0000950170-23-016685 | 10-Q | XBRL Viewer | Dynavax Technologies Corp

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Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 174,350	$ 202,004
Marketable securities available-for-sale	477,606	422,391
Accounts receivaAccounts receivables, net of allowance for doubtful accounts of $12,313 and $0 at March 31, 2023 and December 31, 2022, respectivelybles, net	101,738	145,130
Other receivables	3,128	2,385
Inventories, net	57,693	59,446
Prepaid expenses and other current assets	15,626	85,629
Total current assets	830,141	916,985
Property and equipment, net	38,159	37,596
Operating lease right-of-use assets	25,433	25,745
Goodwill	2,038	2,006
Restricted cash	210	207
Other assets	73,941	3,311
Total assets	969,922	985,850
Current liabilities:
Accounts payable	7,296	3,211
Accrued research and development	5,155	4,775
CEPI accrual (Note 6)	47,401	107,738
Accrued liabilities	27,833	30,719
Other current liabilities	3,830	3,631
current liabilities	91,515	150,074
Convertible Notes, net of debt discount of $3,645 and $3,922 at March 31, 2023 and December 31, 2022, respectively (Note 7)	221,855	221,578
Long-term portion of lease liabilities	32,131	32,801
CEPI accrual long-term	60,337	0
Other long-term liabilities	352	384
Total liabilities	406,190	404,837
Commitments and contingencies (Note 5)
Stockholders’ equity:
Common stock: $0.001 par value; 278,000 shares authorized at March 31, 2023 and December 31, 2022; 128,472 shares and 127,604 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively	128	128
Preferred stock: $0.001 par value; 5,000 shares authorized at March 31, 2023 and December 31, 2022; zero shares outstanding at March 31, 2023 and December 31, 2022, respectively	0	0
Additional paid-in capital	1,516,331	1,510,518
Accumulated other comprehensive (loss) gain	(4,200)	(5,438)
Accumulated deficit	(948,527)	(924,195)
Total stockholders’ equity	563,732	581,013
Total liabilities and stockholders’ equity	$ 969,922	$ 985,850

Equity Plans and Stock-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2023

Share-Based Payment Arrangement, Noncash Expense [Abstract]

Option Activity under Stock-Based Compensation Plans

The following table summarizes the activity of stock options for the three months ended March 31, 2023:


	Shares Underlying Outstanding Options (in thousands)			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Term (years)		Aggregate Intrinsic Value (in thousands)
Balance as of December 31, 2022		9,339		$	10.70		4.61	$	16,291
Options granted		1,663			11.10
Options exercised		(41	)		5.84
Options cancelled:
Options forfeited (unvested)		(29	)		10.16
Options expired (vested)		(197	)		22.83
Balance as of March 31, 2023		10,735		$	10.56		4.84	$	11,820
Vested and expected to vest as of March 31, 2023		10,435		$	10.53		4.79	$	11,808
Exercisable as of March 31 2023		6,281		$	9.89		3.99	$	11,049

Summary of Restricted Stock Units Activity

The following table summarizes the activity of RSUs for the three months ended March 31, 2023:


	Number of Shares (in thousands)			Weighted-Average Grant-Date Fair Value Per Share
Non-vested as of December 31, 2022		3,479		$	11.00
Granted		2,152			11.06
Vested (1)		(1,236	)		10.12
Forfeited		(101	)		11.65
Non-vested as of March 31, 2023		4,294		$	11.27

Summary Of Performance Based Restricted Stock Unit

We granted market-based performance restricted stock units (“PSUs”) to certain executives. These PSUs vest upon a specified market condition. The summary of PSU activities for the three months ended March 31, 2023 is as follows:


	Number of Shares (in thousands)		Weighted-Average Grant-Date Fair Value Per Share
Non-vested as of December 31, 2022		193	$	11.62
Granted		364		18.25
Non-vested as of March 31, 2023		557	$	15.95

Fair Value-Based Measurements and Weighted-Average Assumptions

The weighted-average assumptions used in the calculations of these fair value measurements are as follows:


	Stock Options						Market-Based Performance Stock Units (“PSUs”)
	Three Months Ended						Three Months Ended
	March 31,						March 31,
	2023			2022			2023			2022
Weighted-average fair value per share	$	7.28		$	8.05		$	18.25		$	11.62
Risk-free interest rate		4.0	%		1.9	%		4.3	%		1.7	%
Expected life (in years)		4.5			4.5			2.9			2.9
Volatility		0.8			0.8			0.9			0.9

Stock-Based Compensation Expense

The following table summarizes stock-based compensation expense recorded in each component of operating expenses in our condensed consolidated statements of operations, and amounts capitalized to our inventories, net (in thousands):


	Three Months Ended
	March 31,
	2023		2022
Research and development	$	2,112	$	1,276
Selling, general and administrative		6,830		5,427
Cost of sales - product		695		160
Inventories, net		397		783
Total	$	10,034	$	7,646

Inventories, Net - Summary of Inventories (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Raw materials	$ 22,400	$ 25,517
Work-in-process	19,661	23,934
Finished goods	15,632	9,995
Total	$ 57,693	$ 59,446

Convertible Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands	1 Months Ended	3 Months Ended
	May 31, 2021 USD ($)	Mar. 31, 2023 USD ($) Days $ / shares shares
Debt Instrument [Line Items]
Fair value of the convertible notes		$ 269,100
2.50% Convertible Senior Notes Due 2026
Debt Instrument [Line Items]
Aggregate principal amount	$ 200,000	225,500
Debt interest rate	2.50%
Additional issue amount	$ 25,500
Debt issuance and offering costs	5,700	$ 3,600
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 \| Days		20
Debt instrument, convertible, threshold consecutive trading days \| Days		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 (subject to the partial redemption limitation described in the indenture governing the Convertible Notes), at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.
Debt instrument, 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 \| Days		20
Debt instrument, convertible, threshold consecutive trading days \| Days		30
2.50% Convertible Senior Notes Due 2026 \| Debt Instrument, Conversion, Period One \| Maximum
Debt Instrument [Line Items]
Debt instrument, convertible, threshold percentage of stock price trigger		130.00%
2.50% Convertible Senior Notes Due 2026 \| Debt Instrument, Conversion, Period Two
Debt Instrument [Line Items]
Debt instrument, convertible, threshold trading days \| Days		5
Debt instrument, convertible, threshold consecutive trading days \| Days		10
2.50% Convertible Senior Notes Due 2026 \| Debt Instrument, Conversion, Period Two \| Maximum
Debt Instrument [Line Items]
Debt instrument, convertible, threshold percentage of stock price trigger		98.00%
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

Collaboration, Development and Supply Agreements - Additional Information (Detail) - USD ($) $ in Thousands		1 Months Ended		3 Months Ended
	Apr. 26, 2023	Aug. 31, 2023	Sep. 30, 2021	Mar. 31, 2023	Mar. 31, 2022	Apr. 27, 2023	Dec. 31, 2022
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Allowance for doubtful accounts receivables				$ 12,313			$ 0
Account Receivable				3,128			2,385
Revenue recognized				46,925	$ 113,992
Accrued liabilities				27,833			30,719
CEPI Partners [Member]
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Advance payment from customer				175,000
Repayment of Advance from Customer				67,300
Long-term deferred revenue				0			0
Deferred Revenue, Noncurrent, Total				0			0
Accrual Long Term Balance				60,300
Accrued liabilities				47,400			107,700
Clover
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized					22,300
Clover \| Supply Agreement
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Contract asset balance							$ 71,300
Biological E. Limited \| Supply Agreement
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized					67,300
U.S. Department of Defense
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Revenue recognized				3,500	$ 1,600
Proceeds from grant			$ 22,000
Subsequent Event \| Biological E. Limited
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Allowance for doubtful accounts receivables						$ 12,300
Additional future payment	$ 5,500	$ 12,300
Repayment of Advance from Customer						47,400
Accounts Receivable Net Current						14,500
Advance payment received	125,000	250,000
Prepayment of advance payment	$ 13,500	$ 1,000
CEPI Member \| Clover
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Accrual Long Term Balance				60,300
CEPI Member \| Biological E. Limited
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Allowance for doubtful accounts receivables				12,300
Advance payment from customer				47,400
Account Receivable				$ 61,900
CEPI Member \| Subsequent Event
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Accounts Receivable Net Current						$ 47,400

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2023	Apr. 28, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Current Fiscal Year End Date	--12-31
Entity File Number	001-34207
Entity Registrant Name	Dynavax Technologies Corporation
Entity Central Index Key	0001029142
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	DVAX
Security Exchange Name	NASDAQ
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
Entity Common Stock, Shares Outstanding		128,489,060

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Revenues:
Total revenues	$ 46,925	$ 113,992
Operating expenses:
Cost of sales - product	14,712	39,962
Research and development	13,605	11,095
Selling, general and administrative	36,543	32,172
Bad debt expense	12,313	0
Total operating expenses	77,173	83,229
(Loss) income from operations	(30,248)	30,763
Other income (expense):
Interest income	6,597	261
Interest expense	(1,686)	(1,680)
Sublease income	1,598	1,609
Change in fair value of warrant liability (Note 10)	0	1,801
Other	23	105
Net income (loss) before income taxes	(23,716)	32,859
Provision for income taxes	(616)	0
Net income (loss)	$ (24,332)	$ 32,859
Net income per share attributable to common stockholders
Basic	$ (0.19)	$ 0.26
Diluted	$ (0.19)	$ 0.22
Weighted-average shares used in computing net income per share attributable to common stockholders:
Basic	127,921	124,555
Diluted	127,921	149,425
Product
Revenues:
Total revenues	$ 43,451	$ 112,327
Other Revenue
Revenues:
Total revenues	$ 3,474	$ 1,665

Equity Plans and Stock-Based Compensation - Option Activity under Stock-Based Compensation Plans (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
Shares Underlying Outstanding Options
Beginning balance	9,339
Options granted	1,663
Options exercised	(41)
Options forfeited (unvested)	(29)
Options expired (vested)	(197)
Ending balance	10,735	9,339
Vested and expected to vest as of March 31, 2023	10,435
Exercisable as of March 31 2023	6,281
Weighted-Average Exercise Price Per Share
Beginning balance	$ 10.70
Options granted	11.10
Options exercised	5.84
Options forfeited (unvested)	10.16
Options expired (vested)	22.83
Ending balance	10.56	$ 10.70
Vested and expected to vest as of March 31, 2023	10.53
Exercisable as of March 31 2023	$ 9.89
Weighted-Average Remaining Contractual Term (years)
Weighted - Average Remaining Contractual Term (years), balance	4 years 10 months 2 days	4 years 7 months 9 days
Vested and expected to vest as of March 31, 2023	4 years 9 months 14 days
Exercisable as of March 31 2023	3 years 11 months 26 days
Aggregate Intrinsic Value
Balance as of December 31, 2022	$ 16,291
Balance as of March 31, 2023	11,820	$ 16,291
Vested and expected to vest as of March 31, 2023	11,808
Exercisable as of March 31 2023	$ 11,049

Organization and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022	May 31, 2021
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Long-term debt, net of debt discount	$ 3,645		$ 3,922
Net (loss) income	(24,332)	$ 32,859
2.50% Convertible Senior Notes Due 2026
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Aggregate principal amount	225,500			$ 200,000
Debt interest rate				2.50%
Long-term debt, net of debt discount	$ 3,600
Debt maturity date	May 15, 2026
HEPLISAV-B
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Minimum age approved for vaccine prevention of infection caused	18 years

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Common Stock and Warrants - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended
	Aug. 06, 2020	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Class Of Stock [Line Items]
Common stock, shares outstanding		128,471,773		127,604,000
Common stock, par value		$ 0.001		$ 0.001
Preferred stock, par value		$ 0.001		$ 0.001
Preferred stock, shares outstanding		0		0
Change in fair value of warrant liability		$ 0	$ (1,801)
Warrants
Class Of Stock [Line Items]
Cash Settlement of warrants			$ 8,500
Number of common stock warrants exercised			1,882,600
Warrants \| Other Income, Net
Class Of Stock [Line Items]
Change in fair value of warrant liability			$ 1,800
2017 ATM Agreement
Class Of Stock [Line Items]
Remaining proceeds from common stock, under sales agreement		$ 120,500
Maximum
Class Of Stock [Line Items]
Common stock sales agreement aggregate sales proceeds	$ 150,000
Maximum \| 2017 ATM Agreement
Class Of Stock [Line Items]
Commission on gross sales proceeds of common stock	3.00%

Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Current portion of lease liabilities (included in other current liabilities)	$ 3,830	$ 3,631
Long-term portion of lease liabilities	32,131	32,801
Total operating lease liabilities	$ 35,961	$ 36,432

Revenue Recognition

3 Months Ended

Mar. 31, 2023

Revenue Recognition [Abstract]

Revenue Recognition

8. 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):


	Three Months Ended						Three Months Ended
	March 31, 2023						March 31, 2022
	U.S.		Non U.S.		Total		U.S.		Non U.S.		Total
Product revenue, net
HEPLISAV-B	$	43,451	$	-	$	43,451	$	20,810	$	-	$	20,810
CpG 1018 adjuvant		-		-		-		-		91,517		91,517
Total product revenue, net	$	43,451	$	-	$	43,451	$	20,810	$	91,517	$	112,327
Other revenue		3,474		-		3,474		1,606		59		1,665
Total revenues	$	46,925	$	-	$	46,925	$	22,416	$	91,576	$	113,992

Revenues from Major Customers and Collaboration Partners

The following table summarizes HEPLISAV-B product revenue from each of our three largest customers (as a percentage of total HEPLISAV-B net product revenue):


	Three Months Ended
	March 31,
	2023			2022
Largest customer		27	%		25	%
Second largest customer		22	%		20	%
Third largest customer		17	%		16	%

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 net product revenue):


	Three Months Ended
	March 31,
	2023			2022
Largest collaboration partner		0	%		74	%
Second largest collaboration partner		0	%		24	%
Third largest collaboration partner		0	%		2	%

Contract Balances

The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories for the three months ended March 31, 2023 (in thousands):


	Balance at Beginning of Period		Provisions related to current period sales		Credit or payments made during the period			Adjustments related to prior periods			Balance at End of Period
Three months ended March 31, 2023:
Accounts receivable reserves (1)	$	8,179	$	11,821	$	(10,686	)	$	(198	)	$	9,116
Revenue reserve accruals (2)	$	10,552	$	9,700	$	(8,040	)	$	490		$	12,702

(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 revenue and a corresponding contract asset as our right to consideration is conditioned on something other than the passage of time. See Note 6 for further discussion. The following table summarizes balances and activities in our contract asset account (in thousands):


	Balance at Beginning of Period		Additions		Subtractions			Reclassification (1)			Balance at End of Period
Three months ended March 31, 2023
Contract asset, included in other current assets (2)	$	71,965	$	3,398	$	(2,554	)	$	(71,307	)	$	1,502
Contract asset, included in other assets	$	-	$	-	$	-		$	71,307		$	71,307

(1) The Clover contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. See Note 6 for further discussion.

(2) The $1.5 million of contract asset is derived from our agreement with the DoD.

- 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

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Tax Disclosure [Abstract]
Provision for income taxes	$ 616	$ 0
Effective Tax Rate	2.60%	0.00%

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies Disclosure [Abstract]

Summary of Operating Lease Expense

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


	Three Months Ended March 31,
	2023		2022
Operating lease expense	$	1,388	$	1,607

Summary of Balance Sheet Classification of Operating Lease Liabilities

The balance sheet classification of our operating lease liabilities was as follows (in thousands):


	March 31, 2023		December 31, 2022
Operating lease liabilities:
Current portion of lease liabilities (included in other current liabilities)	$	3,830	$	3,631
Long-term portion of lease liabilities		32,131		32,801
Total operating lease liabilities	$	35,961	$	36,432

Summary of Maturities of Sublease Income and Operating Lease Liabilities

As of March 31, 2023, the maturities of our sublease income and operating lease liabilities were as follows (in thousands):


Years ending December 31,	Sublease Income		Operating Lease Liabilities
2023 (remaining)	$	4,154	$	5,324
2024		5,684		7,190
2025		5,854		6,565
2026		6,030		5,903
2027		6,211		6,043
Thereafter		21,500		21,240
Total	$	49,433		52,265
Less:
Present value adjustment				(16,304	)
Total			$	35,961

Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate

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


	March 31, 2023			December 31, 2022
Weighted average remaining lease term	7.4 years			7.6 years
Weighted average discount rate		10.1	%		10.1	%

Inventories, Net (Tables)

3 Months Ended

Mar. 31, 2023

Inventory Disclosure [Abstract]

Summary of Inventories

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


	March 31, 2023		December 31, 2022
Raw materials	$	22,400	$	25,517
Work-in-process		19,661		23,934
Finished goods		15,632		9,995
Total	$	57,693	$	59,446

Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail)	Mar. 31, 2023	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Weighted average remaining lease term	7 years 4 months 24 days	7 years 7 months 6 days
Weighted average discount rate	10.10%	10.10%

Equity Plans and Stock-Based Compensation -Summary Of Performance Based Restricted Stock Unit (Detail) - Performance Based Restricted Stock Units shares in Thousands	3 Months Ended
	Mar. 31, 2023 $ / shares shares
Weighted-Average Grant-Date Fair Value Per Share
Non-vested, Beginning Balance \| $ / shares	$ 11.62
Granted \| $ / shares	18.25
Non-vested, Ending Balance \| $ / shares	$ 15.95
Number of Shares
Non-vested, Beginning Balance \| shares	193
Granted \| shares	364
Non-vested, Ending Balance \| shares	557

Common Stock and Warrants

3 Months Ended

Mar. 31, 2023

Preferred Stock Common Stock And Warrants [Abstract]

Common Stock, Preferred Stock and Warrants

10. Common Stock and Warrants

Common Stock

As of March 31, 2023, there were 128,471,773 shares of our common stock outstanding.

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 March 31, 2023, we had $120.5 million remaining under the 2020 ATM Agreement.

Warrants

During the three months ended March 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 three months ended March 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 condensed 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
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

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-Name Accounting Standards Codification
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Publisher FASB
-Name Accounting Standards Codification
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Net Income Per Share

3 Months Ended

Mar. 31, 2023

Earnings Per Share [Abstract]

Net Income Per Share

9. Net (Loss) Income Per Share

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

For the calculation of diluted net income per share, net income attributable to common stockholders for basic net income per share is adjusted by the effect of dilutive securities, including awards under our equity compensation plans and change in fair value of warrant liability. Diluted net income per share attributable to common stockholders is computed by dividing the resulting net income attributable to common stockholders by the weighted-average number of fully diluted common shares outstanding.

The numerators and denominators of the basic net (loss) income and diluted net income per share computations for our common stock are calculated as follows (in thousands):


	Three Months Ended
	March 31,
	2023			2022
Numerator
Net (loss) income	$	(24,332	)	$	32,859
Less: undistributed earnings allocated to participating securities		-			(131	)
Net (loss) income attributable to common stockholders, basic		(24,332	)		32,728
Add: undistributed earnings allocated to participating securities		-			131
Less: removal of change in fair value of warrant liability		-			(1,801	)
Add: interest expense on convertible notes		-			1,259
Net (loss) income attributable to common stockholders, diluted	$	(24,332	)	$	32,317
Denominator
Weighted average common stock outstanding, basic		127,921			124,555
Effect of dilutive shares:
Stock-based compensation plans		-			3,001
Dilutive warrants		-			326
Convertible Notes (as converted to common stock)		-			21,543
Weighted average common stock outstanding, diluted		127,921			149,425

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


	Three months ended March 31,
	2023		2022
Outstanding securities not included in diluted net (loss) income per share calculation:
Stock options and stock awards		15,622		8,415
Convertible Notes (as converted to common stock)		21,543		-
Total		37,165		8,415

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Operating activities
Net (loss) income	$ (24,332)	$ 32,859
Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities:
Depreciation and amortization	1,013	985
Amortization of right-of-use assets and loss on disposal of property and equipment	642	743
Accretion of discounts on marketable securities	(3,498)	(181)
Change in fair value of warrant liability	0	(1,801)
Stock-based compensation expense	10,034	7,646
Bad debt expense	12,313	0
Non-cash interest expense	1,686	1,680
Changes in operating assets and liabilities:
Accounts and other receivables, net	30,336	(5,120)
Inventories, net	1,753	(17,703)
Prepaid manufacturing	0	21,325
Prepaid expenses and other current assets	(1,304)	(9,231)
Other assets	677	(49)
Accounts payable	4,096	16,938
CEPI accrual (Note 6)	0	(21,478)
Lease liabilities	(793)	(806)
Deferred revenue	0	(36,661)
Accrued liabilities and other liabilities	(5,001)	(39,589)
Net cash provided by (used in) operating activities	27,622	(50,443)
Investing activities
Purchases of marketable securities	(185,301)	(250,375)
Proceeds from maturities of marketable securities	134,250	35,250
Purchases of property and equipment, net	(1,283)	(1,358)
Net cash used in investing activities	(52,334)	(216,483)
Financing activities
Proceeds from warrants exercised	0	8,455
Proceeds from exercise of stock options and/or release of restricted stock awards, net	239	1,122
Proceeds from Employee Stock Purchase Plan	777	710
Payments for taxes related to net share settlement of RSUs	(4,106)	0
Net cash (used in) provided by financing activities	(3,090)	10,287
Effect of exchange rate changes on cash and cash equivalents, and restricted cash	151	(134)
Net decrease in cash and cash equivalents, and restricted cash	(27,651)	(256,773)
Cash and cash equivalents, and restricted cash at beginning of period	202,211	436,408
Cash and cash equivalents, and restricted cash at end of period	174,560	179,635
Supplemental disclosure of cash flow information
Cash paid during the period for income taxes	32	87
Reclassification of contract asset from other current assets to other assets	71,307	0
Reclassification of CEPI accrual to CEPI accrual long-term	(60,337)	0
Non-cash investing and financing activities:
Purchases of property and equipment, not yet paid	926	2,007
Right-of-use assets obtained in exchange of operating lease liabilities	$ 278	$ 1,173

Fair Value Measurements - Additional Information (Detail) $ in Millions	Mar. 31, 2023 USD ($)
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Fair value of the convertible notes	$ 269.1

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	$ 174,350	$ 202,004
Unrealized Gains	0	0
Unrealized Losses	0	0
Estimated Fair Value	174,350	202,004
Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	478,346	423,796
Unrealized Gains	71	12
Unrealized Losses	(811)	(1,417)
Estimated Fair Value	477,606	422,391
Marketable Securities Available-for-Sale \| Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	652,696	625,800
Unrealized Gains	71	12
Unrealized Losses	(811)	(1,417)
Estimated Fair Value	651,956	624,395
Cash \| Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	18,598	29,586
Unrealized Gains	0	0
Unrealized Losses	0	0
Estimated Fair Value	18,598	29,586
Money Market Funds \| Cash and Cash Equivalents
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	155,752	172,418
Unrealized Gains	0	0
Unrealized Losses	0	0
Estimated Fair Value	155,752	172,418
U.S. Treasuries \| Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	22,707	42,502
Unrealized Gains	11	0
Unrealized Losses	(21)	(194)
Estimated Fair Value	22,697	42,308
U.S. Government Agency Securities \| Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	127,248	88,429
Unrealized Gains	33	0
Unrealized Losses	(356)	(397)
Estimated Fair Value	126,925	88,032
Corporate Debt Securities \| Marketable Securities Available-for-Sale
Cash Cash Equivalents And Marketable Securities [Line Items]
Amortized Cost	328,391	292,865
Unrealized Gains	27	12
Unrealized Losses	(434)	(826)
Estimated Fair Value	$ 327,984	$ 292,051

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Investments, Debt and Equity Securities [Abstract]
Gross realized losses on investmnents	$ 0	$ 0

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

3 Months Ended

Mar. 31, 2023

Investments, Debt and Equity Securities [Abstract]

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

3. 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 condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows (in thousands):


	March 31, 2023		December 31, 2022		March 31, 2022		December 31, 2021
Cash and cash equivalents	$	174,350	$	202,004	$	179,421	$	436,189
Restricted cash		210		207		214		219
Total cash and cash equivalents, and restricted cash shown in the condensed consolidated statements of cash flows	$	174,560	$	202,211	$	179,635	$	436,408

Restricted cash balances relate to certificates of deposit issued as collateral to certain letters of credit issued as security to our facility leases (see Note 5).

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


	Amortized Cost		Unrealized Gains		Unrealized Losses			Estimated Fair Value
March 31, 2023
Cash and cash equivalents:
Cash	$	18,598	$	-	$	-		$	18,598
Money market funds		155,752		-		-			155,752
Total cash and cash equivalents		174,350		-		-			174,350
Marketable securities available-for-sale:
U.S. treasuries		22,707		11		(21	)		22,697
U.S. government agency securities		127,248		33		(356	)		126,925
Corporate debt securities		328,391		27		(434	)		327,984
Total marketable securities available-for-sale		478,346		71		(811	)		477,606
Total cash and cash equivalents, and marketable securities	$	652,696	$	71	$	(811	)	$	651,956
December 31, 2022
Cash and cash equivalents:
Cash	$	29,586	$	-	$	-		$	29,586
Money market funds		172,418		-		-			172,418
Total cash and cash equivalents		202,004		-		-			202,004
Marketable securities available-for-sale:
U.S. treasuries		42,502		-		(194	)		42,308
U.S. government agency securities		88,429		-		(397	)		88,032
Corporate debt securities		292,865		12		(826	)		292,051
Total marketable securities available-for-sale		423,796		12		(1,417	)		422,391
Total cash and cash equivalents, and marketable securities	$	625,800	$	12	$	(1,417	)	$	624,395

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


	March 31, 2023
	Amortized Cost		Estimated Fair Value
Mature in one year or less	$	439,791	$	439,006
Mature after one year through two years		38,555		38,600
	$	478,346	$	477,606

We have classified our entire investment portfolio as available-for-sale and available for use in current operations and accordingly have classified all investments as short-term. Available-for-sale securities are carried at fair value based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the securities. Unrealized losses are included in accumulated other comprehensive loss in stockholders’ equity. Upon adoption of ASC 326 we determine whether a decline in the fair value of our AFS debt securities below their amortized cost basis (i.e., an impairment) is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in other comprehensive income (loss), net of applicable taxes. Credit-related impairments (if any) are recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Both the allowance and the adjustment to net income can be reversed if conditions change.

There were no realized gains or losses from the sale of marketable securities during the three months ended March 31, 2023 and 2022. We do not intend to sell, and are not required to sell, the investments that are in an unrealized loss position before recovery of their amortized cost basis. During the three months ended March 31, 2023, we did not record an allowance for credit losses, as

management believes any such losses would be immaterial based on the investment-grade credit rating for each of the investments as of March 31, 2023. As such, there have been no declines in fair value that have been identified as a credit-related impairment.

Computation of Basic and Diluted Net (Loss) Income Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract]
Net (loss) income	$ (24,332)	$ 32,859
Less: undistributed earnings allocated to participating securities	0	(131)
Net (loss) income attributable to common stockholders, basic	(24,332)	32,728
Add: undistributed earnings allocated to participating securities	0	131
Less: Removal of change in fair value of warrant liability	0	(1,801)
Add: interest expense on convertible notes	0	1,259
Net (loss) income attributable to common stockholders, diluted	$ (24,332)	$ 32,317
Weighted average common stock outstanding, basic	127,921	124,555
Effect of dilutive shares:
Stock-based compensation plans	$ 0	$ 3,001
Dilutive warrants	0	326
Convertible Notes (as converted to common stock)	0	21,543
Weighted average common stock outstanding, diluted	127,921	149,425

Equity Plans and Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs)
shares in Thousands

3 Months Ended

Mar. 31, 2023

$ / shares

Number of Shares

Non-vested, Beginning Balance | shares

3,479

Granted | shares

2,152

Vested | shares

(1,236)

^[1]

Forfeited | shares

(101)

Non-vested, Ending Balance | shares

4,294

Weighted-Average Grant-Date Fair Value Per Share

Non-vested, Beginning Balance | $ / shares

$ 11.00

Granted | $ / shares

11.06

Vested | $ / shares

10.12

^[1]

Forfeited | $ / shares

11.65

Non-vested, Ending Balance | $ / shares

$ 11.27

[1]

(1) Inclusive of approximately 490,350 RSUs for the three months ended March 31, 2023, which were not converted into shares due to net share settlement in order to cover the required amount of employee withholding taxes. The value of the withheld shares was classified as a reduction to additional paid-in capital.

Revenue Recognition - Schedule of Revenues from Major Customers (Detail) - Product Concentration Risk [Member] - Revenue Benchmark [Member]	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Largest Customer \| HEPLISAV-B
Concentration Risk [Line Items]
Percentage of product revenue	27.00%	25.00%
Second Largest Customer \| HEPLISAV-B
Concentration Risk [Line Items]
Percentage of product revenue	22.00%	20.00%
Third Largest Customer \| HEPLISAV-B
Concentration Risk [Line Items]
Percentage of product revenue	17.00%	16.00%
Largest Collaboration Partner \| CpG 1018 adjuvant
Concentration Risk [Line Items]
Percentage of product revenue	0.00%	74.00%
Second Largest Collaboration Partner \| CpG 1018 adjuvant
Concentration Risk [Line Items]
Percentage of product revenue	0.00%	24.00%
Third largest collaboration partner \| CpG 1018 adjuvant
Concentration Risk [Line Items]
Percentage of product revenue	0.00%	2.00%

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Statement of Comprehensive Income [Abstract]
Net (loss) income	$ (24,332)	$ 32,859
Other comprehensive income (loss), net of tax:
Change in unrealized loss on marketable securities available-for-sale	666	(1,272)
Cumulative foreign currency translation adjustments	572	(625)
Total other comprehensive income (loss)	1,238	(1,897)
Total comprehensive (loss) income	$ (23,094)	$ 30,962

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

Amount after tax and reclassification adjustments of other comprehensive income (loss).

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 45
-Paragraph 1A
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126968391&loc=SL7669619-108580

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 50
-Paragraph 4
-URI https://asc.fasb.org/extlink&oid=124431353&loc=SL124442407-227067

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 2
-URI https://asc.fasb.org/extlink&oid=126973232&loc=d3e21463-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 830
-SubTopic 30
-Section 45
-Paragraph 17
-URI https://asc.fasb.org/extlink&oid=118261656&loc=d3e32136-110900

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(21))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 55
-Paragraph 15
-URI https://asc.fasb.org/extlink&oid=124507222&loc=d3e1436-108581

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 830
-SubTopic 30
-Section 45
-Paragraph 20
-URI https://asc.fasb.org/extlink&oid=118261656&loc=d3e32211-110900

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 830
-SubTopic 30
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6450520&loc=d3e32583-110901

Reference 9: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 50
-Paragraph 5
-URI https://asc.fasb.org/extlink&oid=124431353&loc=SL124442411-227067

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 45
-Paragraph 1B
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126968391&loc=SL7669625-108580

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(23))
-URI https://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(19))
-URI https://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

+ Details

Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2023

Fair Value Disclosures [Abstract]

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

The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands):


	Level 1		Level 2		Level 3		Total
March 31, 2023
Assets
Money market funds	$	155,752	$	-	$	-	$	155,752
U.S. treasuries		-		22,697		-		22,697
U.S. government agency securities		-		126,925		-		126,925
Corporate debt securities		-		327,984		-		327,984
Total assets	$	155,752	$	477,606	$	-	$	633,358

	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

Collaborative Research, Development and License Agreements

3 Months Ended

Mar. 31, 2023

Research and Development [Abstract]

Collaboration, Development and Supply Agreements

6. Collaboration, Development and Supply Agreements

Coalition for Epidemic Preparedness Innovations

In January 2021, we entered into an agreement (together with subsequent amendments, the “CEPI Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) for the manufacture and reservation of a specified quantity of CpG 1018 adjuvant (“CpG 1018 Materials”). In May 2021, we entered into the first amendment to the CEPI Agreement. The CEPI Agreement enables CEPI to direct the supply of CpG 1018 Materials to CEPI partner(s). CEPI partner(s) would purchase CpG 1018 Materials under separately negotiated agreements. The CEPI Agreement also allows us to sell CpG 1018 Materials to third parties if not purchased by a CEPI partner within a two-year term.

In exchange for reserving CpG 1018 Materials and agreeing to sell CpG 1018 Materials to CEPI partner(s) at pre-negotiated prices, CEPI agreed to provide payments in the form of an interest-free, unsecured, forgivable loan (the “Advance Payments”). We are obligated to repay the Advance Payments, in proportion to quantity sold, if and to the extent we receive payments from sales of CpG 1018 Materials reserved under the CEPI Agreement. If the vaccine programs pursued by CEPI partner(s) are unsuccessful and no alternative use is found for CpG 1018 Materials reserved under the CEPI Agreement, the applicable Advance Payments will be forgiven at the end of the two-year term.

Through March 31, 2023, we have received Advance Payments totaling approximately $175.0 million pursuant to the CEPI Agreement, of which $67.3 million have been repaid. As of March 31, 2023, remaining Advance Payments totaling $47.4 million in CEPI accrual and $60.3 million in CEPI accrual long-term were reflected in our condensed consolidated balance sheets, representing the outstanding balance of the CEPI Advance Payments relating to the Bio E Supply Agreement and Clover Supply Agreement (each as defined and discussed below), respectively. As of December 31, 2022, we recorded Advance Payments of $107.7 million included in CEPI accrual. There were no deferred revenue balances related to the CEPI Agreement as of March 31, 2023 and December 31, 2022.

As a subsequent event, on April 27, 2023, we entered into a waiver and second amendment to the CEPI Agreement by and between us and CEPI (the “CEPI-Bio E Assignment Agreement”). Pursuant to the CEPI-Bio E Assignment Agreement, CEPI has forgiven the entirety of the outstanding Advance Payments for CpG 1018 Materials allocated to and ordered by Bio E under the CEPI Agreement, and has assumed our previous rights to $47.4 million of Bio E accounts receivable.

Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited

In June 2021, we entered into an agreement with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited (collectively, “Clover”), for the commercial supply of CpG 1018 adjuvant, for use with Clover’s COVID-19 vaccine candidate, SCB-2019 (together with subsequent amendments, the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Clover’s commercialization of vaccines containing SCB-2019 and CpG 1018 adjuvant (“Clover Product”). The Clover Supply Agreement also provides terms for Clover to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. In 2022 and 2023, we signed four amendments to the Clover Supply Agreement. The terms and conditions of the Clover Supply Agreement were operative through December 2022, and as of March 31, 2023, we had satisfied all delivery obligations thereunder.

For CpG 1018 adjuvant reserved for Clover under the CEPI Agreement, Clover is obligated to pay us the purchase price upon the earliest of (i) the true-up exercise, (ii) within a specified period after Clover delivers Clover Product to a customer, or (iii) Clover’s receipt of payment for Clover Product from a customer. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement, we recognize product revenue and a corresponding contract asset as our right to consideration is contingent on something other than the passage of time, as outlined above.

The contract asset of $71.3 million relating to Clover was included in other current assets as of December 31, 2022, and it was subsequently reclassified to other assets (long term) as of March 31, 2023. The contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product.

Corresponding CEPI Advance Payments of $60.3 million relating to Clover are recorded in CEPI accrual long-term in our condensed consolidated balance sheets as of March 31, 2023. These Advance Payments may be repaid using cash collected from Clover or forgiven in accordance with the CEPI Agreement. We had no accounts receivable balance from Clover as of March 31, 2023 and December 31, 2022. We did not recognize CpG 1018 adjuvant net product revenue from Clover for the three months ended March 31, 2023. We recognized CpG 1018 adjuvant net product revenue of $22.3 million from Clover for the three months ended March 31, 2022.

Biological E. Limited

In July 2021, we entered into an agreement (together with subsequent amendments, the “Bio E Supply Agreement”) with Biological E. Limited (“Bio E”), for the commercial supply of CpG 1018 adjuvant, for use with Bio E’s subunit COVID-19 vaccine candidate, CORBEVAX™. Under the Bio E Supply Agreement, Bio E committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Bio E’s commercialization of its CORBEVAX vaccine (“Bio E Product”) with specified delivery dates in 2021 and the first quarter of 2022. The Bio E Supply Agreement also provides terms for Bio E to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. In June 2022 and in October 2022, we entered into amendments to the Bio E Supply Agreement (the “Bio E Amendment No 1” and the “Bio E Amendment No 2”, together the “Bio E Amendments”). The Bio E Amendments primarily established: (i) a new payment schedule for certain outstanding invoices related to the CEPI product to be the earlier of December 31, 2022, or receipt of certain amounts from Bio E from the Government of India in connection with their Advance Purchase agreement for CORBEVAX, and (ii) further modified the scope of the Bio E Supply Agreement, by reducing certain quantities of CpG 1018 adjuvant to be delivered. The terms and conditions of the Bio E Supply Agreement were operative through December 2022, and as of March 31, 2023, we had satisfied all delivery obligations thereunder.

As of March 31, 2023, net accounts receivable from Bio E, which relates to CpG 1018 Materials delivered under the Bio E Supply Agreement and CEPI Agreement, was $61.9 million, net of an allowance for doubtful accounts of $12.3 million. The allowance for doubtful accounts of $12.3 million was determined by assessing changes in Bio E’s credit risk, contemplation of ongoing negotiations relating to Bio E Amendment No 3 (defined below), and Bio E's dependence on cash collections from the Government of India, which have been delayed and significantly reduced in connection with the overall reduction in demand for CORBEVAX from the Government of India. In connection with the Bio E accounts receivable, a corresponding liability for CEPI Advance Payments of $47.4 million (the “Bio E CEPI Advance”) is recorded in CEPI accrual, reflecting amounts previously provided by CEPI under the CEPI Agreement in our condensed consolidated balance sheets as of March 31, 2023. As of March 31, 2023, the Bio E CEPI Advance may be repaid using cash collected from Bio E or, in the alternative, forgiven in accordance with the CEPI Agreement.

As a subsequent event, on April 26, 2023, we entered into a third amendment to the Bio E Supply Agreement (the “Bio E Amendment No 3”), and on April 27, 2023, we entered into the CEPI-Bio E Assignment Agreement. Pursuant to the CEPI-Bio E Assignment Agreement, CEPI has forgiven the entirety of remaining amounts outstanding relating to the Bio E CEPI Advance Payments for CpG 1018 Materials allocated to Bio E and has assumed our previous rights to collect $47.4 million of Bio E accounts receivable. The CEPI-Bio E Assignment Agreement results in a remaining accounts receivable balance from Bio E of $14.5 million, net of the allowance for doubtful accounts of $12.3 million discussed above. Pursuant to the Bio E Amendment No 3, on April 26, 2023, we collected $13.5 million from Bio E and expect to collect the remaining $1.0 million in August 2023. The Bio E Amendment No 3 provides for additional future payment of either $5.5 million in the event that Bio E receives at least $125.0 million, or $12.3 million in the event that Bio E receives at least $250.0 million in future payments from the Government of India associated with its CORBEVAX product on or before August 15, 2025. These additional amounts are not considered collectible until the achievement of these future milestones.

We did not recognize CpG 1018 adjuvant net product revenue from Bio E for the three months ended March 31, 2023. We recognized CpG 1018 adjuvant net product revenue of $67.3 million from Bio E for the three months ended March 31, 2022.

U.S. Department of Defense

In September 2021, we entered into an agreement with the DoD for the development of a recombinant plague vaccine adjuvanted with CpG 1018 adjuvant for approximately $22.0 million over two and a half years. Under the agreement, we will conduct a Phase 2 clinical trial combining our CpG 1018 adjuvant with the DoD's rF1V vaccine. For the three months ended March 31, 2023 and 2022, we recognized revenue of $3.5 million and $1.6 million, respectively, which is included in other revenue in our condensed consolidated statements of operations.

Convertible Notes (Tables)

3 Months Ended

Mar. 31, 2023

Debt Disclosure [Abstract]

Summary of Interest Expenses Related to Convertible Notes

The following table presents the components of interest expense related to Convertible Notes (in thousands):


	Three Months Ended
	March 31,
	2023		2022
Stated coupon interest	$	1,409	$	1,409
Amortization of debt issuance cost		277		269
Total interest expense	$	1,686	$	1,678

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

3 Months Ended

Mar. 31, 2023

USD ($)

Accounts receivable reserves

Valuation And Qualifying Accounts Disclosure [Line Items]

Balance at Beginning of Period

$ 8,179

^[1]

11,821

^[1]

Credit or payments made during the period

(10,686)

^[1]

Product Revenue Allowance And Reserves Adjustments Related To Prior Period

(198)

^[1]

Balance at End of Period

9,116

^[1]

Revenue Reserve Accruals [Member]

Valuation And Qualifying Accounts Disclosure [Line Items]

Balance at Beginning of Period

10,552

^[2]

9,700

^[2]

Credit or payments made during the period

(8,040)

^[2]

Product Revenue Allowance And Reserves Adjustments Related To Prior Period

490

^[2]

Balance at End of Period

$ 12,702

^[2]

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

Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive (Loss) Income	Accumulated Deficit
Beginning Balances at Dec. 31, 2021	$ 222,374	$ 123	$ 1,441,868	$ (2,266)	$ (1,217,351)
Beginning Balances (in shares) at Dec. 31, 2021		122,945
Issuance of common stock upon exercise of stock options, shares		155
Issuance of common stock upon exercise of stock options	1,122	$ 0	1,122
Issuance of common stock upon release of restricted stock awards, shares		1,236
Issuance of common stock upon release of restricted stock awards		$ 1	(1)
Issuance of common stock upon exercise of warrants (Shares)		1,879
Issuance of common stock upon exercise of warrants	24,670	$ 2	24,668
Issuance of common stock under Employee Stock Purchase Plan	710		710
Issuance of common stock under Employee Stock Purchase Plan (in shares)		82
Stock compensation expense	7,646		7,646
Total other comprehensive income (Loss)	(1,897)			(1,897)
Net (loss) income	32,859				32,859
Ending Balances at Mar. 31, 2022	287,484	$ 126	1,476,013	(4,163)	(1,184,492)
Ending Balances (in shares) at Mar. 31, 2022		126,297
Beginning Balances at Dec. 31, 2022	581,013	$ 128	1,510,518	(5,438)	(924,195)
Beginning Balances (in shares) at Dec. 31, 2022		127,604
Issuance of common stock upon exercise of stock options, shares		41
Issuance of common stock upon exercise of stock options	239		239
Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings	(5,237)		(5,237)
Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings(share)		746
Issuance of common stock under Employee Stock Purchase Plan	777		777
Issuance of common stock under Employee Stock Purchase Plan (in shares)		81
Stock compensation expense	10,034		10,034
Total other comprehensive income (Loss)	1,238			1,238
Net (loss) income	(24,332)				(24,332)
Ending Balances at Mar. 31, 2023	$ 563,732	$ 128	$ 1,516,331	$ (4,200)	$ (948,527)
Ending Balances (in shares) at Mar. 31, 2023		128,472

Revenue Recognition - Summary of balances and activities in our contract asset account (Details)
$ in Thousands

3 Months Ended

Mar. 31, 2023

USD ($)

Reclassification (1)

$ 71,307

^[1]

Balance at End of Period

71,307

CpG 1018 adjuvant

Balance at Beginning of Period

71,965

^[2]

Additions

3,398

^[2]

Subtractions

(2,554)

^[2]

Reclassification (1)

(71,307)

^[1],[2]

Balance at End of Period

$ 1,502

^[2]

[1]	(1) The Clover contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. See Note 6 for further discussion
[2]	(2) The $1.5 million of contract asset is derived from our agreement with the DoD.

Organization and Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2023

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and Summary of Significant Accounting Policies

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 in areas of significant unmet need, leveraging our demonstrated expertise and capabilities in vaccines and our proven, proprietary vaccine adjuvant technology. 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. As of March 31, 2023, we have satisfied all delivery obligations under these global commercial supply agreements. 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"). We are also working to advance product candidates utilizing our CpG 1018 adjuvant through discovery efforts and through preclinical and clinical collaborations with third-party research organizations, including an ongoing collaboration with the Icahn School of Medicine at Mount Sinai investigating universal and seasonal influenza vaccine candidates and Queensland Institute of Medical Research, testing poly T cell epitope proteins with other antigens in preclinical models.

Basis of Presentation

Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period.

The condensed consolidated balance sheet as of December 31, 2022 has been derived from audited financial statements at that date, but excludes some disclosures required by GAAP for complete financial statements.

The unaudited condensed consolidated financial statements and these notes should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”).

The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiaries, Dynavax GmbH, located in Düsseldorf, Germany, Dynavax India LLP, located in India, and a branch of Dynavax registered in Italy. All significant intercompany accounts and transactions among these entities have been eliminated from the unaudited condensed consolidated financial statements. We operate in one business segment: discovery, development and commercialization of novel vaccines.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that may affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes, including amounts of revenues and expenses during the reported periods. Management’s estimates are based on historical information available as of the date of the unaudited condensed consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. On an ongoing basis, we evaluate our estimates, judgments and methodologies. Significant estimates and assumptions in the unaudited condensed consolidated financial statements include those related to revenue recognition; accounts receivable; useful lives of long-lived assets, impairment of long-lived assets, including goodwill; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; balance sheet classification of convertible notes; income taxes, including the valuation allowance for deferred tax assets; research and development expenses; contingencies and share-based compensation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.

Recent Accounting Pronouncements

Accounting Standards Update 2016-13

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments, which was codified in Accounting Standards Codification (“ASC”) 326, Financial Instruments — Credit Losses (“ASC 326"). The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, ASC 326 became effective for us for fiscal years beginning after December 15, 2022. As such, we adopted ASC 326 effective January 1, 2023, utilizing the modified retrospective transition method. Upon adoption, we updated our impairment model to utilize a forward-looking current expected credit losses (“CECL”) model in place of the incurred loss methodology for financial instruments measured at amortized cost, primarily including our accounts receivable and contract asset. In relation to available-for-sale (“AFS") debt securities, the guidance eliminates the concept of “other-than-temporary” impairment, and instead focuses on determining whether any impairment is a result of a credit loss or other factors. The adoption of ASC 326 did not have a material impact on our unaudited condensed consolidated financial statements as of the adoption date.

Convertible Notes

3 Months Ended

Mar. 31, 2023

Debt Disclosure [Abstract]

Convertible Notes

7. 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 and we issued an additional $25.5 million of the Convertible Notes in May 2021. Total proceeds from the issuance of the Convertible Notes, net of debt issuance and offering costs of $5.7 million, were $219.8 million. We used $190.2 million of the net proceeds to retire our previous loan agreement with CRG Servicing LLC and $27.2 million of the net proceeds to pay the costs of the Capped Calls described below.

The Convertible Notes are general unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021. The Convertible Notes mature on May 15, 2026, unless converted, redeemed or repurchased prior to such date.

The Convertible Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, at an initial conversion rate of 95.5338 shares of our common stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $10.47 per share of our common stock. The Convertible Notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding February 15, 2026, only under the following circumstances:

•

During any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;

•

During the five business day period after any ten consecutive trading day period (the “measurement period”), in which the “trading price” (as defined the indenture governing the Convertible Notes) per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day;

•

If we call such Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or

•

Upon the occurrence of specified corporate events as set forth in the indenture governing the Convertible Notes.

On or after February 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders of the Convertible Notes may convert all or any portion of their Convertible Notes regardless of the foregoing circumstances.

Since we have the election of repaying the Convertible Notes in cash, shares of our common stock, or a combination of both, we continued to classify the Convertible Notes as long-term debt on the condensed consolidated balance sheets as of March 31, 2023.

We may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation described in the indenture governing the Convertible Notes), at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If we undergo a fundamental change (as set forth in the indenture governing the Convertible Notes), noteholders may require us to repurchase for cash all or any portion of their Convertible Notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events (as set forth in the indenture governing the Convertible Notes) or if we deliver a notice of redemption prior to the maturity date, we will, in certain circumstances, adjust the conversion rate for a noteholder who elects to convert its notes in connection with such a corporate event or such notice of redemption.

We accounted for the Convertible Notes as a single liability in accordance with ASU 2020-06 - Accounting for Convertible Instruments and Contracts in an Entity's Own Equity (“ASU 2020-06”). As of March 31, 2023, the Convertible Notes were recorded at the aggregate principal amount of $225.5 million less unamortized issuance costs of $3.6 million as a long-term liability on the condensed consolidated balance sheets. As of March 31, 2023, the fair value of the Convertible Notes was $269.1 million. The fair value was estimated using a reputable third-party valuation model based on observable inputs and is considered Level 2 in the fair

value hierarchy. The debt issuance costs are amortized to interest expense over the contractual term of the Convertible Notes at an effective interest rate of 3.1%.

The following table presents the components of interest expense related to Convertible Notes (in thousands):


	Three Months Ended
	March 31,
	2023		2022
Stated coupon interest	$	1,409	$	1,409
Amortization of debt issuance cost		277		269
Total interest expense	$	1,686	$	1,678

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 condensed 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

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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 6: http://www.xbrl.org/2003/role/disclosureRef
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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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+ Details

Equity Plans and Stock-Based Compensation

3 Months Ended

Mar. 31, 2023

Share-Based Payment Arrangement, Noncash Expense [Abstract]

Equity Plans and Stock-Based Compensation

11. Equity Plans and Stock-Based Compensation

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 March 31, 2023, the Amended 2018 EIP and the Amended and Restated 2014 Employee Stock Purchase Plan are our active 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 seven years unless earlier terminated by the Board of Directors. As of March 31, 2023, there were 10,238,290 shares of common stock reserved for issuance under the Amended 2018 EIP.

Under our Amended 2018 EIP, we may grant stock options, RSUs, performance-based awards, and other awards that are settled in shares of our common stock. Our equity awards generally vest over a three-year period contingent upon continuous service and unless exercised, expire seven or ten years from the date of grant (or earlier upon termination of continuous service). Activity under our stock plans is set forth below:

Stock Options

The following table summarizes the activity of stock options for the three months ended March 31, 2023:


	Shares Underlying Outstanding Options (in thousands)			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Term (years)		Aggregate Intrinsic Value (in thousands)
Balance as of December 31, 2022		9,339		$	10.70		4.61	$	16,291
Options granted		1,663			11.10
Options exercised		(41	)		5.84
Options cancelled:
Options forfeited (unvested)		(29	)		10.16
Options expired (vested)		(197	)		22.83
Balance as of March 31, 2023		10,735		$	10.56		4.84	$	11,820
Vested and expected to vest as of March 31, 2023		10,435		$	10.53		4.79	$	11,808
Exercisable as of March 31 2023		6,281		$	9.89		3.99	$	11,049

Restricted Stock Units

The following table summarizes the activity of RSUs for the three months ended March 31, 2023:


	Number of Shares (in thousands)			Weighted-Average Grant-Date Fair Value Per Share
Non-vested as of December 31, 2022		3,479		$	11.00
Granted		2,152			11.06
Vested (1)		(1,236	)		10.12
Forfeited		(101	)		11.65
Non-vested as of March 31, 2023		4,294		$	11.27

Market-based Performance Stock Units


	Number of Shares (in thousands)		Weighted-Average Grant-Date Fair Value Per Share
Non-vested as of December 31, 2022		193	$	11.62
Granted		364		18.25
Non-vested as of March 31, 2023		557	$	15.95

Performance-based Options

As of March 31, 2023, approximately 36,000 shares underlying performance-based options were outstanding.

Significant Assumptions in Estimating Fair Value

The fair value of each time-based option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows:


	Stock Options						Market-Based Performance Stock Units (“PSUs”)
	Three Months Ended						Three Months Ended
	March 31,						March 31,
	2023			2022			2023			2022
Weighted-average fair value per share	$	7.28		$	8.05		$	18.25		$	11.62
Risk-free interest rate		4.0	%		1.9	%		4.3	%		1.7	%
Expected life (in years)		4.5			4.5			2.9			2.9
Volatility		0.8			0.8			0.9			0.9

Stock-based Compensation

Compensation expense is based on awards ultimately expected to vest and reflects estimated forfeitures. For equity awards with time-based vesting, the fair value is amortized to expense on a straight-line basis over the vesting periods.

We have also granted performance-based equity awards to certain of our employees. For equity awards with performance-based vesting criteria, the fair value is amortized to expense when the achievement of the vesting criteria becomes probable. We recognized $0.4 million and $0.3 million of stock-based compensation expense for PSUs during the three months ended March 31, 2023 and 2022, respectively.


	Three Months Ended
	March 31,
	2023		2022
Research and development	$	2,112	$	1,276
Selling, general and administrative		6,830		5,427
Cost of sales - product		695		160
Inventories, net		397		783
Total	$	10,034	$	7,646

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Allowance for doubtful accounts receivables	$ 12,313	$ 0
Long-term debt, net of debt discount	$ 3,645	$ 3,922
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	278,000,000	278,000,000
Common stock, shares issued	128,472,000	127,604,000
Common stock, shares outstanding	128,471,773	127,604,000

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022	Dec. 31, 2021
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract]
Cash and cash equivalents	$ 174,350	$ 202,004	$ 179,421	$ 436,189
Restricted cash	210	207	214	219
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows	$ 174,560	$ 202,211	$ 179,635	$ 436,408

Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Sublease Income
2023 (remaining)	$ 4,154
2024	5,684
2025	5,854
2026	6,030
2027	6,211
Thereafter	21,500
Total	49,433
Operating Lease Liabilities
2023 (remaining)	5,324
2024	7,190
2025	6,565
2026	5,903
2027	6,043
Thereafter	21,240
Total	52,265
Present value adjustment	(16,304)
Total	$ 35,961	$ 36,432

Convertible Notes - Summary of Interest Expenses Related to Convertible Notes (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Debt Disclosure [Abstract]
Stated coupon interest	$ 1,409	$ 1,409
Amortization of debt issuance cost	277	269
Total interest expense	$ 1,686	$ 1,678

Revenue Recognition (Tables)

3 Months Ended

Mar. 31, 2023

Summary of Disaggregation of Revenues

The following table disaggregates our product revenue, net by product and geographic region and disaggregates our other revenues by geographic region (in thousands):


	Three Months Ended						Three Months Ended
	March 31, 2023						March 31, 2022
	U.S.		Non U.S.		Total		U.S.		Non U.S.		Total
Product revenue, net
HEPLISAV-B	$	43,451	$	-	$	43,451	$	20,810	$	-	$	20,810
CpG 1018 adjuvant		-		-		-		-		91,517		91,517
Total product revenue, net	$	43,451	$	-	$	43,451	$	20,810	$	91,517	$	112,327
Other revenue		3,474		-		3,474		1,606		59		1,665
Total revenues	$	46,925	$	-	$	46,925	$	22,416	$	91,576	$	113,992

HEPLISAV-B

Schedule of Revenues from Major Customers

The following table summarizes HEPLISAV-B product revenue from each of our three largest customers (as a percentage of total HEPLISAV-B net product revenue):


	Three Months Ended
	March 31,
	2023			2022
Largest customer		27	%		25	%
Second largest customer		22	%		20	%
Third largest customer		17	%		16	%

Summary of Product Revenue Allowance and Reserve Categories

The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories for the three months ended March 31, 2023 (in thousands):


	Balance at Beginning of Period		Provisions related to current period sales		Credit or payments made during the period			Adjustments related to prior periods			Balance at End of Period
Three months ended March 31, 2023:
Accounts receivable reserves (1)	$	8,179	$	11,821	$	(10,686	)	$	(198	)	$	9,116
Revenue reserve accruals (2)	$	10,552	$	9,700	$	(8,040	)	$	490		$	12,702

(1)

Reserves are for chargebacks, discounts and other fees.

(2)

Accruals are for returns, rebates and other fees.

CpG 1018 adjuvant

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 net product revenue):


	Three Months Ended
	March 31,
	2023			2022
Largest collaboration partner		0	%		74	%
Second largest collaboration partner		0	%		24	%
Third largest collaboration partner		0	%		2	%

Summarizes 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		Subtractions			Reclassification (1)			Balance at End of Period
Three months ended March 31, 2023
Contract asset, included in other current assets (2)	$	71,965	$	3,398	$	(2,554	)	$	(71,307	)	$	1,502
Contract asset, included in other assets	$	-	$	-	$	-		$	71,307		$	71,307

(1) The Clover contract asset was reclassified to long term assets to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. See Note 6 for further discussion.

(2) The $1.5 million of contract asset is derived from our agreement with the DoD.

Equity Plans and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	$ 0	$ 3,001
Stock-based compensation expense	10,034	7,646
Research and Development
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	2,112	1,276
Selling, General and Administrative
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	6,830	5,427
Cost of Sales - Product
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	695	160
Inventory
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items]
Stock-based compensation expense	$ 397	$ 783

Income Taxes

3 Months Ended

Mar. 31, 2023

Income Tax Disclosure [Abstract]

Income Taxes

12. Income Taxes

We are subject to U.S. federal, state and foreign income taxes. For the three months ended March 31, 2023, we recorded a provision for income taxes of $0.6 million. For the three months ended March 31, 2022, we recorded no provision for income taxes. Our effective tax rate was approximately (2.6)% and 0% for the three months ended March 31, 2023 and 2022, respectively. The

primary difference between the effective tax rate and the federal statutory rate is due to the benefit of net operating losses utilized during the periods and the full valuation allowance we established on our federal, state, and certain foreign deferred tax assets.

The tax benefit of net operating losses, temporary differences and credit carryforwards is required to be recorded as an asset to the extent that management assesses that realization is "more likely than not." Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carryforward period. A high degree of judgment is required to determine if, and the extent to which, valuation allowances should be recorded against deferred tax assets. In making such determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. Based on all available evidence as of March 31, 2023, both positive and negative, and the weight of that evidence to the extent such evidence can be objectively verified, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not more likely than not to be realized, and, accordingly, has provided a valuation allowance.

- 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
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Inventories, Net

3 Months Ended

Mar. 31, 2023

Inventory Disclosure [Abstract]

Inventories, net

4. Inventories, net

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


	March 31, 2023		December 31, 2022
Raw materials	$	22,400	$	25,517
Work-in-process		19,661		23,934
Finished goods		15,632		9,995
Total	$	57,693	$	59,446

Equity Plans and Stock-Based Compensation - Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Share-based Payment Arrangement, Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average fair value per share	$ 7.28	$ 8.05
Risk-free interest rate	4.00%	1.90%
Expected life (in years)	4 years 6 months	4 years 6 months
Volatility	0.80%	0.80%
Market Based Performance Stock Unit
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average fair value per share	$ 18.25	$ 11.62
Risk-free interest rate	4.30%	1.70%
Expected life (in years)	2 years 10 months 24 days	2 years 10 months 24 days
Volatility	0.90%	0.90%

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

3 Months Ended

Mar. 31, 2023

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

Reconciliation of Cash, Cash Equivalents and Restricted Cash


	March 31, 2023		December 31, 2022		March 31, 2022		December 31, 2021
Cash and cash equivalents	$	174,350	$	202,004	$	179,421	$	436,189
Restricted cash		210		207		214		219
Total cash and cash equivalents, and restricted cash shown in the condensed consolidated statements of cash flows	$	174,560	$	202,211	$	179,635	$	436,408

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
March 31, 2023
Cash and cash equivalents:
Cash	$	18,598	$	-	$	-		$	18,598
Money market funds		155,752		-		-			155,752
Total cash and cash equivalents		174,350		-		-			174,350
Marketable securities available-for-sale:
U.S. treasuries		22,707		11		(21	)		22,697
U.S. government agency securities		127,248		33		(356	)		126,925
Corporate debt securities		328,391		27		(434	)		327,984
Total marketable securities available-for-sale		478,346		71		(811	)		477,606
Total cash and cash equivalents, and marketable securities	$	652,696	$	71	$	(811	)	$	651,956
December 31, 2022
Cash and cash equivalents:
Cash	$	29,586	$	-	$	-		$	29,586
Money market funds		172,418		-		-			172,418
Total cash and cash equivalents		202,004		-		-			202,004
Marketable securities available-for-sale:
U.S. treasuries		42,502		-		(194	)		42,308
U.S. government agency securities		88,429		-		(397	)		88,032
Corporate debt securities		292,865		12		(826	)		292,051
Total marketable securities available-for-sale		423,796		12		(1,417	)		422,391
Total cash and cash equivalents, and marketable securities	$	625,800	$	12	$	(1,417	)	$	624,395

Maturities of Marketable Securities Available-for-Sale

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


	March 31, 2023
	Amortized Cost		Estimated Fair Value
Mature in one year or less	$	439,791	$	439,006
Mature after one year through two years		38,555		38,600
	$	478,346	$	477,606

Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Assets
Total assets	$ 633,358	$ 594,809
Money Market Funds
Assets
Total assets	155,752	172,418
U.S. Treasuries
Assets
Total assets	22,697	42,308
U.S. Government Agency Securities
Assets
Total assets	126,925	88,032
Corporate Debt Securities
Assets
Total assets	327,984	292,051
Fair Value, Inputs, Level 1
Assets
Total assets	155,752	172,418
Fair Value, Inputs, Level 1 \| Money Market Funds
Assets
Total assets	155,752	172,418
Fair Value, Inputs, Level 1 \| U.S. Treasuries
Assets
Total assets		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
Fair Value, Inputs, Level 2
Assets
Total assets	477,606	422,391
Fair Value, Inputs, Level 2 \| Money Market Funds
Assets
Total assets	0	0
Fair Value, Inputs, Level 2 \| U.S. Treasuries
Assets
Total assets	22,697	42,308
Fair Value, Inputs, Level 2 \| U.S. Government Agency Securities
Assets
Total assets	126,925	88,032
Fair Value, Inputs, Level 2 \| Corporate Debt Securities
Assets
Total assets	327,984	292,051
Fair Value, Inputs, Level 3
Assets
Total assets	0	0
Fair Value, Inputs, Level 3 \| Money Market Funds
Assets
Total assets	0	0
Fair Value, Inputs, Level 3 \| U.S. Treasuries
Assets
Total assets	0	0
Fair Value, Inputs, Level 3 \| U.S. Government Agency Securities
Assets
Total assets		0
Fair Value, Inputs, Level 3 \| Corporate Debt Securities
Assets
Total assets	$ 0	$ 0

Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands	Mar. 31, 2023 USD ($)
Amortized Cost
Mature in one year or less	$ 439,791
Mature after one year through two years	38,555
Debt Securities, Available-for-sale, Maturity, Allocated and Single Maturity Date, Amortized Cost, Total	478,346
Estimated Fair Value
Mature in one year or less	439,006
Mature after one year through two years	38,600
Total estimated fair value	$ 477,606

Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares shares in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Outstanding securities not included in diluted net income (loss) per share calculation:
Outstanding securities not included in diluted net loss per share calculation	37,165	8,415
Stock Options and Stock Awards
Outstanding securities not included in diluted net income (loss) per share calculation:
Outstanding securities not included in diluted net loss per share calculation	15,622	8,415
Convertible Notes
Outstanding securities not included in diluted net income (loss) per share calculation:
Outstanding securities not included in diluted net loss per share calculation	21,543	0

Commitments and Contingencies - Additional Information (Detail) € in Millions	1 Months Ended			3 Months Ended
	May 31, 2022 USD ($)	Sep. 30, 2021 USD ($)	Nov. 30, 2009 USD ($)	Mar. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2023	Mar. 31, 2023 EUR (€)	Mar. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)	May 31, 2021 USD ($)	Dec. 31, 2004 EUR (€)
Loss Contingencies [Line Items]
Lease expiration date				Mar. 31, 2031
Option to extend				The subtenant has no option to extend the sublease term
Sublease income				$ 1,598,000	$ 1,609,000
Percentage of excess rent paid to landlord							50.00%	50.00%
Cash paid for amounts included in the measurement of operating lease liabilities				1,700,000	1,700,000
Long-term debt, net of debt discount								$ 3,645,000	$ 3,922,000
Selling, general and administrative				36,543,000	$ 32,172,000
Liabilities, Current								91,515,000	150,074,000
HEPLISAV-B
Loss Contingencies [Line Items]
Purchase Obligation, Total								40,800,000	43,400,000
Non-cancelable purchase and other commitments								40,800,000	$ 43,400,000
Asset Purchase Agreement
Loss Contingencies [Line Items]
Liabilities, Current								0
Symphony Dynamo Holdings LLC
Loss Contingencies [Line Items]
License arrangement contingent consideration percentage			50.00%
License Arrangement Contingent Payment To Acquire License			$ 50,000,000
License arrangement upfront payment			$ 50,000,000
TriSalus
Loss Contingencies [Line Items]
Payment to holdings				$ 2,500,000
Payment received for Pre-commercialization milestone	$ 1,000,000.0	$ 1,000,000.0
TriSalus \| 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 [Member]
Loss Contingencies [Line Items]
Financial Instruments, Owned, at Fair Value \| €											€ 0.2
2.50% Convertible Senior Notes Due 2026
Loss Contingencies [Line Items]
Aggregate principal amount								225,500,000		$ 200,000,000.0
Long-term debt, net of debt discount								$ 3,600,000
Debt maturity date				May 15, 2026
Emeryville, California (Premises)
Loss Contingencies [Line Items]
Lease option to extend				Certain of these leases also include options to renew or extend the lease for two successive five-year terms
Maximum [Member] \| Emeryville, California (Premises)
Loss Contingencies [Line Items]
lease term						12 years
Minimum [Member] \| Emeryville, California (Premises)
Loss Contingencies [Line Items]
lease term							3 years	3 years

Commitments and Contingencies

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

5. Commitments and Contingencies

Leases

We lease our facilities in Emeryville, California and Düsseldorf, Germany. We lease and sublease certain manufacturing and office space with lease terms ranging from 3 to 12 years. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include options to renew or extend the lease for two successive five-year terms. These optional periods have not been considered in the determination of the right-of-use assets or lease liabilities associated with these leases as we did not consider the exercise of these options to be reasonably certain.

We also sublease one of our leased premises to a third party. Rent is subject to scheduled annual increases and the subtenant is responsible for certain operating expenses and taxes throughout the life of the sublease. The sublease term expires on March 31, 2031, unless earlier terminated, concurrent with the term of our lease. The subtenant has no option to extend the sublease term. Sublease income was $1.6 million for each of the three months ended March 31, 2023 and 2022. Sublease income is included in other income (expense) in our condensed 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):


	Three Months Ended March 31,
	2023		2022
Operating lease expense	$	1,388	$	1,607

Cash paid for amounts included in the measurement of lease liabilities was $1.7 million for each of the three months ended March 31, 2023 and 2022, and were included in change in lease liabilities in our condensed consolidated statements of cash flows.

The balance sheet classification of our operating lease liabilities was as follows (in thousands):


	March 31, 2023		December 31, 2022
Operating lease liabilities:
Current portion of lease liabilities (included in other current liabilities)	$	3,830	$	3,631
Long-term portion of lease liabilities		32,131		32,801
Total operating lease liabilities	$	35,961	$	36,432

As of March 31, 2023, the maturities of our sublease income and operating lease liabilities were as follows (in thousands):


Years ending December 31,	Sublease Income		Operating Lease Liabilities
2023 (remaining)	$	4,154	$	5,324
2024		5,684		7,190
2025		5,854		6,565
2026		6,030		5,903
2027		6,211		6,043
Thereafter		21,500		21,240
Total	$	49,433		52,265
Less:
Present value adjustment				(16,304	)
Total			$	35,961

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


	March 31, 2023			December 31, 2022
Weighted average remaining lease term	7.4 years			7.6 years
Weighted average discount rate		10.1	%		10.1	%

Commitments

As of March 31, 2023 and December 31, 2022, our material non-cancelable purchase and other commitments for the supply of HEPLISAV-B totaled $40.8 million and $43.4 million, respectively. As of March 31, 2023 and December 31, 2022, we have no material non-cancelable purchase and other commitments for the supply of CpG 1018 adjuvant.

As of March 31, 2023, the aggregate principal amount of our convertible senior notes ("Convertible Notes") was $225.5 million, excluding debt discount of $3.6 million (see Note 7).

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 March 31, 2023 and was collateralized by a certificate of deposit for €0.2 million, which has been included in restricted cash in the condensed consolidated balance sheets as of March 31, 2023.

In conjunction with our agreement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50% of the first $50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including our immune-oncology compound, SD-101. In July 2020, we sold assets related to SD-101 to Surefire Medical, Inc. d/b/a TriSalus Life Sciences (“TriSalus”). We paid $2.5 million to Holdings in August 2020. In each of September 2021 and May 2022, 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 condensed consolidated statements of operations in the third quarter of 2021 and second quarter of 2022. We paid Holdings $0.5 million in each of September 2021 and May 2022. We included the payments in selling, general and administrative expenses in our condensed consolidated statements of operations in the third quarter of 2021 and second quarter of 2022. No liability has been recorded under this agreement as of March 31, 2023.

Contingencies

From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, results of operations, or cash flows in a particular period.

Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Operating lease expense	$ 1,388	$ 1,607

Fair Value Measurements

3 Months Ended

Mar. 31, 2023

Fair Value Disclosures [Abstract]

Fair Value Measurements

2. 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 three months ended March 31, 2023.

The carrying amounts of cash equivalents, accounts and other receivables, accounts payable and accrued liabilities are considered reasonable estimates of their respective fair value because of their short-term nature.

Recurring Fair Value Measurements

The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands):


	Level 1		Level 2		Level 3		Total
March 31, 2023
Assets
Money market funds	$	155,752	$	-	$	-	$	155,752
U.S. treasuries		-		22,697		-		22,697
U.S. government agency securities		-		126,925		-		126,925
Corporate debt securities		-		327,984		-		327,984
Total assets	$	155,752	$	477,606	$	-	$	633,358

	Level 1		Level 2		Level 3		Total
December 31, 2022
Assets
Money market funds	$	172,418	$	-	$	-	$	172,418
U.S. treasuries		-		42,308		-		42,308
U.S. government agency securities		-		88,032		-		88,032
Corporate debt securities		-		292,051		-		292,051
Total assets	$	172,418	$	422,391	$	-	$	594,809

Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.

U.S. treasuries, U.S. government agency securities and corporate debt securities are measured at fair value using Level 2 inputs. We review trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy.

- 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

Net Income Per Share (Tables)

3 Months Ended

Mar. 31, 2023

Earnings Per Share [Abstract]

Computation of Basic and Diluted Net Income Per Share

The numerators and denominators of the basic net (loss) income and diluted net income per share computations for our common stock are calculated as follows (in thousands):


	Three Months Ended
	March 31,
	2023			2022
Numerator
Net (loss) income	$	(24,332	)	$	32,859
Less: undistributed earnings allocated to participating securities		-			(131	)
Net (loss) income attributable to common stockholders, basic		(24,332	)		32,728
Add: undistributed earnings allocated to participating securities		-			131
Less: removal of change in fair value of warrant liability		-			(1,801	)
Add: interest expense on convertible notes		-			1,259
Net (loss) income attributable to common stockholders, diluted	$	(24,332	)	$	32,317
Denominator
Weighted average common stock outstanding, basic		127,921			124,555
Effect of dilutive shares:
Stock-based compensation plans		-			3,001
Dilutive warrants		-			326
Convertible Notes (as converted to common stock)		-			21,543
Weighted average common stock outstanding, diluted		127,921			149,425

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

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


	Three months ended March 31,
	2023		2022
Outstanding securities not included in diluted net (loss) income per share calculation:
Stock options and stock awards		15,622		8,415
Convertible Notes (as converted to common stock)		21,543		-
Total		37,165		8,415

Revenue Recognition - Summary of Disaggregation of Revenues (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Disaggregation Of Revenue [Line Items]
Total revenues	$ 46,925	$ 113,992
UNITED STATES
Disaggregation Of Revenue [Line Items]
Total revenues	46,925	22,416
Non-US
Disaggregation Of Revenue [Line Items]
Total revenues	0	91,576
HEPLISAV-B
Disaggregation Of Revenue [Line Items]
Total revenues	43,451	20,810
HEPLISAV-B \| UNITED STATES
Disaggregation Of Revenue [Line Items]
Total revenues	43,451	20,810
HEPLISAV-B \| Non-US
Disaggregation Of Revenue [Line Items]
Total revenues	0	0
CpG 1018 adjuvant
Disaggregation Of Revenue [Line Items]
Total revenues	0	91,517
CpG 1018 adjuvant \| UNITED STATES
Disaggregation Of Revenue [Line Items]
Total revenues	0	0
CpG 1018 adjuvant \| Non-US
Disaggregation Of Revenue [Line Items]
Total revenues	0	91,517
Product
Disaggregation Of Revenue [Line Items]
Total revenues	43,451	112,327
Product \| UNITED STATES
Disaggregation Of Revenue [Line Items]
Total revenues	43,451	20,810
Product \| Non-US
Disaggregation Of Revenue [Line Items]
Total revenues	0	91,517
Other Revenue
Disaggregation Of Revenue [Line Items]
Total revenues	3,474	1,665
Other Revenue \| UNITED STATES
Disaggregation Of Revenue [Line Items]
Total revenues	3,474	1,606
Other Revenue \| Non-US
Disaggregation Of Revenue [Line Items]
Total revenues	$ 0	$ 59

- 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
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-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

Organization and Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Basis of Presentation	Basis of Presentation Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period. The condensed consolidated balance sheet as of December 31, 2022 has been derived from audited financial statements at that date, but excludes some disclosures required by GAAP for complete financial statements. The unaudited condensed consolidated financial statements and these notes should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiaries, Dynavax GmbH, located in Düsseldorf, Germany, Dynavax India LLP, located in India, and a branch of Dynavax registered in Italy. All significant intercompany accounts and transactions among these entities have been eliminated from the unaudited condensed consolidated financial statements. We operate in one business segment: discovery, development and commercialization of novel vaccines.
Use of Estimates	Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that may affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes, including amounts of revenues and expenses during the reported periods. Management’s estimates are based on historical information available as of the date of the unaudited condensed consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. On an ongoing basis, we evaluate our estimates, judgments and methodologies. Significant estimates and assumptions in the unaudited condensed consolidated financial statements include those related to revenue recognition; accounts receivable; useful lives of long-lived assets, impairment of long-lived assets, including goodwill; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; balance sheet classification of convertible notes; income taxes, including the valuation allowance for deferred tax assets; research and development expenses; contingencies and share-based compensation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
Recent Accounting Pronouncements	Recent Accounting Pronouncements Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments, which was codified in Accounting Standards Codification (“ASC”) 326, Financial Instruments — Credit Losses (“ASC 326"). The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, ASC 326 became effective for us for fiscal years beginning after December 15, 2022. As such, we adopted ASC 326 effective January 1, 2023, utilizing the modified retrospective transition method. Upon adoption, we updated our impairment model to utilize a forward-looking current expected credit losses (“CECL”) model in place of the incurred loss methodology for financial instruments measured at amortized cost, primarily including our accounts receivable and contract asset. In relation to available-for-sale (“AFS") debt securities, the guidance eliminates the concept of “other-than-temporary” impairment, and instead focuses on determining whether any impairment is a result of a credit loss or other factors. The adoption of ASC 326 did not have a material impact on our unaudited condensed consolidated financial statements as of the adoption date.

Equity Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022	May 31, 2022	Jun. 30, 2021	Jan. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Increase in aggregate number of shares of common stock authorized for issuance				15,000,000
Employee Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Options vesting period	7 years
Restricted Stock Units (RSUs) [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Restricted stock units awards outstanding	4,294,000		3,479,000
Performance Based Restricted Stock Units [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Restricted stock units awards outstanding	557,000		193,000
Performance Shares [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense related to restricted stock	$ 0.4	$ 0.3
Maximum \| Restricted Stock Units (RSUs) [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expiration period	10 years
Minimum \| Restricted Stock Units (RSUs) [Member]
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]
Newly reserved shares of common stock	10,238,290				3,250,000	1,500,000,000
2014 Employee Stock Purchase Plan \| Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares issued to employees				32,600,000
Performance Based Vesting Schedule [Member] \| Performance Based Restricted Stock Units [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Restricted stock units awards outstanding	36,000