Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | May. 05, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | AVEO | |
Entity Registrant Name | AVEO PHARMACEUTICALS INC | |
Entity Central Index Key | 1,325,879 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 58,181,715 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 18,056 | $ 26,634 |
Marketable securities | 5,749 | 7,501 |
Restricted cash | 4,000 | |
Accounts receivable | 1,736 | 4,641 |
Prepaid expenses and other current assets | 1,123 | 1,600 |
Total current assets | 30,664 | 40,376 |
Property and equipment, net | 18 | 23 |
Other assets | 124 | 143 |
Total assets | 30,806 | 40,542 |
Current liabilities: | ||
Accounts payable | 340 | 1,425 |
Accrued expenses | 2,843 | 4,106 |
Loans payable, net of discount | 3,019 | 2,053 |
Deferred revenue | 660 | 814 |
Settlement liability (Note 11) | 4,000 | 4,000 |
Total current liabilities | 10,862 | 12,398 |
Loans payable, net of current portion and discount | 6,537 | 7,418 |
Deferred revenue | 2,832 | 2,881 |
Other liabilities | $ 660 | $ 618 |
Stockholders’ equity: | ||
Preferred stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding | ||
Common stock, $.001 par value: 200,000 shares authorized; 58,182 and 58,182 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | $ 58 | $ 58 |
Additional paid-in capital | 512,594 | 512,201 |
Accumulated other comprehensive income (loss) | 2 | (3) |
Accumulated deficit | (502,739) | (495,029) |
Total stockholders’ equity | 9,915 | 17,227 |
Total liabilities and stockholders’ equity | $ 30,806 | $ 40,542 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
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 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 58,182,000 | 58,182,000 |
Common stock, shares outstanding | 58,182,000 | 58,182,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Income Statement [Abstract] | ||
Collaboration and licensing revenue | $ 1,203 | $ 134 |
Operating expenses: | ||
Research and development | 5,972 | 2,695 |
General and administrative | 2,463 | 3,255 |
Restructuring and lease exit | 4,333 | |
Operating Expenses, Total | 8,435 | 10,283 |
Loss from operations | (7,232) | (10,149) |
Other income and expense: | ||
Other expense, net | (9) | (14) |
Interest expense | (386) | (716) |
Interest income | 17 | 5 |
Other expense, net | (378) | (725) |
Loss before provision for income taxes | (7,610) | (10,874) |
Provision for income taxes | (100) | |
Net loss | $ (7,710) | $ (10,874) |
Net loss per share ─ basic and diluted | $ (0.13) | $ (0.21) |
Weighted average number of common shares outstanding | 58,166 | 52,638 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (7,710) | $ (10,874) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on available-for-sale securities | 5 | |
Comprehensive loss | $ (7,705) | $ (10,874) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Operating activities | ||
Net loss | $ (7,710) | $ (10,874) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Impairment of property and equipment | 232 | |
Depreciation and amortization | 5 | 4,488 |
Accretion | 199 | |
Loss on disposal of fixed assets | (20) | |
Stock-based compensation | 390 | 427 |
Non-cash interest expense | 86 | 125 |
Amortization of premium and discount on investments | 3 | 14 |
Changes in operating assets and liabilities: | ||
Restricted cash | (4,000) | 37 |
Accounts receivable | 2,905 | 1,394 |
Prepaid expenses and other current assets | 492 | 337 |
Other noncurrent assets | 19 | 26 |
Accounts payable | (1,085) | (626) |
Accrued expenses | (1,263) | (2,900) |
Deferred revenue | (203) | (76) |
Lease exit obligation | (3,345) | |
Deferred rent | (5,200) | |
Other liabilities | 42 | (58) |
Net cash used in operating activities | (10,319) | (15,820) |
Investing activities | ||
Purchases of marketable securities | (5,746) | (6,048) |
Proceeds from maturities and sales of marketable securities | 7,500 | 1,500 |
Proceeds from sale of property and equipment | 928 | |
Net cash provided by (used in) investing activities | 1,754 | (3,620) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 4,353 | |
Proceeds from exercise of stock options and issuance of common and restricted stock | 2 | 73 |
Debt issuance costs | (15) | |
Principal payments on loans payable | (2,757) | |
Net cash (used by) provided by financing activities | (13) | 1,669 |
Net decrease in cash and cash equivalents | (8,578) | (17,771) |
Cash and cash equivalents at beginning of period | 26,634 | 52,306 |
Cash and cash equivalents at end of period | 18,056 | 34,535 |
Supplemental cash flow information | ||
Cash paid for interest | $ 301 | $ 617 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | (1) Organization AVEO Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company’s proprietary platform has delivered unique insights into cancer and related disease. The Company’s strategy is to leverage these biomarker insights and partner resources to advance the development of its clinical pipeline. The Company’s pipeline of product candidates includes tivozanib, a potent, selective, long half-life vascular endothelial growth factor tyrosine kinase inhibitor of all three vascular endothelial growth factors. In June 2013, the U.S. Food and Drug Administration issued a complete response letter denying the Company’s application for approval of the use of tivozanib in first-line treatment of advanced renal cell carcinoma (“RCC”), citing concerns regarding the negative trend in overall survival in the Company’s pivotal phase 3 trial. Subject to the availability of sufficient financial resources, the Company is planning to conduct a second phase 3 trial of tivozanib in the third-line treatment of patients with refractory RCC in order to address the overall survival concerns presented in the June 2013 complete response letter from the FDA and to support a request for regulatory approval of tivozanib in the United States as a third-line treatment and as a first-line treatment. The Company is also planning to conduct a phase 1/2 trial of tivozanib in combination with an immune checkpoint (PD-1) inhibitor for the treatment of RCC. The Company is evaluating all options for funding, including partnerships, for the clinical and regulatory advancement of tivozanib as a single agent and in combination. I The Company also has a pipeline of monoclonal antibodies, including: (i) Ficlatuzumab, a potent anti-HFG antibody that inhibits the activity of the HGF/c-Met pathway and for which the Company has completed a phase 2 clinical trial and has entered into a partnership with Biodesix, Inc. (“Biodesix”) to advance clinical development; (ii) AV-203, a potent, high affinity inhibitor of ErbB3 function that has demonstrated anti-tumor activity in multiple preclinical models and for which the Company has completed a phase 1 dose escalation trial and has entered into a partnership with CANbridge Life Sciences Ltd. (“CANbridge”) to advance clinical development; (iii) AV-380, a potent humanized IgG1 inhibitory monoclonal antibody targeting growth differentiating factor-15, or GDF15, a divergent member of the TGF-ß family, for the potential treatment or prevention of cachexia, which the Company has licensed to Novartis International Pharmaceutical Ltd. (“Novartis”); and (iv) AV-353, a potent inhibitory antibody specific to Notch 3, which has demonstrated an ability in preclinical models to potentially reverse disease phenotype for pulmonary arterial hypertension (“PAH”), and for which the Company is currently seeking a partner to advance development in PAH. As used throughout these condensed consolidated financial statements, the terms “AVEO,” and the “Company” refer to the business of AVEO Pharmaceuticals, Inc. and its two wholly-owned subsidiaries, AVEO Pharma Limited and AVEO Securities Corporation. The Company has devoted substantially all of its resources to its drug discovery efforts, comprising research and development, conducting clinical trials for its product candidates, protecting its intellectual property and general and administrative functions relating to these operations. The Company has an accumulated deficit as of March 31, 2016 of approximately $502.7 million, and is subject to a number of risks including the need for substantial additional capital for research and product development. The Company will need additional funding to support its planned operating activities, and the timing and nature of activities contemplated for 2016 and thereafter will be conducted subject to the availability of sufficient financial resources. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | (2) Basis of Presentation These condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, AVEO Pharma Limited and AVEO Securities Corporation. The Company has eliminated all significant intercompany accounts and transactions in consolidation. The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results for the three months ended March 31, 2016 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2016 or any other future period. The information presented in the condensed consolidated financial statements and related footnotes at March 31, 2016, and for the three months ended March 31, 2016 and 2015, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes as of December 31, 2015 have been derived from the Company’s audited financial statements. For further information, refer to the consolidated financial statements and accompanying footnotes included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2015, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2016. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | (3) Significant Accounting Policies Revenue Recognition The Company’s revenues are generated primarily through collaborative research, development and commercialization agreements. The terms of these agreements generally contain multiple elements, or deliverables, which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii) research and development activities to be performed on behalf of the collaborative partner, and (iii) in certain cases, services in connection with the manufacturing of pre-clinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, up-front license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. When evaluating multiple element arrangements, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company typically uses best estimate of selling price to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes best estimate of selling price to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements and internally developed models that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s best estimate of selling price, the Company evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration among multiple deliverables. The Company typically receives non-refundable, up-front payments when licensing its intellectual property in conjunction with a research and development agreement. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s research and development obligations. If management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until management can reasonably estimate when the performance obligation ends. When management believes the license to its intellectual property has stand-alone value, the Company generally recognizes revenue attributed to the license upon delivery. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts for those arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheets. At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company aggregates its milestones into four categories: (i) clinical and development milestones, (ii) regulatory milestones, (iii) commercial milestones, and (iv) patent-related milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase. For example, a milestone payment may be due to the Company upon the initiation of a phase 3 clinical trial for a new indication, which is the last phase of clinical development and could eventually contribute to marketing approval by the U.S. Food and Drug Administration (“FDA”) or other global regulatory authorities. Regulatory milestones are typically achieved upon acceptance of the submission for marketing approval of a product candidate or upon approval to market the product candidate by the FDA or other global regulatory authorities. For example, a milestone payment may be due to the Company upon the FDA’s acceptance of a New Drug Application (“NDA”). Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Patent-related milestones are typically achieved when a patent application is filed or a patent is issued with respect to certain intellectual property related to the applicable collaboration. Revenues from clinical and development, regulatory, and patent-related milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, are recognized upon successful accomplishment of the milestones. The Company has concluded that the clinical and development, regulatory and patent-related milestones pursuant to its current research and development arrangements are substantive. Milestones that are not considered substantive are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including personnel-related costs such as salaries and stock-based compensation, facilities, research-related overhead, clinical trial costs, manufacturing costs and costs of other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received. Cash and Cash Equivalents The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents at March 31, 2016 consisted of money market funds and corporate debt securities maintained by an investment manager totaling $9.1 million. Cash equivalents at December 31, 2015 consisted of money market funds, U.S. government agency securities and corporate debt securities, including commercial paper, maintained by an investment manager totaling $16.3 million. The carrying values of the Company’s cash equivalent securities approximate fair value due to their short term maturities. Marketable Securities Marketable securities at March 31, 2016 consisted of U.S. government agency securities and corporate debt securities, including commercial paper, maintained by an investment manager. Marketable securities at December 31, 2015 consisted of government agency and corporate debt securities, including commercial paper, maintained by an investment manager. Credit risk is reduced as a result of the Company’s policy to limit the amount invested in any one issuance. Marketable securities consist primarily of investments which have expected average maturity dates in excess of three months, but not longer than 24 months. The Company classifies these investments as available-for-sale. Unrealized gains and losses are included in other comprehensive loss until realized. The cost of securities sold is based on the specific identification method. There were no realized gains or losses recognized on the sale or maturity of marketable securities during the three months ended March 31, 2016 and 2015. Available-for-sale securities at March 31, 2016 and December 31, 2015 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value (in thousands) March 31, 2016: Corporate debt securities (Due within 1 year) $ 4,748 $ 2 $ — $ 4,750 Government agency securities (Due within 1 year) 999 — — 999 $ 5,747 $ 2 $ — $ 5,749 December 31, 2015: Corporate debt securities (Due within 1 year) $ 6,504 $ — $ (3 ) $ 6,501 Government agency securities (Due within 1 year) 1,000 — — 1,000 $ 7,504 $ — $ (3 ) $ 7,501 The aggregate unrealized loss for the Company’s corporate debt securities was less than $1,000 as of March 31, 2016. Marketable securities in an unrealized loss position at December 31, 2015 consisted of the following: Aggregate Fair Value Unrealized Losses (in thousands) Corporate debt securities (Due within 1 year) $ 4,100 $ (3 ) Government agency securities (Due within 1 year) 1,000 — $ 5,100 $ (3 ) Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk related to cash deposits due to the financial position of the depository institutions in which those deposits are held. The Company’s credit risk related to marketable securities is reduced as a result of the Company’s policy to limit the amount invested in any one issuance. The Company’s accounts receivable primarily consist of amounts due to the Company from licensees and collaborators. As of March 31, 2016, the Company had $1.7 million of receivables outstanding, including $0.9 million due from CANbridge pursuant to the Company’s licensing arrangement for AV-203 (refer to Note 7), $0.7 million due from Biodesix pursuant to the Company’s collaboration arrangement for AV-299 (refer to Note 7) and $0.2 million due from Astellas pursuant to the Company’s former collaboration arrangement for tivozanib. The Company has not experienced any material losses related to receivables from individual licensees or collaborators. Fair Value Measurements The Company records cash equivalents and marketable securities at fair value. The accounting standards for fair value measurements establish a hierarchy that distinguishes between fair value measurements based on market data (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels: · Level 1—Quoted market prices in active markets for identical assets or liabilities. Assets that are valued utilizing only Level 1 inputs include money market funds. · Level 2—Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Assets that are valued utilizing Level 2 inputs include U.S. government agency securities and corporate bonds, including commercial paper. These investments have been initially valued at the transaction price and are subsequently valued, at the end of each reporting period, utilizing third party pricing services or other observable market data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, and other industry and economic events. The Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by pricing services as of March 31, 2016. · Level 3—Unobservable inputs developed using estimates and assumptions developed by the Company, which reflect those that a market participant would use. The Company currently has no assets or liabilities measured at fair value on a recurring basis that utilize Level 3 inputs. The following tables summarize the cash equivalents and marketable securities measured at fair value on a recurring basis in the accompanying condensed consolidated balance sheets as of March 31, 2016 and December 31, 2015. Fair Value Measurements of Cash Equivalents and Marketable Securities as of March 31, 2016 Level 1 Level 2 Level 3 Total (in thousands) Cash equivalents $ 6,907 $ 2,143 $ — $ 9,050 Marketable securities — 5,749 — 5,749 $ 6,907 $ 7,892 $ — $ 14,799 Fair Value Measurements of Cash Equivalents and Marketable Securities as of December 31, 2015 Level 1 Level 2 Level 3 Total (in thousands) Cash equivalents $ 11,462 $ 4,812 $ — $ 16,274 Marketable securities — 7,501 — 7,501 $ 11,462 $ 12,313 $ — $ 23,775 The fair value of the Company’s loans payable at March 31, 2016, computed pursuant to a discounted cash flow technique using a market interest rate, was $10.1 million and is considered a Level 3 fair value measurement. The effective interest rate, which reflects the current market rate, considers the fair value of the warrant issued in connection with the loan, loan issuance costs and the deferred financing charge. Property and Equipment Property and equipment are stated at cost and are depreciated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repair costs are charged to expense as incurred. Long-lived Assets The Company reviews long-lived assets, including property and equipment, for impairment whenever changes in business circumstances indicate that the carrying amount of the asset may not be fully recoverable. No impairment charges were recognized during the three months ended March 31, 2016. The Company recognized $0.2 million of impairment losses for the three months ended March 31, 2015 related to leasehold improvements. Basic and Diluted Loss per Common Share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted loss per share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares and dilutive common share equivalents then outstanding which excludes unvested restricted stock. Potential common share equivalents consist of the incremental common shares issuable upon the exercise of stock options and warrants. Since the Company had a net loss for all periods presented, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per common share is the same. The following table sets forth the potential common shares excluded from the calculation of net loss per common share-diluted for the three months ended March 31, 2016 and 2015 because their inclusion would have been anti-dilutive: Outstanding at March 31, 2016 2015 (in thousands) Options outstanding 5,584 5,861 Warrants outstanding 609 609 6,193 6,470 Stock-Based Compensation Under the Company’s stock-based compensation programs, the Company periodically grants stock options and restricted stock to employees, directors and nonemployee consultants. The Company also issues shares under an employee stock purchase plan. The fair value of all awards is recognized in the Company’s statements of operations over the requisite service period for each award. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period. Other awards, such as performance-based awards that vest upon the achievement of specified goals, are expensed using the accelerated attribution method if achievement of the specified goals is considered probable. The Company has also granted awards that vest upon the achievement of market conditions. Per Accounting Standards Codification (“ASC”) 718 Share-Based Payments, The fair value of equity-classified awards to employees and directors are measured at fair value on the date the awards are granted. Awards to nonemployee consultants are recorded at their fair values and are re-measured as of each balance sheet date until the recipient’s services are complete. During the three months ended March 31, 2016 and 2015, the Company recorded the following stock-based compensation expense: Three Months Ended March 31, 2016 2015 (in thousands) Research and development $ 125 $ 125 General and administrative 265 233 Restructuring ─ 69 $ 390 $ 427 Stock-based compensation expense is allocated to research and development and general and administrative expense based upon the department of the employee to whom each award was granted. Expenses recognized in connection with the modification of awards in connection with the Company’s strategic restructurings are allocated to restructuring expense. No related tax benefits of the stock-based compensation expense have been recognized. Income Taxes The Company provides for income taxes using the asset-liability method. Under this method, deferred tax assets and liabilities are recognized based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company calculates its provision for income taxes on ordinary income based on its projected annual tax rate for the year. Uncertain tax positions are recognized if the position is more-likely-than-not to be sustained upon examination by a tax authority. Unrecognized tax benefits represent tax positions for which reserves have been established. As of March 31, 2016, the Company is forecasting a net loss for the year ended December 31, 2016. The Company maintains a full valuation allowance on all deferred tax assets. For the three months ended March 31, 2016, the Company recorded a $0.1 million provision for income taxes related to withholding taxes incurred in a foreign jurisdiction. Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment principally in the United States. As of March 31, 2016, the Company has $0.9 million of net assets located in the United Kingdom. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires the Company’s management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Recent Accounting Pronouncements For a discussion of recent accounting pronouncements adopted by the Company, please refer to Note 2, “Significant Accounting Policies,” included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed with the SEC on March 15, 2016. The Company did not adopt any new accounting pronouncements during the three months ended March 31, 2016 that had a material effect on the Company’s condensed consolidated financial statements. In May 2014, the Financial Accounting Standards Board (“FASB”) issued a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance under US GAAP. The standard was originally scheduled to be effective for public entities for annual and interim periods beginning after December 15, 2016. In July 2015, the standard was deferred and will now be effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for annual and interim periods beginning after December 15, 2016. The Company is currently evaluating the effect this standard will have on its revenue recognition policies and its financial statements, including how the standard will be adopted. In August 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. In March 2016, the FASB issued ASU No. 2016-09, Compensation─Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Collaborations and License Agre
Collaborations and License Agreements | 3 Months Ended |
Mar. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborations and License Agreements | (4) Collaborations and License Agreements CANbridge In March 2016, the Company entered into a collaboration and license agreement with CANbridge Life Sciences Ltd. (“CANbridge”). Under the terms of the license agreement, the Company granted CANbridge the exclusive right to develop, manufacture and commercialize AV-203, the Company’s proprietary ErbB3 (HER3) inhibitory antibody, for the diagnosis, treatment and prevention of disease in humans and animals in all countries other than the United States, Canada and Mexico (the “Licensed Territory”). Under the terms of the license agreement, if the Company determines to grant a license to any ErbB3 inhibitory antibody in the United States, Canada or Mexico, the Company is obligated to first negotiate with CANbridge for the grant to CANbridge of a license to such rights. In addition, for a period of time following the completion of certain proof-of-concept clinical studies by CANbridge involving the use of AV-203 for the treatment of squamous cell esophagus cancer, the Company has agreed to negotiate exclusively with CANbridge for (a) the right to co-develop ErbB3 inhibitory antibody products for the treatment of squamous cell esophagus cancer or (b) the right to include the United States, Canada and Mexico as part of the Licensed Territory under the license agreement. The effective date of the license agreement is March 16, 2016 (the “Effective Date”). CANbridge made an upfront payment to the Company of $1.0 million in April 2016. This amount was included in accounts receivable on the Company’s balance sheet as of March 31, 2016 net of $0.1 million of withholding taxes. CANbridge has agreed to reimburse the Company $1.0 million for certain manufacturing costs and expenses previously incurred by the Company with respect to AV-203, $0.5 million of which will be due to the Company on the earlier of (i) the date of validation by CANbridge of certain manufacturing development activities conducted by the Company prior to the Effective Date or (ii) twelve months from the Effective Date, and the remaining $0.5 million of which will be due to the Company on the earlier of (i) the date of validation by CANbridge of such manufacturing development activities or (ii) eighteen months from the Effective Date. The Company is also eligible to receive up to $42.0 million in potential development and regulatory milestone payments and up to $90.0 million in potential sales based milestone payments based on annual net sales of licensed products. Upon commercialization, the Company is eligible to receive a tiered royalty, with a percentage range in the low double digits, on net sales of approved licensed products. CANbridge’s obligation to pay royalties for each licensed product expires on a country-by-country basis on the later of the expiration of patent rights covering such licensed product in such country, the expiration of regulatory data exclusivity in such country and ten years after the first commercial sale of such licensed product in such country. CANbridge is obligated to use commercially reasonable efforts to develop and commercialize AV-203 in each of China, Japan, the United Kingdom, France, Italy, Spain, and Germany. CANbridge has responsibility for all activities and costs associated with the further development, manufacture, regulatory filings and commercialization of AV-203 in the Licensed Territory. The term of the license agreement commenced on the Effective Date and will continue until the last to expire royalty term applicable to licensed products. Either party may terminate the license agreement in the event of a material breach by the other party that remains uncured for a period of 45 days, in the case of a material breach of a payment obligation, and 90 days in the case of any other material breach. CANbridge may terminate the license agreement without cause at any time upon 180 days’ prior written notice to the Company. The Company may terminate the license agreement upon thirty days’ prior written notice if CANbridge challenges any of the patent rights licensed to CANbridge under the license agreement. The Company and CANbridge have each agreed to not directly or indirectly develop or commercialize any ErbB3 inhibitory antibody product during the term of the license agreement other than pursuant to the license agreement. A percentage of any milestone and royalty payments received by the Company, excluding upfront and reimbursement payments, are due to Biogen Idec International GMBH (“Biogen”) as a sublicensing fee under the option and license agreement between the Company and Biogen dated March 18, 2009, as amended. Activities under the agreement were evaluated under ASC 605-25 Revenue Recognition—Multiple Element Arrangements The agreement with CANbridge includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive license to develop and commercialize AV-203 in the licensed territories, (ii) the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of AV-203 and (iii) the Company’s obligation to participate on a joint steering committee during the proof-of-concept development period. The relative selling price of the Company’s joint steering committee participation had de minimis value. The Company determined that the delivered license and know-how did have stand-alone value from the undelivered element and have accounted for these items as separate deliverables. The Company allocated the up-front consideration of $1.0 million to the units of accounting and recognized the $1.0 million attributed to the delivered license and know-how during the three months ended March 31, 2016. The Company believes the regulatory milestones that may be achieved under the license agreement are consistent with the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and, accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when each such milestone is achieved. Factors considered in this determination included scientific and regulatory risks that must be overcome to achieve each milestone, the level of effort and investment required to achieve each milestone, and the monetary value attributed to each milestone. EUSA In December 2015, the Company entered into a license agreement with EUSA Pharma (UK) Limited (“EUSA”) Under the license agreement, EUSA made a research and development funding payment to the Company of $2.5 million during the year ended December 31, 2015. EUSA is required to make a further research and development funding payment of $4.0 million upon the grant by the European Medicines Agency (“EMA”) of marketing approval for tivozanib for treatment of RCC. The Company is eligible to receive additional research funding from EUSA, including up to $20.0 million if the Company conducts a phase 3 study in third-line RCC and EUSA elects to utilize data generated by the study, and up to $2.0 million for a potential phase 1 combination study with a checkpoint inhibitor. The Company will be entitled to receive milestone payments of $2.0 million per country upon reimbursement approval for RCC in each of France, Germany, Italy, Spain and the United Kingdom, and an additional $2.0 million for the grant of marketing approval in three of the following five countries: Argentina, Australia, Brazil, South Africa and Venezuela. The Company is also eligible to receive a payment of $2.0 million in connection with EUSA’s filing with the EMA for marketing approval for tivozanib for the treatment of each of up to three additional indications and $5.0 million per indication in connection with the EMA’s grant of marketing approval for each of up to three additional indications, as well as potentially up to $335.0 million upon EUSA’s achievement of certain sales thresholds. The Company is also eligible to receive tiered double digit royalties on net sales, if any, of licensed products in the Licensed Territories ranging from a low double digit up to mid-twenty percent depending on the level of annual net sales. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin Co., Ltd. (formerly Kirin Brewery Co., Ltd.) (“KHK”) as a sublicensing fee under the license agreement between AVEO and KHK dated as of December 21, 2006 , pursuant to which the Company acquired exclusive rights to develop and commercialize tivozanib for all human diseases outside of Asia (the “KHK License Agreement”). The research and development funding payments under the EUSA license agreement are not subject to sublicensing payment to KHK. EUSA is obligated to use commercially reasonable efforts to develop and commercialize tivozanib throughout the Licensed Territories. With the exception of certain support to be provided by the Company in connection with the application for marketing approval by the EMA, EUSA has responsibility for all activities and costs associated with the further development, manufacture, regulatory filings and commercialization of tivozanib in the Licensed Territories. Activities under the agreement were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with EUSA includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive license to develop and commercialize the tivozanib in the licensed territories; (ii) the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of tivozanib; (iii) the Company’s obligation to cooperate with EUSA and support its efforts to file for marketing approval in the licensed territories, (iv) the Company’s obligation to provide access to certain regulatory information resulting from the Company’s ongoing development activities outside of the licensed territories and (v) the Company’s participation in a joint steering committee. The Company determined that the delivered license did not have stand-alone value from the undelivered elements and have accounted for these items as a single bundled deliverable. The Company allocated up-front consideration of $2.5 million to the bundled unit of accounting and is recognizing it over the Company’s performance period through April 2022, the remaining patent life of tivozanib. The Company recognized approximately $0.1 million as revenue during the three months ended March 31, 2016. The Company believes the regulatory milestones that may be achieved under the EUSA agreement are consistent with the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and, accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when each such milestone is achieved. Factors considered in this determination included scientific and regulatory risks that must be overcome to achieve each milestone, the level of effort and investment required to achieve each milestone, and the monetary value attributed to each milestone. No milestone payments have been earned as of March 31, 2016. Novartis In August 2015, the Company entered into a license agreement with Novartis. Under the license agreement, the Company has granted to Novartis the exclusive right to develop and commercialize worldwide the Company’s proprietary antibody AV-380 and related AVEO antibodies that bind to Growth Differentiation Factor 15 (“GDF15”) for the treatment and prevention of diseases and other conditions in all indications in humans (the “Product”). Pursuant to the license agreement, Novartis made an upfront payment to the Company of $15.0 million within fifteen days of the effective date. Novartis also has acquired the Company’s inventory of clinical quality, AV-380 biological drug substance and reimbursed the Company for approximately $3.5 million for such existing inventory. The Company is also eligible to receive (a) up to $53.0 million in potential clinical and development milestone payments and up to $105.0 million in potential regulatory milestone payments tied to the commencement of clinical trials and to regulatory approvals of products developed under the license agreement in the United States, the European Union and Japan; and (b) up to $150.0 million in potential commercial milestone payments based on annual net sales of such products. Upon commercialization, the Company is eligible to receive tiered royalties on net sales of approved products ranging from the high single digits to the low double digits. Novartis has responsibility under the license agreement for the development, manufacture and commercialization of the Company’s antibodies and any resulting approved therapeutic products. The Company has agreed that it will not directly or indirectly develop, manufacture or commercialize any GDF15 modulator as a human therapeutic during the term of the license agreement. Activities under the agreement with Novartis were evaluated under ASC 605-25, to determine whether such activities represented a multiple element revenue arrangement. The agreement with Novartis includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive, worldwide license to develop and commercialize the Product; (ii) the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of the Product; and (iii) the Company’s obligation to cooperate with Novartis’ requests for transition assistance during a 90 day period. The Company determined that the option to purchase the Company’s existing inventory was a contingent deliverable. The Company determined the delivered license and obligation to transfer technical knowledge and data have standalone value from the undelivered cooperation. The Company allocated up-front consideration of $15.0 million to the delivered license and technical knowledge and recognized this amount as revenue during the year ended December 31, 2015. The relative selling price of the undelivered cooperation had de minimis The Company received a cash payment of $3.5 million related to the delivery of its inventory of clinical quality drug substance to Novartis during the three months ended March 31, 2016. No amounts were due to the Company from Novartis as of March 31, 2016. Pharmstandard In August 2015, the Company entered into a license agreement with JSC “Pharmstandard-Ufimskiy Vitamin Plant,” a company registered under the laws of the Russian Federation (“Pharmstandard”). Pharmstandard is a subsidiary of Pharmstandard OJSC. Under the license agreement, the Company has granted to Pharmstandard the exclusive, sublicensable right to develop, manufacture and commercialize tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (the “Licensed Territories”) for all diseases and conditions in humans, excluding non-oncologic ocular conditions. Pharmstandard is obligated to use commercially reasonable efforts to develop and commercialize tivozanib throughout the Licensed Territories, and Pharmstandard has responsibility for all activities and costs associated with the further development, manufacture, regulatory filings and commercialization of tivozanib in the Licensed Territories. Pharmstandard filed an application for marketing authorization in Russia for tivozanib for the treatment of renal cell carcinoma in December 2015. Under the license agreement, Pharmstandard is required to make an upfront payment to AVEO of $1.5 million, of which $1.0 million was paid during the year ended December 31, 2015 and $0.5 million is payable within fifteen business days of the date the license agreement is registered with the Federal Service for Intellectual Property of the Russian Federation. The Company is also eligible to receive $7.5 million in connection with the first marketing authorization of tivozanib in Russia. If Russian regulatory authorities require additional studies to be conducted by Pharmstandard prior to approval, this amount would be reduced to $3.0 million. In addition, the Company is eligible to receive $3.0 million for each additional approved indication of tivozanib, if Pharmstandard elects to seek any such approvals, as well as a high single-digit royalty on net sales in the Licensed Territories. A percentage of all upfront, milestone and royalty payments received by AVEO are due to KHK as a sublicensing fee under the KHK License Agreement. Pharmstandard has recently informed the Company that, based on adverse economic and financial conditions in Russia, they are seeking to renegotiate their obligation to make milestone payments to the Company under the license agreement. Activities under the agreement with Pharmstandard were evaluated under , upon request, to all clinical data, regulatory filings, safety data and manufacturing data to Pharmstandard for use in the development and commercialization of tivozanib in the Licensed Territories The Company determined the delivered license does not have standalone value from the undelivered items and that the arrangement should be treated as a single unit of accounting. The Company allocated the upfront payment of $1.0 million to the bundled unit of accounting and is recognizing it over the Company’s performance period through April 2022, the remaining patent life of tivozanib. The Company recognized approximately $38,000 as revenue during the three months ended March 31, 2016. The Company believes the regulatory milestones that may be achieved under the Pharmstandard agreement are consistent with the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and, accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when such milestone is achieved. Factors considered in this determination included scientific and regulatory risks that must be overcome to achieve each milestone, the level of effort and investment required to achieve each milestone, and the monetary value attributed to each milestone. Ophthotech Corporation In November 2014 the Company entered into a research and exclusive option agreement (the “Option Agreement”), with Ophthotech Corporation (“Ophthotech”) pursuant to which the Company provided Ophthotech an exclusive option to enter into a definitive license agreement whereby the Company would grant Ophthotech the right to develop and commercialize tivozanib outside of Asia for the potential diagnosis, prevention and treatment of non-oncologic diseases or conditions of the eye in humans. Pursuant to this Option Agreement, the Company granted to Ophthotech an exclusive, royalty-free license or sublicense, as applicable, under intellectual property rights controlled by the Company solely to perform the research and development activities related to the use of tivozanib for the specific purposes outlined in the agreement during the Option Period (as defined below). These activities include formulation work for ocular administration, preclinical research and the conduct of a phase 1/2a, proof of concept clinical trial of a product containing tivozanib in patients with wet age-related macular degeneration, (the “POC Study”). Ophthotech paid the Company $0.5 million in consideration for the grant of the option. Such amount is non-refundable and not creditable against any other amounts due under the agreement. The Company is obligated to make available to Ophthotech, at no cost to Ophthotech, certain quantities of tivozanib hydrochloride solely for conducting its Option Period research including manufacturing additional quantities of tivozanib in the event stability data indicates that the current supply will expire prior to the end of February 2017. During the Option Period, if Ophthotech elects to continue the development of tivozanib for non-oncologic diseases of the eye, the Company is entitled to receive a one-time milestone payment of $2.0 million upon acceptance of the first Investigational New Drug application for the purpose of conducting a human clinical study of tivozanib in ocular diseases (the “IND Submission Milestone Payment”). The Company is also entitled to receive a one-time milestone payment of $6.0 million (the “Clinical Efficacy Milestone Payment”), on the earlier of (a) December 31, 2016 and (b) the later to occur of: (i) the achievement of a clinical milestone in the POC Study (the “Clinical Efficacy Milestone”) and (ii) the earlier of (A) the date twelve (12) months after our and Ophthotech’s agreement as to the form and substance of the KHK Amendment (as defined below) or (B) the date ninety (90) days after the entry into the KHK Amendment, subject to the Company’s right to terminate the Option Agreement on 90 days’ written notice (the date on which such payment is due, referred to as the “Clinical Efficacy Milestone Payment Trigger Date”). Ophthotech may exercise the option at any time until the latest to occur of: (i) twelve (12) months after the achievement of the Clinical Efficacy Milestone, (ii) ninety (90) days after the Clinical Efficacy Milestone Payment Trigger Date, and (iii) thirty (30) days after the Company and Ophthotech agree as to the definitive form of license agreement (the “Option Period”). During the Option Period, the Company will not grant a license to any third party that would preclude the Company from being able to grant to Ophthotech the rights and licenses that are contemplated by the definitive license agreement, and the Company will not engage in any research, development or commercialization of tivozanib in the field covered by the contemplated definitive license agreement, except as specified in the Option Agreement. The terms of the Option Agreement are subject to the Company’s obligations to KHK under the KHK License Agreement. A percentage of all payments received by the Company under the Option Agreement and any definitive license agreement must be paid to KHK. The Company is required to maintain the KHK License Agreement in effect, and not enter into any amendment or termination thereof that would adversely affect the Company’s rights, during the option period. During the Option Period, the Company and Ophthotech are obligated to negotiate in good faith the form and substance of a definitive license agreement, as well as the form and substance of an amendment to the KHK License Agreement (the “KHK Amendment”) to modify certain rights and obligations of the parties and sublicensees thereunder, particularly with respect to rights to improvements that are not specifically related to tivozanib, and regulatory affairs matters. If Ophthotech exercises the option, Ophthotech is required to pay the Company a one-time option exercise fee of $2.0 million in addition to the IND Submission Milestone Payment if such payment has not then been previously paid. If upon exercise of the option, the Clinical Efficacy Milestone Payment Trigger Date has not yet occurred, the Company shall be entitled to the Clinical Efficacy Milestone Payment at such time that the Clinical Efficacy Milestone Payment Date does occur if the license agreement remains in effect as of such date. The license agreement, if entered into upon Ophthotech’s exercise of the option, will provide for the Company to be entitled to receive (i) $10.0 million upon meeting certain efficacy and safety endpoints in phase 2 clinical trials that would enable the commencement of a phase 3 clinical trial, (ii) $20.0 million upon marketing approval in the United States, (iii) $20.0 million upon marketing approval in the UK, Germany, Spain, Italy and France and (iv) up to $45.0 million in sales-based milestone payments. Ophthotech would also be required to pay tiered, double digit royalties, up to the mid-teens, on net sales of tivozanib or products containing tivozanib. Activities under the agreement with Ophthotech were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with Ophthotech includes the following non-contingent deliverables: (i) the Company’s obligation to grant an exclusive option to Ophthotech to enter into a license agreement to develop and commercialize products incorporating tivozanib for treatment of diseases of the eye outside of Asia during the Option Period (the “Option Grant Deliverable”); (ii) the Company’s obligation to enter into an amendment with KHK to modify the terms of the existing KHK agreement to negotiate a mutually acceptable form of license agreement; and (iii) the Company’s obligation to transfer research-grade tivozanib drug substance for Ophthotech to conduct the Option Period research. The Company determined that the delivered Option Grant Deliverable did not have standalone value from the remaining deliverables since Ophthotech could not obtain the intended benefit of the option without the remaining deliverables. Similarly, the remaining deliverables have no standalone value without the Option Grant Deliverable. The Company is accounting for the deliverables as one unit of accounting. Under the Option Agreement, the Company received a cash payment of $0.5 million during the year ended December 31, 2014. The Company deferred the payment and is recording the deferred revenue over the Company’s period of performance, which is currently estimated to be through December 2017. The Company recorded approximately $28,000 and $58,000 of revenue during the three months ended March 31, 2016 and 2015, respectively. Biodesix In April 2014, the Company entered into a worldwide agreement with Biodesix to develop and commercialize ficlatuzumab, the Company’s its hepatocyte growth factor (“HGF”) inhibitory antibody, with BDX004, a proprietary companion diagnostic test developed by Biodesix and derived from VeriStrat ® Pending marketing approval of ficlatuzumab and subject to a commercialization agreement to be entered into after receipt of results from the NSCLC POC Trial, each party would share equally in commercialization profits and losses, subject to the Company’s right to be the lead commercialization party. Biodesix is solely responsible for the BDX004 development costs, as well as BDX004 sales and marketing costs. Subject to and following the approval of the BDX004 test as a companion diagnostic for ficlatuzumab, Biodesix has agreed to make the BDX004 test available and use commercially reasonable efforts to seek reimbursement in all geographies where ficlatuzumab is approved. The Company has agreed to reimburse Biodesix a pre-specified amount, under certain circumstances for BDX004 tests performed. Prior to the first commercial sale of ficlatuzumab and after the earlier of (i) the Cap being reached or (ii) the completion of the NSCLC POC Trial, each party has the right to elect to discontinue participating in further development or commercialization efforts with respect to ficlatuzumab, which is referred to as an “Opt-Out”. If either AVEO or Biodesix elects to Opt-Out, with such party referred to as the “Opting-Out Party”, then the Opting-Out Party shall not be responsible for any future costs associated with developing and commercializing ficlatuzumab other than any ongoing clinical trials. After election of an Opt-Out, the non-opting out party shall have sole decision-making authority with respect to further development and commercialization of ficlatuzumab. Additionally, the Opting-Out Party shall be entitled to receive, if ficlatuzumab is successfully developed and commercialized, a royalty equal to 10% of net sales of ficlatuzumab throughout the world, if any, subject to offsets under certain circumstances. If Biodesix elects to Opt-Out, it will continue to be responsible for its development and commercialization obligations with respect to BDX004. If AVEO elects to Opt-Out, it will continue to make the existing supply of ficlatuzumab available to Biodesix for the purposes of enabling Biodesix to complete the development of ficlatuzumab, and Biodesix will have the right to commercialize ficlatuzumab. Prior to any Opt-Out, the parties shall share equally in any payments received from a third party licensee; provided, however, after any Opt-Out, the Opting-Out Party shall be entitled to receive only a reduced portion of such third party payments. The agreement will remain in effect until the expiration of all payment obligations between the parties related to development and commercialization of ficlatuzumab, unless earlier terminated. Activities under the agreement with Biodesix were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with Biodesix includes the following non-contingent deliverables: (i) the Company’s obligation to deliver perpetual, non-exclusive rights to certain intellectual property including clinical and biomarker data related to ficlatuzumab for use in developing and commercializing BDX004; (ii) the Company’s obligation to deliver technology improvements and data developed during the NSCLC POC Trial to Biodesix; (iii) the Company’s obligation to participate in the joint steering committee during the NSCLC POC Trial; (iv) the Company’s obligation to perform certain development activities associated with the NSCLC POC Trial; (v) the Company’s obligation to supply clinical material for use in conducting the NSCLC POC Trial; and (vi) the Company’s obligation to deliver clinical specimens and data during the NSCLC POC Trial. The Company concluded that any deliverables that would be delivered after the NSCLC POC Trial is complete are contingent deliverables because these services are contingent upon the results of the NSCLC POC Trial. As these deliverables are contingent, and are not at an incremental discount, they are not evaluated as deliverables at the inception of the arrangement. These contingent deliverables will be evaluated and accounted for separately as each related contingency is resolved. As of March 31, 2016, no contingent deliverables had been provided by the Company. The Company determined that the delivered item, or the perpetual, non-exclusive rights to certain intellectual property for use in developing and commercializing BDX004 did not have standalone value from the remaining deliverables since Biodesix could not obtain the intended benefit of the license without the remaining deliverables. Since the remaining deliverables will be performed over the same period of performance there is no difference in accounting for the deliverables as one unit or multiple units of accounting, and therefore, the Company is accounting for the deliverables as one unit of accounting. The Company records the consideration earned while conducting the NSCLC POC Trial, which consists of reimbursements from Biodesix for expenses related to the trial under the Cap, as a reduction to research and development expense using the proportional performance method over the respective period of performance. As a result of the cost sharing provisions in the agreement, the Company reduced research and development expenses by approximately $0.9 million during the three months ended March 31, 2016 and 2015. The amount due to the Company from Biodesix pursuant to the cost-sharing provision was $0.7 million and $0.9 million at March 31, 2016 and 2015, respectively. Under the agreement, the Company received cash payments of $1.3 million and $1.8 million during the three months ended March 31, 2016 and 2015, respectively. St. Vincent’s In July 2012, the Company entered into a license agreement with St. Vincent’s Hospital Sydney Limited (“St. Vincent’s”), under which the Company obtained an exclusive, worldwide license to research, develop, manufacture and commercialize products for human therapeutic, preventative and palliative applications that benefit from inhibition or decreased expression or activity of MIC-1, which is also referred to as GDF15. Under the agreement, the Company has the right to grant sublicenses subject to certain restrictions. Under the license agreement, St. Vincent’s also granted the Company non-exclusive rights for certain related diagnostic products and research tools. In order to sublicense certain necessary intellectual property rights to Novartis in August 2015, the Company and St. Vincent’s amended and restated the license agreement (the “Amended St. Vincent’s Agreement”). Under the Amended St. Vincent’s Agreement, the Company was required to make an upfront payment to St. Vincent’s of $1.5 million. St. Vincent’s is also eligible to receive up to approximately $18.9 million in connection with development a |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2016 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | (5) Accrued Expenses Accrued expenses consisted of the following as of March 31, 2016 and December 31, 2015: March 31, 2016 December 31, 2015 (in thousands) Clinical expenses $ 1,108 $ 1,793 Professional fees 675 573 Salaries and benefits 423 938 Manufacturing and distribution 198 173 Restructuring 196 357 Other 243 272 $ 2,843 $ 4,106 |
Loans Payable
Loans Payable | 3 Months Ended |
Mar. 31, 2016 | |
Debt Disclosure [Abstract] | |
Loans Payable | (6) Loans Payable On May 28, 2010, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Technology II, L.P. and Hercules Technology III, L.P., affiliates of Hercules Technology Growth (collectively, “Hercules”), pursuant to which the Company received a loan in the aggregate principal amount of $25.0 million. The Company was required to repay the aggregate principal balance under the Loan Agreement in 30 equal monthly installments of principal starting on January 1, 2012. On March 31, 2012, the Company entered into an amendment to the Loan Agreement, pursuant to which the Company increased the principal amount under the Loan Agreement to $26.5 million. Under the amendment to the Loan Agreement, the date on which the Company was required to begin repaying the aggregate principal balance was extended to April 1, 2013, at which point the Company began repaying such balance in 30 equal monthly installments. On September 24, 2014, the Company further amended the Loan Agreement with Hercules (the “Amended Loan Agreement”). Pursuant to the Amended Loan Agreement, the Company received a new loan in the aggregate principal amount of $10.0 million and amended the terms of the Loan Agreement with an outstanding principal balance of $11.6 million. The Company was not required to pay principal on the original loan until January 1, 2015, at which time the Company was required to commence making 12 principal and interest payments ending December 1, 2015. The original loan was fully paid as of December 2015. Pursuant to the Amended Loan Agreement, the Company is not required to pay principal on the new loan of $10.0 million for a period of time until May 1, 2016. The period during which the Company is not required to pay principal was extended six months from November 1, 2015 to May 1, 2016 upon executing the Company’s license agreement with Novartis and may be further extended if the Company continues to achieve certain performance milestones, after which time, the Company is required to make monthly principal and interest payments with the last principal and interest payment due on January 1, 2018. The Amended Loan Agreement has an end-of-term payment of approximately $0.5 million due on January 1, 2018 or on such earlier date as the new loan is prepaid. The Company accounted for the Amended Loan Agreement as a loan modification in accordance with ASC 470-50, Debt—Modifications and Extinguishments. The Company must make interest payments on the loan each month it remains outstanding. Per annum interest is payable on the principal balance of both loans at the greater of 11.9% and an amount equal to 11.9% plus the prime rate of interest minus 4.75% as determined daily, provided however, that the per annum interest shall not exceed 15.0% (11.9% as of March 31, 2016). In addition to the obligations and covenants existing under the Loan Agreement, the Amended Loan Agreement contains a financial covenant, whereby the Company has agreed to maintain, with respect to the new loan of $10.0 million, a liquidity ratio equal to or greater than 1.25 to 1.00 of the then outstanding loan balance or the equivalent of $12.5 million in unrestricted and unencumbered cash and cash equivalents as of March 31, 2016. The financial covenant shall not apply after such time that the Company receives favorable data both with respect to its phase 2 clinical trial of ficlatuzumab and a phase 1 clinical trial of AV-380. The Company was in compliance with this and all other financial covenants at March 31, 2016 that are included in the Loan Agreement and Amended Loan Agreement. The Loan Agreement required a deferred financing charge of $1.3 million which was paid in May 2012 related to the amendment of the Loan Agreement. The Loan Agreement also included an additional deferred financing charge of $1.2 million which was paid in June 2014, and was recorded as a loan discount and is being amortized to interest expense over the term of the loan borrowed under the Loan Agreement using the effective interest rate method. The Company had recorded a liability for the full amount of the charge since the payment of such amount was not contingent on any future event. The Company incurred approximately $0.2 million in loan issuance costs paid directly to Hercules under the Loan Agreement, which were offset against the loan proceeds and are accounted for as a loan discount. As part of the Loan Agreement, on June 2, 2010, the Company issued warrants to the lenders to purchase up to 156,641 shares of the Company’s common stock at an exercise price equal to $7.98 per share. The Company recorded the relative fair value of the warrants of approximately $0.8 million as stockholders’ equity and as a discount to the related loan outstanding and is amortizing the value of the discount to interest expense over the term of the loan using the effective interest method. On July 21, 2011, Hercules exercised these warrants and they are no longer outstanding. As part of the Amended Loan Agreement, on September 24, 2014, the Company issued warrants to the lenders to purchase up to 608,696 shares of the Company’s common stock at an exercise price equal to $1.15 per share. The Company recorded the relative fair value of the warrants of approximately $0.4 million as stockholders’ equity and as a discount to the related loan outstanding and is amortizing the value of the discount to interest expense over the term of the loan using the effective interest method. As part of the Loan Agreement, Hercules also received an option, subject to the Company’s written consent, not to be unreasonably withheld, to purchase, either with cash or through conversion of outstanding principal under the loan, up to $2.0 million of equity of the Company sold in any sale by the Company to third parties of equity securities resulting in at least $10.0 million in net cash proceeds to the Company, subject to certain exceptions. The Company has evaluated the embedded conversion option, and has concluded that it does not need to be bifurcated and separately accounted for. No amount will be recognized for the conversion feature until such time as the conversion feature is exercised and it can be determined whether a beneficial conversion feature exists. As of March 31, 2016, the aggregate principal balance outstanding was $10.0 million. The loans are secured by a lien on all the Company’s personal property (other than intellectual property), whether owned as of, or acquired after, the date of the Amended Loan Agreement. The Amended Loan Agreement defines events of default, including the occurrence of an event that results in a material adverse effect upon the Company’s business operations, properties, assets or condition (financial or otherwise), its ability to perform its obligations under and in accordance with the terms of the Amended Loan Agreement, or upon the ability of the lenders to enforce any of their rights or remedies with respect to such obligations, or upon the collateral under the Loan Agreement, the related liens or the priority thereof. As of March 31, 2016, Hercules has not asserted any events of default and the Company does not believe that there has been a material adverse change as defined in the loan agreement. The Company has determined that the risk of subjective acceleration under the material adverse events clause is remote and therefore has classified the outstanding principal in current and long-term liabilities based on the timing of scheduled principal payments. Future minimum payments under the loans payable outstanding as of March 31, 2016 are as follows (amounts in thousands): Years Ending December 31: 2016 (9 months remaining) $ 3,199 2017 4,645 2018 4,269 12,113 Less amount representing interest (1,572 ) Less discount (445 ) Less deferred charges (540 ) Less current portion (3,019 ) Loans payable, net of current portion and discount $ 6,537 |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2016 | |
Equity [Abstract] | |
Common Stock | (7) Common Stock ATM Sales Agreement In February 2015, the Company entered into an at-the-market issuance sales agreement (the “Sales Agreement”) with FBR & Co. (formerly MLV & Co. LLC) (“FBR”), pursuant to which the Company could issue and sell shares of its common stock from time to time up to an aggregate amount of $17.9 million, at the Company’s option, through FBR as its sales agent. Sales of common stock through FBR may be made by any method that is deemed an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including by means On May 7, 2015, the Company filed a shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale by the Company of up to $100.0 million of its common stock, preferred stock, debt securities, warrants and/or units (the “2015 Shelf”). The 2015 Shelf was filed to replace the Company’s existing $250.0 million shelf registration statement (the “2012 Shelf”). On May 7, 2015, the Company also amended its Sales Agreement with FBR to provide for the offering, issuance and sale by the Company of up to $15.0 million of its common stock under the 2015 Shelf, which replaced the Company’s existing $17.9 million offering that expired along with the expired 2012 Shelf. As of March 31, 2016, the Company has sold approximately 5.9 million shares pursuant to the Sales Agreement, as amended, resulting in proceeds of approximately $10.2 million, net of commissions and issuance costs. No additional shares were issued during the three months ended March 31, 2016. Approximately $9.0 million remains available for sale under the Sales Agreement. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | (8) Stock-based Compensation Stock Plans The Company issued stock options and had restricted stock awards outstanding during the three months ended March 31, 2016. A summary of the status of the Company’s stock option activity at March 31, 2016 and changes during the three months then ended is presented in the table and narrative below. Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2015 4,796,005 $ 3.78 Granted 1,139,500 $ 1.08 Exercised ─ ─ Forfeited (351,085 ) $ 1.38 Outstanding at March 31, 2016 5,584,420 $ 3.38 7.17 $ 88,258 Vested or expected to vest at March 31, 2016 3,176,655 $ 5.04 5.82 $ 43,329 Exercisable at March 31, 2016 2,537,373 $ 6.00 4.99 $ 27,625 Stock options to purchase 321,000 shares of common stock contain market conditions which were not deemed probable of vesting at March 31, 2016. The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Three Months Ended March 31, 2016 2015 Volatility factor 73.79%-73.91% 78.7% Expected term (in years) 6.25 6.25 Risk-free interest rates 1.38% 1.54% Dividend yield — — The risk-free interest rate is determined based upon the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the options being valued. The Company does not expect to pay dividends in the foreseeable future. The Company does not have sufficient history to support a calculation of volatility and expected term using only its historical data. As such, the Company has used a weighted-average volatility considering the Company’s own volatility since March 2010, and the volatilities of several peer companies. For purposes of identifying similar entities, the Company considered characteristics such as industry, length of trading history, similar vesting terms and in-the-money option status. Due to lack of available option activity data, the Company elected to use the “simplified” method for “plain vanilla” options to estimate the expected term of the stock option grants. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option. Based upon these assumptions, the weighted-average grant date fair value of stock options granted to employees during the three months ended March 31, 2016 and 2015 was $0.71 per share and $0.62 per share, respectively. The Company is required to include an estimate of the value of the awards that will be forfeited in calculating compensation costs, which the Company estimates based upon actual historical forfeitures. The forfeiture estimates are recognized over the requisite service period of the awards on a straight-line basis. The Company estimated its forfeiture rate to be approximately 76% and 70% as of March 31, 2016 and 2015, respectively. As of March 31, 2016, there was $0.7 million of total unrecognized stock-based compensation expense related to stock options granted to employees under the Company’s 2002 Stock Incentive Plan and 2010 Stock Incentive Plan (collectively, the “Plans”). The expense is expected to be recognized over a weighted-average period of 3.0 years. The intrinsic value of options exercised during the three months ended March 31, 2015 was $13,000. No options were exercised during the three months ended March 31, 2016. The restricted stock activity for the three months ended March 31, 2016 is as follows: Number Weighted- Average Fair-Value Unvested at December 31, 2015 42,750 $ 1.61 Granted — — Vested/Released (42,750 ) 1.61 Unvested at March 31, 2016 — — As of March 31, 2016, there was no unrecognized stock-based compensation expense related to restricted stock awards granted under the Plan. |
Strategic Restructuring
Strategic Restructuring | 3 Months Ended |
Mar. 31, 2016 | |
Restructuring And Related Activities [Abstract] | |
Strategic Restructuring | (9) Strategic Restructuring On January 6, 2015, the Board of the Company approved a strategic restructuring of the Company that eliminated the Company’s internal research function and aligned the Company’s resources with the Company’s future strategic plans. As part of this restructuring, the Company eliminated approximately two-thirds of the Company’s workforce, or 40 positions across the organization. The Company substantially completed the restructuring during the quarter-ended March 31, 2015. The following table summarizes the components of the Company’s restructuring activity recorded in operating expenses and in accrued expenses in the accompanying consolidated balance sheet: Restructuring amounts accrued at December 31, 2015 Restructuring expense incurred during the three months ended March 31, 2016 Restructuring amounts paid during the three months ended March 31, 2016 Restructuring amounts accrued at March 31, 2016 (in thousands) Employee severance, benefits and related costs. $ 357 — $ (161 ) 196 The Company is obligated to continue to pay the remaining amounts accrued through the third quarter of 2016. |
Facility Lease Exit
Facility Lease Exit | 3 Months Ended |
Mar. 31, 2016 | |
Facility Lease Exit [Abstract] | |
Facility Lease Exit | (10) Facility Lease Exit In September 2014, the Company entered into the Lease Termination Agreement pursuant to which the Company immediately surrendered leased space at 650 East Kendall Street in Cambridge, Massachusetts that it had previously ceased using earlier in 2014. In connection with the Lease Termination Agreement, the Company agreed to pay the landlord a termination fee totaling $15.6 million. The Company also agreed to surrender its remaining leased space upon 90 days written notice prior to September 24, 2015. In February 2015, the Company provided notice that it would surrender the remaining space on May 29, 2015. Accordingly, the Company revised the estimated useful life of its leasehold improvements related to this office space and amortized such assets through May 2015, resulting in an additional $1.4 million of depreciation expense during the three months ended March 31, 2015. Similarly, the Company accelerated the amortization of its deferred rent and leasehold improvement allowance associated with this office space through May 2015, resulting in an additional $1.7 million of amortization during the three months ended March 31, 2015. |
Legal Proceedings
Legal Proceedings | 3 Months Ended |
Mar. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | (11) Legal Proceedings Two class action lawsuits have been filed against the Company and certain of its former officers and members of its board of directors, (Tuan Ha-Ngoc, David N. Johnston, William Slichenmyer and Ronald DePinho), in the United States District Court for the District of Massachusetts, one captioned Paul Sanders v. Aveo Pharmaceuticals, Inc., et al., No. 1:13-cv-11157-JLT, filed on May 9, 2013, and the other captioned Christine Krause v. AVEO Pharmaceuticals, Inc., et al., No. 1:13-cv-11320-JLT, filed on May 31, 2013. On December 4, 2013, the District Court consolidated the complaints as In re AVEO Pharmaceuticals, Inc. Securities Litigation et al., No. 1:13-cv-11157-DJC, and an amended complaint was filed on February 3, 2014. The amended complaint purported to be brought on behalf of shareholders who purchased the Company’s common stock between January 3, 2012 and May 1, 2013. The amended complaint generally alleged that the Company and certain of its present and former officers and directors violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the phase 3 trial design and results for the Company’s TIVO-1 study in an effort to lead investors to believe that the drug would receive approval from the FDA. The lawsuit seeks unspecified damages, interest, attorneys’ fees, and other costs. The consolidated amended complaint was dismissed without prejudice on March 20, 2015, and the lead plaintiffs then filed a second amended complaint bringing similar allegations. The Company moved to dismiss again, and after a second round of briefing and oral argument, the court ruled in the Company’s favor and dismissed the second amended complaint with prejudice on November 18, 2015. The lead plaintiffs have appealed the court’s decision to the United States Court of Appeals for the First Circuit. They have also filed a motion to vacate and reconsider the district court’s judgment, which we have opposed. The Company denies any allegations of wrongdoing and intends to continue to vigorously defend against this lawsuit. However, there is no assurance that the Company will be successful in its defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of the action. Moreover, the Company is unable to predict the outcome or reasonably estimate a range of possible loss at this time. On April 4, 2014, Karen J. van Ingen, a purported purchaser of AVEO stock, filed a derivative complaint allegedly on behalf of AVEO in the United States District Court for the District of Massachusetts, Civil Action No. 1:14-cv-11672-DJC, naming AVEO, as a nominal defendant and also naming as defendants present and former members of the Company’s board of directors, including Tuan Ha-Ngoc, Henri A. Termeer, Kenneth M. Bate, Anthony B. Evnin, Robert Epstein, Raju Kucherlapati, Robert C. Young, and Kenneth E. Weg. The complaint alleged breach of fiduciary duty and abuse of control between January 2012 and May 2013 with respect to allegedly misleading statements and omissions regarding tivozanib. The lawsuit seeks, among other relief, unspecified damages, costs and expenses, including attorneys’ fees, an order requiring us to implement certain corporate governance reforms, restitution from the defendants and such other relief as the court might find just and proper. The Company filed a motion to dismiss the derivative complaint, and after briefing and oral argument, on March 18, 2015 the Court ruled in the Company’s favor and dismissed the case with prejudice. The plaintiff then filed a motion seeking to vacate the Court’s order of dismissal and permit filing of an amended complaint, which the Company opposed, and which the Court denied on June 30, 2015. The plaintiff has appealed the Court’s decision to the United States Court of Appeals for the First Circuit. The Company denies any allegations of wrongdoing and intends to continue to vigorously defend this lawsuit. However, there is no assurance that the Company will be successful in its defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of this action. Moreover, the Company is unable to predict the outcome or reasonably estimate a range of possible loss at this time. On July 3, 2013, the staff (the “SEC Staff”) of the United States Securities and Exchange Commission (the “Commission”) served a subpoena on the Company for documents and information concerning tivozanib, including related communications with the FDA, investors and others. The Company fully cooperated with the inquiry. In September 2015, the SEC Staff invited the Company to discuss the settlement of potential claims that the SEC Staff may recommend that the Commission bring against the Company asserting that it violated federal securities laws by omitting to disclose to investors the recommendation made to the Company by the staff of the U.S. Food and Drug Administration, on May 11, 2012, that the Company conduct an additional clinical trial with respect to tivozanib. Through these discussions with the SEC Staff, an agreement was reached to settle those claims for a total amount of $4.0 million, subject to the approval of the Commission. On March 29, 2016, the Commission filed a complaint against the Company and three of its former officers in the U.S. District Court for the District of Massachusetts (the “Court”) alleging that the Company misled investors about its efforts to obtain FDA approval for tivozanib. Without admitting or denying the allegations in the Commission’s complaint, the Company consented to the entry of a final judgment pursuant to which it would pay the Commission a $4 million civil penalty to settle the Commission’s claims against the Company. The settlement was subject to Court approval. On March 31, 2016, the Court entered a final judgment which (i) approved the settlement; (ii) permanently enjoined the Company from violating Section 17(a) of the Securities Act of 1933, as amended, Sections 10(b) and 13(a) of the Securities Exchange Act of 1934, as amended, and rules 10b-5, 12b-20, 13a-1, 13a-11 and 13a-13 promulgated thereunder; and (iii) ordered the Company to pay the agreed-to civil penalty. The Commission’s action against the Company’s three former officers is still pending. The Company is not a party to any litigation or discussions between the SEC Staff and the former officers, and the Company can make no assurance regarding the outcome of that action or the Commission’s claims against those individuals. |
Significant Accounting Polici18
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition The Company’s revenues are generated primarily through collaborative research, development and commercialization agreements. The terms of these agreements generally contain multiple elements, or deliverables, which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii) research and development activities to be performed on behalf of the collaborative partner, and (iii) in certain cases, services in connection with the manufacturing of pre-clinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, up-front license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. When evaluating multiple element arrangements, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company typically uses best estimate of selling price to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes best estimate of selling price to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements and internally developed models that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s best estimate of selling price, the Company evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration among multiple deliverables. The Company typically receives non-refundable, up-front payments when licensing its intellectual property in conjunction with a research and development agreement. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s research and development obligations. If management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until management can reasonably estimate when the performance obligation ends. When management believes the license to its intellectual property has stand-alone value, the Company generally recognizes revenue attributed to the license upon delivery. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts for those arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheets. At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company aggregates its milestones into four categories: (i) clinical and development milestones, (ii) regulatory milestones, (iii) commercial milestones, and (iv) patent-related milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase. For example, a milestone payment may be due to the Company upon the initiation of a phase 3 clinical trial for a new indication, which is the last phase of clinical development and could eventually contribute to marketing approval by the U.S. Food and Drug Administration (“FDA”) or other global regulatory authorities. Regulatory milestones are typically achieved upon acceptance of the submission for marketing approval of a product candidate or upon approval to market the product candidate by the FDA or other global regulatory authorities. For example, a milestone payment may be due to the Company upon the FDA’s acceptance of a New Drug Application (“NDA”). Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Patent-related milestones are typically achieved when a patent application is filed or a patent is issued with respect to certain intellectual property related to the applicable collaboration. Revenues from clinical and development, regulatory, and patent-related milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, are recognized upon successful accomplishment of the milestones. The Company has concluded that the clinical and development, regulatory and patent-related milestones pursuant to its current research and development arrangements are substantive. Milestones that are not considered substantive are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. |
Research and Development Expenses | Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including personnel-related costs such as salaries and stock-based compensation, facilities, research-related overhead, clinical trial costs, manufacturing costs and costs of other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents at March 31, 2016 consisted of money market funds and corporate debt securities maintained by an investment manager totaling $9.1 million. Cash equivalents at December 31, 2015 consisted of money market funds, U.S. government agency securities and corporate debt securities, including commercial paper, maintained by an investment manager totaling $16.3 million. The carrying values of the Company’s cash equivalent securities approximate fair value due to their short term maturities. |
Marketable Securities | Marketable Securities Marketable securities at March 31, 2016 consisted of U.S. government agency securities and corporate debt securities, including commercial paper, maintained by an investment manager. Marketable securities at December 31, 2015 consisted of government agency and corporate debt securities, including commercial paper, maintained by an investment manager. Credit risk is reduced as a result of the Company’s policy to limit the amount invested in any one issuance. Marketable securities consist primarily of investments which have expected average maturity dates in excess of three months, but not longer than 24 months. The Company classifies these investments as available-for-sale. Unrealized gains and losses are included in other comprehensive loss until realized. The cost of securities sold is based on the specific identification method. There were no realized gains or losses recognized on the sale or maturity of marketable securities during the three months ended March 31, 2016 and 2015. Available-for-sale securities at March 31, 2016 and December 31, 2015 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value (in thousands) March 31, 2016: Corporate debt securities (Due within 1 year) $ 4,748 $ 2 $ — $ 4,750 Government agency securities (Due within 1 year) 999 — — 999 $ 5,747 $ 2 $ — $ 5,749 December 31, 2015: Corporate debt securities (Due within 1 year) $ 6,504 $ — $ (3 ) $ 6,501 Government agency securities (Due within 1 year) 1,000 — — 1,000 $ 7,504 $ — $ (3 ) $ 7,501 The aggregate unrealized loss for the Company’s corporate debt securities was less than $1,000 as of March 31, 2016. Marketable securities in an unrealized loss position at December 31, 2015 consisted of the following: Aggregate Fair Value Unrealized Losses (in thousands) Corporate debt securities (Due within 1 year) $ 4,100 $ (3 ) Government agency securities (Due within 1 year) 1,000 — $ 5,100 $ (3 ) |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk related to cash deposits due to the financial position of the depository institutions in which those deposits are held. The Company’s credit risk related to marketable securities is reduced as a result of the Company’s policy to limit the amount invested in any one issuance. The Company’s accounts receivable primarily consist of amounts due to the Company from licensees and collaborators. As of March 31, 2016, the Company had $1.7 million of receivables outstanding, including $0.9 million due from CANbridge pursuant to the Company’s licensing arrangement for AV-203 (refer to Note 7), $0.7 million due from Biodesix pursuant to the Company’s collaboration arrangement for AV-299 (refer to Note 7) and $0.2 million due from Astellas pursuant to the Company’s former collaboration arrangement for tivozanib. The Company has not experienced any material losses related to receivables from individual licensees or collaborators. |
Fair Value Measurements | Fair Value Measurements The Company records cash equivalents and marketable securities at fair value. The accounting standards for fair value measurements establish a hierarchy that distinguishes between fair value measurements based on market data (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels: · Level 1—Quoted market prices in active markets for identical assets or liabilities. Assets that are valued utilizing only Level 1 inputs include money market funds. · Level 2—Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Assets that are valued utilizing Level 2 inputs include U.S. government agency securities and corporate bonds, including commercial paper. These investments have been initially valued at the transaction price and are subsequently valued, at the end of each reporting period, utilizing third party pricing services or other observable market data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, and other industry and economic events. The Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by pricing services as of March 31, 2016. · Level 3—Unobservable inputs developed using estimates and assumptions developed by the Company, which reflect those that a market participant would use. The Company currently has no assets or liabilities measured at fair value on a recurring basis that utilize Level 3 inputs. The following tables summarize the cash equivalents and marketable securities measured at fair value on a recurring basis in the accompanying condensed consolidated balance sheets as of March 31, 2016 and December 31, 2015. Fair Value Measurements of Cash Equivalents and Marketable Securities as of March 31, 2016 Level 1 Level 2 Level 3 Total (in thousands) Cash equivalents $ 6,907 $ 2,143 $ — $ 9,050 Marketable securities — 5,749 — 5,749 $ 6,907 $ 7,892 $ — $ 14,799 Fair Value Measurements of Cash Equivalents and Marketable Securities as of December 31, 2015 Level 1 Level 2 Level 3 Total (in thousands) Cash equivalents $ 11,462 $ 4,812 $ — $ 16,274 Marketable securities — 7,501 — 7,501 $ 11,462 $ 12,313 $ — $ 23,775 The fair value of the Company’s loans payable at March 31, 2016, computed pursuant to a discounted cash flow technique using a market interest rate, was $10.1 million and is considered a Level 3 fair value measurement. The effective interest rate, which reflects the current market rate, considers the fair value of the warrant issued in connection with the loan, loan issuance costs and the deferred financing charge. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost and are depreciated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repair costs are charged to expense as incurred. |
Long-lived Assets | Long-lived Assets The Company reviews long-lived assets, including property and equipment, for impairment whenever changes in business circumstances indicate that the carrying amount of the asset may not be fully recoverable. No impairment charges were recognized during the three months ended March 31, 2016. The Company recognized $0.2 million of impairment losses for the three months ended March 31, 2015 related to leasehold improvements. |
Basic and Diluted Loss per Common Share | Basic and Diluted Loss per Common Share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted loss per share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares and dilutive common share equivalents then outstanding which excludes unvested restricted stock. Potential common share equivalents consist of the incremental common shares issuable upon the exercise of stock options and warrants. Since the Company had a net loss for all periods presented, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per common share is the same. The following table sets forth the potential common shares excluded from the calculation of net loss per common share-diluted for the three months ended March 31, 2016 and 2015 because their inclusion would have been anti-dilutive: Outstanding at March 31, 2016 2015 (in thousands) Options outstanding 5,584 5,861 Warrants outstanding 609 609 6,193 6,470 |
Stock-Based Compensation | Stock-Based Compensation Under the Company’s stock-based compensation programs, the Company periodically grants stock options and restricted stock to employees, directors and nonemployee consultants. The Company also issues shares under an employee stock purchase plan. The fair value of all awards is recognized in the Company’s statements of operations over the requisite service period for each award. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period. Other awards, such as performance-based awards that vest upon the achievement of specified goals, are expensed using the accelerated attribution method if achievement of the specified goals is considered probable. The Company has also granted awards that vest upon the achievement of market conditions. Per Accounting Standards Codification (“ASC”) 718 Share-Based Payments, The fair value of equity-classified awards to employees and directors are measured at fair value on the date the awards are granted. Awards to nonemployee consultants are recorded at their fair values and are re-measured as of each balance sheet date until the recipient’s services are complete. During the three months ended March 31, 2016 and 2015, the Company recorded the following stock-based compensation expense: Three Months Ended March 31, 2016 2015 (in thousands) Research and development $ 125 $ 125 General and administrative 265 233 Restructuring ─ 69 $ 390 $ 427 Stock-based compensation expense is allocated to research and development and general and administrative expense based upon the department of the employee to whom each award was granted. Expenses recognized in connection with the modification of awards in connection with the Company’s strategic restructurings are allocated to restructuring expense. No related tax benefits of the stock-based compensation expense have been recognized. |
Income Taxes | Income Taxes The Company provides for income taxes using the asset-liability method. Under this method, deferred tax assets and liabilities are recognized based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company calculates its provision for income taxes on ordinary income based on its projected annual tax rate for the year. Uncertain tax positions are recognized if the position is more-likely-than-not to be sustained upon examination by a tax authority. Unrecognized tax benefits represent tax positions for which reserves have been established. As of March 31, 2016, the Company is forecasting a net loss for the year ended December 31, 2016. The Company maintains a full valuation allowance on all deferred tax assets. For the three months ended March 31, 2016, the Company recorded a $0.1 million provision for income taxes related to withholding taxes incurred in a foreign jurisdiction. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment principally in the United States. As of March 31, 2016, the Company has $0.9 million of net assets located in the United Kingdom. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires the Company’s management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements For a discussion of recent accounting pronouncements adopted by the Company, please refer to Note 2, “Significant Accounting Policies,” included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed with the SEC on March 15, 2016. The Company did not adopt any new accounting pronouncements during the three months ended March 31, 2016 that had a material effect on the Company’s condensed consolidated financial statements. In May 2014, the Financial Accounting Standards Board (“FASB”) issued a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance under US GAAP. The standard was originally scheduled to be effective for public entities for annual and interim periods beginning after December 15, 2016. In July 2015, the standard was deferred and will now be effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for annual and interim periods beginning after December 15, 2016. The Company is currently evaluating the effect this standard will have on its revenue recognition policies and its financial statements, including how the standard will be adopted. In August 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. In March 2016, the FASB issued ASU No. 2016-09, Compensation─Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Significant Accounting Polici19
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Available-For-Sale Securities | Available-for-sale securities at March 31, 2016 and December 31, 2015 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value (in thousands) March 31, 2016: Corporate debt securities (Due within 1 year) $ 4,748 $ 2 $ — $ 4,750 Government agency securities (Due within 1 year) 999 — — 999 $ 5,747 $ 2 $ — $ 5,749 December 31, 2015: Corporate debt securities (Due within 1 year) $ 6,504 $ — $ (3 ) $ 6,501 Government agency securities (Due within 1 year) 1,000 — — 1,000 $ 7,504 $ — $ (3 ) $ 7,501 |
Marketable Securities in Unrealized Loss Position | Marketable securities in an unrealized loss position at December 31, 2015 consisted of the following: Aggregate Fair Value Unrealized Losses (in thousands) Corporate debt securities (Due within 1 year) $ 4,100 $ (3 ) Government agency securities (Due within 1 year) 1,000 — $ 5,100 $ (3 ) |
Summary of Cash Equivalents and Marketable Securities Measured at Fair Value on Recurring Basis | The following tables summarize the cash equivalents and marketable securities measured at fair value on a recurring basis in the accompanying condensed consolidated balance sheets as of March 31, 2016 and December 31, 2015. Fair Value Measurements of Cash Equivalents and Marketable Securities as of March 31, 2016 Level 1 Level 2 Level 3 Total (in thousands) Cash equivalents $ 6,907 $ 2,143 $ — $ 9,050 Marketable securities — 5,749 — 5,749 $ 6,907 $ 7,892 $ — $ 14,799 Fair Value Measurements of Cash Equivalents and Marketable Securities as of December 31, 2015 Level 1 Level 2 Level 3 Total (in thousands) Cash equivalents $ 11,462 $ 4,812 $ — $ 16,274 Marketable securities — 7,501 — 7,501 $ 11,462 $ 12,313 $ — $ 23,775 |
Potential Common Shares Excluded from Calculation of Net Loss Per Common Share | The following table sets forth the potential common shares excluded from the calculation of net loss per common share-diluted for the three months ended March 31, 2016 and 2015 because their inclusion would have been anti-dilutive: Outstanding at March 31, 2016 2015 (in thousands) Options outstanding 5,584 5,861 Warrants outstanding 609 609 6,193 6,470 |
Stock-Based Compensation Expense | During the three months ended March 31, 2016 and 2015, the Company recorded the following stock-based compensation expense: Three Months Ended March 31, 2016 2015 (in thousands) Research and development $ 125 $ 125 General and administrative 265 233 Restructuring ─ 69 $ 390 $ 427 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following as of March 31, 2016 and December 31, 2015: March 31, 2016 December 31, 2015 (in thousands) Clinical expenses $ 1,108 $ 1,793 Professional fees 675 573 Salaries and benefits 423 938 Manufacturing and distribution 198 173 Restructuring 196 357 Other 243 272 $ 2,843 $ 4,106 |
Loans Payable (Tables)
Loans Payable (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of March 31, 2016 are as follows (amounts in thousands): Years Ending December 31: 2016 (9 months remaining) $ 3,199 2017 4,645 2018 4,269 12,113 Less amount representing interest (1,572 ) Less discount (445 ) Less deferred charges (540 ) Less current portion (3,019 ) Loans payable, net of current portion and discount $ 6,537 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The Company issued stock options and had restricted stock awards outstanding during the three months ended March 31, 2016. A summary of the status of the Company’s stock option activity at March 31, 2016 and changes during the three months then ended is presented in the table and narrative below. Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2015 4,796,005 $ 3.78 Granted 1,139,500 $ 1.08 Exercised ─ ─ Forfeited (351,085 ) $ 1.38 Outstanding at March 31, 2016 5,584,420 $ 3.38 7.17 $ 88,258 Vested or expected to vest at March 31, 2016 3,176,655 $ 5.04 5.82 $ 43,329 Exercisable at March 31, 2016 2,537,373 $ 6.00 4.99 $ 27,625 |
Assumptions used in Black-Scholes Pricing Model for New Grants | The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Three Months Ended March 31, 2016 2015 Volatility factor 73.79%-73.91% 78.7% Expected term (in years) 6.25 6.25 Risk-free interest rates 1.38% 1.54% Dividend yield — — |
Restricted Stock Activity | The restricted stock activity for the three months ended March 31, 2016 is as follows: Number Weighted- Average Fair-Value Unvested at December 31, 2015 42,750 $ 1.61 Granted — — Vested/Released (42,750 ) 1.61 Unvested at March 31, 2016 — — |
Strategic Restructuring (Tables
Strategic Restructuring (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Restructuring And Related Activities [Abstract] | |
Restructuring Activity Recorded in Operating Expenses and in Accrued Expenses | The following table summarizes the components of the Company’s restructuring activity recorded in operating expenses and in accrued expenses in the accompanying consolidated balance sheet: Restructuring amounts accrued at December 31, 2015 Restructuring expense incurred during the three months ended March 31, 2016 Restructuring amounts paid during the three months ended March 31, 2016 Restructuring amounts accrued at March 31, 2016 (in thousands) Employee severance, benefits and related costs. $ 357 — $ (161 ) 196 |
Organization - Additional Infor
Organization - Additional Information (Detail) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016USD ($)Subsidiary | Dec. 31, 2015USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Number of subsidiaries | Subsidiary | 2 | |
Accumulated deficit | $ | $ (502,739) | $ (495,029) |
Significant Accounting Polici25
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | ||
Mar. 31, 2016USD ($)Segment | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | |
Significant Accounting Policies [Line Items] | |||
Cash equivalents | $ 9,100,000 | $ 16,300,000 | |
Realized gain (loss) recognized on sale of marketable securities | 0 | $ 0 | |
Aggregate unrealized losses of securities | 3,000 | ||
Accounts receivable | 1,736,000 | $ 4,641,000 | |
Assets measured at level 3 on recurring basis | 0 | ||
Liabilities measured at level 3 on recurring basis | 0 | ||
Impairment losses | 0 | $ 200,000 | |
Tax benefits of the stock based compensation expenses recognized | 0 | ||
Income tax provision or expense | $ 100,000 | ||
Number of operating segments | Segment | 1 | ||
United Kingdom | |||
Significant Accounting Policies [Line Items] | |||
Net assets located in the United Kingdom | $ 900,000 | ||
Level 3 | |||
Significant Accounting Policies [Line Items] | |||
Fair value of loan payable | 10,100,000 | ||
C A Nbridge Life Sciences Ltd | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable | 900,000 | ||
Biodesix | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable | 700,000 | ||
Astellas Pharma Incorporation | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable | $ 200,000 | ||
Minimum | |||
Significant Accounting Policies [Line Items] | |||
Marketable securities maturity term | 3 months | ||
Maximum | |||
Significant Accounting Policies [Line Items] | |||
Marketable securities maturity term | 24 months | ||
Maximum | Corporate debt securities | |||
Significant Accounting Policies [Line Items] | |||
Aggregate unrealized losses of securities | $ 1,000 |
Available for Sale Securities (
Available for Sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 5,747 | $ 7,504 |
Unrealized Gains | 2 | |
Unrealized Losses | (3) | |
Fair Value | 5,749 | 7,501 |
Corporate debt securities | Due within 1 year | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,748 | 6,504 |
Unrealized Gains | 2 | |
Unrealized Losses | (3) | |
Fair Value | 4,750 | 6,501 |
Government agency securities | Due within 1 year | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 999 | 1,000 |
Fair Value | $ 999 | $ 1,000 |
Marketable Securities in Unreal
Marketable Securities in Unrealized Loss Position (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Investments Unrealized Loss Position [Line Items] | |
Aggregate Fair Value | $ 5,100 |
Unrealized Losses | (3) |
Corporate debt securities | Due within 1 year | |
Investments Unrealized Loss Position [Line Items] | |
Aggregate Fair Value | 4,100 |
Unrealized Losses | (3) |
Government agency securities | Due within 1 year | |
Investments Unrealized Loss Position [Line Items] | |
Aggregate Fair Value | $ 1,000 |
Summary of Cash Equivalents and
Summary of Cash Equivalents and Marketable Securities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 5,749 | $ 7,501 |
Fair Value Measurements Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 9,050 | 16,274 |
Marketable securities | 5,749 | 7,501 |
Cash Equivalents, and Marketable Securities Fair Value Disclosure, Total | 14,799 | 23,775 |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 6,907 | 11,462 |
Cash Equivalents, and Marketable Securities Fair Value Disclosure, Total | 6,907 | 11,462 |
Fair Value Measurements Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,143 | 4,812 |
Marketable securities | 5,749 | 7,501 |
Cash Equivalents, and Marketable Securities Fair Value Disclosure, Total | $ 7,892 | $ 12,313 |
Potential Common Shares Exclude
Potential Common Shares Excluded from Calculation of Net Loss Per Common Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 6,193 | 6,470 |
Stock Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 5,584 | 5,861 |
Warrant | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 609 | 609 |
Stock Based Compensation Expens
Stock Based Compensation Expense for Equity-Classified Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 390 | $ 427 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 125 | 125 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 265 | 233 |
Restructuring | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 69 |
Collaborations and License Ag31
Collaborations and License Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Apr. 30, 2016USD ($) | Aug. 31, 2015USD ($) | Nov. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Mar. 31, 2016USD ($)Indication | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 30, 2014USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaboration revenue | $ 1,203,000 | $ 134,000 | |||||||
Amounts due from pursuant to the cost-sharing provisions | 1,736,000 | $ 4,641,000 | |||||||
Clinical Efficacy Milestone | Option and License Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | $ 6,000,000 | ||||||||
CANbridge | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
License agreement date | Mar. 16, 2016 | ||||||||
Collaborations and license agreements, milestone payment received | $ 0 | ||||||||
Amounts due from pursuant to the cost-sharing provisions | 900,000 | ||||||||
CANbridge | Licensing Agreements | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Accounts receivable, net | 100,000 | ||||||||
Reimbursable amount for manufacturing costs and expenses. | $ 1,000,000 | ||||||||
Collaborations and license agreements, time period from first commercial sale of certain product upon which the agreement expires | 10 years | ||||||||
Collaborations and license agreements, written notice period for termination | 30 days | ||||||||
Collaborations and license agreements, written notice period for termination other material breach | 90 days | ||||||||
Collaborations and license agreements, written notice period for termination without cause | 180 days | ||||||||
Allocation of upfront payment | $ 1,000,000 | ||||||||
Collaboration revenue | 1,000,000 | ||||||||
CANbridge | Licensing Agreements | Subsequent Event | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | $ 1,000,000 | ||||||||
CANbridge | Licensing Agreements | Sales Based Milestone Payments | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | 90,000,000 | ||||||||
CANbridge | Licensing Agreements | Development and Regulatory Milestone Events | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | $ 42,000,000 | ||||||||
CANbridge | Licensing Agreements | Clinical Efficacy Milestone | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, written notice period for termination | 45 days | ||||||||
CANbridge | Licensing Agreements | Due Within Twelve Months From Effective Date | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Reimbursable amount for manufacturing costs and expenses. | $ 500,000 | ||||||||
CANbridge | Licensing Agreements | Due Within Eighteen Months From Effective Date | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Reimbursable amount for manufacturing costs and expenses. | $ 500,000 | ||||||||
EUSA | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
License agreement date | Dec. 21, 2006 | ||||||||
Collaborations and license agreements, expected milestone receivable | $ 4,000,000 | ||||||||
Research and development funding received | 2,500,000 | 2,500,000 | |||||||
Payments received in connection with indications | $ 2,000,000 | ||||||||
Eligible number of indications | Indication | 3 | ||||||||
Payments received in connection with additional indications | $ 5,000,000 | ||||||||
Potential payments received in connection with additional indications | 335,000,000 | ||||||||
Collaborations and license agreements, milestone payment received | 100,000 | ||||||||
EUSA | Utilization of Data Generated by Planned Phase Three Study | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Milestone payment to be received | 20,000,000 | ||||||||
EUSA | Potential Phase One Combination Study | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Milestone payment to be received | 2,000,000 | ||||||||
EUSA | Marketing Approval in France, Germany, Italy, Spain and the United Kingdom | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Milestone payment to be received | 2,000,000 | ||||||||
EUSA | Marketing Approval in Argentina, Australia, Brazil, South Africa and Venezuela | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Milestone payment to be received | $ 2,000,000 | ||||||||
Novartis | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | $ 15,000,000 | ||||||||
Period for payment of license fees | 15 days | ||||||||
Reimbursable inventory | 3,500,000 | ||||||||
License and service revenue | $ 3,500,000 | ||||||||
Amounts due from pursuant to the cost-sharing provisions | 0 | ||||||||
Novartis | Sales Based Milestone Payments | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | 150,000,000 | ||||||||
Novartis | Clinical Efficacy Milestone | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | 53,000,000 | ||||||||
Novartis | Regulatory Milestone Events | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | 105,000,000 | ||||||||
Novartis | License and Technical Knowledge | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaboration revenue | 15,000,000 | ||||||||
Pharmstandard | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | 1,500,000 | ||||||||
Allocation of upfront payment | 1,000,000 | ||||||||
Collaboration revenue | $ 38,000 | ||||||||
Period for payment of license fees | 15 days | ||||||||
Upfront license payment | 1,000,000 | ||||||||
Pharmstandard | Receivable within fifteen business days of the date the license agreement is registered with the Federal Service for Intellectual Property of the Russian Federation | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
License fees receivable | $ 500,000 | ||||||||
Pharmstandard | Receivable With First Marketing Authorization | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
License fees receivable | 7,500,000 | ||||||||
Pharmstandard | Receivable If Additional Regulatory Studies Required Prior To Approval | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
License fees receivable | 3,000,000 | ||||||||
Pharmstandard | Receivable For Each Additional Approval | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
License fees receivable | $ 3,000,000 | ||||||||
Ophthotech Corporation | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
One time option exercise fee | $ 2,000,000 | ||||||||
Ophthotech Corporation | Option and License Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Upfront license payment | $ 500,000 | ||||||||
License expiration period | 2017-02 | ||||||||
Collaborations and license agreements, payment received | $ 500,000 | ||||||||
Collaborations and license agreements, revenue recognized | 28,000 | 58,000 | |||||||
Ophthotech Corporation | Sales Based Milestone Payments | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, milestone payment received | 45,000,000 | ||||||||
Ophthotech Corporation | Phase Two Clinical Trials | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, milestone payment received | 10,000,000 | ||||||||
Ophthotech Corporation | Marketing Approval in the United States | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, milestone payment received | 20,000,000 | ||||||||
Ophthotech Corporation | Marketing Approval in the UK, Germany, Spain, Italy and France | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, milestone payment received | $ 20,000,000 | ||||||||
Ophthotech Corporation | Clinical Efficacy Milestone | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, written notice period for termination | 90 days | ||||||||
Ophthotech Corporation | Ind Submission Milestone Payment | Option and License Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | ||||||||
Biodesix | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Amounts due from pursuant to the cost-sharing provisions | 700,000 | ||||||||
Biodesix | N S C L C P O C Trial | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Amounts due from pursuant to the cost-sharing provisions | 700,000 | 900,000 | |||||||
Collaborations and license agreements, payment received | 1,300,000 | 1,800,000 | |||||||
Responsible percentage of development and regulatory costs after cap reached | 50.00% | ||||||||
Collaborations and license agreements, royalties payment on net sales | 10.00% | ||||||||
Biodesix | N S C L C P O C Trial | Research and development | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Payments received and recorded as an increased (decreased) to expense pursuant to cost-sharing provisions | $ 900,000 | 900,000 | |||||||
Biodesix | N S C L C P O C Trial | Maximum | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Funding | $ 15,000,000 | ||||||||
St Vincent's Hospital Sydney Limited | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Amendment agreement date | 2015-08 | ||||||||
License fees payable | $ 18,900,000 | ||||||||
Collaborations and license agreements, milestone payment | 400,000 | ||||||||
St Vincent's Hospital Sydney Limited | Licensing Agreements | Up-front Payment Arrangement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, cash payment | 1,500,000 | ||||||||
Biogen Idec International GmbH | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, revenue recognized | $ 14,100,000 | ||||||||
Collaborations and license agreements, deferred revenue | 14,700,000 | ||||||||
Collaborations and license agreements, relative selling price of the deliverable | $ 600,000 | ||||||||
Biogen Idec International GmbH | Maximum | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Royalty payments | 50,000,000 | ||||||||
Biogen Idec International GmbH | Option and License Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, revenue recognized | 38,000 | 76,000 | |||||||
Astellas Pharma Inc. | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Amounts due from pursuant to the cost-sharing provisions | 200,000 | ||||||||
Astellas Pharma Inc. | Astellas Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Amounts due from pursuant to the cost-sharing provisions | 200,000 | (200,000) | |||||||
Astellas Pharma Inc. | Astellas Agreement | Research and development | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Payments received and recorded as an increased (decreased) to expense pursuant to cost-sharing provisions | (200,000) | 200,000 | |||||||
Astellas Pharma Inc. | Collaboration and License Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Collaborations and license agreements, payment received | $ 100,000 | $ 500,000 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Payables And Accruals [Abstract] | ||
Clinical expenses | $ 1,108 | $ 1,793 |
Professional fees | 675 | 573 |
Salaries and benefits | 423 | 938 |
Manufacturing and distribution | 198 | 173 |
Restructuring | 196 | 357 |
Other | 243 | 272 |
Accrued expenses | $ 2,843 | $ 4,106 |
Loans Payable - Additional Info
Loans Payable - Additional Information (Detail) | Sep. 24, 2014USD ($)$ / sharesshares | Mar. 31, 2012USD ($) | Jun. 02, 2010USD ($)$ / sharesshares | May. 28, 2010USD ($) | Mar. 31, 2016USD ($)Installment | Jun. 30, 2014USD ($) | May. 31, 2012USD ($) |
Debt Instrument [Line Items] | |||||||
Loan outstanding | $ 11,600,000 | $ 10,000,000 | |||||
Loan payable, end-of-term payment due | 540,000 | ||||||
Deferred financing charge | $ 1,200,000 | $ 1,300,000 | |||||
Warrants issued to lenders as part of new loan agreement, shares of common stock to purchase | shares | 608,696 | 156,641 | |||||
Warrants issued to lenders as part of new loan agreement, exercise price | $ / shares | $ 1.15 | $ 7.98 | |||||
Warrants issued to lenders as part of new loan agreement, fair value | $ 400,000 | $ 800,000 | |||||
Maximum amount of debt conversion | $ 2,000,000 | ||||||
Loans Payable | Security Agreement Hercules | |||||||
Debt Instrument [Line Items] | |||||||
Loan payable, aggregate principal amount | $ 26,500,000 | $ 25,000,000 | |||||
Loan payable, start date of first principal payment | Apr. 1, 2013 | ||||||
Loan payable, Commencement date | Jan. 1, 2012 | ||||||
Loan payable, number of installments of principal and interest | Installment | 30 | ||||||
Loan payable, frequency of installments of principal and interest | 30 equal monthly installments | ||||||
Loan payable, description of interest rate terms | Per annum interest is payable on the principal balance of both loans at the greater of 11.9% and an amount equal to 11.9% plus the prime rate of interest minus 4.75% as determined daily, provided however, that the per annum interest shall not exceed 15.0% (11.9% as of March 31, 2016). | ||||||
Loan payable, interest rate, base rate | 11.90% | ||||||
Loan payable, interest rate, additional rate deducted from base rate | 4.75% | ||||||
Loan payable, maximum per annum interest rate | 15.00% | ||||||
Loan payable, interest rate | 11.90% | ||||||
Loan issuance costs paid | $ 200,000 | ||||||
Debt instrument convertible beneficial conversion feature | $ 0 | ||||||
Loans Payable | Security Agreement Hercules | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Loan payable, interest rate | 11.90% | ||||||
Option to purchase equity, net cash proceeds of equity securities | $ 10,000,000 | ||||||
Loans Payable | Hercules Amended Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Loan payable, aggregate principal amount | $ 10,000,000 | ||||||
Loan payable, Commencement date | Jan. 1, 2015 | ||||||
Loan payable, number of installments of principal and interest | Installment | 12 | ||||||
Loan payable, frequency of installments of principal and interest | Monthly principal and interest payments | ||||||
Loan payable, due date | Jan. 1, 2018 | ||||||
Loan payable, end-of-term payment due | $ 500,000 | ||||||
Liquidity ratio | 125.00% | ||||||
Option to purchase equity, description | The Company has agreed to maintain, with respect to the new loan of $10.0 million, a liquidity ratio equal to or greater than 1.25 to 1.00 or the equivalent of $12.5 million in unrestricted and unencumbered cash and cash equivalents. | ||||||
Loans Payable | Hercules Amended Loan Agreement | Financial covenant | |||||||
Debt Instrument [Line Items] | |||||||
Unrestricted and unencumbered cash and cash equivalents | $ 12,500,000 |
Future Minimum Payments Under L
Future Minimum Payments Under Loans Payable (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Debt Disclosure [Abstract] | ||
2016 (9 months remaining) | $ 3,199 | |
2,017 | 4,645 | |
2,018 | 4,269 | |
Long-term Debt, Gross, Total | 12,113 | |
Less amount representing interest | (1,572) | |
Less discount | (445) | |
Less deferred charges | (540) | |
Less current portion Loans Payable Current | (3,019) | $ (2,053) |
Loans payable, net of current portion and discount | $ 6,537 | $ 7,418 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | 3 Months Ended | ||||
Mar. 31, 2016 | Dec. 31, 2015 | May. 07, 2015 | Mar. 31, 2015 | Feb. 28, 2015 | |
Class Of Stock [Line Items] | |||||
Common stock sales agreement, aggregate offering amount | $ 58,000 | $ 58,000 | |||
Offering, issuance and sale of stocks and securities, shelf registration | $ 250,000,000 | ||||
Common stock, shares issued | 58,182,000 | 58,182,000 | |||
Number of additional shares issued | 0 | ||||
Maximum | |||||
Class Of Stock [Line Items] | |||||
Offering, issuance and sale of stocks and securities, shelf registration | $ 100,000,000 | ||||
F B R Co | |||||
Class Of Stock [Line Items] | |||||
Common stock, shares issued | 5,900,000 | ||||
proceeds from sale of shares | $ 10,200,000 | ||||
Common Stock Available For Sale Under Sales Agreement | $ 9,000,000 | ||||
F B R Co | Maximum | |||||
Class Of Stock [Line Items] | |||||
Common stock sales agreement, aggregate offering amount | $ 15,000,000 | $ 17,900,000 | |||
Common stock sales agreement commission, percentage | 3.00% |
Stock Option Activity (Detail)
Stock Option Activity (Detail) | 3 Months Ended |
Mar. 31, 2016USD ($)$ / sharesshares | |
Options | |
Outstanding at beginning of period | shares | 4,796,005 |
Granted | shares | 1,139,500 |
Forfeited | shares | (351,085) |
Outstanding at end of period | shares | 5,584,420 |
Vested or expected to vest at March 31, 2016 | shares | 3,176,655 |
Exercisable at March 31, 2016 | shares | 2,537,373 |
Weighted-Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 3.78 |
Granted | $ / shares | 1.08 |
Forfeited | $ / shares | 1.38 |
Outstanding at end of period | $ / shares | 3.38 |
Vested or expected to vest at March 31, 2016 | $ / shares | 5.04 |
Exercisable at March 31, 2016 | $ / shares | $ 6 |
Weighted-Average Remaining Contractual Term | |
Outstanding at March 31, 2016 | 7 years 2 months 1 day |
Vested or expected to vest at March 31, 2016 | 5 years 9 months 26 days |
Exercisable at March 31, 2016 | 4 years 11 months 27 days |
Aggregate Intrinsic Value | |
Outstanding at end of year | $ | $ 88,258 |
Vested or expected to vest at end of year | $ | 43,329 |
Exercisable at end of year | $ | $ 27,625 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options issued to purchase common stock | 5,584,420 | 4,796,005 | |
Total unrecognized stock-based compensation expense related to stock options granted | $ 700,000 | ||
Total unrecognized stock-based compensation expense related to restricted stock awards granted | $ 0 | ||
Awards With Market Conditions | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options issued to purchase common stock | 321,000 | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average grant date fair value of stock options granted | $ 0.71 | $ 0.62 | |
Share based payment award forfeiture rates | 76.00% | 70.00% | |
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 3 years | ||
Intrinsic value of options exercised | $ 0 | $ 13,000 |
Assumptions Used in Black Schol
Assumptions Used in Black Scholes Pricing Model for New Grants (Detail) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Volatility factor, minimum | 73.79% | |
Volatility factor, maximum | 73.91% | |
Volatility factor | 78.70% | |
Expected term (in years) | 6 years 3 months | 6 years 3 months |
Risk-free interest rates | 1.38% | 1.54% |
Restricted Stock Activity (Deta
Restricted Stock Activity (Detail) | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Number of Shares | |
Unvested at beginning of period | shares | 42,750 |
Vested/Released | shares | (42,750) |
Weighted-Average Grant-Date Fair Value | |
Unvested at beginning of period | $ / shares | $ 1.61 |
Vested/Released | $ / shares | $ 1.61 |
Strategic Restructuring - Addit
Strategic Restructuring - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2016Position | |
Restructuring And Related Activities [Abstract] | |
Restructuring plan, completion date | Mar. 31, 2015 |
Restructuring plan, percentage of number of positions eliminated | 66.67% |
Restructuring plan, number of positions eliminated | 40 |
Restructuring Activity Recorded
Restructuring Activity Recorded in Operating Expenses and Accrued Expenses (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2016USD ($) | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring amounts accrued, beginning balance | $ 357 |
Restructuring amounts accrued, ending balance | 196 |
Employee Severance | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring amounts accrued, beginning balance | 357 |
Restructuring amounts paid | (161) |
Restructuring amounts accrued, ending balance | $ 196 |
Facility Lease Exit - Additiona
Facility Lease Exit - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Sep. 30, 2014 | Mar. 31, 2016 | |
Facility Lease Exit Disclosure [Line Items] | ||
Notice period to surrender remaining leased space | 90 days | |
3rd Amendment, Lease exit costs associated with 650 E. Kendall. | ||
Facility Lease Exit Disclosure [Line Items] | ||
Lease exit expense incurred | $ 15.6 | |
Leased space surrendering date | May 29, 2015 | |
3rd Amendment, Lease exit costs associated with 650 E. Kendall. | Leasehold Improvements | ||
Facility Lease Exit Disclosure [Line Items] | ||
Additional charge to depreciation expense due to revision of estimated useful life | $ 1.4 | |
3rd Amendment, Lease exit costs associated with 650 E. Kendall. | Deferred Rent And Leasehold Improvement | ||
Facility Lease Exit Disclosure [Line Items] | ||
Additional charge to depreciation expense due to revision of estimated useful life | $ 1.7 |
Legal Proceedings -Additional I
Legal Proceedings -Additional Information (Detail) $ in Thousands | Mar. 31, 2016USD ($)LegalMatter | Dec. 31, 2015USD ($) |
Commitments And Contingencies Disclosure [Abstract] | ||
Class action lawsuits | LegalMatter | 2 | |
Reserve for settlement of fines | $ | $ 4,000 | $ 4,000 |