Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 20, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | DVAX | ||
Entity Registrant Name | Dynavax Technologies Corp | ||
Entity Central Index Key | 0001029142 | ||
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 | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 130,614,772 | ||
Entity Public Float | $ 0.9 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-34207 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0728374 | ||
Entity Address, Address Line One | 2100 Powell Street | ||
Entity Address, Address Line Two | Suite 720 | ||
Entity Address, City or Town | Emeryville | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94608 | ||
City Area Code | 510 | ||
Local Phone Number | 848-5100 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | true | ||
Documents Incorporated by Reference | Portions of the Definitive Proxy Statement for the registrant’s 2024 Annual Meeting of Stockholders are incorporated by reference into Part III, Items 10-14 of this Form 10-K. The Definitive Proxy Statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2023. | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | San Francisco, California | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 150,279 | $ 202,004 |
Marketable securities available-for-sale | 592,023 | 422,391 |
Accounts receivables, net of allowance for doubtful accounts of $12,313 and $0 at December 31, 2023 and December 31, 2022, respectively | 40,607 | 145,130 |
Other receivables | 3,926 | 2,385 |
Inventories | 53,290 | 59,446 |
Prepaid expenses and other current assets | 18,995 | 85,629 |
Total current assets | 859,120 | 916,985 |
Property and equipment, net | 37,297 | 37,596 |
Operating lease right-of-use assets | 24,287 | 25,745 |
Goodwill | 2,067 | 2,006 |
Other assets (Note 9 ) | 74,325 | 3,518 |
Total assets | 997,096 | 985,850 |
Current liabilities: | ||
Accounts payable | 5,245 | 3,211 |
Accrued research and development | 2,982 | 4,775 |
CEPI accrual (Note 9) | 0 | 107,738 |
Accrued liabilities (Note 7) | 49,448 | 30,719 |
Other current liabilities | 4,520 | 3,631 |
Total current liabilities | 62,195 | 150,074 |
Convertible Notes, net of debt discount of $2,802 and $3,922 at December 31, 2023 and December 31, 2022, respectively (Note 10) | 222,698 | 221,578 |
Long-term portion of lease liabilities | 29,720 | 32,801 |
CEPI accrual long-term (Note 9) | 60,337 | 0 |
Other long-term liabilities | 74 | 384 |
Total liabilities | 375,024 | 404,837 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value, 5,000 shares authorized at December 31, 2023, and 2022; zero shares outstanding at December 31, 2023 and 2022 | 0 | 0 |
Common stock: $0.001 par value; 278,000 shares authorized at December 31, 2023, and 2022; 129,530 shares and 127,604 shares issued and outstanding at December 31, 2023 and 2022, respectively | 130 | 128 |
Additional paid-in capital | 1,554,634 | 1,510,518 |
Accumulated other comprehensive loss | (2,108) | (5,438) |
Accumulated deficit | (930,584) | (924,195) |
Total stockholders’ equity | 622,072 | 581,013 |
Total liabilities and stockholders’ equity | $ 997,096 | $ 985,850 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivables | $ 12,313 | $ 0 |
Debt instrument, debt discount | $ 2,802 | $ 3,922 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 278,000,000 | 278,000,000 |
Common stock, shares issued | 129,530,000 | 127,604,000 |
Common stock, shares outstanding | 129,530,228 | 127,604,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues: | |||
Total revenues | $ 232,284 | $ 722,683 | $ 439,442 |
Operating expenses: | |||
Cost of sales - product | 50,167 | 262,153 | 173,572 |
Research and development | 54,886 | 46,600 | 32,228 |
Selling, general and administrative | 152,946 | 131,408 | 100,156 |
Gain on sale of assets (Note 8) | (1,000) | (1,000) | (1,000) |
Bad debt expense (Note 9) | 12,313 | 0 | 0 |
Total operating expenses | 269,312 | 439,161 | 304,956 |
(Loss) income from operations | (37,028) | 283,522 | 134,486 |
Other (expense) income: | |||
Interest income | 31,993 | 7,912 | 140 |
Interest expense | (6,757) | (6,732) | (11,176) |
Sublease income | 7,577 | 7,685 | 7,735 |
Loss on debt extinguishment (Note 11) | 0 | 0 | (5,232) |
Change in fair value of warrant liability (Note 14) | 0 | 1,801 | (49,354) |
Other | (152) | 111 | 922 |
Net (loss) income before income taxes, Total | (4,367) | 294,299 | 77,521 |
Provision for income taxes | (2,022) | (1,143) | (808) |
Net (loss) income | (6,389) | 293,156 | 76,713 |
Undistributed earnings allocated to participating securities | 0 | (283) | (4,569) |
Net (loss) income allocable to common stockholders, basic | $ (6,389) | $ 292,873 | $ 72,144 |
Basic net (loss) income per share allocable to common stockholders | $ (0.05) | $ 2.32 | $ 0.62 |
Diluted net (loss) income per share allocable to common stockholders | $ (0.05) | $ 1.97 | $ 0.57 |
Weighted-average shares used in computing basic net (loss) income per share allocable to common stockholders | 128,733 | 126,398 | 116,264 |
Weighted-average shares used in computing diluted net (loss) income per share allocable to common stockholders | 128,733 | 150,797 | 133,006 |
Product | |||
Revenues: | |||
Total revenues | $ 213,295 | $ 713,645 | $ 437,099 |
Other Revenue | |||
Revenues: | |||
Total revenues | $ 18,989 | $ 9,038 | $ 2,343 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net (loss) income | $ (6,389) | $ 293,156 | $ 76,713 |
Other comprehensive income (loss), net of tax: | |||
Change in unrealized loss on marketable securities available-for-sale | 2,251 | (1,407) | (30) |
Cumulative foreign currency translation adjustments | 1,079 | (1,765) | (2,509) |
Total other comprehensive income (loss) | 3,330 | (3,172) | (2,539) |
Total comprehensive (loss) income | $ (3,059) | $ 289,984 | $ 74,174 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Preferred Stock | Additional Paid-in Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning Balances at Dec. 31, 2020 | $ 58,693 | $ 110 | $ 0 | $ 1,352,374 | $ 273 | $ (1,294,064) |
Beginning Balances (in shares) at Dec. 31, 2020 | 110,190,000 | 4,000 | ||||
Conversion of Preferred Stock | $ 4 | $ 0 | (4) | |||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 4,140,000 | (4,000) | ||||
Issuance of common stock upon exercise of stock options | 1,035,000 | |||||
Issuance of common stock upon release of restricted stock awards | 525,000 | |||||
Issuance Of Common Stock Upon Release Of Restricted Stock Awards | (107) | (107) | ||||
Issuance of common stock upon exercise of stock options | 6,684 | $ 2 | 6,682 | |||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement (Shares) | 2,879,000 | |||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement | 28,156 | $ 3 | $ 0 | 28,153 | ||
Issuance of common stock under Employee Stock Purchase Plan | 841 | 841 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 217,000 | |||||
Issuance of common stock upon exercise of warrants (Shares) | 3,959,000 | |||||
Issuance of common stock upon exercise of warrants | 59,888 | $ 4 | 0 | 59,884 | ||
Issuance of capped call options (see Note 10) | (27,240) | (27,240) | ||||
Stock compensation expense | 21,285 | 21,285 | ||||
Total other comprehensive income (loss) | (2,539) | (2,539) | ||||
Net (loss) income | 76,713 | 76,713 | ||||
Ending Balances at Dec. 31, 2021 | 222,374 | $ 123 | 0 | 1,441,868 | (2,266) | (1,217,351) |
Ending Balances (in shares) at Dec. 31, 2021 | 122,945,000 | |||||
Issuance of common stock upon exercise of stock options | 1,194,000 | |||||
Issuance of common stock upon release of restricted stock awards | 1,432,000 | |||||
Issuance Of Common Stock Upon Release Of Restricted Stock Awards | $ 1 | (1) | ||||
Issuance of common stock upon exercise of stock options | 9,640 | $ 2 | 0 | 9,638 | ||
Issuance of common stock under Employee Stock Purchase Plan | 1,430 | 1,430 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 154,000 | |||||
Issuance of common stock upon exercise of warrants (Shares) | 1,879,000 | |||||
Issuance of common stock upon exercise of warrants | 24,670 | $ 2 | 0 | 24,668 | ||
Stock compensation expense | 32,915 | 32,915 | ||||
Total other comprehensive income (loss) | (3,172) | (3,172) | ||||
Net (loss) income | 293,156 | 293,156 | ||||
Ending Balances at Dec. 31, 2022 | 581,013 | $ 128 | 0 | 1,510,518 | (5,438) | (924,195) |
Ending Balances (in shares) at Dec. 31, 2022 | 127,604,000 | |||||
Issuance of common stock upon exercise of stock options | 850,000 | |||||
Issuance of common stock upon exercise of stock options | 6,361 | $ 1 | 0 | 6,360 | ||
Issuance of common stock upon release of restricted stock awards | 915,000 | |||||
Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings | (6,370) | $ 1 | (6,371) | |||
Issuance of common stock under Employee Stock Purchase Plan | 1,535 | 1,535 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 161,000 | |||||
Stock compensation expense | 42,592 | 42,592 | ||||
Total other comprehensive income (loss) | 3,330 | 3,330 | ||||
Net (loss) income | (6,389) | (6,389) | ||||
Ending Balances at Dec. 31, 2023 | $ 622,072 | $ 130 | $ 0 | $ 1,554,634 | $ (2,108) | $ (930,584) |
Ending Balances (in shares) at Dec. 31, 2023 | 129,530,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | |||
Net (loss) income | $ (6,389) | $ 293,156 | $ 76,713 |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 4,342 | 3,812 | 4,296 |
Amortization of right-of-use assets | 2,934 | 2,856 | 2,762 |
Inventory write-off | 0 | 34,288 | 2,588 |
Amortization of premiums (accretion of discounts) on marketable securities | (16,555) | (4,181) | 470 |
Loss on debt extinguishment | 0 | 0 | 5,232 |
Change in fair value of warrant liability | 0 | (1,801) | 49,354 |
Stock-based compensation expense | 42,592 | 32,915 | 21,285 |
Non-cash interest expense | 1,120 | 1,088 | 1,608 |
Gain on sale of assets | (1,000) | (1,000) | (1,000) |
Bad debt expense (Note 9) | 12,313 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts and other receivables, net | 43,268 | (15,699) | (109,155) |
Inventories, net | 3,909 | (32,399) | (234) |
Prepaid manufacturing | 0 | 159,655 | (130,232) |
Prepaid expenses and other current assets | (4,673) | (11,865) | (64,558) |
Other assets | 570 | 87 | 175 |
Accounts payable | 1,952 | 691 | (767) |
CEPI accrual (Note 9) | 0 | (21,110) | 128,848 |
Lease liabilities | (3,629) | (3,125) | (3,234) |
Deferred revenue | 0 | (349,864) | 311,652 |
Accrued and other liabilities | 19,809 | (24,788) | 39,725 |
Net cash provided by operating activities | 100,563 | 62,716 | 335,528 |
Investing activities | |||
Purchases of marketable securities | (636,921) | (632,306) | (164,928) |
Proceeds from maturities and redemptions of marketable securities | 486,097 | 322,450 | 187,630 |
Purchases of property and equipment, net | (4,104) | (7,139) | (9,477) |
Proceeds from sale of assets, net of transaction costs | 1,000 | 1,000 | 1,000 |
Net cash (used in) provided by investing activities | (153,928) | (315,995) | 14,225 |
Financing activities | |||
Proceeds from issuances of common stock, net | 0 | 0 | 28,156 |
Proceeds from issuance of Convertible Notes, net | 0 | 0 | 219,822 |
Purchases of capped call options | 0 | 0 | (27,240) |
Repayment of long-term debt | 0 | 0 | (190,194) |
Proceeds from warrants exercises | 0 | 8,455 | 17,814 |
Proceeds from exercise of stock options and release of restricted stock awards, net | 6,360 | 9,639 | 6,577 |
Proceeds from Employee Stock Purchase Plan | 1,535 | 1,431 | 841 |
Payments for taxes related to net share settlement of RSUs | (6,509) | 0 | 0 |
Net cash provided by financing activities | 1,386 | 19,525 | 55,776 |
Effect of exchange rate changes on cash and cash equivalents, and restricted cash | 324 | (443) | (1,431) |
Net increase (decrease) in cash and cash equivalents, and restricted cash | (51,655) | (234,197) | 404,098 |
Cash and cash equivalents, and restricted cash at beginning of year | 202,211 | 436,408 | 32,310 |
Cash and cash equivalents, and restricted cash at end of year | 150,556 | 202,211 | 436,408 |
Supplemental disclosure of cash flow information | |||
Cash paid during the year for income taxes | 2,014 | 2,208 | 1,312 |
Cash paid during the year for interest | 5,638 | 5,638 | 9,815 |
Reclassification of contract asset from other current assets to other assets | 71,307 | 0 | 0 |
Reclassification of CEPI accrual to CEPI accrual long-term | (60,337) | 0 | 0 |
Advance Payments forgiven per CEPI-Bio E Assignment Agreement (Note 9) | (47,401) | 0 | 0 |
Non-cash investing and financing activities: | |||
Purchases of property and equipment, not yet paid | 299 | 1,015 | 591 |
Right-of-use assets obtained in exchange for operating lease liabilities | $ 1,332 | $ 2,848 | $ 2,468 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”) is a commercial stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. Our first marketed product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] is approved in the United States, the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. In May 2022, we commenced commercial shipments of HEPLISAV-B in Germany. We are advancing a pipeline of differentiated product candidates that leverage our CpG 1018® adjuvant, the adjuvant used in HEPLISAV-B, to develop improved vaccines in indications with unmet medical needs. These programs include vaccine candidates under development for shingles and Tdap, and a plague vaccine candidate program in collaboration with and fully funded by the U.S. Department of Defense ("DoD"). Additionally. we manufacture and have supplied in the past CpG 1018 adjuvant, the adjuvant used in HEPLISAV-B, through both commercial supply agreements, and through preclinical and clinical research collaborations with third-party organizations. As of December 31, 2022, we had satisfied all delivery obligations under our commercial supply agreements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include our accounts and those of our wholly-owned subsidiaries, Dynavax GmbH located in Düsseldorf, Germany, Dynavax India LLP in India and a branch of Dynavax in Italy. All intercompany accounts and transactions among the entities have been eliminated from the consolidated financial statements. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. Foreign Currency Translation We consider the local currency to be the functional currency for our international subsidiaries, Dynavax GmbH, located in Düsseldorf, Germany, Dynavax India LLP, and a branch of Dynavax registered in Italy. Accordingly, assets and liabilities denominated in this foreign currency 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 during the year. Currency translation adjustments arising from period to period are charged or credited to accumulated other comprehensive income (loss) in stockholders’ equity. As of Decemb er 31, 2023 and 2022, the cumulative translation adjustments balance was $ ( 3.0 ) million and $( 4.0 ) million, respectively, primarily related to the translation of Dynavax GmbH assets, liabilities and operating results from Euros to U.S. dollars. F or the years ended December 31, 2023, 2022 and 2021, we reported an unrealized foreign currency translation gain (loss) of $ 1.1 million, $( 1.8 ) million and $( 2.5 ) million, respectively. Realized gains and losses resulting from currency transactions are included in other (expense) income in the consolidated statements of operations. For the years ended December 31, 2023, 2022 and 2021, we reported a (loss) gain of $( 0.1 ) mi llion, $ 0.1 million and $ 0.9 million, respectively, resulting from currency transactions in our consolidated statements of operations. Segment Information Operating segments are defined as components of an entity for which discrete financial information is available that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. Our Chief Executive Officer is the CODM. The CODM reviews financial information presented on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. As such, management has determined that we operate in one operating segment that is focused on the discovery, development, and commercialization of innovative vaccines. Net assets outside of the U.S. w ere less than 10 % of total net assets as of December 31, 2023 and 2022. Cash and Cash Equivalents and Marketable Securities We consider all 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. treasuries, 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 loss in stockholders’ equity. Commencing with our adoption of (“ASC”) 326, Financial Instruments — Credit Losses (“ASC 326") on January 1, 2023, we determine whether a decline in the fair value of our available-for-sale ("AFS") debt securities below their amortized cost basis (i.e., an impairment) is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in other comprehensive income (loss), net of applicable taxes. Credit-related impairments (if any) are recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Both the allowance and the adjustment to net income can be reversed if conditions change. To date, there have been no declines in fair value that have been identified as a credit-related impairment. Concentration of Credit Risk and Other Risks and Uncertainties 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 the 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. treasuries, U.S. government agency securities and corporate debt securities. We have not experienced any significant losses on our cash equivalents and marketable securities. Our accounts receivable balance consists, primarily, of amounts due from product sales. Accounts receivable are recorded net of reserves for chargebacks, distribution fees, trade discounts and doubtful accounts. We estimate our allowance for doubtful accounts based on an evaluation of the aging of our receivables. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. During the year ended December 31, 2023, we recorded an allowance for doubtful accounts of $ 12.3 million, which was determined by assessing changes in Biological E. Limited's (“Bio E”) credit risk, contemplation of ongoing negotiations relating to Bio E Amendment No. 3 (See Note 9), and Bio E's dependence on cash collections from the Government of India, which have been delayed and significantly reduced in connection with the overall reduction in demand for CORBEVAX from the Government of India. As of December 31, 2023 and 2022 , three customers collectively represented approximately 81 % and 78 % of our HEPLISAV-B trade receivable balance, respectively. As of December 31, 2023, we had no CpG 1018 adjuvant trade receivable balance. As of December 31, 2022, one customer represented approximately 100 % of our CpG 1018 adjuvant trade receivable balance . Our product candidates will require approval from the United States Food and Drug Administration ("FDA") and foreign regulatory agencies before commercial sales can commence. There can be no assurance that our product candidates will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on our business and may impact our business in the future. In addition, after the approval of HEPLISAV-B by the FDA, there is still an ongoing risk of adverse events that did not appear during the drug approval process that could affect our authorizations in the future. 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 product candidates, product liability, the volatility of our stock price and the need to obtain additional financing. Our long-lived assets located in the United States as of December 31, 2023 and 2022, represented 31 % and 34 % of our total assets, respectively, and the remaining long-lived assets were located in Germany. Inventories HEPLISAV-B Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the years ended December 31, 2023 and 2022, there w ere no invento ry reserves or write-offs recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to the required regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory. Instead, those are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. CpG 1018 Adjuvant Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the year ended December 31, 2023, there was no remaining CpG 1018 adjuvant inventory balance. For the year ended December 31, 2022 , we recorded $ 34.3 million of inventory write-off to cost of sales - product, in connection with cancelled orders and the reduction in demand for CpG 1018 adjuvant reflected in the Clover Supply Agreement, as amended (See Note 9). 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, while 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, 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, undiscounted future operating cash flows of long-lived assets are compared to their respective carrying value. If the carrying value is greater than the undiscounted future operating cash flows of long-lived assets, the long-lived assets are written down to their respective fair values and an impairment loss is recorded. Fair value is determined primarily using the discounted cash flows expected to be generated from the use of assets. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. There have been no material adjustments to these estimates during the years presented. Leases We determine if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset, and whether we have the right to control the identified asset. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and long-term portion of lease liabilities in our consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term, and lease liabilities represent our obligation to make lease payments arising from the lease. The classification of our leases as operating or finance leases along with the initial measurement and recognition of the associated ROU assets and lease liabilities is performed at the lease commencement date. The measurement of ROU assets and lease liabilities is based on the present value of future lease payments over the lease term. The ROU asset also includes the effect of any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. As the implicit rate in our leases is generally unknown, we use our incremental borrowing rate based on information available at the lease commencement date in determining the present value of future lease payments. We consider our credit risk, term of the lease, total lease payments and adjust for the impacts of collateral, as necessary, when calculating our incremental borrowing rate. The lease terms may include options to extend or terminate the lease when it is reasonably certain we will exercise any such options. Rent expense for our operating leases is recognized on a straight-line basis over the lease term. Variable lease payments are recorded as an expense in the period incurred. We have elected not to apply the recognition requirements of Accounting Standards Codification ASC 842, Leases ("ASC 842") , for short-term leases. We have also elected the practical expedient to not separate lease components from non-lease components. As lessors, we determine if an arrangement includes a lease at inception. We elected the practical expedient to not separate lease components from non-lease components. Sublease income is recognized on a straight-line basis over the expected lease term and is included in other income (expense) in our consolidated statements of operations. Goodwill Goodwill represents the excess purchase price over the fair value of tangible and intangible assets acquired and liabilities assumed. Our goodwill balance relates to our acquisition of Dynavax GmbH in 2006. Goodwill is not amortized, but instead is reviewed for impairment test at least annually, or more frequently if events occur or circumstances change that would indicate the carrying amount may be impaired. Goodwill is assigned to, and impairment testing is performed at, the reporting unit level. 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. No impairment has been identified for the years presented. Convertible Notes We account for our 2.50 % convertible senior notes due in 2026 (“Convertible Notes”), as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the consolidated balance sheets (See Note 10). We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the Convertible Notes, using the effective interest method, as interest expense on the consolidated statements of operations. Capped Calls We evaluate financial instruments under ASC 815, Derivatives and Hedging ("ASC 815") . The capped calls purchased in connection with the Convertible Notes financing ("Capped Calls") cover the same number of shares of common stock that initially underlie the Convertible Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for the equity classification continue to be met. Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration, which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, Revenue from Contracts with Customers ("ASC 606") , we apply the following five step model: • identify the contract(s) with a customer; • identify the performance obligation(s) in the contract; • determine the transaction price; • allocate the transaction price to the performance obligation(s) in the contract; and • recognize revenue when (or as) we satisfy a performance obligation. Product Revenue, Net – HEPLISAV-B We sell HEPLISAV-B to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year , there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net - HEPLISAV-B, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks and rebates, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. Chargebacks: Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Rebates: Under certain contracts, Customers may obtain rebates for purchasing minimum volumes of our product. We estimate these rebates based upon the expected purchases and the contractual rebate rate and record this estimate as a reduction in revenue in the period the related revenue is recognized. Product Revenue, Net – CpG 1018 Adjuvant We also sell our innovative adjuvant, CpG 1018 adjuvant, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of Customers under ASC 606. Therefore, we accounted for our CpG 1018 adjuvant sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net - CpG 1018 adjuvant, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Our CpG 1018 adjuvant customers have purchased a significant quantity of CpG 1018 adjuvant as part of their initial COVID-19 vaccine development inventory. Accordingly, we did not recognize CpG 1018 adjuvant net product revenue during the year ended December 31, 2023. Other Revenue Other revenue includes revenue from our agreement with the DoD, collaboration and manufacturing service revenue. We have entered into grant agreements, collaborative arrangements and arrangements to provide manufacturing services to other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. 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. We estimate research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to us at that time. There have been no material adjustments to the prior period accrued estimates for clinical trial activities during the years presented. Stock-Based Compensation Stock-based compensation expense for restricted stock units ("RSUs"), market-based performance stock units ("PSUs") and stock options is estimated at the grant date based on the award’s estimated fair value. For awards that vest based on service conditions and market conditions, we use a straight-line method to recognize compensation expense over the award’s requisite service period, assuming estimated forfeiture rates. For awards that contain performance conditions, we determine the appropriate amount to expense at each reporting date based on the anticipated achievement of performance targets, which requires judgement, including forecasting the achievement of future specified targets. At the date performance conditions are determined to be probable of achievement, we record a cumulative expense catch-up, with remaining expense amortized over the remaining service period. Throughout the performance period, we re-assesses the estimated performance and updates the number of performance-based awards that we believe will ultimately vest. Fair value of RSUs is determined at the date of grant using our closing stock price, with the exception of PSUs, which are measured using the Monte Carlo simulation method on the date of grant. Our determination of the fair value 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 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 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 of stock options granted in the future. Changes in the fair value 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 expense recognized in future periods. We derive the expected term assumption primarily based on our historical settlement experience, while considering options that have not yet completed a full life cycle. Stock-based compensation expense 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 expense could be materially impacted in the period of revision. There have been no material adjustments to these estimates during the years presented. Income Taxes The asset and liability approach is used to recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. Tax law and rate changes are reflected in income in the period such changes are enacted. We include interest and penaltie |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements We measure 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. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. There wer e no t ransfers between Level 1, 2 and 3 during the years ended December 31, 2023 and 2022. The carrying amounts of cash equivalents, accounts and other receivables, 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, 2023 Assets Money market funds $ 131,635 $ - $ - $ 131,635 U.S. treasuries - 74,237 - 74,237 U.S. government agency securities - 216,688 - 216,688 Corporate debt securities - 308,552 - 308,552 Total assets $ 131,635 $ 599,477 $ - $ 731,112 Level 1 Level 2 Level 3 Total December 31, 2022 Assets Money market funds $ 172,418 $ - $ - $ 172,418 U.S. treasuries - 42,308 - 42,308 U.S. government agency securities - 88,032 - 88,032 Corporate debt securities - 292,051 - 292,051 Total assets $ 172,418 $ 422,391 $ - $ 594,809 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. U.S. treasuries, U.S. government agency securities and corporate debt securities are measured at fair value using Level 2 inputs. We review trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. Warrants were issued in connection with the underwritten public offering in August 2019 and are accounted for as a derivative liability at fair value (See Note 14). The fair value of the warrant liability was estimated using the Black-Scholes model, which requires assumptions such as expected term, expected volatility and risk-free interest rate. These assumptions are subjective and require judgment to develop. Expected term is estimated using the full remaining contractual term of the warrants. We determine expected volatility based on our historical common stock price volatility. The warrant liability was classified as a Level 3 instrument as its value was based on unobservable inputs that are supported by little or no market activity. As of December 31, 2022, all 1,882,600 of the outstanding warrants as of December 31, 2021 have been exercised or expired. The following table provides a summary of changes in the fair value warrant liability for year ended December 31, 2022 (in thousands): Balance at December 31, 2021 $ 18,016 Decrease in fair value of warrants exercised ( 1,801 ) Warrants exercised or expired ( 16,215 ) Balance at December 31, 2022 $ - |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 4. Cash and Cash Equivalents, Restricted Cash and Marketable Securities The following table provides a reconciliation of cash and cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows (in thousands): December 31, 2023 2022 2021 Cash and cash equivalents $ 150,279 $ 202,004 $ 436,189 Restricted cash (1) 277 207 219 Total cash and cash equivalents, and restricted cash shown in the $ 150,556 $ 202,211 $ 436,408 (1) Restricted cash is included in "Other assets" in the Consolidated Balance Sheets. Restricted cash balances relate to certificates of deposit issued as collateral to certain letters of credit issued as security to our lease arrangements (See Note 8). Cash and cash equivalents, and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated December 31, 2023 Cash and cash equivalents: Cash $ 11,190 $ - $ - $ 11,190 Money market funds 131,635 - - 131,635 Corporate debt securities 7,453 1 - 7,454 Total cash and cash equivalents 150,278 1 - 150,279 Marketable securities available-for-sale: U.S. treasuries 74,109 172 ( 44 ) 74,237 U.S. government agency securities 216,265 692 ( 269 ) 216,688 Corporate debt securities 300,803 315 ( 20 ) 301,098 Total marketable securities available-for-sale 591,177 1,179 ( 333 ) 592,023 Total cash and cash equivalents, and marketable securities $ 741,455 $ 1,180 $ ( 333 ) $ 742,302 December 31, 2022 Cash and cash equivalents: Cash $ 29,586 $ - $ - $ 29,586 Money market funds 172,418 - - 172,418 Total cash and cash equivalents 202,004 - - 202,004 Marketable securities available-for-sale: U.S. treasuries 42,502 - ( 194 ) 42,308 U.S. government agency securities 88,429 - ( 397 ) 88,032 Corporate debt securities 292,865 12 ( 826 ) 292,051 Total marketable securities available-for-sale 423,796 12 ( 1,417 ) 422,391 Total cash and cash equivalents, and marketable securities $ 625,800 $ 12 $ ( 1,417 ) $ 624,395 The maturities of our marketable securities available-for-sale are as follows (in thousands): . December 31, 2023 Amortized Estimated Mature in one year or less $ 440,131 $ 440,104 Mature after one year through two years 151,046 151,919 $ 591,177 $ 592,023 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. Unrealized losses are included in accumulated other comprehensive loss in stockholders’ equity. Commencing with our adoption of ASC 326 on January 1, 2023, we determine whether a decline in the fair value of our AFS debt securities below their amortized cost basis (i.e., an impairment) is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in other comprehensive income (loss), net of applicable taxes. Credit-related impairments (if any) are recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Both the allowance and the adjustment to net income can be reversed if conditions change. There we re no realized gains or losses from the sale of marketable securities for the years ended December 31, 2023 and 2022. We do not intend to sell, and are not required to sell, the investments that are in an unrealized loss position before recovery of their amortized cost basis. For the year ended December 31, 2023, we did not record an allowance for credit losses, as management believes any such losses would be immaterial based on the investment-grade credit rating for each of the investments as of December 31, 2023. As such, there have been no declines in fair value that have been identified as a credit-related impairment. |
Inventories, Net
Inventories, Net | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories, net | 5. Inventories The following table presents inventories (in thousands): December 31, 2023 2022 Raw materials $ 27,256 $ 25,517 Work-in-process 18,954 23,934 Finished goods 7,080 9,995 Total $ 53,290 $ 59,446 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, net Property and equipment consist of the following (in thousands): Estimated Useful December 31, Life (In years) 2023 2022 Manufacturing equipment 5 - 13 $ 15,752 $ 15,139 Lab equipment 5 - 13 2,827 2,360 Computer equipment 3 5,060 4,720 Furniture and fixtures 3 - 13 2,467 2,464 Leasehold improvements 2 - 12 37,201 28,822 Assets in progress 5,822 11,613 69,129 65,118 Less accumulated depreciation and amortization ( 31,832 ) ( 27,522 ) Total $ 37,297 $ 37,596 Depreciation and amortization expense on property and equipment was $ 4.3 mil lion, $ 3.8 million and $ 4.3 million for the years ended December 31, 2023, 2022 and 2021, respectively. |
Current Accrued Liabilities
Current Accrued Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Disclosure Component Of Current Accrued Liabilities And Accrued Research And Development [Abstract] | |
Current Accrued Liabilities | 7. Current Accrued Liabilities Current accrued liabilities consist of the following (in thousands): December 31, 2023 2022 Payroll and related expenses $ 17,069 $ 14,261 Revenue reserve accruals 21,004 10,552 Accrued inventory 4,456 2,209 Other accrued liabilities 6,919 3,697 Total $ 49,448 $ 30,719 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Leases We lease our facilities in Emeryville, California and Düsseldorf, Germany. We lease and sublease certain manufacturing and office space with lease terms ranging from 3 to 12 years. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include options to renew or extend the lease for two successive five-year terms. These optional periods have not been considered in the determination of the right-of-use assets or lease liabilities associated with these leases as we did not consider the exercise of these options to be reasonably certain. We also sublease one of our leased premises to a third party. Rent is subject to scheduled annual increases and the subtenant is responsible for certain operating expenses and taxes throughout the life of the sublease. The sublease term expires on March 31, 2031 , unless earlier terminated, concurrent with the term of our lease. The subtenant has no option to extend the sublease term. Sublease income wa s $ 7.6 m illion, $ 7.7 million and $ 7.7 million for the years ended December 31, 2023, 2022 and 2021, respectively. Sublease income is included in other income (expense) in our consolidated statements of operations. Rent received from the subtenant in excess of rent paid to the landlord shall be shared by paying the landlord 50 % of the excess rent. The excess rent is considered a variable lease payment and the total estimated payments are being recognized as additional rent expense on a straight-line basis. Our lease expense comprises of the following (in thousands): Year Ended December 31, 2023 2022 2021 Operating lease expense $ 5,563 $ 6,222 $ 6,265 Cash paid for amounts included in the measurement of lease liabilities for the years ended December 31, 2023, 2022, and 2021 was $ 7.2 million, $ 6.8 million, and $ 7.0 million, respectively and were included in change in lease liabilities in our consolidated statement of cash flows. The balance sheet classification of our operating lease liabilities was as follows (in thousands): December 31, 2023 2022 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 4,496 $ 3,631 Long-term portion of lease liabilities 29,720 32,801 Total operating lease liabilities $ 34,216 $ 36,432 As of December 31, 2023, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2024 $ 5,684 $ 7,605 2025 5,854 6,980 2026 6,030 6,122 2027 6,211 6,052 2028 6,397 6,215 Thereafter 15,103 15,062 Total $ 45,279 48,036 Less: Present value adjustment ( 13,820 ) Total $ 34,216 The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liabilities were as follows: December 31, 2023 2022 Weighted average remaining lease term 6.7 years 7.6 years Weighted average discount rate 10.1 % 10.1 % Commitments As of December 31, 2023, our material non-cancelable purchase and other commitments for the supply of HEPLISAV-B totaled $ 43.4 million. The following summarizes our material purchase commitments at December 31, 2023 and the effect those obligations are expected to have on our liquidity and cash flows in future periods (in thousands): Years ending December 31, (in thousands) 2024 $ 18,866 2025 11,983 2026 12,516 2027 - 2028 - Thereafter - Total $ 43,365 On September 7, 2023 (the “Effective Date”), we entered into an agreement (the “Avecia Supply Agreement”) with Nitto Denko Avecia Inc. (“Avecia”) for the manufacture and supply of our CpG 1018 adjuvant using a specific production process. Under the Avecia Supply Agreement, Avecia has agreed to produce and supply to us quantities of CpG 1018 adjuvant ordered by us after the Effective Date. Subject to certain conditions in the Avecia Supply Agreement, we are obligated to purchase all of our annual volume requirements of CpG 1018 adjuvant from Avecia up to a specified production capacity. We may alternatively order CpG 1018 adjuvant produced using a different production process pursuant to the existing supply agreement between us and Avecia dated October 1, 2012 (the “2012 Agreement”). As of December 31, 2023, our aggregate minimum commitment for the supply of CpG 1018 adjuvant under the Avecia Supply Agreement was $ 7.4 million within the next 12 months. As of December 31, 2022, w e had no non-cancelable purchase and other commitments for the supply of CpG 1018 adjuvant . 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 also rely on and have entered into agreements with research institutions, contract research organizations and clinical investigators as well as clinical material manufacturers. 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. As of December 31, 2023, the aggregate principal amount of our convertible senior notes ("Convertible Notes") was $ 225.5 million, excluding debt discount of $ 2.8 million (See Note 10). During 2004, we 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 30, 2023 and was collateralized by a certificate of deposit for € 0.2 million, which has been included in restricted cash in the consolidated balance sheets as of December 31, 2023 and 2022. In conjunction with our agreement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50 % of the first $ 50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including our immune-oncology compound, SD-101. In July 2020, we sold assets related to SD-101 to Surefire Medical, Inc. d/b/a TriSalus Life Sciences (“TriSalus”). We paid $ 2.5 million to Holdings in August 2020. In each of September 2021, May 2022 and September 2023, we received $ 1.0 million from TriSalus because it met pre-commercialization milestones. We recorded the proceeds as gain on sale of assets in our consolidated statements of operations. We paid Holdings $ 0.5 million in each of September 2021, May 2022 and October 2023. We included the payments in selling, general and administrative expenses in our consolidated statements of operations. Contingencies 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, results of operations, or cash flows in a particular period. |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
Collaborative Research, Development and License Agreements | 9. Collaborative Research, Development and License Agreements Coalition for Epidemic Preparedness Innovations In January 2021, we entered into an agreement (together with subsequent amendments, the “CEPI Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) for the manufacture and reservation of a specified quantity of CpG 1018 adjuvant (“CpG 1018 Materials”). In May 2021, we entered into the first amendment to the CEPI Agreement. The CEPI Agreement enables CEPI to direct the supply of CpG 1018 Materials to CEPI partner(s). CEPI partner(s) would purchase CpG 1018 Materials under separately negotiated agreements. The CEPI Agreement also allows us to sell CpG 1018 Materials to third parties if not purchased by a CEPI partner within a two-year term. In exchange for reserving CpG 1018 Materials and agreeing to sell CpG 1018 Materials to CEPI partner(s) at pre-negotiated prices, CEPI agreed to provide payments in the form of an interest-free, unsecured, forgivable loan (the “Advance Payments”). We are obligated to repay the Advance Payments, in proportion to quantity sold, if and to the extent we receive payments from sales of CpG 1018 Materials reserved under the CEPI Agreement. If the vaccine programs pursued by CEPI partner(s) are unsuccessful and no alternative use is found for CpG 1018 Materials reserved under the CEPI Agreement, the applicable Advance Payments will be forgiven at the end of the two-year term. On April 27, 2023, we entered into a waiver and second amendment to the CEPI Agreement by and between us and CEPI (the “CEPI-Bio E Assignment Agreement”). Pursuant to the CEPI-Bio E Assignment Agreement, CEPI has forgiven the entirety of the outstanding Advance Payments for CpG 1018 Materials allocated to and ordered by Bio E under the CEPI Agreement and has assumed our previous rights to $ 47.4 million of Bio E accounts receivable. Through Decembe r 31, 2023, we received Advance Payments totaling approximately $ 175.0 million pursuant to the CEPI Agreement, of which $ 67.3 million have been repaid and $ 47.4 million have been forgiven (as discussed above). As of December 31, 2023, remaining Advance Payments totaling $ 60.3 million in CEPI accrual long-term were reflected in our consolidated balance sheets, representing the outstanding balance of the Advance Payments relating to the Clover Supply Agreement (as defined and discussed below). As of December 31, 2022, we recorded Advance Payments of $ 107.7 million included in CEPI accrual. There were no deferred revenue balances related to the CEPI Agreement as of December 31, 2023 and December 31, 2022. Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited In June 2021, we entered into an agreement with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited (collectively, “Clover”), for the commercial supply of CpG 1018 adjuvant, for use with Clover’s COVID-19 vaccine candidate, SCB-2019 (together with subsequent amendments, the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Clover’s commercialization of vaccines containing SCB-2019 and CpG 1018 adjuvant (“Clover Product”). The Clover Supply Agreement also provides terms for Clover to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. In 2022 and 2023, we signed four amendments to the Clover Supply Agreement. The terms and conditions of the Clover Supply Agreement were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder. For CpG 1018 adjuvant reserved for Clover under the CEPI Agreement, Clover is obligated to pay us the purchase price upon the earliest of (i) the true-up exercise, (ii) within a specified period after Clover delivers Clover Product to a customer, or (iii) Clover’s receipt of payment for Clover Product from a customer. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement, we recognize product revenue and a corresponding contract asset as our right to consideration is contingent on something other than the passage of time, as outlined above. The contract asset of $ 71.3 million relating to Clover was included in other current assets as of December 31, 2022. The contract asset was subsequently reclassified to other assets (long term) and remains classified in other assets (long term) as of December 31, 2023. The contract asset was reclassified to other assets (long term) to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. Corresponding Advance Payments of $ 60.3 million relating to Clover are recorded in CEPI accrual long-term in our consolidated balance sheets as of December 31, 2023. These Advance Payments may be repaid using cash collected from Clover or forgiven in accordance with the CEPI Agreement. We had no accounts receivable balance from Clover as of December 31, 2023 and December 31, 2022. We did no t recognize CpG 1018 adjuvant net product revenue from Clover for the year ended December 31, 2023. We recognized CpG 1018 adjuvant net product revenue o f $ 288.0 mill ion for the year ended December 31, 2022. Additionally, during the year ended December 31, 2022 and in connection with amendments to the Clover Supply Agreement, which reduced or cancelled certain orders for CpG 1018 adjuvant, we recorded an inventory write-off of $ 34.3 million of excess CpG 1018 adjuvant raw materials and finish goods inventory. This excess inventory write-off was reflected as a charge to cost of sales – product, in the consolidated statements of operations for the year ended December 31, 2022. Biological E. Limited In July 2021, we entered into an agreement (together with subsequent amendments, the “Bio E Supply Agreement”) with Biological E. Limited (“Bio E”), for the commercial supply of CpG 1018 adjuvant, for use with Bio E’s subunit COVID-19 vaccine candidate, CORBEVAX. Under the Bio E Supply Agreement, Bio E committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Bio E’s commercialization of its CORBEVAX vaccine (“Bio E Product”) with specified delivery dates in 2021 and the first quarter of 2022. The Bio E Supply Agreement also provides terms for Bio E to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. In June 2022 and in October 2022, we entered into amendments to the Bio E Supply Agreement (the “Bio E Amendment No. 1” and the “Bio E Amendment No. 2,” together the “Bio E Amendments”). The Bio E Amendments primarily established: (i) a new payment schedule for certain outstanding invoices related to the CEPI product to be the earlier of December 31, 2022, or receipt of certain amounts from Bio E from the Government of India in connection with their advance purchase agreement for CORBEVAX, and (ii) further modified the scope of the Bio E Supply Agreement, by reducing certain quantities of CpG 1018 adjuvant to be delivered. The terms and conditions of the Bio E Supply Agreement were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder. As of December 31, 2023, we had no accounts receivable balance from Bio E. During the first quarter of 2023, we recorded an allowance for doubtful accounts of $ 12.3 million, which was determined by assessing changes in Bio E’s credit risk, contemplation of ongoing negotiations relating to Bio E Amendment No. 3 (defined below), and Bio E's dependence on cash collections from the Government of India, which have been delayed and significantly reduced in connection with the overall reduction in demand for CORBEVAX from the Government of India. On April 26, 2023, we entered into a third amendment to the Bio E Supply Agreement (the “Bio E Amendment No. 3”), and on April 27, 2023, we entered into the CEPI-Bio E Assignment Agreement. Pursuant to the CEPI-Bio E Assignment Agreement, CEPI has forgiven the entirety of remaining amounts outstanding relating to a liability for Advance Payments of $ 47.4 million (the “Bio E CEPI Advance Payments”) for CpG 1018 Materials allocated to Bio E, and has assumed our previous rights to collect $ 47.4 million of Bio E accounts receivable. Pursuant to the Bio E Amendment No. 3, we collected $ 14.5 million from Bio E (including $ 13.5 million in April 2023 and $ 1.0 million in August 2023). Accordingly, as of December 31, 2023, the CEPI-Bio E Assignment Agreement resulted in: (i) no accounts receivable balance, and (ii) the derecognition of $ 47.4 million CEPI accrual in connection with the Bio E CEPI Advance Payments. The Bio E Amendment No. 3 provides for additional future payment of either $ 5.5 million in the event that Bio E receives at least $ 125.0 million, or $ 12.3 million in the event that Bio E receives at least $ 250.0 million in future payments from the Government of India associated with its CORBEVAX product on or before August 15, 2025. These additional amounts are not considered collectible until the achievement of these future milestones. We did no t recognize CpG 1018 adjuvant net product revenue from Bio E for the year ended December 31, 2023. We recognized CpG 1018 adjuvant net product revenue of $ 206.2 million for the year ended December 31, 2022. U.S. Department of Defense In September 2021, we entered into an agreement with the DoD for the development of a recombinant plague vaccine adjuvanted with CpG 1018 adjuvant for approximately $ 22.0 million over two and a half years. Under the agreement, we are conducting a Phase 2 clinical trial combining our CpG 1018 adjuvant with the DoD's rF1V vaccine. In July 2023, we executed a contract modification with the DoD to support advancement into a nonhuman primate challenge study, with the agreement now totaling $ 33.7 million through 2025. For the years ended December 31, 2023 and 2022, we recognized revenue of $ 17.6 million and $ 8.8 million, respectively, which is included in other revenue in our consolidated statements of operations. |
Convertible Notes
Convertible Notes | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Convertible Notes | 10. Convertible Notes In May 2021, we issued $ 225.5 million of Convertible Notes in a private placement. Total proceeds from the issuance of the Convertible Notes, net of debt issuance and offering costs of $ 5.7 million, were $ 219.8 million. We used $ 190.2 million of the net proceeds to retire our previous loan agreement with CRG Servicing LLC and $ 27.2 million of the net proceeds to pay the costs of the Capped Calls described below. The Convertible Notes are general, unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021. The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased prior to such date. The Convertible Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, at an initial conversion rate of 95.5338 shares of our common stock per $ 1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $ 10.47 per share of our common stock. The Convertible Notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding February 15, 2026, only under the following circumstances: • During any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price on each applicable trading day; • During the five business day period after any ten consecutive trading day period (the “measurement period”), in which the “trading price” (as defined in the indenture governing the Convertible Notes) per $ 1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; • If we call such Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or • Upon the occurrence of specified corporate events as set forth in the indenture governing the Convertible Notes. On or after February 15, 2026, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders of the Convertible Notes may convert all or any portion of their Convertible Notes regardless of the foregoing circumstances. Since we have the election of repaying the Convertible Notes in cash, shares of our common stock, or a combination of both, we continued to classify the Convertible Notes as long-term debt on the consolidated balance sheets as of December 31, 2023. We may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation described in the indenture governing the Convertible Notes), at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If we undergo a fundamental change (as set forth in the indenture governing the Convertible Notes), noteholders may require us to repurchase for cash all or any portion of their Convertible Notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events (as set forth in the indenture governing the Convertible Notes) or if we deliver a notice of redemption prior to the maturity date, we will, in certain circumstances, adjust the conversion rate for a noteholder who elects to convert its notes in connection with such a corporate event or such notice of redemption. We accounted for the Convertible Notes as a single liability in accordance with ASU 2020-06 - Accounting for Convertible Instruments and Contracts in an Entity's Own Equity (“ASU 2020-06”). As of December 31, 2023, the Convertible Notes were recorded at the aggregate principal amount of $ 225.5 million less unamortized issuance costs of $ 2.8 million as a long-term liability on the consolidated balance sheets. As of December 31, 2023, the fair value of the Convertible Notes was $ 330.1 million. The fair value was estimated using a reputable third-party valuation model based on observable inputs and is considered Level 2 in the fair value hierarchy. The debt issuance costs are amortized to interest expense over the contractual term of the Convertible Notes at an effective interest rate of 3.1 %. The following table presents the components of interest expense related to Convertible Notes (in thousands): Year Ended December 31, 2023 2022 Stated coupon interest $ 5,636 $ 5,638 Amortization of debt issuance cost 1,121 1,094 Total interest expense $ 6,757 $ 6,732 Capped Calls In connection with the issuance of the Convertible Notes, we entered into capped call transactions with one of the initial purchasers of the Convertible Notes and other financial institutions, totaling $ 27.2 million (the “Capped Calls”). The Capped Calls cover, subject to customary adjustments, the number of shares of our common stock that initially underlie the Convertible Notes (or 21,542,871 shares of our common stock). The Capped Calls have an initial strike price and an initial cap price of $ 10.47 per share and $ 15.80 per share, respectively, subject to certain adjustments. Conditions that cause adjustments to the initial strike price of the Capped Calls mirror conditions that result in corresponding adjustments to the conversion price of the Convertible Notes. The Capped Calls are expected to offset the potential dilution to our common stock as a result of any conversion of the Convertible Notes, subject to a cap based on the cap price. For accounting purposes, the Capped Calls are considered separate financial instruments and not part of the Convertible Notes. As the Capped Calls transactions meet certain accounting criteria, we recorded the cost of the Capped Calls, totaling $ 27.2 million, as a reduction to additional paid-in capital within the consolidated statements of stockholders’ equity. |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 11. Long-Term Debt Long-Term Debt On February 20, 2018, we entered into a $ 175.0 million term Loan Agreement with CRG Servicing LLC. We borrowed $ 100.0 million under the Loan Agreement at closing and the remaining $ 75.0 million in March 2019 (collectively, “Term Loans”). Net proceeds under the Loan Agreement were $ 173.3 million. The Term Loans under the Loan Agreement bore interest at a rate equal to 9.5 % per annum. The Term Loans had a maturity date of December 31, 2023 . In May 2021, we repaid the principal on the Term Loans, in full, using the net proceeds from the Convertible Notes issuance. In connection with the early repayment of the Term Loans, in the year ended December 31, 2021, we recorded $ 5.2 million loss on debt extinguishment related to the amount we paid to terminate the Term Loans in excess of its carrying value at the time of the repayment. Our final payment of $ 190.2 million to CRG Servicing LLC satisfied all of our obligations under the Loan Agreement. With the full repayment of the Term Loans, all security interests, covenants, liens and encumbrances under the Loan Agreement were permanently released. We recorded $ 7.0 million of i nterest expense related to the Term Loans during the year ended December 31, 2021. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2023 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 12. Revenue Recognition Disaggregation of Revenues The following table disaggregates our product revenue, net by product and geographic region and disaggregates our other revenues by geographic region (in thousands): Year Ended Year Ended Year Ended December 31, 2023 December 31, 2022 December 31, 2021 U.S. Non U.S. Total U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 213,295 $ - $ 213,295 $ 124,996 $ 941 $ 125,937 $ 61,870 $ - $ 61,870 CpG 1018 adjuvant - - - - 587,708 587,708 - 375,229 375,229 Total product revenue, net $ 213,295 $ - $ 213,295 $ 124,996 $ 588,649 $ 713,645 $ 61,870 $ 375,229 $ 437,099 Other revenue 17,650 1,339 18,989 8,774 264 9,038 1,915 428 2,343 Total revenues $ 230,945 $ 1,339 $ 232,284 $ 133,770 $ 588,913 $ 722,683 $ 63,785 $ 375,657 $ 439,442 Revenues from Major Customers and Collaboration Partners All of our HEPLISAV-B sales in the U.S. are to certain wholesalers and specialty distributors whose principal customers include independent hospitals and clinics, integrated delivery networks, public health clinics and prisons, the Department of Defense, the Department of Veterans Affairs and retail pharmacies. All of our HEPLISAV-B sales in Germany are to one distributor. The following table summarizes HEPLISAV-B product revenue from each of our three largest customers (as a percentage of total HEPLISAV-B net product revenue): Year Ended December 31, 2023 2022 2021 Largest customer 28 % 21 % 21 % Second largest customer 27 % 17 % 19 % Third largest customer 17 % 16 % 19 % The following table summarizes CpG 1018 adjuvant product revenue from each of our three largest collaboration partners (as a percentage of total CpG 1018 adjuvant product revenue): Year Ended December 31, 2023 2022 2021 Largest collaboration partner 0 % 49 % 49 % Second largest collaboration partner 0 % 35 % 24 % Third largest collaboration partner 0 % 12 % 19 % Contract Balances The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories (in thousands): Balance at Provisions Credit or payments Adjustments related to prior periods Balance Year ended December 31, 2023: Accounts receivable reserves (1) $ 8,179 $ 55,604 $ ( 54,143 ) $ ( 2,629 ) $ 7,011 Revenue reserve accruals (2) $ 10,552 $ 46,062 $ ( 38,207 ) $ 2,597 $ 21,004 Year ended December 31, 2022: Accounts receivable reserves (1) $ 3,823 $ 34,758 $ ( 30,402 ) $ - $ 8,179 Revenue reserve accruals (2) $ 8,253 $ 24,806 $ ( 22,507 ) $ - $ 10,552 (1) Reserves are for chargebacks, discounts and other fees . (2) Accruals are for returns, rebates and other fees . When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement to Clover and perform services under our agreement with the DoD, we recognize product revenue and a corresponding contract asset as our right to consideration is conditioned on something other than the passage of time. See Note 9 for fu rther discussion. The following table summarizes balances and activities in our contract asset account (in thousands): Balance at Additions Subtractions Reclassification (1) Balance Year ended December 31, 2023: Contract asset, included in other current assets (2) $ 71,965 $ 17,650 $ ( 16,919 ) $ ( 71,307 ) $ 1,389 Contract asset, included in other assets (long term) $ - $ - $ - $ 71,307 $ 71,307 Year ended December 31, 2022: Contract asset $ 62,525 $ 17,556 $ ( 8,116 ) $ - $ 71,965 (1) The Clover contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. See Note 9 for further discussion. (2) The $1.4 million of contract asset is derived from our agreement with the DoD . |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net (Loss) Income Per Share Basic net (loss) income per share is computed by dividing net (loss) income attributable to common stockholders by the weighted-average number of shares of our common stock outstanding. For the calculation of diluted net income per share, net income attributable to common stockholders for basic net income per share is adjusted by the effect of dilutive securities, including awards under our equity compensation plans and change in fair value of warrant liability. Diluted net income per share attributable to common stockholders is computed by dividing the resulting net income attributable to common stockholders by the weighted-average number of fully diluted common shares outstanding. The numerators and denominators of the basic net (loss) income and diluted net income per share computations for our common stock are calculated as follows (in thousands): Year Ended December 31, 2023 2022 2021 Numerator Net (loss) income $ ( 6,389 ) $ 293,156 $ 76,713 Less: undistributed earnings allocated to participating securities ( 283 ) ( 4,569 ) Net (loss) income allocable to common stockholders, basic ( 6,389 ) 292,873 72,144 Add: undistributed earnings allocated to Series B and warrants - 283 4,569 Less: undistributed earnings allocated to Series B and warrants - - ( 4,190 ) Add: interest expense on convertible notes - 5,044 3,168 Less: removal of change in fair value of warrant liability - ( 1,801 ) - Net (loss) income allocable to common stockholders, diluted $ ( 6,389 ) $ 296,399 $ 75,691 Denominator Weighted average shares used to compute net (loss) income 128,733 126,398 116,264 Effect of dilutive shares: Stock-based compensation plans - 2,774 3,075 Convertible Notes (as converted to common stock) - 21,543 13,667 Effect of dilutive warrants - 82 - Weighted average shares used to compute net (loss) income 128,733 150,797 133,006 The following were excluded from the calculation of diluted net (loss) income per share as the effect of their inclusion would have been anti-dilutive (in thousands). December 31, 2023 2022 2021 Outstanding securities not included in diluted net (loss) income Stock options and stock awards 15,158 7,165 5,953 Convertible Notes (as converted to common stock) 21,543 - - Warrants (as exercisable into common stock) - - 1,883 |
Common Stock and Warrants
Common Stock and Warrants | 12 Months Ended |
Dec. 31, 2023 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock and Warrants | 14. Common Stock and Warrants Common Stock Outstanding As of December 31, 2023, there were 129,530,228 sh ares of our common stock outstanding. We entered into an at-the-market Sales Agreement with Cowen and Company, LLC (“Cowen”) on August 6, 2020 and an amendment to such agreement on August 3, 2023 (the sales agreement as amended, the “ATM Agreement”). Under the ATM Agreement, we may offer and sell from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $ 120.0 million through Cowen as our sales agent. We agreed to pay Cowen a commission of up to 3 % of the gross sales proceeds of any common stock sold through Cowen under the ATM Agreement. As of December 31, 2023, w e ha d approximately $ 120.0 million rema ining under the ATM Agreement. Warrants During the year ended December 31, 2022, all of the 1,882,600 outstanding warrants as of December 31, 2021 were exercised or expired, resulting in cash proceeds totaling $ 8.5 million. For the year ended December 31, 2022, we recognized the decrease in the estimated fair value of warrant liability of $ 1.8 million as income in other income (expense) in our consolidated statements of operations. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement, Noncash Expense [Abstract] | |
Equity Plans and Stock-Based Compensation | 15. Equity Plans and Stock-Based Compensation Equity Plans In January 2021, we adopted the Dynavax Technologies Corporation 2021 Inducement Award Plan (“2021 Inducement Plan”), pursuant to which we reserved 1,500,000 shares of common stock for issuance under the plan to be used exclusively for grants of awards to individuals who were not previously our employees or directors. In June 2021, we amended the 2021 Inducement Plan (“Amended 2021 Inducement Plan”) to increase the number of shares of common stock reserved under the 2021 Inducement Plan to 3,250,000 . The Amended 2021 Inducement Plan was terminated effective as of April 3, 2022 and, therefore, there are no shares of our common stock available for grant. In May 2022, our stockholders approved the amendment and restatement of our 2018 Equity Incentive Plan (the “Amended 2018 EIP”) to, among other things, increase the authorized number of shares of common stock by 15,000,000 . The maximum number of shares of common stock that may be issued under the Amended 2018 EIP, will not exceed 32,600,000 shares of common stock. As of December 31, 2023, the Amended 2018 EIP and the Amended and Restated 2014 Employee Stock Purchase Plan are our active plans (the "Plans"). The Amended 2018 EIP is administered by our Board of Directors, or a designated committee of the Board of Directors, and awards granted under the Amended 2018 EIP have a term of 7 years unless earlier terminated by the Board of Directors. As of December 31, 2023, there were 9,388,428 shares of common stock reserved for issuance under the Amended 2018 EIP. Under our Amended 2018 EIP, we may grant stock options, RSUs, performance-based awards, and other awards that are settled in shares of our common stock. Our equity awards generally vest over a three-year period contingent upon continuous service and unless exercised, expire seven or ten years from the date of grant (or earlier upon termination of continuous service). Activity under our stock plans is set forth below: Stock Options The following table summarizes the activity of stock options for the year ended December 31, 2023: Shares Underlying Weighted-Average Exercise Weighted-Average Aggregate Balance at December 31, 2022 9,339 $ 10.70 4.61 $ 16,291 Options granted 1,982 11.17 Options exercised ( 850 ) 7.48 Options cancelled: Options forfeited (unvested) ( 90 ) 10.93 Options expired (vested) ( 261 ) 21.39 Balance at December 31, 2023 10,120 $ 10.78 4.18 $ 37,388 Vested and expected to vest at December 31, 2023 9,976 $ 10.77 4.15 $ 37,024 Exercisable at December 31, 2023 7,014 $ 10.40 3.50 $ 29,613 Stock-based compensation expense related to options was approximat ely $ 18.7 milli on, $ 17.2 million and $ 11.1 million for the years ended December 31, 2023, 2022 and 2021, respectively . The total intrinsic value of stock options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 5.0 million, $ 7.7 million, and $ 7.9 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, 2023, 2022 and 2021 was $ 19.5 million, $ 17.5 million and $ 9.0 million, respectively. Restricted Stock Units The following table summarizes the activity of RSUs for the year ended December 31, 2023: Number of Shares Weighted-Average Non-vested as of December 31, 2022 3,479 $ 11.00 Granted 2,748 11.48 Vested (1) ( 1,515 ) 10.13 Forfeited ( 267 ) 11.45 Non-vested as of December 31, 2023 4,445 $ 11.57 (1) Inclusive of approximately 600,145 RSUs for the year ended December 31, 2023, which were not converted into shares due to net share settlement in order to cover the required amount of employee withholding taxes. The value of the withheld shares was classified as a reduction to additional paid-in capital. Stock-based compensation expense related to RSUs was approximat ely $ 20.4 milli on, $ 13.2 million and $ 7.9 million for the years ended December 31, 2023, 2022 and 2021, respectively . The aggregate fair value of the RSUs outstanding as of December 31, 2023, 2022 and 2021, based on our stock price on that date, was $ 62.2 mi llion, $ 37.0 million and $ 37.3 million, respectively. The total fair value of RSUs vested during the years ended December 31, 2023, 2022 and 2021 was $ 16.1 m illion, $ 15.7 million and $ 4.7 million, respectively. Market-based Performance Stock Units We granted PSUs to certain executives. These PSUs vest upon a specified market condition. The summary of PSU activities for the year ended December 31, 2023 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2022 193 $ 11.62 Granted 364 18.25 Non-vested as of December 31, 2023 557 $ 15.95 Stock-based compensation expense related to PSUs was approximately $ 2.5 million, $ 0.8 million and $ 1.8 million for the years ended December 31, 2023, 2022 and 2021, respectively. The aggregate intrinsic value of the PSUs outstanding as of December 31, 2023, 2022 and 2021, based on our stock price on that date, was $ 7.8 million, $ 2.1 million and $ 3.3 million, respectively. Performance-based Options As of December 31, 2023, approximatel y 36,000 shares underlying performance-based options were outstanding. Significant Assumptions in Estimating Option Fair Value T he fair value of each time-based option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows : Stock Options Market-Based Performance Stock Units Employee Stock Purchase Plan Year Ended December 31, Year Ended December 31, Year Ended December 31, 2023 2022 2021 2023 2022 2021 2023 2022 2021 Weighted-average fair value $ 7.32 $ 7.95 $ 7.17 $ 18.25 $ 11.62 $ 8.40 $ 5.35 $ 7.37 $ 6.48 Risk-free interest rate 4.0 % 2.0 % 0.7 % 4.3 % 1.7 % From 0.03 % to 1.92 % 4.9 % 2.1 % 0.1 % Expected life (in years) 4.5 4.5 4.5 2.9 2.9 2.9 1.3 1.3 1.2 Expected volatility 0.8 0.8 0.9 0.9 0.9 0.9 0.7 1.0 1.0 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. 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. Forfeiture estimates are based on historical employee turnover. The dividend yield is zero percent for all years and is based on our history and expectation of dividend payouts. Stock-based Compensation 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. We have also granted performance-based equity awards to certain of our employees. For equity awards with performance-based vesting criteria, the fair value is amortized to expense when the achievement of the vesting criteria becomes probable. The following table summarizes stock-based compensation expense recorded in each component of operating expenses in our consolidated statements of operations, and amounts capitalized to our inventories (in thousands ): Year Ended December 31, 2023 2022 2021 Employees and directors stock-based compensation expense $ 42,592 $ 32,915 $ 21,285 Year Ended December 31, 2023 2022 2021 Research and development $ 9,285 $ 5,954 $ 3,818 Selling, general and administrative 29,069 23,118 14,894 Cost of sales - product 1,839 1,123 553 Inventories 2,399 2,720 2,020 Total $ 42,592 $ 32,915 $ 21,285 As of December 31, 2023, the total unrecognized compensation cost related to non-vested stock options and RSUs deemed probable of vesting, including all stock options with time-based vesting, net of estimated forfeitures, amounted to $ 46.1 million, which is expected to be recognized over the remaining weighted-average vesting period of 1 . 6 years. As of December 31, 2023, the total unrecognized compensation cost related to PSUs amounted to $ 5.5 million. Employee Stock Purchase Plan The Amended and Restated 2014 Employee Stock Purchase Plan (the “Employee Stock Purchase Plan”) provides for the purchase of common stock by eligible employees. In May 2021, our stockholders approved the amendment and restatement of the Employee Stock Purchase Plan to increase the authorized number of shares of common stock by 1,000,000 . The maximum number of shares of common stock that may be issued under the Employee Stock Purchase Plan will not exceed 1,850,000 shares of common stock. 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 two-year 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). For the year ended December 31, 2023, employees have acquired approximately 161,000 shares of our common stock under the Employee Stock Purchase Plan and approximately 722,000 shares of our common stock remained available for future purchases under the Employee Stock Purchase Plan. As of December 31, 2023, the total unrecognized compensation cost related to shares of our common stock under the Employee Stock Purchase Plan amounted to $ 1.0 million, which is expected to be recognized over the remaining weighted-average vesting period of 1 . 2 years. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Pension and Other Postretirement Benefits Cost (Reversal of Cost) [Abstract] | |
Employee Benefit Plan | 16. 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. Our contribution to the 401(k) Plan was approximately $ 1.3 million , $ 0.9 million and $ 0.3 million for the years ended December 31, 2023, 2022 and 2021, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 17. Income Taxes Consolidated (loss) income before provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2023 2022 2021 U.S. $ ( 6,275 ) $ 292,460 $ 75,954 Non U.S. 1,908 1,839 1,567 Total $ ( 4,367 ) $ 294,299 $ 77,521 The components of the consolidated income tax provision for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Year Ended December 31, 2023 Year Ended December 31, 2022 Year Ended December 31, 2021 Current Federal $ ( 178 ) $ ( 165 ) $ 345 State 1,533 897 260 Non-US 667 411 203 Total current tax expense 2,022 1,143 808 Deferred Federal - - - State - - - Non-US - - - Total deferred tax expense - - - Total income tax expense $ 2,022 $ 1,143 $ 808 The difference between the consolidated income tax provision and the amount computed by applying the federal statutory income tax rate to the consolidated income before income taxes in the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Year Ended December 31, 2023 2022 2021 Income tax provision (benefit) at federal statutory rate $ ( 917 ) $ 61,775 $ 16,397 State tax 574 ( 2,942 ) 3,576 Business credits ( 2,050 ) ( 3,246 ) ( 982 ) Uncertain tax positions 334 586 424 Deferred compensation charges 830 ( 473 ) 131 Change in valuation allowance 1,466 ( 324 ) ( 86,847 ) Section 162(m) limitation 1,963 1,779 1,241 Mark-to-market of warrants - ( 378 ) 10,364 Net operating loss and tax credit limitation - ( 56,908 ) 56,459 Other (1) ( 518 ) 879 ( 290 ) Foreign taxes 340 395 335 Total income tax expense $ 2,022 $ 1,143 $ 808 (1) Certain prior year amounts have been reclassified to conform to the current year presentation. In 2022 and 2021, Foreign taxes were included in Other. Deferred tax assets and liabilities consisted of the following (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 96,336 $ 113,228 Research credit carryforwards 34,940 33,444 Section 174 capitalization 22,556 15,308 Lease liability 8,868 9,530 Stock compensation 10,572 7,780 Accruals and reserves 15,808 9,089 Other 348 337 Total deferred tax assets 189,428 188,716 Less valuation allowance ( 180,387 ) ( 178,920 ) Net deferred tax assets 9,041 9,796 Deferred tax liabilities: Fixed assets ( 2,667 ) ( 2,916 ) Operating lease right-of-use assets ( 6,345 ) ( 6,785 ) Other ( 29 ) ( 95 ) Total deferred tax liabilities ( 9,041 ) ( 9,796 ) 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. A high degree of judgment is required to determine if, and the extent to which, valuation allowances should be recorded against deferred tax assets. In making such determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. Based on all available evidence as of December 31, 2023, both positive and negative, and the weight of that evidence to the extent such evidence can be objectively verified, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not more likely than not to be realized, and, accordingly, has provided a valuation allowance. The valuation allowance increased by $ 1.5 million during the year ended December 31, 2023 and decreased by $ 0.3 million during the year ended December 31, 2022. The increase in valuation allowance during the year ended December 31, 2023 was due to an increase in our deferred tax assets, predominantly related to Section 174 capitalization and increased reserves largely offset by utilization of net operating losses. The decrease in valuation allowance during the year ended December 31, 2022 was due to a decrease in our deferred tax assets, predominantly related to utilization of net operating losses, offset by updates to the Section 382 analysis. As of December 31, 2023, we had federal net operating loss carryforwards of approximately $ 23.1 million, which began to expire in the year 2024 , federal net operating loss carryforwards of approximatel y $ 353.5 million, which do not expire and federal research and development tax credits of approximately $ 28.3 million, whi ch expire in the years 2024 through 2043 . As of December 31, 2023, we had net operating loss carryforwards for California and other states for income tax purposes of approximately $ 283.9 million, which expire in the years 2024 through 2040 , and California state research and development tax credits of approximately $ 22.3 million, which do not expire. As of December 31, 2023, we had no remaining net operating loss carryforwards for foreign income tax purposes. Uncertain Income Tax positions The total amount of unrecognized tax benefits was $ 12.1 million and $ 11.3 million as of December 31, 2023 and 2022, respectively. If recognized, none of the unrecognized tax benefits would affect the effective tax rate. The following table summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2023 2022 Balance at beginning of year $ ( 11,339 ) $ ( 5,615 ) Tax positions related to the current year Additions ( 762 ) ( 670 ) Reductions - - Tax positions related to the prior year Additions - ( 5,054 ) Reductions - - Settlements - - Lapses in statute - Balance at end of year $ ( 12,101 ) $ ( 11,339 ) Our policy is to account for interest and penalties as inco me tax expense. As of December 31, 2023, there was no interest and no penalties recognized in the provision for income taxes. As of December 31, 2022, there were no interest and no penalties recognized in the provision for income taxes. We do not anticipate any significant change within 12 months of this reporting date of its uncertain tax positions. 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 there is a change in ownership, as defined, the annual utilization of such carryforwards could be limited. For the year ended December 31, 2021, we completed a preliminary analysis under Section 382 of the Internal Revenue Code indicating we experienced ownership changes in 2008, 2010, 2012, and 2019 that limited the future use of our pre-change federal and state net operating loss carryforwards and federal research and development tax credits. We finalized the study during the year ended December 31, 2022 and concluded that we only experienced ownership changes in 2008, 2010, and 2012, resulting in a significant reduction in the federal and state net operating loss carryforwards and federal research and development tax credits that are expected to expire unused. We have revised the net operating loss carryforwards and research and development tax credits that are expected to expire unused as a result of the annual limitations in the deferred tax assets and corresponding uncertain tax positions as of December 31, 2022. There were no changes to our Section 382 analysis as of December 31, 2023. We are subject to income tax examinations for U.S. federal and state income taxes from 2002 forward. We are subject to tax examination in Germany from 2018 forward, in India from 2019 forward and in Italy from 2021 forward. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include our accounts and those of our wholly-owned subsidiaries, Dynavax GmbH located in Düsseldorf, Germany, Dynavax India LLP in India and a branch of Dynavax in Italy. All intercompany accounts and transactions among the entities have been eliminated from the consolidated financial statements. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. |
Foreign Currency Translation | Foreign Currency Translation We consider the local currency to be the functional currency for our international subsidiaries, Dynavax GmbH, located in Düsseldorf, Germany, Dynavax India LLP, and a branch of Dynavax registered in Italy. Accordingly, assets and liabilities denominated in this foreign currency 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 during the year. Currency translation adjustments arising from period to period are charged or credited to accumulated other comprehensive income (loss) in stockholders’ equity. As of Decemb er 31, 2023 and 2022, the cumulative translation adjustments balance was $ ( 3.0 ) million and $( 4.0 ) million, respectively, primarily related to the translation of Dynavax GmbH assets, liabilities and operating results from Euros to U.S. dollars. F or the years ended December 31, 2023, 2022 and 2021, we reported an unrealized foreign currency translation gain (loss) of $ 1.1 million, $( 1.8 ) million and $( 2.5 ) million, respectively. Realized gains and losses resulting from currency transactions are included in other (expense) income in the consolidated statements of operations. For the years ended December 31, 2023, 2022 and 2021, we reported a (loss) gain of $( 0.1 ) mi llion, $ 0.1 million and $ 0.9 million, respectively, resulting from currency transactions in our consolidated statements of operations. |
Segment Information | Segment Information Operating segments are defined as components of an entity for which discrete financial information is available that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. Our Chief Executive Officer is the CODM. The CODM reviews financial information presented on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. As such, management has determined that we operate in one operating segment that is focused on the discovery, development, and commercialization of innovative vaccines. Net assets outside of the U.S. w ere less than 10 % of total net assets as of December 31, 2023 and 2022. |
Cash and Cash Equivalents and Marketable Securities | Cash and Cash Equivalents and Marketable Securities We consider all 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. treasuries, 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 loss in stockholders’ equity. Commencing with our adoption of (“ASC”) 326, Financial Instruments — Credit Losses (“ASC 326") on January 1, 2023, we determine whether a decline in the fair value of our available-for-sale ("AFS") debt securities below their amortized cost basis (i.e., an impairment) is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in other comprehensive income (loss), net of applicable taxes. Credit-related impairments (if any) are recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Both the allowance and the adjustment to net income can be reversed if conditions change. To date, there have been no declines in fair value that have been identified as a credit-related impairment. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties 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 the 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. treasuries, U.S. government agency securities and corporate debt securities. We have not experienced any significant losses on our cash equivalents and marketable securities. Our accounts receivable balance consists, primarily, of amounts due from product sales. Accounts receivable are recorded net of reserves for chargebacks, distribution fees, trade discounts and doubtful accounts. We estimate our allowance for doubtful accounts based on an evaluation of the aging of our receivables. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. During the year ended December 31, 2023, we recorded an allowance for doubtful accounts of $ 12.3 million, which was determined by assessing changes in Biological E. Limited's (“Bio E”) credit risk, contemplation of ongoing negotiations relating to Bio E Amendment No. 3 (See Note 9), and Bio E's dependence on cash collections from the Government of India, which have been delayed and significantly reduced in connection with the overall reduction in demand for CORBEVAX from the Government of India. As of December 31, 2023 and 2022 , three customers collectively represented approximately 81 % and 78 % of our HEPLISAV-B trade receivable balance, respectively. As of December 31, 2023, we had no CpG 1018 adjuvant trade receivable balance. As of December 31, 2022, one customer represented approximately 100 % of our CpG 1018 adjuvant trade receivable balance . Our product candidates will require approval from the United States Food and Drug Administration ("FDA") and foreign regulatory agencies before commercial sales can commence. There can be no assurance that our product candidates will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on our business and may impact our business in the future. In addition, after the approval of HEPLISAV-B by the FDA, there is still an ongoing risk of adverse events that did not appear during the drug approval process that could affect our authorizations in the future. 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 product candidates, product liability, the volatility of our stock price and the need to obtain additional financing. Our long-lived assets located in the United States as of December 31, 2023 and 2022, represented 31 % and 34 % of our total assets, respectively, and the remaining long-lived assets were located in Germany. |
Inventories, net | Inventories HEPLISAV-B Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the years ended December 31, 2023 and 2022, there w ere no invento ry reserves or write-offs recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to the required regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory. Instead, those are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. CpG 1018 Adjuvant Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the year ended December 31, 2023, there was no remaining CpG 1018 adjuvant inventory balance. For the year ended December 31, 2022 , we recorded $ 34.3 million of inventory write-off to cost of sales - product, in connection with cancelled orders and the reduction in demand for CpG 1018 adjuvant reflected in the Clover Supply Agreement, as amended (See Note 9). |
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, while 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, 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, undiscounted future operating cash flows of long-lived assets are compared to their respective carrying value. If the carrying value is greater than the undiscounted future operating cash flows of long-lived assets, the long-lived assets are written down to their respective fair values and an impairment loss is recorded. Fair value is determined primarily using the discounted cash flows expected to be generated from the use of assets. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. There have been no material adjustments to these estimates during the years presented. |
Leases | Leases We determine if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset, and whether we have the right to control the identified asset. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and long-term portion of lease liabilities in our consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term, and lease liabilities represent our obligation to make lease payments arising from the lease. The classification of our leases as operating or finance leases along with the initial measurement and recognition of the associated ROU assets and lease liabilities is performed at the lease commencement date. The measurement of ROU assets and lease liabilities is based on the present value of future lease payments over the lease term. The ROU asset also includes the effect of any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. As the implicit rate in our leases is generally unknown, we use our incremental borrowing rate based on information available at the lease commencement date in determining the present value of future lease payments. We consider our credit risk, term of the lease, total lease payments and adjust for the impacts of collateral, as necessary, when calculating our incremental borrowing rate. The lease terms may include options to extend or terminate the lease when it is reasonably certain we will exercise any such options. Rent expense for our operating leases is recognized on a straight-line basis over the lease term. Variable lease payments are recorded as an expense in the period incurred. We have elected not to apply the recognition requirements of Accounting Standards Codification ASC 842, Leases ("ASC 842") , for short-term leases. We have also elected the practical expedient to not separate lease components from non-lease components. As lessors, we determine if an arrangement includes a lease at inception. We elected the practical expedient to not separate lease components from non-lease components. Sublease income is recognized on a straight-line basis over the expected lease term and is included in other income (expense) in our consolidated statements of operations. |
Goodwill | Goodwill Goodwill represents the excess purchase price over the fair value of tangible and intangible assets acquired and liabilities assumed. Our goodwill balance relates to our acquisition of Dynavax GmbH in 2006. Goodwill is not amortized, but instead is reviewed for impairment test at least annually, or more frequently if events occur or circumstances change that would indicate the carrying amount may be impaired. Goodwill is assigned to, and impairment testing is performed at, the reporting unit level. 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. No impairment has been identified for the years presented. |
Convertible Notes | Convertible Notes We account for our 2.50 % convertible senior notes due in 2026 (“Convertible Notes”), as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the consolidated balance sheets (See Note 10). We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the Convertible Notes, using the effective interest method, as interest expense on the consolidated statements of operations. |
Capped Calls | Capped Calls We evaluate financial instruments under ASC 815, Derivatives and Hedging ("ASC 815") . The capped calls purchased in connection with the Convertible Notes financing ("Capped Calls") cover the same number of shares of common stock that initially underlie the Convertible Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for the equity classification continue to be met. |
Revenue Recognition | Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration, which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, Revenue from Contracts with Customers ("ASC 606") , we apply the following five step model: • identify the contract(s) with a customer; • identify the performance obligation(s) in the contract; • determine the transaction price; • allocate the transaction price to the performance obligation(s) in the contract; and • recognize revenue when (or as) we satisfy a performance obligation. Product Revenue, Net – HEPLISAV-B We sell HEPLISAV-B to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year , there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net - HEPLISAV-B, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks and rebates, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. Chargebacks: Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Rebates: Under certain contracts, Customers may obtain rebates for purchasing minimum volumes of our product. We estimate these rebates based upon the expected purchases and the contractual rebate rate and record this estimate as a reduction in revenue in the period the related revenue is recognized. Product Revenue, Net – CpG 1018 Adjuvant We also sell our innovative adjuvant, CpG 1018 adjuvant, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of Customers under ASC 606. Therefore, we accounted for our CpG 1018 adjuvant sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net - CpG 1018 adjuvant, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Our CpG 1018 adjuvant customers have purchased a significant quantity of CpG 1018 adjuvant as part of their initial COVID-19 vaccine development inventory. Accordingly, we did not recognize CpG 1018 adjuvant net product revenue during the year ended December 31, 2023. Other Revenue Other revenue includes revenue from our agreement with the DoD, collaboration and manufacturing service revenue. We have entered into grant agreements, collaborative arrangements and arrangements to provide manufacturing services to other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. |
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. We estimate research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to us at that time. There have been no material adjustments to the prior period accrued estimates for clinical trial activities during the years presented. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for restricted stock units ("RSUs"), market-based performance stock units ("PSUs") and stock options is estimated at the grant date based on the award’s estimated fair value. For awards that vest based on service conditions and market conditions, we use a straight-line method to recognize compensation expense over the award’s requisite service period, assuming estimated forfeiture rates. For awards that contain performance conditions, we determine the appropriate amount to expense at each reporting date based on the anticipated achievement of performance targets, which requires judgement, including forecasting the achievement of future specified targets. At the date performance conditions are determined to be probable of achievement, we record a cumulative expense catch-up, with remaining expense amortized over the remaining service period. Throughout the performance period, we re-assesses the estimated performance and updates the number of performance-based awards that we believe will ultimately vest. Fair value of RSUs is determined at the date of grant using our closing stock price, with the exception of PSUs, which are measured using the Monte Carlo simulation method on the date of grant. Our determination of the fair value 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 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 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 of stock options granted in the future. Changes in the fair value 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 expense recognized in future periods. We derive the expected term assumption primarily based on our historical settlement experience, while considering options that have not yet completed a full life cycle. Stock-based compensation expense 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 expense could be materially impacted in the period of revision. There have been no material adjustments to these estimates during the years presented. |
Income Taxes | Income Taxes The asset and liability approach is used to recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. Tax law and rate changes are reflected in income in the period such changes are enacted. We include interest and penalties related to income taxes, including unrecognized tax benefits, within income tax expense. Our income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax regulations. We recognize liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While we believe we have appropriate support for the positions taken on our tax returns, we regularly assess the potential outcomes of examinations by tax authorities in determining the adequacy of our provision for income taxes. We continually assess the likelihood and amount of potential adjustments and adjust the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. Judgment is required in determining our provision for income taxes, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. Based on all available evidence, both positive and negative, and the weight of that evidence to the extent such evidence can be objectively verified, we believe that recognition of the deferred tax assets arising from future tax benefits is currently not more likely than not to be realized and, accordingly, we have determined a need for a full valuation allowance. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments , which was codified in Accounting Standards Codification ASC 326, Financial Instruments — Credit Losses . The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, ASC 326 became effective for us for fiscal years beginning after December 15, 2022. As such, we adopted ASC 326 effective January 1, 2023, utilizing the modified retrospective transition method. Upon adoption, we updated our impairment model to utilize a forward-looking current expected credit losses (“CECL”) model in place of the incurred loss methodology for financial instruments measured at amortized cost, primarily including our accounts receivable and contract asset. In relation to AFS debt securities, the guidance eliminates the concept of “other-than-temporary” impairment, and instead focuses on determining whether any impairment is a result of a credit loss or other factors. The adoption of ASC 326 did not have a material impact on our consolidated financial statements as of the adoption date. In November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-09. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy for Financial Assets and Liabilities 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, 2023 Assets Money market funds $ 131,635 $ - $ - $ 131,635 U.S. treasuries - 74,237 - 74,237 U.S. government agency securities - 216,688 - 216,688 Corporate debt securities - 308,552 - 308,552 Total assets $ 131,635 $ 599,477 $ - $ 731,112 Level 1 Level 2 Level 3 Total December 31, 2022 Assets Money market funds $ 172,418 $ - $ - $ 172,418 U.S. treasuries - 42,308 - 42,308 U.S. government agency securities - 88,032 - 88,032 Corporate debt securities - 292,051 - 292,051 Total assets $ 172,418 $ 422,391 $ - $ 594,809 |
Summary of Changes in Fair Value Warrant liability | The following table provides a summary of changes in the fair value warrant liability for year ended December 31, 2022 (in thousands): Balance at December 31, 2021 $ 18,016 Decrease in fair value of warrants exercised ( 1,801 ) Warrants exercised or expired ( 16,215 ) Balance at December 31, 2022 $ - |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Cash, Cash Equivalents, and Short-Term Investments [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash and cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows (in thousands): December 31, 2023 2022 2021 Cash and cash equivalents $ 150,279 $ 202,004 $ 436,189 Restricted cash (1) 277 207 219 Total cash and cash equivalents, and restricted cash shown in the $ 150,556 $ 202,211 $ 436,408 (1) Restricted cash is included in "Other assets" in the Consolidated Balance Sheets. |
Summary of Cash, Cash Equivalents and Marketable Securities | Cash and cash equivalents, and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated December 31, 2023 Cash and cash equivalents: Cash $ 11,190 $ - $ - $ 11,190 Money market funds 131,635 - - 131,635 Corporate debt securities 7,453 1 - 7,454 Total cash and cash equivalents 150,278 1 - 150,279 Marketable securities available-for-sale: U.S. treasuries 74,109 172 ( 44 ) 74,237 U.S. government agency securities 216,265 692 ( 269 ) 216,688 Corporate debt securities 300,803 315 ( 20 ) 301,098 Total marketable securities available-for-sale 591,177 1,179 ( 333 ) 592,023 Total cash and cash equivalents, and marketable securities $ 741,455 $ 1,180 $ ( 333 ) $ 742,302 December 31, 2022 Cash and cash equivalents: Cash $ 29,586 $ - $ - $ 29,586 Money market funds 172,418 - - 172,418 Total cash and cash equivalents 202,004 - - 202,004 Marketable securities available-for-sale: U.S. treasuries 42,502 - ( 194 ) 42,308 U.S. government agency securities 88,429 - ( 397 ) 88,032 Corporate debt securities 292,865 12 ( 826 ) 292,051 Total marketable securities available-for-sale 423,796 12 ( 1,417 ) 422,391 Total cash and cash equivalents, and marketable securities $ 625,800 $ 12 $ ( 1,417 ) $ 624,395 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): . December 31, 2023 Amortized Estimated Mature in one year or less $ 440,131 $ 440,104 Mature after one year through two years 151,046 151,919 $ 591,177 $ 592,023 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table presents inventories (in thousands): December 31, 2023 2022 Raw materials $ 27,256 $ 25,517 Work-in-process 18,954 23,934 Finished goods 7,080 9,995 Total $ 53,290 $ 59,446 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Component of Property and Equipment, Net | Property and equipment consist of the following (in thousands): Estimated Useful December 31, Life (In years) 2023 2022 Manufacturing equipment 5 - 13 $ 15,752 $ 15,139 Lab equipment 5 - 13 2,827 2,360 Computer equipment 3 5,060 4,720 Furniture and fixtures 3 - 13 2,467 2,464 Leasehold improvements 2 - 12 37,201 28,822 Assets in progress 5,822 11,613 69,129 65,118 Less accumulated depreciation and amortization ( 31,832 ) ( 27,522 ) Total $ 37,297 $ 37,596 |
Current Accrued Liabilities (Ta
Current Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Disclosure Component Of Current Accrued Liabilities And Accrued Research And Development [Abstract] | |
Component of Current Accrued Liabilities | Current accrued liabilities consist of the following (in thousands): December 31, 2023 2022 Payroll and related expenses $ 17,069 $ 14,261 Revenue reserve accruals 21,004 10,552 Accrued inventory 4,456 2,209 Other accrued liabilities 6,919 3,697 Total $ 49,448 $ 30,719 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Expense | Our lease expense comprises of the following (in thousands): Year Ended December 31, 2023 2022 2021 Operating lease expense $ 5,563 $ 6,222 $ 6,265 |
Summary of Balance Sheet Classification of Operating Lease Liabilities | The balance sheet classification of our operating lease liabilities was as follows (in thousands): December 31, 2023 2022 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 4,496 $ 3,631 Long-term portion of lease liabilities 29,720 32,801 Total operating lease liabilities $ 34,216 $ 36,432 |
Summary of Maturities of Sublease Income and Operating Lease Liabilities | As of December 31, 2023, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2024 $ 5,684 $ 7,605 2025 5,854 6,980 2026 6,030 6,122 2027 6,211 6,052 2028 6,397 6,215 Thereafter 15,103 15,062 Total $ 45,279 48,036 Less: Present value adjustment ( 13,820 ) Total $ 34,216 |
Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate | The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liabilities were as follows: December 31, 2023 2022 Weighted average remaining lease term 6.7 years 7.6 years Weighted average discount rate 10.1 % 10.1 % |
Schedule of Material Purchase Commitments | The following summarizes our material purchase commitments at December 31, 2023 and the effect those obligations are expected to have on our liquidity and cash flows in future periods (in thousands): Years ending December 31, (in thousands) 2024 $ 18,866 2025 11,983 2026 12,516 2027 - 2028 - Thereafter - Total $ 43,365 |
Convertible Notes (Tables)
Convertible Notes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Interest Expenses Related to Convertible Notes | The following table presents the components of interest expense related to Convertible Notes (in thousands): Year Ended December 31, 2023 2022 Stated coupon interest $ 5,636 $ 5,638 Amortization of debt issuance cost 1,121 1,094 Total interest expense $ 6,757 $ 6,732 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Disaggregation of Revenues | The following table disaggregates our product revenue, net by product and geographic region and disaggregates our other revenues by geographic region (in thousands): Year Ended Year Ended Year Ended December 31, 2023 December 31, 2022 December 31, 2021 U.S. Non U.S. Total U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 213,295 $ - $ 213,295 $ 124,996 $ 941 $ 125,937 $ 61,870 $ - $ 61,870 CpG 1018 adjuvant - - - - 587,708 587,708 - 375,229 375,229 Total product revenue, net $ 213,295 $ - $ 213,295 $ 124,996 $ 588,649 $ 713,645 $ 61,870 $ 375,229 $ 437,099 Other revenue 17,650 1,339 18,989 8,774 264 9,038 1,915 428 2,343 Total revenues $ 230,945 $ 1,339 $ 232,284 $ 133,770 $ 588,913 $ 722,683 $ 63,785 $ 375,657 $ 439,442 |
HEPLISAV-B | |
Schedule of Revenues from Major Customers | The following table summarizes HEPLISAV-B product revenue from each of our three largest customers (as a percentage of total HEPLISAV-B net product revenue): Year Ended December 31, 2023 2022 2021 Largest customer 28 % 21 % 21 % Second largest customer 27 % 17 % 19 % Third largest customer 17 % 16 % 19 % |
Summary of Product Revenue Allowance and Reserve Categories | The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories (in thousands): Balance at Provisions Credit or payments Adjustments related to prior periods Balance Year ended December 31, 2023: Accounts receivable reserves (1) $ 8,179 $ 55,604 $ ( 54,143 ) $ ( 2,629 ) $ 7,011 Revenue reserve accruals (2) $ 10,552 $ 46,062 $ ( 38,207 ) $ 2,597 $ 21,004 Year ended December 31, 2022: Accounts receivable reserves (1) $ 3,823 $ 34,758 $ ( 30,402 ) $ - $ 8,179 Revenue reserve accruals (2) $ 8,253 $ 24,806 $ ( 22,507 ) $ - $ 10,552 (1) Reserves are for chargebacks, discounts and other fees . (2) Accruals are for returns, rebates and other fees . |
CpG 1018 | |
Schedule of Revenues from Major Customers | The following table summarizes CpG 1018 adjuvant product revenue from each of our three largest collaboration partners (as a percentage of total CpG 1018 adjuvant product revenue): Year Ended December 31, 2023 2022 2021 Largest collaboration partner 0 % 49 % 49 % Second largest collaboration partner 0 % 35 % 24 % Third largest collaboration partner 0 % 12 % 19 % |
Summary of balances and activities in our contract asset account | The following table summarizes balances and activities in our contract asset account (in thousands): Balance at Additions Subtractions Reclassification (1) Balance Year ended December 31, 2023: Contract asset, included in other current assets (2) $ 71,965 $ 17,650 $ ( 16,919 ) $ ( 71,307 ) $ 1,389 Contract asset, included in other assets (long term) $ - $ - $ - $ 71,307 $ 71,307 Year ended December 31, 2022: Contract asset $ 62,525 $ 17,556 $ ( 8,116 ) $ - $ 71,965 (1) The Clover contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. See Note 9 for further discussion. (2) The $1.4 million of contract asset is derived from our agreement with the DoD . |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The numerators and denominators of the basic net (loss) income and diluted net income per share computations for our common stock are calculated as follows (in thousands): Year Ended December 31, 2023 2022 2021 Numerator Net (loss) income $ ( 6,389 ) $ 293,156 $ 76,713 Less: undistributed earnings allocated to participating securities ( 283 ) ( 4,569 ) Net (loss) income allocable to common stockholders, basic ( 6,389 ) 292,873 72,144 Add: undistributed earnings allocated to Series B and warrants - 283 4,569 Less: undistributed earnings allocated to Series B and warrants - - ( 4,190 ) Add: interest expense on convertible notes - 5,044 3,168 Less: removal of change in fair value of warrant liability - ( 1,801 ) - Net (loss) income allocable to common stockholders, diluted $ ( 6,389 ) $ 296,399 $ 75,691 Denominator Weighted average shares used to compute net (loss) income 128,733 126,398 116,264 Effect of dilutive shares: Stock-based compensation plans - 2,774 3,075 Convertible Notes (as converted to common stock) - 21,543 13,667 Effect of dilutive warrants - 82 - Weighted average shares used to compute net (loss) income 128,733 150,797 133,006 |
Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share | The following were excluded from the calculation of diluted net (loss) income per share as the effect of their inclusion would have been anti-dilutive (in thousands). December 31, 2023 2022 2021 Outstanding securities not included in diluted net (loss) income Stock options and stock awards 15,158 7,165 5,953 Convertible Notes (as converted to common stock) 21,543 - - Warrants (as exercisable into common stock) - - 1,883 |
Equity Plans and Stock-Based _2
Equity Plans and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement, Noncash Expense [Abstract] | |
Summary of Option Activity Under Stock-Based Compensation Plans | The following table summarizes the activity of stock options for the year ended December 31, 2023: Shares Underlying Weighted-Average Exercise Weighted-Average Aggregate Balance at December 31, 2022 9,339 $ 10.70 4.61 $ 16,291 Options granted 1,982 11.17 Options exercised ( 850 ) 7.48 Options cancelled: Options forfeited (unvested) ( 90 ) 10.93 Options expired (vested) ( 261 ) 21.39 Balance at December 31, 2023 10,120 $ 10.78 4.18 $ 37,388 Vested and expected to vest at December 31, 2023 9,976 $ 10.77 4.15 $ 37,024 Exercisable at December 31, 2023 7,014 $ 10.40 3.50 $ 29,613 |
Summary of Non-vested Restricted Stock Units Activity | The following table summarizes the activity of RSUs for the year ended December 31, 2023: Number of Shares Weighted-Average Non-vested as of December 31, 2022 3,479 $ 11.00 Granted 2,748 11.48 Vested (1) ( 1,515 ) 10.13 Forfeited ( 267 ) 11.45 Non-vested as of December 31, 2023 4,445 $ 11.57 (1) Inclusive of approximately 600,145 RSUs for the year ended December 31, 2023, which were not converted into shares due to net share settlement in order to cover the required amount of employee withholding taxes. The value of the withheld shares was classified as a reduction to additional paid-in capital. |
Summary of Performance Based Restricted Stock Unit | The summary of PSU activities for the year ended December 31, 2023 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2022 193 $ 11.62 Granted 364 18.25 Non-vested as of December 31, 2023 557 $ 15.95 |
Summary of Fair Value-Based Measurements and Weighted-Average Assumptions | The weighted-average assumptions used in the calculations of these fair value measurements are as follows : Stock Options Market-Based Performance Stock Units Employee Stock Purchase Plan Year Ended December 31, Year Ended December 31, Year Ended December 31, 2023 2022 2021 2023 2022 2021 2023 2022 2021 Weighted-average fair value $ 7.32 $ 7.95 $ 7.17 $ 18.25 $ 11.62 $ 8.40 $ 5.35 $ 7.37 $ 6.48 Risk-free interest rate 4.0 % 2.0 % 0.7 % 4.3 % 1.7 % From 0.03 % to 1.92 % 4.9 % 2.1 % 0.1 % Expected life (in years) 4.5 4.5 4.5 2.9 2.9 2.9 1.3 1.3 1.2 Expected volatility 0.8 0.8 0.9 0.9 0.9 0.9 0.7 1.0 1.0 |
Summary of Stock-Based Compensation Expense | The following table summarizes stock-based compensation expense recorded in each component of operating expenses in our consolidated statements of operations, and amounts capitalized to our inventories (in thousands ): Year Ended December 31, 2023 2022 2021 Employees and directors stock-based compensation expense $ 42,592 $ 32,915 $ 21,285 Year Ended December 31, 2023 2022 2021 Research and development $ 9,285 $ 5,954 $ 3,818 Selling, general and administrative 29,069 23,118 14,894 Cost of sales - product 1,839 1,123 553 Inventories 2,399 2,720 2,020 Total $ 42,592 $ 32,915 $ 21,285 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Component of Consolidated (Loss) Income Before Provision for Income Taxes | Consolidated (loss) income before provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2023 2022 2021 U.S. $ ( 6,275 ) $ 292,460 $ 75,954 Non U.S. 1,908 1,839 1,567 Total $ ( 4,367 ) $ 294,299 $ 77,521 |
Components of Income Tax Provision | The components of the consolidated income tax provision for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Year Ended December 31, 2023 Year Ended December 31, 2022 Year Ended December 31, 2021 Current Federal $ ( 178 ) $ ( 165 ) $ 345 State 1,533 897 260 Non-US 667 411 203 Total current tax expense 2,022 1,143 808 Deferred Federal - - - State - - - Non-US - - - Total deferred tax expense - - - Total income tax expense $ 2,022 $ 1,143 $ 808 |
Difference Between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate | The difference between the consolidated income tax provision and the amount computed by applying the federal statutory income tax rate to the consolidated income before income taxes in the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Year Ended December 31, 2023 2022 2021 Income tax provision (benefit) at federal statutory rate $ ( 917 ) $ 61,775 $ 16,397 State tax 574 ( 2,942 ) 3,576 Business credits ( 2,050 ) ( 3,246 ) ( 982 ) Uncertain tax positions 334 586 424 Deferred compensation charges 830 ( 473 ) 131 Change in valuation allowance 1,466 ( 324 ) ( 86,847 ) Section 162(m) limitation 1,963 1,779 1,241 Mark-to-market of warrants - ( 378 ) 10,364 Net operating loss and tax credit limitation - ( 56,908 ) 56,459 Other (1) ( 518 ) 879 ( 290 ) Foreign taxes 340 395 335 Total income tax expense $ 2,022 $ 1,143 $ 808 (1) Certain prior year amounts have been reclassified to conform to the current year presentation. In 2022 and 2021, Foreign taxes were included in Other. |
Component of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities consisted of the following (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 96,336 $ 113,228 Research credit carryforwards 34,940 33,444 Section 174 capitalization 22,556 15,308 Lease liability 8,868 9,530 Stock compensation 10,572 7,780 Accruals and reserves 15,808 9,089 Other 348 337 Total deferred tax assets 189,428 188,716 Less valuation allowance ( 180,387 ) ( 178,920 ) Net deferred tax assets 9,041 9,796 Deferred tax liabilities: Fixed assets ( 2,667 ) ( 2,916 ) Operating lease right-of-use assets ( 6,345 ) ( 6,785 ) Other ( 29 ) ( 95 ) Total deferred tax liabilities ( 9,041 ) ( 9,796 ) Net deferred tax assets $ - $ - |
Schedule of Unrecognized Tax Benefits | The following table summarizes the activity related to our unrecognized tax benefits: Year Ended December 31, 2023 2022 Balance at beginning of year $ ( 11,339 ) $ ( 5,615 ) Tax positions related to the current year Additions ( 762 ) ( 670 ) Reductions - - Tax positions related to the prior year Additions - ( 5,054 ) Reductions - - Settlements - - Lapses in statute - Balance at end of year $ ( 12,101 ) $ ( 11,339 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2023 | |
HEPLISAV-B | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Minimum age approved for vaccine prevention of infection caused | 18 years |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Unrealized foreign currency translation (loss) gain | $ 1,100 | $ (1,800) | $ (2,500) |
Realized foreign currency translation (loss) gain | $ (100) | $ 100 | 900 |
Percentage of long lived assets | 31% | 34% | |
Inventory write-off | $ 0 | $ 34,288 | $ 2,588 |
Inventory write-offs recognized | 34,300 | ||
Goodwill impairment | 0 | ||
Allowance for doubtful accounts | $ 12,300 | ||
2.50% Convertible Senior Notes Due 2026 | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Debt interest rate | 2.50% | ||
Product | Trade Receivable | Credit Concentration Risk | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Concentration risk, customer | one | ||
Product | Trade Receivable | Customer Concentration Risk | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Concentration risk, percentage | 100% | ||
HEPLISAV-B | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Inventory write-off | $ 0 | ||
HEPLISAV-B | Credit Concentration Risk | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Concentration risk, customer | three | three | |
HEPLISAV-B | Trade Receivable | Credit Concentration Risk | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Concentration risk, percentage | 81% | 78% | |
Maximum | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Cash equivalents original maturity period | 3 months | ||
Percentage of long lived assets | 10% | 10% | |
Expected period of payment to be received | 1 year | ||
Dynavax GmbH | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Cumulative translation adjustment | $ (3,000) | $ (4,000) |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Transfers in or out of Level 3 | $ 0 | $ 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Number of shares | 1,882,600 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Total assets | $ 731,112 | $ 594,809 |
Money Market Funds | ||
Assets | ||
Total assets | 131,635 | 172,418 |
U.S. Treasuries | ||
Assets | ||
Total assets | 74,237 | 42,308 |
U.S. Government Agency Securities | ||
Assets | ||
Total assets | 216,688 | 88,032 |
Corporate Debt Securities | ||
Assets | ||
Total assets | 308,552 | 292,051 |
Fair Value, Inputs, Level 1 | ||
Assets | ||
Total assets | 131,635 | 172,418 |
Fair Value, Inputs, Level 1 | Money Market Funds | ||
Assets | ||
Total assets | 131,635 | 172,418 |
Fair Value, Inputs, Level 1 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | Corporate Debt Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 | ||
Assets | ||
Total assets | 599,477 | 422,391 |
Fair Value, Inputs, Level 2 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 | U.S. Treasuries | ||
Assets | ||
Total assets | 74,237 | 42,308 |
Fair Value, Inputs, Level 2 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 216,688 | 88,032 |
Fair Value, Inputs, Level 2 | Corporate Debt Securities | ||
Assets | ||
Total assets | 308,552 | 292,051 |
Fair Value, Inputs, Level 3 | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate Debt Securities | ||
Assets | ||
Total assets | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assumptions to Estimate the Fair Value of Warrant Liability (Detail) shares in Thousands | Dec. 31, 2022 shares |
Fair Value, Inputs, Level 3 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Number of shares | 1,882,600 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Changes in Fair Value Warrant liability (Detail) - Fair Value, Inputs, Level 3 $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Beginning Balance | $ 18,016 |
Decrease in fair value of warrants exercised | (1,801) |
Warrants exercised | (16,215) |
Ending Balance | $ 0 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract] | |||||
Cash and cash equivalents | $ 150,279 | $ 202,004 | $ 436,189 | ||
Restricted cash | [1] | 277 | 207 | 219 | |
Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows | $ 150,556 | $ 202,211 | $ 436,408 | $ 32,310 | |
[1] Restricted cash is included in "Other assets" in the Consolidated Balance Sheets. |
Cash, Cash Equivalents, Restr_4
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 150,278 | $ 202,004 |
Unrealized Gains | 1 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 150,279 | 202,004 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 591,177 | 423,796 |
Unrealized Gains | 1,179 | 12 |
Unrealized Losses | (333) | (1,417) |
Estimated Fair Value | 592,023 | 422,391 |
Marketable Securities Available-for-Sale | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 741,455 | 625,800 |
Unrealized Gains | 1,180 | 12 |
Unrealized Losses | (333) | (1,417) |
Estimated Fair Value | 742,302 | 624,395 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 11,190 | 29,586 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 11,190 | 29,586 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 131,635 | 172,418 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 131,635 | 172,418 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 7,453 | |
Unrealized Gains | 1 | |
Unrealized Losses | 0 | |
Estimated Fair Value | 7,454 | |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 300,803 | 292,865 |
Unrealized Gains | 315 | 12 |
Unrealized Losses | (20) | (826) |
Estimated Fair Value | 301,098 | 292,051 |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 74,109 | 42,502 |
Unrealized Gains | 172 | 0 |
Unrealized Losses | (44) | (194) |
Estimated Fair Value | 74,237 | 42,308 |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 216,265 | 88,429 |
Unrealized Gains | 692 | 0 |
Unrealized Losses | (269) | (397) |
Estimated Fair Value | $ 216,688 | $ 88,032 |
Cash, Cash Equivalents, Restr_5
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Dec. 31, 2023 USD ($) |
Amortized Cost | |
Mature in one year or less | $ 440,131 |
Mature after one year through two years | 151,046 |
Total amortized cost | 591,177 |
Estimated Fair Value | |
Mature in one year or less | 440,104 |
Mature after one year through two years | 151,919 |
Total estimated fair value | $ 592,023 |
Cash, Cash Equivalents, Restr_6
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||
Debt Securities, Available-for-Sale, Realized Loss | $ 0 | $ 0 |
Inventories, Net - Summary of I
Inventories, Net - Summary of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 27,256 | $ 25,517 |
Work-in-process | 18,954 | 23,934 |
Finished goods | 7,080 | 9,995 |
Total | $ 53,290 | $ 59,446 |
Inventories, Net - Additional I
Inventories, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Inventory [Line Items] | ||
Finished goods | $ 7,080 | $ 9,995 |
Inventory write-offs recognized | $ 34,300 |
Intangible Assets, Net - Additi
Intangible Assets, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Finite Lived Intangible Assets [Line Items] | |||
Selling, general and administrative | $ 152,946 | $ 131,408 | $ 100,156 |
Property and Equipment, Net - C
Property and Equipment, Net - Component of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Manufacturing equipment | $ 15,752 | $ 15,139 |
Lab equipment | 2,827 | 2,360 |
Computer equipment | 5,060 | 4,720 |
Furniture and fixtures | 2,467 | 2,464 |
Leasehold improvements | 37,201 | 28,822 |
Assets in progress | 5,822 | 11,613 |
Property, plant and equipment, gross | 69,129 | 65,118 |
Less accumulated depreciation and amortization | (31,832) | (27,522) |
Total | $ 37,297 | $ 37,596 |
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) | 13 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) | 2 years | |
Leasehold Improvements | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 12 years |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation and amortization | $ 4,342 | $ 3,812 | $ 4,296 |
Current Accrued Liabilities - C
Current Accrued Liabilities - Component of Current Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities Abstract | ||
Payroll and related expenses | $ 17,069 | $ 14,261 |
Revenue reserve accruals | 21,004 | 10,552 |
Accrued inventory | 4,456 | 2,209 |
Other accrued liabilities | 6,919 | 3,697 |
Total | $ 49,448 | $ 30,719 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions | 1 Months Ended | 12 Months Ended | ||||||||||||
Oct. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) | May 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | May 31, 2021 USD ($) | Aug. 31, 2020 USD ($) | Jul. 31, 2019 | Nov. 30, 2009 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 | Dec. 31, 2023 EUR (€) | Dec. 31, 2022 EUR (€) | |
Loss Contingencies [Line Items] | ||||||||||||||
Lease expiration date | Mar. 31, 2031 | |||||||||||||
Option to extend | The subtenant has no option to extend the sublease term. | |||||||||||||
Sublease income | $ 7,577 | $ 7,685 | $ 7,735 | |||||||||||
Percentage of excess rent paid to landlord | 50% | 50% | ||||||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | $ 7,200 | 6,800 | $ 7,000 | |||||||||||
Long-term debt discount | 2,802 | $ 3,922 | ||||||||||||
Non-cancelable purchase and other commitments | $ 43,365 | |||||||||||||
Description of Avecia Supply Agreement | On September 7, 2023 (the “Effective Date”), we entered into an agreement (the “Avecia Supply Agreement”) with Nitto Denko Avecia Inc. (“Avecia”) for the manufacture and supply of our CpG 1018 adjuvant using a specific production process. Under the Avecia Supply Agreement, Avecia has agreed to produce and supply to us quantities of CpG 1018 adjuvant ordered by us after the Effective Date. Subject to certain conditions in the Avecia Supply Agreement, we are obligated to purchase all of our annual volume requirements of CpG 1018 adjuvant from Avecia up to a specified production capacity. We may alternatively order CpG 1018 adjuvant produced using a different production process pursuant to the existing supply agreement between us and Avecia dated October 1, 2012 (the “2012 Agreement”). As of December 31, 2023, our aggregate minimum commitment for the supply of CpG 1018 adjuvant under the Avecia Supply Agreement was $7.4 million within the next 12 months. As of December 31, 2022, we had no non-cancelable purchase and other commitments for the supply of CpG 1018 adjuvant. | |||||||||||||
Aggregate minimum commitment | $ 7,400 | |||||||||||||
HEPLISAV-B | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Non-cancelable purchase and other commitments | 43,400 | |||||||||||||
2.50% Convertible Senior Notes Due 2026 | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Aggregate principal amount | $ 225,500 | 225,500 | ||||||||||||
Long-term debt discount | $ 2,800 | |||||||||||||
Symphony Dynamo Holdings Llc | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
License arrangement contingent consideration percentage | 50% | |||||||||||||
License arrangement upfront payment | $ 50,000 | |||||||||||||
Trisalus Life Sciences | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Payment to holdings | $ 2,500 | |||||||||||||
Payment received for pre-commercialization milestone | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||||
Trisalus Life Sciences | Asset Purchase Agreement | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Payment made for pre-commercialization milestone | $ 500 | $ 500 | $ 500 | |||||||||||
Deutsche Bank Securities | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Financial instruments owned at fair value | € | € 0.2 | € 0.2 | ||||||||||||
Deutsche Bank Securities | Letter of Credit | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Financial instruments owned at fair value | € | € 0.2 | |||||||||||||
California | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Lease option to extend | Certain of these leases also include options to renew or extend the lease for two successive five-year terms. | |||||||||||||
Existence of option to extend | false | |||||||||||||
California | Maximum | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Initial lease term | 12 years | 12 years | ||||||||||||
California | Minimum | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Initial lease term | 3 years | 3 years | ||||||||||||
Powell Street Sublease | California | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Existence of option to extend | false |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease expense | $ 5,563 | $ 6,222 | $ 6,265 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Current portion of lease liabilities (included in other current liabilities) | $ 4,496 | $ 3,631 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Long-term portion of lease liabilities | $ 29,720 | $ 32,801 |
Total operating lease liabilities | $ 34,216 | $ 36,432 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Sublease Income | ||
2024 | $ 5,684 | |
2025 | 5,854 | |
2026 | 6,030 | |
2027 | 6,211 | |
2028 | 6,397 | |
Thereafter | 15,103 | |
Total | 45,279 | |
Operating Lease Liabilities | ||
2024 | 7,605 | |
2025 | 6,980 | |
2026 | 6,122 | |
2027 | 6,052 | |
2028 | 6,215 | |
Thereafter | 15,062 | |
Total | 48,036 | |
Present value adjustment | (13,820) | |
Total | $ 34,216 | $ 36,432 |
Commitments and Contingencies_5
Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail) | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 6 years 8 months 12 days | 7 years 7 months 6 days |
Weighted average discount rate | 10.10% | 10.10% |
Commitments and Contingencies_6
Commitments and Contingencies - Schedule of Material Purchase Commitments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 18,866 |
2025 | 11,983 |
2026 | 12,516 |
2027 | 0 |
2028 | 0 |
Thereafter | 0 |
Total | $ 43,365 |
Collaborative Research, Devel_2
Collaborative Research, Development and License Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||
Apr. 26, 2023 | Jul. 31, 2023 | Apr. 30, 2023 | Sep. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 31, 2023 | Apr. 27, 2023 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | $ 232,284 | $ 722,683 | $ 439,442 | ||||||
Inventory write-offs recognized | 34,300 | ||||||||
Advance payment from customer | (47,401) | 0 | $ 0 | ||||||
Repayment of advance from customer | $ 47,400 | ||||||||
Accrued liabilities | 49,448 | 30,719 | |||||||
Allowance for doubtful accounts receivables | 12,313 | 0 | |||||||
Prepayment of advance payment | $ 13,500 | ||||||||
Increase in revenue adjustment | $ 33,700 | ||||||||
CpG 1018 | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Inventory write-offs recognized | 34,300 | ||||||||
CEPI | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Accounts receivable | 47,400 | ||||||||
CEPI Partners | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Advance payment from customer | 175,000 | ||||||||
Repayment of advance from customer | 67,300 | ||||||||
Accrued liabilities | 47,400 | 107,700 | |||||||
Accrual long-term balance | 60,300 | ||||||||
Long-term deferred revenue | 0 | 0 | |||||||
Clover | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 0 | 288,000 | |||||||
Accrual long-term balance | 60,300 | ||||||||
Biological E. Limited | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Repayment of advance from customer | $ 47,400 | $ 47,400 | |||||||
Advance payment received | 125,000 | $ 250,000 | |||||||
Accounts receivable | 1,000 | ||||||||
Prepayment of advance payment | 14,500 | ||||||||
Additional future payment | $ 5,500 | $ 12,300 | |||||||
U.S. Department of Defense | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 17,600 | 8,800 | |||||||
Proceeds from grant | $ 22,000 | ||||||||
Supply Agreement | Clover | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Contract asset balance | 71,300 | ||||||||
Supply Agreement | Biological E. Limited | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | $ 0 | $ 206,200 |
Convertible Notes (Additional I
Convertible Notes (Additional Information) (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2021 USD ($) | Dec. 31, 2023 USD ($) Days $ / shares shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | ||||
Proceeds from issuance of Convertible Notes, net | $ 0 | $ 0 | $ 219,822 | |
Debt instrument, convertible, threshold trading days | Days | 20 | |||
Fair value of the convertible notes | $ 330,100 | |||
2.50% Convertible Senior Notes Due 2026 | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | $ 225,500 | $ 225,500 | ||
Debt interest rate | 2.50% | |||
Debt issuance and offering costs | 5,700 | $ 2,800 | ||
Proceeds from issuance of Convertible Notes, net | 219,800 | |||
Debt instrument, interest rate terms | The Convertible Notes are general, unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021. | |||
Debt maturity date | May 15, 2026 | |||
Initial conversion rate | 95.5338 | |||
Debt conversion, original debt, principal amount converted | $ 1,000 | |||
Debt instrument, conversion price per share | $ / shares | $ 10.47 | |||
Debt Instrument, redemption, description | We may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation described in the indenture governing the Convertible Notes), at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. | |||
Debt instrument interest rate, effective percentage | 3.10% | |||
2.50% Convertible Senior Notes Due 2026 | Minimum | ||||
Debt Instrument [Line Items] | ||||
Debt conversion, original debt, principal amount converted | $ 1,000 | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold consecutive trading days | Days | 30 | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period Two | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold trading days | Days | 5 | |||
Debt instrument, convertible, threshold consecutive trading days | Days | 10 | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period Two | Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold percentage of stock price trigger | 98% | |||
Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Repayments of debt | 190,200 | |||
Capped Calls | ||||
Debt Instrument [Line Items] | ||||
Net Proceeds to Pay the Costs | $ 27,200 | $ 27,200 | ||
Number of shares converted | shares | 21,542,871 | |||
Initial strike price | $ / shares | $ 10.47 | |||
Initial cap price | $ / shares | $ 15.8 | |||
Reduction to additional paid-in capital, capped calls cost | $ 27,200 |
Convertible Notes - Summary of
Convertible Notes - Summary of Interest Expenses Related to Convertible Notes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Disclosure [Abstract] | ||
Stated coupon interest | $ 5,636 | $ 5,638 |
Amortization of debt issuance cost | 1,121 | 1,094 |
Total interest expense | $ 6,757 | $ 6,732 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||||
Feb. 20, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 29, 2019 | |
Debt Instrument [Line Items] | |||||
Debt instrument, debt discount | $ 2,802 | $ 3,922 | |||
Interest expense related to initial term loan | 6,757 | 6,732 | |||
Loss on debt extinguishment (Note 11) | 0 | 0 | $ (5,232) | ||
Repayment of long-term debt | $ 0 | $ 0 | 190,194 | ||
Loan Agreement | |||||
Debt Instrument [Line Items] | |||||
Interest expense related to initial term loan | 7,000 | ||||
CRG Servicing LLC | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 175,000 | ||||
Net proceeds from the initial term loan | $ 173,300 | ||||
Debt interest rate | 9.50% | ||||
Debt maturity date | Dec. 31, 2023 | ||||
Current borrowing capacity | $ 100,000 | $ 75,000 | |||
Loss on debt extinguishment (Note 11) | $ 5,200 | ||||
Repayment of long-term debt | $ 190,200 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Disaggregation of Revenues (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 232,284 | $ 722,683 | $ 439,442 |
U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 230,945 | 133,770 | 63,785 |
Non U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 1,339 | 588,913 | 375,657 |
HEPLISAV-B | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 213,295 | 125,937 | 61,870 |
HEPLISAV-B | U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 213,295 | 124,996 | 61,870 |
HEPLISAV-B | Non U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 0 | 941 | 0 |
CpG 1018 | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 0 | 587,708 | 375,229 |
CpG 1018 | U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 0 | 0 | 0 |
CpG 1018 | Non U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 0 | 587,708 | 375,229 |
Product | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 213,295 | 713,645 | 437,099 |
Product | U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 213,295 | 124,996 | 61,870 |
Product | Non U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 0 | 588,649 | 375,229 |
Other Revenue | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 18,989 | 9,038 | 2,343 |
Other Revenue | U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 17,650 | 8,774 | 1,915 |
Other Revenue | Non U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 1,339 | $ 264 | $ 428 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Revenues from Major Customers (Details) - Revenue Benchmark [Member] - Product Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Largest Customer | HEPLISAV-B | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 28% | 21% | 21% |
Second Largest Customer | HEPLISAV-B | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 27% | 17% | 19% |
Third Largest Customer | HEPLISAV-B | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 17% | 16% | 19% |
Largest Collaboration Partner | CpG 1018 | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 0% | 49% | 49% |
Second Largest Collaboration Partner | CpG 1018 | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 0% | 35% | 24% |
Third Largest Collaboration Partner | CpG 1018 | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 0% | 12% | 19% |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Accounts Receivable Reserves | |||
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of period | [1] | $ 8,179 | $ 3,823 |
Provisions related to current period sales | [1] | 55,604 | 34,758 |
Credit or payments made during the period | [1] | (54,143) | (30,402) |
Adjustments related to prior periods | [1] | (2,629) | 0 |
Balance at end of period | [1] | 7,011 | 8,179 |
Revenue Reserve Accruals | |||
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of period | [2] | 10,552 | 8,253 |
Provisions related to current period sales | [2] | 46,062 | 24,806 |
Credit or payments made during the period | [2] | (38,207) | (22,507) |
Adjustments related to prior periods | [2] | 2,597 | 0 |
Balance at end of period | [2] | $ 21,004 | $ 10,552 |
[1] Reserves are for chargebacks, discounts and other fees Accruals are for returns, rebates and other fees |
Revenue Recognition - Summary_3
Revenue Recognition - Summary of Balances and Activities in our Contract Asset Account (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | |||
Contract Asset Account [Abstract] | ||||
Contract asset, reclassification | [1] | $ 71,307 | ||
Balance at end of period | 71,307 | |||
Cp G1018 [Member] | ||||
Contract Asset Account [Abstract] | ||||
Balance at beginning of period | 71,965 | [2] | $ 62,525 | |
Contract asset, additions | 17,650 | [2] | 17,556 | |
Contract asset, subtractions | (16,919) | [2] | (8,116) | |
Contract asset, reclassification | [1],[2] | (71,307) | ||
Balance at end of period | [2] | $ 1,389 | $ 71,965 | |
[1] The Clover contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. See Note 9 for further discussion. The $1.4 million of contract asset is derived from our agreement with the DoD |
Net (Loss) Income Per Share- Co
Net (Loss) Income Per Share- Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract] | |||
Net (loss) income | $ (6,389) | $ 293,156 | $ 76,713 |
Less: undistributed earnings allocated to participating securities | (283) | (4,569) | |
Net (loss) income allocable to common stockholders, basic | (6,389) | 292,873 | 72,144 |
Add: undistributed earnings allocated to Series B and warrants | 0 | 283 | 4,569 |
Less: undistributed earnings allocated to Series B and warrants | 0 | 0 | (4,190) |
Add: interest expense on convertible notes | 0 | 5,044 | 3,168 |
Less: removal of change in fair value of warrant liability | 0 | (1,801) | 0 |
Net income (loss) allocable to common stockholders, diluted | $ (6,389) | $ 296,399 | $ 75,691 |
Weighted-average shares used in computing basic net (loss) income per share allocable to common stockholders | 128,733 | 126,398 | 116,264 |
Stock-based compensation expense | $ 0 | $ 2,774 | $ 3,075 |
Convertible Notes (as converted to common stock) | 0 | 21,543 | 13,667 |
Effect of dilutive warrants | 0 | 82 | 0 |
Weighted average shares used to compute net (loss) income allocable to common stockholders per share, diluted | 128,733 | 150,797 | 133,006 |
Net (Loss) Income Per Share - O
Net (Loss) Income Per Share - Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net (loss) income allocable to common stockholders per share calculation | 0 | 21,543 | 13,667 |
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) income allocable to common stockholders per share calculation | 15,158 | 7,165 | 5,953 |
Warrants | |||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net (loss) income allocable to common stockholders per share calculation | 0 | 0 | 1,883 |
Convertible Notes | |||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net (loss) income allocable to common stockholders per share calculation | 21,543 | 0 | 0 |
Common Stock and Warrants - Add
Common Stock and Warrants - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Aug. 06, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Class Of Stock [Line Items] | ||||
Common stock, shares outstanding | 129,530,228 | 127,604,000 | ||
Change in fair value of warrant liability | $ 0 | $ (1,801) | $ 49,354 | |
Warrants | ||||
Class Of Stock [Line Items] | ||||
Number of common stock warrants exercised | 1,882,600 | |||
Proceeds from warrants exercised | 8,500 | |||
Warrants | Other Income (Expense) | ||||
Class Of Stock [Line Items] | ||||
Change in fair value of warrant liability | $ 1,800 | |||
2017 ATM Agreement | ||||
Class Of Stock [Line Items] | ||||
Remaining proceeds from common stock, under sales agreement | $ 120,000 | |||
Maximum | ||||
Class Of Stock [Line Items] | ||||
Common stock sales agreement aggregate sales proceeds | $ 120,000 | |||
Maximum | 2017 ATM Agreement | ||||
Class Of Stock [Line Items] | ||||
Commission on gross sales proceeds of common stock | 3% |
Equity Plans and Stock-Based _3
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||||||
May 28, 2014 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | May 31, 2022 | Jun. 30, 2021 | May 31, 2021 | Jan. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Increase in aggregate number of shares of common stock authorized for issuance | 15,000,000 | 1,000,000 | ||||||
Stock-based compensation expense | $ 0 | $ 2,774 | $ 3,075 | |||||
Expected dividend yield | 0% | |||||||
Restricted Stock Units (RSUs) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock based compensation expense related to restricted stock | $ 20,400 | 13,200 | 7,900 | |||||
Aggregate intrinsic value | 62,200 | 37,000 | 37,300 | |||||
Fair value of restricted stock units | $ 16,100 | $ 15,700 | 4,700 | |||||
Restricted stock unit awards outstanding | 4,445,000 | 3,479,000 | ||||||
Employee Stock Option | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options vesting period | 7 years | |||||||
Stock-based compensation expense | $ 18,700 | $ 17,200 | 11,100 | |||||
Intrinsic value of options exercised | 5,000 | 7,700 | 7,900 | |||||
Fair value of stock options vested | 19,500 | 17,500 | 9,000 | |||||
Market Based Performance Stock Unit | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock based compensation expense related to restricted stock | 2,500 | 800 | 1,800 | |||||
Aggregate intrinsic value | $ 7,800 | $ 2,100 | $ 3,300 | |||||
Restricted stock unit awards outstanding | 557,000 | 193,000 | ||||||
Minimum | Restricted Stock Units (RSUs) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Expiration period | 7 years | |||||||
Maximum | Restricted Stock Units (RSUs) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Expiration period | 10 years | |||||||
2018 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Newly reserved shares of common stock | 9,388,428 | 3,250,000 | 1,500,000 | |||||
Time Based Vesting Schedule | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation cost related to non-vested equity awards | $ 46,100 | |||||||
Unrecognized compensation cost, weighted-average vesting period | 1 year 7 months 6 days | |||||||
Time Based Vesting Schedule | Performance Based Restricted Stock Units | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation cost related to non-vested equity awards | $ 5,500 | |||||||
Performance Based Vesting Schedule | Performance Based Restricted Stock Units | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Restricted stock unit awards outstanding | 36,000 | |||||||
2014 Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation cost related to non-vested equity awards | $ 1,000 | |||||||
Unrecognized compensation cost, weighted-average vesting period | 1 year 2 months 12 days | |||||||
Shares issued to employees | 161,000 | |||||||
Shares remaining available for future purchases | 722,000 | |||||||
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% | |||||||
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% | |||||||
2014 Employee Stock Purchase Plan | Maximum | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares remaining available for future purchases | 32,600,000 | 1,850,000 |
Equity Plans and Stock-Based _4
Equity Plans and Stock-Based Compensation - Option Activity under Stock-Based Compensation Plans (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Shares Underlying Outstanding Options | ||
Beginning balance | 9,339 | |
Options granted | 1,982 | |
Options exercised | (850) | |
Options cancelled: | ||
Options forfeited (unvested) | (90) | |
Options expired (vested) | (261) | |
Ending balance | 10,120 | 9,339 |
Vested and expected to vest at December 31, 2023 | 9,976 | |
Exercisable at December 31, 2023 | 7,014 | |
Weighted-Average Exercise Price Per Share | ||
Beginning balance | $ 10.7 | |
Options granted | 11.17 | |
Options exercised | 7.48 | |
Options cancelled: | ||
Options forfeited (unvested) | 10.93 | |
Options expired (vested) | 21.39 | |
Ending balance | 10.78 | $ 10.7 |
Vested and expected to vest at December 31, 2023 | 10.77 | |
Exercisable at December 31, 2023 | $ 10.4 | |
Weighted-Average Remaining Contractual Term (years) | ||
Balance at December 31 | 4 years 2 months 4 days | 4 years 7 months 9 days |
Vested and expected to vest at December 31, 2023 | 4 years 1 month 24 days | |
Exercisable at December 31, 2023 | 3 years 6 months | |
Aggregate Intrinsic Value | ||
Balance at December 31, 2022 | $ 16,291 | |
Balance at December 31, 2023 | 37,388 | $ 16,291 |
Vested and expected to vest at December 31, 2023 | 37,024 | |
Exercisable at December 31, 2023 | $ 29,613 |
Equity Plans and Stock-Based _5
Equity Plans and Stock-Based Compensation - Summary of Non-vested Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs) shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 $ / shares shares | ||
Number of Shares | ||
Non-vested, Beginning Balance | shares | 3,479 | |
Granted | shares | 2,748 | |
Vested | shares | (1,515) | [1] |
Forfeited | shares | (267) | |
Non-vested, Ending Balance | shares | 4,445 | |
Weighted-Average Grant-Date Fair Value Per Share | ||
Non-vested, Beginning Balance | $ / shares | $ 11 | |
Granted | $ / shares | 11.48 | |
Vested | $ / shares | 10.13 | [1] |
Forfeited | $ / shares | 11.45 | |
Non-vested, Ending Balance | $ / shares | $ 11.57 | |
[1] Inclusive of approximately 600,145 RSUs for the year ended December 31, 2023, which were not converted into shares due to net share settlement in order to cover the required amount of employee withholding taxes. The value of the withheld shares was classified as a reduction to additional paid-in capital. |
Equity Plans and Stock-Based _6
Equity Plans and Stock-Based Compensation - Summary Of Performance Based Restricted Stock Unit (Details) - Market Based Performance Stock Unit shares in Thousands | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested, Beginning Balance | shares | 193 |
Granted | shares | 364 |
Non-vested, Ending Balance | shares | 557 |
Non-vested, Beginning Balance | $ / shares | $ 11.62 |
Granted | $ / shares | 18.25 |
Non-vested, Ending Balance | $ / shares | $ 15.95 |
Equity Plans and Stock-Based _7
Equity Plans and Stock-Based Compensation - Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 7.32 | $ 7.95 | $ 7.17 |
Risk-free interest rate | 4% | 2% | 0.70% |
Expected life (in years) | 4 years 6 months | 4 years 6 months | 4 years 6 months |
Expected Volatility | 0.80% | 0.80% | 0.90% |
Market Based Performance Stock Unit | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 18.25 | $ 11.62 | $ 8.4 |
Risk-free interest rate | 4.30% | 1.70% | |
Expected life (in years) | 2 years 10 months 24 days | 2 years 10 months 24 days | 2 years 10 months 24 days |
Expected Volatility | 0.90% | 0.90% | 0.90% |
Market Based Performance Stock Unit | Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 0.03% | ||
Market Based Performance Stock Unit | Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 1.92% | ||
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 5.35 | $ 7.37 | $ 6.48 |
Risk-free interest rate | 4.90% | 2.10% | 0.10% |
Expected life (in years) | 1 year 3 months 18 days | 1 year 3 months 18 days | 1 year 2 months 12 days |
Expected Volatility | 0.70% | 1% | 1% |
Equity Plans and Stock-Based _8
Equity Plans and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Employees and directors stock-based compensation expense | $ 42,592 | $ 32,915 | $ 21,285 |
Stock-based compensation expense | 0 | 2,774 | 3,075 |
Research and Development | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 9,285 | 5,954 | 3,818 |
Selling, General and Administrative | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 29,069 | 23,118 | 14,894 |
Cost of Sales - Product | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 1,839 | 1,123 | 553 |
Inventory | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | $ 2,399 | $ 2,720 | $ 2,020 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pension and Other Postretirement Benefits Cost (Reversal of Cost) [Abstract] | |||
Contributions to 401 (k) plan | $ 1.3 | $ 0.9 | $ 0.3 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Component of Consolidated (Loss) Income Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (6,275) | $ 292,460 | $ 75,954 |
Non U.S. | 1,908 | 1,839 | 1,567 |
Total | $ (4,367) | $ 294,299 | $ 77,521 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | |||
Provision for income taxes | $ 2,022 | $ 1,143 | $ 808 |
Increase (decrease) in valuation allowance | 1,500 | 300 | |
Net operating loss carryforwards | 353,500 | ||
Unrecognized tax benefits | 12,101 | 11,339 | $ 5,615 |
Unrecognized tax benefits would affect the effective tax rate | 0 | ||
Interest related to unrecognized tax benefits | 0 | 0 | |
Penalties related to unrecognized tax benefits | 0 | $ 0 | |
Federal | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 23,100 | ||
Federal | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2024 | ||
Federal | Research And Development Tax Credits | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount | $ 28,300 | ||
Federal | Research And Development Tax Credits | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount, expiration year | 2024 | ||
Federal | Research And Development Tax Credits | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount, expiration year | 2043 | ||
California and Other States | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 283,900 | ||
California and Other States | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2024 | ||
California and Other States | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2040 | ||
California State | Research And Development Tax Credits | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount | $ 22,300 | ||
Foreign | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 0 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current | |||
Federal | $ (178) | $ (165) | $ 345 |
State | 1,533 | 897 | 260 |
Non-US | 667 | 411 | 203 |
Total current tax expense | 2,022 | 1,143 | 808 |
Deferred | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Non-US | 0 | 0 | 0 |
Total deferred tax expense | 0 | 0 | 0 |
Total income tax expense | $ 2,022 | $ 1,143 | $ 808 |
Income taxes - Schedule of Diff
Income taxes - Schedule of Difference between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Income tax provision (benefit) at federal statutory rate | $ (917) | $ 61,775 | $ 16,397 |
State tax | 574 | (2,942) | 3,576 |
Business credits | (2,050) | (3,246) | (982) |
Uncertain tax positions | 334 | 586 | 424 |
Deferred compensation charges | 830 | (473) | 131 |
Change in valuation allowance | 1,466 | (324) | (86,847) |
Section 162(m) limitation | 1,963 | 1,779 | 1,241 |
Mark-to-market of warrants | 0 | (378) | 10,364 |
Net operating loss and tax credit limitation | 0 | (56,908) | 56,459 |
Other | (518) | 879 | (290) |
Foreign taxes | 340 | 395 | 335 |
Total income tax expense | $ 2,022 | $ 1,143 | $ 808 |
Income taxes - Schedule of Co_2
Income taxes - Schedule of Component of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 96,336 | $ 113,228 |
Research credit carryforwards | 34,940 | 33,444 |
Section 174 capitalization | 22,556 | 15,308 |
Lease liability | 8,868 | 9,530 |
Stock compensation | 10,572 | 7,780 |
Accruals and reserves | 15,808 | 9,089 |
Other | 348 | 337 |
Total deferred tax assets | 189,428 | 188,716 |
Less valuation allowance | (180,387) | (178,920) |
Net deferred tax assets | 9,041 | 9,796 |
Deferred tax liabilities: | ||
Fixed assets | (2,667) | (2,916) |
Operating lease right-of-use assets | (6,345) | (6,785) |
Other | (29) | (95) |
Total deferred tax liabilities | (9,041) | (9,796) |
Net deferred tax assets | $ 0 | $ 0 |
Income taxes - Schedule of Unre
Income taxes - Schedule of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Balance at Beginning Balance | $ (11,339) | $ (5,615) |
Tax positions related to the current year, Additions | (762) | (670) |
Tax positions related to the current year, Reductions | 0 | 0 |
Tax positions related to the prior year, Additions | 0 | (5,054) |
Tax positions related to the prior year, Reductions | 0 | 0 |
Tax positions related to the prior year, Settlements | 0 | 0 |
Tax positions related to the prior year, Lapses in statute | 0 | |
Balance at Ending Balance | $ (12,101) | $ (11,339) |