Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 15, 2016 | Jun. 30, 2015 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | DISCOVERY LABORATORIES INC /DE/ | ||
Entity Central Index Key | 946,486 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $ 49.5 | ||
Entity Common Stock, Shares Outstanding | 8,191,289 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | true | ||
Amendment Description | This Amendment No. 1 on Form 10-K/A (the “Amendment”) to the Annual Report on Form 10-K of Discovery Laboratories, Inc. (the Company) for the fiscal year ended December 31, 2015, filed with the Securities and Exchange Commission on March 29, 2016 (the Original Filing), is being filed solely to correct an inadvertent error appearing in (i) Item 7. Management’s Discussion and Analysis – Liquidity and Capital Resources in the second paragraph, on page 67, and (ii) Note 3 to the Company’s Consolidated Financial Statements and Notes, in the second paragraph, on page F-8. In the last sentence of each of the foregoing paragraphs, the phrase “within the expected time line in the fourth quarter of 2015” has been changed to read “within the expected time line in the fourth quarter of 2016.” In addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, new certifications by our principal executive officers and principal financial officer are filed as exhibits to this Amendment under Item 15 of Part IV hereof. Except for the foregoing amended information, this Amendment does not alter or update any other information contained in the Original Filing. This Amendment does not reflect events that may have occurred subsequent to the Original Filing. | ||
Document Period End Date | Dec. 31, 2015 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and cash equivalents | $ 38,722 | $ 44,711 |
Inventory, net | 0 | 27 |
Prepaid interest, current portion | 1,710 | 0 |
Prepaid expenses and other current assets | 362 | 821 |
Total current assets | 40,794 | 45,559 |
Property and equipment, net | 1,039 | 1,637 |
Restricted cash | 225 | 225 |
Prepaid interest, non-current portion | 2,319 | 0 |
Other assets | 0 | 78 |
Total Assets | 44,377 | 47,499 |
Current Liabilities: | ||
Accounts payable | 3,263 | 350 |
Accrued expenses | 7,582 | 6,116 |
Deferred revenue | 0 | 43 |
Common stock warrant liability | 223 | 1,258 |
Equipment loans, current portion | 0 | 62 |
Total current liabilities | 11,068 | 7,829 |
Long-term Debt: | ||
Long term debt, gross | 25,000 | 30,000 |
Discount on long-term debt | 0 | (9,698) |
Long-term debt, net | 25,000 | 20,302 |
Other liabilities | 43 | 169 |
Total liabilities | 36,111 | 28,300 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding | 0 | 0 |
Common stock, $0.001 par value; 36,000,000 shares authorized; 8,196,011 and 6,114,843 shares issued at December 31, 2015 and 2014, respectively; 8,194,519 and 6,113,351 shares outstanding at December 31, 2015 and 2014, respectively | 8 | 6 |
Additional paid-in capital | 590,490 | 546,255 |
Accumulated deficit | (579,178) | (524,008) |
Treasury stock (at cost); 1,492 shares | (3,054) | (3,054) |
Total stockholders' equity | 8,266 | 19,199 |
Total liabilities & stockholders' equity | $ 44,377 | $ 47,499 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Stockholders' Equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 36,000,000 | |
Common stock, shares issued (in shares) | 8,196,011 | 6,114,843 |
Common stock, shares outstanding (in shares) | 8,194,519 | 6,113,351 |
Treasury stock (at cost) (in shares) | 1,492 | 1,492 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | ||
Product sales | $ 7 | $ 312 |
Grant revenue | 980 | 2,523 |
Total revenues | 987 | 2,835 |
Expenses: | ||
Cost of product sales | 929 | 2,671 |
Research and development | 28,888 | 26,690 |
Selling, general, and administrative | 11,004 | 16,732 |
Total expenses | 40,821 | 46,093 |
Operating loss | (39,834) | (43,258) |
Change in fair value of common stock warrant liability | 851 | 3,791 |
Other income / (expense): | ||
Loss on debt extinguishment | (11,758) | 0 |
Interest and other income | 237 | 6 |
Interest and other expense | (4,666) | (4,597) |
Other income / (expense), net | (16,187) | (4,591) |
Net loss | $ (55,170) | $ (44,058) |
Net loss per common share | ||
Basic (in dollars per share) | $ (7.98) | $ (7.28) |
Diluted (in dollars per share) | $ (7.98) | $ (7.84) |
Weighted average number of common shares outstanding | ||
Basic (in shares) | 6,967 | 6,078 |
Diluted (in shares) | 6,967 | 6,145 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] | Total |
Balance at Dec. 31, 2013 | $ 6 | $ 541,499 | $ (479,950) | $ (3,054) | $ 58,501 |
Balance (in shares) at Dec. 31, 2013 | 6,047,000 | (1,000) | |||
Changes in Stockholders' Equity [Roll Forward] | |||||
Net Loss | $ 0 | 0 | (44,058) | $ 0 | (44,058) |
Issuance of common stock, 401(k) Plan employer match | $ 0 | 944 | 0 | $ 0 | $ 944 |
Issuance of common stock, 401(k) Plan employer match (in shares) | 43,000 | 0 | 42,371 | ||
Exercise of common stock warrants | $ 0 | 803 | 0 | $ 0 | $ 803 |
Exercise of common stock warrants (in shares) | 20,000 | 0 | |||
Exercise of stock options for cash | $ 0 | 30 | 0 | $ 0 | 30 |
Exercise of stock options for cash (in shares) | 1,000 | 0 | |||
Issuance of common stock, consultants | $ 0 | 38 | 0 | $ 0 | 38 |
Issuance of common stock, consultants (in shares) | 1,000 | 0 | |||
Stock-based compensation expense | $ 0 | 2,941 | 0 | $ 0 | 2,941 |
Stock-based compensation expense (in shares) | 3,000 | ||||
Balance at Dec. 31, 2014 | $ 6 | 546,255 | (524,008) | $ (3,054) | $ 19,199 |
Balance (in shares) at Dec. 31, 2014 | 6,115,000 | (1,000) | 6,113,351 | ||
Changes in Stockholders' Equity [Roll Forward] | |||||
Net Loss | $ 0 | 0 | (55,170) | $ 0 | $ (55,170) |
Issuance of common stock, July 2015 financing | $ 2 | 37,626 | 0 | 37,628 | |
Issuance of common stock, July 2015 financing (in shares) | 1,792,000 | ||||
Issuance of common stock, 401(k) Plan employer match | $ 0 | 539 | 0 | $ 0 | $ 539 |
Issuance of common stock, 401(k) Plan employer match (in shares) | 94,000 | 0 | 94,114 | ||
Exercise of common stock warrants | $ 0 | 320 | 0 | $ 0 | $ 320 |
Exercise of common stock warrants (in shares) | 194,000 | 0 | |||
Issuance of common stock warrants | $ 0 | 4,053 | 0 | $ 0 | 4,053 |
Issuance of common stock warrants (in shares) | 0 | ||||
Stock-based compensation expense | $ 0 | 1,697 | 0 | 0 | 1,697 |
Stock-based compensation expense (in shares) | 1,000 | ||||
Balance at Dec. 31, 2015 | $ 8 | $ 590,490 | $ (579,178) | $ (3,054) | $ 8,266 |
Balance (in shares) at Dec. 31, 2015 | 8,196,000 | (1,000) | 8,194,519 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flow from operating activities: | ||
Net loss | $ (55,170) | $ (44,058) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 712 | 818 |
Change in provision for excess inventory | (174) | 1,873 |
Stock-based compensation and 401(k) plan employer match | 2,235 | 3,923 |
Fair value adjustment of common stock warrants | (851) | (3,791) |
Amortization of discount on long-term debt | 1,287 | 1,948 |
Loss on debt extinguishment | 11,758 | 0 |
Debt discount write-off | 707 | 0 |
Loss on sale of equipment | 84 | 0 |
Reduction in required restricted cash under lease agreement | 0 | 100 |
Amortization of prepaid interest | 971 | 0 |
Changes in: | ||
Inventory | 201 | (1,788) |
Accounts receivable | 0 | 67 |
Prepaid expenses and other current assets | 459 | (44) |
Accounts payable | 2,913 | (1,083) |
Accrued expenses | 1,466 | 1,331 |
Deferred revenue | (43) | (96) |
Other assets | 67 | 0 |
Other liabilities | (126) | (369) |
Net cash used in operating activities | (33,504) | (41,169) |
Cash flow from investing activities: | ||
Purchase of property and equipment | (458) | (780) |
Proceeds from sale of property and equipment | 270 | 0 |
Net cash used in investing activities | (188) | (780) |
Cash flow from financing activities: | ||
Proceeds from issuance of securities, net of expenses | 32,629 | 0 |
Proceeds from exercise of common stock warrants and options | 136 | 457 |
Principal payments on long-term debt | (5,000) | 0 |
Repayment of equipment loans | (62) | (80) |
Net cash provided by financing activities | 27,703 | 377 |
Net decrease in cash and cash equivalents | (5,989) | (41,572) |
Cash and cash equivalents - beginning of year | 44,711 | 86,283 |
Cash and cash equivalents - end of year | 38,722 | 44,711 |
Supplementary disclosure of cash flows information: | ||
Interest paid | $ 1,468 | $ 2,630 |
The Company and Description of
The Company and Description of Business | 12 Months Ended |
Dec. 31, 2015 | |
The Company and Description of Business [Abstract] | |
The Company and Description of Business | Note 1 – The Company and Description of Business Discovery Laboratories, Inc. (referred to as “we,” “us,” or the “Company”) is a biotechnology company focused on developing novel KL 4 4 4 Our core development program, AEROSURF ® (lucinactant for inhalation), is focused on improving the management of respiratory distress syndrome (RDS) in premature infants, a serious respiratory condition that can result in long-term respiratory problems, developmental delay and death. Premature infants born prior to 37 weeks gestational age may not have fully developed natural lung surfactant and therefore may need surfactant therapy to sustain life. Higher incidence and severity of RDS are correlated with younger gestational ages; however, RDS can occur at any premature gestational age. RDS is the most prevalent respiratory disease in the neonatal intensive care unit (NICU). Surfactant therapy is a life-saving treatment for RDS and the primary therapy to address an underlying surfactant deficiency. Surfactants currently available in the U.S. are animal-derived and must be administered using invasive endotracheal intubation and mechanical ventilation, each of which may result in serious respiratory conditions and other complications. Intubation is associated with To avoid these risks, many premature infants are initially treated with noninvasive respiratory support, such as nasal continuous positive airway pressure (nCPAP). since nCPAP does not address the underlying surfactant deficiency, many premature infants respond poorly to nCPAP (typically within the first 72 hours of life) and may require intubation and delayed surfactant therapy (an outcome referred to as nCPAP failure). In addition, many premature infants with RDS who receive surfactant therapy as initial therapy are capable of breathing without mechanical ventilation, but require surfactant therapy for RDS. Because surfactant therapy requires intubation, these infants generally are supported with mechanical ventilation for either a limited or extended period of time. If surfactant therapy could be administered noninvasively, neonatologists would be able to provide surfactant therapy to these premature infants without exposing them to the risks associated with intubation and mechanical ventilation AEROSURF is an investigational combination drug/device product that combines our proprietary KL 4 4 4 The drug product component of our AEROSURF product candidate is a lyophilized (freeze-dried) dosage form of our KL 4 ® 4 4 |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2015 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | Note 2 – Basis of Presentation The accompanying consolidated financial statements reflect a 1-for-14 reverse split of our common stock and a change in the number of shares of common stock authorized for issuance under our Amended and Restated Certificate of Incorporation, as amended (Certificate of Incorporation), that was approved by our Board of Directors and stockholders and made effective on January 22, 2016. All share and per share information herein that relates to our common stock has been retroactively restated to reflect the reverse stock split and reduction in authorized shares. |
Liquidity Risks and Management'
Liquidity Risks and Management's Plans | 12 Months Ended |
Dec. 31, 2015 | |
Liquidity Risks and Management's Plans [Abstract] | |
Liquidity Risks and Management's Plans | Note 3 – Liquidity Risks and Management’s Plans As of December 31, 2015, we had cash and cash equivalents of approximately $38.7 million, current accounts payable and accrued expenses of $10.8 million, and $25 million of long-term debt under a secured loan (Deerfield Loan) with affiliates of Deerfield Management, L.P. (Deerfield). The principal portion of the debt is payable in two equal installments in February 2018 (subject to potential deferral in certain circumstances) and February 2019. Before any additional financings or other transactions, we anticipate that we will have sufficient cash available to support our development programs, business operations and debt service obligations through the first quarter of 2017. We have incurred substantial losses since inception, due to investments in research and development, manufacturing, the commercialization of SURFAXIN, including marketing, commercial and medical affairs activities, and we expect to continue to incur substantial losses over the next four to five years. To secure the significant additional capital that we will need, we expect to utilize all or a combination of potential strategic alliances, collaboration agreements and other strategic transactions, public or private equity offerings (including our ATM Program), or through debt arrangements. We also believe that our success in these efforts will be largely dependent upon our ability to successfully and timely complete the AEROSURF phase 2b clinical trial. Failure to complete the clinical trial within the expected time line in the fourth quarter of 2016 and obtain acceptable and promising results could have a material adverse effect on our ability to secure the additional capital that we will require, through strategic transactions or otherwise, and our ability to continue as a going concern. Our ability to secure capital under our ATM Program or pursuant to public offerings under our 2014 Universal Shelf will be constrained by the value of our equity securities held by nonaffiliated persons and entities (public float), which as of March 18, 2016 is approximately $13.4 million. Our 2014 Universal Shelf was filed on Form S-3, which limits the size of primary securities offerings conducted by companies that have a public float of less than $75 million in any 12-month period to no more than one-third of their public float. Based on the closing market price of our common stock on March 18, 2016 ($1.65) we could raise up to approximately $4.5 million under our 2014 Universal Shelf. To raise capital, we may be required to seek other forms of transactions, including, for example, under a registration statement on Form S-1, the preparation and maintenance of which would be more time consuming and costly, or private placements, potentially with registration rights or priced at a discount to the market value of our stock, or other transactions, any of which could result in substantial equity dilution of stockholders’ interests. In addition, although we have regained compliance with the Minimum Bid Price Requirement of the Nasdaq Listing Rules, certain other Nasdaq listing requirements that require us to maintain a market capitalization of at least $35 million or stockholders’ equity of at least $2.5 million. If we fail to meet both of these requirements, we would receive another delisting notice from the Nasdaq Capital Market, which could further depress the value of our stock. In addition, to be able to raise sufficient capital to support our activities in the near term through public or private equity offerings, given our current per share market price, we may have to seek approval from our stockholders to increase the number of shares of common stock authorized for issuance under our Certificate of Incorporation. Moreover, if any such offering were to involve the issuance of common stock in excess of 20% of our outstanding common stock, we may be required under Nasdaq Listing Rules to seek stockholder approval before we can proceed. There can be no assurance that we would be successful in obtaining such approvals. Failure to secure the additional capital that we will need, whether from non-dilutive sources or from equity offerings, would have a material adverse impact on our business and our ability to continue as a going concern. We have in the past collaborated with research organizations and universities to assess the potential utility of our KL 4 An important priority for us is to identify potential strategic transactions, including without limitation strategic alliances and collaboration arrangements that would potentially provide additional capital to support our AEROSURF development activities and strategic resources to support the registration and commercial introduction of AEROSURF. We seek a significant strategic alliance partner that has broad experience, including local regulatory and product-development expertise and, if AEROSURF is approved, an ability to support the commercial introduction of AEROSURF in the EU and other selected markets outside the U.S. Such alliances typically also provide financial resources, in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses. We have engaged in discussions with potential counterparties and a number of these entities have expressed interest in AEROSURF and our KL 4 Our future capital requirements will depend upon many factors, including our efforts to (i) advance the AEROSURF development program to completion of the phase 2b clinical trials as planned; (ii) assure near- and long-term continuity of supply for our lyophilized KL 4 surfactant and ADS and related components with CMOs to support our clinical activities, (iv) develop our ADS for use in a planned phase 3 clinical program and, if approved, early commercial activities, (v) prepare for and conduct an AEROSURF phase 3 clinical program, which likely will be designed to enroll significantly more premature infants than our phase 2 clinical trials, and (vi) secure one or more strategic alliances or other collaboration arrangements to support our development programs and commercialization of our approved products, if any. There can be no assurance that our AEROSURF development program will be successful within our anticipated time frame, if at all; that we will be able to secure regulatory approval for AEROSURF and our other potential KL 4 surfactant product candidates in the U.S. and other markets; or that we will be successful in securing the capital we will require when needed. Failure to secure the necessary additional capital when needed could have a material adverse effect on our business, financial condition and results of operations Even if we succeed in our efforts and subsequently commercialize our products, we may never achieve sufficient sales revenue to achieve or maintain profitability. As of December 31, 2015, we had outstanding warrants to purchase approximately million shares of our common stock that are exercisable at various prices on different dates into 2024. This includes 4.8 million warrants issued in a July 2015 public offering with an exercise price of $9.80 per share, and 2.9 million pre-funded warrants, of which the entire purchase price was pre-paid upon issuance. Upon exercise of the pre-funded warrants, we would issue the shares to the holders and receive no additional proceeds. The accompanying financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. In the future, our ability to continue as a going concern is dependent on our ability to raise additional capital to fund our research and development programs and meet our obligations on a timely basis. If we are unable to secure the required additional capital, we will likely not have sufficient cash flows and liquidity to fund our business operations, which could significantly limit our ability to continue as a going concern. In that event, we may be forced to limit our development programs and consider other means of creating value for our stockholders, such as licensing the development and/or commercialization of products that we consider valuable and might otherwise plan to develop ourselves. If we are unable to raise the necessary capital, we may be forced to curtail all of our activities and, ultimately, cease operations. Even if we are able to secure additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline. Moreover, if we fail in the future to make any required payment under our Deerfield Loan or fail to comply with any commitments contained in the loan documents, Deerfield would be able to declare us in default regarding that indebtedness, which could result in the acceleration of the payment obligations under all or a portion of our indebtedness. Since we have pledged substantially all of our assets to secure our obligations under the Deerfield Loan, a debt default would enable the lenders to foreclose on our assets securing the debt and could significantly diminish the market value and marketability of our common stock. Our December 31, 2015 financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue in existence. As of December 31, 2015, 36 million shares of common stock and 5 million shares of preferred stock were authorized under our Certificate of Incorporation and approximately million shares of common stock and 5 million shares of preferred stock were available for issuance and not otherwise reserved |
Accounting Policies and Recent
Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies and Recent Accounting Pronouncements [Abstract] | |
Accounting Policies and Recent Accounting Pronouncements | Note 4 – Accounting Policies and Recent Accounting Pronouncements The consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the U. S. Consolidation The consolidated financial statements include all of the accounts of Discovery Laboratories, Inc. and its inactive subsidiary, Acute Therapeutics, Inc. All intercompany transactions and balances have been eliminated in consolidation. Use of estimates The preparation of financial statements, in conformity with accounting principles generally accepted in the U. S., requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and cash equivalents Cash and cash equivalents are held in U.S. banks and consist of liquid investments and money market funds with a maturity from date of purchase of 90 days or less that are readily convertible into cash . Fair value of financial instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying amount of cash equivalents is equal to their respective fair values at December 31, 2015 and 2014, respectively. Warrants classified as liabilities are recorded at their fair market value. Other financial instruments, including long-term debt, accounts payable and accrued expenses, are carried at cost, which we believe approximates fair value. Property and equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to ten years). Leasehold improvements are amortized over the shorter of the estimated useful lives or the remaining term of the lease. Repairs and maintenance costs are charged to expense as incurred. Restricted cash Restricted cash consists of a certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated May 26, 2004 and amended January 3, 2013 for our headquarters location in Warrington, Pennsylvania ( See, Long-lived assets Our long-lived assets, primarily consisting of equipment, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable, or its estimated useful life has changed significantly. When the undiscounted cash flows of an asset are less than its carrying value, an impairment is recorded and the asset is written down to estimated value. No impairment was recorded during the years ended December 31, 2015 and 2014 as management believes there are no circumstances that indicate the carrying amount of the assets will not be recoverable. In the second quarter of 2015, we closed the Totowa Facility and sold manufacturing equipment for total cash proceeds of $0.3 million, resulting in a $0.1 million loss from the sale and disposal of these assets. Grant revenue We recognize grant revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Research and development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred. Stock-based compensation Stock-based compensation is accounted for under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718, Stock Compensation Warrant accounting We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity See, Collaborative arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements Income taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. Net loss per common share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. For the years ended December 31, 2015 and 2014, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 9.1 million and 1.6 million shares, respectively. As of December 31, 2015, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. As of December 31, 2014, there were 1.2 million shares of common stock potentially issuable upon the exercise of stock options and warrants excluded from the computation of diluted net loss per common share because their impact would have been anti-dilutive. In accordance with ASC Topic 260, “Earnings per Share,” when calculating diluted net loss per common share, a gain associated with the decrease in the fair value of warrants classified as derivative liabilities results in an adjustment to the net loss; and the dilutive impact of the assumed exercise of these warrants results in an adjustment to the weighted average common shares outstanding. We utilize the treasury stock method to calculate the dilutive impact of the assumed exercise of warrants classified as derivative liabilities. For the year ended December 31, 2015, the effect of the adjustments for warrants classified as derivative liabilities was anti-dilutive. For the year ended December 31, 2014, the effect of the adjustments for warrants classified as derivative liabilities was dilutive. The table below provides information pertaining to the calculation of diluted net loss per common share for the periods presented: (in thousands) December 31, 2015 2014 Numerator: Net loss as reported $ (55,170 ) $ (44,058 ) Less: income from change in fair value of warrant liability (851 ) (3,791 ) Numerator for diluted net loss per common share $ (56,021 ) $ (47,849 ) Denominator: Basic weighted average common shares outstanding 6,967 6,078 Dilutive common shares from assumed warrant exercises – 67 Diluted weighted average common shares outstanding 6,967 6,145 We do not have any components of other comprehensive income (loss). Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL 4 surfactant drug products from single-source suppliers. In addition, 4 The loss of one or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations. Business segments We currently operate in one business segment, which is the research and development of products focused on surfactant therapies for respiratory disorders and diseases, and the manufacture and commercial sales of approved products. We are managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do not operate separate lines of business with respect to our product candidates. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers In August 2014, the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) Presentation of Financial Statements – Going Concern In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes and the adoption of this update is not expected to have a material effect on |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | Note 5 – Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows: · Level 1 – Quoted prices in active markets for identical assets and liabilities. · Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Fair Value on a Recurring Basis Assets and liabilities measured at fair value on a recurring basis are categorized in the table below as of December 31, 2015 and 2014: Fair Value Fair value measurement using (in thousands) December 31, 2015 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 38,722 $ 38,722 $ – $ – Certificate of deposit 225 225 – – Total Assets $ 38,947 $ 38,947 $ – $ – Liabilities: Common stock warrants $ 223 $ – $ – $ 223 Fair Value Fair value measurement using (in thousands) December 31, 2014 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 44,711 $ 44,711 $ – $ – Certificate of deposit 225 225 – – Total Assets $ 44,936 $ 44,936 $ – $ – Liabilities: Common stock warrants $ 1,258 $ – $ – $ 1,258 The following table summarizes changes in the fair value of the common stock warrants measured on a recurring basis using Level 3 inputs for 2015 and 2014: (in thousands) Balance at January 1, 2014 $ 5,425 Exercise of warrants (1) (376 ) Change in fair value of common stock warrant liability (3,791 ) Balance at December 31, 2014 $ 1,258 Exercise of warrants (1) (184 ) Change in fair value of common stock warrant liability (851 ) Balance at December 31, 2015 $ 223 (1) See, Note 8 – Common Stock Warrant Liability. The significant unobservable inputs used in the fair value measurement of the common stock warrants measured on a recurring basis are the historical volatility of our common stock market price, expected term of the applicable warrants, and the risk-free interest rate based on the U.S. Treasury yield curve in effect at the measurement date. In addition to the significant unobservable inputs noted above, certain fair value measurements also take into account an assumption of the likelihood and timing of the occurrence of an event that would result in an adjustment to the exercise price in accordance with the anti-dilutive pricing provisions in certain of the warrants. Any significant increases or decreases in the unobservable inputs, with the exception of the risk-free interest rate, may result in significantly higher or lower fair value measurements. Significant Unobservable Input December 31, Assumptions of Level 3 Valuations 2015 2014 Historical volatility 159 % 55% – 84 % Expected term (in years) 0.2 0.1 – 1.1 Risk-free interest rate 0.15 % 0.03% – 0.31 % Fair Value of Long-Term Debt At December 31, 2015, the estimated fair value of the Deerfield Loan ( see, Note 9 – Deerfield Loan) approximated the carrying value of $25.0 million. At December 31, 2014, the estimated fair value of the Deerfield Loan was $22.2 million compared to a carrying value, net of discounts, of $20.3 million. was based on discounting the future contractual cash flows to the present value at the valuation date Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment [Abstract] | |
Property and Equipment | Note 6 – Property and Equipment Property and equipment comprises the following: December 31, (in thousands) 2015 2014 Manufacturing, laboratory & office equipment $ 6,290 $ 9,154 Furniture & fixtures 778 817 Leasehold improvements 2,437 2,718 Subtotal 9,505 12,689 Accumulated depreciation and amortization (8,466 ) (11,052 ) Property and equipment, net $ 1,039 $ 1,637 Depreciation expense on property and equipment for the years ended December 31, 2015 and 2014 was $0.7 million and $0.8 million, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 7 – Accrued Expenses Accrued expenses are comprised of the following: December 31, (in thousands) 2015 2014 Salaries, bonus & benefits $ 2,387 $ 2,332 Research and development 3,254 1,641 Manufacturing operations 1,097 876 Professional fees 326 376 Sales and marketing – 318 Other 518 573 Total accrued expenses $ 7,582 $ 6,116 |
Common Stock Warrant Liability
Common Stock Warrant Liability | 12 Months Ended |
Dec. 31, 2015 | |
Common Stock Warrant Liability [Abstract] | |
Common Stock Warrant Liability | Note 8 – Common Stock Warrant Liability We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity On February 22, 2011, we issued registered warrants (2011 Warrants) that expired on February 22, 2016 and had a fair value at issuance of $8.0 million. As of December 31, 2015, there were 0.3 million warrant shares potentially issuable upon exercise of these warrants, with a fair value of $0.2 million. These warrants contained anti-dilution provisions that in certain circumstances would adjust the exercise price if we issued any common stock, securities convertible into common stock, or other securities (subject to certain exceptions) at a value below the then-existing exercise price of the warrants. Although by their express terms, these warrants were not subject to potential cash settlement, due to the nature of the anti-dilution provisions, they were classified as derivative liabilities and reported, at each balance sheet date, at estimated fair value determined using a trinomial pricing model. The exercise price of these warrants was adjusted downward to $2.66 per share at the time of the July 2015 public offering. During the year ended December 31, 2015, holders of the 2011 Warrants exercised warrants to purchase 51,193 shares of our common stock at an exercise price of $2.66 per share, resulting in proceeds to us of $0.1 million. During the year ended December 31, 2014, holders of the 2011 Warrants exercised warrants to purchase 20,346 shares of our common stock at an exercise price of $21.00 per share, resulting in proceeds to us of $0.4 million. Changes in the estimated fair value of warrants classified as derivative liabilities are reported in the accompanying Consolidated Statement of Operations as the “Change in fair value of common stock warrants.” |
Deerfield Loan
Deerfield Loan | 12 Months Ended |
Dec. 31, 2015 | |
Deerfield Loan [Abstract] | |
Deerfield Loan | Note 9 – Deerfield Loan Long-term debt consists solely of amounts due under a loan (Deerfield Loan) with affiliates of Deerfield Management Company, L.P. (Deerfield) for the periods presented: (in thousands) December 31, 2015 2014 Note payable $ 25,000 $ 30,000 Unamortized discount – (9,698 ) Long-term debt, net of discount $ 25,000 $ 20,302 Under the terms of the Deerfield loan agreement, Deerfield made two advances, the first upon execution of the agreement in February 2013 in the amount of $10 million, and the second upon the first commercial sale of SURFAXIN in December 2013 in the amount of $20 million. In connection with each advance, we paid Deerfield a transaction fee equal to 1.5% of the amount disbursed. The outstanding principal accrued interest at a rate of 8.75%, payable quarterly in cash. The Deerfield Loan agreement also contains customary terms and conditions, representations and warranties and affirmative and negative covenants, including restrictions on our ability to incur additional indebtedness and grant additional liens on our assets, but it does not require us to meet minimum financial and revenue performance covenants. In addition, all amounts outstanding under the Deerfield Loan may become immediately due and payable upon (i) an “Event of Default,” as defined in the Deerfield Loan agreement, including, among other things, the consummation of a change of control transaction or the sale of more than 50% of our assets (a Major Transaction). Upon execution of the Deerfield Loan, we issued to Deerfield warrants to purchase approximately 0.2 million shares of our common stock at an exercise price of $39.34 per share We initially recorded the loan as long-term debt at its face value of $30.0 million less debt discounts and issuance costs consisting of (i) $11.7 million fair value of the Deerfield Warrants issued upon the first advance and the second advance (0.5 million warrants in total), and (ii) a $450,000 transaction fee. The discount was being accreted to the $30 million loan over its term using the effective interest method. The Deerfield Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic 815 “Derivatives and Hedging – Contracts in Entity’s Own Equity” The fair value of the Deerfield Warrants at issuance was calculated using the Black-Scholes option-pricing model. The significant Level 3 unobservable inputs used in valuing the Deerfield Warrants are the historical volatility of our common stock market price, expected term of the warrants, and the risk-free interest rate based on the U.S. Treasury yield curve in effect at the measurement date. Any significant increases or decreases in the unobservable inputs, with the exception of the risk-free interest rate, would have resulted in a significantly higher or lower fair value measurement. Significant Unobservable Input Assumptions of Level 3 Valuations Historical volatility 101% Expected term (in years) 5.2 – 6.0 Risk-free interest rate 1.2% – 1.5% On July 9, 2015, we entered into an amendment to our Deerfield Loan agreement and related notes (Deerfield Notes) to better align our Deerfield Loan principal repayment obligations with anticipated milestones under our clinical development program for AEROSURF. Under the terms of the amendment, (i) upon execution, we prepaid in cash $2.5 million of the principal amounts outstanding, (ii) on July 22, 2015, upon the occurrence of the July 2015 public offering, we prepaid in cash an additional $2.5 million of the principal amounts outstanding, (iii) the principal installment originally due in February 2017 was eliminated and (iv) each of the principal payments due in February 2018 and February 2019 was increased to $12.5 million. We also paid Deerfield’s expenses (including reasonable counsel fees and expenses) incurred in connection with the amendment. Under the Deerfield Loan agreement, the $12.5 million principal installment due in February 2018 may be deferred one year if we achieve the market capitalization milestone set forth in the Deerfield Loan agreement. On July 22, 2015, we entered into a second amendment to our Deerfield Loan agreement and Deerfield Notes, pursuant to which (a) upon closing the July 2015 public offering on July 22, 2015, we prepaid in cash $2.5 million of the principal amounts outstanding, as contemplated by the first amendment, and (b) Deerfield purchased and accepted $5 million Series A and Series B units offered in our July 2015 public offering in satisfaction of $5 million of future interest payments due under the Deerfield Notes. In addition, (i) we paid in cash when due on September 30, 2015, all accrued and unpaid interest under the Deerfield Notes for the period from June 30, 2015 to July 22, 2015 at the original rate of 8.75%; (ii) Deerfield agreed to apply the $5 million prepaid interest accruing from and after July 23, 2015, as and when such payments are due and payable, as follows; first second The restructuring of the Deerfield Loan was accounted for as an extinguishment of debt in accordance with ASC Topic 470, Debt – Modifications and Extinguishments , and as a result, we have incurred an $11.8 million non-cash loss on debt extinguishment consisting the difference between the reacquisition price of the Deerfield Loan and the net carrying amount of the extinguished Deerfield Loan, which includes $4.1 million in fair value of the Series A and Series B warrants issued to Deerfield as part of the Series A and Series B units Deerfield agreed to purchase and accept in our July 2015 public offering in satisfaction of $5 million of future interest payments due under the Deerfield Notes. The following amounts comprise the Deerfield Loan interest expense for the periods presented: (in thousands) December 31, 2015 2014 Cash interest expense $ 1,451 $ 2,625 Non-cash amortization of debt discounts 1,287 1,948 Debt discount write-off 707 – Amortization of prepaid interest expense 971 – Amortization of debt costs 12 19 Write-off of debt costs 66 – Total Deerfield Loan interest expenses 4,494 $ 4,592 Cash interest expense represents interest at an annual rate of 8.75% on the outstanding principal amount for the period, paid in cash on a quarterly basis. Non-cash amortization of debt discount represents the amortization of transaction fees and the fair value of the Deerfield Warrants. Series A and Series B units Deerfield agreed to purchase and accept in our July 2015 public offering in satisfaction of $5 million of future interest payments due under the Deerfield Notes. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 10 – Stockholders’ Equity Registered Public Offerings On July 22, 2015, we completed a registered public offering of 1,791,667 Series A units and 3,000,000 Series B units each at a price per unit of $8.40, resulting in gross proceeds of $40.25 million ($37.6 million net after underwriting discount and expenses), including the exercise in full by the underwriters of their option to purchase up to an additional 625,000 Series A units at a price per unit of $8.40 to cover over-allotments. The proceeds included $5.0 million in non-cash consideration from Deerfield in the form of a reduction in future interest payments due under the Deerfield Loan ( see, At-the-Market Program (ATM Program) Stifel ATM Program On February 11, 2013, we entered into an At-the-Market Equity Sales Agreement (ATM Agreement) with Stifel, Nicolaus & Company, Incorporated (Stifel), under which Stifel, as our exclusive agent, at our discretion and at such times that we may determine from time to time, may sell over a three-year period up to a maximum of $25,000,000 of shares of our common stock (ATM Program). We are not required to sell any shares at any time during the term of the ATM Program If we issue a sale notice to Stifel, we may designate the minimum price per share at which shares may be sold and the maximum number of shares that Stifel is directed to sell during any selling period. As a result, prices are expected to vary as between purchasers and during the term of the offering. Stifel may sell the shares by any method deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, which may include ordinary brokers’ transactions on The Nasdaq Capital Market ® , or otherwise at market prices prevailing at the time of sale or prices related to such prevailing market prices, or as otherwise agreed by Stifel and us. Either party may suspend the offering under the ATM Agreement by notice to the other party The ATM Agreement, as amended on February 11, 2016, will terminate upon the earliest of: (1) the sale of all shares subject to the ATM Agreement, (2) February 11, 2019 or (3) the termination of the ATM Agreement in accordance with its terms. Either party may terminate the ATM Agreement at any time upon written notification to the other party in accordance with the ATM Agreement, and upon such termination, the offering will terminate. We agreed to pay Stifel a commission equal to 3.0% of the gross sales price of any shares sold pursuant to the ATM Agreement. With the exception of expenses related to the shares, Stifel will be responsible for all of its own costs and expenses incurred in connection with the offering. 401(k) Plan Employer Match We have a voluntary 401(k) savings plan (401(k) Plan) covering eligible employees that allows for periodic discretionary company matches equal to a percentage of each participant’s contributions (up to the maximum deduction allowed, excluding “catch up” amounts). We currently provide for the company match by issuing shares of common stock that are registered pursuant to a registration statement on Form S-8 filed with the U.S. Securities and Exchange Commission (SEC). For the years ended December 31, 2015 and 2014, the match resulted in the issuance of 94,114 and 42,371 shares of common stock, respectively. December 31, 2015 and 2014 Common Shares Reserved for Future Issuance Common shares reserved for potential future issuance upon exercise of warrants The chart below summarizes shares of our common stock reserved for future issuance upon the exercise of warrants: (in thousands, except price per share data) December 31, Exercise Price Expiration Date 2015 2014 Battelle – 2014 collaboration agreement (1) 107 107 $ 70.00 10/10/2024 Investors – July 2015 financing 4,792 – $ 9.80 07/22/2022 Investors – July 2015 financing (prefunded) 2,857 – – 07/22/2022 Deerfield – 2013 loan 500 500 $ 39.34 2/13/2019 Former employee 2 2 $ 44.80 3/18/2016 Investors – February 2011 financing 274 325 $ 2.66 2/22/2016 PharmaBio – October 2010 financing – 6 $ 57.40 10/13/2015 Investors – June 2010 financing – 85 $ 84.00 6/22/2015 Kingsbridge – June 2010 CEFF – 6 $ 93.66 12/11/2015 PharmaBio – April 2010 financing – 10 $ 148.26 4/30/2015 Investors – February 2010 financing – 66 $ 178.50 2/23/2015 Total 8,532 1,107 (1) See Note 12 for further details on the Battelle collaboration agreement Common shares reserved for potential future issuance upon exercise of stock options or granting of additional equity incentive awards As of December 31, 2015 and 2014, we had 0.4 million and 0.5 million shares, respectively, available for potential future issuance under the 2011 Long-Term Incentive Plan (the 2011 Plan). On January 21, 2016, at a Special Meeting of Stockholders, our stockholders authorized the issuance of an additional 1.1 million shares under the 2011 Long-Term Incentive Plan, which shares were registered on Form S-8 on January 27, 2016. Common shares reserved for potential future issuance under our 401(k) Plan As of December 31, 2015 and 2014, we had 4,567 and 438, respectively, reserved for potential future issuance under the 401(k) Plan. On October 27, 2015 the Board of Directors approved the issuance of 78,571 shares of c ommon stock that may be issued pursuant to our 401(k) Plan. These shares were registered on Form S-8 on January 6, 2016. |
Stock Options and Stock-based E
Stock Options and Stock-based Employee Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Stock Options and Stock-based Employee Compensation [Abstract] | |
Stock Options and Stock-based Employee Compensation | Note 11 – Stock Options and Stock-based Employee Compensation Long-Term Incentive Plans We have the 2011 Plan that provides for the grant of long-term equity and cash incentive compensation awards and replaced a 2007 Long-Term Incentive Plan (the 2007 Plan). Awards outstanding under the 2007 and an earlier 1998 Plan (expired) will continue to be governed by the terms of the plans and award agreements under which they were granted. Under the 2011 Plan, we may grant awards for up to 2.0 million shares of our common stock. Additionally, any shares returnable to the 2007 Plan as a result of cancellations, expirations and forfeitures will be returned to, and become available for issuance under, the 2011 Plan. Shares returnable to the 1998 Plan as a result of cancellations, expirations and forfeitures will not become available for issuance under the 1998 Plan or the 2011 Plan. Awards under the Plan may include stock options, stock appreciation rights (SARs), restricted stock awards (RSAs), restricted stock units, other performance and stock-based awards, and dividend equivalents. An administrative committee (the Committee – currently the Compensation Committee of the Board of Directors) or Committee delegates may determine the types, the number of shares covered by, and the terms and conditions of, such awards. Eligible participants may include any of our employees, directors, advisors or consultants. Stock options and restricted stock units (RSUs) outstanding and available for future issuance are as follows: December 31, 2015 2014 Stock Options and RSUs Outstanding 2011 Plan 493 437 2007 Plan 17 18 1998 Plan 12 13 Total Outstanding 522 468 Available for Future Grants under 2011 Plan 420 476 No SARs, RSAs, other performance and stock-based awards, or dividend equivalents have been granted under the 2011 Plan. A summary of activity under our long-term incentive plans is presented below: (in thousands, except for weighted-average data) Stock Options Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Outstanding at January 1, 2015 467 $ 63.04 Granted 185 15.64 Forfeited or expired (135 ) 42.81 Outstanding at December 31, 2015 517 $ 51.35 6.6 Vested and exercisable at December 31, 2015 294 $ 74.84 4.9 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Average Grant Date Fair Value Unvested at January 1, 2015 1 $ 23.94 Awarded 5 $ 6.72 Vested (1 ) $ 23.94 Unvested at December 31, 2015 5 $ 6.72 Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options granted during the years ended December 31, 2015 and 2014 was $10.48 and $25.48, respectively. The weighted-average grant-date fair value of RSUs granted during the years ended December 31, 2015 and 2014 was $6.72 and $23.94, respectively. The total intrinsic value of options outstanding, vested, and exercisable as of December 31, 2015 are each $0. Stock-Based Compensation We recognized stock-based compensation expense in accordance ASC Topic 718 for the years ended December 31, 2015 and 2014 of $1.7 million and $2.9 million, respectively. Stock-based compensation expense was classified as follows: December 31, (in thousands) 2015 2014 Research and development $ 642 $ 1,014 Selling, general and administrative 1,054 1,927 Total $ 1,696 $ 2,941 The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates within the valuation model. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant. December 31, 2015 2014 Weighted average expected volatility 83% 100% Weighted average expected term 5.5 years 5.4 years Weighted average risk-free interest rate 1.50% 1.65% Expected dividends – – The total fair value of the underlying shares of the options vested during 2015 and 2014 equals $2.7 million and $3.1 million, respectively. As of December 31, 2015, there was $1.9 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2011 Plan. That cost is expected to be recognized over a weighted-average vesting period of 1.8 years. |
Corporate Partnership, Licensin
Corporate Partnership, Licensing and Research Funding Agreements | 12 Months Ended |
Dec. 31, 2015 | |
Corporate Partnership, Licensing and Research Funding Agreements [Abstract] | |
Corporate Partnership, Licensing and Research Funding Agreements | Note 12 – Corporate Partnership, Licensing and Research Funding Agreements Licensing and Research Funding Agreements Battelle Memorial Institute In October 2014, we entered into a collaboration agreement with Battelle providing for the further development of our ADS for potential use in our planned phase 3 clinical program for AEROSURF for the treatment of RDS in premature infants and, if AEROSURF is approved for commercial sale by the FDA or other regulatory authority, initial commercial supply. Under our agreement, we and Battelle plan to design, develop, and complete the testing, verification, and documentation of an improved AEROSURF system, and share equally in the related development costs. These costs are recognized in research and development expense as incurred and were $3.1 million and $0.3 million for the years ended December 31, 2015 and 2014, respectively. In connection with the collaboration agreement, we issued to Battelle two warrants to purchase shares of our common stock, each having an exercise price of $70.00 per share and a term of 10 years, subject to earlier termination under certain circumstances set forth therein, including (i) a warrant to purchase up to 71,429 shares of our common stock, exercisable upon successful completion by Battelle of development activities described above (Initial Warrant), and (ii) a warrant to purchase up to 35,714 shares of our common stock (Additional Warrant; and together with the Initial Warrant, the Battelle Warrants), exercisable if and only if Battelle successfully completes the development activities no later than July 15, 2016, which date was adjusted, and may be further adjusted, as provided in the Collaboration Agreement. We and Battelle have agreed to execute a registration rights agreement providing for the registration of the resale of shares underlying the Battelle Warrants. The Battelle Warrants may be exercised for cash only, except that, in the event a registration statement is not effective at the time of exercise and if an exemption from registration is otherwise available at that time, the Battelle Warrants may be exercised on a cashless basis. The Battelle Warrants were issued pursuant to an exemption from registration contained in Regulation D, Rule 506. The Battelle Warrants are accounted for as equity instruments under the applicable accounting guidance of ASC Topic 815. If Battelle successfully completes their activities under the agreement, we have agreed to pay Battelle royalties equal to a low single-digit percentage of the worldwide net sales and license royalties on sales of AEROSURF for the treatment of RDS in premature infants, up to an aggregate limit of $25 million. Philip Morris USA Inc. and Philip Morris Products S.A. Under license agreements with Philip Morris USA Inc. (PMUSA) and Philip Morris Products S.A. (PMPSA), we hold exclusive worldwide licenses to the ADS technology for use with pulmonary surfactants (alone or in combination with any other pharmaceutical compound(s)) for all respiratory diseases and conditions (the foregoing uses in each territory, the Exclusive Field), and an exclusive license in the U.S. for use with certain non-surfactant drugs to treat a wide range of pediatric and adult respiratory indications in hospitals and other health care institutions. We generally are obligated to pay royalties at a rate equal to a low single-digit percent of sales of products sold in the Exclusive Field (as defined in the license agreements) in the territories, including sales of aerosol devices and related components that are not based on the capillary aerosolization technology (unless we exercise our right to terminate the license with respect to a specific indication). We also agreed to pay minimum royalties quarterly beginning in 2014, but are entitled to a reduction of future royalties in an amount equal to the excess of any minimum royalty paid over royalties actually earned in prior periods. We paid the minimum royalty of $400,000 and $300,000 in 2015 and 2014, respectively, related to these license agreements. Johnson & Johnson and Ortho Pharmaceutical Corporation We, Johnson & Johnson (J&J) and its wholly-owned subsidiary, Ortho Pharmaceutical Corporation, are parties to a license agreement granting to us an exclusive worldwide license to the J&J proprietary KL 4 Laboratorios del Dr. Esteve, S.A. We have a strategic alliance with Laboratorios del Dr. Esteve, S.A. (Esteve) for the development, marketing and sales of a broad portfolio of potential KL 4 4 4 |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2015 | |
Commitments [Abstract] | |
Commitments | Note 13 – Commitments Operating Leases Our operating leases consist primarily of facility leases for our operations in Pennsylvania and New Jersey. We maintain our headquarters in Warrington, Pennsylvania. The facility is 39,594 square feet and serves as the main operating facility for drug and device development, regulatory, analytical technical services, research and development, and administration. In January 2013, the lease was amended to extend the term an additional five years through February 2018. The total aggregate base rental payments remaining under the extended portion of the lease are approximately $2.0 million. Until June 30, 2015, we leased approximately 21,000 square feet of space for our manufacturing operations in Totowa, New Jersey (Totowa Facility), at an annual rent of $525,000. The lease for this facility, which was used to manufacture SURFAXIN drug product, expired on June 30, 2015 Rent expense under these leases was $1.0 million and $1.2 million for the years ended December 31, 2015 and 2014, respectively. Battelle Collaboration In accordance with terms of the Battelle agreement ( See, Restructuring Plan In April 2015, we implemented a restructuring plan to voluntarily cease the commercialization of SURFAXIN and focus our resources on the development of our aerosolized KL 4 The total severance cost for all impacted employees is $2.9 million, of which $1.0 million was accrued as of December 31, 2014 for Totowa employees. The remaining $1.9 million was charged to expense 2015 ($1.0 million to research and development expenses and $0.9 million to selling, general and administrative expenses). We paid $2.6 million of the severance and retention benefits during 2015. The remaining $0.3 million will be paid through June 30, 2016. |
Litigation
Litigation | 12 Months Ended |
Dec. 31, 2015 | |
Litigation [Abstract] | |
Litigation | Note 14 – Litigation We are not aware of any pending or threatened legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations. We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes [Abstract] | |
Income Taxes | Note 15 – Income Taxes Since our inception, we have never recorded a provision or benefit for Federal and state income taxes. The reconciliation of the income tax benefit computed at the Federal statutory rates to our recorded tax benefit for the years ended December 31, 2015 and 2014 is as follows: (in thousands) December 31, 2015 2014 Income tax benefit, statutory rates $ 18,758 $ 14,980 State taxes on income, net of Federal benefit 3,760 2,871 Research and development tax credit 1,047 1,472 Employee related (340 ) (2,131 ) Warrant valuation related 289 1,289 Income tax benefit 23,514 18,481 Valuation allowance (23,514 ) (18,481 ) Income tax benefit $ – $ – The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at December 31, 2015 and 2014, are as follows: (in thousands) December 31, 2015 2014 Long-term deferred tax assets: Net operating loss carryforwards (Federal and state) $ 218,203 $ 191,643 Research and development tax credits 13,917 12,927 Compensation expense on stock 2,776 2,588 Charitable contribution carryforward 6 7 Inventory reserve – 907 Deferred revenue – 16 Other accrued 469 1,088 Depreciation 482 2,630 Capitalized research and development – 1,123 Total long-term deferred tax assets 235,853 212,929 Less: valuation allowance (235,853 ) (212,929 ) Deferred tax assets, net of valuation allowance $ – $ – We are in a net deferred tax asset position at December 31, 2015 and 2014 before the consideration of a valuation allowance. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. It is our policy to classify interest and penalties recognized on uncertain tax positions as a component of income tax expense. There was neither interest nor penalties accrued as of December 31, 2015 or 2014, nor were any incurred in 2015 or 2014. At December 31, 2015 and 2014, we had available carryforward net operating losses for Federal tax purposes of $540.2 million and $473.3 million, respectively, and a research and development tax credit carryforward of $13.9 million and $12.9 million, respectively. The Federal net operating loss and research and development tax credit carryforwards will continue to expire through 2035. At December 31, 2015, we had available carryforward Federal and State net operating losses of $5.2 million and $0.4 million, respectively, related to stock-based compensation, the tax effect of which will result in a credit to equity as opposed to income tax expense, to the extent these losses are utilized in the future. At December 31, 2015 and 2014, we had available carryforward losses of approximately $527.1 million and $470.4 million, respectively, for state tax purposes. Of the $527.1 million state tax carryforward losses, $503.7 million is associated with the state of Pennsylvania, with the remainder associated with the other 10 states within which we have established tax nexus. Utilization of net operating loss (NOL) and research and development (R&D) credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. There also could be additional ownership changes in the future, which may result in additional limitations in the utilization of the carryforward NOLs and credits. A full valuation allowance has been provided against our research and development credits and, if a future assessment requires an adjustment, an adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheet or statement of operations if an adjustment were required. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Selected Quarterly Financial Data (Unaudited) [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | Note 16 – Selected Quarterly Financial Data (Unaudited) The following tables contain unaudited statement of operations information for each quarter of 2015 and 2014. The operating results for any quarter are not necessarily indicative of results for any future period. 2015 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Product sales $ 7 $ – $ – $ – $ 7 Grant revenues 184 75 66 655 980 Total revenues 191 75 66 655 987 Expenses: Cost of sales 929 – – – 929 Research and development 7,082 7,129 6,452 8,225 28,888 Selling, General and administrative 3,353 3,383 2,057 2,211 11,004 Total expenses 11,364 10,512 8,509 10,436 40,821 Operating loss (11,173 ) (10,437 ) (8,443 ) (9,781 ) (39,834 ) Change in fair value of common stock warrant liability (31 ) 469 139 274 851 Other expense, net (975 ) (1,358 ) (13,252 ) (602 ) (16,187 ) Net loss $ (12,179 ) $ (11,326 ) $ (21,556 ) $ (10,109 ) $ (55,170 ) Net loss per common share - basic $ (1.96 ) $ (1.82 ) $ (2.80 ) $ (1.26 ) $ (7.98 ) Net loss per common share - diluted $ (1.96 ) $ (1.82 ) $ (2.80 ) $ (1.26 ) $ (7.98 ) Weighted average number of common shares outstanding - basic 6,114 6,125 7,550 8,050 6,967 Weighted average number of common shares outstanding - diluted 6,114 6,125 7,550 8,050 6,967 2014 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Product sales $ 28 $ 42 $ 106 $ 136 $ 312 Grant revenues 3 1,051 421 1,048 2,523 Total revenues 31 1,093 527 1,184 2,835 Expenses: Cost of sales 781 731 257 902 2,671 Research and development 5,590 6,858 6,471 7,771 26,690 Selling, General and administrative 4,423 4,446 4,126 3,737 16,732 Total expenses 10,794 12,035 10,854 12,410 46,093 Operating loss (10,763 ) (10,942 ) (10,327 ) (11,226 ) (43,258 ) Change in fair value of common stock warrant liability 378 1,448 173 1,792 3,791 Other expense, net (1,091 ) (1,129 ) (1,170 ) (1,201 ) (4,591 ) Net loss $ (11,476 ) $ (10,623 ) $ (11,324 ) $ (10,635 ) $ (44,058 ) Net loss per common share - basic $ (1.96 ) $ (1.68 ) $ (1.82 ) $ (1.68 ) $ (7.28 ) Net loss per common share - diluted $ (1.96 ) $ (1.96 ) $ (1.82 ) $ (2.10 ) $ (7.84 ) Weighted average number of common shares outstanding - basic 6,052 6,076 6,086 6,097 6,078 Weighted average number of common shares outstanding - diluted 6,052 6,134 6,086 6,111 6,145 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 17 Subsequent Events We evaluated all events or transactions that occurred after December 31, 2015 through the date we issued these financial statements. During this period, we noted two subsequent events as described below: Share Consolidation On January 21, 2016, at a Special Meeting of Stockholders, our stockholders approved proposals authorizing the Board of Directors, in its discretion, to implement a reverse split based on an exchange ratio in a designated range and to reduce the number of authorized shares of common stock at one half the exchange ratio implemented for the reverse split. We filed a Certificate of Amendment to our Certificate of Incorporation to (i) effect a share consolidation, or reverse split, of the common stock, par value $0.001 per share, at a ratio of 1-for-14, effective at 12:01 a.m. on January 22, 2016, and (ii) reduce the number of authorized shares of common stock under our Certificate of Incorporation from 250 million to 36 million. Because the Amendment did not reduce the number of authorized shares of common stock in the same proportion as the reverse split, the Amendment had the effect of increasing the amount of common stock available for issuance relative to the amount of common stock available for issuance prior to the Amendment. Further, any warrants, options, restricted stock units and rights outstanding as of the effective date that were subject to adjustment were adjusted in accordance with the terms thereof. Those adjustments may have included, without limitation, changes to the number of shares of common stock that may be obtained upon exercise or conversion of these securities, and changes to the applicable exercise or purchase price. The stockholders also approved the issuance of an additional 1.1 million shares under the 2011 Long-Term Incentive Plan. Executive Severance On February 1, 2016, the Company announced the appointment of Craig Fraser to serve as our President and Chief Executive Officer, effective February 1, 2016. Upon recommendation of the Nomination and Governance Committee of our Board of Directors also appointed Mr. Fraser to serve as a member of the Board, effective immediately. In connection with the foregoing, effective February 1, 2016, we terminated the Employment Agreement of our then President and Chief Executive Officer (the Former CEO). In connection therewith, upon execution by the Former CEO of a plenary release in form satisfactory to us, he became entitled under his Employment Agreement to the following severance and other benefits, in addition to any vested benefits under our company plans or policies: (i) a pro rata bonus equal to a percentage of his Annual Bonus Amount determined by dividing the aggregate bonuses paid to other contract executives for the year 2016 by the aggregate target bonuses of such other contract executives for 2016, and further prorated for the number of days the Former CEO was employed during 2016, payable at the time that other contract executives are paid bonuses with respect to 2016; (ii) a severance amount equal to the sum of the Former CEO’s base salary then in effect and his Annual Bonus Amount, payable in equal installments through August 1, 2017 (the Severance Period); and (iii) all stock options held by the Former CEO will continue to vest during the Severance Period, and continue to be exercisable for up to 36 months after the date of termination. From and after the end of the Severance Period, the Former CEO will forfeit all of his unvested stock options in accordance with the terms of the 2011 Plan. The Former CEO also is subject to non-competition and non-solicitation restrictions for 12 months and 18 months, respectively, after the date of termination under a separate confidentiality agreement. All of our obligations under the Employment Agreement will cease if at any time during the Severance Period the Former CEO engages in a material breach of the Employment Agreement and fails to cure such breach within five business days after receipt from us of notice of such breach. |
Accounting Policies and Recen24
Accounting Policies and Recent Accounting Pronouncements (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies and Recent Accounting Pronouncements [Abstract] | |
Consolidation | Consolidation The consolidated financial statements include all of the accounts of Discovery Laboratories, Inc. and its inactive subsidiary, Acute Therapeutics, Inc. All intercompany transactions and balances have been eliminated in consolidation. |
Use of estimates | Use of estimates The preparation of financial statements, in conformity with accounting principles generally accepted in the U. S., requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and cash equivalents | Cash and cash equivalents Cash and cash equivalents are held in U.S. banks and consist of liquid investments and money market funds with a maturity from date of purchase of 90 days or less that are readily convertible into cash . |
Fair value of financial instruments | Fair value of financial instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying amount of cash equivalents is equal to their respective fair values at December 31, 2015 and 2014, respectively. Warrants classified as liabilities are recorded at their fair market value. Other financial instruments, including long-term debt, accounts payable and accrued expenses, are carried at cost, which we believe approximates fair value. |
Property and equipment | Property and equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to ten years). Leasehold improvements are amortized over the shorter of the estimated useful lives or the remaining term of the lease. Repairs and maintenance costs are charged to expense as incurred. |
Restricted cash | Restricted cash Restricted cash consists of a certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated May 26, 2004 and amended January 3, 2013 for our headquarters location in Warrington, Pennsylvania ( See, |
Long-lived assets | Long-lived assets Our long-lived assets, primarily consisting of equipment, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable, or its estimated useful life has changed significantly. When the undiscounted cash flows of an asset are less than its carrying value, an impairment is recorded and the asset is written down to estimated value. No impairment was recorded during the years ended December 31, 2015 and 2014 as management believes there are no circumstances that indicate the carrying amount of the assets will not be recoverable. In the second quarter of 2015, we closed the Totowa Facility and sold manufacturing equipment for total cash proceeds of $0.3 million, resulting in a $0.1 million loss from the sale and disposal of these assets. |
Grant revenue | Grant revenue We recognize grant revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. |
Research and development | Research and development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred. |
Stock-based compensation | Stock-based compensation Stock-based compensation is accounted for under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718, Stock Compensation |
Warrant accounting | Warrant accounting We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity See, |
Collaborative arrangements | Collaborative arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements |
Income taxes | Income taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. |
Net loss per common share | Net loss per common share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. For the years ended December 31, 2015 and 2014, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 9.1 million and 1.6 million shares, respectively. As of December 31, 2015, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. As of December 31, 2014, there were 1.2 million shares of common stock potentially issuable upon the exercise of stock options and warrants excluded from the computation of diluted net loss per common share because their impact would have been anti-dilutive. In accordance with ASC Topic 260, “Earnings per Share,” when calculating diluted net loss per common share, a gain associated with the decrease in the fair value of warrants classified as derivative liabilities results in an adjustment to the net loss; and the dilutive impact of the assumed exercise of these warrants results in an adjustment to the weighted average common shares outstanding. We utilize the treasury stock method to calculate the dilutive impact of the assumed exercise of warrants classified as derivative liabilities. For the year ended December 31, 2015, the effect of the adjustments for warrants classified as derivative liabilities was anti-dilutive. For the year ended December 31, 2014, the effect of the adjustments for warrants classified as derivative liabilities was dilutive. The table below provides information pertaining to the calculation of diluted net loss per common share for the periods presented: (in thousands) December 31, 2015 2014 Numerator: Net loss as reported $ (55,170 ) $ (44,058 ) Less: income from change in fair value of warrant liability (851 ) (3,791 ) Numerator for diluted net loss per common share $ (56,021 ) $ (47,849 ) Denominator: Basic weighted average common shares outstanding 6,967 6,078 Dilutive common shares from assumed warrant exercises – 67 Diluted weighted average common shares outstanding 6,967 6,145 We do not have any components of other comprehensive income (loss). |
Concentration of Suppliers | Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL 4 surfactant drug products from single-source suppliers. In addition, 4 The loss of one or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations. |
Business segments | Business segments We currently operate in one business segment, which is the research and development of products focused on surfactant therapies for respiratory disorders and diseases, and the manufacture and commercial sales of approved products. We are managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do not operate separate lines of business with respect to our product candidates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers In August 2014, the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) Presentation of Financial Statements – Going Concern In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes and the adoption of this update is not expected to have a material effect on |
Accounting Policies and Recen25
Accounting Policies and Recent Accounting Pronouncements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies and Recent Accounting Pronouncements [Abstract] | |
Calculation of diluted net loss per common share | The table below provides information pertaining to the calculation of diluted net loss per common share for the periods presented: (in thousands) December 31, 2015 2014 Numerator: Net loss as reported $ (55,170 ) $ (44,058 ) Less: income from change in fair value of warrant liability (851 ) (3,791 ) Numerator for diluted net loss per common share $ (56,021 ) $ (47,849 ) Denominator: Basic weighted average common shares outstanding 6,967 6,078 Dilutive common shares from assumed warrant exercises – 67 Diluted weighted average common shares outstanding 6,967 6,145 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements [Abstract] | |
Assets and liabilities measured at fair value | Assets and liabilities measured at fair value on a recurring basis are categorized in the table below as of December 31, 2015 and 2014: Fair Value Fair value measurement using (in thousands) December 31, 2015 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 38,722 $ 38,722 $ – $ – Certificate of deposit 225 225 – – Total Assets $ 38,947 $ 38,947 $ – $ – Liabilities: Common stock warrants $ 223 $ – $ – $ 223 Fair Value Fair value measurement using (in thousands) December 31, 2014 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 44,711 $ 44,711 $ – $ – Certificate of deposit 225 225 – – Total Assets $ 44,936 $ 44,936 $ – $ – Liabilities: Common stock warrants $ 1,258 $ – $ – $ 1,258 |
Common stock warrants measured at Level 3 inputs on recurring basis | The following table summarizes changes in the fair value of the common stock warrants measured on a recurring basis using Level 3 inputs for 2015 and 2014: (in thousands) Balance at January 1, 2014 $ 5,425 Exercise of warrants (1) (376 ) Change in fair value of common stock warrant liability (3,791 ) Balance at December 31, 2014 $ 1,258 Exercise of warrants (1) (184 ) Change in fair value of common stock warrant liability (851 ) Balance at December 31, 2015 $ 223 (1) See, Note 8 – Common Stock Warrant Liability. |
Significant unobservable input assumption used for valuation | Any significant increases or decreases in the unobservable inputs, with the exception of the risk-free interest rate, may result in significantly higher or lower fair value measurements. Significant Unobservable Input December 31, Assumptions of Level 3 Valuations 2015 2014 Historical volatility 159 % 55% – 84 % Expected term (in years) 0.2 0.1 – 1.1 Risk-free interest rate 0.15 % 0.03% – 0.31 % |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment [Abstract] | |
Property and equipment | Property and equipment comprises the following: December 31, (in thousands) 2015 2014 Manufacturing, laboratory & office equipment $ 6,290 $ 9,154 Furniture & fixtures 778 817 Leasehold improvements 2,437 2,718 Subtotal 9,505 12,689 Accumulated depreciation and amortization (8,466 ) (11,052 ) Property and equipment, net $ 1,039 $ 1,637 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses [Abstract] | |
Accrued expenses | Accrued expenses are comprised of the following: December 31, (in thousands) 2015 2014 Salaries, bonus & benefits $ 2,387 $ 2,332 Research and development 3,254 1,641 Manufacturing operations 1,097 876 Professional fees 326 376 Sales and marketing – 318 Other 518 573 Total accrued expenses $ 7,582 $ 6,116 |
Deerfield Loan (Tables)
Deerfield Loan (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Deerfield Loan [Abstract] | |
Long term debt included in balance sheet | Long-term debt consists solely of amounts due under a loan (Deerfield Loan) with affiliates of Deerfield Management Company, L.P. (Deerfield) for the periods presented: (in thousands) December 31, 2015 2014 Note payable $ 25,000 $ 30,000 Unamortized discount – (9,698 ) Long-term debt, net of discount $ 25,000 $ 20,302 |
Significant unobservable input assumptions of Level 3 valuations | Any significant increases or decreases in the unobservable inputs, with the exception of the risk-free interest rate, would have resulted in a significantly higher or lower fair value measurement. Significant Unobservable Input Assumptions of Level 3 Valuations Historical volatility 101% Expected term (in years) 5.2 – 6.0 Risk-free interest rate 1.2% – 1.5% |
Interest expense included in statement of operations | The following amounts comprise the Deerfield Loan interest expense for the periods presented: (in thousands) December 31, 2015 2014 Cash interest expense $ 1,451 $ 2,625 Non-cash amortization of debt discounts 1,287 1,948 Debt discount write-off 707 – Amortization of prepaid interest expense 971 – Amortization of debt costs 12 19 Write-off of debt costs 66 – Total Deerfield Loan interest expenses 4,494 $ 4,592 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity [Abstract] | |
Common shares reserved for future issuance, warrants | The chart below summarizes shares of our common stock reserved for future issuance upon the exercise of warrants: (in thousands, except price per share data) December 31, Exercise Price Expiration Date 2015 2014 Battelle – 2014 collaboration agreement (1) 107 107 $ 70.00 10/10/2024 Investors – July 2015 financing 4,792 – $ 9.80 07/22/2022 Investors – July 2015 financing (prefunded) 2,857 – – 07/22/2022 Deerfield – 2013 loan 500 500 $ 39.34 2/13/2019 Former employee 2 2 $ 44.80 3/18/2016 Investors – February 2011 financing 274 325 $ 2.66 2/22/2016 PharmaBio – October 2010 financing – 6 $ 57.40 10/13/2015 Investors – June 2010 financing – 85 $ 84.00 6/22/2015 Kingsbridge – June 2010 CEFF – 6 $ 93.66 12/11/2015 PharmaBio – April 2010 financing – 10 $ 148.26 4/30/2015 Investors – February 2010 financing – 66 $ 178.50 2/23/2015 Total 8,532 1,107 (1) See Note 12 for further details on the Battelle collaboration agreement |
Stock Options and Stock-based31
Stock Options and Stock-based Employee Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stock Options and Stock-based Employee Compensation [Abstract] | |
Stock options and restricted stock units (RSUs) outstanding and available for future issuance | Stock options and restricted stock units (RSUs) outstanding and available for future issuance are as follows: December 31, 2015 2014 Stock Options and RSUs Outstanding 2011 Plan 493 437 2007 Plan 17 18 1998 Plan 12 13 Total Outstanding 522 468 Available for Future Grants under 2011 Plan 420 476 |
Summary of stock option activity | A summary of activity under our long-term incentive plans is presented below: (in thousands, except for weighted-average data) Stock Options Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Outstanding at January 1, 2015 467 $ 63.04 Granted 185 15.64 Forfeited or expired (135 ) 42.81 Outstanding at December 31, 2015 517 $ 51.35 6.6 Vested and exercisable at December 31, 2015 294 $ 74.84 4.9 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Average Grant Date Fair Value Unvested at January 1, 2015 1 $ 23.94 Awarded 5 $ 6.72 Vested (1 ) $ 23.94 Unvested at December 31, 2015 5 $ 6.72 |
Employee stock-based compensation | Stock-based compensation expense was classified as follows: December 31, (in thousands) 2015 2014 Research and development $ 642 $ 1,014 Selling, general and administrative 1,054 1,927 Total $ 1,696 $ 2,941 |
Weighted-average assumptions in estimating fair value of options | The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant. December 31, 2015 2014 Weighted average expected volatility 83% 100% Weighted average expected term 5.5 years 5.4 years Weighted average risk-free interest rate 1.50% 1.65% Expected dividends – – |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes [Abstract] | |
Schedule of effective income tax rate reconciliation | The reconciliation of the income tax benefit computed at the Federal statutory rates to our recorded tax benefit for the years ended December 31, 2015 and 2014 is as follows: (in thousands) December 31, 2015 2014 Income tax benefit, statutory rates $ 18,758 $ 14,980 State taxes on income, net of Federal benefit 3,760 2,871 Research and development tax credit 1,047 1,472 Employee related (340 ) (2,131 ) Warrant valuation related 289 1,289 Income tax benefit 23,514 18,481 Valuation allowance (23,514 ) (18,481 ) Income tax benefit $ – $ – |
Schedule of deferred tax assets and liabilities | The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at December 31, 2015 and 2014, are as follows: (in thousands) December 31, 2015 2014 Long-term deferred tax assets: Net operating loss carryforwards (Federal and state) $ 218,203 $ 191,643 Research and development tax credits 13,917 12,927 Compensation expense on stock 2,776 2,588 Charitable contribution carryforward 6 7 Inventory reserve – 907 Deferred revenue – 16 Other accrued 469 1,088 Depreciation 482 2,630 Capitalized research and development – 1,123 Total long-term deferred tax assets 235,853 212,929 Less: valuation allowance (235,853 ) (212,929 ) Deferred tax assets, net of valuation allowance $ – $ – |
Selected Quarterly Financial 33
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Selected Quarterly Financial Data (Unaudited) [Abstract] | |
Schedule of quarterly financial information | The following tables contain unaudited statement of operations information for each quarter of 2015 and 2014. The operating results for any quarter are not necessarily indicative of results for any future period. 2015 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Product sales $ 7 $ – $ – $ – $ 7 Grant revenues 184 75 66 655 980 Total revenues 191 75 66 655 987 Expenses: Cost of sales 929 – – – 929 Research and development 7,082 7,129 6,452 8,225 28,888 Selling, General and administrative 3,353 3,383 2,057 2,211 11,004 Total expenses 11,364 10,512 8,509 10,436 40,821 Operating loss (11,173 ) (10,437 ) (8,443 ) (9,781 ) (39,834 ) Change in fair value of common stock warrant liability (31 ) 469 139 274 851 Other expense, net (975 ) (1,358 ) (13,252 ) (602 ) (16,187 ) Net loss $ (12,179 ) $ (11,326 ) $ (21,556 ) $ (10,109 ) $ (55,170 ) Net loss per common share - basic $ (1.96 ) $ (1.82 ) $ (2.80 ) $ (1.26 ) $ (7.98 ) Net loss per common share - diluted $ (1.96 ) $ (1.82 ) $ (2.80 ) $ (1.26 ) $ (7.98 ) Weighted average number of common shares outstanding - basic 6,114 6,125 7,550 8,050 6,967 Weighted average number of common shares outstanding - diluted 6,114 6,125 7,550 8,050 6,967 2014 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Product sales $ 28 $ 42 $ 106 $ 136 $ 312 Grant revenues 3 1,051 421 1,048 2,523 Total revenues 31 1,093 527 1,184 2,835 Expenses: Cost of sales 781 731 257 902 2,671 Research and development 5,590 6,858 6,471 7,771 26,690 Selling, General and administrative 4,423 4,446 4,126 3,737 16,732 Total expenses 10,794 12,035 10,854 12,410 46,093 Operating loss (10,763 ) (10,942 ) (10,327 ) (11,226 ) (43,258 ) Change in fair value of common stock warrant liability 378 1,448 173 1,792 3,791 Other expense, net (1,091 ) (1,129 ) (1,170 ) (1,201 ) (4,591 ) Net loss $ (11,476 ) $ (10,623 ) $ (11,324 ) $ (10,635 ) $ (44,058 ) Net loss per common share - basic $ (1.96 ) $ (1.68 ) $ (1.82 ) $ (1.68 ) $ (7.28 ) Net loss per common share - diluted $ (1.96 ) $ (1.96 ) $ (1.82 ) $ (2.10 ) $ (7.84 ) Weighted average number of common shares outstanding - basic 6,052 6,076 6,086 6,097 6,078 Weighted average number of common shares outstanding - diluted 6,052 6,134 6,086 6,111 6,145 |
Basis of Presentation (Details)
Basis of Presentation (Details) | Jan. 22, 2016 |
Subsequent Event [Member] | |
Basis of Presentation [Line Items] | |
Reverse stock split ratio | 14 |
Liquidity Risks and Managemen35
Liquidity Risks and Management's Plans (Details) $ / shares in Units, $ in Thousands | Mar. 18, 2016USD ($)$ / shares | Dec. 31, 2015USD ($)Installment | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Liquidity Risks and Management's Plans [Abstract] | ||||
Cash and cash equivalents | $ 38,722 | $ 44,711 | $ 86,283 | |
Current accounts payable and accrued expenses | 10,800 | |||
Long-term debt, gross | $ 25,000 | 30,000 | ||
Number of principal debt repayment installments | Installment | 2 | |||
Stockholders' Equity [Line Items] | ||||
Stockholders equity | $ 8,266 | $ 19,199 | $ 58,501 | |
Excess percentage of common stock issued to acquire additional capital | 20.00% | |||
Minimum [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Future substantial losses expected over the period | 4 years | |||
Maximum [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Future substantial losses expected over the period | 5 years | |||
ATM Program [Member] | Subsequent Event [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Value of equity securities held by non affiliates and entities | $ 13,400 | |||
Maximum public float considered for primary securities offerings | $ 75,000 | |||
Period consider for maximum public float | 12 months | |||
Market price of common stock (in dollars per share) | $ / shares | $ 1.65 | |||
Maximum amount can be raised from public offerings | $ 4,500 | |||
ATM Program [Member] | Minimum [Member] | Subsequent Event [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Market capitalization | 35,000 | |||
Stockholders equity | $ 2,500 |
Liquidity Risks and Managemen36
Liquidity Risks and Management's Plans, Warrants (Details) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Class of Warrant or Right [Line Items] | ||
Exercise price of warrants (in dollars per share) | $ 39.34 | |
Number of warrant shares issuable (in shares) | 8,500,000 | |
Common stock, shares authorized (in shares) | 36,000,000 | |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Common stock available for future issuance (in shares) | 18,300,000 | |
Preferred stock reserved for future issuance (in shares) | 5,000,000 | |
July 2015 Public Offering [Member] | ||
Class of Warrant or Right [Line Items] | ||
Exercise price of warrants (in dollars per share) | $ 9.80 | |
Number of warrants issued (in shares) | 4,800,000 | |
Prefunded Warrants [Member] | July 2015 Public Offering [Member] | ||
Class of Warrant or Right [Line Items] | ||
Number of warrants issued (in shares) | 2,900,000 |
Accounting Policies and Recen37
Accounting Policies and Recent Accounting Pronouncements (Details) shares in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2015USD ($)shares | Sep. 30, 2015USD ($)shares | Jun. 30, 2015USD ($)shares | Mar. 31, 2015USD ($)shares | Dec. 31, 2014USD ($)shares | Sep. 30, 2014USD ($)shares | Jun. 30, 2014USD ($)shares | Mar. 31, 2014USD ($)shares | Dec. 31, 2015USD ($)Segmentshares | Dec. 31, 2014USD ($)shares | |
Long-lived assets [Abstract] | ||||||||||
Impairment of long-lived assets | $ 0 | $ 0 | ||||||||
Proceeds from sale of property and equipment | $ 300,000 | 270,000 | 0 | |||||||
Loss from sale and disposal of long-lived assets | 100,000 | (84,000) | 0 | |||||||
Numerator [Abstract] | ||||||||||
Net loss as reported | $ (10,109,000) | $ (21,556,000) | $ (11,326,000) | $ (12,179,000) | $ (10,635,000) | $ (11,324,000) | $ (10,623,000) | $ (11,476,000) | (55,170,000) | (44,058,000) |
Less: income from change in fair value of warrant liability | (851,000) | (3,791,000) | ||||||||
Numerator for diluted net loss per common share | $ (56,021,000) | $ (47,849,000) | ||||||||
Denominator [Abstract] | ||||||||||
Basic weighted average common shares outstanding (in shares) | shares | 8,050 | 7,550 | 6,125 | 6,114 | 6,097 | 6,086 | 6,076 | 6,052 | 6,967 | 6,078 |
Dilutive common shares from assumed warrant exercises (in shares) | shares | 0 | 67 | ||||||||
Diluted weighted average common shares outstanding (in shares) | shares | 8,050 | 7,550 | 6,125 | 6,114 | 6,111 | 6,086 | 6,134 | 6,052 | 6,967 | 6,145 |
Number of shares of common stock potentially issuable upon the exercise of stock options and warrants (in shares) | shares | 9,100 | 1,600 | ||||||||
Potential common stock issuable upon exercise of stock options and warrants (in shares) | shares | 1,200 | |||||||||
Business segments [Abstract] | ||||||||||
Number of operating segments | Segment | 1 | |||||||||
Minimum [Member] | ||||||||||
Property and equipment [Line Items] | ||||||||||
Estimated useful life of property and equipment | 3 years | |||||||||
Maximum [Member] | ||||||||||
Property and equipment [Line Items] | ||||||||||
Estimated useful life of property and equipment | 10 years |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Liabilities [Abstract] | ||
Fair value of loan | $ 25,000 | $ 22,200 |
Long-Term Debt | 25,000 | 20,302 |
Recurring [Member] | ||
Assets [Abstract] | ||
Fair Value | 38,947 | 44,936 |
Recurring [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Fair Value | 38,947 | 44,936 |
Recurring [Member] | Level 2 [Member] | ||
Assets [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Level 3 [Member] | ||
Assets [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Cash and cash equivalents [Member] | ||
Assets [Abstract] | ||
Fair Value | 38,722 | 44,711 |
Recurring [Member] | Cash and cash equivalents [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Fair Value | 38,722 | 44,711 |
Recurring [Member] | Cash and cash equivalents [Member] | Level 2 [Member] | ||
Assets [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Cash and cash equivalents [Member] | Level 3 [Member] | ||
Assets [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Certificate of Deposit [Member] | ||
Assets [Abstract] | ||
Fair Value | 225 | 225 |
Recurring [Member] | Certificate of Deposit [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Fair Value | 225 | 225 |
Recurring [Member] | Certificate of Deposit [Member] | Level 2 [Member] | ||
Assets [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Certificate of Deposit [Member] | Level 3 [Member] | ||
Assets [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Common Stock Warrant [Member] | ||
Liabilities [Abstract] | ||
Fair Value | 223 | 1,258 |
Recurring [Member] | Common Stock Warrant [Member] | Level 1 [Member] | ||
Liabilities [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Common Stock Warrant [Member] | Level 2 [Member] | ||
Liabilities [Abstract] | ||
Fair Value | 0 | 0 |
Recurring [Member] | Common Stock Warrant [Member] | Level 3 [Member] | ||
Liabilities [Abstract] | ||
Fair Value | $ 223 | $ 1,258 |
Fair Value Measurements, Level
Fair Value Measurements, Level 3 Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | ||
Fair value measurements of common stock warrants using significant unobservable inputs (level 3) | |||
Balance at beginning of period | $ 1,258 | ||
Balance at end of period | 223 | $ 1,258 | |
Level 3 [Member] | |||
Fair value measurements of common stock warrants using significant unobservable inputs (level 3) | |||
Balance at beginning of period | 1,258 | 5,425 | |
Exercise of warrants | [1] | (184) | (376) |
Change in fair value of common stock warrant liability | (851) | (3,791) | |
Balance at end of period | $ 223 | $ 1,258 | |
[1] | See, Note 8 - Common Stock Warrant Liability. |
Fair Value Measurements, Signif
Fair Value Measurements, Significant Unobservable input assumptions of Level 3 valuations (Details) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ||
Historical Volatility | 159.00% | |
Expected Term | 2 months 12 days | |
Risk-free interest rate | 0.15% | |
Minimum [Member] | Level 3 [Member] | ||
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ||
Historical Volatility | 55.00% | |
Expected Term | 1 month 6 days | |
Risk-free interest rate | 0.03% | |
Maximum [Member] | Level 3 [Member] | ||
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ||
Historical Volatility | 84.00% | |
Expected Term | 1 year 1 month 6 days | |
Risk-free interest rate | 0.31% |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property and equipment [Line Items] | ||
Property and equipment, gross | $ 9,505 | $ 12,689 |
Accumulated depreciation and amortization | (8,466) | (11,052) |
Property and equipment, net | 1,039 | 1,637 |
Depreciation expense | 700 | 800 |
Manufacturing, laboratory & office equipment [Member] | ||
Property and equipment [Line Items] | ||
Property and equipment, gross | 6,290 | 9,154 |
Furniture & fixtures [Member] | ||
Property and equipment [Line Items] | ||
Property and equipment, gross | 778 | 817 |
Leasehold improvements [Member] | ||
Property and equipment [Line Items] | ||
Property and equipment, gross | $ 2,437 | $ 2,718 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accrued Expenses [Abstract] | ||
Salaries, bonus & benefits | $ 2,387 | $ 2,332 |
Research and development | 3,254 | 1,641 |
Manufacturing operations | 1,097 | 876 |
Professional fees | 326 | 376 |
Sales and marketing | 0 | 318 |
Other | 518 | 573 |
Total accrued expenses | $ 7,582 | $ 6,116 |
Common Stock Warrant Liability
Common Stock Warrant Liability (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Feb. 22, 2011 | |
Estimated fair value of warrants accounted for as derivative liabilities [Abstract] | |||
Fair value of warrants | $ 223 | $ 1,258 | |
Number of warrant shares potentially issuable (in shares) | 8,500,000 | ||
Exercise price of warrants (in dollars per share) | $ 39.34 | ||
2011 Warrants [Member] | |||
Estimated fair value of warrants accounted for as derivative liabilities [Abstract] | |||
Warrants issuance date | Feb. 22, 2011 | ||
Warrants expiration date | Feb. 22, 2016 | ||
Fair value of warrants | $ 200 | $ 8,000 | |
Number of warrant shares potentially issuable (in shares) | 300,000 | ||
Exercise price of warrants (in dollars per share) | $ 2.66 | $ 21 | |
Exercise of warrants by warrant holders to purchase common stock (in shares) | 51,193 | 20,346 | |
Proceeds from exercise of warrants | $ 100 | $ 400 |
Deerfield Loan (Details)
Deerfield Loan (Details) $ / shares in Units, shares in Millions | Jul. 22, 2015USD ($) | Jul. 09, 2015USD ($) | Dec. 03, 2013USD ($) | Feb. 13, 2013USD ($) | Dec. 31, 2015USD ($)Disbursement$ / sharesshares | Dec. 31, 2014USD ($) |
Line of Credit Facility [Line Items] | ||||||
Date facility agreement entered | Feb. 13, 2013 | |||||
Loan facility, maximum amount | $ 30,000,000 | |||||
Number of advances | Disbursement | 2 | |||||
Transaction fee, percentage | 1.50% | |||||
Cash interest rate under loan facility | 8.75% | |||||
Percentage sale of assets | 50.00% | |||||
Number of shares under issued warrants (in shares) | shares | 0.5 | |||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 39.34 | |||||
Percentage of common stock, maximum | 9.985% | |||||
Fair value of warrants issued under both the first and second advance | $ 11,700,000 | |||||
Transaction fee | 450,000 | |||||
Amount of units sold in public offering | 37,628,000 | |||||
Non-cash loss on debt extinguishment | (11,758,000) | $ 0 | ||||
Carrying value of Facility Agreement [Abstract] | ||||||
Note Payable | 25,000,000 | 30,000,000 | ||||
Unamortized discount | 0 | (9,698,000) | ||||
Long-term debt, net | $ 25,000,000 | 20,302,000 | ||||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | ||||||
Historical volatility | 159.00% | |||||
Expected term | 2 months 12 days | |||||
Risk-free interest rate | 0.15% | |||||
Interest expense [Abstract] | ||||||
Cash interest expense | $ 1,451,000 | 2,625,000 | ||||
Non-cash amortization of debt discounts | 1,287,000 | 1,948,000 | ||||
Debt discount write-off | 707,000 | 0 | ||||
Amortization of prepaid interest expense | 971,000 | 0 | ||||
Amortization of debt costs | 12,000 | 19,000 | ||||
Write-off of debt costs | 66,000 | 0 | ||||
Total Deerfield Loan interest expenses | $ 4,494,000 | $ 4,592,000 | ||||
Deerfield Warrants [Member] | ||||||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | ||||||
Historical volatility | 101.00% | |||||
Minimum [Member] | Deerfield Warrants [Member] | ||||||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | ||||||
Expected term | 5 years 2 months 12 days | |||||
Risk-free interest rate | 1.20% | |||||
Maximum [Member] | Deerfield Warrants [Member] | ||||||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | ||||||
Expected term | 6 years | |||||
Risk-free interest rate | 1.50% | |||||
Deerfield Debt Restructuring [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Cash interest rate under loan facility | 8.75% | |||||
Prepayment of principal amount of loan outstanding | $ 2,500,000 | $ 2,500,000 | ||||
Amount of units sold in public offering | 5,000,000 | |||||
Additional right to prepayment of principal amount of loan outstanding | 2,500,000 | |||||
Principal amount of loan outstanding payable in February 2018 | 12,500,000 | 12,500,000 | ||||
Principal amount of loan outstanding payable in February 2019 | 12,500,000 | $ 12,500,000 | ||||
Deferred period for loan payment | 1 year | |||||
Principal amount of loan payable, prepayment amount | $ 5,000,000 | |||||
Remaining interest due on the principal amount outstanding | 8.25% | |||||
Common stock valuation prior to change in control | $ 100,000,000 | |||||
Non-cash loss on debt extinguishment | $ 11,800,000 | |||||
Non-cash loss on debt extinguishment related to fair value of warrants | $ 4,100,000 | |||||
Principal amount of loan payable, future interest obligation | $ 5,000,000 | |||||
First Advance [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Proceeds from advanced funds | $ 10,000,000 | |||||
Number of shares under issued warrants (in shares) | shares | 0.2 | |||||
Second Advance [Member] | ||||||
Line of Credit Facility [Line Items] | ||||||
Proceeds from advanced funds | $ 20,000,000 | |||||
Number of shares under issued warrants (in shares) | shares | 0.3 |
Stockholders' Equity, Registere
Stockholders' Equity, Registered Public Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 22, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Stockholders' Equity [Line Items] | |||
Exercise price of warrants (in dollars per share) | $ 39.34 | ||
Common Stock [Member] | |||
Stockholders' Equity [Line Items] | |||
Issuance of common stock, July 2015 financing (in shares) | 1,792,000 | ||
2011 Warrants [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise price of warrants (in dollars per share) | $ 2.66 | $ 21 | |
Registered Public Offerings [Member] | |||
Stockholders' Equity [Line Items] | |||
Gross proceeds from issuance of units | $ 40,250 | ||
Net proceeds from issuance of common stock | $ 37,600 | ||
Class of warrants may not exercise to extent | 9.99% | ||
Class of warrants exercise may be elected by holders | 4.99% | ||
Registered Public Offerings [Member] | Deerfield Debt Restructuring [Member] | |||
Stockholders' Equity [Line Items] | |||
Non-cash consideration received | $ 5,000 | ||
Registered Public Offerings [Member] | Series A Units [Member] | |||
Stockholders' Equity [Line Items] | |||
Issuance of common stock, July 2015 financing (in shares) | 1,791,667 | ||
Sale of unit price per unit (in dollars per unit) | $ 8.40 | ||
Number of warrants required to purchase one share of common stock (in shares) | 1 | ||
Exercise price of warrants (in dollars per share) | $ 8.40 | ||
Registered Public Offerings [Member] | Series A Warrant [Member] | |||
Stockholders' Equity [Line Items] | |||
Number of warrants required to purchase one share of common stock (in shares) | 1 | ||
Exercise price of warrants (in dollars per share) | $ 9.80 | ||
Registered Public Offerings [Member] | Series B Units [Member] | |||
Stockholders' Equity [Line Items] | |||
Issuance of common stock, July 2015 financing (in shares) | 3,000,000 | ||
Sale of unit price per unit (in dollars per unit) | $ 8.40 | ||
Number of warrants required to purchase one share of common stock (in shares) | 1 | ||
Exercise price of warrants (in dollars per share) | $ 8.40 | ||
Registered Public Offerings [Member] | Series B Warrant [Member] | |||
Stockholders' Equity [Line Items] | |||
Number of warrants required to purchase one share of common stock (in shares) | 1 | ||
Exercise price of warrants (in dollars per share) | $ 9.80 | ||
Over-Allotment [Member] | Series A Units [Member] | |||
Stockholders' Equity [Line Items] | |||
Issuance of common stock, July 2015 financing (in shares) | 625,000 |
Stockholders' Equity, ATM Progr
Stockholders' Equity, ATM Program and 401(k) Matching Contributions (Details) - USD ($) | Feb. 11, 2013 | Dec. 31, 2015 | Dec. 31, 2014 |
Stockholders' Equity [Line Items] | |||
Issuance of common stock, 401(k) employer match (in shares) | 94,114 | 42,371 | |
Expense associated with 401(k) plan | $ 500,000 | $ 1,000,000 | |
Stifel ATM Program [Member] | |||
Stockholders' Equity [Line Items] | |||
Period of agency agreement | 3 years | ||
Maximum value of potential common stock available for issue | $ 25,000,000 | ||
Percentage sales commission on shares | 3.00% |
Stockholders' Equity, Common Sh
Stockholders' Equity, Common Shares Reserved for Future Issuance (Details) - $ / shares | 12 Months Ended | ||||
Dec. 31, 2015 | Jan. 21, 2016 | Oct. 27, 2015 | Dec. 31, 2014 | ||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 8,532,000 | 1,107,000 | |||
Exercise Price (in dollars per share) | $ 39.34 | ||||
2011 Long-Term Incentive Plan [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for future issuance (in shares) | 420,000 | 476,000 | |||
2011 Long-Term Incentive Plan [Member] | Subsequent Event [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for future issuance (in shares) | 1,100,000 | ||||
401(k) Plan [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 4,567 | 78,571 | 438 | ||
Battelle - 2014 Collaboration Agreement [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | [1] | 107,000 | 107,000 | ||
Exercise Price (in dollars per share) | [1] | $ 70 | |||
Expiration Date | [1] | Oct. 10, 2024 | |||
Investors - July 2015 Financing [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 4,792,000 | 0 | |||
Exercise Price (in dollars per share) | $ 9.80 | ||||
Expiration Date | Jul. 22, 2022 | ||||
Investors - July 2015 Financing (Prefunded) [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 2,857,000 | 0 | |||
Exercise Price (in dollars per share) | $ 0 | ||||
Expiration Date | Jul. 22, 2022 | ||||
Deerfield - 2013 Loan [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 500,000 | 500,000 | |||
Exercise Price (in dollars per share) | $ 39.34 | ||||
Expiration Date | Feb. 13, 2019 | ||||
Former Employee [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 2,000 | 2,000 | |||
Exercise Price (in dollars per share) | $ 44.80 | ||||
Expiration Date | Mar. 18, 2016 | ||||
Investor - February 2011 Financing [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 274,000 | 325,000 | |||
Exercise Price (in dollars per share) | $ 2.66 | ||||
Expiration Date | Feb. 22, 2016 | ||||
PharmaBio - October 2010 Financing [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 0 | 6,000 | |||
Exercise Price (in dollars per share) | $ 57.40 | ||||
Expiration Date | Oct. 13, 2015 | ||||
Investor - June 2010 Financing [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 0 | 85,000 | |||
Exercise Price (in dollars per share) | $ 84 | ||||
Expiration Date | Jun. 22, 2015 | ||||
Kingsbridge - June 2010 CEFF [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 0 | 6,000 | |||
Exercise Price (in dollars per share) | $ 93.66 | ||||
Expiration Date | Dec. 11, 2015 | ||||
PharmaBio - April 2010 Financing [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 0 | 10,000 | |||
Exercise Price (in dollars per share) | $ 148.26 | ||||
Expiration Date | Apr. 30, 2015 | ||||
Investor - February 2010 Financing [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock available for issuance (in shares) | 0 | 66,000 | |||
Exercise Price (in dollars per share) | $ 178.50 | ||||
Expiration Date | Feb. 23, 2015 | ||||
[1] | See Note 12 for further details on the Battelle collaboration agreement. |
Stock Options and Stock-based48
Stock Options and Stock-based Employee Compensation (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | ||
Total outstanding (in shares) | 522 | 468 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Stock options outstanding, beginning of period (in shares) | 467 | |
Granted (in shares) | 185 | |
Forfeited or expired (in shares) | (135) | |
Stock options outstanding, end of period (in shares) | 517 | 467 |
Vested and exercisable at end of period (in shares) | 294 | |
Weighted Average Exercise Price [Roll Forward] | ||
Outstanding, beginning of period (in dollars per share) | $ 63.04 | |
Granted (in dollars per share) | 15.64 | |
Forfeited or expired (in dollars per share) | 42.81 | |
Outstanding, end of period (in dollars per share) | 51.35 | $ 63.04 |
Vested and exercisable at end of period (in dollars per share) | $ 74.84 | |
Outstanding, weighted average remaining contractual term | 6 years 7 months 6 days | |
Vested and exercisable, weighted average remaining contractual term | 4 years 10 months 24 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Weighted average grant date fair value of options granted (in dollars per share) | $ 10.48 | $ 25.48 |
Options, outstanding, total intrinsic value | $ 0 | |
Options, vested, total intrinsic value | 0 | |
Options, exercisable, total intrinsic value | $ 0 | |
Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Unvested RSAs outstanding (in shares), beginning of period | 1 | |
Awarded (in shares) | 5 | |
Vested (in shares) | (1) | |
Unvested RSAs outstanding (in shares), end of period | 5 | 1 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Unvested at beginning of period (in dollars per share) | $ 23.94 | |
Awarded (in dollars per share) | 6.72 | |
Vested (in dollars per share) | 23.94 | |
Unvested at end of period (in dollars per share) | $ 6.72 | $ 23.94 |
2011 Long-Term Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized (in shares) | 2,000 | |
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | ||
Total outstanding (in shares) | 493 | 437 |
Available for future grants under 2011 plan (in shares) | 420 | 476 |
Duration of continuous service | 2 years | |
Term of award | 10 years | |
2007 Equity Incentive Plan [Member] | ||
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | ||
Total outstanding (in shares) | 17 | 18 |
1998 Equity Incentive Plan [Member] | ||
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | ||
Total outstanding (in shares) | 12 | 13 |
Stock Options and Stock-based49
Stock Options and Stock-based Employee Compensation, Options Outstanding, Vested and Exercisable (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Employee stock-based compensation | $ 1,696 | $ 2,941 |
Weighted-average assumptions used in estimating fair value of stock options [Abstract] | ||
Weighted average expected volatility | 83.00% | 100.00% |
Weighted average expected term | 5 years 6 months | 5 years 4 months 24 days |
Weighted average risk-free interest rate | 1.50% | 1.65% |
Expected dividends | 0.00% | 0.00% |
Fair value of options vested during period | $ 2,700 | $ 3,100 |
Unrecognized compensation cost related to non-vested share-based compensation arrangements | $ 1,900 | |
Weighted-average vesting period of stock options | 1 year 9 months 18 days | |
Research and Development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Employee stock-based compensation | $ 642 | 1,014 |
Selling, General & Administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Employee stock-based compensation | $ 1,054 | $ 1,927 |
Corporate Partnership, Licens50
Corporate Partnership, Licensing and Research Funding Agreements (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2012 | |
Licensing and Research Funding Agreements [Abstract] | |||||||||||
Research and development expense | $ 8,225,000 | $ 6,452,000 | $ 7,129,000 | $ 7,082,000 | $ 7,771,000 | $ 6,471,000 | $ 6,858,000 | $ 5,590,000 | $ 28,888,000 | $ 26,690,000 | |
Exercise price of warrants (in dollars per share) | $ 39.34 | $ 39.34 | |||||||||
Laboratories del Dr. Esteve, S.A. [Abstract] | |||||||||||
Percent of cash upfront and milestone fees payable to Esteve | 10.00% | 10.00% | |||||||||
Maximum aggregate cash upfront and milestone fees payable to Esteve | $ 20,000,000 | $ 20,000,000 | |||||||||
Battelle - 2014 Collaboration Agreement [Member] | |||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||
Research and development expense | $ 3,100,000 | 300,000 | |||||||||
Number of warrants to purchase shares of common stock (in shares) | 2 | 2 | |||||||||
Term of collaboration agreement | 10 years | ||||||||||
Exercise price of warrants (in dollars per share) | $ 70 | $ 70 | |||||||||
Maximum royalty paid to Battelle on successful completion of activities | $ 25,000,000 | ||||||||||
Battelle - 2014 Collaboration Agreement [Member] | Additional Warrants [Member] | |||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||
Number of warrant shares issuable (in shares) | 35,714 | 35,714 | |||||||||
Battelle - 2014 Collaboration Agreement [Member] | Initial Warrants [Member] | |||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||
Number of warrant shares issuable (in shares) | 71,429 | 71,429 | |||||||||
Phillip Morris - License Agreement [Member] | |||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||
Royalty paid | $ 400,000 | $ 300,000 | |||||||||
Johnson & Johnson - License Agreement [Member] | |||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||
Potential license fee payable | $ 2,500,000 | 2,500,000 | |||||||||
License fees paid | $ 950,000 | ||||||||||
Payment of license costs subject to FDA approval | $ 500,000 |
Commitments (Details)
Commitments (Details) | Jan. 31, 2013USD ($) | Jun. 30, 2015USD ($)ft² | Dec. 31, 2015USD ($)ft² | Dec. 31, 2014USD ($) |
Commitments [Abstract] | ||||
Estimated development costs | $ 6,600,000 | |||
Operating Leased Assets [Line Items] | ||||
Rent expense | 1,000,000 | $ 1,200,000 | ||
Retention plan [Line Items] | ||||
Employee severance cost | 2,900,000 | |||
Employee severance cost charged to expense | 1,900,000 | |||
Accrued severance cost amount | $ 1,000,000 | |||
Severance and retention benefits paid | 2,600,000 | |||
Severance and retention benefits to be paid in future periods | $ 300,000 | |||
Headquarters [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Leased Area of Real Estate Property | ft² | 39,594 | |||
Lease extension term | 5 years | |||
Aggregate rental payments | $ 2,000,000 | |||
Sterile Manufacturing Facility [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Leased Area of Real Estate Property | ft² | 21,000 | |||
Annual rent of leased property | $ 525,000 | |||
Research and Development Expenses [Member] | ||||
Retention plan [Line Items] | ||||
Employee severance cost charged to expense | $ 1,000,000 | |||
Selling, General and Administrative Expenses [Member] | ||||
Retention plan [Line Items] | ||||
Employee severance cost charged to expense | $ 900,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Reconciliation of income tax benefit to Federal statutory rates [Abstract] | ||
Income tax benefit, statutory rates | $ 18,758 | $ 14,980 |
State taxes on income, net of Federal benefit | 3,760 | 2,871 |
Research and development tax credit | 1,047 | 1,472 |
Employee related | (340) | (2,131) |
Warrant valuation related | 289 | 1,289 |
Income tax benefit | 23,514 | 18,481 |
Valuation allowance | (23,514) | (18,481) |
Income tax benefit | 0 | 0 |
Long-term deferred tax assets [Abstract] | ||
Net operating loss carryforwards(Federal and state) | 218,203 | 191,643 |
Research and development tax credits | 13,917 | 12,927 |
Compensation expense on stock | 2,776 | 2,588 |
Charitable contribution carryforward | 6 | 7 |
Inventory reserve | 0 | 907 |
Deferred revenue | 0 | 16 |
Other accrued | 469 | 1,088 |
Depreciation | 482 | 2,630 |
Capitalized research and development | 0 | 1,123 |
Total long-term deferred tax assets | 235,853 | 212,929 |
Less: valuation allowance | (235,853) | (212,929) |
Deferred tax assets, net of valuation allowance | 0 | 0 |
Operating Loss Carryforwards [Line Items] | ||
Unrecognized tax benefits income tax penalties and interest accrued | 0 | 0 |
Unrecognized tax benefits income tax penalties and interest expense | 0 | 0 |
Research Tax Credit Carryforward [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward amount | $ 13,900 | 12,900 |
Internal Revenue Service (IRS) [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards expiration dates | Dec. 31, 2035 | |
Tax credit carryforward expiration date | Dec. 31, 2035 | |
Operating loss carryforwards | $ 540,200 | 473,300 |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 527,100 | $ 470,400 |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 5,200 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 400 | |
Pennsylvania [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 503,700 |
Selected Quarterly Financial 53
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | ||||||||||
Product sales | $ 0 | $ 0 | $ 0 | $ 7 | $ 136 | $ 106 | $ 42 | $ 28 | $ 7 | $ 312 |
Grant Revenues | 655 | 66 | 75 | 184 | 1,048 | 421 | 1,051 | 3 | 980 | 2,523 |
Total revenues | 655 | 66 | 75 | 191 | 1,184 | 527 | 1,093 | 31 | 987 | 2,835 |
Expenses: | ||||||||||
Cost of sales | 0 | 0 | 0 | 929 | 902 | 257 | 731 | 781 | 929 | 2,671 |
Research and development | 8,225 | 6,452 | 7,129 | 7,082 | 7,771 | 6,471 | 6,858 | 5,590 | 28,888 | 26,690 |
Selling, General and administrative | 2,211 | 2,057 | 3,383 | 3,353 | 3,737 | 4,126 | 4,446 | 4,423 | 11,004 | 16,732 |
Total expenses | 10,436 | 8,509 | 10,512 | 11,364 | 12,410 | 10,854 | 12,035 | 10,794 | 40,821 | 46,093 |
Operating loss | (9,781) | (8,443) | (10,437) | (11,173) | (11,226) | (10,327) | (10,942) | (10,763) | (39,834) | (43,258) |
Change in fair value of common stock warrant liability | 274 | 139 | 469 | (31) | 1,792 | 173 | 1,448 | 378 | 851 | 3,791 |
Other expense, net | (602) | (13,252) | (1,358) | (975) | (1,201) | (1,170) | (1,129) | (1,091) | (16,187) | (4,591) |
Net loss | $ (10,109) | $ (21,556) | $ (11,326) | $ (12,179) | $ (10,635) | $ (11,324) | $ (10,623) | $ (11,476) | $ (55,170) | $ (44,058) |
Net loss per common share - basic (in dollars per share) | $ (1.26) | $ (2.80) | $ (1.82) | $ (1.96) | $ (1.68) | $ (1.82) | $ (1.68) | $ (1.96) | $ (7.98) | $ (7.28) |
Net loss per common share - diluted (in dollars per share) | $ (1.26) | $ (2.80) | $ (1.82) | $ (1.96) | $ (2.10) | $ (1.82) | $ (1.96) | $ (1.96) | $ (7.98) | $ (7.84) |
Weighted average number of common shares outstanding - basic (in shares) | 8,050 | 7,550 | 6,125 | 6,114 | 6,097 | 6,086 | 6,076 | 6,052 | 6,967 | 6,078 |
Weighted average number of common shares outstanding - diluted (in shares) | 8,050 | 7,550 | 6,125 | 6,114 | 6,111 | 6,086 | 6,134 | 6,052 | 6,967 | 6,145 |
Subsequent Events (Details)
Subsequent Events (Details) shares in Thousands | Feb. 01, 2016 | Jan. 22, 2016$ / sharesshares | Jan. 21, 2016shares | Dec. 31, 2015Event$ / sharesshares | Dec. 31, 2014$ / sharesshares |
Subsequent Events [Abstract] | |||||
Number of subsequent event | Event | 2 | ||||
Subsequent Event [Line Items] | |||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||
2011 Long-Term Incentive Plan [Member] | |||||
Subsequent Event [Line Items] | |||||
Number of shares authorized (in shares) | 2,000 | ||||
Common stock available for future issuance (in shares) | 420 | 476 | |||
Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Portion of exchange ratio to reduce common stock authorized | 0.5 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | ||||
Reverse stock split ratio | 14 | ||||
Number of shares authorized (in shares) | 36,000 | 250,000 | |||
Maximum period after termination for stock options to be exercisable | 36 months | ||||
Period of non-competition restrictions after termination | 12 months | ||||
Period of non-solicitation restrictions after termination | 18 months | ||||
Period for cure of breach | 5 days | ||||
Subsequent Event [Member] | 2011 Long-Term Incentive Plan [Member] | |||||
Subsequent Event [Line Items] | |||||
Common stock available for future issuance (in shares) | 1,100 |