' tax benefit | 34.00% | 34.00% | 34.00% |
Other permanent adjustments | -2.30% | -2.30% | -2.20% |
Research and development credit | 0.30% | 3.50% | 0.00% |
Federal valuation allowance | -32.00% | -35.20% | -31.80% |
Effective Income Tax Rate Reconciliation, Percent, Total | 0.00% | 0.00% | 0.00% |
Deferred_Tax_Assets_Detail
Deferred Tax Assets (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Deferred tax assets (liabilities): | ||
Start-up costs | $8,739,000 | $8,851,000 |
Capitalized research and development costs | 30,276,000 | 24,844,000 |
Reserves and accruals | 6,052,000 | 4,530,000 |
Property and equipment | 94,000 | 105,000 |
Research and development credit | 1,636,000 | 1,508,000 |
Net operating loss carryforwards | 16,656,000 | 12,198,000 |
Total gross deferred tax assets | 63,453,000 | 52,036,000 |
Valuation allowance | -63,453,000 | -52,036,000 |
Net deferred tax assets | $0 | $0 |
Stock_Options_Additional_Infor
Stock Options - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | ||
7-May-14 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Schedule Of Stock Options [Line Items] | ||||
Stock incentive plan, shares authorized | 19,800,000 | 12,300,000 | ||
Options granted to participants | 10.00% | |||
Stock incentive plan, additional shares authorized | 7,500,000 | |||
Stock-based compensation | $6,319,707 | $5,954,928 | $4,225,322 | |
Weighted average estimated fair value of stock options granted | $1.42 | $1.22 | $3.19 | |
Total unrecognized compensation costs related to non-vested stock options | 9,200,000 | |||
Total unrecognized compensation costs related to non-vested stock options, weighted-average period of recognition | 2 years | |||
Aggregate intrinsic value of stock options | 0 | 0 | 3,044 | |
Incentive Stock Options | ||||
Schedule Of Stock Options [Line Items] | ||||
Options granted to participants | 10.00% | |||
Employees | Employee Awards | ||||
Schedule Of Stock Options [Line Items] | ||||
Award vesting period | 4 years | |||
Nonemployees | ||||
Schedule Of Stock Options [Line Items] | ||||
Stock-based compensation | $181,323 | $166,679 | $52,190 | |
Minimum | ||||
Schedule Of Stock Options [Line Items] | ||||
Options granted to participants owning more than 10% of outstanding voting stock, exercise price percentage | 110.00% | |||
Minimum | Incentive Stock Options | ||||
Schedule Of Stock Options [Line Items] | ||||
Option expiration period | 5 years | |||
Maximum | ||||
Schedule Of Stock Options [Line Items] | ||||
Option expiration period | 10 years |
Summary_of_Stock_Option_Activi
Summary of Stock Option Activity (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding Options, Number of Shares, Options exercised | -5,219 | ||
Aggregate Intrinsic Value | $519,622 | ||
Stock Incentive Plan 2003 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares Available For Grant, Beginning Balance | 542,218 | 4,393,985 | 763,829 |
Shares Available For Grant, Shares reserved | 7,500,000 | 8,000,000 | |
Shares Available For Grant, Options granted | -1,257,500 | -4,346,000 | -4,462,873 |
Shares Available For Grant, Options exercised | 0 | 0 | 0 |
Shares Available For Grant, Options cancelled | 289,008 | 494,233 | 93,029 |
Shares Available For Grant, Ending Balance | 7,073,726 | 542,218 | 4,393,985 |
Outstanding Options, Number of Shares, Beginning Balance | 11,687,300 | 7,835,533 | 3,470,908 |
Outstanding Options, Number of Shares, Shares reserved | 0 | 0 | 0 |
Outstanding Options, Number of Shares, Options granted | 1,257,500 | 4,346,000 | 4,462,873 |
Outstanding Options, Number of Shares, Options exercised | -5,219 | ||
Outstanding Options, Number of Shares, Options cancelled | -289,008 | -494,233 | -93,029 |
Outstanding Options, Number of Shares, Ending Balance | 12,655,792 | 11,687,300 | 7,835,533 |
Outstanding Options, Weighted-Average Exercise Price, Beginning Balance | $2.56 | $3.28 | $3.17 |
Outstanding Options, Weighted-Average Exercise Price, Shares reserved | $0 | $0 | $0 |
Outstanding Options, Weighted-Average Exercise Price, Options granted | $1.63 | $1.32 | $3.35 |
Outstanding Options, Weighted-Average Exercise Price, Options exercised | $2.43 | ||
Outstanding Options, Weighted-Average Exercise Price, Options cancelled | $2.41 | $3 | $2.79 |
Outstanding Options, Weighted-Average Exercise Price, Ending Balance | $2.47 | $2.56 | $3.28 |
Aggregate Intrinsic Value | $519,622 | $3,284,696 |
Options_Outstanding_Vested_and
Options Outstanding Vested and Currently Exercisable by Exercise Price (Detail) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of shares outstanding | 12,655,792 |
Aggregate Intrinsic Value | $519,622 |
Number of Options | 7,373,354 |
Weighted-Average Exercise Price | $2.79 |
Aggregate Intrinsic Value | 216,439 |
$0.01 to $2.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price, lower limit | $0.01 |
Exercise price, upper limit | $2 |
Number of shares outstanding | 6,310,699 |
Weighted-Average remaining contractual life (Years) | 8 years |
Aggregate Intrinsic Value | 519,622 |
Number of Options | 2,766,588 |
Weighted-Average Exercise Price | $1.52 |
Aggregate Intrinsic Value | $216,439 |
$2.01 to $3.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price, lower limit | $2.01 |
Exercise price, upper limit | $3 |
Number of shares outstanding | 2,146,297 |
Weighted-Average remaining contractual life (Years) | 5 years 10 months 24 days |
Number of Options | 1,963,787 |
Weighted-Average Exercise Price | $2.63 |
$3.01 to $5.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price, lower limit | $3.01 |
Exercise price, upper limit | $5 |
Number of shares outstanding | 4,085,480 |
Weighted-Average remaining contractual life (Years) | 7 years 4 months 24 days |
Number of Options | 2,529,663 |
Weighted-Average Exercise Price | $3.41 |
$5.01 to $10.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price, lower limit | $5.01 |
Exercise price, upper limit | $10 |
Number of shares outstanding | 4,166 |
Weighted-Average remaining contractual life (Years) | 4 years 1 month 6 days |
Number of Options | 4,166 |
Weighted-Average Exercise Price | $8.40 |
> $10.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price, lower limit | $10 |
Exercise price, upper limit | >10 |
Number of shares outstanding | 109,150 |
Weighted-Average remaining contractual life (Years) | 3 years 3 months 18 days |
Number of Options | 109,150 |
Weighted-Average Exercise Price | $23.54 |
StockBased_Compensation_for_No
Stock-Based Compensation for Non Employees (Detail) (Nonemployees) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rates, minimum | 0.08% | 0.26% | 0.24% |
Risk-free interest rates, maximum | 2.63% | 2.98% | 2.05% |
Expected dividends | 0.00% | 0.00% | 0.00% |
Expected Volatility, minimum | 56.54% | 80.00% | 63.48% |
Expected Volatility, maximum | 139.65% | 143.00% | 142.25% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 6 months | 1 year 6 months | 2 years |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 9 years 6 months 4 days | 9 years 9 months 4 days | 9 years 3 months |
Estimated_GrantDate_Fair_Value
Estimated Grant-Date Fair Values of Employee Stock Options (Detail) (Employees) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 1.73% | 0.94% | 0.90% |
Risk-free interest rate, maximum | 1.96% | 1.33% | 1.09% |
Expected dividends | 0.00% | 0.00% | 0.00% |
Expected volatility factor, minimum | 118.64% | 148.00% | 137.58% |
Expected volatility factor, maximum | 120.70% | 149.00% | 143.98% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 6 years | 6 years | 6 years |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Stock_Warrant_Activity_Detail
Stock Warrant Activity (Detail) (Common Stock) | 12 Months Ended | |||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||||
Common Stock | ||||||
Class of Warrant or Right [Line Items] | ||||||
Beginning Balance | 25,550,625 | 21,216,447 | 23,923,301 | |||
Granted | 5,508,000 | [1] | 106,746 | [1] | ||
Exercised | -1,328,270 | -20,325 | -2,813,600 | |||
Cancelled | -22,650 | -1,153,497 | ||||
Ending Balance | 24,199,705 | 25,550,625 | 21,216,447 | |||
Beginning Balance | 1.99 | [2] | 2.6 | [2] | 2.55 | [2] |
Granted | 1.14 | [1],[2] | 2.34 | [1],[2] | ||
Exercised | 1.69 | [2] | 1.38 | [2] | 2.18 | [2] |
Cancelled | 48.56 | [2] | 9.14 | [2] | ||
Ending Balance | 1.96 | [2] | 1.99 | [2] | 2.6 | [2] |
[1] | See Notes 8 and 10 for discussions relating to the issuance of warrants in 2013 and 2012. | |||||
[2] | Represents weighted-average exercise price per share. |
Warrants_Additional_Informatio
Warrants - Additional Information (Detail) (Warrants to purchase common stock) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Warrants to purchase common stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Warrant outstanding, weighted-average remaining contractual life | 1 year 10 months 6 days | 2 years 10 months 13 days |
Related_Party_Transactions_Add
Related Party Transactions - Additional Information (Detail) | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | |||||||||||||||||||||||||
Apr. 16, 2012 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Feb. 27, 2013 | Feb. 27, 2013 | Dec. 31, 2014 | Dec. 20, 2012 | Jun. 01, 2011 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Sep. 25, 2014 | Sep. 25, 2014 | Dec. 31, 2014 | 31-May-13 | Jan. 22, 2013 | Jun. 01, 2011 | Oct. 06, 2014 | Jan. 22, 2014 | Dec. 31, 2014 | Dec. 31, 2014 | Jun. 30, 2014 | Dec. 31, 2014 | Dec. 31, 2014 | 31-May-14 | Dec. 31, 2014 | 31-May-15 | Dec. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2014 | Jan. 22, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Feb. 27, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | |
USD ($) | USD ($) | USD ($) | USD ($) | Warrants to purchase common stock | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Agreement - Anthony Jansz | Consulting Services | Consulting Services | Common Stock | Common Stock | Common Stock | ||
USD ($) | AUD | AUD | USD ($) | AUD | USD ($) | USD ($) | Amendment No. 2 | Amendment No. 2 | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Stock Option Outstanding | Subsequent Event | USD ($) | USD ($) | ||||||||||
USD ($) | AUD | USD ($) | USD ($) | USD ($) | USD ($) | Amendment No. 2 | Vest on January 22, 2014 | Vest on January 22, 2014 | Vest on January 22, 2015 | Prior to June 30, 2014 | Prior to June 30, 2014 | Vest on May 31, 2014 | Vest on May 31, 2014 | Vest on May 31, 2015 | Vest on May 31, 2015 | Vest upon implementation of Australian Specialty Clinic Commercial Validation Project prior to December 31, 2013 | Vest upon Company successfully obtaining an Item Listing for Maestro Rechargeable System implantation by December 31, 2014 | Prior to December 31, 2014 | Prior to December 31, 2014 | Prior to December 31, 2013 | Prior to December 31, 2013 | Stock Option Outstanding | |||||||||||||||||||
USD ($) | Scenario, Forecast | Vest on January 22, 2015 | |||||||||||||||||||||||||||||||||||||||
Transactions with Third Party [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Stock Issued (in shares) | 2,271,705 | 13,770,000 | 4,690,824 | 7,917,755 | |||||||||||||||||||||||||||||||||||||
Warrant issued | 5,508,000 | ||||||||||||||||||||||||||||||||||||||||
Purchase price per share | $0.95 | ||||||||||||||||||||||||||||||||||||||||
Consulting agreement term | 4 years | ||||||||||||||||||||||||||||||||||||||||
Consulting fee | $10,000 | 12,000 | 96,000 | $79,000 | 12,000 | $10,000 | 12,000 | ||||||||||||||||||||||||||||||||||
Award granted, shares | 100,000 | 75,000 | 50,000 | 25,000 | |||||||||||||||||||||||||||||||||||||
Award granted, price per share | $1.31 | $2.65 | $2.76 | $1.14 | |||||||||||||||||||||||||||||||||||||
Award vesting period | 48 months | ||||||||||||||||||||||||||||||||||||||||
Grant date fair value of award grant | 153,000 | 103,000 | 108,000 | 16,000 | |||||||||||||||||||||||||||||||||||||
Award vested, shares | 16,667 | 16,667 | 16,667 | ||||||||||||||||||||||||||||||||||||||
Award expected to vest, shares | 25,000 | 16,667 | 16,666 | 25,000 | 25,000 | 16,666 | |||||||||||||||||||||||||||||||||||
Award vesting date | 22-Jan-14 | 22-Jan-15 | 31-May-14 | 31-May-15 | |||||||||||||||||||||||||||||||||||||
Latest date for approval of Australian reimbursement for the remaining options to vest | 30-Jun-14 | 31-Dec-14 | 31-Dec-13 | ||||||||||||||||||||||||||||||||||||||
Number of shares not vested | 25,000 | 25,000 | 25,000 | ||||||||||||||||||||||||||||||||||||||
Stock-based compensation | 40,000 | 126,000 | 23,000 | ||||||||||||||||||||||||||||||||||||||
Payment for consulting services | 196,000 | 154,000 | 195,000 | ||||||||||||||||||||||||||||||||||||||
Selling,general and administrative expenses | $14,561,656 | $13,658,824 | $11,960,893 | $253,000 | $146,000 |
Shares_Purchased_by_Related_Pa
Shares Purchased by Related Parties (Detail) (USD $) | 0 Months Ended | 12 Months Ended | |||
Feb. 27, 2013 | Apr. 20, 2012 | Apr. 16, 2012 | Dec. 31, 2013 | Dec. 31, 2014 | |
Transactions with Third Party [Line Items] | |||||
Stock Issued (in shares) | 2,271,705 | ||||
Proceeds, before expenses, to the Company | $13,100,000 | $5,000,000 | $11,000,000 | ||
Common Stock | |||||
Transactions with Third Party [Line Items] | |||||
Stock Issued (in shares) | 13,770,000 | 7,917,755 | 4,690,824 | ||
Anthony Jansz | |||||
Transactions with Third Party [Line Items] | |||||
Proceeds, before expenses, to the Company | $142,500 | ||||
Anthony Jansz | Common Stock | |||||
Transactions with Third Party [Line Items] | |||||
Stock Issued (in shares) | 150,000 | ||||
Warrants to purchase common stock | |||||
Transactions with Third Party [Line Items] | |||||
Warrants Purchased | 5,508,000 | ||||
Warrants to purchase common stock | Anthony Jansz | |||||
Transactions with Third Party [Line Items] | |||||
Warrants Purchased | 60,000 |
Commitments_and_Contingencies_1
Commitments and Contingencies - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | ||||||||
Oct. 01, 2008 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2005 | Mar. 31, 2010 | Dec. 31, 2009 | Dec. 31, 2008 | Dec. 31, 2007 | Dec. 31, 2006 | Dec. 31, 2011 | Dec. 31, 2010 | |
Loss Contingencies [Line Items] | ||||||||||||
Operating lease agreement term | 7 years | |||||||||||
Operating lease agreement expiration date | 30-Sep-15 | |||||||||||
Total rent expense | $270,872 | $270,872 | $270,872 | |||||||||
Number of months that require patients to be followed out in clinical trials | 60 months | |||||||||||
Collaborative obesity device research and development agreement, term | 5 years | |||||||||||
Research and development expense | 11,031,619 | 11,075,493 | 10,668,044 | |||||||||
Amendment One | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Collaborative obesity device research and development agreement, extension period | 2 years | |||||||||||
Retainer Fees | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Research and development expense | 250,000 | 250,000 | 250,000 | 250,000 | 250,000 | |||||||
Retainer Fees | Amendment One | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Research and development expense | 100,000 | 100,000 | ||||||||||
Retainer Fees | Amendment No. 2 | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Research and development expense | 75,000 | |||||||||||
Minimum | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Operating lease, monthly base rent | 19,570 | |||||||||||
Maximum | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Operating lease, monthly base rent | 24,643 |
Future_Minimum_Lease_Payment_D
Future Minimum Lease Payment (Detail) (USD $) | Dec. 31, 2014 |
Leases Future Minimum Payments [Line Items] | |
2015 | $221,789 |
Quarterly_Information_Detail
Quarterly Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Quarterly Financial Data [Line Items] | |||||||||||
Net loss | ($6,181,000) | ($5,714,000) | ($7,501,000) | ($6,732,000) | ($6,573,000) | ($6,303,000) | ($6,323,000) | ($6,581,000) | ($26,128,720) | ($25,780,659) | ($23,460,103) |
Basic and diluted net loss per share | ($0.09) | ($0.08) | ($0.11) | ($0.10) | ($0.11) | ($0.11) | ($0.11) | ($0.14) | ($0.39) | ($0.47) | ($0.59) |