Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 01, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | DVAX | |
Entity Registrant Name | Dynavax Technologies Corporation | |
Entity Central Index Key | 0001029142 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 126,473,586 | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-34207 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-0728374 | |
Entity Address, Address Line One | 2100 Powell Street | |
Entity Address, Address Line Two | Suite 720 | |
Entity Address, City or Town | Emeryville | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94608 | |
City Area Code | 510 | |
Local Phone Number | 848-5100 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 249,091 | $ 436,189 |
Marketable securities available-for-sale | 269,078 | 109,761 |
Other receivables | 1,972 | 15,600 |
Inventories, net | 73,979 | 61,335 |
Prepaid manufacturing | 54,477 | 159,655 |
Prepaid expenses and other current assets | 134,538 | 73,764 |
Total current assets | 955,405 | 972,520 |
Property and equipment, net | 36,286 | 35,020 |
Operating lease right-of-use assets | 25,785 | 25,964 |
Goodwill | 1,958 | 2,125 |
Restricted cash | 202 | 219 |
Other assets | 3,363 | 3,398 |
Total assets | 1,022,999 | 1,039,246 |
Current liabilities: | ||
Accounts payable | 4,959 | 2,600 |
Accrued research and development | 3,678 | 4,688 |
CEPI accrual (Note 6) | 107,370 | 128,848 |
Accrued liabilities | 34,146 | 49,796 |
Warrant liability | 0 | 18,016 |
Deferred revenue | 191,998 | 349,864 |
Other current liabilities | 3,047 | 2,590 |
Total current liabilities | 345,198 | 556,402 |
Convertible Notes, net of debt discount of $4,470 and $5,010 at June 30, 2022 and December 31, 2021, respectively | 221,030 | 220,490 |
Long-term portion of lease liabilities | 33,677 | 34,316 |
Other long-term liabilities | 295 | 5,664 |
Total liabilities | 600,200 | 816,872 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock: $0.001 par value; 278,000 shares authorized at June 30, 2022 and December 31, 2021; 126,439 shares and 122,945 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 126 | 123 |
Additional paid-in capital | 1,484,970 | 1,441,868 |
Accumulated other comprehensive (loss) gain | (6,560) | (2,266) |
Accumulated deficit | (1,055,737) | (1,217,351) |
Total stockholders’ equity | 422,799 | 222,374 |
Total liabilities and stockholders’ equity | 1,022,999 | 1,039,246 |
Trade Accounts Receivable [Member] | ||
Current assets: | ||
Accounts receivables, net | $ 172,270 | $ 116,216 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Long-term debt, net of debt discount | $ 4,470 | $ 5,010 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 278,000,000 | 278,000,000 |
Common stock, shares issued | 126,439,000 | 122,945,000 |
Common stock, shares outstanding | 126,439,073 | 122,945,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 256,464 | $ 52,767 | $ 370,456 | $ 136,102 |
Operating expenses: | ||||
Cost of sales - product | 83,369 | 14,845 | 123,331 | 39,470 |
Research and development | 9,689 | 7,167 | 20,784 | 14,925 |
Selling, general and administrative | 36,179 | 21,583 | 68,351 | 44,006 |
Gain on sale of assets (Note 5) | (1,000) | 0 | (1,000) | 0 |
Total operating expenses | 128,237 | 43,595 | 211,466 | 98,401 |
Income from operations | 128,227 | 9,172 | 158,990 | 37,701 |
Other income (expense): | ||||
Interest income | 765 | 48 | 1,026 | 95 |
Interest expense | (1,683) | (3,109) | (3,363) | (7,821) |
Sublease income | 2,025 | 1,670 | 3,634 | 3,692 |
Loss on debt extinguishment | 0 | (5,232) | 0 | (5,232) |
Change in fair value of warrant liability (Note 10) | 0 | 2,097 | 1,801 | (23,455) |
Other | 40 | (173) | 145 | 384 |
Net income before income taxes | 129,374 | 4,473 | 162,233 | 5,364 |
Provision for income taxes | (619) | 0 | (619) | 0 |
Net income | $ 128,755 | $ 4,473 | $ 161,614 | $ 5,364 |
Net income per share attributable to common stockholders | ||||
Basic | $ 1.02 | $ 0.04 | $ 1.29 | $ 0.04 |
Diluted | $ 0.87 | $ 0.02 | $ 1.08 | $ 0.04 |
Weighted-average shares used in computing net income per share attributable to common stockholders: | ||||
Basic | 126,347 | 114,629 | 125,456 | 113,339 |
Diluted | 149,905 | 118,830 | 149,821 | 114,978 |
Product | ||||
Revenues: | ||||
Total revenues | $ 255,320 | $ 52,677 | $ 367,647 | $ 135,562 |
Other Revenue | ||||
Revenues: | ||||
Total revenues | $ 1,144 | $ 90 | $ 2,809 | $ 540 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income/(loss) | $ 128,755 | $ 4,473 | $ 161,614 | $ 5,364 |
Other comprehensive income (loss), net of tax: | ||||
Change in unrealized gain (loss) on marketable securities available-for-sale | (629) | 38 | (1,901) | 29 |
Foreign currency translation adjustments | (1,768) | 375 | (2,393) | (1,015) |
Total other comprehensive income (loss) | (2,397) | 413 | (4,294) | (986) |
Total comprehensive income | $ 126,358 | $ 4,886 | $ 157,320 | $ 4,378 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Preferred Stock | Additional Paid-in Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning Balances at Dec. 31, 2020 | $ 58,693 | $ 110 | $ 0 | $ 1,352,374 | $ 273 | $ (1,294,064) |
Beginning Balances (in shares) at Dec. 31, 2020 | 110,190 | 4 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards, net | 1,335 | 1,335 | ||||
Issuance of common upon exercise of stock options and restricted stock awards, net (in shares) | 833 | |||||
Exercise of warrants | 7,928 | $ 1 | 7,927 | |||
Exercise of warrants, shares | 750 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 383 | 383 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 104 | |||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement | 28,156 | $ 3 | 28,153 | |||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement (Shares) | 2,879 | |||||
Purchase of capped call options related to issuance of Convertible Notes | (27,240) | (27,240) | ||||
Stock compensation expense | 9,747 | 9,747 | ||||
Total other comprehensive income (Loss) | (986) | (986) | ||||
Net income | 5,364 | 5,364 | ||||
Ending Balances at Jun. 30, 2021 | 83,380 | $ 114 | $ 0 | 1,372,679 | (713) | (1,288,700) |
Ending Balances (in shares) at Jun. 30, 2021 | 114,756 | 4 | ||||
Beginning Balances at Mar. 31, 2021 | 99,762 | $ 114 | $ 0 | 1,393,947 | (1,126) | (1,293,173) |
Beginning Balances (in shares) at Mar. 31, 2021 | 114,563 | 4 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards, net | 948 | 948 | ||||
Issuance of common upon exercise of stock options and restricted stock awards, net (in shares) | 193 | |||||
Purchase of capped call options related to issuance of Convertible Notes | (27,240) | (27,240) | ||||
Stock compensation expense | 5,024 | 5,024 | ||||
Total other comprehensive income (Loss) | 413 | 413 | ||||
Net income | 4,473 | 4,473 | ||||
Ending Balances at Jun. 30, 2021 | 83,380 | $ 114 | $ 0 | 1,372,679 | (713) | (1,288,700) |
Ending Balances (in shares) at Jun. 30, 2021 | 114,756 | 4 | ||||
Beginning Balances at Dec. 31, 2021 | 222,374 | $ 123 | $ 0 | 1,441,868 | (2,266) | (1,217,351) |
Beginning Balances (in shares) at Dec. 31, 2021 | 122,945 | 0 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards, net | 2,150 | $ 1 | 2,149 | |||
Issuance of common upon exercise of stock options and restricted stock awards, net (in shares) | 1,533 | |||||
Issuance of common stock upon exercise of warrants (Shares) | 1,879 | |||||
Issuance of common stock upon exercise of warrants | 24,670 | $ 2 | 24,668 | |||
Issuance of common stock under Employee Stock Purchase Plan | 710 | 710 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 82 | |||||
Stock compensation expense | 15,575 | 15,575 | ||||
Total other comprehensive income (Loss) | (4,294) | (4,294) | ||||
Net income | 161,614 | 161,614 | ||||
Ending Balances at Jun. 30, 2022 | 422,799 | $ 126 | $ 0 | 1,484,970 | (6,560) | (1,055,737) |
Ending Balances (in shares) at Jun. 30, 2022 | 126,439 | 0 | ||||
Beginning Balances at Mar. 31, 2022 | 287,484 | $ 126 | $ 0 | 1,476,013 | (4,163) | (1,184,492) |
Beginning Balances (in shares) at Mar. 31, 2022 | 126,297 | 0 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards, net | 1,028 | 1,028 | ||||
Issuance of common upon exercise of stock options and restricted stock awards, net (in shares) | 142 | |||||
Stock compensation expense | 7,929 | 7,929 | ||||
Total other comprehensive income (Loss) | (2,397) | (2,397) | ||||
Net income | 128,755 | 128,755 | ||||
Ending Balances at Jun. 30, 2022 | $ 422,799 | $ 126 | $ 0 | $ 1,484,970 | $ (6,560) | $ (1,055,737) |
Ending Balances (in shares) at Jun. 30, 2022 | 126,439 | 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities | ||
Net income | $ 161,614 | $ 5,364 |
Adjustments to reconcile net income to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 2,085 | 2,202 |
Amortization of right-of-use assets and loss on disposal of property and equipment | 1,644 | 1,326 |
(Accretion of discounts) amortization of premium on marketable securities | (498) | 369 |
Loss on debt extinguishment | 0 | 5,232 |
Change in fair value of warrant liability | (1,801) | 23,455 |
Stock compensation expense | 15,575 | 9,747 |
Non-cash interest expense | 540 | 2,806 |
Gain on sale of assets (Note 5) | (1,000) | 0 |
Changes in operating assets and liabilities: | ||
Accounts and other receivables, net | (42,426) | (83,239) |
Inventories, net | (12,644) | (22,762) |
Prepaid manufacturing | 105,178 | (6,875) |
Prepaid expenses and other current assets | (60,774) | (247) |
Other assets | 35 | (265) |
Accounts payable | 2,319 | 7,209 |
CEPI accrual (Note 6) | (21,478) | 0 |
Lease liabilities | (1,678) | (1,554) |
Deferred revenue | (157,866) | 91,345 |
Long Term Deferred Revenue | 0 | 106,950 |
Accrued liabilities and other liabilities | (22,617) | 7,757 |
Net cash provided by (used in) operating activities | (33,792) | 148,820 |
Investing activities | ||
Purchases of marketable securities | (313,660) | (164,928) |
Proceeds from maturities and redemptions of marketable securities | 152,950 | 81,355 |
Purchases of property and equipment, net | (4,271) | (2,812) |
Proceeds from sale of assets, net of transaction costs | 1,000 | |
Net cash used in investing activities | (163,981) | (86,385) |
Financing activities | ||
Proceeds from issuance of common stock, net | 0 | 28,156 |
Proceeds from issuance of Convertible Notes, net | 0 | 219,822 |
Purchases of capped call options | 0 | (27,240) |
Repayment of long-term debt | 0 | (190,194) |
Proceeds from warrants exercises | 8,455 | 3,376 |
Proceeds from exercise of stock options and restricted stock awards, net | 2,150 | 1,335 |
Proceeds from Employee Stock Purchase Plan | 710 | 383 |
Net cash provided by financing activities | 11,315 | 35,638 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (657) | (546) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (187,115) | 97,527 |
Cash, cash equivalents and restricted cash at beginning of period | 436,408 | 32,310 |
Cash, cash equivalents and restricted cash at end of period | 249,293 | 129,837 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for income taxes | 509 | 0 |
Cash paid during the period for interest | 2,819 | 2,053 |
Non-cash investing and financing activities: | ||
Purchases of property and equipment, not yet paid | 1,214 | 2,131 |
Right-of-use assets obtained in exchange of lease liabilities | $ 1,767 | $ 0 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”), is a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines. Our first marketed product, HEPLISAV-B® (Hepatitis B Vaccine (Recombinant), Adjuvanted) is approved in the United States and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. In May 2022, we commenced commercial shipments of HEPLISAV-B in Germany. We also manufacture and sell CpG 1018®, the adjuvant used in HEPLISAV-B, and have established a portfolio of global commercial supply agreements in the development of COVID-19 vaccines across a variety of vaccine platforms. Additionally, we are advancing a multi-program clinical pipeline leveraging CpG 1018 adjuvant to develop improved vaccines in indications with unmet medical needs including phase 1 clinical trials in Tdap and shingles, and a phase 2 clinical trial in plague in collaboration with and fully funded by the U.S. Department of Defense ("DoD"). 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, 2021 has been derived from audited financial statements at that date, but excludes 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, 2021 , 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 in India and a branch of Dynavax registered in Italy. All significant intercompany accounts and transactions among these entities have been eliminated from the condensed consolidated financial statements. We operate in one business segment: discovery, development and commercialization of novel vaccines. Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that may affect the amounts reported in the 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 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 condensed consolidated financial statements include those related to revenue recognition; accounts receivable; useful lives of long-lived assets, impairment of long-lived assets, including goodwill; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; fair value of warrants; balance sheet classification of Convertible Notes; income taxes, including the valuation allowance for deferred tax assets; research and development expenses; contingencies and share-based compensation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions and could be further impacted by the COVID-19 pandemic. Changes in estimates are reflected in reported results in the period in which they become known. Summary of Significant Accounting Policies Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Accounting Standards Codification (“ASC”) 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net – HEPLISAV-B We sell HEPLISAV-B to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short term and we expect to receive payment in less than one-year , there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks and rebates, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. For the three and six months ended June 30, 2022, we recorded an adjustment resulting in $ 0.7 million increase in HEPLISAV-B net product revenue. For the three and six months ended June 30, 2021, there were no material adjustments to these estimates recognized. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. Chargebacks: Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Rebates: Under certain contracts, customers may obtain rebates for purchasing minimum volumes of our product. We estimate these rebates based upon the expected purchases and the contractual rebate rate and record this estimate as a reduction in revenue in the period the related revenue is recognized. Product Revenue, Net – CpG 1018 We also sell our innovative adjuvant, CpG 1018, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccines. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 adjuvant sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. In the second quarter of 2022, we entered into a bill and hold arrangement. When we entered into this arrangement, we determined if the customer obtained control of the product by determining (a) the reason for the bill-and-hold arrangement; (b) whether the product was identified separately as belonging to the customer; (c) whether the product was ready for physical transfer to the customer; and (d) whether we were unable to utilize the product or direct it to another customer. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Other Revenue Other revenue includes revenue from our agreement with the DoD, grant, collaboration and manufacturing service revenue. We have entered into grant agreements, collaborative arrangements and arrangements to provide manufacturing services to other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. Inventories, net HEPLISAV-B Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out ("FIFO") basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the three and six months ended June 30, 2022 and 2021, there were no inventory reserves recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to the required regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. CpG 1018 Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a FIFO basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the three and six months ended June 30, 2022 and 2021, there were no inventory reserves recognized. Convertible Notes We account for our 2.50 % convertible senior notes due 2026 (“Convertible Notes”), see Note 7, as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the condensed consolidated balance sheets. We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the Convertible Notes, using the effective interest method, as interest expense on the condensed consolidated statements of operations. Capped Calls We evaluate financial instruments under ASC 815. The capped call transactions purchased in connection with the Convertible Notes financing ("Capped Calls") cover the same number of shares of common stock that initially underlie the Convertible Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for the equity classification continue to be met. Recent Accounting Pronouncements Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. For public business entities, excluding smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2019. Furthermore, the one-time determination of whether an entity is eligible to be a smaller reporting company shall be based on an entity’s most recent determination as of November 15, 2019, in accordance with SEC regulations. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, this ASU and its subsequent updates, will be effective for fiscal years beginning after December 15, 2022. We are currently evaluating the impact this standard will have on our condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
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 and six months ended June 30, 2022. The carrying amounts of cash equivalents, accounts and other receivables, accounts payable and accrued liabilities are considered reasonable estimates of their respective fair value because of their short-term nature. Recurring Fair Value Measurements The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) and liabilities measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total June 30, 2022 Assets Money market funds $ 211,632 $ - $ - $ 211,632 U.S. treasuries - 62,891 - 62,891 U.S. government agency securities - 1,748 - 1,748 Corporate debt securities - 227,907 - 227,907 Total assets $ 211,632 $ 292,546 $ - $ 504,178 Level 1 Level 2 Level 3 Total December 31, 2021 Assets Money market funds $ 429,194 $ - $ - $ 429,194 U.S. treasuries - 4,004 - 4,004 U.S. government agency securities - 26,548 - 26,548 Corporate debt securities - 79,209 - 79,209 Total assets $ 429,194 $ 109,761 $ - $ 538,955 Liabilities Warrant liability $ - $ - $ 18,016 $ 18,016 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. U.S. treasuries, U.S. government agency securities and corporate debt securities are measured at fair value using Level 2 inputs. We review trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. Warrants were issued in connection with the underwritten public offering in August 2019 and are accounted for as a derivative liability at fair value (see Note 10). As of June 30, 2022, all 1,882,600 of the outstanding warrants as of December 31, 2021 have been exercised or expired. The following table provides a summary of changes in the fair value warrant liability for the six months ended June 30, 2022 (in thousands): Balance at December 31, 2021 $ 18,016 Decrease in fair value of warrants exercised and/or expired ( 1,801 ) Warrants exercised and/or expired ( 16,215 ) Balance at June 30, 2022 $ - Convertible Notes As of June 30, 2022, the fair value of the Convertible Notes was $ 337.3 m illion. 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 (see Note 7). |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 3. Cash, Cash Equivalents, Restricted Cash and Marketable Securities The following table provides a reconciliation of cash, 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): June 30, December 31, June 30, December 31, Cash and cash equivalents $ 249,091 $ 436,189 $ 129,608 $ 32,073 Restricted cash 202 219 229 237 Total cash, cash equivalents and restricted cash shown $ 249,293 $ 436,408 $ 129,837 $ 32,310 Restricted cash balances relate to certificates of deposit issued as collateral to certain letters of credit issued as security to our facility leases (see Note 5). Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated June 30, 2022 Cash and cash equivalents: Cash $ 13,991 $ - $ - $ 13,991 Money market funds 211,632 - - 211,632 Corporate debt securities 23,478 - ( 10 ) 23,468 Total cash and cash equivalents 249,101 - ( 10 ) 249,091 Marketable securities available-for-sale: U.S. treasuries 63,190 - ( 299 ) 62,891 U.S. government agency securities 1,750 - ( 2 ) 1,748 Corporate debt securities 206,028 - ( 1,589 ) 204,439 Total marketable securities available-for-sale 270,968 - ( 1,890 ) 269,078 Total cash, cash equivalents and marketable securities $ 520,069 $ - $ ( 1,900 ) $ 518,169 December 31, 2021 Cash and cash equivalents: Cash $ 6,995 $ - $ - $ 6,995 Money market funds 429,194 - - 429,194 Total cash and cash equivalents 436,189 - - 436,189 Marketable securities available-for-sale: U.S. treasuries 4,005 - ( 1 ) 4,004 U.S. government agency securities 26,555 - ( 7 ) 26,548 Corporate debt securities 79,200 9 - 79,209 Total marketable securities available-for-sale 109,760 9 ( 8 ) 109,761 Total cash, cash equivalents and marketable securities $ 545,949 $ 9 $ ( 8 ) $ 545,950 The maturities of our marketable securities available-for-sale are as follows (in thousands): June 30, 2022 Amortized Estimated Mature in one year or less $ 270,968 $ 269,078 Mature after one year through two years - - $ 270,968 $ 269,078 We have classified our entire investment portfolio as available-for-sale and available for use in current operations and accordingly have classified all investments as short-term. Available-for-sale securities are carried at fair value based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the securities, with unrealized gains and losses included in accumulated other comprehensive loss in stockholders’ equity. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: • whether the investment has been in a continuous unrealized loss position for over 12 months; • the duration to maturity of our investments; • our intention and ability to hold the investment to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. There were no r ealized gains or losses from the sale of marketable securities during the three and six months ended June 30, 2022 and 2021. Investments with unrealized losses longer than 12 months were insignificant as of June 30, 2022. We do not intend to sell, and are not required to sell, the investments that are in an unrealized loss position before recovery of their amortized cost basis. As such, there have been no declines in fair value that have been identified as other than temporary. |
Inventories, Net
Inventories, Net | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories, net | Inventories, net The following table presents inventories, net (in thousands): June 30, 2022 December 31, 2021 Raw materials $ 32,789 $ 26,637 Work-in-process 18,189 14,748 Finished goods 23,001 19,950 Total $ 73,979 $ 61,335 As of June 30, 2022 and December 31, 2021, included in finished goods inventory was $ 11.4 million and $ 18.6 million of HEPLISAV-B inventory, respectively. The remaining balance in finished goods inventory was CpG 1018 adjuvant for our collaboration partners. We recorded prepaid manufacturing costs related to prepayments made to third-party manufacturers of CpG 1018 adjuvant, of $ 54.5 million and $ 159.7 million as of June 30, 2022 and December 31, 2021, respectively. We expect these costs to be converted into inventory within the next twelve months. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Leases We lease our facilities in Emeryville, California and Düsseldorf, Germany. In July 2019, we entered into a sublease for office space located at 2100 Powell Street, Suite 900, Emeryville, California (the “Powell Street Sublease”) for our corporate headquarters. Under the terms of the Powell Street Sublease, we leased 23,976 square feet at the rate of $ 3.90 per square foot, paid on a monthly basis. We were also responsible for certain operating expenses and taxes throughout the life of the Powell Street Sublease. The Powell Street Sublease expired on June 30, 2022. There was no option to extend the sublease term. In March 2022, we entered into a lease agreement (“Powell Street Lease”) for office space located at 2100 Powell Street, Suite 720, Emeryville, California to replace the Powell Street Sublease which expired on June 30, 2022. The Powell Street Lease commenced on June 1, 2022 ("Powell Street Commencement Date"). Under the Powell Street Lease, we are leasing 8,053 square feet at the rate of $ 4.65 per square foot, paid on a monthly basis. The first two monthly rent payments following the Powell Street Commencement Date will be abated. Rent is subject to scheduled annual increases, and we are responsible for certain operating expenses and taxes throughout the life of the Powell Street Lease. The Powell Street Lease will continue until July 31, 2025. There is no option to extend the lease term. In September 2018, we entered into a lease (“Horton Street Master Lease”) for office and laboratory space located at 5959 Horton Street, Emeryville, California (“Horton Street Premises”). Under the terms of the Horton Street Master Lease, we are leasing 75,662 square feet at the rate of $ 4.75 per square foot, paid on a monthly basis, starting on April 1, 2019 (“Horton Street Commencement Date”). Rent is subject to scheduled annual increases, and we are also responsible for certain operating expenses and taxes throughout the life of Horton Street Master Lease. In connection with the Horton Street Master Lease, we have received tenant improvement allowance totaling $ 8.1 million through June 30, 2022. The Horton Street Master Lease has an initial term of 12 years, following the Horton Street Commencement Date with an option to extend the lease for two successive five-year terms. The optional periods were not included in the lease term used in determining the right-of-use asset or the lease liability as we did not consider it reasonably certain that we would exercise the options. The operating lease right-of-use assets and liabilities on our June 30, 2022 condensed consolidated balance sheets primarily relate to the Horton Street Master Lease. Lease expense related to the Horton Street Master Lease is included in operating expense in our condensed consolidated statements of operations. In connection with the organizational restructuring in May 2019, we did not occupy the Horton Street Premises and in July 2019, we entered into an agreement to sublease the Horton Street Premises to a third party (“Horton Street Sublease”). Under the terms of the Horton Street Sublease, we are subleasing the entire 75,662 rentable square feet at the rate of $ 5.50 per square foot, paid on a monthly basis. Rent is subject to scheduled annual increases and the subtenant (“Horton Street Subtenant”) is responsible for certain operating expenses and taxes throughout the life of the Horton Street Sublease. The Horton Street Sublease term is until March 31, 2031 , unless earlier terminated, concurrent with the term of our Horton Street Master Lease. The Horton Street Subtenant has no option to extend the sublease term. Sublease income for the three and six months ended June 30, 2022 were $ 2.0 million and $ 3.6 million, respectively. For the three and six months ended June 30, 2021, we recognized sublease income of $ 1.7 million and $ 3.7 million, respectively. Sublease income is included in other income (expense) in our condensed consolidated statements of operations. Under the terms of the Horton Street Master Lease, rent received from the Horton Street 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. In September 2021, we entered into a commercial lease agreement in Düsseldorf, Germany (the "New Düsseldorf Lease") for the same space that we were previously leasing in Düsseldorf, Germany with the same landlord. The New Düsseldorf Lease became effective on January 1, 2022. The New Düsseldorf Lease has an initial term of 10 years, beginning on January 1, 2022, with an option to extend the lease for two successive five-year terms. The optional periods were not included in the lease term used in determining the right-of-use assets and liabilities as we did not consider it reasonably certain that we would exercise the options. Beginning on January 1, 2024, the base rent is subject to an annual increase at the same percentage of Consumer Price Index of Germany. We are also responsible for certain operating expenses and taxes throughout the life of the New Düsseldorf Lease. Our lease expense comprises of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Operating lease expense $ 1,867 $ 1,570 $ 3,474 $ 3,130 Cash paid for amounts included in the measurement of lease liabilities for the six months ended June 30, 2022 and 2021 was $ 3.5 million and $ 3.4 million, respectively, and was included in change in lease liabilities in our condensed consolidated statements of cash flows. The balance sheet classification of our operating lease liabilities was as follows (in thousands): June 30, 2022 December 31, 2021 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 3,039 $ 2,577 Long-term portion of lease liabilities 33,677 34,316 Total operating lease liabilities $ 36,716 $ 36,893 As of June 30, 2022, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2022 (remaining) $ 2,709 $ 3,195 2023 5,518 6,512 2024 5,684 6,646 2025 5,854 6,123 2026 6,030 5,861 Thereafter 27,712 27,161 Total $ 53,507 55,498 Less: Present value adjustment ( 18,782 ) Total $ 36,716 The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: June 30, 2022 December 31, 2021 Weighted average remaining lease term 8.25 years 9.1 years Weighted average discount rate 10.1 % 10.1 % Commitments As of June 30, 2022, our material non-cancelable purchase and other commitments, for the supply of HEPLISAV-B and CpG 1018, totaled $ 115.7 million. As of June 30, 2022, the aggregate principal amount of our Convertible Notes was $ 225.5 million, excluding debt discount of $ 4.5 million (see Note 7). The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased prior to such date. During 2004, we established a letter of credit with Deutsche Bank as security for our Düsseldorf lease in the amount of € 0.2 million (Euros). The letter of credit remained outstanding through June 30, 2022 and is 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 June 30, 2022. In conjunction with our agreement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50 % of the first $ 50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including our immune-oncology compound, SD-101. In July 2020, we sold assets related to SD-101 to Surefire Medical, Inc. d/b/a TriSalus Life Sciences (“TriSalus”). We paid $ 2.5 million to Holdings in August 2020. In each of September 2021 and May 2022, we received $ 1.0 million from TriSalus because it met a pre-commercialization milestone. We recorded the proceeds as gain on sale of assets in our condensed consolidated statements of operations in the third quarter of 2021 and second quarter of 2022. We paid Holdings $ 0.5 million in each of September 2021 and May 2022. We included the payments in selling, general and administrative expenses in our condensed consolidated statements of operations in the third quarter of 2021 and second quarter of 2022. No liability has been recorded under this agreement as of June 30, 2022. Contingencies From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, results of operations, or cash flows in a particular period. |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 6 Months Ended |
Jun. 30, 2022 | |
Research and Development [Abstract] | |
Collaboration, Development and Supply Agreements | 6. Collaboration, Development and Supply Agreements Coalition for Epidemic Preparedness Innovations In January 2021, we entered into an agreement (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”). The CEPI Agreement enables CEPI to direct the supply of CpG 1018 Materials to CEPI partner(s). CEPI partner(s) would purchase CpG 1018 Materials under separately negotiated agreements. The CEPI Agreement also allows us to sell CpG 1018 Materials to third parties if not purchased by a CEPI partner within a two-year term. In exchange for reserving CpG 1018 Materials and agreeing to sell CpG 1018 Materials to CEPI partner(s) at pre-negotiated prices, CEPI agreed to provide payments in the form of an interest-free, unsecured, forgivable loan (the “Advance Payments”) of up to $ 99.0 million. We are obligated to repay the Advance Payments, in proportion to quantity sold, if and to the extent we receive payments from sales of CpG 1018 Materials reserved under the CEPI Agreement. If the vaccine programs pursued by CEPI partner(s) are unsuccessful and no alternative use is found for CpG 1018 Materials reserved under the CEPI Agreement, the applicable Advance Payments will be forgiven at the end of the two-year term. In May 2021, we entered into the first Amendment to the CEPI Agreement. This Amendment provided for the manufacture and reservation of an additional specified quantity of CpG 1018 adjuvant. In exchange for reserving an additional specified quantity of CpG 1018 adjuvant, CEPI agreed to provide additional Advance Payments of up to $ 77.4 million, together with the initial CEPI Agreement, for total Advance Payments of up to $ 176.4 million. We determined that the accounting of the Advance Payments is under the scope of ASC 606. The Advance Payments are to cover the costs of manufacture and to reserve CpG 1018 Materials, which is an output of our ordinary activities. As such, the Advance Payments are initially classified as long-term deferred revenue in our condensed consolidated balance sheets. We are obligated to repay CEPI, in proportion to quantity sold and within a certain period, upon receipt of payment from CEPI partner(s). Thus, when we deliver CpG 1018 Materials to CEPI partner(s) or when we receive payment from CEPI partner(s), we reclassify the Advanced Payments from long-term deferred revenue to accrued liabilities. We recognize the Advance Payments as revenue when the amount (or a portion thereof) is forgiven by CEPI when (i) the CpG 1018 Materials are not sold through to CEPI partner(s), (ii) there is no alternative use and (iii) the CpG 1018 Materials are destroyed. Through June 30, 2022, we have received Advance Payments totaling approximately $ 175.1 million pursuant to the CEPI Agreement, as amended. Advance payments totaling $ 107.4 million and $ 128.8 million were recorded as CEPI accrual in our condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021, respectively. There was no deferred revenue balance related to the CEPI Agreement as of June 30, 2022. As of December 31, 2021, deferred revenue totaling $ 5.4 million were recorded as other long-term liabilities in our condensed consolidated balance sheets. There was no CEPI receivable balance recorded as of June 30, 2022. As of December 31, 2021, we recorded $ 14.6 million in CEPI receivable which is included in other receivables in our condensed consolidated balance sheets. Zhejiang Clover Biopharmaceuticals, Inc. and Clover Hong Kong Inc. In June 2021, we entered into an agreement with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Hong Kong Inc. (collectively, “Clover”), for the commercial supply of CpG 1018 adjuvant, for use with Clover’s COVID-19 vaccine candidate, SCB-2019 (the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover has committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, as amended, for use in Clover’s commercialization of vaccines containing SCB-2019 and CpG 1018 adjuvant (“Clover Product”). The Clover Supply Agreement also provides terms for Clover to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. The terms and conditions of the Clover Supply Agreement are through December 2022. Pricing for CpG 1018 adjuvant is variable depending on the destination where Clover ultimately sells Clover Product to. Pursuant to the Clover Supply Agreement, our initial invoicing is at the lowest price tier, with a true-up mechanism to issue additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Clover Product exceeds a threshold specified in the Clover Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price. For CpG 1018 adjuvant reserved for Clover under the CEPI Agreement, as amended, Clover is obligated to pay the purchase price upon the earliest of (i) the true-up exercise, (ii) within a specified period after Clover delivers Clover Product to a customer, or (iii) Clover’s receipt of payment for Clover Product from a customer. For CpG 1018 adjuvant ordered by Clover outside the CEPI Agreement, as amended, Clover is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Clover, upon our acceptance of such purchase order, and the remainder of the purchase price upon the release of such CpG 1018 adjuvant. We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Clover. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement, as amended, we recognize product revenue and a corresponding contract asset as our right to consideration is contingent on something other than the passage of time, as outlined above. As of June 30, 2022 and December 31, 2021, our contract asset balance of $ 71.3 million and $ 62.5 million, respectively was included in other current assets in our condensed consolidated balance sheets. As of June 30, 2022 and December 31, 2021, we recorded accounts receivable balance of $ 19.2 million and $ 2.1 million from Clover, respectively. As of June 30, 2022 and December 31, 2021, we recognized approximately $ 138.7 million and $ 191.1 million, respectively, in deferred revenue for a portion of Clover’s binding commitment to purchase CpG 1018 adjuvant outside the CEPI Agreement, as amended. There was no deferred revenue recognized for a portion of Clover’s binding commitment to purchase CpG 1018 adjuvant that was reserved for Clover under the CEPI Agreement, as amended. For the three and six months ended June 30, 2022, we recognized CpG 1018 product revenue, net of $ 91.3 million and $ 113.6 million, respectively. There was no product revenue recognized under the Clover Supply Agreement for the three and six months ended June 30, 2021. Biological E. Limited In July 2021, we entered into an agreement (the “Bio E Supply Agreement”) with Biological E. Limited (“Bio E”), for the commercial supply of CpG 1018 adjuvant, for use with Bio E’s subunit COVID-19 vaccine candidate, CORBEVAX. Under the Bio E Supply Agreement, Bio E has committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, as amended, for use in Bio E’s commercialization of its CORBEVAX vaccine (“Bio E Product”) with specified delivery dates in 2021 and the first quarter of 2022. The Bio E Supply Agreement also provides terms for Bio E to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. The terms and conditions of the Bio E Supply Agreement are through December 2022. Pricing for CpG 1018 adjuvant is variable depending on the destination where Bio E ultimately sells Bio E Product to. Pursuant to the Bio E Supply Agreement, our initial invoicing will be at the lowest price tier, with a true-up mechanism to issue additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Bio E Product exceeds a threshold specified in the Bio E Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price. For CpG 1018 adjuvant reserved for Bio E under the CEPI Agreement, as amended, Bio E is obligated to pay, in full, the aggregate purchase price, as set forth in a purchase order submitted by Bio E, upon delivery of CpG 1018 adjuvant. For CpG 1018 adjuvant ordered by Bio E outside the CEPI Agreement, as amended, Bio E is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Bio E, upon our acceptance of such purchase order, and the remainder of the purchase price upon the delivery of such CpG 1018 adjuvant. We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Bio E. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. As of June 30, 2022 and December 31, 2021, we recorded accounts receivable balance of $ 95.6 million and $ 96.1 million from Bio E, respectively. As of June 30, 2022 and December 31, 2021 , we recognized approximately $ 47.7 million and $ 103.3 million, respectively, in deferred revenue for a portion of Bio E’s binding commitment to purchase CpG 1018 adjuvant outside the CEPI Agreement, as amended. There was no deferred revenue recognized for a portion of Bio E’s binding commitment to purchase CpG 1018 adjuvant that was reserved for Bio E under the CEPI Agreement, as amended. For the three and six months ended June 30, 2022, we recognized CpG 1018 adjuvant net product revenue of $ 51.0 million and $ 118.3 million, respectively from Bio E. There was no product revenue recognized under the Bio E Supply Agreement for the three and six months ended June 30, 2021. PT Bio Farma (Persero) In May 2022, we entered into a commercial supply agreement (the “Bio Farma Supply Agreement”) with PT Bio Farma (Persero) (“Bio Farma”) to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the development and commercialization of Bio Farma’s COVID-19 vaccine, adjuvanted with our CpG 1018 adjuvant (“Bio Farma Product”), for delivery in the second quarter and third quarter of 2022. The Bio Farma Supply Agreement also provides terms for Bio Farma to order additional quantities of CpG 1018 adjuvant for delivery throughout the life of the agreement. The terms and conditions of the Bio Farma Supply Agreement are through May 2023. Pricing for CpG 1018 adjuvant is variable depending on the destination where Bio Farma ultimately sells Bio Farma Product to. Pursuant to the Bio Farma Supply Agreement, our initial invoicing will be at the lowest price tier, with a true-up mechanism to issue additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Bio Farma Product exceeds a threshold specified in the Bio Farma Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price. Bio Farma is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Bio Farma, upon our acceptance of such purchase order, and the remainder of the purchase price upon the delivery of such CpG 1018 adjuvant. We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Bio Farma. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. As of June 30, 2022, we recorded accounts receivable balance of $ 17.9 million from Bio Farma. As of June 30, 2022, we recognized approximately $ 5.5 million in deferred revenue for a portion of Bio Farma’s binding commitment to purchase CpG 1018 adjuvant. For the three and six months ended June 30, 2022, we recognized CpG 1018 adjuvant net product revenue from Bio Farma of $ 12.3 million and $ 14.3 million, respectively. Medigen Vaccine Biologics In February 2021, we entered into a Supply Agreement (“Medigen Supply Agreement”) with Medigen Vaccine Biologics (“Medigen”) to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the development and commercialization of Medigen’s COVID-19 vaccine for delivery in the first and second quarters of 2021. In August 2021, we entered into a second supply agreement (“Medigen Supply Agreement No. 2”) to manufacture and supply additional specified quantities of CpG 1018 adjuvant for delivery in the third and fourth quarter of 2021. The terms and conditions of the Medigen Supply Agreement and the Medigen Supply Agreement No. 2 were through December 2021. Under Medigen Supply Agreement No. 2, pricing for CpG 1018 adjuvant is variable depending on the destination where Medigen ultimately sells Medigen Product to. Pursuant to the Medigen Supply Agreement No. 2, we invoice Medigen based on the highest-tier price, with a true-up mechanism to issue credit to Medigen for the difference between the initial invoice price and the lower tiered price, if any. We invoice Medigen a specified percentage of the aggregate price of the order upon acceptance of the order and the remaining upon delivery. In addition, we are entitled to a royalty calculated as a percentage of the adjusted net sales. We recognize revenue upon transfer of control of CpG 1018 adjuvant to Medigen at the highest-tiered price. The potential royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. There was no accounts receivable balance from Medigen recorded as of June 30, 2022. As of December 31, 2021, we recorded accounts receivable balance of $ 2.4 million from Medigen. There was no product revenue recognized from Medigen for the three and six months ended June 30, 2022. For the three and six months ended June 30, 2021, we recognized CpG 1018 adjuvant net product revenue from Medigen of $ 10.6 million and $ 17.5 million, respectively. Valneva SE In April 2020, we entered into a collaboration agreement ("Valneva Collaboration Agreement") with Valneva Scotland Limited (“Valneva”) to provide CpG 1018 adjuvant for use in the development of Valneva’s COVID-19 vaccine candidate ("VLA2001"). The Valneva Collaboration Agreement was amended in July 2020, to provide additional quantities of CpG 1018 adjuvant. In September 2020, we entered into a supply agreement (“Valneva Supply Agreement”) with Valneva to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the commercialization of VLA2001. We concluded that the Valneva Collaboration Agreement and the Valneva Supply Agreement were entered into at or near the same time, with the same customer and were negotiated as a package with a single commercial objective to provide CpG 1018 adjuvant to Valneva. Therefore, the Valneva Collaboration Agreement and the Valneva Supply Agreement should be combined and accounted for as a single arrangement. In October 2021, we and Valneva entered into a letter agreement (the “Valneva Amendment”) modifying certain deliverables of the Valneva Supply Agreement. Specifically, the Valneva Amendment modifies the original Valneva Supply Agreement as follows: (1) cancels certain purchase orders for CpG 1018 adjuvant previously issued under the original Valneva Supply Agreement that had not been fulfilled as of the date of the Valneva Amendment; and (2) provides a future delivery schedule for commercial supply of CpG 1018 adjuvant through the end of 2022. As of the date of the Valneva Amendment, we had received non-refundable advance payments of approximately $ 55.4 million associated with the cancelled purchase orders. The terms and conditions of the Valneva Supply Agreement, as amended by the Valneva Amendment, were through our final delivery date in June 2022. In accordance with revenue recognition guidance in ASC 606, the Valneva Amendment was determined to be a contract modification and will be accounted for prospectively as one agreement with consideration allocated to future performance obligations. We have identified one remaining performance obligation which is the delivery of CpG 1018 adjuvant through the end of 2022. The total amount of consideration allocated to the remaining performance obligation includes approximately $ 55.4 million of advance payments received as of the date of the Valneva Amendment plus additional future consideration to be received in connection with final delivery of product. We satisfied our remaining performance obligation to deliver CpG 1018 adjuvant under the Valneva Amendment in June 2022. Accordingly, we recognized the $ 55.4 million of advance payments as product revenue in the second quarter of 2022. As of June 30, 2022 there was no deferred revenue balance related to Valneva. As of December 31 2021, deferred revenue related to Valneva was $ 55.4 million. As of June 30, 2022, we recorded accounts receivable balance of $ 12.6 million. As of December 31, 2021, there was no accounts receivable balance related to Valneva. For each of the three and six months ended June 30, 2022, we recognized CpG 1018 adjuvant net product revenue of $ 68.0 million from Valneva which was recognized under a bill and hold arrangement. For the three and six months ended June 30, 2021, we recognized CpG 1018 adjuvant net product revenue of $ 24.5 million and $ 89.4 million, respectively. U.S. Department of Defense In September 2021, we entered into an agreement with the DoD for the development of a recombinant plague vaccine adjuvanted with CpG 1018 for approximately $ 22.0 million over two and a half years. Under the agreement, we will conduct a Phase 2 clinical trial combining our CpG 1018 adjuvant with the DoD's rF1V vaccine. For the three and six months ended June 30, 2022 , we recognized revenue of $ 1.1 million and $ 2.7 million, respectively which are included in other revenue in our condensed consolidated statements of operations. There was no revenue recognized under the DoD agreement for the three and six months ended June 30, 2021. Serum Institute of India Pvt. Ltd. In June 2017, we entered into an agreement to provide Serum Institute of India Pvt. Ltd. (“SIIPL”) with technical support. In consideration, SIIPL agreed to pay us at an agreed upon hourly rate for services and reimburse certain out-of-pocket expenses. In addition, we have rights to commercialization of certain potential products manufactured at the SIIPL facility. For the three and six months ended June 30, 2022, we recognized revenue of $ 34,326 and $ 0.1 million, respectively, which are included in other revenue in our condensed consolidated statements of operations. For the three and six months ended June 30, 2021, we recognized revenue of $ 0.1 million and $ 0.3 million, respectively. |
Convertible Notes
Convertible Notes | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Convertible Notes | 7. Convertible Notes In May 2021, we issued $ 200.0 million aggregate principal amount of 2.50 % convertible senior notes due 2026 in a private placement. The purchasers also partially exercised their option to purchase additional Convertible Notes and we issued an additional $ 25.5 million of the Convertible Notes in May 2021. Total proceeds from the issuance of the Convertible Notes, net of debt issuance and offering costs of $ 5.7 million, were $ 219.8 million. We used $ 190.2 million of the net proceeds to retire our previous loan agreement with CRG Servicing LLC and $ 27.2 million of the net proceeds to pay the costs of the Capped Calls described below. The Convertible Notes are general unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year. 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: 1. 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; 2. 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; 3. 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 4. 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. As of July 1, 2022, the conditions allowing holders of the Convertible Notes to convert were not met. As a result, the Convertible Notes are not convertible, in whole or in part, at the option of the holders during the three months ended September 30, 2022. 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 June 30, 2022. 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. As a result of adopting ASU 2020-06, we accounted for the Convertible Notes as a single liability. As of June 30, 2022, the Convertible Notes were recorded at the aggregate principal amount of $ 225.5 million less unamortized issuance costs of $ 4.5 million as a long-term liability on the condensed consolidated balance sheets. As of June 30, 2022, the fair value of the Convertible Notes was $ 337.3 million. See Note 2. 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 Six Months Ended June 30, June 30, 2022 2021 2022 2021 Stated coupon interest $ 1,409 $ 736 $ 2,819 $ 736 Amortization of debt issuance cost 271 137 540 137 Total interest expense $ 1,680 $ 873 $ 3,359 $ 873 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 (the "Option Counterparties"), 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 under the terms of the Capped Calls. The Capped Call Transactions are freestanding and are considered separately exercisable from 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 | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 June 30, 2021 U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 31,739 $ 941 $ 32,680 $ 13,688 $ - $ 13,688 CpG 1018 - 222,640 222,640 - 38,989 38,989 Total product revenue, net $ 31,739 $ 223,581 $ 255,320 $ 13,688 $ 38,989 $ 52,677 Other revenue 1,083 61 1,144 - 90 90 Total revenues $ 32,822 $ 223,642 $ 256,464 $ 13,688 $ 39,079 $ 52,767 Six Months Ended Six Months Ended June 30, 2022 June 30, 2021 U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 52,549 $ 941 $ 53,490 $ 21,991 $ - $ 21,991 CpG 1018 - 314,157 314,157 - 113,571 113,571 Total product revenue, net $ 52,549 $ 315,098 $ 367,647 $ 21,991 $ 113,571 $ 135,562 Other revenue 2,689 120 2,809 260 280 540 Total revenues $ 55,238 $ 315,218 $ 370,456 $ 22,251 $ 113,851 $ 136,102 Revenues from Major Customers and Collaboration Partners The following table summarizes HEPLISAV-B product revenue from each of our three largest Customers (as a percentage of total HEPLISAV-B net product revenue): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Largest Customer 18 % 28 % 21 % 28 % Second largest Customer 18 % 21 % 18 % 23 % Third largest Customer 18 % 16 % 17 % 17 % The following table summarizes CpG 1018 product revenue from each of our three largest collaboration partners (as a percentage of total CpG 1018 adjuvant net product revenue): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Largest collaboration partner 41 % 63 % 38 % 79 % Second largest collaboration partner 31 % 27 % 36 % 15 % Third largest collaboration partner 23 % 10 % 22 % 5 % Contract Balances The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories for the six months ended June 30, 2022 (in thousands): Balance at Provisions Credit or Balance Six months ended June 30, 2022: Accounts receivable reserves(1) $ 3,823 $ 15,201 $ ( 12,602 ) $ 6,422 Revenue reserve accruals(2) 8,253 10,333 ( 9,945 ) 8,641 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. We recognize revenue and a corresponding contract asset when our right to consideration is conditioned on something other than the passage of time. The following table summarizes balances and activities in our contract asset account (in thousands): Balance at Additions (1) Subtractions (2) Balance Six months ended June 30, 2022: Contract asset $ 62,525 $ 12,134 $ ( 3,151 ) $ 71,508 (1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement, as amended. (2) Subtractions are reclassifications from contract asset to accounts receivables. Payments received or invoices issued before we satisfy our performance obligations are recorded as deferred revenue until we satisfy such performance obligations. Our deferred revenue activities are related to CpG 1018 adjuvant product sales. The following table summarizes balances and activities in our deferred revenue accounts for the six months ended June 30, 2022 (in thousands): Balance at Additions (1) Subtractions (2) Revenue recognized in the current period included in deferred revenue balance at the beginning of the period Balance Six months ended June 30, 2022: Deferred revenue $ 349,864 $ 12,068 $ ( 6,534 ) $ ( 163,400 ) $ 191,998 Long-term deferred revenue 5,385 6,582 ( 11,967 ) - - (1) Additions are primarily payments received or invoices issued before we satisfy our performance obligations. (2) Subtractions are primarily revenues recognized in the period included in deferred revenue during the period and reclassification from long-term deferred revenue to accrued liabilities. |
Net Income Per Share
Net Income Per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Income Per Share | 9. Net Income Per Share We compute net income per share of common stock using the two-class method required for participating securities. We consider warrants to be participating securities because holders of such shares have dividend rights in the event of our declaration of a dividend for common shares. Undistributed earnings allocated to participating securities are subtracted from net income in determining net income attributable to common stockholders. Basic net income per share is computed by dividing net income attributable to common stockholders by the weighted-average number of shares of our common stock outstanding. For the calculation of diluted net income per share, net income attributable to common stockholders for basic net income per share is adjusted by the effect of dilutive securities, including awards under our equity compensation plans and change in fair value of warrant liability. Diluted net income per share attributable to common stockholders is computed by dividing the resulting net income attributable to common stockholders by the weighted-average number of fully diluted common shares outstanding. The numerators and denominators of the basic and diluted net income per share computations for our common stock are calculated as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator Net income $ 128,755 $ 4,473 $ 161,614 $ 5,364 Less: undistributed earnings allocated to participating securities - ( 333 ) ( 316 ) ( 410 ) Net income attributable to common stockholders, basic 128,755 4,140 161,298 4,954 Add: undistributed earnings allocated to participating securities - - 316 - Less: removal of change in fair value of warrant liability - ( 2,097 ) ( 1,801 ) - Add: interest expense on convertible notes 1,260 - 2,519 - Net income attributable to common stockholders, diluted $ 130,015 $ 2,043 $ 162,332 $ 4,954 Denominator Weighted average common stock outstanding, basic 126,347 114,629 125,456 113,339 Effect of dilutive shares: Stock-based compensation plans 2,015 1,630 2,659 1,639 Dilutive warrants - 2,571 163 - Convertible Notes (as converted to common stock) 21,543 - 21,543 - Weighted average common stock outstanding, diluted 149,905 118,830 149,821 114,978 The following were excluded from the calculation of diluted net income per share as the effect of their inclusion would have been anti-dilutive (in thousands). Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Outstanding securities not included in diluted net income (loss) per share Stock options and stock awards 9,647 6,991 9,067 8,476 Series B Convertible Preferred Stock (as converted to common - 4,140 - 4,140 Warrants (as exercisable into common stock) - - - 2,474 Convertible Notes (as converted to common stock) - 11,363 - 5,713 Total 9,647 22,494 9,067 20,803 |
Common Stock, Preferred Stock a
Common Stock, Preferred Stock and Warrants | 6 Months Ended |
Jun. 30, 2022 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock, Preferred Stock and Warrants | 10. Common Stock, Preferred Stock and Warrants Common Stock As of June 30, 2022, there were 126,439,073 shares of our common stock outstanding. In August 2019, we sold 18,525,000 shares of our common stock, par value $ 0.001 per share, 4,840 shares of our Series B Convertible Preferred Stock, par value $ 0.001 per share (“Series B Preferred Stock”) and warrants to purchase up to an aggregate of 5,841,250 shares of our common stock in an underwritten public offering (the “Offering”) for aggregate net proceeds of approximately $ 65.6 million. Investment funds associated with Bain Capital Life Sciences Investors, LLC (“Bain Capital Life Sciences”) purchased approximately $ 35.0 million of common stock, Series B Preferred Stock and warrants in the Offering on the same terms as the other investors in the Offering. Following the Offering, Andrew A. F. Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, was appointed to our board of directors. On August 6, 2020, we entered into an at-the-market Sales Agreement (the “2020 ATM Agreement”) with Cowen and Company, LLC (“Cowen”), under which we may offer and sell from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $ 150 million through Cowen as our sales agent. We agreed to pay Cowen a commission of up to 3 % of the gross sales proceeds of any common stock sold through Cowen under the 2020 ATM Agreement. As of June 30, 2022, we had $ 120.5 million remaining under the 2020 ATM Agreement. Preferred Stock As of June 30, 2022, all of the Series B Preferred Stock had been converted into common stock. Warrants During the three months ended March 31, 2022, all of the 1,882,600 outstanding warrants as of December 31, 2021 were exercised or expired resulting in cash proceeds totaling $ 8.5 million. For the three months ended June 30, 2022, there was no change in the estimated fair value of warrant liability recognized in other income (expense) in our condensed consolidated statements of operations. For the six months ended June 30, 2022, we recognized the decrease in the estimated fair value of warrant liability of $ 1.8 million as income in other income (expense) in our condensed consolidated statements of operations. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement, Noncash Expense [Abstract] | |
Equity Plans and Stock-Based Compensation | 11. Equity Plans and Stock-Based Compensation 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 June 30, 2022, the Amended 2018 EIP and the Amended and Restated 2014 Employee Stock Purchase Plan are our active plans. The Amended 2018 EIP is administered by our Board of Directors, or a designated committee of the Board of Directors, and awards granted under the Amended 2018 EIP have a term of 7 years unless earlier terminated by the Board of Directors. As of June 30, 2022, there were 15,465,070 shares of common stock reserved for issuance under the Amended 2018 EIP. Activity under our stock plans is set forth below: Shares Weighted- Weighted- Aggregate Balance as of December 31, 2021 10,399 $ 11.55 4.16 42,756 Options granted 2,053 12.54 Options exercised ( 287 ) 7.49 Options cancelled: Options forfeited (unvested) ( 73 ) 9.52 Options expired (vested) ( 566 ) 20.63 Balance at June 30, 2022 11,526 11.40 4.37 31,382 Vested and expected to vest at June 30, 2022 11,146 $ 11.37 4.31 $ 30,946 Exercisable at June 30, 2022 6,542 $ 11.52 3.09 $ 21,654 Restricted stock unit activity under our stock-based compensation plans during the six months ended June 30, 2022 was as follows (in thousands except per share amounts): Number of Shares Weighted-Average Non-vested as of December 31, 2021 2,651 $ 8.30 Granted 2,021 12.42 Vested ( 1,009 ) 8.21 Forfeited ( 168 ) 10.40 Non-vested as of June 30, 2022 3,495 10.60 We granted performance-based restricted stock unit (“PSU”) to certain executives. These PSUs vest upon a specified market condition. The summary of PSU activities for the six months ended June 30, 2022 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2021 237 $ 8.40 Granted 193 11.62 Vested ( 237 ) 8.40 Non-vested as of June 30, 2022 193 $ 11.62 The fair value-based measurement of each option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows: Stock Options Stock Options Market-Based Performance Stock Unit (“PSUs”) Three Months Ended Six Months Ended Six Months Ended June 30, June 30, June 30 2022 2021 2022 2021 2022 Weighted-average fair value per share $ 7.39 $ 6.20 $ 7.97 $ 6.57 $ 11.62 Risk-free interest rate 2.9 % 0.9 % 2.01 % 0.6 % 1.7 % Expected life (in years) 4.5 4.5 4.5 4.5 2.9 Volatility 0.8 0.9 0.8 1.0 0.9 The components of stock-based compensation expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Research and development $ 1,463 $ 937 $ 2,739 $ 1,809 Selling, general and administrative 5,597 3,445 11,024 6,589 Cost of sales - product 143 155 303 324 Inventory 726 487 1,509 1,025 Total $ 7,929 $ 5,024 $ 15,575 $ 9,747 Compensation expense is based on awards ultimately expected to vest and reflects estimated forfeitures. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes We are subject to U.S. federal, state and foreign income taxes. For each of the three and six months ended June 30, 2022, we recorded a provision for income taxes of approximately $ 0.6 million and our effective tax rate was approximately 0.4 %. T he 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 June 30, 2022, 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 and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2021 has been derived from audited financial statements at that date, but excludes 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, 2021 , 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 in India and a branch of Dynavax registered in Italy. All significant intercompany accounts and transactions among these entities have been eliminated from the 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 condensed consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that may affect the amounts reported in the 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 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 condensed consolidated financial statements include those related to revenue recognition; accounts receivable; useful lives of long-lived assets, impairment of long-lived assets, including goodwill; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; fair value of warrants; balance sheet classification of Convertible Notes; income taxes, including the valuation allowance for deferred tax assets; research and development expenses; contingencies and share-based compensation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions and could be further impacted by the COVID-19 pandemic. Changes in estimates are reflected in reported results in the period in which they become known. |
Revenue Recognition | Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Accounting Standards Codification (“ASC”) 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net – HEPLISAV-B We sell HEPLISAV-B to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short term and we expect to receive payment in less than one-year , there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks and rebates, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. For the three and six months ended June 30, 2022, we recorded an adjustment resulting in $ 0.7 million increase in HEPLISAV-B net product revenue. For the three and six months ended June 30, 2021, there were no material adjustments to these estimates recognized. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. Chargebacks: Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Rebates: Under certain contracts, customers may obtain rebates for purchasing minimum volumes of our product. We estimate these rebates based upon the expected purchases and the contractual rebate rate and record this estimate as a reduction in revenue in the period the related revenue is recognized. Product Revenue, Net – CpG 1018 We also sell our innovative adjuvant, CpG 1018, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccines. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 adjuvant sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. In the second quarter of 2022, we entered into a bill and hold arrangement. When we entered into this arrangement, we determined if the customer obtained control of the product by determining (a) the reason for the bill-and-hold arrangement; (b) whether the product was identified separately as belonging to the customer; (c) whether the product was ready for physical transfer to the customer; and (d) whether we were unable to utilize the product or direct it to another customer. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Other Revenue Other revenue includes revenue from our agreement with the DoD, grant, collaboration and manufacturing service revenue. We have entered into grant agreements, collaborative arrangements and arrangements to provide manufacturing services to other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. |
Inventories, net | Inventories, net HEPLISAV-B Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out ("FIFO") basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the three and six months ended June 30, 2022 and 2021, there were no inventory reserves recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to the required regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. CpG 1018 Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a FIFO basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the three and six months ended June 30, 2022 and 2021, there were no inventory reserves recognized. |
Convertible Notes | Convertible Notes We account for our 2.50 % convertible senior notes due 2026 (“Convertible Notes”), see Note 7, as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the condensed consolidated balance sheets. We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the Convertible Notes, using the effective interest method, as interest expense on the condensed consolidated statements of operations. |
Capped Calls | Capped Calls We evaluate financial instruments under ASC 815. The capped call transactions purchased in connection with the Convertible Notes financing ("Capped Calls") cover the same number of shares of common stock that initially underlie the Convertible Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for the equity classification continue to be met. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. For public business entities, excluding smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2019. Furthermore, the one-time determination of whether an entity is eligible to be a smaller reporting company shall be based on an entity’s most recent determination as of November 15, 2019, in accordance with SEC regulations. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, this ASU and its subsequent updates, will be effective for fiscal years beginning after December 15, 2022. We are currently evaluating the impact this standard will have on our condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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) and liabilities measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total June 30, 2022 Assets Money market funds $ 211,632 $ - $ - $ 211,632 U.S. treasuries - 62,891 - 62,891 U.S. government agency securities - 1,748 - 1,748 Corporate debt securities - 227,907 - 227,907 Total assets $ 211,632 $ 292,546 $ - $ 504,178 Level 1 Level 2 Level 3 Total December 31, 2021 Assets Money market funds $ 429,194 $ - $ - $ 429,194 U.S. treasuries - 4,004 - 4,004 U.S. government agency securities - 26,548 - 26,548 Corporate debt securities - 79,209 - 79,209 Total assets $ 429,194 $ 109,761 $ - $ 538,955 Liabilities Warrant liability $ - $ - $ 18,016 $ 18,016 |
Summary of Changes in Fair Value Warrant liability | The following table provides a summary of changes in the fair value warrant liability for the six months ended June 30, 2022 (in thousands): Balance at December 31, 2021 $ 18,016 Decrease in fair value of warrants exercised and/or expired ( 1,801 ) Warrants exercised and/or expired ( 16,215 ) Balance at June 30, 2022 $ - |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Cash, Cash Equivalents, and Short-Term Investments [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, 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): June 30, December 31, June 30, December 31, Cash and cash equivalents $ 249,091 $ 436,189 $ 129,608 $ 32,073 Restricted cash 202 219 229 237 Total cash, cash equivalents and restricted cash shown $ 249,293 $ 436,408 $ 129,837 $ 32,310 |
Summary of Cash, Cash Equivalents and Marketable Securities | Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated June 30, 2022 Cash and cash equivalents: Cash $ 13,991 $ - $ - $ 13,991 Money market funds 211,632 - - 211,632 Corporate debt securities 23,478 - ( 10 ) 23,468 Total cash and cash equivalents 249,101 - ( 10 ) 249,091 Marketable securities available-for-sale: U.S. treasuries 63,190 - ( 299 ) 62,891 U.S. government agency securities 1,750 - ( 2 ) 1,748 Corporate debt securities 206,028 - ( 1,589 ) 204,439 Total marketable securities available-for-sale 270,968 - ( 1,890 ) 269,078 Total cash, cash equivalents and marketable securities $ 520,069 $ - $ ( 1,900 ) $ 518,169 December 31, 2021 Cash and cash equivalents: Cash $ 6,995 $ - $ - $ 6,995 Money market funds 429,194 - - 429,194 Total cash and cash equivalents 436,189 - - 436,189 Marketable securities available-for-sale: U.S. treasuries 4,005 - ( 1 ) 4,004 U.S. government agency securities 26,555 - ( 7 ) 26,548 Corporate debt securities 79,200 9 - 79,209 Total marketable securities available-for-sale 109,760 9 ( 8 ) 109,761 Total cash, cash equivalents and marketable securities $ 545,949 $ 9 $ ( 8 ) $ 545,950 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): June 30, 2022 Amortized Estimated Mature in one year or less $ 270,968 $ 269,078 Mature after one year through two years - - $ 270,968 $ 269,078 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table presents inventories, net (in thousands): June 30, 2022 December 31, 2021 Raw materials $ 32,789 $ 26,637 Work-in-process 18,189 14,748 Finished goods 23,001 19,950 Total $ 73,979 $ 61,335 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Expense | Our lease expense comprises of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Operating lease expense $ 1,867 $ 1,570 $ 3,474 $ 3,130 |
Summary of Balance Sheet Classification of Operating Lease Liabilities | The balance sheet classification of our operating lease liabilities was as follows (in thousands): June 30, 2022 December 31, 2021 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 3,039 $ 2,577 Long-term portion of lease liabilities 33,677 34,316 Total operating lease liabilities $ 36,716 $ 36,893 |
Summary of Maturities of Sublease Income and Operating Lease Liabilities | As of June 30, 2022, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2022 (remaining) $ 2,709 $ 3,195 2023 5,518 6,512 2024 5,684 6,646 2025 5,854 6,123 2026 6,030 5,861 Thereafter 27,712 27,161 Total $ 53,507 55,498 Less: Present value adjustment ( 18,782 ) Total $ 36,716 |
Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate | The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: June 30, 2022 December 31, 2021 Weighted average remaining lease term 8.25 years 9.1 years Weighted average discount rate 10.1 % 10.1 % |
Convertible Notes (Tables)
Convertible Notes (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Interest Expenses Related to Convertible Notes | The following table presents the components of interest expense related to Convertible Notes (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Stated coupon interest $ 1,409 $ 736 $ 2,819 $ 736 Amortization of debt issuance cost 271 137 540 137 Total interest expense $ 1,680 $ 873 $ 3,359 $ 873 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Summary of Disaggregation of Revenues | The following table disaggregates our product revenue, net by product and geographic region and disaggregates our other revenues by geographic region (in thousands): Three Months Ended Three Months Ended June 30, 2022 June 30, 2021 U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 31,739 $ 941 $ 32,680 $ 13,688 $ - $ 13,688 CpG 1018 - 222,640 222,640 - 38,989 38,989 Total product revenue, net $ 31,739 $ 223,581 $ 255,320 $ 13,688 $ 38,989 $ 52,677 Other revenue 1,083 61 1,144 - 90 90 Total revenues $ 32,822 $ 223,642 $ 256,464 $ 13,688 $ 39,079 $ 52,767 Six Months Ended Six Months Ended June 30, 2022 June 30, 2021 U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 52,549 $ 941 $ 53,490 $ 21,991 $ - $ 21,991 CpG 1018 - 314,157 314,157 - 113,571 113,571 Total product revenue, net $ 52,549 $ 315,098 $ 367,647 $ 21,991 $ 113,571 $ 135,562 Other revenue 2,689 120 2,809 260 280 540 Total revenues $ 55,238 $ 315,218 $ 370,456 $ 22,251 $ 113,851 $ 136,102 |
Summary of Deferred Revenue | The following table summarizes balances and activities in our deferred revenue accounts for the six months ended June 30, 2022 (in thousands): Balance at Additions (1) Subtractions (2) Revenue recognized in the current period included in deferred revenue balance at the beginning of the period Balance Six months ended June 30, 2022: Deferred revenue $ 349,864 $ 12,068 $ ( 6,534 ) $ ( 163,400 ) $ 191,998 Long-term deferred revenue 5,385 6,582 ( 11,967 ) - - (1) Additions are primarily payments received or invoices issued before we satisfy our performance obligations. (2) Subtractions are primarily revenues recognized in the period included in deferred revenue during the period and reclassification from long-term deferred revenue to accrued liabilities. |
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 Six Months Ended June 30, June 30, 2022 2021 2022 2021 Largest Customer 18 % 28 % 21 % 28 % Second largest Customer 18 % 21 % 18 % 23 % Third largest Customer 18 % 16 % 17 % 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 six months ended June 30, 2022 (in thousands): Balance at Provisions Credit or Balance Six months ended June 30, 2022: Accounts receivable reserves(1) $ 3,823 $ 15,201 $ ( 12,602 ) $ 6,422 Revenue reserve accruals(2) 8,253 10,333 ( 9,945 ) 8,641 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. |
CpG 1018 | |
Schedule of Revenues from Major Customers | The following table summarizes CpG 1018 product revenue from each of our three largest collaboration partners (as a percentage of total CpG 1018 adjuvant net product revenue): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Largest collaboration partner 41 % 63 % 38 % 79 % Second largest collaboration partner 31 % 27 % 36 % 15 % Third largest collaboration partner 23 % 10 % 22 % 5 % |
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 (1) Subtractions (2) Balance Six months ended June 30, 2022: Contract asset $ 62,525 $ 12,134 $ ( 3,151 ) $ 71,508 (1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement, as amended. (2) Subtractions are reclassifications from contract asset to accounts receivables. |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Income Per Share | The numerators and denominators of the basic and diluted net income per share computations for our common stock are calculated as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator Net income $ 128,755 $ 4,473 $ 161,614 $ 5,364 Less: undistributed earnings allocated to participating securities - ( 333 ) ( 316 ) ( 410 ) Net income attributable to common stockholders, basic 128,755 4,140 161,298 4,954 Add: undistributed earnings allocated to participating securities - - 316 - Less: removal of change in fair value of warrant liability - ( 2,097 ) ( 1,801 ) - Add: interest expense on convertible notes 1,260 - 2,519 - Net income attributable to common stockholders, diluted $ 130,015 $ 2,043 $ 162,332 $ 4,954 Denominator Weighted average common stock outstanding, basic 126,347 114,629 125,456 113,339 Effect of dilutive shares: Stock-based compensation plans 2,015 1,630 2,659 1,639 Dilutive warrants - 2,571 163 - Convertible Notes (as converted to common stock) 21,543 - 21,543 - Weighted average common stock outstanding, diluted 149,905 118,830 149,821 114,978 |
Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share | The following were excluded from the calculation of diluted net income per share as the effect of their inclusion would have been anti-dilutive (in thousands). Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Outstanding securities not included in diluted net income (loss) per share Stock options and stock awards 9,647 6,991 9,067 8,476 Series B Convertible Preferred Stock (as converted to common - 4,140 - 4,140 Warrants (as exercisable into common stock) - - - 2,474 Convertible Notes (as converted to common stock) - 11,363 - 5,713 Total 9,647 22,494 9,067 20,803 |
Equity Plans and Stock-Based _2
Equity Plans and Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement, Noncash Expense [Abstract] | |
Option Activity under Stock-Based Compensation Plans | Activity under our stock plans is set forth below: Shares Weighted- Weighted- Aggregate Balance as of December 31, 2021 10,399 $ 11.55 4.16 42,756 Options granted 2,053 12.54 Options exercised ( 287 ) 7.49 Options cancelled: Options forfeited (unvested) ( 73 ) 9.52 Options expired (vested) ( 566 ) 20.63 Balance at June 30, 2022 11,526 11.40 4.37 31,382 Vested and expected to vest at June 30, 2022 11,146 $ 11.37 4.31 $ 30,946 Exercisable at June 30, 2022 6,542 $ 11.52 3.09 $ 21,654 |
Summary of Restricted Stock Units Activity | Restricted stock unit activity under our stock-based compensation plans during the six months ended June 30, 2022 was as follows (in thousands except per share amounts): Number of Shares Weighted-Average Non-vested as of December 31, 2021 2,651 $ 8.30 Granted 2,021 12.42 Vested ( 1,009 ) 8.21 Forfeited ( 168 ) 10.40 Non-vested as of June 30, 2022 3,495 10.60 |
Summary Of Performance Based Restricted Stock Unit | We granted performance-based restricted stock unit (“PSU”) to certain executives. These PSUs vest upon a specified market condition. The summary of PSU activities for the six months ended June 30, 2022 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2021 237 $ 8.40 Granted 193 11.62 Vested ( 237 ) 8.40 Non-vested as of June 30, 2022 193 $ 11.62 |
Fair Value-Based Measurements and Weighted-Average Assumptions | The fair value-based measurement of each option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows: Stock Options Stock Options Market-Based Performance Stock Unit (“PSUs”) Three Months Ended Six Months Ended Six Months Ended June 30, June 30, June 30 2022 2021 2022 2021 2022 Weighted-average fair value per share $ 7.39 $ 6.20 $ 7.97 $ 6.57 $ 11.62 Risk-free interest rate 2.9 % 0.9 % 2.01 % 0.6 % 1.7 % Expected life (in years) 4.5 4.5 4.5 4.5 2.9 Volatility 0.8 0.9 0.8 1.0 0.9 |
Stock-Based Compensation Expense | The components of stock-based compensation expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Research and development $ 1,463 $ 937 $ 2,739 $ 1,809 Selling, general and administrative 5,597 3,445 11,024 6,589 Cost of sales - product 143 155 303 324 Inventory 726 487 1,509 1,025 Total $ 7,929 $ 5,024 $ 15,575 $ 9,747 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | May 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Long-term debt, net of debt discount | $ 4,470,000 | $ 4,470,000 | $ 5,010,000 | |||
Net income | 128,755,000 | $ 4,473,000 | $ 161,614,000 | $ 5,364,000 | ||
Maximum | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Expected period of payment to be received | 1 year | |||||
2.50% Convertible Senior Notes Due 2026 | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Aggregate principal amount | $ 225,500,000 | $ 225,500,000 | $ 200,000,000 | |||
Debt interest rate | 2.50% | 2.50% | 2.50% | |||
Long-term debt, net of debt discount | $ 4,500,000 | $ 4,500,000 | ||||
Debt maturity date | May 15, 2026 | |||||
HEPLISAV-B | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Minimum age approved for vaccine prevention of infection caused | 18 years | |||||
Increase in revenue adjustment | 700,000 | $ 700,000 | ||||
Inventory reserve | 0 | 0 | 0 | 0 | ||
CpG 1018 | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Inventory reserve | $ 0 | $ 0 | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) $ in Millions | Jun. 30, 2022 USD ($) shares |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value of the convertible notes | $ | $ 337.3 |
Fair Value, Inputs, Level 2 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Number of shares | shares | 1,882,600,000 |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Assets | ||
Total assets | $ 504,178 | $ 538,955 |
Money Market Funds | ||
Assets | ||
Total assets | 211,632 | 429,194 |
U.S. Treasuries | ||
Assets | ||
Total assets | 62,891 | 4,004 |
U.S. Government Agency Securities | ||
Assets | ||
Total assets | 1,748 | 26,548 |
Corporate Debt Securities | ||
Assets | ||
Total assets | 227,907 | 79,209 |
Warrant Liability | ||
Liabilities | ||
Total liabilities | 18,016 | |
Fair Value, Inputs, Level 1 | ||
Assets | ||
Total assets | 211,632 | 429,194 |
Fair Value, Inputs, Level 1 | Money Market Funds | ||
Assets | ||
Total assets | 211,632 | 429,194 |
Fair Value, Inputs, Level 1 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | Corporate Debt Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | Warrant Liability | ||
Liabilities | ||
Total liabilities | 0 | |
Fair Value, Inputs, Level 2 | ||
Assets | ||
Total assets | 292,546 | 109,761 |
Fair Value, Inputs, Level 2 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 | U.S. Treasuries | ||
Assets | ||
Total assets | 62,891 | 4,004 |
Fair Value, Inputs, Level 2 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 1,748 | 26,548 |
Fair Value, Inputs, Level 2 | Corporate Debt Securities | ||
Assets | ||
Total assets | 227,907 | 79,209 |
Fair Value, Inputs, Level 2 | Warrant Liability | ||
Liabilities | ||
Total liabilities | 0 | |
Fair Value, Inputs, Level 3 | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate Debt Securities | ||
Assets | ||
Total assets | $ 0 | 0 |
Fair Value, Inputs, Level 3 | Warrant Liability | ||
Liabilities | ||
Total liabilities | $ 18,016 |
Summary of Changes in Fair Valu
Summary of Changes in Fair Value Warrant liability (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Balance | $ 18,016 |
Decrease in fair value of warrants exercised and/or expired | (1,801) |
Warrants exercised and/or expired | (16,215) |
Balance | $ 0 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 249,091 | $ 436,189 | $ 129,608 | $ 32,073 |
Restricted cash | 202 | 219 | 229 | 237 |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ 249,293 | $ 436,408 | $ 129,837 | $ 32,310 |
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 | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 249,101 | $ 436,189 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (10) | 0 |
Estimated Fair Value | 249,091 | 436,189 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 270,968 | 109,760 |
Unrealized Gains | 0 | 9 |
Unrealized Losses | (1,890) | (8) |
Estimated Fair Value | 269,078 | 109,761 |
Marketable Securities Available-for-Sale | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 520,069 | 545,949 |
Unrealized Gains | 0 | 9 |
Unrealized Losses | (1,900) | (8) |
Estimated Fair Value | 518,169 | 545,950 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 13,991 | 6,995 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 13,991 | 6,995 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 211,632 | 429,194 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 211,632 | 429,194 |
U.S. Treasuries | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 63,190 | |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 4,005 | |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (299) | (1) |
Estimated Fair Value | 62,891 | 4,004 |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 1,750 | 26,555 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (2) | (7) |
Estimated Fair Value | 1,748 | 26,548 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 23,478 | |
Unrealized Gains | 0 | |
Unrealized Losses | (10) | |
Estimated Fair Value | 23,468 | |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 206,028 | 79,200 |
Unrealized Gains | 0 | 9 |
Unrealized Losses | (1,589) | 0 |
Estimated Fair Value | $ 204,439 | $ 79,209 |
Cash, Cash Equivalents, Restr_5
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Jun. 30, 2022 USD ($) |
Amortized Cost | |
Mature in one year or less | $ 270,968 |
Mature after one year through two years | 0 |
Debt Securities, Available-for-sale, Maturity, Allocated and Single Maturity Date, Amortized Cost, Total | 270,968 |
Estimated Fair Value | |
Mature in one year or less | 269,078 |
Mature after one year through two years | 0 |
Total estimated fair value | $ 269,078 |
Cash, Cash Equivalents, Restr_6
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 32,789 | $ 26,637 |
Work-in-process | 18,189 | 14,748 |
Finished goods | 23,001 | 19,950 |
Total | $ 73,979 | $ 61,335 |
Inventories, Net - Additional I
Inventories, Net - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory [Line Items] | ||
Prepaid manufacturing | $ 54,477 | $ 159,655 |
Finished goods | 23,001 | 19,950 |
HEPLISAV-B | ||
Inventory [Line Items] | ||
Finished goods inventory | 11,400 | 18,600 |
CpG 1018 Adjuvant Inventory | ||
Inventory [Line Items] | ||
Prepaid manufacturing | $ 54,500 | $ 159,700 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||||
Sep. 17, 2018 USD ($) ft² | May 31, 2022 USD ($) | Mar. 31, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Aug. 31, 2020 USD ($) | Jul. 31, 2019 USD ($) ft² | Nov. 30, 2009 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 EUR (€) | Dec. 31, 2021 USD ($) | May 31, 2021 USD ($) | Dec. 31, 2004 EUR (€) | |
Loss Contingencies [Line Items] | |||||||||||||||
Sublease income | $ 2,025,000 | $ 1,670,000 | $ 3,634,000 | $ 3,692,000 | |||||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | 3,500,000 | 3,400,000 | |||||||||||||
Long-term debt, net of debt discount | 4,470,000 | 4,470,000 | $ 5,010,000 | ||||||||||||
Gain on sale of assets | 1,000,000 | 0 | 1,000,000 | 0 | |||||||||||
Selling, general and administrative | 36,179,000 | 21,583,000 | 68,351,000 | 44,006,000 | |||||||||||
Non-cancelable purchase and other commitments | 115,700,000 | 115,700,000 | |||||||||||||
Symphony Dynamo Holdings LLC | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
License arrangement contingent consideration percentage | 50% | ||||||||||||||
License Arrangement Contingent Payment To Acquire License | $ 50,000,000 | ||||||||||||||
License arrangement upfront payment | $ 50,000,000 | ||||||||||||||
TriSalus | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Payment to holdings | $ 2,500,000 | ||||||||||||||
Payment received for Pre-commercialization milestone | $ 1,000,000 | $ 1,000,000 | |||||||||||||
TriSalus | Asset Purchase Agreement | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Payment made for Pre-commercialization milestone | $ 500,000 | $ 500,000 | |||||||||||||
Deutsche Bank Securities | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Financial Instruments, Owned, at Fair Value | € | € 0.2 | ||||||||||||||
Deutsche Bank Securities | Letter of Credit [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Financial Instruments, Owned, at Fair Value | € | € 0.2 | ||||||||||||||
2.50% Convertible Senior Notes Due 2026 | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Aggregate principal amount | 225,500,000 | 225,500,000 | $ 200,000,000 | ||||||||||||
Long-term debt, net of debt discount | $ 4,500,000 | $ 4,500,000 | |||||||||||||
Debt maturity date | May 15, 2026 | ||||||||||||||
Powell Street Sublease | Emeryville, California (Premises) | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Lease area | ft² | 8,053 | 23,976 | |||||||||||||
Base rent per square feet | $ 4.65 | $ 3.90 | |||||||||||||
Horton Street Master Lease | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Percentage of excess rent paid to landlord | 50% | 50% | 50% | ||||||||||||
Horton Street Master Lease | Emeryville, California (Premises) | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Lease area | ft² | 75,662 | ||||||||||||||
Base rent per square feet | $ 4.75 | ||||||||||||||
Operations commencement date | Apr. 01, 2019 | ||||||||||||||
Tenant improvement allowance | $ 8,100 | ||||||||||||||
Lease option to extend | The Horton Street Master Lease has an initial term of 12 years, following the Horton Street Commencement Date with an option to extend the lease for two successive five-year terms. | ||||||||||||||
Horton Street Sublease | Emeryville, California (Premises) | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Lease area | ft² | 75,662 | ||||||||||||||
Base rent per square feet | $ 5.50 | ||||||||||||||
Lease expiration date | Mar. 31, 2031 | ||||||||||||||
Option to extend | The Horton Street Subtenant has no option to extend the sublease term. | ||||||||||||||
Horton Street Sublease | Emeryville, California (Premises) | Other Income (Expense) | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Sublease income | $ 2,000,000 | $ 1,700,000 | $ 3,600,000 | $ 3,700,000 | |||||||||||
Dusseldorf Lease | Germany | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Lease option to extend | The New Düsseldorf Lease has an initial term of 10 years, beginning on January 1, 2022, with an option to extend the lease for two successive five-year terms. |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease expense | $ 1,867 | $ 1,570 | $ 3,474 | $ 3,130 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Current portion of lease liabilities (included in other current liabilities) | $ 3,039 | $ 2,577 |
Long-term portion of lease liabilities | 33,677 | 34,316 |
Total operating lease liabilities | $ 36,716 | $ 36,893 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Sublease Income | ||
2022 (remaining) | $ 2,709 | |
2023 | 5,518 | |
2024 | 5,684 | |
2025 | 5,854 | |
2026 | 6,030 | |
Thereafter | 27,712 | |
Total | 53,507 | |
Operating Lease Liabilities | ||
2022 (remaining) | 3,195 | |
2023 | 6,512 | |
2024 | 6,646 | |
2025 | 6,123 | |
2026 | 5,861 | |
Thereafter | 27,161 | |
Total | 55,498 | |
Present value adjustment | (18,782) | |
Total | $ 36,716 | $ 36,893 |
Commitments and Contingencies_5
Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail) | Jun. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 8 years 3 months | 9 years 1 month 6 days |
Weighted average discount rate | 10.10% | 10.10% |
Collaboration, Development and
Collaboration, Development and Supply Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Sep. 30, 2021 | May 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Oct. 31, 2021 | Jan. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Account Receivable | $ 1,972,000 | $ 1,972,000 | $ 15,600,000 | ||||||
Revenue recognized | 256,464,000 | $ 52,767,000 | 370,456,000 | $ 136,102,000 | |||||
Accrued liabilities | 34,146,000 | 34,146,000 | 49,796,000 | ||||||
CpG 1018 | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 91,300,000 | 113,600,000 | |||||||
CEPI Partners [Member] | Reservation Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Increase in interest free unsecured forgiveable loan maximum borrowing capacity | $ 77,400,000 | ||||||||
Interest free unsecured forgiveable loan Maximum borrowing capacity | $ 176,400,000 | ||||||||
Clover | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 0 | 0 | |||||||
Clover | Supply Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue | 138,700,000 | 138,700,000 | 191,100,000 | ||||||
Accounts Receivable Net Current | 19,200,000 | 19,200,000 | 2,100,000 | ||||||
Contract asset balance | 71,300,000 | 71,300,000 | 62,500,000 | ||||||
Medigen | Supply Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 10,600,000 | 17,500,000 | |||||||
Accounts Receivable Net Current | 2,400,000 | ||||||||
Valneva SE | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Advance payment from customer | $ 55,400,000 | ||||||||
Consideration Allocated To The Remaining Performance Obligation | $ 55,400,000 | ||||||||
Deferred revenue | 55,400,000 | 55,400,000 | |||||||
Valneva SE | Supply Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue | 0 | 0 | 55,400,000 | ||||||
Revenue recognized | 68,000,000 | 24,500,000 | 68,000,000 | 89,400,000 | |||||
Accounts Receivable Net Current | 12,600,000 | 12,600,000 | 0 | ||||||
Biological E. Limited | Supply Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue | 47,700,000 | 47,700,000 | 103,300,000 | ||||||
Revenue recognized | 51,000,000 | 118,300,000 | |||||||
Accounts Receivable Net Current | 95,600,000 | 95,600,000 | 96,100,000 | ||||||
PT Bio Farma (Persero) | Supply Agreement | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue | 5,500,000 | 5,500,000 | |||||||
Revenue recognized | 12,300,000 | 14,300,000 | |||||||
Accounts Receivable Net Current | 17,900,000 | 17,900,000 | |||||||
U.S. Department of Defense | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 1,100,000 | 2,700,000 | |||||||
Proceeds from grant | $ 22,000,000 | ||||||||
Serum Institute of India Pvt. Ltd. | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | $ 100,000 | $ 300,000 | |||||||
Serum Institute of India Pvt. Ltd. | Other Revenues | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 34,326,000 | 100,000 | |||||||
CEPI Member | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Interest- free unsecured forgivable loan | $ 99,000,000 | ||||||||
Advance payment from customer | 175,100,000 | 175,100,000 | |||||||
Long-term deferred revenue | 5,400,000 | ||||||||
Account Receivable | 0 | 0 | 14,600,000 | ||||||
Accrued liabilities | $ 107,400,000 | $ 107,400,000 | $ 128,800,000 |
Convertible Notes - Additional
Convertible Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |
May 31, 2021 USD ($) | Jun. 30, 2022 USD ($) Days $ / shares shares | Jun. 30, 2021 USD ($) | |
Debt Instrument [Line Items] | |||
Proceeds from issuance of Convertible Notes, net | $ 0 | $ 219,822 | |
Fair value of the convertible notes | 337,300 | ||
2.50% Convertible Senior Notes Due 2026 | |||
Debt Instrument [Line Items] | |||
Aggregate principal amount | $ 200,000 | $ 225,500 | |
Debt interest rate | 2.50% | 2.50% | |
Additional issue amount | $ 25,500 | ||
Debt issuance and offering costs | 5,700 | $ 4,500 | |
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. | ||
Debt maturity date | May 15, 2026 | ||
Initial conversion rate | 95.5338 | ||
Debt conversion, original debt, principal amount converted | $ 1,000 | ||
Debt instrument, conversion price per share | $ / shares | $ 10.47 | ||
Debt instrument, convertible, threshold trading days | Days | 20 | ||
Debt instrument, convertible, threshold consecutive trading days | Days | 30 | ||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | ||
Debt Instrument, redemption, description | We may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation described in the indenture governing the Convertible Notes), at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. | ||
Debt instrument, redemption earliest date | May 20, 2024 | ||
Percentage of principal redeemed | 100% | ||
Debt instrument interest rate, effective percentage | 3.10% | ||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | |||
Debt Instrument [Line Items] | |||
Debt instrument, convertible, threshold trading days | Days | 20 | ||
Debt instrument, convertible, threshold consecutive trading days | Days | 30 | ||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | Maximum | |||
Debt Instrument [Line Items] | |||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | ||
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 | $ 15.80 | ||
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Disclosure [Abstract] | ||||
Stated coupon interest | $ 1,409 | $ 736 | $ 2,819 | $ 736 |
Amortization of debt issuance cost | 271 | 137 | 540 | 137 |
Total interest expense | $ 1,680 | $ 873 | $ 3,359 | $ 873 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Disaggregation of Revenues (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 256,464 | $ 52,767 | $ 370,456 | $ 136,102 |
UNITED STATES | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 32,822 | 13,688 | 55,238 | 22,251 |
Non-US | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 223,642 | 39,079 | 315,218 | 113,851 |
HEPLISAV-B | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 32,680 | 13,688 | 53,490 | 21,991 |
HEPLISAV-B | UNITED STATES | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 31,739 | 13,688 | 52,549 | 21,991 |
HEPLISAV-B | Non-US | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 941 | 0 | 941 | 0 |
CpG 1018 | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 222,640 | 38,989 | 314,157 | 113,571 |
CpG 1018 | UNITED STATES | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 0 | 0 | 0 | 0 |
CpG 1018 | Non-US | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 222,640 | 38,989 | 314,157 | 113,571 |
Product | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 255,320 | 52,677 | 367,647 | 135,562 |
Product | UNITED STATES | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 31,739 | 13,688 | 52,549 | 21,991 |
Product | Non-US | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 223,581 | 38,989 | 315,098 | 113,571 |
Other Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 1,144 | 90 | 2,809 | 540 |
Other Revenue | UNITED STATES | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 1,083 | 0 | 2,689 | 260 |
Other Revenue | Non-US | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 61 | $ 90 | $ 120 | $ 280 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Revenues from Major Customers (Detail) - Product Concentration Risk [Member] - Revenue Benchmark [Member] | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Largest Customer | HEPLISAV-B | ||||
Concentration Risk [Line Items] | ||||
Percentage of product revenue | 18% | 28% | 21% | 28% |
Second Largest Customer | HEPLISAV-B | ||||
Concentration Risk [Line Items] | ||||
Percentage of product revenue | 18% | 21% | 18% | 23% |
Third Largest Customer | HEPLISAV-B | ||||
Concentration Risk [Line Items] | ||||
Percentage of product revenue | 18% | 16% | 17% | 17% |
Largest Collaboration Partner | CpG 1018 | ||||
Concentration Risk [Line Items] | ||||
Percentage of product revenue | 41% | 63% | 38% | 79% |
Second Largest Collaboration Partner | CpG 1018 | ||||
Concentration Risk [Line Items] | ||||
Percentage of product revenue | 31% | 27% | 36% | 15% |
Third largest collaboration partner | CpG 1018 | ||||
Concentration Risk [Line Items] | ||||
Percentage of product revenue | 23% | 10% | 22% | 5% |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 USD ($) | ||
Accounts Receivable Reserves | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | $ 3,823 | [1] |
Provisions related to current period sales | 15,201 | [1] |
Credit or payments made during the period | (12,602) | [1] |
Balance at End of Period | 6,422 | [1] |
Revenue Reserve Accruals | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | 8,253 | [2] |
Provisions related to current period sales | 10,333 | [2] |
Credit or payments made during the period | (9,945) | [2] |
Balance at End of Period | $ 8,641 | [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 $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 USD ($) | ||
Balance at Beginning of Period | $ 62,525 | |
Additions (1) | 12,134 | [1] |
Subtractions (2) | (3,151) | [2] |
Balance at End of Period | $ 71,508 | |
[1] (1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement, as amended. (2) Subtractions are reclassifications from contract asset to accounts receivables. |
Revenue Recognition - Summary_4
Revenue Recognition - Summary of Balances and Activities Deferred Revenue Accounts (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 USD ($) | ||
Deferred Revenue Arrangement [Line Items] | ||
Balance at Beginning of Period | $ 349,864 | |
Balance at End of Period | 191,998 | |
CpG 1018 | ||
Deferred Revenue Arrangement [Line Items] | ||
Balance at Beginning of Period | 349,864 | |
Additions (1) | 12,068 | [1] |
Subtractions (2) | (6,534) | [2] |
Revenue recognized in the current period included in deferred revenue balance at the beginning of the period | (163,400) | |
Balance at End of Period | 191,998 | |
Long-term Deferred Revenue | CpG 1018 | ||
Deferred Revenue Arrangement [Line Items] | ||
Balance at Beginning of Period | 5,385 | |
Additions (1) | 6,582 | [1] |
Subtractions (2) | $ (11,967) | [2] |
[1] Additions are primarily payments received or invoices issued before we satisfy our performance obligations. Subtractions are primarily revenues recognized in the period included in deferred revenue during the period and reclassification from long-term deferred revenue to accrued liabilities. |
Computation of Basic and Dilute
Computation of Basic and Diluted Net (Loss) Income Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract] | ||||
Net income | $ 128,755 | $ 4,473 | $ 161,614 | $ 5,364 |
Less: undistributed earnings allocated to participating securities | 0 | (333) | (316) | (410) |
Net (loss) income attributable to common stockholders, basic | 128,755 | 4,140 | 161,298 | 4,954 |
Add: undistributed earnings allocated to participating securities | 0 | 0 | 316 | 0 |
Less: Removal of change in fair value of warrant liability | 0 | (2,097) | (1,801) | 23,455 |
Interest Expense, Medium-term Notes | 1,260 | 0 | 2,519 | 0 |
Net loss attributable to common stockholders, diluted | $ 130,015 | $ 2,043 | $ 162,332 | $ 4,954 |
Weighted average common stock outstanding, basic | 126,347 | 114,629 | 125,456 | 113,339 |
Effect of dilutive shares: | ||||
Stock-based compensation plans | 2,015 | 1,630 | 2,659 | 1,639 |
Effect of dilutive warrants | 0 | 2,571 | 163 | 0 |
Convertible Notes (as converted to common stock) | 21,543 | 0 | 21,543 | 0 |
Weighted average common stock outstanding, diluted | 149,905 | 118,830 | 149,821 | 114,978 |
Outstanding Stock Options and S
Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Outstanding securities not included in diluted net income (loss) per share calculation: | ||||
Outstanding securities not included in diluted net loss per share calculation | 9,647 | 22,494 | 9,067 | 20,803 |
Warrants | ||||
Outstanding securities not included in diluted net income (loss) per share calculation: | ||||
Outstanding securities not included in diluted net loss per share calculation | 0 | 0 | 0 | 2,474 |
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 | 9,647 | 6,991 | 9,067 | 8,476 |
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 | 0 | 11,363 | 0 | 5,713 |
Series B Convertible Preferred Stock | ||||
Outstanding securities not included in diluted net income (loss) per share calculation: | ||||
Outstanding securities not included in diluted net loss per share calculation | 0 | 4,140 | 0 | 4,140 |
Common Stock, Preferred Stock_2
Common Stock, Preferred Stock and Warrants - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Aug. 06, 2020 | Aug. 31, 2019 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Class Of Stock [Line Items] | ||||||||
Common stock, shares outstanding | 126,439,073 | 126,439,073 | 122,945,000 | |||||
Issuance of common stock and preferred stock (in shares) | 18,525,000 | |||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Cash Settlement of warrants | $ 8,500 | |||||||
Number of common stock warrants exercised | 1,882,600 | |||||||
Change in fair value of warrant liability | $ 0 | $ (2,097) | $ (1,801) | $ 23,455 | ||||
Warrants | Other Income, Net | ||||||||
Class Of Stock [Line Items] | ||||||||
Change in fair value of warrant liability | 1,800 | |||||||
Bain Life Sciences | ||||||||
Class Of Stock [Line Items] | ||||||||
Net cash proceeds received from issuance or sale of equity | $ 35,000 | |||||||
Offering | ||||||||
Class Of Stock [Line Items] | ||||||||
Net cash proceeds received from issuance or sale of equity | $ 65,600 | |||||||
2017 ATM Agreement | ||||||||
Class Of Stock [Line Items] | ||||||||
Remaining proceeds from common stock, under sales agreement | $ 120,500 | |||||||
Series B Convertible Preferred Stock | ||||||||
Class Of Stock [Line Items] | ||||||||
Issuance of common stock and preferred stock (in shares) | 4,840 | |||||||
Preferred stock, par value | $ 0.001 | |||||||
Maximum | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock sales agreement aggregate sales proceeds | $ 150,000 | |||||||
Maximum | Offering | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant issued | 5,841,250 | |||||||
Maximum | 2017 ATM Agreement | ||||||||
Class Of Stock [Line Items] | ||||||||
Commission on gross sales proceeds of common stock | 3% |
Equity Plans and Stock-Based _3
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - shares | 6 Months Ended | |
Jun. 30, 2022 | May 31, 2022 | |
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 | |
2018 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Newly reserved shares of common stock | 15,465,070 | |
2014 Employee Stock Purchase Plan | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Shares issued to employees | 32,600,000 |
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 | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Shares Underlying Outstanding Options | ||
Beginning balance | 10,399 | |
Options granted | 2,053 | |
Options exercised | (287) | |
Ending balance | 11,526 | 10,399 |
Vested and expected to vest as of June 30, 2022 | 11,146 | |
Exercisable as of June 30, 2022 | 6,542 | |
Weighted-Average Exercise Price Per Share | ||
Beginning balance | $ 11.55 | |
Options granted | 12.54 | |
Options exercised | 7.49 | |
Ending balance | 11.40 | $ 11.55 |
Vested and expected to vest as of June 30, 2022 | 11.37 | |
Exercisable as of June 30, 2022 | $ 11.52 | |
Weighted-Average Remaining Contractual Term (years) | ||
Weighted - Average Remaining Contractual Term (years), balance | 4 years 4 months 13 days | 4 years 1 month 28 days |
Vested and expected to vest as of June 30, 2022 | 4 years 3 months 21 days | |
Exercisable as of June 30, 2022 | 3 years 1 month 2 days | |
Aggregate Intrinsic Value | ||
Balance as of December 31, 2021 | $ 42,756 | |
Balance as of June 30, 2022 | 31,382 | $ 42,756 |
Vested and expected to vest as of June 30, 2022 | 30,946 | |
Exercisable as of June 30, 2022 | $ 21,654 | |
Unvested | ||
Shares Underlying Outstanding Options | ||
Options cancelled | (73) | |
Weighted-Average Exercise Price Per Share | ||
Options cancelled | $ 9.52 | |
Vested | ||
Shares Underlying Outstanding Options | ||
Options cancelled | (566) | |
Weighted-Average Exercise Price Per Share | ||
Options cancelled | $ 20.63 |
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 | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Number of Shares | |
Non-vested, Beginning Balance | shares | 2,651 |
Granted | shares | 2,021 |
Vested | shares | (1,009) |
Forfeited | shares | (168) |
Non-vested, Ending Balance | shares | 3,495 |
Weighted-Average Grant-Date Fair Value Per Share | |
Non-vested, Beginning Balance | $ / shares | $ 8.30 |
Granted | $ / shares | 12.42 |
Vested | $ / shares | 8.21 |
Forfeited | $ / shares | 10.40 |
Non-vested, Ending Balance | $ / shares | $ 10.60 |
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 | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Weighted-Average Grant-Date Fair Value Per Share | |
Non-vested, Beginning Balance | $ / shares | $ 8.40 |
Granted | $ / shares | 11.62 |
Vested | $ / shares | 8.40 |
Non-vested, Ending Balance | $ / shares | $ 11.62 |
Number of Shares | |
Non-vested, Beginning Balance | shares | 237 |
Granted | shares | 193 |
Vested | shares | (237) |
Non-vested, Ending Balance | shares | 193 |
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Payment Arrangement, Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted-average fair value per share | $ 7.39 | $ 6.20 | $ 7.97 | $ 6.57 |
Risk-free interest rate | 2.90% | 0.90% | 2.01% | 0.60% |
Expected life (in years) | 4 years 6 months | 4 years 6 months | 4 years 6 months | 4 years 6 months |
Volatility | 0.80% | 0.90% | 0.80% | 1% |
Market Based Performance Stock Unit | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted-average fair value per share | $ 11.62 | |||
Risk-free interest rate | 1.70% | |||
Expected life (in years) | 2 years 10 months 24 days | |||
Volatility | 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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | $ 7,929 | $ 5,024 | $ 15,575 | $ 9,747 |
Research and Development | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 1,463 | 937 | 2,739 | 1,809 |
Selling, General and Administrative | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 5,597 | 3,445 | 11,024 | 6,589 |
Cost of Sales - Product | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 143 | 155 | 303 | 324 |
Inventory | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | $ 726 | $ 487 | $ 1,509 | $ 1,025 |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 619 | $ 0 | $ 619 | $ 0 |
Effective Tax Rate | 0.40% | 0.40% |