Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | PTLA | |
Entity Registrant Name | PORTOLA PHARMACEUTICALS INC | |
Entity Central Index Key | 1,269,021 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 52,705,617 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 77,722 | $ 57,514 |
Short-term investments | 278,246 | 251,759 |
Receivables from collaborators | 57 | |
Prepaid expenses and other current assets | 20,499 | 5,747 |
Total current assets | 376,467 | 315,077 |
Property and equipment, net | 5,406 | 2,776 |
Long-term investments | 83,030 | |
Prepaid and other long-term assets | 12,987 | 15,612 |
Total assets | 394,860 | 416,495 |
Current liabilities: | ||
Accounts payable | 9,173 | 14,084 |
Accrued compensation and employee benefits | 3,841 | 3,512 |
Accrued research and development | 23,742 | 12,545 |
Accrued and other liabilities | 3,697 | 1,421 |
Deferred revenue, current portion | 8,705 | 9,569 |
Total current liabilities | 49,158 | 41,131 |
Deferred revenue, long-term | 20,726 | 27,016 |
Other long-term liabilities | 2,068 | 546 |
Total liabilities | $ 71,952 | $ 68,693 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.001 par value, 100,000,000 shares authorized at September 30, 2015 and December 31, 2014; 52,704,383 and 48,766,806 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | $ 53 | $ 49 |
Additional paid-in capital | 906,031 | 770,789 |
Accumulated deficit | (583,196) | (422,797) |
Accumulated other comprehensive income/(loss) | 20 | (239) |
Total stockholders’ equity | 322,908 | 347,802 |
Total liabilities and stockholders’ equity | $ 394,860 | $ 416,495 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
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 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 52,704,383 | 48,766,806 |
Common stock, shares outstanding | 52,704,383 | 48,766,806 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Income Statement [Abstract] | ||||
Collaboration and license revenue | $ 2,912 | $ 2,427 | $ 7,656 | $ 7,213 |
Operating expenses: | ||||
Research and development | 48,405 | 31,780 | 140,563 | 88,918 |
Selling, general and administrative | 10,071 | 6,424 | 27,987 | 16,601 |
Total operating expenses | 58,476 | 38,204 | 168,550 | 105,519 |
Loss from operations | (55,564) | (35,777) | (160,894) | (98,306) |
Interest and other income (expense), net | 406 | (16) | 495 | 437 |
Net loss | $ (55,158) | $ (35,793) | $ (160,399) | $ (97,869) |
Net loss per share attributable to common stockholders: | ||||
Basic and diluted | $ (1.05) | $ (0.86) | $ (3.12) | $ (2.37) |
Shares used to compute net loss per share attributable to common stockholders: | ||||
Basic and diluted | 52,576,005 | 41,402,037 | 51,428,117 | 41,233,206 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (55,158) | $ (35,793) | $ (160,399) | $ (97,869) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities, net of tax | 111 | (46) | 259 | (79) |
Total comprehensive loss | $ (55,047) | $ (35,839) | $ (160,140) | $ (97,948) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Operating activities | ||
Net loss | $ (160,399) | $ (97,869) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 942 | 1,142 |
Amortization of premium on investment securities | 2,548 | 2,669 |
Stock-based compensation expense | 16,032 | 6,876 |
Gain on retirement of equipment | (11) | |
Unrealized loss on foreign currency forward contracts | 114 | |
Changes in operating assets and liabilities: | ||
Receivables from collaborators | 57 | 236 |
Prepaid expenses and other current assets | (14,753) | (797) |
Prepaid and other long-term assets | 2,625 | (9,954) |
Accounts payable | (5,332) | 9,354 |
Accrued compensation and employee benefits | 383 | (40) |
Accrued research and development | 11,197 | (1,973) |
Accrued and other liabilities | 2,276 | (610) |
Deferred revenue | (7,154) | 33,787 |
Other long-term liabilities | 1,522 | 418 |
Net cash used in operating activities | (150,067) | (56,647) |
Investing activities | ||
Purchases of property and equipment | (3,150) | (1,329) |
Proceeds from sale of equipment | 11 | |
Purchases of investments | (187,166) | (156,009) |
Proceeds from maturities of investments | 241,422 | 145,661 |
Net cash provided by/(used) in investing activities | 51,117 | (11,677) |
Financing activities | ||
Proceeds from public offering of common stock, net of underwriters discount | 108,772 | |
Payment of public offering cost | (358) | (239) |
Proceeds from issuance of common stock pursuant to equity award plans | 10,744 | 3,934 |
Net cash provided by financing activities | 119,158 | 3,695 |
Net increase/(decrease) in cash and cash equivalents | 20,208 | (64,629) |
Cash and cash equivalents at beginning of period | 57,514 | 117,773 |
Cash and cash equivalents at end of period | $ 77,722 | $ 53,144 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2015 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | 1. Organization Portola Pharmaceuticals, Inc. (the “Company” or “we” or “our” or “us”) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis, other hematologic diseases and inflammation for patients who currently have limited or no approved treatment options. We were incorporated in September 2003 in Delaware. Our headquarters and operations are located in South San Francisco, California and we operate in one segment. Our Phase 3 programs address significant unmet medical needs in the area of thrombosis, or blood clots. Betrixaban, a Food and Drug Administration, or FDA-designated Fast-Track novel oral once-daily inhibitor of Factor Xa is in a Phase 3 clinical trial for extended duration prophylaxis, or preventive treatment, of a form of thrombosis known as venous thromboembolism, in acute medically ill patients for 35 days of in-hospital and post-discharge use. Our second Phase 3 compound, Andexanet alfa, a FDA-designated breakthrough therapy and orphan drug, is a recombinant protein designed to reverse anticoagulant activity in patients treated with a Factor Xa inhibitor. Andexanet alfa has potential indications to reverse anticoagulant activity in patients taking a direct or indirect Factor Xa inhibitor who suffer a major bleeding episode or require emergency surgery. Our third product candidate Cerdulatinib, is an orally available kinase inhibitor that inhibits spleen tyrosine kinase, or Syk, and janus kinases, or JAK, enzymes that regulate important signaling pathways and is being developed for hematologic, or blood, cancers and inflammatory disorders. We are currently in a Phase 1/2a proof-of-concept study with Cerdulatinib in non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. In the Phase 1 dose escalation portion of the study, we have yet to reach the maximum tolerated dose and enrollment continues.We have also partnered with Ora, Inc. or Ora for the development of a proprietary Syk specific inhibitor. In March 2015, we completed an underwritten public offering of 2,870,000 shares of our Common Stock, which included 374,348 shares of Common Stock issued pursuant to the over-allotment option granted to our underwriters, at a public offering price of $40.00 per share. The net proceeds from the offering to us including the over-allotment option, net of underwriting discounts, commissions and offering expenses of approximately $358,000, were approximately $108.4 million. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Consolidation and Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the amounts of the Company and our wholly-owned subsidiaries and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of our financial information. The results of operations for the three and nine months ended September 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other interim period or for any other future year. The condensed consolidated balance sheet as of December 31, 2014 has been derived from audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. Certain prior-period amounts have been reclassified to conform to the current-period presentation. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2014 included in our Annual Report on Form 10-K filed March 2, 2015 with the SEC. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities and the reported amounts of revenues and expenses in the condensed consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, clinical trial accruals, fair value of assets and liabilities, income taxes, variable interest entities and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates. Variable Interest Entities We review agreements we enter into with third party entities, pursuant to which we may have a variable interest in that entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, we assess whether or not we are the primary beneficiary of that entity. In determining whether we are the primary beneficiary of an entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If we determine we are the primary beneficiary of a VIE, we consolidate the operations and financial position of the VIE into our consolidated financial statements. Our determination about whether we should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. Cash and Cash Equivalents Cash and cash equivalents consist of cash and other highly liquid investments with original maturities of three months or less from the date of purchase. Investments All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments in debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated comprehensive income/ (loss). Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income (expense), net. Collaboration Collaboration customers who accounted for 10% or more of total collaboration and license revenues were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Daiichi Sankyo, Inc. 40 % 63 % 45 % 43 % Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. 45 % 28 % 38 % 39 % Bristol-Myers Squibb Company and Pfizer Inc. 13 % 7 % 15 % 15 % Revenue Recognition We generate revenue from collaboration and license agreements for the development and commercialization of our products. Collaboration and license agreements may include non-refundable or partially refundable upfront license fees, partial or complete reimbursement of research and development costs, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. Our performance obligations under our collaborations include the transfer of intellectual property rights (licenses), obligations to provide research and development services and related clinical drug supply, obligation to provide regulatory approval services and obligations to participate on certain development and/or commercialization committees with the collaborators. Upfront payments are recorded as deferred revenue in our condensed consolidated balance sheet and are recognized as collaboration revenue over our estimated period of performance that is consistent with the terms of the research and development obligations contained in each collaboration agreement. We regularly review the estimated periods of performance related to our collaborations based on the progress made under each arrangement. Our estimates of our performance period may change over the course of the collaboration term. Such a change could have a material impact on the amount of revenue we record in future periods. Payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is defined as an event that can only be achieved based on our performance and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones subject to this guidance. Further, the amounts received must relate solely to prior performance, be reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Payments contingent upon achievement of events that are not considered substantive milestones are allocated to the respective arrangements unit of accounting when received and recognized as revenue based on the revenue recognition policy for that unit of accounting. Amounts from sales of licenses are recognized as revenue. Amounts received as funding of research and development or regulatory approval activities are recognized as revenue if the collaboration arrangement involves the sale of our research or development and regulatory approval services at amounts that exceed our cost. However, such funding is recognized as a reduction in research and development expense when we engage in a research and development project jointly with another entity, with both entities participating in project activities and sharing costs and potential benefits of the arrangement. Amounts related to research and development and regulatory approval funding are recognized as the related services or activities are performed, in accordance with the contract terms. Payments may be made to or by us based on the number of full-time equivalent researchers assigned to the collaboration project and the related research and development expenses incurred. Foreign Currency Transactions and Hedging We have financial transactions denominated in foreign currencies, primarily the Euro and British Pound, and, as a result, are exposed to changes in foreign currency exchange rates. We manage a portion of these cash flow exposures through purchasing and holding of Euros and British Pounds and the use of foreign currency forward contracts. Our foreign currency forward contracts are not designated as hedges for accounting purposes. Gains or losses on foreign currency forward contracts are intended to offset gains or losses on the underlying net exposures in an effort to reduce the earnings and cash flow volatility resulting from fluctuating foreign currency exchange rates. Foreign currency deposits we hold are remeasured using period end spot rates. Foreign currency forward contracts are marked to market at the end of each period and recorded as gains and losses in the condensed consolidated statements of operations. We held no foreign currency forward contracts at September 30, 2015 or December 31, 2014. We recorded an unrealized loss of $113,000 and $114,000 in interest and other income (expense), net in our condensed consolidated statements of operations related to foreign currency forward contracts for the three and nine months ended September 30, 2014, respectively. During the three and nine months ended September 30, 2014, we settled foreign currency forward contracts and recognized a realized loss of $75,000 and $326,000, respectively, in interest and other income (expense), net. Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparty, a major financial institution, is unable to meet the terms of the agreement. Our management does not expect material losses as a result of defaults by the counterparty. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to Common Stockholders is calculated by dividing the net loss attributable to Common Stockholders by the weighted-average number of shares of Common Stock outstanding for the period. Diluted net loss per share attributable to Common Stockholders is computed by giving effect to all potential dilutive Common Stock equivalents outstanding for the period. Diluted net loss per share attributable to Common Stockholders is the same as basic net loss per share attributable to Common Stockholders, since the effects of potentially dilutive securities are antidilutive. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board(the “FASB”), jointly with the International Accounting Standards Board, issued ASU 2014-09, Revenue from Contracts with Customers In February 2015, the Financial Accounting Standards Board (the “FASB”) issued ASU 2015-02, Consolidation: amendment to the consolidation analysis |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The carrying amounts of certain of our financial instruments, including cash and cash equivalents, investments, receivables from collaborators, prepaid expenses and other current assets and accounts payable, approximate their fair value due to their short term nature. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2 – Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 – Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that were measured on a recurring basis (in thousands): September 30, 2015 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 21,351 $ — $ — $ 21,351 Corporate notes and commercial paper — 181,962 — 181,962 U.S. government agency securities — 140,056 — 140,056 Total financial assets $ 21,351 $ 322,018 $ — $ 343,369 December 31, 2014 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 24,915 $ — $ — $ 24,915 Corporate notes and commercial paper — 226,047 — 226,047 U.S. government agency securities — 120,169 — 120,169 Total financial assets $ 24,915 $ 346,216 $ — $ 371,131 We estimate the fair values of our corporate notes and commercial paper and U.S government agency securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs. There were no transfers between Level 1 and Level 2 during the periods presented. |
Financial Instruments
Financial Instruments | 9 Months Ended |
Sep. 30, 2015 | |
Investments Debt And Equity Securities [Abstract] | |
Financial Instruments | 4. Financial Instruments Cash equivalents and investments, all of which are classified as available-for-sale securities, consisted of the following (in thousands): September 30, 2015 December 31, 2014 Estimated Estimated Unrealized Unrealized Fair Unrealized Unrealized Fair Cost Gain (Loss) Value Cost Gain (Loss) Value Money market funds $ 21,351 $ — $ — $ 21,351 $ 24,915 $ — $ — $ 24,915 Corporate notes and commercial paper 181,981 14 (33 ) 181,962 226,209 8 (170 ) 226,047 U.S. government agency securities 140,017 39 (1 ) 140,056 120,246 4 (81 ) 120,169 $ 343,349 $ 53 $ (34 ) $ 343,369 $ 371,370 $ 12 $ (251 ) $ 371,131 Classified as: Cash equivalents $ 65,123 $ 36,342 Short-term investments 278,246 251,759 Long-term investments — 83,030 Total cash equivalents and investments $ 343,369 $ 371,131 At September 30, 2015, the remaining contractual maturities of available-for-sale securities were less than one year and at December 31, 2014, the remaining contractual maturities of available-for-sale securities were less than two years. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2015 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration and License Agreements | 5. Collaboration and License Agreements Summary of Collaboration-Related Revenue We have recognized revenue from our collaboration and license agreements as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Daiichi Sankyo $ 1,154 $ 1,523 $ 3,424 $ 3,133 Bayer and Janssen 1,316 676 2,922 2,782 BMS and Pfizer 388 164 1,152 1,109 Lee's Pharmaceutical 54 64 158 189 Total collaboration and license revenue $ 2,912 $ 2,427 $ 7,656 $ 7,213 Daiichi Sankyo, Inc. (“Daiichi Sankyo”) In June 2013, we entered into an agreement with Daiichi Sankyo to include subjects dosed with edoxaban, their Factor Xa inhibitor product, in one of our Phase 2 proof-of-concept studies of Andexanet alfa. We are responsible for the cost of conducting this clinical study. Under the terms of the agreement, Daiichi Sankyo provided us with an upfront fee of $6.0 million, $3.0 million of which was subject to refund if Daiichi Sankyo decided to terminate the agreement. We are obligated to participate on a JCC with Daiichi Sankyo to oversee the collaboration activities under the agreement. We identified the following performance deliverables under the agreement: 1) the obligation to provide research and development services, which includes supplying Andexanet alfa and providing a final written report, and 2) the obligation to participate on the JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the revenue associated with these two deliverables. We have accounted for the research and development services and our participation on the JCC as a single unit of accounting as neither deliverable has standalone value and both obligations will be delivered throughout the estimated period of performance. The total non-contingent consideration under this agreement of $3.0 million was fully recognized as revenue on a straight-line basis over the estimated non-contingent performance period through the first quarter of 2014. The recognition of contingent consideration under this agreement of $3.0 million commenced upon resolution of the contingency in the first quarter of 2014 and was originally being recognized over the remaining estimated period of performance through the first quarter of 2015. During the fourth quarter of 2014 we decided to include edoxaban data in our initial BLA submission and thus updated the performance period associated with the contingent payment to be through the fourth quarter of 2015. During the three and nine months ended September 30, 2015 and 2014, we recognized $264,000 and $782,000, and $662,000 and $2.3 million, respectively, in collaboration revenue associated with the contingent and non-contingent elements of this arrangement. The deferred revenue balance under this agreement as of September 30, 2015 was $263,000. In July 2014, we entered into an agreement with Daiichi Sankyo to study the safety and efficacy of Andexanet alfa as a reversal agent to their oral Factor Xa inhibitor, edoxaban, in our Phase 3 and Phase 4 studies. We are responsible for the cost of conducting these clinical studies. Pursuant to our agreement with Daiichi Sankyo we are obligated to provide research, development and regulatory services and to participate in a JCC in exchange for an upfront nonrefundable fee of $15.0 million, up to two contingent payments totaling $5.0 million which are payable upon the initiation of our Phase 3 study and achievement of certain events associated with scaling up our manufacturing process to support a commercial launch, and up to four payments totaling $20.0 million which are payable upon acceptance of filing and regulatory approval of Andexanet alfa as a reversal agent to edoxaban by the FDA and EMA. We identified the following non-cancellable performance deliverables under the agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying Andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate on the JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout the estimated period of performance and therefore are accounted for as a single unit of accounting. The total upfront consideration under this agreement is being recognized as revenue on a straight-line basis over the estimated performance period through the third quarter of 2018. We have determined all but one of the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and the payment terms within the agreement are commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved and collectability is reasonably assured. As of September 30, 2015, no amounts had been recognized as collaboration revenue for any of these milestones. Amounts for the contingent payment not considered to be a substantive milestone will be deferred when received and recognized as collaboration revenue on a straight-line basis over the remaining performance period. During the three and nine months ended September 30, 2015 and 2014, we recognized $890,000 and $2.6 million, and $861,000 and $861,000 in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2015 was $10.6 million. Bayer Pharma, AG (“Bayer”) and Janssen Pharmaceuticals, Inc. (“Janssen”) In February 2013, we entered into a three-way agreement with Bayer and Janssen to include subjects dosed with rivaroxaban, their Factor Xa inhibitor product, in one of our Phase 2 proof-of-concept studies of Andexanet alfa. We are responsible for the cost of conducting this clinical study. Under the terms of the agreement, Bayer and Janssen have each provided us with an upfront and non-refundable fee of $2.5 million, for an aggregate fee of $5.0 million. The agreement also provides for additional non-refundable payments to us from Bayer and Janssen of $250,000 each for an aggregate of $500,000 following the delivery of the final written study report of our Phase 2 proof-of-concept studies of Andexanet alfa. Also, we are obligated to participate on a JCC with Bayer and Janssen to oversee the collaboration activities under the agreement. We identified the following performance deliverables under the agreement: 1) the obligation to provide research and development services, which includes supplying Andexanet alfa and providing a final written report, and 2) the obligation to participate on a JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the revenue associated with these two deliverables. We have accounted for the research and development services and our participation on the JCC as a single unit of accounting as neither deliverable has standalone value and both obligations will be delivered throughout the estimated period of performance. We originally estimated the period of performance to be through the fourth quarter of 2013. During 2013, we added more cohorts than originally planned as part of the original study design at the inception of our agreement and therefore adjusted our period of performance to be through the fourth quarter of 2014. The total consideration under this agreement was recognized on a straight-line basis over the estimated performance period through the fourth quarter of 2014 and $500,000 was recognized in the third quarter of 2015 following the delivery of the final written study report of our Phase 2 proof-of-concept studies of Andexanet alfa. During the three and nine months ended September 30, 2015, we recognized $500,000 in collaboration revenue under this agreement. For the three and nine months ended September 30, 2014, we recognized $316,000 and $1.1million, in collaboration revenue under this agreement, respectively. There was no deferred revenue balance under this agreement as of September 30, 2015. In January 2014, we entered into a three-way agreement with Bayer and Janssen to study the safety and efficacy of Andexanet alfa as a reversal agent to their oral Factor Xa inhibitor, rivaroxaban, in our Phase 3 studies. We are responsible for the cost of conducting this clinical study. Pursuant to our agreement with Bayer and Janssen we are obligated to provide research, development and regulatory services and to participate in a JCC in exchange for an upfront nonrefundable fee of $10.0 million, up to three contingent payments totaling $7.0 million which are payable upon achievement of certain events associated with scaling up our manufacturing process to support a commercial launch, and up to three payments totaling $8.0 million which are payable upon initiation of our Phase 3 study and regulatory approval of Andexanet alfa as a reversal agent to rivaroxaban by the FDA and European Medicines Agency (“EMA”). We identified the following non-cancellable performance deliverables under the agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying Andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate on the JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout the estimated period of performance and therefore are accounted for as a single unit of accounting. The total upfront consideration under this agreement is being recognized as revenue on a straight-line basis over the estimated period of performance period. In the third quarter of 2014 we updated our estimated period of performance from the first quarter of 2017 to the first quarter of 2018 to reflect a modification to our clinical development and regulatory plans. We have determined all but one of the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and the payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved and collectability is reasonably assured. As of September 30, 2015, no amounts had been recognized as collaboration revenue for any of these milestones. The contingent payment of $3.0 million, not considered to be a substantive milestone, was received in the third quarter of 2014 and is being recognized as collaboration revenue on a straight-line basis over the estimated performance period through the first quarter of 2018. During the three and nine months ended September 30, 2015 and 2014, we recognized $816,000 and $2.4 million and $361,000 and $1.7 million, in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2015 was $8.1 million. Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) In January 2014, we entered into a collaboration agreement with BMS and Pfizer to further study Andexanet alfa as a reversal agent for their jointly owned FDA approved oral Factor Xa inhibitor, apixaban, through Phase 3 studies. We initiated Phase 3 studies in the first half of 2014. We are responsible for the cost of conducting this clinical study. Pursuant to our agreement with BMS and Pfizer we are obligated to provide research, development and regulatory approval services and participate in the Joint Collaboration Committee (“JCC”) in exchange for a partially refundable upfront fee of $13.0 million and up to $12.0 million of contingent milestone payments due upon achievement of certain development and regulatory events. All consideration received and to be earned under this agreement is subject to a 50% refund contingent upon certain regulatory and/or clinical events. We identified the following non-cancellable performance deliverables under the January 2014 agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying Andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate on the JCC. We considered the provisions of the multiple-elements arrangement guidance in determining how to recognize the total agreement consideration. We determined that none of the deliverables have standalone value and all of these obligations will be delivered throughout the estimated period of performance and therefore are accounted for as a single unit of accounting. The non-contingent upfront consideration under this agreement of $6.5 million is being recognized on a straight-line basis over the estimated period of performance. In the third quarter of 2014, we revised the remaining estimated period of performance from the first quarter of 2017 to the first quarter of 2018 to reflect a modification to our clinical development and regulatory plans. The contingent upfront consideration of $6.5 million will be recognized if and when the refundable nature of these amounts lapses based upon the achievement of specified regulatory and/or clinical events. The contingent milestone payments under the January 2014 agreement are not considered substantive because a portion may be refunded upon certain events. The non-contingent portion of the milestone payment will be recognized as collaboration revenue on a straight-line basis over the estimated period of performance, which is now through the first quarter of 2018. The contingent portion of the milestone payments will be recognized if and when the refundable nature of these amounts lapses based upon the achievement of specified regulatory and/or clinical events. None of these milestones had been earned or received at September 30, 2015 and up to $10.0 million of contingent milestone payments may still be achieved pursuant to the terms of the agreement During the three and nine months ended September 30, 2015 and 2014, we recognized $388,000 and $1.2 million, and $164,000 and $1.1 million, in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2015 was $10.3 million. Lee’s Pharmaceutical (HK) Ltd (“Lee’s”) In January 2013, we entered into an agreement with Lee’s to jointly expand our Phase 3 APEX Study of Betrixaban into China. Under the terms of the agreement, Lee’s provided us with an upfront and non-refundable fee of $700,000 and will reimburse our costs in connection with the expansion of our APEX study into China. Lee’s will lead this study and the regulatory interactions with China’s State Food and Drug Administration. We granted Lee’s an exclusive option to negotiate for the exclusive commercial rights to Betrixaban in China, which may be exercised by Lee’s for 60 days after it receives the primary data analysis report from the Phase 3 APEX study. We identified the following deliverables under the agreement with Lee’s: 1) the granting of an exclusive option to negotiate for the exclusive commercial rights to Betrixaban in China, 2) the obligation to manufacture and supply product in support of the APEX study in China, 3) the obligation to participate in a joint working group, and 4) the delivery of the primary data analysis report from our APEX study. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value and therefore are accounted for as a single unit of accounting with the upfront fee recognized as revenue on a straight-line basis over the estimated period of performance. Any reimbursements we may receive from Lee’s for the costs we incur in connection with this agreement are expected to be immaterial. During the three and nine months ended September 30, 2015 and 2014, we recognized $54,000 and $158,000, and $64,000 and $189,000, in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2015 was $104,000. Ora, Inc. (“Ora”) In May 2015, we entered into a license and collaboration agreement with Ora pursuant to which we granted Ora an exclusive license to co-develop and co-commercialize one of our specific Syk inhibitors, PRT2761. Ora has the primary responsibility for conducting the research and development and regulatory activities under this agreement. We are obligated to provide assistance in accordance with the agreed- upon development plan as well as participate on various committees. Under the terms of this risk and cost sharing agreement, each party will incur its own share of development costs. Third-party related development costs will be shared by Ora and us at approximately 60% and 40%, respectively, until an End of Phase 2 meeting with the FDA, and equally thereafter. We are entitled to receive either 50% of the profits, if any, generated by future sales of the products developed under the agreement or royalty payments on such sales, should we opt out of the agreement. We may opt out of the agreement any time prior to 90 days after an End of Phase 2 meeting with the FDA. The timing of the exercise of our opt out rights would impact future royalties we would be entitled to receive from Ora. Each party may also buy out the rights and interests in the licensed compound by paying the greater of $6.0 million or two times the actual aggregate development cost incurred by both parties before or 90 days after an End of Phase 2 meeting with the FDA. All costs we incur in connection with this agreement will be recognized as research and development expenses. During the three and nine months ended September 30, 2015, cost of $230,000 has been incurred related to this agreement. Aciex Therapeutics, Inc. (“Aciex”) In February 2013, we entered into a license and collaboration agreement with Aciex pursuant to which we granted Aciex an exclusive license to co-develop and co-commercialize Cerdulatinib (PRT2070) and certain related compounds for nonsystemic indications, such as the treatment and prevention of ophthalmological diseases by topical administration and allergic rhinitis by intranasal administration. In April 2014, this agreement was amended to release all rights for Cerdulatinib to Portola. The collaboration is now focused on development of other related compounds for topical ophthalmic indications. Under the terms of this risk and cost sharing agreement, Portola and Aciex will each incur and report their own internal research and development costs. Further, third-party related development costs will be shared by Aciex and us 60% and 40%, respectively, until the end of the Phase 2 clinical study, and then equally afterwards. Also, we are entitled to receive either 50% of the profits, if any, generated by future sales of the products developed under the agreement, or royalty payments. Aciex has the primary responsibility for conducting the research and development activities under this agreement. We are obligated to provide assistance in accordance with the agreed upon development plan as well as participate on various committees. We can opt out of our obligation to share in the development costs at various points in time, the timing of which impacts future royalties we may receive based on product sales made by Aciex. All net costs we incur in connection with this agreement will be recognized as research and development expenses. During the three and nine months ended September 30, 2015 and 2014 no such costs have been incurred related to this agreement. In October 2014, Aciex was acquired by Nicox S.A. As of September 30, 2015, there has been no change to our agreement with Aciex. Biogen Idec, Inc. (“Biogen Idec”) In October 2011, we entered into an exclusive, worldwide license and collaboration agreement with Biogen Idec to develop and commercialize selective, novel oral Syk inhibitors for the treatment of autoimmune and inflammatory diseases. In November 2012, we exercised our option to convert the agreement to a fully out-licensed agreement. After the election, we relinquished our right to share profits from sales of products related to PRT2607 and other selective Syk inhibitors, but were entitled to receive future payments up to approximately $370.0 million based on the occurrence of certain development and regulatory events for all licensed compounds. In April 2014, we entered into an amendment to the Biogen Idec license and collaboration agreement under which Biogen Idec released one of the Syk kinase inhibitors to us and we would be required to pay Biogen Idec $15.0 million upon the completion of certain commercial milestones and pay royalties on sales of products approved for the Syk inhibitor. In May 2015, our agreement with Biogen Idec terminated in its entirety effective July 2015. The effect of termination resulted in return to us of all compounds subject to the license and collaboration agreement and eliminated all potential future payments from and to Biogen Idec. We did not record any reduction to research and development expense pursuant to the agreement for the three and nine months ended September 30, 2015. During the three and nine months ended September 30, 2014 we recorded a reduction in research expense of $23,080 and $178,700, respectively. |
Commercial Supply Agreement
Commercial Supply Agreement | 9 Months Ended |
Sep. 30, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commercial Supply Agreement | 6. Commercial Supply Agreement In July 2014, we entered into an agreement with CMC ICOS Biologics, Inc. (“CMC Biologics”), a subsidiary of CMC Biologics S.à.r.l., a privately-held contract manufacturing organization, pursuant to which CMC Biologics will manufacture clinical and commercial supply of Andexanet alfa and perform pre-validation and validation work on our behalf. Under the agreement, we are required to purchase an aggregate fixed number of batches of Andexanet alfa from CMC Biologics beginning in 2015 through 2021. Total batch commitments under the agreement can be increased or decreased based on the achievement of milestones relating to the regulatory approval process for Andexanet alfa, expansion of existing manufacturing capacity and operational qualification of CMC Biologics’ manufacturing facilities. We made an upfront payment to CMC Biologics in the amount of $10.0 million in July 2014 and a reservation payment to CMC Biologics of $4.6 million in November 2014. Both payments will be credited against our future purchases of batches under the agreement. Total fixed commitments under the agreement for the purchases of clinical and commercial batches, not taking into account possible price and batch adjustments per the terms of the agreement, are approximately $293.9 million. Payments made for purchases of batches under the agreement as of September 30, 2015 amount to $18.7 million. The term of the agreement is seven years and may be early terminated by either party for the other party’s uncured material breach or insolvency. We may also terminate the agreement if CMC Biologics is unable to add additional manufacturing capacity on a timely basis, if certain manufacturing-related regulatory events do not occur before certain deadlines, or if the batch yield is below a certain threshold, in which case we are not obligated to pay CMC Biologics a termination payment and CMC Biologics will be obligated to refund the uncredited amounts of the upfront payment and reservation payment. In addition, we may terminate the agreement unilaterally if we discontinue the development and commercialization of Andexanet alfa for regulatory, safety, efficacy or other commercial reasons, or if the projected market demand or gross margin of Andexanet alfa is below a minimum threshold. A termination agreement under these provisions will obligate us to pay CMC Biologics a termination fee between $5.0 million and $30.0 million, depending on the date of termination. The termination fee is highest from 2015 through 2017, and then decreases through 2021. Any remaining upfront payments or reservation payments we have made, not yet credited against the purchase of batches, at the time of termination will be applied against the termination fee. Under the lease accounting guidance, we determined that the agreement does not contain an embedded lease because the agreement does not convey the right to control the use of CMC Biologics’ facility. We based this determination on, among other factors, our right to physically access and/or operate CMC Biologics’ facility and one or more parties, other than us, and taking more than a minor amount of the output that will be produced or generated by the CMC Biologics facility during the term of our agreement. Under the consolidation guidance, we determined that CMC Biologics is a VIE, but that we are not CMC Biologics’ primary beneficiary and therefore consolidation of CMC Biologics by us is not required. We based this determination on, among other factors, the upfront and reservation payment being akin to a form of subordinated financing, the fixed pricing terms of the arrangement creating variability that is absorbed by us, and that we do not have the power to direct the activities that most significantly affect the economic performance of CMC Biologics. As of September 30, 2015, we have not provided financial, or other, support to CMC Biologics that was not previously contractually required. The upfront and reservation payment of $14.6 million is recorded as $12.3 million in prepaid and other long-term assets and $2.3 million is recorded in prepaid expenses and other current assets in the condensed consolidated balance sheet. The payments made for purchases of batches of $14.1 million are recorded in prepaid expenses and other current assets in the condensed consolidated balance sheet. These assets represent our maximum exposure to loss under this agreement at September 30, 2015. The upfront payment will be charged to research and development expense, prior to regulatory approval of Andexanet alfa, as the batches are delivered. We are currently not able to quantify the exposure to losses associated with the fixed pricing terms of this agreement. |
Stock Based Compensation
Stock Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Based Compensation | 7. Stock Based Compensation In January 2013, our Board of Directors adopted our 2013 Equity Incentive Plan, or the 2013 Plan, which became effective upon of the closing of our initial public offering in May 2013. The following table summarizes option activity under our 2013 Equity Incentive Plan and related information during the nine months ended September 30, 2015: Shares Subject to Weighted- Outstanding Average Exercise Options Price Per Share Balance at December 31, 2014 4,249,168 $ 14.77 Options granted 1,649,691 $ 37.32 Options exercised (1,034,140 ) $ 9.58 Options canceled (152,365 ) $ 28.13 Balance at September 30, 2015 4,712,354 $ 23.25 The estimated grant date fair values of the employee stock options were calculated using the Black Scholes valuation model, based on the following assumptions: Three Month Ended September 30, Nine Month Ended September 30, 2015 2014 2015 2014 Risk-free interest rate 1.77 % 1.89 % 1.65 % 1.89 % Expected life 6.0 years 5.8 years 6.0 years 5.9 years Expected volatility 65 % 79 % 65 % 80 % Dividend yield — — — — The following table summarizes restricted stock units (RSUs) activity, including performance-based RSUs activity, under our 2013 Equity Incentive Plan and related information during the nine months ended September 30, 2015: Shares Subject to Weighted- Outstanding Average grant date RSUs fair value per share Balance at December 31, 2014 — $ — RSUs granted 203,258 $ 32.14 RSUs exercised — $ — RSUs canceled (11,485 ) $ 30.12 Balance at September 30, 2015 191,773 $ 32.26 During the first quarter of 2015, we granted restricted stock units (RSUs) to certain of our employees. RSUs are share awards that entitle the holder to receive freely tradable shares of our Common Stock upon vesting. The RSUs cannot be transferred, and until they vest, the shares are subject to forfeiture if employment terminates prior to the release of the vesting restrictions. The RSUs, generally vest equal amounts on each of the first three year anniversaries of the grant date, provided the employee remains continuously employed with us. The fair value of the RSUs is equal to the closing price of our Common Stock on the grant date. In January and June 2015, we granted market-based performance stock unit (PSU) awards to our executive officers. Each PSU represents a contingent right to receive one share of our Common Stock upon achievement of a market-based performance measurement and subject to the recipients continued employment. At any time during the four years following the date of the grant, a portion of the PSUs will vest one year after the date the average closing price of our Common Stock on the NASDAQ Global Select Market is above $50.00 per share for 45 consecutive trading days, and the remaining portion of the grant will vest one year after the date the average closing price of our Common Stock is above $60.00 per share for 45 consecutive trading days. The weighted-average fair value of the PSUs was determined using the Monte Carlo simulation models incorporating the following assumptions: Nine Month Ended September 30, 2015 PSUs Number of PSUs granted 165,000 Weighted-average grant date stock price $ 31.95 Weighted-average risk-free interest rate 1.13 % Weighted-average volatility 62 % Dividend yield — Weighted- average fair value per share of PSUs granted ($50 Vesting Hurdle) $ 25.65 Weighted- average fair value per share of PSUs granted ($60 Vesting Hurdle) $ 23.24 The estimated PSU expense is being recognized, on an accelerated basis over the estimated requisite service period, with no adjustments in the future periods based upon our actual Common Stock price. In June 2015, the Compensation Committee of our Board of Directors approved a program to award up to 69,625 performance-based RSUs to certain non-executive employees based on the achievement of goals related to the development of Andexanet alfa and Betrixaban. Each award represents a contingent right to receive one share of our Common Stock upon the achievement of certain performance conditions by pre-specified dates and the award recipients continued employment. At September 30, 2015 certain performance conditions related to awards associated with Betrixaban development goals had not yet been finalized or objectively defined. Therefore, the fair value of these awards is being re-measured using our Common Stock price at each reporting period until the time at which the performance conditions are completed or sufficiently defined. During the third quarter of 2015, performance conditions were finalized and achieved related to the development of Andexanet alfa and 16,058 performance-based RSUs were no longer subject to remeasurement. The estimated expense associated with these awards is also being recognized, on an accelerated basis, over the estimated requisite service period. The table below sets forth the functional classification of stock-based compensation expense, net of estimated forfeitures, for the periods presented (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 3,252 $ 953 $ 8,004 $ 3,321 Selling, general and administrative 2,849 1,197 8,028 3,555 Total stock-based compensation $ 6,101 $ 2,150 $ 16,032 $ 6,876 |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 8. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to Common Stockholders has been computed by dividing the net loss by the weighted-average number of shares of Common Stock outstanding during the period. Diluted net loss per share attributable to Common Stockholders is calculated by dividing net loss by the weighted average number of shares of Common Stock and potential dilutive securities outstanding during the period. The following common equivalent shares were excluded from the computation of diluted net loss per share attributable to Common Stockholders for the periods presented because including them would have been anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Stock options to purchase Common Stock 4,712,354 4,159,895 4,712,354 4,159,895 Common stock warrants 1,500 6,240 1,500 6,240 Restricted stock units 191,773 — 191,773 — Performance stock units 165,000 — 165,000 — |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Consolidation and Basis of Presentation | Consolidation and Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the amounts of the Company and our wholly-owned subsidiaries and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of our financial information. The results of operations for the three and nine months ended September 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other interim period or for any other future year. The condensed consolidated balance sheet as of December 31, 2014 has been derived from audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. Certain prior-period amounts have been reclassified to conform to the current-period presentation. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2014 included in our Annual Report on Form 10-K filed March 2, 2015 with the SEC. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities and the reported amounts of revenues and expenses in the condensed consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, clinical trial accruals, fair value of assets and liabilities, income taxes, variable interest entities and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates. |
Variable Interest Entities | Variable Interest Entities We review agreements we enter into with third party entities, pursuant to which we may have a variable interest in that entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, we assess whether or not we are the primary beneficiary of that entity. In determining whether we are the primary beneficiary of an entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If we determine we are the primary beneficiary of a VIE, we consolidate the operations and financial position of the VIE into our consolidated financial statements. Our determination about whether we should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and other highly liquid investments with original maturities of three months or less from the date of purchase. |
Investments | Investments All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments in debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated comprehensive income/ (loss). Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income (expense), net. |
Collaboration Customer Concentration | Collaboration Collaboration customers who accounted for 10% or more of total collaboration and license revenues were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Daiichi Sankyo, Inc. 40 % 63 % 45 % 43 % Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. 45 % 28 % 38 % 39 % Bristol-Myers Squibb Company and Pfizer Inc. 13 % 7 % 15 % 15 % |
Revenue Recognition | Revenue Recognition We generate revenue from collaboration and license agreements for the development and commercialization of our products. Collaboration and license agreements may include non-refundable or partially refundable upfront license fees, partial or complete reimbursement of research and development costs, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. Our performance obligations under our collaborations include the transfer of intellectual property rights (licenses), obligations to provide research and development services and related clinical drug supply, obligation to provide regulatory approval services and obligations to participate on certain development and/or commercialization committees with the collaborators. Upfront payments are recorded as deferred revenue in our condensed consolidated balance sheet and are recognized as collaboration revenue over our estimated period of performance that is consistent with the terms of the research and development obligations contained in each collaboration agreement. We regularly review the estimated periods of performance related to our collaborations based on the progress made under each arrangement. Our estimates of our performance period may change over the course of the collaboration term. Such a change could have a material impact on the amount of revenue we record in future periods. Payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is defined as an event that can only be achieved based on our performance and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones subject to this guidance. Further, the amounts received must relate solely to prior performance, be reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Payments contingent upon achievement of events that are not considered substantive milestones are allocated to the respective arrangements unit of accounting when received and recognized as revenue based on the revenue recognition policy for that unit of accounting. Amounts from sales of licenses are recognized as revenue. Amounts received as funding of research and development or regulatory approval activities are recognized as revenue if the collaboration arrangement involves the sale of our research or development and regulatory approval services at amounts that exceed our cost. However, such funding is recognized as a reduction in research and development expense when we engage in a research and development project jointly with another entity, with both entities participating in project activities and sharing costs and potential benefits of the arrangement. Amounts related to research and development and regulatory approval funding are recognized as the related services or activities are performed, in accordance with the contract terms. Payments may be made to or by us based on the number of full-time equivalent researchers assigned to the collaboration project and the related research and development expenses incurred. |
Foreign Currency Transactions and Hedging | Foreign Currency Transactions and Hedging We have financial transactions denominated in foreign currencies, primarily the Euro and British Pound, and, as a result, are exposed to changes in foreign currency exchange rates. We manage a portion of these cash flow exposures through purchasing and holding of Euros and British Pounds and the use of foreign currency forward contracts. Our foreign currency forward contracts are not designated as hedges for accounting purposes. Gains or losses on foreign currency forward contracts are intended to offset gains or losses on the underlying net exposures in an effort to reduce the earnings and cash flow volatility resulting from fluctuating foreign currency exchange rates. Foreign currency deposits we hold are remeasured using period end spot rates. Foreign currency forward contracts are marked to market at the end of each period and recorded as gains and losses in the condensed consolidated statements of operations. We held no foreign currency forward contracts at September 30, 2015 or December 31, 2014. We recorded an unrealized loss of $113,000 and $114,000 in interest and other income (expense), net in our condensed consolidated statements of operations related to foreign currency forward contracts for the three and nine months ended September 30, 2014, respectively. During the three and nine months ended September 30, 2014, we settled foreign currency forward contracts and recognized a realized loss of $75,000 and $326,000, respectively, in interest and other income (expense), net. Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparty, a major financial institution, is unable to meet the terms of the agreement. Our management does not expect material losses as a result of defaults by the counterparty. |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to Common Stockholders is calculated by dividing the net loss attributable to Common Stockholders by the weighted-average number of shares of Common Stock outstanding for the period. Diluted net loss per share attributable to Common Stockholders is computed by giving effect to all potential dilutive Common Stock equivalents outstanding for the period. Diluted net loss per share attributable to Common Stockholders is the same as basic net loss per share attributable to Common Stockholders, since the effects of potentially dilutive securities are antidilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board(the “FASB”), jointly with the International Accounting Standards Board, issued ASU 2014-09, Revenue from Contracts with Customers In February 2015, the Financial Accounting Standards Board (the “FASB”) issued ASU 2015-02, Consolidation: amendment to the consolidation analysis |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Percentage of Revenue from Significant Collaboration Customers | Collaboration customers who accounted for 10% or more of total collaboration and license revenues were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Daiichi Sankyo, Inc. 40 % 63 % 45 % 43 % Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. 45 % 28 % 38 % 39 % Bristol-Myers Squibb Company and Pfizer Inc. 13 % 7 % 15 % 15 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities Measured on Recurring Basis | The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that were measured on a recurring basis (in thousands): September 30, 2015 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 21,351 $ — $ — $ 21,351 Corporate notes and commercial paper — 181,962 — 181,962 U.S. government agency securities — 140,056 — 140,056 Total financial assets $ 21,351 $ 322,018 $ — $ 343,369 December 31, 2014 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 24,915 $ — $ — $ 24,915 Corporate notes and commercial paper — 226,047 — 226,047 U.S. government agency securities — 120,169 — 120,169 Total financial assets $ 24,915 $ 346,216 $ — $ 371,131 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Investments Debt And Equity Securities [Abstract] | |
Cash Equivalents and Investments Classified as Available-for-sale Securities | Cash equivalents and investments, all of which are classified as available-for-sale securities, consisted of the following (in thousands): September 30, 2015 December 31, 2014 Estimated Estimated Unrealized Unrealized Fair Unrealized Unrealized Fair Cost Gain (Loss) Value Cost Gain (Loss) Value Money market funds $ 21,351 $ — $ — $ 21,351 $ 24,915 $ — $ — $ 24,915 Corporate notes and commercial paper 181,981 14 (33 ) 181,962 226,209 8 (170 ) 226,047 U.S. government agency securities 140,017 39 (1 ) 140,056 120,246 4 (81 ) 120,169 $ 343,349 $ 53 $ (34 ) $ 343,369 $ 371,370 $ 12 $ (251 ) $ 371,131 Classified as: Cash equivalents $ 65,123 $ 36,342 Short-term investments 278,246 251,759 Long-term investments — 83,030 Total cash equivalents and investments $ 343,369 $ 371,131 |
Collaboration and License Agr19
Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Revenue from Collaboration and License Agreements | We have recognized revenue from our collaboration and license agreements as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Daiichi Sankyo $ 1,154 $ 1,523 $ 3,424 $ 3,133 Bayer and Janssen 1,316 676 2,922 2,782 BMS and Pfizer 388 164 1,152 1,109 Lee's Pharmaceutical 54 64 158 189 Total collaboration and license revenue $ 2,912 $ 2,427 $ 7,656 $ 7,213 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Option Activities | The following table summarizes option activity under our 2013 Equity Incentive Plan and related information during the nine months ended September 30, 2015: Shares Subject to Weighted- Outstanding Average Exercise Options Price Per Share Balance at December 31, 2014 4,249,168 $ 14.77 Options granted 1,649,691 $ 37.32 Options exercised (1,034,140 ) $ 9.58 Options canceled (152,365 ) $ 28.13 Balance at September 30, 2015 4,712,354 $ 23.25 |
Fair Values of Employee Stock Options | The estimated grant date fair values of the employee stock options were calculated using the Black Scholes valuation model, based on the following assumptions: Three Month Ended September 30, Nine Month Ended September 30, 2015 2014 2015 2014 Risk-free interest rate 1.77 % 1.89 % 1.65 % 1.89 % Expected life 6.0 years 5.8 years 6.0 years 5.9 years Expected volatility 65 % 79 % 65 % 80 % Dividend yield — — — — |
Summary of Restricted Stock Units (RSUs) Activity Including Performance-Based RSUs | The following table summarizes restricted stock units (RSUs) activity, including performance-based RSUs activity, under our 2013 Equity Incentive Plan and related information during the nine months ended September 30, 2015: Shares Subject to Weighted- Outstanding Average grant date RSUs fair value per share Balance at December 31, 2014 — $ — RSUs granted 203,258 $ 32.14 RSUs exercised — $ — RSUs canceled (11,485 ) $ 30.12 Balance at September 30, 2015 191,773 $ 32.26 |
Assumptions used to Determine Weighted-Average Fair Value of Performance Stock Units | Nine Month Ended September 30, 2015 PSUs Number of PSUs granted 165,000 Weighted-average grant date stock price $ 31.95 Weighted-average risk-free interest rate 1.13 % Weighted-average volatility 62 % Dividend yield — Weighted- average fair value per share of PSUs granted ($50 Vesting Hurdle) $ 25.65 Weighted- average fair value per share of PSUs granted ($60 Vesting Hurdle) $ 23.24 |
Classification of Stock-Based Compensation Expense | The table below sets forth the functional classification of stock-based compensation expense, net of estimated forfeitures, for the periods presented (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 3,252 $ 953 $ 8,004 $ 3,321 Selling, general and administrative 2,849 1,197 8,028 3,555 Total stock-based compensation $ 6,101 $ 2,150 $ 16,032 $ 6,876 |
Net Loss per Share Attributab21
Net Loss per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Common Equivalent Shares Excluded from Computation of Diluted Net Loss | The following common equivalent shares were excluded from the computation of diluted net loss per share attributable to Common Stockholders for the periods presented because including them would have been anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Stock options to purchase Common Stock 4,712,354 4,159,895 4,712,354 4,159,895 Common stock warrants 1,500 6,240 1,500 6,240 Restricted stock units 191,773 — 191,773 — Performance stock units 165,000 — 165,000 — |
Organization - Additional Infor
Organization - Additional Information (Detail) | 1 Months Ended | 9 Months Ended |
Mar. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2015Segment | |
Organization And Nature Of Business [Line Items] | ||
Number of operating segment | Segment | 1 | |
Follow on offering price per share | $ / shares | $ 40 | |
Proceeds from offering and over-allotment option, net | $ 108,400,000 | |
Follow-on Offering | ||
Organization And Nature Of Business [Line Items] | ||
Stock issued during the period | shares | 2,870,000 | |
Underwriting discounts, commissions and offering expenses, net | $ 358,000 | |
Underwriters Overallotment Option | ||
Organization And Nature Of Business [Line Items] | ||
Stock issued during the period | shares | 374,348 |
Revenue Accounted for 10% or Mo
Revenue Accounted for 10% or More of Total Collaboration and License Revenues (Detail) - Customer Concentration Risk - Sales Revenue, Net | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Daiichi Sankyo, Inc ("Daiichi") | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 40.00% | 63.00% | 45.00% | 43.00% |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 45.00% | 28.00% | 38.00% | 39.00% |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 13.00% | 7.00% | 15.00% | 15.00% |
Summary of Significant Accoun24
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2015 | Dec. 31, 2014 | |
Accounting Policies [Abstract] | ||||
Foreign currency forward Contract | $ 0 | $ 0 | ||
Unrealized loss | $ (113,000) | $ (114,000) | ||
Realized loss | $ (75,000) | $ (326,000) |
Fair Value of Financial Assets,
Fair Value of Financial Assets, and Liabilities, Allocated into Level 1, Level 2, and Level 3 Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Financial Assets: | ||
Total financial assets | $ 343,369 | $ 371,131 |
Fair Value, Inputs, Level 1 | ||
Financial Assets: | ||
Total financial assets | 21,351 | 24,915 |
Fair Value, Inputs, Level 2 | ||
Financial Assets: | ||
Total financial assets | 322,018 | 346,216 |
Money market funds | ||
Financial Assets: | ||
Total financial assets | 21,351 | 24,915 |
Money market funds | Fair Value, Inputs, Level 1 | ||
Financial Assets: | ||
Total financial assets | 21,351 | 24,915 |
Corporate notes and commercial paper | ||
Financial Assets: | ||
Total financial assets | 181,962 | 226,047 |
Corporate notes and commercial paper | Fair Value, Inputs, Level 2 | ||
Financial Assets: | ||
Total financial assets | 181,962 | 226,047 |
U.S. government agency securities | ||
Financial Assets: | ||
Total financial assets | 140,056 | 120,169 |
U.S. government agency securities | Fair Value, Inputs, Level 2 | ||
Financial Assets: | ||
Total financial assets | $ 140,056 | $ 120,169 |
Fair Values Measurements - Addi
Fair Values Measurements - Additional Information (Detail) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Fair Value Disclosures [Abstract] | ||
Fair value assets transfers from level 1 to level 2 | $ 0 | $ 0 |
Fair value assets transfers from level 2 to level 1 | $ 0 | $ 0 |
Cash Equivalents and Investment
Cash Equivalents and Investments Classified as Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | $ 343,349 | $ 371,370 |
Unrealized Gain | 53 | 12 |
Unrealized (Loss) | (34) | (251) |
Estimated Fair Value | 343,369 | 371,131 |
Money market funds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 21,351 | 24,915 |
Estimated Fair Value | 21,351 | 24,915 |
Corporate notes and commercial paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 181,981 | 226,209 |
Unrealized Gain | 14 | 8 |
Unrealized (Loss) | (33) | (170) |
Estimated Fair Value | 181,962 | 226,047 |
U.S. government agency securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 140,017 | 120,246 |
Unrealized Gain | 39 | 4 |
Unrealized (Loss) | (1) | (81) |
Estimated Fair Value | 140,056 | 120,169 |
Cash equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 65,123 | 36,342 |
Short-term investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | $ 278,246 | 251,759 |
Long-term investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | $ 83,030 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Investments Debt And Equity Securities [Abstract] | ||
Available For Sale Securities Contractual Maturity | 1 year | 2 years |
Available-for-sale Securities, Gross Realized Gain (Loss) | $ 0 | $ 0 |
Summary of Revenue from Collabo
Summary of Revenue from Collaboration and License Agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Collaboration and license revenue | $ 2,912 | $ 2,427 | $ 7,656 | $ 7,213 |
Daiichi Sankyo, Inc ("Daiichi") | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Collaboration and license revenue | 1,154 | 1,523 | 3,424 | 3,133 |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Collaboration and license revenue | 1,316 | 676 | 2,922 | 2,782 |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Collaboration and license revenue | 388 | 164 | 1,152 | 1,109 |
Lee’s Pharmaceutical (HK) Ltd (“Lee’s”) | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Collaboration and license revenue | $ 54 | $ 64 | $ 158 | $ 189 |
Collaboration and License Agr30
Collaboration and License Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | 24 Months Ended | ||||||||
Jul. 31, 2014 | Apr. 30, 2014 | Jan. 31, 2014 | Feb. 28, 2013 | Jan. 31, 2013 | Nov. 30, 2012 | Sep. 30, 2015 | Sep. 30, 2014 | Mar. 31, 2014 | Jun. 30, 2013 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2015 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Collaboration and license revenue | $ 2,912,000 | $ 2,427,000 | $ 7,656,000 | $ 7,213,000 | |||||||||
Research and development | 48,405,000 | 31,780,000 | 140,563,000 | 88,918,000 | |||||||||
Daiichi Sankyo, Inc ("Daiichi") | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Collaborative arrangement upfront payment to be received | $ 6,000,000 | ||||||||||||
Upfront fee subject to refund | $ 3,000,000 | ||||||||||||
Non-contingent consideration being recognized as revenue over estimated period of performance | $ 3,000,000 | ||||||||||||
Contingent and non-contingent consideration to be recognized after resolution of contingency | 264,000 | 662,000 | 782,000 | 2,300,000 | |||||||||
Deferred revenue | 263,000 | 263,000 | |||||||||||
Upfront fee | $ 15,000,000 | ||||||||||||
Contingent payment receivable upon achievement | 5,000,000 | ||||||||||||
Milestone Payments of Development and Regulatory Event | $ 20,000,000 | ||||||||||||
Collaboration and license revenue | 1,154,000 | 1,523,000 | 3,424,000 | 3,133,000 | |||||||||
Daiichi Sankyo, Inc ("Daiichi") | Collaborative Agreement to Study Safety and Efficacy of Andexanet Alfa | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Deferred revenue | 10,600,000 | 10,600,000 | |||||||||||
Collaboration and license revenue | 890,000 | 861,000 | 2,600,000 | 861,000 | |||||||||
Daiichi Sankyo, Inc ("Daiichi") | Collaborative Agreement to Study Safety and Efficacy of Andexanet Alfa | Future Contingent Payments | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Collaboration and license revenue | 0 | ||||||||||||
Daiichi Sankyo, Inc ("Daiichi") | Scenario Forecast | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Contingent consideration to be recognized after resolution of contingency | $ 3,000,000 | ||||||||||||
Bayer Pharma AG | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Upfront fee | $ 2,500,000 | ||||||||||||
Additional non-refundable fee | 250,000 | ||||||||||||
Janssen Pharmaceuticals, Inc. | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Upfront fee | 2,500,000 | ||||||||||||
Additional non-refundable fee | 250,000 | ||||||||||||
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Upfront fee | $ 10,000,000 | 5,000,000 | |||||||||||
Contingent payment receivable upon achievement | 7,000,000 | ||||||||||||
Milestone Payments of Development and Regulatory Event | 8,000,000 | ||||||||||||
Collaboration and license revenue | 1,316,000 | 676,000 | 2,922,000 | 2,782,000 | |||||||||
Additional non-refundable fee | $ 500,000 | ||||||||||||
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | February 2013 Agreement | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Deferred revenue | 0 | 0 | |||||||||||
Collaboration and license revenue | 500,000 | 316,000 | 500,000 | 1,100,000 | |||||||||
Collaborative Arrangement Payment Received | 500,000 | ||||||||||||
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | January 2014 Agreement | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Deferred revenue | 8,100,000 | 8,100,000 | |||||||||||
Collaboration and license revenue | 816,000 | 361,000 | 2,400,000 | 1,700,000 | |||||||||
Contingent Payments Received | 3,000,000 | ||||||||||||
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Future Contingent Payments | January 2014 Agreement | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Collaboration and license revenue | 0 | ||||||||||||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Non-contingent consideration being recognized as revenue over estimated period of performance | 6,500,000 | ||||||||||||
Contingent consideration to be recognized after resolution of contingency | 6,500,000 | ||||||||||||
Upfront fee | 13,000,000 | ||||||||||||
Milestone Payments of Development and Regulatory Event | $ 12,000,000 | ||||||||||||
Collaboration and license revenue | 388,000 | 164,000 | 1,152,000 | 1,109,000 | |||||||||
Percentage of consideration received under agreement | 50.00% | ||||||||||||
Milestone payments of regulatory and clinical event | 10,000,000 | ||||||||||||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | January 2014 Agreement | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Deferred revenue | 10,300,000 | 10,300,000 | |||||||||||
Collaboration and license revenue | 388,000 | 164,000 | 1,200,000 | 1,100,000 | |||||||||
Lee’s Pharmaceutical (HK) Ltd (“Lee’s”) | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Deferred revenue | 104,000 | 104,000 | |||||||||||
Upfront fee | $ 700,000 | ||||||||||||
Collaboration and license revenue | 54,000 | 64,000 | $ 158,000 | 189,000 | |||||||||
Notice period for agreement termination | 60 days | ||||||||||||
Ora, Inc. (“Ora”) | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Notice period for agreement termination | 90 days | ||||||||||||
Development costs, percent | 60.00% | ||||||||||||
Percentage of profits entitle to receive under agreement | 50.00% | ||||||||||||
Rights to buy compound interests and licensed agreements | Each party may also buy out the rights and interests in the licensed compound by paying the greater of $6.0 million or two times the actual aggregate development cost incurred by both parties before or 90 days after an End of Phase 2 meeting with the FDA. | ||||||||||||
Research and development | 230,000 | $ 230,000 | |||||||||||
Ora, Inc. (“Ora”) | PORTOLA PHARMACEUTICALS INC | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Development costs, percent | 40.00% | ||||||||||||
Aciex Therapeutics, Inc. (“Aciex”) | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Development costs, percent | 60.00% | ||||||||||||
Percentage of profits entitle to receive under agreement | 50.00% | ||||||||||||
Research and development | 0 | 0 | $ 0 | 0 | |||||||||
Aciex Therapeutics, Inc. (“Aciex”) | PORTOLA PHARMACEUTICALS INC | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
Development costs, percent | 40.00% | ||||||||||||
Biogen Idec | |||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||
License fee receivable upon occurrence of certain development and regulatory events | $ 370,000,000 | ||||||||||||
Payments Upon the Completion of Certain Commercial Milestones | $ 15,000,000 | ||||||||||||
Reduction in research and development expense | $ 0 | $ 23,080 | $ 0 | $ 178,700 |
Commercial Supply Agreement - A
Commercial Supply Agreement - Additional Information (Detail) - USD ($) | 1 Months Ended | 9 Months Ended | ||
Jul. 31, 2014 | Sep. 30, 2015 | Dec. 31, 2014 | Nov. 01, 2014 | |
Long Term Purchase Commitment [Line Items] | ||||
Prepaid and other long-term assets | $ 12,987,000 | $ 15,612,000 | ||
Prepaid expenses and other current assets | 20,499,000 | $ 5,747,000 | ||
CMC ICOS Biologics Inc | ||||
Long Term Purchase Commitment [Line Items] | ||||
Commercial supply agreement upfront payment | $ 10,000,000 | |||
Commercial supply (manufacturing services) agreement reservation payment | $ 4,600,000 | |||
Commercial agreement fixed commitment amount | 293,900,000 | |||
Payments made for purchases of batches related to commercial supply agreement | $ 18,700,000 | |||
Term of commercial supply agreement | 7 years | |||
Purchases of batches recorded in prepaid expenses and other current assets | $ 14,100,000 | |||
CMC ICOS Biologics Inc | Upfront and Reservation Payment | ||||
Long Term Purchase Commitment [Line Items] | ||||
Prepaid expenses and other assets | 14,600,000 | |||
Prepaid and other long-term assets | 12,300,000 | |||
Prepaid expenses and other current assets | $ 2,300,000 | |||
CMC ICOS Biologics Inc | Minimum | ||||
Long Term Purchase Commitment [Line Items] | ||||
Termination fees payment under obligation | 5,000,000 | |||
CMC ICOS Biologics Inc | Maximum | ||||
Long Term Purchase Commitment [Line Items] | ||||
Termination fees payment under obligation | $ 30,000,000 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Shares Subject to Outstanding Options | |
Beginning balance | shares | 4,249,168 |
Options granted | shares | 1,649,691 |
Options exercised | shares | (1,034,140) |
Options canceled | shares | (152,365) |
Ending balance | shares | 4,712,354 |
Weighted-Average Exercise Price Per Share | |
Beginning balance | $ 14.77 |
Options granted | 37.32 |
Options exercised | 9.58 |
Options canceled | 28.13 |
Ending balance | $ 23.25 |
Estimated Grant Date Fair Value
Estimated Grant Date Fair Values of Employee Stock Options (Detail) - Employee Stock Option | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk-free interest rate | 1.77% | 1.89% | 1.65% | 1.89% |
Expected life | 6 years | 5 years 9 months 18 days | 6 years | 5 years 10 months 24 days |
Expected volatility | 65.00% | 79.00% | 65.00% | 80.00% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Summary of Restricted Stock Uni
Summary of Restricted Stock Units (RSUs) Activity Including Performance-Based RSUs (Detail) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Shares Subject to Outstanding Options | |
RSUs granted | shares | 203,258 |
RSUs canceled | shares | (11,485) |
Ending balance | shares | 191,773 |
Weighted-Average Exercise Price Per Share | |
RSUs granted | $ 32.14 |
RSUs canceled | 30.12 |
Ending balance | $ 32.26 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2015 | |
Restricted Stock Units (RSUs) | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Vesting period | 3 years | ||
Performance-based RSUs awarded based on achievement of development goals | 203,258 | ||
Performance Shares | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Vesting period | 4 years | ||
Number of common stock earned per share | 100.00% | ||
Consecutive trading period required to earn PSU | 45 days | ||
Vesting rights | At any time during the four years following the date of the grant, a portion of the PSUs will vest one year after the date the average closing price of our Common Stock on the NASDAQ Global Select Market is above $50.00 per share for 45 consecutive trading days, and the remaining portion of the grant will vest one year after the date the average closing price of our Common Stock is above $60.00 per share for 45 consecutive trading days | ||
Performance-based RSUs awarded based on achievement of development goals | 16,058 | 165,000 | |
Performance Shares | Maximum | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Performance-based RSUs awarded based on achievement of development goals, available for grant | 69,625 | 69,625 | |
Performance Shares | $50 Vesting Hurdle | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Minimum average market closing price to earn PSU | $ 50 | ||
Performance Shares | $60 Vesting Hurdle | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Minimum average market closing price to earn PSU | $ 60 |
Weighted-Average Fair Value of
Weighted-Average Fair Value of Performance Stock Units (Detail) - Performance Shares | 3 Months Ended | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | Sep. 30, 2015$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of PSUs granted | shares | 16,058 | 165,000 |
Weighted-average grant date stock price | $ 31.95 | $ 31.95 |
Weighted-average risk-free interest rate | 1.13% | |
Weighted-average volatility | 62.00% | |
Dividend yield | 0.00% | |
$50 Vesting Hurdle | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted- average fair value per share of PSUs granted | $ 25.65 | |
$60 Vesting Hurdle | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted- average fair value per share of PSUs granted | $ 23.24 |
Weighted-Average Fair Value o37
Weighted-Average Fair Value of Performance Stock Units (Parenthetical) (Detail) - Performance Shares | 9 Months Ended |
Sep. 30, 2015$ / shares | |
$50 Vesting Hurdle | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Minimum average market closing price to earn PSU | $ 50 |
$60 Vesting Hurdle | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Minimum average market closing price to earn PSU | $ 60 |
Classification of Stock-Based C
Classification of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 6,101 | $ 2,150 | $ 16,032 | $ 6,876 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 3,252 | 953 | 8,004 | 3,321 |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 2,849 | $ 1,197 | $ 8,028 | $ 3,555 |
Common Equivalent Shares Exclud
Common Equivalent Shares Excluded from Computation of Diluted Net Loss per Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stock options to purchase common stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from computation of diluted net loss per share | 4,712,354 | 4,159,895 | 4,712,354 | 4,159,895 |
Common stock warrants | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from computation of diluted net loss per share | 1,500 | 6,240 | 1,500 | 6,240 |
Restricted Stock Units (RSUs) | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from computation of diluted net loss per share | 191,773 | 191,773 | ||
Performance Shares | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Common stock equivalents excluded from computation of diluted net loss per share | 165,000 | 165,000 |