Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 03, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
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 | 57,020,110 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 135,669 | $ 188,480 |
Short-term investments | 182,528 | 130,291 |
Restricted cash (SRX Cardio) | 174 | 178 |
Prepaid research and development | 5,898 | 7,299 |
Prepaid expenses and other current assets | 3,312 | 2,680 |
Total current assets | 327,581 | 328,928 |
Property and equipment, net | 5,795 | 6,143 |
Intangible asset | 3,151 | 3,151 |
Prepaid and other long-term assets | 4,168 | 5,214 |
Total assets | 340,695 | 343,436 |
Current liabilities: | ||
Accounts payable | 9,487 | 14,546 |
Accrued compensation and employee benefits | 3,399 | 4,806 |
Accrued research and development | 11,169 | 23,818 |
Accrued and other liabilities | 3,283 | 1,696 |
Deferred revenue, current portion | 20,798 | 20,798 |
Total current liabilities | 48,136 | 65,664 |
Notes payable, long-term | 50,485 | 49,815 |
Long term debt | 47,803 | |
Long term obligation to Collaborator | 8,000 | 8,000 |
Deferred revenue, long-term | 19,837 | 24,965 |
Other long-term liabilities | 2,707 | 2,303 |
Total liabilities | 176,968 | 150,747 |
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 March 31, 2017 and December 31, 2016; 57,009,237 and 56,544,218 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 58 | 57 |
Additional paid-in capital | 1,121,628 | 1,108,832 |
Accumulated deficit | (959,980) | (918,345) |
Accumulated other comprehensive income/(loss) | (91) | (12) |
Total stockholders’ equity | 161,615 | 190,532 |
Noncontrolling interest (SRX Cardio) | 2,112 | 2,157 |
Total stockholders' equity | 163,727 | 192,689 |
Total liabilities and stockholders’ equity | $ 340,695 | $ 343,436 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2017 | Dec. 31, 2016 |
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 | 57,009,237 | 56,544,218 |
Common stock, shares outstanding | 57,009,237 | 56,544,218 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Income Statement [Abstract] | ||
Collaboration and license revenue | $ 5,128 | $ 8,258 |
Operating expenses: | ||
Research and development | 30,645 | 58,813 |
Selling, general and administrative | 15,021 | 14,751 |
Total operating expenses | 45,666 | 73,564 |
Loss from operations | (40,538) | (65,306) |
Interest and other income, net | 413 | 332 |
Interest expense | (1,639) | |
Net loss | (41,764) | (64,974) |
Net loss attributable to noncontrolling interest (SRX Cardio) | 45 | |
Net loss attributable to Portola | $ (41,719) | $ (64,974) |
Net loss per share attributable to Portola common stockholders: | ||
Basic and diluted | $ (0.74) | $ (1.15) |
Shares used to compute net loss per share attributable to Portola common stockholders: | ||
Basic and diluted | 56,692,788 | 56,397,881 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (41,764) | $ (64,974) |
Other comprehensive income: | ||
Unrealized gain (loss) on available-for-sale securities, net of tax | (79) | 216 |
Comprehensive loss | (41,843) | (64,758) |
Comprehensive loss attributable to noncontrolling interest (SRX Cardio) | 45 | |
Total comprehensive loss attributable to Portola | $ (41,798) | $ (64,758) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Operating activities | ||
Net loss | $ (41,764) | $ (64,974) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 504 | 457 |
Amortization of premium on investment securities | 161 | 474 |
Non-cash interest expense | 1,639 | |
Stock-based compensation expense | 9,034 | 7,069 |
Changes in operating assets and liabilities: | ||
Prepaid research and development | 1,401 | 6,122 |
Prepaid expenses and other current assets | (632) | (236) |
Prepaid and other long-term assets | 1,046 | 816 |
Accounts payable | (5,123) | 3,344 |
Accrued compensation and employee benefits | (1,407) | (2,750) |
Accrued research and development | (12,649) | (6,621) |
Accrued and other liabilities | 1,587 | 137 |
Deferred revenue | (5,128) | 17,992 |
Other long-term liabilities | (205) | (166) |
Net cash used in operating activities | (51,536) | (38,336) |
Investing activities | ||
Purchases of property and equipment | (113) | (1,335) |
Decrease in restricted cash (SRX Cardio) | 4 | 79 |
Purchases of investments | (147,781) | (52,544) |
Proceeds from maturities of investments | 95,304 | 115,684 |
Net cash (used in) provided by investing activities | (52,586) | 61,884 |
Financing activities | ||
Proceeds from debt issuance, net | 48,000 | |
Payment of public offering cost | (242) | |
Debt issuance costs paid | (536) | |
Proceeds from issuance of common stock pursuant to equity award plans | 3,847 | 910 |
Net cash provided by financing activities | 51,311 | 668 |
Net (decrease) increase in cash and cash equivalents | (52,811) | 24,216 |
Cash and cash equivalents at beginning of period | 188,480 | 186,488 |
Cash and cash equivalents at end of period | $ 135,669 | $ 210,704 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | 1. Organization Portola Pharmaceuticals, Inc. ® Our two late stage development programs address significant unmet medical needs in the area of thrombosis, or blood clots. Our lead compound, betrixaban, is a U.S. Food and Drug Administration, or FDA, designated Fast-Track novel oral once-daily inhibitor of Factor Xa. Our second compound, andexanet alfa, an FDA-designated breakthrough therapy and orphan drug, is a recombinant protein designed to reverse anticoagulant activity in patients treated with a Factor Xa inhibitor. Our third compound, cerdulatinib, is being developed for hematologic, or blood, cancers and inflammatory disorders. Cerdulatinib is an orally available dual kinase inhibitor that inhibits spleen tyrosine kinase, or Syk, and janus kinases, or JAK, enzymes that regulate important signaling pathways. We also have an early stage program of highly selective Syk inhibitors, one of which is partnered with Ora, Inc., or Ora, and another early stage program to develop a drug in the field of hypercholesterolemia. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2017 | |
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 Portola and its wholly-owned subsidiaries and a development partner that is a variable interest entity (a “VIE”) for which Portola is deemed, under applicable accounting guidance, to be the primary beneficiary as of March 31, 2017. The unaudited condensed consolidated financial statements 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 months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other interim period or for any other future year. The condensed consolidated balance sheet as of December 31, 2016 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. The accompanying unaudited 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, 2016 included in our Annual Report on Form 10-K filed on March 1, 2017 with the SEC. Reclassification Certain immaterial reclassifications have been made to prior period amounts to conform to current period presentation. This reclassification did not have an impact on our results of operations or financial condition as of December 31, 2016. 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 including short-term and long-term classification, embedded derivative liabilities, income taxes, in-process research and development, the consolidation of VIEs and deconsolidation of VIEs 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 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. In-process Research and Development Asset In-process research and development asset relates to our consolidated VIE and is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If the project is completed, which generally occurs if and when regulatory approval to market a product is obtained, the carrying value of the related intangible asset is amortized as a part of cost of product revenues over the remaining estimated life of the asset beginning in the period in which the project is completed. If the asset becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs. The in-process research and development asset is tested for impairment on an annual basis, and more frequently if indicators are present or changes in circumstances suggest that impairment may exist. See Note 7, “Asset Acquisition and License Agreements,” to these condensed consolidated financial statements for further information. 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 in Marketable Securities All investments in marketable securities 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 our 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 were 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, net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income, net. Collaboration Collaboration customers who accounted for 10% or more of total collaboration and license revenues were as follows: Three Months Ended March 31, 2017 2016 Daiichi Sankyo, Inc. 43 % 41 % Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. 16 % 40 % Bristol-Myers Squibb Company and Pfizer Inc. 34 % 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 may include the transfer of intellectual property rights (licenses), obligations to provide research and development services and related clinical drug supply, obligations to provide regulatory approval services and obligations to participate on certain development and/or commercialization committees with the collaborators. If we determine that multiple deliverables exist, the consideration is allocated to one or more units of accounting based upon the best estimate of the selling price of each deliverable. The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. In order to account for multiple element arrangements, we identify the deliverables at the inception of the arrangement and each deliverable within a multiple deliverable revenue arrangement is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and substantially in our control. A delivered item or items that do not qualify as a separate unit of accounting within the arrangement shall be combined with the other applicable undelivered items within the arrangement. For a combined unit of accounting, non-refundable upfront payments are recognized in a manner consistent with the final deliverable, which has generally been ratably over the period we provide research and development services. Amounts received in advance of performance are recorded as deferred revenue in our condensed consolidated balance sheet and are recognized as collaboration revenue. 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 received from our collaboration and license agreements are recognized as revenue if the collaboration arrangement involves the sale of services associated with the development and commercialization of our products at amounts that exceed our cost. Under certain collaboration arrangements, we receive reimbursement for a portion of our research and development costs. 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. Net Loss per Share Attributable to Portola Common Stockholders Basic net loss per share attributable to Portola Common Stockholders is calculated by dividing the net loss attributable to Portola Common Stockholders by the weighted-average number of shares of Common Stock outstanding for the period. Diluted net loss per share attributable to Portola Common Stockholders is the same as basic net loss per share attributable to Portola Common Stockholders, since the effects of potentially dilutive securities are antidilutive. Recent Accounting Pronouncements In January 2017, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. . In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force). In October 2016, the FASB issued ASU No. 2016-17, Consolidation (Topic 810): Interests Held through Related Parties That Are under Common Control. In October 2016, FASB issued ASU No. 2016-16, Income Taxes (topic 740) We are currently evaluating the impact of our pending adoption of this standard on our condensed consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230) We are currently evaluating the impact of our pending adoption of this standard on our condensed consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers Revenue from Contracts with Customers Principal versus Agent Considerations Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients The new revenue standard permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). We plan to adopt the standard in the first quarter of 2018 using the modified retrospective method. Although we are still evaluating our contracts and assessing all the potential impacts of the standard, we anticipate the adoption may have a material impact on our condensed consolidated financial statements. Specifically, the timing of recognition for certain contingent payments from our collaborators may be impacted by the adoption of the new revenue standard. ASU No. 2014-09 differs from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments or contingent payments. Under our current accounting policy, we recognize contingent or milestone payments as revenue in the period that the payment-triggering event occurred or is achieved. However, under the new revenue standard, it is possible to start to recognize contingent or milestone payments before the payment-triggering event is completely achieved, subject to management’s assessment of whether it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2017 | |
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, restricted cash, short-term investments, receivables from collaborations, prepaid research and development, prepaid expenses and other current assets accounts payable, accrued research and development, accrued compensation and employee benefits, accrued and other liabilities and deferred revenue, approximate their fair value due to their short maturities. 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. In certain cases where there is limited activity or less transparency around inputs to valuation, the related assets or liabilities are classified as Level 3. Our embedded derivative liabilities are measured at fair value using a Monte Carlo simulation model and are included as a component of other long-term liabilities on the condensed consolidated balance sheets. The assumptions used in the Monte Carlo simulation model include: 1) our estimates of both the probability and timing of regulatory approval of andexanet alfa by geographical region and other related events; 2) probability weighted net sales of andexanet alfa; 3) our risk adjusted discount rate that includes a company specific risk premium; 4) cost of debt; 5) volatility; 6) the probability of a change in control occurring during the term of the note; and 7) probability of an event of default. The valuation of our embedded derivative liabilities is most sensitive to the probability of andexanet alfa achieving regulatory approval given the binary nature of such an approval event and the correlation to other assumptions included in the model. In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3. Our noncontrolling interest includes the fair value of the contingent milestone and royalty payments, which is valued based on Level 3 inputs. See Note 7, " ," 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): March 31, 2017 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 14,888 $ — $ — $ 14,888 Corporate notes and commercial paper — 172,173 — 172,173 U.S. government agency securities — 99,251 — 99,251 Total financial assets $ 14,888 $ 271,424 $ — $ 286,312 Financial Liabilities: Embedded derivatives liabilities $ — $ — $ 855 $ 855 December 31, 2016 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 6,254 $ — $ — $ 6,254 Corporate notes and commercial paper — 133,099 — 133,099 U.S. government agency securities — 55,936 — 55,936 Total financial assets $ 6,254 $ 189,035 $ — $ 195,289 Financial Liabilities: Embedded derivatives liabilities $ — $ — $ 246 $ 246 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 any of the levels of the fair value hierarchy during the periods presented. |
Financial Instruments
Financial Instruments | 3 Months Ended |
Mar. 31, 2017 | |
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): March 31, 2017 December 31, 2016 Estimated Estimated Unrealized Unrealized Fair Unrealized Unrealized Fair Cost Gain (Loss) Value Cost Gain (Loss) Value Money market funds $ 14,888 $ — $ — $ 14,888 $ 6,254 $ — $ — $ 6,254 Corporate notes and commercial paper 172,213 1 (41 ) 172,173 133,112 1 (14 ) $ 133,099 U.S. government agency securities 99,302 3 (54 ) 99,251 55,934 5 (3 ) $ 55,936 $ 286,403 $ 4 $ (95 ) $ 286,312 $ 195,300 $ 6 $ (17 ) $ 195,289 Classified as: Cash equivalents $ 103,784 $ 64,998 Short-term investments 182,528 130,291 Long-term investments — — Total cash equivalents and investments $ 286,312 $ 195,289 At March 31, 2017 and December 31, 2016, the remaining contractual maturities of available-for-sale securities were less than one year. There have been no significant realized losses on available-for-sale securities for the periods presented. |
Collaboration and License Agree
Collaboration and License Agreements | 3 Months Ended |
Mar. 31, 2017 | |
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 March 31, 2017 2016 BMS and Pfizer $ 1,758 $ 1,254 Daiichi Sankyo 2,181 3,385 Bayer and Janssen 799 3,307 Bayer 390 260 Other — 52 Total collaboration and license revenue $ 5,128 $ 8,258 Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) In 2014 we entered into an agreement with BMS and Pfizer to study andexanet alfa as a reversal agent to apixaban in our Phase 3 studies. As of March 31, 2017, we have no further milestone payments eligible for achievement under this agreement and continue to recognize the non-contingent payments received on a straight-line basis over the period of performance, which is estimated to be through the first quarter of 2018. During the three months ended March 31, 2017 and 2016, we recognized $0.6 million and $0.5 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of March 31, 2017 was $10.6 million. In 2016 we entered into an agreement with BMS and Pfizer whereby they obtained exclusive rights to develop and commercialize andexanet alfa in Japan and we are responsible for certain research, development and manufacturing activities. As of March 31, 2017, we have milestone payments totaling up to $20.0 million that remain eligible for achievement upon certain regulatory events and up to $70.0 million which may be earned upon the achievement of specified annual net sales volumes in Japan in addition to royalties ranging from 5% to 15% on net sales of andexanet alfa in Japan. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the first quarter of 2019. During the Daiichi Sankyo, Inc. (“Daiichi Sankyo”) In 2014, as amended in 2016, we entered into an agreement with Daiichi Sankyo to study andexanet alfa as a reversal agent to edoxaban. As of March 31, 2017, we have milestone payments totaling up to $12.5 million that remain eligible for achievement upon the occurrence of certain clinical events and patient enrollment targets. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the third quarter of 2018. The $8.0 million refundable portion of the upfront consideration is recorded as an obligation to collaborator and will be relieved as we make royalty payments or written off should we fail to commercialize andexanet alfa. During the three months ended March 31, 2017 and 2016, we recognized $1.8 million and $3.4 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of March 31, 2017 was $10.8 million. In 2016 we entered into an agreement with Daiichi Sankyo associated with the pursuit of regulatory approval of andexanet alfa as a reversal agent to edoxaban in Japan. As of March 31, 2017, we have milestone payments totaling up to $10.0 million eligible for achievement upon initial and final regulatory approval of andexanet alfa as a reversal agent to edoxaban in Japan. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the first quarter of 2019. During the three months ended March 31, 2017 we recognized $0.4 million in collaboration revenue under this agreement. The deferred revenue balance under this agreement as of March 31, 2017 was $3.3 million. Bayer Pharma, AG (“Bayer”) and Janssen Pharmaceuticals, Inc. (“Janssen”) In 2014 we entered into an agreement with Bayer and Janssen to study andexanet alfa as a reversal agent to rivaroxaban in our Phase 3 studies. As of March 31, 2017, we have milestone payments totaling up to $5.0 million that remain eligible for achievement upon the occurrence of certain events associated with scaling up our manufacturing process. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the first quarter of 2018. During the three months ended March 31, 2017 and 2016, we recognized $0.8 million and $3.3 million in collaboration revenue including milestone payment under this agreement, respectively. The deferred revenue balance under this agreement as of March 31, 2017 was $3.2 million. Bayer Pharma, AG (“Bayer”) In 2016 we entered into an agreement with Bayer associated with the pursuit of regulatory approval of andexanet alfa as a reversal agent to rivaroxaban in Japan. As of March 31, 2017, the $10.0 million milestone payment associated with regulatory approval of andexanet alfa as a reversal agent to rivaroxaban in Japan remains eligible for achievement. We continue to recognize non-contingent consideration received under the agreement on a straight-line basis over the period of performance, which is estimated to be through the first quarter of 2019. During the three months ended March 31, 2017 and 2016, we recognized $0.4 million and $0.3million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of March 31, 2017 was $3.2 million. |
Purchase Commitments
Purchase Commitments | 3 Months Ended |
Mar. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Purchase Commitments | 6. Purchase Commitments Commercial Supply Agreement In 2016, we entered into an Amended Restated Commercial Supply Agreement (“aCSA”) with CMC ICOS Biologics, Inc. (“CMC ”), a subsidiary of AGC Asahi Glass, that amends and restates the terms of the original Commercial Supply Agreement. We have made firm orders to manufacture 20 batches in 2017 and are required to make a non-refundable manufacturing reservation payment of $2.5 million for ten batches to be manufactured in 2018 contingent upon CMC’s successful delivery of services related to our BLA re-submission to the FDA. Pursuant to the terms of the aCSA, we received a $33.7 million credit, which may be applied to either satisfy or partially offset specified amounts owed to CMC for services rendered under the aCSA, existing obligations/payables to CMC as of the execution date and future services to be rendered through December 31, 2017. For the three months ended March 31, 2017, the Company utilized $3.8 million of these credits as a reduction of R&D expense to settle accounts payable and accrued liabilities related to specified services rendered by CMC. Under the consolidation guidance, we determined that CMC is a VIE and we are not the primary beneficiary and therefore consolidation of CMC is not required. As of March 31, 2017, we have not provided financial or other support to CMC that was not previously contractually required. We have recorded $1.0 million of accounts payable, $0.1 million of accrued research and development and $2.3 million of prepaid manufacturing services in our condensed consolidated balance sheet as of March 31, 2017. Our agreement with CMC does not require us to fund operations at CMC and therefore, we quantify our maximum exposure to loss as the aggregate value of prepaid manufacturing services as of March 31, 2017. Further, we believe that our total exposure to losses associated with the fixed pricing terms of this agreement is de minimis given the cost per batch, number of batches and time frame over which the batches will be manufactured, pursuant to the amended agreement. Betrixaban Manufacturing Agreement In 2016 we entered into a Manufacturing Agreement, as amended, with Hovione, Limited, (“Hovione”), pursuant to which Hovione will manufacture active pharmaceutical ingredient for betrixaban at commercial scale and perform process validation during the term of the agreement. As of March 31, 2017, we have recorded as $2.0 million in prepaid research and development and $4.1 million in prepaid and other long-term assets under the agreement, and will make up to $22.1 million of additional cancellable payments throughout the term of the Agreement, ending June 2018. |
Asset Acquisition and License A
Asset Acquisition and License Agreements | 3 Months Ended |
Mar. 31, 2017 | |
Research And Development [Abstract] | |
Asset Acquisition and License Agreements | 7. Asset Acquisition and License Agreements SRX Cardio, LLC In 2016 we entered into an exclusive license agreement with SRX Cardio, LLC (“SRX Cardio”) to explore a novel approach to develop a drug in the field of hypercholesterolemia. We determined that SRX Cardio is, and as of March 31, 2017, continues to be a variable interest entity that requires consolidation. Accordingly, we have consolidated the financial statements of SRX Cardio since inception of the agreement on December 1, 2015 by (a) eliminating all intercompany balances and transactions; and (b) allocating loss attributable to the noncontrolling interest in SRX Cardio to net loss attributable to noncontrolling interest in our consolidated statement of operations and reflecting noncontrolling interest on our consolidated balance sheet. Our interest in SRX Cardio is limited to the development of the intellectual property asset. As of March 31, 2017, we have not provided financial or other support to SRX Cardio that was not previously contracted or required. We recorded SRX Cardio’s $0.2 million of cash as restricted cash because (a) we do not have any interest in or control over SRX Cardio's cash and (b) the agreement does not provide for these assets to be used for the development of the intellectual property assets developed pursuant to this agreement. |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2017 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 8. Long-term Debt Note Payable In December 2016, we entered into a supplemental funding support agreement with BMS and Pfizer whereby we received $50.0 million in exchange for two promissory notes totaling $65.0 million that become due in December 2024. The use of funds is restricted to development activities needed for regulatory approval of andexant alfa by the FDA and European Medicines Agency (“EMA”) as provided for in the agreement. Pursuant to the terms of the agreement, we are required to pay down the note each quarter in an amount equal to 5% of net sales of andexanet alfa in the United States and European Union(“EU”). Should the initial regulatory approval of andexanet alfa in the USA and EU not be achieved by January 1, 2019, one hundred percent of payments due to us under the Japan License agreement and fifty percent of all other andexanet alfa license fees and milestone payments received from third party collaborators will be applied to the notes payable. In addition, if the approval of andexanet alfa in the United States and EU is not achieved by January 1, 2019, we are able to reduce the repayment amount to $60.0 million if such amount is paid by December 31, 2021 and regardless of the timing of regulatory approval, we may reduce the repayment amount to $62.5 million if such amount is paid by December 31, 2023. Any unpaid amounts shall become immediately due upon: 1) a change of control of our company; 2) an event of default; and 3) termination for breach. We have the right to prepay the repayment amount at any time without any penalty. The accounting for such funding agreement requires us to make certain estimates and assumptions, including timing of andexanet alfa approval, timing of royalty payments due to BMS and Pfizer, the expected rate of return to BMS and Pfizer, the split between current and long-term portions of the obligation and accretion of related interest expense. The upfront cash receipt of $50.0 million is recorded as notes payable, long term at issuance. We are accruing for interest over the term of the related note. The carrying values of the notes payable at March 31, 2017 and December 31, 2016, including accrued interest of $0.7 million and $0.1 million, are $50.5 million and $49.8 million, respectively. We evaluated the features of the notes payable and determined that certain features which require acceleration of payments such as pursuant to a change of control or an event of default, as well as the terms that adjust the total amount of interest required to be paid based upon the timing of initial regulatory approval in the United States and EU require bifurcation and fair value recognition. We determined the fair value of each derivative using a Monte Carlo simulation model taking into account the probability of these events occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 3 to the condensed consolidated financial statements. The aggregate fair value of the embedded derivatives at issuance date was $0.3 million included in other long-term liabilities. The Company will remeasure the embedded derivatives to fair value each reporting period until the repayment, termination or maturity of the long-term note payable. For the three months ended March 31, 2017, the remeasurement gain(loss) of embedded derivatives was insignificant. The estimated fair value of the note payable at March 31, 2017 was $54.7 million and the fair value was measured using Level 3 inputs. The estimated fair market value was calculated using a Monte Carlo simulation model with inputs consistent with those used in determining the embedded derivative values as described in Note 3. Royalty-based Financing In February 2017, we entered into a purchase and sale agreement (the “Royalty Sales Agreement”) with HealthCare Royalty Partners and its affiliates. (“HCR”) whereby HCR acquired a royalty interest in future worldwide net sales of andexanet alfa. We received $50.0 million upon closing and have the right to receive an additional $100.0 million if U.S. regulatory approval of andexanet alfa is received prior to October 2018. We are required to pay HCR a royalty of 2.0% based on tiered net worldwide sales of andexanet alfa. If the additional $100.0 million is received from HCR, the tiered royalty rate will increase to a range of 7.85% to 3.58%, as the applicable rate decreases starting at worldwide net sales levels above $150 million. Total royalty payments are capped at 195% of the funded amount, however, the royalty rates are subject to increase if the timing of marketing and manufacturing approvals from the FDA is not received before the dates within 2018 specified in the Royalty Sales Agreement. If andexanet alfa is not approved for commercial sale the Company has no repayment obligations under this agreement. We have evaluated the terms of the Royalty Sales Agreement and concluded that the features of the funded amount are similar to those of a debt instrument. Accordingly, we have accounted for the transaction as long-term debt. As the repayment of the s We evaluated the terms of the debt and determined that certain features, such as the increase in the repayment amount up to $125.0 million upon a change of control and the variability in the royalty payments based upon the timing of initial regulatory approval in the United States and EU, are embedded derivatives that require bifurcation from the debt instrument and fair value recognition. We determined the fair value of each derivative using a Monte Carlo simulation model taking into account the probability of these events occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 3 to these condensed consolidated financial statements. The aggregate fair value of the embedded derivatives at issuance date was $0.6 million and is included in other long-term liabilities. The Company will remeasure the embedded derivatives to fair value each reporting period until the time the features lapse and/or termination of the Royalty Sales Agreement. The effective interest rate as of March 31, 2017 was 13.8%. For the three months ended March 31, 2017, accrued interest in the amount of $0.9 million was added to the principal balance of the debt. In connection with the Royalty Sales Agreement, we paid HCR a fee of $2.0 million and incurred additional debt issuance costs totaling $0.6 million, which includes expenses that we paid on behalf of HCR and expenses incurred directly by us. Debt issuance costs have been netted against the debt as of March 31, 2017 and are being amortized over the estimated term of the debt using the effective interest method. For the three months ended March 31, 2017, we recognized interest expense, including amortization of the debt discount, related to the debt of $0.9 million. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs requires that we make estimates that could impact the short and long-term classification of these costs, as well as the period over which these costs will be amortized. The carrying value of the debt as of March 31, 2017 was $47.8 million, inclusive of payment-in-kind interest expense of $0.9 million and net of unamortized debt discount of $2.5 million. The estimated fair value of long-term debt at March 31, 2017 was $43.3 million and the fair value was measured using Level 3 inputs. The estimated fair market value was calculated using a Monte Carlo simulation model with inputs consistent with those used in determining the embedded derivative values as described in Note 3. |
Stock Based Compensation
Stock Based Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Based Compensation | 9. Stock Based Compensation In January 2013, our Board of Directors adopted our 2013 Equity Incentive Plan (the “2013 Plan”), which became effective upon of the closing of our initial public offering in May 2013. On January 1, 2017, the number of shares available for issuance under the 2013 Plan automatically increased by a number of shares equal to 5% of the total common stock outstanding at December 31, 2016. As of March 31, 2017, there were 15,032,633 shares reserved under the 2013 Plan for the future issuance of equity awards. Stock Options The following table summarizes stock option activity under our 2013 Plan and related information during the three months ended March 31, 2017: Shares Subject Weighted- Outstanding Average Exercise Options Price Per Share Balance at December 31, 2016 5,817,116 $ 25.26 Options granted 1,036,100 27.04 Options exercised (196,871 ) 15.86 Options canceled (71,202 ) 33.34 Balance at March 31, 2017 6,585,143 $ 25.73 Performance Stock Options (“PSOs”) In May 2016, the Compensation Committee of our Board of Directors approved the commencement of granting performance stock option awards to our executive and senior officers. PSOs represent a contingent right to purchase our Common Stock upon achievement of specified conditions. The PSOs granted in May 2016 will vest upon the achievement of certain regulatory and manufacturing goals related to our lead programs. As of March 31, 2017, there was $2.0 million of unrecognized compensation costs related to the PSOs which management currently estimates to be probable of vesting and which we estimate will be recognized over a weighted-average period of 1.4 years. The following table summarizes PSO activity under our 2013 Plan and related information during the three months ended March 31, 2017: Shares Subject Weighted- Outstanding Average Exercise Options Price Per Share Balance at December 31, 2016 180,752 $ 23.76 Options granted — — Options exercised — — Options canceled — — Balance at March 31, 2017 180,752 $ 23.76 Restricted Stock Units (“RSUs”) In January 2015, the Compensation Committee of our Board of Directors approved the commencement of granting restricted stock units, to our employees. RSUs are share awards that entitle the holder to receive freely tradable shares of our Common Stock upon vesting. The following table summarizes RSU activity, under our 2013 Plan and related information: Shares Subject to Weighted- Outstanding Average grant date RSUs fair value per share Balance at December 31, 2016 546,507 $ 28.38 RSUs granted 306,050 25.54 RSUs released (211,882 ) 28.26 RSUs canceled (8,932 ) 27.37 Balance at March 31, 2017 631,743 $ 27.06 Performance Stock Units In January 2015, the Compensation Committee of our Board of Directors approved the commencement of granting performance stock units to our employees. PSUs are share awards that entitle the holder to receive freely tradable shares of our Common Stock upon achievement of specified conditions. In January 2016, the Compensation Committee of our Board of Directors approved a program to award up to 102,906 PSUs to the management team based on the achievement of certain commercial and regulatory goals related to andexanet alfa and betrixaban, respectively. related to andexanet alfa. As of March 31, 2017, there was $0.3 million of unrecognized compensation costs related to the PSUs which management currently estimates to be probable of vesting and which we currently estimate will be recognized over a weighted-average period of 0.6 years. The following table summarizes PSU activity, under our 2013 Plan and related information: Shares Subject to Weighted- Outstanding Average grant date PSUs fair value per share Balance at December 31, 2016 285,866 $ 29.24 PSUs granted 143,750 25.54 PSUs released (8,917 ) 50.30 PSUs canceled (51,581 ) 33.53 Balance at March 31, 2017 369,118 $ 26.69 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 March 31, 2017 2016 Research and development $ 4,150 $ 3,030 Selling, general and administrative 4,884 4,039 Total stock-based compensation $ 9,034 $ 7,069 |
Net Loss per Share Attributable
Net Loss per Share Attributable to Portola Common Stockholders | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Portola Common Stockholders | 10. Net Loss per Share Attributable to Portola Common Stockholders Basic net loss per share attributable to Portola Common Stockholders has been computed by dividing the net loss attributable to Portola Common Stockholders by the weighted-average number of shares of Common Stock outstanding during the period. Diluted net loss per share attributable to Portola Common Stockholders is calculated by dividing net loss attributable to Portola Common Stockholders by the weighted average number of shares of Common Stock and potential dilutive securities outstanding during the period. The following common stock equivalent shares were excluded from the computation of diluted net loss per share attributable to Portola Common Stockholders for the three months ended March 31, 2017 and 2016 because including them would have been anti-dilutive: 2017 2016 Stock options to purchase common stock 6,585,143 5,615,484 Performance stock options 180,752 — Common stock warrants 1,500 1,500 Restricted stock units 631,743 318,228 Performance stock units 369,118 293,694 Employee stock purchase plan 5,816 8,867 |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Consolidation and Basis of Presentation | Consolidation and Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the amounts of Portola and its wholly-owned subsidiaries and a development partner that is a variable interest entity (a “VIE”) for which Portola is deemed, under applicable accounting guidance, to be the primary beneficiary as of March 31, 2017. The unaudited condensed consolidated financial statements 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 months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other interim period or for any other future year. The condensed consolidated balance sheet as of December 31, 2016 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. The accompanying unaudited 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, 2016 included in our Annual Report on Form 10-K filed on March 1, 2017 with the SEC. |
Reclassification | Reclassification Certain immaterial reclassifications have been made to prior period amounts to conform to current period presentation. This reclassification did not have an impact on our results of operations or financial condition as of December 31, 2016. |
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 including short-term and long-term classification, embedded derivative liabilities, income taxes, in-process research and development, the consolidation of VIEs and deconsolidation of VIEs 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 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. |
In-process Research and Development Asset | In-process Research and Development Asset In-process research and development asset relates to our consolidated VIE and is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If the project is completed, which generally occurs if and when regulatory approval to market a product is obtained, the carrying value of the related intangible asset is amortized as a part of cost of product revenues over the remaining estimated life of the asset beginning in the period in which the project is completed. If the asset becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs. The in-process research and development asset is tested for impairment on an annual basis, and more frequently if indicators are present or changes in circumstances suggest that impairment may exist. See Note 7, “Asset Acquisition and License Agreements,” to these condensed consolidated financial statements for further information. |
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 in Marketable Securities | Investments in Marketable Securities All investments in marketable securities 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 our 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 were 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, net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income, 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 March 31, 2017 2016 Daiichi Sankyo, Inc. 43 % 41 % Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. 16 % 40 % Bristol-Myers Squibb Company and Pfizer Inc. 34 % 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 may include the transfer of intellectual property rights (licenses), obligations to provide research and development services and related clinical drug supply, obligations to provide regulatory approval services and obligations to participate on certain development and/or commercialization committees with the collaborators. If we determine that multiple deliverables exist, the consideration is allocated to one or more units of accounting based upon the best estimate of the selling price of each deliverable. The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. In order to account for multiple element arrangements, we identify the deliverables at the inception of the arrangement and each deliverable within a multiple deliverable revenue arrangement is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and substantially in our control. A delivered item or items that do not qualify as a separate unit of accounting within the arrangement shall be combined with the other applicable undelivered items within the arrangement. For a combined unit of accounting, non-refundable upfront payments are recognized in a manner consistent with the final deliverable, which has generally been ratably over the period we provide research and development services. Amounts received in advance of performance are recorded as deferred revenue in our condensed consolidated balance sheet and are recognized as collaboration revenue. 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 received from our collaboration and license agreements are recognized as revenue if the collaboration arrangement involves the sale of services associated with the development and commercialization of our products at amounts that exceed our cost. Under certain collaboration arrangements, we receive reimbursement for a portion of our research and development costs. 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. |
Net Loss per Share Attributable to Portola Common Stockholders | Net Loss per Share Attributable to Portola Common Stockholders Basic net loss per share attributable to Portola Common Stockholders is calculated by dividing the net loss attributable to Portola Common Stockholders by the weighted-average number of shares of Common Stock outstanding for the period. Diluted net loss per share attributable to Portola Common Stockholders is the same as basic net loss per share attributable to Portola Common Stockholders, since the effects of potentially dilutive securities are antidilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In January 2017, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. . In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force). In October 2016, the FASB issued ASU No. 2016-17, Consolidation (Topic 810): Interests Held through Related Parties That Are under Common Control. In October 2016, FASB issued ASU No. 2016-16, Income Taxes (topic 740) We are currently evaluating the impact of our pending adoption of this standard on our condensed consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230) We are currently evaluating the impact of our pending adoption of this standard on our condensed consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers Revenue from Contracts with Customers Principal versus Agent Considerations Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients The new revenue standard permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). We plan to adopt the standard in the first quarter of 2018 using the modified retrospective method. Although we are still evaluating our contracts and assessing all the potential impacts of the standard, we anticipate the adoption may have a material impact on our condensed consolidated financial statements. Specifically, the timing of recognition for certain contingent payments from our collaborators may be impacted by the adoption of the new revenue standard. ASU No. 2014-09 differs from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments or contingent payments. Under our current accounting policy, we recognize contingent or milestone payments as revenue in the period that the payment-triggering event occurred or is achieved. However, under the new revenue standard, it is possible to start to recognize contingent or milestone payments before the payment-triggering event is completely achieved, subject to management’s assessment of whether it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
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 March 31, 2017 2016 Daiichi Sankyo, Inc. 43 % 41 % Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. 16 % 40 % Bristol-Myers Squibb Company and Pfizer Inc. 34 % 15 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
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): March 31, 2017 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 14,888 $ — $ — $ 14,888 Corporate notes and commercial paper — 172,173 — 172,173 U.S. government agency securities — 99,251 — 99,251 Total financial assets $ 14,888 $ 271,424 $ — $ 286,312 Financial Liabilities: Embedded derivatives liabilities $ — $ — $ 855 $ 855 December 31, 2016 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 6,254 $ — $ — $ 6,254 Corporate notes and commercial paper — 133,099 — 133,099 U.S. government agency securities — 55,936 — 55,936 Total financial assets $ 6,254 $ 189,035 $ — $ 195,289 Financial Liabilities: Embedded derivatives liabilities $ — $ — $ 246 $ 246 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
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): March 31, 2017 December 31, 2016 Estimated Estimated Unrealized Unrealized Fair Unrealized Unrealized Fair Cost Gain (Loss) Value Cost Gain (Loss) Value Money market funds $ 14,888 $ — $ — $ 14,888 $ 6,254 $ — $ — $ 6,254 Corporate notes and commercial paper 172,213 1 (41 ) 172,173 133,112 1 (14 ) $ 133,099 U.S. government agency securities 99,302 3 (54 ) 99,251 55,934 5 (3 ) $ 55,936 $ 286,403 $ 4 $ (95 ) $ 286,312 $ 195,300 $ 6 $ (17 ) $ 195,289 Classified as: Cash equivalents $ 103,784 $ 64,998 Short-term investments 182,528 130,291 Long-term investments — — Total cash equivalents and investments $ 286,312 $ 195,289 |
Collaboration and License Agr21
Collaboration and License Agreements (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
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 March 31, 2017 2016 BMS and Pfizer $ 1,758 $ 1,254 Daiichi Sankyo 2,181 3,385 Bayer and Janssen 799 3,307 Bayer 390 260 Other — 52 Total collaboration and license revenue $ 5,128 $ 8,258 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity under our 2013 Plan and related information during the three months ended March 31, 2017: Shares Subject Weighted- Outstanding Average Exercise Options Price Per Share Balance at December 31, 2016 5,817,116 $ 25.26 Options granted 1,036,100 27.04 Options exercised (196,871 ) 15.86 Options canceled (71,202 ) 33.34 Balance at March 31, 2017 6,585,143 $ 25.73 |
Summary of PSO Activity | The following table summarizes PSO activity under our 2013 Plan and related information during the three months ended March 31, 2017: Shares Subject Weighted- Outstanding Average Exercise Options Price Per Share Balance at December 31, 2016 180,752 $ 23.76 Options granted — — Options exercised — — Options canceled — — Balance at March 31, 2017 180,752 $ 23.76 |
Summary of RSU Activity | The following table summarizes RSU activity, under our 2013 Plan and related information: Shares Subject to Weighted- Outstanding Average grant date RSUs fair value per share Balance at December 31, 2016 546,507 $ 28.38 RSUs granted 306,050 25.54 RSUs released (211,882 ) 28.26 RSUs canceled (8,932 ) 27.37 Balance at March 31, 2017 631,743 $ 27.06 |
Summary of PSU Activity | The following table summarizes PSU activity, under our 2013 Plan and related information: Shares Subject to Weighted- Outstanding Average grant date PSUs fair value per share Balance at December 31, 2016 285,866 $ 29.24 PSUs granted 143,750 25.54 PSUs released (8,917 ) 50.30 PSUs canceled (51,581 ) 33.53 Balance at March 31, 2017 369,118 $ 26.69 |
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 March 31, 2017 2016 Research and development $ 4,150 $ 3,030 Selling, general and administrative 4,884 4,039 Total stock-based compensation $ 9,034 $ 7,069 |
Net Loss per Share Attributab23
Net Loss per Share Attributable to Portola Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Common Stock Equivalent Shares Excluded from Computation of Diluted Net Loss | The following common stock equivalent shares were excluded from the computation of diluted net loss per share attributable to Portola Common Stockholders for the three months ended March 31, 2017 and 2016 because including them would have been anti-dilutive: 2017 2016 Stock options to purchase common stock 6,585,143 5,615,484 Performance stock options 180,752 — Common stock warrants 1,500 1,500 Restricted stock units 631,743 318,228 Performance stock units 369,118 293,694 Employee stock purchase plan 5,816 8,867 |
Organization - Additional Infor
Organization - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2017Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segment | 1 |
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 | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Daiichi Sankyo, Inc ("Daiichi") | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 43.00% | 41.00% |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 16.00% | 40.00% |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 34.00% | 15.00% |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Millions | Mar. 31, 2017USD ($) |
ASU No. 2016-09 | |
Summary Of Significant Accounting Policies [Line Items] | |
Cumulative effect of differed tax assets | $ 14 |
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 | Mar. 31, 2017 | Dec. 31, 2016 |
Financial Assets: | ||
Total financial assets | $ 286,312 | $ 195,289 |
Money market funds | ||
Financial Assets: | ||
Total financial assets | 14,888 | 6,254 |
Corporate notes and commercial paper | ||
Financial Assets: | ||
Total financial assets | 172,173 | 133,099 |
U.S. government agency securities | ||
Financial Assets: | ||
Total financial assets | 99,251 | 55,936 |
Embedded derivative liabilities | ||
Financial Liabilities: | ||
Total financial liabilities | 855 | 246 |
Fair Value, Inputs, Level 1 | ||
Financial Assets: | ||
Total financial assets | 14,888 | 6,254 |
Fair Value, Inputs, Level 1 | Money market funds | ||
Financial Assets: | ||
Total financial assets | 14,888 | 6,254 |
Fair Value, Inputs, Level 2 | ||
Financial Assets: | ||
Total financial assets | 271,424 | 189,035 |
Fair Value, Inputs, Level 2 | Corporate notes and commercial paper | ||
Financial Assets: | ||
Total financial assets | 172,173 | 133,099 |
Fair Value, Inputs, Level 2 | U.S. government agency securities | ||
Financial Assets: | ||
Total financial assets | 99,251 | 55,936 |
Fair Value, Inputs, Level 3 | Embedded derivative liabilities | ||
Financial Liabilities: | ||
Total financial liabilities | $ 855 | $ 246 |
Fair Values Measurements - Addi
Fair Values Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
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 |
Fair value liabilities transfers from level 1 to level 2 | 0 | 0 |
Fair value liabilities transfers from level 2 to level 1 | 0 | 0 |
Fair value assets transfers into level 3 | 0 | 0 |
Fair value assets transfers out of level 3 | 0 | 0 |
Fair value liabilities transfers into level 3 | 0 | 0 |
Fair value liabilities transfers out of level 3 | $ 0 | $ 0 |
Cash Equivalents and Investment
Cash Equivalents and Investments Classified as Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | $ 286,403 | $ 195,300 |
Unrealized Gains | 4 | 6 |
Unrealized (Losses) | (95) | (17) |
Estimated Fair Value | 286,312 | 195,289 |
Money market funds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 14,888 | 6,254 |
Estimated Fair Value | 14,888 | 6,254 |
Corporate notes and commercial paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 172,213 | 133,112 |
Unrealized Gains | 1 | 1 |
Unrealized (Losses) | (41) | (14) |
Estimated Fair Value | 172,173 | 133,099 |
U.S. government agency securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 99,302 | 55,934 |
Unrealized Gains | 3 | 5 |
Unrealized (Losses) | (54) | (3) |
Estimated Fair Value | 99,251 | 55,936 |
Cash equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 103,784 | 64,998 |
Short-term investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | $ 182,528 | $ 130,291 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Investments Debt And Equity Securities [Abstract] | ||
Available For Sale Securities Contractual Maturity | 1 year | 1 year |
Summary of Revenue from Collabo
Summary of Revenue from Collaboration and License Agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | $ 5,128 | $ 8,258 |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 1,758 | 1,254 |
Daiichi Sankyo, Inc ("Daiichi") | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 2,181 | 3,385 |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 799 | 3,307 |
Bayer Pharma AG | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | $ 390 | 260 |
Other | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | $ 52 |
Collaboration and License Agr32
Collaboration and License Agreements - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | $ 5,128,000 | $ 8,258,000 |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 1,758,000 | 1,254,000 |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | 2014 Agreement | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payments eligible for achievement | 0 | |
Collaboration and license revenue | 600,000 | 500,000 |
Deferred revenue | 10,600,000 | |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | 2016 Agreement | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 1,200,000 | 800,000 |
Deferred revenue | 9,500,000 | |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | 2016 Agreement | Maximum | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Payment receivable upon the achievement of certain regulatory events | 20,000,000 | |
Payment receivable upon the achievement of annual net sales volumes | $ 70,000,000 | |
Percentage of royalties entitle to receive under agreement | 15.00% | |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | 2016 Agreement | Minimum | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Percentage of royalties entitle to receive under agreement | 5.00% | |
Daiichi Sankyo, Inc ("Daiichi") | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | $ 2,181,000 | 3,385,000 |
Daiichi Sankyo, Inc ("Daiichi") | 2014 Agreement | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 1,800,000 | 3,400,000 |
Deferred revenue | 10,800,000 | |
Milestone payments of regulatory clinical event and patient enrollment targets | 12,500,000 | |
Contingent and non-contingent consideration to be recognized after resolution of contingency | 8,000,000 | |
Daiichi Sankyo, Inc ("Daiichi") | 2016 Agreement | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 400,000 | |
Deferred revenue | 3,300,000 | |
Daiichi Sankyo, Inc ("Daiichi") | 2016 Agreement | Maximum | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payments eligible for achievement of initial and final regulatory approval | 10,000,000 | |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 799,000 | 3,307,000 |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | 2014 Agreement | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 800,000 | 3,300,000 |
Deferred revenue | 3,200,000 | |
Milestone payments eligible for achievement of certain events | 5,000,000 | |
Bayer Pharma AG | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 390,000 | 260,000 |
Bayer Pharma AG | 2016 Agreement | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and license revenue | 400,000 | $ 300,000 |
Deferred revenue | 3,200,000 | |
Milestone payment associated with regulatory approval | $ 10,000,000 |
Purchase Commitments - Addition
Purchase Commitments - Additional Information (Detail) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($)Batch | |
Long Term Purchase Commitment [Line Items] | ||
Accounts payables | $ 9,487,000 | $ 14,546,000 |
Accrued research and development | 11,169,000 | 23,818,000 |
Prepaid research and development | 5,898,000 | 7,299,000 |
Prepaid and other long-term assets | $ 4,168,000 | $ 5,214,000 |
CMC ICOS Biologics Inc | ||
Long Term Purchase Commitment [Line Items] | ||
Number of batches to be manufactured, 2017 | Batch | 20 | |
Non-refundable manufacturing reservation payments committed | $ 2,500,000 | |
Purchase commitment, description | We have made firm orders to manufacture 20 batches in 2017 and are required to make a non-refundable manufacturing reservation payment of $2.5 million for ten batches to be manufactured in 2018 contingent upon CMC’s successful delivery of services related to our BLA re-submission to the FDA | |
Number of batches to be manufactured, 2018 | Batch | 10 | |
Purchase obligation services received | $ 33,700,000 | |
Repayment of accounts payable and accrued liabilities | 3,800,000 | |
Accounts payables | 1,000,000 | |
Accrued research and development | 100,000 | |
Prepaid manufacturing services | 2,300,000 | |
Hovione, Limited | ||
Long Term Purchase Commitment [Line Items] | ||
Prepaid research and development | 2,000,000 | |
Prepaid and other long-term assets | 4,100,000 | |
Hovione, Limited | Maximum | ||
Long Term Purchase Commitment [Line Items] | ||
Cancellable additional purchase commitments | $ 22,100,000 |
Asset Acquisition and License34
Asset Acquisition and License Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Dec. 31, 2016 | |
Asset Acquisition [Line Items] | ||
Restricted cash (SRX Cardio) | $ 174 | $ 178 |
Net loss attributable to Non Controlling interest (SRX Cardio) | $ (45) | |
SRX Cardio | ||
Asset Acquisition [Line Items] | ||
Variable interest entity, Terms of arrangements | Accordingly, we have consolidated the financial statements of SRX Cardio since inception of the agreement on December 1, 2015 by (a) eliminating all intercompany balances and transactions; and (b) allocating loss attributable to the noncontrolling interest in SRX Cardio to net loss attributable to noncontrolling interest in our consolidated statement of operations and reflecting noncontrolling interest on our consolidated balance sheet. | |
Restricted cash (SRX Cardio) | $ 200 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2017USD ($) | Dec. 31, 2016USD ($)PromissoryNote | Mar. 31, 2017USD ($) | |
Debt Instrument [Line Items] | |||
Carrying value of notes payable | $ 49,815,000 | $ 50,485,000 | |
Long-term debt | 47,803,000 | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | |||
Debt Instrument [Line Items] | |||
Embedded derivative liabilities | 600,000 | ||
Amount received under royalty sales agreement | $ 50,000,000 | ||
Additional amount receivable upon U.S. regulatory approval | 100,000,000 | ||
Royalty sales agreement fee | 2,000,000 | ||
Additional debt issuance costs | 600,000 | ||
Interest expense, including amortization of debt discount | 900,000 | ||
Long-term debt | 47,800,000 | ||
Payment-in-kind interest expense | 900,000 | ||
Outstanding debt, net of unamortized debt discount | 2,500,000 | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Maximum | |||
Debt Instrument [Line Items] | |||
Repayment amount | $ 125,000,000 | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Scenario One | |||
Debt Instrument [Line Items] | |||
Percentage of royalty obligated to pay of net worldwide sales | 2.00% | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Scenario Two | |||
Debt Instrument [Line Items] | |||
Target payment for royalty obligation | $ 100,000,000 | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Scenario Two | Maximum | |||
Debt Instrument [Line Items] | |||
Percentage of royalty obligated to pay of net worldwide sales | 7.85% | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Scenario Two | Minimum | |||
Debt Instrument [Line Items] | |||
Percentage of royalty obligated to pay of net worldwide sales | 3.58% | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Scenario Three | |||
Debt Instrument [Line Items] | |||
Percentage of royalty obligated to pay of net worldwide sales | 195.00% | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa | Scenario Three | Minimum | |||
Debt Instrument [Line Items] | |||
Target payment for royalty obligation | $ 150,000,000 | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Fair Value, Inputs, Level 3 | Andexanet Alfa | |||
Debt Instrument [Line Items] | |||
Estimated fair value of long-term debt | 43,300,000 | ||
HealthCare Royalty Partners and its Affiliates (“HCR”) | Andexanet Alfa License Agreement with All Countries Excluding Japan | |||
Debt Instrument [Line Items] | |||
Notes payable, accrued interest | $ 900,000 | ||
Effective interest rate | 13.80% | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | |||
Debt Instrument [Line Items] | |||
Debt instrument repayment terms, description | if the approval of andexanet alfa in the USA and EU is not achieved by January 1, 2019, we are able to reduce the repayment amount to $60.0 million if such amount is paid by December 31, 2021 and regardless of the timing of regulatory approval, we may reduce the repayment amount to $62.5 million if such amount is paid by December 31, 2023. Any unpaid amounts shall become immediately due upon: 1) our change of control; 2) event of default; and 3) termination for breach. We have the right to prepay the repayment amount at any time without any penalty. | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Paid by December 31, 2021 | |||
Debt Instrument [Line Items] | |||
Repayment amount | $ 60,000,000 | ||
Repayment date | Dec. 31, 2021 | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Paid by December 31, 2023 | |||
Debt Instrument [Line Items] | |||
Repayment amount | $ 62,500,000 | ||
Repayment date | Dec. 31, 2023 | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Andexanet Alfa License Agreement with All Countries Excluding Japan | |||
Debt Instrument [Line Items] | |||
Percentage of license fees and milestone payments converted to notes payable upon initial regulatory approval not achieved | 50.00% | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | United States and European Union | |||
Debt Instrument [Line Items] | |||
Initial regulatory approval date | Jan. 1, 2019 | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | United States and European Union | Andexanet Alfa License Agreement with All Countries Excluding Japan | |||
Debt Instrument [Line Items] | |||
Percentage of net sales to be paid in each quarter | 5.00% | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Japan License Agreement | |||
Debt Instrument [Line Items] | |||
Percentage of payment receivable upon initial regulatory approval not achieved | 100.00% | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Promissory Notes | |||
Debt Instrument [Line Items] | |||
Proceeds from notes payable | $ 50,000,000 | ||
Number of debt instruments | PromissoryNote | 2 | ||
Promissory notes, face amount | $ 65,000,000 | ||
Promissory notes due date | 2024-12 | ||
Notes payable, accrued interest | $ 100,000 | $ 700,000 | |
Carrying value of notes payable | 49,800,000 | 50,500,000 | |
Embedded derivative liabilities | $ 300,000 | ||
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Promissory Notes | Fair Value, Inputs, Level 3 | |||
Debt Instrument [Line Items] | |||
Estimated fair value of notes payable | $ 54,700,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017 | Dec. 31, 2016 | Jan. 31, 2017 | Jan. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage increase in number of common stock outstanding | 5.00% | |||
Common stock reserved, shares | 15,032,633 | |||
Performance Stock Options (PSOs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unamortized share based compensation expected to be recognized over the remaining vesting period | $ 2 | |||
Unamortized share based compensation expected recognition period | 1 year 4 months 24 days | |||
Performance Stock Units (PSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unamortized share based compensation expected to be recognized over the remaining vesting period | $ 0.3 | |||
Unamortized share based compensation expected recognition period | 7 months 6 days | |||
Performance Stock Units (PSUs) | Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Performance-based RSUs awarded based on achievement of development goals, available for grant | 143,750 | 102,906 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) - Employee Stock Option - 2013 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Shares Subject to Outstanding Stock Options | |
Beginning balance | shares | 5,817,116 |
Options granted | shares | 1,036,100 |
Options exercised | shares | (196,871) |
Options canceled | shares | (71,202) |
Ending balance | shares | 6,585,143 |
Weighted-Average Exercise Price Per Share | |
Beginning balance | $ / shares | $ 25.26 |
Options granted | $ / shares | 27.04 |
Options exercised | $ / shares | 15.86 |
Options canceled | $ / shares | 33.34 |
Ending balance | $ / shares | $ 25.73 |
Summary of PSO Activity (Detail
Summary of PSO Activity (Detail) - Performance Stock Options (PSOs) - 2013 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Shares Subject to Outstanding Stock Options | |
Beginning balance | shares | 180,752 |
Ending balance | shares | 180,752 |
Weighted-Average Exercise Price Per Share | |
Beginning balance | $ / shares | $ 23.76 |
Ending balance | $ / shares | $ 23.76 |
Summary of RSU Activity (Detail
Summary of RSU Activity (Detail) - Restricted Stock Units (RSUs) - 2013 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Shares Subject to Outstanding Options | |
Beginning balance | shares | 546,507 |
RSUs granted | shares | 306,050 |
RSUs released | shares | (211,882) |
RSUs canceled | shares | (8,932) |
Ending balance | shares | 631,743 |
Weighted-Average grant date fair value per share | |
Beginning balance | $ / shares | $ 28.38 |
RSUs granted | $ / shares | 25.54 |
RSUs released | $ / shares | 28.26 |
RSUs canceled | $ / shares | 27.37 |
Ending balance | $ / shares | $ 27.06 |
Summary of PSU Activity (Detail
Summary of PSU Activity (Detail) - Performance Stock Units (PSUs) - 2013 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Shares Subject to Outstanding Options | |
Beginning balance | shares | 285,866 |
RSUs granted | shares | 143,750 |
RSUs released | shares | (8,917) |
RSUs canceled | shares | (51,581) |
Ending balance | shares | 369,118 |
Weighted-Average grant date fair value per share | |
Beginning balance | $ / shares | $ 29.24 |
RSUs granted | $ / shares | 25.54 |
RSUs released | $ / shares | 50.30 |
RSUs canceled | $ / shares | 33.53 |
Ending balance | $ / shares | $ 26.69 |
Classification of Stock-Based C
Classification of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 9,034 | $ 7,069 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 4,150 | 3,030 |
Selling, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 4,884 | $ 4,039 |
Common Stock Equivalent Shares
Common Stock Equivalent Shares Excluded from Computation of Diluted Net Loss per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
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 | 6,585,143 | 5,615,484 |
Performance stock options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 180,752 | |
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 | 1,500 |
Restricted stock units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 631,743 | 318,228 |
Performance stock units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 369,118 | 293,694 |
Employee stock purchase plan | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 5,816 | 8,867 |