Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2014 | Mar. 06, 2015 | Jun. 30, 2014 |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | DISCOVERY LABORATORIES INC /DE/ | ||
Entity Central Index Key | 946486 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $128 | ||
Entity Common Stock, Shares Outstanding | 85,586,914 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current Assets: | ||
Cash and cash equivalents | $44,711 | $86,283 |
Accounts receivable | 0 | 67 |
Inventory, net | 27 | 112 |
Prepaid expenses and other current assets | 821 | 777 |
Total current assets | 45,559 | 87,239 |
Property and equipment, net | 1,637 | 1,656 |
Restricted cash | 225 | 325 |
Other assets | 78 | 97 |
Total Assets | 47,499 | 89,317 |
Current Liabilities: | ||
Accounts payable | 350 | 1,433 |
Accrued expenses | 6,116 | 4,785 |
Deferred revenue | 43 | 139 |
Common stock warrant liability | 1,258 | 5,425 |
Equipment loans, current portion | 62 | 73 |
Total current liabilities | 7,829 | 11,855 |
Long-term debt, $30,000 net of discount of $9,698 at December 31, 2014 and $11,646 at December 31, 2013 | 20,302 | 18,354 |
Equipment loans, non-current portion | 0 | 69 |
Other liabilities | 169 | 538 |
Total liabilities | 28,300 | 30,816 |
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; 250,000,000 and 150,000,000 shares authorized at December 31, 2014 and 2013, respectively; 85,607,806 and 84,659,111 shares issued at December 31, 2014 and 2013, respectively; 85,586,914 and 84,638,219 shares outstanding at December 31, 2014 and 2013, respectively | 86 | 85 |
Additional paid-in capital | 546,175 | 541,420 |
Accumulated deficit | -524,008 | -479,950 |
Treasury stock (at cost); 20,892 shares at December 31, 2013 and 2012 | -3,054 | -3,054 |
Total stockholders' equity | 19,199 | 58,501 |
Total liabilities & stockholders' equity | $47,499 | $89,317 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
LIABILITIES & STOCKHOLDERS' EQUITY | ||
Long term debt, gross | $30,000 | $30,000 |
Long-term debt, discount | $9,698 | $11,646 |
Stockholders' Equity: | ||
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
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) | $0.00 | $0.00 |
Common stock, shares authorized (in shares) | 250,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 85,607,806 | 84,659,111 |
Common stock, shares outstanding (in shares) | 85,586,914 | 84,638,219 |
Treasury stock (at cost) (in shares) | 20,892 | 20,892 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 12 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Revenues: | |||
Product sales | $312 | $0 | $0 |
Grant revenue | 2,523 | 388 | 195 |
Total revenues | 2,835 | 388 | 195 |
Expenses: | |||
Cost of product sales | 2,671 | 517 | 0 |
Research and development | 26,690 | 27,661 | 21,570 |
Selling, general & administrative | 16,732 | 16,718 | 16,444 |
Total expenses | 46,093 | 44,896 | 38,014 |
Operating loss | -43,258 | -44,508 | -37,819 |
Change in fair value of common stock warrant liability | 3,791 | 761 | 555 |
Other income / (expense): | |||
Interest and other income | 6 | 3 | 6 |
Interest and other expense | -4,597 | -1,471 | -57 |
Other income / (expense), net | -4,591 | -1,468 | -51 |
Net loss | ($44,058) | ($45,215) | ($37,315) |
Net loss per common share | |||
Basic (in dollars per share) | ($0.52) | ($0.82) | ($0.95) |
Diluted (in dollars per share) | ($0.56) | ($0.82) | ($0.95) |
Weighted-average number of common shares outstanding | |||
Basic (in shares) | 85,095 | 55,258 | 39,396 |
Diluted (in shares) | 86,025 | 55,258 | 39,396 |
Consolidated_Statements_of_Cha
Consolidated Statements of Changes in Stockholders' Equity (USD $) | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] | Treasury Stock [Member] | Treasury Stock [Member] | Treasury Stock [Member] | Treasury Stock [Member] | Total | February 2011 Financing [Member] | March 2012 Financing [Member] | May 2013 Financing [Member] | November 2013 Financing [Member] |
In Thousands, except Share data, unless otherwise specified | February 2011 Financing [Member] | March 2012 Financing [Member] | May 2013 Financing [Member] | November 2013 Financing [Member] | February 2011 Financing [Member] | March 2012 Financing [Member] | May 2013 Financing [Member] | November 2013 Financing [Member] | February 2011 Financing [Member] | March 2012 Financing [Member] | May 2013 Financing [Member] | November 2013 Financing [Member] | February 2011 Financing [Member] | March 2012 Financing [Member] | May 2013 Financing [Member] | November 2013 Financing [Member] | |||||||||
Balance at Dec. 31, 2011 | $25 | $401,713 | ($397,420) | ($3,054) | $1,264 | ||||||||||||||||||||
Balance (in shares) at Dec. 31, 2011 | 24,603,000 | -21,000 | |||||||||||||||||||||||
Changes in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||||||
Net loss | 0 | 0 | -37,315 | 0 | -37,315 | ||||||||||||||||||||
Issuance of common stock, 401(k) Plan employer match | 0 | 763 | 0 | 0 | 763 | ||||||||||||||||||||
Issuance of common stock, 401(k) employer match (in shares) | 317,000 | 0 | 316,543 | ||||||||||||||||||||||
Issuance of common stock, financing | 16 | 42,074 | 0 | 0 | 42,090 | ||||||||||||||||||||
Issuance of common stock, financing (in shares) | 16,072,000 | ||||||||||||||||||||||||
Issuance of common stock, ATM financing | 1 | 1,460 | 0 | 0 | 1,461 | ||||||||||||||||||||
Issuance of common stock, ATM financing (in shares) | 350,000 | ||||||||||||||||||||||||
Exercise of common stock warrants | 2 | 6,875 | 0 | 0 | 6,877 | ||||||||||||||||||||
Exercise of common stock warrants (in shares) | 2,289,000 | ||||||||||||||||||||||||
Exercise of stock options for cash | 0 | 6 | 0 | 0 | 6 | ||||||||||||||||||||
Exercise of stock options for cash (in shares) | 3,000 | ||||||||||||||||||||||||
Issuance of common stock, consultants | 0 | 96 | 0 | 0 | 96 | ||||||||||||||||||||
Issuance of common stock, consultants (in shares) | 40,000 | ||||||||||||||||||||||||
Stock-based compensation expense | 0 | 2,411 | 0 | 0 | 2,411 | ||||||||||||||||||||
Stock-based compensation expense (in shares) | 0 | ||||||||||||||||||||||||
Balance at Dec. 31, 2012 | 44 | 455,398 | -434,735 | -3,054 | 17,653 | ||||||||||||||||||||
Balance (in shares) at Dec. 31, 2012 | 43,674,000 | -21,000 | |||||||||||||||||||||||
Changes in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||||||
Net loss | 0 | 0 | -45,215 | 0 | -45,215 | ||||||||||||||||||||
Issuance of common stock, 401(k) Plan employer match | 0 | 959 | 0 | 0 | 959 | ||||||||||||||||||||
Issuance of common stock, 401(k) employer match (in shares) | 510,000 | 0 | 510,047 | ||||||||||||||||||||||
Issuance of common stock, financing | 11 | 29 | 15,102 | 53,836 | 0 | 0 | 0 | 0 | 15,113 | 53,865 | |||||||||||||||
Issuance of common stock, financing (in shares) | 10,847,000 | 28,750,000 | 0 | ||||||||||||||||||||||
Issuance of common stock, ATM financing | 1 | 1,795 | 0 | 0 | 1,796 | ||||||||||||||||||||
Issuance of common stock, ATM financing (in shares) | 714,000 | ||||||||||||||||||||||||
Issuance of common stock warrants, Deerfield | 0 | 11,729 | 0 | 0 | 11,729 | ||||||||||||||||||||
Issuance of common stock warrants, Deerfield (in shares) | 0 | ||||||||||||||||||||||||
Exercise of common stock warrants | 0 | 290 | 0 | 0 | 290 | ||||||||||||||||||||
Exercise of common stock warrants (in shares) | 114,000 | 0 | |||||||||||||||||||||||
Exercise of stock options for cash | 0 | 34 | 0 | 0 | 34 | ||||||||||||||||||||
Exercise of stock options for cash (in shares) | 18,000 | 0 | |||||||||||||||||||||||
Issuance of common stock, consultants | 0 | 67 | 0 | 0 | 67 | ||||||||||||||||||||
Issuance of common stock, consultants (in shares) | 32,000 | 0 | |||||||||||||||||||||||
Stock-based compensation expense | 0 | 2,210 | 0 | 0 | 2,210 | ||||||||||||||||||||
Stock-based compensation expense (in shares) | 0 | ||||||||||||||||||||||||
Balance at Dec. 31, 2013 | 85 | 541,420 | -479,950 | -3,054 | 58,501 | ||||||||||||||||||||
Balance (in shares) at Dec. 31, 2013 | 84,659,000 | -21,000 | 84,638,219 | ||||||||||||||||||||||
Changes in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||||||
Net loss | 0 | 0 | -44,058 | 0 | -44,058 | ||||||||||||||||||||
Issuance of common stock, 401(k) Plan employer match | 1 | 943 | 0 | 0 | 944 | ||||||||||||||||||||
Issuance of common stock, 401(k) employer match (in shares) | 593,000 | 0 | 593,198 | ||||||||||||||||||||||
Exercise of common stock warrants | 0 | 803 | 0 | 0 | 803 | ||||||||||||||||||||
Exercise of common stock warrants (in shares) | 285,000 | 0 | |||||||||||||||||||||||
Exercise of stock options for cash | 0 | 30 | 0 | 0 | 30 | ||||||||||||||||||||
Exercise of stock options for cash (in shares) | 17,000 | 0 | 17,000 | ||||||||||||||||||||||
Issuance of common stock, consultants | 0 | 38 | 0 | 0 | 38 | ||||||||||||||||||||
Issuance of common stock, consultants (in shares) | 18,000 | 0 | |||||||||||||||||||||||
Stock-based compensation expense | 0 | 2,941 | 0 | 0 | 2,941 | ||||||||||||||||||||
Stock-based compensation expense (in shares) | 36,000 | ||||||||||||||||||||||||
Balance at Dec. 31, 2014 | $86 | $546,175 | ($524,008) | ($3,054) | $19,199 | ||||||||||||||||||||
Balance (in shares) at Dec. 31, 2014 | 85,608,000 | -21,000 | 85,586,914 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Cash flow from operating activities: | |||
Net loss | ($44,058) | ($45,215) | ($37,315) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 818 | 707 | 1,150 |
Provision for excess inventory | 1,873 | 514 | 0 |
Stock-based compensation and 401(k) Plan employer match | 3,923 | 3,236 | 3,270 |
Fair value adjustment of common stock warrants | -3,791 | -761 | -555 |
Amortization of discount on long-term debt | 1,948 | 534 | 0 |
Loss on disposal of equipment | 0 | 0 | 42 |
Reduction in required restricted cash under lease agreement | 100 | 75 | 0 |
Changes in: | |||
Inventory | -1,788 | -431 | -195 |
Accounts receivable | 67 | -67 | 0 |
Prepaid expenses and other current assets | -44 | -58 | -277 |
Accounts payable | -1,083 | 267 | 55 |
Accrued expenses | 1,331 | 626 | 1,187 |
Deferred revenue | -96 | 139 | 0 |
Other assets | 0 | -115 | 0 |
Other liabilities | -369 | 95 | -246 |
Net cash used in operating activities | -41,169 | -40,454 | -32,884 |
Cash flow from investing activities: | |||
Purchase of property and equipment | -780 | -608 | -636 |
Net cash used in investing activities | -780 | -608 | -636 |
Cash flow from financing activities: | |||
Proceeds from issuance of securities, net of expenses | 0 | 70,774 | 43,551 |
Proceeds from issuance of long-term debt | 0 | 30,000 | 0 |
Payment of debt issuance costs | 0 | -450 | 0 |
Proceeds from exercise of common stock warrants and options | 457 | 204 | 6,747 |
Principal payments under equipment loans | -80 | -75 | -75 |
Net cash provided by financing activities | 377 | 100,453 | 50,223 |
Net increase/ (decrease) in cash and cash equivalents | -41,572 | 59,391 | 16,703 |
Cash and cash equivalents - beginning of year | 86,283 | 26,892 | 10,189 |
Cash and cash equivalents - end of year | 44,711 | 86,283 | 26,892 |
Supplementary disclosure of cash flows information: | |||
Interest paid | $2,630 | $920 | $13 |
The_Company_and_Description_of
The Company and Description of Business | 12 Months Ended | |
Dec. 31, 2014 | ||
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 specialty biotechnology company focused on creating life-saving products for critical-care patients with respiratory disease and improving the standard of care in pulmonary medicine. Our proprietary drug technology produces a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to pulmonary surfactant, a substance produced naturally in the lung and essential for normal respiratory function and survival. We are developing our KL4 surfactant in liquid, lyophilized and aerosolized dosage forms. We are also developing novel aerosol drug delivery technologies potentially to enable efficient delivery of our aerosolized KL4 surfactant. We believe that our proprietary technologies may make it possible to develop a pipeline of products to address a variety of respiratory diseases for which there are few or no approved therapies. | ||
Our development programs have been focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants. RDS is a serious respiratory condition caused by insufficient surfactant production in underdeveloped lungs of premature infants. RDS is the most prevalent respiratory disease in the Neonatal Intensive Care Unit (NICU) and can result in long-term respiratory problems, developmental delay and death. Our first KL4 surfactant drug product, SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants at high risk for RDS, was approved by the United States Food and Drug Administration (FDA) in 2012. SURFAXIN is our KL4 surfactant in liquid form and is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal-derived surfactants currently used in the United States (U.S.). SURFAXIN has been commercially available since November 2013. However, revenue growth has been slower than expected and we currently believe that more of our capital and resources than previously anticipated would have to be allocated to SURFAXIN. Therefore, we are pursuing, with the intention of promptly implementing, a strategic alternative for SURFAXIN. See, "Note 2 – Liquidity Risks and Management's Plans." | ||
Premature infants with severe RDS currently are treated with surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, invasive procedures that may each result in serious respiratory conditions and other complications. To avoid such complications, many neonatologists treat infants with less severe RDS by less invasive means, typically nasal continuous positive airway pressure (nCPAP). Unfortunately, a significant number of premature infants on nCPAP will respond poorly (an outcome referred to as nCPAP failure) and may require delayed surfactant therapy. Since neonatologists currently cannot predict which infants will experience nCPAP failure, neonatologists are faced with difficult choices in treating infants with less severe RDS. This is because the medical outcomes for those infants who experience nCPAP failure and receive delayed surfactant therapy may be less favorable than the outcomes for infants who received surfactant therapy in the first hours of life. | ||
AEROSURF® is an investigational combination drug/device product that combines our KL4 surfactant with our proprietary capillary aerosol generator (CAG) technology. With AEROSURF, neonatologists potentially will be able to administer aerosolized KL4 surfactant to premature infants supported with nCPAP alone, without having to resort to invasive intubation and mechanical ventilation. By enabling delivery of our aerosolized KL4 surfactant using less invasive procedures, we believe that AEROSURF will address a serious unmet medical need and potentially enable the treatment of a significantly greater number of premature infants with RDS who could benefit from surfactant therapy but are currently not treated. | ||
In the future, we expect to leverage the information, data and know-how that we gain from our development efforts with SURFAXIN and AEROSURF to support development of a potential product pipeline to address serious critical care respiratory conditions in children and adults in pediatric and adult intensive care units (PICUs and ICUs). While we currently are focused primarily on the development of AEROSURF through phase 2 clinical trials, we have explored and plan in the future to explore potential opportunities to address a variety of respiratory conditions that may benefit from KL4 surfactant therapy where there are no currently approved therapies other than supportive respiratory care. | ||
We believe that our aerosolized KL4 surfactant, alone or in combination with other pharmaceutical compounds, has the potential to be developed to address a range of serious respiratory conditions and may be an effective intervention for such conditions as acute lung injury (ALI), including acute radiation exposure to the lung (acute pneumonitis and delayed lung injury), chemical-induced ALI, and influenza-induced ALI. In addition, we may explore opportunities to apply KL4 surfactant therapies to treat conditions such as chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, diseases involving mucociliary clearance disorders, such chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). We believe that we have an opportunity to develop a broad pipeline of KL4 surfactant products to address these and other conditions. |
Liquidity_Risks_and_Management
Liquidity Risks and Management's Plans | 12 Months Ended | |
Dec. 31, 2014 | ||
Liquidity Risks and Management's Plans [Abstract] | ||
Liquidity Risks and Management's Plans | Note 2 – | Liquidity Risks and Management’s Plans |
We have incurred substantial losses since inception, due to investments in research and development, manufacturing, and, more recently, commercialization and medical affairs activities, and we expect to continue to incur substantial losses over the next several years. Historically, we have funded our business operations through various sources, including public and private securities offerings, debt facilities, strategic alliances, committed equity financing facilities (CEFFs), at-the-market equity programs, and capital equipment financings. | ||
As of December 31, 2014, we had cash and cash equivalents of $44.7 million and long-term debt of $30 million under our loan with affiliates of Deerfield Management Company, L.P. (Deerfield) (see, “ – Note 9 – Deerfield Loan”). For the next several years, we expect that our cash outflow requirements, for development programs, operations and debt service, will outpace the rate at which we may generate revenues. Therefore, to execute our business strategy, advance our development programs, pay debt obligations and fund our operations, we will require significant additional infusions of capital until such time as we are able to generate sufficient revenues from the sale of approved products, from potential strategic alliances and commercialization agreements, and from other sources that are sufficient to offset our cash flow requirements. Following the approval of SURFAXIN, we established our own specialty respiratory critical care commercial and medical affairs organization and made investments in manufacturing, quality systems, supply chain, and distribution capabilities. Notwithstanding, revenue growth has been slower than expected and we currently believe that more of our capital and resources than previously anticipated would have to be allocated to SURFAXIN. We also believe that our limited capital and resources should be invested in the development of aerosolized KL4 surfactant, beginning with AEROSURF. Therefore, we are pursuing, with the intention of promptly implementing, a strategic alternative for SURFAXIN that potentially could be (i) a strategic alliance or collaboration arrangement, which we expect would require a lease extension for our Totowa Facility and may require consent under our Deerfield Loan, or (ii) ceasing commercialization activities for SURFAXIN. We would prefer an alliance or collaboration arrangement with a pharmaceutical company that has existing commercial capabilities, including substantial sales, marketing and medical resources and experience in the introduction of hospital-based products. However, there can be no assurance that we will succeed in such efforts. In connection with either a strategic alliance or collaboration agreement for SURFAXIN or cessation of commercialization activities, we expect that we likely will incur one-time transition-related costs associated with such event. Before any additional financings and taking into account our plan to quickly reduce cash outflows related to SURFAXIN through either (i) a strategic alliance or, in the event we are unable to secure a strategic alliance in the near term, (ii) ceasing commercial activities, we anticipate that we will have sufficient cash available to fund our operations and debt service obligations through the first quarter of 2016. | ||
To secure the necessary capital to fund our development programs, an important priority for us is to identify strategic transactions that could provide additional capital and strategic resources to support the continued development and commercial introduction of our RDS products in markets outside the U.S. For our AEROSURF development program, we seek a significant strategic alliance with a partner that has broad experience in markets outside the U.S., including 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. If our efforts to secure an alliance for SURFAXIN in the U.S. are successful, we may seek a strategic alliance that could provide regulatory expertise in designated markets where regulatory marketing authorization is facilitated by the information contained in our new drug application (NDA) approved by the FDA, support the commercial introduction of SURFAXIN in such markets and provide for a sharing of revenues. Under our Battelle Collaboration Agreement, at our discretion from time to time, we may elect to defer payment of amounts due to Battelle in respect of our share of development costs for up to 12 months. We currently have deferred certain payments and may continue to defer payments through the completion of the development project. In addition, under our ATM Program, subject to market conditions, we may sell up to approximately $23 million of common stock at such times and in such amounts that we deem appropriate, subject to a 3% commission. We also may consider public and private equity offerings or other financing transactions, including potentially secured equipment financing facilities or other similar transactions. | ||
Our future capital requirements will depend upon many factors, including our efforts to (i) advance the AEROSURF development program to completion of the phase 2 clinical trials as planned; (ii) reduce or eliminate our capital and resources allocated to the commercialization of SURFAXIN in the U.S. (iii) assure long-term continuity of supply for our KL4 surfactant drug product, potentially at our manufacturing facility in Totowa, NJ (Totowa Facility) and with CMOs, (iv) further the development of our CAG 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; 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, in markets outside the U.S. We believe that we will be better positioned to enter into a significant strategic alliance for AEROSURF if we obtain encouraging results from the AEROSURF phase 2 clinical program. | ||
Given the uncertainty associated with our business strategy as planned, there can be no assurance (i) that our AEROSURF development program will be successful within our anticipated time frame, if at all, (ii) that any of our approved products will be commercially viable, (iii) that we will be able to execute our long-term manufacturing plan to secure continuity of drug product supply, (iv) that we will be able to secure regulatory marketing authorization for AEROSURF and our other potential KL4 surfactant product candidates in the U.S. and other markets, or (v) that the ATM Program will be available when needed, if at all, or (vi) that we otherwise will be able to obtain additional capital when needed and on acceptable terms. We will require significant additional capital to execute our business strategy, pay debt service and sustain operations. Failure to secure the necessary additional capital when needed would 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, 2014, we had outstanding warrants to purchase approximately 15.5 million shares of our common stock at various prices, exercisable on different dates into 2024. This includes warrants to purchase 7 million shares that were issued to Deerfield in connection with the Deerfield Loan at an exercise price of $2.81 per share (Deerfield Warrants). The Deerfield Warrants may be exercised for cash or on a cashless basis. In lieu of paying cash upon exercise, the holders also may elect to reduce the principal amount of the Deerfield Loan in an amount sufficient to satisfy the exercise price of the Deerfield Warrants. In addition to the Deerfield Warrants, we have outstanding warrants issued in February 2011 to purchase approximately 4.6 million shares of common stock that expire in February 2016 and contain anti-dilution provisions that adjust the exercise price if we issue 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. These warrants currently have an exercise price of $1.50 per share. If the market price of our common stock should exceed $1.50 at any time prior to the expiration date of these warrants (February 2016) and if the holders determine in their discretion to exercise these warrants (and we have an effective registration statement covering the warrant shares to be issued upon exercise of the warrants), we potentially could receive up to approximately $6.8 million. There can be no assurance that the price of our common stock will achieve the needed level, that holders of the Deerfield Warrants would choose to exercise their warrants for cash, or that holders of any of our outstanding warrants would choose to exercise any or all of their warrants prior to the applicable warrant expiration dates. Moreover, if our outstanding warrants are exercised, such exercises likely will be at a discount to the then-market value of our common stock and have a dilutive effect on the value of our shares of common stock at the time of exercise. | ||
As of December 31, 2014, 250 million shares of common stock were authorized under our Amended and Restated Certificate of Incorporation, as amended, and approximately 135.7 million shares of common stock were available for issuance and not otherwise reserved. |
Accounting_Policies_and_Recent
Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Accounting Policies and Recent Accounting Pronouncements [Abstract] | |||||||||||||
Accounting Policies and Recent Accounting Pronouncements | Note 3 – | 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, 2014 and 2013, respectively. Warrants classified as liabilities are recorded at their fair market value. Other financial instruments, including accounts payable and accrued expenses, are carried at cost, which we believe approximates fair value. | |||||||||||||
Accounts receivable | |||||||||||||
Trade accounts receivable are recorded net of allowances for prompt payment discounts and doubtful accounts. | |||||||||||||
Inventory | |||||||||||||
Inventories, which are recorded at the lower of cost or market, include materials, labor, and other direct and indirect costs and are valued at cost using the first-in, first-out method. We capitalize inventories produced in preparation for commercial launch when all regulatory approvals needed to enable the commercial launch of the product are received and the related costs will be recoverable through the commercial sale of the product. Costs incurred prior to FDA approval of drug products and registration of medical devices is recorded in our statement of operations as research and development expense. Inventories are evaluated for impairment through consideration of factors such as the net realizable value, lower of cost or market, obsolescence, and expiry. Inventories do not have carrying values that exceed either cost or net realizable value. | |||||||||||||
We evaluate our expiry risk by evaluating current and future product demand relative to product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and hospital ordering practices. | |||||||||||||
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, Note 13 – Commitments, for further discussion on our leases). Under terms of the lease agreement, the required restricted cash balance was reduced by $100,000 to $225,000 in October 2014. | |||||||||||||
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, 2014, 2013, and 2012 as management believes there are no circumstances that indicate the carrying amount of the assets will not be recoverable. | |||||||||||||
Financing costs related to long-term debt | |||||||||||||
Costs associated with obtaining long-term debt, including the fair value of warrants issued in connection with the debt and transaction fees, are amortized over the term of the related debt using the effective interest method. | |||||||||||||
Deferred revenue | |||||||||||||
Deferred revenue reflects amounts related to sales of SURFAXIN to our specialty distributor, which are then deferred and recognized as revenue once product has been sold through to the hospital and all revenue recognition criteria have been met. | |||||||||||||
Product sales | |||||||||||||
Revenues from product sales are recognized when (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable and (4) collectability is reasonably assured. | |||||||||||||
Our products are distributed in the U.S. using a specialty distributor. Under this model, the specialty distributor purchases and takes physical delivery and title of product, and then sells to hospitals. We began the commercial introduction of SURFAXIN in the fourth quarter of 2013 and we currently cannot make a reasonable estimate of future product returns when product is delivered to the specialty distributor. Therefore, we currently do not recognize revenue upon product shipment to the specialty distributor, even though the distributor is invoiced upon product shipment. Instead, we recognize revenue once product has been sold through to the hospital and all revenue recognition criteria have been met. Once product has been delivered to a hospital, the risk of material returns is significantly mitigated. In developing estimates for sales returns, we consider the shelf life of the product, expected demand based on market data and return rates of other surfactant products. | |||||||||||||
Product sales are recorded net of accruals for estimated chargebacks, discounts, specialty distributor deductions and returns. | |||||||||||||
· | Chargebacks. Chargebacks are discounts that occur when contracted customers purchase directly from our specialty distributor. Contracted customers, which primarily consist of Group Purchasing Organizations member hospitals, generally purchase the product at a discounted price. Our specialty distributor, in turn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the customer. The allowance for specialty distributor chargebacks is based on known sales to contracted customers. | ||||||||||||
· | Sales discounts. Sales discounts are offered to certain contracted customers based upon a customer’s historical volume of surfactant product purchases. Customers must enter into a Letter of Participation (LOP) with us to receive sales discounts. Sales discounts are periodically adjusted on a prospective basis based upon the customer’s purchases of SURFAXIN, as provided in the LOP. The allowance for sales discounts is based on known sales to contracted customers. | ||||||||||||
· | Specialty distributor deductions. Our specialty distributor is offered various forms of consideration including allowances, service fees and prompt payment discounts. Specialty distributor allowances and service fees are provided for in our contractual agreement and are generally a percentage of the purchase price paid by the specialty distributor. The specialty distributor is offered a prompt pay discount for payment within a specified period. | ||||||||||||
· | Returns. Sales of our products are not subject to a general right of return; however, we will accept product that is damaged or defective when shipped or for expired product up to six months subsequent to its expiry date. | ||||||||||||
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” (ASC Topic 718). See, Note 11 – Stock Options and Stock-based Employee Compensation, for a detailed description of our recognition of stock-based compensation expense. The fair value of stock option grants is recognized evenly over the vesting period of the options or over the period between the grant date and the time the option becomes non-forfeitable by the employee, whichever is shorter. | |||||||||||||
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” (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. We classify derivative warrant liabilities on the consolidated balance sheet as current liabilities, which are revalued at each balance sheet date subsequent to the initial issuance. Depending on the terms of a warrant agreement, we use the Black-Scholes or trinomial pricing models to value the related derivative warrant liabilities. Changes in the fair value of the warrants are reflected in the consolidated statement of operations as “Change in the fair value of common stock warrant liability.” See, “– Note 8 – Common Stock Warrant Liability,” for a detailed description of our accounting for derivative warrant liabilities. | |||||||||||||
Collaborative arrangements | |||||||||||||
We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808 Collaborative Arrangements (ASC Topic 808). See, “ – Note 12 – Corporate Partnership, Licensing and Research Funding Agreements – Battelle Memorial Institute,” for a description of our accounting for the Battelle Collaboration Agreement. | |||||||||||||
Income taxes | |||||||||||||
We account for income taxes in accordance with ASC Topic 740, “Accounting for Income Taxes” (ASC Topic 740), which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. | |||||||||||||
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, 2014, 2013, and 2012, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 22.0 million, 20.2 million and 11.9 million shares, respectively. As of December 31, 2014, 2013, and 2012, there were 17.4 million, 15.4 million, and 7.0 million shares, respectively, 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, 2014, the effect of the adjustments for warrants classified as derivative liabilities was dilutive. For the years ended December 31, 2013 and 2012, the effect of the adjustments for warrants classified as derivative liabilities was anti-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, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator: | |||||||||||||
Net loss as reported | $ | (44,058 | ) | $ | (45,215 | ) | $ | (37,315 | ) | ||||
Less: income from change in fair value of warrant liability | (3,791 | ) | – | – | |||||||||
Numerator for diluted net loss per common share | $ | (47,849 | ) | $ | (45,215 | ) | $ | (37,315 | ) | ||||
Denominator: | |||||||||||||
Basic weighted average common shares outstanding | 85,095 | 55,258 | 39,396 | ||||||||||
Dilutive common shares from assumed warrant exercises | 930 | – | – | ||||||||||
Diluted weighted average common shares outstanding | 86,025 | 55,258 | 39,396 | ||||||||||
We do not have any components of other comprehensive income (loss). | |||||||||||||
Concentration of Suppliers | |||||||||||||
We currently obtain the active pharmaceutical ingredients (APIs) of our KL4 surfactant drug products from single-source suppliers. In addition, we rely on a number of third-party institutions and laboratories that perform various studies as well as quality control release and stability testing and other activities related to our KL4 surfactant development and manufacturing activities. At the present time, several of these laboratories are single-source providers. The loss of one or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations. | |||||||||||||
Major customer and concentration of credit risk | |||||||||||||
We currently sell our products to one exclusive pharmaceutical specialty distributor in the U.S. We periodically assess the financial strength of our specialty distributor and establish allowances for anticipated uncollectible amounts, if necessary. As of December 31, 2014 and 2013, we have not recorded an allowance for doubtful accounts. | |||||||||||||
Business segments | |||||||||||||
We currently operate in one business segment, which is the research and development of products focused on surfactant replacement 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, which requires an entity to recognize revenue at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. generally accepted accounting principles (GAAP) when it becomes effective. The new standard is effective for us in the annual period ending December 31, 2017, including interim periods within that annual period. Early application is not permitted. We are evaluating the effect that ASU 2014-09 will have on our consolidated financial statements and related disclosures. The standard permits the use of either the retrospective or cumulative effect transition method. We have not yet selected a transition method nor determined the effect of the standard on our financial reporting. | |||||||||||||
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern, which requires management to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management will also be required to evaluate and disclose whether its plans alleviate that doubt. The standard defines substantial doubt as when it is probable (i.e., likely) that the entity will be unable to meet its obligations as they become due within one year of the date the financial statements are issued (or available to be issued, when applicable). The ASU is effective for the annual period ending December 31, 2016 and interim periods thereafter. Early application is permitted. We are evaluating the effect that ASU 2014-15 will have on our consolidated financial statements and related disclosures. The standard permits the use of either the retrospective or cumulative effect transition method. We have not yet selected a transition method nor determined the effect of the standard on our financial reporting. |
Fair_Value_Measurements
Fair Value Measurements | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||||||
Fair Value Measurements | Note 4 – | 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, 2014 and 2013: | |||||||||||||||||
Fair Value | Fair value measurement using | ||||||||||||||||
(in thousands) | 31-Dec-14 | 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 | |||||||||
Fair Value | Fair value measurement using | ||||||||||||||||
(in thousands) | 31-Dec-13 | Level 1 | Level 2 | Level 3 | |||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 86,283 | $ | 86,283 | $ | – | $ | – | |||||||||
Certificate of deposit | 325 | 325 | – | – | |||||||||||||
Total Assets | $ | 86,608 | $ | 86,608 | $ | – | $ | – | |||||||||
Liabilities: | |||||||||||||||||
Common stock warrants | $ | 5,425 | $ | – | $ | – | $ | 5,425 | |||||||||
The following table summarizes changes in the fair value of the common stock warrants measured on a recurring basis using Level 3 inputs for 2013 and 2014: | |||||||||||||||||
(in thousands) | |||||||||||||||||
Balance at January 1, 2013 | $ | 6,305 | |||||||||||||||
Exercise of warrants (1) | (119 | ) | |||||||||||||||
Change in fair value of common stock warrant liability | (761 | ) | |||||||||||||||
Balance at December 31, 2013 | $ | 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 | |||||||||||||||
-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. | |||||||||||||||||
December 31, | |||||||||||||||||
Significant Unobservable Input Assumptions of Level 3 Valuations | 2014 | 2013 | |||||||||||||||
Historical volatility | 55% – 84% | 62% –76% | |||||||||||||||
Expected term (in years) | 0.1 – 1.1 | 0.4 – 2.1 | |||||||||||||||
Risk-free interest rate | 0.03% – 0.31% | 0.08% – 0.44% | |||||||||||||||
Fair Value of Long-Term Debt | |||||||||||||||||
At December 31, 2014, the estimated fair value of the Deerfield Loan (see, Note 9 – Deerfield Loan) was $22.2 million compared to a carrying value, net of discounts, of $20.3 million. At December 31, 2013, the estimated fair value of the Deerfield Loan was $23.6 million compared to a carrying value, net of discounts, of $18.4 million. The estimated fair value of the Deerfield Loan is based on discounting the future contractual cash flows to the present value at the valuation date. This analysis utilizes certain Level 3 unobservable inputs, including current cost of capital. Considerable judgment is required to interpret market data and to develop estimates of fair value. The estimates presented are not necessarily indicative of amounts we could realize in a current market exchange. The use of alternative market assumptions and estimation methodologies could have a material effect on these estimates of fair value. 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. |
Inventory
Inventory | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventory [Abstract] | |||||||||
Inventory | Note 5 – | Inventory | |||||||
Inventory is comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Raw materials | $ | – | $ | 52 | |||||
Finished goods, net of reserves | 27 | 60 | |||||||
Total inventories, net | $ | 27 | $ | 112 | |||||
As of December 31, 2014, there was $0.5 million of raw materials purchased prior to October 4, 2013, the date the FDA approved updated SURFAXIN product specifications and enabled the commercial introduction of SURFAXIN. These raw materials have a carrying value of zero, as the costs to purchase this material were expensed in the period of purchase as research and development expense, and accordingly are not reflected in the inventory balances shown above. These raw materials are anticipated to be used in manufacturing development, research and development activities and in the manufacture of commercial product. | |||||||||
Inventory reserves as of December 31, 2014 and December 31, 2013 were $2.4 million and $0.5 million, respectively. Inventory reserves reflect costs of SURFAXIN finished goods inventories that are not anticipated to be recoverable through the commercial sale of the product during the initial launch period due to product expiration. These reserves ensure that the inventory carrying values do not exceed net realizable value. Inventory reserves are recorded as a component of cost of goods sold. |
Property_and_Equipment
Property and Equipment | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property and Equipment [Abstract] | |||||||||
Property and Equipment | Note 6 – | Property and Equipment | |||||||
Property and equipment is comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Manufacturing, laboratory & office equipment | $ | 9,154 | $ | 8,383 | |||||
Furniture & fixtures | 817 | 816 | |||||||
Leasehold improvements | 2,718 | 2,711 | |||||||
Subtotal | 12,689 | 11,910 | |||||||
Accumulated depreciation and amortization | (11,052 | ) | (10,254 | ) | |||||
Property and equipment, net | $ | 1,637 | $ | 1,656 | |||||
Depreciation expense on property and equipment for the years ended December 31, 2014, 2013, and 2012 was $0.8 million, $0.7 million, and $0.9 million, respectively. |
Accrued_Expenses
Accrued Expenses | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Expenses [Abstract] | |||||||||
Accrued Expenses | Note 7 – | Accrued Expenses | |||||||
Accrued expenses are comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Salaries, bonus & benefits | $ | 2,332 | $ | 1,849 | |||||
Research and development | 1,641 | 270 | |||||||
Manufacturing operations | 876 | 1,707 | |||||||
Professional fees | 376 | 393 | |||||||
Sales and marketing | 318 | 161 | |||||||
All other | 573 | 405 | |||||||
Total accrued expenses | $ | 6,116 | $ | 4,785 |
Common_Stock_Warrant_Liability
Common Stock Warrant Liability | 12 Months Ended | |||||||||||||||||||||
Dec. 31, 2014 | ||||||||||||||||||||||
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 (ASC 815), either as derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. | ||||||||||||||||||||||
The form of warrant agreement for the registered warrants that we issued in our May 2009 and February 2010 public offering generally provide that, in the event a related registration statement or an exemption from registration is not available for the issuance or resale of the warrant shares upon exercise of the warrants, the holder may exercise the warrants on a cashless basis. Notwithstanding the availability of cashless exercise, under GAAP, these registered warrants are deemed to be subject to potential net cash settlement and must be classified as derivative liabilities because (i) under federal securities laws, issuing freely-tradable registered shares upon exercise of the warrants may not be within our control in all circumstances, and (ii) the warrant agreements do not expressly provide that there is no circumstance in which we may be required to effect a net cash settlement of the warrants. The accounting guidance expressly precludes an evaluation of the likelihood that cash settlement could occur. Accordingly, the February 2010 warrants have been classified as a derivative liability and reported, at each balance sheet date, at estimated fair value determined using the Black-Scholes option-pricing model. | ||||||||||||||||||||||
The form of warrant agreement for the registered warrants that we issued in the February 2011 public offering (February 2011 warrants) contain anti-dilutive provisions that adjust the exercise price if we issue 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 February 2011 warrants. Although by their express terms, these warrants are not subject to potential cash settlement, due to the nature of the anti-dilution provisions, these warrants have been 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 at issuance of $3.20 was adjusted downward to $2.80 per share at the time of the March 2012 public offering and to $1.50 per share at the time of the May 2013 public offering. | ||||||||||||||||||||||
Selected terms and estimated fair value of warrants accounted for as derivative are as follows: | ||||||||||||||||||||||
Fair Value of Warrants | ||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||
Issuance Date | Number of Warrant Shares Issuable | Exercise Price | Warrant Expiration Date | Value at Issuance Date | December 31, | |||||||||||||||||
2014 | 2013 | |||||||||||||||||||||
2/23/10 | 916,669 | 12.75 | 2/23/15 | $ | 5,701 | $ | – | $ | 6 | |||||||||||||
2/22/11 | 4,550,100 | 1.5 | 2/22/16 | 8,004 | 1,258 | 5,419 | ||||||||||||||||
$ | 1,258 | $ | 5,425 | |||||||||||||||||||
During the year ended December 31, 2014, holders of the February 2011 five-year warrants exercised warrants to purchase 284,850 shares of common stock for total proceeds of $0.4 million. During the year ended December 31, 2013, holders of the February 2011 five-year warrants exercised warrants to purchase 113,800 shares of common stock for total proceeds of $0.2 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, 2014 | |||||||||||||
Deerfield Loan [Abstract] | |||||||||||||
Deerfield Loan | Note 9 – | Deerfield Loan | |||||||||||
Long-term debt consists solely of amounts due under a $30 million loan (Deerfield Loan) with affiliates of Deerfield Management Company, L.P. (Deerfield) for the periods presented: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | ||||||||||||
Note payable | $ | 30,000 | $ | 30,000 | |||||||||
Unamortized discount | (9,698 | ) | (11,646 | ) | |||||||||
Long-term debt, net of discount | $ | 20,302 | $ | 18,354 | |||||||||
Under the terms of the related agreement, Deerfield advanced funds to us in two separate disbursements. Deerfield made the first disbursement, in the amount of $10 million, on February 13, 2013, upon execution of the related agreement (First Disbursement). Deerfield made the second disbursement, in the amount of $20 million, on December 3, 2013 (Second Disbursement), following the first commercial sale of SURFAXIN. | |||||||||||||
The loan may be prepaid in whole or in part without penalty at any time. In addition, the principal amount of the loan may be reduced to the extent that holders of the notes elect to apply all or a portion of the principal amount outstanding under the loan to satisfy the exercise price of all or a portion of the Deerfield Warrants (discussed below) upon exercise. The principal amount of the loan is payable in three $10 million annual installments beginning in February 2017, provided that the amount payable in February 2017 shall be deferred for one year if either (i) our “Net Sales” (defined below) for the immediately preceding 12-month period are at least $20 million, or (ii) our “Equity Value” (defined below) is at least $200 million; and provided further, that the amount payable in February 2018 (together with any amount deferred in February 2017) shall be deferred until February 2019 if either (i) our “Net Sales” for the immediately preceding 12-month period are at least $30 million, or (ii) our “Equity Value” is at least $250 million. For the purposes of the foregoing deferrals of principal, “Net Sales” means, without duplication, the gross amount invoiced by us or on our behalf, any of our subsidiaries or any direct or indirect assignee or licensee for products, sold globally in bona fide, arm’s length transactions, less customary deductions determined without duplication in accordance with generally accepted accounting principles; and “Equity Value” means, with respect to each measurement date, the product of (x) the number of issued and outstanding shares of our common stock on such measurement date multiplied by (y) the per share closing price of our common stock on such measurement date. Accordingly, if the milestones are achieved in each year, payment of the principal amount could be deferred until the sixth anniversary date of the loan, on February 13, 2019. | |||||||||||||
The amount received and outstanding under the Deerfield Loan accrues interest at an annual rate of 8.75%, payable quarterly in cash. The Deerfield Loan agreement contains customary terms and conditions but does not require us to meet minimum financial and revenue performance covenants. In connection with each advance, we paid Deerfield a transaction fee equal to 1.5% of the amount disbursed. The Deerfield Loan agreement also contains various representations and warranties and affirmative and negative covenants customary for financings of this type, including restrictions on our ability to incur additional indebtedness and grant additional liens on our assets. 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, in which case Deerfield would have the right to require us to repay the outstanding principal amount of the loan, plus any accrued and unpaid interest thereon, or (ii) the occurrence of certain events as defined in the facility 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). | |||||||||||||
In connection with the execution of the Deerfield Loan and receipt of the First Disbursement, we issued to Deerfield warrants to purchase approximately 2.3 million shares of our common stock at an exercise price of $2.81 per share. Upon receipt of the Second Disbursement, we issued to Deerfield warrants to purchase an additional 4.7 million shares of our common stock at an exercise price of $2.81 per share (together with the warrants issued in connection with the First Disbursement, the Deerfield Warrants). The number of shares of common stock into which the Deerfield Warrants are exercisable and the exercise price of any Deerfield Warrant will be adjusted to reflect any stock splits, recapitalizations or similar adjustments in the number of outstanding shares of common stock. | |||||||||||||
The Deerfield Warrants will expire on the sixth anniversary of the facility agreement, February 13, 2019, and contain certain limitations that generally prevent the holder from acquiring shares upon exercise of the Deerfield Warrants or any part thereof that would result in the number of shares beneficially owned by such holder to exceed 9.985% of the total number of shares of our common stock then issued and outstanding. A holder of the Deerfield Warrants may exercise all or a portion of such Deerfield Warrants either for cash or on a cashless basis. In connection with a Major Transaction, as defined in the Deerfield Warrants, to the extent of consideration payable to stockholders in cash in connection with such Major Transaction, the holder may have the option to redeem the Deerfield Warrants or that portion of the Deerfield Warrant for cash in an amount equal to the Black-Scholes value (as defined in the Deerfield Warrants) of the Deerfield Warrants or that portion of the Deerfield Warrants redeemed. In addition, in connection with a Major Transaction, to the extent of any consideration payable to stockholders in securities, or in the event of an Event of Default, the holder may have the option to exercise the Deerfield Warrants and receive therefor that number of shares of Common Stock that equals the Black-Scholes value of the Deerfield Warrants or that portion of the Deerfield Warrants exercised. Prior to a holder exercising the Deerfield Warrants for shares in such transactions, the Company may elect to terminate the Deerfield Warrants or that portion of the Deerfield Warrants being exercised and pay the holder cash in an amount equal to the Black-Scholes value of the Deerfield Warrants. | |||||||||||||
We 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 Disbursement and the Second Disbursement (7 million warrants in total), and (ii) a $450,000 transaction fee. The discount is 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” (ASC 815) and have been classified as 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% | ||||||||||||
The following amounts comprise the Deerfield Loan interest expense for the periods presented: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Cash interest expense | $ | 2,625 | $ | 911 | $ | – | |||||||
Non-cash amortization of debt discounts | 1,948 | 534 | – | ||||||||||
Amortization of debt costs | 19 | 18 | – | ||||||||||
Total Deerfield Loan interest expenses | $ | 4,592 | $ | 1,463 | $ | – | |||||||
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 warrants issued in connection with the Deerfield Loan. The amortization of debt costs represents legal costs incurred in connection with the Deerfield Loan. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Stockholders' Equity [Abstract] | ||||||||||||||
Stockholders' Equity | Note 10 – | Stockholders’ Equity | ||||||||||||
Registered Public Offerings | ||||||||||||||
On November 5, 2013, we completed a registered public offering of 25,000,000 shares of our common stock, at a price of $2.00 per share resulting in gross proceeds of $50.0 million ($46.8 million net proceeds). We also granted the underwriters a 30-day option to purchase up to an additional 3,750,000 shares of common stock at an offering price of $2.00 per share. On November 8, 2013, the underwriters exercised their option in full, resulting in additional gross proceeds of $7.5 million ($7.1 million net proceeds). | ||||||||||||||
On May 10, 2013, we completed a registered public offering of 9,500,000 shares of our common stock, at a price of $1.50 per share resulting in gross proceeds of $14.3 million ($13.2 million net proceeds). We also granted the underwriters a 30-day option to purchase up to an additional 1,425,000 shares of common stock at an offering price of $1.50 per share. On May 28, 2013, the underwriters exercised their option to purchase 1,347,000 shares of common stock at a price of $1.50 per share, resulting in additional gross proceeds of $2.0 million ($1.9 million net proceeds). | ||||||||||||||
On March 21, 2012, we completed a registered public offering of 16,071,429 shares of our common stock, at a price of $2.80 per share resulting in gross proceeds of $45.0 million ($42.1 million net proceeds). We also granted the underwriters a 30-day option to purchase up to an additional 2,410,714 shares of common stock at an offering price of $2.80 per share, which expired unexercised in April 2012. | ||||||||||||||
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 will terminate upon the earliest of: (1) the sale of all shares subject to the ATM Agreement, (2) February 11, 2016 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. | ||||||||||||||
On October 15, 2013, we completed an offering under the ATM Program and issued 713,920 shares of our common stock for an aggregate purchase price of approximately $2.0 million, resulting in net proceeds to us of approximately $1.8 million, after deducting commissions. As of December 31, 2014, approximately $23 million remained available under the ATM Program. | ||||||||||||||
Lazard ATM Program | ||||||||||||||
On December 14, 2011, we entered into a Sales Agency Agreement (Agency Agreement) with Lazard Capital Markets LLC (Lazard), under which Lazard, as our exclusive agent could sell up to a maximum of $15,000,000 of shares of our common stock through an “at-the-market” program (Lazard ATM Program). We agreed (i) to pay Lazard a commission equal to 3.0% of the gross proceeds of any sales, and (ii) to reimburse Lazard for certain expenses incurred. In connection with initiation of coverage of our stock by an analyst affiliated with Lazard, we agreed with Lazard to terminate the Lazard ATM Program effective August 6, 2012. | ||||||||||||||
On March 12, 2012, we completed an offering of 350,374 shares of our common stock for an aggregate purchase price of approximately $1.6 million, resulting in net proceeds to us of approximately $1.5 million, after deducting commissions. | ||||||||||||||
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, 2014, 2013, and 2012, the match resulted in the issuance of 593,198, 510,047, and 316,543, shares of common stock, respectively. Expenses associated with the 401(k) match for the years ended December 31, 2014, 2013, and 2012 were $1.0 million, $1.0 million and $0.8 million, respectively. | ||||||||||||||
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 | Expiration | |||||||||||
2014 | 2013 | Price | Date | |||||||||||
Battelle – 2014 collaboration agreement(1) | 1,500 | – | $ | 5 | 10/10/24 | |||||||||
Deerfield – 2013 loan | 7,000 | 7,000 | $ | 2.81 | 2/13/19 | |||||||||
Former employee | 30 | 30 | $ | 3.2 | 3/18/16 | |||||||||
Investors – February 2011 financing | 4,550 | 4,835 | $ | 1.5 | 2/22/16 | |||||||||
PharmaBio – October 2010 financing | 79 | 79 | $ | 4.1 | 10/13/15 | |||||||||
Investors – June 2010 financing | 1,190 | 1,190 | $ | 6 | 6/22/15 | |||||||||
Kingsbridge – June 2010 CEFF | 83 | 83 | $ | 6.69 | 12/11/15 | |||||||||
PharmaBio – April 2010 financing | 135 | 135 | $ | 10.59 | 4/30/15 | |||||||||
Investors – February 2010 financing | 917 | 917 | $ | 12.75 | 2/23/15 | |||||||||
Investors – May 2009 financing | – | 467 | $ | 17.25 | 5/13/14 | |||||||||
Kingsbridge – December 2008 CEFF | – | 45 | $ | 22.7 | 6/12/14 | |||||||||
Total | 15,484 | 14,781 | ||||||||||||
(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, 2014 and 2013, we had 6.7 million and 2.9 million shares, respectively, available for potential future issuance under the 2011 Long-Term Incentive Plan (the 2011 Plan). | ||||||||||||||
Common shares reserved for potential future issuance under our 401(k) Plan | ||||||||||||||
As of December 31, 2014 and 2013, we had 6,130 and 166,243, respectively, reserved for potential future issuance under the 401(k) Plan. |
Stock_Options_and_Stockbased_E
Stock Options and Stock-based Employee Compensation | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
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 12.8 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, | |||||||||||||
2014 | 2013 | ||||||||||||
Stock Options and RSUs Outstanding | |||||||||||||
2011 Plan | 6,113 | 4,919 | |||||||||||
2007 Plan | 257 | 258 | |||||||||||
1998 Plan | 182 | 251 | |||||||||||
Total Outstanding | 6,552 | 5,428 | |||||||||||
Available for Future Grants under 2011 Plan | 6,667 | 2,894 | |||||||||||
No SARs, RSAs, other performance and stock-based awards, or dividend equivalents have been granted under the 2011 Plan. Although individual grants may vary, option awards generally are exercisable upon vesting, vest based upon three years of continuous service, and have a 10-year term. | |||||||||||||
A summary of activity under our long-term incentive plans is presented below: | |||||||||||||
(in thousands, except for weighted-average data) | |||||||||||||
Stock Options | Shares | Weighted- | Weighted- | ||||||||||
Average | Average | ||||||||||||
Exercise | Remaining | ||||||||||||
Price | Contractual | ||||||||||||
Term (In Yrs) | |||||||||||||
Outstanding at January 1, 2014 | 5,428 | $ | 6.51 | ||||||||||
Granted | 1,786 | 2.39 | |||||||||||
Exercised | (17 | ) | 1.83 | ||||||||||
Forfeited or expired | (663 | ) | 15.57 | ||||||||||
Outstanding at December 31, 2014 | 6,534 | $ | 4.5 | 7.3 | |||||||||
Exercisable at December 31, 2014 | 3,599 | $ | 6.23 | 6.3 | |||||||||
(in thousands, except for weighted-average data) | |||||||||||||
Restricted Stock Units | Shares | Weighted- | |||||||||||
Average | |||||||||||||
Grant | |||||||||||||
Date Fair | |||||||||||||
Value | |||||||||||||
Unvested at January 1, 2014 | 19 | $ | 1.69 | ||||||||||
Awarded | 36 | $ | 1.71 | ||||||||||
Vested | (36 | ) | $ | 1.7 | |||||||||
Unvested at December 31, 2014 | 19 | $ | 1.71 | ||||||||||
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, 2014, 2013, and 2012 was $1.82, $1.79, and $2.02, respectively. The weighted-average grant-date fair value of RSUs granted during the years ended December 31, 2014 and 2013 was $1.71 and $1.69, respectively. There were no RSUs granted during the year ended December 31, 2012. The total intrinsic value of options outstanding, vested, and exercisable as of December 31, 2014 are each $0. | |||||||||||||
Stock-Based Compensation | |||||||||||||
We recognized stock-based compensation expense in accordance ASC Topic 718 for the years ended December 31, 2014, 2013, and 2012, of $2.9 million, $2.2 million and $2.4 million, respectively. | |||||||||||||
Stock-based compensation expense was classified as follows: | |||||||||||||
December 31, | |||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 1,014 | $ | 784 | $ | 487 | |||||||
Selling, general and administrative | 1,927 | 1,426 | 1,924 | ||||||||||
Total | $ | 2,941 | $ | 2,210 | $ | 2,411 | |||||||
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, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Weighted average expected volatility | 100% | 109% | 111% | ||||||||||
Weighted average expected term | 5.4 years | 4.7 years | 4.6 years | ||||||||||
Weighted average risk-free interest rate | 1.65% | 0.73% | 0.74% | ||||||||||
Expected dividends | – | – | – | ||||||||||
The total fair value of the underlying shares of the options vested during 2014, 2013, and 2012, equals $3.1 million, $1.9 million and $2.2 million, respectively. As of December 31, 2014, there was $3.4 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 1.6 years. |
Corporate_Partnership_Licensin
Corporate Partnership, Licensing and Research Funding Agreements | 12 Months Ended | |
Dec. 31, 2014 | ||
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 CAG 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 $0.3 million for the year ended December 31, 2014. | ||
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 $5.00 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 1.0 million 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 0.5 million 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 May 31, 2016, which date may be 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 CAG 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 $300,000 in 2014 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 KL4 surfactant technology. Under the license agreement, we are obligated to pay fees of up to $2.5 million in the aggregate upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for certain designated products. We have paid $950,000 to date for milestones that have been achieved including a $500,000 milestone payment in 2012 that became due as a result of the FDA’s approval of SURFAXIN. In addition, we are required to make royalty payments at different rates, depending upon type of revenue and country, in amounts in the range of a high single-digit percent of net sales (as defined in the license agreement) of licensed products sold by us or sublicensees, or, if greater, a percentage of royalty income from sublicensees in the low double digits. | ||
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 KL4 surfactant products in Andorra, Greece, Italy, Portugal, and Spain. Antonio Esteve, Ph.D., a principal of Esteve, served as a member of our Board of Directors from May 2002 until January 2013. Esteve will pay us a transfer price on sales of our KL4 surfactant products. We will be responsible for the manufacture and supply of all of the covered products and Esteve will be responsible for all sales and marketing in the territory. Esteve is obligated to make stipulated cash payments to us upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for the covered products. In addition, Esteve has agreed to contribute to phase 3 clinical trials for the covered products by conducting and funding development performed in the territory. As part of a 2004 restructuring in which Esteve returned certain rights to us in certain territories (Former Esteve Territories), we agreed to pay Esteve 10% of any cash up front and milestone fees (up to a maximum aggregate of $20 million) that we receive in connection with any strategic collaborations for the development and/or commercialization of certain of our KL4 surfactant products in the Former Esteve Territories. |
Commitments
Commitments | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||
Commitments [Abstract] | |||||||||||||||||||||||||||||
Commitments | Note 13 – | Commitments | |||||||||||||||||||||||||||
Future payments due under contractual obligations at December 31, 2014 are as follows: | |||||||||||||||||||||||||||||
(in thousands) | 2015 | 2016 | 2017 | 2018 | 2019 | There-after | Total | ||||||||||||||||||||||
Operating lease obligations | $ | 1,239 | $ | 961 | $ | 943 | $ | 158 | $ | – | $ | – | $ | 3,301 | |||||||||||||||
Equipment loan obligations | 69 | – | – | – | – | – | 69 | ||||||||||||||||||||||
Total | $ | 1,308 | $ | 961 | $ | 943 | $ | 158 | $ | – | $ | – | $ | 3,370 | |||||||||||||||
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 under the lease prior to the extension were approximately $7.2 million and the total aggregate base rental payments under the extended portion of the lease are approximately $4.9 million. | |||||||||||||||||||||||||||||
We lease approximately 21,000 square feet of space for our manufacturing operations in Totowa, New Jersey, at an annual rent of $525,000. This space is specifically designed for the manufacture and filling of sterile pharmaceuticals in compliance with cGMP and is our only manufacturing facility. The lease expires on June 30, 2015. For a discussion of our manufacturing strategy, See, “Item 1 – Business – Business Operations – Manufacturing and Distribution,” in our Annual Report on Form 10-K. | |||||||||||||||||||||||||||||
Rent expense under these leases was $1.2 million for the year ended December 31, 2014 and $1.0 million for each of the years ended December 31, 2013 and 2012. | |||||||||||||||||||||||||||||
Battelle Collaboration | |||||||||||||||||||||||||||||
In accordance with terms of the Battelle agreement (See, – Note 12 – Corporate Partnership, Licensing and Research Funding Agreements), we and Battelle plan to design, develop, and complete the testing, verification, and documentation of an improved AEROSURF system, and share equally in the development plan costs. If this project is successfully completed in accordance with the development plan, based upon current estimates, we expect to incur development costs of approximately $6.0 million through 2016. | |||||||||||||||||||||||||||||
Retention Plan | |||||||||||||||||||||||||||||
On September 13, 2013, our Board of Directors approved an employee severance and retention plan for employees at the Totowa Facility that initially was intended to retain our manufacturing personnel should we be unable to secure long-term utilization of the Facility beyond the scheduled lease expiration on June 30, 2015. The retention plan provides severance and retention bonuses that encourage employees to stay with us through the Facility closing date (and beyond for certain employees). The plan has two components: (1) plant management (three individuals) has received an award of stock options that will vest in full in June 2016, and will be eligible for a retention bonus payable in June 2016, provided that they remain employed with us in June 2016; and (2) non-union employees (eight individuals) will be eligible to receive both severance and retention bonuses, payable upon closure of the Totowa Facility, provided that they remain employed with us through the date of closure. If we secure an extension of our lease for the Totowa Facility beyond June 30, 2015, plant management bonuses nevertheless will be paid as provided in the plan in June 2016, and non-union employees will remain eligible to receive severance and retention bonuses under the plan upon the eventual closure of the Facility, provided they remain employed with us through the date of closure. The total cash amount expected to be paid for severance and retention through June 2016 is approximately $0.9 million. The plan-related expense incurred during the years ended December 31, 2014 and 2013 is $0.5 million and $0.1 million, respectively, and is included in research and development expense and cost of product sales. The related liability as of December 31, 2014 and 2013 is $0.6 million and $0.1 million, respectively. | |||||||||||||||||||||||||||||
In addition, there are 12 employees at the Totowa Facility (approximately 11% of our total labor force) who are subject to a collective bargaining agreement and will be eligible to receive severance upon closure of the Totowa Facility. The related liability is $0.4 million as of December 31, 2014 and 2013. |
Litigation
Litigation | 12 Months Ended | |
Dec. 31, 2014 | ||
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, 2014 | |||||||||||||
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, 2014, 2013, and 2012 is as follows: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Income tax benefit, statutory rates | $ | 14,980 | $ | 15,373 | $ | 12,687 | |||||||
State taxes on income, net of Federal benefit | 2,871 | 2,922 | 2,288 | ||||||||||
Research and development tax credit | 1,472 | 517 | 332 | ||||||||||
Employee related | (2,131 | ) | (766 | ) | (988 | ) | |||||||
Warrant valuation related | 1,289 | 259 | 189 | ||||||||||
Income tax benefit | 18,481 | 18,305 | 14,508 | ||||||||||
Valuation allowance | (18,481 | ) | (18,305 | ) | (14,508 | ) | |||||||
Income tax benefit | $ | – | $ | – | $ | – | |||||||
The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at December 31, 2014 and 2013, are as follows: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | ||||||||||||
Long-term deferred tax assets: | |||||||||||||
Net operating loss carryforwards (Federal and state) | $ | 191,643 | $ | 175,258 | |||||||||
Research and development tax credits | 12,927 | 10,604 | |||||||||||
Compensation expense on stock | 2,588 | 3,276 | |||||||||||
Charitable contribution carryforward | 7 | 7 | |||||||||||
Inventory reserve | 907 | 198 | |||||||||||
Deferred revenue | 16 | 53 | |||||||||||
Other accrued | 1,088 | 1,024 | |||||||||||
Depreciation | 2,630 | 2,714 | |||||||||||
Capitalized research and development | 1,123 | 1,326 | |||||||||||
Total long-term deferred tax assets | 212,929 | 194,460 | |||||||||||
Less: valuation allowance | (212,929 | ) | (194,460 | ) | |||||||||
Deferred tax assets, net of valuation allowance | $ | – | $ | – | |||||||||
We are in a net deferred tax asset position at December 31, 2014 and 2013 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, 2014 or 2013, nor were any incurred in 2014, 2013, or 2012. | |||||||||||||
At December 31, 2014 and 2013, we had available carryforward net operating losses for Federal tax purposes of $473.3 million and $432.1 million, respectively, and a research and development tax credit carryforward of $12.9 million and $10.6 million, respectively. The Federal net operating loss and research and development tax credit carryforwards began to expire in 2008 and will continue through 2034. | |||||||||||||
At December 31, 2014, 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, 2014 and 2013, we had available carryforward losses of approximately $470.4 million and $433.7 million, respectively, for state tax purposes. Of the $470.4 million state tax carryforward losses, $436.0 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_D
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||
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 2014 and 2013. The operating results for any quarter are not necessarily indicative of results for any future period. | |||||||||||||||||||||
2014 Quarters Ended: | |||||||||||||||||||||
(in thousands, except per share data) | Mar. 31 | 30-Jun | 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 | $ | (0.14 | ) | $ | (0.12 | ) | $ | (0.13 | ) | $ | (0.12 | ) | $ | (0.52 | ) | ||||||
Net loss per common share - diluted | (0.14 | ) | (0.14 | ) | (0.13 | ) | (0.15 | ) | (0.56 | ) | |||||||||||
Weighted average number of common shares outstanding - basic | 84,728 | 85,061 | 85,209 | 85,358 | 85,095 | ||||||||||||||||
Weighted average number of common shares outstanding - diluted | 84,728 | 85,882 | 85,209 | 85,560 | 86,025 | ||||||||||||||||
2013 Quarters Ended: | |||||||||||||||||||||
(in thousands, except per share data) | Mar. 31 | 30-Jun | Sept. 30 | Dec. 31 | Total Year | ||||||||||||||||
Grant revenues | $ | 72 | $ | 182 | $ | 60 | $ | 74 | $ | 388 | |||||||||||
Expenses: | |||||||||||||||||||||
Cost of sales | – | – | – | 517 | 517 | ||||||||||||||||
Research and development | 8,472 | 6,863 | 6,574 | 5,752 | 27,661 | ||||||||||||||||
Selling, General and administrative | 4,220 | 4,129 | 4,299 | 4,070 | 16,718 | ||||||||||||||||
Total expenses | 12,692 | 10,992 | 10,873 | 10,339 | 44,896 | ||||||||||||||||
Operating loss | (12,620 | ) | (10,810 | ) | (10,813 | ) | (10,265 | ) | (44,508 | ) | |||||||||||
Change in fair value of common stock warrant liability | 162 | 2,525 | (1,059 | ) | (867 | ) | 761 | ||||||||||||||
Other expense, net | (177 | ) | (342 | ) | (352 | ) | (597 | ) | (1,468 | ) | |||||||||||
Net loss | $ | (12,635 | ) | $ | (8,627 | ) | $ | (12,224 | ) | $ | (11,729 | ) | $ | (45,215 | ) | ||||||
Net loss per common share - basic | $ | (0.29 | ) | $ | (0.18 | ) | $ | (0.22 | ) | $ | (0.16 | ) | $ | (0.82 | ) | ||||||
Net loss per common share - diluted | (0.29 | ) | (0.22 | ) | (0.22 | ) | (0.16 | ) | (0.82 | ) | |||||||||||
Weighted average number of common shares outstanding - basic | 43,657 | 49,135 | 54,792 | 73,129 | 55,258 | ||||||||||||||||
Weighted average number of common shares outstanding - diluted | 43,657 | 49,866 | 54,792 | 73,129 | 55,258 |
Accounting_Policies_and_Recent1
Accounting Policies and Recent Accounting Pronouncements (Policies) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Accounting Policies and Recent Accounting Pronouncements [Abstract] | |||||||||||||
Basis of presentation | The consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the U. S. | ||||||||||||
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, 2014 and 2013, respectively. Warrants classified as liabilities are recorded at their fair market value. Other financial instruments, including accounts payable and accrued expenses, are carried at cost, which we believe approximates fair value. | |||||||||||||
Accounts receivable | Accounts receivable | ||||||||||||
Trade accounts receivable are recorded net of allowances for prompt payment discounts and doubtful accounts. | |||||||||||||
Inventory | Inventory | ||||||||||||
Inventories, which are recorded at the lower of cost or market, include materials, labor, and other direct and indirect costs and are valued at cost using the first-in, first-out method. We capitalize inventories produced in preparation for commercial launch when all regulatory approvals needed to enable the commercial launch of the product are received and the related costs will be recoverable through the commercial sale of the product. Costs incurred prior to FDA approval of drug products and registration of medical devices is recorded in our statement of operations as research and development expense. Inventories are evaluated for impairment through consideration of factors such as the net realizable value, lower of cost or market, obsolescence, and expiry. Inventories do not have carrying values that exceed either cost or net realizable value. | |||||||||||||
We evaluate our expiry risk by evaluating current and future product demand relative to product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and hospital ordering practices. | |||||||||||||
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, Note 13 – Commitments, for further discussion on our leases). Under terms of the lease agreement, the required restricted cash balance was reduced by $100,000 to $225,000 in October 2014. | |||||||||||||
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, 2014, 2013, and 2012 as management believes there are no circumstances that indicate the carrying amount of the assets will not be recoverable. | |||||||||||||
Financing costs related to long-term debt | Financing costs related to long-term debt | ||||||||||||
Costs associated with obtaining long-term debt, including the fair value of warrants issued in connection with the debt and transaction fees, are amortized over the term of the related debt using the effective interest method. | |||||||||||||
Deferred revenue | Deferred revenue | ||||||||||||
Deferred revenue reflects amounts related to sales of SURFAXIN to our specialty distributor, which are then deferred and recognized as revenue once product has been sold through to the hospital and all revenue recognition criteria have been met. | |||||||||||||
Product sales | Product sales | ||||||||||||
Revenues from product sales are recognized when (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable and (4) collectability is reasonably assured. | |||||||||||||
Our products are distributed in the U.S. using a specialty distributor. Under this model, the specialty distributor purchases and takes physical delivery and title of product, and then sells to hospitals. We began the commercial introduction of SURFAXIN in the fourth quarter of 2013 and we currently cannot make a reasonable estimate of future product returns when product is delivered to the specialty distributor. Therefore, we currently do not recognize revenue upon product shipment to the specialty distributor, even though the distributor is invoiced upon product shipment. Instead, we recognize revenue once product has been sold through to the hospital and all revenue recognition criteria have been met. Once product has been delivered to a hospital, the risk of material returns is significantly mitigated. In developing estimates for sales returns, we consider the shelf life of the product, expected demand based on market data and return rates of other surfactant products. | |||||||||||||
Product sales are recorded net of accruals for estimated chargebacks, discounts, specialty distributor deductions and returns. | |||||||||||||
· | Chargebacks. Chargebacks are discounts that occur when contracted customers purchase directly from our specialty distributor. Contracted customers, which primarily consist of Group Purchasing Organizations member hospitals, generally purchase the product at a discounted price. Our specialty distributor, in turn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the customer. The allowance for specialty distributor chargebacks is based on known sales to contracted customers. | ||||||||||||
· | Sales discounts. Sales discounts are offered to certain contracted customers based upon a customer’s historical volume of surfactant product purchases. Customers must enter into a Letter of Participation (LOP) with us to receive sales discounts. Sales discounts are periodically adjusted on a prospective basis based upon the customer’s purchases of SURFAXIN, as provided in the LOP. The allowance for sales discounts is based on known sales to contracted customers. | ||||||||||||
· | Specialty distributor deductions. Our specialty distributor is offered various forms of consideration including allowances, service fees and prompt payment discounts. Specialty distributor allowances and service fees are provided for in our contractual agreement and are generally a percentage of the purchase price paid by the specialty distributor. The specialty distributor is offered a prompt pay discount for payment within a specified period. | ||||||||||||
· | Returns. Sales of our products are not subject to a general right of return; however, we will accept product that is damaged or defective when shipped or for expired product up to six months subsequent to its expiry date. | ||||||||||||
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” (ASC Topic 718). See, Note 11 – Stock Options and Stock-based Employee Compensation, for a detailed description of our recognition of stock-based compensation expense. The fair value of stock option grants is recognized evenly over the vesting period of the options or over the period between the grant date and the time the option becomes non-forfeitable by the employee, whichever is shorter. | |||||||||||||
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” (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. We classify derivative warrant liabilities on the consolidated balance sheet as current liabilities, which are revalued at each balance sheet date subsequent to the initial issuance. Depending on the terms of a warrant agreement, we use the Black-Scholes or trinomial pricing models to value the related derivative warrant liabilities. Changes in the fair value of the warrants are reflected in the consolidated statement of operations as “Change in the fair value of common stock warrant liability.” See, “– Note 8 – Common Stock Warrant Liability,” for a detailed description of our accounting for derivative warrant liabilities. | |||||||||||||
Collaborative arrangements | Collaborative arrangements | ||||||||||||
We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808 Collaborative Arrangements (ASC Topic 808). See, “ – Note 12 – Corporate Partnership, Licensing and Research Funding Agreements – Battelle Memorial Institute,” for a description of our accounting for the Battelle Collaboration Agreement. | |||||||||||||
Income taxes | Income taxes | ||||||||||||
We account for income taxes in accordance with ASC Topic 740, “Accounting for Income Taxes” (ASC Topic 740), which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. | |||||||||||||
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, 2014, 2013, and 2012, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 22.0 million, 20.2 million and 11.9 million shares, respectively. As of December 31, 2014, 2013, and 2012, there were 17.4 million, 15.4 million, and 7.0 million shares, respectively, 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, 2014, the effect of the adjustments for warrants classified as derivative liabilities was dilutive. For the years ended December 31, 2013 and 2012, the effect of the adjustments for warrants classified as derivative liabilities was anti-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, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator: | |||||||||||||
Net loss as reported | $ | (44,058 | ) | $ | (45,215 | ) | $ | (37,315 | ) | ||||
Less: income from change in fair value of warrant liability | (3,791 | ) | – | – | |||||||||
Numerator for diluted net loss per common share | $ | (47,849 | ) | $ | (45,215 | ) | $ | (37,315 | ) | ||||
Denominator: | |||||||||||||
Basic weighted average common shares outstanding | 85,095 | 55,258 | 39,396 | ||||||||||
Dilutive common shares from assumed warrant exercises | 930 | – | – | ||||||||||
Diluted weighted average common shares outstanding | 86,025 | 55,258 | 39,396 | ||||||||||
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 KL4 surfactant drug products from single-source suppliers. In addition, we rely on a number of third-party institutions and laboratories that perform various studies as well as quality control release and stability testing and other activities related to our KL4 surfactant development and manufacturing activities. At the present time, several of these laboratories are single-source providers. The loss of one or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations. | |||||||||||||
Major customer and concentration of credit risk | Major customer and concentration of credit risk | ||||||||||||
We currently sell our products to one exclusive pharmaceutical specialty distributor in the U.S. We periodically assess the financial strength of our specialty distributor and establish allowances for anticipated uncollectible amounts, if necessary. As of December 31, 2014 and 2013, we have not recorded an allowance for doubtful accounts. | |||||||||||||
Business segments | Business segments | ||||||||||||
We currently operate in one business segment, which is the research and development of products focused on surfactant replacement 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, which requires an entity to recognize revenue at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. generally accepted accounting principles (GAAP) when it becomes effective. The new standard is effective for us in the annual period ending December 31, 2017, including interim periods within that annual period. Early application is not permitted. We are evaluating the effect that ASU 2014-09 will have on our consolidated financial statements and related disclosures. The standard permits the use of either the retrospective or cumulative effect transition method. We have not yet selected a transition method nor determined the effect of the standard on our financial reporting. | |||||||||||||
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern, which requires management to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management will also be required to evaluate and disclose whether its plans alleviate that doubt. The standard defines substantial doubt as when it is probable (i.e., likely) that the entity will be unable to meet its obligations as they become due within one year of the date the financial statements are issued (or available to be issued, when applicable). The ASU is effective for the annual period ending December 31, 2016 and interim periods thereafter. Early application is permitted. We are evaluating the effect that ASU 2014-15 will have on our consolidated financial statements and related disclosures. The standard permits the use of either the retrospective or cumulative effect transition method. We have not yet selected a transition method nor determined the effect of the standard on our financial reporting. |
Accounting_Policies_and_Recent2
Accounting Policies and Recent Accounting Pronouncements (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
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, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator: | |||||||||||||
Net loss as reported | $ | (44,058 | ) | $ | (45,215 | ) | $ | (37,315 | ) | ||||
Less: income from change in fair value of warrant liability | (3,791 | ) | – | – | |||||||||
Numerator for diluted net loss per common share | $ | (47,849 | ) | $ | (45,215 | ) | $ | (37,315 | ) | ||||
Denominator: | |||||||||||||
Basic weighted average common shares outstanding | 85,095 | 55,258 | 39,396 | ||||||||||
Dilutive common shares from assumed warrant exercises | 930 | – | – | ||||||||||
Diluted weighted average common shares outstanding | 86,025 | 55,258 | 39,396 |
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
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, 2014 and 2013: | ||||||||||||||||
Fair Value | Fair value measurement using | ||||||||||||||||
(in thousands) | 31-Dec-14 | 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 | |||||||||
Fair Value | Fair value measurement using | ||||||||||||||||
(in thousands) | 31-Dec-13 | Level 1 | Level 2 | Level 3 | |||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 86,283 | $ | 86,283 | $ | – | $ | – | |||||||||
Certificate of deposit | 325 | 325 | – | – | |||||||||||||
Total Assets | $ | 86,608 | $ | 86,608 | $ | – | $ | – | |||||||||
Liabilities: | |||||||||||||||||
Common stock warrants | $ | 5,425 | $ | – | $ | – | $ | 5,425 | |||||||||
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 2013 and 2014: | ||||||||||||||||
(in thousands) | |||||||||||||||||
Balance at January 1, 2013 | $ | 6,305 | |||||||||||||||
Exercise of warrants (1) | (119 | ) | |||||||||||||||
Change in fair value of common stock warrant liability | (761 | ) | |||||||||||||||
Balance at December 31, 2013 | $ | 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 | |||||||||||||||
-1 | See, Note 8 – Common Stock Warrant Liability. | ||||||||||||||||
Significant unobservable input assumption used for valuation | 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. | ||||||||||||||||
December 31, | |||||||||||||||||
Significant Unobservable Input Assumptions of Level 3 Valuations | 2014 | 2013 | |||||||||||||||
Historical volatility | 55% – 84% | 62% –76% | |||||||||||||||
Expected term (in years) | 0.1 – 1.1 | 0.4 – 2.1 | |||||||||||||||
Risk-free interest rate | 0.03% – 0.31% | 0.08% – 0.44% |
Inventory_Tables
Inventory (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventory [Abstract] | |||||||||
Schedule of Inventory | Inventory is comprised of the following: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Raw materials | $ | – | $ | 52 | |||||
Finished goods, net of reserves | 27 | 60 | |||||||
Total inventories, net | $ | 27 | $ | 112 |
Property_and_Equipment_Tables
Property and Equipment (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property and Equipment [Abstract] | |||||||||
Property and equipment | Property and equipment is comprised of the following: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Manufacturing, laboratory & office equipment | $ | 9,154 | $ | 8,383 | |||||
Furniture & fixtures | 817 | 816 | |||||||
Leasehold improvements | 2,718 | 2,711 | |||||||
Subtotal | 12,689 | 11,910 | |||||||
Accumulated depreciation and amortization | (11,052 | ) | (10,254 | ) | |||||
Property and equipment, net | $ | 1,637 | $ | 1,656 |
Accrued_Expenses_Tables
Accrued Expenses (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Expenses [Abstract] | |||||||||
Accrued expenses | Accrued expenses are comprised of the following: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Salaries, bonus & benefits | $ | 2,332 | $ | 1,849 | |||||
Research and development | 1,641 | 270 | |||||||
Manufacturing operations | 876 | 1,707 | |||||||
Professional fees | 376 | 393 | |||||||
Sales and marketing | 318 | 161 | |||||||
All other | 573 | 405 | |||||||
Total accrued expenses | $ | 6,116 | $ | 4,785 |
Common_Stock_Warrant_Liability1
Common Stock Warrant Liability (Tables) | 12 Months Ended | |||||||||||||||||||||
Dec. 31, 2014 | ||||||||||||||||||||||
Common Stock Warrant Liability [Abstract] | ||||||||||||||||||||||
Estimated fair value of warrants accounted for derivative liabilities | Selected terms and estimated fair value of warrants accounted for as derivative are as follows: | |||||||||||||||||||||
Fair Value of Warrants | ||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||
Issuance Date | Number of Warrant Shares Issuable | Exercise Price | Warrant Expiration Date | Value at Issuance Date | December 31, | |||||||||||||||||
2014 | 2013 | |||||||||||||||||||||
2/23/10 | 916,669 | 12.75 | 2/23/15 | $ | 5,701 | $ | – | $ | 6 | |||||||||||||
2/22/11 | 4,550,100 | 1.5 | 2/22/16 | 8,004 | 1,258 | 5,419 | ||||||||||||||||
$ | 1,258 | $ | 5,425 |
Deerfield_Loan_Tables
Deerfield Loan (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Deerfield Loan [Abstract] | |||||||||||||
Long term debt included in balance sheet | Long-term debt consists solely of amounts due under a $30 million loan (Deerfield Loan) with affiliates of Deerfield Management Company, L.P. (Deerfield) for the periods presented: | ||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | ||||||||||||
Note payable | $ | 30,000 | $ | 30,000 | |||||||||
Unamortized discount | (9,698 | ) | (11,646 | ) | |||||||||
Long-term debt, net of discount | $ | 20,302 | $ | 18,354 | |||||||||
Significant unobservable input assumptions of Level 3 valuations | 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% | ||||||||||||
Interest expense included in statement of operations | The following amounts comprise the Deerfield Loan interest expense for the periods presented: | ||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Cash interest expense | $ | 2,625 | $ | 911 | $ | – | |||||||
Non-cash amortization of debt discounts | 1,948 | 534 | – | ||||||||||
Amortization of debt costs | 19 | 18 | – | ||||||||||
Total Deerfield Loan interest expenses | $ | 4,592 | $ | 1,463 | $ | – |
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
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 | Expiration | |||||||||||
2014 | 2013 | Price | Date | |||||||||||
Battelle – 2014 collaboration agreement(1) | 1,500 | – | $ | 5 | 10/10/24 | |||||||||
Deerfield – 2013 loan | 7,000 | 7,000 | $ | 2.81 | 2/13/19 | |||||||||
Former employee | 30 | 30 | $ | 3.2 | 3/18/16 | |||||||||
Investors – February 2011 financing | 4,550 | 4,835 | $ | 1.5 | 2/22/16 | |||||||||
PharmaBio – October 2010 financing | 79 | 79 | $ | 4.1 | 10/13/15 | |||||||||
Investors – June 2010 financing | 1,190 | 1,190 | $ | 6 | 6/22/15 | |||||||||
Kingsbridge – June 2010 CEFF | 83 | 83 | $ | 6.69 | 12/11/15 | |||||||||
PharmaBio – April 2010 financing | 135 | 135 | $ | 10.59 | 4/30/15 | |||||||||
Investors – February 2010 financing | 917 | 917 | $ | 12.75 | 2/23/15 | |||||||||
Investors – May 2009 financing | – | 467 | $ | 17.25 | 5/13/14 | |||||||||
Kingsbridge – December 2008 CEFF | – | 45 | $ | 22.7 | 6/12/14 | |||||||||
Total | 15,484 | 14,781 | ||||||||||||
(1) See Note 12 for further details on the Battelle collaboration agreement. |
Stock_Options_and_Stockbased_E1
Stock Options and Stock-based Employee Compensation (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
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, | |||||||||||||
2014 | 2013 | ||||||||||||
Stock Options and RSUs Outstanding | |||||||||||||
2011 Plan | 6,113 | 4,919 | |||||||||||
2007 Plan | 257 | 258 | |||||||||||
1998 Plan | 182 | 251 | |||||||||||
Total Outstanding | 6,552 | 5,428 | |||||||||||
Available for Future Grants under 2011 Plan | 6,667 | 2,894 | |||||||||||
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- | Weighted- | ||||||||||
Average | Average | ||||||||||||
Exercise | Remaining | ||||||||||||
Price | Contractual | ||||||||||||
Term (In Yrs) | |||||||||||||
Outstanding at January 1, 2014 | 5,428 | $ | 6.51 | ||||||||||
Granted | 1,786 | 2.39 | |||||||||||
Exercised | (17 | ) | 1.83 | ||||||||||
Forfeited or expired | (663 | ) | 15.57 | ||||||||||
Outstanding at December 31, 2014 | 6,534 | $ | 4.5 | 7.3 | |||||||||
Exercisable at December 31, 2014 | 3,599 | $ | 6.23 | 6.3 | |||||||||
(in thousands, except for weighted-average data) | |||||||||||||
Restricted Stock Units | Shares | Weighted- | |||||||||||
Average | |||||||||||||
Grant | |||||||||||||
Date Fair | |||||||||||||
Value | |||||||||||||
Unvested at January 1, 2014 | 19 | $ | 1.69 | ||||||||||
Awarded | 36 | $ | 1.71 | ||||||||||
Vested | (36 | ) | $ | 1.7 | |||||||||
Unvested at December 31, 2014 | 19 | $ | 1.71 | ||||||||||
Employee stock-based compensation | Stock-based compensation expense was classified as follows: | ||||||||||||
December 31, | |||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 1,014 | $ | 784 | $ | 487 | |||||||
Selling, general and administrative | 1,927 | 1,426 | 1,924 | ||||||||||
Total | $ | 2,941 | $ | 2,210 | $ | 2,411 | |||||||
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, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Weighted average expected volatility | 100% | 109% | 111% | ||||||||||
Weighted average expected term | 5.4 years | 4.7 years | 4.6 years | ||||||||||
Weighted average risk-free interest rate | 1.65% | 0.73% | 0.74% | ||||||||||
Expected dividends | – | – | – |
Commitments_Tables
Commitments (Tables) | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||
Commitments [Abstract] | |||||||||||||||||||||||||||||
Future payments due under contractual obligations | Future payments due under contractual obligations at December 31, 2014 are as follows: | ||||||||||||||||||||||||||||
(in thousands) | 2015 | 2016 | 2017 | 2018 | 2019 | There-after | Total | ||||||||||||||||||||||
Operating lease obligations | $ | 1,239 | $ | 961 | $ | 943 | $ | 158 | $ | – | $ | – | $ | 3,301 | |||||||||||||||
Equipment loan obligations | 69 | – | – | – | – | – | 69 | ||||||||||||||||||||||
Total | $ | 1,308 | $ | 961 | $ | 943 | $ | 158 | $ | – | $ | – | $ | 3,370 |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
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, 2014, 2013, and 2012 is as follows: | ||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | 2012 | |||||||||||
Income tax benefit, statutory rates | $ | 14,980 | $ | 15,373 | $ | 12,687 | |||||||
State taxes on income, net of Federal benefit | 2,871 | 2,922 | 2,288 | ||||||||||
Research and development tax credit | 1,472 | 517 | 332 | ||||||||||
Employee related | (2,131 | ) | (766 | ) | (988 | ) | |||||||
Warrant valuation related | 1,289 | 259 | 189 | ||||||||||
Income tax benefit | 18,481 | 18,305 | 14,508 | ||||||||||
Valuation allowance | (18,481 | ) | (18,305 | ) | (14,508 | ) | |||||||
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, 2014 and 2013, are as follows: | ||||||||||||
(in thousands) | December 31, | ||||||||||||
2014 | 2013 | ||||||||||||
Long-term deferred tax assets: | |||||||||||||
Net operating loss carryforwards (Federal and state) | $ | 191,643 | $ | 175,258 | |||||||||
Research and development tax credits | 12,927 | 10,604 | |||||||||||
Compensation expense on stock | 2,588 | 3,276 | |||||||||||
Charitable contribution carryforward | 7 | 7 | |||||||||||
Inventory reserve | 907 | 198 | |||||||||||
Deferred revenue | 16 | 53 | |||||||||||
Other accrued | 1,088 | 1,024 | |||||||||||
Depreciation | 2,630 | 2,714 | |||||||||||
Capitalized research and development | 1,123 | 1,326 | |||||||||||
Total long-term deferred tax assets | 212,929 | 194,460 | |||||||||||
Less: valuation allowance | (212,929 | ) | (194,460 | ) | |||||||||
Deferred tax assets, net of valuation allowance | $ | – | $ | – |
Selected_Quarterly_Financial_D1
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) [Abstract] | |||||||||||||||||||||
Schedule of quarterly financial information | The following tables contain unaudited statement of operations information for each quarter of 2014 and 2013. The operating results for any quarter are not necessarily indicative of results for any future period. | ||||||||||||||||||||
2014 Quarters Ended: | |||||||||||||||||||||
(in thousands, except per share data) | Mar. 31 | 30-Jun | 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 | $ | (0.14 | ) | $ | (0.12 | ) | $ | (0.13 | ) | $ | (0.12 | ) | $ | (0.52 | ) | ||||||
Net loss per common share - diluted | (0.14 | ) | (0.14 | ) | (0.13 | ) | (0.15 | ) | (0.56 | ) | |||||||||||
Weighted average number of common shares outstanding - basic | 84,728 | 85,061 | 85,209 | 85,358 | 85,095 | ||||||||||||||||
Weighted average number of common shares outstanding - diluted | 84,728 | 85,882 | 85,209 | 85,560 | 86,025 | ||||||||||||||||
2013 Quarters Ended: | |||||||||||||||||||||
(in thousands, except per share data) | Mar. 31 | 30-Jun | Sept. 30 | Dec. 31 | Total Year | ||||||||||||||||
Grant revenues | $ | 72 | $ | 182 | $ | 60 | $ | 74 | $ | 388 | |||||||||||
Expenses: | |||||||||||||||||||||
Cost of sales | – | – | – | 517 | 517 | ||||||||||||||||
Research and development | 8,472 | 6,863 | 6,574 | 5,752 | 27,661 | ||||||||||||||||
Selling, General and administrative | 4,220 | 4,129 | 4,299 | 4,070 | 16,718 | ||||||||||||||||
Total expenses | 12,692 | 10,992 | 10,873 | 10,339 | 44,896 | ||||||||||||||||
Operating loss | (12,620 | ) | (10,810 | ) | (10,813 | ) | (10,265 | ) | (44,508 | ) | |||||||||||
Change in fair value of common stock warrant liability | 162 | 2,525 | (1,059 | ) | (867 | ) | 761 | ||||||||||||||
Other expense, net | (177 | ) | (342 | ) | (352 | ) | (597 | ) | (1,468 | ) | |||||||||||
Net loss | $ | (12,635 | ) | $ | (8,627 | ) | $ | (12,224 | ) | $ | (11,729 | ) | $ | (45,215 | ) | ||||||
Net loss per common share - basic | $ | (0.29 | ) | $ | (0.18 | ) | $ | (0.22 | ) | $ | (0.16 | ) | $ | (0.82 | ) | ||||||
Net loss per common share - diluted | (0.29 | ) | (0.22 | ) | (0.22 | ) | (0.16 | ) | (0.82 | ) | |||||||||||
Weighted average number of common shares outstanding - basic | 43,657 | 49,135 | 54,792 | 73,129 | 55,258 | ||||||||||||||||
Weighted average number of common shares outstanding - diluted | 43,657 | 49,866 | 54,792 | 73,129 | 55,258 |
Liquidity_Risks_and_Management1
Liquidity Risks and Management's Plans (Details) (USD $) | 12 Months Ended | ||||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | 31-May-13 | Mar. 31, 2012 | Feb. 22, 2011 | |
Liquidity Risks and Management's Plans [Abstract] | |||||||
Cash and cash equivalents | $44,711,000 | $86,283,000 | $26,892,000 | $10,189,000 | |||
Long-term debt, gross | 30,000,000 | ||||||
Class of Warrant or Right [Line Items] | |||||||
Exercise price of warrants (in dollars per share) | $2.81 | ||||||
Number of warrant shares issuable (in shares) | 15,500,000 | ||||||
Potential value of common stock issuable upon exercise of warrants | 803,000 | 290,000 | 6,877,000 | ||||
Common stock, shares authorized (in shares) | 250,000,000 | 150,000,000 | |||||
Common stock available for future issuance (in shares) | 135,700,000 | ||||||
Deerfield Management Company [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Exercise price of warrants (in dollars per share) | $2.81 | ||||||
Number of warrant shares issuable (in shares) | 7,000,000 | ||||||
Potential value of common stock issuable upon exercise of warrants | 6,800,000 | ||||||
Issued February 22, 2011 [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Exercise price of warrants (in dollars per share) | $1.50 | $1.50 | $2.80 | $3.20 | |||
Number of warrant shares issuable (in shares) | 4,550,100 | ||||||
ATM Program [Member] | |||||||
Stockholders' Equity [Line Items] | |||||||
Maximum period to defer payment | 12 months | ||||||
Maximum value of potential common stock available for issue | $23,000,000 | ||||||
Percentage sales commission on shares (in hundredths) | 3.00% |
Accounting_Policies_and_Recent3
Accounting Policies and Recent Accounting Pronouncements (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Segment | |||||||||||
Restricted Cash [Abstract] | |||||||||||
Restricted cash | $225,000 | $225,000 | |||||||||
Decrease in restricted cash | 100,000 | ||||||||||
Long-lived assets [Abstract] | |||||||||||
Impairment of long-lived assets | 0 | 0 | 0 | ||||||||
Numerator [Abstract] | |||||||||||
Net loss as reported | -10,635,000 | -11,324,000 | -10,623,000 | -11,476,000 | -11,729,000 | -12,224,000 | -8,627,000 | -12,635,000 | -44,058,000 | -45,215,000 | -37,315,000 |
Less: income from change in fair value of warrant liability | -3,791,000 | 0 | 0 | ||||||||
Numerator for diluted net loss per common share | ($47,849,000) | ($45,215,000) | ($37,315,000) | ||||||||
Denominator [Abstract] | |||||||||||
Basic weighted average common shares outstanding (in shares) | 85,358,000 | 85,209,000 | 85,061,000 | 84,728,000 | 73,129,000 | 54,792,000 | 49,135,000 | 43,657,000 | 85,095,000 | 55,258,000 | 39,396,000 |
Dilutive common shares from assumed warrant exercises (in shares) | 930,000 | 0 | 0 | ||||||||
Diluted weighted average common shares outstanding (in shares) | 85,560,000 | 85,209,000 | 85,882,000 | 84,728,000 | 73,129,000 | 54,792,000 | 49,866,000 | 43,657,000 | 86,025,000 | 55,258,000 | 39,396,000 |
Number of shares of common stock potentially issuable exercise of certain stock options and warrants (in shares) | 22,000,000 | 20,200,000 | 11,900,000 | ||||||||
Potential common stock issuable upon exercise of stock options and warrants (in shares) | 17,400,000 | 15,400,000 | 7,000,000 | ||||||||
Business segments [Abstract] | |||||||||||
Number of operating segments | 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 $) | Dec. 31, 2014 | Dec. 31, 2013 |
Liabilities [Abstract] | ||
Fair value of loan | $22,200,000 | $23,600,000 |
Long-Term Debt | 20,302,000 | 18,354,000 |
Recurring [Member] | ||
Assets [Abstract] | ||
Fair Value | 44,936,000 | 86,608,000 |
Recurring [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Fair Value | 44,936,000 | 86,608,000 |
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 | 44,711,000 | 86,283,000 |
Recurring [Member] | Cash and cash equivalents [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Fair Value | 44,711,000 | 86,283,000 |
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 | 225,000 | 325,000 |
Recurring [Member] | Certificate of Deposit [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Fair Value | 225,000 | 325,000 |
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 | 1,258,000 | 5,425,000 |
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 | $1,258,000 | $5,425,000 |
Fair_Value_Measurements_Level_
Fair Value Measurements, Level 3 Rollforward (Details) (USD $) | 12 Months Ended | |||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | ||
Fair value measurements of common stock warrants using significant unobservable inputs (level 3) | ||||
Balance at end of period | $1,258 | $5,425 | ||
Level 3 [Member] | ||||
Fair value measurements of common stock warrants using significant unobservable inputs (level 3) | ||||
Balance at beginning of period | 5,425 | 6,305 | ||
Exercise of warrants | -376 | [1] | -119 | [1] |
Change in fair value of common stock warrant liability | -3,791 | -761 | ||
Balance at end of period | $1,258 | $5,425 | ||
[1] | See, Note 8 - Common Stock Warrant Liability. |
Fair_Value_Measurements_Signif
Fair Value Measurements, Significant Unobservable input assumptions of Level 3 valuations (Details) (Level 3 [Member]) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Minimum [Member] | ||
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ||
Historical Volatility (in hundredths) | 55.00% | 62.00% |
Expected Term (in years) | 0 years 1 month 6 days | 0 years 4 months 24 days |
Risk-free interest rate (in hundredths) | 0.03% | 0.08% |
Maximum [Member] | ||
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ||
Historical Volatility (in hundredths) | 84.00% | 76.00% |
Expected Term (in years) | 1 year 1 month 6 days | 2 years 1 month 6 days |
Risk-free interest rate (in hundredths) | 0.31% | 0.44% |
Inventory_Details
Inventory (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Inventories, current [Abstract] | ||
Raw materials | $0 | $52,000 |
Finished goods, net of reserves | 27,000 | 60,000 |
Total inventories, net | 27,000 | 112,000 |
Raw materials on hand purchased prior to October 4, 2013 | 500,000 | |
Inventory reserves | $2,400 | $500 |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Property and equipment [Line Items] | |||
Property and equipment, gross | $12,689,000 | $11,910,000 | |
Accumulated depreciation and amortization | -11,052,000 | -10,254,000 | |
Property and equipment, net | 1,637,000 | 1,656,000 | |
Depreciation expense | 800,000 | 700,000 | 900,000 |
Manufacturing, laboratory & office equipment [Member] | |||
Property and equipment [Line Items] | |||
Property and equipment, gross | 9,154,000 | 8,383,000 | |
Furniture & fixtures [Member] | |||
Property and equipment [Line Items] | |||
Property and equipment, gross | 817,000 | 816,000 | |
Leasehold improvements [Member] | |||
Property and equipment [Line Items] | |||
Property and equipment, gross | $2,718,000 | $2,711,000 |
Accrued_Expenses_Details
Accrued Expenses (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Expenses [Abstract] | ||
Salaries, bonus & benefits | $2,332 | $1,849 |
Research and development | 1,641 | 270 |
Manufacturing operations | 876 | 1,707 |
Professional fees | 376 | 393 |
Sales and marketing | 318 | 161 |
All other | 573 | 405 |
Total accrued expenses | $6,116 | $4,785 |
Common_Stock_Warrant_Liability2
Common Stock Warrant Liability (Details) (USD $) | 0 Months Ended | 12 Months Ended | ||||
Feb. 23, 2010 | Feb. 22, 2011 | Dec. 31, 2014 | Dec. 31, 2013 | 31-May-13 | Mar. 31, 2012 | |
Estimated fair value of warrants accounted for as derivative liabilities [Abstract] | ||||||
Number of Warrant Shares Issuable (in shares) | 15,500,000 | |||||
Fair Value of Warrants | $1,258,000 | $5,425,000 | ||||
Exercise price of warrants (in dollars per share) | $2.81 | |||||
Five Year Warrant 2 [Member] | ||||||
Estimated fair value of warrants accounted for as derivative liabilities [Abstract] | ||||||
Issuance Date | 23-Feb-10 | |||||
Number of Warrant Shares Issuable (in shares) | 916,669 | |||||
Exercise Price (in dollars per share) | $12.75 | |||||
Warrant Expiration Date | 23-Feb-15 | |||||
Fair Value of Warrants | 5,701,000 | 0 | 6,000 | |||
February 2011 warrants [Member] | ||||||
Class of Warrant or Right [Line Items] | ||||||
Exercisable period of warrants | 5 years | |||||
Estimated fair value of warrants accounted for as derivative liabilities [Abstract] | ||||||
Issuance Date | 22-Feb-11 | |||||
Number of Warrant Shares Issuable (in shares) | 4,550,100 | |||||
Exercise Price (in dollars per share) | $1.50 | |||||
Warrant Expiration Date | 22-Feb-16 | |||||
Fair Value of Warrants | 8,004,000 | 1,258,000 | 5,419,000 | |||
Exercise of warrants by warrant holders to purchase common stock (in shares) | 284,850 | 113,800 | ||||
Proceeds from exercise of warrants | $400,000 | $200,000 | ||||
Exercise price of warrants (in dollars per share) | $3.20 | $1.50 | $1.50 | $2.80 |
Deerfield_Loan_Details
Deerfield Loan (Details) (USD $) | 12 Months Ended | ||
Share data in Millions, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Disbursement | |||
Line of Credit Facility [Line Items] | |||
Date facility agreement entered | 13-Feb-13 | ||
Loan facility, maximum amount | $30,000,000 | ||
Number of disbursements | 2 | ||
Loan facility payment terms | The principal amount of the loan is payable in three $10 million annual installments beginning in February 2017, provided that the amount payable in February 2017 shall be deferred for one year if either (i) our bNet Salesb (defined below) for the immediately preceding 12-month period are at least $20 million, or (ii) our bEquity Valueb (defined below) is at least $200 million; and provided further, that the amount payable in February 2018 (together with any amount deferred in February 2017) shall be deferred until February 2019 if either (i) our bNet Salesb for the immediately preceding 12-month period are at least $30 million, or (ii) our bEquity Valueb is at least $250 million. | ||
Transaction fee, percentage (in hundredths) | 1.50% | ||
Cash interest rate under loan facility (in hundredths) | 8.75% | ||
Percentage sale of assets (in hundredths) | 50.00% | ||
Number of shares under issued warrants (in shares) | 7 | ||
Exercise price of warrants (in dollars per share) | $2.81 | ||
Percentage of common stock, maximum (in hundredths) | 9.99% | ||
Fair value of warrants issued under both the first and second disbursement | 11,700,000 | ||
Transaction fee | 450,000 | ||
Carrying value of Facility Agreement [Abstract] | |||
Note Payable | 30,000,000 | 30,000,000 | |
Unamortized discount | -9,698,000 | -11,646,000 | |
Long-term debt, net of discount | 20,302,000 | 18,354,000 | |
Interest expense [Abstract] | |||
Cash interest expense | 2,625,000 | 911,000 | 0 |
Non-cash amortization of debt discounts | 1,948,000 | 534,000 | 0 |
Amortization of debt costs | 19,000 | 18,000 | 0 |
Total Deerfield Loan interest expenses | 4,592,000 | 1,463,000 | 0 |
Deerfield Warrants [Member] | |||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | |||
Historical Volatility (in hundredths) | 101.00% | ||
Minimum [Member] | Deerfield Warrants [Member] | |||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | |||
Expected Term (in years) | 5 years 2 months 12 days | ||
Risk-free interest rate (in hundredths) | 1.20% | ||
Maximum [Member] | Deerfield Warrants [Member] | |||
Significant unobservable input assumptions of Level 3 valuations [Abstract] | |||
Expected Term (in years) | 6 years | ||
Risk-free interest rate (in hundredths) | 1.50% | ||
First Disbursement [Member] | |||
Line of Credit Facility [Line Items] | |||
Number of shares under issued warrants (in shares) | 2.3 | ||
Second Disbursement [Member] | |||
Line of Credit Facility [Line Items] | |||
Number of shares under issued warrants (in shares) | 4.7 | ||
Fourth anniversary [Member] | Minimum [Member] | |||
Line of Credit Facility [Line Items] | |||
Net sales for 12-month period immediately preceding repayment date | 20,000,000 | ||
Equity Value at repayment date | 200,000,000 | ||
Sixth anniversary [Member] | Minimum [Member] | |||
Line of Credit Facility [Line Items] | |||
Net sales for 12-month period immediately preceding repayment date | 30,000,000 | ||
Equity Value at repayment date | $250,000,000 |
Stockholders_Equity_Registered
Stockholders' Equity, Registered Public Offerings (Details) (Registered Public Offerings [Member], Common Stock [Member], USD $) | 0 Months Ended | 1 Months Ended | |||||||
Nov. 08, 2013 | Nov. 05, 2013 | 28-May-13 | 10-May-13 | Apr. 30, 2012 | Mar. 21, 2012 | Dec. 05, 2013 | Jun. 10, 2013 | Apr. 30, 2012 | |
Registered Public Offerings [Member] | Common Stock [Member] | |||||||||
Stockholders' Equity [Line Items] | |||||||||
Issuance of common stock, financing (in shares) | 25,000,000 | 9,500,000 | 16,071,429 | ||||||
Issue price of common unit (in dollars per unit) | $2 | $2 | $1.50 | $1.50 | $2.80 | $2.80 | $2.80 | ||
Gross proceeds | $7,500,000 | $50,000,000 | $2,000,000 | $14,300,000 | $45,000,000 | ||||
Net proceeds from issuance of common stock | $7,100,000 | $46,800,000 | $1,900,000 | $13,200,000 | $42,100,000 | ||||
Number of days option granted to underwriters | 30 days | 30 days | 30 days | ||||||
Number of shares covered under options granted to underwriter (in shares) | 3,750,000 | 1,425,000 | 2,410,714 | ||||||
Number of shares exercised by the underwriter | 3,750,000 | 1,347,000 | 0 |
Stockholders_Equity_Committed_
Stockholders' Equity, Committed Equity Financing Facility (Details) (2011 Long-Term Incentive Plan [Member], USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
2011 Long-Term Incentive Plan [Member] | ||
Stockholders' Equity [Line Items] | ||
Maximum value of potential common stock available for issue | $6.70 | $2.90 |
Stockholders_Equity_ATM_Progra
Stockholders' Equity, ATM Program and 401(k) Matching Contributions (Details) (USD $) | 12 Months Ended | 0 Months Ended | |||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Mar. 12, 2012 | Dec. 14, 2011 | Oct. 15, 2013 | Feb. 11, 2013 | |
Stockholders' Equity [Line Items] | |||||||
Issuance of common stock, 401(k) employer match (in shares) | 593,198 | 510,047 | 316,543 | ||||
Expense associated with 401(k) plan | $1,000,000 | $1,000,000 | $800,000 | ||||
Lazard ATM Program [Member] | |||||||
Stockholders' Equity [Line Items] | |||||||
Maximum value of potential common stock available for issue | 15,000,000 | ||||||
Percentage sales commission on shares (in hundredths) | 3.00% | ||||||
Issuance of common stock, financing (in shares) | 350,374 | ||||||
Issuance of common stock, financing | 1,600,000 | ||||||
Net proceeds from issuance of stock | 1,500,000 | ||||||
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 (in hundredths) | 3.00% | ||||||
Issuance of common stock, financing (in shares) | 713,920 | ||||||
Issuance of common stock, financing | 2,000,000 | ||||||
Net proceeds from issuance of stock | 1,800,000 | ||||||
Amount available under the ATM Program | $23,000,000 |
Stockholders_Equity_Common_Sha
Stockholders' Equity, Common Shares Reserved for Future Issuance (Details) (USD $) | 12 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | |||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 15,484,000 | 14,781,000 | ||
Exercise Price (in dollars per share) | $2.81 | |||
Former Employee [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 30,000 | 30,000 | ||
Exercise Price (in dollars per share) | $3.20 | |||
Expiration Date | 18-Mar-16 | |||
401(k) Plan [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 6,130 | 166,243 | ||
Battelle - 2014 Collaboration Agreement [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 1,500,000 | [1] | 0 | [1] |
Exercise Price (in dollars per share) | $5 | [1] | ||
Expiration Date | 10-Oct-24 | [1] | ||
Deerfield - 2013 Loan [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 7,000,000 | 7,000,000 | ||
Exercise Price (in dollars per share) | $2.81 | |||
Expiration Date | 13-Feb-19 | |||
Investor - February 2011 Financing [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 4,550,000 | 4,835,000 | ||
Exercise Price (in dollars per share) | $1.50 | |||
Expiration Date | 22-Feb-16 | |||
PharmaBio - October 2010 Financing [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 79,000 | 79,000 | ||
Exercise Price (in dollars per share) | $4.10 | |||
Expiration Date | 13-Oct-15 | |||
Investor - June 2010 Financing [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 1,190,000 | 1,190,000 | ||
Exercise Price (in dollars per share) | $6 | |||
Expiration Date | 22-Jun-15 | |||
Kingsbridge - June 2010 CEFF [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 83,000 | 83,000 | ||
Exercise Price (in dollars per share) | $6.69 | |||
Expiration Date | 11-Dec-15 | |||
PharmaBio - April 2010 Financing [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 135,000 | 135,000 | ||
Exercise Price (in dollars per share) | $10.59 | |||
Expiration Date | 30-Apr-15 | |||
Investor - February 2010 Financing [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 917,000 | 917,000 | ||
Exercise Price (in dollars per share) | $12.75 | |||
Expiration Date | 23-Feb-15 | |||
Investor - May 2009 Financing [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 0 | 467,000 | ||
Exercise Price (in dollars per share) | $17.25 | |||
Expiration Date | 13-May-14 | |||
Kingsbridge - December 2008 CEFF [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for issuance (in shares) | 0 | 45,000 | ||
Exercise Price (in dollars per share) | $22.70 | |||
Expiration Date | 12-Jun-14 | |||
2011 Long-Term Incentive Plan [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Common stock available for future issuance (in shares) | 6.7 | 2.9 | ||
[1] | See Note 12 for further details on the Batelle collaboration. |
Stock_Options_and_Stockbased_E2
Stock Options and Stock-based Employee Compensation (Details) (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | |||
Total Outstanding (in shares) | 6,552,000 | 5,428,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Stock options outstanding, beginning of period (in shares) | 5,428,000 | ||
Granted (in shares) | 1,786,000 | ||
Exercised (in shares) | -17,000 | ||
Forfeited or expired (in shares) | -663,000 | ||
Stock options outstanding, end of period (in shares) | 6,534,000 | 5,428,000 | |
Exercisable at end of period (in shares) | 3,599,000 | ||
Weighted Average Exercise Price [Roll Forward] | |||
Outstanding, beginning of period (in dollars per share) | $6.51 | ||
Granted (in dollars per share) | $2.39 | ||
Exercised (in dollars per share) | $1.83 | ||
Forfeited or expired (in dollars per share) | $15.57 | ||
Outstanding, end of period (in dollars per share) | $4.50 | $6.51 | |
Exercisable at end of period (in dollars per share) | $6.23 | ||
Outstanding, weighted average remaining contractual term | 7 years 3 months 18 days | ||
Exercisable, weighted average remaining contractual term | 6 years 3 months 18 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) | $1.82 | $1.79 | $2.02 |
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 | 19,000 | ||
Awarded (in shares) | 36,000 | ||
Vested (in shares) | -36,000 | ||
Unvested RSAs outstanding (in shares), end of period | 19,000 | ||
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) | $1.69 | ||
Awarded (in dollars per share) | $1.71 | ||
Vested (in dollars per share) | $1.70 | ||
Unvested at end of period (in dollars per share) | $1.71 | $0 | |
2011 Long-Term Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares authorized (in shares) | 12,800,000 | ||
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | |||
Total Outstanding (in shares) | 6,113,000 | 4,919,000 | |
Available for Future Grants under 2011 Plan (in shares) | 6,667,000 | 2,894,000 | |
Duration of continuous service | 3 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) | 257,000 | 258,000 | |
1998 Equity Incentive Plan [Member] | |||
Stock options and restricted stock units (RSUs) outstanding and available for future issuance [Abstract] | |||
Total Outstanding (in shares) | 182,000 | 251,000 |
Stock_Options_and_Stockbased_E3
Stock Options and Stock-based Employee Compensation, Options Outstanding, Vested and Exercisable (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Employee stock-based compensation | $2,941,000 | $2,210,000 | $2,411,000 |
Weighted-average assumptions used in estimating fair value of stock options [Abstract] | |||
Weighted average expected volatility (in hundredths) | 100.00% | 109.00% | 111.00% |
Weighted average expected term | 5 years 4 months 24 days | 4 years 8 months 12 days | 4 years 7 months 6 days |
Weighted average risk-free interest rate (in hundredths) | 1.65% | 0.73% | 0.74% |
Expected dividends (in hundredths) | 0.00% | 0.00% | 0.00% |
Fair value of options vested during period | 3,100,000 | 1,900,000 | 2,200,000 |
Unrecognized compensation cost related to non-vested share-based compensation arrangements | 3,400,000 | ||
Weighted-average vesting period of stock options | 1 year 7 months 6 days | ||
Research and Development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Employee stock-based compensation | 1,014,000 | 784,000 | 487,000 |
Selling, General & Administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Employee stock-based compensation | $1,927,000 | $1,426,000 | $1,924,000 |
Corporate_Partnership_Licensin1
Corporate Partnership, Licensing and Research Funding Agreements (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||||
Share data in Millions, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||
Licensing and Research Funding Agreements [Abstract] | |||||||||||||
Research and development expense | $7,771,000 | $6,471,000 | $6,858,000 | $5,590,000 | $5,752,000 | $6,574,000 | $6,863,000 | $8,472,000 | $26,690,000 | $27,661,000 | $21,570,000 | ||
Exercise price of warrants (in dollars per share) | $2.81 | $2.81 | |||||||||||
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 | 300,000 | ||||||||||||
Term of collaboration agreement | 10 years | ||||||||||||
Exercise price of warrants (in dollars per share) | $5 | [1] | $5 | [1] | |||||||||
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) | 0.5 | 0.5 | |||||||||||
Battelle - 2014 Collaboration Agreement [Member] | Initial Warrants [Member] | |||||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||||
Number of warrant shares issuable (in shares) | 1 | 1 | |||||||||||
Phillip Morris - License Agreement [Member] | |||||||||||||
Licensing and Research Funding Agreements [Abstract] | |||||||||||||
Royalty paid | 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 | ||||||||||||
[1] | See Note 12 for further details on the Batelle collaboration. |
Commitments_Details
Commitments (Details) (USD $) | 12 Months Ended | 0 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jan. 31, 2013 | |
Component | ||||
Operating lease obligations [Abstract] | ||||
2015 | $1,239,000 | |||
2016 | 961,000 | |||
2017 | 943,000 | |||
2018 | 158,000 | |||
2019 | 0 | |||
Thereafter | 0 | |||
Total | 3,301,000 | |||
Equipment loan obligation [Abstract] | ||||
2015 | 69,000 | |||
2016 | 0 | |||
2017 | 0 | |||
2018 | 0 | |||
2019 | 0 | |||
There-after | 0 | |||
Total | 69,000 | |||
Total Contractual Obligations [Abstract] | ||||
Total 2015 | 1,308,000 | |||
Total 2016 | 961,000 | |||
Total 2017 | 943,000 | |||
Total 2018 | 158,000 | |||
Total 2019 | 0 | |||
Total Thereafter | 0 | |||
Contractual Obligations, Total | 3,370,000 | |||
Operating Leased Assets [Line Items] | ||||
Rent expense | 1,200,000 | 1,000,000 | 1,000,000 | |
Estimated development costs | 6,000,000 | |||
Retention plan [Line Items] | ||||
Number of components for retention plan | 2 | |||
Amount estimated for severance and retention | 900,000 | |||
Liability for severance and retention | 600,000 | 100,000 | ||
Expense Related to Severance and Retention During the Period | 500,000 | 100,000 | ||
Plant Management [Member] | ||||
Retention plan [Line Items] | ||||
Number of employees receiving retention plan awards | 3 | |||
Non-Union employees [Member] | ||||
Retention plan [Line Items] | ||||
Number of employees receiving retention plan awards | 8 | |||
Collective Bargaining Agreement [Member] | ||||
Retention plan [Line Items] | ||||
Number of employees receiving retention plan awards | 12 | |||
Percentage of total labor force (in hundredths) | 11.00% | |||
Liability for severance and retention | 400,000 | 400,000 | ||
Headquarters [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Leased Area of Real Estate Property | 39,594 | |||
Lease extension term | 5 years | |||
Aggregate rental payments | 7,200,000 | 4,900,000 | ||
Sterile Manufacturing Facility [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Leased Area of Real Estate Property | 21,000 | |||
Annual rent of leased property | $525,000 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Reconciliation of income tax benefit to Federal statutory rates [Abstract] | |||
Income tax benefit, statutory rates | $14,980,000 | $15,373,000 | $12,687,000 |
State taxes on income, net of Federal benefit | 2,871,000 | 2,922,000 | 2,288,000 |
Research and development tax credit | 1,472,000 | 517,000 | 332,000 |
Employee related | -2,131,000 | -766,000 | -988,000 |
Warrant valuation related | 1,289,000 | 259,000 | 189,000 |
Income tax benefit | 18,481,000 | 18,305,000 | 14,508,000 |
Valuation allowance | -18,481,000 | -18,305,000 | -14,508,000 |
Income tax benefit | 0 | 0 | 0 |
Long-term deferred tax assets [Abstract] | |||
Net operating loss carryforwards(Federal and state) | 191,643,000 | 175,258,000 | |
Research and development tax credits | 12,927,000 | 10,604,000 | |
Compensation expense on stock | 2,588,000 | 3,276,000 | |
Charitable contribution carryforward | 7,000 | 7,000 | |
Inventory reserve | 907,000 | 198,000 | |
Deferred revenue | 16,000 | 53,000 | |
Other accrued | 1,088,000 | 1,024,000 | |
Depreciation | 2,630,000 | 2,714,000 | |
Capitalized research and development | 1,123,000 | 1,326,000 | |
Total long-term deferred tax assets | 212,929,000 | 194,460,000 | |
Less: valuation allowance | -212,929,000 | -194,460,000 | |
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 | 0 |
Research Tax Credit Carryforward [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward amount | 12,900,000 | 10,600,000 | |
Internal Revenue Service (IRS) [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 473,300,000 | 432,100,000 | |
Internal Revenue Service (IRS) [Member] | Minimum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards expiration dates | 31-Dec-08 | ||
Internal Revenue Service (IRS) [Member] | Maximum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards expiration dates | 31-Dec-34 | ||
Internal Revenue Service (IRS) [Member] | Research Tax Credit Carryforward [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward expiration date | expire in 2008 and will continue through 2034 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 470,400,000 | 433,700,000 | |
Federal [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 5,200,000 | ||
State [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 400,000 | ||
PENNSYLVANIA [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $436,000,000 |
Selected_Quarterly_Financial_D2
Selected Quarterly Financial Data (Unaudited) (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Revenues: | |||||||||||
Product sales | $136 | $106 | $42 | $28 | $312 | $0 | $0 | ||||
Grant Revenues | 1,048 | 421 | 1,051 | 3 | 74 | 60 | 182 | 72 | 2,523 | 388 | 195 |
Total revenues | 1,184 | 527 | 1,093 | 31 | 2,835 | 388 | 195 | ||||
Expenses: | |||||||||||
Cost of sales | 902 | 257 | 731 | 781 | 517 | 0 | 0 | 0 | 2,671 | 517 | 0 |
Research and development | 7,771 | 6,471 | 6,858 | 5,590 | 5,752 | 6,574 | 6,863 | 8,472 | 26,690 | 27,661 | 21,570 |
Selling, General and administrative | 3,737 | 4,126 | 4,446 | 4,423 | 4,070 | 4,299 | 4,129 | 4,220 | 16,732 | 16,718 | 16,444 |
Total expenses | 12,410 | 10,854 | 12,035 | 10,794 | 10,339 | 10,873 | 10,992 | 12,692 | 46,093 | 44,896 | 38,014 |
Operating loss | -11,226 | -10,327 | -10,942 | -10,763 | -10,265 | -10,813 | -10,810 | -12,620 | -43,258 | -44,508 | -37,819 |
Change in fair value of common stock warrant liability | 1,792 | 173 | 1,448 | 378 | -867 | -1,059 | 2,525 | 162 | 3,791 | 761 | 555 |
Other expense, net | -1,201 | -1,170 | -1,129 | -1,091 | -597 | -352 | -342 | -177 | -4,591 | -1,468 | -51 |
Net loss | ($10,635) | ($11,324) | ($10,623) | ($11,476) | ($11,729) | ($12,224) | ($8,627) | ($12,635) | ($44,058) | ($45,215) | ($37,315) |
Net loss per common share - basic (in dollars per share) | ($0.12) | ($0.13) | ($0.12) | ($0.14) | ($0.16) | ($0.22) | ($0.18) | ($0.29) | ($0.52) | ($0.82) | ($0.95) |
Net loss per common share - diluted (in dollars per share) | ($0.15) | ($0.13) | ($0.14) | ($0.14) | ($0.16) | ($0.22) | ($0.22) | ($0.29) | ($0.56) | ($0.82) | ($0.95) |
Weighted average number of common shares outstanding - basic (in shares) | 85,358 | 85,209 | 85,061 | 84,728 | 73,129 | 54,792 | 49,135 | 43,657 | 85,095 | 55,258 | 39,396 |
Weighted average number of common shares outstanding - diluted (in shares) | 85,560 | 85,209 | 85,882 | 84,728 | 73,129 | 54,792 | 49,866 | 43,657 | 86,025 | 55,258 | 39,396 |