Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
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, $0.001 par value | |
Trading Symbol | DVAX | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-0728374 | |
Entity Address, Address Line One | 2100 Powell Street | |
Entity Address, Address Line Two | Suite 720 | |
Entity Address, City or Town | Emeryville | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94608 | |
City Area Code | 510 | |
Local Phone Number | 848-5100 | |
Entity Common Stock, Shares Outstanding | 130,891,710 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 132,033 | $ 150,279 |
Marketable securities available-for-sale | 591,505 | 592,023 |
Accounts receivaAccounts receivables, net of allowance for doubtful accounts of $12,313 and $0 at March 31, 2024 and December 31, 2023, respectively. | 44,161 | 40,607 |
Other receivables | 1,993 | 3,926 |
Inventories, net | 61,806 | 53,290 |
Prepaid expenses and other current assets | 19,788 | 18,995 |
Total current assets | 851,286 | 859,120 |
Property and equipment, net | 36,413 | 37,297 |
Operating lease right-of-use assets | 23,392 | 24,287 |
Goodwill | 2,022 | 2,067 |
Other assets | 73,452 | 74,325 |
Total assets | 986,565 | 997,096 |
Current liabilities: | ||
Accounts payable | 2,431 | 5,245 |
Accrued research and development | 3,137 | 2,982 |
Accrued liabilities | 45,841 | 49,448 |
Other current liabilities | 4,593 | 4,520 |
current liabilities | 56,002 | 62,195 |
Convertible Notes, net of debt discount of $2,516 and $2,802 at March 31, 2024 and December 31, 2023, respectively (Note 7) | 222,984 | 222,698 |
Long-term portion of lease liabilities | 28,559 | 29,720 |
CEPI accrual long-term | 60,337 | 60,337 |
Other long-term liabilities | 203 | 74 |
Total liabilities | 368,085 | 375,024 |
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 | 131 | 130 |
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 | 1,562,027 | 1,554,634 |
Accumulated other comprehensive (loss) gain | (4,373) | (2,108) |
Accumulated deficit | (939,305) | (930,584) |
Total stockholders’ equity | 618,480 | 622,072 |
Total liabilities and stockholders’ equity | $ 986,565 | $ 997,096 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Allowance for doubtful accounts receivables | $ 12,313 | $ 12,313 |
Long-term debt, net of debt discount | $ 2,516 | $ 2,802 |
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 outstanding | 130,859,129 | 129,530,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenues: | ||
Total revenues | $ 50,790 | $ 46,925 |
Operating expenses: | ||
Cost of sales - product | 10,966 | 14,712 |
Research and development | 13,528 | 13,605 |
Selling, general and administrative | 44,065 | 36,543 |
Bad debt expense | 0 | 12,313 |
Total operating expenses | 68,559 | 77,173 |
(Loss) income from operations | (17,769) | (30,248) |
Other income (expense): | ||
Interest income | 9,468 | 6,597 |
Interest expense | (1,695) | (1,686) |
Sublease (expense) income (Note 5) | (1,602) | 1,598 |
Other | 101 | 23 |
Net loss before income taxes | (11,497) | (23,716) |
Benefit from (provision for) income taxes | 2,776 | (616) |
Net loss | $ (8,721) | $ (24,332) |
Net income per share attributable to common stockholders | ||
Basic | $ (0.07) | $ (0.19) |
Diluted | $ (0.07) | $ (0.19) |
Weighted-average shares used in computing net income per share attributable to common stockholders: | ||
Basic | 130,200 | 127,921 |
Diluted | 130,200 | 127,921 |
Product | ||
Revenues: | ||
Total revenues | $ 47,845 | $ 43,451 |
Other Revenue | ||
Revenues: | ||
Total revenues | $ 2,945 | $ 3,474 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (8,721) | $ (24,332) |
Other comprehensive income (loss), net of tax: | ||
Change in unrealized loss on marketable securities available-for-sale | (1,457) | 666 |
Cumulative foreign currency translation adjustments | (808) | 572 |
Total other comprehensive (loss) income | (2,265) | 1,238 |
Total comprehensive loss | $ (10,986) | $ (23,094) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - 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, 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 | (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 | ||||
Beginning Balances at Dec. 31, 2023 | 622,072 | $ 130 | 1,554,634 | (2,108) | (930,584) |
Beginning Balances (in shares) at Dec. 31, 2023 | 129,530 | ||||
Issuance of common stock upon exercise of stock options, shares | 240 | ||||
Issuance of common stock upon exercise of stock options | 1,635 | 1,635 | |||
Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings | (8,159) | $ 1 | (8,160) | ||
Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings(share) | 995 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 904 | 904 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 94 | ||||
Stock compensation expense | 13,014 | 13,014 | |||
Total other comprehensive income (Loss) | (2,265) | (2,265) | |||
Net loss | (8,721) | (8,721) | |||
Ending Balances at Mar. 31, 2024 | $ 618,480 | $ 131 | $ 1,562,027 | $ (4,373) | $ (939,305) |
Ending Balances (in shares) at Mar. 31, 2024 | 130,859 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net income (loss) | $ (8,721) | $ (24,332) |
Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 1,124 | 1,013 |
Amortization of right-of-use assets | 824 | 642 |
Accretion of discounts on marketable securities | (4,528) | (3,498) |
Sublease termination loss (Note 5) | 4,765 | 0 |
Stock-based compensation expense | 13,014 | 10,034 |
Bad debt expense (Note 6) | 0 | 12,313 |
Non-cash interest expense | 1,695 | 1,686 |
Inventory write-off | 1,264 | 0 |
Changes in operating assets and liabilities: | ||
Accounts and other receivables, net | (1,621) | 30,336 |
Inventories | (9,780) | 1,753 |
Prepaid expenses and other current assets | (4,800) | (1,304) |
Other assets | 118 | 677 |
Accounts payable | (2,640) | 4,096 |
Lease liabilities | (1,025) | (793) |
Accrued and other liabilities | (6,368) | (5,001) |
Net cash (used in) provided by operating activities | (16,679) | 27,622 |
Investing activities | ||
Purchases of marketable securities | (150,685) | (185,301) |
Proceeds from maturities and redemption of marketable securities | 154,265 | 134,250 |
Purchases of property and equipment, net | (749) | (1,283) |
Net cash provided by (used in) investing activities | 2,831 | (52,334) |
Financing activities | ||
Proceeds from exercise of stock options | 1,635 | 239 |
Proceeds from Employee Stock Purchase Plan | 904 | 777 |
Payments for taxes related to net share settlement of restricted stock units | (6,742) | (4,106) |
Net cash used in financing activities | (4,203) | (3,090) |
Effect of exchange rate changes on cash and cash equivalents, and restricted cash | (201) | 151 |
Net decrease in cash and cash equivalents, and restricted cash | (18,252) | (27,651) |
Cash and cash equivalents, and restricted cash at beginning of period | 150,556 | 202,211 |
Cash and cash equivalents, and restricted cash at end of period | 132,304 | 174,560 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for income taxes | 949 | 32 |
Reclassification of contract asset from other current assets to other assets | 0 | 71,307 |
Reclassification of CEPI accrual to CEPI accrual long-term | 0 | (60,337) |
Non-cash investing and financing activities: | ||
Purchases of property and equipment, not yet paid | 355 | 926 |
Right-of-use assets obtained in exchange of operating lease liabilities | $ 0 | $ 278 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”) is a commercial stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. Our first marketed product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] is approved in the United States, the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. In May 2022, we commenced commercial shipments of HEPLISAV-B in Germany. We are advancing a pipeline of differentiated product candidates that leverage our CpG 1018® adjuvant, the adjuvant used in HEPLISAV-B, to develop improved vaccines in indications with unmet medical needs. These programs include vaccine candidates under development for shingles and Tdap, and a plague vaccine candidate program in collaboration with and fully funded by the U.S. Department of Defense ("DoD"). Additionally. we manufacture and have supplied in the past CpG 1018 adjuvant, the adjuvant used in HEPLISAV-B, through both commercial supply agreements, and through preclinical and clinical research collaborations with third-party organizations. 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, 2023 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, 2023 , 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; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; 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 November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-09. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024. 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, 2024 Assets Money market funds $ 120,106 $ - $ - $ 120,106 U.S. treasuries - 102,363 - 102,363 U.S. government agency securities - 169,861 - 169,861 Corporate debt securities - 319,811 - 319,811 Total assets $ 120,106 $ 592,035 $ - $ 712,141 Level 1 Level 2 Level 3 Total December 31, 2023 Assets Money market funds $ 131,635 $ - $ - $ 131,635 U.S. treasuries - 74,237 - 74,237 U.S. government agency securities - 216,688 - 216,688 Corporate debt securities - 308,552 - 308,552 Total assets $ 131,635 $ 599,477 $ - $ 731,112 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. |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 3 Months Ended |
Mar. 31, 2024 | |
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, December 31, March 31, December 31, Cash and cash equivalents $ 132,033 $ 150,279 $ 174,350 $ 202,004 Restricted cash (1) 271 277 210 207 Total cash and cash equivalents, and restricted cash shown $ 132,304 $ 150,556 $ 174,560 $ 202,211 (1) Restricted cash is included in "Other assets" in the Condensed Consolidated Balance Sheets. Restricted cash balances relate to certificates of deposit issued as collateral to certain letters of credit issued as security to our lease arrangements (see Note 5). Cash and cash equivalents, and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated March 31, 2024 Cash and cash equivalents: Cash $ 11,397 $ - $ - $ 11,397 Money market funds 120,106 - - 120,106 Corporate debt securities 530 - - 530 Total cash and cash equivalents 132,033 - - 132,033 Marketable securities available-for-sale: U.S. treasuries 102,575 20 ( 232 ) 102,363 U.S. government agency securities 170,070 158 ( 367 ) 169,861 Corporate debt securities 319,472 70 ( 261 ) 319,281 Total marketable securities available-for-sale 592,117 248 ( 860 ) 591,505 Total cash and cash equivalents, and marketable securities $ 724,150 $ 248 $ ( 860 ) $ 723,538 December 31, 2023 Cash and cash equivalents: Cash $ 11,190 $ - $ - $ 11,190 Money market funds 131,635 - - 131,635 Corporate debt securities 7,453 1 - 7,454 Total cash and cash equivalents 150,278 1 - 150,279 Marketable securities available-for-sale: U.S. treasuries 74,109 172 ( 44 ) 74,237 U.S. government agency securities 216,265 692 ( 269 ) 216,688 Corporate debt securities 300,803 315 ( 20 ) 301,098 Total marketable securities available-for-sale 591,177 1,179 ( 333 ) 592,023 Total cash and cash equivalents, and marketable securities $ 741,455 $ 1,180 $ ( 333 ) $ 742,302 The maturities of our marketable securities available-for-sale are as follows (in thousands): March 31, 2024 Amortized Estimated Mature in one year or less $ 371,571 $ 371,273 Mature after one year through two years 220,546 220,232 $ 592,117 $ 591,505 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. We determine whether a decline in the fair value of our available-for-sale ("AFS") debt securities below their amortized cost basis (i.e., an impairment) is due to credit-related factors or noncredit-related factors. Any impairment that is not credit related is recognized in other comprehensive income (loss), net of applicable taxes. Credit-related impairments (if any) are recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Both the allowance and the adjustment to net income can be reversed if conditions change. There we re no realized gains or losses from the sale of marketable securities during the three months ended March 31, 2024 and 2023. 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, 2024, 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, 2024. As such, there have been no declines in fair value that have been identified as a credit-related impairment. |
Inventories, Net
Inventories, Net | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
Inventories, net | 4. Inventories The following table presents inventories (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 19,660 $ 27,256 Work-in-process 33,969 18,954 Finished goods 8,177 7,080 Total $ 61,806 $ 53,290 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
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. Sublease Termination and New Sublease On February 22, 2024, our third-party subtenant obtained the approval of a voluntary petition for relief under Chapter 11 of the United States Code. As a consequence, the sublease agreement with that third-party for the subleased premises (approximately 75,662 square feet of office/laboratory space located at 5959 Horton Street, Emeryville, California) was terminated effective March 7, 2024. Simultaneously, on March 7, 2024, we entered into a new sublease agreement with a different third-party under similar conditions and for the same premises. Rent from the new sublease agreement is subject to scheduled annual increases, and the subtenant is responsible for certain operating expenses and taxes throughout the life of the sublease. The new 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. As a result of the termination of the existing sublease agreement, we recognized a net loss of approximately $ 3.5 million comprising primarily of a $ 4.8 million write-off of the accrued rent asset balance as of March 7, 2024, partially offset by the collection of a termination payment of $ 1.3 million. Sublease income for the three months ended March 31, 2024 was $ 1.9 million. Sublease income for the three months ended March 31, 2023 was $ 1.6 million. Both the net loss on sublease termination and the sublease income are included net in “Sublease (loss) income” within “other income (expense)” in our condensed consolidated statements of operations. Rent received from the new 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, 2024 2023 Operating lease expense $ 1,416 $ 1,388 Cash paid for amounts included in the measurement of lease liabilities wa s $ 1.9 million and $ 1.7 m illion for the three months ended March 31, 2024 and 2023, respectively, and were included in change in lease liabilities in our condensed consolidated statement of cash flows. The balance sheet classification of our operating lease liabilities was as follows (in thousands): March 31, 2024 December 31, 2023 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 4,557 $ 4,496 Long-term portion of lease liabilities 28,559 29,720 Total operating lease liabilities $ 33,116 $ 34,216 As of March 31, 2024, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2024 (remaining) $ 3,700 $ 5,716 2025 6,127 6,966 2026 6,342 6,107 2027 6,564 6,038 2028 6,794 6,201 Thereafter 16,191 15,021 Total $ 45,718 46,049 Less: Present value adjustment ( 12,933 ) Total $ 33,116 The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liabilities were as follows: March 31, 2024 December 31, 2023 Weighted average remaining lease term 6.5 years 6.7 years Weighted average discount rate 10.1 % 10.1 % Commitments As of March 31, 2024 and December 31, 2023, our material non-cancelable purchase and other commitments for the supply of HEPLISAV-B total ed $ 40.5 million and $ 43.4 million, respectively. On September 7, 2023 (the “Effective Date”), we entered into an agreement (the “Avecia Supply Agreement”) with Nitto Denko Avecia Inc. (“Avecia”) for the manufacture and supply of our CpG 1018 adjuvant using a specific production process. Under the Avecia Supply Agreement, Avecia has agreed to produce and supply to us quantities of CpG 1018 adjuvant ordered by us after the Effective Date. Subject to certain conditions in the Avecia Supply Agreement, we are obligated to purchase all of our annual volume requirements of CpG 1018 adjuvant from Avecia up to a specified production capacity. We may alternatively order CpG 1018 adjuvant produced using a different production process pursuant to the existing supply agreement between us and Avecia dated October 1, 2012 (the “2012 Agreement”). Included in the balance of our material non-cancelable purchase and other commitments for the supply of HEPLISAV-B, as of March 31, 2024 and December 31, 2023, our aggregate minimum commitment for the supply of CpG 1018 adjuvant under the Avecia Supply Agreement totaled $ 7.4 million for each period, anticipated within the next 12 months. In addition to the non-cancelable commitments included above, we have entered into contractual arrangements that obligate us to make payments to the contractual counterparties upon the occurrence of future events. In addition, in the normal course of operations, we have entered into license and other agreements and intend to continue to seek additional rights relating to compounds or technologies in connection with our discovery, manufacturing and development programs. Under the terms of the agreements, we may be required to pay future up-front fees, milestones and royalties on net sales of products originating from the licensed technologies, if any, or other payments contingent upon the occurrence of future events that cannot reasonably be estimated. We also rely on and have entered into agreements with research institutions, contract research organizations and clinical investigators as well as clinical material manufacturers. These agreements are terminable by us upon written notice. Generally, we are liable only for actual effort expended by the organizations at any point in time during the contract through the notice period. As of March 31, 2024, the aggregate principal amount of our convertible senior notes ("Convertible Notes") was $ 225.5 million, excluding debt discount of $ 2.5 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, 2024 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, 2024. In conjunction with our agreement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50 % of the first $ 50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including our immune-oncology compound, SD-101. In July 2020, we sold assets related to SD-101 to Surefire Medical, Inc. d/b/a TriSalus Life Sciences (“TriSalus”). We paid $ 2.5 million to Holdings in August 2020. In each of September 2021, May 2022 and September 2023, we received $ 1.0 million from TriSalus because it met pre-commercialization milestones. We recorded the proceeds as gain on sale of assets in our condensed consolidated statements of operations. We paid Holdings $ 0.5 million in each of September 2021, May 2022 and October 2023. We included the payments in selling, general and administrative expenses in our condensed consolidated statements of operations. No liability has been recorded under this agreement as of March 31, 2024. Contingencies From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, results of operations, or cash flows in a particular period. |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Research and Development [Abstract] | |
Collaboration, Development and Supply Agreements | 6. Collaborative Research, Development and License Agreements Coalition for Epidemic Preparedness Innovations In January 2021, we entered into an agreement (together with subsequent amendments, the “CEPI Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) for the manufacture and reservation of a specified quantity of CpG 1018 adjuvant (“CpG 1018 Materials”). In May 2021, we entered into the first amendment to the CEPI Agreement. The CEPI Agreement enables CEPI to direct the supply of CpG 1018 Materials to CEPI partner(s). CEPI partner(s) would purchase CpG 1018 Materials under separately negotiated agreements. The CEPI Agreement also allows us to sell CpG 1018 Materials to third parties if not purchased by a CEPI partner within a two-year term. In exchange for reserving CpG 1018 Materials and agreeing to sell CpG 1018 Materials to CEPI partner(s) at pre-negotiated prices, CEPI agreed to provide payments in the form of an interest-free, unsecured, forgivable loan (the “Advance Payments”). We are obligated to repay the Advance Payments, in proportion to quantity sold, if and to the extent we receive payments from sales of CpG 1018 Materials reserved under the CEPI Agreement. If the vaccine programs pursued by CEPI partner(s) are unsuccessful and no alternative use is found for CpG 1018 Materials reserved under the CEPI Agreement, the applicable Advance Payments will be forgiven at the end of the two-year term. On April 27, 2023, we entered into a waiver and second amendment to the CEPI Agreement by and between us and CEPI (the “CEPI-Bio E Assignment Agreement”). Pursuant to the CEPI-Bio E Assignment Agreement, CEPI has forgiven the entirety of the outstanding Advance Payments for CpG 1018 Materials allocated to and ordered by Bio E under the CEPI Agreement and has assumed our previous rights to $ 47.4 million of Bio E accounts receivable. Through March 31, 2024, we received Advance Payments totaling approximately $ 175.0 mill ion pursuant to the CEPI Agreement, of which $ 67.3 million have been repaid and $ 47.4 million have been forgiven (as discussed above). As of March 31, 2024, remaining Advance Payments totaling $ 60.3 million in CEPI accrual long-term were reflected in our condensed consolidated balance s heets, representing the outstanding balance of the Advance Payments relating to the Clover Supply Agreement (as defined and discussed below). There were no deferred revenue balances related to the CEPI Agreement as of March 31, 2024 and December 31, 2023. Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited In June 2021, we entered into an agreement with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited (collectively, “Clover”), for the commercial supply of CpG 1018 adjuvant, for use with Clover’s COVID-19 vaccine candidate, SCB-2019 (together with subsequent amendments, the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Clover’s commercialization of vaccines containing SCB-2019 and CpG 1018 adjuvant (“Clover Product”). The Clover Supply Agreement also provides terms for Clover to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. In 2022 and 2023, we signed four amendments to the Clover Supply Agreement. The terms and conditions of the Clover Supply Agreement were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder. For CpG 1018 adjuvant reserved for Clover under the CEPI Agreement, Clover is obligated to pay us the purchase price upon the earliest of (i) the true-up exercise, (ii) within a specified period after Clover delivers Clover Product to a customer, or (iii) Clover’s receipt of payment for Clover Product from a customer. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement, we recognize product revenue and a corresponding contract asset as our right to consideration is contingent on something other than the passage of time, as outlined above. The contract asset of $ 71.3 million relating to Clover was included in other assets (long term) as of March 31, 2024 and December 31, 2023. The contract asset was included in other assets (long term) to reflect the timing of expected long term demand for CpG 1018 adjuvant for Clover Product. Corresponding Advance Payments of $ 60.3 million relating to Clover are recorded in CEPI accrual long-term in our condensed consolidated balance sheets as of March 31, 2024. 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, 2024 and December 31, 2023. Biological E. Limited In July 2021, we entered into an agreement (together with subsequent amendments, the “Bio E Supply Agreement”) with Biological E. Limited (“Bio E”), for the commercial supply of CpG 1018 adjuvant, for use with Bio E’s subunit COVID-19 vaccine candidate, CORBEVAX. Under the Bio E Supply Agreement, Bio E committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Bio E’s commercialization of its CORBEVAX vaccine (“Bio E Product”) with specified delivery dates in 2021 and the first quarter of 2022. The Bio E Supply Agreement also provides terms for Bio E to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. In June 2022 and in October 2022, we entered into amendments to the Bio E Supply Agreement (the “Bio E Amendment No. 1” and the “Bio E Amendment No. 2,” together the “Bio E Amendments”). The Bio E Amendments primarily established: (i) a new payment schedule for certain outstanding invoices related to the CEPI product to be the earlier of December 31, 2022, or receipt of certain amounts from Bio E from the Government of India in connection with their advance purchase agreement for CORBEVAX, and (ii) further modified the scope of the Bio E Supply Agreement, by reducing certain quantities of CpG 1018 adjuvant to be delivered. The terms and conditions of the Bio E Supply Agreement were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder. As of March 31, 2024, we had no net accounts receivable balance from Bio E. In 2023, we recorded an allowance for doubtful accounts of $ 12.3 million, which was determined by assessing changes in Bio E’s credit risk, contemplation of ongoing negotiations relating to Bio E Amendment No. 3 (defined below), and Bio E's dependence on cash collections from the Government of India, which have been delayed and significantly reduced in connection with the overall reduction in demand for CORBEVAX from the Government of India. On April 26, 2023, we entered into a third amendment to the Bio E Supply Agreement (the “Bio E Amendment No. 3”), and on April 27, 2023, we entered into the CEPI-Bio E Assignment Agreement. Pursuant to the CEPI-Bio E Assignment Agreement, CEPI has forgiven the entirety of remaining amounts outstanding relating to a liability for Advance Payments of $ 47.4 million (the “Bio E CEPI Advance Payments”) for CpG 1018 Materials allocated to Bio E, and has assumed our previous rights to collect $ 47.4 million of Bio E accounts receivable. Pursuant to the Bio E Amendment No. 3, we collected $ 14.5 million from Bio E (including $ 13.5 million in April 2023 and $ 1.0 million in August 2023). Accordingly, as of March 31, 2024, the CEPI-Bio E Assignment Agreement resulted in: (i) no net accounts receivable balance, and (ii) the derecognition of $ 47.4 million CEPI accrual in connection with the Bio E CEPI Advance Payments. The Bio E Amendment No. 3 provides for additional future payment of either $ 5.5 million in the event that Bio E receives at least $ 125.0 million, or $ 12.3 million in the event that Bio E receives at least $ 250.0 million in future payments from the Government of India associated with its CORBEVAX product on or before August 15, 2025. These additional amounts are not considered collectible until the achievement of these future milestones. U.S. Department of Defense In September 2021, we entered into an agreement with the DoD for the development of a recombinant plague vaccine adjuvanted with CpG 1018 adjuvant for approximately $ 22.0 million over two and a half years. Under the agreement, we are conducting a Phase 2 clinical trial combining our CpG 1018 adjuvant with the DoD's rF1V vaccine. In July 2023 and March 2024, we executed contract modifications with the DoD to support advancement into a nonhuman primate challenge study and a Chemistry, Manufacturing and Control ("CMC") Gap analysis, with the agreement now totaling $ 38.0 million through 2025. For the three months ended March 31, 2024 and 2023, we recognized revenue o f $ 2.8 million and $ 3.5 million, respectively, which is included in other revenue in our condensed consolidated statements of operations. |
Convertible Notes
Convertible Notes | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Convertible Notes | 7. Convertible Notes In May 2021, we issued $ 225.5 million of Convertible Notes in a private placement. Total proceeds from the issuance of the Convertible Notes, net of debt issuance and offering costs of $ 5.7 million, were $ 219.8 million. We used $ 190.2 million of the net proceeds to retire our previous loan agreement with CRG Servicing LLC and $ 27.2 million of the net proceeds to pay the costs of the Capped Calls described below. The Convertible Notes are general unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021. The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased prior to such date. The Convertible Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, at an initial conversion rate of 95.5338 shares of our common stock per $ 1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $ 10.47 per share of our common stock. The Convertible Notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding February 15, 2026, only under the following circumstances: • During any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price on each applicable trading day; • During the five business day period after any ten consecutive trading day period (the “measurement period”), in which the “trading price” (as defined 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, 2024. 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, 2024, the Convertible Notes were recorded at the aggregate principal amount of $ 225.5 million less unamortized issuance costs of $ 2.5 million as a long-term liability on the condensed consolidated balance sheets. As of March 31, 2024, the fair value of the Convertible Notes was $ 300.6 mil lion. 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, 2024 2023 Stated coupon interest $ 1,409 $ 1,409 Amortization of debt issuance cost 286 277 Total interest expense $ 1,695 $ 1,686 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. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 March 31, 2023 U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 46,699 $ 1,146 $ 47,845 $ 43,451 $ - $ 43,451 Total product revenue, net $ 46,699 $ 1,146 $ 47,845 $ 43,451 $ - $ 43,451 Other revenue 2,802 143 2,945 3,474 - 3,474 Total revenues $ 49,501 $ 1,289 $ 50,790 $ 46,925 $ - $ 46,925 Revenues from Major Customers and Collaboration Partners All of our HEPLISAV-B sales in the U.S. are to certain wholesalers and specialty distributors whose principal customers include independent hospitals and clinics, integrated delivery networks, public health clinics and prisons, the Department of Defense, the Department of Veterans Affairs and retail pharmacies. All of our HEPLISAV-B sales in Germany are to one distributor. The following table summarizes HEPLISAV-B product revenue from each of our three largest customers (as a percentage of total HEPLISAV-B net product revenue): Three Months Ended March 31, 2024 2023 Largest customer 27 % 27 % Second largest customer 19 % 22 % Third largest customer 18 % 17 % 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, 2024 (in thousands): Balance at Provisions Credit or Adjustments related to prior periods Balance Three months ended March 31, 2024: Accounts receivable reserves (1) $ 7,011 $ 13,375 $ ( 13,622 ) $ - $ 6,764 Revenue reserve accruals (2) $ 21,004 $ 10,968 $ ( 9,698 ) $ - $ 22,274 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. When we perform services under our agreement with the DoD, we recognize product revenue and a corresponding contract asset as our right to consideration is conditioned on something other than the passage of time. See Note 6 for further discussion. The following table summarizes balances and activities in our contract asset account (in thousands): Balance at Additions Subtractions Balance Three months ended March 31, 2024 Contract asset, included in other current assets (1) $ 1,389 $ 2,802 $ ( 2,017 ) $ 2,174 Contract asset, included in other assets (long term) (2) $ 71,307 $ - $ - $ 71,307 (1) The $2.2 million of contract asset is derived from our agreement with the DoD. (2) The Clover contract asset was included in 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. |
Net Income Per Share
Net Income Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Income Per Share | 9. Net Loss Per Share Basic net loss per share is computed by dividing net loss 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 and diluted net income per share computations for our common stock are calculated as follows (in thousands): Three Months Ended March 31, 2024 2023 Numerator Net loss attributable to common stockholders, basic and diluted $ ( 8,721 ) $ ( 24,332 ) Denominator Weighted average common stock outstanding, basic and diluted 130,200 127,921 Net loss per share attributable to common stockholders Basic $ ( 0.07 ) $ ( 0.19 ) Diluted $ ( 0.07 ) $ ( 0.19 ) The following were excluded from the calculation of diluted net loss per share as the effect of their inclusion would have been anti-dilutive (in thousands). Three months ended March 31, 2024 2023 Outstanding securities not included in diluted net loss per share calculation: Stock options and stock awards 18,161 15,622 Convertible Notes (as converted to common stock) 21,543 21,543 Total 39,704 37,165 |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2024 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock | 10. Common Stock Common Stock Outstanding As of March 31, 2024, there wer e 130,859,129 sh ares of our common stock outstanding. We entered into an at-the-market Sales Agreement with Cowen and Company, LLC (“Cowen”) on August 6, 2020 and an amendment to such agreement on August 3, 2023 (the sales agreement as amended, the “ATM Agreement”). Under the ATM Agreement, we may offer and sell from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $ 120.0 million through Cowen as our sales agent. We agreed to pay Cowen a commission of up to 3 % of the gross sales proceeds of any common stock sold through Cowen under the ATM Agreement. As of March 31, 2024, w e ha d $ 120.0 million rema ining under the ATM Agreement. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement, Noncash Expense [Abstract] | |
Equity Plans and Stock-Based Compensation | 11. Equity Plans and Stock-Based Compensation Equity Plans In January 2021, we adopted the Dynavax Technologies Corporation 2021 Inducement Award Plan (“2021 Inducement Plan”), pursuant to which we reserved 1,500,000 shares of common stock for issuance under the plan to be used exclusively for grants of awards to individuals who were not previously our employees or directors. In June 2021, we amended the 2021 Inducement Plan (“Amended 2021 Inducement Plan”) to increase the number of shares of common stock reserved under the 2021 Inducement Plan to 3,250,000 . The Amended 2021 Inducement Plan was terminated effective as of April 3, 2022 and, therefore, there are no shares of our common stock available for grant. In May 2022, our stockholders approved the amendment and restatement of our 2018 Equity Incentive Plan (the “Amended 2018 EIP”) to, among other things, increase the authorized number of shares of common stock by 15,000,000 . The maximum number of shares of common stock that may be issued under the Amended 2018 EIP, will not exceed 32,600,000 shares of common stock. As of March 31, 2024, the Amended 2018 EIP and the Amended and Restated 2014 Employee Stock Purchase Plan are our active plans (the "Plans"). Th e 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, 2024, there were 3,035,397 shares o f common stock reserved for issuance under the Amended 2018 EIP. Under our Amended 2018 EIP , we may grant stock options, restricted stock units ("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 Plans is set forth below: Stock Options The following table summarizes the activity of stock options for the three months ended March 31, 2024 : Shares Weighted- Weighted- Aggregate Balance as of December 31, 2023 10,120 $ 10.78 4.18 $ 37,388 Options granted 1,505 12.46 Options exercised ( 240 ) 6.82 Options cancelled: Options forfeited (unvested) ( 2 ) 9.52 Options expired (vested) ( 89 ) 15.46 Balance as of March 31, 2024 11,294 $ 11.05 4.39 $ 23,032 Vested and expected to vest as of March 31, 2024 11,050 $ 11.03 4.35 $ 22,954 Exercisable as of March 31, 2024 7,653 $ 10.56 3.59 $ 20,912 Restricted Stock Units The following table summarizes the activity of RSUs for the three months ended March 31, 2024 : Number of Shares Weighted-Average Non-vested as of December 31, 2023 4,445 $ 11.57 Granted 2,962 12.49 Vested (1) ( 1,637 ) 11.11 Forfeited ( 54 ) 12.91 Non-vested as of March 31, 2024 5,716 $ 12.16 (1) Inclusive of approximately 642,344 RSUs for the three months ended March 31, 2024, 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. Market-based Performance Stock Units 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, 2024 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2023 557 $ 15.95 Granted 558 17.23 Non-vested as of March 31, 2024 1,115 $ 16.59 Performance-based Options As of March 31, 2024, approximately 36,000 s hares underlying performance-based options were outstanding. Significant Assumptions in Estimating Option Fair Value T he fair value of each time-based option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows : Stock Options Market-Based Performance Stock Units Three Months Ended Three Months Ended March 31, March 31, 2024 2023 2024 2023 Weighted-average fair value per share $ 7.88 $ 7.28 $ 17.23 $ 18.25 Risk-free interest rate 4.2 % 4.0 % 4.3 % 4.3 % Expected life (in years) 4.5 4.5 2.9 2.9 Volatility 0.8 0.8 0.6 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. 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 (in thousands ): Three Months Ended March 31, 2024 2023 Research and development $ 2,665 $ 2,112 Selling, general and administrative 8,920 6,830 Cost of sales - product 559 695 Inventories 870 397 Total $ 13,014 $ 10,034 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 and 2023, we recorded an income tax benefit of $ 2.8 million and an income tax provision of $ 0.6 million, respectively. Our effective tax rate was approximately 24.2 % and ( 2.6 )% for the three months ended March 31, 2024 and 2023, respectively. For the three months ended March 31, 2024, the primar y difference between the effective tax rate and the federal statutory rate is driven by state and foreign tax expense. For the three months ended March 31, 2023, 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, 2024, 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. |
Organization (Policies)
Organization (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 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, 2023 , 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; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; 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 November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-09. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 Assets Money market funds $ 120,106 $ - $ - $ 120,106 U.S. treasuries - 102,363 - 102,363 U.S. government agency securities - 169,861 - 169,861 Corporate debt securities - 319,811 - 319,811 Total assets $ 120,106 $ 592,035 $ - $ 712,141 Level 1 Level 2 Level 3 Total December 31, 2023 Assets Money market funds $ 131,635 $ - $ - $ 131,635 U.S. treasuries - 74,237 - 74,237 U.S. government agency securities - 216,688 - 216,688 Corporate debt securities - 308,552 - 308,552 Total assets $ 131,635 $ 599,477 $ - $ 731,112 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Cash, Cash Equivalents, and Short-Term Investments [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash and cash equivalents, and restricted cash reported within the 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, December 31, March 31, December 31, Cash and cash equivalents $ 132,033 $ 150,279 $ 174,350 $ 202,004 Restricted cash (1) 271 277 210 207 Total cash and cash equivalents, and restricted cash shown $ 132,304 $ 150,556 $ 174,560 $ 202,211 (1) Restricted cash is included in "Other assets" in the Condensed Consolidated Balance Sheets. |
Summary of Cash, Cash Equivalents and Marketable Securities | Cash and cash equivalents, and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated March 31, 2024 Cash and cash equivalents: Cash $ 11,397 $ - $ - $ 11,397 Money market funds 120,106 - - 120,106 Corporate debt securities 530 - - 530 Total cash and cash equivalents 132,033 - - 132,033 Marketable securities available-for-sale: U.S. treasuries 102,575 20 ( 232 ) 102,363 U.S. government agency securities 170,070 158 ( 367 ) 169,861 Corporate debt securities 319,472 70 ( 261 ) 319,281 Total marketable securities available-for-sale 592,117 248 ( 860 ) 591,505 Total cash and cash equivalents, and marketable securities $ 724,150 $ 248 $ ( 860 ) $ 723,538 December 31, 2023 Cash and cash equivalents: Cash $ 11,190 $ - $ - $ 11,190 Money market funds 131,635 - - 131,635 Corporate debt securities 7,453 1 - 7,454 Total cash and cash equivalents 150,278 1 - 150,279 Marketable securities available-for-sale: U.S. treasuries 74,109 172 ( 44 ) 74,237 U.S. government agency securities 216,265 692 ( 269 ) 216,688 Corporate debt securities 300,803 315 ( 20 ) 301,098 Total marketable securities available-for-sale 591,177 1,179 ( 333 ) 592,023 Total cash and cash equivalents, and marketable securities $ 741,455 $ 1,180 $ ( 333 ) $ 742,302 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): March 31, 2024 Amortized Estimated Mature in one year or less $ 371,571 $ 371,273 Mature after one year through two years 220,546 220,232 $ 592,117 $ 591,505 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table presents inventories (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 19,660 $ 27,256 Work-in-process 33,969 18,954 Finished goods 8,177 7,080 Total $ 61,806 $ 53,290 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Expense | Our lease expense comprises of the following (in thousands): Three Months Ended March 31, 2024 2023 Operating lease expense $ 1,416 $ 1,388 |
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, 2024 December 31, 2023 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 4,557 $ 4,496 Long-term portion of lease liabilities 28,559 29,720 Total operating lease liabilities $ 33,116 $ 34,216 |
Summary of Maturities of Sublease Income and Operating Lease Liabilities | As of March 31, 2024, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2024 (remaining) $ 3,700 $ 5,716 2025 6,127 6,966 2026 6,342 6,107 2027 6,564 6,038 2028 6,794 6,201 Thereafter 16,191 15,021 Total $ 45,718 46,049 Less: Present value adjustment ( 12,933 ) Total $ 33,116 |
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, 2024 December 31, 2023 Weighted average remaining lease term 6.5 years 6.7 years Weighted average discount rate 10.1 % 10.1 % |
Convertible Notes (Tables)
Convertible Notes (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 2023 Stated coupon interest $ 1,409 $ 1,409 Amortization of debt issuance cost 286 277 Total interest expense $ 1,695 $ 1,686 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 March 31, 2023 U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 46,699 $ 1,146 $ 47,845 $ 43,451 $ - $ 43,451 Total product revenue, net $ 46,699 $ 1,146 $ 47,845 $ 43,451 $ - $ 43,451 Other revenue 2,802 143 2,945 3,474 - 3,474 Total revenues $ 49,501 $ 1,289 $ 50,790 $ 46,925 $ - $ 46,925 |
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, 2024 2023 Largest customer 27 % 27 % Second largest customer 19 % 22 % Third largest customer 18 % 17 % |
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, 2024 (in thousands): Balance at Provisions Credit or Adjustments related to prior periods Balance Three months ended March 31, 2024: Accounts receivable reserves (1) $ 7,011 $ 13,375 $ ( 13,622 ) $ - $ 6,764 Revenue reserve accruals (2) $ 21,004 $ 10,968 $ ( 9,698 ) $ - $ 22,274 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. |
CpG 1018 adjuvant | |
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 Additions Subtractions Balance Three months ended March 31, 2024 Contract asset, included in other current assets (1) $ 1,389 $ 2,802 $ ( 2,017 ) $ 2,174 Contract asset, included in other assets (long term) (2) $ 71,307 $ - $ - $ 71,307 (1) The $2.2 million of contract asset is derived from our agreement with the DoD. (2) The Clover contract asset was included in 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. |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Income Per Share | The numerators and denominators of the basic net loss and diluted net income per share computations for our common stock are calculated as follows (in thousands): Three Months Ended March 31, 2024 2023 Numerator Net loss attributable to common stockholders, basic and diluted $ ( 8,721 ) $ ( 24,332 ) Denominator Weighted average common stock outstanding, basic and diluted 130,200 127,921 Net loss per share attributable to common stockholders Basic $ ( 0.07 ) $ ( 0.19 ) Diluted $ ( 0.07 ) $ ( 0.19 ) |
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 per share as the effect of their inclusion would have been anti-dilutive (in thousands). Three months ended March 31, 2024 2023 Outstanding securities not included in diluted net loss per share calculation: Stock options and stock awards 18,161 15,622 Convertible Notes (as converted to common stock) 21,543 21,543 Total 39,704 37,165 |
Equity Plans and Stock-Based _2
Equity Plans and Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 : Shares Weighted- Weighted- Aggregate Balance as of December 31, 2023 10,120 $ 10.78 4.18 $ 37,388 Options granted 1,505 12.46 Options exercised ( 240 ) 6.82 Options cancelled: Options forfeited (unvested) ( 2 ) 9.52 Options expired (vested) ( 89 ) 15.46 Balance as of March 31, 2024 11,294 $ 11.05 4.39 $ 23,032 Vested and expected to vest as of March 31, 2024 11,050 $ 11.03 4.35 $ 22,954 Exercisable as of March 31, 2024 7,653 $ 10.56 3.59 $ 20,912 |
Summary of Restricted Stock Units Activity | The following table summarizes the activity of RSUs for the three months ended March 31, 2024 : Number of Shares Weighted-Average Non-vested as of December 31, 2023 4,445 $ 11.57 Granted 2,962 12.49 Vested (1) ( 1,637 ) 11.11 Forfeited ( 54 ) 12.91 Non-vested as of March 31, 2024 5,716 $ 12.16 |
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, 2024 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2023 557 $ 15.95 Granted 558 17.23 Non-vested as of March 31, 2024 1,115 $ 16.59 |
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 Three Months Ended Three Months Ended March 31, March 31, 2024 2023 2024 2023 Weighted-average fair value per share $ 7.88 $ 7.28 $ 17.23 $ 18.25 Risk-free interest rate 4.2 % 4.0 % 4.3 % 4.3 % Expected life (in years) 4.5 4.5 2.9 2.9 Volatility 0.8 0.8 0.6 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 (in thousands ): Three Months Ended March 31, 2024 2023 Research and development $ 2,665 $ 2,112 Selling, general and administrative 8,920 6,830 Cost of sales - product 559 695 Inventories 870 397 Total $ 13,014 $ 10,034 |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jul. 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Long-term debt, net of debt discount | $ 2,516 | $ 2,802 | |
Increase in revenue adjustment | $ 38,000 | ||
2.50% Convertible Senior Notes Due 2026 | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Long-term debt, net of debt discount | $ 2,500 | ||
HEPLISAV-B | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Minimum age approved for vaccine prevention of infection caused | 18 years |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) $ in Millions | Mar. 31, 2024 USD ($) |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value of the convertible notes | $ 300.6 |
Fair Value Hierarchy for Financ
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, 2024 | Dec. 31, 2023 |
Assets | ||
Total assets | $ 712,141 | $ 731,112 |
Money Market Funds | ||
Assets | ||
Total assets | 120,106 | 131,635 |
U.S. Treasuries | ||
Assets | ||
Total assets | 102,363 | 74,237 |
U.S. Government Agency Securities | ||
Assets | ||
Total assets | 169,861 | 216,688 |
Corporate Debt Securities | ||
Assets | ||
Total assets | 319,811 | 308,552 |
Fair Value, Inputs, Level 1 | ||
Assets | ||
Total assets | 120,106 | 131,635 |
Fair Value, Inputs, Level 1 | Money Market Funds | ||
Assets | ||
Total assets | 120,106 | 131,635 |
Fair Value, Inputs, Level 1 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | Corporate Debt Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 | ||
Assets | ||
Total assets | 592,035 | 599,477 |
Fair Value, Inputs, Level 2 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 | U.S. Treasuries | ||
Assets | ||
Total assets | 102,363 | 74,237 |
Fair Value, Inputs, Level 2 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 169,861 | 216,688 |
Fair Value, Inputs, Level 2 | Corporate Debt Securities | ||
Assets | ||
Total assets | 319,811 | 308,552 |
Fair Value, Inputs, Level 3 | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate Debt Securities | ||
Assets | ||
Total assets | $ 0 | $ 0 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract] | |||||
Cash and cash equivalents | $ 132,033 | $ 150,279 | $ 174,350 | $ 202,004 | |
Restricted cash | [1] | 271 | 277 | 210 | 207 |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ 132,304 | $ 150,556 | $ 174,560 | $ 202,211 | |
[1] Restricted cash is included in "Other assets" in the Condensed Consolidated Balance Sheets. |
Cash, Cash Equivalents, Restr_4
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 132,033 | $ 150,278 |
Unrealized Gains | 0 | 1 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 132,033 | 150,279 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 592,117 | 591,177 |
Unrealized Gains | 248 | 1,179 |
Unrealized Losses | (860) | (333) |
Estimated Fair Value | 591,505 | 592,023 |
Marketable Securities Available-for-Sale | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 724,150 | 741,455 |
Unrealized Gains | 248 | 1,180 |
Unrealized Losses | (860) | (333) |
Estimated Fair Value | 723,538 | 742,302 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 11,397 | 11,190 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 11,397 | 11,190 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 120,106 | 131,635 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 120,106 | 131,635 |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 102,575 | 74,109 |
Unrealized Gains | 20 | 172 |
Unrealized Losses | (232) | (44) |
Estimated Fair Value | 102,363 | 74,237 |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 170,070 | 216,265 |
Unrealized Gains | 158 | 692 |
Unrealized Losses | (367) | (269) |
Estimated Fair Value | 169,861 | 216,688 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 530 | 7,453 |
Unrealized Gains | 0 | 1 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 530 | 7,454 |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 319,472 | 300,803 |
Unrealized Gains | 70 | 315 |
Unrealized Losses | (261) | (20) |
Estimated Fair Value | $ 319,281 | $ 301,098 |
Cash, Cash Equivalents, Restr_5
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Mar. 31, 2024 USD ($) |
Amortized Cost | |
Mature in one year or less | $ 371,571 |
Mature after one year through two years | 220,546 |
Total amortized cost | 592,117 |
Estimated Fair Value | |
Mature in one year or less | 371,273 |
Mature after one year through two years | 220,232 |
Total estimated fair value | $ 591,505 |
Cash, Cash Equivalents, Restr_6
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | ||
Gross realized losses on investmnents | $ 0 | $ 0 |
Inventories, Net - Summary of I
Inventories, Net - Summary of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 19,660 | $ 27,256 |
Work-in-process | 33,969 | 18,954 |
Finished goods | 8,177 | 7,080 |
Total | $ 61,806 | $ 53,290 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | |||||||||||
Mar. 07, 2024 USD ($) | Oct. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) | May 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Aug. 31, 2020 USD ($) | Nov. 30, 2009 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2024 EUR (€) | Feb. 22, 2024 ft² | Dec. 31, 2023 USD ($) | May 31, 2021 USD ($) | |
Loss Contingencies [Line Items] | |||||||||||||
Lease area | ft² | 75,662 | ||||||||||||
Termination of sublease agreement | $ 3,500 | ||||||||||||
Write-off of accrued balance | 4,800 | ||||||||||||
Collection of termination payment | $ 1,300 | ||||||||||||
Sublease (expense) income (Note 5) | $ 1,900 | $ 1,600 | |||||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | 1,900 | 1,700 | |||||||||||
Long-term debt, net of debt discount | 2,516 | $ 2,802 | |||||||||||
Selling, general and administrative | 44,065 | $ 36,543 | |||||||||||
Aggregate minimum commitment | $ 7,400 | 7,400 | |||||||||||
Description of Avecia Supply Agreement | On September 7, 2023 (the “Effective Date”), we entered into an agreement (the “Avecia Supply Agreement”) with Nitto Denko Avecia Inc. (“Avecia”) for the manufacture and supply of our CpG 1018 adjuvant using a specific production process. Under the Avecia Supply Agreement, Avecia has agreed to produce and supply to us quantities of CpG 1018 adjuvant ordered by us after the Effective Date. Subject to certain conditions in the Avecia Supply Agreement, we are obligated to purchase all of our annual volume requirements of CpG 1018 adjuvant from Avecia up to a specified production capacity. We may alternatively order CpG 1018 adjuvant produced using a different production process pursuant to the existing supply agreement between us and Avecia dated October 1, 2012 (the “2012 Agreement”). Included in the balance of our material non-cancelable purchase and other commitments for the supply of HEPLISAV-B, as of March 31, 2024 and December 31, 2023, our aggregate minimum commitment for the supply of CpG 1018 adjuvant under the Avecia Supply Agreement totaled $7.4 million for each period, anticipated within the next 12 months. | ||||||||||||
Liabilities, Current | $ 56,002 | 62,195 | |||||||||||
HEPLISAV-B | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Purchase Obligation, Total | 40,500 | 43,400 | |||||||||||
Non-cancelable purchase and other commitments | 40,500 | $ 43,400 | |||||||||||
Symphony Dynamo Holdings LLC | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
License arrangement contingent consideration percentage | 50% | ||||||||||||
License Arrangement Contingent Payment To Acquire License | $ 50,000 | ||||||||||||
License arrangement upfront payment | $ 50,000 | ||||||||||||
TriSalus | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Payment to holdings | $ 2,500 | ||||||||||||
Payment received for Pre-commercialization milestone | $ 1,000 | $ 1,000 | $ 1,000 | ||||||||||
TriSalus | Asset Purchase Agreement | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Payment made for Pre-commercialization milestone | $ 500 | $ 500 | $ 500 | ||||||||||
Deutsche Bank Securities | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Financial Instruments, Owned, at Fair Value | € | € 0.2 | ||||||||||||
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 | $ 225,500 | |||||||||||
Long-term debt, net of debt discount | $ 2,500 | ||||||||||||
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 | 12 years | |||||||||||
Minimum [Member] | Emeryville, California (Premises) | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
lease term | 3 years | 3 years |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease expense | $ 1,416 | $ 1,388 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Current portion of lease liabilities (included in other current liabilities) | $ 4,557 | $ 4,496 |
Long-term portion of lease liabilities | 28,559 | 29,720 |
Total operating lease liabilities | $ 33,116 | $ 34,216 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Sublease Income | ||
2024 (remaining) | $ 3,700 | |
2025 | 6,127 | |
2026 | 6,342 | |
2027 | 6,564 | |
2028 | 6,794 | |
Thereafter | 16,191 | |
Total | 45,718 | |
Operating Lease Liabilities | ||
2024 (remaining) | 5,716 | |
2025 | 6,966 | |
2026 | 6,107 | |
2027 | 6,038 | |
2028 | 6,201 | |
Thereafter | 15,021 | |
Total | 46,049 | |
Present value adjustment | (12,933) | |
Total | $ 33,116 | $ 34,216 |
Commitments and Contingencies_5
Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail) | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 6 years 6 months | 6 years 8 months 12 days |
Weighted average discount rate | 10.10% | 10.10% |
Collaboration, Development and
Collaboration, Development and Supply Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||
Apr. 26, 2023 | Apr. 30, 2023 | Sep. 30, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Aug. 31, 2023 | Apr. 27, 2023 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Allowance for doubtful accounts receivables | $ 12,313 | $ 12,313 | ||||||
Repayment of Advance from Customer | $ 47,400 | |||||||
Account Receivable | 1,993 | 3,926 | ||||||
Revenue recognized | 50,790 | $ 46,925 | ||||||
Accrued liabilities | 45,841 | $ 49,448 | ||||||
Inventory write-off | 1,264 | 0 | ||||||
Prepayment of advance payment | $ 13,500 | |||||||
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 | |||||||
Deferred Revenue, Noncurrent, Total | 0 | |||||||
Accrual Long Term Balance | 60,300 | |||||||
Accrued liabilities | 47,400 | |||||||
Clover | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Accrual Long Term Balance | 60,300 | |||||||
Clover | Supply Agreement | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Contract asset balance | 71,300 | |||||||
Biological E. Limited | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Additional future payment | $ 5,500 | $ 12,300 | ||||||
Repayment of Advance from Customer | 47,400 | 47,400 | ||||||
Accounts Receivable Net Current | 1,000 | |||||||
Advance payment received | 125,000 | $ 250,000 | ||||||
Prepayment of advance payment | $ 14,500 | |||||||
U.S. Department of Defense | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Revenue recognized | $ 2,800 | $ 3,500 | ||||||
Proceeds from grant | $ 22,000 | |||||||
CEPI Member | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Accounts Receivable Net Current | $ 47,400 |
Convertible Notes - Additional
Convertible Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended |
May 31, 2021 USD ($) | Mar. 31, 2024 USD ($) Days $ / shares shares | |
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold trading days | Days | 20 | |
Fair value of the convertible notes | $ 300,600 | |
2.50% Convertible Senior Notes Due 2026 | ||
Debt Instrument [Line Items] | ||
Aggregate principal amount | $ 225,500 | 225,500 |
Debt issuance and offering costs | 5,700 | $ 2,500 |
Proceeds from issuance of Convertible Notes, net | 219,800 | |
Debt instrument, interest rate terms | The Convertible Notes are general unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021. | |
Debt maturity date | May 15, 2026 | |
Initial conversion rate | 95.5338 | |
Debt conversion, original debt, principal amount converted | $ 1,000 | |
Debt instrument, conversion price per share | $ / shares | $ 10.47 | |
Debt Instrument, redemption, description | We may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation described in the indenture governing the Convertible Notes), at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. | |
Debt instrument interest rate, effective percentage | 3.10% | |
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | ||
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold consecutive trading days | Days | 30 | |
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | Maximum | ||
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | |
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period Two | ||
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold trading days | Days | 5 | |
Debt instrument, convertible, threshold consecutive trading days | Days | 10 | |
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period Two | Maximum | ||
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold percentage of stock price trigger | 98% | |
Loan Agreement | ||
Debt Instrument [Line Items] | ||
Repayments of debt | 190,200 | |
Capped Calls | ||
Debt Instrument [Line Items] | ||
Net Proceeds to Pay the Costs | $ 27,200 | $ 27,200 |
Number of shares converted | shares | 21,542,871 | |
Initial strike price | $ / shares | $ 10.47 | |
Initial cap price | $ / shares | $ 15.8 | |
Reduction to additional paid-in capital, capped calls cost | $ 27,200 |
Convertible Notes - Summary of
Convertible Notes - Summary of Interest Expenses Related to Convertible Notes (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Debt Disclosure [Abstract] | ||
Stated coupon interest | $ 1,409 | $ 1,409 |
Amortization of debt issuance cost | 286 | 277 |
Total interest expense | $ 1,695 | $ 1,686 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Disaggregation of Revenues (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 50,790 | $ 46,925 |
UNITED STATES | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 49,501 | 46,925 |
Non-US | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 1,289 | 0 |
HEPLISAV-B | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 47,845 | 43,451 |
HEPLISAV-B | UNITED STATES | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 46,699 | 43,451 |
HEPLISAV-B | Non-US | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 1,146 | 0 |
Product | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 47,845 | 43,451 |
Product | UNITED STATES | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 46,699 | 43,451 |
Product | Non-US | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 1,146 | 0 |
Other Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 2,945 | 3,474 |
Other Revenue | UNITED STATES | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 2,802 | 3,474 |
Other Revenue | Non-US | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 143 | $ 0 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Revenues from Major Customers (Detail) - HEPLISAV-B - Product Concentration Risk [Member] - Revenue Benchmark [Member] | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Largest Customer | ||
Concentration Risk [Line Items] | ||
Percentage of product revenue | 27% | 27% |
Second Largest Customer | ||
Concentration Risk [Line Items] | ||
Percentage of product revenue | 19% | 22% |
Third Largest Customer | ||
Concentration Risk [Line Items] | ||
Percentage of product revenue | 18% | 17% |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 USD ($) | ||
Accounts receivable reserves | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | $ 7,011 | [1] |
Provisions related to current period sales | 13,375 | [1] |
Credit or payments made during the period | (13,622) | [1] |
Adjustments related to prior periods | 0 | [1] |
Balance at End of Period | 6,764 | [1] |
Revenue Reserve Accruals [Member] | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | 21,004 | [2] |
Provisions related to current period sales | 10,968 | [2] |
Credit or payments made during the period | (9,698) | [2] |
Adjustments related to prior periods | 0 | [2] |
Balance at End of Period | $ 22,274 | [2] |
[1] Reserves are for chargebacks, discounts and other fees. Accruals are for returns, rebates and other fees. |
Revenue Recognition - Summary_3
Revenue Recognition - Summary of balances and activities in our contract asset account (Details) - CpG 1018 adjuvant $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 USD ($) | ||
Balance at Beginning of Period | $ 71,307 | [1] |
Balance at Beginning of Period | 1,389 | [2] |
Additions | 2,802 | [2] |
Subtractions | (2,017) | [2] |
Balance at End of Period | 2,174 | [2] |
Balance at End of Period | $ 71,307 | [1] |
[1] The Clover contract asset was included in 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. The $2.2 million of contract asset is derived from our agreement with the DoD. |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net (Loss) Income Per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract] | ||
Net (loss) income attributable to common stockholders, basic | $ (8,721) | $ (24,332) |
Net (loss) income attributable to common stockholders, diluted | $ (8,721) | $ (24,332) |
Weighted average common stock outstanding, basic | 130,200 | 127,921 |
Weighted average common stock outstanding, diluted | 130,200 | 127,921 |
Net loss per share attributable to common stockholders, Basic | $ (0.07) | $ (0.19) |
Net loss per share attributable to common stockholders, Diluted | $ (0.07) | $ (0.19) |
Net Loss Per Share - Outstandin
Net Loss Per Share - Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Outstanding securities not included in diluted net income (loss) per share calculation: | ||
Outstanding securities not included in diluted net loss per share calculation | 39,704 | 37,165 |
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 | 18,161 | 15,622 |
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 | 21,543 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||
Aug. 06, 2020 | Mar. 31, 2024 | Dec. 31, 2023 | |
Class Of Stock [Line Items] | |||
Common stock, shares outstanding | 130,859,129 | 129,530,000 | |
Common stock, par value | $ 0.001 | $ 0.001 | |
Preferred stock, par value | $ 0.001 | $ 0.001 | |
Preferred stock, shares outstanding | 0 | 0 | |
2017 ATM Agreement | |||
Class Of Stock [Line Items] | |||
Remaining proceeds from common stock, under sales agreement | $ 120 | ||
Maximum | |||
Class Of Stock [Line Items] | |||
Common stock sales agreement aggregate sales proceeds | $ 120 | ||
Maximum | 2017 ATM Agreement | |||
Class Of Stock [Line Items] | |||
Commission on gross sales proceeds of common stock | 3% |
Equity Plans and Stock-Based _3
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - shares | 3 Months Ended | ||||
Mar. 31, 2024 | Dec. 31, 2023 | 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 | 5,716,000 | 4,445,000 | |||
Performance Based Restricted Stock Units [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Restricted stock units awards outstanding | 1,115,000 | 557,000 | |||
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 | 3,035,397 | 3,250,000 | 1,500,000 | ||
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 |
Equity Plans and Stock-Based _4
Equity Plans and Stock-Based Compensation - Option Activity under Stock-Based Compensation Plans (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Shares Underlying Outstanding Options | ||
Beginning balance | 10,120 | |
Options granted | 1,505 | |
Options exercised | (240) | |
Options forfeited (unvested) | (2) | |
Options expired (vested) | (89) | |
Ending balance | 11,294 | 10,120 |
Vested and expected to vest as of March 31, 2024 | 11,050 | |
Exercisable as of March 31, 2024 | 7,653 | |
Weighted-Average Exercise Price Per Share | ||
Beginning balance | $ 10.78 | |
Options granted | 12.46 | |
Options exercised | 6.82 | |
Options forfeited (unvested) | 9.52 | |
Options expired (vested) | 15.46 | |
Ending balance | 11.05 | $ 10.78 |
Vested and expected to vest as of March 31, 2024 | 11.03 | |
Exercisable as of March 31, 2024 | $ 10.56 | |
Weighted-Average Remaining Contractual Term (years) | ||
Weighted - Average Remaining Contractual Term (years), balance | 4 years 4 months 20 days | 4 years 2 months 4 days |
Vested and expected to vest as of March 31, 2024 | 4 years 4 months 6 days | |
Exercisable as of March 31, 2024 | 3 years 7 months 2 days | |
Aggregate Intrinsic Value | ||
Balance as of December 31, 2023 | $ 37,388 | |
Balance as of March 31, 2024 | 23,032 | $ 37,388 |
Vested and expected to vest as of March 31, 2024 | 22,954 | |
Exercisable as of March 31, 2024 | $ 20,912 |
Equity Plans and Stock-Based _5
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, 2024 $ / shares shares | ||
Number of Shares | ||
Non-vested, Beginning Balance | shares | 4,445 | |
Granted | shares | 2,962 | |
Vested | shares | (1,637) | [1] |
Forfeited | shares | (54) | |
Non-vested, Ending Balance | shares | 5,716 | |
Weighted-Average Grant-Date Fair Value Per Share | ||
Non-vested, Beginning Balance | $ / shares | $ 11.57 | |
Granted | $ / shares | 12.49 | |
Vested | $ / shares | 11.11 | [1] |
Forfeited | $ / shares | 12.91 | |
Non-vested, Ending Balance | $ / shares | $ 12.16 | |
[1] (1) Inclusive of approximately 642,344 RSUs for the three months ended March 31, 2024, which were not converted into shares due to net share settlement in order to cover the required amount of employee withholding taxes. The value of the withheld shares was classified as a reduction to additional paid-in capital. |
Equity Plans and Stock-Based _6
Equity Plans and Stock-Based Compensation -Summary Of Performance Based Restricted Stock Unit (Detail) - Performance Based Restricted Stock Units shares in Thousands | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of Shares | |
Non-vested, Beginning Balance | shares | 557 |
Granted | shares | 558 |
Non-vested, Ending Balance | shares | 1,115 |
Weighted-Average Grant-Date Fair Value Per Share | |
Non-vested, Beginning Balance | $ / shares | $ 15.95 |
Granted | $ / shares | 17.23 |
Non-vested, Ending Balance | $ / shares | $ 16.59 |
Equity Plans and Stock-Based _7
Equity Plans and Stock-Based Compensation - Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Payment Arrangement, Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average fair value per share | $ 7.88 | $ 7.28 |
Risk-free interest rate | 4.20% | 4% |
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 | $ 17.23 | $ 18.25 |
Risk-free interest rate | 4.30% | 4.30% |
Expected life (in years) | 2 years 10 months 24 days | 2 years 10 months 24 days |
Volatility | 0.60% | 0.90% |
Equity Plans and Stock-Based _8
Equity Plans and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | $ 13,014 | $ 10,034 |
Research and Development | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 2,665 | 2,112 |
Selling, General and Administrative | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 8,920 | 6,830 |
Cost of Sales - Product | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 559 | 695 |
Inventory | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | $ 870 | $ 397 |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | ||
Benefit from (provision for) income taxes | $ 2,776 | $ (616) |
Effective Tax Rate | 24.20% | 2.60% |