Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Feb. 28, 2014 | Jun. 28, 2013 |
Document Document And Entity Information [Abstract] | ' | ' | ' |
Entity Registrant Name | 'Galena Biopharma, Inc. | ' | ' |
Trading Symbol | 'GALE | ' | ' |
Entity Central Index Key | '0001390478 | ' | ' |
Current Fiscal Year End Date | '--12-31 | ' | ' |
Entity Filer Category | 'Accelerated Filer | ' | ' |
Document Type | '10-K | ' | ' |
Document Period End Date | 31-Dec-13 | ' | ' |
Document Fiscal Year Focus | '2013 | ' | ' |
Document Fiscal Period Focus | 'FY | ' | ' |
Amendment Flag | 'false | ' | ' |
Entity Well-known Seasoned Issuer | 'No | ' | ' |
Entity Current Reporting Status | 'Yes | ' | ' |
Entity Voluntary Filers | 'No | ' | ' |
Entity Public Float | ' | ' | $185,711 |
Entity Common Stock, Shares Outstanding | ' | 117,879,459 | ' |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $47,787 | $32,807 |
Restricted cash | 200 | 101 |
Marketable securities | 0 | 2,678 |
Accounts Receivable, Net, Current | 3,683 | 0 |
Inventories | 386 | 0 |
Prepaid expenses | 1,399 | 535 |
Total current assets | 53,455 | 36,121 |
Equipment and furnishings, net | 665 | 29 |
Abstral rights | 14,979 | ' |
In-process research and development | 12,864 | 12,864 |
Goodwill | 5,898 | 5,898 |
Deposits and other assets | 115 | 74 |
Total assets | 87,976 | 54,986 |
Current liabilities: | ' | ' |
Accounts payable | 2,660 | 1,976 |
Accrued expense and other current liabilities | 8,667 | 2,038 |
Current maturities of capital lease obligations | 6 | 6 |
Fair value of warrants potentially settleable in cash | 48,965 | 10,964 |
Current contingent purchase price consideration | 0 | 935 |
Current portion of long-term debt | 2,149 | 0 |
Total current liabilities | 62,447 | 15,919 |
Capital lease obligations, net of current maturities | 26 | 51 |
Deferred tax liability, non-current | 5,053 | 5,053 |
Contingent purchase price consideration, net of current portion | 6,821 | 6,207 |
Total long-term debt, net | 7,743 | 0 |
Total liabilities | 82,090 | 27,230 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding | ' | ' |
Common stock, $0.0001 par value; 200,000,000 shares authorized, 110,100,701 shares issued and 109,425,701 shares outstanding at December 31, 2013; 125,000,000 shares authorized, 83,595,837 shares issued and 82,920,837 outstanding at December 31, 2012 | 10 | 8 |
Additional paid-in capital | 188,600 | 132,168 |
Accumulated other comprehensive income | 0 | 1,626 |
Accumulated deficit | 178,875 | 102,197 |
Less treasury shares at cost, 675,000 shares | -3,849 | -3,849 |
Total stockholders' equity | 5,886 | 27,756 |
Total liabilities and stockholders' equity | $87,976 | $54,986 |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
Statement of Financial Position [Abstract] | ' | ' |
Preferred stock, par value (usd per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (usd per share) | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 125,000,000 |
Common stock, shares issued | 110,100,701 | 83,595,837 |
Common stock, shares outstanding | 109,425,701 | 82,920,837 |
Treasury stock, shares | 675,000 | 675,000 |
CONSOLIDATED_STATEMENTS_OF_COM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Income Statement [Abstract] | ' | ' | ' |
Net revenue | $2,487 | $0 | $0 |
Costs and expenses: | ' | ' | ' |
Cost of Revenue | 520 | 0 | 0 |
Research and development | 21,076 | 14,614 | 3,851 |
Selling, general and administrative | 14,600 | 6,585 | 8,635 |
Amortization of certain acquired intangible assets | 131 | 0 | 0 |
Total costs and expenses | 36,327 | 21,199 | 12,486 |
Operating loss | -33,840 | -21,199 | -12,486 |
Non-operating income (expense): | ' | ' | ' |
Interest income (expense), net | -807 | -33 | -7 |
Other income (expense) | -40,979 | -13,145 | 9,086 |
Total non-operating income (expense), net | -41,786 | -13,178 | 9,079 |
Loss from continuing operations before income taxes | -75,626 | -34,377 | -3,407 |
Income tax expense (benefit) | 1,052 | -1,052 | ' |
Loss from continuing operations | -76,678 | -33,325 | -3,407 |
Loss from discontinued operations | 0 | -1,644 | -8,078 |
Net loss | -76,678 | -34,969 | -11,485 |
Net loss per common share: | ' | ' | ' |
Basic and diluted per share, continuing operations (usd per share) | ($0.85) | ($0.53) | ($0.09) |
Basic and diluted loss per share, discontinued operations (usd per share) | $0 | ($0.03) | ($0.22) |
Basic and diluted net loss per share (usd per share) | ($0.85) | ($0.56) | ($0.32) |
Weighted-average common shares outstanding: basic and diluted | 90,181,501 | 62,480,666 | 36,334,413 |
Comprehensive loss | ' | ' | ' |
Net loss | -76,678 | -34,969 | -11,485 |
Reclassification of unrealized gain upon sale of marketable securities | -2,678 | 0 | 0 |
Unrealized gain on marketable securities | ' | 2,678 | ' |
Tax effect of reclassification of unrealized gain upon sale of marketable securities | 1,052 | 0 | 0 |
Tax effect of unrealized gain on marketable securities | 0 | -1,052 | 0 |
Total comprehensive loss | ($78,304) | ($33,343) | ($11,485) |
CONSOLIDATED_STATEMENT_OF_STOC
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (USD $) | Total | September 2013 Common Stock Offering [Member] | Long-term Debt Financing [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] |
September 2013 Common Stock Offering [Member] | Long-term Debt Financing [Member] | |||||||||
Beginning balance at Dec. 31, 2010 | $2,430,000 | ' | ' | $2,000 | $62,020,000 | ' | ' | $0 | ($55,743,000) | ($3,849,000) |
Beginning balance, shares at Dec. 31, 2010 | ' | ' | ' | 19,047,759 | ' | ' | ' | ' | ' | ' |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, shares | ' | ' | ' | 18,650,000 | ' | ' | ' | ' | ' | ' |
Issuance of common stock | 18,615,000 | ' | ' | 2,000 | 18,613,000 | ' | ' | ' | ' | ' |
Common stock warrants issued in connection with common stock offering | -12,709,000 | ' | ' | ' | -12,709,000 | ' | ' | ' | ' | ' |
Issuance of stock in lieu of cash bonus, shares | ' | ' | ' | 147,040 | ' | ' | ' | ' | ' | ' |
Issuance of stock in lieu of cash bonus | 171,000 | ' | ' | ' | 171,000 | ' | ' | ' | ' | ' |
Issuance of resticted stock units, shares | ' | ' | ' | 220,729 | ' | ' | ' | ' | ' | ' |
Issuance of restricted stock units | 256,000 | ' | ' | ' | 256,000 | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for services, shares | ' | ' | ' | 53,558 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for services | 73,000 | ' | ' | ' | 73,000 | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of warrants, shares | ' | ' | ' | 4,301,000 | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of warrants | 3,270,000 | ' | ' | ' | 3,270,000 | ' | ' | ' | ' | ' |
Issuance of common stock in connection with employee stock purchase plan, shares | ' | ' | ' | 18,824 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in connection with employee stock purchase plan | 15,000 | ' | ' | ' | 15,000 | ' | ' | ' | ' | ' |
Issuance of common stock in settlement of contingent purchase price consideration | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock in settlement of contingent purchase price consideration, shares | ' | ' | ' | 4,974,090 | ' | ' | ' | ' | ' | ' |
Issuance of common stock related to acquisition | 6,367,000 | ' | ' | 1,000 | 6,366,000 | ' | ' | ' | ' | ' |
Issuance of common stock subject to employee termination agreements, shares | ' | ' | ' | 398,453 | ' | ' | ' | ' | ' | ' |
Issuance of common stock subject to employee termination agreements | 350,000 | ' | ' | ' | 350,000 | ' | ' | ' | ' | ' |
Stock based compensation for directors and employees | 2,774,000 | ' | ' | ' | 2,774,000 | ' | ' | ' | ' | ' |
Stock based compensation for services | -15,000 | ' | ' | ' | -15,000 | ' | ' | ' | ' | ' |
Net liabilities distributed in connection with the RXi spin-off | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | -11,485,000 | ' | ' | ' | ' | ' | ' | ' | -11,485,000 | ' |
Ending balance at Dec. 31, 2011 | 10,112,000 | ' | ' | 5,000 | 81,184,000 | ' | ' | 0 | -67,228,000 | -3,849,000 |
Ending balance, shares at Dec. 31, 2011 | ' | ' | ' | 47,811,453 | ' | ' | ' | ' | ' | ' |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, shares | ' | ' | ' | 25,486,960 | ' | ' | ' | ' | ' | ' |
Issuance of common stock | 36,378,000 | ' | ' | 2,000 | 36,376,000 | ' | ' | ' | ' | ' |
Common stock warrants issued in connection with common stock offering | -7,286,000 | ' | ' | ' | -7,286,000 | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for services, shares | ' | ' | ' | 288,285 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for services | 364,000 | ' | ' | ' | 364,000 | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of warrants, shares | ' | ' | ' | 8,433,003 | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of warrants | 16,551,000 | ' | ' | 1,000 | 16,550,000 | ' | ' | ' | ' | ' |
Repurchase Of Common Stock Warrant | -266,000 | ' | ' | ' | -266,000 | ' | ' | ' | ' | ' |
Issuance of common stock in connection with employee stock purchase plan, shares | ' | ' | ' | 234,350 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in connection with employee stock purchase plan | 93,000 | ' | ' | ' | 93,000 | ' | ' | ' | ' | ' |
Issuance of common stock in settlement of contingent purchase price consideration, shares | ' | ' | ' | 1,315,849 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in settlement of contingent purchase price consideration | 1,579,000 | ' | ' | ' | 1,579,000 | ' | ' | ' | ' | ' |
Stock based compensation for directors and employees | 794,000 | ' | ' | ' | 794,000 | ' | ' | ' | ' | ' |
Stock based compensation for services | 600,000 | ' | ' | ' | 600,000 | ' | ' | ' | ' | ' |
Net liabilities distributed in connection with the RXi spin-off | 2,159,000 | ' | ' | ' | 2,159,000 | ' | ' | ' | ' | ' |
Unrealized gain on marketable securities, net of tax | 1,626,000 | ' | ' | ' | ' | ' | ' | 1,626,000 | ' | ' |
Exercise of stock options, shares | ' | ' | ' | 25,937 | ' | ' | ' | ' | ' | ' |
Exercise of stock options | 21,000 | ' | ' | ' | 21,000 | ' | ' | ' | ' | ' |
Net loss | -34,969,000 | ' | ' | ' | ' | ' | ' | ' | -34,969,000 | ' |
Ending balance at Dec. 31, 2012 | 27,756,000 | ' | ' | 8,000 | 132,168,000 | ' | ' | 1,626,000 | -102,197,000 | -3,849,000 |
Ending balance, shares at Dec. 31, 2012 | ' | ' | ' | 83,595,837 | ' | ' | ' | ' | ' | ' |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, shares | ' | ' | ' | 20,125,000 | ' | ' | ' | ' | ' | ' |
Issuance of common stock | 37,539,000 | ' | ' | 2,000 | 37,537,000 | ' | ' | ' | ' | ' |
Common stock warrants issued in connection with common stock offering | ' | -8,238,000 | 351,000 | ' | ' | -8,238,000 | 351,000 | ' | ' | ' |
Issuance of common stock upon exercise of warrants, shares | ' | ' | ' | 5,320,669 | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of warrants | 22,064,000 | ' | ' | ' | 22,064,000 | ' | ' | ' | ' | ' |
Issuance of common stock in connection with employee stock purchase plan, shares | 243,510 | ' | ' | 52,532 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in connection with employee stock purchase plan | 163,000 | ' | ' | ' | 163,000 | ' | ' | ' | ' | ' |
Issuance of common stock in settlement of contingent purchase price consideration, shares | ' | ' | ' | 492,988 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in settlement of contingent purchase price consideration | 1,247,000 | ' | ' | ' | 1,247,000 | ' | ' | ' | ' | ' |
Issuance of common stock related to acquisition | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for services, shares | ' | ' | ' | 99,998 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for services | 211,000 | ' | ' | ' | 211,000 | ' | ' | ' | ' | ' |
Stock based compensation for directors and employees | 1,886,000 | ' | ' | ' | 1,886,000 | ' | ' | ' | ' | ' |
Stock based compensation for services | 644,000 | ' | ' | ' | 644,000 | ' | ' | ' | ' | ' |
Net liabilities distributed in connection with the RXi spin-off | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reclassification of unrealized gain upon the sale of marketable securities, net of tax of $1,052 | -1,626,000 | ' | ' | ' | ' | ' | ' | -1,626,000 | ' | ' |
Exercise of stock options, shares | 289,000 | ' | ' | 413,677 | ' | ' | ' | ' | ' | ' |
Exercise of stock options | 567,000 | ' | ' | ' | 567,000 | ' | ' | ' | ' | ' |
Net loss | -76,678,000 | ' | ' | ' | ' | ' | ' | ' | -76,678,000 | ' |
Ending balance at Dec. 31, 2013 | $5,886,000 | ' | ' | $10,000 | $188,600,000 | ' | ' | $0 | ($178,875,000) | ($3,849,000) |
Ending balance, shares at Dec. 31, 2013 | ' | ' | ' | 110,100,701 | ' | ' | ' | ' | ' | ' |
CONSOLIDATED_STATEMENT_OF_STOC1
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) (USD $) | 9 Months Ended | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Statement of Stockholders' Equity [Abstract] | ' | ' | ' | ' |
Reclassification Of Warrant Liability Upon Exercise | ($10,843) | ($14,249) | $10,843 | ' |
Tax on unrealized gain on marketable securities | ' | 0 | 1,052 | 0 |
Tax effect of reclassification of unrealized gain upon sale of marketable securities | ' | $1,052 | $0 | $0 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 9 Months Ended | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Cash flows from operating activities: | ' | ' | ' | ' |
Net loss | ' | ($76,678) | ($34,969) | ($11,485) |
Adjustment to reconcile net loss to net cash used in operating activities: | ' | ' | ' | ' |
Depreciation and amortization expense | ' | 452 | 49 | 163 |
Loss on disposal of equipment | ' | 0 | 0 | 7 |
Gain on sale of marketable securities | ' | -3,911 | 0 | 0 |
Deferred taxes | ' | 1,052 | -1,052 | ' |
Non-cash stock-based compensation | ' | 2,530 | 1,394 | 3,001 |
Fair value of common stock warrants issued in exchange for services | ' | ' | 0 | 108 |
Fair value of common stock issued in exchange for services | ' | 211 | 364 | 73 |
Change in fair value of common stock warrants | ' | 44,001 | 10,775 | -8,981 |
Change in fair value of contingent consideration | ' | 926 | 2,370 | -109 |
Changes in operating assets and liabilities: | ' | ' | ' | ' |
Accounts receivable | ' | -3,683 | 0 | 0 |
Inventories | ' | -386 | 0 | 0 |
Prepaid expenses and other assets | ' | -832 | -396 | -99 |
Accounts payable | ' | 684 | 641 | 500 |
Accrued expenses and other current liabilities | ' | 6,726 | -139 | 2,154 |
Net cash used in operating activities | ' | -28,908 | -20,963 | -14,668 |
Cash flows from investing activities: | ' | ' | ' | ' |
Change in restricted cash | ' | -99 | ' | -101 |
Cash paid for acquisition of Abstral rights | ' | -15,143 | ' | ' |
Cash received in Apthera acquisition | ' | 0 | 0 | 168 |
Proceeds from sale of marketable securities | ' | 3,911 | 0 | 0 |
Cash paid for purchase of equipment and furnishings | ' | -705 | ' | -53 |
Cash transferred with the RXi spin-off | ' | ' | -87 | ' |
Net cash provided by (used in) investing activities | ' | -12,036 | -87 | 14 |
Cash flows from financing activities: | ' | ' | ' | ' |
Net proceeds from issuance of common stock | ' | 37,539 | 36,378 | 18,615 |
Cash paid for repurchase of warrants | ' | ' | -266 | ' |
Net proceeds from exercise of stock options | ' | 567 | 21 | ' |
Proceeds from exercise of warrants | ' | 7,815 | 5,708 | 150 |
Proceeds from common stock issued in connection with ESPP | ' | 163 | 93 | 15 |
Net proceeds from issuance of RXi convertible notes payable | ' | ' | 500 | 500 |
Net proceeds from issuance of long-term debt | ' | 9,865 | 0 | 0 |
Repayments of capital lease obligations | ' | -25 | -10 | -84 |
Net cash provided by financing activities | ' | 55,924 | 42,424 | 19,196 |
Net increase in cash and cash equivalents | ' | 14,980 | 21,374 | 4,542 |
Cash and cash equivalents at the beginning of period | 11,433 | 32,807 | 11,433 | 6,891 |
Cash and cash equivalents at end of period | ' | 47,787 | 32,807 | 11,433 |
Supplemental disclosure of cash flow information: | ' | ' | ' | ' |
Cash received during the periods for interest | 1 | 19 | ' | 2 |
Cash paid during the periods for interest | 1 | 547 | ' | 6 |
Supplemental disclosure of non-cash investing and financing activities: | ' | ' | ' | ' |
Fair value of warrants issued in connection with common stock recorded as cost of equity | 7,286 | 8,238 | ' | 12,709 |
Issuance of common stock in exchange of outstanding warrants | 0 | 0 | ' | 3,120 |
Net liabilities distributed in connection with the RXi spin-off | 2,246 | 0 | 2,159 | 0 |
Reclassification of warrant liabilities upon exercise | 10,843 | 14,249 | -10,843 | ' |
Issuance of common stock in settlement of contingent purchase price consideration | 1,579 | 1,247 | 1,579 | ' |
Change in fair value of marketable securities before settlement | 2,678 | -2,678 | ' | ' |
Fair value of shares issued to acquire NeuVax | 0 | 0 | ' | 6,367 |
Fair value of contingent purchase price consideration in connection with NeuVax acquisition | 0 | 0 | ' | 6,460 |
Net assets acquired, excluding cash of $168 | ' | $0 | $0 | $12,827 |
CONSOLIDATED_STATEMENTS_OF_CAS1
CONSOLIDATED STATEMENTS OF CASH FLOWS CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (USD $) | 12 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2011 |
Statement of Cash Flows [Abstract] | ' |
Cash excluding from net assets acquired | $168 |
Business_and_Basis_of_Presenta
Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2013 | |
Accounting Policies [Abstract] | ' |
Business and Basis of Presentation | ' |
Business and Basis of Presentation | |
Galena Biopharma, Inc. (“we,” “us,” “our,” “Galena” or the “company”) is a biopharmaceutical company focused on developing and commercializing innovative, targeted treatments that address major unmet medical needs to advance cancer care. | |
Galena is developing peptide vaccine (off-the-shelf) cancer immunotherapies, which address patient populations of cancer survivors to prevent disease recurrence by harnessing the patient's own immune system to seek out and attack any residual cancer. In this case, 25% of resectable node-positive breast cancer patients, despite having no evidence of disease following surgery and chemo/radiation therapy, will still relapse within three years. Increased presence of circulating tumor cells (CTCs) predict Disease Free Survival (DFS) and Overall Survival (OS) - suggesting a dormancy of isolated micrometastases, which over time, leads to recurrence. Our lead product, NeuVaxTM (nelipepimut-S) elicits a robust, specific and durable killer CD8+ cytotoxic T lymphocyte (CTLs) response to lyse HER2 expressing tumor cells. | |
NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CTLs following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on our Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter, investigator-sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche). | |
Our second product candidate, GALE-301 (Folate Binding Protein, or “FBP”), is derived from a protein that is over-expressed (20-80 fold) in more than 90% of ovarian and endometrial cancers. FBP is a highly immunogenic peptide that can stimulate CTLs to recognize and destroy preclinical FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF). Galena’s FBP vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. | |
Our third product candidate, GALE-401 (anagrelide controlled release (CR)) was acquired on January 13, 2014. GALE-401 contains the active ingredient anagrelide, an FDA-approved product, which has been in use since the late 1990s for the treatment of essential thrombocythemia (ET). GALE-401 is a reformulated, controlled release version of anagrelide that is currently only given as an immediate release (IR) version. Multiple Phase 1 studies in an aggregate 90 patients have shown the drug to be effective at lowering platelet levels while reducing side effects that prevent patients from taking their therapy regularly. Based on a regulatory meeting with the FDA, Galena believes a 505(b)(2) regulatory filing is an acceptable paradigm for approval of GALE-401, with the reference drug Agrylin® (anagrelide; Shire Pharmaceuticals). The Phase 1 program has provided the desired PK/PD (pharmacokinetic/pharmacodynamic) profile to enable the Phase 2 initiation in 2014. | |
Our first commercial product, Abstral® (fentanyl) Sublingual Tablets, is an important treatment option for inadequately controlled breakthrough cancer pain (BTcP) which affects an estimated 40%-80% of all cancer patients. Abstral is approved by the FDA, as a sublingual (under the tongue) tablet for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a convenient sublingual tablet which is designed to dissolve under the tongue in seconds, provide relief of breakthrough pain within minutes, and match the duration of the pain episode. | |
Basis of Presentation and Significant Accounting Policies | |
The accompanying consolidated financial statements included herein have been prepared by Galena pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Unless the context otherwise indicates, references in this these notes to the “company,” “we,” “us” or “our” refer (i) to Galena, our wholly owned subsidiary, Apthera, Inc., or “Apthera,” and our former subsidiary, RXi Pharmaceuticals Corporation, or “RXi,” collectively, prior to our partial spin-off of RXi in April 2012; and (ii) to Galena and Apthera, together, after the partial spin-off. | |
Based on the product launch of Abstral and the significant commercial operations during the second half of 2013, Galena is no longer a development stage entity in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 915, "Development Stage Entities," and the financial statements for the period ended December 31, 2013 will no longer reflect financial information since inception. | |
Uses of Estimates in Preparation of Financial Statements — The preparation of these consolidated financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates. | |
Principles of Consolidation — The consolidated financial statements include the accounts of Galena and its wholly owned subsidiary. All material intercompany accounts have been eliminated in consolidation. | |
Reclassifications — Certain prior year amounts have been reclassified to conform to current year presentation. These reclassifications had no effect on net loss per share. | |
Cash and Cash Equivalents — The company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts and demand deposits. | |
Restricted Cash — Restricted cash consists of certificates of deposit on hand with the company’s financial institutions as collateral for its corporate credit cards. | |
Marketable Securities — Marketable securities consist of shares of common stock of our former subsidiary, RXi Pharmaceuticals Corporation, a publicly traded company, and are classified as available-for-sale and carried at fair value on the balance sheet. Changes in the fair value of marketable securities are recorded as other comprehensive income (loss). | |
Fair Value of Financial Instruments — The carrying amounts reported in the balance sheet for cash equivalents, marketable securities, accounts receivable, accounts payable, and capital leases approximate their fair values due to their short-term nature and market rates of interest. | |
Accounts Receivable - The company maintains credit limits for all customers based upon several factors, including but not limited to financial condition and stability, payment history, published credit reports and use of credit references. Management performs analysis to evaluate accounts receivables to ensure recorded amounts reflect estimate net realizable value. | |
Inventories — Inventories are stated at the lower of cost or market value and are determined using the first-in, first-out ("FIFO") method. Inventories consist of Abstral work-in-process and finished goods. The company has entered into manufacturing and supply agreements for the manufacture and packing of Abstral finished goods. As of December 31, 2013, the company had inventories of $386,000, consisting of $270,000 of work-in-process and $116,000 of finished goods. The company had no inventory as of December 31, 2012. | |
Equipment and Furnishings — Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. | |
Goodwill and Intangible Assets — Goodwill and indefinite-lived intangible assets are not amortized but are tested annually for impairment at the reporting unit level, or more frequently if events and circumstances indicate impairment may have occurred. Factors the company considers important that could trigger an interim review for impairment include, but are not limited to, the following: | |
•Significant changes in the manner of its use of acquired assets or the strategy for its overall business; | |
•Significant negative industry or economic trends; | |
•Significant decline in stock price for a sustained period; and | |
•Significant decline in market capitalization relative to net book value. | |
Goodwill and other intangible assets with indefinite lives are evaluated for impairment first by a qualitative assessment to determine the likelihood of impairment. If it is determined that impairment is more likely than not, the company will then proceed to the two step impairment test. The first step is to compare the fair value of the reporting unit to the carrying amount of the reporting unit (the “First Step”). If the carrying amount exceeds the fair value, a second step must be followed to calculate impairment (the “Second Step”). Otherwise, if the fair value of the reporting unit exceeds the carrying amount, the goodwill is not considered to be impaired as of the measurement date. In its review of the carrying value of the goodwill for its single reporting unit and its indefinite-lived intangible assets, the company determines fair values of its goodwill using the market approach, and its indefinite-lived intangible assets using the income approach. | |
Intangible assets not considered indefinite-lived are reviewed for impairment when facts or circumstances suggest that the carrying value of these assets may not be recoverable. The company’s policy is to identify and record impairment losses, if necessary, on intangible product rights when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. | |
The company performed its review for impairment using the qualitative assessment for both goodwill and indefinite-lived intangible assets, and has determined that there has been no impairment to these assets as of December 31, 2013. | |
Revenue Recognition - The company recognizes revenue from the sale of Abstral. Revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred and title has passed, (iii) the price is fixed or determinable and (iv) collectability is reasonably assured. | |
We sell Abstral product in the United States to wholesale pharmaceutical distributors and retail pharmacies, or collectively, our "customers," subject to rights of return. During the year ended December 31, 2013, we began recognizing Abstral product sales at the time title transfers to our customer, and providing for an estimate of future product returns. Revenue from product sales is recorded net of provisions for estimated returns, prompt pay discounts, wholesaler discounts, rebates, chargebacks, patient assistance program rebates and other deductions as needed. | |
Returns - The company estimates future returns based on historical return information, as well as information regarding prescription information and sell-through trends, in relation to the estimated amount of product in the sales channels and product expiration dates. No reserve for future returns was deemed necessary at December 31, 2013. | |
Product Sales Discounts and Allowances - The company recognizes revenue at the point of sale to its wholesale pharmaceutical distributors and retail pharmacies and the allowances for product returns, rebates and allowances are recognized at the point of sale. The company is required to make significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the company will be required to make adjustments to these allowances in the future. | |
Prompt Pay Discounts - As an incentive for prompt payment, the company offers a cash discount to customers, generally 2% of gross sales. The company expects that all customers will comply with the contractual terms to earn the discount. The company records the discount as an allowance against accounts receivable and a reduction of revenue. | |
Wholesaler Discounts - The company offers discounts to certain wholesalers and distributors based on contractually determined rates. The company accrues the discount as a reduction of receivables due from the wholesalers upon shipment to the respective wholesale distributors and retail pharmacies and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. | |
Rebates - The company participates in certain rebate programs, which provide discounted prescriptions to members of group purchasing organization and specialty pharmacies. Under these rebate programs, the company pays a rebate to the third-party administrator of the program, generally two to the three months after the quarter in which prescriptions subject to the rebate are filled. The company estimates and accrues these rebates based on current contract prices, historical and estimated future percentages of product sold to qualifying member pharmacies and estimated levels of inventory in the distribution channel. Rebates are recognized as a reduction in the period that the related revenue is recognized. | |
Chargebacks - The company provides discounts primarily to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid or Medicare contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the company the difference between the current retail price and the price the entity paid for the product. The company estimates and accrues chargebacks based on estimated wholesaler inventory levels, current contract prices and historic chargeback activity. Chargebacks are recognized as a reduction of revenue in the period the related revenue is recognized. | |
Patient Assistance Programs - The company offers discount card programs to patients for Abstral in which patients receive discounts on their Abstral prescriptions that are reimbursed by the company. The company estimates the total amount that will be recognized based on a percentage of actual redemption applied to inventory in the distribution and retail channel and recognizes the discount as a reduction of revenue and as an other current liability (see Note 6) in the same period the related revenue is recognized. | |
Acquisitions and In-Licensing — For all in-licensed products and technologies, we perform an analysis to determine whether we hold a variable interest or a controlling financial interest in a variable interest entity. On the basis of our interpretations and conclusions, we determine whether the acquisition falls under the purview of variable interest entity accounting and if so, consider the necessity to consolidate the acquisition. As of December 31, 2013, we determined there were no variable interest entities required to be consolidated. | |
We also perform an analysis to determine if the assets and liabilities acquired in an acquisition qualify as a "business." The excess of the purchase price over the fair value of the net assets acquired can only be recognized as goodwill in a business combination. | |
The acquisition of the Abstral U.S. rights has been accounted for as an asset acquisition and not a business combination. The purchase price, including transaction costs, was recorded as an intangible asset related to the license and distribution rights acquired in the transaction. No other significant assets or liabilities were acquired or assumed in the transaction. The license and distribution rights will be amortized over ten years in a pattern based on our Abstral sales projections. Amortization expense, related to the Abstral rights, of $131,000 was recorded in amortization of certain acquired intangible assess in the statement of comprehensive loss for the year ended December 31, 2013. There was no amortization recorded prior to the year ended December 31, 2013. Refer to Note 15 for further information regarding the acquisition of Abstral U.S. rights. | |
Contingent Purchase Price Consideration — Contingent consideration is recorded at the estimated fair value as of the acquisition date. The fair value of the contingent consideration is remeasured at each reporting period with any adjustments in fair value included in our consolidated statement of comprehensive loss. | |
Patents and Patent Application Costs — Although the company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred. | |
Share-based Compensation — The company follows the provisions of the FASB ASC Topic 718, “Compensation — Stock Compensation” (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based payment awards made to employees, non-employee directors, and consultants, including stock options and warrants. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period. | |
For stock options and warrants granted as consideration for services rendered by non-employees, the company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50 (“ASC 505-50”), “ Equity Based Payments to Non- Employees.” Non-employee option and warrant grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to vesting, the value of these options and warrants, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the company’s common stock and the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options and warrants granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options are fully vested. | |
Research and Development Expenses — Research and development costs are expensed as incurred. Included in research and development costs are wages, benefits and other operating costs, facilities, supplies, external services and overhead related to our research and development departments, and clinical trial expenses. | |
Clinical trial expenses include direct costs associated with contract research organizations ("CROs"), as well as well as patient-related costs at sites at which our trials are being conducted. | |
Direct costs associated with our CROs are generally payable on a time and materials basis, or when certain enrollment and monitoring milestones are achieved. Expense related to a milestone is recognized in the period in which the milestone is achieved or in which we determine that it is more likely than not that it will be achieved. | |
The invoicing from clinical trial sites can lag several months. We accrue these site costs based on our estimate of upfront set-up costs upon the screening of the first patient at each site, and the patient related costs based on our knowledge of patient enrollment status at each site. | |
Income Taxes — The company recognizes liabilities or assets for the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts in the financial statements in accordance with FASB ASC 740-10, “Accounting for Income Taxes” (“ASC 740-10”). These temporary differences will result in taxable or deductible amounts in future years when the reported amounts of the assets or liabilities are recovered or settled. ASC 740-10 requires that a valuation allowance be established when management determines that it is more likely than not that all or a portion of a deferred asset will not be realized. The company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary, at least on an annual basis. During this evaluation, the company reviews its forecasts of income in conjunction with other positive and negative evidence surrounding the realizability of its deferred income tax assets to determine if a valuation allowance is required. Adjustments to the valuation allowance will increase or decrease the company’s income tax provision or benefit. The recognition and measurement of benefits related to the company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws, new interpretations of existing laws, and rulings by taxing authorities. Differences between actual results and the company’s assumptions or changes in the company’s assumptions in future periods are recorded in the period they become known. | |
For the year ended December 31, 2013, we recognized an income tax expense of $1,052,000, which offsets the tax impact related to the unrealized gain on our marketable securities that were reclassified to realized gain on the sale of marketable securities during the year. We continue to maintain a full valuation allowance against our net deferred tax assets. | |
Concentrations of Credit Risk — Financial instruments that potentially subject the company to significant concentrations of credit risk consist principally of cash and cash equivalents. The company maintains cash balances in several accounts with two banks, which at times are in excess of federally insured limits. As of December 31, 2013, the company’s cash equivalents were invested in money market mutual funds. The company’s investment policy does not allow investment in any debt securities rated less than “investment grade” by national ratings services. The company has not experienced any losses on its deposits of cash and cash equivalents. As of December 31, 2013, we had approximately $47,240,000 in interest-bearing accounts above federally insured limits. | |
Comprehensive Loss — Comprehensive loss consists of our net loss and other comprehensive income related to the unrealized gain (loss), net of tax, on our marketable securities, which are classified as available-for-sale. |
Recently_Adopted_Accounting_Pr
Recently Adopted Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2013 | |
Accounting Changes and Error Corrections [Abstract] | ' |
Recently Adopted Accounting Pronouncements | ' |
Recently Adopted Accounting Pronouncements | |
In February 2013, the FASB issued ASU No. 2013-02, Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income, a new accounting pronouncement intended to improve the reporting of reclassifications out of accumulated other comprehensive income. The new standard requires an entity to provide information about the amounts reclassified out of accumulated other comprehensive income by component. The new standard also requires an entity to present, either on the face of the statement where net income is presented or in the notes, significant amounts reclassified out of accumulated other comprehensive income by the respective line items of net income if the amount reclassified is required to be reclassified to net income in its entirety in the same reporting period. For amounts not required to be reclassified in their entirety in the same reporting period, an entity is required to cross-reference to other required disclosures that provide additional detail about those amounts. The new standard was effective for reporting periods beginning after December 31, 2012. Adoption of this new standard for the year ended December 31, 2013 did not have a material impact on the company’s consolidated financial statements. |
NeuVaxTM_Acquisition
NeuVaxTM Acquisition | 12 Months Ended | ||||||
Dec. 31, 2013 | |||||||
Business Combinations [Abstract] | ' | ||||||
NeuVaxTM Acquisition | ' | ||||||
NeuVax™ Acquisition | |||||||
On April 13, 2011, the company acquired its late stage product candidate, NeuVax, through a merger acquisition of Apthera, Inc., a Delaware corporation (“Apthera”), with Apthera surviving as a wholly-owned subsidiary of the company. At the closing of the merger, the company issued to Apthera’s stockholders approximately 5.0 million shares of common stock of the company and agreed to pay to the former Apthera shareholders future contingent consideration of up to $32 million based on the achievement of specified development and commercial milestones relating to the NeuVax, of which $2 million had been paid as of December 31, 2013. The remaining $30 million of contingent consideration is payable, at the election of the company, in cash or in additional shares of common stock valued for this purpose at the market price of the company common stock when the contingent consideration becomes payable. | |||||||
The goodwill associated with the acquisition is not deductible for tax purposes. | |||||||
The purchase price consideration and allocation of purchase price were as follows (in thousands): | |||||||
Calculation of allocable purchase price: | |||||||
Fair value of shares issued at closing including escrowed shares expected to be released | $ | 6,367 | (i) | ||||
Estimated value of earn-out | 6,460 | ||||||
Total allocable purchase price | $ | 12,827 | |||||
Allocation of purchase price: | |||||||
Cash | $ | 168 | |||||
Prepaid expenses and other current assets | 14 | ||||||
Equipment and furnishings | 11 | ||||||
Goodwill | 5,898 | ||||||
In-process research and development | 12,864 | ||||||
Accounts payable | (931 | ) | |||||
Accrued expenses and other current liabilities | (143 | ) | |||||
Notes payable | (1 | ) | |||||
Deferred tax liability, non-current | (5,053 | ) | |||||
$ | 12,827 | ||||||
(i) | The value of the company’s common stock was based upon a per share value of $1.28, the closing price of the company’s common stock as of the close of business on April 13, 2011. | ||||||
The company recorded the estimated fair value of the contingent consideration at $6.5 million based on the expected probability of achieving the specified development and commercial milestones relating to the company’s NeuVax product candidate and then applying a discount rate, based on a corporate debt interest rate index publicly issued, to the expected future payments. The expected timing and probability of achieving each milestone and the discount rates applied are reviewed quarterly using the most current information to measure the contingent consideration as of the reporting date. On January 19, 2012, the first milestone was achieved, and the company issued into escrow in favor of the former Apthera shareholders $1,000,000, or 1,315,849 shares, of common stock in payment of the related contingent consideration. The number of shares was based on the $0.76 closing price of the company’s common stock as reported on The NASDAQ Capital Market on January 18, 2012, the day prior to achievement of the first milestone. In September 2012, the escrowed shares were released to the former Apthera shareholders from escrow, and the company paid to the former Apthera shareholders cash of $35,016, representing an interest factor of ten percent 10% per annum on the $1,000,000 amount of the milestone payment from February 10, 2012 through the day immediately prior to the release of the escrowed shares. During the year ended December 31, 2012, the company recorded additional other expense of $579,000, related to the change in the fair value of the escrowed shares up to the date of release from escrow. In June 2013, the company achieved another milestone under the contingent value rights agreement, resulting in a $1,247,000 milestone payment that was paid by issuing 492,988 shares of our common stock. | |||||||
The increase in the fair value of the contingent liability during the years ended December 31, 2013 and 2012, was $926,000 and $2,370,000, respectively, and the decrease in the fair value of the contingent liability during the year ended December 31, 2011 was $109,000. The changes in the fair value of the contingent liability are included in other income (expense) in the accompanying consolidated statements of expenses. The fair value of the contingent liability at December 31, 2013 and 2012 was $6,821,000 and $7,142,000, of which $0 and $935,000 is recorded as a current contingent liability, respectively. | |||||||
The following presents the unaudited, pro forma net loss and pro forma net loss per common share of the company for year ended December 31, 2011 as if the company’s acquisition of Apthera occurred as of January 1, 2011 (in thousands expect for per share data): | |||||||
For the Year Ended | |||||||
December 31, 2011 | |||||||
Net loss from continuing operations | $ | (4,700 | ) | ||||
Net loss from discontinued operations | $ | (8,078 | ) | ||||
Net loss per common share, continuing operations | $ | (0.12 | ) | ||||
Net loss per common share, discontinued operations | $ | (0.21 | ) | ||||
Net loss per common share | $ | (0.34 | ) |
RXi_Spinoff
RXi Spin-off | 12 Months Ended |
Dec. 31, 2013 | |
Discontinued Operations and Disposal Groups [Abstract] | ' |
RXi Spin-off | ' |
RXi Spin-off | |
On September 24, 2011, the company entered into a contribution agreement with our former subsidiary, RXi Pharmaceuticals Corporation, or “RXi,” pursuant to which we assigned and contributed to RXi substantially all of the company’s RNAi-related technologies and assets. The contributed assets consisted primarily of our novel RNAi compounds and licenses relating to our RNAi technologies, as well as the lease of our Worcester, Massachusetts laboratory facility, fixed assets and other equipment located at the facility and our employment arrangements with certain scientific, corporate and administrative personnel who became employees of RXi. The company also contributed $1.5 million of cash to the capital of RXi. | |
Pursuant to the contribution agreement, RXi assumed certain accrued expenses of our former RXI-109 development program and all subsequent obligations under the contributed licenses, employment arrangements and other agreements. RXi also has agreed to make future milestone payments to us of up to $45 million, consisting of two one-time payments of $15 million and $30 million, respectively, if RXi achieves annual net sales equal to or greater than $500 million and $1 billion, respectively, of any covered products that may be developed with the contributed RNAi technologies. | |
The company agreed in the securities purchase agreement to distribute to our stockholders on a share-for-share basis a total of approximately 66,959,894 RXi shares, which distribution was made in April 2012. The company retained 33,476,595 shares of common stock of RXi, which were subject to a one-year lock-up period that expired on April 27, 2013. On July 24, 2013, RXi effected a 1-for-30 reverse stock split of its outstanding shares of common stock, including RXi shares held by the company. During the year ended December 31, 2013, the company sold 1,115,887 RXi shares, on a post-split basis, for total proceeds of $3,911,000, which is included in other income as realized gains on sale of marketable securities. There were no shares sold during the year ended December 31, 2012. | |
The company fully liquidated its position in RXi common stock during the year ended December 31, 2013. The value of RXi shares held by the company at December 31, 2012 was $2,678,000, based on the closing price of RXi shares on the last trading day of the year of $2.40 per share, on a post-split basis, as reported on the OTCQX marketplace. | |
The company classified the RXi activities for previously reported periods as discontinued operations in the accompanying condensed consolidated statements of comprehensive loss retroactively for all periods presented. The net assets of RXi were removed from the condensed consolidated balance sheet as of the date of the spin-off, and were recorded as an equity distribution. |
Fair_Value_Measurements
Fair Value Measurements | 12 Months Ended | |||||||||||||||
Dec. 31, 2013 | ||||||||||||||||
Fair Value Disclosures [Abstract] | ' | |||||||||||||||
Fair Value Measurements | ' | |||||||||||||||
Fair Value Measurements | ||||||||||||||||
The company follows ASC 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are as defined as follows: | ||||||||||||||||
Level 1 — quoted prices in active markets for identical assets or liabilities. | ||||||||||||||||
Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date. | ||||||||||||||||
Level 3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date. | ||||||||||||||||
The company categorized its cash equivalents and marketable securities as Level 1 inputs. The valuations for Level 1 were determined based on a “market approach” using quoted prices in active markets for identical assets. Valuation of these assets does not require a significant degree of judgment. The company categorized its warrants potentially settleable in cash as Level 2 inputs. The warrants are measured at market value on a recurring basis and are being marked to market each quarter-end until they are completely settled. The warrants are valued using an appropriate pricing model, using assumptions consistent with our application of ASC 718. The contingent purchase price consideration is categorized as Level 3 inputs and is measured at its estimated fair value on a recurring basis and is adjusted at each quarter-end until it is completely settled. The contingent price consideration is valued based on the expected timing of milestones, the expected probability of success for each milestone and discount rates based on a corporate debt interest rate index publicly issued. | ||||||||||||||||
The following tables present information about our assets and liabilities measured at fair value on a recurring basis in the condensed consolidated balance sheets (in thousands): | ||||||||||||||||
Description | December 31, 2013 | Quoted Prices In | Significant Other | Unobservable | ||||||||||||
Active Markets | Observable Inputs | Inputs | ||||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||||
Assets: | ||||||||||||||||
Cash equivalents | $ | 42,349 | $ | 42,349 | $ | — | $ | — | ||||||||
Marketable securities | — | — | — | — | ||||||||||||
Total assets measured and recorded at fair value | $ | 42,349 | $ | 42,349 | $ | — | $ | — | ||||||||
Liabilities: | ||||||||||||||||
Warrants potentially settleable in cash | $ | 48,965 | $ | — | $ | 48,965 | $ | — | ||||||||
Contingent purchase price consideration | 6,821 | — | — | 6,821 | ||||||||||||
Total liabilities measured and recorded at fair value | $ | 55,786 | $ | — | $ | 48,965 | $ | 6,821 | ||||||||
Description | December 31, 2012 | Quoted Prices In | Significant Other | Unobservable | ||||||||||||
Active Markets | Observable Inputs | Inputs | ||||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||||
Assets: | ||||||||||||||||
Cash equivalents | $ | 32,431 | $ | 32,431 | $ | — | $ | — | ||||||||
Marketable securities | 2,678 | 2,678 | — | — | ||||||||||||
Total assets measured and recorded at fair value | $ | 35,109 | $ | 35,109 | $ | — | $ | — | ||||||||
Liabilities: | ||||||||||||||||
Warrants potentially settleable in cash | $ | 10,964 | $ | — | $ | 10,964 | $ | — | ||||||||
Contingent purchase price consideration | 7,142 | — | — | 7,142 | ||||||||||||
Total liabilities measured and recorded at fair value | $ | 18,106 | $ | — | $ | 10,964 | $ | 7,142 | ||||||||
The company has not transferred any financial instruments into or out of Level 3 classification during the years ended December 31, 2013 or 2012. A reconciliation of the beginning and ending Level 3 liabilities for the years ended December 31, 2013 and 2012 is as follows (in thousands): | ||||||||||||||||
Fair Value | ||||||||||||||||
Measurements | ||||||||||||||||
Using Significant | ||||||||||||||||
Unobservable | ||||||||||||||||
Inputs | ||||||||||||||||
(Level 3) | ||||||||||||||||
Balance, January 1, 2012 | $ | 6,351 | ||||||||||||||
Milestone payment | (1,579 | ) | ||||||||||||||
Change in the estimated fair value of the contingent purchase price consideration | 2,370 | |||||||||||||||
Balance, December 31, 2012 | 7,142 | |||||||||||||||
Milestone payment | (1,247 | ) | ||||||||||||||
Change in the estimated fair value of the contingent purchase price consideration | 926 | |||||||||||||||
Balance at December 31, 2013 | $ | 6,821 | ||||||||||||||
The fair value of the contingent purchase price consideration is measured at the end of each reporting period using Level 3 inputs in a probability-weighted, discounted cash-outflow model. The significant unobservable assumptions include the probability of achieving each milestone, the date we expect to reach the milestone, and a determination of present value factors used to discount future expected cash outflows. |
Accrued_Expenses_and_Other_Cur
Accrued Expenses and Other Current Liabilities | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
Payables and Accruals [Abstract] | ' | |||||||
Accrued Expenses and Other Current Liabilities | ' | |||||||
Accrued Expenses and Other Current Liabilities | ||||||||
Accrued expenses and other current liabilities consist of the following (in thousands): | ||||||||
December 31, | ||||||||
2013 | 2012 | |||||||
Clinical development expense | $ | 3,109 | $ | 1,705 | ||||
Patient assistance programs | 2,618 | — | ||||||
Compensation and related benefits | 1,999 | 217 | ||||||
Professional fees | 713 | 116 | ||||||
Royalties | 158 | — | ||||||
Interest expense | 70 | — | ||||||
Accrued expenses and other current liabilities | $ | 8,667 | $ | 2,038 | ||||
Longterm_Debt
Long-term Debt | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Debt Disclosure [Abstract] | ' | ||||
Long-term Debt | ' | ||||
Long-term Debt | |||||
On May 8, 2013 we entered into a loan and security agreement with Oxford Finance LLC, as collateral agent, and related lenders under which we may borrow up to $15 million (the “Loan”) in two tranches. We borrowed the first tranche of $10 million on May 8, 2013, and may borrow the second tranche of $5 million on or before May 31, 2014, subject to our achievement of certain operational and financial conditions. There is no assurance these conditions will be achieved. The Loan payments will include 12 months of interest-only payments at the fixed coupon rate of 8.45%, followed by 30 months of amortization of principal and interest until maturity in November 2016. In connection with the Loan, we paid the lender a 1% cash facility fee and a 5.5% cash final payment and granted to the lenders seven-year warrants to purchase up to 182,186 shares of our common stock at an exercise price of $2.47, which equaled a 20-day average market price of our common stock prior to the date of the grant. | |||||
As of December 31, 2013, future schedule principal payments to be made on long-term debt are as follows (in thousands): | |||||
For the year ending December 31, 2014 | $ | 2,149 | |||
2015 | 3,938 | ||||
2016 | 3,913 | ||||
Total future principal payments | 10,000 | ||||
Unamortized debt issuance costs (net of fair value of warrants issued) | (108 | ) | |||
Total debt | 9,892 | ||||
Less current portion | (2,149 | ) | |||
Total long-term debt, net | $ | 7,743 | |||
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | |||||||||||||||||||
Dec. 31, 2013 | ||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ' | |||||||||||||||||||
Commitments and Contingencies | ' | |||||||||||||||||||
Commitments and Contingencies | ||||||||||||||||||||
The company acquires assets still in development and enters into research and development arrangements with third parties that often require milestone and royalty payments based on the progress of the asset through development stages. Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory agency. In certain agreements, the company is required to make royalty payments based upon a percentage of the sales. Because of the contingent nature of these payments, they are not included in the table of contractual obligations shown below. | ||||||||||||||||||||
These arrangements may be material individually, and in the unlikely event that milestones for multiple products covered by these arrangements were reached in the same period, the aggregate charge to expense could be material to the results of operations. In addition, these arrangements often give the company the discretion to unilaterally terminate development of the product, which would allow the company to avoid making the contingent payments; however, the company is unlikely to cease development if the compound successfully achieves clinical testing objectives. The company’s contractual obligations that will require future cash payments as of December 31, 2013 are as follows (in thousands): | ||||||||||||||||||||
Operating | Non-Cancelable | Subtotal | Cancelable | Total | ||||||||||||||||
Leases(1) | Employment | License | ||||||||||||||||||
Agreements(2) | Agreements(3) | |||||||||||||||||||
2014 | $ | 72 | $ | 450 | $ | 522 | $ | 325 | $ | 847 | ||||||||||
2015 | 74 | 300 | 374 | 350 | 724 | |||||||||||||||
2016 | 83 | 100 | 183 | 350 | 533 | |||||||||||||||
2017 | 82 | — | 82 | 350 | 432 | |||||||||||||||
2018 | 70 | — | 70 | 6,865 | 6,935 | |||||||||||||||
Total | $ | 381 | $ | 850 | $ | 1,231 | $ | 8,240 | $ | 9,471 | ||||||||||
(1) | Operating leases are primarily facility and equipment related obligations with third party vendors. Operating lease expenses during the years ended December 31, 2013, 2012, and 2011 were approximately $77,000, $139,000 and $233,000, respectively. | |||||||||||||||||||
(2) | Employment agreement obligations include management contracts, as well as scientific advisory board member compensation agreements. Certain agreements, which have been revised from time to time, provide for minimum salary levels, adjusted annually at the discretion of the Compensation Committee, as well as for minimum bonuses that are payable. | |||||||||||||||||||
(3) | License agreements generally relate to the company’s obligations with The Board of Regents, University of Texas and Henry Jackson Foundation for our oncology therapies. The company continually assesses the progress of its licensed technology and the progress of its research and development efforts as it relates to its licensed technology and may terminate with notice to the licensor at any time. In the event these licenses are terminated, no amounts will be due. | |||||||||||||||||||
The company applies the disclosure provisions FASB ASC Topic 460 (“ASC 460”), “ Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others ”, to its agreements that contain guarantee or indemnification clauses. The company provides (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to us. These indemnifications give rise only to the disclosure provisions of ASC 460. To date, the company has not incurred costs as a result of these obligations and does not expect to incur material costs in the future. Accordingly, the company has not accrued any liabilities in its financial statements related to these indemnifications. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2013 | |
Equity [Abstract] | ' |
Stockholders' Equity | ' |
Stockholders’ Equity | |
Preferred Stock — The company has authorized up to 5,000,000 shares of preferred stock, $0.0001 par value per share, for issuance. The preferred stock will have such rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be determined by the company’s board of directors upon its issuance. To date, the company has not issued any preferred shares. | |
Common Stock — The company has authorized up to 200,000,000 shares of common stock, $0.0001 par value per share, for issuance. Shares of common stock are reserved as follows: | |
April 2012 Registered Direct Offering — On April 13, 2012, the company completed an underwritten public offering of 9,751,000 shares of common stock for gross proceeds of approximately $14.6 million, resulting in approximately $13.5 million of net proceeds to the company after deducting the underwriting discounts and commissions and offering expenses. | |
December 2012 Registered Direct Offering — On December 18, 2012, the company closed an underwritten public offering of 15,156,250 units at a price to the public of $1.60 per unit for gross proceeds of $24.3 million (the “December 2012 Offering”). The offering provided approximately $22.5 million to the company after deducting the underwriting discounts and commissions and offering expenses. Each unit consists of (i) one share of common stock, and (ii) a five-year warrant to purchase 0.50 of a share of common stock at an exercise price of $1.90 per share (subject to anti-dilution adjustment provisions). | |
September 2013 Underwritten Public Offering - On September 18, 2013 the company closed an underwritten public offering of 17,500,000 units at a price to the public of $2.00 per unit for gross proceeds of $35 million (the "September 2013 Offering"). Each unit consists of one share of common stock, and a warrant to purchase 0.35 of a share of common stock at an exercise price of $2.50 per share. The offering included an over-allotment option for the underwriters to purchase an additional 2,625,000 shares of common stock and/or warrants up to 918,750 share of common stock. On September 23, 2013, the underwriters exercised their over-allotment option in full. The additional gross proceeds to the company as a result of the full exercise of the over-allotment option were approximately $5.2 million. The total net proceeds of the September 2013 offering, including the exercise of the over-allotment option, were $37.5 million, after deducting underwriting discounts and commissions and offering expenses payable by the company. | |
Other Equity Transactions — On January 20, 2012, The company sold 579,710 shares of our common stock for $400,000, the fair market value on the date of issuance, to Kwang Dong Pharmaceuticals Company, as part of an existing license agreement for NeuVax covering territorial rights for the compound in South Korea that the company acquired in its merger acquisition with Apthera. During 2013, the company issued a total of 492,988 shares of common stock to the holders of the company's outstanding contingent value rights holders for a milestone payment with a total fair market value of $1,247,000. |
Warrants
Warrants | 12 Months Ended | |||||||||||||||||||||||||||
Dec. 31, 2013 | ||||||||||||||||||||||||||||
Warrants and Rights Note Disclosure [Abstract] | ' | |||||||||||||||||||||||||||
Warrants | ' | |||||||||||||||||||||||||||
Warrants | ||||||||||||||||||||||||||||
The following is a summary of warrant activity for the years ended December 31, 2013 and 2012 (in thousands): | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | Consultant | Total | |||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | and Oxford Warrants | ||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Outstanding, January 1, 2012 | — | — | 9,470 | 2,400 | 540 | 978 | 733 | 14,121 | ||||||||||||||||||||
Granted | — | 7,578 | — | — | — | — | 400 | 7,978 | ||||||||||||||||||||
Exercised | — | — | (6,624 | ) | (2,039 | ) | (180 | ) | — | (40 | ) | (8,883 | ) | |||||||||||||||
Outstanding, December 31, 2012 | — | 7,578 | 2,846 | 361 | 360 | 978 | 1,093 | 13,216 | ||||||||||||||||||||
Granted | 7,044 | — | — | — | — | — | 182 | 7,226 | ||||||||||||||||||||
Exercised | (602 | ) | (2,661 | ) | (1,688 | ) | (185 | ) | (70 | ) | — | (196 | ) | (5,402 | ) | |||||||||||||
Expired | — | — | — | — | — | — | (190 | ) | (190 | ) | ||||||||||||||||||
Outstanding, December 31, 2013 | 6,442 | 4,917 | 1,158 | 176 | 290 | 978 | 889 | 14,850 | ||||||||||||||||||||
Expiration | Sep-18 | Dec-17 | Apr-17 | Mar-16 | Mar-16 | Aug-14 | Varies 2014-2020 | |||||||||||||||||||||
Warrants consist of warrants potentially settleable in cash, which are liability-classified warrants, and equity-classified warrants. | ||||||||||||||||||||||||||||
Warrants classified as liabilities | ||||||||||||||||||||||||||||
Liability-classified warrants consist of warrants to purchase common stock issued in connection with equity financings in September 2013, December 2012, April 2011, March 2011, March 2010 and August 2009. These warrants are potentially settleable in cash and were determined not to be indexed to our common stock. | ||||||||||||||||||||||||||||
The estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease or increase in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the condensed consolidated statement of comprehensive loss as other income (expense). The fair value of the warrants is estimated using an appropriate pricing model with the following inputs: | ||||||||||||||||||||||||||||
As of December 31, 2013 | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | |||||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | |||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Strike price | $ | 2.5 | $ | 1.9 | $ | 0.65 | $ | 0.65 | $ | 2.15 | $ | 4.5 | ||||||||||||||||
Expected term (years) | 4.72 | 3.98 | 3.31 | 2.18 | 2.24 | 0.59 | ||||||||||||||||||||||
Volatility % | 71.97 | % | 71.38 | % | 71.71 | % | 73.45 | % | 73.36 | % | 66.85 | % | ||||||||||||||||
Risk-free rate % | 1.61 | % | 1.25 | % | 0.93 | % | 0.45 | % | 0.47 | % | 0.11 | % | ||||||||||||||||
As of December 31, 2012 | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | |||||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | |||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Strike price | — | $ | 1.9 | $ | 0.65 | $ | 0.65 | $ | 2.18 | $ | 4.5 | |||||||||||||||||
Expected term (years) | 0 | 4.98 | 4.3 | 3.18 | 3.24 | 1.59 | ||||||||||||||||||||||
Volatility % | — | 80.93 | % | 82.48 | % | 69.9 | % | 69.79 | % | 74.13 | % | |||||||||||||||||
Risk-free rate % | — | 0.72 | % | 0.59 | % | 0.39 | % | 0.4 | % | 0.21 | % | |||||||||||||||||
The company’s expected volatility is based on a combination of implied volatilities of similar publicly traded entities. The expected life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero coupon rates in effect at the time of valuation. The dividend yield used in the pricing model is zero, because the company has no present intention to pay cash dividends. | ||||||||||||||||||||||||||||
The changes in fair value of the warrant liability for the years ended December 31, 2013 and 2012 were as follows (in thousands): | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | Total | ||||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | |||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Warrant liability, January 1, 2012 | $ | — | $ | — | $ | 3,145 | $ | 421 | $ | 116 | $ | 64 | $ | 3,746 | ||||||||||||||
Fair value of warrants granted | — | 7,286 | — | — | — | — | 7,286 | |||||||||||||||||||||
Fair value of warrants exercised | — | — | (8,130 | ) | (2,456 | ) | (257 | ) | — | (10,843 | ) | |||||||||||||||||
Change in fair value of warrants | — | (332 | ) | 8,295 | 2,413 | 328 | 71 | 10,775 | ||||||||||||||||||||
Warrant liability, December 31, 2012 | — | 6,954 | 3,310 | 378 | 187 | 135 | 10,964 | |||||||||||||||||||||
Fair value of warrants granted | 8,238 | — | — | — | — | — | 8,238 | |||||||||||||||||||||
Fair value of warrants exercised | (1,931 | ) | (8,482 | ) | (3,455 | ) | (260 | ) | (121 | ) | — | (14,249 | ) | |||||||||||||||
Change in fair value of warrants | 16,643 | 19,588 | 5,214 | 645 | 879 | 1,043 | 44,012 | |||||||||||||||||||||
Warrant liability, December 31, 2013 | $ | 22,950 | $ | 18,060 | $ | 5,069 | $ | 763 | $ | 945 | $ | 1,178 | $ | 48,965 | ||||||||||||||
Warrants classified as equity | ||||||||||||||||||||||||||||
Equity-classified warrants consist of warrants issued in connection with consulting services provided to us. Additionally, on May 8, 2013 as a part of our Loan financing, we granted Oxford Financial LLC warrants to purchase 182,186 shares of common stock at an exercise price of $2.47, which equaled to the 20-day average market price of our common stock prior to the date of the grant. The warrants were valued using the Black Scholes model. The fair value assumptions for the grant included a volatility of 75.34%, expected term of seven years, risk free rate of 1.20%, and a dividend rate of 0.00%. The fair value of the warrants granted was $1.93 per share. These warrants are recorded in equity at fair value upon issuance, and not as liabilities, and are not subject to adjustment to fair value in subsequent reporting periods. |
Stock_Based_Compensation
Stock Based Compensation | 12 Months Ended | |||||||||||
Dec. 31, 2013 | ||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||
Stock Based Compensation | ' | |||||||||||
Stock-Based Compensation | ||||||||||||
Options to Purchase Shares of Common Stock — The company follows the provisions ASC 718, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, non-employee directors and consultants, including employee stock options. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period. | ||||||||||||
For stock options and warrants granted in consideration for services rendered by non-employees, the company recognizes compensation expense in accordance with the requirements of ASC Topic 505-50. Non-employee option and warrant grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to vesting, the value of these options and warrants, as calculated using the Black-Scholes option-pricing model, is being re-measured using the fair value of the company’s common stock and the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options and warrants granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options and warrants are fully vested. | ||||||||||||
The following table summarizes the components of stock-based compensation expense in the Consolidated Statements of Comprehensive Loss for the years ended December 31, 2013, 2012, and 2011 (in thousands): | ||||||||||||
2013 | 2012 | 2011 | ||||||||||
Research and development | $ | 754 | $ | 580 | $ | 139 | ||||||
Selling, general, and administrative | 2,150 | 1,179 | 2,386 | |||||||||
Total stock-based compensation | $ | 2,904 | $ | 1,759 | $ | 2,525 | ||||||
The company uses the Black-Scholes option-pricing model and the following weighted-average assumptions to determine the fair value of all its stock options granted: | ||||||||||||
2013 | 2012 | |||||||||||
Risk free interest rate | 1.57 | % | 1.05 | % | ||||||||
Volatility | 77.98 | % | 75.76 | % | ||||||||
Expected lives (years) | 6.25 | 6.13 | ||||||||||
Expected dividend yield | 0 | % | 0 | % | ||||||||
The weighted-average fair value of options granted during the years ended December 31, 2013 and 2012 was $1.98 and $0.70 per share, respectively. | ||||||||||||
The company’s expected common stock price volatility assumption is based upon the volatility of a basket of comparable companies. The expected life assumptions for employee grants were based upon the simplified method provided for under ASC 718-10, which averages the contractual term of the company’s options of ten years with the average vesting term of four years for an average of six years. The expected life assumptions for non-employees were based upon the contractual term of the option. The dividend yield assumption is zero, because the company has never paid cash dividends and presently has no intention of paying cash dividends in the future. The risk-free interest rate used for each grant was also based upon prevailing short-term interest rates. The company has estimated an annualized forfeiture rate of 15% for options granted to its employees, 8% for options granted to senior management and zero for non-employee directors. The company will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated. | ||||||||||||
As of December 31, 2013, there was $12,033,000 of unrecognized compensation cost related to outstanding options that is expected to be recognized as a component of the company’s operating expenses over a weighted-average period of 2.78 years. | ||||||||||||
As of December 31, 2013, an aggregate of 16,500,000 shares of common stock were reserved for issuance under the company’s 2007 Incentive Plan, including 13,159,000 shares subject to outstanding common stock options granted under the plan and 1,927,000 shares available for future grants. The administrator of the plan determines the times when an option may become exercisable. Vesting periods of options granted to date have not exceeded four years. The options generally will expire, unless previously exercised, no later than ten years from the grant date. | ||||||||||||
The following table summarizes option activity of the company: | ||||||||||||
Total | Weighted | |||||||||||
Number of | Average | |||||||||||
Shares | Exercise | |||||||||||
(In Thousands) | Price | |||||||||||
Outstanding at December 31, 2012 | 7,672 | $ | 2.54 | |||||||||
Granted | 7,113 | 2.87 | ||||||||||
Exercised | (289 | ) | 1.21 | |||||||||
Cancelled | (1,337 | ) | 2.8 | |||||||||
Outstanding at December 31, 2013 | 13,159 | $ | 2.73 | |||||||||
Options exercisable at December 31, 2013 | 6,557 | $ | 2.63 | |||||||||
The weighted average remaining contractual life of options outstanding as of December 31, 2013, 2012, and 2011 was 8.09, 7.87, and 7.56, respectively. The weighted average remaining contractual life of options exercisable as of December 31, 2013, 2012, and 2011 was 6.76, 7.38, and 6.87, respectively. | ||||||||||||
The aggregate intrinsic value of outstanding options as of December 31, 2013 and 2012 was $30,537,000 and $2,288,000, respectively. The aggregate intrinsic value of exercisable options as of December 31, 2013 and 2012 was $16,376,000 and $1,394,000, respectively. There was no aggregate intrinsic value of exercisable or outstanding options as of December 31, 2011. The aggregate intrinsic value is calculated based on the positive difference between the closing fair market value of the company's common stock and the exercise price of the underlying options. | ||||||||||||
The aggregate intrinsic value of options exercised during the years ended December 31, 2013 and 2012 was $890,000 and $18,000, respectively. There were no options exercised during the year ended December 31, 2011. | ||||||||||||
Employee Stock Purchase Plan — The company also has an employee stock purchase plan (“ESPP”) which allows employees to contribute up to 15% of their cash earnings, subject to certain maximums, to be used to purchase shares of our common stock on each semi-annual purchase date. The purchase price is equal to 85% of the market value per share on either the first or last day of the semi-annual period, whichever is lower. Our ESPP is non-compensatory pursuant to the provisions of generally accepted accounting principles for share-based compensation expense. The ESPP contains an “evergreen provision” with annual increases in the number of shares available for issuance on the first day of each year through January 1, 2015 equal to the lesser of: (a) 250,000 shares increased on each anniversary of the adoption of the Plan by 1% of the total shares of stock then outstanding and (b) 1,000,000 shares. As of December 31, 2013, an aggregate of 756,490 shares of common stock were authorized and available for future issuance under the ESPP. The company has issued 243,510 shares under the ESPP through December 31, 2013. | ||||||||||||
Restricted Stock Units — In addition to options to purchase shares of common stock, the company may grant restricted stock units (“RSU”) as part of its compensation package. If granted, each RSU would be granted at the fair market value of the company's common stock on the date of grant. Vesting is determined on a grant-by-grant basis. | ||||||||||||
In 2011, the company granted a total of 220,729 RSUs. The RSUs granted in 2011 had an aggregate intrinsic value of $256,000 and fully vested during 2012. There were no RSU's granted in 2012 and 2013. |
Other_Income_Expense_Notes
Other Income (Expense) (Notes) | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
Other Income and Expenses [Abstract] | ' | ||||||||||||
Other Income (Expense) | ' | ||||||||||||
Other Income (Expense) | |||||||||||||
Other income (expense) is summarized as follows (in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2013 | 2012 | 2011 | |||||||||||
Change in fair value of warrants potentially settleable in cash | $ | (44,001 | ) | $ | (10,775 | ) | $ | 8,986 | |||||
Realized gain on sale of marketable securities | 3,911 | — | — | ||||||||||
Change in fair value of the contingent purchase price liability | (926 | ) | (2,370 | ) | 109 | ||||||||
Miscellaneous other income | 37 | — | (9 | ) | |||||||||
Total other income (expense) | $ | (40,979 | ) | $ | (13,145 | ) | $ | 9,086 | |||||
Net_Loss_Per_Share
Net Loss Per Share | 12 Months Ended | |||||
Dec. 31, 2013 | ||||||
Earnings Per Share [Abstract] | ' | |||||
Net Loss Per Share | ' | |||||
Net Loss Per Share | ||||||
The company accounts for and discloses net loss per common share in accordance with FASB ASC Topic 260 “Earnings per Share.” Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares that would have been outstanding during the period assuming the issuance of common shares for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exercise of stock options and warrants. | ||||||
The following table sets forth the potentially dilutive common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive (in thousands): | ||||||
December 31, | ||||||
2013 | 2012 | |||||
Warrants to purchase common stock | 14,850 | 13,216 | ||||
Options to purchase common stock | 13,159 | 7,672 | ||||
Total | 28,009 | 20,888 | ||||
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
Income Taxes | ' | ||||||||
Income Taxes | |||||||||
The components of federal and state income tax expense (benefit) are as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
Current | |||||||||
Federal | $ | — | $ | — | |||||
State | — | — | |||||||
Total current | — | — | |||||||
Deferred expense (benefit) | |||||||||
Federal | 894 | (894 | ) | ||||||
State | 158 | (158 | ) | ||||||
Total deferred | 1,052 | (1,052 | ) | ||||||
Total income tax expense (benefit) | $ | 1,052 | $ | (1,052 | ) | ||||
The components of net deferred tax assets are as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
Net operating loss carryforwards | $ | 33,539 | $ | 23,632 | |||||
Tax credit carryforwards | 3,549 | 3,201 | |||||||
Unrealized gain on marketable securities | — | (1,052 | ) | ||||||
Stock based compensation | 8,322 | 7,944 | |||||||
Other | 12 | (328 | ) | ||||||
Licensing deduction deferral | 8,682 | 8,194 | |||||||
Gross deferred tax assets | 54,104 | 41,591 | |||||||
Valuation allowance | (54,104 | ) | (41,591 | ) | |||||
Net deferred tax asset | $ | — | $ | — | |||||
The components of net deferred tax liabilities are as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
In-process research and development not subject to future amortization for tax purposes | $ | 5,053 | $ | 5,053 | |||||
Gross deferred tax liability | $ | 5,053 | $ | 5,053 | |||||
The provision for income taxes differs from the provision computed by applying the federal statutory rate to net loss before income taxes as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
Expected federal income tax benefit | $ | (25,713 | ) | $ | (11,688 | ) | |||
State income taxes after credits | (3,676 | ) | (1,067 | ) | |||||
Unrealized gain on marketable securities | 1,052 | (1,052 | ) | ||||||
Changes in warrant value | 17,283 | 3,664 | |||||||
Stock compensation | 813 | 152 | |||||||
Effect of change in valuation allowance | 11,408 | 8,939 | |||||||
Income tax credits | (240 | ) | — | ||||||
Other | 125 | — | |||||||
$ | 1,052 | $ | (1,052 | ) | |||||
The company has incurred net operating losses from inception. At December 31, 2013, the company had domestic federal and state net operating loss carryforwards of approximately $83.9 million and $49.8 million, respectively, available to reduce future taxable income, which expire at various dates beginning in 2013 through 2033. The company also had federal and state research and development tax credit carryforwards of approximately $2.2 million and $2.0 million, respectively, available to reduce future tax liabilities and which expire at various dates beginning in 2023 through 2032. The income tax expense for the year ended December 31, 2013 relates to the realized gain on sale of marketable securities. | |||||||||
Approximately $280,000 of the company's net operating loss carryforwards were generated as a result of deductions related to the exercises of stock options and disqualifying dispositions. If utilized, this portion of the Company's carrforwards, as tax effected, will be accounted for as a direct increase to contributed capital rather than as a reduction of that year's provision for income taxes. Net operating loss carryforwards created by excess tax benefits from the exercise of stock options are not recorded as deferred tax assets. The deferred tax assets related to net operating losses have been accordingly reduced by $109,000 for the year ended December 31, 2013. | |||||||||
Under the provisions of the Internal Revenue Code, certain substantial changes in the company’s ownership may result in a limitation on the amount of net operating loss carryforwards and research and development credit carryforwards which could be utilized annually to offset future taxable income and taxes payable. | |||||||||
Based on an assessment of all available evidence including, but not limited to the company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies, the company has concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a 100% deferred income tax valuation allowance has been recorded against these assets. The valuation allowance increased by $12.5 million and $5.1 million for the years ended December 31, 2013 and 2012, respectively. | |||||||||
The company files income tax returns in the U.S. federal, Massachusetts, Colorado, California and Oregon jurisdictions. The company is subject to tax examinations for the 2009 tax year and beyond. The company does not believe there will be any material changes in its unrecognized tax positions over the next 12 months. The company has not incurred any interest or penalties. In the event that the company is assessed interest or penalties at some point in the future, they will be classified in the financial statements as general and administrative expense. |
License_Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2013 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ' |
License Agreements | ' |
License Agreements | |
As part of its business, the company enters into licensing agreements with third parties that often require milestone and royalty payments based on the progress of the licensed asset through development and commercial stages. Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory agency, and the company may be required to make royalty payments based upon a percentage of net sales of the product. The expenditures required under these arrangements in any period may be material and are likely to fluctuate from period to period. | |
These arrangements sometimes permit the company to unilaterally terminate development of the product and thereby avoid future contingent payments; however, the company is unlikely to cease development if the compound successfully achieves clinical testing objectives. | |
In conjunction with the acquisition of NeuVaxTM, the company acquired rights and assumed obligations under a license agreement among Apthera and The University of Texas M. D. Anderson Cancer Center (“MDACC”) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (“HJF”) which grants exclusive worldwide rights to a U.S. patent covering the nelipepimut-S peptide and several U.S. and foreign patents and patent applications covering methods of using the peptide as a vaccine. Under the terms of this license, we are required to pay an annual maintenance fee of $200,000, we paid a milestone payment of $200,000 upon commencing the Phase 3 PRESENT trial of NeuVax and other clinical milestone payments, as well as royalty payments based on sales of NeuVax or other therapeutic products developed from the licensed technologies. | |
Effective December 3, 2012, we entered into a license and supply agreement with ABIC Marketing Limited, a subsidiary of Teva Pharmaceuticals (“ABIC”), under which we granted ABIC exclusive rights to seek marketing approval in Israel for our NeuVax product candidate for intradermal injection for the treatment of breast cancer following its approval by the FDA or the European Medicines Agency, and to market, sell and distribute NeuVax in Israel assuming such approval is obtained. ABIC’s rights also include a right of first refusal in Israel for all future indications for which NeuVax may be approved. Under the license and supply agreement, ABIC will assume responsibility for regulatory registration of NeuVax in Israel, provide financial support for local development, and commercialize the product in the region in exchange for making royalty payments to us based on future sales of NeuVax. ABIC also agrees in the license and supply agreement to purchase from us all supplies of NeuVax at a price determined according to a specified formula. | |
On March 18, 2013, we acquired Abstral® (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB (ORX.ST), an emerging specialty pharmaceutical company based in Sweden. Abstral has been approved by the U.S. Food and Drug Administration (FDA) and is a transmucosal immediate-release fentanyl (TIRF) product. | |
Under our agreement with Orexo, we assumed responsibility for the U.S. commercialization of Abstral and for all regulatory and reporting matters in the U.S. We also agreed to establish and maintain through 2015 a specified minimum commercial field force to market, sell and distribute Abstral and to use commercially reasonable efforts to reach the specified sales milestones. Orexo is entitled to reacquire the U.S. rights to Abstral from us for no consideration if we breach our obligations to establish and maintain the requisite sales force throughout the marketing period. We recently launched U.S. commercial sales of Abstral. | |
In exchange for the U.S. rights to Abstral, (1) we paid Orexo $10 million in March 2013 and a $5 million milestone payment in cash in October 2013 upon the approval by the FDA of a specified U.S. manufacturer of Abstral; and (2) we agreed to pay to Orexo: (a) three one-time future cash milestone payments based on our net sales of Abstral; and (b) a low double-digit royalty on future net sales. No further milestone or royalty payments will be due after the date on which all claims of the last remaining licensed patents expire (currently 2019) or become invalidated by a governmental agency. | |
On January 12, 2014, we acquired worldwide rights to anagrelide controlled release (CR), which we renamed GALE-401, through our acquisition of Mills Pharmaceuticals, LLC ("Mills"). GALE-401 contains the active ingredient anagrelide, an FDA-approved product, which has been in use since the late 1990s for the treatment of essential thrombocythemia (ET). Under the terms of the acquisition agreement, we paid $2 million to the former owners of Mills. Additionally, the former owners are entitled to receive one-time payments of up to an aggregate of 4,000,000 shares of the company's common stock upon the achievement of specified regulatory milestones and $3 million upon FDA approval of a new drug application in respect to GALE-401. Mills holds an exclusive license to develop and commercialize anagrelide CR, pursuant to a license agreement with BioVascular, Inc. Under the terms of the license agreement, Mills agreed to pay BioVascular, Inc. a mid-to-low single digit royalty on net revenue from the sale of licensed products and future cash milestone payments based on specified regulatory milestones. Mills is also responsible for patent prosecution and maintenance. |
Significant_Customers_and_Conc
Significant Customers and Concentration of Credit Risk | 12 Months Ended |
Dec. 31, 2013 | |
Risks and Uncertainties [Abstract] | ' |
Significant Customer and Concentration of Credit Risk | ' |
Significant Customers and Concentration of Credit Risk | |
The company is engaged in the business of developing and commercializing pharmaceutical products. The company has one commercial product, Abstral, available in six dosing strengths, and all sales reported are in the United States. | |
The company had product sales to three customers that represented more than 10% of revenue for the three months ended December 31, 2013. Customers A, B, and C had product shipments that accounted for 34%, 26%, and 25%, respectively, of sales for the year ended December 31, 2013. No revenue was recognized prior to the year ended December 31, 2013. | |
The company had accounts receivable from three customers that represented more than 10% of total accounts receivable balance as of December 31, 2013. Customers A, B, and C had accounts receivable of 54%, 11%, and 25%, respectively, of the total accounts receivable balance as of December 31, 2013. There was no accounts receivable balance as of December 31, 2012. |
Related_Party_Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2013 | |
Related Party Transactions [Abstract] | ' |
Related Party Transactions | ' |
Related Party Transactions | |
Since 2011, the company has retained TroyGould PC as outside corporate counsel. Sanford J. Hillsberg, the Chairman of the company, is a senior lawyer with TroyGould PC. The company incurred $577,000 for services provided by TroyGould PC during the year ended December 31, 2013, as wells as $100,000 for services related to our underwritten public offering in September 2013, which is recorded as reduction of gross proceeds from the issuance of common stock as of December 31, 2013. At December 31, 2013, Galena owed $177,000 to TroyGould PC. |
Employee_Benefit_Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2013 | |
Compensation and Retirement Disclosure [Abstract] | ' |
Employee Benefit Plan | ' |
Employee Benefit Plan | |
The company sponsors a 401(k) retirement savings plan (the “Plan”). Participation in the Plan is available to full-time employees who meet eligibility requirements. Eligible employees may defer a portion of their salary as defined by Internal Revenue Service regulations. The company may make matching contributions on behalf of all participants in the 401(k) Plan in an amount determined by the company’s board of directors. The company may also make additional discretionary profit sharing contributions in amounts as determined by the board of directors, subject to statutory limitations. Matching and profit-sharing contributions, if any, are subject to a vesting schedule; all other contributions are at all times fully vested. The company intends the 401(k) Plan, and the accompanying trust, to qualify under Sections 401(k) and 501 of the Internal Revenue Code so that contributions by employees to the 401(k) Plan, and income earned (if any) on plan contributions, are not taxable to employees until withdrawn from the 401(k) Plan, and so that the company will be able to deduct its contributions, if any, when made. The trustee under the 401(k) Plan, at the direction of each participant, invests the assets of the 401(k) Plan in any of a number of investment options. For the year ending December 31, 2013, the company made matching contributions totaling $35,000. There were no contributions to the plan in 2012 or 2011. |
Selected_Quarterly_Financial_D
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | ' | ||||||||||||||||
Selected Quarterly Financial Data (Unaudited) | ' | ||||||||||||||||
Selected Quarterly Financial Data (Unaudited) | |||||||||||||||||
The following amounts are in thousands, except per share amounts: | |||||||||||||||||
1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||||||||||||
2013 | |||||||||||||||||
Net revenue | $ | — | $ | — | $ | 1,170 | $ | 1,317 | |||||||||
Gross profit on net revenue (1) | $ | — | $ | — | $ | 869 | $ | 967 | |||||||||
Net loss | $ | (9,293 | ) | $ | (9,597 | ) | $ | (9,287 | ) | $ | (48,501 | ) | |||||
Net loss per share | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.46 | ) | |||||
2012 | |||||||||||||||||
Net revenue | $ | — | $ | — | $ | — | $ | — | |||||||||
Gross profit on net revenue | $ | — | $ | — | $ | — | $ | — | |||||||||
Net loss | $ | (24,761 | ) | $ | (196 | ) | $ | (6,261 | ) | $ | (3,751 | ) | |||||
Net loss per share | $ | (0.52 | ) | $ | — | $ | (0.09 | ) | $ | (0.05 | ) | ||||||
(1) | Gross profit for the quarter ended December 31, 2013 is calculated by taking net revenue less cost of revenue and amortization of certain acquired intangible assets, which is consistent with the gross profit reported for the quarter ended September 30, 2013. |
Subsequent_Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2013 | |
Subsequent Events [Abstract] | ' |
Subsequent Events | ' |
Subsequent Events | |
The company evaluated all events or transactions that occurred after December 31, 2013 up through the date these financial statements were issued. Other than as disclosed elsewhere in the notes to the condensed consolidated financial statements, the company did not have any material recognizable or unrecognizable subsequent events, except as described below. | |
For the period of January 1, 2014 through March 14, 2014, we issued an additional 5,072,900 shares of our common stock as a result of 5,095,616 warrant exercises. Cash proceeds from the warrant exercises during this period were $9,371,000. As of March 14, 2014, we had 9,753,815 warrants outstanding. | |
For the period of January 1, 2014 through March 14, 2014, we issued an additional 3,158,338 shares of our common stock as a result of 3,182,764 stock option exercises. Cash proceeds from the stock option exercises during this period were $3,889,000. As of March 14, 2014 we had 9,335,403 stock options outstanding. | |
Effective January 14, 2014, we entered into a strategic development and commercialization partnership with Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's"). We licensed commercial rights to Dr. Reddy's for NeuVax in breast and gastric cancers in India. Dr. Reddy's will lead the Phase 2 development of NeuVax in gastric cancer, significantly expanding the potential addressable patient population. | |
In February and March 2014, two purported shareholder derivative complaints-Fagin v. Ahn, No. 140202384 (Or. Cir. Ct.), and Werbowsky v. Hillsberg, No. 3:14-cv-382 (D. Or.)-were filed against our company, as nominal defendant, and certain of our officers and directors in the Circuit Court of Oregon for the County of Multnomah and in the United States District Court for the District of Oregon. The complaints allege, among other things, breaches of fiduciary duties and abuse of control by the officers and directors in connection with various public statements purportedly issued by us or on our behalf and sales of our common stock by the officers and directors in January and February of this year. | |
In March 2014, three purported securities class action complaints- Deering v. Galena Biopharma, Inc., No. 3:14-cv-367 (D. Or.), Hau v. Galena Biopharma, Inc., No. 3:14-cv-389 (D. Or.), and Clavijo v. Galena Biopharma, Inc., No. 3:14-cv-410 (D. Or.)-were filed against our company and certain of our officers in the United States District Court for the District of Oregon. The complaints allege that the defendants violated the federal securities laws by making materially false and misleading statements in press releases and in filings with the SEC arising out of the same circumstances that are the subject of the derivative actions described above. | |
In February 2014, we learned that the SEC is investigating certain matters relating to our company and an outside investor-relations firm that we retained in 2013. We have been in contact with the SEC staff through our counsel and are cooperating with the investigation. | |
Based on the very early stage of the litigation, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters. |
Business_and_Basis_of_Presenta1
Business and Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2013 | |
Accounting Policies [Abstract] | ' |
Uses of Estimates in Preparation of Financial Statements | ' |
Uses of Estimates in Preparation of Financial Statements — The preparation of these consolidated financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates. | |
Principles of Consolidation | ' |
Principles of Consolidation — The consolidated financial statements include the accounts of Galena and its wholly owned subsidiary. All material intercompany accounts have been eliminated in consolidation. | |
Reclassifications | ' |
Reclassifications — Certain prior year amounts have been reclassified to conform to current year presentation. These reclassifications had no effect on net loss per share. | |
Cash and Cash Equivalents | ' |
Cash and Cash Equivalents — The company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts and demand deposits. | |
Restricted Cash | ' |
Restricted Cash — Restricted cash consists of certificates of deposit on hand with the company’s financial institutions as collateral for its corporate credit cards | |
Marketable Securities | ' |
Marketable Securities — Marketable securities consist of shares of common stock of our former subsidiary, RXi Pharmaceuticals Corporation, a publicly traded company, and are classified as available-for-sale and carried at fair value on the balance sheet. Changes in the fair value of marketable securities are recorded as other comprehensive income (loss). | |
Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments — The carrying amounts reported in the balance sheet for cash equivalents, marketable securities, accounts receivable, accounts payable, and capital leases approximate their fair values due to their short-term nature and market rates of interest. | |
Inventories | ' |
Inventories — Inventories are stated at the lower of cost or market value and are determined using the first-in, first-out ("FIFO") method. Inventories consist of Abstral work-in-process and finished goods. The company has entered into manufacturing and supply agreements for the manufacture and packing of Abstral finished goods. As of December 31, 2013, the company had inventories of $386,000, consisting of $270,000 of work-in-process and $116,000 of finished goods. The company had no inventory as of December 31, 2012. | |
Equipment and Furnishings | ' |
Equipment and Furnishings — Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. | |
Goodwill and Intangible Assets | ' |
Goodwill and Intangible Assets — Goodwill and indefinite-lived intangible assets are not amortized but are tested annually for impairment at the reporting unit level, or more frequently if events and circumstances indicate impairment may have occurred. Factors the company considers important that could trigger an interim review for impairment include, but are not limited to, the following: | |
•Significant changes in the manner of its use of acquired assets or the strategy for its overall business; | |
•Significant negative industry or economic trends; | |
•Significant decline in stock price for a sustained period; and | |
•Significant decline in market capitalization relative to net book value. | |
Goodwill and other intangible assets with indefinite lives are evaluated for impairment first by a qualitative assessment to determine the likelihood of impairment. If it is determined that impairment is more likely than not, the company will then proceed to the two step impairment test. The first step is to compare the fair value of the reporting unit to the carrying amount of the reporting unit (the “First Step”). If the carrying amount exceeds the fair value, a second step must be followed to calculate impairment (the “Second Step”). Otherwise, if the fair value of the reporting unit exceeds the carrying amount, the goodwill is not considered to be impaired as of the measurement date. In its review of the carrying value of the goodwill for its single reporting unit and its indefinite-lived intangible assets, the company determines fair values of its goodwill using the market approach, and its indefinite-lived intangible assets using the income approach. | |
Intangible assets not considered indefinite-lived are reviewed for impairment when facts or circumstances suggest that the carrying value of these assets may not be recoverable. The company’s policy is to identify and record impairment losses, if necessary, on intangible product rights when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. | |
The company performed its review for impairment using the qualitative assessment for both goodwill and indefinite-lived intangible assets, and has determined that there has been no impairment to these assets as of December 31, 2013. | |
Revenue Recognition | ' |
Revenue Recognition - The company recognizes revenue from the sale of Abstral. Revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred and title has passed, (iii) the price is fixed or determinable and (iv) collectability is reasonably assured. | |
We sell Abstral product in the United States to wholesale pharmaceutical distributors and retail pharmacies, or collectively, our "customers," subject to rights of return. During the year ended December 31, 2013, we began recognizing Abstral product sales at the time title transfers to our customer, and providing for an estimate of future product returns. Revenue from product sales is recorded net of provisions for estimated returns, prompt pay discounts, wholesaler discounts, rebates, chargebacks, patient assistance program rebates and other deductions as needed. | |
Returns - The company estimates future returns based on historical return information, as well as information regarding prescription information and sell-through trends, in relation to the estimated amount of product in the sales channels and product expiration dates. No reserve for future returns was deemed necessary at December 31, 2013. | |
Product Sales Discounts and Allowances - The company recognizes revenue at the point of sale to its wholesale pharmaceutical distributors and retail pharmacies and the allowances for product returns, rebates and allowances are recognized at the point of sale. The company is required to make significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the company will be required to make adjustments to these allowances in the future. | |
Prompt Pay Discounts - As an incentive for prompt payment, the company offers a cash discount to customers, generally 2% of gross sales. The company expects that all customers will comply with the contractual terms to earn the discount. The company records the discount as an allowance against accounts receivable and a reduction of revenue. | |
Wholesaler Discounts - The company offers discounts to certain wholesalers and distributors based on contractually determined rates. The company accrues the discount as a reduction of receivables due from the wholesalers upon shipment to the respective wholesale distributors and retail pharmacies and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. | |
Rebates - The company participates in certain rebate programs, which provide discounted prescriptions to members of group purchasing organization and specialty pharmacies. Under these rebate programs, the company pays a rebate to the third-party administrator of the program, generally two to the three months after the quarter in which prescriptions subject to the rebate are filled. The company estimates and accrues these rebates based on current contract prices, historical and estimated future percentages of product sold to qualifying member pharmacies and estimated levels of inventory in the distribution channel. Rebates are recognized as a reduction in the period that the related revenue is recognized. | |
Chargebacks - The company provides discounts primarily to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid or Medicare contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the company the difference between the current retail price and the price the entity paid for the product. The company estimates and accrues chargebacks based on estimated wholesaler inventory levels, current contract prices and historic chargeback activity. Chargebacks are recognized as a reduction of revenue in the period the related revenue is recognized. | |
Patient Assistance Programs - The company offers discount card programs to patients for Abstral in which patients receive discounts on their Abstral prescriptions that are reimbursed by the company. The company estimates the total amount that will be recognized based on a percentage of actual redemption applied to inventory in the distribution and retail channel and recognizes the discount as a reduction of revenue and as an other current liability (see Note 6) in the same period the related revenue is recognized. | |
Acquisitions and In-Licensing | ' |
Goodwill and Intangible Assets — Goodwill and indefinite-lived intangible assets are not amortized but are tested annually for impairment at the reporting unit level, or more frequently if events and circumstances indicate impairment may have occurred. Factors the company considers important that could trigger an interim review for impairment include, but are not limited to, the following: | |
•Significant changes in the manner of its use of acquired assets or the strategy for its overall business; | |
•Significant negative industry or economic trends; | |
•Significant decline in stock price for a sustained period; and | |
•Significant decline in market capitalization relative to net book value. | |
Goodwill and other intangible assets with indefinite lives are evaluated for impairment first by a qualitative assessment to determine the likelihood of impairment. If it is determined that impairment is more likely than not, the company will then proceed to the two step impairment test. The first step is to compare the fair value of the reporting unit to the carrying amount of the reporting unit (the “First Step”). If the carrying amount exceeds the fair value, a second step must be followed to calculate impairment (the “Second Step”). Otherwise, if the fair value of the reporting unit exceeds the carrying amount, the goodwill is not considered to be impaired as of the measurement date. In its review of the carrying value of the goodwill for its single reporting unit and its indefinite-lived intangible assets, the company determines fair values of its goodwill using the market approach, and its indefinite-lived intangible assets using the income approach. | |
Intangible assets not considered indefinite-lived are reviewed for impairment when facts or circumstances suggest that the carrying value of these assets may not be recoverable. The company’s policy is to identify and record impairment losses, if necessary, on intangible product rights when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. | |
The company performed its review for impairment using the qualitative assessment for both goodwill and indefinite-lived intangible assets, and has determined that there has been no impairment to these assets as of December 31, 2013. | |
Acquisitions and In-Licensing — For all in-licensed products and technologies, we perform an analysis to determine whether we hold a variable interest or a controlling financial interest in a variable interest entity. On the basis of our interpretations and conclusions, we determine whether the acquisition falls under the purview of variable interest entity accounting and if so, consider the necessity to consolidate the acquisition. As of December 31, 2013, we determined there were no variable interest entities required to be consolidated. | |
We also perform an analysis to determine if the assets and liabilities acquired in an acquisition qualify as a "business." The excess of the purchase price over the fair value of the net assets acquired can only be recognized as goodwill in a business combination. | |
The acquisition of the Abstral U.S. rights has been accounted for as an asset acquisition and not a business combination. The purchase price, including transaction costs, was recorded as an intangible asset related to the license and distribution rights acquired in the transaction. No other significant assets or liabilities were acquired or assumed in the transaction. The license and distribution rights will be amortized over ten years in a pattern based on our Abstral sales projections. Amortization expense, related to the Abstral rights, of $131,000 was recorded in amortization of certain acquired intangible assess in the statement of comprehensive loss for the year ended December 31, 2013. There was no amortization recorded prior to the year ended December 31, 2013. Refer to Note 15 for further information regarding the acquisition of Abstral U.S. rights. | |
Contingent Purchase Price Consideration | ' |
Contingent Purchase Price Consideration — Contingent consideration is recorded at the estimated fair value as of the acquisition date. The fair value of the contingent consideration is remeasured at each reporting period with any adjustments in fair value included in our consolidated statement of comprehensive loss. | |
Patents and Patent Application Costs | ' |
Patents and Patent Application Costs — Although the company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred. | |
Share-based Compensation | ' |
Share-based Compensation — The company follows the provisions of the FASB ASC Topic 718, “Compensation — Stock Compensation” (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based payment awards made to employees, non-employee directors, and consultants, including stock options and warrants. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period. | |
For stock options and warrants granted as consideration for services rendered by non-employees, the company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50 (“ASC 505-50”), “ Equity Based Payments to Non- Employees.” Non-employee option and warrant grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to vesting, the value of these options and warrants, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the company’s common stock and the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options and warrants granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options are fully vested. | |
Research and Development Expenses | ' |
Research and Development Expenses — Research and development costs are expensed as incurred. Included in research and development costs are wages, benefits and other operating costs, facilities, supplies, external services and overhead related to our research and development departments, and clinical trial expenses. | |
Clinical trial expenses include direct costs associated with contract research organizations ("CROs"), as well as well as patient-related costs at sites at which our trials are being conducted. | |
Direct costs associated with our CROs are generally payable on a time and materials basis, or when certain enrollment and monitoring milestones are achieved. Expense related to a milestone is recognized in the period in which the milestone is achieved or in which we determine that it is more likely than not that it will be achieved. | |
The invoicing from clinical trial sites can lag several months. We accrue these site costs based on our estimate of upfront set-up costs upon the screening of the first patient at each site, and the patient related costs based on our knowledge of patient enrollment status at each site. | |
Income Taxes | ' |
Income Taxes — The company recognizes liabilities or assets for the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts in the financial statements in accordance with FASB ASC 740-10, “Accounting for Income Taxes” (“ASC 740-10”). These temporary differences will result in taxable or deductible amounts in future years when the reported amounts of the assets or liabilities are recovered or settled. ASC 740-10 requires that a valuation allowance be established when management determines that it is more likely than not that all or a portion of a deferred asset will not be realized. The company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary, at least on an annual basis. During this evaluation, the company reviews its forecasts of income in conjunction with other positive and negative evidence surrounding the realizability of its deferred income tax assets to determine if a valuation allowance is required. Adjustments to the valuation allowance will increase or decrease the company’s income tax provision or benefit. The recognition and measurement of benefits related to the company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws, new interpretations of existing laws, and rulings by taxing authorities. Differences between actual results and the company’s assumptions or changes in the company’s assumptions in future periods are recorded in the period they become known. | |
Concentrations of Credit Risk | ' |
Concentrations of Credit Risk — Financial instruments that potentially subject the company to significant concentrations of credit risk consist principally of cash and cash equivalents. The company maintains cash balances in several accounts with two banks, which at times are in excess of federally insured limits. As of December 31, 2013, the company’s cash equivalents were invested in money market mutual funds. The company’s investment policy does not allow investment in any debt securities rated less than “investment grade” by national ratings services. The company has not experienced any losses on its deposits of cash and cash equivalents. | |
Comprehensive Loss | ' |
Comprehensive Loss — Comprehensive loss consists of our net loss and other comprehensive income related to the unrealized gain (loss), net of tax, on our marketable securities, which are classified as available-for-sale. | |
Fair Value Measurement | ' |
Fair Value Measurements | |
The company follows ASC 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are as defined as follows: | |
Level 1 — quoted prices in active markets for identical assets or liabilities. | |
Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date. | |
Level 3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date. | |
The company categorized its cash equivalents and marketable securities as Level 1 inputs. The valuations for Level 1 were determined based on a “market approach” using quoted prices in active markets for identical assets. Valuation of these assets does not require a significant degree of judgment. The company categorized its warrants potentially settleable in cash as Level 2 inputs. The warrants are measured at market value on a recurring basis and are being marked to market each quarter-end until they are completely settled. The warrants are valued using an appropriate pricing model, using assumptions consistent with our application of ASC 718. The contingent purchase price consideration is categorized as Level 3 inputs and is measured at its estimated fair value on a recurring basis and is adjusted at each quarter-end until it is completely settled. The contingent price consideration is valued based on the expected timing of milestones, the expected probability of success for each milestone and discount rates based on a corporate debt interest rate index publicly issued. | |
Net Loss Per Share | ' |
Net Loss Per Share | |
The company accounts for and discloses net loss per common share in accordance with FASB ASC Topic 260 “Earnings per Share.” Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares that would have been outstanding during the period assuming the issuance of common shares for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exercise of stock options and warrants. |
NeuVaxTM_Acquisition_Tables
NeuVaxTM Acquisition (Tables) | 12 Months Ended | ||||||
Dec. 31, 2013 | |||||||
Business Combinations [Abstract] | ' | ||||||
Purchase Price Consideration and Allocation of Purchase Price | ' | ||||||
The purchase price consideration and allocation of purchase price were as follows (in thousands): | |||||||
Calculation of allocable purchase price: | |||||||
Fair value of shares issued at closing including escrowed shares expected to be released | $ | 6,367 | (i) | ||||
Estimated value of earn-out | 6,460 | ||||||
Total allocable purchase price | $ | 12,827 | |||||
Allocation of purchase price: | |||||||
Cash | $ | 168 | |||||
Prepaid expenses and other current assets | 14 | ||||||
Equipment and furnishings | 11 | ||||||
Goodwill | 5,898 | ||||||
In-process research and development | 12,864 | ||||||
Accounts payable | (931 | ) | |||||
Accrued expenses and other current liabilities | (143 | ) | |||||
Notes payable | (1 | ) | |||||
Deferred tax liability, non-current | (5,053 | ) | |||||
$ | 12,827 | ||||||
(i) | The value of the company’s common stock was based upon a per share value of $1.28, the closing price of the company’s common stock as of the close of business on April 13, 2011. | ||||||
Pro Forma Net Loss and Pro Forma Net Loss Per Common Share | ' | ||||||
The following presents the unaudited, pro forma net loss and pro forma net loss per common share of the company for year ended December 31, 2011 as if the company’s acquisition of Apthera occurred as of January 1, 2011 (in thousands expect for per share data): | |||||||
For the Year Ended | |||||||
December 31, 2011 | |||||||
Net loss from continuing operations | $ | (4,700 | ) | ||||
Net loss from discontinued operations | $ | (8,078 | ) | ||||
Net loss per common share, continuing operations | $ | (0.12 | ) | ||||
Net loss per common share, discontinued operations | $ | (0.21 | ) | ||||
Net loss per common share | $ | (0.34 | ) |
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 12 Months Ended | |||||||||||||||
Dec. 31, 2013 | ||||||||||||||||
Fair Value Disclosures [Abstract] | ' | |||||||||||||||
Contingent Purchase Price Consideration, Measured at Estimated Fair Value on Recurring Basis | ' | |||||||||||||||
Description | December 31, 2013 | Quoted Prices In | Significant Other | Unobservable | ||||||||||||
Active Markets | Observable Inputs | Inputs | ||||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||||
Assets: | ||||||||||||||||
Cash equivalents | $ | 42,349 | $ | 42,349 | $ | — | $ | — | ||||||||
Marketable securities | — | — | — | — | ||||||||||||
Total assets measured and recorded at fair value | $ | 42,349 | $ | 42,349 | $ | — | $ | — | ||||||||
Liabilities: | ||||||||||||||||
Warrants potentially settleable in cash | $ | 48,965 | $ | — | $ | 48,965 | $ | — | ||||||||
Contingent purchase price consideration | 6,821 | — | — | 6,821 | ||||||||||||
Total liabilities measured and recorded at fair value | $ | 55,786 | $ | — | $ | 48,965 | $ | 6,821 | ||||||||
Description | December 31, 2012 | Quoted Prices In | Significant Other | Unobservable | ||||||||||||
Active Markets | Observable Inputs | Inputs | ||||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||||
Assets: | ||||||||||||||||
Cash equivalents | $ | 32,431 | $ | 32,431 | $ | — | $ | — | ||||||||
Marketable securities | 2,678 | 2,678 | — | — | ||||||||||||
Total assets measured and recorded at fair value | $ | 35,109 | $ | 35,109 | $ | — | $ | — | ||||||||
Liabilities: | ||||||||||||||||
Warrants potentially settleable in cash | $ | 10,964 | $ | — | $ | 10,964 | $ | — | ||||||||
Contingent purchase price consideration | 7,142 | — | — | 7,142 | ||||||||||||
Total liabilities measured and recorded at fair value | $ | 18,106 | $ | — | $ | 10,964 | $ | 7,142 | ||||||||
Reconciliation of Level 3 Liabilities | ' | |||||||||||||||
A reconciliation of the beginning and ending Level 3 liabilities for the years ended December 31, 2013 and 2012 is as follows (in thousands): | ||||||||||||||||
Fair Value | ||||||||||||||||
Measurements | ||||||||||||||||
Using Significant | ||||||||||||||||
Unobservable | ||||||||||||||||
Inputs | ||||||||||||||||
(Level 3) | ||||||||||||||||
Balance, January 1, 2012 | $ | 6,351 | ||||||||||||||
Milestone payment | (1,579 | ) | ||||||||||||||
Change in the estimated fair value of the contingent purchase price consideration | 2,370 | |||||||||||||||
Balance, December 31, 2012 | 7,142 | |||||||||||||||
Milestone payment | (1,247 | ) | ||||||||||||||
Change in the estimated fair value of the contingent purchase price consideration | 926 | |||||||||||||||
Balance at December 31, 2013 | $ | 6,821 | ||||||||||||||
Accrued_Expenses_and_Other_Cur1
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended | |||||||
Dec. 31, 2013 | ||||||||
Payables and Accruals [Abstract] | ' | |||||||
Schedule of Accrued Expenses and Other Current Liabilities | ' | |||||||
Accrued expenses and other current liabilities consist of the following (in thousands): | ||||||||
December 31, | ||||||||
2013 | 2012 | |||||||
Clinical development expense | $ | 3,109 | $ | 1,705 | ||||
Patient assistance programs | 2,618 | — | ||||||
Compensation and related benefits | 1,999 | 217 | ||||||
Professional fees | 713 | 116 | ||||||
Royalties | 158 | — | ||||||
Interest expense | 70 | — | ||||||
Accrued expenses and other current liabilities | $ | 8,667 | $ | 2,038 | ||||
Longterm_Debt_Tables
Long-term Debt (Tables) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Debt Disclosure [Abstract] | ' | ||||
Schedule of Future Principal Payments | ' | ||||
As of December 31, 2013, future schedule principal payments to be made on long-term debt are as follows (in thousands): | |||||
For the year ending December 31, 2014 | $ | 2,149 | |||
2015 | 3,938 | ||||
2016 | 3,913 | ||||
Total future principal payments | 10,000 | ||||
Unamortized debt issuance costs (net of fair value of warrants issued) | (108 | ) | |||
Total debt | 9,892 | ||||
Less current portion | (2,149 | ) | |||
Total long-term debt, net | $ | 7,743 | |||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | |||||||||||||||||||
Dec. 31, 2013 | ||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ' | |||||||||||||||||||
Schedule of Contractual Obligations and Future Cash Payments | ' | |||||||||||||||||||
The company’s contractual obligations that will require future cash payments as of December 31, 2013 are as follows (in thousands): | ||||||||||||||||||||
Operating | Non-Cancelable | Subtotal | Cancelable | Total | ||||||||||||||||
Leases(1) | Employment | License | ||||||||||||||||||
Agreements(2) | Agreements(3) | |||||||||||||||||||
2014 | $ | 72 | $ | 450 | $ | 522 | $ | 325 | $ | 847 | ||||||||||
2015 | 74 | 300 | 374 | 350 | 724 | |||||||||||||||
2016 | 83 | 100 | 183 | 350 | 533 | |||||||||||||||
2017 | 82 | — | 82 | 350 | 432 | |||||||||||||||
2018 | 70 | — | 70 | 6,865 | 6,935 | |||||||||||||||
Total | $ | 381 | $ | 850 | $ | 1,231 | $ | 8,240 | $ | 9,471 | ||||||||||
(1) | Operating leases are primarily facility and equipment related obligations with third party vendors. Operating lease expenses during the years ended December 31, 2013, 2012, and 2011 were approximately $77,000, $139,000 and $233,000, respectively. | |||||||||||||||||||
(2) | Employment agreement obligations include management contracts, as well as scientific advisory board member compensation agreements. Certain agreements, which have been revised from time to time, provide for minimum salary levels, adjusted annually at the discretion of the Compensation Committee, as well as for minimum bonuses that are payable. | |||||||||||||||||||
(3) | License agreements generally relate to the company’s obligations with The Board of Regents, University of Texas and Henry Jackson Foundation for our oncology therapies. The company continually assesses the progress of its licensed technology and the progress of its research and development efforts as it relates to its licensed technology and may terminate with notice to the licensor at any time. In the event these licenses are terminated, no amounts will be due. |
Warrants_Tables
Warrants (Tables) | 12 Months Ended | |||||||||||||||||||||||||||
Dec. 31, 2013 | ||||||||||||||||||||||||||||
Warrants and Rights Note Disclosure [Abstract] | ' | |||||||||||||||||||||||||||
Schedule of Warrant Activity | ' | |||||||||||||||||||||||||||
The following is a summary of warrant activity for the years ended December 31, 2013 and 2012 (in thousands): | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | Consultant | Total | |||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | and Oxford Warrants | ||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Outstanding, January 1, 2012 | — | — | 9,470 | 2,400 | 540 | 978 | 733 | 14,121 | ||||||||||||||||||||
Granted | — | 7,578 | — | — | — | — | 400 | 7,978 | ||||||||||||||||||||
Exercised | — | — | (6,624 | ) | (2,039 | ) | (180 | ) | — | (40 | ) | (8,883 | ) | |||||||||||||||
Outstanding, December 31, 2012 | — | 7,578 | 2,846 | 361 | 360 | 978 | 1,093 | 13,216 | ||||||||||||||||||||
Granted | 7,044 | — | — | — | — | — | 182 | 7,226 | ||||||||||||||||||||
Exercised | (602 | ) | (2,661 | ) | (1,688 | ) | (185 | ) | (70 | ) | — | (196 | ) | (5,402 | ) | |||||||||||||
Expired | — | — | — | — | — | — | (190 | ) | (190 | ) | ||||||||||||||||||
Outstanding, December 31, 2013 | 6,442 | 4,917 | 1,158 | 176 | 290 | 978 | 889 | 14,850 | ||||||||||||||||||||
Expiration | Sep-18 | Dec-17 | Apr-17 | Mar-16 | Mar-16 | Aug-14 | Varies 2014-2020 | |||||||||||||||||||||
Fair Value of Warrants is Estimated Using Black-Scholes Option Pricing Model | ' | |||||||||||||||||||||||||||
The fair value of the warrants is estimated using an appropriate pricing model with the following inputs: | ||||||||||||||||||||||||||||
As of December 31, 2013 | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | |||||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | |||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Strike price | $ | 2.5 | $ | 1.9 | $ | 0.65 | $ | 0.65 | $ | 2.15 | $ | 4.5 | ||||||||||||||||
Expected term (years) | 4.72 | 3.98 | 3.31 | 2.18 | 2.24 | 0.59 | ||||||||||||||||||||||
Volatility % | 71.97 | % | 71.38 | % | 71.71 | % | 73.45 | % | 73.36 | % | 66.85 | % | ||||||||||||||||
Risk-free rate % | 1.61 | % | 1.25 | % | 0.93 | % | 0.45 | % | 0.47 | % | 0.11 | % | ||||||||||||||||
As of December 31, 2012 | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | |||||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | |||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Strike price | — | $ | 1.9 | $ | 0.65 | $ | 0.65 | $ | 2.18 | $ | 4.5 | |||||||||||||||||
Expected term (years) | 0 | 4.98 | 4.3 | 3.18 | 3.24 | 1.59 | ||||||||||||||||||||||
Volatility % | — | 80.93 | % | 82.48 | % | 69.9 | % | 69.79 | % | 74.13 | % | |||||||||||||||||
Risk-free rate % | — | 0.72 | % | 0.59 | % | 0.39 | % | 0.4 | % | 0.21 | % | |||||||||||||||||
Changes in Fair Value of Warrant Liability | ' | |||||||||||||||||||||||||||
The changes in fair value of the warrant liability for the years ended December 31, 2013 and 2012 were as follows (in thousands): | ||||||||||||||||||||||||||||
September | December | April 2011 | March | March | August | Total | ||||||||||||||||||||||
2013 | 2012 | Warrants | 2011 | 2010 | 2009 | |||||||||||||||||||||||
Warrants | Warrants | Warrants | Warrants | Warrants | ||||||||||||||||||||||||
Warrant liability, January 1, 2012 | $ | — | $ | — | $ | 3,145 | $ | 421 | $ | 116 | $ | 64 | $ | 3,746 | ||||||||||||||
Fair value of warrants granted | — | 7,286 | — | — | — | — | 7,286 | |||||||||||||||||||||
Fair value of warrants exercised | — | — | (8,130 | ) | (2,456 | ) | (257 | ) | — | (10,843 | ) | |||||||||||||||||
Change in fair value of warrants | — | (332 | ) | 8,295 | 2,413 | 328 | 71 | 10,775 | ||||||||||||||||||||
Warrant liability, December 31, 2012 | — | 6,954 | 3,310 | 378 | 187 | 135 | 10,964 | |||||||||||||||||||||
Fair value of warrants granted | 8,238 | — | — | — | — | — | 8,238 | |||||||||||||||||||||
Fair value of warrants exercised | (1,931 | ) | (8,482 | ) | (3,455 | ) | (260 | ) | (121 | ) | — | (14,249 | ) | |||||||||||||||
Change in fair value of warrants | 16,643 | 19,588 | 5,214 | 645 | 879 | 1,043 | 44,012 | |||||||||||||||||||||
Warrant liability, December 31, 2013 | $ | 22,950 | $ | 18,060 | $ | 5,069 | $ | 763 | $ | 945 | $ | 1,178 | $ | 48,965 | ||||||||||||||
Stock_Based_Compensation_Table
Stock Based Compensation (Tables) | 12 Months Ended | |||||||||||
Dec. 31, 2013 | ||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||
Schedule of Components of Stock-based Compensation Expense | ' | |||||||||||
The following table summarizes the components of stock-based compensation expense in the Consolidated Statements of Comprehensive Loss for the years ended December 31, 2013, 2012, and 2011 (in thousands): | ||||||||||||
2013 | 2012 | 2011 | ||||||||||
Research and development | $ | 754 | $ | 580 | $ | 139 | ||||||
Selling, general, and administrative | 2,150 | 1,179 | 2,386 | |||||||||
Total stock-based compensation | $ | 2,904 | $ | 1,759 | $ | 2,525 | ||||||
Assumptions for Option Grants Issued | ' | |||||||||||
The company uses the Black-Scholes option-pricing model and the following weighted-average assumptions to determine the fair value of all its stock options granted: | ||||||||||||
2013 | 2012 | |||||||||||
Risk free interest rate | 1.57 | % | 1.05 | % | ||||||||
Volatility | 77.98 | % | 75.76 | % | ||||||||
Expected lives (years) | 6.25 | 6.13 | ||||||||||
Expected dividend yield | 0 | % | 0 | % | ||||||||
Stock Option Activity | ' | |||||||||||
The following table summarizes option activity of the company: | ||||||||||||
Total | Weighted | |||||||||||
Number of | Average | |||||||||||
Shares | Exercise | |||||||||||
(In Thousands) | Price | |||||||||||
Outstanding at December 31, 2012 | 7,672 | $ | 2.54 | |||||||||
Granted | 7,113 | 2.87 | ||||||||||
Exercised | (289 | ) | 1.21 | |||||||||
Cancelled | (1,337 | ) | 2.8 | |||||||||
Outstanding at December 31, 2013 | 13,159 | $ | 2.73 | |||||||||
Options exercisable at December 31, 2013 | 6,557 | $ | 2.63 | |||||||||
Other_Income_Expense_Tables
Other Income (Expense) (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
Other Income and Expenses [Abstract] | ' | ||||||||||||
Schedule of Other Income (Expense) | ' | ||||||||||||
Other Income (Expense) | |||||||||||||
Other income (expense) is summarized as follows (in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2013 | 2012 | 2011 | |||||||||||
Change in fair value of warrants potentially settleable in cash | $ | (44,001 | ) | $ | (10,775 | ) | $ | 8,986 | |||||
Realized gain on sale of marketable securities | 3,911 | — | — | ||||||||||
Change in fair value of the contingent purchase price liability | (926 | ) | (2,370 | ) | 109 | ||||||||
Miscellaneous other income | 37 | — | (9 | ) | |||||||||
Total other income (expense) | $ | (40,979 | ) | $ | (13,145 | ) | $ | 9,086 | |||||
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 12 Months Ended | |||||
Dec. 31, 2013 | ||||||
Earnings Per Share [Abstract] | ' | |||||
Common Shares Excluded from Net Loss | ' | |||||
The following table sets forth the potentially dilutive common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive (in thousands): | ||||||
December 31, | ||||||
2013 | 2012 | |||||
Warrants to purchase common stock | 14,850 | 13,216 | ||||
Options to purchase common stock | 13,159 | 7,672 | ||||
Total | 28,009 | 20,888 | ||||
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
Components of Federal and State Income Tax Expense (Benefit) | ' | ||||||||
The components of federal and state income tax expense (benefit) are as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
Current | |||||||||
Federal | $ | — | $ | — | |||||
State | — | — | |||||||
Total current | — | — | |||||||
Deferred expense (benefit) | |||||||||
Federal | 894 | (894 | ) | ||||||
State | 158 | (158 | ) | ||||||
Total deferred | 1,052 | (1,052 | ) | ||||||
Total income tax expense (benefit) | $ | 1,052 | $ | (1,052 | ) | ||||
Components of Net Deferred Tax Assets | ' | ||||||||
The components of net deferred tax assets are as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
Net operating loss carryforwards | $ | 33,539 | $ | 23,632 | |||||
Tax credit carryforwards | 3,549 | 3,201 | |||||||
Unrealized gain on marketable securities | — | (1,052 | ) | ||||||
Stock based compensation | 8,322 | 7,944 | |||||||
Other | 12 | (328 | ) | ||||||
Licensing deduction deferral | 8,682 | 8,194 | |||||||
Gross deferred tax assets | 54,104 | 41,591 | |||||||
Valuation allowance | (54,104 | ) | (41,591 | ) | |||||
Net deferred tax asset | $ | — | $ | — | |||||
Components of Net Deferred Tax Liabilities | ' | ||||||||
The components of net deferred tax liabilities are as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
In-process research and development not subject to future amortization for tax purposes | $ | 5,053 | $ | 5,053 | |||||
Gross deferred tax liability | $ | 5,053 | $ | 5,053 | |||||
Schedule of Provision Computed by Applying Federal Statutory Rate | ' | ||||||||
The provision for income taxes differs from the provision computed by applying the federal statutory rate to net loss before income taxes as follows (in thousands): | |||||||||
As of December 31, | |||||||||
2013 | 2012 | ||||||||
Expected federal income tax benefit | $ | (25,713 | ) | $ | (11,688 | ) | |||
State income taxes after credits | (3,676 | ) | (1,067 | ) | |||||
Unrealized gain on marketable securities | 1,052 | (1,052 | ) | ||||||
Changes in warrant value | 17,283 | 3,664 | |||||||
Stock compensation | 813 | 152 | |||||||
Effect of change in valuation allowance | 11,408 | 8,939 | |||||||
Income tax credits | (240 | ) | — | ||||||
Other | 125 | — | |||||||
$ | 1,052 | $ | (1,052 | ) | |||||
Selected_Quarterly_Financial_D1
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | ' | ||||||||||||||||
Schedule of Quarterly Financial Data (Unaudited) | ' | ||||||||||||||||
The following amounts are in thousands, except per share amounts: | |||||||||||||||||
1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||||||||||||
2013 | |||||||||||||||||
Net revenue | $ | — | $ | — | $ | 1,170 | $ | 1,317 | |||||||||
Gross profit on net revenue (1) | $ | — | $ | — | $ | 869 | $ | 967 | |||||||||
Net loss | $ | (9,293 | ) | $ | (9,597 | ) | $ | (9,287 | ) | $ | (48,501 | ) | |||||
Net loss per share | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.46 | ) | |||||
2012 | |||||||||||||||||
Net revenue | $ | — | $ | — | $ | — | $ | — | |||||||||
Gross profit on net revenue | $ | — | $ | — | $ | — | $ | — | |||||||||
Net loss | $ | (24,761 | ) | $ | (196 | ) | $ | (6,261 | ) | $ | (3,751 | ) | |||||
Net loss per share | $ | (0.52 | ) | $ | — | $ | (0.09 | ) | $ | (0.05 | ) | ||||||
(1) | Gross profit for the quarter ended December 31, 2013 is calculated by taking net revenue less cost of revenue and amortization of certain acquired intangible assets, which is consistent with the gross profit reported for the quarter ended September 30, 2013. |
Business_and_Basis_of_Presenta2
Business and Basis of Presentation (Additional Information) (Detail) (USD $) | 1 Months Ended | 12 Months Ended | ||
Mar. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Schedule Of Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' |
Highly-liquid debt instruments maturity days | ' | '90 days | ' | ' |
Inventories | ' | $386,000 | $0 | ' |
Inventories, work-in-process | ' | 270,000 | ' | ' |
Inventories, finished goods | ' | 116,000 | ' | ' |
Prompyt pay discount, percent of gross sales | ' | 0 | ' | ' |
Amortization period of license and distribution rights | ' | '10 years | ' | ' |
Amortization of Abstral rights | ' | 131,000 | ' | ' |
Cash paid for acquisition of Abstral rights | 10,000,000 | 15,143,000 | ' | ' |
Income tax expense (benefit) | ' | 1,052,000 | -1,052,000 | ' |
Interest bearing accounts | ' | $47,240,000 | ' | ' |
Minimum [Member] | Equipment and Furnishings [Member] | ' | ' | ' | ' |
Schedule Of Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' |
Estimated useful lives | ' | '3 years | ' | ' |
Maximum [Member] | Equipment and Furnishings [Member] | ' | ' | ' | ' |
Schedule Of Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' |
Estimated useful lives | ' | '5 years | ' | ' |
RXi_Spinoff_Additional_Informa
RXi Spin-off (Additional Information) (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Apr. 30, 2012 | Sep. 24, 2011 | |
Related Party Transaction [Line Items] | ' | ' | ' |
Proceeds from sale of shares after spin-off | $3,911,000 | ' | ' |
RXi [Member] | ' | ' | ' |
Related Party Transaction [Line Items] | ' | ' | ' |
Cash contribution in capital | ' | ' | 1,500,000 |
Proceeds from technology revenue | 45,000,000 | ' | ' |
Proceeds from technology revenue under condition one | 15,000,000 | ' | ' |
Proceeds from technology revenue under condition two | 30,000,000 | ' | ' |
Minimum estimated sales | 500,000,000 | ' | ' |
Estimated sales | 1,000,000,000 | ' | ' |
Number of shares distributed to surrenders under spin-off | ' | 66,959,894 | ' |
Number of shares retained by company under spin-off | ' | 33,476,595 | ' |
Lock up period of shares under spin-off | '1 year | ' | ' |
Expiration date of shares under spin-off | 27-Apr-13 | ' | ' |
Number of shares sold by company after spin-off | 1,115,887 | ' | ' |
Retained price per shares under spin-off | $2.40 | ' | ' |
Retained value of shares under spin-off | $2,678,000 | ' | ' |
NeuVaxTM_Acquisition_Additiona
NeuVaxTM Acquisition (Additional Information) (Detail) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended | ||||||
Apr. 13, 2011 | Jun. 30, 2013 | Sep. 30, 2012 | Jan. 19, 2012 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Feb. 10, 2012 | Jan. 18, 2012 | |
Business Combinations [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Date of acquisition of Apthera, Inc. | 13-Apr-11 | ' | ' | ' | ' | ' | ' | ' | ' |
Approximate shares of common stock issued to Apthera's stockholders | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Future contingent payments | $32,000,000 | ' | ' | ' | $30,000,000 | ' | ' | ' | ' |
Estimated value of the earn-out consideration | 6,460,000 | ' | ' | ' | ' | ' | 6,460,000 | ' | ' |
Contingent liability | ' | ' | ' | 1,000,000 | ' | ' | ' | ' | ' |
Restricted shares of common stock issued | ' | ' | ' | 1,315,849 | ' | ' | ' | ' | ' |
Increase in number of milestone shares on obtaining shareholder approval | ' | ' | ' | ' | ' | ' | ' | ' | $0.76 |
Payment to the former Apthera shareholders in cash | ' | ' | 35,000 | ' | ' | ' | ' | ' | ' |
Payment to the former Apthera shareholders in cash at an interest factor | ' | ' | ' | ' | ' | ' | ' | 10.00% | ' |
Additional other expense related to fair value of the shares on the date of issuance | ' | ' | ' | ' | ' | 579,000 | ' | ' | ' |
MIlestone Payment | ' | 1,247,000 | ' | ' | 2,000,000 | ' | ' | ' | ' |
Shares Issued for Milestone Payment | ' | 492,988 | ' | ' | ' | ' | ' | ' | ' |
Increase in the fair value of the contingent liability | ' | ' | ' | ' | 926,000 | 2,370,000 | ' | ' | ' |
Decrease in the fair value of the contingent liability | ' | ' | ' | ' | ' | ' | 109,000 | ' | ' |
Fair value of the contingent liability | ' | ' | ' | ' | 6,821,000 | 7,142,000 | ' | ' | ' |
Current contingent liability | ' | ' | ' | ' | $0 | $935,000 | ' | ' | ' |
NeuVaxTM_Acquisition_Purchase_
NeuVaxTM Acquisition (Purchase Price Consideration and Allocation of Purchase Price) (Detail) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Apr. 13, 2011 |
In Thousands, unless otherwise specified | ||||
Calculation of allocable purchase price: | ' | ' | ' | ' |
Fair value of shares issued at closing including escrowed shares expected to be released | ' | ' | $6,367 | ' |
Estimated value of earn-out | ' | ' | 6,460 | 6,460 |
Total allocable purchase price | 0 | 0 | 12,827 | ' |
Allocation of purchase price: | ' | ' | ' | ' |
Cash | ' | ' | 168 | ' |
Prepaid expenses and other current assets | ' | ' | 14 | ' |
Equipment and furnishings | ' | ' | 11 | ' |
Goodwill | ' | ' | 5,898 | ' |
In-process research and development | ' | ' | 12,864 | ' |
Accounts payable | ' | ' | -931 | ' |
Accrued expenses and other current liabilities | ' | ' | -143 | ' |
Notes payable | ' | ' | -1 | ' |
Deferred tax liability, non-current | ' | ' | -5,053 | ' |
Total allocable purchase price | $0 | $0 | $12,827 | ' |
NeuVaxTM_Acquisition_Purchase_1
NeuVaxTM Acquisition (Purchase Price Consideration and Allocation of Purchase Price) (Parenthetical) (Detail) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | Apr. 13, 2011 |
Business Combinations [Abstract] | ' | ' | ' |
Value of the company's common stock | $0.00 | $0.00 | $1.28 |
NeuVaxTM_Acquisition_Pro_Forma
NeuVaxTM Acquisition (Pro Forma Net Loss and Pro Forma Net Loss Per Common Share) (Detail) (USD $) | 12 Months Ended |
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2011 |
Business Combinations [Abstract] | ' |
Net loss from continuing operations | ($4,700) |
Net loss from discontinued operations | ($8,078) |
Net loss per common share, continuing operations | ($0.12) |
Net loss per common share, discontinued operations | ($0.21) |
Net loss per common share | ($0.34) |
Fair_Value_Measurements_Contin
Fair Value Measurements (Contingent Purchase Price Consideration, Measured at Estimated Fair Value on Recurring Basis) (Detail) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | |||
Assets: | ' | ' | ' |
Cash equivalents | $47,240 | ' | ' |
Marketable securities | 0 | 2,678 | ' |
Liabilities: | ' | ' | ' |
Warrants potentially settleable in cash | 48,965 | 10,964 | ' |
Unobservable Inputs (Level 3) [Member] | ' | ' | ' |
Liabilities: | ' | ' | ' |
Contingent purchase price consideration | 6,821 | 7,142 | 6,351 |
Fair Value, Measurements, Recurring [Member] | ' | ' | ' |
Assets: | ' | ' | ' |
Cash equivalents | 42,349 | 32,431 | ' |
Marketable securities | 0 | 2,678 | ' |
Total assets | 42,349 | 35,109 | ' |
Liabilities: | ' | ' | ' |
Warrants potentially settleable in cash | 48,965 | 10,964 | ' |
Contingent purchase price consideration | 6,821 | 7,142 | ' |
Total liabilities | 55,786 | 18,106 | ' |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | ' | ' | ' |
Assets: | ' | ' | ' |
Cash equivalents | 42,349 | 32,431 | ' |
Marketable securities | 0 | 2,678 | ' |
Total assets | 42,349 | 35,109 | ' |
Liabilities: | ' | ' | ' |
Warrants potentially settleable in cash | 0 | 0 | ' |
Contingent purchase price consideration | 0 | 0 | ' |
Total liabilities | 0 | 0 | ' |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ' | ' | ' |
Assets: | ' | ' | ' |
Cash equivalents | 0 | 0 | ' |
Marketable securities | 0 | 0 | ' |
Total assets | 0 | 0 | ' |
Liabilities: | ' | ' | ' |
Warrants potentially settleable in cash | 48,965 | 10,964 | ' |
Contingent purchase price consideration | 0 | 0 | ' |
Total liabilities | 48,965 | 10,964 | ' |
Fair Value, Measurements, Recurring [Member] | Unobservable Inputs (Level 3) [Member] | ' | ' | ' |
Assets: | ' | ' | ' |
Cash equivalents | 0 | 0 | ' |
Marketable securities | 0 | 0 | ' |
Total assets | 0 | 0 | ' |
Liabilities: | ' | ' | ' |
Warrants potentially settleable in cash | 0 | 0 | ' |
Contingent purchase price consideration | 6,821 | 7,142 | ' |
Total liabilities | $6,821 | $7,142 | ' |
Fair_Value_Measurements_Reconc
Fair Value Measurements (Reconciliation of Level 3 Liabilities) (Detail) (USD $) | 1 Months Ended | 12 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ' | ' | ' | ' |
MIlestone Payment | $1,247 | $2,000 | ' | ' |
Change in the estimated fair value of the contingent purchase price consideration | ' | -926 | -2,370 | 109 |
Unobservable Inputs (Level 3) [Member] | ' | ' | ' | ' |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ' | ' | ' | ' |
Beginning Balance Liabilities | ' | 7,142 | 6,351 | ' |
MIlestone Payment | ' | -1,247 | -1,579 | ' |
Change in the estimated fair value of the contingent purchase price consideration | ' | -926 | -2,370 | ' |
Ending Balance Liabilities | ' | $6,821 | $7,142 | ' |
Accrued_Expenses_and_Other_Cur2
Accrued Expenses and Other Current Liabilities (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Payables and Accruals [Abstract] | ' | ' |
Contract research organizations | $3,109 | $1,705 |
Patient assistance programs | 2,618 | 0 |
Compensation and related benefits | 1,999 | 217 |
Professional fees | 713 | 116 |
Accrued Royalties, Current | 158 | 0 |
Interest expense | 70 | 0 |
Accrued expense and other current liabilities | $8,667 | $2,038 |
Longterm_Debt_Additional_Infor
Long-term Debt (Additional Information) (Details) (USD $) | 0 Months Ended | |
In Millions, except Share data, unless otherwise specified | 8-May-13 | Sep. 18, 2013 |
Debt Instrument [Line Items] | ' | ' |
Loan, amount | $15 | ' |
Term for interest only payments | '12 months | ' |
Interest payments at the fixed coupon rate | 8.45% | ' |
Term for principal and interest payments | '30 months | ' |
Cash facility fee percentage | 1.00% | ' |
Cash final payment percentage | 5.50% | ' |
Warrant term | '7 years | ' |
Number of shares availabe from warrants | ' | 0.35 |
Exercise price (usd per share) | 2.47 | 2.5 |
Duration of average market price used for warrant exercise price | '20 days | ' |
Maximum [Member] | ' | ' |
Debt Instrument [Line Items] | ' | ' |
Number of shares availabe from warrants | 182,186 | ' |
First Tranche [Member] | ' | ' |
Debt Instrument [Line Items] | ' | ' |
Loan, amount | 10 | ' |
Second Tranche [Member] | ' | ' |
Debt Instrument [Line Items] | ' | ' |
Loan, amount | $5 | ' |
Longterm_Debt_Schedule_of_Futu
Long-term Debt (Schedule of Future Principal Payments) (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Debt Disclosure [Abstract] | ' | ' |
2014 | $2,149 | ' |
2015 | 3,938 | ' |
2016 | 3,913 | ' |
Total future principal payments | 10,000 | ' |
Unamortized debt issuance costs (net of fair value of warrants issued) | -108 | ' |
Total debt | 9,892 | ' |
Long-term Debt, Current Maturities | -2,149 | 0 |
Total long-term debt, net | $7,743 | $0 |
Commitments_and_Contingencies_1
Commitments and Contingencies (Schedule of Contractual Obligations and Future Cash Payments) (Detail) (USD $) | Dec. 31, 2013 |
In Thousands, unless otherwise specified | |
Loss Contingencies [Line Items] | ' |
2014 | $847 |
2015 | 724 |
2016 | 533 |
2017 | 432 |
2018 | 6,935 |
Total | 9,471 |
Operating Leases [Member] | ' |
Loss Contingencies [Line Items] | ' |
2014 | 72 |
2015 | 74 |
2016 | 83 |
2017 | 82 |
2018 | 70 |
Total | 381 |
Non-Cancelable Employment Agreements [Member] | ' |
Loss Contingencies [Line Items] | ' |
2014 | 450 |
2015 | 300 |
2016 | 100 |
2017 | 0 |
2018 | 0 |
Total | 850 |
Subtotal [Member] | ' |
Loss Contingencies [Line Items] | ' |
2014 | 522 |
2015 | 374 |
2016 | 183 |
2017 | 82 |
2018 | 70 |
Total | 1,231 |
Cancelable License Agreements [Member] | ' |
Loss Contingencies [Line Items] | ' |
2014 | 325 |
2015 | 350 |
2016 | 350 |
2017 | 350 |
2018 | 6,865 |
Total | $8,240 |
Commitments_and_Contingencies_2
Commitments and Contingencies (Schedule of Contractual Obligations and Future Cash Payments) (Parenthetical) (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Commitments and Contingencies Disclosure [Abstract] | ' | ' | ' |
Operating lease expenses | $77 | $139 | $233 |
Stockholders_Equity_Additional
Stockholders' Equity (Additional Information) (Detail) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended | 0 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | |||||||||
Sep. 23, 2013 | Sep. 18, 2013 | Dec. 18, 2012 | Apr. 13, 2012 | Sep. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | 8-May-13 | Apr. 13, 2011 | Sep. 18, 2013 | Sep. 18, 2013 | Dec. 18, 2012 | Jan. 21, 2012 | Dec. 31, 2013 | Jan. 21, 2012 | Dec. 31, 2013 | |
Common Stock [Member] | Warrants to purchase common stock [Member] | Warrants to purchase common stock [Member] | Kwang Dong Pharmaceutical Company [Member] | Kwang Dong Pharmaceutical Company [Member] | Kwang Dong Pharmaceutical Company [Member] | Kwang Dong Pharmaceutical Company [Member] | |||||||||||
Common Stock [Member] | Common Stock [Member] | ||||||||||||||||
Class of Stock [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred stock, shares authorized | ' | ' | ' | ' | ' | 5,000,000 | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred stock, par value (usd per share) | ' | ' | ' | ' | ' | $0.00 | $0.00 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock, shares authorized | ' | ' | ' | ' | ' | 200,000,000 | 125,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock, par value (usd per share) | ' | ' | ' | ' | ' | $0.00 | $0.00 | ' | ' | $1.28 | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock, shares | ' | 17,500,000 | ' | 9,751,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 579,710 | 492,988 |
Share Price | ' | $2 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from Issuance or Sale of Equity | $5,200,000 | $35,000,000 | $24,300,000 | $14,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of Shares Per Unit | ' | 1 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares availabe from warrants | ' | 0.35 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Class of Warrant or Right, Exercise Price of Warrants or Rights | ' | 2.5 | ' | ' | ' | ' | ' | ' | 2.47 | ' | ' | ' | ' | ' | ' | ' | ' |
Stock Issued During Period, Shares, Overallotment Option | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,625,000 | 918,750 | ' | ' | ' | ' | ' |
Proceeds From Issuance or Sale of Equity, Net Underwriting Discounts, Commissions and Offering Expenses | ' | ' | 22,500,000 | 13,500,000 | 37,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrant To Purchase Share Of Common Stock | ' | ' | 0.5 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Class Of Warrant Or Right Exercise Price Of Warrants | ' | ' | $1.90 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants Issued Under Underwritten Public Offering | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15,156,250 | ' | ' | ' | ' |
Class Of Warrant Or Right Exercise Price Of Warrants Under Underwritten Public Offering | ' | ' | $1.60 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock | ' | ' | ' | ' | ' | $37,539,000 | $36,378,000 | $18,615,000 | ' | ' | ' | ' | ' | $400,000 | $1,247,000 | ' | ' |
Warrants_Schedule_of_Warrant_A
Warrants (Schedule of Warrant Activity) (Detail) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 13,216,000 | 14,121,000 |
Granted | 7,226,000 | 7,978,000 |
Exercised | -5,402,000 | -8,883,000 |
Expired | -190,000 | ' |
Warrants outstanding , Ending balance | 14,850,000 | 13,216,000 |
September 2013 Warrant [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 0 | 0 |
Granted | 7,044,000 | 0 |
Exercised | -602,000 | 0 |
Warrants outstanding , Ending balance | 6,442,000 | 0 |
Expiration | 18-Sep-18 | ' |
December 2012 Warrants [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 7,578,000 | 0 |
Granted | 0 | 7,578,000 |
Exercised | -2,661,000 | 0 |
Warrants outstanding , Ending balance | 4,917,000 | 7,578,000 |
Expiration | 31-Dec-17 | ' |
April 2011 Warrants [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 2,846,000 | 9,470,000 |
Granted | 0 | 0 |
Exercised | -1,688,000 | -6,624,000 |
Warrants outstanding , Ending balance | 1,158,000 | 2,846,000 |
Expiration | 30-Apr-17 | ' |
March 2011 Warrants [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 361,000 | 2,400,000 |
Granted | 0 | 0 |
Exercised | -185,000 | -2,039,000 |
Warrants outstanding , Ending balance | 176,000 | 361,000 |
Expiration | 31-Mar-16 | ' |
March 2010 Warrants [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 360,000 | 540,000 |
Granted | 0 | 0 |
Exercised | -70,000 | -180,000 |
Warrants outstanding , Ending balance | 290,000 | 360,000 |
Expiration | 31-Mar-16 | ' |
August 2009 Warrants [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 978,000 | 978,000 |
Granted | 0 | 0 |
Exercised | 0 | 0 |
Warrants outstanding , Ending balance | 978,000 | 978,000 |
Expiration | 31-Aug-14 | ' |
Consultant Warrants [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Warrants outstanding , Beginning balance | 1,093,000 | 733,000 |
Granted | 182,000 | 400,000 |
Exercised | -196,000 | -40,000 |
Expired | -190,000 | ' |
Warrants outstanding , Ending balance | 889,000 | 1,093,000 |
Consultant Warrants [Member] | Minimum [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Expiration | 31-Dec-14 | ' |
Consultant Warrants [Member] | Maximum [Member] | ' | ' |
Class of Warrant or Right, Outstanding [Roll Forward] | ' | ' |
Expiration | 31-Dec-20 | ' |
Warrants_Fair_Value_of_Warrant
Warrants (Fair Value of Warrants is Estimated Using Black-Scholes Option Pricing Model) (Detail) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
September 2013 Warrant [Member] | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Strike price | $2.50 | $0 |
Expected term (years) | '4 years 8 months 19 days | '0 years |
Volatility % | 71.97% | 0.00% |
Risk-free rate % | 1.61% | 0.00% |
December 2012 Warrants [Member] | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Strike price | $1.90 | $1.90 |
Expected term (years) | '3 years 11 months 23 days | '4 years 11 months 23 days |
Volatility % | 71.38% | 80.93% |
Risk-free rate % | 1.25% | 0.72% |
April 2011 Warrants [Member] | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Strike price | $0.65 | $0.65 |
Expected term (years) | '3 years 3 months 22 days | '4 years 3 months 18 days |
Volatility % | 71.71% | 82.48% |
Risk-free rate % | 0.93% | 0.59% |
March 2011 Warrants [Member] | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Strike price | $0.65 | $0.65 |
Expected term (years) | '2 years 2 months 5 days | '3 years 2 months 5 days |
Volatility % | 73.45% | 69.90% |
Risk-free rate % | 0.45% | 0.39% |
March 2010 Warrants [Member] | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Strike price | $2.15 | $2.18 |
Expected term (years) | '2 years 2 months 27 days | '3 years 2 months 27 days |
Volatility % | 73.36% | 69.79% |
Risk-free rate % | 0.47% | 0.40% |
August 2009 Warrants [Member] | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Strike price | $4.50 | $4.50 |
Expected term (years) | '7 months 2 days | '1 year 7 months 2 days |
Volatility % | 66.85% | 74.13% |
Risk-free rate % | 0.11% | 0.21% |
Warrants_Changes_in_Fair_Value
Warrants (Changes in Fair Value of Warrant Liability) (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2013 |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | $10,964 | $3,746 | $48,965 |
Fair Value of Warrants Granted | 8,238 | 7,286 | ' |
Fair value of warrants exercised | -14,249 | 10,843 | ' |
Change in fair value of warrants | 44,012 | 10,775 | ' |
Warrant liability, Ending balance | ' | 10,964 | 48,965 |
September 2013 Warrant [Member] | ' | ' | ' |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | 0 | 0 | 22,950 |
Fair Value of Warrants Granted | 8,238 | 0 | ' |
Fair value of warrants exercised | -1,931 | 0 | ' |
Change in fair value of warrants | 16,643 | 0 | ' |
Warrant liability, Ending balance | ' | 0 | 22,950 |
December 2012 Warrants [Member] | ' | ' | ' |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | 6,954 | 0 | 18,060 |
Fair Value of Warrants Granted | ' | 7,286 | ' |
Fair value of warrants exercised | -8,482 | 0 | ' |
Change in fair value of warrants | 19,588 | -332 | ' |
Warrant liability, Ending balance | ' | 6,954 | 18,060 |
April 2011 Warrants [Member] | ' | ' | ' |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | 3,310 | 3,145 | 5,069 |
Fair Value of Warrants Granted | ' | 0 | ' |
Fair value of warrants exercised | -3,455 | 8,130 | ' |
Change in fair value of warrants | 5,214 | 8,295 | ' |
Warrant liability, Ending balance | ' | 3,310 | 5,069 |
March 2011 Warrants [Member] | ' | ' | ' |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | 378 | 421 | 763 |
Fair Value of Warrants Granted | ' | 0 | ' |
Fair value of warrants exercised | -260 | 2,456 | ' |
Change in fair value of warrants | 645 | 2,413 | ' |
Warrant liability, Ending balance | ' | 378 | 763 |
March 2010 Warrants [Member] | ' | ' | ' |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | 187 | 116 | 945 |
Fair Value of Warrants Granted | ' | 0 | ' |
Fair value of warrants exercised | -121 | 257 | ' |
Change in fair value of warrants | 879 | 328 | ' |
Warrant liability, Ending balance | ' | 187 | 945 |
August 2009 Warrants [Member] | ' | ' | ' |
Class of Warrant or Right, Fair Value [Roll Forward] | ' | ' | ' |
Warrant liability, Beginning balance | 135 | 64 | 1,178 |
Fair Value of Warrants Granted | ' | 0 | ' |
Fair value of warrants exercised | 0 | 0 | ' |
Change in fair value of warrants | 1,043 | 71 | ' |
Warrant liability, Ending balance | ' | $135 | $1,178 |
Warrants_Warrants_Classified_a
Warrants (Warrants Classified as Equity) (Details) (USD $) | 0 Months Ended | |
8-May-13 | Sep. 18, 2013 | |
Warrants and Rights Note Disclosure [Abstract] | ' | ' |
Warrants Granted, Number of Shares | 182,186 | ' |
Class of Warrant or Right, Exercise Price of Warrants or Rights | 2.47 | 2.5 |
Number of Days Averaged for Exercise Price | '20 days | ' |
Fair Value Assumptions, Expected Volatility Rate | 75.34% | ' |
Fair Value Assumptions, Expected Term | '7 years | ' |
Fair Value Assumptions, Risk Free Interest Rate | 1.20% | ' |
Fair Value Assumptions, Expected Dividend Rate | 0.00% | ' |
Fair Value of Warrants Granted, per Share | $1.93 | ' |
Stock_Based_Compensation_Compo
Stock Based Compensation (Components of Stock-based Compensation Expense) (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated share based compensation expense | $2,904 | $1,759 | $2,525 |
Research and Development Expense [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated share based compensation expense | 754 | 580 | 139 |
Selling, General and Administrative Expenses [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated share based compensation expense | $2,150 | $1,179 | $2,386 |
Stock_Based_Compensation_Assum
Stock Based Compensation (Assumptions for Option Grants Issued) (Detail) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ' |
Risk free interest rate | 1.57% | 1.05% |
Volatility | 77.98% | 75.76% |
Expected lives (years) | '6 years 3 months | '6 years 1 month 17 days |
Expected dividend yield | 0.00% | 0.00% |
Stock_Based_Compensation_Addit
Stock Based Compensation (Additional Information) (Detail) (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Weighted average exercise price, granted | $1.98 | $0.70 | ' |
Averages contractual term | '10 years | ' | ' |
Estimated annualized forfeiture rate for options granted to employees | 15.00% | ' | ' |
Estimated annualized forfeiture rate for options granted to senior management | 8.00% | ' | ' |
Unrecognized compensation cost | $12,033 | ' | ' |
Operating expenses weighted average period | '2 years 9 months 11 days | ' | ' |
Shares subject to outstanding common stock options granted | 7,113,000 | ' | ' |
Weighted average contractual term for options outstanding | '8 years 1 month 2 days | '7 years 10 months 13 days | '7 years 6 months 22 days |
Weighted average contractual term for options exercisable | '6 years 9 months 4 days | '7 years 4 months 17 days | '6 years 10 months 13 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | 30,537 | 2,288 | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | 16,376 | 1,394 | ' |
Aggregate Intrinsic Value Of Stock Options Exercisable | $890 | $18 | ' |
Issuance of common stock in connection with employee stock purchase plan, shares | 243,510 | ' | ' |
Minimum [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Average vesting term | '4 years | ' | ' |
Maximum [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Average vesting term | '6 years | ' | ' |
2007 Incentive Plan [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Shares of common stock reserved for issuance | 16,500,000 | ' | ' |
Shares subject to outstanding common stock options granted | 13,159,000 | ' | ' |
Shares available for future grants | 1,927,000 | ' | ' |
Vesting periods of options granted | '4 years | ' | ' |
Options expire from date of grant | '10 years | ' | ' |
Employee Stock Purchase Plan [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Shares of common stock reserved for issuance | 756,490 | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Percentage Earning Of Participants | ' | 15.00% | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | ' | 85.00% | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 250,000 | ' | ' |
Percentage Increase In Number Of Shares Available For Future Issuance Under Stock Based Awards | 1.00% | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Issued | 1,000,000 | ' | ' |
Restricted Stock Units (RSUs) [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Equity instrument granted | 0 | 0 | 220,729 |
Intrinsic value of equity instrument | ' | ' | 256,000 |
Stock_Based_Compensation_Stock
Stock Based Compensation (Stock Option Activity) (Detail) (USD $) | 12 Months Ended |
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ' |
Total Number of Shares, outstanding Beginning Balance | 7,672 |
Stock options activity, Total Number of Shares, Granted | 7,113 |
Stock options activity, Total Number of Shares, Exercised | -289 |
Stock options activity, Total Number of Shares, Cancelled | -1,337 |
Total Number of Shares, outstanding Ending Balance | 13,159 |
Total Number of Shares, exercisable | 6,557 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | ' |
Stock options activity, Weighted Average Exercise Price, Beginning balance | $2.54 |
Stock options activity, Weighted Average Exercise Price, Granted | $2.87 |
Stock options activity, Weighted Average Exercise Price, Exercised | $1.21 |
Stock options activity, Weighted Average Exercise Price, Cancelled | $2.80 |
Stock options activity, Weighted Average Exercise Price, Ending balance | $2.73 |
Stock options activity, Weighted Average Exercise Price, exercisable | $2.63 |
Stock options activity, Aggregate Intrinsic Value, Beginning balance | $2,288 |
Stock options activity, Aggregate Intrinsic Value, Ending balance | $30,537 |
Other_Income_Expense_Schedule_
Other Income (Expense) (Schedule of Other Income (Expense)) (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Other Income and Expenses [Abstract] | ' | ' | ' |
Change in fair value of warrants potentially settleable in cash | ($44,001) | ($10,775) | $8,986 |
Realized gain on sale of marketable securities | 3,911 | 0 | 0 |
Change in fair value of the contingent purchase price liability | -926 | -2,370 | 109 |
Miscellaneous other income | 37 | 0 | -9 |
Total other income (expense) | ($40,979) | ($13,145) | $9,086 |
Net_Loss_Per_Share_Common_Shar
Net Loss Per Share (Common Shares Excluded from Net Loss) (Detail) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Shares of common stock issuable upon the exercise which were excluded from the computation of diluted earnings per share | 28,009 | 20,888 |
Warrants to purchase common stock [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Shares of common stock issuable upon the exercise which were excluded from the computation of diluted earnings per share | 14,850 | 13,216 |
Options to purchase common stock [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Shares of common stock issuable upon the exercise which were excluded from the computation of diluted earnings per share | 13,159 | 7,672 |
Income_Taxes_Components_of_Fed
Income Taxes (Components of Federal and State Income Tax Expense (Benefit)) (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Current | ' | ' | ' |
Federal | $0 | $0 | ' |
State | 0 | 0 | ' |
Total current | 0 | 0 | ' |
Deferred | ' | ' | ' |
Federal | 894 | -894 | ' |
State | 158 | -158 | ' |
Total deferred | 1,052 | -1,052 | ' |
Total income tax expense (benefit) | $1,052 | ($1,052) | ' |
Income_Taxes_Components_of_Net
Income Taxes (Components of Net Deferred Tax Assets) (Detail) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Income Tax Disclosure [Abstract] | ' | ' |
Net operating loss carryforwards | $33,539 | $23,632 |
Tax credit carryforwards | 3,549 | 3,201 |
Unrealized gain on marketable securities | 0 | -1,052 |
Stock based compensation | 8,322 | 7,944 |
Other | 12 | -328 |
Licensing deduction deferral | 8,682 | 8,194 |
Gross deferred tax assets | 54,104 | 41,591 |
Valuation allowance | -54,104 | -41,591 |
Net deferred tax asset | $0 | $0 |
Income_Taxes_Components_of_Net1
Income Taxes (Components of Net Deferred Tax Liabilities) (Detail) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Income Tax Disclosure [Abstract] | ' | ' |
In-process research and development not subject to future amortization for tax purposes | $5,053 | $5,053 |
Gross deferred tax liability | $5,053 | $5,053 |
Income_Taxes_Schedule_of_Provi
Income Taxes (Schedule of Provision Computed by Applying Federal Statutory Rate) (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Income Tax Disclosure [Abstract] | ' | ' | ' |
Expected federal income tax benefit | ($25,713) | ($11,688) | ' |
State income taxes after credits | -3,676 | -1,067 | ' |
Unrealized gain on marketable securities | 1,052 | -1,052 | ' |
Changes in warrant value | 17,283 | 3,664 | ' |
Stock compensation | 813 | 152 | ' |
Effect of change in valuation allowance | 11,408 | 8,939 | ' |
Income tax credits | -240 | 0 | ' |
Other | 125 | 0 | ' |
Total income tax expense (benefit) | $1,052 | ($1,052) | ' |
Income_Taxes_Additional_Inform
Income Taxes (Additional Information) (Detail) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Tax Credit Carryforward [Line Items] | ' | ' |
Federal operating loss carryforwards | $83,900,000 | ' |
State operating loss carryforwards | 49,800,000 | ' |
Operating loss carryforwards, exercise of stock options | 280,000 | ' |
Decrease in deferred tax assets | 109,000 | ' |
Deferred income tax valuation | ' | 100.00% |
Increase in valuation allowance | 12,500,000 | 5,100,000 |
Domestic Tax Authority [Member] | ' | ' |
Tax Credit Carryforward [Line Items] | ' | ' |
Research and development tax credit carryforwards | 2,200,000 | ' |
State and Local Jurisdiction [Member] | ' | ' |
Tax Credit Carryforward [Line Items] | ' | ' |
Research and development tax credit carryforwards | $2,000,000 | ' |
License_Agreements_Additional_
License Agreements (Additional Information) (Detail) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended | 0 Months Ended | |||||
Apr. 13, 2011 | Mar. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2013 | Mar. 31, 2013 | Dec. 31, 2013 | Jan. 13, 2014 | |
Orexo [Member] | Orexo [Member] | M D Anderson Cancer Center [Member] | Subsequent Event [Member] | ||||||
Mills Pharmaceuticals LLC [Member] | |||||||||
License And Collaboration Agreements [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Annual maintenance fee | ' | ' | ' | ' | ' | ' | ' | $200,000 | ' |
Milestone payment for Phase 3 | ' | ' | ' | ' | ' | ' | ' | 200,000 | ' |
Cash paid for acquisition of Abstral rights | ' | 10,000,000 | 15,143,000 | ' | ' | ' | ' | ' | ' |
Remaining cash held of Abstral rights | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' |
Estimated year of licensed patents expiration | ' | ' | ' | ' | ' | '2019 | ' | ' | ' |
Upfront cash payment | ' | ' | ' | ' | ' | ' | ' | ' | 2,000,000 |
One-time payment of share upon achievement of regulatory milestones | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | 4,000,000 |
Contingent payment upon FDA approval | ' | ' | ' | ' | ' | ' | ' | ' | $3,000,000 |
Significant_Customers_and_Conc1
Significant Customers and Concentration of Credit Risk (Details) | 3 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | |
customers | Sales Revenue, Product Line [Member] | Product Shipments [Member] | Product Shipments [Member] | Product Shipments [Member] | Accounts Receivable [Member] | Accounts Receivable [Member] | Accounts Receivable [Member] | |
products | Customer A [Member] | Customer B [Member] | Customer C [Member] | Customer A [Member] | Customer B [Member] | Customer C [Member] | ||
dosing_strength | ||||||||
Concentration Risk [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Number of commercial products | 1 | ' | ' | ' | ' | ' | ' | ' |
Number of dosing strengths | 6 | ' | ' | ' | ' | ' | ' | ' |
Number of major customers | 3 | ' | ' | ' | ' | ' | ' | ' |
Concentration risk percentage | ' | 10.00% | 34.00% | 26.00% | 25.00% | 54.00% | 11.00% | 25.00% |
Related_Party_Transactions_Det
Related Party Transactions (Details) (Troy Gould Pc [Member], USD $) | Dec. 31, 2013 | Dec. 31, 2013 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | Professional Fees [Member] | Services Related to IPO [Member] | |
Related Party Transaction [Line Items] | ' | ' | ' |
Related party expenses | ' | $577 | $100 |
Due to related party | $177 | ' | ' |
Employee_Benefit_Plan_Details
Employee Benefit Plan (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Compensation and Retirement Disclosure [Abstract] | ' | ' | ' |
Employer contribution | $35,000 | $0 | $0 |
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 |
Quarterly Financial Information Disclosure [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net revenue | $1,317 | $1,170 | $0 | $0 | $0 | $0 | $0 | $0 | $2,487 | $0 | $0 |
Gross profit on net revenue | 967 | 869 | 0 | 0 | 0 | 0 | 0 | 0 | ' | ' | ' |
Net loss | ($48,501) | ($9,287) | ($9,597) | ($9,293) | ($3,751) | ($6,261) | ($196) | ($24,761) | ($76,678) | ($34,969) | ($11,485) |
Net loss per share (usd per share) | ($0.46) | ($0.11) | ($0.11) | ($0.11) | ($0.05) | ($0.09) | $0 | ($0.52) | ' | ' | ' |
Subsequent_Events_Details
Subsequent Events - (Details) (USD $) | 12 Months Ended | 3 Months Ended | ||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Mar. 14, 2014 | Mar. 14, 2014 | Mar. 14, 2014 |
Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | ||||
Common Stock [Member] | Common Stock [Member] | |||||
Subsequent Event [Line Items] | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of warrants, shares | ' | ' | ' | ' | 5,072,900 | ' |
Warrants exercised | 5,402,000 | 8,883,000 | ' | ' | ' | 5,095,616 |
Proceeds from warrant exercises | ' | ' | ' | ' | ' | $9,371 |
Warrants outstanding | 14,850,000 | 13,216,000 | 14,121,000 | ' | ' | 9,753,815 |
Issuance of common stock in connection with employee stock purchase plan, shares | 243,510 | ' | ' | ' | 3,158,338 | ' |
Exercise of stock options, shares | 289,000 | ' | ' | 3,182,764 | ' | ' |
Net proceeds from exercise of stock options | $567 | $21 | ' | $3,889 | ' | ' |
Options outstanding, shares | 13,159,000 | 7,672,000 | ' | 9,335,403 | ' | ' |