Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | May. 03, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | DVAX | |
Entity Registrant Name | DYNAVAX TECHNOLOGIES CORP | |
Entity Central Index Key | 1,029,142 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 38,495,782 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 38,858 | $ 44,812 |
Marketable securities available-for-sale | 127,989 | 151,313 |
Accounts receivable | 1,164 | 1,394 |
Prepaid expenses and other current assets | 2,728 | 2,427 |
Total current assets | 170,739 | 199,946 |
Property and equipment, net | 15,894 | 13,804 |
Goodwill | 2,127 | 2,043 |
Restricted cash | 617 | 609 |
Other assets | 267 | 231 |
Total assets | 189,644 | 216,633 |
Current liabilities: | ||
Accounts payable | 3,476 | 3,433 |
Accrued research and development | 6,027 | 7,361 |
Accrued liabilities | 13,251 | 15,337 |
Deferred revenues | 1,759 | 2,654 |
Total current liabilities | 24,513 | 28,785 |
Other long-term liabilities | 700 | 769 |
Total liabilities | $ 25,213 | $ 29,554 |
Commitments and contingencies (Note 4) | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value; 5,000 shares authorized at March 31, 2016 and December 31, 2015; no shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | ||
Common stock: $0.001 par value; 69,500 shares authorized at March 31, 2016 and December 31, 2015; 38,496 and 38,446 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | $ 38 | $ 38 |
Additional paid-in capital | 893,278 | 889,698 |
Accumulated other comprehensive loss | (2,135) | (2,930) |
Accumulated deficit | (726,750) | (699,727) |
Total stockholders’ equity | 164,431 | 187,079 |
Total liabilities and stockholders’ equity | $ 189,644 | $ 216,633 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 69,500,000 | 69,500,000 |
Common stock, shares issued | 38,496,000 | 38,446,000 |
Common stock, shares outstanding | 38,495,502 | 38,446,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenues: | ||
Collaboration revenue | $ 895 | $ 471 |
Grant revenue | 39 | 148 |
Service and license revenue | 8 | 8 |
Total revenues | 942 | 627 |
Operating expenses: | ||
Research and development | 20,067 | 22,220 |
General and administrative | 8,169 | 4,859 |
Total operating expenses | 28,236 | 27,079 |
Loss from operations | (27,294) | (26,452) |
Other income (expense): | ||
Interest income | 225 | 27 |
Interest expense | (247) | |
Other income, net | 46 | 455 |
Net loss | $ (27,023) | $ (26,217) |
Basic and diluted net loss per share | $ (0.70) | $ (0.97) |
Weighted average shares used to compute basic and diluted net loss per share | 38,472 | 27,065 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (27,023) | $ (26,217) |
Other comprehensive income (loss): | ||
Unrealized gain on marketable securities available-for-sale | 109 | 8 |
Cumulative foreign currency translation adjustments | 686 | (1,294) |
Total other comprehensive income (loss) | 795 | (1,286) |
Total comprehensive loss | $ (26,228) | $ (27,503) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Operating activities | ||
Net loss | $ (27,023) | $ (26,217) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 402 | 335 |
Accretion of discounts and amortization of premiums on marketable securities | 75 | 171 |
Accretion of debt discount related to debt financing | (51) | |
Accretion of end of term payment related to debt financing | 57 | |
Cash-settled portion of stock-based compensation expense | 328 | |
Stock compensation expense | 3,244 | 1,954 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 230 | (182) |
Prepaid expenses and other current assets | (301) | 580 |
Restricted cash and other assets | (36) | |
Accounts payable | 658 | 2,043 |
Accrued liabilities and other long term liabilities | (3,816) | (2,357) |
Deferred revenues | (895) | (472) |
Net cash used in operating activities | (27,134) | (24,139) |
Investing activities | ||
Purchases of marketable securities | (61,057) | (18,654) |
Proceeds from maturities of marketable securities | 84,420 | 8,750 |
Purchases of property and equipment, net | (2,611) | (618) |
Net cash provided by (used in) investing activities | 20,752 | (10,522) |
Financing activities | ||
Proceeds from exercise of stock options and restricted stock awards | 75 | 10 |
Proceeds from exercise of warrants | 26 | |
Proceeds from Employee Stock Purchase Plan | 261 | 103 |
Net cash provided by financing activities | 336 | 139 |
Effect of exchange rate changes on cash and cash equivalents | 92 | (276) |
Net decrease in cash and cash equivalents | (5,954) | (34,798) |
Cash and cash equivalents at beginning of period | 44,812 | 49,511 |
Cash and cash equivalents at end of period | 38,858 | 14,713 |
Non-cash investing and financing activities: | ||
Cash paid during the period for interest | 184 | |
Disposal of fully depreciated property and equipment | 1,154 | 4 |
Net change in unrealized gain on marketable securities | $ 109 | $ 8 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”), is a clinical-stage biopharmaceutical company that uses toll-like receptor (“TLR”) biology to discover and develop novel vaccines and therapeutics. Our development programs are focused on vaccines and cancer immunotherapy. We were incorporated in California in August 1996 under the name Double Helix Corporation, and we changed our name to Dynavax Technologies Corporation in September 1996. We reincorporated in Delaware in 2000. Basis of Presentation Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period. The condensed consolidated balance sheet at December 31, 2015, has been derived from audited financial statements at that date, but excludes disclosures required by GAAP for complete financial statements. The unaudited condensed consolidated financial statements and these notes should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiaries, Dynavax GmbH and Dynavax International, B.V. Dynavax International, B.V. was dissolved in January 2015. All significant intercompany accounts and transactions among these entities have been eliminated from the condensed consolidated financial statements. We operate in one business segment: the discovery and development of biopharmaceutical products. Liquidity and Financial Condition We have incurred significant operating losses and negative cash flows from operations since our inception. As of March 31, 2016, we had cash, cash equivalents and marketable securities of $166.8 million. . We expect to continue to spend substantial funds in connection with seeking regulatory approval and other costs relating to, preparation for the anticipated commercial launch of HEPLISAV-B TM , which could have an adverse impact on our ability to achieve our intended business objectives. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ materially from these estimates. Summary of Significant Accounting Policies There have been no significant changes in our significant accounting policies during the three months ended March 31, 2016, as compared with those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2015. Revenue Recognition Our revenues consist of amounts earned from collaborations, grants and fees from services and licenses. We enter into license and manufacturing agreements and collaborative research and development arrangements with pharmaceutical and biotechnology partners that may involve multiple deliverables. Our arrangements may include one or more of the following elements: upfront license payments, cost reimbursement for the performance of research and development activities, milestone payments, other contingent payments, contract manufacturing service fees, royalties and license fees. Each deliverable in the arrangement is evaluated to determine whether it meets the criteria to be accounted for as a separate unit of accounting or whether it should be combined with other deliverables. In order to account for the multiple-element arrangements, the Company identifies the deliverables included within the arrangement and evaluates which deliverables represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. We recognize revenue when there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. Non-refundable upfront fees received for license and collaborative agreements entered into and other payments under collaboration agreements where we have continuing performance obligations related to the payments are deferred and recognized over our estimated performance period. Revenue is recognized on a ratable basis, unless we determine that another method is more appropriate, through the date at which our performance obligations are completed. Management makes its best estimate of the period over which we expect to fulfill our performance obligations, which may include clinical development activities. Given the uncertainties of research and development collaborations, significant judgment is required to determine the duration of the performance period. We recognize cost reimbursement revenue under collaborative agreements as the related research and development costs are incurred, as provided for under the terms of these agreements. Contingent consideration received for the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is defined as an event having all of the following characteristics: (i) there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, (ii) the event can only be achieved based in whole or in part on either the entity’s performance or a specific outcome resulting from the entity’s performance and (iii) if achieved, the event would result in additional payments being due to the entity. Our license and collaboration agreements with our partners provide for payments to be paid to us upon the achievement of development milestones. Given the challenges inherent in developing biologic products, there is substantial uncertainty whether any such milestones will be achieved at the time we entered into these agreements. In addition, we evaluate whether the development milestones meet the criteria to be considered substantive. The conditions include: (i) the development work is contingent on either of the following: (a) the vendor’s performance to achieve the milestone or (b) the enhancement of the value of the deliverable item or items as a result of a specific outcome resulting from the vendor’s performance to achieve the milestone; (ii) it relates solely to past performance and (iii) it is reasonable relative to all the deliverable and payment terms within the arrangement. As a result of our analysis, we consider our development milestones to be substantive and, accordingly, we expect to recognize as revenue future payments received from such milestones as we achieve each milestone. Milestone payments that are contingent upon the achievement of substantive at-risk performance criteria are recognized in full upon achievement of those milestone events in accordance with the terms of the agreement and assuming all other revenue recognition criteria have been met. All revenue recognized to date under our collaborative agreements has been nonrefundable. Our license and collaboration agreements with certain partners also provide for contingent payments to be paid to us based solely upon the performance of our partner. For such contingent payments we expect to recognize the payments as revenue upon receipt, provided that revenue recognition criteria have been satisfied. Revenues from manufacturing services are recognized upon meeting the criteria for substantial performance and acceptance by the customer. Revenue from royalty payments is contingent on future sales activities by our licensees. Royalty revenue is recognized when all revenue recognition criteria have been satisfied. Revenue from government and private agency grants is recognized as the related research expenses are incurred and to the extent that funding is approved. Additionally, we recognize revenue based on the facilities and administrative cost rate reimbursable per the terms of the grant awards. Research and Development Expenses and Accruals Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. We contract with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. Our accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. We may terminate these contracts upon written notice and we are generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances we may be further responsible for termination fees and penalties. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior period accrued estimates for clinical trial activities through March 31, 2016. Recent Accounting Pronouncements Accounting Standards Update 2014-09 In May 2014, the Financial Accounting Standards Board (“FASB”) issued guidance codified in ASC 606, Revenue Recognition — Revenue from Contracts with Customers, which amends the guidance in former ASC 605, Revenue Recognition, which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This Accounting Standards Update (“ASU”) is based on the principle that revenue is recognized to depict the transfer of 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. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB deferred the effective date for annual reporting periods beginning after December 15, 2017 (including interim periods within those periods) , with early application permitted . Accounting Standards Update 2015-17 In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Subtopic 740): Balance Sheet Classification of Deferred Taxes, The ASU requires entities to classify deferred tax liabilities and assets as noncurrent in a classified statement of financial position The Company is currently evaluating the impact of this standard on its financial statements. Accounting Standards Update 2016-02 In February 2016, the FASB issued ASU No. 2016-02, Leases Accounting Standards Update 2016-08 In March 2016, the FASB issued ASU No. 2016-08 “Revenue from Contracts with Customers (Topic 606) - Principal versus Agent Considerations (Reporting Revenue Gross versus Net).” ASU No. 2016-08 requires an entity to determine whether the nature of its promise to provide goods or services to a customer is performed in a principal or agent capacity and to recognize revenue in a gross or net manner based on its principal/agent designation. ASU No. 2016-08 is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2017, with early application permitted. The Company is currently evaluating the impact this guidance will have on its financial statements. Accounting Standards Update 2016-09 In March 2016, the FASB issued ASU No. 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification on the statement of cash flows and forfeitures. ASU 2016-09 is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2016, with early application permitted. The Company is currently evaluating the impact this guidance will have on its financial statements. Accounting Standards Update 2016-10 In April 2016, the FASB issued ASU No. 2016-10 “Revenue from Contracts with Customers (Topic 606) – Identifying Performance Obligations and Licensing.” ASU No. 2016-10 clarifies the following two aspects of Topic 606: identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. ASU No. 2016-10 is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2017, with early application permitted. The Company is currently evaluating the impact this guidance will have on its financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 2. Fair Value Measurements The Company measures fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: · Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities; · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and · Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities; therefore, requiring an entity to develop its own valuation techniques and assumptions. The carrying amounts of cash equivalents, accounts receivable, accounts payable and accrued liabilities are considered reasonable estimates of their respective fair value because of their short-term nature. Recurring Fair Value Measurements The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis as of March 31, 2016 and December 31, 2015 (in thousands): Level 1 Level 2 Level 3 Total March 31, 2016 Money market funds $ 24,982 $ - $ - $ 24,982 U.S. Treasuries - 6,574 - 6,574 U.S. Government agency securities - 29,611 - 29,611 Corporate debt securities - 99,650 - 99,650 Total $ 24,982 $ 135,835 $ - $ 160,817 Level 1 Level 2 Level 3 Total December 31, 2015 Money market funds $ 21,193 $ - $ - $ 21,193 U.S. Government agency securities - 17,622 - 17,622 Corporate debt securities - 152,749 - 152,749 Total $ 21,193 $ 170,371 $ - $ 191,564 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. U.S. Treasuries, U.S. Government agency securities and corporate debt securities are measured at fair value using Level 2 inputs. We review trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. There were no transfers between Level 1 and Level 2 during the three months ended March 31, 2016. |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 3 Months Ended |
Mar. 31, 2016 | |
Cash Cash Equivalents And Short Term Investments [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 3. Cash, cash equivalents and marketable securities The following is a summary of cash, cash equivalents and marketable securities available-for-sale as of March 31, 2016 and December 31, 2015 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value March 31, 2016 Cash and cash equivalents: Cash $ 6,030 $ - $ - $ 6,030 Money market funds 24,982 - - 24,982 U.S. Government agency securities 4,999 - - 4,999 Corporate debt securities 2,847 - - 2,847 Total cash and cash equivalents 38,858 - - 38,858 Marketable securities available-for-sale: U.S. Treasuries 6,573 2 (1 ) 6,574 U.S. Government agency securities 24,604 8 - 24,612 Corporate debt securities 96,691 112 - 96,803 Total marketable securities available-for-sale 127,868 122 (1 ) 127,989 Total cash, cash equivalents and marketable securities $ 166,726 $ 122 $ (1 ) $ 166,847 December 31, 2015 Cash and cash equivalents: Cash $ 4,561 $ - $ - $ 4,561 Money market funds 21,193 - - 21,193 Corporate debt securities 19,052 7 (1 ) 19,058 Total cash and cash equivalents 44,806 7 (1 ) 44,812 Marketable securities available-for-sale: U.S. Government agency securities 17,628 - (6 ) 17,622 Corporate debt securities 133,679 71 (59 ) 133,691 Total marketable securities available-for-sale 151,307 71 (65 ) 151,313 Total cash, cash equivalents and marketable securities $ 196,113 $ 78 $ (66 ) $ 196,125 The maturities of our marketable securities available-for-sale are as follows (in thousands): March 31, 2016 Amortized Cost Estimated Fair Value Mature in one year or less $ 127,868 $ 127,989 Mature after one year through two years - - $ 127,868 $ 127,989 We have classified our entire investment portfolio as available-for-sale and available for use in current operations and accordingly have classified all investments as short-term. Available-for-sale securities are carried at fair value, with unrealized gains and losses included in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: · Whether the investment has been in a continuous realized loss position for over 12 months; · the duration to maturity of our investments; · our intention and ability to hold the investments to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; · the credit rating, financial condition and near-term prospects of the issuer; and · the type of investments made. To date, there have been no declines in fair value that have been identified as other than temporary. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 4. Commitments and Contingencies We lease our facilities in Berkeley, California (“Berkeley Lease”) and Düsseldorf, Germany (“Düsseldorf Lease”) under operating leases that expire in June 2018 and March 2023, respectively. The Berkeley Lease provides for periods of escalating rent. The total cash payments over the life of the lease are divided by the total number of months in the lease period and the average rent is charged to expense each month during the lease period. We entered into sublease agreements under the Düsseldorf Lease for a certain portion of the leased space. Total net rent expense related to our operating leases for both three month periods ended March 31, 2016 and 2015, was $0.5 million. Deferred rent was $0.4 million and $0.5 million as of March 31, 2016 and December 31, 2015, respectively. Future minimum payments under the non-cancelable portion of our operating leases at March 31, 2016, excluding payments from sublease agreements, are as follows (in thousands): Year ending December 31, 2016 (remaining) $ 1,757 2017 2,385 2018 1,327 2019 485 2020 485 Thereafter 1,091 Total $ 7,530 In addition to the non-cancelable commitments included above, we have entered into contractual arrangements that obligate us to make payments to the contractual counterparties upon the occurrence of future events. In addition, in the normal course of operations, we have entered into license and other agreements and intend to continue to seek additional rights relating to compounds or technologies in connection with our discovery, manufacturing and development programs. Under the terms of the agreements, we may be required to pay future up-front fees, milestones and royalties on net sales of products originating from the licensed technologies, if any, or other payments contingent upon the occurrence of future events that cannot reasonably be estimated. We rely on research institutions, contract research organizations, clinical investigators as well as clinical and commercial material manufacturers of our product candidates. As of March 31, 2016, under the terms of our agreements, including certain agreements relating to HBV-23, we are obligated to make future payments of approximately $10.5 million through 2016. These agreements are terminable by us upon written notice. Generally, we are liable only for actual effort expended by the organizations at any point in time during the contract through the notice period. From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, financial statements, results of operations, or cash flows in a particular period. |
Collaborative Research and Deve
Collaborative Research and Development Agreements | 3 Months Ended |
Mar. 31, 2016 | |
Research And Development [Abstract] | |
Collaborative Research and Development Agreements | 5. Collaborative Research and Development Agreements AstraZeneca In September 2006, we entered into a research collaboration and license agreement with AstraZeneca AB (“AstraZeneca”) for the discovery and development of TLR9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease. In October 2011, we amended our agreement with AstraZeneca to provide that we would conduct initial clinical development of AZD1419 and AstraZeneca agreed to fund all program expenses to cover the cost of development activities through Phase 2a. Under the terms of the amended agreement, we received an initial payment of $3.0 million in 2011 to begin the clinical development program. We and AstraZeneca agreed to advance AZD1419 towards a Phase 1 clinical trial, which resulted in a development funding payment of $6.0 million received in the fourth quarter of 2012. In January 2014, we amended our agreement with AstraZeneca for the clinical development of AZD1419 whereby responsibility for conducting clinical trials was transferred from Dynavax to AstraZeneca upon completion of the Phase 1 trial. In the first quarter of 2014, we received a $5.4 million payment that was due upon execution of this amended agreement. In December 2014, we amended our agreement with AstraZeneca whereby AstraZeneca would fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma. In the fourth quarter of 2014, we received an $8.0 million payment upon execution of this amendment, to be applied towards research and development expenses incurred in conducting the Phase 2a study. In January 2016, we amended our agreement with AstraZeneca whereby AstraZeneca will conduct the Phase 2a safety and efficacy trial of AZD1419 in patients with asthma that originally was to be conducted by Dynavax. We therefore revised the estimated remaining period of performance of development from June 2018 to September 2016. The remaining balance as of December 31, 2015 related to deferred payments of $5.4 million, received in the first quarter of 2014, and $3.0 million, received in 2011, are nonrefundable and are being recognized starting in January 2016 over the estimated remaining period of performance of development work through September 2016. Under the terms of the January 2016 amendment, the $8.0 million payment received in December 2014, which was also deferred and is being recognized as research and development expenses are incurred, will be returned to AstraZeneca or applied to future milestone payments that may be earned by us under the agreement, net of amounts we recognize as development work is performed. In December 2015, we reclassified $7.4 million of the $8.0 million payment from deferred revenue to a current liability. As of March 31, 2016, the current liability related to the payment was $7.3 million on the accompanying condensed consolidated balance sheet. Under the terms of this agreement, as amended, we are eligible to receive up to $100 million in additional milestone payments, based on the achievement of certain development and regulatory objectives. Additionally, upon commercialization, we are eligible to receive tiered royalties ranging from the mid to high single-digits based on product sales of any products originating from the collaboration. We have the option to co-promote in the United States products arising from the collaboration, if any. AstraZeneca has the right to sublicense its rights upon our prior consent. The following table summarizes the revenues earned under our agreement with AstraZeneca, included as collaboration revenue in our condensed consolidated statements of operations (in thousands): Three Months Ended March 31, 2016 2015 Initial payment $ 174 $ 63 Subsequent payment 651 237 Performance of research activities 70 171 Total $ 895 $ 471 As of March 31, 2016 and December 31, 2015, total deferred revenue from the initial payment, subsequent payment and development funding payments was $1.8 million and $2.7 million, respectively. Absent early termination, the agreement will expire when all of AstraZeneca’s payment obligations expire. AstraZeneca has the right to terminate the agreement at any time upon prior written notice and either party may terminate the agreement early upon written notice if the other party commits an uncured material breach of the agreement. National Institutes of Health (“NIH”) and Other Funding We have been awarded various grants from the NIH and the NIH’s National Institute of Allergy and Infectious Disease (“NIAID”) in order to fund research. The awards are related to specific research objectives and we earn revenue as the related research expenses are incurred. We have earned revenue during the three month periods ended March 31, 2016 and 2015 from the following awards: · August 2014, the NIH awarded us $0.2 million to fund research in developing a transgenic mouse model to study human TLR9 role in disease. · May 2012, the NIH awarded us $0.4 million to fund development of TLR8 inhibitors for treatment of rheumatoid arthritis. In February 2016, the NIH awarded us an additional $0.5 million to fund this study. · August 2010, the NIAID awarded us a grant to take a systems biology approach to study the differences between individuals who do or do not respond to vaccination against the hepatitis B virus. This study is one of several projects conducted under a grant to the Baylor Institute of Immunology Research in Dallas as part of the Human Immune Phenotyping Centers program. We have been awarded a total of $1.4 million under this grant. The following table summarizes the revenues recognized under the various arrangements with the NIH (in thousands): Three Months Ended March 31, 2016 2015 NIH contracts $ 39 $ 148 Total grant revenue $ 39 $ 148 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 6. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period and giving effect to all potentially dilutive common shares using the treasury-stock method. For purposes of this calculation, common stock subject to repurchase by us, outstanding options, stock awards, Series B Convertible Preferred Stock, and warrants are considered to be potentially dilutive common shares and are only included in the calculation of diluted net loss per share when their effect is dilutive. Stock options, Series B Convertible Preferred Stock, warrants and stock awards totaling approximately 3,610,000 and 5,310,000 shares of common stock as of March 31, 2016 and 2015, respectively, were excluded from the calculation of diluted net loss per share for the three months ended March 31, 2016 and 2015, because the effect of their inclusion would have been anti-dilutive. For periods in which the Company has a net loss and no instruments are determined to be dilutive, such as the three months ended March 31, 2016 and 2015, basic and diluted net loss per share are the same. |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2016 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock | 7. Common Stock Common Stock Outstanding As of March 31, 2016, there were 38,495,502 shares of our common stock outstanding. On November 12, 2015, we entered into an At Market Issuance Sales Agreement (the “2015 ATM Agreement”) with Cowen under which we could offer and sell our common stock from time to time up to aggregate sales proceeds of $90 million through Cowen as our sales agent. As of March 31, 2016, we have sold no shares of common stock under the 2015 ATM Agreement. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Share Based Compensation [Abstract] | |
Equity Plans and Stock-Based Compensation | 8. Equity Plans and Stock-Based Compensation Option activity under our stock-based compensation plans during the three months ended March 31, 2016 was as follows (in thousands except per share amounts): Shares Underlying Outstanding Options (in thousands) Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2015 2,891 $ 23.34 Options granted 229 21.48 Options exercised (12 ) 13.69 Options cancelled: Options forfeited (unvested) (9 ) 17.87 Options cancelled (vested) (36 ) 49.30 Balance at March 31, 2016 3,063 22.97 7.02 $ 4,835 Vested and expected to vest at March 31, 2016 2,996 23.09 6.98 $ 4,663 Exercisable at March 31, 2016 1,509 26.49 5.11 $ 2,204 Restricted stock unit activity under our stock-based compensation plans during the three months ended March 31, 2016 was as follows (in thousands except per share amounts): Number of Shares (In thousands) Weighted-Average Grant-Date Fair Value Non-vested as of December 31, 2015 195 $ 17.52 Granted 379 $ 21.48 Vested (23 ) $ 15.55 Forfeited or expired (1 ) $ 16.00 Non-vested as of March 31, 2016 550 $ 20.34 The aggregate intrinsic value of the restricted stock units outstanding as of March 31, 2016, based on our stock price on that date, was $10.6 million. As of March 31, 2016, approximately 189,000 shares underlying stock options and restricted stock units awards with performance-based vesting criteria were outstanding. Vesting criteria for these performance-based awards have not been met as of March 31, 2016. Under our stock-based compensation plans, option awards generally vest over a four-year period contingent upon continuous service and expire ten years from the date of grant (or earlier upon termination of continuous service). The fair value-based measurement of each option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value-based measurements and weighted-average assumptions used in the calculations of these measurements are as follows: Stock Options Employee Stock Purchase Plan Three Months Ended Three Months Ended March 31, March 31, 2016 2015 2016 2015 Weighted-average fair value $ 13.11 $ 10.85 $ 8.18 $ 17.32 Risk-free interest rate 1.5 % 1.6 % 0.6 % 0.4 % Expected life (in years) 5.6 5.8 1.2 1.2 Volatility 0.7 0.8 0.6 2.4 We recognized stock-based compensation expense of $3.2 million and $2.0 million for the three months ended March 31, 2016 and 2015, respectively. The components of stock-based compensation expense were (in thousands): Three Months Ended March 31, 2016 2015 Research and development $ 1,515 $ 885 General and administrative 1,729 1,069 Total $ 3,244 $ 1,954 As of March 31, 2016, the total unrecognized compensation cost related to non-vested equity awards including all awards with time-based vesting amounted to $22.1 million, which is expected to be recognized over the remaining weighted-average vesting period of 2.6 years. Additionally, as of March 31, 2016, the total unrecognized compensation cost related to equity awards with performance-based vesting criteria not deemed probable of vesting amounted to $5.9 million. Employee Stock Purchase Plan In May 2014, stockholders of the Company approved the 2014 Employee Stock Purchase Plan (the “Purchase Plan”), pursuant to which the Company may issue up to 50,000 |
Organization and Summary of S15
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period. The condensed consolidated balance sheet at December 31, 2015, has been derived from audited financial statements at that date, but excludes disclosures required by GAAP for complete financial statements. The unaudited condensed consolidated financial statements and these notes should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiaries, Dynavax GmbH and Dynavax International, B.V. Dynavax International, B.V. was dissolved in January 2015. All significant intercompany accounts and transactions among these entities have been eliminated from the condensed consolidated financial statements. We operate in one business segment: the discovery and development of biopharmaceutical products. |
Liquidity and Financial Condition | Liquidity and Financial Condition We have incurred significant operating losses and negative cash flows from operations since our inception. As of March 31, 2016, we had cash, cash equivalents and marketable securities of $166.8 million. . We expect to continue to spend substantial funds in connection with seeking regulatory approval and other costs relating to, preparation for the anticipated commercial launch of HEPLISAV-B TM , which could have an adverse impact on our ability to achieve our intended business objectives. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ materially from these estimates. |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There have been no significant changes in our significant accounting policies during the three months ended March 31, 2016, as compared with those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2015. |
Revenue Recognition | Revenue Recognition Our revenues consist of amounts earned from collaborations, grants and fees from services and licenses. We enter into license and manufacturing agreements and collaborative research and development arrangements with pharmaceutical and biotechnology partners that may involve multiple deliverables. Our arrangements may include one or more of the following elements: upfront license payments, cost reimbursement for the performance of research and development activities, milestone payments, other contingent payments, contract manufacturing service fees, royalties and license fees. Each deliverable in the arrangement is evaluated to determine whether it meets the criteria to be accounted for as a separate unit of accounting or whether it should be combined with other deliverables. In order to account for the multiple-element arrangements, the Company identifies the deliverables included within the arrangement and evaluates which deliverables represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. We recognize revenue when there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. Non-refundable upfront fees received for license and collaborative agreements entered into and other payments under collaboration agreements where we have continuing performance obligations related to the payments are deferred and recognized over our estimated performance period. Revenue is recognized on a ratable basis, unless we determine that another method is more appropriate, through the date at which our performance obligations are completed. Management makes its best estimate of the period over which we expect to fulfill our performance obligations, which may include clinical development activities. Given the uncertainties of research and development collaborations, significant judgment is required to determine the duration of the performance period. We recognize cost reimbursement revenue under collaborative agreements as the related research and development costs are incurred, as provided for under the terms of these agreements. Contingent consideration received for the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is defined as an event having all of the following characteristics: (i) there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, (ii) the event can only be achieved based in whole or in part on either the entity’s performance or a specific outcome resulting from the entity’s performance and (iii) if achieved, the event would result in additional payments being due to the entity. Our license and collaboration agreements with our partners provide for payments to be paid to us upon the achievement of development milestones. Given the challenges inherent in developing biologic products, there is substantial uncertainty whether any such milestones will be achieved at the time we entered into these agreements. In addition, we evaluate whether the development milestones meet the criteria to be considered substantive. The conditions include: (i) the development work is contingent on either of the following: (a) the vendor’s performance to achieve the milestone or (b) the enhancement of the value of the deliverable item or items as a result of a specific outcome resulting from the vendor’s performance to achieve the milestone; (ii) it relates solely to past performance and (iii) it is reasonable relative to all the deliverable and payment terms within the arrangement. As a result of our analysis, we consider our development milestones to be substantive and, accordingly, we expect to recognize as revenue future payments received from such milestones as we achieve each milestone. Milestone payments that are contingent upon the achievement of substantive at-risk performance criteria are recognized in full upon achievement of those milestone events in accordance with the terms of the agreement and assuming all other revenue recognition criteria have been met. All revenue recognized to date under our collaborative agreements has been nonrefundable. Our license and collaboration agreements with certain partners also provide for contingent payments to be paid to us based solely upon the performance of our partner. For such contingent payments we expect to recognize the payments as revenue upon receipt, provided that revenue recognition criteria have been satisfied. Revenues from manufacturing services are recognized upon meeting the criteria for substantial performance and acceptance by the customer. Revenue from royalty payments is contingent on future sales activities by our licensees. Royalty revenue is recognized when all revenue recognition criteria have been satisfied. Revenue from government and private agency grants is recognized as the related research expenses are incurred and to the extent that funding is approved. Additionally, we recognize revenue based on the facilities and administrative cost rate reimbursable per the terms of the grant awards. |
Research and Development Expenses and Accruals | Research and Development Expenses and Accruals Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. We contract with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. Our accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. We may terminate these contracts upon written notice and we are generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances we may be further responsible for termination fees and penalties. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior period accrued estimates for clinical trial activities through March 31, 2016. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2014-09 In May 2014, the Financial Accounting Standards Board (“FASB”) issued guidance codified in ASC 606, Revenue Recognition — Revenue from Contracts with Customers, which amends the guidance in former ASC 605, Revenue Recognition, which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This Accounting Standards Update (“ASU”) is based on the principle that revenue is recognized to depict the transfer of 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. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB deferred the effective date for annual reporting periods beginning after December 15, 2017 (including interim periods within those periods) , with early application permitted . Accounting Standards Update 2015-17 In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Subtopic 740): Balance Sheet Classification of Deferred Taxes, The ASU requires entities to classify deferred tax liabilities and assets as noncurrent in a classified statement of financial position The Company is currently evaluating the impact of this standard on its financial statements. Accounting Standards Update 2016-02 In February 2016, the FASB issued ASU No. 2016-02, Leases Accounting Standards Update 2016-08 In March 2016, the FASB issued ASU No. 2016-08 “Revenue from Contracts with Customers (Topic 606) - Principal versus Agent Considerations (Reporting Revenue Gross versus Net).” ASU No. 2016-08 requires an entity to determine whether the nature of its promise to provide goods or services to a customer is performed in a principal or agent capacity and to recognize revenue in a gross or net manner based on its principal/agent designation. ASU No. 2016-08 is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2017, with early application permitted. The Company is currently evaluating the impact this guidance will have on its financial statements. Accounting Standards Update 2016-09 In March 2016, the FASB issued ASU No. 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification on the statement of cash flows and forfeitures. ASU 2016-09 is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2016, with early application permitted. The Company is currently evaluating the impact this guidance will have on its financial statements. Accounting Standards Update 2016-10 In April 2016, the FASB issued ASU No. 2016-10 “Revenue from Contracts with Customers (Topic 606) – Identifying Performance Obligations and Licensing.” ASU No. 2016-10 clarifies the following two aspects of Topic 606: identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. ASU No. 2016-10 is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2017, with early application permitted. The Company is currently evaluating the impact this guidance will have on its financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy for Financial Assets Measured at Fair Value on Recurring Basis | The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis as of March 31, 2016 and December 31, 2015 (in thousands): Level 1 Level 2 Level 3 Total March 31, 2016 Money market funds $ 24,982 $ - $ - $ 24,982 U.S. Treasuries - 6,574 - 6,574 U.S. Government agency securities - 29,611 - 29,611 Corporate debt securities - 99,650 - 99,650 Total $ 24,982 $ 135,835 $ - $ 160,817 Level 1 Level 2 Level 3 Total December 31, 2015 Money market funds $ 21,193 $ - $ - $ 21,193 U.S. Government agency securities - 17,622 - 17,622 Corporate debt securities - 152,749 - 152,749 Total $ 21,193 $ 170,371 $ - $ 191,564 |
Cash, Cash Equivalents and Ma17
Cash, Cash Equivalents and Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Cash Cash Equivalents And Short Term Investments [Abstract] | |
Summary of Cash, Cash Equivalents and Marketable Securities Available-for-Sale | The following is a summary of cash, cash equivalents and marketable securities available-for-sale as of March 31, 2016 and December 31, 2015 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value March 31, 2016 Cash and cash equivalents: Cash $ 6,030 $ - $ - $ 6,030 Money market funds 24,982 - - 24,982 U.S. Government agency securities 4,999 - - 4,999 Corporate debt securities 2,847 - - 2,847 Total cash and cash equivalents 38,858 - - 38,858 Marketable securities available-for-sale: U.S. Treasuries 6,573 2 (1 ) 6,574 U.S. Government agency securities 24,604 8 - 24,612 Corporate debt securities 96,691 112 - 96,803 Total marketable securities available-for-sale 127,868 122 (1 ) 127,989 Total cash, cash equivalents and marketable securities $ 166,726 $ 122 $ (1 ) $ 166,847 December 31, 2015 Cash and cash equivalents: Cash $ 4,561 $ - $ - $ 4,561 Money market funds 21,193 - - 21,193 Corporate debt securities 19,052 7 (1 ) 19,058 Total cash and cash equivalents 44,806 7 (1 ) 44,812 Marketable securities available-for-sale: U.S. Government agency securities 17,628 - (6 ) 17,622 Corporate debt securities 133,679 71 (59 ) 133,691 Total marketable securities available-for-sale 151,307 71 (65 ) 151,313 Total cash, cash equivalents and marketable securities $ 196,113 $ 78 $ (66 ) $ 196,125 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): March 31, 2016 Amortized Cost Estimated Fair Value Mature in one year or less $ 127,868 $ 127,989 Mature after one year through two years - - $ 127,868 $ 127,989 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Payments Under Non-Cancelable Portion of Operating Leases | Future minimum payments under the non-cancelable portion of our operating leases at March 31, 2016, excluding payments from sublease agreements, are as follows (in thousands): Year ending December 31, 2016 (remaining) $ 1,757 2017 2,385 2018 1,327 2019 485 2020 485 Thereafter 1,091 Total $ 7,530 |
Collaborative Research and De19
Collaborative Research and Development Agreements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Astra Zeneca | |
Summary of Revenue Recognized under Various Agreements | The following table summarizes the revenues earned under our agreement with AstraZeneca, included as collaboration revenue in our condensed consolidated statements of operations (in thousands): Three Months Ended March 31, 2016 2015 Initial payment $ 174 $ 63 Subsequent payment 651 237 Performance of research activities 70 171 Total $ 895 $ 471 |
National Institutes of Health | |
Summary of Revenue Recognized under Various Agreements | The following table summarizes the revenues recognized under the various arrangements with the NIH (in thousands): Three Months Ended March 31, 2016 2015 NIH contracts $ 39 $ 148 Total grant revenue $ 39 $ 148 |
Equity Plans and Stock-Based 20
Equity Plans and Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Share Based Compensation [Abstract] | |
Option Activity under Stock-Based Compensation Plans | Option activity under our stock-based compensation plans during the three months ended March 31, 2016 was as follows (in thousands except per share amounts): Shares Underlying Outstanding Options (in thousands) Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2015 2,891 $ 23.34 Options granted 229 21.48 Options exercised (12 ) 13.69 Options cancelled: Options forfeited (unvested) (9 ) 17.87 Options cancelled (vested) (36 ) 49.30 Balance at March 31, 2016 3,063 22.97 7.02 $ 4,835 Vested and expected to vest at March 31, 2016 2,996 23.09 6.98 $ 4,663 Exercisable at March 31, 2016 1,509 26.49 5.11 $ 2,204 |
Summary of Restricted Stock Units Activity | Restricted stock unit activity under our stock-based compensation plans during the three months ended March 31, 2016 was as follows (in thousands except per share amounts): Number of Shares (In thousands) Weighted-Average Grant-Date Fair Value Non-vested as of December 31, 2015 195 $ 17.52 Granted 379 $ 21.48 Vested (23 ) $ 15.55 Forfeited or expired (1 ) $ 16.00 Non-vested as of March 31, 2016 550 $ 20.34 |
Fair Value-Based Measurements and Weighted-Average Assumptions | The fair value-based measurements and weighted-average assumptions used in the calculations of these measurements are as follows: Stock Options Employee Stock Purchase Plan Three Months Ended Three Months Ended March 31, March 31, 2016 2015 2016 2015 Weighted-average fair value $ 13.11 $ 10.85 $ 8.18 $ 17.32 Risk-free interest rate 1.5 % 1.6 % 0.6 % 0.4 % Expected life (in years) 5.6 5.8 1.2 1.2 Volatility 0.7 0.8 0.6 2.4 |
Stock-Based Compensation Expense | The components of stock-based compensation expense were (in thousands): Three Months Ended March 31, 2016 2015 Research and development $ 1,515 $ 885 General and administrative 1,729 1,069 Total $ 3,244 $ 1,954 |
Organization and Summary of S21
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2016USD ($)Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segment | Segment | 1 |
Cash, cash equivalents and marketable securities | $ | $ 166.8 |
Fair Value Hierarchy for Financ
Fair Value Hierarchy for Financial Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 160,817 | $ 191,564 |
Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 24,982 | 21,193 |
Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 135,835 | 170,371 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 24,982 | 21,193 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 24,982 | 21,193 |
U.S. Treasuries | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 6,574 | |
U.S. Treasuries | Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 6,574 | |
U.S. Government Agency Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 29,611 | 17,622 |
U.S. Government Agency Securities | Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 29,611 | 17,622 |
Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 99,650 | 152,749 |
Corporate Debt Securities | Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 99,650 | $ 152,749 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | Mar. 31, 2016USD ($) |
Fair Value Disclosures [Abstract] | |
Transfers between level 1 and level 2 | $ 0 |
Summary of Cash, Cash Equivalen
Summary of Cash, Cash Equivalents and Marketable Securities Available-for-Sale (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 166,726 | $ 196,113 |
Unrealized Gains | 122 | 78 |
Unrealized Losses | (1) | (66) |
Estimated Fair Value | 166,847 | 196,125 |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 38,858 | 44,806 |
Unrealized Gains | 7 | |
Unrealized Losses | (1) | |
Estimated Fair Value | 38,858 | 44,812 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 127,868 | 151,307 |
Unrealized Gains | 122 | 71 |
Unrealized Losses | (1) | (65) |
Estimated Fair Value | 127,989 | 151,313 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 6,030 | 4,561 |
Estimated Fair Value | 6,030 | 4,561 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 24,982 | 21,193 |
Estimated Fair Value | 24,982 | 21,193 |
U.S. Government Agency Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 4,999 | |
Estimated Fair Value | 4,999 | |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 24,604 | 17,628 |
Unrealized Gains | 8 | |
Unrealized Losses | (6) | |
Estimated Fair Value | 24,612 | 17,622 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 2,847 | 19,052 |
Unrealized Gains | 7 | |
Unrealized Losses | (1) | |
Estimated Fair Value | 2,847 | 19,058 |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 96,691 | 133,679 |
Unrealized Gains | 112 | 71 |
Unrealized Losses | (59) | |
Estimated Fair Value | 96,803 | $ 133,691 |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 6,573 | |
Unrealized Gains | 2 | |
Unrealized Losses | (1) | |
Estimated Fair Value | $ 6,574 |
Summary of Amortized Cost and E
Summary of Amortized Cost and Estimated Fair Value of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Mar. 31, 2016USD ($) |
Amortized Cost | |
Mature in one year or less | $ 127,868 |
Mature after one year through two years | 0 |
Total amortized cost | 127,868 |
Estimated Fair Value | |
Mature in one year or less | 127,989 |
Mature after one year through two years | 0 |
Total estimated fair value | $ 127,989 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | |
Loss Contingencies [Line Items] | |||
Rent expense, net | $ 0.5 | $ 0.5 | |
Deferred rent | 0.4 | $ 0.5 | |
Future payments obligation | $ 10.5 | ||
Berkeley, California (the "Berkeley Lease") | |||
Loss Contingencies [Line Items] | |||
Operating leases expiration date | 2018-06 | ||
Dusseldorf, Germany (the "Dusseldorf Lease") | |||
Loss Contingencies [Line Items] | |||
Operating leases expiration date | 2023-03 |
Future Minimum Payments Under N
Future Minimum Payments Under Non-Cancelable Portion of Operating Leases (Detail) $ in Thousands | Mar. 31, 2016USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2016 (remaining) | $ 1,757 |
2,017 | 2,385 |
2,018 | 1,327 |
2,019 | 485 |
2,020 | 485 |
Thereafter | 1,091 |
Total | $ 7,530 |
Collaborative Research and De28
Collaborative Research and Development Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | ||||||||
Oct. 31, 2011 | Mar. 31, 2016 | Dec. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2012 | Feb. 29, 2016 | Dec. 31, 2015 | Aug. 31, 2014 | May. 31, 2012 | Aug. 31, 2010 | |
Deferred Revenue Arrangement [Line Items] | ||||||||||
Accrued research and development liability | $ 6,027,000 | $ 7,361,000 | ||||||||
Accrued current liabilities | 13,251,000 | 15,337,000 | ||||||||
Maximum | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Additional revenue recognized | 100,000,000 | |||||||||
Astra Zeneca | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Collaboration Revenue | $ 3,000,000 | $ 8,000,000 | $ 5,400,000 | $ 6,000,000 | ||||||
Accrued current liabilities | 7,300,000 | |||||||||
Deferred revenue | $ 1,800,000 | $ 2,700,000 | ||||||||
National Institutes of Health | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Grants receivable | $ 200,000 | |||||||||
National Institutes of Health | Rheumatoid Arthritis | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Grants receivable | $ 500,000 | $ 400,000 | ||||||||
National Institute of Allergy and Infectious Diseases | Hepatitis B Virus | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Grants receivable | $ 1,400,000 |
Summary of Revenue Recognized u
Summary of Revenue Recognized under Various Agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Product Information [Line Items] | ||
Total revenues | $ 942 | $ 627 |
Grant revenue | 39 | 148 |
Astra Zeneca | ||
Product Information [Line Items] | ||
Initial payment | 174 | 63 |
Subsequent payment | 651 | 237 |
Performance of research activities | 70 | 171 |
Total revenues | 895 | 471 |
National Institutes of Health | ||
Product Information [Line Items] | ||
Grant revenue | $ 39 | $ 148 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Earnings Per Share [Abstract] | ||
Stock options, Series B Convertible Preferred Stock, warrants and stock awards excluding calculation of diluted net loss per share | 3,610,000 | 5,310,000 |
Dilutive securities, effect on basic earnings per share | $ 0 | $ 0 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | Nov. 12, 2015 | Mar. 31, 2016 | Dec. 31, 2015 |
Class Of Stock [Line Items] | |||
Common stock, shares outstanding | 38,495,502 | 38,446,000 | |
Cowen | |||
Class Of Stock [Line Items] | |||
Issuance of common stock, (in shares) | 0 | ||
Maximum | Cowen | |||
Class Of Stock [Line Items] | |||
Common stock sales agreement aggregate sales proceeds | $ 90,000,000 |
Option Activity under Stock-Bas
Option Activity under Stock-Based Compensation Plans (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended |
Mar. 31, 2016USD ($)$ / sharesshares | |
Number of Options Outstanding | |
Beginning balance | shares | 2,891 |
Options granted | shares | 229 |
Options exercised | shares | (12) |
Ending balance | shares | 3,063 |
Vested and expected to vest at end of period | shares | 2,996 |
Exercisable at end of period | shares | 1,509 |
Weighted-Average Price Per Share | |
Beginning balance | $ / shares | $ 23.34 |
Options granted | $ / shares | 21.48 |
Options exercised | $ / shares | 13.69 |
Ending balance | $ / shares | 22.97 |
Vested and expected to vest at end of period | $ / shares | 23.09 |
Exercisable at end of period | $ / shares | $ 26.49 |
Weighted Average Remaining Contractual Life (In years) | |
Balance at March 31, 2016 | 7 years 7 days |
Outstanding options vested and expected to vest at end of period | 6 years 11 months 23 days |
Options exercisable at end of period | 5 years 1 month 10 days |
Aggregate Intrinsic Value | |
Balance at March 31, 2016 | $ | $ 4,835 |
Outstanding options (vested and expected to vest) at end of period | $ | 4,663 |
Options exercisable at end of period | $ | $ 2,204 |
Unvested | |
Number of Options Outstanding | |
Options cancelled | shares | (9) |
Weighted-Average Price Per Share | |
Options cancelled | $ / shares | $ 17.87 |
Vested | |
Number of Options Outstanding | |
Options cancelled | shares | (36) |
Weighted-Average Price Per Share | |
Options cancelled | $ / shares | $ 49.30 |
Summary of Restricted Stock Uni
Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs) shares in Thousands | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Number of shares | |
Beginning Balance | shares | 195 |
Granted | shares | 379 |
Vested | shares | (23) |
Forfeited or expired | shares | (1) |
Ending Balance | shares | 550 |
Weighted Average Grant Date Fair Value | |
Beginning Balance | $ / shares | $ 17.52 |
Granted | $ / shares | 21.48 |
Vested | $ / shares | 15.55 |
Forfeited or expired | $ / shares | 16 |
Ending Balance | $ / shares | $ 20.34 |
Equity Plans and Stock-Based 34
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
May. 31, 2014 | Mar. 31, 2016 | Mar. 31, 2015 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 3,244 | $ 1,954 | |
Time Based Vesting Schedule | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total unrecognized compensation cost related to non-vested equity awards | $ 22,100 | ||
Total unrecognized compensation cost, weighted-average vesting period | 2 years 7 months 6 days | ||
Performance Based Vesting Schedule | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total unrecognized compensation cost related to non-vested equity awards | $ 5,900 | ||
2014 Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares issued to employees | 50,000 | 40,670 | |
Shares remaining available for future purchases | 9,330 | ||
2014 Employee Stock Purchase Plan | The commencement of the offer period (generally, the sixteenth day in February or August) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Purchase price per share as percentage of fair market value of common stock | 85.00% | ||
2014 Employee Stock Purchase Plan | The exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Purchase price per share as percentage of fair market value of common stock | 85.00% | ||
Restricted Stock Units (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Aggregate intrinsic value | $ 10,600 | ||
Performance based Vesting Condition | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares underlying stock options and restricted stock units awards with performance-based vesting criteria | 189,000 | ||
Employee Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options vesting period | 4 years | ||
Expiration period | 10 years |
Fair Value-Based Measurements a
Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average fair value | $ 8.18 | $ 17.32 |
Risk-free interest rate | 0.60% | 0.40% |
Expected life (in years) | 1 year 2 months 12 days | 1 year 2 months 12 days |
Volatility | 0.60% | 2.40% |
Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average fair value | $ 13.11 | $ 10.85 |
Risk-free interest rate | 1.50% | 1.60% |
Expected life (in years) | 5 years 7 months 6 days | 5 years 9 months 18 days |
Volatility | 0.70% | 0.80% |
Stock-Based Compensation Expens
Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | $ 3,244 | $ 1,954 |
Research and Development | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 1,515 | 885 |
General and Administrative | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | $ 1,729 | $ 1,069 |