0000950170-23-004130 | 10-K | XBRL Viewer | Dynavax Technologies Corp

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Document and Entity Information - USD ($) $ in Billions	12 Months Ended
Document and Entity Information - USD ($) $ in Billions	Dec. 31, 2022	Feb. 21, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2022
Document Fiscal Year Focus	2022
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		127,686,631
Entity Public Float			$ 1.1
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 2023 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, 2022.
Auditor Name	Ernst & Young LLP
Auditor Location	San Francisco, California
Auditor Firm ID	42

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 202,004	$ 436,189
Marketable securities available-for-sale	422,391	109,761
Accounts receivables, net	145,130	116,216
Other receivables	2,385	15,600
Inventories, net	59,446	61,335
Prepaid manufacturing	0	159,655
Prepaid expenses and other current assets	85,629	73,764
Total current assets	916,985	972,520
Property and equipment, net	37,596	35,020
Operating lease right-of-use assets	25,745	25,964
Goodwill	2,006	2,125
Restricted cash	207	219
Other assets	3,311	3,398
Total assets	985,850	1,039,246
Current liabilities:
Accounts payable	3,211	2,600
Accrued research and development	4,775	4,688
CEPI accrual (Note 9)	107,738	128,848
Accrued liabilities (Note 7)	30,719	49,796
Warrant liability	0	18,016
Deferred revenue	0	349,864
Other current liabilities	3,631	2,590
Total current liabilities	150,074	556,402
Convertible Notes, net of debt discount of $3,922 and $5,010 at December 31, 2022 and December 31, 2021, respectively (Note 10)	221,578	220,490
Long-term portion of lease liabilities	32,801	34,316
Other long-term liabilities	384	5,664
Total liabilities	404,837	816,872
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock: $0.001 par value, 5,000 shares authorized at December 31, 2022, and 2021; zero shares outstanding at December 31, 2022 and 2021	0	0
Common stock: $0.001 par value; 278,000 shares authorized at December 31, 2022, and 2021; 127,604 shares and 122,945 shares issued and outstanding at December 31, 2022 and 2021, respectively	128	123
Additional paid-in capital	1,510,518	1,441,868
Accumulated other comprehensive (loss)	(5,438)	(2,266)
Accumulated deficit	(924,195)	(1,217,351)
Total stockholders’ equity	581,013	222,374
Total liabilities and stockholders’ equity	$ 985,850	$ 1,039,246

Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Long-term debt, net of debt discount	$ 3,922	$ 5,010
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	127,604,000	122,945,000
Common stock, shares outstanding	127,604,026	122,945,000

Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Revenues:
Total revenues	$ 722,683	$ 439,442	$ 46,551
Operating expenses:
Cost of sales - product	262,153	173,572	11,410
Cost of sales - amortization of intangible assets	0	0	2,500
Research and development	46,600	32,228	28,607
Selling, general and administrative	131,408	100,156	79,256
Gain on sale of assets	(1,000)	(1,000)	(6,851)
Total operating expenses	439,161	304,956	114,922
Income (loss) from operations	283,522	134,486	(68,371)
Other income (expense):
Interest income	7,912	140	1,260
Interest expense	(6,732)	(11,176)	(19,062)
Sublease income	7,685	7,735	7,706
Loss on debt extinguishment	0	(5,232)	0
Change in fair value of warrant liability (Note 14)	1,801	(49,354)	4,124
Other	111	922	(897)
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total	294,299	77,521	(75,240)
Provision for income taxes	(1,143)	(808)	0
Net income (loss)	293,156	76,713	(75,240)
Undistributed earnings allocated to participating securities	(283)	(4,569)	0
Net income (loss) allocable to common stockholders, basic	$ 292,873	$ 72,144	$ (75,240)
Basic net loss per share allocable to common stockholders	$ 2.32	$ 0.62	$ (0.75)
Diluted net loss per share allocable to common stockholders	$ 1.97	$ 0.57	$ (0.78)
Weighted average shares used to compute basic net loss per share allocable to common stockholders	126,398	116,264	100,753
Weighted average shares used to compute diluted net loss per share allocable to common stockholders	150,797	133,006	101,504
Product
Revenues:
Total revenues	$ 713,645	$ 437,099	$ 39,307
Other Revenue
Revenues:
Total revenues	$ 9,038	$ 2,343	$ 7,244

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Statement of Comprehensive Income [Abstract]
Net income (loss)	$ 293,156	$ 76,713	$ (75,240)
Other comprehensive income (loss), net of tax:
Reclassification of realized gain on available-for-sale securities recognized in interest income			(21)
Change in unrealized loss on marketable securities available-for-sale	(1,407)	(30)	(20)
Cumulative foreign currency translation adjustments	(1,765)	(2,509)	2,701
Total other comprehensive (loss) income	(3,172)	(2,539)	2,660
Total comprehensive loss	$ 289,984	$ 74,174	$ (72,580)

- Definition

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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, 2019	$ 8,290	$ 84		$ 1,229,417	$ (2,387)	$ (1,218,824)
Beginning Balances (in shares) at Dec. 31, 2019		83,871,000	5,000
Conversion of Preferred Stock	1	$ 1
Stock Issued During Period, Shares, Conversion of Convertible Securities		700,000	(1,000)
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net	289	$ 1		288
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares)		1,209,000
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement (Shares)		24,215,000
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement	108,537	$ 24		108,513
Issuance of common stock under Employee Stock Purchase Plan	672			672
Issuance of common stock under Employee Stock Purchase Plan (in shares)		195,000
Stock compensation expense	13,484			13,484
Total other comprehensive income (loss)	2,660				2,660
Net income (loss)	(75,240)					(75,240)
Ending Balances at Dec. 31, 2020	58,693	$ 110	$ 0	1,352,374	273	(1,294,064)
Ending Balances (in shares) at Dec. 31, 2020		110,190,000	4,000
Conversion of Preferred Stock		$ 4		(4)
Stock Issued During Period, Shares, Conversion of Convertible Securities		4,140,000
Stock Redeemed During Period, Shares, Conversion of Convertible Securities (in shares)			(4,000)
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net	6,577	$ 2		6,575
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares)		1,560,000
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		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		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 income (loss)	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	0
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net	9,640	$ 3		9,637
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares)		2,626,000
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		24,668
Stock compensation expense	32,915			32,915
Total other comprehensive income (loss)	(3,172)				(3,172)
Net income (loss)	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	0

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Operating activities
Net income (loss)	$ 293,156	$ 76,713	$ (75,240)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization	3,812	4,296	4,273
Amortization of right-of-use assets	2,856	2,715	2,562
Inventory write-off	34,288	2,588	0
Loss (gain) on disposal of property and equipment and from lease termination	0	47	(98)
Amortization of premiums (accretion of discounts) on marketable securities	(4,181)	470	535
Realized gain on available-for-sale securities	0	0	(57)
Loss on debt extinguishment	0	5,232	0
Change in fair value of warrant liability	(1,801)	49,354	(4,124)
Stock compensation expense	32,915	21,285	13,484
Cost of sales - amortization of intangible assets	0	0	2,500
Non-cash interest expense	1,088	1,608	2,542
Tenant improvements provided by the landlord	0	0	1,137
Gain on sale of assets	(1,000)	(1,000)	(6,851)
Changes in operating assets and liabilities:
Accounts and other receivables, net	(15,699)	(109,155)	(13,775)
Inventories, net	(32,399)	(234)	(22,357)
Prepaid manufacturing	159,655	(130,232)	(29,423)
Prepaid expenses and other current assets	(11,865)	(64,558)	(1,826)
Other assets	87	175	(229)
Accounts payable	691	(767)	(3,448)
CEPI accrual (Note 9)	(21,110)	128,848	0
Lease liabilities	(3,125)	(3,234)	(2,872)
Deferred revenue	(349,864)	311,652	38,212
Accrued and other liabilities	(24,788)	39,725	2,804
Net cash provided by (used in) operating activities	62,716	335,528	(92,251)
Investing activities
Acquisition of technology licenses	0	0	(7,000)
Purchases of marketable securities	(632,306)	(164,928)	(201,786)
Proceeds from maturities and redemptions of marketable securities	322,450	187,630	148,565
Proceeds from sales of marketable securities	0	0	30,910
Purchases of property and equipment, net	(7,139)	(9,477)	(4,072)
Proceeds from sale of assets, net of transaction costs	1,000	1,000	6,851
Net cash (used in) provided by investing activities	(315,995)	14,225	(26,532)
Financing activities
Proceeds from issuances of common stock, net	0	28,156	108,538
Proceeds from issuance of Convertible Notes, net	0	219,822	0
Purchases of capped call options	0	(27,240)	0
Repayment of long-term debt	0	(190,194)	0
Proceeds from warrants exercises	8,455	17,814	0
Proceeds from exercise of stock options and release of restricted stock awards, net	9,639	6,577	289
Proceeds from Employee Stock Purchase Plan	1,431	841	672
Net cash provided by financing activities	19,525	55,776	109,499
Effect of exchange rate changes on cash and cash equivalents, and restricted cash	(443)	(1,431)	1,494
Net increase (decrease) in cash and cash equivalents, and restricted cash	(234,197)	404,098	(7,790)
Cash and cash equivalents, and restricted cash at beginning of year	436,408	32,310	40,100
Cash and cash equivalents, and restricted cash at end of year	202,211	436,408	32,310
Supplemental disclosure of cash flow information
Cash paid during the year for income taxes	2,208	1,312	0
Cash paid during the year for interest	5,638	9,815	16,541
Non-cash investing and financing activities:
Purchases of property and equipment, not yet paid	1,015	591	361
Right-of-use assets obtained in exchange for operating lease liabilities	$ 2,848	$ 2,468	$ 0

Organization	12 Months Ended
Organization	Dec. 31, 2022
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 focused on developing and commercializing innovative vaccines. Our first marketed product, HEPLISAV-B® (Hepatitis B Vaccine (Recombinant), Adjuvanted) is approved in the United States and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. In May 2022, we commenced commercial shipments of HEPLISAV-B in Germany. We also manufacture and sell CpG 1018®, the adjuvant used in HEPLISAV-B, and have established a portfolio of global commercial supply agreements in the development of COVID-19 vaccines across a variety of vaccine platforms utilizing CpG 1018 adjuvant. Additionally, we are advancing a multi-program clinical pipeline leveraging CpG 1018 adjuvant to develop improved vaccines in indications with unmet medical needs including Phase 1 clinical trials in Tdap and shingles, and a Phase 2 clinical trial in plague in collaboration with and fully funded by the U.S. Department of Defense ("DoD").

Summary of Significant Accounting Policies	12 Months Ended
Summary of Significant Accounting Policies	Dec. 31, 2022
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 and could be further impacted by the COVID-19 pandemic. 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 December 31, 2022 and 2021, the cumulative translation adjustments balance was $(4.0) million and $(2.3) million, respectively, primarily related to the translation of Dynavax GmbH assets, liabilities and operating results from Euros to U.S. dollars. For the years ended December 31, 2022, 2021 and 2020, we reported an unrealized foreign currency translation (loss) gain of $(1.8) million, $(2.5) million and $2.7 million, respectively. Realized gains and losses resulting from currency transactions are included in other income (expense) in the consolidated statements of operations. For the years ended December 31, 2022, 2021 and 2020, we reported a gain (loss) of $0.1 million, $0.9 million and $(0.8) 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. were less than 10% of total net assets as of December 31, 2022 and 2021. 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. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: • whether the investment has been in a continuous realized loss position for over 12 months; • the duration to maturity of our investments; • our intention and ability to hold the investment to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. To date, there have been no declines in fair value that have been identified as other than temporary. Concentration of Credit Risk and Other Risks and Uncertainties 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. To date, we have not recorded any allowance for doubtful accounts. As of December 31, 2022 and 2021, three customers collectively represented approximately 78% and 76% of our HEPLISAV-B trade receivable balance, respectively. As of December 31, 2022 and 2021, one customer represented approximately 100% and 94% of our CpG 1018 adjuvant trade receivable balance, respectively. 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 products 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. 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, 2022 and 2021, represented 34% and 43% of our total assets, respectively, and the remaining long-lived assets were located in Germany. Inventories, net HEPLISAV-B Inventories, net 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, 2022, there were no inventory write-offs recognized. For the year ended December 31, 2021, we wrote-off approximately $2.6 million associated with HEPLISAV-B excess and obsolete inventory, that was a result of decreased sales due to the COVID-19 pandemic, which is included in cost of sales – product. 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, net 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, 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). For the year ended December 31, 2021, there were no inventory write-offs recognized. Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. We evaluate the carrying value of long-lived assets, 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 assets, other current liabilities and long-term portion of lease liabilities in our consolidated balance sheets. Right-of-use (“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, 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, 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. 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") 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 performance-based RSUs with market conditions, 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 giving consideration to 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 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 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. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. For public business entities, excluding smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2019. Furthermore, the one-time determination of whether an entity is eligible to be a smaller reporting company shall be based on an entity’s most recent determination as of November 15, 2019, in accordance with SEC regulations. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, this ASU and its subsequent updates, are effective for fiscal years beginning after December 15, 2022. We expect to adopt ASU No. 2016-13 effective January 1, 2023. We do not expect the adoption to have a material impact on our consolidated financial statements.

Fair Value Measurements

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

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 were no transfers between Level 1, 2 and 3 during the years ended December 31, 2022 and 2021.

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) and liabilities measured at fair value on a recurring basis (in thousands):


	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

	Level 1		Level 2		Level 3		Total
December 31, 2021
Assets
Money market funds	$	429,194	$	-	$	-	$	429,194
U.S. treasuries		-		4,004		-		4,004
U.S. government agency securities		-		26,548		-		26,548
Corporate debt securities		-		79,209		-		79,209
Total assets	$	429,194	$	109,761	$	-	$	538,955
Liabilities
Warrant liability	$	-	$	-	$	18,016	$	18,016

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 judgement 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 is classified as a Level 3 instrument as its value is 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 and 2021 (in thousands):


Balance at December 31, 2020	$	10,736
Decrease in fair value of warrants exercised		(4,765	)
Warrants exercised		(42,074	)
Increase in the estimated fair value of warrant liability upon revaluation		54,119
Balance at December 31, 2021	$	18,016
Decrease in fair value of warrants exercised or expired		(1,801	)
Warrants exercised or expired		(16,215	)
Balance at December 31, 2022	$	-

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

12 Months Ended

Dec. 31, 2022

Investments, Debt and Equity Securities [Abstract]

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

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
	2022		2021		2020
Cash and cash equivalents	$	202,004	$	436,189	$	32,073
Restricted cash		207		219		237
Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows	$	202,211	$	436,408	$	32,310

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 Cost		Unrealized Gains		Unrealized Losses			Estimated Fair Value
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
December 31, 2021
Cash and cash equivalents:
Cash	$	6,995	$	-	$	-		$	6,995
Money market funds		429,194		-		-			429,194
Total cash and cash equivalents		436,189		-		-			436,189
Marketable securities available-for-sale:
U.S. treasuries		4,005		-		(1	)		4,004
U.S. government agency securities		26,555		-		(7	)		26,548
Corporate debt securities		79,200		9		-			79,209
Total marketable securities available-for-sale		109,760		9		(8	)		109,761
Total cash and cash equivalents, and marketable securities	$	545,949	$	9	$	(8	)	$	545,950

The maturities of our marketable securities available-for-sale are as follows (in thousands):


.	December 31, 2022
	Amortized Cost		Estimated Fair Value
Mature in one year or less	$	367,013	$	365,709
Mature after one year through two years		56,783		56,682
	$	423,796	$	422,391

There were no realized gains or losses from the sale of marketable securities for each of the years ended December 31, 2022 and 2021. There were no investments with unrealized losses longer than 12 months as of December 31, 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. As such, there have been no declines in fair value that have been identified as other than temporary.

Inventories, Net

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Inventories, net

The following table presents inventories, net (in thousands):


	December 31
	2022		2021
Raw materials	$	25,517	$	26,637
Work-in-process		23,934		14,748
Finished goods		9,995		19,950
Total	$	59,446	$	61,335

As of December 31, 2022 and December 31, 2021, included in finished goods inventory were $10.0 million and $18.6 million of HEPLISAV-B inventory, respectively. As of December 31, 2021, included in finished goods inventory were $1.3 million of CpG 1018 adjuvant inventory.

As of December 31, 2022, there we no prepaid manufacturing costs related to prepayments made to third-party manufacturers of CpG 1018 adjuvant. As of December 31 2021, we recorded $159.7 million of prepaid manufacturing costs related to prepayments made to third-party manufacturers of CpG 1018 adjuvant. During 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 associated with the Clover Supply Agreement, as amended (See Note 9).

Property and Equipment, Net

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

Property and Equipment, net

Property and equipment consist of the following (in thousands):


	Estimated Useful	December 31,
	Life (In years)	2022			2021
Manufacturing equipment	5-13	$	15,139		$	12,532
Lab equipment	5-13		2,360			2,492
Computer equipment	3		4,720			5,336
Furniture and fixtures	3-13		2,464			2,463
Leasehold improvements	2-12		28,822			27,634
Assets in progress			11,613			9,941
			65,118			60,398
Less accumulated depreciation and amortization			(27,522	)		(25,378	)
Total		$	37,596		$	35,020

Depreciation and amortization expense on property and equipment was $3.8 million, $4.3 million and $4.3 million for the years ended December 31, 2022, 2021 and 2020, respectively.

Current Accrued Liabilities and Accrued Research and Development

12 Months Ended

Dec. 31, 2022

Disclosure Component Of Current Accrued Liabilities And Accrued Research And Development [Abstract]

Current Accrued Liabilities and Accrued Research and Development

Current Accrued Liabilities

Current accrued liabilities consist of the following (in thousands):


	December 31,
	2022		2021
Payroll and related expenses	$	14,261	$	13,011
Revenue reserve accruals		10,552		8,253
Accrued inventory		2,209		20,868
Other accrued liabilities		3,697		7,664
Total	$	30,719	$	49,796

Commitments and Contingencies

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

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 renewal options at our election to renew or extend the lease for two successive five-year terms. These optional periods have not been considered in the determination of the ROU 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 was $7.7 million for each of the years ended

December 31, 2022, 2021 and 2020. 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,
	2022		2021		2020
Operating lease expense	$	6,222	$	6,265	$	6,267

Cash paid for amounts included in the measurement of lease liabilities for the years ended December 31, 2022, 2021, and 2020 was $6.8 million, $7.0 million, and $6.9 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, 2022		December 31, 2021
Operating lease liabilities:
Current portion of lease liabilities (included in other current liabilities)	$	3,631	$	2,577
Long-term portion of lease liabilities		32,801		34,316
Total operating lease liabilities	$	36,432	$	36,893

At December 31, 2022, the maturities of our sublease income and operating lease liabilities were as follows (in thousands):


Years ending December 31,	Sublease Income		Operating Lease Liabilities
2023	$	5,518	$	6,943
2024		5,684		7,073
2025		5,854		6,448
2026		6,030		5,875
2027		6,211		6,033
Thereafter		21,500		21,203
Total	$	50,797		53,575
Less:
Present value adjustment				(17,143	)
Total			$	36,432

The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows:


	December 31, 2022			December 31, 2021
Weighted average remaining lease term	7.6 years			9.1 years
Weighted average discount rate		10.1	%		10.1	%

Commitments

As of December 31, 2022, our purchase commitments include non-cancelable purchase commitments for the supply of HEPLISAV-B. As of December 31, 2022, we have no material non-cancelable purchase and other commitments, for the

supply of CpG 1018 adjuvant. The following summarizes our material purchase commitments at December 31, 2022 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)
2023	$	9,312
2024		10,857
2025		11,367
2026		11,872
2027		—
Thereafter		—
Total	$	43,408

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, 2022, the aggregate principal amount of our convertible senior notes due 2026 ("Convertible Notes") was $225.5 million, excluding debt discount of $3.9 million (See Note 10). The Convertible Notes mature on May 15, 2026, unless converted, redeemed or repurchased in accordance with their terms prior to such date.

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 31, 2022 and is 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, 2022 and 2021.

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 the years ended December 31, 2022 and 2021, we received $1.0 million from TriSalus because it met a pre-commercialization milestone. We recorded the proceeds as gain on sale of assets in our consolidated statements of operations in the years ended December 31, 2022 and 2021. We also paid Holdings $0.5 million in each of years ended December 31, 2022 and 2021. We included such payments in selling, general and administrative expenses in our consolidated statements of operations. No liability has been recorded under this agreement as of December 31, 2022.

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, financial statements, results of operations, or cash flows in a particular period.

Collaborative Research, Development and License Agreements

12 Months Ended

Dec. 31, 2022

Research and Development [Abstract]

Collaborative Research, Development and License Agreements

Coalition for Epidemic Preparedness Innovations

In September 2020, we entered into a Reservation Agreement for the Provision of Goods (the “Reservation Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) to make available specified quantities of CpG 1018 adjuvant, for purchases at certain prices, to CEPI and its COVID-19 vaccine development partners. Payments received under the Reservation Agreement are considered an exchange for our CpG 1018 adjuvant, which is an output of our ordinary activities. As such, we account for the arrangement under the scope of ASC 606. Advance payments are recorded as deferred revenue and recognized as revenue in the period when we satisfy our performance obligation to deliver CpG 1018 ordered or when CEPI’s right to place an order expires. Pursuant to the Reservation Agreement, we received $6.3 million from CEPI in September 2020 for production scale-up and a fourth quarter 2020 reservation fee. In October 2020, CEPI terminated the Reservation Agreement and its right to place an order expired. Therefore, we recognized $6.3 million as other revenue in the year ended December 31, 2020.

In January 2021, we entered into an agreement (the “CEPI Agreement”) with CEPI for the manufacture and reservation of a specified quantity of CpG 1018 adjuvant (“CpG 1018 Materials”). 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”) of up to $99.0 million. 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.

In May 2021, we entered into the first Amendment to the CEPI Agreement. This Amendment provided for the manufacture and reservation of an additional specified quantity of CpG 1018 adjuvant. In exchange for reserving an additional specified quantity of CpG 1018 adjuvant, CEPI agreed to provide additional Advance Payments of up to $77.4 million, together with the initial CEPI Agreement, for total Advance Payments of up to $176.4 million.

We determined that the accounting of the Advance Payments is under the scope of ASC 606. The Advance Payments are to cover the costs of manufacture and to reserve CpG 1018 Materials, which is an output of our ordinary activities. As such, the Advance Payments are initially classified as long-term deferred revenue in our consolidated balance sheets. We are obligated to repay CEPI, in proportion to quantity sold and within a certain period, upon receipt of payment from CEPI partner(s). Thus, when we deliver CpG 1018 Materials to CEPI partner(s) or when we receive payment from CEPI partner(s), we reclassify the Advanced Payments from long-term deferred revenue to accrued liabilities. We recognize the Advance Payments as revenue when the amount (or a portion thereof) is forgiven by CEPI when (i) the CpG 1018 Materials are not sold through to CEPI partner(s), (ii) there is no alternative use and (iii) the CpG 1018 Materials are destroyed.

Through December 31, 2022, we have received Advance Payments totaling approximately $175.0 million pursuant to the CEPI Agreement, as amended. Advance payments totaling $107.7 million and $128.8 million were recorded as CEPI accrual in our consolidated balance sheets as of December 31, 2022 and December 31, 2021, respectively, reflecting the outstanding balance of the CEPI Advance Payments. There was no deferred revenue balance related to the CEPI Agreement as of December 31, 2022. As of December 31, 2021, deferred revenue totaling $5.4 million was recorded as other long-term liabilities in our consolidated balance sheets. There was no CEPI accounts receivable balance as of December 31, 2022. As of December 31, 2021, we recorded $14.6 million in CEPI accounts receivable, which is included in other receivables in our consolidated balance sheets.

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 (the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover has committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, as amended, 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. 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.

Pricing for CpG 1018 adjuvant is variable depending on the destination where Clover ultimately sells Clover Product to. Pursuant to the Clover Supply Agreement, our initial invoicing is at the lowest price tier, with a true-up mechanism to issue an additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Clover Product exceeds a threshold specified in the Clover Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price.

For CpG 1018 adjuvant reserved for Clover under the CEPI Agreement, as amended, Clover is obligated to pay 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. For CpG 1018 adjuvant ordered by Clover outside the CEPI Agreement, as amended, Clover is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Clover, upon our acceptance of such purchase order, and the remainder of the purchase price upon the release of such CpG 1018 adjuvant.

We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Clover. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement, as amended, 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.

In August of 2022, we signed an amendment (the “Clover Amendment No 1”) to the Clover Supply Agreement. Per the Clover Amendment No 1, we and Clover agreed to modify the scope of the Clover Supply Agreement by reducing certain quantities of CpG 1018 adjuvant, which we originally intended to deliver in accordance with a purchase order previously issued by Clover (the "Original Purchase Order"). Per the Clover Amendment No 1, the Original Purchase Order was modified to deliver less quantities of CpG 1018 adjuvant (the “Modified Purchase Order”). Prior to the Clover Amendment No 1, we had received an advance payment of $68.0 million corresponding to the Original Purchase Order. Certain of the previously received advance payments have been applied (i) in the amount of $24.1 million as cancellation fees to recover manufacturing costs incurred with contract manufacturing organizations (“CMOs”) in connection with the cancelled portion of the Original Purchase Order, (ii) as final payment of $14.6 million for the remaining quantities of CpG 1018 adjuvant to be delivered under the Modified Purchase Order, and (iii) as final payment of $29.3 million for quantities of CpG 1018 adjuvant to be delivered through December 31, 2022.

Prior to the Clover Amendment No 1, no quantities of CpG 1018 adjuvant had been delivered to Clover in connection with the Original Purchase Order. Therefore, no revenue had been recognized by us up to that point in time. The Clover Amendment No 1 was determined to be a contract modification in accordance with ASC 606. That is because the modification resulted in a decrease in scope of the original contract, and the remaining goods to be transferred under the Modified Purchase Order were deemed to be distinct. The total amount of consideration allocated to the remaining performance obligation totaled $53.2 million, which was recognized as product revenue, net, in the year ended December 31, 2022 upon the fulfilment of the Modified Purchase Order including delivery of CpG 1018 adjuvant.

In October 2022, we executed the second amendment to the Clover Supply Agreement (the “Clover Amendment No 2”). Pursuant to the Clover Amendment No 2, we and Clover agreed to amend certain payment terms and further reduce certain quantities of CpG 1018 adjuvant to be delivered to Clover (the “Cancelled Portion”). The Clover Amendment No 2 primarily established: (i) a revised delivery schedule of CpG 1018 adjuvant were delivered through December 31, 2022, (ii) revised payment terms for certain amounts to be received from Clover, and (iii) potential future collections of approximately $10.0 million payable by Clover upon the fulfillment of certain financing or net sales milestones.

The Clover Amendment No 2 was determined to be a contract modification in accordance with ASC 606. That is because the modification resulted in a decrease in scope of the original contract, as amended, and the remaining goods to be transferred under the Modified Purchase Order were deemed to be distinct. The total amount of consideration allocated to the remaining performance obligation totaled $87.0 million, which was recognized as product revenue, net, in the year ended December 31, 2022 upon the fulfilment of the Modified Purchase Order including delivery of CpG 1018 adjuvant.

The terms and conditions of the Clover Supply Agreement, as amended, were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder.

Contract asset balances of $71.3 million and $62.5 million, were included in other current assets in our consolidated balance sheets, as of December 31, 2022 and 2021, respectively. We had no accounts receivable balance from Clover as of December 31, 2022. Our accounts receivable balance from Clover totaled $2.1 million as of December 31, 2021. We recognized CpG 1018 adjuvant net product revenue of $288.0 million and $72.2 million from Clover, for the years ended December 31, 2022 and 2021, respectively.

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 (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 has committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, as amended, 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. 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.

Pricing for CpG 1018 adjuvant is variable depending on the destination where Bio E ultimately sells Bio E Product to. Pursuant to the Bio E Supply Agreement, our initial invoicing will be at the lowest price tier, with a true-up mechanism to issue an additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Bio E Product exceeds a threshold specified in the Bio E Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price.

For CpG 1018 adjuvant reserved for Bio E under the CEPI Agreement, as amended, Bio E is obligated to pay, in full, the aggregate purchase price, as set forth in a purchase order submitted by Bio E, upon delivery of CpG 1018 adjuvant. For CpG 1018 adjuvant ordered by Bio E outside the CEPI Agreement, as amended, Bio E is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Bio E, upon our acceptance of such purchase order, and the remainder of the purchase price upon the delivery of such CpG 1018 adjuvant.

We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Bio E. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue.

In June 2022, we entered into an amendment to the Bio E Supply Agreement (the “Bio E Amendment No 1”). The Bio E Amendment No 1 primarily established 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 Biological E from the Government of India in connection with their Advance Purchase agreement for CORBEVAX.

In October 2022, we entered into a second amendment to the Bio E Supply Agreement (the “Bio E Amendment No 2”), as amended. Per the Bio E Amendment No 2, we and Bio E agreed to modify the scope of the Bio E Supply Agreement, as amended by reducing certain quantities of CpG 1018 adjuvant, which we originally intended to deliver in accordance with a purchase order previously issued by Bio E. Additionally, the Bio E Amendment No 2 extends payment terms for certain accounts receivable. The Bio E Amendment No 2 was determined to be a contract modification in accordance with ASC 606. That is because the modification resulted in a decrease in scope of the original contract, and the remaining goods to be transferred under the amended agreement were deemed to be distinct. The total amount of consideration allocated to the remaining performance obligation totaled $60.2 million, which was recognized as product revenue, net, in the year ended December 31, 2022 upon the fulfilment of the amended agreement including delivery of CpG 1018 adjuvant.

The terms and conditions of the Bio E Supply Agreement, as amended, were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder.

Our accounts receivable balance from Bio E totaled $117.8 million and $96.1 million, as of December 31, 2022 and 2021, respectively. We recognized CpG 1018 adjuvant net product revenue of $206.2 million and $185.7 million from Bio E, for the years ended December 31, 2022 and 2021, respectively.

PT Bio Farma (Persero)

In May 2022, we entered into a commercial supply agreement (the “Bio Farma Supply Agreement”) with PT Bio Farma (Persero) (“Bio Farma”) to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the development and commercialization of Bio Farma’s COVID-19 vaccine, adjuvanted with our CpG 1018 adjuvant (“Bio Farma Product”), for delivery during the year ended December 31, 2022. The Bio Farma Supply Agreement also provides terms for Bio Farma to order additional quantities of CpG 1018 adjuvant for delivery throughout the life of the agreement. The terms and conditions of the Bio Farma Supply Agreement are operative through May 2023. Our supply obligations under this contract have been fully satisfied as of December 31, 2022, and we have no remaining deliverables under this arrangement.

Pricing for CpG 1018 adjuvant is variable depending on the destination where Bio Farma ultimately sells Bio Farma Product to. Pursuant to the Bio Farma Supply Agreement, our initial invoicing will be at the lowest price tier, with a true-up mechanism to issue an additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Bio Farma Product exceeds a threshold specified in the Bio Farma Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price. Bio Farma is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Bio Farma, upon our acceptance of such purchase order, and the remainder of the purchase price upon the delivery of such CpG 1018 adjuvant.

We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Bio Farma. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue.

There was no accounts receivable or deferred revenue balance from Bio Farma as of December 31, 2022. We recognized CpG 1018 adjuvant net product revenue of $25.4 million from Bio Farma for the year ended December 31, 2022.

Medigen Vaccine Biologics

In February 2021, we entered into a Supply Agreement (“Medigen Supply Agreement”) with Medigen Vaccine Biologics (“Medigen”) to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the development and commercialization of Medigen’s COVID-19 vaccine for delivery in the first and second quarters of 2021. In August 2021, we entered into a second supply agreement (“Medigen Supply Agreement No. 2”) to manufacture and supply additional specified quantities of CpG 1018 adjuvant for delivery in the third and fourth quarter of 2021. The terms and conditions of the Medigen Supply Agreement and the Medigen Supply Agreement No. 2 were operative through December 2021, and as of December 31, 2022, we had satisfied all delivery obligations thereunder.

Under Medigen Supply Agreement No. 2, pricing for CpG 1018 adjuvant is variable depending on the destination where Medigen ultimately sells Medigen Product to. Pursuant to the Medigen Supply Agreement No. 2, we invoice Medigen based on the highest-tier price, with a true-up mechanism to issue credit to Medigen for the difference between the initial invoice price and the lower tiered price, if any. We invoice Medigen a specified percentage of the aggregate price of the order upon acceptance of the order and the remaining upon delivery. In addition, we are entitled to a royalty calculated as a percentage of the adjusted net sales.

We recognize revenue upon transfer of control of CpG 1018 adjuvant to Medigen at the highest-tiered price. The potential royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue.

We had no accounts receivable from Medigen as of December 31, 2022. Our accounts receivable from Medigen totaled $2.4 million as of December 31, 2021. We did not recognize CpG 1018 adjuvant net product revenue from Medigen during the year ended December 31, 2022. We recognized CpG 1018 adjuvant net product revenue of $26.7 million and $1.2 million from Medigen, for the years ended December 31, 2021 and 2020, respectively.

Valneva SE

In April 2020, we entered into a collaboration agreement ("Valneva Collaboration Agreement") with Valneva Scotland Limited (“Valneva”) to provide CpG 1018 adjuvant for use in the development of Valneva’s COVID-19 vaccine candidate ("VLA2001"). The Valneva Collaboration Agreement was amended in July 2020, to provide additional quantities of CpG 1018 adjuvant. In September 2020, we entered into a supply agreement (“Valneva Supply Agreement”) with Valneva to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the commercialization of VLA2001.

We concluded that the Valneva Collaboration Agreement and the Valneva Supply Agreement were entered into at or near the same time, with the same customer and were negotiated as a package with a single commercial objective to provide CpG 1018 adjuvant to Valneva. Therefore, the Valneva Collaboration Agreement and the Valneva Supply Agreement should be combined and accounted for as a single arrangement.

In October 2021, we and Valneva entered into a letter agreement (the “Valneva Amendment”) modifying certain deliverables of the Valneva Supply Agreement. Specifically, the Valneva Amendment modifies the original Valneva Supply Agreement as follows: (1) cancels certain purchase orders for CpG 1018 adjuvant previously issued under the original Valneva Supply Agreement that had not been fulfilled as of the date of the Valneva Amendment; and (2) provides a future delivery schedule for commercial supply of CpG 1018 adjuvant through the end of 2022. As of the date of the Valneva Amendment, we had received non-refundable advance payments of approximately $55.4 million associated with the cancelled purchase orders. The terms and conditions of the Valneva Supply Agreement, as amended by the Valneva Amendment, were operative through our final delivery date in June 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder.

In accordance with revenue recognition guidance in ASC 606, the Valneva Amendment was determined to be a contract modification and will be accounted for prospectively as one agreement with consideration allocated to future performance obligations. We have identified one remaining performance obligation, which was the delivery of CpG 1018 adjuvant through the end of 2022. The total amount of consideration allocated to the remaining performance obligation includes approximately $55.4 million of advance payments received as of the date of the Valneva Amendment plus additional future consideration to be received in connection with final delivery of product. We satisfied our remaining performance obligation to deliver CpG 1018 adjuvant under the Valneva Amendment in June 2022. Accordingly, we recognized the $55.4 million of advance payments as product revenue in the year ended December 31, 2022.

As of December 31, 2022, there was no deferred revenue balance related to Valneva. As of December 31, 2021, deferred revenue related to Valneva was $55.4 million. There was no accounts receivable balance related to Valneva, as of December 31, 2022 and 2021. We recognized CpG 1018 net product revenue of $68.0 million, $89.4 million and $2.0 million for the years ended December 31, 2022, 2021 and 2020, respectively.

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. We recognized revenue of $8.8 million and $0.5 million for the years ended December 31, 2022 and 2021, which is included in other revenue in our consolidated statements of operations.

Convertible Notes

12 Months Ended

Dec. 31, 2022

Debt Disclosure [Abstract]

Convertible Notes

10.

Convertible Notes

In May 2021, we issued $200.0 million aggregate principal amount of 2.50% convertible senior notes due 2026 in a private placement. The purchasers also partially exercised their option to purchase additional Convertible Notes in May 2021 and we issued an additional $25.5 million of the Convertible Notes. 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 repay, in full, our outstanding debt and other obligations under the loan agreement with CRG Servicing LLC (the "Loan Agreement") (See Note 11) and $27.2 million of the net proceeds to pay the costs of the capped call transactions (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 in accordance with their terms 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 commencing after September 30, 2021 (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 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 continue to classify the Convertible Notes as long-term debt on the consolidated balance sheets as of December 31, 2022.

We may redeem for cash all or any portion of 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 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.

As a result of adopting ASU 2020-06, we accounted for the Convertible Notes as a single liability. As of December 31, 2022 and 2021, the Convertible Notes were recorded at the aggregate principal amount of $225.5 million less unamortized issuance costs of $3.9 million as a long-term liability on the consolidated balance sheets. As of December 31, 2022, the fair value of the Convertible Notes was $284.8 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, 2022		Year Ended December 31, 2021
Stated coupon interest	$	5,638	$	3,555
Amortization of debt issuance cost		1,094		669
Total interest expense	$	6,732	$	4,224

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.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 470
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (d)
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

+ Details

Long-Term Debt

12 Months Ended

Dec. 31, 2022

Debt Disclosure [Abstract]

Long-Term Debt

11.

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 and $19.1 million of interest expense related to the Term Loans during the years ended December 31, 2021 and 2020, respectively.

Revenue Recognition

12 Months Ended

Dec. 31, 2022

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, 2022						December 31, 2021						December 31, 2020
	U.S.		Non U.S.		Total		U.S.		Non U.S.		Total		U.S.		Non U.S.		Total
Product revenue, net
HEPLISAV-B	$	124,996	$	941	$	125,937	$	61,870	$	-	$	61,870	$	36,030	$	-	$	36,030
CpG 1018 adjuvant		-		587,708		587,708		-		375,229		375,229		-		3,277		3,277
Total product revenue, net	$	124,996	$	588,649	$	713,645	$	61,870	$	375,229	$	437,099	$	36,030	$	3,277	$	39,307
Other revenue		8,774		264		9,038		1,915		428		2,343		-		7,244		7,244
Total revenues	$	133,770	$	588,913	$	722,683	$	63,785	$	375,657	$	439,442	$	36,030	$	10,521	$	46,551

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 product revenue):


	Year Ended
	December 31,
	2022			2021			2020
Largest Customer		21	%		21	%		21	%
Second largest Customer		17	%		19	%		20	%
Third largest Customer		16	%		19	%		20	%

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,
	2022			2021			2020
Largest collaboration partner		49	%		49	%		62	%
Second largest collaboration partner		35	%		24	%		36	%
Third largest collaboration partner		12	%		19	%		2	%

Contract Balances

The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories (in thousands):


	Balance at Beginning of Period		Provisions related to current period sales		Credit or payments made during the period			Balance at End of Period
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
Year ended December 31, 2021:
Accounts receivable reserves (1)	$	2,836	$	18,209	$	(17,222	)	$	3,823
Revenue reserve accruals (2)	$	6,040	$	13,077	$	(10,864	)	$	8,253

(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 further discussion. The following table summarizes balances and activities in our contract asset account (in thousands):


	Balance at Beginning of Period		Additions (1)		Subtractions			Balance at End of Period
Year ended December 31, 2022:
Contract asset (2)	$	62,525	$	17,556	$	(8,116	)	$	71,965
Year ended December 31, 2021:
Contract asset	$	-	$	62,525	$	-		$	62,525

(1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement and for services performed under our agreement with the DoD.

(2) Includes $0.7 million of contract assets derived from our agreement with the DoD.

Payments received or invoices issued before we satisfy our performance obligations are recorded as deferred revenue until we satisfy such performance obligations. Our deferred revenue activities are related to CpG 1018 adjuvant product sales. The following table summarizes balances and activities in our deferred revenue accounts (in thousands):


	Balance at Beginning of Period		Additions (1)		Subtractions (2)			Revenue recognized in the current period included in deferred revenue balance at the beginning of the period			Balance at End of Period
Year ended December 31, 2022:
Deferred revenue	$	349,864	$	45,596	$	(45,955	)	$	(349,505	)	$	-
Long-term deferred revenue	$	5,385	$	6,582	$	(11,967	)	$	-		$	-
Year ended December 31, 2021:
Deferred revenue	$	38,212	$	371,860	$	(21,996	)	$	(38,212	)	$	349,864
Long-term deferred revenue	$	-	$	168,467	$	(163,082	)	$	-		$	5,385

(1) Additions are primarily payments received or invoices issued before we satisfy our performance obligations.

(2) Subtractions are primarily revenues recognized in the period and reclassification from long-term deferred revenue to CEPI accrual.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

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+ Details

Net Loss Per Share

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Net Loss Per Share

13.

Net Income (Loss) Per Share

We compute net income (loss) per share of common stock using the two-class method required for participating securities. We consider Series B Preferred Stocks and warrants to be participating securities because holders of such shares have dividend rights in the event of our declaration of a dividend for common shares. Undistributed earnings allocated to participating securities are subtracted from net income (loss) in determining net income (loss) attributable to common stockholders.

Basic net income (loss) per share is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of shares of our common stock outstanding.

For the calculation of diluted net income (loss) per share, net income (loss) attributable to common stockholders for basic net income (loss) 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 (loss) per share attributable to common stockholders is computed by dividing the resulting net income (loss) attributable to common stockholders by the weighted-average number of fully diluted common shares outstanding.


	Year Ended
	December 31,
	2022			2021			2020
Numerator
Net income (loss)	$	293,156		$	76,713		$	(75,240	)
Less: undistributed earnings allocated to participating securities		(283	)		(4,569	)		-
Net income (loss) allocable to common stockholders, basic		292,873			72,144			(75,240	)
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	)		-			(4,124	)
Net income (loss) allocable to common stockholders, diluted	$	296,399		$	75,691		$	(79,364	)
Denominator
Weighted average shares used to compute net income (loss) allocable to common stockholders per share, basic		126,398			116,264			100,753
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			-			751
Weighted average shares used to compute net income (loss) allocable to common stockholders per share, diluted		150,797			133,006			101,504

The following were excluded from the calculation of diluted net income (loss) per share as the effect of their inclusion would have been anti-dilutive:


	December 31,
	2022		2021		2020
Outstanding securities not included in diluted net income (loss) allocable to common stockholders per share calculation (in thousands):
Stock options and stock awards		7,165		5,953		10,299
Series B Convertible Preferred Stock (as converted to common stock)		-		-		4,140
Warrants (as exercisable into common stock)		-		1,883		-

Common Stock

12 Months Ended

Dec. 31, 2022

Preferred Stock Common Stock And Warrants [Abstract]

Common Stock

14.

Common Stock

Common Stock Outstanding

As of December 31, 2022, there were 127,604,026 shares of our common stock outstanding.

In August 2019, we sold 18,525,000 shares of our common stock, par value $0.001 per share, 4,840 shares of our Series B Convertible Preferred Stock, par value $0.001 per share (“Series B Preferred Stock”) and warrants to purchase up to an aggregate of 5,841,250 shares of our common stock in an underwritten public offering (the “Offering”) for aggregate net proceeds of approximately $65.6 million. Investment funds associated with Bain Capital Life Sciences Investors, LLC (“Bain Capital Life Sciences”) purchased approximately $35.0 million of common stock, Series B Preferred Stock and warrants in the Offering on the same terms as the other investors in the Offering. Following the Offering, Andrew A. F. Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, was appointed to our board of directors.

On August 6, 2020, we entered into an at-the-market Sales Agreement (the “2020 ATM Agreement”) with Cowen and Company, LLC (“Cowen”), under which 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 $150 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 2020 ATM Agreement. As of December 31, 2022, we had $120.5 million remaining under the 2020 ATM Agreement.

Preferred Stock Outstanding

In August 2021, all of the 4,140 shares of Series B Preferred Stock were converted into 4,140,000 shares of common stock. Therefore, there were no Series B Preferred Stock outstanding as of December 31, 2022 and 2021.

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.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-Topic 505
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+ Details

Equity Plans and Stock-Based Compensation

12 Months Ended

Dec. 31, 2022

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, 2022, 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, 2022, there were 15,252,440 shares of common stock reserved for issuance under the Amended 2018 EIP.

Under our Plans, 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 period ended December 31, 2022:


	Shares Underlying Outstanding Options (in thousands)			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Term (years)		Aggregate Intrinsic Value (in thousands)
Balance at December 31, 2021		10,399		$	11.55		4.16	$	42,756
Options granted		2,100			12.50
Options exercised		(1,194	)		8.07
Options cancelled:
Options forfeited (unvested)		(105	)		9.40
Options expired (vested)		(1,861	)		19.28
Balance at December 31, 2022		9,339		$	10.70		4.61	$	16,291
Vested and expected to vest at December 31, 2022		9,148		$	10.66		4.58	$	16,235
Exercisable at December 31, 2022		5,528		$	10.02		3.83	$	13,984

The total intrinsic value of stock options exercised during the years ended December 31, 2022, 2021 and 2020 was $7.7 million, $7.9 million, and $0.1 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, 2022, 2021 and 2020 was $17.5 million, $9.0 million and $13.8 million, respectively.

Restricted Stock Units

The following table summarizes the activity of RSUs for the period ended December 31, 2022:


	Number of Shares (In thousands)			Weighted-Average Grant-Date Fair Value
Non-vested as of December 31, 2021		2,651		$	8.30
Granted		2,310			12.36
Vested		(1,195	)		7.72
Forfeited		(287	)		10.69
Non-vested as of December 31, 2022		3,479		$	11.00

Stock-based compensation expense related to RSUs was approximately $13.2 million for the year ended December 31, 2022. The aggregate fair value of the RSUs outstanding as of December 31, 2022, based on our stock price on that date, was $37.0 million.

The total fair value of RSUs vested during the years ended December 31, 2022, 2021 and 2020 was $15.7 million, $4.7 million and $4.9 million, respectively.

Market-based Performance Stock Units

We granted market-based performance stock units (“PSUs”) to certain executives. These PSUs vest upon a specified market condition. The summary of PSU activities for the year ended December 31, 2022 is as follows:


	Number of Shares (in thousands)			Weighted-Average Grant-Date Fair Value Per Share
Non-vested as of December 31, 2021		237		$	8.40
Granted		193			11.62
Vested		(237	)		8.40
Non-vested as of December 31, 2022		193		$	11.62

Stock-based compensation expense related to PSUs was approximately $0.8 million and $1.8 million for the years ended December 31, 2022 and 2021, respectively. The aggregate intrinsic value of the PSUs outstanding as of December 31, 2022 and 2021, based on our stock price on that date, was $2.1 million and $3.3 million, respectively.

Performance-based Restricted Awards and Performance-based Options

As of December 31, 2022, approximately 31,100 and 36,000 shares underlying performance-based restricted awards and performance-based options, respectively, were outstanding.

Significant Assumptions in Estimating Option Fair Value

The fair value of each 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									PSUs					Employee Stock Purchase Plan
	Year Ended December 31,									Year Ended December 31,					Year Ended December 31,
	2022			2021			2020			2022			2021		2022			2021			2020
Weighted-average fair value	$	7.95		$	7.17		$	3.91		$	11.62		$	8.40	$	7.37		$	6.48		$	2.82
Risk-free interest rate		2.0	%		0.7	%		1.0	%		1.7	%	From 0.03% to 1.92%			2.1	%		0.1	%		0.9	%
Expected life (in years)		4.5			4.5			4.5			2.9			2.9		1.3			1.2			1.2
Expected volatility		0.8			0.9			0.9			0.9			0.9		1.0			1.0			0.7

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. Stock-based compensation for the year ended December 31, 2020 included reversal of expenses related to cancellation of certain equity grants in the year ended December 31, 2020.

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. We recognized $1.0 million and $0.1 million of stock-based compensation expense for performance-based restricted awards during the years ended December 31, 2022 and 2020, respectively. No stock-based compensation expense for awards with performance-based vesting criteria was recognized for the year ended December 31, 2021.

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, net (in thousands):


	Year Ended December 31,
	2022		2021		2020
Employees and directors stock-based compensation expense	$	32,915	$	21,285	$	13,484

	Year Ended December 31,
	2022		2021		2020
Research and development	$	5,954	$	3,818	$	1,000
Selling, general and administrative		23,118		14,894		9,585
Cost of sales - product		1,123		553		619
Inventories, net		2,720		2,020		2,280
Total	$	32,915	$	21,285	$	13,484

As of December 31, 2022, the total unrecognized compensation cost related to non-vested stock options and awards deemed probable of vesting, including all stock options with time-based vesting, net of estimated forfeitures, amounted to $43.4 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.6 years. As of December 31, 2022, there was no unrecognized compensation cost related to performance-based restricted awards. As of December 31, 2022, the total unrecognized compensation cost related to PSUs amounted to $1.6 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, 2022, employees have acquired approximately 155,000 shares of our common stock under the Employee Stock Purchase Plan and approximately 884,000 shares of our common stock remained available for future purchases under the Employee Stock Purchase Plan.

As of December 31, 2022, the total unrecognized compensation cost related to shares of our common stock under the Employee Stock Purchase Plan amounted to $0.6 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.1 years.

Employee Benefit Plan	12 Months Ended
Employee Benefit Plan	Dec. 31, 2022
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 $0.9 million, $0.3 million and $0.2 million for the years ended December 31, 2022, 2021 and 2020, respectively.

- Definition

The entire disclosure for retirement benefits.

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+ Details

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

17. Income Taxes

Consolidated income (loss) before provision for income taxes consisted of the following (in thousands):


	Year Ended December 31,
	2022		2021		2020
U.S.	$	292,460	$	75,954	$	(76,324	)
Non U.S.		1,839		1,567		1,084
Total	$	294,299	$	77,521	$	(75,240	)

There was no income tax provision for the year ended December 31, 2020. The components of the consolidated income tax provision for the years ended December 31, 2022 and December 31, 2021 were as follows (in thousands):


	Year Ended December 31, 2022			Year Ended December 31, 2021
Current
Federal	$	(165	)	$	345
State		897			260
Non-US		411			203
Total current tax expense		1,143			808
Deferred
Federal		-			-
State		-			-
Non-US		-			-
Total deferred tax expense		-			-

Total income tax expense	$	1,143		$	808

No income tax expense was recorded for the year ended December 31, 2020 due to a full valuation allowance position. 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, 2022, December 31, 2021 and December 31, 2020 were as follows (in thousands):


	Year Ended December 31,
	2022			2021			2020
Income tax provision (benefit) at federal statutory rate	$	61,775		$	16,397		$	(15,756	)
State tax		(2,942	)		3,576			(3,194	)
Business credits		(3,246	)		(982	)		(773	)
Uncertain tax positions		586			424			193
Deferred compensation charges		(473	)		131			809
Change in valuation allowance		(324	)		(86,847	)		19,009
Section 162(m) limitation		1,779			1,241			473
Mark-to-market of warrants		(378	)		10,364			(866	)
Net operating loss and tax credit limitation		(56,908	)		56,459			-
Other		1,274			45			105
Total income tax expense	$	1,143		$	808		$	-

Deferred tax assets and liabilities consisted of the following (in thousands):


	December 31,
	2022			2021
Deferred tax assets:
Net operating loss carryforwards	$	113,228		$	155,503
Research credit carryforwards		33,444			12,870
Section 174 capitalization		15,308			-
Lease liability		9,530			8,515
Stock compensation		7,780			5,798
Accruals and reserves		9,089			5,792
Other		337			212
Total deferred tax assets		188,716			188,690
Less valuation allowance		(178,920	)		(179,253	)
Net deferred tax assets		9,796			9,437
Deferred tax liabilities:
Fixed assets		(2,916	)		(3,283	)
Operating lease right-of-use assets		(6,785	)		(6,124	)
Other		(95	)		(30	)
Total deferred tax liabilities		(9,796	)		(9,437	)
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, 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 against all of its deferred tax assets.

The valuation allowance decreased by $0.3 million and $86.8 million during the years ended December 31, 2022 and 2021, respectively. 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. The decrease in valuation allowance during the year ended December 31, 2021 was due to a decrease in our deferred tax assets, predominantly related to utilization of net operating losses and Section 382 limitations.

As of December 31, 2022, we had federal net operating loss carryforwards of approximately $96.3 million, which began to expire in the year 2023, federal net operating loss carryforwards of approximately $353.5 million, which do not expire and federal research and development tax credits of approximately $26.2 million, which expire in the years 2023 through 2042.

As of December 31, 2022, we had net operating loss carryforwards for California and other states for income tax purposes of approximately $308.8 million, which expire in the years 2023 through 2040, and California state research and development tax credits of approximately $22.1 million, which do not expire.

As of December 31, 2022, we had net operating loss carryforwards for foreign income tax purposes of approximately $0.7 million, which do not expire.

Uncertain Income Tax positions

The total amount of unrecognized tax benefits was $11.3 million and $5.6 million as of December 31, 2022 and 2021, 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,
	2022			2021
Balance at beginning of year	$	(5,615	)	$	(10,565	)
Tax positions related to the current year
Additions		(670	)		(308	)
Reductions		-			-
Tax positions related to the prior year
Additions		(5,054	)		-
Reductions		-			5,258
Settlements		-			-
Lapses in statute		-			-
Balance at end of year	$	(11,339	)	$	(5,615	)

Our policy is to account for interest and penalties as income tax expense. As of December 31, 2022, there were no interest and no penalties recognized in the provision for income taxes. As of December 31, 2021, there were no interest and $0.2 million of penalties related to unrecognized tax benefits 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.

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.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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+ Details

Summary of Significant Accounting Policies (Policies)	12 Months Ended
Summary of Significant Accounting Policies (Policies)	Dec. 31, 2022
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 and could be further impacted by the COVID-19 pandemic. 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 December 31, 2022 and 2021, the cumulative translation adjustments balance was $(4.0) million and $(2.3) million, respectively, primarily related to the translation of Dynavax GmbH assets, liabilities and operating results from Euros to U.S. dollars. For the years ended December 31, 2022, 2021 and 2020, we reported an unrealized foreign currency translation (loss) gain of $(1.8) million, $(2.5) million and $2.7 million, respectively. Realized gains and losses resulting from currency transactions are included in other income (expense) in the consolidated statements of operations. For the years ended December 31, 2022, 2021 and 2020, we reported a gain (loss) of $0.1 million, $0.9 million and $(0.8) 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. were less than 10% of total net assets as of December 31, 2022 and 2021.
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. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: • whether the investment has been in a continuous realized loss position for over 12 months; • the duration to maturity of our investments; • our intention and ability to hold the investment to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. To date, there have been no declines in fair value that have been identified as other than temporary.
Concentration of Credit Risk and Other Risks and Uncertainties	Concentration of Credit Risk and Other Risks and Uncertainties 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. To date, we have not recorded any allowance for doubtful accounts. As of December 31, 2022 and 2021, three customers collectively represented approximately 78% and 76% of our HEPLISAV-B trade receivable balance, respectively. As of December 31, 2022 and 2021, one customer represented approximately 100% and 94% of our CpG 1018 adjuvant trade receivable balance, respectively. 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 products 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. 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, 2022 and 2021, represented 34% and 43% of our total assets, respectively, and the remaining long-lived assets were located in Germany.
Inventories, net	Inventories, net HEPLISAV-B Inventories, net 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, 2022, there were no inventory write-offs recognized. For the year ended December 31, 2021, we wrote-off approximately $2.6 million associated with HEPLISAV-B excess and obsolete inventory, that was a result of decreased sales due to the COVID-19 pandemic, which is included in cost of sales – product. 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, net 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, 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). For the year ended December 31, 2021, there were no inventory write-offs recognized.
Long-Lived Assets	Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. We evaluate the carrying value of long-lived assets, 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 assets, other current liabilities and long-term portion of lease liabilities in our consolidated balance sheets. Right-of-use (“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, 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, 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. 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") 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 performance-based RSUs with market conditions, 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 giving consideration to 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. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. For public business entities, excluding smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2019. Furthermore, the one-time determination of whether an entity is eligible to be a smaller reporting company shall be based on an entity’s most recent determination as of November 15, 2019, in accordance with SEC regulations. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, this ASU and its subsequent updates, are effective for fiscal years beginning after December 15, 2022. We expect to adopt ASU No. 2016-13 effective January 1, 2023. We do not expect the adoption to have a material impact on our consolidated financial statements.

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis


	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

	Level 1		Level 2		Level 3		Total
December 31, 2021
Assets
Money market funds	$	429,194	$	-	$	-	$	429,194
U.S. treasuries		-		4,004		-		4,004
U.S. government agency securities		-		26,548		-		26,548
Corporate debt securities		-		79,209		-		79,209
Total assets	$	429,194	$	109,761	$	-	$	538,955
Liabilities
Warrant liability	$	-	$	-	$	18,016	$	18,016

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 and 2021 (in thousands):


Balance at December 31, 2020	$	10,736
Decrease in fair value of warrants exercised		(4,765	)
Warrants exercised		(42,074	)
Increase in the estimated fair value of warrant liability upon revaluation		54,119
Balance at December 31, 2021	$	18,016
Decrease in fair value of warrants exercised or expired		(1,801	)
Warrants exercised or expired		(16,215	)
Balance at December 31, 2022	$	-

Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables)

12 Months Ended

Dec. 31, 2022

Cash, Cash Equivalents, and Short-Term Investments [Abstract]

Reconciliation of Cash, Cash Equivalents and Restricted Cash


	December 31
	2022		2021		2020
Cash and cash equivalents	$	202,004	$	436,189	$	32,073
Restricted cash		207		219		237
Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows	$	202,211	$	436,408	$	32,310

Summary of Cash, Cash Equivalents and Marketable Securities

Cash and cash equivalents, and marketable securities consist of the following (in thousands):


	Amortized Cost		Unrealized Gains		Unrealized Losses			Estimated Fair Value
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
December 31, 2021
Cash and cash equivalents:
Cash	$	6,995	$	-	$	-		$	6,995
Money market funds		429,194		-		-			429,194
Total cash and cash equivalents		436,189		-		-			436,189
Marketable securities available-for-sale:
U.S. treasuries		4,005		-		(1	)		4,004
U.S. government agency securities		26,555		-		(7	)		26,548
Corporate debt securities		79,200		9		-			79,209
Total marketable securities available-for-sale		109,760		9		(8	)		109,761
Total cash and cash equivalents, and marketable securities	$	545,949	$	9	$	(8	)	$	545,950

Maturities of Marketable Securities Available-for-Sale

The maturities of our marketable securities available-for-sale are as follows (in thousands):


.	December 31, 2022
	Amortized Cost		Estimated Fair Value
Mature in one year or less	$	367,013	$	365,709
Mature after one year through two years		56,783		56,682
	$	423,796	$	422,391

Inventories, Net (Tables)

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Summary of Inventories

The following table presents inventories, net (in thousands):


	December 31
	2022		2021
Raw materials	$	25,517	$	26,637
Work-in-process		23,934		14,748
Finished goods		9,995		19,950
Total	$	59,446	$	61,335

As of December 31, 2022 and December 31, 2021, included in finished goods inventory were $10.0 million and $18.6 million of HEPLISAV-B inventory, respectively.

Property and Equipment, Net (Tables)

12 Months Ended

Dec. 31, 2022

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)	2022			2021
Manufacturing equipment	5-13	$	15,139		$	12,532
Lab equipment	5-13		2,360			2,492
Computer equipment	3		4,720			5,336
Furniture and fixtures	3-13		2,464			2,463
Leasehold improvements	2-12		28,822			27,634
Assets in progress			11,613			9,941
			65,118			60,398
Less accumulated depreciation and amortization			(27,522	)		(25,378	)
Total		$	37,596		$	35,020

Current Accrued Liabilities and Accrued Research and Development (Tables)

12 Months Ended

Dec. 31, 2022

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,
	2022		2021
Payroll and related expenses	$	14,261	$	13,011
Revenue reserve accruals		10,552		8,253
Accrued inventory		2,209		20,868
Other accrued liabilities		3,697		7,664
Total	$	30,719	$	49,796

Commitments and Contingencies (Tables)

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Summary of Operating Lease Expense

Our lease expense comprises of the following (in thousands):


	Year Ended December 31,
	2022		2021		2020
Operating lease expense	$	6,222	$	6,265	$	6,267

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, 2022		December 31, 2021
Operating lease liabilities:
Current portion of lease liabilities (included in other current liabilities)	$	3,631	$	2,577
Long-term portion of lease liabilities		32,801		34,316
Total operating lease liabilities	$	36,432	$	36,893

Summary of Maturities of Sublease Income and Operating Lease Liabilities

At December 31, 2022, the maturities of our sublease income and operating lease liabilities were as follows (in thousands):


Years ending December 31,	Sublease Income		Operating Lease Liabilities
2023	$	5,518	$	6,943
2024		5,684		7,073
2025		5,854		6,448
2026		6,030		5,875
2027		6,211		6,033
Thereafter		21,500		21,203
Total	$	50,797		53,575
Less:
Present value adjustment				(17,143	)
Total			$	36,432

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 liability were as follows:


	December 31, 2022			December 31, 2021
Weighted average remaining lease term	7.6 years			9.1 years
Weighted average discount rate		10.1	%		10.1	%

Schedule of Material Purchase Commitments

The following summarizes our material purchase commitments at December 31, 2022 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)
2023	$	9,312
2024		10,857
2025		11,367
2026		11,872
2027		—
Thereafter		—
Total	$	43,408

Convertible Notes (Tables)

12 Months Ended

Dec. 31, 2022

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, 2022		Year Ended December 31, 2021
Stated coupon interest	$	5,638	$	3,555
Amortization of debt issuance cost		1,094		669
Total interest expense	$	6,732	$	4,224

Revenue Recognition (Tables)

12 Months Ended

Dec. 31, 2022

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, 2022						December 31, 2021						December 31, 2020
	U.S.		Non U.S.		Total		U.S.		Non U.S.		Total		U.S.		Non U.S.		Total
Product revenue, net
HEPLISAV-B	$	124,996	$	941	$	125,937	$	61,870	$	-	$	61,870	$	36,030	$	-	$	36,030
CpG 1018 adjuvant		-		587,708		587,708		-		375,229		375,229		-		3,277		3,277
Total product revenue, net	$	124,996	$	588,649	$	713,645	$	61,870	$	375,229	$	437,099	$	36,030	$	3,277	$	39,307
Other revenue		8,774		264		9,038		1,915		428		2,343		-		7,244		7,244
Total revenues	$	133,770	$	588,913	$	722,683	$	63,785	$	375,657	$	439,442	$	36,030	$	10,521	$	46,551

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 product revenue):


	Year Ended
	December 31,
	2022			2021			2020
Largest Customer		21	%		21	%		21	%
Second largest Customer		17	%		19	%		20	%
Third largest Customer		16	%		19	%		20	%

Summary of Product Revenue Allowance and Reserve Categories


	Balance at Beginning of Period		Provisions related to current period sales		Credit or payments made during the period			Balance at End of Period
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
Year ended December 31, 2021:
Accounts receivable reserves (1)	$	2,836	$	18,209	$	(17,222	)	$	3,823
Revenue reserve accruals (2)	$	6,040	$	13,077	$	(10,864	)	$	8,253

(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,
	2022			2021			2020
Largest collaboration partner		49	%		49	%		62	%
Second largest collaboration partner		35	%		24	%		36	%
Third largest collaboration partner		12	%		19	%		2	%

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 Beginning of Period		Additions (1)		Subtractions			Balance at End of Period
Year ended December 31, 2022:
Contract asset (2)	$	62,525	$	17,556	$	(8,116	)	$	71,965
Year ended December 31, 2021:
Contract asset	$	-	$	62,525	$	-		$	62,525

(1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement and for services performed under our agreement with the DoD.

(2) Includes $0.7 million of contract assets derived from our agreement with the DoD.

Summary of Deferred Revenue

The following table summarizes balances and activities in our deferred revenue accounts (in thousands):


	Balance at Beginning of Period		Additions (1)		Subtractions (2)			Revenue recognized in the current period included in deferred revenue balance at the beginning of the period			Balance at End of Period
Year ended December 31, 2022:
Deferred revenue	$	349,864	$	45,596	$	(45,955	)	$	(349,505	)	$	-
Long-term deferred revenue	$	5,385	$	6,582	$	(11,967	)	$	-		$	-
Year ended December 31, 2021:
Deferred revenue	$	38,212	$	371,860	$	(21,996	)	$	(38,212	)	$	349,864
Long-term deferred revenue	$	-	$	168,467	$	(163,082	)	$	-		$	5,385

(1) Additions are primarily payments received or invoices issued before we satisfy our performance obligations.

(2) Subtractions are primarily revenues recognized in the period and reclassification from long-term deferred revenue to CEPI accrual.

Net Loss Per Share (Tables)

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Computation of Basic and Diluted Net Loss Per Share


	Year Ended
	December 31,
	2022			2021			2020
Numerator
Net income (loss)	$	293,156		$	76,713		$	(75,240	)
Less: undistributed earnings allocated to participating securities		(283	)		(4,569	)		-
Net income (loss) allocable to common stockholders, basic		292,873			72,144			(75,240	)
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	)		-			(4,124	)
Net income (loss) allocable to common stockholders, diluted	$	296,399		$	75,691		$	(79,364	)
Denominator
Weighted average shares used to compute net income (loss) allocable to common stockholders per share, basic		126,398			116,264			100,753
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			-			751
Weighted average shares used to compute net income (loss) allocable to common stockholders per share, diluted		150,797			133,006			101,504

Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share


	December 31,
	2022		2021		2020
Outstanding securities not included in diluted net income (loss) allocable to common stockholders per share calculation (in thousands):
Stock options and stock awards		7,165		5,953		10,299
Series B Convertible Preferred Stock (as converted to common stock)		-		-		4,140
Warrants (as exercisable into common stock)		-		1,883		-

Equity Plans and Stock-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2022

Share-Based Payment Arrangement, Noncash Expense [Abstract]

Option Activity under Stock-Based Compensation Plans

Activity under our stock plans is set forth below:

Stock Options

The following table summarizes the activity of stock options for the period ended December 31, 2022:


	Shares Underlying Outstanding Options (in thousands)			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Term (years)		Aggregate Intrinsic Value (in thousands)
Balance at December 31, 2021		10,399		$	11.55		4.16	$	42,756
Options granted		2,100			12.50
Options exercised		(1,194	)		8.07
Options cancelled:
Options forfeited (unvested)		(105	)		9.40
Options expired (vested)		(1,861	)		19.28
Balance at December 31, 2022		9,339		$	10.70		4.61	$	16,291
Vested and expected to vest at December 31, 2022		9,148		$	10.66		4.58	$	16,235
Exercisable at December 31, 2022		5,528		$	10.02		3.83	$	13,984

Summary of Non-vested Restricted Stock Units Activity

The following table summarizes the activity of RSUs for the period ended December 31, 2022:


	Number of Shares (In thousands)			Weighted-Average Grant-Date Fair Value
Non-vested as of December 31, 2021		2,651		$	8.30
Granted		2,310			12.36
Vested		(1,195	)		7.72
Forfeited		(287	)		10.69
Non-vested as of December 31, 2022		3,479		$	11.00

Summary Of Performance Based Restricted Stock Unit


	Number of Shares (in thousands)			Weighted-Average Grant-Date Fair Value Per Share
Non-vested as of December 31, 2021		237		$	8.40
Granted		193			11.62
Vested		(237	)		8.40
Non-vested as of December 31, 2022		193		$	11.62

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									PSUs					Employee Stock Purchase Plan
	Year Ended December 31,									Year Ended December 31,					Year Ended December 31,
	2022			2021			2020			2022			2021		2022			2021			2020
Weighted-average fair value	$	7.95		$	7.17		$	3.91		$	11.62		$	8.40	$	7.37		$	6.48		$	2.82
Risk-free interest rate		2.0	%		0.7	%		1.0	%		1.7	%	From 0.03% to 1.92%			2.1	%		0.1	%		0.9	%
Expected life (in years)		4.5			4.5			4.5			2.9			2.9		1.3			1.2			1.2
Expected volatility		0.8			0.9			0.9			0.9			0.9		1.0			1.0			0.7

Stock-Based Compensation Expense


	Year Ended December 31,
	2022		2021		2020
Employees and directors stock-based compensation expense	$	32,915	$	21,285	$	13,484

	Year Ended December 31,
	2022		2021		2020
Research and development	$	5,954	$	3,818	$	1,000
Selling, general and administrative		23,118		14,894		9,585
Cost of sales - product		1,123		553		619
Inventories, net		2,720		2,020		2,280
Total	$	32,915	$	21,285	$	13,484

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Component of Consolidated (Loss) Income Before Provision for Income Taxes

Consolidated income (loss) before provision for income taxes consisted of the following (in thousands):


	Year Ended December 31,
	2022		2021		2020
U.S.	$	292,460	$	75,954	$	(76,324	)
Non U.S.		1,839		1,567		1,084
Total	$	294,299	$	77,521	$	(75,240	)

Components of Income Tax Provision

The components of the consolidated income tax provision for the years ended December 31, 2022 and December 31, 2021 were as follows (in thousands):


	Year Ended December 31, 2022			Year Ended December 31, 2021
Current
Federal	$	(165	)	$	345
State		897			260
Non-US		411			203
Total current tax expense		1,143			808
Deferred
Federal		-			-
State		-			-
Non-US		-			-
Total deferred tax expense		-			-

Total income tax expense	$	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, 2022, December 31, 2021 and December 31, 2020 were as follows (in thousands):


	Year Ended December 31,
	2022			2021			2020
Income tax provision (benefit) at federal statutory rate	$	61,775		$	16,397		$	(15,756	)
State tax		(2,942	)		3,576			(3,194	)
Business credits		(3,246	)		(982	)		(773	)
Uncertain tax positions		586			424			193
Deferred compensation charges		(473	)		131			809
Change in valuation allowance		(324	)		(86,847	)		19,009
Section 162(m) limitation		1,779			1,241			473
Mark-to-market of warrants		(378	)		10,364			(866	)
Net operating loss and tax credit limitation		(56,908	)		56,459			-
Other		1,274			45			105
Total income tax expense	$	1,143		$	808		$	-

Component of Deferred Tax Assets and Liabilities

Deferred tax assets and liabilities consisted of the following (in thousands):


	December 31,
	2022			2021
Deferred tax assets:
Net operating loss carryforwards	$	113,228		$	155,503
Research credit carryforwards		33,444			12,870
Section 174 capitalization		15,308			-
Lease liability		9,530			8,515
Stock compensation		7,780			5,798
Accruals and reserves		9,089			5,792
Other		337			212
Total deferred tax assets		188,716			188,690
Less valuation allowance		(178,920	)		(179,253	)
Net deferred tax assets		9,796			9,437
Deferred tax liabilities:
Fixed assets		(2,916	)		(3,283	)
Operating lease right-of-use assets		(6,785	)		(6,124	)
Other		(95	)		(30	)
Total deferred tax liabilities		(9,796	)		(9,437	)
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,
	2022			2021
Balance at beginning of year	$	(5,615	)	$	(10,565	)
Tax positions related to the current year
Additions		(670	)		(308	)
Reductions		-			-
Tax positions related to the prior year
Additions		(5,054	)		-
Reductions		-			5,258
Settlements		-			-
Lapses in statute		-			-
Balance at end of year	$	(11,339	)	$	(5,615	)

Organization - Additional Information (Detail)	12 Months Ended
Organization - Additional Information (Detail)	Dec. 31, 2022
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 Accounting Policies - Additional Information (Detail) $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($) Segment	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	May 31, 2021 USD ($)
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Number of operating segment \| Segment	1
Long-term debt, net of debt discount	$ 3,922	$ 5,010
Net income (loss)	293,156	76,713	$ (75,240)
Unrealized foreign currency translation (loss) gain	(1,800)	(2,500)	2,700
Currency transaction gain (loss)	$ 100	$ 900	(800)
Percentage of long lived assets	34.00%	43.00%
Inventory write-off	$ 34,288	$ 2,588	$ 0
Inventory write-offs recognized	34,300	$ 0
Goodwill impairment	0
2.50% Convertible Senior Notes Due 2026
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Principal amount	$ 225,500			$ 200,000
Debt interest rate	2.50%			2.50%
Long-term debt, net of debt discount	$ 3,900
Debt maturity date	May 15, 2026
Product \| Credit Concentration Risk
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Concentration risk, customer	one
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	100.00%	94.00%
HEPLISAV-B
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Inventory write-off	$ 0	$ 2,600
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	78.00%	76.00%
Maximum
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Cash equivalents original maturity period	3 months
Percentage of long lived assets	10.00%	10.00%
Expected period of payment to be received	1 year
Dynavax GmbH
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Cumulative translation adjustment	$ (4,000)	$ (2,300)

Fair Value Measurements - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Transfer from level 1 to level 2	$ 0	$ 0
Transfers from level 2 to level 1	0	0
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 Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Assets
Total assets	$ 594,809	$ 538,955
Money Market Funds
Assets
Total assets	172,418	429,194
U.S. Treasuries
Assets
Total assets	42,308	4,004
U.S. Government Agency Securities
Assets
Total assets	88,032	26,548
Corporate Debt Securities
Assets
Total assets	292,051	79,209
Warrants
Liabilities
Warrant liability		18,016
Fair Value, Inputs, Level 1
Assets
Total assets	172,418	429,194
Fair Value, Inputs, Level 1 \| Money Market Funds
Assets
Total assets	172,418	429,194
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 1 \| Warrants
Liabilities
Warrant liability		0
Fair Value, Inputs, Level 2
Assets
Total assets	422,391	109,761
Fair Value, Inputs, Level 2 \| Money Market Funds
Assets
Total assets	0	0
Fair Value, Inputs, Level 2 \| U.S. Treasuries
Assets
Total assets	42,308	4,004
Fair Value, Inputs, Level 2 \| U.S. Government Agency Securities
Assets
Total assets	88,032	26,548
Fair Value, Inputs, Level 2 \| Corporate Debt Securities
Assets
Total assets	292,051	79,209
Fair Value, Inputs, Level 2 \| Warrants
Liabilities
Warrant liability		0
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, Inputs, Level 3 \| Warrants
Liabilities
Warrant liability		$ 18,016

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 - Summary of Changes in Fair Value Warrant liability (Detail) - Fair Value, Inputs, Level 3 - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Beginning Balance	$ 18,016	$ 10,736
Decrease in fair value of warrants exercised	(1,801)	(4,765)
Warrants exercised	(16,215)	(42,074)
Increase in the estimated fair value of warrant liability upon revaluation		54,119
Ending Balance	$ 0	$ 18,016

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract]
Cash and cash equivalents	$ 202,004	$ 436,189	$ 32,073
Restricted cash	207	219	237
Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows	$ 202,211	$ 436,408	$ 32,310	$ 40,100

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, 2022	Dec. 31, 2021
Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	$ 202,004	$ 436,189
Unrealized Gains	0	0
Unrealized Losses	0	0
Estimated Fair Value	202,004	436,189
Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	423,796	109,760
Unrealized Gains	12	9
Unrealized Losses	(1,417)	(8)
Estimated Fair Value	422,391	109,761
Marketable Securities Available-for-Sale \| Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	625,800	545,949
Unrealized Gains	12	9
Unrealized Losses	(1,417)	(8)
Estimated Fair Value	624,395	545,950
Cash \| Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	29,586	6,995
Unrealized Gains	0	0
Unrealized Losses	0	0
Estimated Fair Value	29,586	6,995
Money Market Funds \| Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	172,418	429,194
Unrealized Gains	0	0
Unrealized Losses	0	0
Estimated Fair Value	172,418	429,194
Corporate Debt Securities \| Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	292,865	79,200
Unrealized Gains	12	9
Unrealized Losses	(826)	0
Estimated Fair Value	292,051	79,209
U.S. Treasuries \| Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	42,502	4,005
Unrealized Gains	0	0
Unrealized Losses	(194)	(1)
Estimated Fair Value	42,308	4,004
U.S. Government Agency Securities \| Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	88,429	26,555
Unrealized Gains	0	0
Unrealized Losses	(397)	(7)
Estimated Fair Value	$ 88,032	$ 26,548

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands	Dec. 31, 2022 USD ($)
Amortized Cost
Mature in one year or less	$ 367,013
Mature after one year through two years	56,783
Total amortized cost	423,796
Estimated Fair Value
Mature in one year or less	365,709
Mature after one year through two years	56,682
Total estimated fair value	$ 422,391

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Investments, Debt and Equity Securities [Abstract]
Debt Securities, Available-for-Sale, Realized Loss	$ 0	$ 0

Inventories, Net - Summary of Inventories (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 25,517	$ 26,637
Work-in-process	23,934	14,748
Finished goods	9,995	19,950
Total	$ 59,446	$ 61,335

Inventories, Net - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Inventory [Line Items]
Finished goods	$ 9,995	$ 19,950
Inventory write-offs recognized	34,300	0
Prepaid manufacturing	0	159,655
CpG 1018 Adjuvant Inventory
Inventory [Line Items]
Finished goods		1,300
Inventory write-offs recognized	34,300
Prepaid manufacturing	0	159,700
HEPLISAV-B
Inventory [Line Items]
Finished goods inventory	$ 10,000	$ 18,600

Intangible Assets, Net - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Finite Lived Intangible Assets [Line Items]
Cost of sales - amortization of intangible assets	$ 0	$ 0	$ 2,500
Selling, general and administrative	$ 131,408	$ 100,156	$ 79,256

Property and Equipment, Net - Component of Property and Equipment, Net (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Property Plant And Equipment [Line Items]
Manufacturing equipment	$ 15,139	$ 12,532
Lab equipment	2,360	2,492
Computer equipment	4,720	5,336
Furniture and fixtures	2,464	2,463
Leasehold improvements	28,822	27,634
Assets in progress	11,613	9,941
Property, plant and equipment, gross	65,118	60,398
Less accumulated depreciation and amortization	(27,522)	(25,378)
Total	$ 37,596	$ 35,020
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 - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Abstract]
Depreciation and amortization	$ 3,812	$ 4,296	$ 4,273

Current Accrued Liabilities and Accrued Research and Development - Component of Current Accrued Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Accrued Liabilities Abstract
Payroll and related expenses	$ 14,261	$ 13,011
Revenue reserve accruals	10,552	8,253
Accrued inventory	2,209	20,868
Other accrued liabilities	3,697	7,664
Total	$ 30,719	$ 49,796

Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions	1 Months Ended			12 Months Ended
	Aug. 31, 2020 USD ($)	Jul. 31, 2019	Nov. 30, 2009 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2022 EUR (€)	Dec. 31, 2022 USD ($)	May 31, 2021 USD ($)	Mar. 29, 2019 USD ($)	Feb. 20, 2018 USD ($)	Dec. 31, 2004 EUR (€)
Loss Contingencies [Line Items]
Lease expiration date				Mar. 31, 2031
Sublease income				$ 7,685	$ 7,735	$ 7,706
Cash paid for amounts included in the measurement of operating lease liabilities				$ 6,800	7,000	6,900
Long-term debt, net of debt discount					5,010			$ 3,922
Option to extend				The subtenant has no option to extend the sublease term.
Tenant improvement allowance				$ 0	0	(1,137)
Percentage of excess rent paid to landlord							50.00%	50.00%
Non-cancelable purchase and other commitments								$ 43,408
Liability under agreement					816,872			404,837
Gain on sale of assets				1,000	1,000	6,851
Selling, general and administrative				$ 131,408	100,156	$ 79,256
Current liabilities					556,402			150,074
2.50% Convertible Senior Notes Due 2026
Loss Contingencies [Line Items]
Principal amount								225,500	$ 200,000
Long-term debt, net of debt discount								3,900
Debt maturity date				May 15, 2026
Asset Purchase Agreement
Loss Contingencies [Line Items]
Current liabilities								$ 0
Symphony Dynamo Holdings Llc
Loss Contingencies [Line Items]
License arrangement contingent consideration percentage			50.00%
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
Trisalus Life Sciences \| Asset Purchase Agreement
Loss Contingencies [Line Items]
Payment made for pre-commercialization milestone				$ 500	$ 500
Deutsche Bank Securities
Loss Contingencies [Line Items]
Financial instruments owned at fair value \| €							€ 0.2
Deutsche Bank Securities \| Letter of Credit
Loss Contingencies [Line Items]
Financial instruments owned at fair value \| €												€ 0.2
CRG Servicing LLC
Loss Contingencies [Line Items]
Debt maturity date				Dec. 31, 2023
Maximum borrowing capacity											$ 175,000
Current borrowing capacity										$ 75,000	$ 100,000
Emeryville, California (Premises)
Loss Contingencies [Line Items]
Existence of option to extend		false
Emeryville, California and Dusseldorf, Germany
Loss Contingencies [Line Items]
Lease option to extend				Certain of these leases also include renewal options at our election to renew or extend the lease for two successive five-year terms
Emeryville, California and Dusseldorf, Germany \| Maximum
Loss Contingencies [Line Items]
Lease term							12 years	12 years
Emeryville, California and Dusseldorf, Germany \| Minimum
Loss Contingencies [Line Items]
Lease term							3 years	3 years
Powell Street Sublease \| Emeryville, California (Premises)
Loss Contingencies [Line Items]
Existence of option to extend						false

Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
Operating lease expense	$ 6,222	$ 6,265	$ 6,267

Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Current portion of lease liabilities (included in other current liabilities)	$ 3,631	$ 2,577
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Other current liabilities	Other current liabilities
Long-term portion of lease liabilities	$ 32,801	$ 34,316
Total operating lease liabilities	$ 36,432	$ 36,893

Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Sublease Income
2023	$ 5,518
2024	5,684
2025	5,854
2026	6,030
2027	6,211
Thereafter	21,500
Total	50,797
Operating Lease Liabilities
2023	6,943
2024	7,073
2025	6,448
2026	5,875
2027	6,033
Thereafter	21,203
Total	53,575
Present value adjustment	(17,143)
Total	$ 36,432	$ 36,893

Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail)	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Weighted average remaining lease term	7 years 7 months 6 days	9 years 1 month 6 days
Weighted average discount rate	10.10%	10.10%

Commitments and Contingencies - Schedule of Material Purchase Commitments (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Commitments and Contingencies Disclosure [Abstract]
2023	$ 9,312
2024	10,857
2025	11,367
2026	11,872
2027	0
Thereafter	0
Total	$ 43,408

Collaborative Research, Development and License Agreements - Additional Information (Detail) - USD ($) $ in Thousands		1 Months Ended				3 Months Ended	12 Months Ended
	Dec. 31, 2022	Oct. 31, 2022	Aug. 31, 2022	Sep. 30, 2021	May 31, 2021	Dec. 31, 2020	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Oct. 31, 2021	Jan. 31, 2021
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							$ 722,683	$ 439,442	$ 46,551
Inventory write-offs recognized							34,300	0
Accrued liabilities	$ 30,719						30,719	49,796
Other receivables	2,385						2,385	15,600
Inventory write-off							34,288	2,588	0
CpG 1018
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							288,000	72,200
Inventory write-offs recognized							34,300
Final payment for remaining quantities	29,300
Modified Purchase Order
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							53,200
Coalition for Epidemic Preparedness Innovations
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Interest- free unsecured forgivable loan											$ 99,000
Advance payment from customer	175,000						175,000
Accrued liabilities	107,700						107,700	128,800
Long-term deferred revenue	0						0	5,400
Other receivables	0						0	14,600
Clover
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Advance payment received			$ 68,000
Cancellation fees			24,100
Clover \| CpG 1018
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Potential future collection receivable		$ 10,000
Clover \| Modified Purchase Order \| CpG 1018
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Final payment for remaining quantities			$ 14,600
Valneva SE
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Deferred revenue	55,400						55,400
Advance payment from customer										$ 55,400
Consideration Allocated To The Remaining Performance Obligation										$ 55,400
U.S. Department of Defense
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							8,800	500
Proceeds from grant				$ 22,000
Reservation Agreement \| Coalition for Epidemic Preparedness Innovations
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized						$ 6,300
Reservation fees									6,300
Reservation Agreement \| Coalition for Epidemic Preparedness Innovations Partners
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Increase in interest free unsecured forgiveable loan maximum borrowing capacity					$ 77,400
Interest free unsecured forgiveable loan Maximum borrowing capacity					$ 176,400
Supply Agreement \| Clover
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Contract asset balance	71,300						71,300	62,500
Accounts receivable	0						0	2,100
Supply Agreement \| Biological E. Limited
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized		$ 60,200					206,200	185,700
Accounts receivable	117,800						117,800	96,100
Supply Agreement \| PT Bio Farma (Persero)
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							25,400
Deferred revenue	0						0
Accounts receivable	0						0
Supply Agreement \| Medigen
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized								26,700	1,200
Accounts receivable	0						0	2,400
Supply Agreement \| Valneva SE
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							68,000	89,400	$ 2,000
Deferred revenue	0						0	55,400
Accounts receivable	$ 0						0	$ 0
Clover Amendment No 2
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized							$ 87,000

Convertible Notes (Additional Information) (Details) $ / shares in Units, $ in Thousands	1 Months Ended	12 Months Ended
	May 31, 2021 USD ($)	Dec. 31, 2022 USD ($) d $ / shares shares	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Debt Instrument [Line Items]
Proceeds from issuance of Convertible Notes, net		$ 0	$ 219,822	$ 0
Fair value of the convertible notes		284,800
2.50% Convertible Senior Notes Due 2026
Debt Instrument [Line Items]
Aggregate principal amount	$ 200,000	$ 225,500
Debt interest rate	2.50%	2.50%
Debt issuance and offering costs	$ 5,700	$ 3,900
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, convertible, threshold trading days \| d		20
Debt instrument, convertible, threshold consecutive trading days \| d		30
Debt instrument, convertible, threshold percentage of stock price trigger		130.00%
Debt Instrument, redemption, description		We may redeem for cash all or any portion of 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, redemption earliest date		May 20, 2024
Percentage of principal redeemed		100.00%
Debt instrument interest rate, effective percentage		3.10%
2.50% Convertible Senior Notes Due 2026 \| Debt Instrument, Conversion, Period One
Debt Instrument [Line Items]
Debt instrument, convertible, threshold trading days \| d		20
Debt instrument, convertible, threshold consecutive trading days \| d		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		130.00%
2.50% Convertible Senior Notes Due 2026 \| Debt Instrument, Conversion, Period Two
Debt Instrument [Line Items]
Debt instrument, convertible, threshold trading days \| d		5
Debt instrument, convertible, threshold consecutive trading days \| d		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		98.00%
Optional Notes
Debt Instrument [Line Items]
Additional issue amount	25,500
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		$ 15.80
Reduction to additional paid-in capital, capped calls cost		$ 27,200

Convertible Notes - Summary of Interest Expenses Related to Convertible Notes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Debt Disclosure [Abstract]
Stated coupon interest	$ 5,638	$ 3,555
Amortization of debt issuance cost	1,094	669
Total interest expense	$ 6,732	$ 4,224

Long-Term Debt - Additional Information (Detail) - USD ($) $ in Thousands		3 Months Ended	6 Months Ended	12 Months Ended
	Feb. 20, 2018	Jun. 30, 2021	Jun. 30, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Mar. 29, 2019
Debt Instrument [Line Items]
Long-term debt, net of debt discount				$ 3,922	$ 5,010
Interest expense related to initial term loan				6,732	4,224
Loss on debt extinguishment				0	(5,232)	$ 0
Repayment of long-term debt				$ 0	190,194	0
Loan Agreement
Debt Instrument [Line Items]
Interest expense related to initial term loan					$ 7,000	$ 19,100
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		$ 5,200
Repayment of long-term debt			$ 190,200

Revenue Recognition - Summary of Disaggregation of Revenues (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Disaggregation of Revenue [Line Items]
Total revenues	$ 722,683	$ 439,442	$ 46,551
UNITED STATES
Disaggregation of Revenue [Line Items]
Total revenues	133,770	63,785	36,030
Non-US [Member]
Disaggregation of Revenue [Line Items]
Total revenues	588,913	375,657	10,521
Other Revenue
Disaggregation of Revenue [Line Items]
Total revenues	9,038	2,343	7,244
Other Revenue \| UNITED STATES
Disaggregation of Revenue [Line Items]
Total revenues	8,774	1,915	0
Other Revenue \| Non-US [Member]
Disaggregation of Revenue [Line Items]
Total revenues	264	428	7,244
HEPLISAV-B
Disaggregation of Revenue [Line Items]
Total revenues	125,937	61,870	36,030
HEPLISAV-B \| UNITED STATES
Disaggregation of Revenue [Line Items]
Total revenues	124,996	61,870	36,030
HEPLISAV-B \| Non-US [Member]
Disaggregation of Revenue [Line Items]
Total revenues	941	0	0
CpG 1018
Disaggregation of Revenue [Line Items]
Total revenues	587,708	375,229	3,277
CpG 1018 \| UNITED STATES
Disaggregation of Revenue [Line Items]
Total revenues	0	0	0
CpG 1018 \| Non-US [Member]
Disaggregation of Revenue [Line Items]
Total revenues	587,708	375,229	3,277
Product
Disaggregation of Revenue [Line Items]
Total revenues	713,645	437,099	39,307
Product \| UNITED STATES
Disaggregation of Revenue [Line Items]
Total revenues	124,996	61,870	36,030
Product \| Non-US [Member]
Disaggregation of Revenue [Line Items]
Total revenues	$ 588,649	$ 375,229	$ 3,277

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI https://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Revenue Recognition - Schedule of Revenues from Major Customers (Details) - Revenue Benchmark [Member] - Product Concentration Risk [Member]	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Largest Customer \| HEPLISAV-B
Concentration Risk [Line Items]
Percentage of product revenue	21.00%	21.00%	21.00%
Second Largest Customer \| HEPLISAV-B
Concentration Risk [Line Items]
Percentage of product revenue	17.00%	19.00%	20.00%
Third Largest Customer \| HEPLISAV-B
Concentration Risk [Line Items]
Percentage of product revenue	16.00%	19.00%	20.00%
Largest Collaboration Partner \| CpG 1018
Concentration Risk [Line Items]
Percentage of product revenue	49.00%	49.00%	62.00%
Second Largest Collaboration Partner \| CpG 1018
Concentration Risk [Line Items]
Percentage of product revenue	35.00%	24.00%	36.00%
Third Largest Customer \| CpG 1018
Concentration Risk [Line Items]
Percentage of product revenue	12.00%	19.00%	2.00%

Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B - USD ($)
$ in Thousands

12 Months Ended

Dec. 31, 2022

Dec. 31, 2021

Accounts Receivable Reserves

Valuation And Qualifying Accounts Disclosure [Line Items]

Balance at Beginning of Period

^[1]

$ 3,823

$ 2,836

^[1]

34,758

18,209

Credit or payments made during the period

^[1]

(30,402)

(17,222)

Balance at End of Period

^[1]

8,179

3,823

Revenue Reserve Accruals

Valuation And Qualifying Accounts Disclosure [Line Items]

Balance at Beginning of Period

^[2]

8,253

6,040

^[2]

24,806

13,077

Credit or payments made during the period

^[2]

(22,507)

(10,864)

Balance at End of Period

^[2]

$ 10,552

$ 8,253

[1]	Reserves are for chargebacks, discounts and other fees.
[2]	Accruals are for returns, rebates and other fees.

Revenue Recognition - Summary of balances and activities in our contract asset account (Details) - Cp G1018 [Member] - USD ($)
$ in Thousands

12 Months Ended

Dec. 31, 2022

Dec. 31, 2021

Contract Asset Account [Abstract]

Balance at Beginning of Period

$ 62,525

^[1]

$ 0

Contract asset, Additions

^[2]

17,556

^[1]

62,525

Contract asset, Subtractions

^[1]

8,116

Balance at End of Period

^[1]

$ 71,965

$ 62,525

[1]	Includes $0.7 million of contract assets derived from our agreement with the DoD.
[2]	Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement and for services performed under our agreement with the DoD.

Revenue Recognition - Summary of Balances and Activities Deferred Revenue Accounts (Details) - USD ($)
$ in Thousands

12 Months Ended

Dec. 31, 2022

Dec. 31, 2021

Deferred Revenue Arrangement [Line Items]

Balance at Beginning of Period

$ 349,864

Balance at End of Period

$ 349,864

CpG 1018

Deferred Revenue Arrangement [Line Items]

Balance at Beginning of Period

349,864

38,212

Additions

^[1]

45,596

371,860

Subtractions

^[2]

(45,955)

(21,996)

Revenue recognized in the current period included in deferred revenue balance at the beginning of the period

349,505

38,212

Balance at End of Period

349,864

CpG 1018 | Long-term Deferred Revenue

Deferred Revenue Arrangement [Line Items]

Balance at Beginning of Period

5,385

Additions

^[1]

6,582

168,467

Subtractions

^[2]

(11,967)

(163,082)

Revenue recognized in the current period included in deferred revenue balance at the beginning of the period

Balance at End of Period

$ 0

$ 5,385

[1]	Additions are primarily payments received or invoices issued before we satisfy our performance obligations.
[2]	Subtractions are primarily revenues recognized in the period and reclassification from long-term deferred revenue to CEPI accrual.

Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract]
Net income (loss)	$ 293,156	$ 76,713	$ (75,240)
Less: undistributed earnings allocated to participating securities	(283)	(4,569)	0
Net income (loss) allocable to common stockholders, basic	292,873	72,144	(75,240)
Add: undistributed earnings allocated to Series B and warrants	283	4,569	0
Less: undistributed earnings allocated to Series B and warrants	0	(4,190)	0
Add: interest expense on convertible notes	5,044	3,168	0
Less: removal of change in fair value of warrant liability	(1,801)	0	(4,124)
Net income (loss) allocable to common stockholders, diluted	$ 296,399	$ 75,691	$ (79,364)
Weighted average shares used to compute basic net loss per share allocable to common stockholders	126,398	116,264	100,753
Stock-based compensation expense	$ 2,774	$ 3,075	$ 0
Convertible Notes (as converted to common stock)	21,543	13,667	0
Effect of dilutive warrants	82	0	751
Weighted average shares used to compute net loss allocable to common stockholders per share, diluted	150,797	133,006	101,504

Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares shares in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Outstanding securities not included in diluted net loss per share calculation (in thousands):
Outstanding securities not included in diluted net loss per share calculation	21,543	13,667	0
Stock Options and Stock Awards
Outstanding securities not included in diluted net loss per share calculation (in thousands):
Outstanding securities not included in diluted net loss per share calculation	7,165	5,953	10,299
Warrants
Outstanding securities not included in diluted net loss per share calculation (in thousands):
Outstanding securities not included in diluted net loss per share calculation	0	1,883	0
Series B Convertible Preferred Stock
Outstanding securities not included in diluted net loss per share calculation (in thousands):
Outstanding securities not included in diluted net loss per share calculation	0	0	4,140

Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended		3 Months Ended	12 Months Ended
	Aug. 06, 2020	Aug. 31, 2021	Aug. 31, 2019	Mar. 31, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Class Of Stock [Line Items]
Common stock, shares outstanding					127,604,026	122,945,000
Issuance of common stock and preferred stock (in shares)			18,525,000
Common stock, par value			$ 0.001		$ 0.001	$ 0.001
Preferred stock, par value					$ 0.001	$ 0.001
Proceeds from issuances of common stock, net					$ 0	$ 28,156	$ 108,538
Preferred stock, shares outstanding					0	0
Less: removal of change in fair value of warrant liability					$ (1,801)	$ 49,354	$ (4,124)
Common Stock
Class Of Stock [Line Items]
Number of common stock allowed to purchase		4,140,000
Warrants
Class Of Stock [Line Items]
Proceeds from warrants exercised				$ 8,500
Number of common stock warrants exercised					1,882,600
Warrants \| Other Nonoperating Income (Expense)
Class Of Stock [Line Items]
Less: removal of change in fair value of warrant liability					$ 1,800
Bain Life Sciences
Class Of Stock [Line Items]
Net cash proceeds received from issuance or sale of equity			$ 35,000
Offering
Class Of Stock [Line Items]
Net cash proceeds received from issuance or sale of equity			$ 65,600
2017 ATM Agreement
Class Of Stock [Line Items]
Remaining proceeds from common stock, under sales agreement					$ 120,500
Series B Convertible Preferred Stock
Class Of Stock [Line Items]
Issuance of common stock and preferred stock (in shares)		4,140	4,840
Preferred stock, par value			$ 0.001
Preferred stock, shares outstanding					0	0
Maximum
Class Of Stock [Line Items]
Common stock sales agreement aggregate sales proceeds	$ 150,000
Maximum \| Offering
Class Of Stock [Line Items]
Warrant issued			5,841,250
Maximum \| 2017 ATM Agreement
Class Of Stock [Line Items]
Commission on gross sales proceeds of common stock	3.00%

Equity Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands		12 Months Ended
	May 28, 2014	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	May 31, 2022	Jun. 30, 2021	May 31, 2021	Jan. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding stock awards granted		9,339,000	10,399,000
Total intrinsic value of options exercised		$ 7,700	$ 7,900	$ 100
Total fair value of stock options vested		17,500	9,000	13,800
Share-Based Payment Arrangement, Noncash Expense		$ 32,915	21,285	13,484
Expected dividend yield		0.00%
Stock-based compensation expense		$ 2,774	3,075	0
Increase in aggregate number of shares of common stock authorized for issuance					15,000,000		1,000,000
Restricted Stock Units (RSUs)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense related to restricted stock		13,200
Aggregate intrinsic value				37,000
Total fair value of restricted stock units		$ 15,700	$ 4,700	4,900
Restricted stock unit awards outstanding		3,479,000	2,651,000
Share vested		1,195,000
Employee Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Options vesting period		7 years
Performance Based Vesting Condition
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense related to restricted stock		$ 1,000	$ 0	$ 100
Performance Based Restricted Stock Units
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense related to restricted stock		800	1,800
Aggregate intrinsic value		$ 2,100	$ 3,300
Restricted stock unit awards outstanding		193,000	237,000
Maximum \| Restricted Stock Units (RSUs)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expiration period		10 years
Minimum \| Restricted Stock Units (RSUs)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expiration period		7 years
2018 Equity Incentive Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common Stock, Capital Shares Reserved for Future Issuance		15,252,440				3,250,000,000		1,500,000,000
Time Based Vesting Schedule
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total unrecognized compensation cost related to non-vested equity awards		$ 43,400
Total 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]
Total unrecognized compensation cost related to non-vested equity awards		$ 1,600
Performance Based Vesting Schedule \| Performance Based Restricted Stock Units
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Outstanding stock awards granted		31,100
Restricted stock unit awards outstanding		36,000
2014 Employee Stock Purchase Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total unrecognized compensation cost related to non-vested equity awards		$ 600
Total unrecognized compensation cost, weighted-average vesting period		1 year 1 month 6 days
Shares issued to employees		155,000
Shares remaining available for future purchases		884,000
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	85.00%
2014 Employee Stock Purchase Plan \| The exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Purchase price per share as percentage of fair market value of common stock	85.00%
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		1,850,000,000

Equity Plans and Stock-Based Compensation - Option Activity under Stock-Based Compensation Plans (Detail) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Shares Underlying Outstanding Options
Beginning balance	10,399,000
Options granted	2,100,000
Options exercised	(1,194,000)
Options cancelled	(105,000)
Ending balance	9,339,000	10,399,000
Vested and expected to vest at December 31, 2022	9,148,000
Exercisable at December 31, 2022	5,528,000
Options cancelled	(1,861,000)
Weighted-Average Exercise Price Per Share
Beginning balance	$ 11.55
Options granted	12.50
Options exercised	8.07
Options cancelled	9.40
Ending balance	10.70	$ 11.55
Vested and expected to vest at December 31, 2022	10.66
Exercisable at December 31, 2022	10.02
Options cancelled	$ 19.28
Weighted-Average Remaining Contractual Term (years)
Balance at December 31, 2021	4 years 7 months 9 days	4 years 1 month 28 days
Vested and expected to vest at December 31, 2022	4 years 6 months 29 days
Exercisable at December 31, 2022	3 years 9 months 29 days
Aggregate Intrinsic Value
Balance at December 31, 2021	$ 16,291	$ 42,756
Vested and expected to vest at December 31, 2022	16,235
Exercisable at December 31, 2022	$ 13,984

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, 2022 $ / shares shares
Number of Shares
Non-vested, Beginning Balance \| shares	2,651
Granted \| shares	2,310
Vested \| shares	(1,195)
Forfeited \| shares	(287)
Non-vested, Ending Balance \| shares	3,479
Weighted-Average Grant-Date Fair Value Per Share
Non-vested, Beginning Balance \| $ / shares	$ 8.30
Granted \| $ / shares	12.36
Vested \| $ / shares	7.72
Forfeited \| $ / shares	10.69
Non-vested, Ending Balance \| $ / shares	$ 11.00

Equity Plans and Stock-Based Compensation - Summary Of Performance Based Restricted Stock Unit (Details) - Performance Based Restricted Stock Units shares in Thousands	12 Months Ended
	Dec. 31, 2022 $ / shares shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Non-vested, Beginning Balance \| shares	237
Granted \| shares	193
Forfeited \| shares	(237)
Non-vested, Ending Balance \| shares	193
Non-vested, Beginning Balance \| $ / shares	$ 8.40
Granted \| $ / shares	11.62
Forfeited \| $ / shares	8.40
Non-vested, Ending Balance \| $ / shares	$ 11.62

Equity Plans and Stock-Based Compensation - Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Stock Options
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average fair value	$ 7.95	$ 7.17	$ 3.91
Risk-free interest rate	2.00%	0.70%	1.00%
Expected life (in years)	4 years 6 months	4 years 6 months	4 years 6 months
Expected Volatility	0.80%	0.90%	0.90%
Employee Stock Purchase Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average fair value	$ 7.37	$ 6.48	$ 2.82
Risk-free interest rate	2.10%	0.10%	0.90%
Expected life (in years)	1 year 3 months 18 days	1 year 2 months 12 days	1 year 2 months 12 days
Expected Volatility	1.00%	1.00%	0.70%
PSUs
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average fair value	$ 11.62	$ 8.40
Risk-free interest rate	1.70%
Expected life (in years)	2 years 10 months 24 days	2 years 10 months 24 days
Expected Volatility	0.90%	0.90%
PSUs \| Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk-free interest rate		0.03%
PSUs \| Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk-free interest rate		1.92%

Equity Plans and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Employees and directors stock-based compensation expense	$ 32,915	$ 21,285	$ 13,484
Stock-based compensation expense	2,774	3,075	0
Inventory
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	2,720	2,020	2,280
Research and Development
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	5,954	3,818	1,000
Selling, General and Administrative
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	23,118	14,894	9,585
Cost of Sales - Product
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	$ 1,123	$ 553	$ 619

Employee Benefit Plan - Additional Information (Detail) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Pension and Other Postretirement Benefits Cost (Reversal of Cost) [Abstract]
Contributions to 401 (k) plan	$ 0.9	$ 0.3	$ 0.2

- Definition

Amount of contribution received by defined benefit plan from employer which increases plan assets.

+ References + Details

Component of Consolidated (Loss) Income Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
U.S.	$ 292,460	$ 75,954	$ (76,324)
Non U.S.	1,839	1,567	1,084
Total	$ 294,299	$ 77,521	$ (75,240)

Income Taxes - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Line Items]
Provision for income taxes	$ 1,143,000	$ 808,000	$ 0
Increase (decrease) in valuation allowance	300,000	86,800,000
Net operating loss carryforwards	353,500,000
Unrecognized tax benefits	11,339,000	5,615,000	$ 10,565,000
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	$ 200,000
Federal
Income Tax Disclosure [Line Items]
Net operating loss carryforwards	$ 96,300,000
Federal \| Minimum
Income Tax Disclosure [Line Items]
Net operating loss carryforwards, expiration year	2023
Federal \| Research And Development Tax Credits
Income Tax Disclosure [Line Items]
Tax credit carryforward amount	$ 26,200,000
Federal \| Research And Development Tax Credits \| Minimum
Income Tax Disclosure [Line Items]
Tax credit carryforward amount, expiration year	2023
Federal \| Research And Development Tax Credits \| Maximum
Income Tax Disclosure [Line Items]
Tax credit carryforward amount, expiration year	2042
California and Other States
Income Tax Disclosure [Line Items]
Net operating loss carryforwards	$ 308,800,000
California and Other States \| Minimum
Income Tax Disclosure [Line Items]
Net operating loss carryforwards, expiration year	2023
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	$ 22,100,000
Foreign
Income Tax Disclosure [Line Items]
Net operating loss carryforwards	$ 700,000

Income Taxes - Schedule of income tax provision (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Income Tax Expense (Benefit)	$ 1,143	$ 808	$ 0
Deferred Income Tax Expense (Benefit), Continuing Operations [Abstract]
Federal	0	0
State	0	0
Non-US	0	0
Total deferred tax expense	0	0
Current Income Tax Expense (Benefit), Continuing Operations [Abstract]
Federal	(165)	345
State	897	260
Non-US	411	203
Current Income Tax Expense (Benefit), Total	$ 1,143	$ 808

Difference between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Income tax provision (benefit) at federal statutory rate	$ 61,775	$ 16,397	$ (15,756)
State tax	(2,942)	3,576	(3,194)
Business credits	(3,246)	(982)	(773)
Uncertain tax positions	586	424	193
Deferred compensation charges	(473)	131	809
Change in valuation allowance	(324)	(86,847)	19,009
Section 162(m) limitation	1,779	1,241	473
Mark-to-market of warrants	(378)	10,364	(866)
Net operating loss and tax credit limitation	(56,908)	56,459	0
Other	1,274	45	105
Total income tax expense	$ 1,143	$ 808	$ 0

Component of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Deferred tax assets:
Net operating loss carryforwards	$ 113,228	$ 155,503
Research credit carryforwards	33,444	12,870
Section 174 capitalization	15,308
Lease Liability	9,530	8,515
Stock Compensation	7,780	5,798
Accruals and reserves	9,089	5,792
Other	337	212
Total deferred tax assets	188,716	188,690
Less valuation allowance	(178,920)	(179,253)
Net deferred tax assets	9,796	9,437
Deferred tax liabilities:
Fixed assets	(2,916)	(3,283)
Operating lease right-of-use assets	(6,785)	(6,124)
Other	(95)	(30)
Total deferred tax liabilities	(9,796)	(9,437)
Net deferred tax assets	$ 0	$ 0

Schedule of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Balance at Beginning Balance	$ (5,615)	$ (10,565)
Tax positions related to the current year, Additions	(670)	(308)
Tax positions related to the current year, Reductions	0	0
Tax positions related to the prior year, Additions	(5,054)
Tax positions related to the prior year, Reductions		5,258
Tax positions related to the prior year, Settlements	0	0
Tax positions related to the prior year, Lapses in statute	0	0
Balance at Ending Balance	$ (11,339)	$ (5,615)