Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | VIR | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity Registrant Name | Vir Biotechnology, Inc. | |
Entity Central Index Key | 0001706431 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 133,115,621 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-39083 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-2730369 | |
Entity Address, Address Line One | 499 Illinois Street | |
Entity Address, Address Line Two | Suite 500 | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94158 | |
City Area Code | 415 | |
Local Phone Number | 906-4324 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 963,735 | $ 347,815 |
Short-term investments | 1,359,945 | 217,182 |
Restricted cash and cash equivalents, current | 12,955 | 8,594 |
Receivable from collaboration | 0 | 773,079 |
Equity investments | 22,801 | 143,148 |
Prepaid expenses and other current assets | 54,180 | 73,003 |
Total current assets | 2,413,616 | 1,562,821 |
Intangible assets, net | 32,888 | 33,287 |
Goodwill | 16,937 | 16,937 |
Property and equipment, net | 100,226 | 42,834 |
Operating right-of-use assets | 84,716 | 87,220 |
Restricted cash and cash equivalents, noncurrent | 7,276 | 7,006 |
Long-term investments | 34,102 | 201,388 |
Other assets | 6,209 | 2,775 |
TOTAL ASSETS | 2,695,970 | 1,954,268 |
CURRENT LIABILITIES: | ||
Accounts payable | 2,722 | 6,521 |
Accrued and other liabilities | 282,616 | 236,512 |
Deferred revenue, current portion | 22,865 | 98,209 |
Total current liabilities | 308,203 | 341,242 |
Deferred revenue, noncurrent | 54,653 | 3,815 |
Operating lease liabilities, noncurrent | 126,942 | 133,561 |
Contingent consideration, noncurrent | 30,712 | 22,822 |
Deferred tax liability | 18,439 | 18,439 |
Other long-term liabilities | 7,166 | 2,540 |
TOTAL LIABILITIES | 546,115 | 522,419 |
Commitments and contingencies (Note 8) | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2022 and December 31, 2021; no shares issued and outstanding as of September 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 133,027,358 and 131,161,404 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 13 | 13 |
Additional paid-in capital | 1,682,882 | 1,571,535 |
Accumulated other comprehensive loss | (11,880) | (1,099) |
Retained earnings (accumulated deficit) | 478,840 | (138,600) |
TOTAL STOCKHOLDERS’ EQUITY | 2,149,855 | 1,431,849 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 2,695,970 | $ 1,954,268 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 133,027,358 | 131,161,404 |
Common stock, shares outstanding | 133,027,358 | 131,161,404 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Total revenue | $ 374,557 | $ 103,616 | $ 1,566,387 | $ 282,668 |
Operating expenses: | ||||
Cost of Revenue | 22,253 | 7,836 | 140,323 | 8,988 |
Research and development | 114,166 | 98,669 | 319,475 | 319,665 |
Selling, general and administrative | 43,174 | 50,496 | 123,019 | 105,016 |
Total operating expenses | 179,593 | 157,001 | 582,817 | 433,669 |
Income (loss) from operations | 194,964 | (53,385) | 983,570 | (151,001) |
Other income (expense): | ||||
Change in fair value of equity investments | (13,590) | 164,072 | (120,019) | 164,072 |
Interest income | 9,332 | 11 | 11,920 | 272 |
Other income (expense), net | 27,026 | 64 | 30,447 | (9,430) |
Total other income (expense) | 22,768 | 164,147 | (77,652) | 154,914 |
Income before benefit from (provision for) income taxes | 217,732 | 110,762 | 905,918 | 3,913 |
Provision for income taxes | (42,420) | (334) | (288,478) | (583) |
Net income | $ 175,312 | $ 110,428 | $ 617,440 | $ 3,330 |
Net income per share, basic | $ 1.32 | $ 0.85 | $ 4.66 | $ 0.03 |
Net income per share, diluted | $ 1.30 | $ 0.82 | $ 4.58 | $ 0.02 |
Weighted-average shares outstanding, basic | 132,729,530 | 130,665,831 | 132,422,028 | 129,520,837 |
Weighted-average share outstanding, diluted | 134,963,317 | 133,854,419 | 134,711,777 | 133,318,979 |
Collaboration Revenue [Member] | ||||
Revenues: | ||||
Total revenue | $ 309,145 | $ 102,398 | $ 1,483,860 | $ 107,731 |
Contract Revenue [Member] | ||||
Revenues: | ||||
Total revenue | 39,998 | 315 | 52,534 | 169,581 |
License | ||||
Revenues: | ||||
Total revenue | 22,289 | 0 | 22,289 | 0 |
Grant Revenue | ||||
Revenues: | ||||
Total revenue | $ 3,125 | $ 903 | $ 7,704 | $ 5,356 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Net income | $ 175,312 | $ 110,428 | $ 617,440 | $ 3,330 |
Other comprehensive (loss) income: | ||||
Unrealized (loss) gain on investments | (4,318) | 13 | (10,754) | (71) |
Amortization of actuarial (loss) gain | (9) | 14 | (27) | 42 |
Other comprehensive (loss) income | (4,327) | 27 | (10,781) | (29) |
Comprehensive income | $ 170,985 | $ 110,455 | $ 606,659 | $ 3,301 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Retained Earnings (Accumulated Deficit) |
Beginning balance at Dec. 31, 2020 | $ 716,852 | $ 13 | $ 1,385,301 | $ (1,278) | $ (667,184) |
Beginning balance (in shares) at Dec. 31, 2020 | 127,416,740 | ||||
Issuance of common stock in connection with a collaboration agreement | 85,213 | 85,213 | |||
Issuance of common stock in connection with a collaboration agreement (in shares) | 1,924,927 | ||||
Issuance of common stock to settle a contingent consideration | 1,860 | 1,860 | |||
Issuance of common stock to settle a contingent consideration (in shares) | 42,737 | ||||
Vesting of restricted common stock (in shares) | 89,261 | ||||
Exercise of stock options | 9,635 | 9,635 | |||
Exercise of stock option (in shares) | 1,352,457 | ||||
Stock-based compensation | 59,413 | 59,413 | |||
Other comprehensive income (loss) | (29) | (29) | |||
Net income | 3,330 | 3,330 | |||
Ending balance at Sep. 30, 2021 | 876,274 | $ 13 | 1,541,422 | (1,307) | (663,854) |
Ending balance (in shares) at Sep. 30, 2021 | 130,826,122 | ||||
Beginning balance at Jun. 30, 2021 | 737,325 | $ 13 | 1,512,928 | (1,334) | (774,282) |
Beginning balance (in shares) at Jun. 30, 2021 | 130,479,975 | ||||
Issuance of common stock to settle a contingent consideration | 1,860 | 1,860 | |||
Issuance of common stock to settle a contingent consideration (in shares) | 42,737 | ||||
Vesting of restricted common stock (in shares) | 1,852 | ||||
Exercise of stock options | 3,690 | 3,690 | |||
Exercise of stock option (in shares) | 301,558 | ||||
Stock-based compensation | 22,944 | 22,944 | |||
Other comprehensive income (loss) | 27 | 27 | |||
Net income | 110,428 | 110,428 | |||
Ending balance at Sep. 30, 2021 | 876,274 | $ 13 | 1,541,422 | (1,307) | (663,854) |
Ending balance (in shares) at Sep. 30, 2021 | 130,826,122 | ||||
Beginning balance at Dec. 31, 2021 | $ 1,431,849 | $ 13 | 1,571,535 | (1,099) | (138,600) |
Beginning balance (in shares) at Dec. 31, 2021 | 131,161,404 | 131,161,404 | |||
Issuance of common stock in connection with a collaboration agreement | $ 28,462 | 28,462 | |||
Issuance of common stock in connection with a collaboration agreement (in shares) | 881,365 | ||||
Issuance of common stock under employee stock purchase plan | 2,066 | 2,066 | |||
Issuance of common stock under employee stock purchase plan (Shares) | 94,175 | ||||
Vesting of restricted common stock (in shares) | 323,700 | ||||
Exercise of stock options | 3,602 | 3,602 | |||
Exercise of stock option (in shares) | 566,714 | ||||
Stock-based compensation | 77,217 | 77,217 | |||
Other comprehensive income (loss) | (10,781) | (10,781) | |||
Net income | 617,440 | 617,440 | |||
Ending balance at Sep. 30, 2022 | $ 2,149,855 | $ 13 | 1,682,882 | (11,880) | 478,840 |
Ending balance (in shares) at Sep. 30, 2022 | 133,027,358 | 133,027,358 | |||
Beginning balance at Jun. 30, 2022 | $ 1,952,012 | $ 13 | 1,656,024 | (7,553) | 303,528 |
Beginning balance (in shares) at Jun. 30, 2022 | 132,597,812 | ||||
Vesting of restricted common stock (in shares) | 53,102 | ||||
Exercise of stock options | 2,044 | 2,044 | |||
Exercise of stock option (in shares) | 376,444 | ||||
Stock-based compensation | 24,814 | 24,814 | |||
Other comprehensive income (loss) | (4,327) | (4,327) | |||
Net income | 175,312 | 175,312 | |||
Ending balance at Sep. 30, 2022 | $ 2,149,855 | $ 13 | $ 1,682,882 | $ (11,880) | $ 478,840 |
Ending balance (in shares) at Sep. 30, 2022 | 133,027,358 | 133,027,358 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ 617,440 | $ 3,330 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Change in estimated constraint on profit-sharing amount | 353,526 | 0 |
Depreciation and amortization | 4,431 | 3,891 |
Amortization of intangible assets | 399 | 399 |
Accretion of discounts on investments, net | (1,315) | (859) |
Noncash lease expense | 6,473 | 4,471 |
Change in fair value of equity investments | 120,019 | (164,072) |
Change in estimated fair value of contingent consideration | 7,890 | 63,246 |
Payment for contingent consideration in excess of acquisition date fair value | (93,803) | (8,140) |
Stock-based compensation | 77,217 | 59,413 |
Other | 301 | 486 |
Changes in operating assets and liabilities: | ||
Receivable from collaboration | 491,872 | (93,003) |
Prepaid expenses and other current assets | 11,023 | 1,878 |
Other assets | (3,434) | (1,051) |
Accounts payable | (2,003) | (959) |
Accrued liabilities and other long-term liabilities | 65,144 | (13,490) |
Operating lease liabilities | (2,547) | (383) |
Deferred revenue | (24,506) | 89,559 |
Net cash provided by (used in) operating activities | 1,628,127 | (55,284) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Proceeds from sale of an equipment | 22 | 0 |
Purchases of property and equipment | (55,432) | (8,750) |
Purchases of investments | (1,069,752) | (55,729) |
Maturities of investments | 84,836 | 301,243 |
Proceeds from disposal of an equipment | 0 | 4 |
Net cash (used in) provided by investing activities | (1,040,326) | 236,768 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock in connection with a grant agreement | 28,462 | 0 |
Proceeds from issuance of common stock in connection with a collaboration agreement | 0 | 85,213 |
Payment of principal on financing lease obligation | (183) | (187) |
Proceeds from exercise of stock options | 3,602 | 9,635 |
Issuance of common stock under ESPP | 2,066 | |
Payment of contingent consideration | (1,197) | 0 |
Net cash provided by financing activities | 32,750 | 94,661 |
Net increase in cash, cash equivalents and restricted cash and cash equivalents | 620,551 | 276,145 |
Cash, cash equivalents and restricted cash and cash equivalents at beginning of period | 363,415 | 451,487 |
Cash, cash equivalents and restricted cash and cash equivalents at end of period | 983,966 | 727,632 |
NONCASH INVESTING AND FINANCING ACTIVITIES: | ||
Common stock issued for payment of contingent consideration | 0 | 1,860 |
Property and equipment purchases included in accounts payable and accrued liabilities | 6,413 | 4,191 |
Operating lease liabilities obtained in exchange of right-of-use asset | 3,969 | 90 |
SUPPLEMENTAL DISCLOSURE OF CASHFLOW INFORMATION | ||
Cash paid during the period for income tax | 191,653 | 0 |
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONDENSED CONSOLIDATED BALANCE SHEETS: | ||
Cash and cash equivalents | 963,735 | 714,521 |
Restricted cash and cash equivalents, current | 12,955 | 6,112 |
Restricted cash and cash equivalents, noncurrent | 7,276 | 6,999 |
Total cash, cash equivalents and restricted cash | $ 983,966 | $ 727,632 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Organization | 1. Organization Vir Biotechnology, Inc. (“Vir” or the “Company”) is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Its current pipeline consists of sotrovimab (previously VIR-7831; and where marketing authorization has been granted, marketed under the brand name Xevudy®) and other product candidates targeting coronavirus disease 2019 (“COVID-19”), hepatitis B virus (“HBV”), hepatitis D virus (“HDV”), influenza A virus, and human immunodeficiency virus (“HIV”). Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. In September 2022, the Company formed a new wholly-owned subsidiary in Switzerland, Vir Biotechnology International GmbH (“VBI”), a Swiss limited liability company. The primary purpose of VBI is to support Vir's research and development and international commercial activities outside of the United States. Sales Agreement In November 2020, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”), under which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $ 300.0 million, through or to Cowen, acting as sales agent or principal. The shares will be offered and sold under the Company’s shelf registration statement on Form S-3 and a related prospectus filed with the Securities and Exchange Commission (the “SEC”) on November 10, 2020. The Company will pay Cowen a commission of up to 3.0 % of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Cowen with customary indemnification and contribution rights. As of September 30, 2022 , no shares have been issued under the Sales Agreement. Need for Additional Capital Although the Company recorded net income for the year ended December 31, 2021 and the three and nine months ended September 30, 2022, it has otherwise incurred net losses since inception. The Company expects its earnings to be volatile and may continue to incur net losses over the next several years and may need to raise additional capital to fully implement its business plan. As of September 30, 2022, the Company had retained earnings of $ 478.8 million . The Company had $ 2.4 billion of cash, cash equivalents, and investments as of September 30, 2022. Based on the Company’s current operating plan, management believes that the $ 2.4 billion as of September 30, 2022 will be sufficient to fund its operations through at least the next 12 months from the issuance date of these unaudited condensed consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. The unaudited condensed consolidated financial statements include the accounts of Vir and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial information. The condensed consolidated results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, or for any other future annual or interim period. Certain information and footnote disclosures typically included in the Company’s annual consolidated financial statements have been condensed or omitted. As such, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 28, 2022. Use of Estimates The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expense during the reporting periods. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. Concentration of Credit Risk, Credit Loss and Other Risks and Uncertainties Although the Company received Emergency Use Authorization (“EUA”), temporary authorization or marketing approval for sotrovimab (under the brand name Xevudy®), sotrovimab is currently de-authorized in the U.S. and has limitations in use outside of the U.S. In addition, the Company is still subject to a number of other challenges and risks similar to other biopharmaceutical companies in the early stage, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its other product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of sotrovimab and other product candidates and protection of proprietary technology. If the Company does not successfully obtain regulatory approval, commercialize or partner any of its product candidates, it will be unable to generate revenue from product sales or maintain profitability. In addition, to the extent the COVID-19 pandemic, including the emergence of new variants or subvariants, adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. The Company has implemented a number of plans and policies designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic and geopolitical events, including civil or political unrest (such as the ongoing war between Ukraine and Russia), will continue to have an impact on the clinical development timelines for some of its clinical programs. The extent to which the COVID-19 pandemic impacts the Company’s business, clinical development and regulatory efforts, corporate development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and investments. Cash and cash equivalents are deposited in checking and sweep accounts at a financial institution. Such deposits may, at times, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s investment policy limits investments to certain types of securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments, and issuers of the investments to the extent recorded on the unaudited condensed consolidated balance sheets. As of September 30, 2022, the Company has no off-balance sheet concentrations of credit risk. The Company is exposed to credit losses primarily through receivables from customers and collaborators and through its available-for-sale debt securities. The Company’s expected loss allowance methodology for the receivables is developed using historical collection experience, current and future economic market conditions, a review of the current aging status and financial condition of the entities. Specific allowance amounts are established to record the appropriate allowance for customers that have a higher probability of default. Balances are written off when determined to be uncollectible. The Company’s expected loss allowance methodology for the debt securities is developed by reviewing the extent of the unrealized loss, the size, term, geographical location, and industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. The Company considered the current and expected future economic and market conditions surrounding the COVID-19 pandemic and interest rate policies and determined that the estimate of credit losses was not significantly impacted. During the nine months ended September 30, 2022 and 2021 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk. Investments Investments include available-for-sale debt securities and equity investments, which are carried at estimated fair value. Available-for-Sale Debt Securities The Company’s valuations of marketable securities are generally derived from independent pricing services based on quoted prices in active markets for similar securities at period end. Generally, investments with original maturities beyond three months at the date of purchase and which mature at, or less than 12 months from, the unaudited condensed consolidated balance sheet date are considered short-term investments, with all others considered to be long-term investments. Unrealized gains and losses deemed temporary in nature are reported as a component of accumulated comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the unaudited condensed consolidated statements of operations. The cost of securities sold is based on the specific identification method. Equity Investments Under Accounting Standards Update (“ASU”) No. 2016-01, Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities, the Company measures its investment in equity securities at fair value at each reporting date based on the market price at period end if it has a readily determinable fair value. Otherwise, the investments in equity securities are measured at cost less impairment, adjusted for observable price changes for identical or similar investments of the same issuer unless the Company has significant influence or control over the investee. Changes in fair value resulting from observable price changes are presented as change in fair value of equity investments and changes in fair value resulting from foreign currency translation are included in other income (expense), net on the unaudited condensed consolidated statements of operations. Restricted Cash and Cash Equivalents Restricted cash and cash equivalents represent money market funds to secure standby letters of credit and security deposits with financial institutions, both under office and laboratory space lease agreements. Additionally, funds received from certain grants are restricted as to their use and are therefore classified as restricted cash and cash equivalents. Revenue Recognition Collaboration, License and Contract Revenue Under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when the Company’s customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods and services. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs 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 the Company satisfies a performance obligation. For collaborative arrangements that fall within the scope of ASC 808, Collaborative Arrangements (“ASC 808”), the Company first determines which elements of the collaboration are deemed to be a performance obligation with a customer within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808 and are not subject to the guidance in ASC 606, the Company applies the revenue recognition model under ASC 606, including the royalty exception guidance and/or variable consideration guidance under ASC 606 as described below, or other guidance, as deemed appropriate. When the Company is considered an agent in elements of collaboration arrangements within the scope of ASC 808, it records its share of collaboration revenue in the period in which such sales occur. The Company is considered an agent when the collaboration partner controls the product before transfer to the customers and has the ability to direct the use of and obtain substantially all of the remaining benefits from the product. In these instances, collaboration revenue is based upon the net sales reported by the Company's collaboration partners, net of cost of goods sold and allowable expenses (e.g., manufacturing, distribution, medical affairs, selling, and marketing expenses) in the period. In order to record collaboration revenue, the Company utilizes certain information from its collaboration partner, including actual net product sales and costs incurred for sales activities, and makes key judgments based on business updates related to commercial and clinical activities such as expected commercial demand, commercial supply plan, manufacturing commitments, risks related to expired or obsolete inventories, and risks related to potential product returns or contract terminations. For the periods covered in the financial statements presented, there have been no material changes to prior period estimates of revenues and expenses, except the profit-share amount previously constrained which was partially released in the three months ended September 30, 2022, as discussed in Note 6—Collaboration and License Agreement. The Company has entered into a number of license and collaboration agreements that fall within the scope of ASC 606. The Company evaluates the promised goods or services in these agreements to determine which ones represent distinct performance obligations. These agreements may include the following types of promised goods or services: (i) grants of licenses, (ii) performance of research and development services, and (iii) participation on joint research and/or development committees. They also may include options to obtain licenses to the Company’s intellectual property. Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. These estimates are re-assessed each reporting period as required. These agreements may include the following types of consideration: non-refundable upfront payments, reimbursement for research services, research, development or regulatory milestone payments, profit-sharing arrangements, and royalty and commercial sales milestone payments. If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on their estimated standalone selling prices (“SSP”). The Company estimates the SSP for each distinct performance obligation by considering information such as market conditions, entity-specific factors, and information about its customer that is reasonably available. The Company considers estimation approaches that allow it to maximize the use of observable inputs. These estimation approaches may include the adjusted market assessment approach, the expected cost plus a margin approach or the residual approach. The Company also considers whether to use a different estimation approach or a combination of approaches to estimate the SSP for each distinct performance obligation. Developing certain assumptions (e.g., treatable patient population, expected market share, probability of success and product profitability, discount rate based on weighted-average cost of capital) to estimate the SSP of a distinct performance obligation requires significant judgment. For performance obligations satisfied over time, the Company estimates the efforts needed to complete the performance obligation and recognizes revenue by measuring the progress towards complete satisfaction of the performance obligation using an input measure. For arrangements that include sales-based royalties, including commercial milestone payments based on pre-specified level of sales, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Achievement of these royalties and commercial milestones may solely depend upon the performance of the licensee. Grant Revenue Grants received, including cost reimbursement agreements, are assessed to determine if the agreement should be accounted for as an exchange transaction or a contribution. An agreement is accounted for as a contribution if the resource provider does not receive commensurate value in return for the assets transferred. Contributions are recognized as grant revenue when all donor-imposed conditions have been met. Acquisitions Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, assets acquired, including in-process research and development (“IPR&D”) projects, and liabilities assumed are recorded at their respective fair values as of the acquisition date. Any excess fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with the business combination are recorded at their fair values on the acquisition date and are remeasured each subsequent reporting period until the related contingencies are resolved and are classified as contingent consideration on the unaudited condensed consolidated balance sheets. The changes in fair values of contingent consideration related to the achievement of various milestones are recorded within research and development expenses or selling, general and administrative expenses based on the nature of the relevant underlying activities. When the Company determines that an entity acquired does not meet the definition of a business, the transaction is accounted for as an acquisition of assets. Therefore, the consideration paid to acquire IPR&D is expensed, and no goodwill is recorded. Any contingent consideration is generally recognized only when it becomes payable or is paid. Embedded Derivatives The Company evaluates its acquisitions, collaborative arrangements and other business development transactions to determine if embedded components of these contracts meet the definition of a derivative under ASC 815, Derivatives and Hedging. In general, embedded derivatives are required to be bifurcated from the host instrument if (i) the embedded feature is not clearly and closely related to the host contract and (ii) the embedded feature, if considered a freestanding instrument, meets the definition of a derivative. Embedded derivatives are reported on the unaudited condensed consolidated balance sheets at their estimated fair values. Contingent consideration related to asset acquisitions that meet the definition of an embedded derivative is classified as contingent consideration on the unaudited condensed consolidated balance sheets. Any change in estimated fair values, as determined at each measurement period, are recorded in the unaudited condensed consolidated statements of operations based on the nature of the related contingencies. Changes in fair values of embedded derivatives related to the achievement of various milestones for product candidates are recorded within research and development expenses or selling, general and administrative expenses based on the nature of the relevant underlying activities. Otherwise, changes in fair values are recorded within other income (expense), net. New Accounting Pronouncement Recently Adopted In November 2021, the Financial Accounting Standards Board issued ASU No. 2021-10, Government Assistance (Topic 832) (“ASU 2021-10”), which adds certain disclosure requirements with respect to government assistance, including (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on financial statements. ASU 2021-10 is effective for annual periods beginning after December 15, 2021. The Company's adoption of ASU 2021-10 on January 1, 2022 did not result in any material impact on its consolidated financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows: • Level 1: Inputs which include quoted prices in active markets for identical assets and 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. • 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. The carrying amounts of the Company’s financial instruments, including receivable from collaboration, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. Cash Equivalents and Available-for-Sale Debt Securities The following tables summarize the Company’s Level 1 and Level 2 financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2022 and December 31, 2021: September 30, 2022 Valuation Amortized Gross Gross Aggregate (in thousands) Assets: Money market funds (1) Level 1 $ 978,367 $ — $ — $ 978,367 U.S. government treasuries Level 2 1,385,672 — ( 11,626 ) 1,374,046 Total financial assets $ 2,364,039 $ — $ ( 11,626 ) $ 2,352,413 (1) Includes $ 21.7 million of restricted cash equivalents. December 31, 2021 Valuation Amortized Gross Gross Aggregate (in thousands) Assets: Money market funds (1) Level 1 $ 345,098 $ — $ — $ 345,098 U.S. government treasuries Level 2 419,442 — ( 872 ) 418,570 Total financial assets $ 764,540 $ — $ ( 872 ) $ 763,668 (1) Includes $ 15.6 million of restricted cash equivalents. Accrued interest receivable excluded from both the fair value and amortized cost basis of the available-for-sale debt securities are presented within prepaid expenses and other current assets, and other assets in the unaudited condensed consolidated balance sheets. Accrued interest receivable amounted to $ 2.8 million and $ 1.1 million as of September 30, 2022 and December 31, 2021, respectively. The Company did no t write off any accrued interest receivable during the nine months ended September 30, 2022 and 2021. As of September 30, 2022, there were no in vestments that have been in a continuous unrealized loss position for longer than 12 months. Total net unrealized losses of $ 11.6 million were recorded in accumulated other comprehensive income (loss) as of September 30, 2022. As of September 30, 2022, no securi ties had contractual maturities of longer than two years . Equity Investments As of September 30, 2022, the Company's equity investment consisted solely of ordinary shares of Brii Biosciences Limited (“Brii Bio Parent”). The Company acquired the securities as partial consideration for entering into the collaboration, option and license agreement (the “Brii Agreement”) with Brii Bio Parent and Brii Biosciences Offshore Limited (“Brii Bio”) in May 2018. The Company concluded it does not have a controlling interest or significant influence over Brii Bio based on its ownership percentage and other factors. See further discussion in Note 6—Collaboration and License Agreements. In July 2021, Brii Bio Parent completed its initial public offering (“Brii Bio Parent IPO”) on the Stock Exchange of Hong Kong Limited. Upon the completion of the Brii Bio Parent IPO, the securities were considered to be marketable equity securities and subsequently remeasured at fair value at each reporting date. As of September 30, 2022, the Company remeasured the equity investment at a fair value of $ 22.8 million . For the three and nine months ended September 30, 2022, the Company recognized an unrealized loss of $ 13.6 million and $ 120.0 million, respectively, as other income (expenses) in the unaudited condensed consolidated statement of operations. For the three and nine months ended September 30, 2022, the unrealized loss related to foreign currency translation for the respective periods was immaterial. As of September 30, 2022, the Company classifies its equity investment in Brii Bio Parent as a Level 1 asset within the fair value hierarchy, as the value is based on a quoted market price in an active market. Contingent Consideration Contingent consideration includes potential milestone payments in connection with the acquisitions of Humabs Biomed SA (“Humabs”) and TomegaVax, Inc. (“TomegaVax”). See further discussion in Note 4—Acquisitions. The Company classifies the contingent consideration as Level 3 financial liabilities within the fair value hierarchy as of September 30, 2022 and December 31, 2021. The estimated fair value of the contingent consideration related to the Humabs acquisition was determined by calculating the probability-weighted clinical, regulatory and commercial milestone payments based on the assessment of the likelihood and estimated timing that certain milestones would be achieved. As of September 30, 2022, the Company calculated the estimated fair value of the remaining clinical and regulatory milestones related to VIR-3434 using the following significant unobservable inputs: Unobservable input Range 1 Discount rates 8.1 % - 9.2 % ( 8.7 %) Probability of achievement 22.1 % - 60 % ( 42.1 %) (1) Unobservable inputs were weighted based on the relative fair value of the clinical and regulatory milestone payments. For the commercial milestones, the Company used a Monte Carlo simulation because of the availability of discrete revenue forecasts. As of September 30, 2022, the Monte Carlo simulation assumed a commercial product launch and associated discrete revenue forecasts, as well as the following significant unobservable inputs for the remaining commercial milestones related to VIR-3434: Unobservable input Value Volatility 90.0 % Discount rate 12.0 % Probability of achievement 26.0 % The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due. As of September 30, 2022 and December 31, 2021, the estimated fair value of the contingent consideration related to the Humabs acquisition was $ 29.6 million and $ 17.1 million , respectively, with changes in the estimated fair value recorded in research and development expenses and selling, general and administrative expenses in the unaudited condensed consolidated statements of operations based on the nature of the relevant underlying activities. The estimated fair value of the contingent consideration related to the TomegaVax acquisition was determined by using a Monte Carlo simulation model which included estimates of both the probability and timing to achieve the required per-share price of the Company’s common stock, and incorporates assumptions as to expected volatility and discount rate. The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due. Although the TomegaVax acquisition was accounted for as an asset acquisition, such contingent consideration met the definition of an embedded derivative financial instrument. As of September 30, 2022, the fair value of the remaining contingent consideration was estimated using the following significant unobservable inputs: Unobservable input Value Volatility 90.0 % Risk-free rate 4.1 % As of September 30, 2022 and December 31, 2021, the estimated fair value of the contingent consideration related to the TomegaVax acquisition was $ 1.1 million and $ 5.7 million , respectively, with changes in the estimated fair value recorded in other income (expense), net in the unaudited condensed consolidated statements of operations. The estimated fair value of the contingent consideration related to the Humabs and TomegaVax acquisitions involves significant estimates and assumptions which give rise to measurement uncertainty. The following table sets forth the changes in the estimated fair value of the Company’s contingent consideration (in thousands): Contingent Balance at December 31, 2021 $ 22,822 Changes in fair value 7,890 Balance at September 30, 2022 $ 30,712 |
Acquisitions
Acquisitions | 9 Months Ended |
Sep. 30, 2022 | |
Business Combinations [Abstract] | |
Acquisitions | 4. Acquisitions Acquisition of TomegaVax In September 2016, the Company entered into an agreement and plan of merger (“TomegaVax Merger Agreement”) to acquire all of the equity interests of TomegaVax. The primary asset purchased in the acquisition was an in-process cytomegalovirus (“CMV”) vector-based vaccine platform for use in HBV, HIV, and tuberculosis. The acquisition was accounted for as an asset purchase. In connection with the entry into the TomegaVax Merger Agreement, the Company also entered into a letter agreement with TomegaVax (the “TomegaVax Letter Agreement”), which provides for certain payments to TomegaVax’s former stockholders before September 2024, in each case so long as the Company is continuing to pursue the development of the TomegaVax technology. Under the terms of the TomegaVax Letter Agreement, the Company will be required to pay to the former stockholders of TomegaVax milestone payments of up to an aggregate of $ 30.0 million if the per-share price of the Company’s publicly traded common stock, or implied price per share of the Company’s Series A-1 convertible preferred stock (or common stock upon conversion) upon a certain asset sale, merger or stock sale, is at least $ 45 (as adjusted in the case of any stock dividend, stock split or other similar recapitalization), with the amount of such payments determined by the share price and/or the stage of the Company’s clinical development at the time of the relevant event triggering the payment. The share price of the Company’s publicly traded common stock will be determined using the average of the daily volume-weighted average trading price of the Company’s common stock for each trading day during a consecutive 90-day period. The foregoing payments are payable (i) during any date after the completion of an initial public offering by the Company or any successor or affiliate controlling the TomegaVax technology, provided that no payment will be due before the first anniversary of the initial public offering, (ii) upon the sale of all assets related to the TomegaVax technology or (iii) upon a merger or stock sale of the Company or any successor or affiliate controlling the TomegaVax technology, in each case subject to certain conditions with respect to the timing of the payments. The payments under the TomegaVax Letter Agreement can be made in cash or shares of the Company’s common stock, at the discretion of the Company’s board of directors. In February 2021, the Company achieved one of the milestones related to the specified per-share price of its common stock, which resulted in a $ 10.0 million payable to TomegaVax’s former stockholders. In July 2021, the Company made the milestone payment to the former TomegaVax stockholders through a combination of $ 8.1 million in cash and the issuance of 42,737 shares of common stock with a total fair value of $ 1.9 million. The remaining milestone payments of up to $ 20.0 million in the aggregate will be triggered if (i) the per-share price of the Company’s publicly traded common stock is at least $ 45 (as adjusted in the case of any stock dividend, stock split or other similar recapitalization) and upon the achievement of a certain milestone related to the stage of the Company’s clinical development at the time of the relevant event triggering the payment and/or (ii) the per-share price of the Company’s publicly traded common stock is at least $ 90 (as adjusted in the case of any stock dividend, stock split or other similar recapitalization). The Company determined that the future milestone payments contain net settlement provisions and, therefore, they were required to be accounted for as embedded derivatives under the relevant accounting guidance. As of September 30, 2022 , the estimated fair value of the embedded derivative was $ 1.1 million and was included in the contingent consideration liability on the unaudited condensed consolidated balance sheet. Acquisition of Humabs In August 2017, the Company acquired all of the outstanding equity of Humabs, a private Swiss company, which discovers and develops monoclonal antibodies (“mAbs”) derived from individuals whose immune systems have successfully responded to major diseases. The Company acquired all of Humabs’ rights, title and interest in and to substantially all of the assets of Humabs except for rights under certain license agreements with third parties. The Company is obligated to pass through to the former Humabs shareholders any amounts received by Humabs under such license agreements, net of any program expenses. The transaction was accounted for as an acquisition of a business. In addition to the cash payment and issuance of common stock to the former Humabs shareholders at the acquisition date, the Company also agreed to pay additional amounts in cash upon the achievement of specified milestone events: (i) up to $ 135.0 million upon the achievement of clinical, regulatory and commercial milestones for VIR-3434; and (ii) up to $ 105.0 million upon the achievement of clinical, regulatory and commercial milestones for another product, which the Company elected as a SARS-CoV-2 product, or sotrovimab. During the year ended December 31, 2021, the Company achieved the specified regulatory milestone of $ 35.0 million and sales milestones totaling $ 60.0 million related to sotrovimab, which were paid in January and February 2022, respectively. The estimated fair value of the remaining contingent consideration was $ 29.6 million as of September 30, 2022 . |
Grant Agreements
Grant Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Grant Agreements | 5. Grant Agreements Bill & Melinda Gates Foundation Grants The Company has entered into various grant agreements with the Bill & Melinda Gates Foundation, under which it was awarded grants totaling up to $ 55.7 million to support its HIV vaccine program, tuberculosis vaccine program, HIV vaccinal antibody program and malaria vaccinal antibody program. T he term of the grant agreements will expire at various dates through December 2023, unless earlier terminated by the Bill & Melinda Gates Foundation for the Company’s breach, failure to progress the funded project, in the event of the Company’s change of control, change in the Company’s tax status, or significant changes in the Company’s leadership that the Bill & Melinda Gates Foundation reasonably believes may threaten the success of the project. Concurrently with the execution of the grant agreement for the vaccinal antibody program, the Company entered into a stock purchase agreement with the Bill & Melinda Gates Foundation, under which the Bill & Melinda Gates Foundation purchased 881,365 shares of the Company’s common stock on January 13, 2022, at a price per share of $ 45.38 , for an aggregate purchase price of approximately $ 40.0 million. The fair market value of the common stock issued to the Bill & Melinda Gates Foundation was $ 28.5 million, based on the closing stock price of $ 37.65 per share on the closing date and taking into account a discount for the lack of marketability due to the restrictions in place on the underlying shares, resulting in a $ 11.3 million premium received by the Company. The Company accounted for the common stock issued to the Bill & Melinda Gates Foundation based on its fair market value on the closing date and determined that the premium paid by the Bill & Melinda Gates Foundation should be included in the deferred revenue from the vaccinal antibody grant. Payments received in advance that are related to future research activities along with the aforementioned premium received are deferred and recognized as revenue when the donor-imposed conditions are met, which is as the research and development activities are performed. The premium received by the Company is deferred and recognized over the same period as the grant proportionally. The Company recognized grant revenue of $ 2.8 million and $ 0.9 million for the three months ended September 30, 2022 and 2021 , respectively, and $ 7.4 million and $ 5.2 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022 and December 31, 2021 , the Company had deferred revenue of $ 24.3 million and $ 6.9 million, respectively. As of September 30, 2022 and December 31, 2021 , the Company had zero and $ 1.8 million, respectively, within accrued and other liabilities, which may need to be refunded to the Bill & Melinda Gates Foundation. Biomedical Advanced Research and Development Authority In September 2022, the Company entered into an other transaction for advanced research agreement (the “BARDA Agreement”) with the Biomedical Advanced Research and Development Authority (“BARDA”), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. Under the BARDA Agreement, the Company may receive up to an estimated $ 1.0 billion to advance the development of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats. The Base Period (as defined below) for the BARDA Agreement includes government funding of approximately $ 55.0 million to reimburse expenses incurred by the Company to support the development of VIR-2482, an investigational prophylactic monoclonal antibody designed with the aim to protect against seasonal and pandemic influenza, including expenses related to the Phase 2 pre-exposure prophylaxis trial of VIR-2482. The BARDA Agreement also provides for additional BARDA funding upon the exercise by BARDA of up to twelve options to further support the development of pre-exposure prophylactic antibodies including and beyond VIR-2482 for the prevention of influenza illness or possibly supporting medical countermeasures for other pathogens of pandemic potential. The BARDA Agreement has an initial term that commenced on September 30, 2022 and extends through January 2026 (“Base Period”), which may be extended by mutual written agreement of the Company and BARDA if certain conditions are met or if BARDA exercises any of its options, as described above, and is terminable by the Company and BARDA at any time under specified circumstances, including for convenience. The Company did not recognize any grant revenue from the BARDA Agreement for the three months ended September 30, 2022 . |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration and License Agreements | 6. Collaboration and License Agreements Collaboration Agreements with GSK 2020 GSK Agreement On June 9, 2020, the Company, Glaxo Wellcome UK Limited and Beecham S.A. entered into a definitive collaboration agreement under the terms set forth in the preliminary collaboration agreement entered into by the Company and certain GSK entities in April 2020 (the “2020 Preliminary Agreement”) (such definitive collaboration agreement, the “2020 GSK Agreement”). In December 2021, Beecham S.A. assigned and transferred all its rights, title, interest, and benefit in the 2020 GSK Agreement to GlaxoSmithKline Biologicals S.A. (Glaxo Wellcome UK Limited and GlaxoSmithKline Biologicals S.A., referred to, individually and together, as “GSK”), including all its rights to bring claims under such agreement. Concurrently with the execution of the 2020 Preliminary Agreement, the Company entered into a stock purchase agreement (the “2020 Stock Purchase Agreement”) with Glaxo Group Limited (“GGL”), an affiliate of GSK, under which GGL purchased 6,626,027 shares of the Company’s common stock on April 29, 2020, at a price per share of $ 37.73 , for an aggregate purchase price of approximately $ 250.0 million. After receipt of antitrust clearance on April 22, 2020, the 2020 Preliminary Agreement became effective as of April 29, 2020, which was also the closing date for the 2020 Stock Purchase Agreement (“Effective Date”). Under the terms of the 2020 GSK Agreement, the Company and GSK agreed to collaborate to research, develop and commercialize products for the prevention, treatment and prophylaxis of diseases caused by SARS-CoV-2, the virus that causes COVID-19, and potentially other coronaviruses. The collaboration is focused on the development and commercialization of three types of collaboration products under three programs: (1) antibodies targeting SARS-CoV-2 and potentially other coronaviruses (the “Antibody Program”); (2) vaccines targeting SARS-CoV-2 and potentially other coronaviruses (the “Vaccine Program”), and (3) products based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2 and potentially other coronaviruses (the “Functional Genomics Program”). For four years following the Effective Date, the parties agreed to conduct certain research and development activities under mutually agreed development plans and associated budgets for each of the three programs, and under the oversight of a joint steering committee (“JSC”). The Company is primarily responsible for the development and clinical manufacturing activities for the Antibody Program, and for conducting the initial development activities directed to a vaccine in the Vaccine Program. GSK is primarily responsible for the global commercialization activities for the Antibody Program (including in mainland China, Hong Kong, Macau and Taiwan following the purchase of these rights in May 2022, as described below), the later-stage development, manufacturing and commercialization activities for the Vaccine Program and the development, manufacturing and commercialization activities for the Functional Genomics Program. Subject to an opt-out mechanism and Amendment No. 1 to the 2020 GSK Agreement (described below), the parties share all development costs, manufacturing costs and costs and expenses for the commercialization of the collaboration products, with the Company bearing 72.5 % of such costs for the antibody products, 27.5 % of such costs for the vaccine products, and equal sharing of such costs for the functional genomics products. On a collaboration product-by-collaboration product basis, each party has the one-time right, at specified points in development, to opt-out of its co-funding obligations, and the other party may, at its election, either pursue such program unilaterally, or also cease research and development activities and funding of such collaboration product. If the opt-out provisions are not exercised by either party subject to the terms of the 2020 GSK Agreement, the parties share all profits and losses arising from any collaboration product in the same ratios in which the parties bore development costs for such collaboration program. For each collaboration product as to which a party exercises its opt-out right, the commercializing party pays to the opt-out party royalties on net sales of the applicable collaboration product at rates based on factors such as the stage of development of such collaboration product at the time the opt-out party exercises such right, and whether the opt-out party is the lead party, or a portion of the sublicense revenue if the commercializing party chooses to sublicense or otherwise divest rights to such collaboration product. On an antibody product-by-antibody product basis, the Company has a co-promotion right for such antibody product in the United States, under which the Company has the right to perform up to 20 % of details in connection with such antibody product. The 2020 GSK Agreement will remain in effect with respect to each collaboration program for as long as there is a collaboration product being developed or commercialized by the lead party, or the non-opt-out party, in such program. Either party has the right to terminate the 2020 GSK Agreement in the case of the insolvency of the other party, an uncured material breach of the other party with respect to a collaboration program or collaboration product, or as mutually agreed by the parties. The 2020 GSK Agreement superseded and replaced the 2020 Preliminary Agreement between the parties. The Company considered the ASC 606 criteria for combining contracts and determined that the 2020 GSK Agreement and 2020 Stock Purchase Agreement should be combined into a single contract because they were negotiated and entered into in contemplation of one another. The fair market value of the common stock issued to GGL was $ 206.7 million, based on the closing stock price of $ 36.70 on the date of execution of the 2020 Preliminary Agreement and 2020 Stock Purchase Agreement and taking into account a discount for the lack of marketability due to the restrictions in place on the underlying shares, resulting in a $ 43.3 million premium received by the Company. The Company accounted for the common stock issued to GGL based on its fair market value on the transaction date and determined that the premium paid by GSK should be attributed to the transaction price of the 2020 GSK Agreement. The Company concluded that the 2020 GSK Agreement contained four units of account: (i) the license granted to GSK under the Antibody Program (the “Antibody License”); (ii) the research and development activities (including clinical manufacturing) under the Antibody Program; (iii) the research and development activities under the Vaccine Program; and (iv) the research and development activities under the Functional Genomics Program. The Company considered the guidance in ASC 606 to determine which of these elements of the 2020 GSK Agreement are performance obligations with a customer. The Company determined that the Antibody License is within the scope of ASC 606 and, accordingly, accounted for the Antibody License as a distinct performance obligation under ASC 606. The Antibody License is a functional intellectual property and is distinct from the associated research and development activities to be performed under the program due to its significant standalone functionality. All other elements of the 2020 GSK Agreement, including the research and development activities and participation in the JSC and subcommittees for each collaboration program, were not determined to be distinct performance obligations with a customer. The transaction price for the Antibody License at inception was determined to be $ 43.3 million, representing the premium on the sale of common stock to GSK. The Company determined that GSK can benefit from the Antibody License at the time of grant and, therefore, the related performance obligation is satisfied at a point in time. As such, the Company recognized the $ 43.3 million as contract revenue during the second quarter of 2020. The remaining units of account of the 2020 GSK Agreement were determined to be within the scope of ASC 808 as the Company and GSK are both active participants in the development, manufacturing and commercialization activities and are exposed to significant risks and rewards that are dependent on the commercial success of the activities of the arrangement. Furthermore, the Company and GSK participate in the commercial profit and loss sharing arrangement for each program commensurate with each party’s cost-sharing responsibilities during research and development. Because ASC 808 does not provide recognition and measurement guidance, the Company determined that the guidance in ASC 730, Research and Development, was appropriate to analogize to, based on the nature of the cost-sharing provisions of the 2020 GSK Agreement. The Company has concluded that payments to or reimbursements from GSK related to these services will be accounted for as an increase to or reduction of research and development expenses, respectively. Additionally, the Company is entitled to consideration from GSK related to profit and loss sharing arrangements (including royalties) contingent upon future sales of collaboration products. The Company concluded that any payments from GSK related to the profit and loss sharing arrangement (including royalties) contingent upon the commercialization of the products will be analogized to ASC 606 and, therefore, will be recognized when the related sales occur. In May 2021, the U.S. Food and Drug Administration (“FDA”) granted an EUA in the United States for sotrovimab, the first collaboration product under the Antibody Program. In April 2022, the FDA excluded the use of sotrovimab in all U.S. regions due to the continued proportion of COVID-19 cases caused by certain Omicron subvariants. As the lead party for all manufacturing and commercialization activities, GSK incurs all of the manufacturing, sales and marketing expenses and is the principal on sales transactions with third parties. As described in Note 2—Summary of Significant Accounting Policies, the Company’s accounting policy related to the profit-share is to consider the agreed-upon share of the profit-sharing amounts each quarter and evaluate whether those amounts are subject to potential future adjustments based on the latest available facts and circumstances, subject to the terms of the 2020 GSK Agreement. As the Company is the agent, the Company recognizes its contractual share of the profit-sharing amounts or royalties (in case of an opt-out) as revenue, based on sales net of various estimated deductions such as rebates, discounts, chargebacks, credits and returns, less cost of sales and allowable expenses (including manufacturing, distribution, medical affairs, selling, and marketing expenses) in the period the sale occurs. Manufacturing costs include inventory revaluation adjustments, lower of cost or market inventory adjustments, inventory write-downs and write-offs, and binding purchase commitments with a third-party manufacturer among other manufacturing costs. The Company’s contractual share of the profit-sharing amounts is subject to potential future adjustments to allowable expenses, which represents a form of variable consideration. At each reporting period, the Company evaluates the latest available facts and circumstances to determine whether any portion of profit-sharing amounts should be constrained. As of September 30, 2022, GSK held certain potentially excess binding supply manufacturing commitments of sotrovimab and reserved certain binding manufacturing capacity potentially not expected to be utilized, which have not yet been reported to us as allowable manufacturing expenses for the cumulative profit-sharing amounts to date. We expect GSK to adjust allowable manufacturing expenses for our share of the potential charge for excess supply write-offs and unused binding manufacturing capacity and report to us as cost-sharing amounts in future periods. We evaluated the latest available facts and circumstances to update our evaluation of whether any portion of profit-sharing amounts should be constrained. In doing so, as of September 30, 2022 , based on the current state of the COVID-19 pandemic, including the continued proportion of cases caused by certain Omicron subvariants, discussions with the FDA and other regulatory authorities, and the Company’s expectations for future sales in light of these factors, the Company revised its estimate and determined that $ 379.5 million should be constrained from profit-sharing revenues earned during the nine months ended September 30, 2022 in relation to the Company’s anticipated contractual share of potential future adjustments to manufacturing expenses and selling expenses and recorded such amount as adjustments to profit-sharing amounts. This net profit-sharing amount constrained also includes a reversal of $ 20.4 million from the amount previously constrained as of June 30, 2022, as a result of the agreement reached by the Company and GSK related to the cost-sharing percentage for the sotrovimab manufacturing commitment made by GSK with a third party. The Company will re-assess these estimates each reporting period. Actual results could materially differ from this estimate. During the three and nine months ended September 30, 2022, the Company recorded profit-sharing amounts and profit-sharing amounts constrained as components of collaboration revenue in the unaudited condensed consolidated statements of operations, as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 (in thousands) Collaboration revenue, net Profit-sharing amount $ 291,226 $ 102,398 $ 1,863,374 $ 107,731 Profit-sharing amount constrained ( 2,431 ) — ( 399,864 ) — Profit-sharing amount previously constrained, released 20,350 — 20,350 — Total collaboration revenue, net $ 309,145 $ 102,398 $ 1,483,860 $ 107,731 Costs associated with co-development activities performed under the 2020 GSK Agreement are included in research and development expenses on the unaudited condensed consolidated statements of operations, with any reimbursement of costs by GSK reflected as a reduction of such expenses. Under the 2020 GSK Agreement, the Company recognized additional net research and development expenses of $ 10.4 million and $ 12.0 million for the three months ended September 30, 2022 and 2021 , respectively, and $ 24.0 million and $ 49.2 million for the nine months ended September 30, 2022 and 2021, respectively. Amendment No. 1 to the 2020 GSK Agreement On May 27, 2022, the Company and GSK entered into Amendment No. 1 to the 2020 GSK Agreement (“Amendment No. 1”). Pursuant to Amendment No. 1, the parties acknowledged that the antibody products that had been licensed to WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) in mainland China, Hong Kong, Macau and Taiwan and had reverted to the Company pursuant to the Termination Agreement (described below) are now included in and governed by the 2020 GSK Agreement, subject to certain amendments relating to sotrovimab. Under the terms of Amendment No. 1, GSK has the sole right to develop (including to seek, obtain or maintain regulatory approvals), manufacture and commercialize sotrovimab in and for mainland China, Hong Kong, Macau and Taiwan at GSK's sole cost and expense (other than certain payments for which the Company remains responsible under certain of the Company’s existing agreements with third parties). GSK paid the Company a one-time upfront payment of $ 7.0 million in consideration for the rights and licenses granted to GSK under Amendment No. 1. The Company recognized contract revenue of $ 7.0 million during the three months ended June 30, 2022. In addition, GSK will be obligated to pay the Company tiered royalties on net sales of sotrovimab in mainland China, Hong Kong, Macau and Taiwan in percentages ranging from the high teens to the low thirties. Such royalties are payable to the Company during the term of the 2020 GSK Agreement applicable to the Antibody Program. 2021 Expanded GSK Collaboration On February 14, 2021, the Company and GSK entered into a binding preliminary collaboration agreement (the “2021 Preliminary Agreement”) under which the parties agreed to expand the 2020 GSK Agreement to collaborate on three separate programs: (1) a program to research, develop and commercialize mAbs for the prevention, treatment or prophylaxis of the influenza virus (the “Influenza Program”), excluding VIR-2482 unless GSK exercises its option as described below; (2) an expansion of the parties’ current Functional Genomics Program to focus on functional genomics screens directed to targets associated with respiratory viruses (the “Expanded Functional Genomics Program”); and (3) additional programs to develop neutralizing mAbs directed to up to three non-influenza target pathogens selected by GSK (the “Selected Pathogens” and such programs, the “Additional Programs”). Concurrently with the execution of the 2021 Preliminary Agreement, the Company entered into a stock purchase agreement (the “2021 Stock Purchase Agreement”) with GGL under which GGL agreed to purchase shares of the Company’s common stock for an aggregate purchase price of approximately $ 120.0 million. The consummation of the transactions under each of the 2021 Preliminary Agreement and the 2021 Stock Purchase Agreement were subject to the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, which expiration was effective on March 24, 2021. The 2021 Preliminary Agreement and 2021 Stock Purchase Agreement consummated on March 25, 2021, which the Company used as the measurement date for accounting purposes. On March 31, 2021, the Company closed the sale of 1,924,927 shares of its common stock to GGL. The 2021 Preliminary Agreement was superseded on May 18, 2021 upon execution of the definitive collaboration agreement (the “2021 GSK Agreement”, and collectively with the 2021 Preliminary Agreement, the “2021 GSK Collaboration”). The material terms of the 2021 GSK Agreement, including the promised goods and services, are discussed below and are consistent with those of the 2021 Preliminary Agreement. Under the 2021 GSK Collaboration, the parties will conduct certain research and development activities under mutually agreed development plans and associated budgets for the programs within the expanded collaboration for a period of three years following the effective date. Under the Influenza Program, the parties will collaborate to research, develop and commercialize mAbs for the prevention, treatment or prophylaxis of influenza, including the Company’s influenza mAbs (with respect to VIR-2482, only if GSK exercises its option). The Company may conduct the development and clinical manufacturing activities for VIR-2482 up to the completion of a Phase 2 clinical trial. Provided that the Company conducts and completes a Phase 2 clinical trial for VIR-2482, GSK will have the exclusive option to obtain exclusive rights to co-develop and commercialize VIR-2482 under the Influenza Program (the “VIR-2482 Option”). GSK will be the lead party for development, clinical and commercial manufacturing and commercialization activities for products under the Influenza Program (other than VIR-2482 unless and until GSK exercises the VIR-2482 Option, if applicable). The parties will mutually agree upon the allocation of responsibility for the development of products under the Expanded Functional Genomics Program, and for the development and early-stage manufacturing of products under the Additional Programs if and when GSK decides which Selected Pathogens to pursue. GSK will be primarily responsible for commercial manufacturing and commercialization activities for products under the Expanded Functional Genomics Program and Additional Programs, if and when selected by GSK. For each collaboration program, upon execution of the definitive agreement, the Company will grant GSK certain license rights related to the development, manufacturing and commercialization of products arising from the program. The parties will share 50 % of all development costs in accordance with the budget for each of the collaboration programs (other than for the Selected Pathogens and VIR-2482, unless GSK exercises the VIR-2482 Option), with each party having the right to opt-out of its co-funding obligations at specified points in development. In such case, the party continuing with the program will pay to the opt-out party a royalty on net sales of products arising from such program at specified rates based on the stage of development at which the opt-out is exercised. Following the exercise of an opt-out right by a party, the other party may, at its election, either pursue development and commercialization of such product or program unilaterally, or also cease the conduct and funding of such collaboration product or program. In the absence of any opt-out, the parties will also share 50 % of all profits and losses arising from any collaboration product. GSK made an upfront payment to the Company of $ 225.0 million. If GSK exercises the VIR-2482 Option, GSK will pay the Company an option exercise fee of $ 300.0 million unless certain agreed product criteria for VIR-2482 are not met, in which case the parties will negotiate an alternative option exercise fee. Upon achievement of a pre-defined regulatory milestone for the first product in the Influenza Program, which may be (i) VIR-2482 (if GSK exercised the VIR-2482 Option), (ii) a next-generation mAb, or (iii) any other influenza mAb approved by the JSC to be included in the collaboration, arising from the Influenza Program, GSK will make a milestone payment to the Company of up to $ 200.0 million. The Company concluded that the 2021 GSK Agreement is a collaboration arrangement as defined in ASC 808, Collaborative Agreements, under which certain elements are required to be accounted for under ASC 606 where the counterparty is a customer for a good or service that is a distinct unit of account. In addition, the 2021 GSK Agreement is considered a contract modification to the 2021 Preliminary Agreement and will be accounted for prospectively as a termination of the 2021 Preliminary Agreement and commencement of a new contract. There was no impact to the accounting assessment of the original contract as no goods or services had been delivered to GSK, no performance obligations were satisfied and, accordingly, no contract revenue was recognized under ASC 606 prior to the execution of the 2021 GSK Agreement. The Company considered the ASC 606 criteria for combining contracts and determined that the 2021 GSK Collaboration and 2021 Stock Purchase Agreement should be combined into a single contract because they were negotiated and entered into in contemplation of one another. The fair market value of the common stock issued to GGL was $ 85.2 million, based on the closing stock price of $ 52.70 on March 25, 2021, and taking into account a discount for the lack of marketability due to the restrictions in place on the underlying shares, resulting in a $ 34.8 million premium received by the Company. The Company accounted for the common stock issued to GGL based on its fair market value on the transaction date and determined that the premium paid by GSK should be attributed to the transaction price of the 2021 GSK Agreement. The Company concluded that the 2021 GSK Agreement contained the following units of account: (i) the VIR-2482 Option; (ii) three distinct rights granted to GSK related to the Selected Pathogens (each, a “Selected Pathogen Right”); (iii) the license and know-how to the next-generation mAbs under the Influenza Program (the “Next Gen License”); (iv) the research and development activities for next-generation mAbs under the Influenza Program; and (v) the research and development activities, including license rights and know-how, under the Expanded Functional Genomics Program. The Company considered the guidance in ASC 606 to determine which of these elements of the 2021 GSK Agreement are performance obligations with a customer. The Company determined that the distinct performance obligations under ASC 606 consisted of (i) the Next Gen License and (ii) the three Selected Pathogen Rights, each representing a material right. All other elements of the 2021 GSK Agreement including the VIR-2482 Option, research and development activities, and participation in the JSC and subcommittees for each collaboration program were not determined to be distinct performance obligations with a customer. As of September 30, 2022, GSK had not exercised the VIR-2482 Option or the remaining two Selected Pathogen Rights (see below for GSK's selection of first pathogen). The transaction price for the 2021 GSK Agreement included fixed consideration consisting of the $ 225.0 million upfront fee paid by GSK and $ 34.8 million, representing the premium on the sale of common stock to GSK for a total of $ 259.8 million. All potential future milestones and other payments under the 2021 GSK Agreement are constrained since the Company could not conclude it was probable that a significant reversal in the amount recognized would not occur. The respective estimated SSP for each of the performance obligations was determined to allocate the transaction price. The estimated SSP of each performance obligation was determined using methods that considered relevant market conditions, entity-specific factors and information about GSK, while maximizing the use of available observable inputs and using certain management assumptions (e.g., treatable patient population, expected market share, probability of success and product profitability, discount rate based on weighted-average cost of capital). For the Next Gen License, the Company determined that GSK can benefit from the license at the time the license is granted and, therefore, the related performance obligation is satisfied at a point in time. If any of the Selected Pathogen Rights are exercised, the Company will evaluate the related promises to identify the performance obligations to be transferred and the timing of revenue recognition. If any of the Selected Pathogen Rights expire prior to being exercised, the Company will recognize any deferred revenue allocated to that right as revenue at the time of expiration. The research and development activities for the next-generation mAbs under the Influenza Program and the Expanded Functional Genomics Program were determined to be within the scope of ASC 808 as the Company and GSK are both active participants in the development, manufacturing and commercialization activities and are exposed to significant risks and rewards that are dependent on the commercial success of the activities of the arrangement. Furthermore, the Company and GSK participate in the commercial profit and loss sharing arrangement for each program commensurate with each party’s cost-sharing responsibilities during research and development. Because ASC 808 does not provide recognition and measurement guidance, the Company determined that the guidance in ASC 730, Research and Development, was appropriate to analogize to based on the nature of the cost-sharing provisions of the agreement. The Company has concluded that payments to or reimbursements from GSK related to these services will be accounted for as an increase to or reduction of research and development expenses, respectively. The Company also concluded that any payments from GSK related to the profit and loss sharing arrangement (including royalties) contingent upon the commercialization of the related products will be analogized to ASC 606 and, therefore, will be recognized when the related sales occur. Upon execution of the 2021 GSK Agreement, the Company granted the Next Gen License to GSK and therefore, recognized $ 168.3 million as contract revenue in the second quarter of 2021. As of September 30, 2022, the total unrecognized transaction price of $ 51.7 million is classified as noncurrent deferred revenue on the unaudited condensed consolidated balance sheets related to the remaining performance obligations, being the remaining two material rights resulting from the Selected Pathogen Rights. The Company reclassified the deferred revenue of $ 51.7 million from current to noncurrent as of September 30, 2022 based on the Company's revised expectations for future option exercises by GSK. Costs associated with co-development activities performed under the 2021 GSK Agreement are included in research and development expenses in the unaudited condensed consolidated statements of operations, with any reimbursement of costs by GSK reflected as a reduction of such expenses. During the three and nine months ended September 30, 2022 , the Company recognized additional net research and development expenses of $ 0.3 million and $ 1.3 million, respectively under the 2021 GSK Agreement. During the three and nine months ended September 30, 2021 , the Company recognized a reduction of research and development expenses of $ 0.4 million and $ 1.3 million, respectively, under the 2021 GSK Agreement. Under both the 2020 GSK Agreement and the 2021 GSK Agreement, the Company has a receivable from collaboration of zero and $ 773.1 million as of September 30, 2022 and December 31, 2021, respectively. Option Exercise by GSK In September 2022, GSK exercised its first Selected Pathogen Right, selecting respiratory syncytial virus (“RSV”) as its first pathogen under the Additional Programs of the 2021 GSK Agreement (“First Option Exercise”). GSK agreed to retroactively share the research and development costs that the Company had incurred under its RSV program since April 2022 in accordance with the applicable provisions of the 2021 GSK Agreement. The Company evaluated the First Option Exercise under ASC 606 and identified one performance obligation consisting of the license for a Selected Pathogen Right granted to GSK. The transaction price was determined to be $ 39.8 million which equals the deferred revenue allocated to the first Selected Pathogen Right at the inception of the 2021 GSK Agreement. The Company determined that the license is considered a functional intellectual property that is a distinct performance obligation. Specifically, the Company believes the license is capable of being distinct, as GSK has the capabilities to develop the license either on its own or by contracting with other third-parties. GSK can benefit from the license at the time of grant and, therefore, the related performance obligation is satisfied at a point in time. During the third quarter of 2022, the Company recognized the $ 39.8 million as contract revenue. Brii Biosciences In May 2018, the Company entered into the Brii Agreement with Brii Bio Parent and Brii Bio, pursuant to which the Company granted to Brii Bio, with respect to up to four of the Company’s programs, an exclusive option to obtain exclusive rights to develop and commercialize compounds and products arising from such programs in China, Taiwan, Hong Kong and Macau (collectively, the “China Territory”) for the treatment, palliation, diagnosis, prevention or cure of acute and chronic diseases of infectious pathogen origin or hosted by pathogen infection (the “Field of Use”). The Company’s HBV small interfering ribonucleic acid (“siRNA”) program being developed under the Amended Alnylam Agreement (described below) is included within the Brii Agreement as a program for which Brii Bio may exercise one of its options. In partial consideration for the options granted by the Company to Brii Bio, Brii Bio Parent and Brii Bio granted the Company, with respect to up to four of Brii Bio Parent’s or Brii Bio’s programs, an exclusive option to be granted exclusive rights to develop and commercialize compounds and products arising from such Brii Bio programs in the United States for the Field of Use. The number of options that the Company may exercise for a Brii Bio program is limited to the corresponding number of options that Brii Bio exercises for a Vir program. As partial consideration for the Company’s entry into the Brii Agreement, upon closing of Brii Bio Parent’s Series A preferred stock financing, the Company received ordinary shares equal to 9.9 % of the outstanding shares in Brii Bio Parent. As a result of Brii Bio’s right to exercise one of i |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 7. Balance Sheet Components Property and Equipment, net Property and equipment, net consists of the following: September 30, December 31, (in thousands) Laboratory equipment $ 30,022 $ 20,012 Computer equipment 2,560 1,112 Furniture and fixtures 1,911 1,443 Leasehold improvements 8,780 7,834 Construction in progress 75,877 26,925 Property and equipment, gross 119,150 57,326 Less accumulated depreciation and amortization ( 18,924 ) ( 14,492 ) Total property and equipment, net $ 100,226 $ 42,834 Depreciation and amortization expenses were $ 1.6 million and $ 4.4 million for the three and nine months ended September 30, 2022 , and $ 1.4 million and $ 3.9 million for the three and nine months ended September 30, 2021, respectively. Accrued and Other Liabilities Accrued and other liabilities consist of the following: September 30, December 31, (in thousands) Milestone payable $ — $ 95,000 Net profit-sharing amount 61,684 — Accrued income taxes 98,189 6,217 Accrued royalties 27,771 58,672 Research and development expenses 40,116 28,073 Payroll and related expenses 23,714 29,753 Other professional and consulting expenses 5,633 2,791 Operating lease liabilities, current 4,115 3,927 Excess funds payable under grant agreements — 1,825 Other accrued expenses 21,394 10,254 Total accrued and other liabilities $ 282,616 $ 236,512 Accrued royalties represents royalties earned by third-party licensors, such as Xencor, on net sales of sotrovimab by GSK. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Lease Agreements The Company has various operating lease arrangements for office and laboratory spaces located in California, Oregon, Missouri and Switzerland with contractual lease periods expiring between 2022 and 2033 . These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain lease agreements also provide the Company with the option to renew for additional periods ranging from one to five years . These renewal options are not considered in the remaining lease term unless it is reasonably certain that the Company will exercise such options. Throughout the term of the lease agreements, the Company is responsible for paying certain operating costs, in addition to rent, such as common area maintenance, taxes, utilities and insurance. These additional charges are considered variable lease costs and are recognized in the period in which the costs are incurred. The maturity of the Company’s operating lease liabilities as of September 30, 2022 was as follows (in thousands): Amounts 2022 (excluding the nine months ended September 30, 2022) $ 4,846 2023 19,408 2024 18,567 2025 16,259 2026 16,703 Thereafter 103,855 Total lease payments 179,638 Less: imputed interest ( 40,108 ) Less: net tenant improvement allowance yet to be received ( 26,670 ) Present value of operating lease liabilities $ 112,860 The following amounts were recorded in the unaudited condensed consolidated balance sheets for the periods ended: September 30, December 31, (in thousands) Operating Leases Prepaid expenses and other current assets (1) $ 18,197 $ 49,536 Operating right-of-use assets 84,716 87,220 Accrued and other liabilities $ 4,115 $ 3,927 Operating lease liabilities, noncurrent 126,942 133,561 Total operating lease liabilities $ 131,057 $ 137,488 (1) Current portion of lease liabilities recorded in prepaid expenses and other current assets for which the lease incentives to be received exceed the minimum lease payments to be paid over the next 12 months. Manufacturing and Supply Letter Agreements In April 2020, the Company and Samsung Biologics Co., Ltd. (“Samsung”) entered into a binding letter agreement (the “Samsung Letter Agreement”), under which Samsung performs development and manufacturing services for the Company’s SARS-CoV-2 antibody program. In August 2020, the Company, GlaxoSmithKline Trading Services Limited (“GSKTSL”) and Samsung entered into an Assignment and Novation Agreement effective as of July 31, 2020, under which the Company assigned and transferred to GSKTSL all of the Company’s right, title, and interest in, to and under the Samsung Letter Agreement, and GSKTSL became the Company’s successor in interest in and to all of the Company’s rights, duties, and obligations in, to and under the Samsung Letter Agreement. In August 2020, GSKTSL entered into a Master Services Agreement with Samsung (the “Samsung MSA”) in connection with the performance of the obligations of the Company and GSK under the 2020 GSK Agreement. In accordance with the terms of the 2020 GSK Agreement, the Company continues to be responsible for 72.5 % of the costs under the Samsung MSA, and GSK bears 27.5 % of such costs under the Samsung MSA, subject to certain conditions and exceptions. The Company’s commitment has been substantially recognized on its balance sheet as part of the profit-sharing amount constrained as of September 30, 2022, which is part of accrued and other liabilities, as discussed in Note 6—Collaboration and License Agreements. In September 2022, the Company and a third-party contract development manufacturing organization (the “CDMO”) entered into a letter agreement under which the Company agreed to pay $ 7.2 million to the CDMO to reserve manufacturing capacity for VIR-2482 (“Reservation Fee”). The Reservation Fee will be creditable against a future manufacturing charge if the Company and the CDMO subsequently execute a master service agreement (“MSA”) and scope of work (“SOW”). In addition, the Company is required to pre-pay $ 5.0 million for raw materials that the CDMO will procure to enable manufacturing of VIR-2482. The Reservation Fee and the prepayment of $ 5.0 million are not refundable, even if the Company and the CDMO fail to execute the MSA and SOW. Indemnification In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Under such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, no demands have been made upon the Company to provide indemnification under these agreements, and thus, there are no indemnification claims that the Company is aware of that could have a material effect on the unaudited condensed consolidated balance sheets, unaudited condensed consolidated statements of operations, or unaudited condensed consolidated statements of cash flows. |
Related Party Transaction
Related Party Transaction | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transaction | 9. Related Party Transaction As a result of the Brii Agreement, the Company holds a minority equity interest in Brii Bio through its parent company, Brii Bio Parent. Additionally, a member of the Company’s board of directors serves on Brii Bio Parent’s board of directors. |
Stock-Based Awards
Stock-Based Awards | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Awards | 10. Stock-Based Awards The Company has maintained a stock incentive plan for the issuance of incentive stock options (“ISO”), non-qualified stock options (“NSO”), stock appreciation rights (“SARs”), restricted stock, other stock awards and performance cash awards, to employees, non-employee directors, and consultants. The Company also has an employee stock purchase plan (“ESPP”) for its employees or employees of any of the Company’s designated affiliates. Stock Options Granted to Employees The fair value of stock options granted to employees was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected term of options (in years) 6.1 5.3 - 6.1 5.3 - 6.1 5.3 - 6.1 Expected stock price volatility 110.6 % - 110.8 % 106.9 % - 111.5 % 103.8 % - 111.2 % 103.1 % - 111.5 % Risk-free interest rate 3.0 % - 3.6 % 0.8 % - 1.0 % 1.6 % - 3.6 % 0.6 % - 1.2 % Expected dividend yield — — — — The valuation assumptions for stock options were determined as follows: Expected Term — The expected term represents the period that the stock options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). Expected Volatility — Since inception, the expected volatility was determined by examining the historical volatilities for industry peers and using an average of historical volatilities of the Company’s industry peers. Beginning the first quarter of 2022, the expected volatility is determined by using a blended approach of the Company and its industry peers’ historical volatilities. Risk-Free Interest Rate — The Company based the risk-free interest rate over the expected term of the stock options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant. Expected Dividend Rate — The expected dividend is zero as the Company has not paid nor does it anticipate paying any dividends on its profit interest units in the foreseeable future. Stock-Based Compensation Expense Stock-based compensation is recognized on a straight-line basis over the requisite service period, which is generally the vesting period. The following table sets forth the total stock-based compensation expense for all awards granted to employees and non-employees and the ESPP in the unaudited condensed consolidated statements of operations: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 (in thousands) Research and development $ 12,607 $ 11,165 $ 39,791 $ 30,455 Selling, general and administrative 12,207 11,779 37,426 28,958 Total stock-based compensation $ 24,814 $ 22,944 $ 77,217 $ 59,413 |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | 11. Net Income (Loss) Per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net income (loss) per common share is computed by dividing the net income (loss) by the sum of the weighted-average number of common shares outstanding during the period plus any potential dilutive effects of common stock equivalents outstanding during the period calculated in accordance with the treasury stock method. For periods that the Company was in a net loss position, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential common securities outstanding would have been anti-dilutive The following is a calculation of the basic and diluted net income per share (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net income, basic and diluted $ 175,312 $ 110,428 $ 617,440 $ 3,330 Weighted-average shares outstanding, basic 132,729,530 130,665,831 132,422,028 129,520,837 Weighted-average effect of dilutive securities: Options to purchase common stock 2,144,302 3,173,930 2,227,493 3,757,681 Restricted shares subject to future vesting 75,759 14,658 55,080 36,138 Shares to purchase under Employee Stock Purchase Plan 13,726 — 7,176 — Contingently issuable shares — — — 4,323 Weighted-average shares outstanding, diluted 134,963,317 133,854,419 134,711,777 133,318,979 Net income per share, basic $ 1.32 $ 0.85 $ 4.66 $ 0.03 Net income per share, diluted $ 1.30 $ 0.82 $ 4.58 $ 0.02 Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Options issued and outstanding 8,381,275 6,316,134 8,717,954 5,278,033 Restricted shares subject to future vesting 2,194,050 1,067,204 2,720,818 1,025,454 Total 10,575,325 7,383,338 11,438,772 6,303,487 |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 12. Income Taxes The table below presents our income before benefit from (provision for) income taxes, benefit from (provision for) income taxes and effective tax rate for all periods presented (in thousands): Three Months Ended September 30, Nine Months Ended September 30 2022 2021 2022 2021 Income before provision for income taxes $ 217,732 $ 110,762 $ 905,918 $ 3,913 Provision for income taxes $ ( 42,420 ) $ ( 334 ) $ ( 288,478 ) $ ( 583 ) Effective tax rate 19.5 % 0.3 % 31.8 % 14.9 % We are subject to income taxes in the United States and foreign jurisdictions in which we do business. These foreign jurisdictions have statutory tax rates different from those in the United States. Accordingly, our effective tax rates will vary depending on the relative proportion of foreign to United States income, the utilization of net operating loss and tax credit carry forwards, changes in geographic mix of income and expense, and changes in management’s assessment of matters such as the ability to realize deferred tax assets, and changes in tax laws. The increase in the effective tax rate from the three and nine months ended September 30, 2021 was primarily due to current year collaboration revenue and the requirement under the Tax Cuts and Jobs Act of 2017 for taxpayers to capitalize and amortize research and development expenditures over five or fifteen years pursuant to Section 174 of the Internal Revenue Code of 1986, as amended. Unrecognized tax benefits were $ 10.5 million and $ 7.4 million as of September 30, 2022 and December 31, 2021, respectively, and if recognized, would favorably affect the effective tax rate in future periods . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. The unaudited condensed consolidated financial statements include the accounts of Vir and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial information. The condensed consolidated results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, or for any other future annual or interim period. Certain information and footnote disclosures typically included in the Company’s annual consolidated financial statements have been condensed or omitted. As such, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 28, 2022. |
Use of Estimates | Use of Estimates The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expense during the reporting periods. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. |
Concentration of Credit Risk, Credit Loss and Other Risks and Uncertainties | Concentration of Credit Risk, Credit Loss and Other Risks and Uncertainties Although the Company received Emergency Use Authorization (“EUA”), temporary authorization or marketing approval for sotrovimab (under the brand name Xevudy®), sotrovimab is currently de-authorized in the U.S. and has limitations in use outside of the U.S. In addition, the Company is still subject to a number of other challenges and risks similar to other biopharmaceutical companies in the early stage, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its other product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of sotrovimab and other product candidates and protection of proprietary technology. If the Company does not successfully obtain regulatory approval, commercialize or partner any of its product candidates, it will be unable to generate revenue from product sales or maintain profitability. In addition, to the extent the COVID-19 pandemic, including the emergence of new variants or subvariants, adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. The Company has implemented a number of plans and policies designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic and geopolitical events, including civil or political unrest (such as the ongoing war between Ukraine and Russia), will continue to have an impact on the clinical development timelines for some of its clinical programs. The extent to which the COVID-19 pandemic impacts the Company’s business, clinical development and regulatory efforts, corporate development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and investments. Cash and cash equivalents are deposited in checking and sweep accounts at a financial institution. Such deposits may, at times, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s investment policy limits investments to certain types of securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments, and issuers of the investments to the extent recorded on the unaudited condensed consolidated balance sheets. As of September 30, 2022, the Company has no off-balance sheet concentrations of credit risk. The Company is exposed to credit losses primarily through receivables from customers and collaborators and through its available-for-sale debt securities. The Company’s expected loss allowance methodology for the receivables is developed using historical collection experience, current and future economic market conditions, a review of the current aging status and financial condition of the entities. Specific allowance amounts are established to record the appropriate allowance for customers that have a higher probability of default. Balances are written off when determined to be uncollectible. The Company’s expected loss allowance methodology for the debt securities is developed by reviewing the extent of the unrealized loss, the size, term, geographical location, and industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. The Company considered the current and expected future economic and market conditions surrounding the COVID-19 pandemic and interest rate policies and determined that the estimate of credit losses was not significantly impacted. During the nine months ended September 30, 2022 and 2021 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk. |
Investments | Investments Investments include available-for-sale debt securities and equity investments, which are carried at estimated fair value. Available-for-Sale Debt Securities The Company’s valuations of marketable securities are generally derived from independent pricing services based on quoted prices in active markets for similar securities at period end. Generally, investments with original maturities beyond three months at the date of purchase and which mature at, or less than 12 months from, the unaudited condensed consolidated balance sheet date are considered short-term investments, with all others considered to be long-term investments. Unrealized gains and losses deemed temporary in nature are reported as a component of accumulated comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the unaudited condensed consolidated statements of operations. The cost of securities sold is based on the specific identification method. Equity Investments Under Accounting Standards Update (“ASU”) No. 2016-01, Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities, the Company measures its investment in equity securities at fair value at each reporting date based on the market price at period end if it has a readily determinable fair value. Otherwise, the investments in equity securities are measured at cost less impairment, adjusted for observable price changes for identical or similar investments of the same issuer unless the Company has significant influence or control over the investee. Changes in fair value resulting from observable price changes are presented as change in fair value of equity investments and changes in fair value resulting from foreign currency translation are included in other income (expense), net on the unaudited condensed consolidated statements of operations. |
Restricted Cash and Cash Equivalents | Restricted Cash and Cash Equivalents Restricted cash and cash equivalents represent money market funds to secure standby letters of credit and security deposits with financial institutions, both under office and laboratory space lease agreements. Additionally, funds received from certain grants are restricted as to their use and are therefore classified as restricted cash and cash equivalents. |
Revenue Recognition | Revenue Recognition Collaboration, License and Contract Revenue Under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when the Company’s customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods and services. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs 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 the Company satisfies a performance obligation. For collaborative arrangements that fall within the scope of ASC 808, Collaborative Arrangements (“ASC 808”), the Company first determines which elements of the collaboration are deemed to be a performance obligation with a customer within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808 and are not subject to the guidance in ASC 606, the Company applies the revenue recognition model under ASC 606, including the royalty exception guidance and/or variable consideration guidance under ASC 606 as described below, or other guidance, as deemed appropriate. When the Company is considered an agent in elements of collaboration arrangements within the scope of ASC 808, it records its share of collaboration revenue in the period in which such sales occur. The Company is considered an agent when the collaboration partner controls the product before transfer to the customers and has the ability to direct the use of and obtain substantially all of the remaining benefits from the product. In these instances, collaboration revenue is based upon the net sales reported by the Company's collaboration partners, net of cost of goods sold and allowable expenses (e.g., manufacturing, distribution, medical affairs, selling, and marketing expenses) in the period. In order to record collaboration revenue, the Company utilizes certain information from its collaboration partner, including actual net product sales and costs incurred for sales activities, and makes key judgments based on business updates related to commercial and clinical activities such as expected commercial demand, commercial supply plan, manufacturing commitments, risks related to expired or obsolete inventories, and risks related to potential product returns or contract terminations. For the periods covered in the financial statements presented, there have been no material changes to prior period estimates of revenues and expenses, except the profit-share amount previously constrained which was partially released in the three months ended September 30, 2022, as discussed in Note 6—Collaboration and License Agreement. The Company has entered into a number of license and collaboration agreements that fall within the scope of ASC 606. The Company evaluates the promised goods or services in these agreements to determine which ones represent distinct performance obligations. These agreements may include the following types of promised goods or services: (i) grants of licenses, (ii) performance of research and development services, and (iii) participation on joint research and/or development committees. They also may include options to obtain licenses to the Company’s intellectual property. Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. These estimates are re-assessed each reporting period as required. These agreements may include the following types of consideration: non-refundable upfront payments, reimbursement for research services, research, development or regulatory milestone payments, profit-sharing arrangements, and royalty and commercial sales milestone payments. If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on their estimated standalone selling prices (“SSP”). The Company estimates the SSP for each distinct performance obligation by considering information such as market conditions, entity-specific factors, and information about its customer that is reasonably available. The Company considers estimation approaches that allow it to maximize the use of observable inputs. These estimation approaches may include the adjusted market assessment approach, the expected cost plus a margin approach or the residual approach. The Company also considers whether to use a different estimation approach or a combination of approaches to estimate the SSP for each distinct performance obligation. Developing certain assumptions (e.g., treatable patient population, expected market share, probability of success and product profitability, discount rate based on weighted-average cost of capital) to estimate the SSP of a distinct performance obligation requires significant judgment. For performance obligations satisfied over time, the Company estimates the efforts needed to complete the performance obligation and recognizes revenue by measuring the progress towards complete satisfaction of the performance obligation using an input measure. For arrangements that include sales-based royalties, including commercial milestone payments based on pre-specified level of sales, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Achievement of these royalties and commercial milestones may solely depend upon the performance of the licensee. Grant Revenue Grants received, including cost reimbursement agreements, are assessed to determine if the agreement should be accounted for as an exchange transaction or a contribution. An agreement is accounted for as a contribution if the resource provider does not receive commensurate value in return for the assets transferred. Contributions are recognized as grant revenue when all donor-imposed conditions have been met. |
Acquisitions | Acquisitions Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, assets acquired, including in-process research and development (“IPR&D”) projects, and liabilities assumed are recorded at their respective fair values as of the acquisition date. Any excess fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with the business combination are recorded at their fair values on the acquisition date and are remeasured each subsequent reporting period until the related contingencies are resolved and are classified as contingent consideration on the unaudited condensed consolidated balance sheets. The changes in fair values of contingent consideration related to the achievement of various milestones are recorded within research and development expenses or selling, general and administrative expenses based on the nature of the relevant underlying activities. When the Company determines that an entity acquired does not meet the definition of a business, the transaction is accounted for as an acquisition of assets. Therefore, the consideration paid to acquire IPR&D is expensed, and no goodwill is recorded. Any contingent consideration is generally recognized only when it becomes payable or is paid. |
Embedded Derivatives | Embedded Derivatives The Company evaluates its acquisitions, collaborative arrangements and other business development transactions to determine if embedded components of these contracts meet the definition of a derivative under ASC 815, Derivatives and Hedging. In general, embedded derivatives are required to be bifurcated from the host instrument if (i) the embedded feature is not clearly and closely related to the host contract and (ii) the embedded feature, if considered a freestanding instrument, meets the definition of a derivative. Embedded derivatives are reported on the unaudited condensed consolidated balance sheets at their estimated fair values. Contingent consideration related to asset acquisitions that meet the definition of an embedded derivative is classified as contingent consideration on the unaudited condensed consolidated balance sheets. Any change in estimated fair values, as determined at each measurement period, are recorded in the unaudited condensed consolidated statements of operations based on the nature of the related contingencies. Changes in fair values of embedded derivatives related to the achievement of various milestones for product candidates are recorded within research and development expenses or selling, general and administrative expenses based on the nature of the relevant underlying activities. Otherwise, changes in fair values are recorded within other income (expense), net. |
New Accounting Pronouncement Recently Adopted | New Accounting Pronouncement Recently Adopted In November 2021, the Financial Accounting Standards Board issued ASU No. 2021-10, Government Assistance (Topic 832) (“ASU 2021-10”), which adds certain disclosure requirements with respect to government assistance, including (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on financial statements. ASU 2021-10 is effective for annual periods beginning after December 15, 2021. The Company's adoption of ASU 2021-10 on January 1, 2022 did not result in any material impact on its consolidated financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Summary of Financial Assets Measured at Fair Value on a Recurring Basis | The following tables summarize the Company’s Level 1 and Level 2 financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2022 and December 31, 2021: September 30, 2022 Valuation Amortized Gross Gross Aggregate (in thousands) Assets: Money market funds (1) Level 1 $ 978,367 $ — $ — $ 978,367 U.S. government treasuries Level 2 1,385,672 — ( 11,626 ) 1,374,046 Total financial assets $ 2,364,039 $ — $ ( 11,626 ) $ 2,352,413 (1) Includes $ 21.7 million of restricted cash equivalents. December 31, 2021 Valuation Amortized Gross Gross Aggregate (in thousands) Assets: Money market funds (1) Level 1 $ 345,098 $ — $ — $ 345,098 U.S. government treasuries Level 2 419,442 — ( 872 ) 418,570 Total financial assets $ 764,540 $ — $ ( 872 ) $ 763,668 (1) Includes $ 15.6 million of restricted cash equivalents. |
Summary of Changes in Estimated Fair Value of Contingent Consideration | The following table sets forth the changes in the estimated fair value of the Company’s contingent consideration (in thousands): Contingent Balance at December 31, 2021 $ 22,822 Changes in fair value 7,890 Balance at September 30, 2022 $ 30,712 |
TomegaVax | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Estimated Fair Value of Significant Unobservable Inputs | As of September 30, 2022, the fair value of the remaining contingent consideration was estimated using the following significant unobservable inputs: Unobservable input Value Volatility 90.0 % Risk-free rate 4.1 % |
Humabs | Clinical and Regulatory Milestones | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Estimated Fair Value of Significant Unobservable Inputs | As of September 30, 2022, the Company calculated the estimated fair value of the remaining clinical and regulatory milestones related to VIR-3434 using the following significant unobservable inputs: Unobservable input Range 1 Discount rates 8.1 % - 9.2 % ( 8.7 %) Probability of achievement 22.1 % - 60 % ( 42.1 %) (1) Unobservable inputs were weighted based on the relative fair value of the clinical and regulatory milestone payments. |
Humabs | Commercial Milestones | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Estimated Fair Value of Significant Unobservable Inputs | As of September 30, 2022, the Monte Carlo simulation assumed a commercial product launch and associated discrete revenue forecasts, as well as the following significant unobservable inputs for the remaining commercial milestones related to VIR-3434: Unobservable input Value Volatility 90.0 % Discount rate 12.0 % Probability of achievement 26.0 % |
Collaboration revenue (Tables)
Collaboration revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Recognition [Abstract] | |
Schedule of Collaboration revenue | During the three and nine months ended September 30, 2022, the Company recorded profit-sharing amounts and profit-sharing amounts constrained as components of collaboration revenue in the unaudited condensed consolidated statements of operations, as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 (in thousands) Collaboration revenue, net Profit-sharing amount $ 291,226 $ 102,398 $ 1,863,374 $ 107,731 Profit-sharing amount constrained ( 2,431 ) — ( 399,864 ) — Profit-sharing amount previously constrained, released 20,350 — 20,350 — Total collaboration revenue, net $ 309,145 $ 102,398 $ 1,483,860 $ 107,731 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment Net | Property and equipment, net consists of the following: September 30, December 31, (in thousands) Laboratory equipment $ 30,022 $ 20,012 Computer equipment 2,560 1,112 Furniture and fixtures 1,911 1,443 Leasehold improvements 8,780 7,834 Construction in progress 75,877 26,925 Property and equipment, gross 119,150 57,326 Less accumulated depreciation and amortization ( 18,924 ) ( 14,492 ) Total property and equipment, net $ 100,226 $ 42,834 |
Schedule of Accrued and Other Liabilities | Accrued and other liabilities consist of the following: September 30, December 31, (in thousands) Milestone payable $ — $ 95,000 Net profit-sharing amount 61,684 — Accrued income taxes 98,189 6,217 Accrued royalties 27,771 58,672 Research and development expenses 40,116 28,073 Payroll and related expenses 23,714 29,753 Other professional and consulting expenses 5,633 2,791 Operating lease liabilities, current 4,115 3,927 Excess funds payable under grant agreements — 1,825 Other accrued expenses 21,394 10,254 Total accrued and other liabilities $ 282,616 $ 236,512 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Maturities of Operating Lease Liabilities | The maturity of the Company’s operating lease liabilities as of September 30, 2022 was as follows (in thousands): Amounts 2022 (excluding the nine months ended September 30, 2022) $ 4,846 2023 19,408 2024 18,567 2025 16,259 2026 16,703 Thereafter 103,855 Total lease payments 179,638 Less: imputed interest ( 40,108 ) Less: net tenant improvement allowance yet to be received ( 26,670 ) Present value of operating lease liabilities $ 112,860 |
Schedule of Operating Lease Amounts Recorded in Condensed Consolidated Balance Sheet | The following amounts were recorded in the unaudited condensed consolidated balance sheets for the periods ended: September 30, December 31, (in thousands) Operating Leases Prepaid expenses and other current assets (1) $ 18,197 $ 49,536 Operating right-of-use assets 84,716 87,220 Accrued and other liabilities $ 4,115 $ 3,927 Operating lease liabilities, noncurrent 126,942 133,561 Total operating lease liabilities $ 131,057 $ 137,488 (1) Current portion of lease liabilities recorded in prepaid expenses and other current assets for which the lease incentives to be received exceed the minimum lease payments to be paid over the next 12 months. |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted | The fair value of stock options granted to employees was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected term of options (in years) 6.1 5.3 - 6.1 5.3 - 6.1 5.3 - 6.1 Expected stock price volatility 110.6 % - 110.8 % 106.9 % - 111.5 % 103.8 % - 111.2 % 103.1 % - 111.5 % Risk-free interest rate 3.0 % - 3.6 % 0.8 % - 1.0 % 1.6 % - 3.6 % 0.6 % - 1.2 % Expected dividend yield — — — — |
Summary of Stock-based Compensation Expense | The following table sets forth the total stock-based compensation expense for all awards granted to employees and non-employees and the ESPP in the unaudited condensed consolidated statements of operations: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 (in thousands) Research and development $ 12,607 $ 11,165 $ 39,791 $ 30,455 Selling, general and administrative 12,207 11,779 37,426 28,958 Total stock-based compensation $ 24,814 $ 22,944 $ 77,217 $ 59,413 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Income (loss) Per Share | The following is a calculation of the basic and diluted net income per share (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net income, basic and diluted $ 175,312 $ 110,428 $ 617,440 $ 3,330 Weighted-average shares outstanding, basic 132,729,530 130,665,831 132,422,028 129,520,837 Weighted-average effect of dilutive securities: Options to purchase common stock 2,144,302 3,173,930 2,227,493 3,757,681 Restricted shares subject to future vesting 75,759 14,658 55,080 36,138 Shares to purchase under Employee Stock Purchase Plan 13,726 — 7,176 — Contingently issuable shares — — — 4,323 Weighted-average shares outstanding, diluted 134,963,317 133,854,419 134,711,777 133,318,979 Net income per share, basic $ 1.32 $ 0.85 $ 4.66 $ 0.03 Net income per share, diluted $ 1.30 $ 0.82 $ 4.58 $ 0.02 |
Schedule of Potentially Dilutive Securities Not Included in the Diluted Per Share Calculations | Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Options issued and outstanding 8,381,275 6,316,134 8,717,954 5,278,033 Restricted shares subject to future vesting 2,194,050 1,067,204 2,720,818 1,025,454 Total 10,575,325 7,383,338 11,438,772 6,303,487 |
Income taxes (Tables)
Income taxes (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule Of Income Tax Expense Benefit And Effective Tax Rate | The table below presents our income before benefit from (provision for) income taxes, benefit from (provision for) income taxes and effective tax rate for all periods presented (in thousands): Three Months Ended September 30, Nine Months Ended September 30 2022 2021 2022 2021 Income before provision for income taxes $ 217,732 $ 110,762 $ 905,918 $ 3,913 Provision for income taxes $ ( 42,420 ) $ ( 334 ) $ ( 288,478 ) $ ( 583 ) Effective tax rate 19.5 % 0.3 % 31.8 % 14.9 % |
Organization - Additional Infor
Organization - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | |
Nov. 30, 2020 | Sep. 30, 2022 | Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Aggregate offering price | $ 300,000 | ||
Retained earnings (accumulated deficit) | $ 478,840 | $ (138,600) | |
Cash, cash equivalents and investments | 2,400,000 | ||
Cash, cash equivalents and short-term investments, excluding equity investment | $ 2,400,000 | ||
Common Stock | Sales Agreement | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Issuance of common stock (in shares) | 0 | ||
Percentage of commission rate from sale of shares | 3% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Accounting Policies [Abstract] | ||
Allowance for losses on available-for-sale debt securities | $ 0 | $ 0 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets Measured at Fair Value on a Recurring Basis by Level Within Fair Value Hierarchy (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Financial Assets, Amortized Cost | $ 2,364,039 | $ 764,540 | ||
Financial Assets, Gross Unrealized Holding Gains | 0 | 0 | ||
Financial Assets, Gross Unrealized Holding Losses | (11,626) | (872) | ||
Financial Assets, Aggregate Fair Value | 2,352,413 | 763,668 | ||
Level 1 | Money Market Funds | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Financial Assets, Amortized Cost | 978,367 | [1] | 345,098 | [2] |
Financial Assets, Gross Unrealized Holding Gains | 0 | [1] | 0 | [2] |
Financial Assets, Gross Unrealized Holding Losses | 0 | [1] | 0 | [2] |
Financial Assets, Aggregate Fair Value | 978,367 | [1] | 345,098 | [2] |
Level 2 | U.S. Government Treasuries | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Financial Assets, Amortized Cost | 1,385,672 | 419,442 | ||
Financial Assets, Gross Unrealized Holding Gains | 0 | 0 | ||
Financial Assets, Gross Unrealized Holding Losses | (11,626) | (872) | ||
Financial Assets, Aggregate Fair Value | $ 1,374,046 | $ 418,570 | ||
[1] Includes $ 21.7 million of restricted cash equivalents. Includes $ 15.6 million of restricted cash equivalents. |
Fair Value Measurements - Fin_2
Fair Value Measurements - Financial Assets Measured at Fair Value on a Recurring Basis by Level Within Fair Value Hierarchy (Parenthetical) (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Long-Term Investments | $ 34,102 | $ 201,388 |
Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Restricted cash equivalents | $ 21,700 | $ 15,600 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Accrued interest receivable excluded from fair value and amortized cost basis of available for sale securities | $ 2,800 | $ 2,800 | ||
Write off of accrued interest receivable | 0 | $ 0 | ||
Total unrealized gains recorded in accumulated other comprehensive income (loss) | 11,600 | |||
Brii Bio Parent [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Investment Owned At Fair Value | 22,800 | 22,800 | ||
Increase Decrease In Equity Securities Fv Ni | 13,600 | 120,000 | ||
Humabs | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Estimated fair value of contingent consideration | $ 29,600 | $ 29,600 | $ 17,100 | |
TomegaVax | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Asset Acquisition, Contingent Consideration, Liability | 5,700 | |||
Maximum | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Securities contractual term | 2 years | 2 years | ||
Prepaid Expenses and Other Current Assets | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Accrued interest receivable excluded from fair value and amortized cost basis of available for sale securities | $ 1,100 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Fair Value of Significant Unobservable Inputs (Details) | Sep. 30, 2022 |
TomegaVax | Measurement Input Risk Free Interest Rate | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.041 |
TomegaVax | Measurement Input Expected Volatility | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.900 |
Humabs | Clinical and Regulatory Milestones | Probability of Achievement | Minimum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.221 |
Humabs | Clinical and Regulatory Milestones | Probability of Achievement | Maximum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.60 |
Humabs | Clinical and Regulatory Milestones | Probability of Achievement | Weighted Average | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | (0.421) |
Humabs | Clinical and Regulatory Milestones | Measurement Input, Discount Rate | Minimum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.081 |
Humabs | Clinical and Regulatory Milestones | Measurement Input, Discount Rate | Maximum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.092 |
Humabs | Clinical and Regulatory Milestones | Measurement Input, Discount Rate | Weighted Average | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | (0.087) |
Humabs | Commercial Milestones | Probability of Achievement | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.260 |
Humabs | Commercial Milestones | Measurement Input Expected Revenue Volatility | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.900 |
Humabs | Commercial Milestones | Measurement Input, Discount Rate | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Fair value contingent consideration measurement input | 0.120 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Changes in Estimated Fair Value of Financial Liabilities (Details) - Level 3 - Contingent Consideration Liability $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Balance at December 31, 2021 | $ 22,822 |
Changes in fair value recognized | 7,890 |
Balance at September 30, 2022 | $ 30,712 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |||||
Jul. 31, 2021 USD ($) shares | Feb. 28, 2021 USD ($) Milestone | Sep. 30, 2016 USD ($) $ / shares | Dec. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) | Jul. 01, 2021 USD ($) | Aug. 31, 2017 USD ($) | |
Humabs | |||||||
Business Acquisition [Line Items] | |||||||
Estimated fair value of contingent consideration | $ 17.1 | $ 29.6 | |||||
Humabs | HBV Product | |||||||
Business Acquisition [Line Items] | |||||||
Additional consideration payable upon achievement of specified milestone events, maximum | $ 135 | ||||||
Estimated fair value of contingent consideration | 29.6 | ||||||
Humabs | Another Product | |||||||
Business Acquisition [Line Items] | |||||||
Additional consideration payable upon achievement of specified milestone events, maximum | $ 105 | ||||||
Humabs | SARS-CoV-2 Product | |||||||
Business Acquisition [Line Items] | |||||||
Regulatory milestones achieved | 35 | ||||||
Sales milestone achieved | $ 60 | ||||||
TomegaVax | |||||||
Business Acquisition [Line Items] | |||||||
Minimum common stock conversion price for milestone payments consideration | $ / shares | $ 90 | ||||||
Asset acquisition contingent consideration liability | 1.1 | ||||||
Common stock shares Issued for milestone payment| shares | shares | 42,737 | ||||||
Value of common stock shares Issued for milestone payment | $ 1.9 | ||||||
Payment made for asset acquisition milestone | $ 8.1 | ||||||
TomegaVax | Clinical Development [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Minimum common stock conversion price for milestone payments consideration | $ / shares | $ 45 | ||||||
TomegaVax | TomegaVax Letter Agreement | |||||||
Business Acquisition [Line Items] | |||||||
Milestone payments aggregate amount payable, maximum | $ 30 | ||||||
Minimum common stock conversion price for milestone payments consideration | $ / shares | $ 45 | ||||||
Milestone payments related terms | the Company will be required to pay to the former stockholders of TomegaVax milestone payments of up to an aggregate of $30.0 million if the per-share price of the Company’s publicly traded common stock, or implied price per share of the Company’s Series A-1 convertible preferred stock (or common stock upon conversion) upon a certain asset sale, merger or stock sale, is at least $45 (as adjusted in the case of any stock dividend, stock split or other similar recapitalization), with the amount of such payments determined by the share price and/or the stage of the Company’s clinical development at the time of the relevant event triggering the payment. | ||||||
Number of milestones achieved | Milestone | 1 | ||||||
Asset acquisition contingent consideration liability | $ 10 | $ 1.1 | |||||
TomegaVax | Maximum | |||||||
Business Acquisition [Line Items] | |||||||
Remaining payment for asset acquisition milestone, maximum | $ 20 |
Grant Agreements - Additional I
Grant Agreements - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Jan. 13, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Accrued and other liabilities | $ 282,616 | $ 282,616 | $ 236,512 | |||
Grant Revenue | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Revenue from grants | 3,125 | $ 903 | 7,704 | $ 5,356 | ||
Human Immunodeficiency Virus ('HIV') Grant | Maximum | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Grant awarded amount. maximum | 55,700 | 55,700 | ||||
Vaccinal Antibody Grant | Grant Revenue | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Revenue from grants | 2,800 | $ 900 | 7,400 | $ 5,200 | ||
Vaccinal Antibody Grant | Bill And Melinda Gates Foundation | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Deferred revenue | 24,300 | 24,300 | 6,900 | |||
Common Stock, Shares Purchased | 881,365 | |||||
Common Stock, Shares Purchased, Share Price | $ 45.38 | |||||
Common Stock, Shares Purchased , Aggregate Purchase Price | $ 40,000 | |||||
Common stock, shares issued, fair market value | $ 28,500 | |||||
Closing stock price | $ 37.65 | |||||
Underlying shares, Premium received | $ 11,300 | |||||
Accrued and other liabilities | $ 0 | 0 | $ 1,800 | |||
BARDA | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Potential maximum amount of grant | 1,000,000 | |||||
Maximum amount of grant during the base period | $ 55,000 |
Collaboration and License Agr_2
Collaboration and License Agreements - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||||||||||||||||
May 16, 2022 USD ($) | Mar. 25, 2021 USD ($) $ / shares | Feb. 14, 2021 USD ($) Program | Feb. 14, 2021 USD ($) | Apr. 29, 2020 USD ($) Unit $ / shares shares | May 31, 2018 USD ($) | Oct. 31, 2017 | Jul. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2020 USD ($) | Mar. 31, 2020 | Aug. 31, 2019 USD ($) | Sep. 30, 2018 USD ($) Antibodies | Jul. 31, 2018 USD ($) Product | May 31, 2018 USD ($) Program | Oct. 31, 2017 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 shares | Jun. 30, 2020 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | May 27, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Deferred revenue, current | $ 22,865 | $ 22,865 | $ 98,209 | |||||||||||||||||||||||
Deferred revenue, noncurrent | 54,653 | 54,653 | 3,815 | |||||||||||||||||||||||
Adjustments to profit-sharing amounts | $ 20,400 | |||||||||||||||||||||||||
Cost of revenue | 22,253 | $ 7,836 | 140,323 | $ 8,988 | ||||||||||||||||||||||
Receivable from collaboration | 0 | 0 | 773,079 | |||||||||||||||||||||||
Contract Revenue | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Total revenue | 39,998 | 315 | 52,534 | 169,581 | ||||||||||||||||||||||
Collaboration Revenue | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Total revenue | 309,145 | 102,398 | 1,483,860 | 107,731 | ||||||||||||||||||||||
License | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Total revenue | 22,289 | 0 | 22,289 | 0 | ||||||||||||||||||||||
2020 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Adjustments to profit-sharing amounts | 379,500 | |||||||||||||||||||||||||
GSK | Accrued and Other Liabilities | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Receivable from collaboration | 0 | 0 | $ 773,100 | |||||||||||||||||||||||
2021 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Reclassified deferred revenue | 51,700 | 51,700 | ||||||||||||||||||||||||
Deferred revenue, noncurrent | 51,700 | 51,700 | ||||||||||||||||||||||||
2020 Stock Purchase Agreement | 2020 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 6,626,027 | |||||||||||||||||||||||||
Share purchase price per share | $ / shares | $ 37.73 | |||||||||||||||||||||||||
Issuance of common stock | $ 250,000 | |||||||||||||||||||||||||
Preliminary Collaboration Agreement | 2020 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Number of years conduct certain research and development activities under mutually agreed development plans | 4 years | |||||||||||||||||||||||||
Increase Decrease In Research And Development Expense | 10,400 | 12,000 | $ 24,000 | 49,200 | ||||||||||||||||||||||
Maximum percentage of right to perform details in connection with antibody product | 20% | |||||||||||||||||||||||||
Termination description | Either party has the right to terminate the 2020 GSK Agreement in the case of the insolvency of the other party, an uncured material breach of the other party with respect to a collaboration program or collaboration product, or as mutually agreed by the parties. | |||||||||||||||||||||||||
Number of units of account | Unit | 4 | |||||||||||||||||||||||||
Collaboration type and program | The collaboration is focused on the development and commercialization of three types of collaboration products under three programs: (1) antibodies targeting SARS-CoV-2 and potentially other coronaviruses (the “Antibody Program”); (2) vaccines targeting SARS-CoV-2 and potentially other coronaviruses (the “Vaccine Program”), and (3) products based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2 and potentially other coronaviruses (the “Functional Genomics Program”). | |||||||||||||||||||||||||
Preliminary Collaboration Agreement | 2020 GSK | Antibody Program | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Percentage of development costs | 72.50% | |||||||||||||||||||||||||
Antibody license transaction price | $ 43,300 | |||||||||||||||||||||||||
Total revenue | $ 43,300 | |||||||||||||||||||||||||
Preliminary Collaboration Agreement | 2020 GSK | Vaccine Program | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Percentage of development costs | 27.50% | |||||||||||||||||||||||||
Preliminary Collaboration Agreement | 2021 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Number of separate programs | Program | 3 | |||||||||||||||||||||||||
Upfront payment receivable | $ 225,000 | $ 225,000 | ||||||||||||||||||||||||
Option exercise fee to be received | 300,000 | 300,000 | ||||||||||||||||||||||||
Preliminary Collaboration Agreement | 2021 GSK | Maximum | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Pre-defined regulatory milestone payment | $ 200,000 | 200,000 | ||||||||||||||||||||||||
2020 Preliminary Collaboration Agreement and Stock Purchase Agreement | 2020 GSK | ASC 606 | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Fair market value of the common stock issued | $ 206,700 | |||||||||||||||||||||||||
Common stock price per share | $ / shares | $ 36.70 | |||||||||||||||||||||||||
Premium received on sale price of common stock | $ 43,300 | |||||||||||||||||||||||||
2021 Stock Purchase Agreement | 2021 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 1,924,927 | |||||||||||||||||||||||||
Issuance of common stock | $ 120,000 | |||||||||||||||||||||||||
2021 Preliminary Collaboration Agreement and Stock Purchase Agreement | 2021 GSK | ASC 606 | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Fair market value of the common stock issued | $ 85,200 | |||||||||||||||||||||||||
Common stock price per share | $ / shares | $ 52.70 | |||||||||||||||||||||||||
Premium received on sale price of common stock | $ 34,800 | |||||||||||||||||||||||||
2021 GSK Collaboration | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Number of years conduct certain research and development activities under mutually agreed development plans | 3 years | |||||||||||||||||||||||||
Percentage of share development costs | 50% | |||||||||||||||||||||||||
Percentage of share Profit and loss | 50% | |||||||||||||||||||||||||
2021 GSK Agreement | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Increase Decrease In Research And Development Expense | 300 | 400 | $ 1,300 | 1,300 | ||||||||||||||||||||||
Fixed consideration | $ 225,000 | |||||||||||||||||||||||||
Premium paid on sale price of common stock | $ 34,800 | |||||||||||||||||||||||||
Consideration | $ 259,800 | |||||||||||||||||||||||||
2021 GSK Agreement | Contract Revenue | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Total revenue | $ 168,300 | |||||||||||||||||||||||||
2021 GSK Agreement | GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
contract revenue | 39,800 | |||||||||||||||||||||||||
Deferred revenue | 39,800 | 39,800 | ||||||||||||||||||||||||
Brii Agreement | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Increase Decrease In Research And Development Expense | 0 | 0 | 1,300 | 400 | ||||||||||||||||||||||
Termination description | Each party may terminate for convenience all rights and obligations with respect to any program for which it has an option, with 30 days’ written notice (if the terminating party has not exercised an option for such program) or 180 days' notice (following the exercise of an option for such program). The Brii Agreement may also be terminated by either party for insolvency of the other party, and either party may terminate the Brii Agreement in its entirety or on a program-by-program basis for the other party’s uncured material breach on 60 days’ written notice (or 30 days’ notice following failure to make payment). | |||||||||||||||||||||||||
Written notice to terminate licensed program if not exercise | 30 days | |||||||||||||||||||||||||
Written notice to terminate licensed program if exercise | 180 days | |||||||||||||||||||||||||
Written notice period to terminate licensed program for uncured material breach | 60 days | |||||||||||||||||||||||||
Written notice period to terminate licensed program for failure to make payment | 30 days | |||||||||||||||||||||||||
Brii Agreement | Development Programs Exercised by Vir | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Option exercise fee, high end of the range | $ 50,000 | $ 50,000 | ||||||||||||||||||||||||
Option exercise fee, low end of the range | low tens of millions | |||||||||||||||||||||||||
Regulatory milestone payment on licensed product, high end of the range | $ 100,000 | $ 100,000 | ||||||||||||||||||||||||
Regulatory milestone payment on licensed product, low end of the range | low tens of millions | |||||||||||||||||||||||||
Brii Agreement | Development Programs Exercised by Vir | Maximum | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum sale milestone payment to pay | 175,000 | $ 175,000 | ||||||||||||||||||||||||
Brii Agreement | Development Programs Exercised by Brii | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Option exercise fee, high end of the range | 20,000 | $ 20,000 | ||||||||||||||||||||||||
Option exercise fee, low end of the range | mid-single-digit millions | |||||||||||||||||||||||||
Regulatory milestone payment on licensed product, high end of the range | $ 30,000 | $ 30,000 | ||||||||||||||||||||||||
Regulatory milestone payment on licensed product, low end of the range | mid-single-digit millions | |||||||||||||||||||||||||
Maximum aggregate sales milestone payments | $ 175,000 | |||||||||||||||||||||||||
Range of royalty payment to be received | high-teens to high-twenties | |||||||||||||||||||||||||
Range of royalty payment to be paid | mid-teens to the high-twenties | |||||||||||||||||||||||||
Regulatory milestone payment to be received | $ 30,000 | |||||||||||||||||||||||||
Brii Agreement | Development Programs Exercised by Brii | Maximum | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum sales milestone to pay | 175,000 | $ 175,000 | ||||||||||||||||||||||||
Brii Agreement | Brii Bio Parent | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum number of development program granted from Vir to Brii | Program | 4 | |||||||||||||||||||||||||
Maximum number of development program granted from Brii to Vir | Program | 4 | |||||||||||||||||||||||||
Percentage of ordinary share equal to outstanding share | 9.90% | |||||||||||||||||||||||||
Carrying value of investment at cost | $ 5,700 | |||||||||||||||||||||||||
Deferred revenue | $ 2,300 | |||||||||||||||||||||||||
Options Transaction Price | 22,300 | |||||||||||||||||||||||||
Brii Agreement | Brii Bio Parent | License | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Revenue from related parties | 22,300 | |||||||||||||||||||||||||
Brii Agreement | Brii Bio Parent | VIR-2218 | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Option exercise fee received | 20,000 | $ 20,000 | ||||||||||||||||||||||||
Brii Agreement | Brii Bio | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Deferred revenue, noncurrent | 1,500 | 1,500 | ||||||||||||||||||||||||
Royalty payment obligation expiration period after first commercial sales | 10 years | |||||||||||||||||||||||||
Brii Agreement | Brii Bio | Development Programs Exercised by Brii | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Range of royalty payments to be received | 30,000 | |||||||||||||||||||||||||
Option exercise fee received | 20,000 | |||||||||||||||||||||||||
Brii Agreement | Brii Bio | Development Programs Exercised by Brii | Maximum | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum Sales Milestone To Be Received | $ 175,000 | |||||||||||||||||||||||||
Alnylam Agreement | Alnylam Pharmaceuticals Inc | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Royalty payment obligation expiration period after first commercial sales | 10 years | |||||||||||||||||||||||||
Written notice period to terminate licensed program for uncured material breach | 60 days | |||||||||||||||||||||||||
Written notice period to terminate licensed program for failure to make payment | 30 days | |||||||||||||||||||||||||
Expenses incurred under agreement | 500 | 700 | 800 | 2,400 | ||||||||||||||||||||||
Written notice period for termination of licensed program | 90 days | |||||||||||||||||||||||||
Written Notice period to terminate licensed program if under challenge | 30 days | |||||||||||||||||||||||||
Alnylam Agreement | Alnylam Pharmaceuticals Inc | First siRNA product | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum milestone payment for achievement of specified development and regulatory | $ 190,000 | |||||||||||||||||||||||||
Alnylam Agreement | Alnylam Pharmaceuticals Inc | Each Infectious Disease siRNA | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum milestone payment for achievement of specified development and regulatory | 115,000 | |||||||||||||||||||||||||
Maximum sales milestone payment | $ 100,000 | |||||||||||||||||||||||||
Range of tiered royalties to pay on net sales of products | high single-digits to the sub-teen double-digits | |||||||||||||||||||||||||
Alnylam Agreement | Alnylam Pharmaceuticals Inc | First siRNA Product HBV | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum aggregate sales milestone payment | $ 250,000 | |||||||||||||||||||||||||
Range of tiered royalties to pay on net sales of products | The Company may also be required to pay Alnylam tiered royalties at percentages ranging from the low double-digits to mid-teens on annual net sales of HBV products, and tiered royalties at percentages ranging from the high single-digits to the sub-teen double-digits on annual net sales of licensed infectious disease products, in each case subject to specified reductions and offsets | low double-digits to mid-teens | ||||||||||||||||||||||||
Rockefeller Agreement | Rockefeller | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Termination description | The Company has the right to terminate the Rockefeller Agreement in its entirety, or in part, for any reason on 60 days’ written notice to Rockefeller. Rockefeller may terminate the Rockefeller Agreement on 90 days’ written notice for the Company’s uncured material breach, or if the Company challenges the validity or enforceability of any of the licensed patents, or immediately in the event of the Company’s insolvency. Rockefeller may also terminate the Rockefeller Agreement if the Company ceases to carry on business with respect to the rights granted to the Company under the Rockefeller Agreement. | |||||||||||||||||||||||||
Written notice period to terminate agreement by company | 60 days | |||||||||||||||||||||||||
Written notice period to terminate agreement by counterparty | 90 days | |||||||||||||||||||||||||
Royalty obligation period from date of first commercial sale | 12 years | |||||||||||||||||||||||||
Research and development expense under license agreement | 4,700 | |||||||||||||||||||||||||
Rockefeller Agreement | Rockefeller | Commercialization | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Annual License Maintenance Fees | $ 1,000 | |||||||||||||||||||||||||
Rockefeller Agreement | Rockefeller | First Infectious Disease Product | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum aggregate milestone payment for achievement of specified milestones | $ 80,300 | |||||||||||||||||||||||||
Maximum number of products covered against milestone payment | Product | 6 | |||||||||||||||||||||||||
MedImmune Agreement | Influenza A and Influenza B | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Royalties payment range on net sales of licensed product | mid-single-digits to sub-teen double-digits | |||||||||||||||||||||||||
MedImmune Agreement | MedImmune | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Number of antibodies to develop | Antibodies | 2 | |||||||||||||||||||||||||
MedImmune Agreement | MedImmune | Influenza A and Influenza B | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Termination description | The Company may terminate the MedImmune Agreement in its entirety or on a product-by-product basis, for convenience, upon 120 days’ notice. Either party may terminate the MedImmune Agreement for cause for the other party’s uncured material breach on 60 days’ notice or immediately in the event of bankruptcy of the other party. Additionally, MedImmune may terminate the MedImmune Agreement for cause on 30 days’ written notice if the Company challenges the validity or enforceability of the patents to which the Company has obtained a license under the MedImmune Agreement. | |||||||||||||||||||||||||
Written notice period to terminate licensed program for uncured material breach | 60 days | |||||||||||||||||||||||||
Maximum aggregate milestone payment for achievement of specified milestones | $ 331,500 | |||||||||||||||||||||||||
Written notice period for termination of licensed program | 120 days | |||||||||||||||||||||||||
Written Notice period to terminate licensed program if under challenge | 30 days | |||||||||||||||||||||||||
2019 Xencor Agreement | Xencor | Influenza A and HBV Research Programs | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Royalties payment range on net sales of licensed product | low- to mid-single-digits | |||||||||||||||||||||||||
Maximum aggregate development and regulatory milestone payments | $ 17,800 | |||||||||||||||||||||||||
Maximum aggregate commercial sales milestone payments | 60,000 | |||||||||||||||||||||||||
Maximum aggregate milestone payments | 155,500 | |||||||||||||||||||||||||
2019 Xencor Agreement | Xencor | Influenza A and HBV Research Programs | Maximum | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Maximum aggregate milestone payments | $ 77,800 | |||||||||||||||||||||||||
2019 and 2020 Xencor Agreement | Xencor | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Termination description | The Company may terminate each agreement in its entirety, or on a target-by-target basis, for convenience upon 60 days’ written notice. Either party may terminate each agreement for the other party’s uncured material breach upon 60 days’ written notice (or 30 days in the case of non-payment) or in the event of bankruptcy of the other party immediately upon written notice. Xencor may terminate each agreement immediately upon written notice if the Company challenges, or upon 30 days’ written notice if any of the Company’s sublicensees challenge, the validity or enforceability of any patent licensed to the Company under each respective agreement. | |||||||||||||||||||||||||
Written notice period to terminate licensed program for uncured material breach | 60 days | |||||||||||||||||||||||||
Written notice period to terminate licensed program for failure to make payment | 30 days | |||||||||||||||||||||||||
Written notice period for termination of licensed program | 60 days | |||||||||||||||||||||||||
Written Notice period to terminate licensed program if under challenge | 30 days | |||||||||||||||||||||||||
2020 Xencor Agreement | Xencor | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Royalties Based on Net Sales of Licensed Products | mid-single-digits | |||||||||||||||||||||||||
Royalties payment expiration period | 12 years | |||||||||||||||||||||||||
Cost of revenue | $ 17,800 | $ 6,300 | $ 109,700 | $ 7,200 | ||||||||||||||||||||||
Amendment Number One | 2020 GSK | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Contract revenue | $ 7,000 | |||||||||||||||||||||||||
Upfront payment receivable | $ 7,000 | |||||||||||||||||||||||||
Termination Agreement | WuXi Biologics | ||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||
Upfront Payment | $ 7,000 |
Collaboration and License Agr_3
Collaboration and License Agreements - Collaboration revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Collaboration revenue [line item] | ||||
Profit sharing amount | $ 291,226 | $ 102,398 | $ 1,863,374 | $ 107,731 |
Profit sharing amount constrained | (2,431) | 0 | (399,864) | 0 |
Profit-sharing amount previously constrained, released | 20,350 | 0 | 20,350 | 0 |
Total collaboration revenue, net | $ 309,145 | $ 102,398 | $ 1,483,860 | $ 107,731 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 119,150 | $ 57,326 |
Less accumulated depreciation and amortization | (18,924) | (14,492) |
Total property and equipment, net | 100,226 | 42,834 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 30,022 | 20,012 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 2,560 | 1,112 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,911 | 1,443 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,780 | 7,834 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 75,877 | $ 26,925 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Depreciation and amortization expenses | $ 1,600 | $ 1,400 | $ 4,431 | $ 3,891 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued and Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Milestone payable | $ 0 | $ 95,000 |
Net profit-sharing amount | 61,684 | 0 |
Accrued income taxes | 98,189 | 6,217 |
Accrued royalties | 27,771 | 58,672 |
Research and development expenses | 40,116 | 28,073 |
Payroll and related expenses | 23,714 | 29,753 |
Other professional and consulting expenses | 5,633 | 2,791 |
Operating lease liabilities, current | 4,115 | 3,927 |
Excess funds payable under grant agreements | 0 | 1,825 |
Other accrued expenses | 21,394 | 10,254 |
Total accrued and other liabilities | $ 282,616 | $ 236,512 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended |
Aug. 31, 2020 | Sep. 30, 2022 | |
Commitments And Contingencies [Line Items] | ||
Lease arrangement, contractual expiration period, beginning year | 2022 | |
Lease arrangement, contractual expiration period, ending year | 2033 | |
Lessee, operating lease, existence of option to extend [true false] | true | |
Lessee, operating lease, option to extend | These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain lease agreements also provide the Company with the option to renew for additional periods ranging from one to five years. | |
GSKTSL | Wuxi Biologics Letter Agreement Assignment And master Service Agreements | Antibody Program | ||
Commitments And Contingencies [Line Items] | ||
Percentage of development costs | 72.50% | |
GSK | Wuxi Biologics Letter Agreement Assignment And master Service Agreements | Antibody Program | ||
Commitments And Contingencies [Line Items] | ||
Percentage of development costs responsible by GSK | 27.50% | |
CDMO | ||
Commitments And Contingencies [Line Items] | ||
Payment committed for manufacturing capacity | $ 7.2 | |
Pre pay for raw materials | 5 | |
Non-refundable prepayment for raw materials | $ 5 | |
Minimum [Member] | ||
Commitments And Contingencies [Line Items] | ||
Lessee, operating lease, renewal term | 1 year | |
Maximum | ||
Commitments And Contingencies [Line Items] | ||
Lessee, operating lease, renewal term | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Maturities of Operating Lease Liabilities (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 (excluding the nine months ended September 30, 2022) | $ 4,846 |
2023 | 19,408 |
2024 | 18,567 |
2025 | 16,259 |
2026 | 16,703 |
Thereafter | 103,855 |
Total lease payments | 179,638 |
Less: imputed interest | (40,108) |
Less: net tenant improvement allowance yet to be received | (26,670) |
Present value of operating lease liabilities | $ 112,860 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Operating Lease Amounts Recorded in Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Operating Leases | |||
Prepaid expenses and other current assets | [1] | $ 18,197 | $ 49,536 |
Operating right-of-use assets | $ 84,716 | $ 87,220 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued and other liabilities | Accrued and other liabilities | |
Operating lease liabilities, current | $ 4,115 | $ 3,927 | |
Operating lease liabilities, noncurrent | 126,942 | 133,561 | |
Total operating lease liabilities | $ 131,057 | $ 137,488 | |
[1] Current portion of lease liabilities recorded in prepaid expenses and other current assets for which the lease incentives to be received exceed the minimum lease payments to be paid over the next 12 months. |
Stock-Based Awards - Summary of
Stock-Based Awards - Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected stock price volatility, minimum | 110.60% | 106.90% | 103.80% | 103.10% |
Expected stock price volatility, maximum | 110.80% | 111.50% | 111.20% | 111.50% |
Risk-free interest rate, minimum | 3% | 0.80% | 1.60% | 0.60% |
Risk-free interest rate, maximum | 3.60% | 1% | 3.60% | 1.20% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Minimum | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term of options (in years) | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days | |
Maximum | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term of options (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Awards - Summary _2
Stock-Based Awards - Summary of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 24,814 | $ 22,944 | $ 77,217 | $ 59,413 |
Research and Development Expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 12,607 | 11,165 | 39,791 | 30,455 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 12,207 | $ 11,779 | $ 37,426 | $ 28,958 |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Schedule of Basic and Diluted Net Income (loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net income, basic and diluted | $ 175,312 | $ 110,428 | $ 617,440 | $ 3,330 |
Weighted-average shares outstanding, basic | 132,729,530 | 130,665,831 | 132,422,028 | 129,520,837 |
Weighted-average effect of dilutive securities: | ||||
Options to purchase common stock | 2,144,302 | 3,173,930 | 2,227,493 | 3,757,681 |
Restricted shares subject to future vesting | 75,759 | 14,658 | 55,080 | 36,138 |
Shares to purchase under Employee Stock Purchase Plan | 13,726 | 0 | 7,176 | 0 |
Contingently issuable shares | 0 | 0 | 0 | 4,323 |
Weighted-average shares outstanding, diluted | 134,963,317 | 133,854,419 | 134,711,777 | 133,318,979 |
Net income per share, basic | $ 1.32 | $ 0.85 | $ 4.66 | $ 0.03 |
Net income per share, diluted | $ 1.30 | $ 0.82 | $ 4.58 | $ 0.02 |
Net Income (Loss) Per Share -_2
Net Income (Loss) Per Share - Schedule of Potentially Dilutive Securities Not Included in Diluted Per Share Calculations (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from calculation of diluted net loss per share (in shares) | 10,575,325 | 7,383,338 | 11,438,772 | 6,303,487 |
Options Issued and Outstanding | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from calculation of diluted net loss per share (in shares) | 8,381,275 | 6,316,134 | 8,717,954 | 5,278,033 |
Restricted Shares Subject to Future Vesting | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from calculation of diluted net loss per share (in shares) | 2,194,050 | 1,067,204 | 2,720,818 | 1,025,454 |
Income taxes - Schedule of inco
Income taxes - Schedule of income (loss) before income taxes, income tax (expense) benefit and effective income tax (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Income before provision for income taxes | $ 217,732 | $ 110,762 | $ 905,918 | $ 3,913 |
Provision for income taxes | $ (42,420) | $ (334) | $ (288,478) | $ (583) |
Effective tax rate | 19.50% | 0.30% | 31.80% | 14.90% |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Unrecognized tax benefits | $ 10.5 | $ 7.4 |