Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 03, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | DVAX | |
Entity Registrant Name | Dynavax Technologies Corp | |
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 | 114,588,212 | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-34207 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-0728374 | |
Entity Address, Address Line One | 2100 Powell Street | |
Entity Address, Address Line Two | Suite 900 | |
Entity Address, City or Town | Emeryville | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94608 | |
City Area Code | 510 | |
Local Phone Number | 848-5100 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 79,055 | $ 32,073 |
Marketable securities available-for-sale | 153,619 | 132,963 |
Accounts and other receivables, net | 83,994 | 22,661 |
Inventories, net | 68,846 | 63,689 |
Prepaid manufacturing | 32,642 | 29,423 |
Prepaid expenses and other current assets | 9,377 | 9,206 |
Total current assets | 427,533 | 290,015 |
Property and equipment, net | 30,696 | 30,567 |
Operating lease right-of-use assets | 25,799 | 26,583 |
Goodwill | 2,197 | 2,297 |
Restricted cash | 226 | 237 |
Other assets | 3,668 | 3,573 |
Total assets | 490,119 | 353,272 |
Current liabilities: | ||
Accounts payable | 3,154 | 3,312 |
Accrued research and development | 2,890 | 2,805 |
Accrued liabilities | 16,083 | 19,099 |
Warrant liability | 31,737 | 10,736 |
Deferred revenue | 52,202 | 38,212 |
Other current liabilities | 3,356 | 3,247 |
Total current liabilities | 109,422 | 77,411 |
Long-term debt, net of debt discount of $1,016 and $1,094 at March 31, 2021 and December 31, 2020, respectively | 179,889 | 179,811 |
Long-term deferred revenue | 64,350 | |
Long-term portion of lease liabilities | 33,795 | 34,789 |
Other long-term liabilities | 2,901 | 2,568 |
Total liabilities | 390,357 | 294,579 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock value | ||
Common stock: $0.001 par value; 278,000 shares authorized at March 31, 2021 and December 31, 2020; 114,563 shares and 110,190 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 114 | 110 |
Additional paid-in capital | 1,393,947 | 1,352,374 |
Accumulated other comprehensive (loss) gain | (1,126) | 273 |
Accumulated deficit | (1,293,173) | (1,294,064) |
Total stockholders’ equity | 99,762 | 58,693 |
Total liabilities and stockholders’ equity | 490,119 | 353,272 |
Series B Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock value |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Long-term debt, net of debt discount | $ 1,016 | $ 1,094 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 278,000,000 | 278,000,000 |
Common stock, shares issued | 114,563,000 | 110,190,000 |
Common stock, shares outstanding | 114,563,212 | 110,190,000 |
Series B Convertible Preferred Stock | ||
Preferred stock, shares issued | 4,000 | 4,000 |
Preferred stock, shares outstanding | 4,140 | 4,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenues: | ||
Total revenues | $ 83,335 | $ 10,919 |
Operating expenses: | ||
Cost of sales - amortization of intangible assets | 2,298 | |
Research and development | 7,758 | 4,653 |
Selling, general and administrative | 22,423 | 20,926 |
Total operating expenses | 54,806 | 30,231 |
Income (loss) from operations | 28,529 | (19,312) |
Other income (expense): | ||
Interest income | 47 | 590 |
Interest expense | (4,712) | (4,731) |
Sublease income | 2,022 | 1,926 |
Change in fair value of warrant liability (Note 10) | (25,552) | 8,610 |
Other | 557 | 322 |
Net income (loss) | $ 891 | $ (12,595) |
Net income (loss) per share attributable to common stockholders | ||
Basic | $ 0.01 | $ (0.15) |
Diluted | $ 0.01 | $ (0.25) |
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders: | ||
Basic | 112,035 | 85,477 |
Diluted | 113,469 | 85,648 |
Product | ||
Revenues: | ||
Total revenues | $ 82,885 | $ 10,514 |
Operating expenses: | ||
Cost of sales - product | 24,625 | 2,354 |
Cost of sales - amortization of intangible assets | 2,298 | |
Other Revenue | ||
Revenues: | ||
Total revenues | $ 450 | $ 405 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net income (loss) | $ 891 | $ (12,595) |
Other comprehensive income (loss), net of tax: | ||
Change in unrealized gain on marketable securities available- for-sale | (9) | 291 |
Foreign currency translation adjustments | (1,390) | (479) |
Total other comprehensive loss | (1,399) | (188) |
Total comprehensive loss | $ (508) | $ (12,783) |
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, 2019 | $ 8,290 | $ 84 | $ 1,229,417 | $ (2,387) | $ (1,218,824) | |
Beginning Balances (in shares) at Dec. 31, 2019 | 83,871 | 5 | ||||
Issuance of common stock upon exercise of stock options and restricted stock awards, net | (1) | $ 1 | (2) | |||
Issuance of common upon exercise of stock options and restricted stock awards, net (in shares) | 728 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 311 | 311 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 91 | |||||
Issuance of common stock, net of issuance costs, in conjunction with an At Market Sales Agreement | 14,229 | $ 3 | 14,226 | |||
Issuance of common stock, net of issuance costs, in conjunction with an At Market Sales Agreement (in shares) | 2,909 | |||||
Stock compensation expense | 1,778 | 1,778 | ||||
Total other comprehensive income (Loss) | (188) | (188) | ||||
Net income (loss) | (12,595) | (12,595) | ||||
Ending Balances at Mar. 31, 2020 | 11,824 | $ 88 | 1,245,730 | (2,575) | (1,231,419) | |
Ending Balances (in shares) at Mar. 31, 2020 | 87,599 | 5 | ||||
Beginning Balances at Dec. 31, 2020 | 58,693 | $ 110 | 1,352,374 | 273 | (1,294,064) | |
Beginning Balances (in shares) at Dec. 31, 2020 | 110,190 | 4 | ||||
Exercise of warrants | 7,928 | $ 1 | 7,927 | |||
Stock Issued Exercise of Warrants During Period, Shares, New Issues | 750 | |||||
Issuance of common stock upon exercise of stock options and restricted stock awards, net | 387 | 387 | ||||
Issuance of common upon exercise of stock options and restricted stock awards, net (in shares) | 640 | |||||
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 At Market Sales Agreement | 28,156 | $ 3 | 28,153 | |||
Issuance of common stock, net of issuance costs, in conjunction with an At Market Sales Agreement (in shares) | 2,879 | |||||
Stock compensation expense | 4,723 | 4,723 | ||||
Total other comprehensive income (Loss) | (1,399) | (1,399) | ||||
Net income (loss) | 891 | 891 | ||||
Ending Balances at Mar. 31, 2021 | $ 99,762 | $ 114 | $ 1,393,947 | $ (1,126) | $ (1,293,173) | |
Ending Balances (in shares) at Mar. 31, 2021 | 114,563 | 4 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities | ||
Net income (loss) | $ 891 | $ (12,595) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 1,106 | 1,014 |
Amortization of right-of-use assets | 653 | 634 |
Gain on disposal of property and equipment and from lease termination | (76) | |
Amortization of premium (accretion of discounts) on marketable securities | 221 | (87) |
Change in fair value of warrant liability | 25,552 | (8,610) |
Stock compensation expense | 4,723 | 1,778 |
Cost of sales - amortization of intangible assets | 2,298 | |
Non-cash interest expense | 414 | 1,338 |
Tenant improvements provided by the landlord | 908 | |
Changes in operating assets and liabilities: | ||
Accounts and other receivables, net | (61,333) | 751 |
Inventories, net | (5,157) | (6,767) |
Prepaid manufacturing | 3,219 | |
Prepaid expenses and other current assets | (171) | (1,000) |
Other assets | (95) | 43 |
Accounts payable | (295) | (2,095) |
Lease liabilities | (751) | (672) |
Deferred revenue | 78,340 | |
Accrued liabilities and other liabilities | (2,847) | (3,728) |
Net cash provided by (used in) operating activities | 38,032 | (26,866) |
Investing activities | ||
Acquisition of technology licenses | (7,000) | |
Purchases of marketable securities | (72,016) | (17,985) |
Proceeds from maturities and redemptions of marketable securities | 51,130 | 37,900 |
Purchases of property and equipment, net | (1,747) | (2,352) |
Net cash (used in) provided by investing activities | (22,633) | 10,563 |
Financing activities | ||
Proceeds from issuance of common stock, net | 28,156 | 14,229 |
Proceeds from exercise of warrants | 3,377 | |
Proceeds (tax withholding) from exercise of stock options and restricted stock awards, net | 387 | (1) |
Proceeds from Employee Stock Purchase Plan | 383 | 311 |
Net cash provided by financing activities | 32,303 | 14,539 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (731) | (225) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 46,971 | (1,989) |
Cash, cash equivalents and restricted cash at beginning of period | 32,310 | 40,100 |
Cash, cash equivalents and restricted cash at end of period | 79,281 | 38,111 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 4,296 | 3,412 |
Non-cash investing and financing activities: | ||
Purchases of property and equipment, not yet paid | $ 411 | $ 408 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
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 novel vaccines. Our first marketed product, HEPLISAV-B® (Hepatitis B Vaccine (Recombinant), Adjuvanted) is approved in the United States and European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. We also manufacture and sell CpG 1018, the adjuvant used in HEPLISAV-B. We are working to develop CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. 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 at December 31, 2020 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 our Annual Report on Form 10-K for the year ended December 31, 2020, 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 and Dynavax India LLP in India. 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. Liquidity and Financial Condition As of March 31, 2021, we had cash, cash equivalents and marketable securities of $232.7 million. Prior to January 1, 2021, we incurred net losses in each year since our inception. For the three months ended March 31, 2021, we recorded net income of $0.9 million. We incurred net loss of $12.6 million for three months ended March 31, 2020. We cannot be certain that sales of our products, and the revenue from our other activities are sustainable. Further, we expect to continue to incur substantial expenses as we continue to invest in commercialization of HEPLISAV-B, development of our CpG 1018 adjuvant and clinical trials and other development. If we cannot generate a sufficient amount of revenue from product sales, we will need to finance our operations through strategic alliance and licensing arrangements and/or future public or private debt and equity financings. Raising additional funds through the issuance of equity or debt securities could result in dilution to our existing stockholders, increased fixed payment obligations, or both. In addition, these securities may have rights senior to those of our common stock and could include covenants that would restrict our operations. We currently anticipate that our cash, cash equivalents and short-term marketable securities as of March 31, 2021 Our ability to raise additional capital in the equity and debt markets, should we choose to do so, is dependent on a number of factors, including, but not limited to, the market demand for our common stock, which itself is subject to a number of development and business risks and uncertainties, our creditworthiness and the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. In addition, global financial crises and economic downturns, including those cause by widespread public health crises such as the COVID-19 pandemic, may cause extreme volatility and disruptions in capital and credit markets, and may impact our ability to raise additional capital when needed on acceptable terms, if at all. Adequate financing may not be available to us on acceptable terms, or at all. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. 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. However, the worldwide spread of COVID-19 has resulted in a global slowdown of economic activity which is likely to decrease demand for a broad variety of goods and services, while also disrupting sales channels and marketing activities for an unknown period of time until the disease is contained. We are unable to predict the future effect resulting from the COVID-19 pandemic. Actual results could differ materially from management’s estimates. 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. 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. There have been no material adjustments to these estimates for the three months ended March 31, 2021 and 2020 Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product th at 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 reven ue 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 , shelf life of the product 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 CpG 1018 adjuvant to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 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. 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. Collaboration and Manufacturing Service Revenue We have entered into 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. Collaboration and manufacturing service revenue are recorded in other revenue in the condensed consolidated statements of operations. Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the three months ended March 31, 2021 and 2020, 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. HEPLISAV-B was approved by the United States Food and Drug Administration (“FDA”) on November 9, 2017, at which time we began to capitalize inventory costs associated with the vial presentation of HEPLISAV-B. In March 2018, we received regulatory approval of the pre-filled syringe (“PFS”) presentation of HEPLISAV-B. Prior to FDA approval of HEPLISAV-B, all costs related to the manufacturing of HEPLISAV-B that could potentially be available to support the commercial launch of our products, were charged to research and development expense in the period incurred as there was no alternative future use. Prior to regulatory approval of PFS, costs associated with resuming operating activities at the Düsseldorf manufacturing facility were also included in research and development expense. Subsequent to regulatory approval of PFS, costs associated with resuming manufacturing activities at the Düsseldorf facility were included in cost of sales – product, until commercial production resumed in mid-2018 at which time these costs were recorded as raw materials inventory. Recent Accounting Pronouncements Accounting Standards Update 2019-12 In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740). This ASU simplifies the accounting for income taxes by removing certain exceptions and improving consistent application in certain areas of Topic 740. The ASU is effective for annual periods beginning after December 15, 2020 with early adoption permitted. We adopted this ASU on January 1, 2021 and the adoption of this standard did not have a material impact on our consolidated financial statements. Accounting Standards Update 2020-06 We adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity on January 1, 2021 using the modified retrospective method. This ASU simplifies the accounting for convertible instruments and requires entities to use the if-converted method for all convertible instruments in calculating diluted earnings-per-share. Entities also need to recombine instruments that were previously separated into two units of account if separation is no longer required. The adoption of this ASU did not have a material impact on our condensed consolidated financial statements as there were no outstanding financial instruments that require recombination at January 1, 2021. 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 consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
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. 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 March 31, 2021 Assets Money market funds $ 71,374 $ - $ - $ 71,374 U.S. treasuries - 28,465 - 28,465 U.S. government agency securities - 47,472 - 47,472 Corporate debt securities - 77,682 - 77,682 Total assets $ 71,374 $ 153,619 $ - $ 224,993 Liabilities Warrant liability $ - $ - $ 31,737 $ 31,737 Level 1 Level 2 Level 3 Total December 31, 2020 Assets Money market funds $ 23,128 $ - $ - $ 23,128 U.S. treasuries - 32,579 - 32,579 U.S. government agency securities - 40,321 - 40,321 Corporate debt securities - 61,063 - 61,063 Total assets $ 23,128 $ 133,963 $ - $ 157,091 Liabilities Warrant liability $ - $ - $ 10,736 $ 10,736 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. The fair value of the warrant liability is estimated using the Black-Scholes model which requires assumptions such as expected term, expected volatility and risk-free interest rate. These assumptions are subjective and require judgement to develop. Expected term is estimated using the full remaining contractual term of the warrants. We determine expected volatility based on our historical common stock price volatility. The warrant liability is classified as a Level 3 instrument as its value is based on unobservable inputs that are supported by little or no market activity. As of March 31, 2021, we used the following key assumptions to estimate the fair value of warrant liability: Number of shares 5,090,942 Expected term 0.9 year Expected volatility 1.2 Risk-free interest rate 0.1 % Dividend yield 0 % The following table provides a summary of changes in the fair value warrant liability for the three months ended March 31, 2021 (in thousands): Balance at December 31, 2020 $ 10,736 Increase in fair value of warrants exercised 3,172 Warrants exercised (4,551 ) Increase in the estimated fair value of warrant liability upon revaluation 22,380 Balance at March 31, 2021 $ 31,737 |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 3 Months Ended |
Mar. 31, 2021 | |
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): March 31, 2021 December 31, 2020 March 31, 2020 December 31, 2019 Cash and cash equivalents $ 79,055 $ 32,073 $ 37,899 $ 39,884 Restricted cash 226 237 212 216 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 79,281 $ 32,310 $ 38,111 $ 40,100 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 Cost Unrealized Gains Unrealized Losses Estimated Fair Value March 31, 2021 Cash and cash equivalents: Cash $ 7,681 $ - $ - $ 7,681 Money market funds 71,374 - - 71,374 Total cash and cash equivalents 79,055 - - 79,055 Marketable securities available-for-sale: U.S. treasuries 28,448 17 - 28,465 U.S. government agency securities 47,462 17 (7 ) 47,472 Corporate debt securities 77,687 8 (13 ) 77,682 Total marketable securities available-for-sale 153,597 42 (20 ) 153,619 Total cash, cash equivalents and marketable securities $ 232,652 $ 42 $ (20 ) $ 232,674 December 31, 2020 Cash and cash equivalents: Cash $ 7,945 $ - $ - $ 7,945 Money market funds 23,128 - - 23,128 Corporate debt securities 1,000 - - 1,000 Total cash and cash equivalents 32,073 - - 32,073 Marketable securities available-for-sale: U.S. treasuries 32,548 31 - 32,579 U.S. government agency securities 40,313 14 (6 ) 40,321 Corporate debt securities 60,071 3 (11 ) 60,063 Total marketable securities available-for-sale 132,932 48 (17 ) 132,963 Total cash, cash equivalents and marketable securities $ 165,005 $ 48 $ (17 ) $ 165,036 The maturities of our marketable securities available-for-sale are as follows (in thousands): March 31, 2021 Amortized Cost Estimated Fair Value Mature in one year or less $ 137,849 $ 137,877 Mature after one year through two years 15,748 15,742 $ 153,597 $ 153,619 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 realized gains or losses from the sale of marketable securities during the three months ended March 31, 2021 and 2020. All investments with unrealized losses at March 31, 2021 have been in a loss position for less than twelve months. We do not intend to sell the investments that are in an unrealized loss position before recovery of their amortized cost basis. To date, there have been no declines in fair value that have been identified as other than temporary. |
Inventories, Net
Inventories, Net | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories, net | 4. Inventories, net The following table presents inventories, net (in thousands): March 31, 2021 December 31, 2020 Raw materials $ 25,137 $ 25,121 Work-in-process 20,525 30,293 Finished goods 23,184 8,275 Total $ 68,846 $ 63,689 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
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, Emeryville, California (the “Powell Street Sublease”) and the lease for our former corporate headquarters at 2929 Seventh Street, Berkeley, California was terminated effective August 31, 2019. Under the terms of the Powell Street Sublease, we are leasing 23,976 square feet at the rate of $3.90 per square foot, paid on a monthly basis. Rent is subject to scheduled annual increases and we are responsible for certain operating expenses and taxes throughout the life of the Powell Street Sublease. The Powell Street Sublease will continue until June 30, 2022. There is no option to extend the sublease term. On September 17, 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 (“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 March 31, 2021. The Horton Street Master Lease has an initial term of 12 years, following the Commencement Date with an option to extend the lease for two successive five-year 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 (“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 Subtenant has no option to extend the sublease term. Sublease income for the three months ended March 31, 2021 and 2020 were $2.0 million and $1.9 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 Subtenant in excess of rent paid to the landlord shall be shared by paying the landlord 50% of the excess rent. The excess rent is considered a variable lease payment and the total estimated payments are being recognized as additional rent expense on a straight-line basis. Our lease expense comprises of the following (in thousands): Three Months Ended March 31, 2021 2020 Operating lease expense $ 1,560 $ 1,592 Cash paid for amounts included in the measurement of lease liabilities for each of the three months ended March 31, 2021 and 2020 was $1.7 million and was included in change in lease liabilities in our condensed consolidated statement of cash flows. The balance sheet classification of our operating lease liabilities was as follows (in thousands): March 31, 2021 December 31, 2020 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 3,356 $ 3,247 Long-term portion of lease liabilities 33,795 34,789 Total operating lease liabilities $ 37,151 $ 38,036 At March 31, 2021, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease Liabilities 2021 (remaining) $ 3,915 $ 5,215 2022 5,357 6,240 2023 5,518 5,377 2024 5,684 5,521 2025 5,854 5,670 Thereafter 33,742 30,704 Total $ 60,070 58,727 Less: Present value adjustment (21,576 ) Total $ 37,151 The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: March 31, 2021 December 31, 2020 Weighted average remaining lease term 9.0 years 9.1 years Weighted average discount rate 10.1 % 10.1 % Commitments On February 20, 2018, we entered into a $175.0 million term loan agreement (“Loan Agreement”) with CRG Servicing LLC. We borrowed $100.0 million under the Loan Agreement at closing and the remaining $75.0 million in March 2019 (collectively, “Term Loans”). At our option, until September 30, 2023, a portion of the interest payments may be paid in kind, and thereby added to the principal. Through March 31, 2021, a portion of our interest was paid in kind, which increased the principal amount of the Term Loans. Included in our total contractual obligations of $188.1 million is the principal amount of $175.0 million, paid-in-kind interest of $5.9 million and the backend facility fee of $7.2 million. The Term Loans have a maturity date of December 31, 2023, unless earlier prepaid. See Note 7. As of March 31, 2021, our material non-cancelable purchase and other commitments, for the supply of HEPLISAV-B, CpG 1018 and for clinical research, totaled $90.9 million. During 2004, we established a letter of credit with Deutsche Bank as security for our Düsseldorf lease in the amount of €0.2 million (Euros). The letter of credit remained outstanding through March 31, 2021 and is collateralized by a certificate of deposit for €0.2 million, which has been included in restricted cash in the consolidated balance sheets as of March 31, 2021. In conjunction with our agreement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50% of the first $50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including SD-101. In July 2020, we sold assets related to our SD-101 compound to TriSalus. We paid $2.5 million to Holdings in August 2020. We are obligated to pay Holdings 50% of the contingent pre-commercialization milestone payments that we may receive under the Asset Purchase Agreement. No liability has been recorded under this agreement as of March 31, 2021. Contingencies From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, results of operations, or cash flows in a particular period. |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 3 Months Ended |
Mar. 31, 2021 | |
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 “Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) for the manufacture and reservation of a specified quantity of CpG 1018 (“CpG 1018 Materials”). The 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 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 has agreed to provide advance payments in the form of an interest-free, unsecured, forgivable loan of up to $99.0 million (the “Advance Payments”). We are obligated to repay the Advance Payments, in proportion to quantity sold, if and to the extent we receive payments from sales of CpG 1018 Materials reserved under the 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 Agreement, the applicable Advance Payments will be forgiven at the end of the two-year term. We have 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 classified as deferred revenue in our condensed consolidated balance sheets. In February 2021, we received the first Advance Payment of $45.8 million from CEPI which we recorded as long-term deferred revenue. In March 2021, CEPI executed their option to reserve additional quantity of CpG 1018 Materials. Upon the exercise, we recorded $18.6 million of accounts receivable and long-term deferred revenue. As of March 31, 2021, long-term deferred revenue balance related to CEPI’s Advance Payments was $ 64.4 No revenue was recognized for the three months ended March 31, 2021. Valneva SE In April 2020, we entered into a Collaboration Agreement with Valneva Scotland Limited (“Valneva”) to provide CpG 1018 adjuvant for use in the development of Valneva’s COVID-19 vaccine candidate. The Collaboration Agreement was amended in July 2020, to provide additional quantities of CpG 1018 adjuvant. In September 2020, we entered into a Supply Agreement (“Supply Agreement”) with Valneva to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the commercialization of Valneva's COVID-19 vaccine candidate. We concluded that the Collaboration Agreement and the 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, that is the provision of CpG 1018 adjuvant to Valneva. Therefore, the Collaboration Agreement and the Supply Agreement should be combined and accounted for as a single arrangement. Pursuant to the Supply Agreement, we receive advanced payments to purchase specified quantities of CpG 1018 adjuvant which are recorded as deferred revenue until we deliver the product to Valneva. In the first quarter of 2021, we recognized CpG 1018 product revenue, net of $64.9 million, of which $ 14.2 |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 7. Long-Term Debt On February 20, 2018, we entered into a $175.0 million Loan Agreement with CRG Servicing LLC. Net proceeds under the Loan Agreement were $173.3 million. The Term Loans under the Loan Agreement bear interest at a rate equal to 9.5% per annum. At March 31, 2021, the effective interest rate was 10.3%. At our option, until September 30, 2023, a portion of the interest payments may be paid in kind, and thereby added to the principal. Through March 31, 2021, a portion of our interest was paid in kind, which increased the principal amount of the Term Loans to $180.9 million, excluding debt discount of $1.0 million. The Term Loans have a maturity date of December 31, 2023, unless earlier prepaid. The Term Loans and paid-in-kind interest will be entirely payable at maturity. In August 2019, we entered into a second amendment to the Loan Agreement (the “Second Amendment”). The Second Amendment amended the annual net sales threshold for sales of HEPLISAV-B, revising the twelve-month measurement periods from beginning on January 1 of each year to beginning on July 1 of each year and ending on June 30, 2023. The Second Amendment also revised the fee payable upon partial prepayment or at maturity of the Term Loans from 3% to 4% of the aggregate principal amounts. In November 2020, we entered into a third amendment to the Loan Agreement (the “Third Amendment”). The Third Amendment modified the annual net sales threshold requirement to include sales of CpG 1018 and it removed the annual net sales threshold requirement for the twelve-month period beginning July 1, 2020 and ending on June 30, 2021. In January 2021, we entered into a fourth amendment to the Loan Agreement (the “Fourth Amendment”). The Fourth Amendment amended the Loan Agreement to, among other things, allow us to enter into the Agreement with CEPI and to perform our obligations thereunder. The obligations under the Loan Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in (i) all tangible and intangible assets of the Company and any future subsidiary guarantors, except for certain customary excluded property, and (ii) all of the capital stock owned by the Company and such future subsidiary guarantors (limited, in the case of the stock of certain non-U.S. subsidiaries of the Company and certain U.S. subsidiaries substantially all of whose assets consist of equity interests in non-U.S. subsidiaries, to 65% of the capital stock of such subsidiaries, subject to certain exceptions). The obligations under the Loan Agreement will be guaranteed by each of the Company’s future direct and indirect subsidiaries (other than certain non-U.S. subsidiaries of the Company and certain U.S. subsidiaries substantially all of whose assets consist of equity interests in non-U.S. subsidiaries, subject to certain exceptions). The Loan Agreement contains customary covenants and requires us to comply with a $15.0 million daily minimum combined cash and investment balance covenant and a twelve-month period revenue requirement for sales of HEPLISAV-B and CpG 1018. We recorded $4.7 million of interest expense related to the Term Loans during each of the three months ended March 31, 2021 and 2020. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2021 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 8. Revenue Recognition Our product revenue, net consisted of the following: Three Months Ended March 31, 2021 2020 HEPLISAV-B $ 8,303 $ 10,514 CpG 1018 74,582 - Total $ 82,885 $ 10,514 All of our HEPLISAV-B sales were in the U.S. For the three months ended March 31, 2021 and 2020, our three largest Customers collectively represented approximately 75% and 68% of our HEPLISAV-B product revenue, respectively. All of our CpG 1018 sales were outside the U.S. For the three months ended March 31, 2021, one customer represented approximately 87% of our CpG 1018 product revenue. The following table summarizes balances and activity in HEPLISAV-B product revenue allowance and reserve categories for the three months ended March 31, 2021 (in thousands): Balance at Beginning of Period Provisions related to current period sales Credit or payments made during the period Balance at End of Period Three months ended March 31, 2021: Accounts receivable reserves(1) $ 2,836 $ 1,962 $ (2,469 ) $ 2,329 Revenue reserve accruals(2) $ 6,040 $ 1,641 $ (1,533 ) $ 6,148 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | 9. Net Income (Loss) Per Share We compute net income (loss) per share of common stock using the two-class method required for participating securities. We consider Series B Preferred Stocks and warrants to be participating securities because holders of such shares have dividend rights in the event of our declaration of a dividend for common shares. Undistributed earnings allocated to participating securities are subtracted from net income (loss) in determining net income attributable to common stockholders. Basic net income (loss) per share is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of shares of our common stock outstanding. For the calculation of diluted net income (loss) per share, net income (loss) attributable to common stockholders for basic net income (loss) per share is adjusted by the effect of dilutive securities, including awards under our equity compensation plans and change in fair value of warrant liability. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the resulting net income (loss) attributable to common stockholders by the weighted-average number of fully diluted common shares outstanding. The numerators and denominators of the basic and diluted net income (loss) per share computations for our common stock are calculated as follows (in thousands, except per share amounts): Three Months Ended March 31, 2021 2020 Numerator Net income (loss) $ 891 $ (12,595 ) Less: undistributed earnings allocated to participating securities (70 ) - Net income (loss) attributable to common stockholders, basic $ 821 $ (12,595 ) Less: Removal of change in fair value of warrant liability - (8,610 ) Net income (loss) attributable to common stockholders, diluted $ 821 $ (21,205 ) Denominator Weighted average common stock outstanding, basic 112,035 85,477 Effect of dilutive shares: Stock-based compensation plans 1,434 - Effect of dilutive warrants - 171 Weighted average common stock outstanding, diluted 113,469 85,648 The following were excluded from the calculation of diluted net income (loss) per share as the effect of their inclusion would have been anti-dilutive. March 31, 2021 2020 Outstanding securities not included in diluted net income (loss) per share calculation (in thousands): Stock options and stock awards 7,915 11,443 Series B Convertible Preferred Stock (as converted to common stock) 4,140 4,840 Warrants (as exercisable into common stock) 5,091 - Total 17,146 16,283 |
Common Stock, Preferred Stock a
Common Stock, Preferred Stock and Warrants | 3 Months Ended |
Mar. 31, 2021 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock, Preferred Stock and Warrants | 10. Common Stock, Preferred Stock and Warrants Common Stock As of March 31, 2021, there were 114,563,212 shares of our common stock outstanding. In August 2019, we sold (i) 18,525,000 shares of our common stock, par value $0.001 per share, (ii) 4,840 shares of our Series B Convertible Preferred Stock, par value $0.001 per share (“Series B Preferred Stock”) and (iii) warrants to purchase up to an aggregate of 5,841,250 shares of our common stock in an underwritten public offering (the “Offering”). Each share of common stock was sold together with a warrant to purchase 0.25 shares of common stock, at a combined price of $3.00 per share of common stock and the accompanying warrant. Each share of Series B Preferred Stock was sold together with a warrant to purchase 250 shares of common stock, at a combined price of $ 3,000 per share and the accompanying warrant. Proceeds from the Offering were approximately $ 65.6 million, net of issuance costs of $ 4.5 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 at the public offering price. Pursuant to the Offering, (i) Bain Capital Life Sciences Fund, L.P. purchased 6,826,266 shares of common stock, 3,756 shares of Series B Preferred Stock and warrants to purchase 2,645,566 shares of common stock for a total purchase price of approximately $31.7 million and (ii) BCIP Life Sciences Associates, LP purchased 698,734 shares of common stock, 384 shares of Series B Preferred Stock and warrants to purchase 270,684 shares of common stock for a total purchase price of approximately $3.2 million (together, “Bain Life Sciences Funds”). Bain Capital Life Sciences is the general partner of Bain Life Sciences Funds. The participation by these investors was on the same terms as the other investors in the Offering. Following the Offering, Andrew A. F. Hack, M.D., Ph.D and Managing Director of Bain Capital Life Sciences (a related party), was appointed to our board of directors. On March 11, 2020, we entered into a warrant exchange agreement with Bain Life Sciences Funds pursuant to which we agreed that we would, upon future notice from Bain Life Sciences Funds, exchange all or a portion of the common stock warrants held by Bain Life Sciences Funds for warrants to purchase a new Series C convertible preferred stock (“Series C Warrants”). Each share of Series C convertible preferred stock would be convertible into 1,000 shares of common stock, with a conversion price of $4.50 and would have substantially identical rights to our Series B Preferred Stock. As of March 31, 2021, Bain Life Sciences Funds have not exercised their rights to exchange common stock warrants with Series C Warrants. In May 2020, we completed an underwritten public offering of 16,100,000 shares of our common stock, par value $0.001 per share, including 2,100,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered at a price to the public of $5.00 per share. The net proceeds to us from this offering were approximately $75.4 million, after deducting the underwriting discount and other estimated offering expenses payable by us. Bain Life Sciences Funds purchased 1,000,000 shares of common stock in the underwritten public offering. Bain Capital Life Sciences is the general partner of Bain Life Sciences Funds. The participation by Bain Life Sciences Funds was on the same terms as the other investors in the offering. 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. For the three months ended March 31, 2021, we received net cash proceeds of $28.2 million resulting from sales of 2,878,567 shares of our common stock pursuant to the 2020 ATM Agreement. As of March 31, 2021, we had $120.5 million remaining under the 2020 ATM Agreement. Preferred Stock As of March 31, 2021, there were 4,140 shares of Series B Preferred Stock outstanding. Each share of Series B Preferred Stock is convertible into 1,000 shares of common stock at any time at the holder’s option. However, the holder is prohibited from converting the Series B Preferred Stock into shares of common stock if, as a result of such conversion, the holder and its affiliates would own more than 4.99% of the total number of shares of common stock then issued and outstanding, which percentage may be changed at the holders’ election to a higher or lower percentage (not to exceed 19.99%) upon 61 days’ notice to the Company. In the event of liquidation, dissolution, or winding up, the holder of Series B Preferred Stock will receive payment on shares of Series B Preferred Stock (determined on an as-converted to common stock basis) equal to the amount that would be paid on our common stock. Shares of Series B Preferred Stock generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series B Preferred Stock is required to amend the terms of the Series B Preferred Stock. Holders of Series B Preferred Stock are not entitled to receive any dividends, unless and until specifically declared by our board of directors. The Series B Preferred Stock ranks on parity with our common stock as to distributions of assets upon liquidation, dissolution or winding up. The Series B Preferred Stock may rank senior to, on parity with or junior to any class or series of capital stock created in the future depending upon the specific terms of such future stock issuance. The fair value of the common stock into which the Series B Preferred Stock is convertible exceeded the allocated purchase price of the Series B Preferred Stock by $3.3 million on the date of issuance, for which we recorded a deemed dividend. We recognized a deemed dividend equal to the number of shares of common stock into which the Series B Preferred Stock is convertible multiplied by the difference between the value of the common stock and the Series B Preferred Stock conversion price per share on the date of issuance, which is the date the stock first became convertible. The dividend was reflected as a one-time, non-cash, deemed dividend to the holders of Series B Preferred Stock on the date of issuance. Warrants In the first quarter of 2021, 750,308 of our common stock warrants were exercised. As of March 31, 2021, the following common stock warrants were outstanding: Warrants Issuance Date Shares Issuable (in thousands) Expiration Date Exercise Price per Share Outstanding as of March 31, 2021 (in thousands) August 12, 2019 5,091 February 12, 2022 $ 4.50 5,091 Warrants were exercisable upon issuance. The holder is prohibited from exercising these warrants if, as a result of such exercise, the holder and its affiliates, would own more than 4.99% of the total number of shares of common stock then issued and outstanding, which percentage may be changed at the holders’ election to a higher or lower percentage (not to exceed 19.99%) upon 61 days’ notice to the Company. The warrants contain provisions that may obligate us to repurchase them for an amount that does not represent fair value in the event of a change of control. Due to this provision, the warrants do not meet the criteria to be considered indexed to our own stock. Accordingly, we recorded the warrants as a derivative liability at fair value of $7.4 million on the issuance date, which was estimated using the Black-Scholes model. The warrants will be revalued at each reporting period using the Black-Scholes model and the change in the fair value of the warrants will recognized as other income (expense) in the condensed consolidated statements of operations. At March 31, 2021, the estimated fair value of warrant liability was $31.7 million. For the three months ended March 31, 2021, we recognized the increase in the estimated fair value of warrant liability of $25.6 million as expense in other income (expense) in our condensed consolidated statements of operations. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share Based Compensation [Abstract] | |
Equity Plans and Stock-Based Compensation | 11. Equity Plans and Stock-Based Compensation In January 2021, we adopted the Dynavax Technologies Corporation 2021 Inducement Award Plan (“2021 Inducement Plan”), pursuant to which we reserved 1,500,000 shares of common stock for issuance under the plan to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company. As of March 31, 2021, the 2018 Equity Incentive Plan, as amended, (“Amended 2018 EIP”), the 2021 Inducement Plan and the Amended and Restated 2014 Employee Stock Purchase Plan are our active plans. Under the Amended 2018 EIP, the aggregate number of shares of our common stock that may be issued to employees and directors (subject to adjustment for certain changes in capitalization) is 22,517,869. Under our stock-based compensation plans, option awards generally vest over a three or four-year Shares Underlying Outstanding Options Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Term (years) Aggregate Intrinsic Value Balance at December 31, 2020 8,505 $ 11.57 Options granted 1,996 9.36 Options exercised (119 ) 4.16 Options cancelled: Options forfeited (unvested) (171 ) 7.50 Options expired (vested) (164 ) 19.67 Balance at March 31, 2021 10,047 $ 11.15 4.26 $ 17,816 Vested and expected to vest at March 31, 2021 9,693 $ 11.26 4.18 $ 17,184 Exercisable at March 31, 2021 5,967 $ 13.44 3.05 $ 8,975 Restricted stock unit activity under our stock-based compensation plans during the three months ended March 31, 2021 was as follows (in thousands except per share amounts): Number of Shares (in thousands) Weighted-Average Grant-Date Fair Value Per Share Non-vested as of December 31, 2020 1,794 $ 7.23 Granted 1,796 9.43 Vested (533 ) 8.88 Forfeited (120 ) 8.50 Non-vested as of March 31, 2021 2,937 $ 8.22 We granted performance-based restricted stock unit (“PSU”) to certain executives in February 2021. These PSUs vest upon a specified market condition. The summary of PSU activities for the three months ended March 31, 2021 is as follows: Number of Shares (in thousands) Weighted-Average Grant-Date Fair Value Per Share Non-vested as of December 31, 2020 - $ - Granted 297 8.40 Forfeited (30 ) 8.40 Non-vested as of March 31, 2021 267 $ 8.40 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 Market-Based Performance Stock Unit (“PSUs”) Three Months Ended Three Months Ended March 31, March 31, 2021 2021 2020 Weighted-average fair value per share $ 6.72 $ 3.58 $ 8.40 Risk-free interest rate 0.5 % 1.4 % From 0.03% to 1.92% Expected life (in years) 4.5 4.5 2.9 Volatility 1.0 0.9 0.9 The components of stock-based compensation expense were as follows (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 872 $ (1,573 ) Selling, general and administrative 3,144 2,442 Cost of sales - product 170 136 Inventory 537 773 Total $ 4,723 $ 1,778 Compensation expense is based on awards ultimately expected to vest and reflects estimated forfeitures. Stock-based compensation for the three months ended March 31, 2020 included reversal of expenses related to cancellation of certain equity grants in the first quarter of 2020. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | 12. Subsequent Events CEPI Amendment On May 3, 2021, we entered into the first Amendment (the “Amendment”) to the Agreement with CEPI. The Amendment provides for the manufacture and reservation of an additional specified quantity of CpG 1018 adjuvant (the “Extra Reserved Material”) and helps to accelerate the Company’s efforts to further increase its available inventory of CpG 1018 adjuvant. In exchange for the Company’s reserving additional CpG 1018 adjuvant pursuant to the Amendment, in addition to the $99.0 million previously provided under the Agreement, CEPI has agreed to provide advance payments in the form of an interest-free, unsecured, forgivable loan in an amount equivalent to the anticipated manufacturing costs of all material reserved by CEPI, which, for the Extra Reserved Material covered by the Amendment, is up to an additional $77.4 million, for a total of CEPI’s funding under the Agreement of up to $176.4 million. We intend to establish an additional qualified source of supply for CpG 1018 adjuvant, including a portion of the Extra Reserved Material, which is expected to be available for release during the fourth quarter of 2021. Amendment to CRG Loan Agreement On May 3, 2021, we entered into a fifth amendment to the Loan Agreement with CRG (the “Fifth Amendment”). The Fifth Amendment amended the Loan Agreement to, among other things, allow us to enter into the Amendment with CEPI and to perform our obligations thereunder. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
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 at December 31, 2020 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 our Annual Report on Form 10-K for the year ended December 31, 2020, 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 and Dynavax India LLP in India. 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. |
Liquidity and Financial Condition | Liquidity and Financial Condition As of March 31, 2021, we had cash, cash equivalents and marketable securities of $232.7 million. Prior to January 1, 2021, we incurred net losses in each year since our inception. For the three months ended March 31, 2021, we recorded net income of $0.9 million. We incurred net loss of $12.6 million for three months ended March 31, 2020. We cannot be certain that sales of our products, and the revenue from our other activities are sustainable. Further, we expect to continue to incur substantial expenses as we continue to invest in commercialization of HEPLISAV-B, development of our CpG 1018 adjuvant and clinical trials and other development. If we cannot generate a sufficient amount of revenue from product sales, we will need to finance our operations through strategic alliance and licensing arrangements and/or future public or private debt and equity financings. Raising additional funds through the issuance of equity or debt securities could result in dilution to our existing stockholders, increased fixed payment obligations, or both. In addition, these securities may have rights senior to those of our common stock and could include covenants that would restrict our operations. We currently anticipate that our cash, cash equivalents and short-term marketable securities as of March 31, 2021 Our ability to raise additional capital in the equity and debt markets, should we choose to do so, is dependent on a number of factors, including, but not limited to, the market demand for our common stock, which itself is subject to a number of development and business risks and uncertainties, our creditworthiness and the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. In addition, global financial crises and economic downturns, including those cause by widespread public health crises such as the COVID-19 pandemic, may cause extreme volatility and disruptions in capital and credit markets, and may impact our ability to raise additional capital when needed on acceptable terms, if at all. Adequate financing may not be available to us on acceptable terms, or at all. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. 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. However, the worldwide spread of COVID-19 has resulted in a global slowdown of economic activity which is likely to decrease demand for a broad variety of goods and services, while also disrupting sales channels and marketing activities for an unknown period of time until the disease is contained. We are unable to predict the future effect resulting from the COVID-19 pandemic. Actual results could differ materially from management’s estimates. |
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. 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. There have been no material adjustments to these estimates for the three months ended March 31, 2021 and 2020 Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product th at 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 reven ue 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 , shelf life of the product 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 CpG 1018 adjuvant to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 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. 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. Collaboration and Manufacturing Service Revenue We have entered into 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. Collaboration and manufacturing service revenue are recorded in other revenue in the condensed consolidated statements of operations. |
Inventories | Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the three months ended March 31, 2021 and 2020, 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. HEPLISAV-B was approved by the United States Food and Drug Administration (“FDA”) on November 9, 2017, at which time we began to capitalize inventory costs associated with the vial presentation of HEPLISAV-B. In March 2018, we received regulatory approval of the pre-filled syringe (“PFS”) presentation of HEPLISAV-B. Prior to FDA approval of HEPLISAV-B, all costs related to the manufacturing of HEPLISAV-B that could potentially be available to support the commercial launch of our products, were charged to research and development expense in the period incurred as there was no alternative future use. Prior to regulatory approval of PFS, costs associated with resuming operating activities at the Düsseldorf manufacturing facility were also included in research and development expense. Subsequent to regulatory approval of PFS, costs associated with resuming manufacturing activities at the Düsseldorf facility were included in cost of sales – product, until commercial production resumed in mid-2018 at which time these costs were recorded as raw materials inventory. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2019-12 In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740). This ASU simplifies the accounting for income taxes by removing certain exceptions and improving consistent application in certain areas of Topic 740. The ASU is effective for annual periods beginning after December 15, 2020 with early adoption permitted. We adopted this ASU on January 1, 2021 and the adoption of this standard did not have a material impact on our consolidated financial statements. Accounting Standards Update 2020-06 We adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity on January 1, 2021 using the modified retrospective method. This ASU simplifies the accounting for convertible instruments and requires entities to use the if-converted method for all convertible instruments in calculating diluted earnings-per-share. Entities also need to recombine instruments that were previously separated into two units of account if separation is no longer required. The adoption of this ASU did not have a material impact on our condensed consolidated financial statements as there were no outstanding financial instruments that require recombination at January 1, 2021. 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 consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, 2021 Assets Money market funds $ 71,374 $ - $ - $ 71,374 U.S. treasuries - 28,465 - 28,465 U.S. government agency securities - 47,472 - 47,472 Corporate debt securities - 77,682 - 77,682 Total assets $ 71,374 $ 153,619 $ - $ 224,993 Liabilities Warrant liability $ - $ - $ 31,737 $ 31,737 Level 1 Level 2 Level 3 Total December 31, 2020 Assets Money market funds $ 23,128 $ - $ - $ 23,128 U.S. treasuries - 32,579 - 32,579 U.S. government agency securities - 40,321 - 40,321 Corporate debt securities - 61,063 - 61,063 Total assets $ 23,128 $ 133,963 $ - $ 157,091 Liabilities Warrant liability $ - $ - $ 10,736 $ 10,736 |
Summary of Assumptions to Estimate the Fair Value of Warrant Liability | As of March 31, 2021, we used the following key assumptions to estimate the fair value of warrant liability: Number of shares 5,090,942 Expected term 0.9 year Expected volatility 1.2 Risk-free interest rate 0.1 % Dividend yield 0 % |
Summary of Changes in Fair Value Warrant liability | The following table provides a summary of changes in the fair value warrant liability for the three months ended March 31, 2021 (in thousands): Balance at December 31, 2020 $ 10,736 Increase in fair value of warrants exercised 3,172 Warrants exercised (4,551 ) Increase in the estimated fair value of warrant liability upon revaluation 22,380 Balance at March 31, 2021 $ 31,737 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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): March 31, 2021 December 31, 2020 March 31, 2020 December 31, 2019 Cash and cash equivalents $ 79,055 $ 32,073 $ 37,899 $ 39,884 Restricted cash 226 237 212 216 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 79,281 $ 32,310 $ 38,111 $ 40,100 |
Summary of Cash, Cash Equivalents and Marketable Securities | Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value March 31, 2021 Cash and cash equivalents: Cash $ 7,681 $ - $ - $ 7,681 Money market funds 71,374 - - 71,374 Total cash and cash equivalents 79,055 - - 79,055 Marketable securities available-for-sale: U.S. treasuries 28,448 17 - 28,465 U.S. government agency securities 47,462 17 (7 ) 47,472 Corporate debt securities 77,687 8 (13 ) 77,682 Total marketable securities available-for-sale 153,597 42 (20 ) 153,619 Total cash, cash equivalents and marketable securities $ 232,652 $ 42 $ (20 ) $ 232,674 December 31, 2020 Cash and cash equivalents: Cash $ 7,945 $ - $ - $ 7,945 Money market funds 23,128 - - 23,128 Corporate debt securities 1,000 - - 1,000 Total cash and cash equivalents 32,073 - - 32,073 Marketable securities available-for-sale: U.S. treasuries 32,548 31 - 32,579 U.S. government agency securities 40,313 14 (6 ) 40,321 Corporate debt securities 60,071 3 (11 ) 60,063 Total marketable securities available-for-sale 132,932 48 (17 ) 132,963 Total cash, cash equivalents and marketable securities $ 165,005 $ 48 $ (17 ) $ 165,036 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): March 31, 2021 Amortized Cost Estimated Fair Value Mature in one year or less $ 137,849 $ 137,877 Mature after one year through two years 15,748 15,742 $ 153,597 $ 153,619 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table presents inventories, net (in thousands): March 31, 2021 December 31, 2020 Raw materials $ 25,137 $ 25,121 Work-in-process 20,525 30,293 Finished goods 23,184 8,275 Total $ 68,846 $ 63,689 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Expense | Our lease expense comprises of the following (in thousands): Three Months Ended March 31, 2021 2020 Operating lease expense $ 1,560 $ 1,592 |
Summary of Balance Sheet Classification of Operating Lease Liabilities | The balance sheet classification of our operating lease liabilities was as follows (in thousands): March 31, 2021 December 31, 2020 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 3,356 $ 3,247 Long-term portion of lease liabilities 33,795 34,789 Total operating lease liabilities $ 37,151 $ 38,036 |
Summary of Maturities of Sublease Income and Operating Lease Liabilities | At March 31, 2021, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease Liabilities 2021 (remaining) $ 3,915 $ 5,215 2022 5,357 6,240 2023 5,518 5,377 2024 5,684 5,521 2025 5,854 5,670 Thereafter 33,742 30,704 Total $ 60,070 58,727 Less: Present value adjustment (21,576 ) Total $ 37,151 |
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: March 31, 2021 December 31, 2020 Weighted average remaining lease term 9.0 years 9.1 years Weighted average discount rate 10.1 % 10.1 % |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Summary of Product Revenue | Our product revenue, net consisted of the following: Three Months Ended March 31, 2021 2020 HEPLISAV-B $ 8,303 $ 10,514 CpG 1018 74,582 - Total $ 82,885 $ 10,514 |
HEPLISAV-B | |
Summary of Product Revenue Allowance and Reserve Categories | The following table summarizes balances and activity in HEPLISAV-B product revenue allowance and reserve categories for the three months ended March 31, 2021 (in thousands): Balance at Beginning of Period Provisions related to current period sales Credit or payments made during the period Balance at End of Period Three months ended March 31, 2021: Accounts receivable reserves(1) $ 2,836 $ 1,962 $ (2,469 ) $ 2,329 Revenue reserve accruals(2) $ 6,040 $ 1,641 $ (1,533 ) $ 6,148 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Income (Loss) Per Share | The numerators and denominators of the basic and diluted net income (loss) per share computations for our common stock are calculated as follows (in thousands, except per share amounts): Three Months Ended March 31, 2021 2020 Numerator Net income (loss) $ 891 $ (12,595 ) Less: undistributed earnings allocated to participating securities (70 ) - Net income (loss) attributable to common stockholders, basic $ 821 $ (12,595 ) Less: Removal of change in fair value of warrant liability - (8,610 ) Net income (loss) attributable to common stockholders, diluted $ 821 $ (21,205 ) Denominator Weighted average common stock outstanding, basic 112,035 85,477 Effect of dilutive shares: Stock-based compensation plans 1,434 - Effect of dilutive warrants - 171 Weighted average common stock outstanding, diluted 113,469 85,648 |
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 (loss) per share as the effect of their inclusion would have been anti-dilutive. March 31, 2021 2020 Outstanding securities not included in diluted net income (loss) per share calculation (in thousands): Stock options and stock awards 7,915 11,443 Series B Convertible Preferred Stock (as converted to common stock) 4,140 4,840 Warrants (as exercisable into common stock) 5,091 - Total 17,146 16,283 |
Common Stock, Preferred Stock_2
Common Stock, Preferred Stock and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Summary of Common Stock Warrants Outstanding | In the first quarter of 2021, 750,308 of our common stock warrants were exercised. As of March 31, 2021, the following common stock warrants were outstanding: Warrants Issuance Date Shares Issuable (in thousands) Expiration Date Exercise Price per Share Outstanding as of March 31, 2021 (in thousands) August 12, 2019 5,091 February 12, 2022 $ 4.50 5,091 |
Equity Plans and Stock-Based _2
Equity Plans and Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share Based Compensation [Abstract] | |
Option Activity under Stock-Based Compensation Plans | In January 2021, we adopted the Dynavax Technologies Corporation 2021 Inducement Award Plan (“2021 Inducement Plan”), pursuant to which we reserved 1,500,000 shares of common stock for issuance under the plan to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company. As of March 31, 2021, the 2018 Equity Incentive Plan, as amended, (“Amended 2018 EIP”), the 2021 Inducement Plan and the Amended and Restated 2014 Employee Stock Purchase Plan are our active plans. Under the Amended 2018 EIP, the aggregate number of shares of our common stock that may be issued to employees and directors (subject to adjustment for certain changes in capitalization) is 22,517,869. Under our stock-based compensation plans, option awards generally vest over a three or four-year Shares Underlying Outstanding Options Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Term (years) Aggregate Intrinsic Value Balance at December 31, 2020 8,505 $ 11.57 Options granted 1,996 9.36 Options exercised (119 ) 4.16 Options cancelled: Options forfeited (unvested) (171 ) 7.50 Options expired (vested) (164 ) 19.67 Balance at March 31, 2021 10,047 $ 11.15 4.26 $ 17,816 Vested and expected to vest at March 31, 2021 9,693 $ 11.26 4.18 $ 17,184 Exercisable at March 31, 2021 5,967 $ 13.44 3.05 $ 8,975 |
Summary of Restricted Stock Units Activity | Restricted stock unit activity under our stock-based compensation plans during the three months ended March 31, 2021 was as follows (in thousands except per share amounts): Number of Shares (in thousands) Weighted-Average Grant-Date Fair Value Per Share Non-vested as of December 31, 2020 1,794 $ 7.23 Granted 1,796 9.43 Vested (533 ) 8.88 Forfeited (120 ) 8.50 Non-vested as of March 31, 2021 2,937 $ 8.22 |
Summary Of Performance Based Restricted Stock Unit | We granted performance-based restricted stock unit (“PSU”) to certain executives in February 2021. These PSUs vest upon a specified market condition. The summary of PSU activities for the three months ended March 31, 2021 is as follows: Number of Shares (in thousands) Weighted-Average Grant-Date Fair Value Per Share Non-vested as of December 31, 2020 - $ - Granted 297 8.40 Forfeited (30 ) 8.40 Non-vested as of March 31, 2021 267 $ 8.40 |
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 Market-Based Performance Stock Unit (“PSUs”) Three Months Ended Three Months Ended March 31, March 31, 2021 2021 2020 Weighted-average fair value per share $ 6.72 $ 3.58 $ 8.40 Risk-free interest rate 0.5 % 1.4 % From 0.03% to 1.92% Expected life (in years) 4.5 4.5 2.9 Volatility 1.0 0.9 0.9 |
Stock-Based Compensation Expense | The components of stock-based compensation expense were as follows (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 872 $ (1,573 ) Selling, general and administrative 3,144 2,442 Cost of sales - product 170 136 Inventory 537 773 Total $ 4,723 $ 1,778 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2021USD ($)Segment | Mar. 31, 2020USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||
Number of operating segment | Segment | 1 | |
Cash, cash equivalents and marketable securities | $ 232,700,000 | |
Principal amount including interest paid in kind | $ 180,900,000 | |
Debt maturity date | Dec. 31, 2023 | |
Net income (loss) | $ 891,000 | $ (12,595,000) |
Inventory reserve | $ 0 | $ 0 |
Maximum | ||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||
Expected period of payment to be received | 1 year | |
HEPLISAV-B | ||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||
Minimum age approved for vaccine prevention of infection caused | 18 years |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Fair Value Disclosures [Abstract] | |
Transfers from level 1 to level 2 | $ 0 |
Transfers from level 2 to level 1 | 0 |
Transfers in or out of Level 3 | $ 0 |
Fair Value Hierarchy for Financ
Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Assets | |||
Total assets | $ 224,993 | $ 157,091 | |
Money Market Funds | |||
Assets | |||
Total assets | 71,374 | 23,128 | |
U.S. Treasuries | |||
Assets | |||
Total assets | 28,465 | 32,579 | |
U.S. Government Agency Securities | |||
Assets | |||
Total assets | 47,472 | 40,321 | |
Corporate Debt Securities | |||
Assets | |||
Total assets | 77,682 | 61,063 | |
Warrant Liability | |||
Liabilities | |||
Total liabilities | 31,737 | $ 10,736 | |
Fair Value, Inputs, Level 1 | |||
Assets | |||
Total assets | 71,374 | 23,128 | |
Fair Value, Inputs, Level 1 | Money Market Funds | |||
Assets | |||
Total assets | 71,374 | 23,128 | |
Fair Value, Inputs, Level 2 | |||
Assets | |||
Total assets | 153,619 | 133,963 | |
Fair Value, Inputs, Level 2 | U.S. Treasuries | |||
Assets | |||
Total assets | 28,465 | 32,579 | |
Fair Value, Inputs, Level 2 | U.S. Government Agency Securities | |||
Assets | |||
Total assets | 47,472 | 40,321 | |
Fair Value, Inputs, Level 2 | Corporate Debt Securities | |||
Assets | |||
Total assets | 77,682 | $ 61,063 | |
Fair Value, Inputs, Level 3 | Warrant Liability | |||
Liabilities | |||
Total liabilities | $ 31,737 | $ 10,736 |
Summary of Assumptions to Estim
Summary of Assumptions to Estimate the Fair Value of Warrant Liability (Detail) - Fair Value, Inputs, Level 3 shares in Thousands | Mar. 31, 2021shares |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Number of shares | 5,090,942 |
Expected term | 10 months 24 days |
Expected volatility | 1.2 |
Risk-free interest rate | 0.001 |
Dividend yield | 0 |
Summary of Changes in Fair Valu
Summary of Changes in Fair Value Warrant liability (Detail) - Fair Value, Inputs, Level 3 $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Balance | $ 10,736 |
Increase in fair value of warrants exercised | 3,172 |
Warrants exercised | (4,551) |
Increase in the estimated fair value of warrant liability upon revaluation | 22,380 |
Balance | $ 31,737 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 79,055 | $ 32,073 | $ 37,899 | $ 39,884 |
Restricted cash | 226 | 237 | 212 | 216 |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ 79,281 | $ 32,310 | $ 38,111 | $ 40,100 |
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 | Mar. 31, 2021 | Dec. 31, 2020 |
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 232,652 | $ 165,005 |
Unrealized Gains | 42 | 48 |
Unrealized Losses | (20) | (17) |
Estimated Fair Value | 232,674 | 165,036 |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 79,055 | 32,073 |
Estimated Fair Value | 79,055 | 32,073 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 153,597 | 132,932 |
Unrealized Gains | 42 | 48 |
Unrealized Losses | (20) | (17) |
Estimated Fair Value | 153,619 | 132,963 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 7,681 | 7,945 |
Estimated Fair Value | 7,681 | 7,945 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 71,374 | 23,128 |
Estimated Fair Value | 71,374 | 23,128 |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 28,448 | 32,548 |
Unrealized Gains | 17 | 31 |
Estimated Fair Value | 28,465 | 32,579 |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 47,462 | 40,313 |
Unrealized Gains | 17 | 14 |
Unrealized Losses | (7) | (6) |
Estimated Fair Value | 47,472 | 40,321 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 1,000 | |
Estimated Fair Value | 1,000 | |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 77,687 | 60,071 |
Unrealized Gains | 8 | 3 |
Unrealized Losses | (13) | (11) |
Estimated Fair Value | $ 77,682 | $ 60,063 |
Cash, Cash Equivalents, Restr_5
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Amortized Cost | |
Mature in one year or less | $ 137,849 |
Mature after one year through two years | 15,748 |
Total amortized cost | 153,597 |
Estimated Fair Value | |
Mature in one year or less | 137,877 |
Mature after one year through two years | 15,742 |
Total estimated fair value | $ 153,619 |
Cash, Cash Equivalents, Restr_6
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | ||
Realized gains on investments | $ 0 | $ 0 |
Realized loss on investments | $ 0 | $ 0 |
Inventories, Net - Summary of I
Inventories, Net - Summary of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 25,137 | $ 25,121 |
Work-in-process | 20,525 | 30,293 |
Finished goods | 23,184 | 8,275 |
Total | $ 68,846 | $ 63,689 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | Sep. 17, 2018USD ($)ft² | Feb. 20, 2018USD ($) | Aug. 31, 2020USD ($) | Jul. 31, 2019USD ($)ft² | Nov. 30, 2009USD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Mar. 31, 2021EUR (€) | Dec. 31, 2020USD ($) | Mar. 29, 2019USD ($) | Dec. 31, 2004EUR (€) |
Loss Contingencies [Line Items] | ||||||||||||
Tenant improvement allowance | $ (908,000) | |||||||||||
Sublease income | $ 2,022,000 | 1,926,000 | ||||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | 1,700,000 | 1,700,000 | ||||||||||
Principal amount including interest paid in kind | $ 180,900,000 | |||||||||||
Debt maturity date | Dec. 31, 2023 | |||||||||||
Non-cancelable purchase and other commitments | $ 90,900,000 | |||||||||||
Letter of credit pledged as security | € | € 0.2 | |||||||||||
Collateralized certificate of deposit | € | € 0.2 | |||||||||||
Liability under agreement | 390,357,000 | $ 294,579,000 | ||||||||||
Symphony Dynamo Holdings LLC | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
License arrangement contingent consideration percentage | 50.00% | |||||||||||
License arrangement upfront payment | $ 50,000,000 | |||||||||||
Payment to holdings | $ 2,500,000 | |||||||||||
Symphony Dynamo Holdings LLC | Asset Purchase Agreement | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Liability under agreement | $ 0 | |||||||||||
Contingent precommencialization milestone payments percentage | 50.00% | 50.00% | ||||||||||
CRG Servicing LLC | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Maximum borrowing capacity | $ 175,000,000 | |||||||||||
Current borrowing capacity | $ 100,000,000 | $ 75,000,000 | ||||||||||
total contractual obligations | $ 188,100,000 | |||||||||||
principal amount | 175,000,000 | |||||||||||
Principal amount including interest paid in kind | 5,900,000 | $ 180,900,000 | ||||||||||
backend facility fee | $ 7,200,000 | |||||||||||
Debt maturity date | Dec. 31, 2023 | Dec. 31, 2023 | ||||||||||
Powell Street Sublease | Emeryville, California (Premises) | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Lease area | ft² | 23,976 | |||||||||||
Base rent per square feet | $ 3.90 | |||||||||||
Lease expiration date | Jun. 30, 2022 | |||||||||||
Option to extend | There is no option to extend the sublease term | |||||||||||
Existence of option to extend | false | |||||||||||
Horton Street Master Lease | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Percentage of excess rent paid to landlord | 50.00% | 50.00% | ||||||||||
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. 1, 2019 | |||||||||||
Tenant improvement allowance | $ 8,100,000 | |||||||||||
Initial lease term | 12 years | |||||||||||
Lease option to extend | The Horton Street Master Lease has an initial term of 12 years, following the Commencement Date with an option to extend the lease for two successive five-year terms. | |||||||||||
Renewal term of lease | 5 years | |||||||||||
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 Subtenant has no option to extend the sublease term. | |||||||||||
Existence of option to extend | false | |||||||||||
Horton Street Sublease | Emeryville, California (Premises) | Other Income (Expense) | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Sublease income | $ 2,000,000 | $ 1,900,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Operating lease expense | $ 1,560 | $ 1,592 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Commitments And Contingencies Disclosure [Abstract] | ||
Current portion of lease liabilities (included in other current liabilities) | $ 3,356 | $ 3,247 |
Long-term portion of lease liabilities | 33,795 | 34,789 |
Total operating lease liabilities | $ 37,151 | $ 38,036 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Sublease Income | ||
2021 (remaining) | $ 3,915 | |
2022 | 5,357 | |
2023 | 5,518 | |
2024 | 5,684 | |
2025 | 5,854 | |
Thereafter | 33,742 | |
Total | 60,070 | |
Operating Lease Liabilities | ||
2021 (remaining) | 5,215 | |
2022 | 6,240 | |
2023 | 5,377 | |
2024 | 5,521 | |
2025 | 5,670 | |
Thereafter | 30,704 | |
Total | 58,727 | |
Present value adjustment | (21,576) | |
Total | $ 37,151 | $ 38,036 |
Commitments and Contingencies_5
Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail) | Mar. 31, 2021 | Dec. 31, 2020 |
Commitments And Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 9 years | 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 ($) $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Feb. 28, 2021 | Jan. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Long-term deferred revenue | $ 64,350 | ||||
Revenue recognized | 83,335 | $ 10,919 | |||
Valneva SE | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue | 51,000 | ||||
Valneva SE | Supply Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue | $ 14,200 | ||||
Revenue recognized | $ 64,900 | ||||
CEPI Member | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Interest- free unsecured forgivable loan | $ 99,000 | ||||
Advance payment from customer | 18,600 | $ 45,800 | |||
Long-term deferred revenue | $ 64,400 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) | Feb. 20, 2018 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2020 | Aug. 01, 2019 | Jul. 31, 2019 |
Debt Instrument [Line Items] | |||||||
Principal amount including interest paid in kind | $ 180,900,000 | ||||||
Long-term debt, net of debt discount | $ 1,016,000 | $ 1,094,000 | |||||
Debt maturity date | Dec. 31, 2023 | ||||||
Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Percentage of fee payable upon partial prepayment or maturity | 4.00% | 3.00% | |||||
Percentage of capital stock of subsidiaries subject to certain exception | 65.00% | ||||||
Debt instrument, covenant daily minimum combined cash and investment balance | $ 15,000,000 | ||||||
Interest expense related to initial term loan | $ 4,700,000 | $ 4,700,000 | |||||
CRG Servicing LLC | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | 175,000,000 | ||||||
Net proceeds from the initial term loan | $ 173,300,000 | ||||||
Debt interest rate | 9.50% | ||||||
Debt instrument interest rate, effective percentage | 10.30% | ||||||
Principal amount including interest paid in kind | $ 5,900,000 | $ 180,900,000 | |||||
Long-term debt, net of debt discount | $ 1,000,000 | ||||||
Debt maturity date | Dec. 31, 2023 | Dec. 31, 2023 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Product Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Total revenues | $ 83,335 | $ 10,919 |
HEPLISAV-B | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Total revenues | 8,303 | 10,514 |
CpG 1018 | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Total revenues | 74,582 | |
Product | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Total revenues | $ 82,885 | $ 10,514 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
HEPLISAV-B | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Concentration risk, percentage | 75.00% | 68.00% |
HEPLISAV-B | Revenue | Credit Concentration Risk | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Concentration risk, customer | three largest Customers | |
CpG 1018 | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Concentration risk, percentage | 87.00% | |
CpG 1018 | Revenue | Credit Concentration Risk | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Concentration risk, customer | one customer |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |
Provisions related to current period sales | $ 1,641 |
Credit or payments made during the period | (1,533) |
Balance at Beginning of Period | 6,040 |
Balance at End of Period | 6,148 |
Accounts Receivable Reserves | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |
Balance at Beginning of Period | 2,836 |
Provisions related to current period sales | 1,962 |
Credit or payments made during the period | (2,469) |
Balance at End of Period | $ 2,329 |
Computation of Basic and Dilute
Computation of Basic and Diluted Net Income (Loss) Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract] | ||
Net income (loss) | $ 891 | $ (12,595) |
Less: undistributed earnings allocated to participating securities | (70) | |
Net income (loss) attributable to common stockholders, basic | 821 | (12,595) |
Less: Removal of change in fair value of warrant liability | 25,552 | (8,610) |
Net income (loss) attributable to common stockholders, diluted | $ 821 | $ (21,205) |
Weighted average common stock outstanding, basic | 112,035 | 85,477 |
Effect of dilutive shares: | ||
Stock-based compensation plans | 1,434 | |
Effect of dilutive warrants | 171 | |
Weighted average common stock outstanding, diluted | 113,469 | 85,648 |
Outstanding Stock Options and S
Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Outstanding securities not included in diluted net income (loss) per share calculation (in thousands): | ||
Outstanding securities not included in diluted net loss per share calculation | 17,146,000 | 16,283,000 |
Warrants | ||
Outstanding securities not included in diluted net income (loss) per share calculation (in thousands): | ||
Outstanding securities not included in diluted net loss per share calculation | 5,091,000 | |
Stock Options and Stock Awards | ||
Outstanding securities not included in diluted net income (loss) per share calculation (in thousands): | ||
Outstanding securities not included in diluted net loss per share calculation | 7,915,000 | 11,443,000 |
Series B Convertible Preferred Stock | ||
Outstanding securities not included in diluted net income (loss) per share calculation (in thousands): | ||
Outstanding securities not included in diluted net loss per share calculation | 4,140,000 | 4,840,000 |
Common Stock, Preferred Stock_3
Common Stock, Preferred Stock and Warrants - Additional Information (Detail) - USD ($) | Aug. 06, 2020 | Nov. 03, 2017 | May 31, 2020 | Aug. 31, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Mar. 11, 2020 | Aug. 12, 2019 |
Class Of Stock [Line Items] | |||||||||
Common stock, shares outstanding | 114,563,212 | 110,190,000 | |||||||
Issuance of common stock and preferred stock (in shares) | 18,525,000 | ||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | |||||||
Net cash proceeds received | $ 28,156,000 | $ 14,229,000 | |||||||
Change in fair value of warrant liability | $ 25,552,000 | $ (8,610,000) | |||||||
Common Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 2,879,000 | 2,909,000 | |||||||
Number of common stock allowed to purchase | 1,000 | ||||||||
Conversion price per share | $ 4.50 | ||||||||
Warrants | |||||||||
Class Of Stock [Line Items] | |||||||||
Fair value of derivative liability | $ 31,700,000 | $ 7,400,000 | |||||||
Warrants | Other Income, Net | |||||||||
Class Of Stock [Line Items] | |||||||||
Change in fair value of warrant liability | $ 25,600,000 | ||||||||
Bain Life Sciences | |||||||||
Class Of Stock [Line Items] | |||||||||
Net cash proceeds received from issuance or sale of equity | $ 35,000,000 | ||||||||
Bain Capital Life Sciences Fund, L.P | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 6,826,266 | ||||||||
Number of common stock allowed to purchase | 2,645,566 | ||||||||
Net cash proceeds received from issuance or sale of equity | $ 31,700,000 | ||||||||
BCIP Life Sciences Associates, L.P | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 698,734 | ||||||||
Number of common stock allowed to purchase | 270,684 | ||||||||
Net cash proceeds received from issuance or sale of equity | $ 3,200,000 | ||||||||
Offering | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 2,100,000 | ||||||||
Common stock, par value | $ 0.001 | ||||||||
Number of common stock allowed to purchase | 0.25 | ||||||||
Combined price of common stock and warrant | $ 3 | ||||||||
Net cash proceeds received from issuance or sale of equity | $ 75,400,000 | $ 65,600,000 | |||||||
Payment of issuance costs | $ 4,500,000 | ||||||||
Price of common stock | $ 5 | ||||||||
Offering | Bain Capital Life Sciences Fund, L.P | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 1,000,000 | ||||||||
2017 ATM Agreement | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 2,878,567 | ||||||||
Net cash proceeds received | $ 28,200,000 | ||||||||
Remaining proceeds from common stock, under sales agreement | $ 120,500,000 | ||||||||
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 | ||||||||
Preferred stock, shares outstanding | 4,140 | 4,000 | |||||||
Preferred stock deemed dividend | $ 3,300,000 | ||||||||
Series B Convertible Preferred Stock | Common Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Number of common stock allowed to purchase | 1,000 | ||||||||
Series B Convertible Preferred Stock | Bain Capital Life Sciences Fund, L.P | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 3,756 | ||||||||
Series B Convertible Preferred Stock | BCIP Life Sciences Associates, L.P | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 384 | ||||||||
Series B Convertible Preferred Stock | Offering | |||||||||
Class Of Stock [Line Items] | |||||||||
Number of common stock allowed to purchase | 250 | ||||||||
Combined price of preferred stock and warrant | $ 3,000 | ||||||||
Maximum | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock sales agreement aggregate sales proceeds | $ 150,000,000 | ||||||||
Maximum | Warrants | |||||||||
Class Of Stock [Line Items] | |||||||||
Percentage of common stock held not to exceed for warrant exercises | 19.99% | ||||||||
Maximum | Offering | |||||||||
Class Of Stock [Line Items] | |||||||||
Issuance of common stock and preferred stock (in shares) | 16,100,000 | ||||||||
Warrant issued | 5,841,250 | ||||||||
Maximum | 2017 ATM Agreement | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock sales agreement aggregate sales proceeds | $ 150,000,000 | ||||||||
Commission on gross sales proceeds of common stock | 3.00% | ||||||||
Maximum | Series B Convertible Preferred Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Percentage of common stock held not to exceed for warrant exercises | 19.99% | ||||||||
Minimum | Warrants | |||||||||
Class Of Stock [Line Items] | |||||||||
Percentage of common stock to be held for exercise of warrants | 4.99% | ||||||||
Minimum | Series B Convertible Preferred Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Percentage of common stock to be held for conversion | 4.99% |
Common Stock, Preferred Stock_4
Common Stock, Preferred Stock and Warrants - Summary of Common Stock Warrants Outstanding (Detail) - Warrants shares in Thousands | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Class Of Stock [Line Items] | |
Warrants Issuance Date | Aug. 12, 2019 |
Shares Issuable | shares | 5,091 |
Expiration Date | Feb. 12, 2022 |
Exercise Price per Share | $ / shares | $ 4.50 |
Equity Plans and Stock-Based _3
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - shares | 3 Months Ended | |
Mar. 31, 2021 | Jan. 31, 2021 | |
Minimum | Employee Stock Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options vesting period | 3 years | |
Expiration period | 7 years | |
Maximum | Employee Stock Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options vesting period | 4 years | |
Expiration period | 10 years | |
2018 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Newly reserved shares of common stock | 1,500,000 | |
2014 Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Shares issued to employees | 22,517,869 |
Equity Plans and Stock-Based _4
Equity Plans and Stock-Based Compensation - Option Activity under Stock-Based Compensation Plans (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Shares Underlying Outstanding Options | |
Beginning balance | shares | 8,505 |
Options granted | shares | 1,996 |
Options exercised | shares | (119) |
Ending balance | shares | 10,047 |
Vested and expected to vest at March 31, 2021 | shares | 9,693 |
Exercisable at March 31, 2021 | shares | 5,967 |
Weighted-Average Exercise Price Per Share | |
Beginning balance | $ / shares | $ 11.57 |
Options granted | $ / shares | 9.36 |
Options exercised | $ / shares | 4.16 |
Ending balance | $ / shares | 11.15 |
Vested and expected to vest at March 31, 2021 | $ / shares | 11.26 |
Exercisable at March 31, 2021 | $ / shares | $ 13.44 |
Weighted-Average Remaining Contractual Term (years) | |
Balance at March 31, 2021 | 4 years 3 months 4 days |
Vested and expected to vest at March 31, 2021 | 4 years 2 months 5 days |
Exercisable at March 31, 2021 | 3 years 18 days |
Aggregate Intrinsic Value | |
Balance at March 31, 2021 | $ | $ 17,816 |
Vested and expected to vest at March 31, 2021 | $ | 17,184 |
Exercisable at March 31, 2021 | $ | $ 8,975 |
Unvested | |
Shares Underlying Outstanding Options | |
Options cancelled | shares | (171) |
Weighted-Average Exercise Price Per Share | |
Options cancelled | $ / shares | $ 7.50 |
Vested | |
Shares Underlying Outstanding Options | |
Options cancelled | shares | (164) |
Weighted-Average Exercise Price Per Share | |
Options cancelled | $ / shares | $ 19.67 |
Equity Plans and Stock-Based _5
Equity Plans and Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs) shares in Thousands | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Number of Shares | |
Non-vested, Beginning Balance | shares | 1,794 |
Granted | shares | 1,796 |
Vested | shares | (533) |
Forfeited | shares | (120) |
Non-vested, Ending Balance | shares | 2,937 |
Weighted-Average Grant-Date Fair Value Per Share | |
Non-vested, Beginning Balance | $ / shares | $ 7.23 |
Granted | $ / shares | 9.43 |
Vested | $ / shares | 8.88 |
Forfeited | $ / shares | 8.50 |
Non-vested, Ending Balance | $ / shares | $ 8.22 |
Equity Plans and Stock-Based _6
Equity Plans and Stock-Based Compensation -Summary Of Performance Based Restricted Stock Unit (Detail) - Performance Based Restricted Stock Units shares in Thousands | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Weighted-Average Grant-Date Fair Value Per Share | |
Granted | $ / shares | $ 8.40 |
Forfeited | $ / shares | 8.40 |
Non-vested, Ending Balance | $ / shares | $ 8.40 |
Number of Shares | |
Granted | shares | 297 |
Forfeited | shares | (30) |
Non-vested, Ending Balance | shares | 267 |
Equity Plans and Stock-Based _7
Equity Plans and Stock-Based Compensation - Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement, Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average fair value per share | $ 6.72 | $ 3.58 |
Expected life (in years) | 4 years 6 months | 4 years 6 months |
Volatility | 1.00% | 0.90% |
Minimum | Share-based Payment Arrangement, Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 0.50% | 1.40% |
Market Based Performance Stock Unit | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average fair value per share | $ 8.40 | |
Expected life (in years) | 2 years 10 months 25 days | |
Volatility | 0.90% | |
Market Based Performance Stock Unit | Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 0.03% | |
Market Based Performance Stock Unit | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 1.92% |
Equity Plans and Stock-Based _8
Equity Plans and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | $ 4,723 | $ 1,778 |
Research and Development | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 872 | (1,573) |
Selling, General and Administrative | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 3,144 | 2,442 |
Cost of Sales - Product | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | 170 | 136 |
Inventory | ||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||
Stock-based compensation expense | $ 537 | $ 773 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - CEPI Member - Reservation Agreement - USD ($) | May 03, 2021 | Mar. 31, 2021 |
Subsequent Event [Line Items] | ||
Interest- free unsecured forgivable loan | $ 99,000 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Increase in interest free unsecured forgiveable loan maximum borrowing capacity | $ 77,400 | |
Interest free unsecured forgiveable loan Maximum borrowing capacity | $ 176,400 |