Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 03, 2016 | Jun. 30, 2015 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | DVAX | ||
Entity Registrant Name | DYNAVAX TECHNOLOGIES CORP | ||
Entity Central Index Key | 1,029,142 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 38,482,018 | ||
Entity Public Float | $ 587,052,465 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 44,812 | $ 49,511 |
Marketable securities available-for-sale | 151,313 | 73,141 |
Accounts receivable | 1,394 | 727 |
Prepaid expenses and other current assets | 2,427 | 4,058 |
Total current assets | 199,946 | 127,437 |
Property and equipment, net | 13,804 | 7,924 |
Goodwill | 2,043 | 2,277 |
Restricted cash | 609 | 632 |
Other assets | 231 | 20 |
Total assets | 216,633 | 138,290 |
Current liabilities: | ||
Accounts payable | 3,433 | 1,159 |
Accrued research and development | 7,361 | 6,938 |
Accrued liabilities | 15,337 | 6,317 |
Deferred revenues | 2,654 | 5,865 |
Total current liabilities | 28,785 | 20,279 |
Deferred revenues, net of current portion | 6,900 | |
Long term debt | 9,559 | |
Other long-term liabilities | 769 | 1,070 |
Total liabilities | $ 29,554 | $ 37,808 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Common stock: $0.001 par value; 69,500 shares authorized at December 31, 2015 and 2014, respectively; 38,446 and 26,307 shares issued and outstanding at December 31, 2015 and 2014, respectively | $ 38 | $ 26 |
Additional paid-in capital | 889,698 | 695,058 |
Accumulated other comprehensive loss | (2,930) | (1,669) |
Accumulated deficit | (699,727) | (592,933) |
Total stockholders’ equity | 187,079 | 100,482 |
Total liabilities and stockholders’ equity | $ 216,633 | $ 138,290 |
Series B Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value Authorized: 5,000 shares; Issued and outstanding: Series B Convertible Preferred Stock — No shares at December 31, 2015 and 43 shares at December 31, 2014 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 69,500,000 | 69,500,000 |
Common stock, shares issued | 38,446,000 | 26,307,000 |
Common stock, shares outstanding | 38,445,995 | 26,307,000 |
Series B Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.001 | |
Preferred stock, shares issued | 0 | 43,000 |
Preferred stock, shares outstanding | 0 | 43,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues: | |||
Collaboration revenue | $ 2,765 | $ 7,933 | $ 4,929 |
Grant revenue | 683 | 2,688 | 5,138 |
Service and license revenue | 602 | 411 | 1,184 |
Total revenues | 4,050 | 11,032 | 11,251 |
Operating expenses: | |||
Research and development | 86,943 | 84,580 | 50,870 |
General and administrative | 22,180 | 17,377 | 25,943 |
Unoccupied facility expense | 386 | 926 | |
Total operating expenses | 109,123 | 102,343 | 77,739 |
Loss from operations | (105,073) | (91,311) | (66,488) |
Other income (expense): | |||
Interest income | 205 | 191 | 116 |
Interest expense | (572) | (35) | |
Other income (expense), net | 317 | 433 | (348) |
Loss on extinguishment of debt | (1,671) | ||
Net loss | (106,794) | (90,722) | (66,720) |
Preferred stock deemed dividend | (8,469) | ||
Net loss allocable to common stockholders | $ (106,794) | $ (90,722) | $ (75,189) |
Net loss per share allocable to common stockholders - basic and diluted | $ (3.25) | $ (3.45) | $ (3.83) |
Weighted average shares outstanding used to compute basic and diluted net loss per share allocable to common stockholders | 32,881 | 26,289 | 19,628 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (106,794) | $ (90,722) | $ (66,720) |
Other comprehensive (loss) income: | |||
Unrealized gain (loss) on marketable securities available-for-sale | 11 | 32 | (76) |
Cumulative foreign currency translation adjustments | (1,272) | (1,553) | 523 |
Total other comprehensive (loss) income | (1,261) | (1,521) | 447 |
Total comprehensive loss | $ (108,055) | $ (92,243) | $ (66,273) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Preferred Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balances at Dec. 31, 2012 | $ 114,826 | $ 183 | $ 550,729 | $ (595) | $ (435,491) | |
Beginning Balances (in shares) at Dec. 31, 2012 | 18,279 | |||||
Issuance of common stock upon exercise of stock options and restricted stock awards | 112 | 112 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards (In Shares) | 11 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 224 | 224 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 13 | |||||
Restricted Stock Award Delivered (in shares) | 12 | |||||
Issuance of common stock, net of issuance costs | 80,999 | $ 80 | 80,919 | |||
Issuance of common stock, net of issuance costs (in shares) | 7,957 | |||||
Issuance of Series B convertible preferred stock, net of issuance costs | 44,209 | 44,209 | ||||
Issuance of Series B convertible preferred stock, net of issuance costs (in shares) | 43 | |||||
Initial expenses related to ATM agreement | (143) | (143) | ||||
Warrants exercised (in shares) | 8 | |||||
Stock compensation expense | 12,340 | 12,340 | ||||
Total other comprehensive income (loss) | 447 | 447 | ||||
Net loss | (66,720) | (66,720) | ||||
Ending Balances at Dec. 31, 2013 | 186,294 | $ 263 | 688,390 | (148) | (502,211) | |
Ending Balances (in shares) at Dec. 31, 2013 | 26,280 | 43 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards | 49 | 49 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards (In Shares) | 5 | |||||
Reverse stock split | $ (237) | 237 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 130 | 130 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 11 | |||||
Warrants exercised | 163 | 163 | ||||
Warrants exercised (in shares) | 11 | |||||
Stock compensation expense | 6,089 | 6,089 | ||||
Total other comprehensive income (loss) | (1,521) | (1,521) | ||||
Net loss | (90,722) | (90,722) | ||||
Ending Balances at Dec. 31, 2014 | 100,482 | $ 26 | 695,058 | (1,669) | (592,933) | |
Ending Balances (in shares) at Dec. 31, 2014 | 26,307 | 43 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards | 531 | 531 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards (In Shares) | 37 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 291 | 291 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 23 | |||||
Issuance of common stock, net of issuance costs | 183,897 | $ 7 | 183,890 | |||
Issuance of common stock, net of issuance costs (in shares) | 7,353 | |||||
Issuance of Series B convertible preferred stock, net of issuance costs | 2 | $ 5 | (3) | |||
Issuance of Series B convertible preferred stock, net of issuance costs (in shares) | 4,343 | (43) | ||||
Warrants exercised | 228 | 228 | ||||
Warrants exercised (in shares) | 383 | |||||
Stock compensation expense | 9,703 | 9,703 | ||||
Total other comprehensive income (loss) | (1,261) | (1,261) | ||||
Net loss | (106,794) | (106,794) | ||||
Ending Balances at Dec. 31, 2015 | $ 187,079 | $ 38 | $ 889,698 | $ (2,930) | $ (699,727) | |
Ending Balances (in shares) at Dec. 31, 2015 | 38,446 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating activities | |||
Net loss | $ (106,794) | $ (90,722) | $ (66,720) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,365 | 1,404 | 1,327 |
Loss (gain) on disposal of property and equipment | 46 | (24) | 18 |
Accretion of discounts and amortization of premiums of marketable securities | 660 | 881 | 923 |
Unoccupied facility expense | 386 | 926 | |
Accretion of debt discount related to debt financing | (115) | ||
Cash-settled portion of stock-based compensation expense | 387 | ||
Stock compensation expense | 9,316 | 6,089 | 12,340 |
Loss on extinguishment of debt | 1,671 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | (667) | 900 | (622) |
Prepaid expenses and other current assets | 1,631 | (2,683) | 677 |
Restricted cash and other assets | (211) | 277 | 176 |
Accounts payable | 1,246 | (523) | (657) |
Accrued liabilities and other long term liabilities | 9,017 | 4,810 | (2,291) |
Deferred revenues | (10,111) | 5,467 | (4,770) |
Net cash used in operating activities | (92,559) | (73,738) | (58,673) |
Investing activities | |||
Purchases of marketable securities | (208,936) | (44,807) | (192,044) |
Proceeds from maturities of marketable securities | 130,110 | 137,071 | 142,321 |
Purchases of property and equipment, net | (6,970) | (1,667) | (1,629) |
Net cash (used in) provided by investing activities | (85,796) | 90,597 | (51,352) |
Financing activities | |||
Proceeds from issuances of common stock, net | 183,897 | 80,856 | |
Proceeds from issuances of preferred stock | 44,209 | ||
Payment of debt | (10,988) | ||
Proceeds from exercise of stock options and restricted stock awards | 531 | 49 | 112 |
Proceeds from Employee Stock Purchase Plan | 291 | 130 | 224 |
Proceeds from exercise of warrants | 228 | 163 | |
Proceeds from long-term debt payable to Hercules, net | 9,559 | ||
Net cash provided by financing activities | 173,959 | 9,901 | 125,401 |
Effect of exchange rate changes on cash and cash equivalents | (303) | (371) | 147 |
Net (decrease) increase in cash and cash equivalents | (4,699) | 26,389 | 15,523 |
Cash and cash equivalents at beginning of year | 49,511 | 23,122 | 7,599 |
Cash and cash equivalents at end of year | 44,812 | 49,511 | 23,122 |
Non-cash investing and financing activities: | |||
Cash paid during the year for interest | 720 | ||
Disposal of fully depreciated property and equipment | 1,436 | 841 | 86 |
Net change in unrealized gain (loss) on marketable securities | $ 11 | $ 32 | $ (76) |
Organization
Organization | 12 Months Ended |
Dec. 31, 2015 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | 1. Organization 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. Subsidiaries In April 2006, we completed the acquisition of Dynavax GmbH (formerly known as Rhein Biotech GmbH) Dynavax International, B.V. was dissolved in January 2015. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements include our accounts and those of our wholly-owned subsidiaries. All significant intercompany accounts and transactions among the entities have been eliminated from the 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 December 31, 2015, we had cash, cash equivalents and marketable securities of $196.1 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 U.S. generally accepted accounting principles (“U.S. GAAP”) requires management to make informed estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from these estimates. Foreign Currency Translation We consider the local currency to be the functional currency for our international subsidiary, Dynavax GmbH. Accordingly, assets and liabilities denominated in foreign currencies are translated into U.S. dollars using the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at average exchange rates prevailing throughout the year. Currency translation adjustments arising from period to period are charged or credited to accumulated other comprehensive income (loss) in stockholders’ equity. For the years ended December 31, 2015, 2014 and 2013, we reported an unrealized loss of $1.3 million, an unrealized loss of $1.6 million and an unrealized gain of $0.5 million, respectively. Realized gains and losses resulting from currency transactions are included in the consolidated statements of operations. For the years ended December 31, 2015, 2014 and 2013, we reported a gain of $0.1 million, a gain of $0.4 million and a loss of $0.2 million, respectively, resulting from currency transactions in our consolidated statements of operations. Cash, Cash Equivalents and Marketable Securities We consider all highly liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. Management determines the appropriate classification of marketable securities at the time of purchase. In accordance with our investment policy, we invest in short-term money market funds, U.S. government agency securities and corporate debt securities. We believe these types of investments are subject to minimal credit and market risk. 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 based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities; 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 securities, 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. Concentration of Credit Risk and Other Risks and Uncertainties We operate in one business segment, which is the discovery and development of biopharmaceutical products. We determine our segments based on the way we organize our business by making operating decisions and assessing performance. In fiscal years 2015, 2014 and 2013, 85%, 96% and 89% of our revenues were earned in the United States, respectively, and the remaining revenues were earned in Germany. As of December 31, 2015 and 2014, 11% and 11%, respectively, of our long-lived assets were located in the United States and the remaining long-lived assets were located in Germany. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents, marketable securities and accounts receivable. Our policy is to invest cash in institutional money market funds and marketable securities of U.S. government and corporate issuers with high credit quality to limit the amount of credit exposure. We currently maintain a portfolio of cash equivalents and marketable securities in a variety of securities, including short-term money market funds, U.S. government agency securities and corporate debt securities. We have not experienced any losses on our cash equivalents and marketable securities. Accounts receivable are recorded at invoice value. We review our exposure to accounts receivable, including the requirement for allowances based on management’s judgment. We have not historically experienced any significant losses. We do not currently require collateral for any of our accounts receivable. Our products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that our products will receive any of these required approvals. The denial or delay of such approvals would have a material adverse impact on our business. We are subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of our stock price and the need to obtain additional financing. Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. We evaluate the carrying value of long-lived assets, including intangible assets, whenever events or changes in business circumstances or our planned use of long-lived assets indicate, based on undiscounted future operating cash flows, that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. When an indicator of impairment exists, long-lived assets are written down to their respective fair values. Fair value is determined primarily using the anticipated cash flows discounted at a rate commensurate with the risk involved. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected undiscounted cash flows. No impairments of purchased intangible assets or material impairments of tangible assets have been identified during the years presented. Goodwill Our goodwill balance relates to our April 2006 acquisition of Dynavax GmbH. Goodwill represents the excess purchase price over the fair value of tangible and intangible assets acquired and liabilities assumed. Goodwill is not amortized but is subject to an annual impairment test which consists of a comparison of the fair value of the related reporting unit against its carrying amount including goodwill. If the carrying amount exceeds the fair value, impairment is calculated and recorded as a charge in the consolidated statements of operations. We determined that we have only one operating segment and there are no components of that operating segment that are deemed to be separate reporting units such that we have one reporting unit for purposes of our goodwill impairment testing. We evaluate goodwill for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. 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 December 31, 2015. Stock-Based Compensation Stock-based compensation expense for stock options and other stock awards is estimated at the grant date based on the award’s estimated fair value-based measurement and is recognized on a straight-line basis over the award’s requisite service period, assuming appropriate forfeiture rates. Our determination of the fair value-based measurement of stock options on the date of grant using an option-pricing model is affected by our stock price, as well as assumptions regarding a number of subjective variables. We selected the Black-Scholes option pricing model as the most appropriate method for determining the estimated fair value-based measurement of our stock options. The Black-Scholes model requires the use of highly subjective assumptions which determine the fair value-based measurement of stock options. These assumptions include, but are not limited to, our expected stock price volatility over the term of the awards, and actual and projected employee stock option exercise behaviors. In the future, as additional empirical evidence regarding these input estimates becomes available, we may change or refine our approach of deriving these input estimates. These changes could impact our fair value-based measurement of stock options granted in the future. Changes in the fair value-based measurement of stock awards could materially impact our operating results. Our current estimate of volatility is based on the historical volatility of our stock price. To the extent volatility in our stock price increases in the future, our estimates of the fair value of options granted in the future could increase, thereby increasing stock-based compensation cost recognized in future periods. We derive the expected term assumption primarily based on our historical settlement experience, while giving consideration to options that have not yet completed a full life cycle. Stock-based compensation cost is recognized only for awards ultimately expected to vest. Our estimate of the forfeiture rate is based primarily on our historical experience. To the extent we revise this estimate in the future, our share-based compensation cost could be materially impacted in the period of revision. Income Taxes We account for income taxes using the asset and liability method, under which deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Additionally, we assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. We have provided a full valuation allowance on our deferred tax assets at December 31, 2015 and 2014 because we believe it is more likely than not that our deferred tax assets will not be realized as of December 31, 2015, and 2014. The Company is required to file federal and state income tax returns in the United States and Germany. The preparation of these income tax returns requires the Company to interpret the applicable tax laws and regulations in effect on such jurisdictions, which could impact the amount of tax paid by us. An amount is accrued for the estimate of additional tax liabilities, including interest and penalties, for any uncertain tax positions taken or expected to be taken in an income tax return. We update the accrual for uncertain tax positions as more definitive information becomes available. 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). Accounting Standards Update 2014-15 In August 2014, the FASB issued guidance codified in ASC 205, Presentation of Financial Statements — Going Concern. Accounting Standards Update 2014-15 requires an entity’s management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern and if those conditions exist, to make the required disclosures. The standard is effective for annual periods ending after December 15, 2016, and interim periods therein. The Company does not expect that the adoption of this standard will have a significant impact on its financial statements. Accounting Standards Update 2015-03 In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the corresponding debt liability rather than as an asset. This ASU will be effective for the Company in fiscal year 2016. The Company does not expect that the adoption of this standard will have a significant impact on its financial statements. Accounting Standards Update 2015-05 In April 2015, the FASB issued Accounting Standards Update No. 2015-05 Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer's Accounting for Fees Paid in a Cloud Computing Arrangement. This standard provides guidance about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the software license element of the arrangement should be accounted for consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 is effective for fiscal years beginning after December 15, 2015, and interim periods within those years. This standard can be adopted either prospectively to all arrangements entered into or materially modified after the effective date or retrospectively. The Company is currently evaluating the effect this standard will have on its financial statements. 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 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. 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 (in thousands): 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 Level 1 Level 2 Level 3 Total December 31, 2014 Money market funds $ 46,989 $ - $ - $ 46,989 U.S. government agency securities - 73,141 - 73,141 Total $ 46,989 $ 73,141 $ - $ 120,130 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. 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. 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 twelve months ended December 31, 2015. |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 12 Months Ended |
Dec. 31, 2015 | |
Cash Cash Equivalents And Short Term Investments [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 4. Cash, Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value 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 December 31, 2014 Cash and cash equivalents: Cash $ 2,522 $ - $ - $ 2,522 Money market funds 46,989 - - 46,989 Total cash and cash equivalents 49,511 - - 49,511 Marketable securities available-for-sale: U.S. government agency securities 73,140 11 (10 ) 73,141 Total marketable securities available-for-sale 73,140 11 (10 ) 73,141 Total cash, cash equivalents and marketable securities $ 122,651 $ 11 $ (10 ) $ 122,652 The maturities of our marketable securities available-for-sale are as follows (in thousands): December 31, 2015 Amortized Cost Estimated Fair Value Mature in one year or less $ 151,307 $ 151,313 Mature after one year through two years - - $ 151,307 $ 151,313 There were no realized gains or losses from the sale of marketable securities in the years ended December 31, 2015, 2014 and 2013. All of our investments are classified as short-term and available-for-sale, as we may not hold our investments until maturity. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment as of consist of the following (in thousands): Estimated Useful December 31, Life (In years) 2015 2014 Manufacturing equipment 5-14 $ 6,880 $ 8,171 Lab equipment 5-13 6,096 6,473 Computer equipment 3 2,577 2,196 Furniture and fixtures 3-13 1,362 1,070 Leasehold improvements 5-8 (1) 5,768 5,690 Assets in progress 6,645 935 29,328 24,535 Less accumulated depreciation and amortization (15,524 ) (16,611 ) Total $ 13,804 $ 7,924 (1) Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. Depreciation and amortization expense on property and equipment was $1.4 million, $1.4 million and $1.3 million for the years ended December 31, 2015, 2014 and 2013, respectively. |
Current Accrued Liabilities
Current Accrued Liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure Component Of Current Accrued Liabilities [Abstract] | |
Current Accrued Liabilities | 6 . Current Accrued Liabilities Current accrued liabilities consist of the following (in thousands): December 31, 2015 2014 Payroll and related expenses $ 5,866 $ 4,613 Legal expenses 202 224 Third party research expenses 5,241 5,898 Third party development expenses 2,072 1,000 Return of funding due to AstraZeneca AB (“AstraZeneca”) (Note 9) 7,345 - Other accrued liabilities 1,972 1,520 Total $ 22,698 $ 13,255 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7 . 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. The sublease income is offset against our rent expense. During September 2013, we decided not to occupy a portion of our facility in Berkeley, California. As a result, we recorded an estimated unoccupied facility expense of $0.9 Total net rent expense related to our operating leases for the years ended December 31, 2015, 2014 and 2013, was $2.0 million, $1.7 million and $1.9 million, respectively. Deferred rent was $0.5 million and $0.6 million as of December 31, 2015 and 2014, respectively. Deferred loss on lease was $0.5 million and $0.7 million as of December 31, 2015 and 2014, respectively. Future minimum payments under the non-cancelable portion of our operating leases at December 31, 2015, excluding payments from sublease payments, are as follows (in thousands): Year ending December 31, 2016 $ 2,306 2017 2,355 2018 1,295 2019 466 2020 466 Thereafter 1,048 Total $ 7,936 During 2004, we established a letter of credit with Silicon Valley Bank as security for our Berkeley Lease in the amount of $0.4 million. The letter of credit remained outstanding as of December 31, 2015, and is collateralized by a certificate of deposit for $0.4 million, which has been included in restricted cash in the consolidated balance sheets as of December 31, 2015 and 2014. Under the terms of the Berkeley Lease, if the total amount of our cash, cash equivalents and marketable securities falls below $20 million for a period of more than 30 consecutive days during the lease term, the amount of the required security deposit will increase to $1.1 million, until such time as our projected cash and cash equivalents will exceed $20 million for the remainder of the lease term, or until our actual cash and cash equivalents remains above $20 million for a period of 12 consecutive months. During 2004, we also established a letter of credit with Deutsche Bank as security for our Düsseldorf Lease in the amount of 0.2 million Euros. The letter of credit remained outstanding through December 31, 2015 and is collateralized by a certificate of deposit for 0.2 million Euros, which has been included in restricted cash in the consolidated balance sheets as of December 31, 2015 and 2014. 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 December 31, 2015, under the terms of our agreements, including certain agreements relating to HBV-23, we are obligated to make future payments of approximately $11.2 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. |
Symphony Dynamo, Inc.
Symphony Dynamo, Inc. | 12 Months Ended |
Dec. 31, 2015 | |
Business Combinations [Abstract] | |
Symphony Dynamo, Inc. | 8. Symphony Dynamo, Inc. In conjunction with a financing arrangement with Symphony Capital Partners, L.P. and Symphony Strategic Partners, LLC (collectively, “Symphony”) and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009 |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 12 Months Ended |
Dec. 31, 2015 | |
Research And Development [Abstract] | |
Collaborative Research, Development and License Agreements | 9 . Collaborative Research, Development and License Agreements AstraZeneca In September 2006, we entered into a research collaboration and license agreement with 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 due 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 now conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma that originally was to be conducted by Dynavax. We therefore revised the 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, will be recognized starting in January 2016 over the estimated remaining period of performance of development work through September 2016. The $8.0 million payment received in December 2014 was also deferred and is being recognized as research and development expenses are incurred. Payments previously made by AstraZeneca in respect of development activity by us, net of amounts we recognize as development work is performed, will be returned to AstraZeneca or applied to future milestone payments that may be earned by us under the agreement. We have reclassified $7.4 million from deferred revenue as a current liability related to this payment as of December 31, 2015. See Note 17. 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 consolidated statements of operations (in thousands): Year ended December 31, 2015 2014 2013 Initial payment $ 238 $ 681 $ 720 Subsequent payment 892 2,554 - Performance of research activities 1,635 2,174 2,507 Total $ 2,765 $ 5,409 $ 3,227 As of December 31, 2015 and 2014, total deferred revenue from the initial payment, subsequent payment and development funding payments was $2.7 million and $12.8 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. GlaxoSmithKline (“GSK”) In December 2008, we entered into a worldwide strategic alliance with GSK to discover, develop and commercialize TLR inhibitors. Under the terms of the arrangement, as amended, we agreed to conduct research and early clinical development of product candidates and GSK received an option to license those candidates. Under the collaboration, we conducted a Phase 1 clinical trial in the lead TLR 7/9 program with DV1179 to assess its safety and tolerability in healthy volunteers followed by a Phase 1b/2a study of safety and pharmacodynamics in patients with systematic lupus erythematosus (“SLE”). Under the terms of the arrangement, as amended, we received an initial payment of $10 million in 2008. Revenue from the initial payment from GSK was deferred and is being recognized over the estimated period of performance under the agreement, initially estimated to be seven years. In 2013, we reevaluated and revised the estimated period of performance under the agreement resulting in the recognition of $1.1 In August 2014, we announced results of the Phase 1b/2a clinical trial in which DV1179 did not meet the primary or secondary pharmacodynamic endpoints. The agreement with GSK expired in November 2014. We regained global rights to continue the development of DV1179 and other TLR 7/9 inhibitors for all indications. The following table summarizes the revenues recognized under our agreement with GSK, included as collaboration revenue in our consolidated statements of operations (in thousands): Year ended December 31, 2015 2014 2013 Initial payment $ - $ 2,524 $ 1,702 Total $ - $ 2,524 $ 1,702 As of December 31, 2015 and 2014 no deferred revenue relating to the initial payment remains. 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 years ended December 31, 2015, 2014 and 2013 from the following awards : · August 2014, NIH awarded us $0.2 million to fund research in developing a transgenic mouse model to study human TLR9 role in disease. · September 2013, NIH awarded us $0.2 million to fund research in developing TLR antagonists for therapy of hepatic fibrosis and cirrhosis. · June 2012, NIH awarded us $0.6 million to fund research in screening for inhibitors of TLR8 for treatment of autoimmune diseases. · May 2012, NIH awarded us $0.4 million to fund development of TLR8 inhibitors for treatment of rheumatoid arthritis. · August 2010, 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 will be 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. · September 2008, NIAID awarded us a five-year $17 million contract to develop our ISS technology using TLR9 agonists as vaccine adjuvants. The contract supports adjuvant development for anthrax as well as other disease models. The following table summarizes the revenues recognized under the various arrangements with the NIH and NIAID, included as grant revenue in our consolidated statements of operations (in thousands): Year ended December 31, 2015 2014 2013 NIAID contracts $ - $ 2,095 $ 4,103 All other NIH contracts 683 593 1,035 Total grant revenue $ 683 $ 2,688 $ 5,138 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 10. Long-Term Debt In December 2014, we entered into a Loan and Security Agreement (“Loan Agreement”) with Hercules Technology Growth Capital, Inc. (“Hercules”) under which we could borrow up to $40.0 million in two tranches and for which we paid a $400,000 facility charge to Hercules. We drew down the first tranche of $10.0 million upon closing of the transaction on December 23, 2014. The second tranche, of $30.0 million, was available to In September 2015, we repaid all outstanding amounts under the Loan Agreement, at which time our obligations under the Loan Agreement terminated and Hercules released its security interests in all collateral under the Loan Agreement. We paid to Hercules $11.0 million, which consisted of $10.0 million outstanding principal, accrued but unpaid interest of $38 thousand, end of term fee of $0.8 million and prepayment charges of $0.2 million. We recognized the repayment to be a substantial modification to the debt instrument and applied debt extinguishment accounting to record a one-time loss on extinguishment of debt in the amount of $1.7 million. The interest rate in the Loan Agreement was calculated at a rate equal to the greater of either: (i) 9.75% plus the prime rate as reported from time to time in The Wall Street Journal minus 5.25%, and (ii) 9.75%. Monthly |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. Net Loss Per Share Basic net loss per share allocable to common stockholders is calculated by dividing the net loss allocable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share allocable to common stockholders is computed by dividing the net loss allocable to common stockholders 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 stock options, stock awards, warrants and Series B Convertible Preferred Stock are considered to be potentially dilutive common shares and are only included in the calculation of diluted net loss per share allocable to common stockholders when their effect is dilutive. December 31, 2015 2014 2013 Basic and diluted net loss per share (in thousands, except per share amounts): Numerator: Net loss (106,794 ) (90,722 ) (66,720 ) Preferred stock deemed dividend - - (8,469 ) Net loss allocable to common stockholders $ (106,794 ) $ (90,722 ) $ (75,189 ) Denominator for basic and diluted net loss per share allocable to common stockholders: Weighted-average common shares outstanding 32,881 26,289 19,628 Basic and diluted net loss per share allocable to common stockholders $ (3.25 ) $ (3.45 ) $ (3.83 ) Outstanding warrants, stock options, Series B Convertible Preferred Stock and stock subject to repurchase by us under stock awards were excluded from the calculation of net loss per share allocable to common stockholders as the effect of their inclusion would have been anti-dilutive. December 31, 2015 2014 2013 Outstanding securities not included in diluted net loss per share calculation (in thousands): Stock options and stock awards 3,086 1,998 1,704 Series B Convertible Preferred Stock (as converted to common stock) - 4,343 4,343 Warrants - 1,081 1,246 3,086 7,422 7,293 |
Preferred Stock, Common Stock a
Preferred Stock, Common Stock and Warrants | 12 Months Ended |
Dec. 31, 2015 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Preferred Stock, Common Stock and Warrants | 12. Preferred Stock, Common Stock and Warrants Preferred Stock Outstanding As of December 31, 2015 there were 5,000,000 shares of preferred stock authorized and no shares of Series B Convertible Preferred Stock outstanding. On February 26, 2015, 26,000 shares of our Series B Convertible Preferred Stock were converted into 2,600,000 shares of common stock. On July 23, 2015, 17,430 shares of our Series B Convertible Preferred Stock were converted into 1,743,000 shares of common stock and no Series B Convertible Preferred Stock remained outstanding. Each share of Series B Convertible Preferred Stock was convertible into However, the holder was prohibited from converting the Series B Convertible Preferred Stock into shares of common stock if, as a result of such conversion, the holder and its affiliates would own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution, or winding up, holders of Series B Convertible Preferred Stock will receive a payment equal to $0.001 per share before any proceeds are distributed to the common stockholders. Shares of Series B Convertible Preferred Stock generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series B Convertible Preferred Stock is required to amend the terms of the Series B Convertible Preferred Stock. Holders of Series B Convertible Preferred Stock are not entitled to receive any dividends, unless and until specifically declared by the Company’s board of directors. The Series B Convertible Preferred Stock ranks senior to the Company’s common stock as to distributions of assets upon the Company’s liquidation, dissolution or winding up, whether voluntarily or involuntarily. The Series B Convertible Preferred Stock may rank senior to, on parity with or junior to any class or series of the Company’s capital stock created in the future depending upon the specific terms of such future stock issuance. Preferred Share Purchase Rights On November 4, 2008, our Board of Directors declared a dividend of one preferred share purchase right (a “Right”) for each outstanding share of our Common Stock, par value $0.001 per share (the “Common Shares”). The dividend was payable on November 17, 2008 to the stockholders of record on that date. Each Right entitles the registered holder to purchase from us one one-hundredth of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share (the “Preferred Shares”), at a price of $6.00 per one one-hundredth of a Preferred Share, subject to adjustment. Upon the acquisition of, or announcement of the intent to acquire, 20 percent or more of our outstanding Common Shares by a person, entity or group of affiliated or associated persons (“Acquiring Person”), each holder of a Right, other than Rights held by the Acquiring Person, will have the right to purchase that number of Common Shares having a market value of two times the exercise price of the Right. If we are acquired in a merger or other business combination transaction or 50 percent or more of our assets or earning power are sold to an Acquiring Person, each holder of a Right will thereafter have the right to purchase, at the then current exercise price of the Right, that number of shares of common stock of the acquiring company which at the time of such transaction will have a market value of two times the exercise price of the Right. The Rights plan is intended to maximize the value of the Company in the event of an unsolicited attempt to take over the Company in a manner or on terms not approved by the Company’s Board of Directors. The Rights will expire on November 17, 2018, unless the Rights are earlier redeemed or exchanged by the Company. Common Stock Outstanding As of December 31, 2015, there were 38,445,995 shares of our common stock outstanding. In June and July 2015, we sold an aggregate of 2,125,439 shares of common stock under an At Market Issuance Sales Agreement (the “2014 ATM Agreement”) with Cowen and Company, LLC (“Cowen”) resulting in net proceeds to us of approximately $49.0 million. The 2014 ATM Agreement terminated in July 2015. In July 2015, we completed an underwritten public offering of 5,227,273 shares of our common stock, including 681,818 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered at a price to the public of $27.50 per share. The net proceeds to us from this offering were approximately $134.9 million, after deducting the underwriting discount and other estimated offering expenses payable by us. 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 December 31, 2015, we have sold no shares of common stock under the 2015 ATM Agreement. Warrants As of December 31, 2015, no warrants were outstanding. During the years ended December 31, 2015, and 2014, warrants were exercised to purchase an aggregate of approximately 383,000 and 11,000 shares, respectively, of our common stock. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Share Based Compensation [Abstract] | |
Equity Plans and Stock-Based Compensation | 13. Equity Plans and Stock-Based Compensation Stock Plans Under the 2004 Stock Incentive Plan (“2004 Plan”) options to purchase 292,901 shares of common stock remained outstanding as of December 31, 2015. Under the 2010 Employment Inducement Award Plan (“Inducement Plan”) options to purchase 12,450 shares of common stock remained outstanding as of December 31, 2015. The 2011 Equity Incentive Plan (“2011 Plan”) was approved by the Company’s stockholders and adopted in January 2011. On May 27, 2015, the stockholders of the Company approved an amendment and restatement of the 2011 Plan to increase the number of shares of common stock authorized for issuance under the plan by 2,250,000. The 2011 Plan, as amended, provides for the issuance of up to 11,000,000 shares of our common stock to employees and non-employees of the Company and became effective on January 6, 2011. The 2011 Plan is administered by our Board of Directors, or a designated committee of the Board of Directors, and awards granted under the 2011 Plan have a term of 10 years unless earlier terminated by the Board of Directors. After the adoption of the 2011 Plan, no additional awards were granted under either the 2004 Plan or the Inducement Plan. As of January 6, 2011, all shares subject to awards outstanding under the 2004 Plan and Inducement Plan that expire or are forfeited will be included in the reserve for the 2011 Plan to the extent such shares would otherwise return to such plans. As of December 31, 2015, options to purchase 2,585,223 shares of common stock remained outstanding under the 2011 Plan. As of December 31, 2015, there were 2,097,384 shares of common stock reserved for issuance under the 2011 Plan. Activity under our stock plans is set forth below: 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, 2014 1,820 $ 27.48 Options granted 1,339 18.51 Options exercised (38 ) 15.67 Options cancelled: Options forfeited (unvested) (133 ) 17.07 Options cancelled (vested) (97 ) 45.01 Balance at December 31, 2015 2,891 23.34 6.95 $ 13,234 Vested and expected to vest at December 31, 2015 2,788 23.57 6.88 $ 12,514 Exercisable at December 31, 2015 1,271 29.06 4.43 $ 3,734 The total intrinsic value of stock options exercised during the years ended December 31, 2015, 2014 and 2013 was $0.4 million, $0.1 million and $0.3 million, respectively. The total intrinsic value of exercised stock options is calculated based on the difference between the exercise price and the quoted market price of our common stock as of the close of the exercise date. The total fair value of stock options vested during the years ended December 31, 2015, 2014 and 2013 was $6.9 million, $5.6 million and $12.1 million, respectively. Our non-vested stock awards are comprised of restricted stock units granted with performance and time-based vesting criteria. A summary of the status of non-vested restricted stock units as of December 31, 2015, and activities during 2015 are summarized as follows: Number of Shares (In thousands) Weighted-Average Grant-Date Fair Value Non-vested as of December 31, 2014 179 $ 17.13 Granted 37 $ 20.05 Vested (4 ) $ 20.64 Forfeited or expired (17 ) $ 18.23 Non-vested as of December 31, 2015 195 $ 17.52 Stock-based compensation expense related to restricted stock units was approximately $0.8 million for the year ended December 31, 2015. The aggregate intrinsic value of the restricted stock units outstanding as of December 31, 2015, based on our stock price on that date, was $4.7 million. The weighted average grant-date fair value of restricted stock units granted during the years ended December 31, 2015, 2014 and 2013 was, $20.05, $17.92 and $12.30, respectively. The total fair value of restricted stock units vested during the years ended December 31, 2015 and 2013 was $0.1 million and $0.1 million, respectively. No restricted stock units vested during 2014. Stock-Based Compensation Under our stock-based compensation plans, option awards generally vest over a four-year period contingent upon continuous service and unless exercised, expire ten years from the date of grant (or earlier upon termination of continuous service). The Company has also granted performance-based equity awards to certain of our employees under the 2011 Plan, the 2004 Plan and the Inducement Plan. As of December 31, 2015, approximately 80,000 shares were outstanding related to options and restricted stock units subject to these performance-based vesting criteria. The fair value of each option is estimated on the date of grant using the Black-Scholes option valuation model and the following weighted-average assumptions: Stock Options Employee Stock Purchase Plan Year Ended December 31, Year Ended December 31, 2015 2014 2013 2015 2014 2013 Weighted-average fair value $ 13.37 $ 15.16 $ 24.15 $ 9.18 $ 7.45 $ 9.30 Risk-free interest rate 1.7 % 1.8 % 1.1 % 0.4 % 0.2 % 0.2 % Expected life (in years) 5.9 5.9 5.9 1.2 1.2 1.3 Volatility 0.7 1.4 1.4 0.6 0.9 0.8 Expected volatility is based on historical volatility of our stock price. The expected life of options granted is estimated based on historical option exercise and employee termination data, while giving consideration to options that have not yet completed a full life cycle. Our senior management, who hold a majority of the options outstanding, and other employees were grouped and considered separately for valuation purposes. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The dividend yield is zero percent for all years and is based on our history and expectation of dividend payouts. Compensation expense is based on awards ultimately expected to vest and reflects estimated forfeitures. For equity awards with time-based vesting, the fair value is amortized to expense on a straight-line basis over the vesting periods. For equity awards with performance-based vesting criteria, the fair value is amortized to expense when the achievement of the vesting criteria becomes probable. We recognized the following amounts of stock-based compensation expense (in thousands): Year Ended December 31, 2015 2014 2013 Employees and directors stock-based compensation expense $ 9,316 $ 6,062 $ 11,828 Non-employees stock-based compensation expense - 27 512 Total $ 9,316 $ 6,089 $ 12,340 Year Ended December 31, 2015 2014 2013 Research and development $ 4,123 $ 2,868 $ 4,228 General and administrative 5,193 3,221 8,112 Total $ 9,316 $ 6,089 $ 12,340 During the year ended December 31, 2013, we recognized $1.3 million in additional stock-based compensation expense due to the modification of the terms of stock options for five employees. Stock based compensation expense recognized for the year ended December 31, 2013 included $4.9 million related to employee severance arrangements and $0.5 million for awards to non-employees. As of December 31, 2015, the total unrecognized compensation cost related to non-vested stock options and awards deemed probable of vesting, including all stock options with time-based vesting, net of estimated forfeitures, amounted to $19.4 million, which is expected to be recognized over the remaining weighted-average vesting period of 2.6 years. As of December 31, 2015, the total unrecognized compensation cost related to non-vested stock options not deemed probable of vesting, net of estimated forfeitures, amounted to $3.2 million. Employee Stock Purchase Plan In January 2004, the Board of Directors and stockholders adopted the 2004 Employee Stock Purchase Plan. As of December 31, 2015, 99,600 shares were approved for issuance under the 2004 Employee Stock Purchase Plan, subject to adjustment for a stock split, or any future stock dividend or other similar change in our common stock or capital structure. As of December 31, 2015, employees have acquired 94,709 shares of our common stock under the 2004 Employee Stock Purchase Plan. As of December 31, 2015, no shares of our common stock remained available for future purchases under the 2004 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 shares of its common stock, subject to adjustment, to its employees. The Purchase Plan provides for the purchase of common stock by eligible employees and became effective on May 28, 2014. The purchase price per share is the lesser of (i) 85% of the fair market value of the common stock on the commencement of the offer period (generally, the sixteenth day in February or August) or (ii) 85% of the fair market value of the common stock on the exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August). As of December 31, 2015, employees have acquired 21,979 shares of our common stock under the Purchase Plan and 28,021 shares of our common stock remained available for future purchases under the Purchase Plan. As of December 31, 2015, the total unrecognized compensation cost related to shares of our common stock under the Purchase Plan amounted to $0.2 million, which is expected to be recognized over the remaining weighted-average vesting period of 0.6 years. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2015 | |
Pension And Other Postretirement Benefit Expense [Abstract] | |
Employee Benefit Plan | 14. Employee Benefit Plan We maintain a 401(k) Plan, which qualifies as a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k) Plan, participating employees may defer a portion of their pretax earnings. We may, at our discretion, contribute for the benefit of eligible employees. The Company’s contribution to the 401(k) Plan approximated $0.2 million for the year ended December 31, 2015. No contributions were made during the years ended December 31, 2014 and 2013, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes Consolidated income (loss) before provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2015 2014 2013 U.S. $ (107,450 ) $ (91,121 ) $ (67,004 ) Non U.S. 656 399 284 Total $ (106,794 ) $ (90,722 ) $ (66,720 ) No income tax expense was recorded for the years ended December 31, 2015, 2014 and 2013 due to net operating loss carryforwards to offset the net income at Dynavax GmbH and a valuation allowance which offsets the deferred tax assets. The difference between the consolidated income tax benefit and the amount computed by applying the federal statutory income tax rate to the consolidated loss before income taxes was as follows (in thousands): Year Ended December 31, 2015 2014 2013 Income tax benefit at federal statutory rate $ (36,301 ) $ (30,818 ) $ (22,678 ) State tax (394 ) 1,204 (178 ) Business credits (2,622 ) (1,484 ) (2,515 ) Deferred compensation charges 1,481 2,710 3,072 Change in valuation allowance 36,766 28,093 22,354 Other 1,070 295 (55 ) Total income tax expense $ - $ - $ - Deferred tax assets and liabilities consisted of the following (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carry forwards $ 212,074 $ 178,008 Research tax credit carry forwards 26,285 22,914 Accruals and reserves 9,771 9,053 Capitalized research costs 6,553 8,601 Deferred revenue 908 654 Other 1,375 1,531 Total deferred tax assets 256,966 220,761 Less valuation allowance (256,712 ) (220,544 ) Net deferred tax assets 254 217 Deferred tax liabilities: Fixed Assets (254 ) (217 ) Total deferred tax liabilities (254 ) (217 ) Net deferred tax assets $ - $ - The tax benefit of net operating losses, temporary differences and credit carryforwards is required to be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carryforward period. Because of our recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a full valuation allowance. The valuation allowance increased by $36.2 million, $27.8 million and $22.5 million during the years ended December 31, 2015, 2014 and 2013, respectively. The amount of the valuation allowance for deferred tax assets associated with excess tax deductions from stock based compensation arrangements that will be allocated to contributed capital if the future tax benefits are subsequently recognized is $0.3 million. We intend to postpone remittance of all or part of net investment in Dynavax GmbH (including earnings) indefinitely (i.e., essentially permanently reinvest). As of December 31, 2015, we have cumulative total undistributed losses for non-U.S. subsidiaries. We have not recorded deferred income taxes applicable to undistributed earnings of a foreign subsidiary that are indefinitely reinvested in foreign operations. Generally, such earnings become subject to U.S. tax upon the remittance of dividends and under certain other circumstances. It is not practicable to estimate the amount of the deferred tax liability on such undistributed earnings. As of December 31, 2015, we had federal net operating loss carryforwards of approximately $582.8 million, which will expire in the years 2018 through 2035 and federal research and development tax credits of approximately $19.1 million, which expire in the years 2018 through 2035. As of December 31, 2015, we had net operating loss carryforwards for California state income tax purposes of approximately $192.9 million, which expire in the years 2015 through 2035, and California state research and development tax credits of approximately $14.0 million, which do not expire. As of December 31, 2015, we had net operating loss carryforwards for foreign income tax purposes of approximately $18.8 million, which do not expire. Uncertain Income Tax positions The total amount of unrecognized tax benefits as of December 31, 2015 and 2014 is $2.4 million. If recognized, none of the unrecognized tax benefits would affect the effective tax rate. We had no unrecognized tax benefits as of December 31, 2013. The following table summarizes the activity related to the Company’s unrecognized tax benefits: Balance at December 31, 2014 $ (2,426 ) Tax positions related to the current year Additions - Reductions - Tax positions related to the prior year Additions - Reductions - Balance at December 31, 2015 $ (2,426 ) Our policy is to account for interest and penalties, if any, as a component of general and administrative expense. As of December 31, 2015, the Company had no interest related to unrecognized tax benefits. No amounts of penalties related to unrecognized tax benefits were recognized in the provision for income taxes. The Tax Reform Act of 1986 limits the annual use of net operating loss and tax credit carryforwards in certain situations where changes occur in stock ownership of a company. In the event the Company has a change in ownership, as defined, the annual utilization of such carryforwards could be limited. Due to past equity issuances and changes in ownership of Dynavax common stock, we believe that our ability to use some of our net operating losses and tax credits in the future may be limited. We are subject to income tax examinations for U.S. federal and state income taxes from 1996 forward. We are subject to tax examination in Germany from 2010 forward. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | 16. Selected Quarterly Financial Data (Unaudited; in thousands, except per share amounts) Year Ended December 31, 2015 Q1 Q2 Q3 Q4 Revenues $ 627 $ 1,550 $ 1,188 $ 685 Net loss $ (26,217 ) $ (23,591 ) $ (30,124 ) $ (26,862 ) Net loss allocable to common stockholders $ (26,217 ) $ (23,591 ) $ (30,124 ) $ (26,862 ) Basic and diluted net loss per share allocable to common stockholders $ (0.97 ) $ (0.80 ) $ (0.82 ) $ (0.70 ) Shares used to compute basic and diluted net loss per share allocable to common stockholders 27,065 29,335 36,532 38,429 Year Ended December 31, 2014 Q1 Q2 Q3 Q4 Revenues $ 3,498 $ 3,048 $ 2,209 $ 2,277 Net loss $ (13,840 ) $ (24,777 ) $ (29,819 ) $ (22,286 ) Net loss allocable to common stockholders $ (13,840 ) $ (24,777 ) $ (29,819 ) $ (22,286 ) Basic and diluted net loss per share allocable to common stockholders $ (0.53 ) $ (0.94 ) $ (1.13 ) $ (0.85 ) Shares used to compute basic and diluted net loss per share allocable to common stockholders 26,283 26,286 26,291 26,298 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 17. Subsequent Events In January 2016, we entered into Amendment No. 7 to the Research Collaboration and License Agreement dated September 1, 2006 with AstraZeneca. See Note 9. |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include our accounts and those of our wholly-owned subsidiaries. All significant intercompany accounts and transactions among the entities have been eliminated from the 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 December 31, 2015, we had cash, cash equivalents and marketable securities of $196.1 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 U.S. generally accepted accounting principles (“U.S. GAAP”) requires management to make informed estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from these estimates. |
Foreign Currency Translation | Foreign Currency Translation We consider the local currency to be the functional currency for our international subsidiary, Dynavax GmbH. Accordingly, assets and liabilities denominated in foreign currencies are translated into U.S. dollars using the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at average exchange rates prevailing throughout the year. Currency translation adjustments arising from period to period are charged or credited to accumulated other comprehensive income (loss) in stockholders’ equity. For the years ended December 31, 2015, 2014 and 2013, we reported an unrealized loss of $1.3 million, an unrealized loss of $1.6 million and an unrealized gain of $0.5 million, respectively. Realized gains and losses resulting from currency transactions are included in the consolidated statements of operations. For the years ended December 31, 2015, 2014 and 2013, we reported a gain of $0.1 million, a gain of $0.4 million and a loss of $0.2 million, respectively, resulting from currency transactions in our consolidated statements of operations. |
Cash, Cash Equivalents, and Marketable Securities | Cash, Cash Equivalents and Marketable Securities We consider all highly liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. Management determines the appropriate classification of marketable securities at the time of purchase. In accordance with our investment policy, we invest in short-term money market funds, U.S. government agency securities and corporate debt securities. We believe these types of investments are subject to minimal credit and market risk. 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 based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities; 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 securities, 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. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties We operate in one business segment, which is the discovery and development of biopharmaceutical products. We determine our segments based on the way we organize our business by making operating decisions and assessing performance. In fiscal years 2015, 2014 and 2013, 85%, 96% and 89% of our revenues were earned in the United States, respectively, and the remaining revenues were earned in Germany. As of December 31, 2015 and 2014, 11% and 11%, respectively, of our long-lived assets were located in the United States and the remaining long-lived assets were located in Germany. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents, marketable securities and accounts receivable. Our policy is to invest cash in institutional money market funds and marketable securities of U.S. government and corporate issuers with high credit quality to limit the amount of credit exposure. We currently maintain a portfolio of cash equivalents and marketable securities in a variety of securities, including short-term money market funds, U.S. government agency securities and corporate debt securities. We have not experienced any losses on our cash equivalents and marketable securities. Accounts receivable are recorded at invoice value. We review our exposure to accounts receivable, including the requirement for allowances based on management’s judgment. We have not historically experienced any significant losses. We do not currently require collateral for any of our accounts receivable. Our products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that our products will receive any of these required approvals. The denial or delay of such approvals would have a material adverse impact on our business. We are subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of our stock price and the need to obtain additional financing. |
Long-Lived Assets | Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. We evaluate the carrying value of long-lived assets, including intangible assets, whenever events or changes in business circumstances or our planned use of long-lived assets indicate, based on undiscounted future operating cash flows, that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. When an indicator of impairment exists, long-lived assets are written down to their respective fair values. Fair value is determined primarily using the anticipated cash flows discounted at a rate commensurate with the risk involved. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected undiscounted cash flows. No impairments of purchased intangible assets or material impairments of tangible assets have been identified during the years presented. |
Goodwill | Goodwill Our goodwill balance relates to our April 2006 acquisition of Dynavax GmbH. Goodwill represents the excess purchase price over the fair value of tangible and intangible assets acquired and liabilities assumed. Goodwill is not amortized but is subject to an annual impairment test which consists of a comparison of the fair value of the related reporting unit against its carrying amount including goodwill. If the carrying amount exceeds the fair value, impairment is calculated and recorded as a charge in the consolidated statements of operations. We determined that we have only one operating segment and there are no components of that operating segment that are deemed to be separate reporting units such that we have one reporting unit for purposes of our goodwill impairment testing. We evaluate goodwill for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. |
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 December 31, 2015. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for stock options and other stock awards is estimated at the grant date based on the award’s estimated fair value-based measurement and is recognized on a straight-line basis over the award’s requisite service period, assuming appropriate forfeiture rates. Our determination of the fair value-based measurement of stock options on the date of grant using an option-pricing model is affected by our stock price, as well as assumptions regarding a number of subjective variables. We selected the Black-Scholes option pricing model as the most appropriate method for determining the estimated fair value-based measurement of our stock options. The Black-Scholes model requires the use of highly subjective assumptions which determine the fair value-based measurement of stock options. These assumptions include, but are not limited to, our expected stock price volatility over the term of the awards, and actual and projected employee stock option exercise behaviors. In the future, as additional empirical evidence regarding these input estimates becomes available, we may change or refine our approach of deriving these input estimates. These changes could impact our fair value-based measurement of stock options granted in the future. Changes in the fair value-based measurement of stock awards could materially impact our operating results. Our current estimate of volatility is based on the historical volatility of our stock price. To the extent volatility in our stock price increases in the future, our estimates of the fair value of options granted in the future could increase, thereby increasing stock-based compensation cost recognized in future periods. We derive the expected term assumption primarily based on our historical settlement experience, while giving consideration to options that have not yet completed a full life cycle. Stock-based compensation cost is recognized only for awards ultimately expected to vest. Our estimate of the forfeiture rate is based primarily on our historical experience. To the extent we revise this estimate in the future, our share-based compensation cost could be materially impacted in the period of revision. |
Income Taxes | Income Taxes We account for income taxes using the asset and liability method, under which deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Additionally, we assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. We have provided a full valuation allowance on our deferred tax assets at December 31, 2015 and 2014 because we believe it is more likely than not that our deferred tax assets will not be realized as of December 31, 2015, and 2014. The Company is required to file federal and state income tax returns in the United States and Germany. The preparation of these income tax returns requires the Company to interpret the applicable tax laws and regulations in effect on such jurisdictions, which could impact the amount of tax paid by us. An amount is accrued for the estimate of additional tax liabilities, including interest and penalties, for any uncertain tax positions taken or expected to be taken in an income tax return. We update the accrual for uncertain tax positions as more definitive information becomes available. |
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). Accounting Standards Update 2014-15 In August 2014, the FASB issued guidance codified in ASC 205, Presentation of Financial Statements — Going Concern. Accounting Standards Update 2014-15 requires an entity’s management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern and if those conditions exist, to make the required disclosures. The standard is effective for annual periods ending after December 15, 2016, and interim periods therein. The Company does not expect that the adoption of this standard will have a significant impact on its financial statements. Accounting Standards Update 2015-03 In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the corresponding debt liability rather than as an asset. This ASU will be effective for the Company in fiscal year 2016. The Company does not expect that the adoption of this standard will have a significant impact on its financial statements. Accounting Standards Update 2015-05 In April 2015, the FASB issued Accounting Standards Update No. 2015-05 Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer's Accounting for Fees Paid in a Cloud Computing Arrangement. This standard provides guidance about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the software license element of the arrangement should be accounted for consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. ASU 2015-05 is effective for fiscal years beginning after December 15, 2015, and interim periods within those years. This standard can be adopted either prospectively to all arrangements entered into or materially modified after the effective date or retrospectively. The Company is currently evaluating the effect this standard will have on its financial statements. 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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 (in thousands): 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 Level 1 Level 2 Level 3 Total December 31, 2014 Money market funds $ 46,989 $ - $ - $ 46,989 U.S. government agency securities - 73,141 - 73,141 Total $ 46,989 $ 73,141 $ - $ 120,130 |
Cash, Cash Equivalents and Ma27
Cash, Cash Equivalents and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Cash Cash Equivalents And Short Term Investments [Abstract] | |
Summary of Cash, Cash Equivalents and Marketable Securities Available-for-Sale | Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value 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 December 31, 2014 Cash and cash equivalents: Cash $ 2,522 $ - $ - $ 2,522 Money market funds 46,989 - - 46,989 Total cash and cash equivalents 49,511 - - 49,511 Marketable securities available-for-sale: U.S. government agency securities 73,140 11 (10 ) 73,141 Total marketable securities available-for-sale 73,140 11 (10 ) 73,141 Total cash, cash equivalents and marketable securities $ 122,651 $ 11 $ (10 ) $ 122,652 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): December 31, 2015 Amortized Cost Estimated Fair Value Mature in one year or less $ 151,307 $ 151,313 Mature after one year through two years - - $ 151,307 $ 151,313 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property Plant And Equipment [Abstract] | |
Component of Property and Equipment | Property and equipment as of consist of the following (in thousands): Estimated Useful December 31, Life (In years) 2015 2014 Manufacturing equipment 5-14 $ 6,880 $ 8,171 Lab equipment 5-13 6,096 6,473 Computer equipment 3 2,577 2,196 Furniture and fixtures 3-13 1,362 1,070 Leasehold improvements 5-8 (1) 5,768 5,690 Assets in progress 6,645 935 29,328 24,535 Less accumulated depreciation and amortization (15,524 ) (16,611 ) Total $ 13,804 $ 7,924 (1) Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. |
Current Accrued Liabilities (Ta
Current Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure Component Of Current Accrued Liabilities [Abstract] | |
Component of Current Accrued Liabilities | Current accrued liabilities consist of the following (in thousands): December 31, 2015 2014 Payroll and related expenses $ 5,866 $ 4,613 Legal expenses 202 224 Third party research expenses 5,241 5,898 Third party development expenses 2,072 1,000 Return of funding due to AstraZeneca AB (“AstraZeneca”) (Note 9) 7,345 - Other accrued liabilities 1,972 1,520 Total $ 22,698 $ 13,255 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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 December 31, 2015, excluding payments from sublease payments, are as follows (in thousands): Year ending December 31, 2016 $ 2,306 2017 2,355 2018 1,295 2019 466 2020 466 Thereafter 1,048 Total $ 7,936 |
Collaborative Research, Devel31
Collaborative Research, Development and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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 consolidated statements of operations (in thousands): Year ended December 31, 2015 2014 2013 Initial payment $ 238 $ 681 $ 720 Subsequent payment 892 2,554 - Performance of research activities 1,635 2,174 2,507 Total $ 2,765 $ 5,409 $ 3,227 |
Glaxo Smith Kline | |
Summary of Revenue Recognized under Various Agreements | The following table summarizes the revenues recognized under our agreement with GSK, included as collaboration revenue in our consolidated statements of operations (in thousands): Year ended December 31, 2015 2014 2013 Initial payment $ - $ 2,524 $ 1,702 Total $ - $ 2,524 $ 1,702 |
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 and NIAID, included as grant revenue in our consolidated statements of operations (in thousands): Year ended December 31, 2015 2014 2013 NIAID contracts $ - $ 2,095 $ 4,103 All other NIH contracts 683 593 1,035 Total grant revenue $ 683 $ 2,688 $ 5,138 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Earnings Per Share | December 31, 2015 2014 2013 Basic and diluted net loss per share (in thousands, except per share amounts): Numerator: Net loss (106,794 ) (90,722 ) (66,720 ) Preferred stock deemed dividend - - (8,469 ) Net loss allocable to common stockholders $ (106,794 ) $ (90,722 ) $ (75,189 ) Denominator for basic and diluted net loss per share allocable to common stockholders: Weighted-average common shares outstanding 32,881 26,289 19,628 Basic and diluted net loss per share allocable to common stockholders $ (3.25 ) $ (3.45 ) $ (3.83 ) December 31, 2015 2014 2013 Outstanding securities not included in diluted net loss per share calculation (in thousands): Stock options and stock awards 3,086 1,998 1,704 Series B Convertible Preferred Stock (as converted to common stock) - 4,343 4,343 Warrants - 1,081 1,246 3,086 7,422 7,293 |
Equity Plans and Stock-Based 33
Equity Plans and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Share Based Compensation [Abstract] | |
Option Activity under Stock-Based Compensation Plans | Activity under our stock plans is set forth below: 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, 2014 1,820 $ 27.48 Options granted 1,339 18.51 Options exercised (38 ) 15.67 Options cancelled: Options forfeited (unvested) (133 ) 17.07 Options cancelled (vested) (97 ) 45.01 Balance at December 31, 2015 2,891 23.34 6.95 $ 13,234 Vested and expected to vest at December 31, 2015 2,788 23.57 6.88 $ 12,514 Exercisable at December 31, 2015 1,271 29.06 4.43 $ 3,734 |
Summary of Restricted Stock Units Activity | Our non-vested stock awards are comprised of restricted stock units granted with performance and time-based vesting criteria. A summary of the status of non-vested restricted stock units as of December 31, 2015, and activities during 2015 are summarized as follows: Number of Shares (In thousands) Weighted-Average Grant-Date Fair Value Non-vested as of December 31, 2014 179 $ 17.13 Granted 37 $ 20.05 Vested (4 ) $ 20.64 Forfeited or expired (17 ) $ 18.23 Non-vested as of December 31, 2015 195 $ 17.52 |
Fair Value-Based Measurements and Weighted-Average Assumptions | The fair value of each option is estimated on the date of grant using the Black-Scholes option valuation model and the following weighted-average assumptions: Stock Options Employee Stock Purchase Plan Year Ended December 31, Year Ended December 31, 2015 2014 2013 2015 2014 2013 Weighted-average fair value $ 13.37 $ 15.16 $ 24.15 $ 9.18 $ 7.45 $ 9.30 Risk-free interest rate 1.7 % 1.8 % 1.1 % 0.4 % 0.2 % 0.2 % Expected life (in years) 5.9 5.9 5.9 1.2 1.2 1.3 Volatility 0.7 1.4 1.4 0.6 0.9 0.8 |
Stock-Based Compensation Expense | We recognized the following amounts of stock-based compensation expense (in thousands): Year Ended December 31, 2015 2014 2013 Employees and directors stock-based compensation expense $ 9,316 $ 6,062 $ 11,828 Non-employees stock-based compensation expense - 27 512 Total $ 9,316 $ 6,089 $ 12,340 Year Ended December 31, 2015 2014 2013 Research and development $ 4,123 $ 2,868 $ 4,228 General and administrative 5,193 3,221 8,112 Total $ 9,316 $ 6,089 $ 12,340 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Component of Consolidated Income (Loss) Before Provision for Income Taxes | Consolidated income (loss) before provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2015 2014 2013 U.S. $ (107,450 ) $ (91,121 ) $ (67,004 ) Non U.S. 656 399 284 Total $ (106,794 ) $ (90,722 ) $ (66,720 ) |
Difference Between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate | No income tax expense was recorded for the years ended December 31, 2015, 2014 and 2013 due to net operating loss carryforwards to offset the net income at Dynavax GmbH and a valuation allowance which offsets the deferred tax assets. The difference between the consolidated income tax benefit and the amount computed by applying the federal statutory income tax rate to the consolidated loss before income taxes was as follows (in thousands): Year Ended December 31, 2015 2014 2013 Income tax benefit at federal statutory rate $ (36,301 ) $ (30,818 ) $ (22,678 ) State tax (394 ) 1,204 (178 ) Business credits (2,622 ) (1,484 ) (2,515 ) Deferred compensation charges 1,481 2,710 3,072 Change in valuation allowance 36,766 28,093 22,354 Other 1,070 295 (55 ) Total income tax expense $ - $ - $ - |
Component of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities consisted of the following (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carry forwards $ 212,074 $ 178,008 Research tax credit carry forwards 26,285 22,914 Accruals and reserves 9,771 9,053 Capitalized research costs 6,553 8,601 Deferred revenue 908 654 Other 1,375 1,531 Total deferred tax assets 256,966 220,761 Less valuation allowance (256,712 ) (220,544 ) Net deferred tax assets 254 217 Deferred tax liabilities: Fixed Assets (254 ) (217 ) Total deferred tax liabilities (254 ) (217 ) Net deferred tax assets $ - $ - |
Schedule of Unrecognized Tax Benefits | The following table summarizes the activity related to the Company’s unrecognized tax benefits: Balance at December 31, 2014 $ (2,426 ) Tax positions related to the current year Additions - Reductions - Tax positions related to the prior year Additions - Reductions - Balance at December 31, 2015 $ (2,426 ) |
Selected Quarterly Financial 35
Selected Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | Year Ended December 31, 2015 Q1 Q2 Q3 Q4 Revenues $ 627 $ 1,550 $ 1,188 $ 685 Net loss $ (26,217 ) $ (23,591 ) $ (30,124 ) $ (26,862 ) Net loss allocable to common stockholders $ (26,217 ) $ (23,591 ) $ (30,124 ) $ (26,862 ) Basic and diluted net loss per share allocable to common stockholders $ (0.97 ) $ (0.80 ) $ (0.82 ) $ (0.70 ) Shares used to compute basic and diluted net loss per share allocable to common stockholders 27,065 29,335 36,532 38,429 Year Ended December 31, 2014 Q1 Q2 Q3 Q4 Revenues $ 3,498 $ 3,048 $ 2,209 $ 2,277 Net loss $ (13,840 ) $ (24,777 ) $ (29,819 ) $ (22,286 ) Net loss allocable to common stockholders $ (13,840 ) $ (24,777 ) $ (29,819 ) $ (22,286 ) Basic and diluted net loss per share allocable to common stockholders $ (0.53 ) $ (0.94 ) $ (1.13 ) $ (0.85 ) Shares used to compute basic and diluted net loss per share allocable to common stockholders 26,283 26,286 26,291 26,298 |
Organization - Additional Infor
Organization - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2015 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Date of Acquisition | Apr. 30, 2006 |
Business Acquisition, Description of Acquired Entity | In April 2006, we completed the acquisition of Dynavax GmbH (formerly known as Rhein Biotech GmbH), a wholly-owned subsidiary in Düsseldorf, Germany. |
Summary of Significant Accoun37
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015USD ($)Segment | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Cash, cash equivalents and marketable securities | $ 196.1 | ||
United States | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Percentage of revenue earned | 85.00% | 96.00% | 89.00% |
Percentage of long lived assets | 11.00% | 11.00% | |
Maximum | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Cash equivalents original maturity period | 3 months | ||
Dynavax GmbH | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Currency translation adjustments | $ (1.3) | $ (1.6) | $ 0.5 |
Currency transaction gain (loss) | $ 0.1 | $ 0.4 | $ (0.2) |
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 | Dec. 31, 2015 | Dec. 31, 2014 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 191,564 | $ 120,130 |
Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 21,193 | 46,989 |
Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 170,371 | 73,141 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 21,193 | 46,989 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 21,193 | 46,989 |
U.S. Government Agency Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 17,622 | 73,141 |
U.S. Government Agency Securities | Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 17,622 | $ 73,141 |
Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 152,749 | |
Corporate Debt Securities | Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 152,749 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | Dec. 31, 2015USD ($) |
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 | Dec. 31, 2015 | Dec. 31, 2014 |
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 196,113 | $ 122,651 |
Unrealized Gains | 78 | 11 |
Unrealized Losses | (66) | (10) |
Estimated Fair Value | 196,125 | 122,652 |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 44,806 | 49,511 |
Unrealized Gains | 7 | |
Unrealized Losses | (1) | |
Estimated Fair Value | 44,812 | 49,511 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 151,307 | 73,140 |
Unrealized Gains | 71 | 11 |
Unrealized Losses | (65) | (10) |
Estimated Fair Value | 151,313 | 73,141 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 4,561 | 2,522 |
Estimated Fair Value | 4,561 | 2,522 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 21,193 | 46,989 |
Estimated Fair Value | 21,193 | 46,989 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 19,052 | |
Unrealized Gains | 7 | |
Unrealized Losses | (1) | |
Estimated Fair Value | 19,058 | |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 133,679 | |
Unrealized Gains | 71 | |
Unrealized Losses | (59) | |
Estimated Fair Value | 133,691 | |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 17,628 | 73,140 |
Unrealized Gains | 11 | |
Unrealized Losses | (6) | (10) |
Estimated Fair Value | $ 17,622 | $ 73,141 |
Summary of Amortized Cost and E
Summary of Amortized Cost and Estimated Fair Value of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Amortized Cost | |
Mature in one year or less | $ 151,307 |
Mature after one year through two years | 0 |
Total amortized cost | 151,307 |
Estimated Fair Value | |
Mature in one year or less | 151,313 |
Mature after one year through two years | 0 |
Total estimated fair value | $ 151,313 |
Cash, Cash Equivalents and Ma42
Cash, Cash Equivalents and Marketable Securities - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Investments Debt And Equity Securities [Abstract] | |||
Realized gains or losses from the sale of marketable securities | $ 0 | $ 0 | $ 0 |
Component of Property and Equip
Component of Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property Plant And Equipment [Line Items] | ||
Manufacturing equipment | $ 6,880 | $ 8,171 |
Lab equipment | 6,096 | 6,473 |
Computer equipment | 2,577 | 2,196 |
Furniture and fixtures | 1,362 | 1,070 |
Leasehold improvements | 5,768 | 5,690 |
Assets in progress | 6,645 | 935 |
Property, Plant and Equipment, Gross | 29,328 | 24,535 |
Less accumulated depreciation and amortization | (15,524) | (16,611) |
Total | $ 13,804 | $ 7,924 |
Manufacturing Equipment | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 5 years | |
Manufacturing Equipment | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 14 years | |
Lab Equipment | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 5 years | |
Lab Equipment | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 13 years | |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 3 years | |
Furniture and Fixtures | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 3 years | |
Furniture and Fixtures | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 13 years | |
Leasehold Improvements | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 5 years | |
Leasehold Improvements | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 8 years |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property Plant And Equipment [Abstract] | |||
Depreciation and amortization | $ 1,365 | $ 1,404 | $ 1,327 |
Component of Current Accrued Li
Component of Current Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accrued Liabilities Abstract | ||
Payroll and related expenses | $ 5,866 | $ 4,613 |
Legal expenses | 202 | 224 |
Third party research expenses | 5,241 | 5,898 |
Third party development expenses | 2,072 | 1,000 |
Return of funding due to AstraZeneca AB (“AstraZeneca”) (Note 9) | 7,345 | |
Other accrued liabilities | 1,972 | 1,520 |
Total | $ 22,698 | $ 13,255 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions | 12 Months Ended | |||||
Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2004USD ($) | Dec. 31, 2015EUR (€) | Dec. 31, 2014EUR (€) | |
Loss Contingencies [Line Items] | ||||||
Unoccupied facility expense | $ 386 | $ 926 | ||||
Rent expense, net | $ 2,000 | 1,700 | 1,900 | |||
Deferred rent | 500 | 600 | ||||
Deferred gain (loss) on lease | (500) | (700) | ||||
Cash, cash equivalents and marketable securities | 196,100 | |||||
Future payments obligation | $ 11,200 | |||||
Deutsche Bank Securities | ||||||
Loss Contingencies [Line Items] | ||||||
Letter of credit pledged as security | € | € 0.2 | |||||
Collateralized certificate of deposit | € | € 0.2 | € 0.2 | ||||
Berkeley, California (the "Berkeley Lease") | ||||||
Loss Contingencies [Line Items] | ||||||
Operating leases expiration date | 2018-06 | |||||
Unoccupied facility expense | 400 | $ 900 | ||||
Letter of credit pledged as security | $ 400 | |||||
Collateralized certificate of deposit | $ 400 | $ 400 | ||||
Terms of the lease | If the total amount of our cash, cash equivalents and marketable securities falls below $20 million for a period of more than 30 consecutive days during the lease term, the amount of the required security deposit will increase to $1.1 million, until such time as our projected cash and cash equivalents will exceed $20 million for the remainder of the lease term, or until our actual cash and cash equivalents remains above $20 million for a period of 12 consecutive months. | |||||
Berkeley, California (the "Berkeley Lease") | Contingency, B | ||||||
Loss Contingencies [Line Items] | ||||||
Contingency period for cash, cash equivalents and marketable securities | 12 months | |||||
Berkeley, California (the "Berkeley Lease") | Contingency, B | Minimum | ||||||
Loss Contingencies [Line Items] | ||||||
Cash, cash equivalents and marketable securities | $ 20,000 | |||||
Berkeley, California (the "Berkeley Lease") | Contingency, A | ||||||
Loss Contingencies [Line Items] | ||||||
Increase in amount of the security deposit | $ 1,100 | |||||
Berkeley, California (the "Berkeley Lease") | Contingency, A | Minimum | ||||||
Loss Contingencies [Line Items] | ||||||
Contingency period for cash, cash equivalents and marketable securities | 30 days | |||||
Berkeley, California (the "Berkeley Lease") | Contingency, A | Maximum | ||||||
Loss Contingencies [Line Items] | ||||||
Cash, cash equivalents and marketable securities | $ 20,000 | |||||
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 | Dec. 31, 2015USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,016 | $ 2,306 |
2,017 | 2,355 |
2,018 | 1,295 |
2,019 | 466 |
2,020 | 466 |
Thereafter | 1,048 |
Total | $ 7,936 |
Symphony Dynamo, Inc. - Additio
Symphony Dynamo, Inc. - Additional Information (Detail) - SDI - USD ($) | 1 Months Ended | 12 Months Ended |
Nov. 30, 2009 | Dec. 31, 2015 | |
Business Acquisition Equity Interests Issued Or Issuable [Line Items] | ||
Business acquisition contingent consideration percentage | 50.00% | |
Business acquisition upfront payment | $ 50,000,000 | |
Milestone payments | $ 0 |
Collaborative Research, Devel49
Collaborative Research, Development and License Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Oct. 31, 2011 | Dec. 31, 2008 | Sep. 30, 2008 | Dec. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2012 | Dec. 31, 2015 | Dec. 31, 2014 | Aug. 31, 2014 | Sep. 30, 2013 | Jun. 30, 2012 | May. 31, 2012 | Aug. 31, 2010 | |
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Accrued research and development liability | $ 6,938,000 | $ 7,361,000 | $ 6,938,000 | ||||||||||
Additional revenue recognized | 1,100,000 | ||||||||||||
Deferred revenue | 0 | 0 | 0 | ||||||||||
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 | |||||||||
Deferred revenue | $ 12,800,000 | $ 2,700,000 | $ 12,800,000 | ||||||||||
Glaxo Smith Kline | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Collaboration Revenue | $ 10,000,000 | ||||||||||||
National Institutes of Health | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Grants receivable | $ 200,000 | ||||||||||||
National Institutes of Health | Hepatic Fibrosis and Cirrhosis | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Grants receivable | $ 200,000 | ||||||||||||
National Institutes of Health | Autoimmune Disease | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Grants receivable | $ 600,000 | ||||||||||||
National Institutes of Health | Rheumatoid Arthritis | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Grants receivable | $ 400,000 | ||||||||||||
National Institute of Allergy and Infectious Diseases | Hepatitis B Virus | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Grants receivable | $ 1,400,000 | ||||||||||||
National Institute of Allergy and Infectious Diseases | Iss Technology | |||||||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||||||
Grants receivable | $ 17,000,000 | ||||||||||||
Research collaboration and license agreement period | 5 years |
Summary of Revenue Recognized u
Summary of Revenue Recognized under Various Agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Product Information [Line Items] | |||||||||||
Total revenues | $ 685 | $ 1,188 | $ 1,550 | $ 627 | $ 2,277 | $ 2,209 | $ 3,048 | $ 3,498 | $ 4,050 | $ 11,032 | $ 11,251 |
Grant revenue | 683 | 2,688 | 5,138 | ||||||||
Astra Zeneca | |||||||||||
Product Information [Line Items] | |||||||||||
Initial payment | 238 | 681 | 720 | ||||||||
Subsequent payment | 892 | 2,554 | |||||||||
Performance of research activities | 1,635 | 2,174 | 2,507 | ||||||||
Total revenues | 2,765 | 5,409 | 3,227 | ||||||||
Glaxo Smith Kline | |||||||||||
Product Information [Line Items] | |||||||||||
Initial payment | 2,524 | 1,702 | |||||||||
Total revenues | 2,524 | 1,702 | |||||||||
National Institute of Allergy and Infectious Diseases | |||||||||||
Product Information [Line Items] | |||||||||||
Grant revenue | 2,095 | 4,103 | |||||||||
National Institutes of Health | |||||||||||
Product Information [Line Items] | |||||||||||
Grant revenue | $ 683 | $ 593 | $ 1,035 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) | Dec. 23, 2014USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2014USD ($)TRANCHES | Dec. 31, 2015USD ($) |
Debt Instrument [Line Items] | ||||
Loss on extinguishment of debt | $ 1,671,000 | |||
Loan and Security Agreement | Hercules Technology Growth Capital, Inc. (“Hercules”) | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | $ 40,000,000 | |||
Number of tranches for loan and security agreement | TRANCHES | 2 | |||
Facility charge to Hercules | $ 400,000 | |||
Repayment of loan agreement | $ 11,000,000 | |||
Outstanding principal | 10,000,000 | |||
Accrued unpaid interest | 38,000 | |||
Term fee | 800,000 | |||
Prepayment charges | 200,000 | |||
Loss on extinguishment of debt | 1,700,000 | |||
Debt instrument, interest rate minimum | 9.75% | |||
Debt instrument, interest rate terms | The interest rate in the Loan Agreement was calculated at a rate equal to the greater of either: (i) 9.75% plus the prime rate as reported from time to time in The Wall Street Journal minus 5.25%, and (ii) 9.75%. | |||
Debt instrument, payment terms | Monthly payments made under the Loan Agreement between December 2014 and the date of repayment were interest only. | |||
Loan and Security Agreement | Hercules Technology Growth Capital, Inc. (“Hercules”) | Prime Rate | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 9.75% | |||
Debt instrument, reduction in basis spread on variable rate | 5.25% | |||
Loan and Security Agreement | Hercules Technology Growth Capital, Inc. (“Hercules”) | First Tranche | ||||
Debt Instrument [Line Items] | ||||
Proceeds from lines of credit | $ 10,000,000 | |||
Loan and Security Agreement | Hercules Technology Growth Capital, Inc. (“Hercules”) | Second Tranche | ||||
Debt Instrument [Line Items] | ||||
Proceeds from lines of credit | $ 0 | |||
Available borrowing capacity | $ 30,000,000 |
Computation of Basic and Dilute
Computation of Basic and Diluted Earnings Per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Basic and diluted net loss per share (in thousands, except per share amounts): | |||||||||||
Net loss | $ (26,862) | $ (30,124) | $ (23,591) | $ (26,217) | $ (22,286) | $ (29,819) | $ (24,777) | $ (13,840) | $ (106,794) | $ (90,722) | $ (66,720) |
Preferred stock deemed dividend | (8,469) | ||||||||||
Net loss allocable to common stockholders | $ (26,862) | $ (30,124) | $ (23,591) | $ (26,217) | $ (22,286) | $ (29,819) | $ (24,777) | $ (13,840) | $ (106,794) | $ (90,722) | $ (75,189) |
Denominator for basic and diluted net loss per share allocable to common stockholders: | |||||||||||
Weighted-average common shares outstanding | 38,429 | 36,532 | 29,335 | 27,065 | 26,298 | 26,291 | 26,286 | 26,283 | 32,881 | 26,289 | 19,628 |
Net loss per share allocable to common stockholders - basic and diluted | $ (0.70) | $ (0.82) | $ (0.80) | $ (0.97) | $ (0.85) | $ (1.13) | $ (0.94) | $ (0.53) | $ (3.25) | $ (3.45) | $ (3.83) |
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||||||||||
Outstanding securities not included in diluted net loss per share calculation | 3,086 | 7,422 | 7,293 | ||||||||
Series B Convertible Preferred Stock | |||||||||||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||||||||||
Outstanding securities not included in diluted net loss per share calculation | 4,343 | 4,343 | |||||||||
Stock Options and Stock Awards | |||||||||||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||||||||||
Outstanding securities not included in diluted net loss per share calculation | 3,086 | 1,998 | 1,704 | ||||||||
Warrant | |||||||||||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||||||||||
Outstanding securities not included in diluted net loss per share calculation | 1,081 | 1,246 |
Preferred Stock, Common Stock53
Preferred Stock, Common Stock and Warrants - Additional Information (Detail) | Nov. 12, 2015USD ($) | Jul. 23, 2015shares | Feb. 26, 2015shares | Nov. 04, 2008$ / shares | Jul. 31, 2015USD ($)$ / sharesshares | Jul. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2013USD ($)shares | Dec. 31, 2014$ / sharesshares |
Class Of Stock [Line Items] | |||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | |||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Dividends payable date | Nov. 17, 2008 | ||||||||
Preferred shares price | $ / shares | $ 6 | ||||||||
Rights expiration date | Nov. 17, 2018 | ||||||||
Common stock, shares outstanding | 38,445,995 | 26,307,000 | |||||||
Proceeds from issuance of common stock, net | $ | $ 183,897,000 | $ 80,856,000 | |||||||
Warrants outstanding | 0 | ||||||||
Number of warrants exercised during period | 383,000 | 11,000 | |||||||
Cowen | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock, (in shares) | 2,125,439 | 0 | |||||||
Proceeds from issuance of common stock, net | $ | $ 49,000,000 | ||||||||
Minimum | |||||||||
Class Of Stock [Line Items] | |||||||||
Percentage of common shares outstanding | 20.00% | ||||||||
Percentage of assets | 50.00% | ||||||||
Maximum | Cowen | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock sales agreement aggregate sales proceeds | $ | $ 90,000,000 | ||||||||
Common Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Convertible common stock shares | 1,743,000 | 2,600,000 | |||||||
Issuance of common stock, (in shares) | 7,353,000 | 7,957,000 | |||||||
Common Stock | IPO | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock, (in shares) | 5,227,273 | ||||||||
Public offering net price per share | $ / shares | $ 27.50 | $ 27.50 | |||||||
Net proceeds from offering | $ | $ 134,900,000 | ||||||||
Common Stock | Over-Allotment Option | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock, (in shares) | 681,818 | ||||||||
Series B Convertible Preferred Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Preferred stock, shares outstanding | 0 | 0 | 43,000 | ||||||
Convertible common stock shares | 17,430 | 26,000 | |||||||
Conversion of stock, shares converted | 100 | ||||||||
Convertible common stock shares | 0.01 | ||||||||
Preferred stock, par value | $ / shares | $ 0.001 | ||||||||
Convertible preferred stock, terms of conversion | The holder was prohibited from converting the Series B Convertible Preferred Stock into shares of common stock if, as a result of such conversion, the holder and its affiliates would own more than 9.98% of the total number of shares of common stock then issued and outstanding. | ||||||||
Convertible preferred stock, settlement terms | In the event of the Company’s liquidation, dissolution, or winding up, holders of Series B Convertible Preferred Stock will receive a payment equal to $0.001 per share before any proceeds are distributed to the common stockholders. | ||||||||
Maximum percentage of shares of common stock issued and outstanding from conversion of preferred stock | 9.98% |
Equity Plans and Stock-Based 54
Equity Plans and Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | May. 27, 2015shares | May. 31, 2014shares | Jan. 31, 2011shares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2013USD ($)Employee$ / shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of Common Stock outstanding | 2,891,000 | 1,820,000 | ||||
Total intrinsic value of options exercised | $ | $ 400 | $ 100 | $ 300 | |||
Total fair value of stock options vested | $ | $ 6,900 | 5,600 | 12,100 | |||
Options and restricted stock units outstanding | 80,000 | |||||
Expected dividend yield | 0.00% | |||||
Stock-based compensation expense | $ | $ 9,316 | $ 6,089 | $ 12,340 | |||
Number of employees under stock option | Employee | 5 | |||||
Total unrecognized compensation cost related to non-vested equity awards | $ | 3,200 | |||||
Employee | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ | $ 4,900 | |||||
Non Employee Awards | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ | 500 | |||||
Additional | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ | $ 1,300 | |||||
Restricted Stock Units (RSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock based compensation expense related to restricted stock | $ | 800 | |||||
Aggregate intrinsic value | $ | $ 4,700 | |||||
Grant date fair value of restricted stock | $ / shares | $ 20.05 | $ 17.92 | $ 12.30 | |||
Total fair value of restricted stock units | $ | $ 100 | $ 0 | $ 100 | |||
Employee Stock Option | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Expiration period | 10 years | |||||
Options vesting period | 4 years | |||||
2004 Stock Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of Common Stock outstanding | 292,901 | |||||
2010 Employment Inducement Award Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of Common Stock outstanding | 12,450 | |||||
2011 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of Common Stock outstanding | 2,585,223 | |||||
Expiration period | 10 years | |||||
Shares reserved and approved for issuance | 2,097,384 | |||||
2011 Plan | Maximum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Issuance of common stock shares | 11,000,000 | |||||
Increase in the aggregate number of shares of common stock authorized for issuance | 2,250,000 | |||||
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 | $ | $ 19,400 | |||||
Total unrecognized compensation cost, weighted-average vesting period | 2 years 7 months 6 days | |||||
2004 Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares reserved and approved for issuance | 99,600 | |||||
Shares issued to employees | 94,709 | |||||
Shares remaining available for future purchases | 0 | |||||
2014 Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Total unrecognized compensation cost related to non-vested equity awards | $ | $ 200 | |||||
Total unrecognized compensation cost, weighted-average vesting period | 7 months 6 days | |||||
Shares issued to employees | 50,000 | 21,979 | ||||
Shares remaining available for future purchases | 28,021 | |||||
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% |
Option Activity under Stock Pla
Option Activity under Stock Plans (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Number of Options Outstanding | |
Beginning balance | shares | 1,820 |
Options granted | shares | 1,339 |
Options exercised | shares | (38) |
Ending balance | shares | 2,891 |
Vested and expected to vest at end of period | shares | 2,788 |
Exercisable at end of period | shares | 1,271 |
Weighted-Average Price Per Share | |
Beginning balance | $ / shares | $ 27.48 |
Options granted | $ / shares | 18.51 |
Options exercised | $ / shares | 15.67 |
Ending balance | $ / shares | 23.34 |
Vested and expected to vest at end of period | $ / shares | 23.57 |
Exercisable at end of period | $ / shares | $ 29.06 |
Weighted Average Remaining Contractual Life (In years) | |
Balance at December 31, 2015 | 6 years 11 months 12 days |
Outstanding options vested and expected to vest at end of period | 6 years 10 months 17 days |
Options exercisable at end of period | 4 years 5 months 5 days |
Aggregate Intrinsic Value | |
Balance at December 31, 2015 | $ | $ 13,234 |
Outstanding options (vested and expected to vest) at end of period | $ | 12,514 |
Options exercisable at end of period | $ | $ 3,734 |
Unvested | |
Number of Options Outstanding | |
Options cancelled | shares | (133) |
Weighted-Average Price Per Share | |
Options cancelled | $ / shares | $ 17.07 |
Vested | |
Number of Options Outstanding | |
Options cancelled | shares | (97) |
Weighted-Average Price Per Share | |
Options cancelled | $ / shares | $ 45.01 |
Summary of Restricted Stock Uni
Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Number of shares | |||
Beginning Balance | 179 | ||
Granted | 37 | ||
Vested | (4) | ||
Forfeited or expired | (17) | ||
Ending Balance | 195 | 179 | |
Weighted Average Grant Date Fair Value | |||
Beginning Balance | $ 17.13 | ||
Granted | 20.05 | $ 17.92 | $ 12.30 |
Vested | 20.64 | ||
Forfeited or expired | 18.23 | ||
Ending Balance | $ 17.52 | $ 17.13 |
Fair Value-Based Measurements a
Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 9.18 | $ 7.45 | $ 9.30 |
Risk-free interest rate | 0.40% | 0.20% | 0.20% |
Expected life (in years) | 1 year 2 months 12 days | 1 year 2 months 12 days | 1 year 3 months 18 days |
Volatility | 0.60% | 0.90% | 0.80% |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 13.37 | $ 15.16 | $ 24.15 |
Risk-free interest rate | 1.70% | 1.80% | 1.10% |
Expected life (in years) | 5 years 10 months 24 days | 5 years 10 months 24 days | 5 years 10 months 24 days |
Volatility | 0.70% | 1.40% | 1.40% |
Stock-Based Compensation Expens
Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | $ 9,316 | $ 6,089 | $ 12,340 |
Employees And Directors | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 9,316 | 6,062 | 11,828 |
Non Employee | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 27 | 512 | |
Research and Development | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 4,123 | 2,868 | 4,228 |
General and Administrative | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | $ 5,193 | $ 3,221 | $ 8,112 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Pension And Other Postretirement Benefit Expense [Abstract] | |||
Contributions to 401 (k) plan | $ 200,000 | $ 0 | $ 0 |
Component of Consolidated Incom
Component of Consolidated Income (Loss) Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (107,450) | $ (91,121) | $ (67,004) |
Non U.S. | 656 | 399 | 284 |
Total | $ (106,794) | $ (90,722) | $ (66,720) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Line Items] | |||
Income tax expense | $ 0 | $ 0 | $ 0 |
Increase (decrease) in valuation allowance | 36,200,000 | 27,800,000 | 22,500,000 |
Amount of valuation allowance for deferred tax assets allocated to contributed capital | 300,000 | ||
Unrecognized tax benefits | 2,426,000 | $ 2,426,000 | $ 0 |
Unrecognized tax benefits would affect the effective tax rate | 0 | ||
Interest related to unrecognized tax benefits | 0 | ||
Penalties related to unrecognized tax benefits | 0 | ||
Federal | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 582,800,000 | ||
Federal | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,018 | ||
Federal | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,035 | ||
Federal | Research And Development Tax Credits | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount | $ 19,100,000 | ||
Federal | Research And Development Tax Credits | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount, expiration year | 2,018 | ||
Federal | Research And Development Tax Credits | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount, expiration year | 2,035 | ||
California State | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 192,900,000 | ||
California State | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,015 | ||
California State | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,035 | ||
California State | Research And Development Tax Credits | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount | $ 14,000,000 | ||
Foreign | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 18,800,000 |
Difference between Consolidated
Difference between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at federal statutory rate | $ (36,301,000) | $ (30,818,000) | $ (22,678,000) |
State tax | (394,000) | 1,204,000 | (178,000) |
Business credits | (2,622,000) | (1,484,000) | (2,515,000) |
Deferred compensation charges | 1,481,000 | 2,710,000 | 3,072,000 |
Change in valuation allowance | 36,766,000 | 28,093,000 | 22,354,000 |
Other | 1,070,000 | 295,000 | (55,000) |
Total income tax expense | $ 0 | $ 0 | $ 0 |
Component of Deferred Tax Asset
Component of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 212,074 | $ 178,008 |
Research tax credit carry forwards | 26,285 | 22,914 |
Accruals and reserves | 9,771 | 9,053 |
Capitalized research costs | 6,553 | 8,601 |
Deferred revenue | 908 | 654 |
Other | 1,375 | 1,531 |
Total deferred tax assets | 256,966 | 220,761 |
Less valuation allowance | (256,712) | (220,544) |
Net deferred tax assets | 254 | 217 |
Deferred tax liabilities: | ||
Fixed Assets | (254) | (217) |
Total deferred tax liabilities | $ (254) | $ (217) |
Schedule of Unrecognized Tax Be
Schedule of Unrecognized Tax Benefits (Detail) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax Disclosure [Abstract] | ||
Balance at December 31, 2014 | $ (2,426,000) | $ 0 |
Balance at December 31, 2015 | $ (2,426,000) | $ (2,426,000) |
Selected Quarterly Financial 65
Selected Quarterly Financial Data (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 685 | $ 1,188 | $ 1,550 | $ 627 | $ 2,277 | $ 2,209 | $ 3,048 | $ 3,498 | $ 4,050 | $ 11,032 | $ 11,251 |
Net loss | (26,862) | (30,124) | (23,591) | (26,217) | (22,286) | (29,819) | (24,777) | (13,840) | (106,794) | (90,722) | (66,720) |
Net loss allocable to common stockholders | $ (26,862) | $ (30,124) | $ (23,591) | $ (26,217) | $ (22,286) | $ (29,819) | $ (24,777) | $ (13,840) | $ (106,794) | $ (90,722) | $ (75,189) |
Basic and diluted net loss per share allocable to common stockholders | $ (0.70) | $ (0.82) | $ (0.80) | $ (0.97) | $ (0.85) | $ (1.13) | $ (0.94) | $ (0.53) | $ (3.25) | $ (3.45) | $ (3.83) |
Weighted-average common shares outstanding | 38,429 | 36,532 | 29,335 | 27,065 | 26,298 | 26,291 | 26,286 | 26,283 | 32,881 | 26,289 | 19,628 |