Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2013 | Mar. 07, 2014 | Jun. 30, 2013 |
Document and Entity Information [Abstract] | ' | ' | ' |
Entity Registrant Name | 'DISCOVERY LABORATORIES INC /DE/ | ' | ' |
Entity Central Index Key | '0000946486 | ' | ' |
Current Fiscal Year End Date | '--12-31 | ' | ' |
Entity Well-known Seasoned Issuer | 'No | ' | ' |
Entity Voluntary Filers | 'No | ' | ' |
Entity Current Reporting Status | 'Yes | ' | ' |
Entity Filer Category | 'Accelerated Filer | ' | ' |
Entity Public Float | ' | ' | $70 |
Entity Common Stock, Shares Outstanding | ' | 84,696,919 | ' |
Document Fiscal Year Focus | '2013 | ' | ' |
Document Fiscal Period Focus | 'FY | ' | ' |
Document Type | '10-K | ' | ' |
Amendment Flag | 'false | ' | ' |
Document Period End Date | 31-Dec-13 | ' | ' |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current Assets: | ' | ' |
Cash and cash equivalents | $86,283 | $26,892 |
Accounts receivable | 67 | 0 |
Inventory, net | 112 | 195 |
Prepaid expenses and other current assets | 777 | 719 |
Total current assets | 87,239 | 27,806 |
Property and equipment, net | 1,656 | 1,737 |
Restricted cash | 325 | 400 |
Other assets | 97 | 0 |
Total Assets | 89,317 | 29,943 |
Current Liabilities: | ' | ' |
Accounts payable | 1,433 | 1,166 |
Accrued expenses | 4,785 | 4,159 |
Deferred revenue | 139 | 0 |
Common stock warrant liability | 5,425 | 6,305 |
Equipment loans, current portion | 73 | 69 |
Total current liabilities | 11,855 | 11,699 |
Long-term debt, net of discount of $11,646 at December 31, 2013 and $0 at December 31, 2012 | 18,354 | 0 |
Equipment loans, non-current portion | 69 | 148 |
Other liabilities | 538 | 443 |
Total liabilities | 30,816 | 12,290 |
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; 150,000,000 and 100,000,000 shares authorized at December 31, 2013 and 2012, respectively; 84,659,111 and 43,673,636 shares issued at December 31, 2013 and 2012, respectively; 84,638,219 and 43,652,744 shares outstanding at December 31, 2013 and 2012, respectively | 85 | 44 |
Additional paid-in capital | 541,420 | 455,398 |
Accumulated deficit | -479,950 | -434,735 |
Treasury stock (at cost); 20,892 shares at December 31, 2013 and 2012 | -3,054 | -3,054 |
Total stockholders' equity | 58,501 | 17,653 |
Total liabilities & stockholders' equity | $89,317 | $29,943 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, except Share data, unless otherwise specified | ||
LIABILITIES & STOCKHOLDERS' EQUITY | ' | ' |
Long-term debt, discount | $11,646 | $0 |
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) | 150,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 84,659,111 | 43,673,636 |
Common stock, shares outstanding (in shares) | 84,638,219 | 43,652,744 |
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, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Consolidated Statements of Operations [Abstract] | ' | ' | ' |
Grant revenue | $388 | $195 | $582 |
Expenses: | ' | ' | ' |
Cost of product sales | 517 | 0 | 0 |
Research & development | 27,661 | 21,570 | 17,230 |
Selling, general & administrative | 16,718 | 16,444 | 7,864 |
Total expenses | 44,896 | 38,014 | 25,094 |
Operating loss | -44,508 | -37,819 | -24,512 |
Change in fair value of common stock warrant liability | 761 | 555 | 3,560 |
Other income / (expense): | ' | ' | ' |
Interest and other income | 3 | 6 | 13 |
Interest and other expense | -1,471 | -57 | -26 |
Other income / (expense), net | -1,468 | -51 | -13 |
Net loss | ($45,215) | ($37,315) | ($20,965) |
Net loss per common share - basic and diluted (in dollars per share) | ($0.82) | ($0.95) | ($0.93) |
Weighted average number of common shares outstanding - diluted (in shares) | 55,258 | 39,396 | 22,660 |
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, 2010 | $14 | ' | ' | ' | ' | $385,521 | ' | ' | ' | ' | ($376,455) | ' | ' | ' | ' | ($3,054) | ' | ' | ' | ' | $6,026 | ' | ' | ' | ' |
Balance (in shares) at Dec. 31, 2010 | 13,822,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -21,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Changes in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | -20,965 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | -20,965 | ' | ' | ' | ' |
Issuance of common stock, restricted stock awards | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' |
Issuance of common stock, restricted stock awards (in shares) | 1,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, 401(k) employer match | 0 | ' | ' | ' | ' | 497 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 497 | ' | ' | ' | ' |
Issuance of common stock, 401(k) employer match (in shares) | 265,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 265,185 | ' | ' | ' | ' |
Issuance of common stock, financing | ' | 10 | ' | ' | ' | ' | 13,513 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 13,523 | ' | ' | ' |
Issuance of common stock, financing (in shares) | ' | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, CEFF financings | 1 | ' | ' | ' | ' | 1,315 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 1,316 | ' | ' | ' | ' |
Issuance of common stock, CEFF financings (in shares) | 515,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock-based compensation expense | 0 | ' | ' | ' | ' | 867 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 867 | ' | ' | ' | ' |
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) 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 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, ATM financing | 1 | ' | ' | ' | ' | 1,460 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 1,461 | ' | ' | ' | ' |
Issuance of common stock, ATM financing (in shares) | 350,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercise of common stock warrants | 2 | ' | ' | ' | ' | 6,875 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 6,877 | ' | ' | ' | ' |
Exercise of common stock warrants (in shares) | 2,289,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercise of stock options for cash | 0 | ' | ' | ' | ' | 6 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 6 | ' | ' | ' | ' |
Exercise of stock options for cash (in shares) | 3,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 3,000 | ' | ' | ' | ' |
Issuance of common stock, consultants | 0 | ' | ' | ' | ' | 96 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 96 | ' | ' | ' | ' |
Issuance of common stock, consultants (in shares) | 40,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock-based compensation expense | 0 | ' | ' | ' | ' | 2,411 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 2,411 | ' | ' | ' | ' |
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 | ' | ' | ' | ' | 43,652,744 | ' | ' | ' | ' |
Changes in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | -45,215 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | -45,215 | ' | ' | ' | ' |
Issuance of common stock, 401(k) 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 | 0 | ' | ' | ' | ' | ' |
Issuance of common stock, ATM financing | 1 | ' | ' | ' | ' | 1,795 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 0 | ' | ' | ' | ' | 1,796 | ' | ' | ' | ' |
Issuance of common stock, ATM financing (in shares) | 714,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
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 | ' | ' | ' | ' | 18,000 | ' | ' | ' | ' |
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 | ' | ' | ' | ' |
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 | ' | ' | ' | ' |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Cash flow from operating activities: | ' | ' | ' |
Net loss | ($45,215) | ($37,315) | ($20,965) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization | 707 | 1,150 | 1,234 |
Provision for excess inventory | 514 | 0 | 0 |
Stock-based compensation and 401(k) Plan employer match | 3,236 | 3,270 | 1,364 |
Fair value adjustment of common stock warrants | -761 | -555 | -3,560 |
Amortization of discount on long-term debt | 534 | 0 | 0 |
Loss on disposal of equipment | 0 | 42 | 45 |
Reduction in required restricted cash under lease agreement | 75 | 0 | 0 |
Changes in: | ' | ' | ' |
Inventory | -431 | -195 | 0 |
Accounts receivable | -67 | 0 | 0 |
Prepaid expenses and other current assets | -58 | -277 | -157 |
Accounts payable | 267 | 55 | -574 |
Accrued expenses | 626 | 1,187 | -314 |
Deferred revenue | 139 | 0 | 0 |
Other assets | -115 | 0 | 174 |
Other liabilities | 95 | -246 | 55 |
Net cash used in operating activities | -40,454 | -32,884 | -22,698 |
Cash flow from investing activities: | ' | ' | ' |
Purchase of property and equipment | -608 | -636 | -106 |
Net cash used in investing activities | -608 | -636 | -106 |
Cash flow from financing activities: | ' | ' | ' |
Proceeds from issuance of securities, net of expenses | 70,774 | 43,551 | 22,927 |
Proceeds from issuance of long-term debt | 30,000 | 0 | 0 |
Payment of debt issuance costs | -450 | 0 | 0 |
Proceeds from exercise of common stock warrants and options | 204 | 6,747 | 0 |
Principal payments under equipment loans | -75 | -75 | -145 |
Net cash provided by financing activities | 100,453 | 50,223 | 22,782 |
Net increase/ (decrease) in cash and cash equivalents | 59,391 | 16,703 | -22 |
Cash and cash equivalents - beginning of year | 26,892 | 10,189 | 10,211 |
Cash and cash equivalents - end of year | 86,283 | 26,892 | 10,189 |
Supplementary disclosure of cash flows information: | ' | ' | ' |
Interest paid | $920 | $13 | $20 |
The_Company_and_Description_of
The Company and Description of Business | 12 Months Ended |
Dec. 31, 2013 | |
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 drug delivery technologies potentially to enable efficient delivery of our aerosolized KL4 surfactant. We believe that our proprietary technologies may make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. | |
We are initially focused 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 KL4surfactant 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.). Since November 2013, SURFAXIN has been commercially available in the U.S. | |
Premature infants with severe RDS currently are treated with surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, both 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 not respond well (an outcome referred to as nCPAP failure) and thereafter 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 receive 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). With AEROSURF, neonatologists potentially will be able to administer aerosolized KL4 surfactant to premature infants supported with nCPAP, without having to use invasive intubation and mechanical ventilation. By enabling delivery of our 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. | |
We are also developing a lyophilized (freeze-dried) dosage form of our KL4 surfactant that is stored as a powder and reconstituted to liquid form prior to use with the objective of improving ease of use for healthcare practitioners, as well as potentially to prolong shelf life and eliminate the need for cold-chain storage. We are initially developing this dosage form for use in our AEROSURF development program. We are also planning to seek regulatory advice to determine if we could gain marketing authorization for a lyophilized dosage form of SURFAXIN under a development plan that would be both capital efficient and capable of implementation within a reasonable time. If feasible, we would likely implement such a development plan and would plan to introduce it commercially as a life-cycle extension of SURFAXIN under the name SURFAXIN LS™, in the U.S. and potentially in other markets. | |
To support the commercial introduction of SURFAXIN in the U.S. and our other KL4 surfactant pipeline products, if approved, we have established our own specialty respiratory critical care commercial and medical affairs team. This team includes medical professionals with experience in neonatal/pediatric respiratory critical care, and has focused on products that address neonatal indications, beginning with SURFAXIN. We believe that this team will be positioned to efficiently introduce our other KL4 surfactant products under development, if approved, including AEROSURF and potentially SURFAXIN LS and future applications of our aerosolized KL4 surfactant. | |
In addition, we recognize that our commercial and medical affairs team could potentially support introductions of other synergistic pipeline products, including products owned or developed by third parties for the NICU/PICU. To that end, we would consider potential transactions focused on securing commercial rights to such synergistic products, including in the form of product acquisitions, in-licensing agreements or distribution, marketing or co-marketing arrangements. | |
In the future, we expect that we may be able 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 larger children and adults in pediatric and adult intensive care units (PICUS and ICUs), including Acute Lung Injury (ALI), Chronic Obstructive Pulmonary Disorder (COPD) and Cystic Fibrosis (CF). At the present time, however, we are focusing our resources primarily on the commercial introduction of SURFAXIN and development of AEROSURF through phase 2 clinical trials. Once we have achieved these objectives, we believe we would be in a better position to assess the potential of other development programs to address the critical care needs of patients in the PICU and ICU. | |
We also have developed a disposable aerosol-conducting airway connector for infants that is intended to simplify the delivery of aerosolized medications (including our aerosolized KL4 surfactant) and other inhaled therapies to critical-care patients requiring ventilatory support. This device introduces aerosolized medications directly at the patient interface and minimizes the number of connections in the ventilator circuit. We have registered this device as a Class I, exempt medical device in the U.S. under the name AFECTAIR® and it is currently commercially available in the U.S. | |
The reader is referred to, and encouraged to read in its entirety “Item 1 – Business” of this Annual Report on Form 10-K for the year ended December 31, 2013, which contains a discussion of our Business and Business Strategy, as well as information concerning our proprietary technologies and our current and planned KL4 pipeline programs. |
Liquidity_Risks_and_Management
Liquidity Risks and Management's Plans | 12 Months Ended |
Dec. 31, 2013 | |
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, the use of committed equity financing facilities (CEFFs) and at-the-market equity programs, and capital equipment financings. | |
As of December 31, 2013, we had cash and cash equivalents of $86.3 million and $30 million ($18.4 million net of discount) of long-term debt under our Deerfield Loan with affiliates of Deerfield Management Company, L.P. (Deerfield). See, “Note 9 – Deerfield Loan.” During 2013, we raised aggregate gross proceeds of $75.8 million through public offerings of our common stock, including under our ATM Program. In February 2013, we entered into the Deerfield Loan and, upon execution of the agreement, Deerfield advanced to us $10 million ($9.85 million net of transaction fee). In May 2013, we completed a public offering of 10.847 million shares of common stock, including 1.347 million shares under an option granted to and exercised by the underwriters, at an offering price of $1.50 per share, resulting in gross proceeds of $16.3 million ($15.1 million net of commissions, discounts and expenses). In October 2013, we completed an offering under the ATM Program and issued 713,920 shares of our common stock resulting in net proceeds to us of approximately $1.8 million (net of commissions). In November 2013, we completed a public offering of 28.75 million shares of common stock, including 3.75 million shares under an option granted to and exercised by the underwriters for over-allotments, at an offering price of $2.00 per share resulting in gross proceeds of $57.5 million ($53.9 million net of commissions, discounts and expenses). In December 2013, we received an additional $20 million under the Deerfield Loan ($19.7 million net of transaction fee), which became due under the Deerfield Loan upon the first commercial sale of SURFAXIN. Before any additional financings, including under our ATM Program, we anticipate that we will have sufficient cash available to fund our operations and debt service obligations through the third quarter of 2015. | |
Our future capital requirements depend upon many factors, primarily the success of our efforts to (i) execute the commercial introduction of SURFAXIN in the U.S.; (ii) advance the AEROSURF development program to completion of the phase 2 clinical program as planned in the second half of 2015; and (iii) secure one or more strategic alliances or other collaboration arrangements to support the development and, if approved, commercial introduction of AEROSURF and potentially SURFAXIN in markets outside the U.S. We believe that, if we are able to complete the AEROSURF phase 2 clinical program on a timely basis and obtain encouraging results, and if we are able to successfully advance the commercial introduction of SURFAXIN, our ability to enter into a significant strategic alliance will be enhanced. There can be no assurance, however, that our efforts will be successful, or that we will be able to obtain additional capital to support our activities when needed on acceptable terms, if at all. | |
Even if we succeed with the commercial introduction of SURFAXIN, given the time required to secure formulary acceptance at our target hospitals, we expect our revenues from SURFAXIN to be modest in the first 12-24 months and then increase slowly over time. For the next several years, we expect that our cash outflows for marketing, commercial and medical activities, development programs, operations and debt service will far outpace the rate at which we may generate revenues. Therefore, to execute our business strategy and fund our operations over the long term, we will require significant additional infusions of capital until such time as the net revenues from the sale of approved products, from potential strategic alliances and from other sources are sufficient to offset our cash flow requirements. To secure the necessary capital to fund our development programs, we would prefer to enter into strategic alliances or collaboration arrangements with partners having broad experience in markets outside the U.S., including regulatory and product-development expertise as well as an ability to commercialize our products, if approved. Such alliances typically would also provide financial resources, in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses. Collaboration, co-marketing and other similar arrangements would provide, in addition to an ability to introduce our products in markets outside the U.S., a sharing of revenues. Under our ATM Program (see, “Note 11 - Stockholders' Equity”), 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. However, use of the ATM Program is subject to market and other conditions and the ATM Program could be cancelled at any time by either party. We also may consider public and private equity offerings or other financing transactions, including potentially secured equipment financing facilities or other similar transactions. There can be no assurance, however, that our AEROSURF and other research and development projects will be successful, that our products under development will obtain necessary regulatory approval in the U.S. and other markets, that any approved product, including SURFAXIN, will be commercially viable, that the ATM Program will be available when needed, if at all, or that we will be able to obtain additional capital when needed on acceptable terms, if at all. Even if we succeed in raising additional capital and developing and subsequently commercializing product candidates, we may never achieve sufficient sales revenue to achieve or maintain profitability. | |
The accompanying financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. For the next several years, our ability to continue as a going concern will be dependent on our ability to raise additional capital, to fund our research and development and commercial programs and meet our obligations, including debt service, on a timely basis. If we are unable to successfully raise sufficient additional capital when needed, we will likely not have sufficient cash flows and liquidity to fund our business operations, which could significantly limit our ability to continue as a going concern. In that event, we may be forced to further limit our programs and consider other means of creating value for our stockholders, such as licensing the development and commercialization of products that we consider valuable and would otherwise likely develop ourselves. If we are unable to raise the necessary capital, we may be forced to curtail all of our activities and, ultimately, potentially cease operations. Even if we are able to raise additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline. The balance sheets do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue in existence. | |
As of December 31, 2013, 150 million shares of common stock were authorized under our Amended and Restated Certificate of Incorporation and approximately 42.1 million shares of common stock were available for issuance and not otherwise reserved. | |
In addition, as of December 31, 2013, we had outstanding warrants to purchase approximately 14.8 million shares of our common stock at various prices, exercisable on different dates into 2019. Of these warrants, 7 million warrants were issued to Deerfield in connection with the Deerfield Loan at an exercise price of $2.81 per share. 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 to purchase approximately 4.8 million shares of common stock that were issued in February 2011, are exercisable for five-years, 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 were originally issued with an exercise price of $3.20 per share and thereafter adjusted downward, first to $2.80 per share in March 2012 and then to $1.50 per share following a public offering in May 2013. 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 $7.3 million. Although we believe that, in the future, we will secure additional capital from the exercise of at least a portion of our outstanding warrants, there can be no assurance that the market price of our common stock will equal or exceed price levels that make exercise of outstanding warrants likely or that holders of outstanding warrants will choose to exercise any or all of their warrants prior to the warrant expiration date. 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. | |
Although we currently believe that we will be able to successfully execute our business strategy, there can be no assurance that we will be successful. We will require significant additional capital to satisfy debt obligations and sustain operations, and to complete the development and support the commercial introduction of our products. Failure to secure the necessary additional capital would have a material adverse effect on our business, financial condition and results of operations. |
Accounting_Policies_and_Recent
Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended | ||
Dec. 31, 2013 | |||
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 United States. | |||
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 United States, 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, 2013 and 2012, respectively. 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. The Company capitalizes inventories produced in preparation for commercial launches when the related product candidates receive regulatory approval and that the related costs will be recoverable through the commercial sale of the product. Costs incurred prior to FDA approval of SURFAXIN drug product and registration of our initial AFECTAIR device have been recorded in our statement of operations as research and development expense. Inventory is 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 14 – Commitments, for further discussion on our leases). Under terms of the lease agreement, the required restricted cash balance was reduced to $325,000 in October 2013. | |||
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, 2013, 2012, and 2011 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 SURFAXIN sales to our specialty distributor, which are 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, for that reason, 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 the hospital, the risk of material returns is significantly mitigated. As of December 31, 2013, we have deferred revenue recognition on all product sales since the inception of the commercial launch of SURFAXIN in November 2013. We will recognize those revenues at the point in time when all revenue recognition criteria have been met. | |||
We will begin to recognize revenue at the time of shipment of product to our specialty distributor when we can reasonably estimate expected distributor sales deductions and returns. 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 currently consist primarily of member hospitals of Group Purchasing Organizations, 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 calculated on a quarterly basis based upon the customer’s quarterly 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 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 6 months subsequent to its expiry date. Product that has been administered to patients is no longer subject to any right of return. | ||
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. | |||
We recognized $0.4 million and $0.2 million of grant revenue for the years ended December 31, 2013 and 2012, respectively, for funds received and expended under a $0.6 million Small Business Innovation Research (SBIR) Phase I award to Discovery Labs from National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Center for Medical Counter Measures Against Radiation and Nuclear Threats to assess the ability of KL4surfactant to mitigate the effects of acute radiation exposure to the lung, including acute pneumonitis and delayed lung injury. | |||
For the year ended December 31, 2011, grant revenue represents funds received and expended under a $0.6 million Fast Track SBIR from the NIH to support the development of aerosolized KL4 surfactant for RDS. | |||
Research and development | |||
We track research and development expense by activity, as follows: (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 12 – 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. Stock option expense is generally included in research and development and selling, general and administrative expenses in the accompanying Consolidated Statements of Operations. | |||
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. We use the Black-Scholes or trinomial pricing models, depending on the applicable terms of the warrant agreement, to value the 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. | |||
Income taxes | |||
We account for income taxes in accordance with ASC Topic 740, “Accounting for Income Taxes.” ASC Topic 740 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. For the years ended December 31, 2013, 2012, and 2011, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 20.2 million, 11.9 million and 15.4 million shares, respectively. As a result of the net losses for all periods presented, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. 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, 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 | |||
The Company did not adopt any new accounting pronouncements during 2013 that had a material effect on the Company’s consolidated financial statements. |
Fair_Value_Measurements
Fair Value Measurements | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
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, 2013 and 2012: | |||||||||||||||||
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 | |||||||||
Fair Value | Fair value measurement using | ||||||||||||||||
(in thousands) | 31-Dec-12 | Level 1 | Level 2 | Level 3 | |||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 26,892 | $ | 26,892 | $ | – | $ | – | |||||||||
Certificate of deposit | 400 | 400 | – | – | |||||||||||||
Total Assets | $ | 27,292 | $ | 27,292 | $ | – | $ | – | |||||||||
Liabilities: | |||||||||||||||||
Common stock warrants | $ | 6,305 | $ | $ – | $ | – | $ | 6,305 | |||||||||
The following table summarizes changes in the fair value of the common stock warrants measured on a recurring basis using Level 3 inputs for 2012 and 2013: | |||||||||||||||||
(in thousands) | |||||||||||||||||
Balance at January 1, 2012 | $ | 6,996 | |||||||||||||||
Issuance of common stock warrants | (136 | ) | |||||||||||||||
Change in fair value of common stock warrant liability | (555 | ) | |||||||||||||||
Balance at December 31, 2012 | $ | 6,305 | |||||||||||||||
Exercise of warrants (1) | (119 | ) | |||||||||||||||
Change in fair value of common stock warrant liability | (761 | ) | |||||||||||||||
Balance at December 31, 2013 | $ | 5,425 | |||||||||||||||
-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 the warrant. 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 | 2013 | 2012 | |||||||||||||||
Historical volatility | 62% -76 | % | 56% -80 | % | |||||||||||||
Expected term (in years) | 0.4 – 2.1 | 1.4 – 3.2 | |||||||||||||||
Risk-free interest rate | 0.08% - 0.44 | % | 0.16% - 0.36 | % | |||||||||||||
Fair Value of Long-Term Debt | |||||||||||||||||
At December 31, 2013, the estimated fair value of the Company's Deerfield Loan was $23.6 million compared to a carrying value, net of discounts, of $18.4 million. We had no long-term debt as of December 31, 2012. The estimated fair value of the Deerfield Loan was based on discounting the future contractual cash flows to the present value. 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. |
Inventory
Inventory | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Inventory [Abstract] | ' | ||||||||
Inventory | ' | ||||||||
Note 5 – Inventory | |||||||||
Inventory is comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Raw materials | $ | 52 | $ | 195 | |||||
Finished goods | 60 | – | |||||||
$ | 112 | $ | 195 | ||||||
Raw materials costs in inventory of $52,000 as of December 31, 2013 consisted of the portion of raw materials anticipated to be used in the manufacture of commercial product that were purchased after October 4, 2013, the date the FDA agreed to our updated product specifications for SURFAXIN that allowed us to proceed with the commercial introduction of SURFAXIN. Raw materials on hand as of December 31, 2013 that were purchased prior to October 4, 2013 were $1.6 million. These raw materials have a carrying value of zero, as the costs to purchase this material were expensed as research and development expense in the period purchased, and accordingly are not reflected in the inventory balances shown above. The majority of these raw materials are anticipated to be used in manufacturing development and research and development activities. The remaining portion of these raw materials are anticipated to be used in the manufacture of commercial product. | |||||||||
Raw materials costs in inventory of $195,000 as of December 31, 2012 consisted of the portion of raw materials anticipated to be used in the manufacture of commercial product that were purchased after the FDA agreed granted us marketing approval for SURFAXIN (March 2012). Due to a delay in commercial availability of SURFAXIN drug product until the fourth quarter of 2013, previously capitalized raw material costs of $195,000 as of December 31, 2012 were charged to research and development expense in the first quarter of 2013, as these raw materials were no longer expected to be used in the manufacture of commercial product. | |||||||||
Inventory reserves were $0.5 million as of December 31, 2013 and $0 as of December 31, 2012. The inventory reserves in 2013 primarily reflect costs of SURFAXIN related 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. |
Property_and_Equipment
Property and Equipment | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Property and Equipment [Abstract] | ' | ||||||||
Property and Equipment | ' | ||||||||
Note 6 – Property and Equipment | |||||||||
Property and equipment is comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Manufacturing, laboratory & office equipment | $ | 8,383 | $ | 7,775 | |||||
Furniture & fixtures | 816 | 816 | |||||||
Leasehold improvements | 2,711 | 2,711 | |||||||
Subtotal | 11,910 | 11,302 | |||||||
Accumulated depreciation and amortization | (10,254 | ) | (9,565 | ) | |||||
Property and equipment, net | $ | 1,656 | $ | 1,737 | |||||
Leasehold improvements primarily consist of construction of an analytical and development laboratory in our Warrington, Pennsylvania headquarters, which was completed in 2007. The activities conducted in our laboratory include release and stability testing of raw materials as well as preclinical, clinical and commercial drug product supply. We also perform development work with respect to our aerosolized and lyophilized dosage forms of our KL4 surfactant. In addition, in 2007, we built a microbiology laboratory at our manufacturing facility in Totowa, New Jersey, to support production of our drug product candidates. The microbiology laboratory will be amortized through the end of the lease term for our Totowa, New Jersey facility in June 2015. | |||||||||
Depreciation expense on property and equipment for the years ended December 31, 2013, 2012, and 2011 was $0.7 million, $0.9 million, and $1.3 million, respectively. |
Accrued_Expenses
Accrued Expenses | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Accrued Expenses [Abstract] | ' | ||||||||
Accrued Expenses | ' | ||||||||
Note 7 – Accrued Expenses | |||||||||
Accrued expenses are comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Salaries, bonus & benefits | $ | $1,849 | $ | 1,206 | |||||
Manufacturing operations | 1,707 | 926 | |||||||
Research and development | 270 | 734 | |||||||
Professional fees | 393 | 428 | |||||||
Sales and marketing | 161 | 279 | |||||||
All other | 405 | 586 | |||||||
Total accrued expenses | $ | 4,785 | $ | 4,159 |
Common_Stock_Warrant_Liability
Common Stock Warrant Liability | 12 Months Ended | |||||||||||||||||||||
Dec. 31, 2013 | ||||||||||||||||||||||
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, 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 offerings 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 warrant, the holder may exercise the warrant on a cashless basis. Notwithstanding the availability of cashless exercise, generally accepted accounting principles (GAAP) provide that 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, providing freely-tradable 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 May 2009 and February 2010 warrants have been classified as derivative liabilities 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 five-year warrants that we issued in the February 2011 public offering (February 2011 five-year 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 five-year 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. | ||||||||||||||||||||||
Selected terms and estimated fair value of warrants accounted for as derivative are as follows: | ||||||||||||||||||||||
Fair Value of Warrants | ||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||
Issuance | Number of Warrant Shares Issuable | Exercise | Warrant | Value at | December 31, | |||||||||||||||||
Date | Price | Expiration | Issuance | |||||||||||||||||||
Date | Date | 2013 | 2012 | |||||||||||||||||||
5/13/09 | 466,667 | $ | 17.25 | 5/13/14 | $ | 3,360 | $ | – | $ | – | ||||||||||||
2/23/10 | 916,669 | 12.75 | 2/23/15 | 5,701 | 6 | 104 | ||||||||||||||||
2/22/11 | 4,834,950 | 1.5 | 2/22/16 | 8,004 | 5,419 | 6,201 | ||||||||||||||||
$ | 5,425 | $ | 6,305 | |||||||||||||||||||
In addition, the February 2011 five-year warrants 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. Accordingly, 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. | ||||||||||||||||||||||
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 $170,700. During the year ended December 31, 2012, holders of the February 2011 five-year warrants exercised warrants to purchase 51,250 shares of common stock for total proceeds of $162,000. | ||||||||||||||||||||||
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_Facility
Deerfield Loan Facility | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
Deerfield Loan Facility [Abstract] | ' | ||||||||||||
Deerfield Loan Facility | ' | ||||||||||||
Note 9 – | Deerfield Loan | ||||||||||||
On February 13, 2013, we entered into a secured loan facility (Deerfield Loan) with affiliates of Deerfield Management Company, L.P. (Deerfield) for up to $30 million in secured financing in 2013. As of December 31, 2013, long-term debt consists solely of amounts due under this facility as follows: | |||||||||||||
(in thousands) | |||||||||||||
Note Payable | $ | 30,000 | |||||||||||
Unamortized discount | (11,646 | ) | |||||||||||
Long-term debt, net of discount | $ | 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 equal annual installments on the fourth, fifth and sixth anniversaries of the Deerfield Loan agreement, provided that the amount payable on the fourth anniversary 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 on the fifth anniversary (together with any amount deferred on the fourth anniversary) shall be deferred until the sixth anniversary 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 will accrue 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 have 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, | ||||||||||||
2013 | 2012 | 2011 | |||||||||||
Cash interest expense | $ | 911 | $ | – | $ | – | |||||||
Non-cash amortization of debt discounts | 534 | – | – | ||||||||||
Amortization of debt costs | 18 | – | – | ||||||||||
Total Deerfield Loan interest expenses | $ | 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. |
Equipment_Loan
Equipment Loan | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Equipment Loan [Abstract] | ' | ||||||||
Equipment Loan | ' | ||||||||
Note 10 – Equipment Loan | |||||||||
Our equipment loan comprises the following: | |||||||||
(in thousands) | December 31, | ||||||||
2013 | 2012 | ||||||||
Short-term | 73 | 69 | |||||||
Long-term | 69 | 148 | |||||||
$ | 142 | $ | 217 | ||||||
In September 2008, we entered into a Loan Agreement and Security Agreement with the Commonwealth of Pennsylvania, Department of Community and Economic Development (Department), pursuant to which the Department made a loan to us from the Machinery and Equipment Loan Fund in the amount of $500,000 (MELF Loan) to fund the purchase and installation of new machinery and equipment and the upgrade of existing machinery and equipment at our analytical and development laboratory in Warrington, Pennsylvania. Principal and interest on the MELF Loan is payable in equal monthly installments over a period of seven years. Interest on the principal amount accrues at a fixed rate of five percent (5.0%) per annum. We may prepay the MELF Loan at any time without penalty. | |||||||||
In addition to customary terms and conditions, the MELF Loan requires us to meet certain job retention and job creation goals in Pennsylvania within a three-year period (Jobs Covenant). If we fail to comply with the Jobs Covenant, the Department, in its discretion, may change the interest rate on the Promissory Note to a fixed rate equal to two percentage points above the current prime rate for the remainder of the term. As of September 30, 2011, the end of the three-year Jobs Covenant period, due to our efforts to conserve resources while we focused on securing approval for SURFAXIN, we had not complied with the Jobs Covenant. In response to a request that we filed with the Department in November 2013 for a waiver, the Department granted us an extension through December 31, 2014 to come into compliance with the Jobs Covenant and has waived any interest adjustment until that date. | |||||||||
For the years ended December 31, 2013, 2012, and 2011, we incurred interest expense of $9,000, $13,000 and $20,000, respectively, on our outstanding equipment loan. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended | |||||||||||||
Dec. 31, 2013 | ||||||||||||||
Stockholders' Equity [Abstract] | ' | |||||||||||||
Stockholders' Equity | ' | |||||||||||||
Note 11 – 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. | ||||||||||||||
On February 22, 2011, we completed a registered public offering of 10,000,000 shares of our common stock, 15‑month warrants to purchase five million shares of our common stock, and five-year warrants to purchase five million shares of our common stock. The securities were sold as units, with each unit consisting of one share of common stock, a 15-month warrant to purchase one half share of common stock, and a five-year warrant to purchase one half share of common stock, at a public offering price of $2.35 per unit, resulting in gross proceeds to us of $23.5 million ($21.6 million net). The 15-month warrants had an exercise price per share of $2.94 and expired in May 2012. The five-year warrants expire in February 2016 and were initially exercisable at a price per share of $3.20. The exercise price of the five-year warrants is subject to adjustment if we issue or sell common stock or securities convertible into common stock (in each case, subject to certain exceptions) at a price (determined as set forth in the warrant) that is less than the exercise price of the warrant. In connection with the closing of our public offerings in March 2012 and May 2013, the exercise price of the five-year warrants was adjusted downward to a price per share of $2.80 and $1.50, respectively. | ||||||||||||||
In addition, with respect to the warrants issued in connection with the foregoing offerings, the exercise price and number of shares of common stock issuable upon exercise are subject to adjustment in the event of any stock split, reverse stock split, stock dividend, recapitalization, reorganization or similar transaction. The exercise price and the amount and/or type of property to be issued upon exercise of the warrants are also subject to adjustment if we engage in a “Fundamental Transaction” (such as consolidation or merger, sale or disposal of substantially all of our assets, and among others as defined in the form of the warrant). The warrants are exercisable for cash only, except that if the related registration statement or an exemption from registration is not otherwise available for the resale of the warrant shares, the holder may exercise on a cashless basis. | ||||||||||||||
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, 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, 2013, 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, at our discretion and at such times that we may determine from time to time, could sell over a two-year period 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 to pay Lazard a commission equal to 3.0% of the gross proceeds of any sales under the Lazard ATM Program. We also agreed to reimburse Lazard for certain expenses incurred in connection with entering into the Agency Agreement and provided Lazard with customary representations, warranties and indemnification rights. 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. | ||||||||||||||
Committed Equity Financing Facility (CEFF) | ||||||||||||||
From 2004 through June 2013, we maintained one or more Committed Equity Financing Facilities (CEFFs) with Kingsbridge Capital Limited (Kingsbridge), a private investment group, under which Kingsbridge was committed to purchase, subject to certain conditions, newly-issued shares of our common stock. The CEFFs allowed us, at our discretion, to raise capital, at the time and in amounts deemed suitable to us, to support our business plans. We were not obligated to utilize any of the funds available under any CEFF and our ability to access funds at any time was subject to certain conditions, including stock price and volume limitations. | ||||||||||||||
As of December 31, 2013, we did not have an active CEFF. Three CEFF agreements, dated May 22, 2008, December 12, 2008, and June 11, 2010 (2010 CEFF) expired in June 2011, February 2011, and June 2013, respectively. There were no financings under the May 2008 CEFF or December 2008 CEFF during 2013, 2012 and 2011. The 2010 CEFF Agreement originally provided for the purchase of the lesser of up to 2.1 million shares or a maximum of $35 million, and expired in June 2013. There were no financings completed under the 2010 CEFF in 2012 and 2013. In 2011, we received $1.3 million of gross proceeds from the issuance of 514,990 shares at an average discounted price of $2.56 per share under the 2010 CEFF. | ||||||||||||||
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, 2013, 2012 and 2011, the match resulted in the issuance of 510,047, 316,543, and 265,185, shares of common stock, respectively. Expenses associated with the 401(k) match for the years ended December 31, 2013, 2012, and 2011 were $1.0 million, $0.8 million and $0.5 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 | |||||||||||
2013 | 2012 | Price | Date | |||||||||||
Deerfield – 2013 loan | 7,000 | – | $ | 2.81 | 2/13/19 | |||||||||
Former employee | 30 | 30 | $ | 3.2 | 3/18/16 | |||||||||
Investors – February 2011 financing | 4,835 | 4,949 | $ | 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 | 467 | $ | 17.25 | 5/13/14 | |||||||||
Kingsbridge – December 2008 CEFF | 45 | 45 | $ | 22.7 | 6/12/14 | |||||||||
Kingsbridge – May 2008 CEFF | - | 55 | $ | 37.59 | 11/22/13 | |||||||||
Total | 14,781 | 7,950 | ||||||||||||
Common shares reserved for potential future issuance upon exercise of stock options or granting of additional equity incentive awards | ||||||||||||||
In October 2011, our stockholders approved the adoption of the 2011 Long-Term Incentive Plan (the 2011 Plan). The 2011 Plan provides for the grant of long-term equity and cash incentive compensation awards and replaced the 2007 Long-Term Incentive Plan (the 2007 Plan). The 2011 Plan continues many of the features of the 2007 Plan, but is updated to reflect changes to The Nasdaq Capital Market rules regarding equity compensation, other regulatory changes and market and corporate governance developments. Awards outstanding under the 2007 and our previous, expired plan (1998 Plan) will continue to be governed by the terms of the respective plans and the agreements under which they were granted, although 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. | ||||||||||||||
Stock options and awards outstanding and available for future issuance as of December 31, 2013 and 2012 are as follows: | ||||||||||||||
As of December 31, | ||||||||||||||
2013 | 2012 | |||||||||||||
Stock Options Outstanding | ||||||||||||||
2011 Plan(1) | 4,919 | 3,365 | ||||||||||||
2007 Plan | 258 | 277 | ||||||||||||
1998 Plan | 251 | 355 | ||||||||||||
Total Outstanding | 5,428 | 3,997 | ||||||||||||
Available for Future Grants under 2011 Plan | 2,894 | 2,966 | ||||||||||||
Total | 8,322 | 6,963 | ||||||||||||
(1) See, Note 12 – Stock Options and Stock-based Employee Compensation – Long-Term Incentive Plans. | ||||||||||||||
Common shares reserved for potential future issuance under our 401(k) Plan | ||||||||||||||
As of December 31, 2013 and 2012, we had 166,243 and 26,290, 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, 2013 | |||||||||||||||||||||
Stock Options and Stock-based Employee Compensation [Abstract] | ' | ||||||||||||||||||||
Stock Options and Stock-based Employee Compensation | ' | ||||||||||||||||||||
Note 12 – Stock Options and Stock-based Employee Compensation | |||||||||||||||||||||
Long-Term Incentive Plans | |||||||||||||||||||||
In October 2011, our stockholders approved the 2011 Plan, which replaced the 2007 Plan. (See, Note 11 – Common shares reserved for potential future issuance upon exercise of stock options or granting of additional equity incentive awards.) The 2011 Plan continues many of the features of the 2007 Plan, but is updated to reflect changes to The Nasdaq Capital Market rules regarding equity compensation, other regulatory changes and market and corporate governance developments. Awards outstanding under the 2007 Plan and 1998 Plan continue to be governed by the terms of those plans and the applicable award agreements. | |||||||||||||||||||||
Under the 2011 Plan, we may grant awards for up to 7.8 million shares of our common stock. Additionally, any shares returnable to the 2007 Plan as a result of cancellations, expirations, and forfeitures will become available for issuance under 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. | |||||||||||||||||||||
As of December 31, 2013, under the 2011 Plan, there were 4,919,333 stock options outstanding, 18,936 restricted stock units (“RSUs”) that vest in June 2014 and 2,894,374 shares available for grant. 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 December 31, 2010 | 943 | $ | 56.06 | ||||||||||||||||||
Granted | 1,771 | 1.84 | |||||||||||||||||||
Forfeited or expired | (276 | ) | 44.95 | ||||||||||||||||||
Outstanding at December 31, 2011 | 2,438 | $ | 17.97 | ||||||||||||||||||
Granted | 1,724 | 2.63 | |||||||||||||||||||
Exercised | (3 | ) | 1.83 | ||||||||||||||||||
Forfeited or expired | (162 | ) | 24.39 | ||||||||||||||||||
Outstanding at December 31, 2012 | 3,997 | $ | 11.11 | ||||||||||||||||||
Granted | 1,928 | 2.3 | |||||||||||||||||||
Exercised | (18 | ) | 1.85 | ||||||||||||||||||
Forfeited or expired | (479 | ) | 28.09 | ||||||||||||||||||
Outstanding at December 31, 2013 | 5,428 | $ | 6.51 | 8 | |||||||||||||||||
Exercisable at December 31, 2013 | 2,346 | $ | 12.01 | 6.9 | |||||||||||||||||
(in thousands, except for weighted-average data) | |||||||||||||||||||||
Restricted Stock Units | Shares | Weighted- | Weighted- | ||||||||||||||||||
Average | Average | ||||||||||||||||||||
Exercise | Remaining | ||||||||||||||||||||
Price | Contractual | ||||||||||||||||||||
Term (In Yrs) | |||||||||||||||||||||
Outstanding at December 31, 2012 | – | $ | – | ||||||||||||||||||
Awarded | 19 | – | |||||||||||||||||||
Outstanding at December 31, 2013 | 19 | $ | – | 0.4 | |||||||||||||||||
Exercisable at December 31, 2013 | – | $ | – | 0 | |||||||||||||||||
Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options and awards granted during the years ended December 31, 2013, 2012, and 2011 was $1.79, $2.02, and $1.45, respectively. The weighted-average grant-date fair value of RSUs granted during the year ended December 31, 2013 was $1.69. There were no RSUs granted during the years ended December 31, 2012 and 2011. For the year ended December 31, 2013, there were 18,208 options exercised, resulting in approximately $34,000 in proceeds. For the year ended December 31, 2012, there were 3,334 options exercised, resulting in approximately $6,000 in proceeds. There were no options exercised during the year ended December 31, 2011. The total intrinsic value of options outstanding, vested, and exercisable as of December 31, 2013 is $0.8 million, $0.5 million, and $0.5 million, respectively. | |||||||||||||||||||||
The following table provides detail with regard to options outstanding, vested and exercisable at December 31, 2013: | |||||||||||||||||||||
(shares in thousands) | Outstanding | Vested and Exercisable | |||||||||||||||||||
Price per share | Shares | Weighted- | Weighted- | Shares | Weighted- | Weighted- | |||||||||||||||
Average Price | Average | Average Price | Average | ||||||||||||||||||
per Share | Remaining | per Share | Remaining | ||||||||||||||||||
Contractual Life | Contractual Life | ||||||||||||||||||||
$ | 1.58 - $156.45 | 5,428 | $ | 6.51 | 8.0 Years | 2,346 | $ | 12.01 | 6.9 Years | ||||||||||||
Stock-Based Compensation | |||||||||||||||||||||
We recognized stock-based compensation expense in accordance ASC Topic 718 for the years ended December 31, 2013, 2012, and 2011, of $2.2 million, $2.4 million and $0.9 million, respectively. | |||||||||||||||||||||
Stock-based compensation expense was classified as follows: | |||||||||||||||||||||
December 31, | |||||||||||||||||||||
(in thousands) | 2013 | 2012 | 2011 | ||||||||||||||||||
Research and development | $ | 784 | $ | 487 | $ | 289 | |||||||||||||||
Selling, general and administrative | 1,426 | 1,924 | 578 | ||||||||||||||||||
Total | $ | 2,210 | $ | 2,411 | $ | 867 | |||||||||||||||
On December 31, 2012, our former Chief Executive Officer resigned from his position and as a member of our Board. Under the terms of a separation agreement that we entered into with the former CEO, all of the former CEO’s outstanding options vested immediately and all such options shall remain exercisable to the end of their stated terms. We recognized $0.8 million in stock option modification costs related to these items. | |||||||||||||||||||||
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, | |||||||||||||||||||||
2013 | 2012 | 2011 | |||||||||||||||||||
Weighted average expected volatility | 109 | % | 111 | % | 113 | % | |||||||||||||||
Weighted average expected term | 4.7 years | 4.6 years | 4.8 years | ||||||||||||||||||
Weighted average risk-free interest rate | 0.73 | % | 0.74 | % | 1.08 | % | |||||||||||||||
Expected dividends | – | – | – | ||||||||||||||||||
The total fair value of the underlying shares of the options vested during 2013, 2012, and 2011, equals $1.9 million, $2.2 million and $0.6 million, respectively. As of December 31, 2013, there was $4.0 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 1.7 years. |
Corporate_Partnership_Licensin
Corporate Partnership, Licensing and Research Funding Agreements | 12 Months Ended |
Dec. 31, 2013 | |
Corporate Partnership, Licensing and Research Funding Agreements [Abstract] | ' |
Corporate Partnership, Licensing and Research Funding Agreements | ' |
Note 13 – Corporate Partnership, Licensing and Research Funding Agreements | |
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. | |
Licensing and Research Funding Agreements | |
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. | |
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. |
Commitments
Commitments | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||||||||||
Commitments [Abstract] | ' | ||||||||||||||||||||||||||||
Commitments | ' | ||||||||||||||||||||||||||||
Note 14 – Commitments | |||||||||||||||||||||||||||||
Future payments due under contractual obligations at December 31, 2013 are as follows: | |||||||||||||||||||||||||||||
(in thousands) | 2014 | 2015 | 2016 | 2017 | 2018 | There- | Total | ||||||||||||||||||||||
after | |||||||||||||||||||||||||||||
Operating lease obligations | 1,087 | 1,024 | 934 | 936 | 158 | – | 4,139 | ||||||||||||||||||||||
Equipment loan obligations (1) | 79 | 69 | – | – | – | – | 148 | ||||||||||||||||||||||
Total | $ | 1,166 | $ | 1,093 | $ | 934 | $ | 936 | $ | 158 | $ | – | $ | 4,287 | |||||||||||||||
-1 | See, Note 10 – Equipment Loan | ||||||||||||||||||||||||||||
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 $150,000. This space is specifically designed for the manufacture and filling of sterile pharmaceuticals in compliance with cGMP and is our only manufacturing facility. We have secured an extension of the lease, which was scheduled to expire in December 2014, until to June 30, 2015 for aggregate base rental payments of $306,250 under the extension period. 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 $1.0 million for each of the years ended December 31, 2013, 2012, and 2011, respectively. | |||||||||||||||||||||||||||||
Retention Plan | |||||||||||||||||||||||||||||
On September 13, 2013, our Board of Directors approved an employee severance and retention plan for employees at the Totowa Facility to take effect in the event that we are unable to secure long-term utilization of the Totowa Facility beyond the scheduled lease expiration on June 30, 2015. The retention plan is intended to minimize employee turnover by providing severance and retention bonuses that encourage employees to stay with us through 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, and will be eligible for a retention bonus payable in June 2016, provided that they remain employed with us in June 2016; and (2) provided that they remain employed with us through the successful closure of the Totowa Facility, non-union employees (nine individuals) will be eligible to receive both severance and a retention bonus payable upon such closure. The total cash amount expected to be paid for severance and retention through June 2016 is approximately $1.0 million. The plan-related expense incurred during 2013 is $0.1 million and is included in research and development expense. The related liability is $0.1 million as of December 31, 2013. | |||||||||||||||||||||||||||||
In addition, there are 14 employees at the Totowa Facility who are subject to a collective bargaining agreement and will be eligible to receive severance upon closure of the Totowa Facility. The plan-related expense incurred during 2013 is $30,000 and is included in research and development expense. The related liability is $0.5 million as of December 31, 2013. |
Litigation
Litigation | 12 Months Ended |
Dec. 31, 2013 | |
Litigation [Abstract] | ' |
Litigation | ' |
Note 15 – 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, 2013 | |||||||||||||
Income Taxes [Abstract] | ' | ||||||||||||
Income Taxes | ' | ||||||||||||
Note 16 – 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, 2013, 2012, and 2011 is as follows: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2013 | 2012 | 2011 | |||||||||||
Income tax benefit, statutory rates | $ | 15,373 | $ | 12,687 | $ | 7,128 | |||||||
State taxes on income, net of Federal benefit | 2,922 | 2,288 | 1,633 | ||||||||||
Research and development tax credit | 517 | 332 | 662 | ||||||||||
Employee related | (766 | ) | (988 | ) | (1,758 | ) | |||||||
Warrant valuation related | 259 | 189 | 1,210 | ||||||||||
Income tax benefit | 18,305 | 14,508 | 8,875 | ||||||||||
Valuation allowance | (18,305 | ) | (14,508 | ) | (8,875 | ) | |||||||
Income tax benefit | $ | – | $ | – | $ | – | |||||||
The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at December 31, 2013 and 2012, are as follows: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2013 | 2012 | ||||||||||||
Long-term deferred tax assets: | |||||||||||||
Net operating loss carryforwards (Federal and state) | $ | 175,258 | $ | 160,522 | |||||||||
Research and development tax credits | 10,604 | 9,412 | |||||||||||
Compensation expense on stock | 3,276 | 3,154 | |||||||||||
Charitable contribution carryforward | 7 | 7 | |||||||||||
Inventory reserve | 198 | – | |||||||||||
Deferred revenue | 53 | – | |||||||||||
Other accrued | 1,024 | 524 | |||||||||||
Depreciation | 2,714 | 2,665 | |||||||||||
Capitalized research and development | 1,326 | 1,516 | |||||||||||
Total long-term deferred tax assets | 194,460 | 177,800 | |||||||||||
Less: valuation allowance | (194,460 | ) | (177,800 | ) | |||||||||
Deferred tax assets, net of valuation allowance | $ | – | $ | – | |||||||||
We are in a net deferred tax asset position at December 31, 2013 and 2012 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, 2013 or 2012, nor were any incurred in 2013, 2012, or 2011. | |||||||||||||
At December 31, 2013 and 2012, we had available carryforward net operating losses for Federal tax purposes of $432.1 million and $396.7 million, respectively, and a research and development tax credit carryforward of $10.6 million and $9.4 million, respectively. The Federal net operating loss and research and development tax credit carryforwards began to expire in 2008 and will continue through 2033. | |||||||||||||
At December 31, 2013, 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, 2013 and 2012, we had available carryforward losses of approximately $433.7 million and $392.6 million, respectively, for state tax purposes. Of the $433.7 million state tax carryforward losses, $399.5 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, 2013 | |||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) [Abstract] | ' | ||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) | ' | ||||||||||||||||||||
Note 17 – Selected Quarterly Financial Data (Unaudited) | |||||||||||||||||||||
The following table contains unaudited statement of operations information for each quarter of 2013 and 2012. The operating results for any quarter are not necessarily indicative of results for any future period. | |||||||||||||||||||||
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 | ||||||||||||||||
2012 Quarters Ended: | |||||||||||||||||||||
(in thousands, except per share data) | Mar. 31 | 30-Jun | Sept. 30 | Dec. 31 | Total Year | ||||||||||||||||
Grant Revenues | $ | – | $ | – | $ | – | $ | 195 | $ | 195 | |||||||||||
Expenses: | |||||||||||||||||||||
Research and development | 4,533 | 5,206 | 5,743 | 6,088 | 21,570 | ||||||||||||||||
General and administrative | 2,047 | 3,610 | 4,255 | 6,532 | 16,444 | ||||||||||||||||
Total expenses | 6,580 | 8,816 | 9,998 | 12,620 | 38,014 | ||||||||||||||||
Operating loss | (6,580 | ) | (8,816 | ) | (9,998 | ) | (12,425 | ) | (37,819 | ) | |||||||||||
Change in fair value of common stock warrant liability | (3,434 | ) | 1,680 | (3,309 | ) | 5,618 | 555 | ||||||||||||||
Other expense, net | (2 | ) | (2 | ) | (39 | ) | (8 | ) | (51 | ) | |||||||||||
Net loss | $ | (10,016 | ) | $ | (7,138 | ) | $ | (13,346 | ) | $ | (6,815 | ) | $ | ( 37,315 | ) | ||||||
Net loss per common share - basic and diluted | $ | (0.37 | ) | $ | (0.16 | ) | $ | (0.31 | ) | $ | (0.16 | ) | $ | (0.95 | ) | ||||||
Weighted average number of common shares outstanding | 27,162 | 43,369 | 43,444 | 43,521 | 39,396 |
Accounting_Policies_and_Recent1
Accounting Policies and Recent Accounting Pronouncements (Policies) | 12 Months Ended | ||
Dec. 31, 2013 | |||
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 United States. | |||
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 United States, 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, 2013 and 2012, respectively. 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. The Company capitalizes inventories produced in preparation for commercial launches when the related product candidates receive regulatory approval and that the related costs will be recoverable through the commercial sale of the product. Costs incurred prior to FDA approval of SURFAXIN drug product and registration of our initial AFECTAIR device have been recorded in our statement of operations as research and development expense. Inventory is 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 14 – Commitments, for further discussion on our leases). Under terms of the lease agreement, the required restricted cash balance was reduced to $325,000 in October 2013. | |||
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, 2013, 2012, and 2011 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 SURFAXIN sales to our specialty distributor, which are 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, for that reason, 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 the hospital, the risk of material returns is significantly mitigated. As of December 31, 2013, we have deferred revenue recognition on all product sales since the inception of the commercial launch of SURFAXIN in November 2013. We will recognize those revenues at the point in time when all revenue recognition criteria have been met. | |||
We will begin to recognize revenue at the time of shipment of product to our specialty distributor when we can reasonably estimate expected distributor sales deductions and returns. 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 currently consist primarily of member hospitals of Group Purchasing Organizations, 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 calculated on a quarterly basis based upon the customer’s quarterly 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 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 6 months subsequent to its expiry date. Product that has been administered to patients is no longer subject to any right of return. | ||
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. | |||
We recognized $0.4 million and $0.2 million of grant revenue for the years ended December 31, 2013 and 2012, respectively, for funds received and expended under a $0.6 million Small Business Innovation Research (SBIR) Phase I award to Discovery Labs from National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Center for Medical Counter Measures Against Radiation and Nuclear Threats to assess the ability of KL4surfactant to mitigate the effects of acute radiation exposure to the lung, including acute pneumonitis and delayed lung injury. | |||
For the year ended December 31, 2011, grant revenue represents funds received and expended under a $0.6 million Fast Track SBIR from the NIH to support the development of aerosolized KL4 surfactant for RDS. | |||
Research and development | ' | ||
Research and development | |||
We track research and development expense by activity, as follows: (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 12 – 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. Stock option expense is generally included in research and development and selling, general and administrative expenses in the accompanying Consolidated Statements of Operations. | |||
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. We use the Black-Scholes or trinomial pricing models, depending on the applicable terms of the warrant agreement, to value the 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. | |||
Income taxes | ' | ||
Income taxes | |||
We account for income taxes in accordance with ASC Topic 740, “Accounting for Income Taxes.” ASC Topic 740 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. For the years ended December 31, 2013, 2012, and 2011, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 20.2 million, 11.9 million and 15.4 million shares, respectively. As a result of the net losses for all periods presented, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. 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, 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 | |||
The Company did not adopt any new accounting pronouncements during 2013 that had a material effect on the Company’s consolidated financial statements. |
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
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, 2013 and 2012: | |||||||||||||||||
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 | |||||||||
Fair Value | Fair value measurement using | ||||||||||||||||
(in thousands) | 31-Dec-12 | Level 1 | Level 2 | Level 3 | |||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 26,892 | $ | 26,892 | $ | – | $ | – | |||||||||
Certificate of deposit | 400 | 400 | – | – | |||||||||||||
Total Assets | $ | 27,292 | $ | 27,292 | $ | – | $ | – | |||||||||
Liabilities: | |||||||||||||||||
Common stock warrants | $ | 6,305 | $ | $ – | $ | – | $ | 6,305 | |||||||||
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 2012 and 2013: | |||||||||||||||||
(in thousands) | |||||||||||||||||
Balance at January 1, 2012 | $ | 6,996 | |||||||||||||||
Issuance of common stock warrants | (136 | ) | |||||||||||||||
Change in fair value of common stock warrant liability | (555 | ) | |||||||||||||||
Balance at December 31, 2012 | $ | 6,305 | |||||||||||||||
Exercise of warrants (1) | (119 | ) | |||||||||||||||
Change in fair value of common stock warrant liability | (761 | ) | |||||||||||||||
Balance at December 31, 2013 | $ | 5,425 | |||||||||||||||
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 the warrant. 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 | 2013 | 2012 | |||||||||||||||
Historical volatility | 62% -76 | % | 56% -80 | % | |||||||||||||
Expected term (in years) | 0.4 – 2.1 | 1.4 – 3.2 | |||||||||||||||
Risk-free interest rate | 0.08% - 0.44 | % | 0.16% - 0.36 | % |
Inventory_Tables
Inventory (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Inventory [Abstract] | ' | ||||||||
Schedule of inventory | ' | ||||||||
Inventory is comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Raw materials | $ | 52 | $ | 195 | |||||
Finished goods | 60 | – | |||||||
$ | 112 | $ | 195 |
Property_and_Equipment_Tables
Property and Equipment (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Property and Equipment [Abstract] | ' | ||||||||
Property and equipment | ' | ||||||||
Property and equipment is comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Manufacturing, laboratory & office equipment | $ | 8,383 | $ | 7,775 | |||||
Furniture & fixtures | 816 | 816 | |||||||
Leasehold improvements | 2,711 | 2,711 | |||||||
Subtotal | 11,910 | 11,302 | |||||||
Accumulated depreciation and amortization | (10,254 | ) | (9,565 | ) | |||||
Property and equipment, net | $ | 1,656 | $ | 1,737 |
Accrued_Expenses_Tables
Accrued Expenses (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Accrued Expenses [Abstract] | ' | ||||||||
Accrued expenses | ' | ||||||||
Accrued expenses are comprised of the following: | |||||||||
December 31, | |||||||||
(in thousands) | 2013 | 2012 | |||||||
Salaries, bonus & benefits | $ | 1,849 | $ | 1,206 | |||||
Manufacturing operations | 1,707 | 926 | |||||||
Research and development | 270 | 734 | |||||||
Professional fees | 393 | 428 | |||||||
Sales and marketing | 161 | 279 | |||||||
All other | 405 | 586 | |||||||
Total accrued expenses | $ | 4,785 | $ | 4,159 |
Common_Stock_Warrant_Liability1
Common Stock Warrant Liability (Tables) | 12 Months Ended | |||||||||||||||||||||
Dec. 31, 2013 | ||||||||||||||||||||||
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 | Number of Warrant Shares Issuable | Exercise | Warrant | Value at | December 31, | |||||||||||||||||
Date | Price | Expiration | Issuance | |||||||||||||||||||
Date | Date | 2013 | 2012 | |||||||||||||||||||
5/13/09 | 466,667 | $ | 17.25 | 5/13/14 | $ | 3,360 | $ | – | $ | – | ||||||||||||
2/23/10 | 916,669 | 12.75 | 2/23/15 | 5,701 | 6 | 104 | ||||||||||||||||
2/22/11 | 4,834,950 | 1.5 | 2/22/16 | 8,004 | 5,419 | 6,201 | ||||||||||||||||
$ | 5,425 | $ | 6,305 |
Deerfield_Loan_Facility_Tables
Deerfield Loan Facility (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
Deerfield Loan Facility [Abstract] | ' | ||||||||||||
Long term debt included in balance sheet | ' | ||||||||||||
On February 13, 2013, we entered into a secured loan facility (Deerfield Loan) with affiliates of Deerfield Management Company, L.P. (Deerfield) for up to $30 million in secured financing in 2013. As of December 31, 2013, long-term debt consists solely of amounts due under this facility as follows: | |||||||||||||
(in thousands) | |||||||||||||
Note Payable | $ | 30,000 | |||||||||||
Unamortized discount | (11,646 | ) | |||||||||||
Long-term debt, net of discount | $ | 18,354 | |||||||||||
Significant unobservable input assumptions of Level 3 valuations | ' | ||||||||||||
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 | % | |||||||||||
Interest expense included in statement of operations | ' | ||||||||||||
The following amounts comprise the Deerfield Loan interest expense for the periods presented: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2013 | 2012 | 2011 | |||||||||||
Cash interest expense | $ | 911 | $ | – | $ | – | |||||||
Non-cash amortization of debt discounts | 534 | – | – | ||||||||||
Amortization of debt costs | 18 | – | – | ||||||||||
Total Deerfield Loan interest expenses | $ | 1,463 | $ | – | $ | – |
Equipment_Loan_Tables
Equipment Loan (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Equipment Loan [Abstract] | ' | ||||||||
Schedule of equipment loan | ' | ||||||||
Our equipment loan comprises the following: | |||||||||
(in thousands) | December 31, | ||||||||
2013 | 2012 | ||||||||
Short-term | 73 | 69 | |||||||
Long-term | 69 | 148 | |||||||
$ | 142 | $ | 217 |
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2013 | ||||||||||||||
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 | |||||||||||
2013 | 2012 | Price | Date | |||||||||||
Deerfield – 2013 loan | 7,000 | – | $ | 2.81 | 2/13/19 | |||||||||
Former employee | 30 | 30 | $ | 3.2 | 3/18/16 | |||||||||
Investors – February 2011 financing | 4,835 | 4,949 | $ | 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 | 467 | $ | 17.25 | 5/13/14 | |||||||||
Kingsbridge – December 2008 CEFF | 45 | 45 | $ | 22.7 | 6/12/14 | |||||||||
Kingsbridge – May 2008 CEFF | - | 55 | $ | 37.59 | 11/22/13 | |||||||||
Total | 14,781 | 7,950 | ||||||||||||
Common Shares Reserved for Future Issuance, Share-Based Compensation | ' | |||||||||||||
Stock options and awards outstanding and available for future issuance as of December 31, 2013 and 2012 are as follows: | ||||||||||||||
As of December 31, | ||||||||||||||
2013 | 2012 | |||||||||||||
Stock Options Outstanding | ||||||||||||||
2011 Plan(1) | 4,919 | 3,365 | ||||||||||||
2007 Plan | 258 | 277 | ||||||||||||
1998 Plan | 251 | 355 | ||||||||||||
Total Outstanding | 5,428 | 3,997 | ||||||||||||
Available for Future Grants under 2011 Plan | 2,894 | 2,966 | ||||||||||||
Total | 8,322 | 6,963 | ||||||||||||
(1) See, Note 12 – Stock Options and Stock-based Employee Compensation – Long-Term Incentive Plans. |
Stock_Options_and_Stockbased_E1
Stock Options and Stock-based Employee Compensation (Tables) | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||
Stock Options and Stock-based Employee Compensation [Abstract] | ' | ||||||||||||||||||||
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 December 31, 2010 | 943 | $ | 56.06 | ||||||||||||||||||
Granted | 1,771 | 1.84 | |||||||||||||||||||
Forfeited or expired | (276 | ) | 44.95 | ||||||||||||||||||
Outstanding at December 31, 2011 | 2,438 | $ | 17.97 | ||||||||||||||||||
Granted | 1,724 | 2.63 | |||||||||||||||||||
Exercised | (3 | ) | 1.83 | ||||||||||||||||||
Forfeited or expired | (162 | ) | 24.39 | ||||||||||||||||||
Outstanding at December 31, 2012 | 3,997 | $ | 11.11 | ||||||||||||||||||
Granted | 1,928 | 2.3 | |||||||||||||||||||
Exercised | (18 | ) | 1.85 | ||||||||||||||||||
Forfeited or expired | (479 | ) | 28.09 | ||||||||||||||||||
Outstanding at December 31, 2013 | 5,428 | $ | 6.51 | 8 | |||||||||||||||||
Exercisable at December 31, 2013 | 2,346 | $ | 12.01 | 6.9 | |||||||||||||||||
(in thousands, except for weighted-average data) | |||||||||||||||||||||
Restricted Stock Units | Shares | Weighted- | Weighted- | ||||||||||||||||||
Average | Average | ||||||||||||||||||||
Exercise | Remaining | ||||||||||||||||||||
Price | Contractual | ||||||||||||||||||||
Term (In Yrs) | |||||||||||||||||||||
Outstanding at December 31, 2012 | – | $ | – | ||||||||||||||||||
Awarded | 19 | – | |||||||||||||||||||
Outstanding at December 31, 2013 | 19 | $ | – | 0.4 | |||||||||||||||||
Exercisable at December 31, 2013 | – | $ | – | 0 | |||||||||||||||||
Options Outstanding, Vested and Exercisable | ' | ||||||||||||||||||||
The following table provides detail with regard to options outstanding, vested and exercisable at December 31, 2013: | |||||||||||||||||||||
(shares in thousands) | Outstanding | Vested and Exercisable | |||||||||||||||||||
Price per share | Shares | Weighted- | Weighted- | Shares | Weighted- | Weighted- | |||||||||||||||
Average Price | Average | Average Price | Average | ||||||||||||||||||
per Share | Remaining | per Share | Remaining | ||||||||||||||||||
Contractual Life | Contractual Life | ||||||||||||||||||||
$ | 1.58 - $156.45 | 5,428 | $ | 6.51 | 8.0 Years | 2,346 | $ | 12.01 | 6.9 Years | ||||||||||||
Employee stock-based compensation | ' | ||||||||||||||||||||
Stock-based compensation expense was classified as follows: | |||||||||||||||||||||
December 31, | |||||||||||||||||||||
(in thousands) | 2013 | 2012 | 2011 | ||||||||||||||||||
Research and development | $ | 784 | $ | 487 | $ | 289 | |||||||||||||||
Selling, general and administrative | 1,426 | 1,924 | 578 | ||||||||||||||||||
Total | $ | 2,210 | $ | 2,411 | $ | 867 | |||||||||||||||
Weighted-average assumptions in estimating fair value of options | ' | ||||||||||||||||||||
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, | |||||||||||||||||||||
2013 | 2012 | 2011 | |||||||||||||||||||
Weighted average expected volatility | 109 | % | 111 | % | 113 | % | |||||||||||||||
Weighted average expected term | 4.7 years | 4.6 years | 4.8 years | ||||||||||||||||||
Weighted average risk-free interest rate | 0.73 | % | 0.74 | % | 1.08 | % | |||||||||||||||
Expected dividends | – | – | – |
Commitments_Tables
Commitments (Tables) | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||||||||||
Commitments [Abstract] | ' | ||||||||||||||||||||||||||||
Future Payments Due under Contractual Obligations | ' | ||||||||||||||||||||||||||||
Future payments due under contractual obligations at December 31, 2013 are as follows: | |||||||||||||||||||||||||||||
(in thousands) | 2014 | 2015 | 2016 | 2017 | 2018 | There- | Total | ||||||||||||||||||||||
after | |||||||||||||||||||||||||||||
Operating lease obligations | 1,087 | 1,024 | 934 | 936 | 158 | – | 4,139 | ||||||||||||||||||||||
Equipment loan obligations (1) | 79 | 69 | – | – | – | – | 148 | ||||||||||||||||||||||
Total | $ | 1,166 | $ | 1,093 | $ | 934 | $ | 936 | $ | 158 | $ | – | $ | 4,287 | |||||||||||||||
-1 | See, Note 10 – Equipment Loan |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
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, 2013, 2012, and 2011 is as follows: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2013 | 2012 | 2011 | |||||||||||
Income tax benefit, statutory rates | $ | 15,373 | $ | 12,687 | $ | 7,128 | |||||||
State taxes on income, net of Federal benefit | 2,922 | 2,288 | 1,633 | ||||||||||
Research and development tax credit | 517 | 332 | 662 | ||||||||||
Employee related | (766 | ) | (988 | ) | (1,758 | ) | |||||||
Warrant valuation related | 259 | 189 | 1,210 | ||||||||||
Income tax benefit | 18,305 | 14,508 | 8,875 | ||||||||||
Valuation allowance | (18,305 | ) | (14,508 | ) | (8,875 | ) | |||||||
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, 2013 and 2012, are as follows: | |||||||||||||
(in thousands) | December 31, | ||||||||||||
2013 | 2012 | ||||||||||||
Long-term deferred tax assets: | |||||||||||||
Net operating loss carryforwards (Federal and state) | $ | 175,258 | $ | 160,522 | |||||||||
Research and development tax credits | 10,604 | 9,412 | |||||||||||
Compensation expense on stock | 3,276 | 3,154 | |||||||||||
Charitable contribution carryforward | 7 | 7 | |||||||||||
Inventory reserve | 198 | – | |||||||||||
Deferred revenue | 53 | – | |||||||||||
Other accrued | 1,024 | 524 | |||||||||||
Depreciation | 2,714 | 2,665 | |||||||||||
Capitalized research and development | 1,326 | 1,516 | |||||||||||
Total long-term deferred tax assets | 194,460 | 177,800 | |||||||||||
Less: valuation allowance | (194,460 | ) | (177,800 | ) | |||||||||
Deferred tax assets, net of valuation allowance | $ | – | $ | – |
Selected_Quarterly_Financial_D1
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) [Abstract] | ' | ||||||||||||||||||||
Schedule of Quarterly Financial Information | ' | ||||||||||||||||||||
The following table contains unaudited statement of operations information for each quarter of 2013 and 2012. The operating results for any quarter are not necessarily indicative of results for any future period. | |||||||||||||||||||||
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 | ||||||||||||||||
2012 Quarters Ended: | |||||||||||||||||||||
(in thousands, except per share data) | Mar. 31 | 30-Jun | Sept. 30 | Dec. 31 | Total Year | ||||||||||||||||
Grant Revenues | $ | – | $ | – | $ | – | $ | 195 | $ | 195 | |||||||||||
Expenses: | |||||||||||||||||||||
Research and development | 4,533 | 5,206 | 5,743 | 6,088 | 21,570 | ||||||||||||||||
General and administrative | 2,047 | 3,610 | 4,255 | 6,532 | 16,444 | ||||||||||||||||
Total expenses | 6,580 | 8,816 | 9,998 | 12,620 | 38,014 | ||||||||||||||||
Operating loss | (6,580 | ) | (8,816 | ) | (9,998 | ) | (12,425 | ) | (37,819 | ) | |||||||||||
Change in fair value of common stock warrant liability | (3,434 | ) | 1,680 | (3,309 | ) | 5,618 | 555 | ||||||||||||||
Other expense, net | (2 | ) | (2 | ) | (39 | ) | (8 | ) | (51 | ) | |||||||||||
Net loss | $ | (10,016 | ) | $ | (7,138 | ) | $ | (13,346 | ) | $ | (6,815 | ) | $ | ( 37,315 | ) | ||||||
Net loss per common share - basic and diluted | $ | (0.37 | ) | $ | (0.16 | ) | $ | (0.31 | ) | $ | (0.16 | ) | $ | (0.95 | ) | ||||||
Weighted average number of common shares outstanding | 27,162 | 43,369 | 43,444 | 43,521 | 39,396 |
Liquidity_Risks_and_Management1
Liquidity Risks and Management's Plans (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2010 | Dec. 31, 2013 | Feb. 28, 2013 | Feb. 22, 2011 | Dec. 31, 2013 | 31-May-13 | Dec. 31, 2012 | Mar. 21, 2012 | Feb. 28, 2011 | Mar. 12, 2012 | Dec. 14, 2011 | Dec. 31, 2013 | 31-May-13 | Nov. 30, 2013 | Dec. 31, 2011 | Jun. 30, 2013 | Oct. 15, 2013 | Feb. 11, 2013 | Oct. 31, 2013 |
Deerfield Management Company [Member] | Deerfield Management Company [Member] | Five Year Warrant [Member] | Five Year Warrant [Member] | Five Year Warrant [Member] | Five Year Warrant [Member] | Five Year Warrant [Member] | Five Year Warrant [Member] | Lazard ATM Program [Member] | Lazard ATM Program [Member] | Lazard ATM Program [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | June 2010 CEFF [Member] | June 2010 CEFF [Member] | Stifel ATM Program [Member] | Stifel ATM Program [Member] | Stifel ATM Program [Member] | |||||
Liquidity Risks and Management's Plans [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cash and cash equivalents | $86,283,000 | $26,892,000 | $10,189,000 | $10,211,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Long-term debt, gross | 30,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Long-Term Debt | 18,354,000 | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stockholders' Equity [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock issued during the period (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 350,374 | ' | ' | 10,847,000 | 28,750,000 | 514,990 | ' | 713,920 | ' | 713,920 |
Per share price of common stock issuance (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.50 | ' | ' | ' | ' | ' | ' |
Gross proceeds | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 16,300,000 | 57,500,000 | 1,300,000 | ' | ' | ' | ' |
Net proceeds from issuance of stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,500,000 | ' | ' | 15,100,000 | 53,900,000 | ' | ' | 1,800,000 | ' | 1,800,000 |
Number of shares of common stock issued upon exercise of overallotment (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,347,000 | 3,750,000 | ' | ' | ' | ' | ' |
Maximum value of potential common stock available for issue | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 23,000,000 | ' | ' | ' | 35,000,000 | ' | ' | ' |
Percentage sales commission on shares (in hundredths) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3.00% | 3.00% | ' | ' | ' | ' | ' | 3.00% | ' |
Class of Warrant or Right [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from secured loan upon execution of the agreement | ' | ' | ' | ' | 75,800,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Advanced upon execution of agreement | ' | ' | ' | ' | ' | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Advanced upon execution of agreement, net of transaction fee | ' | ' | ' | ' | ' | 9,850,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercisable period of warrants | ' | ' | ' | ' | ' | ' | '5 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercise price of warrants (in dollars per share) | $2.81 | ' | ' | ' | $2.81 | ' | ' | $1.50 | $1.50 | $2.80 | $2.80 | $3.20 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of warrant shares issuable (in shares) | 14,800,000 | ' | ' | ' | 7,000,000 | ' | ' | 4,948,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential value of common stock issuable upon exercise of warrants, maximum | ' | ' | ' | ' | ' | ' | ' | 7,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock, shares authorized (in shares) | 150,000,000 | 100,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock available for issuance (in shares) | 42,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional proceeds from secured loan | ' | ' | ' | ' | 20,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional proceeds from secured loan net of transaction fee | ' | ' | ' | ' | $19,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Accounting_Policies_and_Recent2
Accounting Policies and Recent Accounting Pronouncements (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Share data in Millions, unless otherwise specified | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2012 | Jun. 30, 2012 | Mar. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Segment | |||||||||||
Restricted Cash [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted cash | $325,000 | ' | ' | ' | ' | ' | ' | ' | $325,000 | ' | ' |
Long-lived assets [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Impairment of long-lived assets | ' | ' | ' | ' | ' | ' | ' | ' | 0 | 0 | 0 |
Grant Revenue [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Grant proceeds | 74,000 | 60,000 | 182,000 | 72,000 | 195,000 | 0 | 0 | 0 | 388,000 | 195,000 | 582,000 |
Net loss per common share [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential common stock issuable upon exercise of stock options and warrants (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | 20.2 | 11.9 | 15.4 |
Business segments [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of operating segments | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' | ' |
SBIR [Member] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Grant Revenue [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Grant awarded | ' | ' | ' | ' | 600,000 | ' | ' | ' | ' | 600,000 | ' |
Grant proceeds | ' | ' | ' | ' | ' | ' | ' | ' | $400,000 | $200,000 | $600,000 |
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, 2013 | Dec. 31, 2012 |
Liabilities [Abstract] | ' | ' |
Fair value of loan | $23,600,000 | $0 |
Long-Term Debt | 18,354,000 | 0 |
Recurring [Member] | ' | ' |
Assets [Abstract] | ' | ' |
Fair Value | 86,608,000 | 27,292,000 |
Recurring [Member] | Level 1 [Member] | ' | ' |
Assets [Abstract] | ' | ' |
Fair Value | 86,608,000 | 27,292,000 |
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 | 86,283,000 | 26,892,000 |
Recurring [Member] | Cash and cash equivalents [Member] | Level 1 [Member] | ' | ' |
Assets [Abstract] | ' | ' |
Fair Value | 86,283,000 | 26,892,000 |
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 | 325,000 | 400,000 |
Recurring [Member] | Certificate of Deposit [Member] | Level 1 [Member] | ' | ' |
Assets [Abstract] | ' | ' |
Fair Value | 325,000 | 400,000 |
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 | 5,425,000 | 6,305,000 |
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 | $5,425,000 | $6,305,000 |
Fair_Value_Measurements_Level_
Fair Value Measurements, Level 3 Rollforward (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | ||
Fair value measurements of common stock warrants using significant unobservable inputs (level 3) | ' | ' | |
Balance at end of period | $5,425,000 | $6,305,000 | |
Level 3 [Member] | ' | ' | |
Fair value measurements of common stock warrants using significant unobservable inputs (level 3) | ' | ' | |
Balance at beginning of period | 6,305,000 | 6,996 | |
Issuance of common stock warrants | ' | -136,000 | |
Exercise of warrants | -119,000 | [1] | ' |
Change in fair value of common stock warrant liability | -761,000 | -555,000 | |
Balance at end of period | $5,425,000 | $6,305,000 | |
[1] | See, Note 8 b 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, 2013 | Dec. 31, 2012 | |
Minimum [Member] | ' | ' |
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ' | ' |
Historical Volatility (in hundredths) | 62.00% | 56.00% |
Expected Term (in years) | '0 years 4 months 24 days | '1 year 4 months 24 days |
Risk-free interest rate (in hundredths) | 0.08% | 0.16% |
Maximum [Member] | ' | ' |
Significant Unobservable Input Assumptions of Level 3 Valuations [Abstract] | ' | ' |
Historical Volatility (in hundredths) | 76.00% | 80.00% |
Expected Term (in years) | '2 years 1 month 6 days | '3 years 2 months 12 days |
Risk-free interest rate (in hundredths) | 0.44% | 0.36% |
Inventory_Details
Inventory (Details) (USD $) | Dec. 31, 2013 | Oct. 04, 2013 | Mar. 31, 2013 | Dec. 31, 2012 |
Inventory [Abstract] | ' | ' | ' | ' |
Raw materials | $52,000 | $1,600,000 | ' | $195,000 |
Finished goods | 60,000 | ' | ' | 0 |
Inventory | 112,000 | ' | ' | 195,000 |
Capitalized raw material now charged to research and development account | ' | ' | 195,000 | ' |
Inventory reserves | $500,000 | ' | ' | $0 |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Property and equipment [Line Items] | ' | ' | ' |
Property and equipment, gross | $11,910,000 | $11,302,000 | ' |
Accumulated depreciation and amortization | -10,254,000 | -9,565,000 | ' |
Property and equipment, net | 1,656,000 | 1,737,000 | ' |
Depreciation expense | 700,000 | 900,000 | 1,300,000 |
Manufacturing, laboratory & office equipment [Member] | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' |
Property and equipment, gross | 8,383,000 | 7,775,000 | ' |
Furniture & fixtures [Member] | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' |
Property and equipment, gross | 816,000 | 816,000 | ' |
Leasehold Improvements [Member] | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' |
Property and equipment, gross | $2,711,000 | $2,711,000 | ' |
Accrued_Expenses_Details
Accrued Expenses (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Accrued Expenses [Abstract] | ' | ' |
Salaries, bonus & benefits | $1,849 | $1,206 |
Manufacturing operations | 1,707 | 926 |
Research and development | 270 | 734 |
Professional fees | 393 | 428 |
Sales and marketing | 161 | 279 |
All other | 405 | 586 |
Total accrued expenses | $4,785 | $4,159 |
Common_Stock_Warrant_Liability2
Common Stock Warrant Liability (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | 13-May-09 | Dec. 31, 2013 | Dec. 31, 2012 | Feb. 23, 2010 | Dec. 31, 2013 | Dec. 31, 2012 | Feb. 22, 2011 | Dec. 31, 2013 | Dec. 31, 2012 | 31-May-13 | Mar. 21, 2012 | Feb. 28, 2011 |
Five Year Warrant 1 [Member] | Five Year Warrant 1 [Member] | Five Year Warrant 1 [Member] | Five Year Warrant 2 [Member] | Five Year Warrant 2 [Member] | Five Year Warrant 2 [Member] | Five Year Warrant 3 [Member] | Five Year Warrant 3 [Member] | Five Year Warrant 3 [Member] | Five Year Warrant 3 [Member] | Five Year Warrant 3 [Member] | Five Year Warrant 3 [Member] | |||
Class of Warrant or Right [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercisable period of warrants | ' | ' | '5 years | ' | ' | '5 years | ' | ' | '5 years | ' | ' | ' | ' | ' |
Estimated fair value of warrants accounted for as derivative liabilities [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance Date | ' | ' | 13-May-09 | ' | ' | 23-Feb-10 | ' | ' | 22-Feb-11 | ' | ' | ' | ' | ' |
Number of Warrant Shares Issuable (in shares) | ' | ' | 466,667 | ' | ' | 916,669 | ' | ' | 4,834,950 | ' | ' | ' | ' | ' |
Exercise Price (in dollars per share) | ' | ' | $17.25 | ' | ' | $12.75 | ' | ' | $1.50 | ' | ' | ' | ' | ' |
Warrant Expiration Date | ' | ' | 13-May-14 | ' | ' | 23-Feb-15 | ' | ' | 22-Feb-16 | ' | ' | ' | ' | ' |
Fair Value of Warrants | $5,425,000 | $6,305,000 | $3,360,000 | $0 | $0 | $5,701,000 | $6,000 | $104,000 | $8,004,000 | $5,419,000 | $6,201,000 | ' | ' | ' |
Exercise of warrants by warrant holders to purchase common stock (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | 113,800 | 51,250 | ' | ' | ' |
Proceeds from exercise of warrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | $170,700 | $162,000 | ' | ' | ' |
Exercise price of warrants (in dollars per share) | $2.81 | ' | ' | ' | ' | ' | ' | ' | ' | $1.50 | $2.80 | $1.50 | $2.80 | $3.20 |
Deerfield_Loan_Facility_Detail
Deerfield Loan Facility (Details) (USD $) | 12 Months Ended | ||
Share data in Millions, except Per Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
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 equal annual installments on the fourth, fifth and sixth anniversaries of the Deerfield Loan agreement, provided that the amount payable on the fourth anniversary 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 on the fifth anniversary (together with any amount deferred on the fourth anniversary) shall be deferred until the sixth anniversary 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 to single holder, 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 | ' | ' |
Unamortized discount | -11,646,000 | 0 | ' |
Long-term debt, net of discount | 18,354,000 | ' | ' |
Interest expense [Abstract] | ' | ' | ' |
Cash interest expense | 911,000 | 0 | 0 |
Non-cash amortization of debt discount | 534,000 | 0 | 0 |
Amortization of debt costs | 18,000 | 0 | 0 |
Total Deerfield Loan interest expenses | 1,463,000 | 0 | 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 | ' | ' |
Equipment_Loan_Details
Equipment Loan (Details) (USD $) | 12 Months Ended | 0 Months Ended | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Sep. 08, 2008 | Dec. 31, 2013 | |
Pennsylvania Machinery and Equipment Loan [Member] | Pennsylvania Machinery and Equipment Loan [Member] | ||||
Debt Instrument [Line Items] | ' | ' | ' | ' | ' |
Short-term | $73,000 | $69,000 | ' | ' | ' |
Long-term | 69,000 | 148,000 | ' | ' | ' |
Total | 142,000 | 217,000 | ' | ' | ' |
Interest expense | 9,000 | 13,000 | 20,000 | ' | ' |
Debt instrument face amount | ' | ' | ' | $500,000 | ' |
Debt instrument, original term | ' | ' | ' | '7 years | ' |
Debt instrument interest rate stated percentage (in hundredths) | ' | ' | ' | 5.00% | ' |
Jobs covenant period | ' | ' | ' | '3 years | ' |
Debt instrument description of variable rate basis | ' | ' | ' | 'current prime rate | ' |
Debt instrument basis spread on variable rate (in hundredths) | ' | ' | ' | 2.00% | ' |
Covenant compliance status | ' | ' | ' | ' | 'due to our efforts to conserve resources while we focused on securing approval for SURFAXIN, we had not complied with the Jobs Covenant. In response to a request that we filed with the Department for a waiver, the Department granted us an extension through December 31, 2014 to come into compliance with the Jobs Covenant and has waived any interest adjustment until that date. |
Stockholders_Equity_Registered
Stockholders' Equity, Registered Public Offerings (Details) (USD $) | Dec. 31, 2013 | 31-May-13 | Nov. 30, 2013 | Nov. 08, 2013 | Nov. 05, 2013 | 28-May-13 | 10-May-13 | Apr. 30, 2012 | Mar. 21, 2012 | Feb. 22, 2011 | Dec. 05, 2013 | Jun. 10, 2013 | Apr. 30, 2012 | Feb. 22, 2011 | Feb. 22, 2011 | 31-May-13 | Mar. 21, 2012 | Feb. 22, 2011 |
In Millions, except Share data, unless otherwise specified | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | Registered Public Offerings [Member] | |
Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Capital Units [Member] | Fifteen Month Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | ||||
Stockholders' Equity [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, financing (in shares) | ' | 10,847,000 | 28,750,000 | ' | 25,000,000 | ' | 9,500,000 | ' | 16,071,429 | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Issue price of common unit (in dollars per unit) | ' | $1.50 | $2 | $2 | $2 | $1.50 | $1.50 | $2.80 | $2.80 | ' | ' | ' | ' | $2.35 | ' | ' | ' | ' |
Gross proceeds | ' | $16.30 | $57.50 | $7.50 | $50 | $2 | $14.30 | ' | $45 | ' | ' | ' | ' | $23.50 | ' | ' | ' | ' |
Net proceeds from issuance of common stock | ' | $15.10 | $53.90 | $7.10 | $46.80 | $1.90 | $13.20 | ' | $42.10 | ' | ' | ' | ' | $21.60 | ' | ' | ' | ' |
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 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares callable by warrants (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' | 5,000,000 |
Number of shares callable per warrant issued (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.5 | ' | ' | 0.5 |
Exercise price of warrants (in dollars per share) | $2.81 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $2.94 | $1.50 | $2.80 | $3.20 |
Stockholders_Equity_Committed_
Stockholders' Equity, Committed Equity Financing Facility (Details) (June 2010 CEFF [Member], USD $) | 12 Months Ended | |
In Millions, except Share data, unless otherwise specified | Dec. 31, 2011 | Jun. 30, 2013 |
June 2010 CEFF [Member] | ' | ' |
Stockholders' Equity [Line Items] | ' | ' |
Common stock available for issuance (in shares) | ' | 2,100,000 |
Maximum value of potential common stock available for issue | ' | $35 |
Shares issued (in shares) | 514,990 | ' |
Gross proceeds | $1.30 | ' |
Discounted average price per share (in dollars per share) | $2.56 | ' |
Stockholders_Equity_ATM_Progra
Stockholders' Equity, ATM Program and 401(k) Matching Contributions (Details) (USD $) | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | |||||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Mar. 12, 2012 | Dec. 14, 2011 | Dec. 31, 2013 | Oct. 15, 2013 | Feb. 11, 2013 | Oct. 31, 2013 | Dec. 31, 2013 | |
Lazard ATM Program [Member] | Lazard ATM Program [Member] | Lazard ATM Program [Member] | Stifel ATM Program [Member] | Stifel ATM Program [Member] | Stifel ATM Program [Member] | Stifel ATM Program [Member] | ||||
Stockholders' Equity [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Period of agency agreement | ' | ' | ' | ' | '2 years | ' | ' | '3 years | ' | ' |
Maximum value of potential common stock available for issue | ' | ' | ' | ' | $15,000,000 | ' | ' | $25,000,000 | ' | ' |
Percentage sales commission on shares (in hundredths) | ' | ' | ' | ' | 3.00% | 3.00% | ' | 3.00% | ' | ' |
Issuance of common stock, financing (in shares) | ' | ' | ' | 350,374 | ' | ' | 713,920 | ' | 713,920 | ' |
Issuance of common stock, financing | ' | ' | ' | 1,600,000 | ' | ' | 2,000,000 | ' | ' | ' |
Net proceeds from issuance of stock | ' | ' | ' | 1,500,000 | ' | ' | 1,800,000 | ' | 1,800,000 | ' |
Amount available under the ATM Program | ' | ' | ' | ' | ' | ' | ' | ' | ' | 23,000,000 |
Issuance of common stock, 401(k) employer match (in shares) | 510,047 | 316,543 | 265,185 | ' | ' | ' | ' | ' | ' | ' |
Expense associated with 401(k) plan | $1,000,000 | $800,000 | $500,000 | ' | ' | ' | ' | ' | ' | ' |
Stockholders_Equity_Common_Sha
Stockholders' Equity, Common Shares Reserved for Future Issuance (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2010 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Jun. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | ||
Stock Compensation Plan [Member] | Stock Compensation Plan [Member] | Former Employee Warrant [Member] | Former Employee Warrant [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Deerfield - 2013 Loan [Member] | Deerfield - 2013 Loan [Member] | Deerfield - 2013 Loan [Member] | Deerfield - 2013 Loan [Member] | Investor Warrants - February 2011 Financing - 1 [Member] | Investor Warrants - February 2011 Financing - 1 [Member] | PharmaBio - October 2010 Financing [Member] | PharmaBio - October 2010 Financing [Member] | Investor Warrants - June 2010 Financing [Member] | Investor Warrants - June 2010 Financing [Member] | Kingsbridge - June 2010 CEFF [Member] | Kingsbridge - June 2010 CEFF [Member] | Investor Warrants - May 2009 Financing [Member] | Investor Warrants - May 2009 Financing [Member] | Kingsbridge - December 2008 CEFF [Member] | Kingsbridge - December 2008 CEFF [Member] | Kingsbridge - May 2008 CEFF [Member] | Kingsbridge - May 2008 CEFF [Member] | June 2010 CEFF [Member] | Investor Warrants - February 2010 Financing [Member] | Investor Warrants - February 2010 Financing [Member] | 2011 Equity Incentive Plan [Member] | 2011 Equity Incentive Plan [Member] | 2007 Equity Incentive Plan [Member] | 2007 Equity Incentive Plan [Member] | 1998 Equity Incentive Plan [Member] | 1998 Equity Incentive Plan [Member] | 401(k) Plan [Member] | 401(k) Plan [Member] | |||||||
Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | Five Year Warrants [Member] | ||||||||||||||||||||||||
Stockholders' Equity [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||
Common stock available for issuance (in shares) | ' | ' | ' | ' | 8,322,000 | 6,963,000 | 30,000 | 30,000 | 14,781,000 | 7,950,000 | 7,000,000 | 0 | 135,000 | 135,000 | 4,835,000 | 4,949,000 | 79,000 | 79,000 | 1,190,000 | 1,190,000 | 83,000 | 83,000 | 467,000 | 467,000 | 45,000 | 45,000 | 0 | 55,000 | 2,100,000 | 917,000 | 917,000 | ' | ' | ' | ' | ' | ' | 166,243 | 26,290 | ||
Exercise Price (in dollars per share) | $2.81 | ' | ' | ' | ' | ' | $3.20 | ' | ' | ' | $2.81 | ' | $10.59 | ' | $1.50 | ' | $4.10 | ' | $6 | ' | $6.69 | ' | $17.25 | ' | $22.70 | ' | $37.59 | ' | ' | $12.75 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||
Expiration Date | ' | ' | ' | ' | ' | ' | 18-Mar-16 | ' | ' | ' | 13-Feb-19 | ' | 30-Apr-15 | ' | 22-Feb-16 | ' | 13-Oct-15 | ' | 22-Jun-15 | ' | 11-Dec-15 | ' | 13-May-14 | ' | 12-Jun-14 | ' | 22-Nov-13 | ' | ' | 23-Feb-15 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||
Common stock reserved for future issuance (in shares) | ' | ' | ' | ' | 8,322,000 | 6,963,000 | 30,000 | 30,000 | 14,781,000 | 7,950,000 | 7,000,000 | 0 | 135,000 | 135,000 | 4,835,000 | 4,949,000 | 79,000 | 79,000 | 1,190,000 | 1,190,000 | 83,000 | 83,000 | 467,000 | 467,000 | 45,000 | 45,000 | 0 | 55,000 | 2,100,000 | 917,000 | 917,000 | ' | ' | ' | ' | ' | ' | 166,243 | 26,290 | ||
Stock options and awards outstanding (in shares) | 5,428,000 | 3,997,000 | 2,438,000 | 943,000 | 5,428,000 | 3,997,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4,919,000 | [1] | 3,365,000 | [1] | 258,000 | 277,000 | 251,000 | 355,000 | ' | ' |
Available for Future Grants (in shares) | ' | ' | ' | ' | 2,894,000 | 2,966,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||
[1] | See, Note 12 b Stock Options and Stock-based Employee Compensation b Long-Term Incentive Plans. |
Stock_Options_and_Stockbased_E2
Stock Options and Stock-based Employee Compensation (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Stock options and awards outstanding (in shares) | 5,428,000 | 3,997,000 | 2,438,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ' | ' | ' |
Stock options outstanding, beginning of period (in shares) | 3,997,000 | 2,438,000 | 943,000 |
Granted (in shares) | 1,928,000 | 1,724,000 | 1,771,000 |
Exercised (in shares) | -18,000 | -3,000 | ' |
Forfeited or expired (in shares) | -479,000 | -162,000 | -276,000 |
Stock options outstanding, end of period (in shares) | 5,428,000 | 3,997,000 | 2,438,000 |
Exercisable at end of period (in shares) | 2,346,000 | ' | ' |
Weighted Average Exercise Price [Roll Forward] | ' | ' | ' |
Outstanding, beginning of period (in dollars per share) | $11.11 | $17.97 | $56.06 |
Granted (in dollars per share) | $2.30 | $2.63 | $1.84 |
Exercised (in dollars per share) | $1.85 | $1.83 | ' |
Forfeited or expired (in dollars per share) | $28.09 | $24.39 | $44.95 |
Outstanding, end of period (in dollars per share) | $6.51 | $11.11 | $17.97 |
Exercisable at end of period (in dollars per share) | $12.01 | ' | ' |
Outstanding, weighted average remaining contractual term | '8 years | ' | ' |
Exercisable, weighted average remaining contractual term | '6 years 10 months 24 days | ' | ' |
Options and awards granted, weighted average grant date fair value (in dollars per share) | $1.79 | $2.02 | $1.45 |
Proceeds from Stock Options Exercised | $34,000 | $6,000 | ' |
Options, outstanding, total intrinsic value | 800,000 | ' | ' |
Options, vested, total intrinsic value | 500,000 | ' | ' |
Options, exercisable, total intrinsic value | $500,000 | ' | ' |
Restricted Stock Awards (RSAs) [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Unvested RSAs outstanding (in shares) | 18,936 | ' | ' |
2011 Equity Incentive Plan [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Number of shares authorized (in shares) | 7,800,000 | ' | ' |
Stock options and awards outstanding (in shares) | 4,919,333 | ' | ' |
Available for future grants (in shares) | 2,894,374 | ' | ' |
Duration of continuous service | '3 years | ' | ' |
Term of award | '10 years | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ' | ' | ' |
Stock options outstanding, end of period (in shares) | 4,919,333 | ' | ' |
Stock_Options_and_Stockbased_E3
Stock Options and Stock-based Employee Compensation, Options Outstanding, Vested and Exercisable (Details) (USD $) | 12 Months Ended | ||
Share data in Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Employee stock-based compensation | $2,210,000 | $2,411,000 | $867,000 |
Modification Compensation Cost | ' | 800,000 | ' |
Weighted-average assumptions used in estimating fair value of stock options [Abstract] | ' | ' | ' |
Weighted average expected volatility (in hundredths) | 109.00% | 111.00% | 113.00% |
Weighted average expected term | '4 years 8 months 12 days | '4 years 7 months 6 days | '4 years 9 months 18 days |
Weighted average risk-free interest rate (in hundredths) | 0.73% | 0.74% | 1.08% |
Expected dividends (in hundredths) | 0.00% | 0.00% | 0.00% |
Fair value of options vested during period | 1,900,000 | 2,200,000 | 600,000 |
Unrecognized compensation cost related to non-vested share-based compensation arrangements | 4,000,000 | ' | ' |
Weighted-average vesting period of stock options | '1 year 8 months 12 days | ' | ' |
Research and Development [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Employee stock-based compensation | 784,000 | 487,000 | 289,000 |
General & Administrative [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Employee stock-based compensation | $1,426,000 | $1,924,000 | $578,000 |
$1.58 - $156.45 [Member] | ' | ' | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' | ' | ' |
Exercise Price Range, Lower Range Limit (in dollars per share) | $1.58 | ' | ' |
Exercise Price Range, Upper Range Limit (in dollars per share) | $156.45 | ' | ' |
Outstanding options (in shares) | 5,428 | ' | ' |
Outstanding, weighted average exercise price (in dollars per share) | $6.51 | ' | ' |
Outstanding, weighted average remaining contractual term | '8 years | ' | ' |
Vested and exercisable options outstanding (in shares) | 2,346 | ' | ' |
Vested and exercisable options, weighted average exercise price (in dollars per share) | $12.01 | ' | ' |
Vested and exercisable options, weighted average remaining contractual term | '6 years 10 months 24 days | ' | ' |
Corporate_Partnership_Licensin1
Corporate Partnership, Licensing and Research Funding Agreements (Details) (USD $) | 12 Months Ended |
Dec. 31, 2013 | |
Laboratories del Dr. Esteve, S.A. [Abstract] | ' |
Percent of cash upfront and milestone fees payable to Esteve | 10.00% |
Maximum aggregate cash upfront and milestone fees payable to Esteve | $20,000,000 |
Licensing and Research Funding Agreements [Abstract] | ' |
Potential license fee payable | 2,500,000 |
License fees paid | 950,000 |
Payment of license costs subject to FDA approval | $500,000 |
Commitments_Details
Commitments (Details) (USD $) | 12 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Feb. 23, 2018 | Dec. 31, 2013 | Dec. 31, 2013 | ||
Component | Plant Management [Member] | Non-Union employees [Member] | Collective Bargaining Agreement [Member] | Headquarters [Member] | Headquarters [Member] | Sterile Manufacturing Facility Through June 30, 2015 [Member] | ||||
Employee | Employee | Employee | sqft | sqft | ||||||
Operating lease obligations [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
2014 | $1,087,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
2015 | 1,024,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
2016 | 934,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
2017 | 936,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
2018 | 158,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Thereafter | 0 | ' | ' | ' | ' | ' | ' | ' | ' | |
Total | 4,139,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Equipment loan obligation [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
2014 | 79,000 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
2015 | 69,000 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
2016 | 0 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
2017 | 0 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
2018 | 0 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
There-after | 0 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
Total | 148,000 | [1] | ' | ' | ' | ' | ' | ' | ' | ' |
Total Contractual Obligations [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Total 2013 | 1,166,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Total 2014 | 1,093,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Total 2015 | 934,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Total 2016 | 936,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Total 2017 | 158,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Total Thereafter | 0 | ' | ' | ' | ' | ' | ' | ' | ' | |
Contractual Obligations, Total | 4,287,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Operating Leased Assets [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Leased Area of Real Estate Property | ' | ' | ' | ' | ' | ' | ' | 39,594 | 21,000 | |
Annual rent of leased property | 150,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Lease extension term | ' | ' | ' | ' | ' | ' | ' | '5 years | ' | |
Aggregate rental payments | ' | ' | ' | ' | ' | ' | 4,900,000 | 7,200,000 | 306,250 | |
Rent expense | 1,000,000 | 1,000,000 | 1,000,000 | ' | ' | ' | ' | ' | ' | |
Retention plan [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Number of components for retention plan | 2 | ' | ' | ' | ' | ' | ' | ' | ' | |
Number of employees receiving retention plan awards | ' | ' | ' | 3 | 9 | 14 | ' | ' | ' | |
Amount estimated for severance and retention | 1,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Liability for severance and retention | 100,000 | ' | ' | ' | ' | 500,000 | ' | ' | ' | |
Expense Related to Severance and Retention During the Period | ' | ' | ' | ' | ' | $30,000 | ' | ' | ' | |
[1] | See, Note 10 b Equipment Loan |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Reconciliation of income tax benefit to Federal statutory rates [Abstract] | ' | ' | ' |
Income tax benefit, statutory rates | $15,373,000 | $12,687,000 | $7,128,000 |
State taxes on income, net of Federal benefit | 2,922,000 | 2,288,000 | 1,633,000 |
Research and development tax credit | 517,000 | 332,000 | 662,000 |
Employee Related | -766,000 | -988,000 | -1,758,000 |
Warrant Valuation Related | 259,000 | 189,000 | 1,210,000 |
Income tax benefit | 18,305,000 | 14,508,000 | 8,875,000 |
Valuation allowance | -18,305,000 | -14,508,000 | -8,875,000 |
Income tax benefit | 0 | 0 | 0 |
Long-term deferred tax assets [Abstract] | ' | ' | ' |
Net operating loss carryforwards(Federal and state) | 175,258,000 | 160,522,000 | ' |
Research and development tax credits | 10,604,000 | 9,412,000 | ' |
Compensation expense on stock | 3,276,000 | 3,154,000 | ' |
Charitable contribution carryforward | 7,000 | 7,000 | ' |
Inventory reserve | 198,000 | 0 | ' |
Deferred revenue | 53,000 | 0 | ' |
Other accrued | 1,024,000 | 524,000 | ' |
Depreciation | 2,714,000 | 2,665,000 | ' |
Capitalized research and development | 1,326,000 | 1,516,000 | ' |
Total long-term deferred tax assets | 194,460,000 | 177,800,000 | ' |
Less: valuation allowance | -194,460,000 | -177,800,000 | ' |
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 | 10,600,000 | 9,400,000 | ' |
Internal Revenue Service (IRS) [Member] | ' | ' | ' |
Operating Loss Carryforwards [Line Items] | ' | ' | ' |
Operating loss carryforwards expiration dates | 'expire in 2008 and will continue through 2033 | ' | ' |
Operating loss carryforwards | 432,100,000 | 396,700,000 | ' |
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 2033 | ' | ' |
State and Local Jurisdiction [Member] | ' | ' | ' |
Operating Loss Carryforwards [Line Items] | ' | ' | ' |
Operating loss carryforwards | 433,700,000 | 392,600,000 | ' |
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 | $399,500,000 | ' | ' |
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, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2012 | Jun. 30, 2012 | Mar. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Selected Quarterly Financial Data (Unaudited) [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Grant Revenues | $74 | $60 | $182 | $72 | $195 | $0 | $0 | $0 | $388 | $195 | $582 |
Expenses: | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cost of sales | 517 | 0 | 0 | 0 | ' | ' | ' | ' | 517 | 0 | 0 |
Research & development | 5,752 | 6,574 | 6,863 | 8,472 | 6,088 | 5,743 | 5,206 | 4,533 | 27,661 | 21,570 | 17,230 |
General and administrative | 4,070 | 4,299 | 4,129 | 4,220 | 6,532 | 4,255 | 3,610 | 2,047 | 16,718 | 16,444 | 7,864 |
Total expenses | 10,339 | 10,873 | 10,992 | 12,692 | 12,620 | 9,998 | 8,816 | 6,580 | 44,896 | 38,014 | 25,094 |
Operating loss | -10,265 | -10,813 | -10,810 | -12,620 | -12,425 | -9,998 | -8,816 | -6,580 | -44,508 | -37,819 | -24,512 |
Change in fair value of common stock warrant liability | -867 | -1,059 | 2,525 | 162 | 5,618 | -3,309 | 1,680 | -3,434 | 761 | 555 | 3,560 |
Other expense, net | -597 | -352 | -342 | -177 | -8 | -39 | -2 | -2 | -1,468 | -51 | -13 |
Net loss | ($11,729) | ($12,224) | ($8,627) | ($12,635) | ($6,815) | ($13,346) | ($7,138) | ($10,016) | ($45,215) | ($37,315) | ($20,965) |
Net loss per common share - basic and diluted (in dollars per share) | ' | ' | ' | ' | ($0.16) | ($0.31) | ($0.16) | ($0.37) | ($0.82) | ($0.95) | ($0.93) |
Weighted average number of common shares outstanding - basic and diluted (in shares) | ' | ' | ' | ' | 43,521 | 43,444 | 43,369 | 27,162 | ' | 39,396 | ' |
Earnings Per Share, Basic [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss per common share - basic (in dollars per share) | ($0.16) | ($0.22) | ($0.18) | ($0.29) | ' | ' | ' | ' | ($0.82) | ' | ' |
Weighted average number of common shares outstanding - basic (in shares) | 73,129 | 54,792 | 49,135 | 43,657 | ' | ' | ' | ' | 55,258 | ' | ' |
Earnings Per Share, Diluted [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss per common share - diluted (in dollars per share) | ($0.16) | ($0.22) | ($0.22) | ($0.29) | ' | ' | ' | ' | ($0.82) | ' | ' |
Weighted average number of common shares outstanding - diluted (in shares) | 73,129 | 54,792 | 49,866 | 43,657 | ' | ' | ' | ' | 55,258 | 39,396 | 22,660 |