Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 03, 2014 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'PTLA | ' |
Entity Registrant Name | 'PORTOLA PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0001269021 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Non-accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 48,632,251 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $53,144 | $117,773 |
Short-term investments | 172,060 | 150,892 |
Receivables from collaborators | 73 | 309 |
Prepaid expenses and other current assets | 4,730 | 3,733 |
Total current assets | 230,007 | 272,707 |
Property and equipment, net | 2,732 | 2,600 |
Long-term investments | 36,803 | 50,371 |
Prepaid and other long-term assets | 10,007 | 53 |
Total assets | 279,549 | 325,731 |
Current liabilities: | ' | ' |
Accounts payable | 12,531 | 3,232 |
Accrued compensation and employee benefits | 2,498 | 2,569 |
Accrued and other liabilities | 15,284 | 17,796 |
Deferred revenue, current portion | 9,875 | 1,958 |
Total current liabilities | 40,188 | 25,555 |
Deferred revenue, long-term | 29,123 | 3,253 |
Other long-term liabilities | 1,006 | 588 |
Total liabilities | 70,317 | 29,396 |
Stockholders’ equity: | ' | ' |
Preferred stock, $0.001 par value, 5,000,000 shares authorized at September 30, 2014 and December 31, 2013; 0 shares issued and outstanding at September 30, 2014 and December 31, 2013 | ' | ' |
Common stock, $0.001 par value, 100,000,000 shares authorized at September 30, 2014 and December 31, 2013; 41,501,999 and 40,915,130 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 42 | 41 |
Additional paid-in capital | 592,755 | 581,911 |
Accumulated deficit | -383,541 | -285,672 |
Accumulated other comprehensive (loss) income | -24 | 55 |
Total stockholders’ equity | 209,232 | 296,335 |
Total liabilities and stockholders’ equity | $279,549 | $325,731 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Statement Of Financial Position [Abstract] | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 41,501,999 | 40,915,130 |
Common stock, shares outstanding | 41,501,999 | 40,915,130 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Income Statement [Abstract] | ' | ' | ' | ' |
Collaboration and license revenue | $2,427 | $2,766 | $7,213 | $8,474 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 31,780 | 18,088 | 88,918 | 56,642 |
General and administrative | 6,424 | 3,907 | 16,601 | 10,654 |
Total operating expenses | 38,204 | 21,995 | 105,519 | 67,296 |
Loss from operations | -35,777 | -19,229 | -98,306 | -58,822 |
Interest and other (expense) income, net | -16 | 679 | 437 | 532 |
Net loss | ($35,793) | ($18,550) | ($97,869) | ($58,290) |
Net loss per share attributable to common stockholders: | ' | ' | ' | ' |
Basic and diluted | ($0.86) | ($0.53) | ($2.37) | ($3.39) |
Shares used to compute net loss per share attributable to common stockholders: | ' | ' | ' | ' |
Basic and diluted | 41,402,037 | 35,200,761 | 41,233,206 | 17,218,475 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Statement Of Income And Comprehensive Income [Abstract] | ' | ' | ' | ' |
Net loss | ($35,793) | ($18,550) | ($97,869) | ($58,290) |
Other comprehensive loss: | ' | ' | ' | ' |
Unrealized (loss) gain on available-for-sale securities, net of tax | -46 | 100 | -79 | 31 |
Total comprehensive loss | ($35,839) | ($18,450) | ($97,948) | ($58,259) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Operating activities | ' | ' |
Net loss | ($97,869) | ($58,290) |
Adjustments to reconcile net loss to cash used in operating activities: | ' | ' |
Depreciation and amortization | 1,142 | 1,015 |
Amortization of premium on investment securities | 2,669 | 1,523 |
Stock-based compensation expense | 6,876 | 3,457 |
Revaluation of convertible preferred stock warrant liability | ' | -24 |
Unrealized (gain) loss on foreign currency forward contracts | 114 | -97 |
Changes in operating assets and liabilities: | ' | ' |
Receivables from collaborators | 236 | 435 |
Prepaid expenses and other current assets | -797 | -540 |
Prepaid and other long-term assets | -9,954 | 361 |
Accounts payable | 9,354 | -3,323 |
Accrued compensation and employee benefits | -40 | 3 |
Accrued and other liabilities | -2,583 | 10,004 |
Deferred revenue | 33,787 | 3,225 |
Other long-term liabilities | 418 | -655 |
Net cash used in operating activities | -56,647 | -42,906 |
Investing activities | ' | ' |
Purchases of property and equipment | -1,329 | -582 |
Purchases of investments | -156,009 | -152,793 |
Proceeds from sales of investments | ' | 6,644 |
Proceeds from maturities of investments | 145,661 | 68,211 |
Net cash used in investing activities | -11,677 | -78,520 |
Financing activities | ' | ' |
Proceeds from initial public offering, net of underwriters discount | ' | 131,026 |
Payment of public offering costs | -239 | -5,025 |
Proceeds from issuance of common stock | 3,934 | 522 |
Net cash provided by financing activities | 3,695 | 126,523 |
Net (decrease) increase in cash and cash equivalents | -64,629 | 5,097 |
Cash and cash equivalents at beginning of period | 117,773 | 53,613 |
Cash and cash equivalents at end of period | $53,144 | $58,710 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2014 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' |
Organization | ' |
1. Organization | |
Portola Pharmaceuticals, Inc. (the “Company” or “we” or “our” or “us”) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis, other hematologic diseases and inflammation for patients who currently have limited or no approved treatment options. We were incorporated in September 2003 in Delaware. Our headquarters and operations are located in South San Francisco, California and we operate in one segment. | |
Our two lead programs address significant unmet medical needs in the area of thrombosis, or blood clots. Our lead compound, Betrixaban, is a novel oral once-daily inhibitor of Factor Xa in Phase 3 development for extended duration prophylaxis, or preventive treatment, of a form of thrombosis known as venous thromboembolism, in acute medically ill patients for up to 35 days of in-hospital and post-discharge use. Our second lead development candidate, Andexanet alfa, an FDA-designated breakthrough therapy, is a recombinant protein designed to reverse the anticoagulant activity in patients treated with a Factor Xa inhibitor who are suffering a major bleeding episode or who require emergency surgery. Our third product candidate Cerdulatinib, formerly PRT2070, is an orally available kinase inhibitor that inhibits spleen tyrosine kinase, or Syk, and janus kinases, or JAK, enzymes that regulate important signaling pathways and is being developed for hematologic, or blood, cancers and inflammatory disorders. Our fourth program of highly selective Syk inhibitors is partnered with Biogen Idec, Inc. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Accounting Policies [Abstract] | ' | |||||||||||||||
Summary of Significant Accounting Policies | ' | |||||||||||||||
2. Summary of Significant Accounting Policies | ||||||||||||||||
Consolidation and Basis of Presentation | ||||||||||||||||
The accompanying unaudited condensed consolidated financial statements include the amounts of the Company and our wholly-owned subsidiary and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), and following 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 financial statements have been prepared on the same basis as our annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of our financial information. The results of operations for the three and nine months ended September 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014. The condensed consolidated balance sheet as of December 31, 2013 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 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, 2013 included in our Annual Report on Form 10-K filed March 3, 2014 with the SEC. | ||||||||||||||||
Use of Estimates | ||||||||||||||||
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the condensed consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, clinical trial accruals, fair value of assets and liabilities, income taxes 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 the entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, we assess whether or not we are the primary beneficiary of that entity. In determining whether we are the primary beneficiary of an entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If we determine we are the primary beneficiary of a VIE, we consolidate the statements of operations and financial condition of the VIE into our consolidated financial statements. | ||||||||||||||||
Our determination about whether we should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. | ||||||||||||||||
Cash and Cash Equivalents | ||||||||||||||||
Cash and cash equivalents consist of cash and other highly liquid investments with original maturities of three months or less from the date of purchase. | ||||||||||||||||
Investments | ||||||||||||||||
All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments in debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated comprehensive income. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income (expense), net. | ||||||||||||||||
Customer Concentration | ||||||||||||||||
Customers who accounted for 10% or more of total revenues were as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Bristol-Myers Squibb Company and Pfizer Inc. | 7 | % | 28 | % | 15 | % | 46 | % | ||||||||
Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. | 28 | % | 37 | % | 39 | % | 41 | % | ||||||||
Daiichi Sankyo, Inc. | 63 | % | 32 | % | 43 | % | 12 | % | ||||||||
Revenue Recognition | ||||||||||||||||
We generate revenue from collaboration and license agreements for the development and commercialization of our products. Collaboration and license agreements may include non-refundable or partially refundable upfront license fees, partial or complete reimbursement of research and development costs, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. Our performance obligations under our collaborations include the transfer of intellectual property rights (licenses), obligations to provide research and development services and related clinical drug supply, obligation to provide regulatory approval services and obligations to participate on certain development and/or commercialization committees with the collaborators. Upfront payments are recorded as deferred revenue in our condensed consolidated balance sheet and are recognized as collaboration revenue over our estimated period of performance that is consistent with the terms of the research and development obligations contained in each collaboration agreement. We regularly review the estimated periods of performance related to our collaborations based on the progress made under each arrangement. Our estimates of our performance period may change over the course of the collaboration term. Such a change could have a material impact on the amount of revenue we record in future periods. | ||||||||||||||||
Payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is defined as an event that can only be achieved based on our performance and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones subject to this guidance. Further, the amounts received must relate solely to prior performance, be reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Payments contingent upon achievement of events that are not considered substantive milestones are allocated to the respective arrangements unit of accounting when received and recognized as revenue based on the revenue recognition policy for that unit of accounting. | ||||||||||||||||
Amounts from sales of licenses are recognized as revenue. Amounts received as funding of research and development or regulatory approval activities are recognized as revenue if the collaboration arrangement involves the sale of our research or development and regulatory approval services at amounts that exceed our cost. However, such funding is recognized as a reduction in research and development expense when we engage in a research and development project jointly with another entity, with both entities participating in project activities and sharing costs and potential benefits of the arrangement. | ||||||||||||||||
Amounts related to research and development and regulatory approval funding are recognized as the related services or activities are performed, in accordance with the contract terms. Payments may be made to or by us based on the number of full-time equivalent researchers assigned to the collaboration project and the related research and development expenses incurred. | ||||||||||||||||
Foreign Currency Transactions and Hedging | ||||||||||||||||
We have transactions denominated in foreign currencies, primarily the Euro, and, as a result, are exposed to changes in foreign currency exchange rates. We manage a portion of these cash flow exposures through the purchase of Euros and the use of foreign currency forward contracts. Our foreign currency forward contracts are not designated as hedges for accounting purposes. Gains or losses on foreign currency forward contracts are intended to offset gains or losses on the underlying net exposures in an effort to reduce the earnings and cash flow volatility resulting from fluctuating foreign currency exchange rates. Foreign currency deposits are remeasured using period end spot rates. Foreign currency forward contracts are marked to market at the end of each period and recorded as gains and losses in the condensed consolidated statements of operations. | ||||||||||||||||
Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparty, a major financial institution, is unable to meet the terms of the agreement. Our management does not expect material losses as a result of defaults by the counterparty. | ||||||||||||||||
Net Loss per Share Attributable to Common Stockholders | ||||||||||||||||
Basic and diluted net loss per share attributable to common stockholders is calculated in conformity with the two-class method required for companies with participating securities. Under the two-class method, in periods when we have net income, basic net income attributable to common stockholders is determined by allocating undistributed earnings, calculated as net income less current period convertible preferred stock noncumulative dividends, between the common stock and the convertible preferred stock. In computing diluted net income attributable to common stockholders, undistributed earnings are re-allocated to reflect the potential impact of dilutive securities. Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. The diluted net income per share attributable to common stockholders is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. In periods when we have incurred a net loss, convertible preferred stock, options and warrants to purchase common stock and convertible preferred stock warrants are considered common equivalent shares but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is antidilutive. | ||||||||||||||||
Recent Accounting Pronouncements | ||||||||||||||||
In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-15, Presentation of Financial Statements – Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, requiring an entity’s management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. This guidance will become effective for us at the end of 2016. Early adoption is permitted. We do not expect this standard to have a material impact on our financial statements. | ||||||||||||||||
In May 2014, the FASB, jointly with the International Accounting Standards Board, issued, issued ASU 2014-09, Revenue from Contracts with Customers. The standard's core principle is that a reporting entity will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In applying this new guidance to contracts within its scope, an entity will: (1) identify the contract(s) with a customer, (2) identify the performance obligation in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation. Additionally, this new guidance will require significantly expanded revenue recognition disclosures. This guidance will become effective for us beginning in the first quarter of 2017. Early application is not permitted. Entities have the option of using either a full retrospective or a modified retrospective approach to adopt this new guidance. We are currently evaluating the impact of our pending adoption of this standard on our financial statements. | ||||||||||||||||
Fair_Value_Measurements
Fair Value Measurements | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Fair Value Disclosures [Abstract] | ' | |||||||||||||||
Fair Value Measurements | ' | |||||||||||||||
3. Fair Value Measurements | ||||||||||||||||
Financial assets and liabilities are recorded at fair value. The carrying amounts of certain of our financial instruments, including cash and cash equivalents, investments, receivables from collaborators, prepaid expenses and other current assets and accounts payable, approximate their fair value due to their short term nature. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: | ||||||||||||||||
Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. | ||||||||||||||||
Level 2 – Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. | ||||||||||||||||
Level 3 – Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. | ||||||||||||||||
The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that was measured on a recurring basis (in thousands): | ||||||||||||||||
30-Sep-14 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 13,588 | $ | — | $ | — | $ | 13,588 | ||||||||
Corporate notes and commercial paper | — | 164,006 | — | 164,006 | ||||||||||||
U.S. government agency securities | — | 60,996 | — | 60,996 | ||||||||||||
Total financial assets | $ | 13,588 | 225,002 | $ | — | 238,590 | ||||||||||
Financial Liabilities: | ||||||||||||||||
Foreign currency forward contracts | $ | — | $ | (68 | ) | $ | — | $ | (68 | ) | ||||||
Total financial liabilities | $ | — | $ | (68 | ) | $ | — | $ | (68 | ) | ||||||
December 31, 2013 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 57,296 | $ | — | $ | — | $ | 57,296 | ||||||||
Corporate notes and commercial paper | — | 182,472 | — | 182,472 | ||||||||||||
U.S. government agency securities | — | 75,289 | — | 75,289 | ||||||||||||
Foreign currency forward contracts | — | 372 | — | 372 | ||||||||||||
Total financial assets | $ | 57,296 | $ | 258,133 | $ | — | $ | 315,429 | ||||||||
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. | ||||||||||||||||
We have elected to use the income approach to value the foreign currency forward contracts, using observable Level 2 market expectations at the measurement date and standard valuation techniques to convert future amounts to a single present amount assuming that participants are motivated, but not compelled, to transact. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset or liability (specifically foreign currency spot and forward rates, and credit risk at commonly quoted intervals). Mid-market pricing is used as a practical expedient for fair value measurements. The fair value measurement of any asset or liability must reflect the non-performance risk of the entity and the counterparty to the transaction. Therefore, the impact of the counterparty’s creditworthiness, when in an asset position, and our creditworthiness, when in a liability position, has also been factored into the fair value measurement of the derivative instruments and did not have a material impact on the fair value of these derivative instruments. Both we and the counterparty are expected to continue to perform under the contractual terms of the instruments. There were no transfers between Level 1 and Level 2 during the periods presented. |
Financial_Instruments
Financial Instruments | 9 Months Ended | |||||||||||||||||||||||||||||||
Sep. 30, 2014 | ||||||||||||||||||||||||||||||||
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): | ||||||||||||||||||||||||||||||||
30-Sep-14 | December 31, 2013 | |||||||||||||||||||||||||||||||
Estimated | Estimated | |||||||||||||||||||||||||||||||
Unrealized | Unrealized | Fair | Unrealized | Unrealized | Fair | |||||||||||||||||||||||||||
Cost | Gain | (Loss) | Value | Cost | Gain | (Loss) | Value | |||||||||||||||||||||||||
Money market funds | $ | 13,588 | $ | — | $ | — | $ | 13,588 | $ | 57,296 | $ | — | $ | — | $ | 57,296 | ||||||||||||||||
Corporate notes and commercial paper | 164,048 | 30 | (72 | ) | 164,006 | 182,426 | 62 | (16 | ) | 182,472 | ||||||||||||||||||||||
U.S. government agency securities | 60,978 | 20 | (2 | ) | 60,996 | 75,278 | 23 | (12 | ) | 75,289 | ||||||||||||||||||||||
$ | 238,614 | $ | 50 | $ | (74 | ) | $ | 238,590 | $ | 315,000 | $ | 85 | $ | (28 | ) | $ | 315,057 | |||||||||||||||
Classified as: | ||||||||||||||||||||||||||||||||
Cash equivalents | $ | 29,727 | $ | 113,794 | ||||||||||||||||||||||||||||
Short-term investments | 172,060 | 150,892 | ||||||||||||||||||||||||||||||
Long-term investments | 36,803 | 50,371 | ||||||||||||||||||||||||||||||
Total cash equivalents and investments | $ | 238,590 | $ | 315,057 | ||||||||||||||||||||||||||||
At September 30, 2014 and December 31, 2013, the remaining contractual maturities of available-for-sale securities were less than two years. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. |
Derivative_Instruments
Derivative Instruments | 9 Months Ended |
Sep. 30, 2014 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | ' |
Derivative Instruments | ' |
5. Derivative Instruments | |
We are exposed to foreign currency exchange rates related to our business operations. To reduce our risks related to these exposures, we utilize certain derivative instruments, namely foreign currency forward contracts. We do not use derivatives for speculative trading purposes. | |
We enter into foreign currency forward contracts, none of which are designated as hedging transactions for accounting purposes, to reduce our exposure to foreign currency fluctuations of certain liabilities denominated in foreign currencies. These exposures are hedged on a quarterly basis. As of September 30, 2014 and December 31, 2013, we had foreign currency forward contracts with notional amounts of €1.1 million ($1.4 million based on the exchange rate as of September 30, 2014) and €7.7 million ($10.6 million based on the exchange rate as of December 31, 2013), respectively, that were not designated as hedges. As of September 30, 2014 and December 31, 2013, we recorded a derivative liability within accrued and other liabilities of $68,000 and a derivative asset within prepaid and other current assets of $372,000, respectively, related to these foreign currency forward contracts. | |
We recorded unrealized losses of $113,000 and $114,000 in interest and other income (expense), net in our condensed consolidated statements of operations related to foreign currency forward contracts for the three and nine months ended September 30, 2014, respectively. During the three and nine months ended September 30, 2014, we settled foreign currency forward contracts and recognized realized losses of $75,000 and $326,000, respectively, in interest and other income (expense), net. During the three and nine months ended September 30, 2013 we recorded unrealized gains of $450,000 and $97,000, respectively, and realized gains of $45,000 and $118,000, respectively. | |
Our derivative financial instruments present certain market and counterparty risks. In general, the market risk related to these contracts is offset by corresponding gains and losses on the hedged transactions. The credit risk associated with these contracts is driven by changes in interest and currency exchange rates and, as a result, varies over time. |
Balance_Sheet_Components
Balance Sheet Components | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Balance Sheet Related Disclosures [Abstract] | ' | |||||||
Balance Sheet Components | ' | |||||||
6. Balance Sheet Components | ||||||||
Accrued and other liabilities consist of the following (in thousands): | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Research and development related | $ | 14,137 | $ | 16,110 | ||||
Legal and accounting fees | 586 | 462 | ||||||
Deferred rent | 104 | 879 | ||||||
Other | 457 | 345 | ||||||
Total accrued liabilities | $ | 15,284 | $ | 17,796 | ||||
Collaboration_and_License_Agre
Collaboration and License Agreements | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Revenue Recognition [Abstract] | ' | ||||||||||||||||
Collaboration and License Agreements | ' | ||||||||||||||||
7. 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 | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Bayer and Janssen | $ | 676 | $ | 1,028 | $ | 2,782 | $ | 3,466 | |||||||||
BMS and Pfizer | 164 | 772 | 1,109 | 3,865 | |||||||||||||
Daiichi Sankyo | 1,523 | 888 | 3,133 | 1,013 | |||||||||||||
Lee's Pharmaceutical | 64 | 78 | 189 | 130 | |||||||||||||
Total collaboration and license revenue | $ | 2,427 | $ | 2,766 | $ | 7,213 | $ | 8,474 | |||||||||
Biogen Idec, Inc. (“Biogen Idec”) | |||||||||||||||||
In October 2011, we entered into an exclusive, worldwide license and collaboration agreement with Biogen Idec, under which Portola and Biogen Idec were to jointly develop and commercialize selective, novel oral Syk inhibitors for the treatment of autoimmune and inflammatory diseases. | |||||||||||||||||
In November 2012, we elected to exercise our option to convert the agreement to a fully out-licensed agreement. After the election, we relinquished our right to share profits from sales of products related to selective Syk inhibitors, but are entitled to receive royalties from sales of these products by Biogen Idec. Following exercise of the option, we are no longer obligated to fund the program under the agreement. The out-licensed agreement provides for potential aggregate future payments to us of up to approximately $370.0 million for all licensed compounds based on the occurrence of certain development and regulatory events. As all contingent consideration payments are based solely on the performance of Biogen Idec, the milestone method of revenue recognition is not applicable to such amounts. Biogen Idec has elected to assume all future development work for Syk inhibitors, including the major indications, such as allergic asthma. This agreement will continue until either party terminates the agreement or until the expiration of Biogen Idec’s royalty obligations under the agreement. Biogen Idec may terminate the agreement without cause upon 120 days’ notice. In such event, we would regain all development rights and Biogen Idec would have no further payment obligations pursuant to the agreement. As of September 30, 2014, no such termination event has occurred. | |||||||||||||||||
In April 2014, we entered into an amendment to the Biogen Idec license and collaboration agreement under which Biogen Idec released one of the Syk kinase inhibitors to us for use in topical ophthalmic indications. Per the terms of the amendment, we will be required to pay $15.0 million upon the completion of certain commercial milestones and pay royalties on sales of products approved for these Syk kinase inhibitors. There was no accounting effect resulting from this amendment. | |||||||||||||||||
During the three and nine months ended September 30, 2014 and 2013, we recorded a reduction in research and development expense of $23,080 and $178,700, and $227,000 and $721,000, respectively, owed by Biogen Idec to us under the cost-sharing terms of the agreement. | |||||||||||||||||
Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) | |||||||||||||||||
In October 2012, we entered into a three-way agreement with BMS and Pfizer to include subjects dosed with apixaban, their jointly-owned product candidate, in one of our Phase 2 proof-of-concept studies of Andexanet alfa. The total consideration under this agreement of $6.0 million was recognized as revenue on a straight-line basis over the estimated performance period through the fourth quarter of 2013. | |||||||||||||||||
During the three and nine months ended September 30, 2013, we recognized $772,000 and $3.9 million in collaboration revenue under this agreement, respectively. There was no deferred revenue recorded as of September 30, 2014 related to this agreement. | |||||||||||||||||
In January 2014, we entered into a three-way agreement with BMS and Pfizer to study the safety and efficacy of Andexanet alfa as a reversal agent to apixaban in our Phase 3 studies. We are responsible for the cost of conducting this clinical study. Pursuant to our agreement with BMS and Pfizer we are obligated to provide research, development and regulatory approval services and participate in the Joint Collaboration Committee (“JCC”) in exchange for a partially refundable upfront fee of $13.0 million and up to $12.0 million of contingent milestone payments due upon achievement of certain development and regulatory events. All consideration received and to be earned under this agreement is subject to a 50% refund contingent upon certain regulatory and/or clinical events. | |||||||||||||||||
We concluded that the January 2014 and October 2012 contracts should each be accounted for as standalone agreements. We identified the following non-cancellable performance deliverables under the January 2014 agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying Andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate on the JCC. We considered the provisions of the multiple-elements arrangement guidance in determining how to recognize the total agreement consideration. We determined that none of the deliverables have standalone value and all of these obligations will be delivered throughout the estimated period of performance and therefore are accounted for as a single unit of accounting. The non-contingent upfront consideration under this agreement of $6.5 million is being recognized on a straight-line basis over the estimated period of performance. In the third quarter of 2014, we revised the remaining estimated period of performance from the first quarter of 2017 to the first quarter of 2018 to reflect a modification to our clinical development and regulatory plans. The contingent upfront consideration of $6.5 million will be recognized if and when the refundable nature of these amounts lapses based upon the achievement of specified regulatory and/or clinical events. | |||||||||||||||||
The contingent milestone payments under the January 2014 agreement are not considered substantive because a portion may be refunded upon certain events. The non-contingent portion of the milestone payment will be recognized as collaboration revenue on a straight-line basis over the estimated period of performance, which is now through the first quarter of 2018. The contingent portion of the milestone payments will be recognized if and when the refundable nature of these amounts lapses based upon the achievement of specified regulatory and/or clinical events. None of these milestones had been earned or received at September 30, 2014. | |||||||||||||||||
During the three and nine months ended September 30, 2014 we recognized $164,000 and $1.1 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2014 was $11.9 million. | |||||||||||||||||
Lee’s Pharmaceutical (HK) Ltd (“Lee’s”) | |||||||||||||||||
In January 2013, we entered into an agreement with Lee’s to jointly expand our Phase 3 APEX Study of Betrixaban into China. Under the terms of the agreement, Lee’s provided us with an upfront and non-refundable fee of $700,000 and will reimburse our costs in connection with the expansion of the APEX study into China. Lee’s will lead this study and the regulatory interactions with China’s State Food and Drug Administration. We granted Lee’s an exclusive option to negotiate for the exclusive commercial rights to Betrixaban in China, which may be exercised by Lee’s for 60 days after it receives the primary data analysis report from the Phase 3 APEX study. | |||||||||||||||||
We identified the following deliverables under the agreement with Lee’s: 1) the granting of an exclusive option to negotiate for the exclusive commercial rights to Betrixaban in China, 2) the obligation to manufacture and supply product in support of the APEX study in China, 3) the obligation to participate in a joint working group, and 4) the delivery of the primary data analysis report from the APEX study. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value and therefore are accounted for as a single unit of accounting with the upfront fee recognized as revenue on a straight-line basis over the estimated period of performance. Any reimbursements we may receive from Lee’s for the costs we incur in connection with this agreement are expected to be immaterial. | |||||||||||||||||
During the three and nine months ended September 30, 2014 and 2013, we recognized $64,000 and $189,000, and $78,000 and $130,000, of collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2014 was $0.3 million. | |||||||||||||||||
Aciex Therapeutics, Inc. (“Aciex”) | |||||||||||||||||
In February 2013, we entered into a license and collaboration agreement with Aciex pursuant to which we granted Aciex an exclusive license to co-develop and co-commercialize Cerdulatinib (PRT2070) and certain related compounds for nonsystemic indications, such as the treatment and prevention of ophthalmological diseases by topical administration and allergic rhinitis by intranasal administration. In April 2014, this agreement was amended to release all rights for Cerdulatinib to Portola. The collaboration is now focused on development of other related compounds for topical ophthalmic indications. Under the terms of this risk and cost sharing agreement, Portola and Aciex will each incur and report their own internal research and development costs. Further, third-party related development costs will be shared by Aciex and us 60% and 40%, respectively, until the end of the Phase 2 clinical study, and then equally afterwards. Also, we are entitled to receive either 50% of the profits, if any, generated by future sales of the products developed under the agreement, or royalty payments. Aciex has the primary responsibility for conducting the research and development activities under this agreement. We are obligated to provide assistance in accordance with the agreed upon development plan as well as participate on various committees. We can opt out of our obligation to share in the development costs at various points in time, the timing of which impacts future royalties we may receive based on product sales made by Aciex. All net costs we incur in connection with this agreement will be recognized as research and development expenses. During the three and nine months ended September 30, 2014 and 2013 no such costs have been incurred related to this agreement. | |||||||||||||||||
In July 2014, Aciex was acquired by Nicox S.A. and the acquisition concluded in October 2014. As of November 10, 2014, there has been no change to our agreement with Aciex. | |||||||||||||||||
Bayer Pharma, AG (“Bayer”) and Janssen Pharmaceuticals, Inc. (“Janssen”) | |||||||||||||||||
In February 2013, we entered into a three-way agreement with Bayer and Janssen to include subjects dosed with rivaroxaban, their Factor Xa inhibitor product, in one of our Phase 2 proof-of-concept studies of Andexanet alfa. We are responsible for the cost of conducting this clinical study. Under the terms of the agreement, Bayer and Janssen have each provided us with an upfront and non-refundable fee of $2.5 million, for an aggregate fee of $5.0 million. The agreement also provides for additional non-refundable payments to us from Bayer and Janssen of $250,000 each for an aggregate of $500,000 following the delivery of the final written study report of our Phase 2 proof-of-concept studies of Andexanet alfa. Also, we are obligated to participate on a JCC with Bayer and Janssen to oversee the collaboration activities under the agreement. | |||||||||||||||||
We identified the following performance deliverables under the agreement: 1) the obligation to provide research and development services, which includes supplying Andexanet alfa and providing a final written report, and 2) the obligation to participate on a JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the revenue associated with these two deliverables. We have accounted for the research and development services and our participation on the JCC as a single unit of accounting as neither deliverable has standalone value and both obligations will be delivered throughout the estimated period of performance. We originally estimated the period of performance to be through the fourth quarter of 2013. During 2013, we added more cohorts than originally planned as part of the original study design at the inception of our agreement and therefore adjusted our period of performance to be through the fourth quarter of 2014. The total consideration under this agreement is being recognized on a straight-line basis over the estimated performance period through the fourth quarter of 2014. | |||||||||||||||||
During the three and nine months ended September 30, 2014 and 2013, we recognized $316,000 and $1.1 million, and $1.0 million and $3.5 million in collaboration revenue under this agreement, respectively. There was no deferred revenue balance under this agreement as of September 30, 2014. | |||||||||||||||||
In January 2014, we entered into a three-way agreement with Bayer and Janssen to study the safety and efficacy of Andexanet alfa as a reversal agent to their oral Factor Xa inhibitor, rivaroxaban, in our Phase 3 studies. We are responsible for the cost of conducting this clinical study. Pursuant to our agreement with Bayer and Janssen we are obligated to provide research, development and regulatory services and to participate in a JCC in exchange for an upfront nonrefundable fee of $10.0 million, up to three contingent payments totaling $7.0 million which are payable upon achievement of certain events associated with scaling up our manufacturing process to support a commercial launch, and up to three payments totaling $8.0 million which are payable upon initiation of our Phase 3 study and regulatory approval of Andexanet alfa as a reversal agent to rivaroxaban by the FDA and European Medicines Agency (“EMA”). | |||||||||||||||||
We identified the following non-cancellable performance deliverables under the agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying Andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate on the JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout the estimated period of performance and therefore are accounted for as a single unit of accounting. The total upfront consideration under this agreement is being recognized as revenue on a straight-line basis over the estimated period of performance period. In the third quarter of 2014 we updated our estimated period of performance from the first quarter of 2017 to the first quarter of 2018 to reflect a modification to our clinical development and regulatory plans. | |||||||||||||||||
We have determined all but one of the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved and collectability is reasonably assured. As of September 30, 2014, no amounts had been recognized as collaboration revenue for any of these milestones. Amounts for the continent payment not considered to be a substantive milestone will be deferred when received and recognized as collaboration revenue on a straight-line basis over the estimated performance period through the first quarter of 2018. During the quarter ended September 30, 2014, $3.0 million of these contingent payments were received and are being recognized over the remaining period of performance. | |||||||||||||||||
During the three and nine months ended September 30, 2014 we recognized $361,000 and $1.7 million in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2014 was $11.3 million. | |||||||||||||||||
Daiichi Sankyo, Inc. (“Daiichi Sankyo”) | |||||||||||||||||
In June 2013, we entered into an agreement with Daiichi Sankyo to include subjects dosed with edoxaban, their Factor Xa inhibitor product, in one of our Phase 2 proof-of-concept studies of Andexanet alfa. We are responsible for the cost of conducting this clinical study. Under the terms of the agreement, Daiichi Sankyo provided us with an upfront fee of $6.0 million, $3.0 million of which was subject to refund if Daiichi Sankyo decided to terminate the agreement. We are obligated to participate on a JCC with Daiichi Sankyo to oversee the collaboration activities under the agreement. | |||||||||||||||||
We identified the following performance deliverables under the agreement: 1) the obligation to provide research and development services, which includes supplying Andexanet alfa and providing a final written report, and 2) the obligation to participate on the JCC. | |||||||||||||||||
We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the revenue associated with these two deliverables. We have accounted for the research and development services and our participation on the JCC as a single unit of accounting as neither deliverable has standalone value and both obligations will be delivered throughout the estimated period of performance. | |||||||||||||||||
The total non-contingent consideration under this agreement of $3.0 million was fully recognized as revenue on a straight-line basis over the estimated non-contingent performance period through the first quarter of 2014. The recognition of contingent consideration under this agreement of $3.0 million commenced upon resolution of the contingency in the first quarter of 2014 and is being recognized over the remaining estimated period of performance through the first quarter of 2015. | |||||||||||||||||
During the three and nine months ended September 30, 2014 and 2013, we recognized $662,000 and $2.3 million, and $888,000 and $1.0 million, in collaboration revenue associated with the contingent and non-contingent elements of this arrangement, respectively. The deferred revenue balance under this agreement as of September 30, 2014 was $1.3 million. | |||||||||||||||||
In July 2014, we entered into an agreement with Daiichi Sankyo to study the safety and efficacy of Andexanet alfa as a reversal agent to their oral Factor Xa inhibitor, edoxaban, in our Phase 3 and Phase 4 studies. We are responsible for the cost of conducting these clinical studies. Pursuant to our agreement with Daiichi Sankyo we are obligated to provide research, development and regulatory services and to participate in a JCC in exchange for an upfront nonrefundable fee of $15.0 million, up to two contingent payments totaling $5.0 million which are payable upon the initiation of our Phase 3 study and achievement of certain events associated with scaling up our manufacturing process to support a commercial launch, and up to four payments totaling $20.0 million which are payable upon acceptance of filing and regulatory approval of Andexanet alfa as a reversal agent to edoxaban by the FDA and EMA. | |||||||||||||||||
We identified the following non-cancellable performance deliverables under the agreement: 1) the obligation to provide research and development services, which include manufacturing and supplying Andexanet alfa and providing various reports, 2) the obligation to provide regulatory approval services, and 3) the obligation to participate on the JCC. We considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration of the agreement. We determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout the estimated period of performance and therefore are accounted for as a single unit of accounting. The total upfront consideration under this agreement is being recognized as revenue on a straight-line basis over the estimated performance period through the third quarter of 2018. | |||||||||||||||||
We have determined all but one of the future contingent payments meet the definition of a milestone and that such milestones are substantive in that the consideration is reasonable relative to all of the deliverables and payment terms within the agreement are commensurate with our performance to achieve the milestone after commencement of the agreement. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved and collectability is reasonably assured. As of September 30, 2014, no amounts had been recognized as collaboration revenue for any of these milestones. Amounts for the continent payment not considered to be a substantive milestone will be deferred when received and recognized as collaboration revenue on a straight-line basis over the remaining performance period. | |||||||||||||||||
During the three and nine months ended September 30, 2014 we recognized $861,000 and $861,000 in collaboration revenue under this agreement, respectively. The deferred revenue balance under this agreement as of September 30, 2014 was $14.1 million. | |||||||||||||||||
Commercial_Supply_Agreements
Commercial Supply Agreements | 9 Months Ended |
Sep. 30, 2014 | |
Commitments And Contingencies Disclosure [Abstract] | ' |
Commercial Supply Agreements | ' |
8. Commercial Supply Agreement | |
In July 2014, we entered into an agreement with CMC ICOS Biologics, Inc. (“CMC Biologics”), a subsidiary of CMC Biologics S.à.r.l., a privately-held contract manufacturing organization, pursuant to which CMC Biologics will manufacture clinical and commercial supply of Andexanet alfa and perform pre-validation and validation work on our behalf. | |
Under the agreement, we are required to purchase an aggregate fixed number of batches of Andexanet alfa from CMC Biologics beginning in 2015 through 2021. Total batch commitments under the agreement can be increased or decreased based on the achievement of milestones relating to the regulatory approval process for Andexanet alfa, expansion of existing manufacturing capacity and operational qualification of CMC Biologics’ manufacturing facilities. We made an upfront payment to CMC Biologics in the amount of $10.0 million in July 2014 and have made a reservation payment to CMC Biologics of $4.6 million in November 2014. Both payments will be credited against our future purchases of batches under the agreement. | |
Total fixed commitments under the agreement for the purchases of clinical and commercial batches, not taking into account possible price and batch adjustments per the terms of the agreement, are approximately $293.9 million. We also committed to approximately $10.4 million worth of pre-validation and validation work which will be conducted pursuant to work orders under the arrangement. | |
The term of the agreement is seven years and may be early terminated by either party for the other party’s uncured material breach or insolvency. We may also terminate the agreement if CMC Biologics is unable to add additional manufacturing capacity on a timely basis, if certain manufacturing-related regulatory events do not occur before certain deadlines, or if the batch yield is below a certain threshold, in which case we are not obligated to pay CMC Biologics a termination payment and CMC Biologics will be obligated to refund the uncredited amounts of the upfront payment and reservation payment. | |
In addition, we may terminate the agreement unilaterally if we discontinue the development and commercialization of Andexanet alfa for regulatory, safety, efficacy or other commercial reasons, or if the projected market demand or gross margin of Andexanet alfa is below a minimum threshold. A termination agreement under these provisions will obligate us to pay CMC Biologics a termination fee between $5.0 million and $30.0 million, depending on the date of termination. The termination fee is highest from 2015 through 2017, and then decreases through 2021. Any remaining upfront payments or reservation payments we have made, not yet credited against the purchase of batches, at the time of termination will be applied against the termination fee. | |
Under the lease accounting guidance, we determined that the agreement does not contain an embedded lease because the agreement does not convey the right to control the use of CMC Biologics’ facility. We based this determination on, among other factors, our right to physically access and/or operate CMC Biologics’ facility and one or more parties, other than us, and taking more than a minor amount of the output that will be produced or generated by the CMC Biologics facility during the term of our agreement. | |
Under the consolidation guidance, we determined that CMC Biologics is a VIE, but that we are not CMC Biologics’ primary beneficiary and therefore consolidation of CMC Biologics by us is not required. We based this determination on, among other factors, the upfront and reservation payment being akin to a form of subordinated financing, the fixed pricing terms of the arrangement creating variability that is absorbed by us, and that we do not have the power to direct the activities that most significantly affect the economic performance of CMC Biologics. | |
As of September 30, 2014, we have not provided financial, or other, support to CMC Biologics that was not previously contractually required. Other than the reservation payment, we are not required to make any additional payments to CMC Biologics. The upfront fee of $10.0 million recorded in prepaid expenses and other long-term assets in the condensed consolidated balance sheet represents our maximum exposure to loss under this agreement at September 30, 2014. The upfront payment will be charged to research and development expense, or cost of sales, upon regulatory approval of Andexanet alfa, as batches are delivered over the term of the agreement. We are currently not able to quantify the exposure to losses associated with the fixed pricing terms of this agreement. |
Stock_Based_Compensation
Stock Based Compensation | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
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, or the 2013 Plan, which became effective upon of the closing of our initial public offering in May 2013. On January 1, 2014, 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, 2013. As of September 30, 2014 there were 6,949,108 shares reserved under the 2013 Plan for the future issuance of equity awards. | ||||||||||||||||
The following table summarizes option activity under our 2013 Equity Incentive Plan and related information during the nine months ended September 30, 2014: | ||||||||||||||||
Shares | ||||||||||||||||
Subject to | Weighted- | |||||||||||||||
Shares Available | Outstanding | Average Exercise | ||||||||||||||
for Grant | Options | Price Per Share | ||||||||||||||
Balance at December 31, 2013 | 81,948 | 3,708,773 | $ | 9.43 | ||||||||||||
Options authorized | 2,045,785 | — | — | |||||||||||||
Options granted | (1,114,013 | ) | 1,114,013 | 25.5 | ||||||||||||
Options exercised | — | (517,481 | ) | 6.41 | ||||||||||||
Options canceled | 145,410 | (145,410 | ) | 18.26 | ||||||||||||
Balance at September 30, 2014 | 1,159,130 | 4,159,895 | $ | 13.8 | ||||||||||||
The estimated grant date fair values of the employee stock options were calculated using the Black Scholes valuation model, based on the following assumptions: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Risk-free interest rate | 1.89 | % | 1.8 | % | 1.89 | % | 1.3 | % | ||||||||
Expected life | 5.8 | 6 | 5.9 | 6 | ||||||||||||
Expected Volatility | 79 | % | 80 | % | 80 | % | 79 | % | ||||||||
Dividend yield | — | — | — | — | ||||||||||||
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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Research and development | $ | 953 | $ | 787 | $ | 3,321 | $ | 1,732 | ||||||||
General and administrative | 1,197 | 747 | 3,555 | 1,725 | ||||||||||||
Total stock-based compensation | $ | 2,150 | $ | 1,534 | $ | 6,876 | $ | 3,457 | ||||||||
Net_Loss_per_Share_Attributabl
Net Loss per Share Attributable to Common Stockholders | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Equity [Abstract] | ' | |||||||||||||||
Net Loss per Share Attributable to Common Stockholders | ' | |||||||||||||||
10. Net Loss per Share Attributable to Common Stockholders | ||||||||||||||||
Basic net loss per share attributable to common stockholders has been computed by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share attributable to common stockholders is calculated by dividing net loss by the weighted average number of shares of common stock and potential dilutive securities outstanding during the period. | ||||||||||||||||
The following common equivalent shares were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Stock options to purchase common stock | 4,159,895 | 3,780,358 | 4,159,895 | 3,780,358 | ||||||||||||
Common stock warrants | 6,240 | 82,575 | 6,240 | 82,575 | ||||||||||||
Subsequent_Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2014 | |
Subsequent Events [Abstract] | ' |
Subsequent Events | ' |
11. Subsequent Events | |
Equity Offering | |
In October 2014, we completed an underwritten public offering of 6,200,000 shares of our common stock at a public offering price of $26.00 per share. In addition, the underwriters of the offering exercised their over-allotment option to purchase an additional 930,000 shares from us at the public offering price of $26.00. The net proceeds from the offering to us including the over-allotment option, net of underwriting discounts and commissions and offering expenses of approximately $10.7 million, were approximately $174.7 million. | |
Manufacturing Supply Agreement | |
In October 2014, we entered into an agreement with Lonza Sales AG (“Lonza”), pursuant to which Lonza, a contract manufacturing organization, will manufacture clinical and commercial supply of Andexanet alfa and perform pre-validation and validation work on our behalf. | |
Under the agreement, we are required to purchase at least seven commercial batches of Andexanet alfa per year from Lonza, over a period of five years following first regulatory approval of the product from Lonza’s facility. We may cancel these orders upon written notice to Lonza, in which case, we will be obligated to pay a cancellation fee ranging from between €10.0 million (or $12.7 million based on the exchange rate as of September 30, 2014) and €13.3 million (or $16.9 million based on the exchange rate as of September 30, 2014), depending on the time of cancellation and any applicable costs related to raw materials and certain pass-through costs. | |
The term of the agreement will end on the fifth anniversary of the date of the first regulatory approval and may be early terminated by either party for the other party’s uncured material breach or insolvency or, prior to the first regulatory approval for any reason on not less than twelve months prior written notice. | |
In addition, we may also terminate the agreement if we discontinue the development or commercialization of Andexanet alfa for regulatory, safety, efficacy or other commercial reasons and for technical reasons after delivery of the first engineering batch but before delivery of the second engineering batch. In such circumstance we will be obligated to pay a termination payment ranging from between €10.0 million (or $12.7 million based on the exchange rate as of September 30, 2014) and €15.0 million (or $19.0 million based on the exchange rate as of September 30, 2014), depending on the time of termination, which includes the cancellation fee, and any applicable costs related to raw materials. | |
In November 2014, we made an upfront payment to Lonza in the amount of €1.2 million (or $1.5 million based on the exchange rate used on the date of payment) and will be required to make additional milestone payments of €2.5 million (or $3.2 million based on the exchange rate as of September 30, 2014) upon Lonza’s achievement of certain regulatory events. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Accounting Policies [Abstract] | ' | |||||||||||||||
Consolidation and Basis of Presentation | ' | |||||||||||||||
Consolidation and Basis of Presentation | ||||||||||||||||
The accompanying unaudited condensed consolidated financial statements include the amounts of the Company and our wholly-owned subsidiary and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), and following 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 financial statements have been prepared on the same basis as our annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of our financial information. The results of operations for the three and nine months ended September 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014. The condensed consolidated balance sheet as of December 31, 2013 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 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, 2013 included in our Annual Report on Form 10-K filed March 3, 2014 with the SEC. | ||||||||||||||||
Use of Estimates | ' | |||||||||||||||
Use of Estimates | ||||||||||||||||
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the condensed consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, clinical trial accruals, fair value of assets and liabilities, income taxes 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 the entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, we assess whether or not we are the primary beneficiary of that entity. In determining whether we are the primary beneficiary of an entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If we determine we are the primary beneficiary of a VIE, we consolidate the statements of operations and financial condition of the VIE into our consolidated financial statements. | ||||||||||||||||
Our determination about whether we should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. | ||||||||||||||||
Cash and Cash Equivalents | ' | |||||||||||||||
Cash and Cash Equivalents | ||||||||||||||||
Cash and cash equivalents consist of cash and other highly liquid investments with original maturities of three months or less from the date of purchase. | ||||||||||||||||
Investments | ' | |||||||||||||||
Investments | ||||||||||||||||
All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments in debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated comprehensive income. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income (expense), net. | ||||||||||||||||
Customer Concentration | ' | |||||||||||||||
Customer Concentration | ||||||||||||||||
Customers who accounted for 10% or more of total revenues were as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Bristol-Myers Squibb Company and Pfizer Inc. | 7 | % | 28 | % | 15 | % | 46 | % | ||||||||
Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. | 28 | % | 37 | % | 39 | % | 41 | % | ||||||||
Daiichi Sankyo, Inc. | 63 | % | 32 | % | 43 | % | 12 | % | ||||||||
Revenue Recognition | ' | |||||||||||||||
Revenue Recognition | ||||||||||||||||
We generate revenue from collaboration and license agreements for the development and commercialization of our products. Collaboration and license agreements may include non-refundable or partially refundable upfront license fees, partial or complete reimbursement of research and development costs, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. Our performance obligations under our collaborations include the transfer of intellectual property rights (licenses), obligations to provide research and development services and related clinical drug supply, obligation to provide regulatory approval services and obligations to participate on certain development and/or commercialization committees with the collaborators. Upfront payments are recorded as deferred revenue in our condensed consolidated balance sheet and are recognized as collaboration revenue over our estimated period of performance that is consistent with the terms of the research and development obligations contained in each collaboration agreement. We regularly review the estimated periods of performance related to our collaborations based on the progress made under each arrangement. Our estimates of our performance period may change over the course of the collaboration term. Such a change could have a material impact on the amount of revenue we record in future periods. | ||||||||||||||||
Payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is defined as an event that can only be achieved based on our performance and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones subject to this guidance. Further, the amounts received must relate solely to prior performance, be reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with our performance to achieve the milestone after commencement of the agreement. Payments contingent upon achievement of events that are not considered substantive milestones are allocated to the respective arrangements unit of accounting when received and recognized as revenue based on the revenue recognition policy for that unit of accounting. | ||||||||||||||||
Amounts from sales of licenses are recognized as revenue. Amounts received as funding of research and development or regulatory approval activities are recognized as revenue if the collaboration arrangement involves the sale of our research or development and regulatory approval services at amounts that exceed our cost. However, such funding is recognized as a reduction in research and development expense when we engage in a research and development project jointly with another entity, with both entities participating in project activities and sharing costs and potential benefits of the arrangement. | ||||||||||||||||
Amounts related to research and development and regulatory approval funding are recognized as the related services or activities are performed, in accordance with the contract terms. Payments may be made to or by us based on the number of full-time equivalent researchers assigned to the collaboration project and the related research and development expenses incurred. | ||||||||||||||||
Foreign Currency Transactions and Hedging | ' | |||||||||||||||
Foreign Currency Transactions and Hedging | ||||||||||||||||
We have transactions denominated in foreign currencies, primarily the Euro, and, as a result, are exposed to changes in foreign currency exchange rates. We manage a portion of these cash flow exposures through the purchase of Euros and the use of foreign currency forward contracts. Our foreign currency forward contracts are not designated as hedges for accounting purposes. Gains or losses on foreign currency forward contracts are intended to offset gains or losses on the underlying net exposures in an effort to reduce the earnings and cash flow volatility resulting from fluctuating foreign currency exchange rates. Foreign currency deposits are remeasured using period end spot rates. Foreign currency forward contracts are marked to market at the end of each period and recorded as gains and losses in the condensed consolidated statements of operations. | ||||||||||||||||
Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparty, a major financial institution, is unable to meet the terms of the agreement. Our management does not expect material losses as a result of defaults by the counterparty. | ||||||||||||||||
Net Loss per Share Attributable to Common Stockholders | ' | |||||||||||||||
Net Loss per Share Attributable to Common Stockholders | ||||||||||||||||
Basic and diluted net loss per share attributable to common stockholders is calculated in conformity with the two-class method required for companies with participating securities. Under the two-class method, in periods when we have net income, basic net income attributable to common stockholders is determined by allocating undistributed earnings, calculated as net income less current period convertible preferred stock noncumulative dividends, between the common stock and the convertible preferred stock. In computing diluted net income attributable to common stockholders, undistributed earnings are re-allocated to reflect the potential impact of dilutive securities. Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. The diluted net income per share attributable to common stockholders is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. In periods when we have incurred a net loss, convertible preferred stock, options and warrants to purchase common stock and convertible preferred stock warrants are considered common equivalent shares but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is antidilutive. | ||||||||||||||||
Recent Accounting Pronouncements | ' | |||||||||||||||
Recent Accounting Pronouncements | ||||||||||||||||
In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-15, Presentation of Financial Statements – Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, requiring an entity’s management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. This guidance will become effective for us at the end of 2016. Early adoption is permitted. We do not expect this standard to have a material impact on our financial statements. | ||||||||||||||||
In May 2014, the FASB, jointly with the International Accounting Standards Board, issued, issued ASU 2014-09, Revenue from Contracts with Customers. The standard's core principle is that a reporting entity will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In applying this new guidance to contracts within its scope, an entity will: (1) identify the contract(s) with a customer, (2) identify the performance obligation in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation. Additionally, this new guidance will require significantly expanded revenue recognition disclosures. This guidance will become effective for us beginning in the first quarter of 2017. Early application is not permitted. Entities have the option of using either a full retrospective or a modified retrospective approach to adopt this new guidance. We are currently evaluating the impact of our pending adoption of this standard on our financial statements. | ||||||||||||||||
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Accounting Policies [Abstract] | ' | |||||||||||||||
Percentage of Revenue from Significant Customers | ' | |||||||||||||||
Customers who accounted for 10% or more of total revenues were as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Bristol-Myers Squibb Company and Pfizer Inc. | 7 | % | 28 | % | 15 | % | 46 | % | ||||||||
Bayer Pharma, AG and Janssen Pharmaceuticals, Inc. | 28 | % | 37 | % | 39 | % | 41 | % | ||||||||
Daiichi Sankyo, Inc. | 63 | % | 32 | % | 43 | % | 12 | % | ||||||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
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 was measured on a recurring basis (in thousands): | ||||||||||||||||
30-Sep-14 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 13,588 | $ | — | $ | — | $ | 13,588 | ||||||||
Corporate notes and commercial paper | — | 164,006 | — | 164,006 | ||||||||||||
U.S. government agency securities | — | 60,996 | — | 60,996 | ||||||||||||
Total financial assets | $ | 13,588 | 225,002 | $ | — | 238,590 | ||||||||||
Financial Liabilities: | ||||||||||||||||
Foreign currency forward contracts | $ | — | $ | (68 | ) | $ | — | $ | (68 | ) | ||||||
Total financial liabilities | $ | — | $ | (68 | ) | $ | — | $ | (68 | ) | ||||||
December 31, 2013 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 57,296 | $ | — | $ | — | $ | 57,296 | ||||||||
Corporate notes and commercial paper | — | 182,472 | — | 182,472 | ||||||||||||
U.S. government agency securities | — | 75,289 | — | 75,289 | ||||||||||||
Foreign currency forward contracts | — | 372 | — | 372 | ||||||||||||
Total financial assets | $ | 57,296 | $ | 258,133 | $ | — | $ | 315,429 | ||||||||
Financial_Instruments_Tables
Financial Instruments (Tables) | 9 Months Ended | |||||||||||||||||||||||||||||||
Sep. 30, 2014 | ||||||||||||||||||||||||||||||||
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): | ||||||||||||||||||||||||||||||||
30-Sep-14 | December 31, 2013 | |||||||||||||||||||||||||||||||
Estimated | Estimated | |||||||||||||||||||||||||||||||
Unrealized | Unrealized | Fair | Unrealized | Unrealized | Fair | |||||||||||||||||||||||||||
Cost | Gain | (Loss) | Value | Cost | Gain | (Loss) | Value | |||||||||||||||||||||||||
Money market funds | $ | 13,588 | $ | — | $ | — | $ | 13,588 | $ | 57,296 | $ | — | $ | — | $ | 57,296 | ||||||||||||||||
Corporate notes and commercial paper | 164,048 | 30 | (72 | ) | 164,006 | 182,426 | 62 | (16 | ) | 182,472 | ||||||||||||||||||||||
U.S. government agency securities | 60,978 | 20 | (2 | ) | 60,996 | 75,278 | 23 | (12 | ) | 75,289 | ||||||||||||||||||||||
$ | 238,614 | $ | 50 | $ | (74 | ) | $ | 238,590 | $ | 315,000 | $ | 85 | $ | (28 | ) | $ | 315,057 | |||||||||||||||
Classified as: | ||||||||||||||||||||||||||||||||
Cash equivalents | $ | 29,727 | $ | 113,794 | ||||||||||||||||||||||||||||
Short-term investments | 172,060 | 150,892 | ||||||||||||||||||||||||||||||
Long-term investments | 36,803 | 50,371 | ||||||||||||||||||||||||||||||
Total cash equivalents and investments | $ | 238,590 | $ | 315,057 | ||||||||||||||||||||||||||||
Balance_Sheet_Components_Table
Balance Sheet Components (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Balance Sheet Related Disclosures [Abstract] | ' | |||||||
Accrued Expenses | ' | |||||||
Accrued and other liabilities consist of the following (in thousands): | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Research and development related | $ | 14,137 | $ | 16,110 | ||||
Legal and accounting fees | 586 | 462 | ||||||
Deferred rent | 104 | 879 | ||||||
Other | 457 | 345 | ||||||
Total accrued liabilities | $ | 15,284 | $ | 17,796 | ||||
Collaboration_and_License_Agre1
Collaboration and License Agreements (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Revenue Recognition [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 | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Bayer and Janssen | $ | 676 | $ | 1,028 | $ | 2,782 | $ | 3,466 | |||||||||
BMS and Pfizer | 164 | 772 | 1,109 | 3,865 | |||||||||||||
Daiichi Sankyo | 1,523 | 888 | 3,133 | 1,013 | |||||||||||||
Lee's Pharmaceutical | 64 | 78 | 189 | 130 | |||||||||||||
Total collaboration and license revenue | $ | 2,427 | $ | 2,766 | $ | 7,213 | $ | 8,474 | |||||||||
Stock_Based_Compensation_Table
Stock Based Compensation (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | |||||||||||||||
Summary of Option Activities | ' | |||||||||||||||
The following table summarizes option activity under our 2013 Equity Incentive Plan and related information during the nine months ended September 30, 2014: | ||||||||||||||||
Shares | ||||||||||||||||
Subject to | Weighted- | |||||||||||||||
Shares Available | Outstanding | Average Exercise | ||||||||||||||
for Grant | Options | Price Per Share | ||||||||||||||
Balance at December 31, 2013 | 81,948 | 3,708,773 | $ | 9.43 | ||||||||||||
Options authorized | 2,045,785 | — | — | |||||||||||||
Options granted | (1,114,013 | ) | 1,114,013 | 25.5 | ||||||||||||
Options exercised | — | (517,481 | ) | 6.41 | ||||||||||||
Options canceled | 145,410 | (145,410 | ) | 18.26 | ||||||||||||
Balance at September 30, 2014 | 1,159,130 | 4,159,895 | $ | 13.8 | ||||||||||||
Fair Values of Employee Stock Options | ' | |||||||||||||||
The estimated grant date fair values of the employee stock options were calculated using the Black Scholes valuation model, based on the following assumptions: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Risk-free interest rate | 1.89 | % | 1.8 | % | 1.89 | % | 1.3 | % | ||||||||
Expected life | 5.8 | 6 | 5.9 | 6 | ||||||||||||
Expected Volatility | 79 | % | 80 | % | 80 | % | 79 | % | ||||||||
Dividend yield | — | — | — | — | ||||||||||||
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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Research and development | $ | 953 | $ | 787 | $ | 3,321 | $ | 1,732 | ||||||||
General and administrative | 1,197 | 747 | 3,555 | 1,725 | ||||||||||||
Total stock-based compensation | $ | 2,150 | $ | 1,534 | $ | 6,876 | $ | 3,457 | ||||||||
Net_Loss_per_Share_Attributabl1
Net Loss per Share Attributable to Common Stockholders (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Equity [Abstract] | ' | |||||||||||||||
Common Equivalent Shares Excluded from Computation of Diluted Net Loss | ' | |||||||||||||||
The following common equivalent shares were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Stock options to purchase common stock | 4,159,895 | 3,780,358 | 4,159,895 | 3,780,358 | ||||||||||||
Common stock warrants | 6,240 | 82,575 | 6,240 | 82,575 | ||||||||||||
Organization_Additional_Inform
Organization - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2014 | |
Segment | |
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 Revenues (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ' | ' | ' | ' |
Concentration Risk [Line Items] | ' | ' | ' | ' |
Concentration risk percentage | 7.00% | 28.00% | 15.00% | 46.00% |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ' | ' | ' | ' |
Concentration Risk [Line Items] | ' | ' | ' | ' |
Concentration risk percentage | 28.00% | 37.00% | 39.00% | 41.00% |
Daiichi Sankyo, Inc ("Daiichi") | ' | ' | ' | ' |
Concentration Risk [Line Items] | ' | ' | ' | ' |
Concentration risk percentage | 63.00% | 32.00% | 43.00% | 12.00% |
Summary_of_Financial_Assets_an
Summary of Financial Assets, and Liabilities, Allocated into Level 1, Level 2, and Level 3 Measured on Recurring Basis (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Financial Assets: | ' | ' |
Total financial assets | $238,590 | $315,429 |
Financial Liabilities: | ' | ' |
Total financial liabilities | -68 | ' |
Fair Value, Inputs, Level 1 | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 13,588 | 57,296 |
Fair Value, Inputs, Level 2 | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 225,002 | 258,133 |
Financial Liabilities: | ' | ' |
Total financial liabilities | -68 | ' |
Money market funds | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 13,588 | 57,296 |
Money market funds | Fair Value, Inputs, Level 1 | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 13,588 | 57,296 |
Corporate notes and commercial paper | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 164,006 | 182,472 |
Corporate notes and commercial paper | Fair Value, Inputs, Level 2 | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 164,006 | 182,472 |
U.S. government agency securities | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 60,996 | 75,289 |
U.S. government agency securities | Fair Value, Inputs, Level 2 | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | 60,996 | 75,289 |
Foreign currency forward contracts | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | ' | 372 |
Financial Liabilities: | ' | ' |
Fair value of financial liabilities measured on a recurring basis | -68 | ' |
Foreign currency forward contracts | Fair Value, Inputs, Level 2 | ' | ' |
Financial Assets: | ' | ' |
Total financial assets | ' | 372 |
Financial Liabilities: | ' | ' |
Fair value of financial liabilities measured on a recurring basis | ($68) | ' |
Fair_Values_Measurements_Addit
Fair Values Measurements - Additional Information (Detail) (USD $) | Sep. 30, 2014 | Jun. 30, 2014 |
Fair Value Disclosures [Abstract] | ' | ' |
Fair value assets transfers from level 1 to level 2 | $0 | ' |
Fair value assets transfers from level 2 to level 1 | ' | $0 |
Cash_Equivalents_and_Investmen
Cash Equivalents and Investments Classified as Available-for-sale Securities (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Cost | $238,614 | $315,000 |
Unrealized Gain | 50 | 85 |
Unrealized (Loss) | -74 | -28 |
Estimated Fair Value | 238,590 | 315,057 |
Money market funds | ' | ' |
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Cost | 13,588 | 57,296 |
Estimated Fair Value | 13,588 | 57,296 |
Corporate notes and commercial paper | ' | ' |
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Cost | 164,048 | 182,426 |
Unrealized Gain | 30 | 62 |
Unrealized (Loss) | -72 | -16 |
Estimated Fair Value | 164,006 | 182,472 |
U.S. government agency securities | ' | ' |
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Cost | 60,978 | 75,278 |
Unrealized Gain | 20 | 23 |
Unrealized (Loss) | -2 | -12 |
Estimated Fair Value | 60,996 | 75,289 |
Cash equivalents | ' | ' |
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Estimated Fair Value | 29,727 | 113,794 |
Short-term investments | ' | ' |
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Estimated Fair Value | 172,060 | 150,892 |
Long-term investments | ' | ' |
Schedule Of Available For Sale Securities [Line Items] | ' | ' |
Estimated Fair Value | $36,803 | $50,371 |
Financial_Instruments_Addition
Financial Instruments - Additional Information (Detail) (USD $) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2014 | Dec. 31, 2013 | |
Investments Debt And Equity Securities [Abstract] | ' | ' |
Available For Sale Securities Contractual Maturity | '2 years | '2 years |
Available-for-sale Securities, Gross Realized Gain (Loss) | $0 | $0 |
Derivative_Instruments_Additio
Derivative Instruments - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | |
USD ($) | USD ($) | USD ($) | USD ($) | EUR (€) | USD ($) | EUR (€) | Accrued And Other Liabilities | Prepaid and Other Current Assets | |
USD ($) | USD ($) | ||||||||
Derivatives Fair Value [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Foreign currency forward contracts, notional amount | $1,400,000 | ' | $1,400,000 | ' | € 1,100,000 | $10,600,000 | € 7,700,000 | ' | ' |
Derivative Liability | ' | ' | ' | ' | ' | ' | ' | 68,000 | ' |
Derivative Asset | ' | ' | ' | ' | ' | ' | ' | ' | 372,000 |
Unrealized (gain) loss on foreign currency forward contracts | 113,000 | -450,000 | 114,000 | -97,000 | ' | ' | ' | ' | ' |
Foreign currency forward contracts recognized realized gain (loss) | ($75,000) | $45,000 | ($326,000) | $118,000 | ' | ' | ' | ' | ' |
Accrued_Expenses_Detail
Accrued Expenses (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Payables And Accruals [Abstract] | ' | ' |
Research and development related | $14,137 | $16,110 |
Legal and accounting fees | 586 | 462 |
Deferred rent | 104 | 879 |
Other | 457 | 345 |
Total accrued liabilities | $15,284 | $17,796 |
Summary_of_Revenue_from_Collab
Summary of Revenue from Collaboration and License Agreements (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Collaboration and license revenue | $2,427 | $2,766 | $7,213 | $8,474 |
Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | ' | ' | ' | ' |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Collaboration and license revenue | 676 | 1,028 | 2,782 | 3,466 |
Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | ' | ' | ' | ' |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Collaboration and license revenue | 164 | 772 | 1,109 | 3,865 |
Daiichi Sankyo, Inc ("Daiichi") | ' | ' | ' | ' |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Collaboration and license revenue | 1,523 | 888 | 3,133 | 1,013 |
Lee's Pharmaceutical (HK) Ltd (“Lee'sâ€) | ' | ' | ' | ' |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Collaboration and license revenue | $64 | $78 | $189 | $130 |
Collaboration_and_License_Agre2
Collaboration and License Agreements - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 6 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Apr. 30, 2014 | Nov. 30, 2012 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jan. 31, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Jan. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Feb. 28, 2013 | Feb. 28, 2013 | Jan. 31, 2014 | Feb. 28, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jul. 31, 2014 | Jun. 30, 2013 | Sep. 30, 2014 | Mar. 31, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | |
PORTOLA PHARMACEUTICALS INC | Biogen Idec | Biogen Idec | Biogen Idec | Biogen Idec | Biogen Idec | Biogen Idec | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Bristol-Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer") | Lee's Pharmaceutical (HK) Ltd (?Lee's?) | Lee's Pharmaceutical (HK) Ltd (?Lee's?) | Lee's Pharmaceutical (HK) Ltd (?Lee's?) | Lee's Pharmaceutical (HK) Ltd (?Lee's?) | Lee's Pharmaceutical (HK) Ltd (?Lee's?) | Lee's Pharmaceutical (HK) Ltd (?Lee's?) | Aciex Therapeutics, Inc. ("Aciex") | Aciex Therapeutics, Inc. ("Aciex") | Aciex Therapeutics, Inc. ("Aciex") | Aciex Therapeutics, Inc. ("Aciex") | Bayer Pharma AG | Janssen Pharmaceuticals, Inc. | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Bayer Pharma, AG ('Bayer") and Janssen Pharmaceuticals, Inc. ("Janssen") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | Daiichi Sankyo, Inc ("Daiichi") | |||||
October 2012 Agreement | October 2012 Agreement | October 2012 Agreement | January 2014 Agreement | January 2014 Agreement | January 2014 Agreement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | January 2014 Agreement | January 2014 Agreement | January 2014 Agreement | January 2014 Agreement | February 2013 Agreement | February 2013 Agreement | February 2013 Agreement | February 2013 Agreement | February 2013 Agreement | Collaborative Arrangement | June Two Thousand Thirteen Agreement | June Two Thousand Thirteen Agreement | June Two Thousand Thirteen Agreement | June Two Thousand Thirteen Agreement | July 2014 Agreement | July 2014 Agreement | July 2014 Agreement | July 2014 Agreement | |||||||||||||||||||||||||||||
Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | Collaborative Arrangement | |||||||||||||||||||||||||||||||||||||||
Future Contingent Payments | Future Contingent Payments | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
License fee receivable upon occurrence of certain development and regulatory events | ' | ' | ' | ' | ' | ' | $370,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Notice period for agreement termination | ' | ' | ' | ' | ' | ' | '120 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '60 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Payments Upon the Completion of Certain Commercial Milestones | ' | ' | ' | ' | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reduction in research and development expense | ' | ' | ' | ' | ' | ' | ' | 23,080 | 227,000 | 179,000 | 721,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,000,000 | 0 | ' | ' | 11,900,000 | ' | ' | ' | 300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 11,300,000 | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | 1,300,000 | ' | ' | ' | ' | 14,100,000 | ' | ' | ' |
Collaboration revenue recognized | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 772,000 | 3,900,000 | ' | 164,000 | 1,100,000 | ' | ' | 64,000 | 78,000 | 189,000 | 130,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 361,000 | 1,700,000 | 0 | ' | 316,000 | 1,000,000 | 1,100,000 | 3,500,000 | ' | ' | ' | ' | ' | 662,000 | 888,000 | 2,300,000 | 1,000,000 | ' | 861,000 | 861,000 | 0 |
Upfront fee | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 13,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | 700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,500,000 | 2,500,000 | 10,000,000 | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone Payments of Development and Regulatory Event | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 8,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of consideration received under agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Non-contingent consideration being recognized as revenue over estimated period of performance | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Contingent consideration to be recognized after resolution of contingency | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Development costs, percent | ' | ' | ' | ' | 40.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 60.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Research and development | 31,780,000 | 18,088,000 | 88,918,000 | 56,642,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | 0 | 0 | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of profits entitle to receive under agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional non-refundable fee | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 250,000 | 250,000 | ' | 500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Contingent payment payable upon achievement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 7,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Contingent Payments Received | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Collaborative arrangement upfront payment to be received | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Upfront fee subject to refund | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $3,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Commercial_Supply_Agreements_A
Commercial Supply Agreements - Additional Information (Detail) (Cmc Icos Biologics Inc, USD $) | 1 Months Ended | |||
In Millions, unless otherwise specified | Jul. 31, 2014 | Jul. 31, 2014 | Jul. 31, 2014 | Nov. 01, 2014 |
Minimum | Maximum | Subsequent Event | ||
Long Term Purchase Commitment [Line Items] | ' | ' | ' | ' |
Commercial supply agreement upfront payment | $10 | ' | ' | ' |
Commercial supply (manufacturing services) agreement reservation payment | ' | ' | ' | 4.6 |
Commercial agreement fixed commitment amount | 293.9 | ' | ' | ' |
Commitments for pre-work orders | 10.4 | ' | ' | ' |
Termination fees payment under obligation | ' | $5 | $30 | ' |
Stock_Based_Compensation_Addit
Stock Based Compensation - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' |
Percentage increase in number of common stock outstanding | 5.00% |
Number of common stock shares reserved for issuance under the 2013 Equity Incentive Plan | 6,949,108 |
Summary_of_Stock_Option_Activi
Summary of Stock Option Activity (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Shares Available for Grant | ' |
Beginning balance | 81,948 |
Options authorized | 2,045,785 |
Options granted | -1,114,013 |
Options canceled | 145,410 |
Ending balance | 1,159,130 |
Shares Subject to Outstanding Options | ' |
Beginning balance | 3,708,773 |
Options granted | 1,114,013 |
Options exercised | -517,481 |
Options canceled | -145,410 |
Ending balance | 4,159,895 |
Weighted-Average Exercise Price Per Share | ' |
Beginning balance | $9.43 |
Options granted | $25.50 |
Options exercised | $6.41 |
Options canceled | $18.26 |
Ending balance | $13.80 |
Fair_Values_of_Employee_Stock_
Fair Values of Employee Stock Options (Detail) (Employee Stock Option) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Employee Stock Option | ' | ' | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ' | ' | ' | ' |
Risk-free interest rate | 1.89% | 1.80% | 1.89% | 1.30% |
Expected life | '5 years 9 months 18 days | '6 years | '5 years 10 months 24 days | '6 years |
Expected Volatility | 79.00% | 80.00% | 80.00% | 79.00% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Classification_of_StockBased_C
Classification of Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Stock-based compensation | $2,150 | $1,534 | $6,876 | $3,457 |
Research and Development Expense | ' | ' | ' | ' |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Stock-based compensation | 953 | 787 | 3,321 | 1,732 |
General and Administrative Expense | ' | ' | ' | ' |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Stock-based compensation | $1,197 | $747 | $3,555 | $1,725 |
Common_Equivalent_Shares_Exclu
Common Equivalent Shares Excluded from Computation of Diluted Net Income (Loss) per Share (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Stock Option | ' | ' | ' | ' |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Common stock equivalents excluded from computation of diluted net loss per share | 4,159,895 | 3,780,358 | 4,159,895 | 3,780,358 |
Common stock warrants | ' | ' | ' | ' |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Common stock equivalents excluded from computation of diluted net loss per share | 6,240 | 82,575 | 6,240 | 82,575 |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) (Subsequent Event) | 1 Months Ended | 0 Months Ended | 1 Months Ended | |||||||||||
In Millions, except Share data, unless otherwise specified | Oct. 31, 2014 | Nov. 07, 2014 | Nov. 07, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 | Oct. 31, 2014 |
USD ($) | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | Minimum | Minimum | Minimum | Minimum | Maximum | Maximum | Maximum | Maximum | Underwritten Public Offering | Over-Allotment Option | |
USD ($) | EUR (€) | Cancellation Fee | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | Lonza Sales AG | USD ($) | USD ($) | ||
USD ($) | EUR (€) | Cancellation Fee | Cancellation Fee | USD ($) | EUR (€) | Cancellation Fee | Cancellation Fee | |||||||
AlfaCommercialBatch | USD ($) | EUR (€) | USD ($) | EUR (€) | ||||||||||
Subsequent Event [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock initial public offering | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,200,000 | ' |
Common stock issued per share | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $26 | $26 |
Purchase of additional shares by underwriters | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 930,000 |
Underwriting discounts, commissions and offering expenses | $10.70 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from public offering, net of underwriters discounts, commissions and offering expenses | 174.7 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Minimum purchases per year | ' | ' | ' | ' | 7 | 7 | ' | ' | ' | ' | ' | ' | ' | ' |
Termination fees payment under obligation | ' | ' | ' | ' | 12.7 | 10 | 12.7 | 10 | 19 | 15 | 16.9 | 13.3 | ' | ' |
Purchase commitment period | ' | ' | ' | '5 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Upfront payment for agreement | ' | 1.5 | 1.2 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone payment | ' | $3.20 | € 2.50 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |