Consolidated Statements of Operations (Parenthetical) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| License and Development Services Revenue | |||
| Revenue from related parties | $ 74 | $ 330 | $ 55 |
| Other Collaboration Revenue | |||
| Revenue from related parties | 33 | 31 | 16 |
| Research and Development | |||
| Net of recoveries from related party for shared costs | 132 | 25 | 3 |
| General and Administrative | |||
| Net of recoveries from related party for shared costs | $ 1 | ||
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Income Statement [Abstract] | |||
| Net income (loss) | $ (267) | $ 53 | $ (123) |
| Other comprehensive loss | (6) | (1) | |
| Comprehensive income (loss) | $ (273) | $ 52 | $ (123) |
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Related party, receivable from collaboration partners | $ 39 | $ 745 |
| Related Parties Contract Assets Noncurrent | 2 | |
| Related party, deferred revenue - current | 97 | 97 |
| Related party, deferred revenue - noncurrent | $ 355 | $ 462 |
| Preferred stock, par value | $ 0.0001 | $ 0.0001 |
| Preferred stock, shares authorized | 10,000,000.0 | 10,000,000.0 |
| Preferred stock, shares issued | 0 | 0 |
| Preferred stock, shares outstanding | 0 | 0 |
| Common stock, par value | $ 0.0001 | $ 0.0001 |
| Common stock, shares authorized | 400,000,000.0 | 400,000,000.0 |
| Common stock, shares issued | 72,900,000 | 70,800,000 |
| Common stock, shares outstanding | 72,900,000 | 70,800,000 |
Consolidated Statements of Stockholders' Equity - USD ($) $ in Millions |
Total |
Equity award programs |
Purchase Agreement
Gilead
|
Common Stock |
Common Stock
Equity award programs
|
Common Stock
Purchase Agreement
Gilead
|
Common stock and additional paid-in-capital |
Common stock and additional paid-in-capital
Equity award programs
|
Common stock and additional paid-in-capital
Purchase Agreement
Gilead
|
Accumulated Deficit |
Accumulated Other Comprehensive Income (Loss) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance at Dec. 31, 2019 | $ 164 | $ 369 | $ (205) | ||||||||
| Balance, shares at Dec. 31, 2019 | 44,200,000 | ||||||||||
| Issuance of common stock | 326 | $ 6 | $ 107 | 326 | $ 6 | $ 107 | |||||
| Issuance of common stock, shares | 6,000,000.0 | 12,700,000 | 800,000 | 6,000,000.0 | |||||||
| Stock-based compensation | 22 | 22 | |||||||||
| Net income (loss) | (123) | (123) | |||||||||
| Balance at Dec. 31, 2020 | 502 | 830 | (328) | ||||||||
| Balance, shares at Dec. 31, 2020 | 63,700,000 | ||||||||||
| Issuance of common stock | 13 | $ 220 | 13 | $ 220 | |||||||
| Issuance of common stock, shares | 1,400,000 | 5,700,000 | |||||||||
| Stock-based compensation | 55 | 55 | |||||||||
| Other comprehensive income (loss) | (1) | $ (1) | |||||||||
| Net income (loss) | 53 | 53 | |||||||||
| Balance at Dec. 31, 2021 | $ 842 | 1,118 | (275) | (1) | |||||||
| Balance, shares at Dec. 31, 2021 | 70,800,000 | 70,800,000 | |||||||||
| Issuance of common stock | $ 23 | $ 23 | |||||||||
| Issuance of common stock, shares | 2,100,000 | ||||||||||
| Stock-based compensation | $ 65 | 65 | |||||||||
| Other comprehensive income (loss) | (6) | (6) | |||||||||
| Net income (loss) | (267) | (267) | |||||||||
| Balance at Dec. 31, 2022 | $ 657 | $ 1,206 | $ (542) | $ (7) | |||||||
| Balance, shares at Dec. 31, 2022 | 72,900,000 | 72,900,000 |
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Statement of Cash Flows [Abstract] | |||
| Receivable from related party | $ 704 | $ (17) | $ (1) |
| Other assets from related party | (2) | ||
| Deferred revenue from related party | $ (107) | (361) | 195 |
| Proceeds from issuance of common stock and rights to purchase additional shares from a related party | $ 220 | $ 164 | |
Organization, Liquidity and Capital Resources |
12 Months Ended |
|---|---|
Dec. 31, 2022 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Organization, Liquidity and Capital Resources | Note 1. Organization, liquidity and capital resources Organization Arcus Biosciences, Inc. (referred to as “Arcus,” “we,” “our,” “us,” or the “Company”) is a clinical-stage biopharmaceutical company focused on creating best-in-class therapies. Using our robust and highly efficient drug discovery capability, we have created a significant portfolio of investigational products which are in clinical development, with our most advanced molecule, an anti-TIGIT antibody, now in four Phase 3 registrational studies targeting lung and gastrointestinal cancers. Our deep portfolio of novel small molecules and enabling antibodies allows us to create highly differentiated therapies, which we are developing to treat multiple large indications. We operate and manage our business as one reportable and operating segment, which is the business of developing and commercializing highly differentiated therapies that have a meaningful impact on patients. Liquidity and Capital Resources As of December 31, 2022, we had cash, cash equivalents and marketable securities of $1.14 billion, which we believe will be sufficient to fund our planned operations for a period of at least twelve months following the date of filing of this report. |
Summary of Significant Accounting Policies |
12 Months Ended |
|---|---|
Dec. 31, 2022 | |
| Accounting Policies [Abstract] | |
| Summary of significant accounting policies | Note 2. Summary of significant accounting policies Basis of Presentation The Consolidated Financial Statements, which include the accounts of Arcus as well as its wholly owned subsidiary, have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. All intercompany transactions and balances have been eliminated in consolidation. We assess whether we are the primary beneficiary of a variable interest entity (“VIE”) at the inception of the arrangement and at each reporting date. This assessment is based on our power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE. We do not have any significant interests in any variable interest entities of which we are the primary beneficiary. Use of Estimates The preparation of the Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Actual results may differ materially from those estimates. Collaborative Arrangements We assess whether our licensing and other agreements are collaborative arrangements based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. For arrangements that we determine are collaborations, we identify each distinct performance obligation, and then determine whether a customer relationship exists for that distinct performance obligation. If we determine a performance obligation within the collaborative arrangement to be with a customer, we apply our revenue accounting policy. If a portion of a distinct bundle of goods or services within the collaborative arrangement is not with a customer, we apply recognition and measurement based on an analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. Revenues We recognize revenue when a customer obtains control of promised goods or services in a contract for an amount that reflects the consideration we expect to receive in exchange for those goods or services. For contracts with customers, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. As part of the accounting for contracts with customers, we develop assumptions that require judgment to determine the standalone selling price of We currently do not have product sales and our revenues are derived from arrangements for the development of our investigational products. Such arrangements may require us to deliver various rights, services and/or goods, including intellectual property rights/licenses, R&D services, manufacturing services and/or commercialization services. The underlying terms of these arrangements may generally include consideration to Arcus in the form of one or more of the following: (i) nonrefundable, up-front license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; (iii) royalties on net sales of licensed products; (iv) fees attributable to options to intellectual property; and (v) profit sharing. In arrangements involving more than one performance obligation, each performance obligation is evaluated to determine whether it qualifies as distinct based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects our best estimate of what the selling price would be if the deliverable was regularly sold by us on a stand-alone basis or by using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods is transferred or services are performed. We evaluate each performance obligation to determine if it can be satisfied at a point in time or over time as services are performed. For performance obligations that are determined to be satisfied over time we determine an appropriate method of measuring progress for purposes of recognizing revenue. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. For arrangements that include sales-based royalties, including milestone payments based on sales thresholds, and for which the license is deemed to be the predominant item to which the royalties relate, we recognize 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). To date, we have not recognized any royalty revenue resulting from any of our arrangements. The accounting for these arrangements requires us to develop estimates and assumptions that require judgment. These estimates may include items such as forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. Actual results may differ materially from those estimates. See Note 5, Revenues, for more information. Research and Development Expenses Research and development (“R&D”) costs are expensed as incurred and primarily include: salaries, benefits and other staff-related costs; facilities and overhead costs; third-party service provider costs for preclinical and clinical studies; laboratory supplies and equipment maintenance costs; consulting; payments under collaborative and other arrangements including milestone payments, licenses and fees; expense reimbursements to collaboration partners; and other related expenses. Under certain collaborative arrangements, we are reimbursed for a portion of the research and development expenses, including costs of drug supplies. When these R&D expenses are incurred under a reimbursement or cost sharing model with a collaboration partner, we record the related reimbursements as a reduction of R&D expense in our Consolidated Statements of Operations. Acquired in-process research and development projects with no alternative future use are recorded in R&D expense upon acquisition. Net payment or reimbursement of R&D costs is recognized when the obligations are incurred or as we become entitled to the cost recovery. See Note 4, License and collaboration agreements, for more information. Clinical study costs are a significant component of R&D expenses. Our clinical studies are primarily performed by third-party contract research organizations (“CROs”). We monitor levels of performance under each significant contract including the extent of patient enrollment and other activities and accrue costs for clinical studies performed over the service periods specified in the contract. We adjust our estimates, if required, based upon our ongoing review of the level of effort and costs actually incurred by the CROs. All of our material CRO contracts are terminable by us upon written notice, and we are generally only liable for actual services completed by the CRO and certain noncancelable expenses incurred at termination. General and Administrative Expenses General and administrative (“G&A”) expenses relate to: finance; human resources; legal and other administrative activities which consist primarily of personnel costs; facilities and overhead costs; legal expenses; and other general and administrative costs. G&A expenses also include cost recoveries associated with collaborative R&D arrangements. Stock-Based Compensation We provide share-based compensation in the form of various types of equity-based awards, including restricted stock units (“RSU”s) and stock options. The fair values of RSU’s and stock options, which are subject to service conditions and vesting, are recognized as compensation expense on a straight-line basis over the service period net of forfeitures as they occur. See Note 8, Stock-based compensation, for more information. Income Taxes We provide for income taxes under the asset and liability method. Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards, measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when we determine it is more likely than not that some or all of the tax benefits will not be realized. We recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by tax authorities. We assess all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and we will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. We include any penalties and interest expense related to income taxes as a component of other expense and interest income, net, as necessary. See Note 6, Income taxes, for more information. Cash Equivalents Cash equivalents consist of marketable securities having an original maturity of three months or less at the time of purchase. Marketable securities We consider our interest-bearing securities investment portfolio as available-for-sale, and accordingly, these investments are recorded at fair value, with unrealized gains and losses recorded in Accumulated Other Comprehensive Income (AOCI). See Note 10, Cash, cash equivalents and marketable securities, and Note 15, Fair value measurements, for more information. Property and Equipment Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets, ranging from to ten years. Leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease term. We review property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. See Note 11, Property and equipment, for more information. Leases We determine whether an arrangement is or contains a lease at contract inception. Operating lease right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of the lease payments over the lease term, which is the non-cancelable period stated in the contract adjusted for any options to extend or terminate when it is reasonably certain that we will exercise that option. Right-of-use assets are adjusted for prepaid lease payments, lease incentives and initial direct costs incurred. Operating lease expense for the minimum lease payments is recognized on a straight-line basis over the lease term. When our operating leases do not provide an implicit interest rate, we generally utilize our incremental borrowing rate, based on the information available at the commencement date to determine the lease liability. We do not recognize the right-of-use assets and liabilities for leases with lease terms of one year or less with payments recognized as operating expenses on a straight-line basis over the lease term. See Note 13, Leases, for more information. Fair Value of Financial Instruments We apply fair value accounting for all financial and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. We define fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities which are required to be recorded at fair value, we consider the principal or most advantageous market in which we would transact and the market-based risk measurements or assumptions that market participants would use in pricing the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risks. See Note 15, Fair value measurements, for more information. Other Significant Accounting Policies Our other significant accounting policies are described in the remaining appropriate notes to the Consolidated Financial Statements. Recent Accounting Pronouncements There have been no new accounting pronouncements issued or adopted during the year ended December 31, 2022 with a significant impact to our financial statements. |
Related Party - Gilead Sciences, Inc. |
12 Months Ended |
|---|---|
Dec. 31, 2022 | |
| Related Party Transactions [Abstract] | |
| Related party - Gilead Sciences, Inc. | Note 3. Related party - Gilead Sciences, Inc. In 2020, we and Gilead Sciences, Inc. (Gilead) entered into an Option, License and Collaboration Agreement (the Gilead Collaboration Agreement), Common Stock Purchase Agreement (the Stock Purchase Agreement), and Investor Rights Agreement (Investor Rights Agreement). In 2021, we amended the Gilead Collaboration Agreement (the Amended Gilead Collaboration Agreement) and the Stock Purchase Agreement (the Amended Stock Purchase Agreement) and in 2022, we amended the Investor Rights Agreement (Amended Investor Rights Agreement). We refer to these agreements collectively as the Gilead Agreements. Stock Purchase Agreement and Investor Rights Agreement In 2020, under the Stock Purchase Agreement, Gilead purchased 5,963,029 shares for a total cost of $200 million, of which $91 million was allocated to the revenue related performance obligations (See Note 5, Revenues for more information) created by the Gilead Collaboration Agreement. In 2021, under the Amended Stock Purchase Agreement, Gilead purchased 5,650,000 shares for a total cost of $220 million. Gilead has the right, at its option until July 2025, to purchase up to a maximum of 35% of the Company’s then-outstanding voting common stock, at a purchase price equal to the greater of a 20% premium to market (based on a trailing five-day average closing price at option exercise) or the $33.54 initial purchase price. Based on the value of our common stock at each contract closing, the right to purchase additional shares had no value. Under the Investor Rights Agreement, Gilead has the right, which they have exercised, to designate two members of our Board of Directors. This agreement also includes a three-year standstill, included a two-year lockup, provided Gilead with registration rights commencing at the end of the lockup period and provides Gilead with pro rata participation rights in certain future financings. In October 2022, we registered Gilead’s shares and the agreement was amended, primarily to extend the two-year lockup period to three-years expiring July 13, 2023. As of December 31, 2022, Gilead held approximately 18.9% of the Company’s outstanding common stock arising from purchases in our May 2020 public offering and purchases under the Stock Purchase Agreement and Amended Stock Purchase Agreement. Collaboration Agreements In 2020, we entered into the Gilead Collaboration Agreement, which gave Gilead an exclusive license to develop and commercialize zimberelimab (the anti PD-1 program) in certain markets and time-limited options to acquire exclusive licenses to develop and commercialize any of our then-current and future clinical programs arising during the 10-year collaboration term, contingent upon $100 million option continuation payments payable on each of the second, fourth, sixth and eighth anniversaries of the agreement. Upon closing of the transaction in July 2020, Gilead made an upfront payment of $175 million. In 2021, we entered into the Amended Gilead Collaboration Agreement pursuant to which Gilead exercised its option to three programs—providing Gilead with exclusive licenses to develop and commercialize domvanalimab and AB308 (collectively, the anti-TIGIT program), etrumadenant (the adenosine receptor antagonist program) and quemliclustat (the CD73 program), in certain markets—for a total payment of $725 million that was received in 2022. The amendment also (i) provided for a slight reduction in the royalties for these three programs, such that Gilead will pay us tiered royalties as a percentage of revenues ranging from the mid-teens to the low twenties; and (ii) removed the $100 million option continuation payment that was otherwise due on the second anniversary of the Gilead Collaboration Agreement. Gilead's option, on a program-by-program basis, will expire after a prescribed period following the achievement of a clinical development milestone in such program and our delivery to Gilead of the requisite data package. Gilead may exercise its option to any program at any time prior to expiration of the option and will pay Arcus an option fee of $150 million per program. With respect to domvanalimab, we are also eligible to receive up to $500 million in potential U.S. regulatory approval milestones. For each program that Gilead opts into, both companies will co-develop and equally share global development costs, subject to certain opt-out rights that we have, and caps on our spending and related subsequent adjustments. For each program, provided we have not exercised our opt-out rights, we have the option to co-promote in the United States with equal sharing of related profits and losses. Gilead has the right to exclusively commercialize outside of the U.S., subject to the rights of our existing partners in any territories. Under the Amended Gilead Collaboration Agreement, Gilead also has option rights to two research programs for which we will lead discovery and early development activities. With respect to these two research programs, Gilead has the right to exercise its option, on a program-by-program basis, either (i) upon our completion of certain IND-enabling activities for an option payment of $60 million or (ii) following the achievement of a clinical development milestone for an option payment of $150 million. These research programs were not determined to be performance obligations at contract inception, due to the very early stages of the programs. As of December 31, 2022, Gilead has licenses to domvanalimab, AB308, etrumadenant, quemliclustat and zimberelimab. For the years ended December 31, 2022, 2021 and 2020; we recognized revenue under this agreement of $107 million, $361 million and $71 million, respectively; and reimbursements from Gilead recognized as reductions in R&D expense of $132 million, $25 million and $3 million, respectively. For the year ended December 31, 2022, we recognized reimbursements from Gilead as reductions in G&A expense of $1 million. For a more detailed discussion on revenues recognized under this collaboration see Note 5, Revenues. |
License and Collaborations |
12 Months Ended |
|---|---|
Dec. 31, 2022 | |
| License And Collaboration Agreements [Abstract] | |
| License and Collaborations | Note 4. License and collaborations We enter into licensing agreements, strategic collaborations and other similar arrangements with third parties for the development and commercialization of certain investigational products. These arrangements may be collaborative and involve two or more parties who are active participants in the operating activities of the collaboration and are exposed to significant risks and rewards depending on the commercial success of the activities. These arrangements may include: non-refundable upfront payments; payments for options to acquire certain rights; potential development and regulatory milestone payments and/or sales-based milestone payments; royalty payments; revenue or profit-sharing arrangements; expense reimbursements; and cost-sharing arrangements. See Note 2, Summary of significant accounting policies, for additional discussion of revenues recognized under these types of arrangements. Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line items in the Consolidated Statements of Operations, net of any payments due to or reimbursements due from our collaboration partners, with such reimbursements being recognized at the time the party becomes obligated to pay. Our significant arrangements are discussed below. Gilead Collaboration See Note 3, Related party - Gilead Sciences, Inc. AstraZeneca Collaboration In 2020, we entered into a collaboration with AstraZeneca to evaluate domvanalimab, our investigational anti-TIGIT antibody, in combination with AstraZeneca’s durvalumab in a registrational Phase 3 clinical trial in patients with unresectable Stage 3 non-small cell lung cancer (NSCLC), known as the PACIFIC-8 trial. Under the collaboration, each company will retain existing rights to their respective molecules and any future commercial economics. AstraZeneca will conduct the trial, and each company will supply their respective investigational product to support the trial. Under the terms of the agreement, we will reimburse AstraZeneca for its share of the trial costs upon the achievement of certain milestones or under certain circumstances if the agreement is terminated early. The portion of the costs that we consider to be unavoidable are accrued in advance of the achievement of the milestone. The PACIFIC-8 trial forms part of the Arcus and Gilead joint development program for domvanalimab and our portion of the trial costs are shared with Gilead. We have recognized a receivable of $2 million from Gilead at December 31, 2022 which is recorded in Other noncurrent assets. For the years ended December 31, 2022 and 2021, under this arrangement we recognized as R&D expense $4 million and $1 million, respectively, before expected recoveries from our cost-sharing agreement with Gilead. At December 31, 2022 and 2021, we have recognized a liability of $5 million and $1 million, respectively, which is recorded in Other noncurrent liabilities. Taiho License In 2017, we entered into an agreement with Taiho Pharmaceutical Co., Ltd (Taiho) under which we granted Taiho exclusive options to programs arising over a five-year period which ended in September 2022 (the Option Period) for an upfront payment of $35 million. Upon an option exercise of a program, Taiho would obtain exclusive development and commercialization rights to investigational products under the program for Japan and certain other territories in Asia (excluding China) (the Taiho Territory). For each option that Taiho exercises, they will be obligated to make a payment of $3 million to $15 million, depending on the development stage of the optioned program. Upon exercise, Taiho is solely responsible for continued development and commercialization in the Taiho Territory. In addition, for each optioned program we would be eligible to receive clinical and regulatory milestones of up to $130 million and commercial milestone payments of up to $145 million with the achievement of certain sales thresholds in the Taiho Territory. We will also receive royalties ranging from high single-digits to mid-teens on net sales of licensed products in the Taiho Territory. Royalties will be payable by product and country commencing on the first commercial sale and ending upon the later of: (a) 10 years; and (b) expiration of the last-to-expire valid claim of our patents covering the manufacture, use or sale. As of December 31, 2022, Taiho has exercised its options to (i) etrumadenant (the adenosine receptor antagonist program); (ii) zimberelimab (the anti PD-1 program); and (iii) domvanalimab and AB308 (collectively, the anti-TIGIT program). For the year ended December 31, 2021, option payments totaling $15 million were recognized as revenue. For the years ended December 31, 2022, 2021 and 2020 we recognized revenue of $5 million, $7 million, and $7 million, respectively, related to the upfront payment. For a more detailed discussion on revenues see Note 5, Revenues. WuXi Biologics License – anti-PD-1 In 2017, we entered into an agreement with WuXi Biologics Ireland Limited (WuXi Biologics) which, as amended, provides us with exclusive rights to (i) develop, use and manufacture products that include an anti-PD-1 antibody, including zimberelimab, worldwide and (ii) commercialize any such products worldwide, except in Greater China. Under the agreement, as of December 31, 2022 we may incur (i) clinical and regulatory milestone payments, and commercialization milestone payments of up to $375 million, (ii) tiered royalties that range from the high single-digits to low teens on net sales of the licensed products and (iii) fees related to any sublicenses. During the years ended December 31, 2021 and 2020, we incurred milestones of $10 million and $5 million, respectively, and for the year ended December 31, 2020, we incurred sub-license fees of $10 million in connection with the Gilead Collaboration Agreement. All payments were recorded as R&D expense. WuXi Biologics License – anti-CD39 In 2020, we entered into an agreement with WuXi Biologics, under which we obtained the exclusive worldwide license to anti-CD39 antibodies discovered under the agreement. We will be responsible for the further development and commercialization of these antibodies. Under the agreement, as of December 31, 2022 we may incur additional clinical and regulatory milestone payments of up to $15 million and royalty payments in the low single digits on net sales of the licensed products. During the year ended December 31, 2022, we made a milestone payment of $2 million which was recorded as R&D expense. Abmuno License In 2016, we entered into an agreement with Abmuno Therapeutics LLC (Abmuno), under which we obtained the exclusive worldwide license to develop, use, manufacture, and commercialize products that include an anti-TIGIT antibody, including domvanalimab. Under the agreement, as of December 31, 2022 we may incur additional clinical, regulatory and commercialization milestone payments of up to $88 million. During the years ended December 31, 2022, 2021 and 2020, we incurred development milestone expenses of $5 million, $5 million and $3 million, respectively, which were recorded as R&D expense. |
Revenues |
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| Revenues | Note 5. Revenues The following table summarizes our revenues by collaboration, category of revenue, and the method of recognition (in millions):
Revenues from Gilead accounted for 96%, 94% and 91% of Total revenues for the years ended December 31, 2022, 2021 and 2020, respectively. The following table summarizes the revenue recognized as a result of changes in the deferred revenue balance (in millions):
Revenue from the Gilead Collaboration Agreement We determined that the Amended Gilead Collaboration Agreement (see Note 3, Related party - Gilead Sciences, Inc., for more information) represented a contract modification and at the amendment closing date of December 21, 2021, we allocated the transaction price to the new and remaining performance obligations. The following table summarizes the transaction price and the allocation of the transaction price to the performance obligations (in millions):
Our assessment of the transaction price for the Amended Gilead Collaboration Agreement included an analysis of amounts we expected to receive, which at contract inception consisted of the upfront cash payment of $725 million, as well as amounts totaling $165 million deferred from the original Gilead transaction. This excludes the $100 million option continuation payment that was eliminated in the amendment. We determined the entire $890 million to be the allocable transaction price as of the amendment closing date, due to the history of timely payments by Gilead including the receipt of $725 million in January 2022. We had $452 million and $559 million of deferred revenue remaining on our Consolidated Balance Sheets related to this collaboration at December 31, 2022 and December 31, 2021, respectively, allocated between current and noncurrent based on the expected timing of future recognition. Total revenues recognized during the year ended December 31, 2022 includes cumulative catch-up revenue of $4 million, due to changes in the total estimated percentage of completion and management's estimated total effort to be incurred in the future to satisfy the performance obligations, primarily related to revised clinical trial assumptions for R&D and commercial activities. This cumulative catch-up reduced net loss per share in the year ended December 31, 2022 by $0.06. We accounted for each performance obligation as follows: Domvanalimab – License Under the Gilead Collaboration Agreement, Gilead obtained an option to the exclusive rights to our anti-TIGIT program, including domvanalimab and AB308, in exchange for an option payment of $275 million, if exercised. Prior to the closing of the Amended Gilead Collaboration Agreement, we had $37 million of deferred revenue on our Consolidated Balance Sheet related to this performance obligation. Effective December 2021, under the Amended Gilead Collaboration Agreement, Gilead exercised the option and obtained an exclusive license to domvanalimab. We determined that this license was distinct based on an evaluation of the delivery of the license, noting that the program was in the later stages of development and it met the criteria for being distinct from the R&D services required under the Amended Gilead Collaboration Agreement. Specifically, the domvanalimab program was in a Phase 3 clinical trial at the time that Gilead acquired the license and the Company concluded that: (i) the R&D services for such later-stage, Phase 3 IP, primarily involved validating the drug’s efficacy, and (ii) the ongoing R&D services do not significantly modify or customize the drug compound such that the IP is not significantly different at the end of the arrangement as a result of the services. We determined the standalone selling price of this license using a discounted cash flow method. We recognized as revenue the full $329 million of the allocated transaction price in the year ended December 31, 2021. Domvanalimab – R&D services We determined that we retain a separate performance obligation to perform further R&D services for Gilead related to domvanalimab. The standalone selling price of this obligation was determined using an expected cost-plus margin approach. We recognize the amounts allocated to these services as the performance obligation is satisfied, calculated as an estimated percentage of completion based on management's estimated total effort for the program. We recognized $5 million in license and R&D services revenue in the year ended December 31, 2022 and no revenue was recognized in 2021 as the R&D services had not yet commenced. At December 31, 2022 we had $30 million of deferred revenue remaining on our Consolidated Balance Sheet related to this performance obligation. Etrumadenant – License and R&D services Under the Gilead Collaboration Agreement Gilead obtained an option to the exclusive rights to our adenosine receptor program, etrumadenant, in exchange for an option payment of $250 million, if exercised. Prior to the closing of the Amended Gilead Collaboration Agreement, we had $127 million of deferred revenue on our Consolidated Balance Sheet related to this performance obligation. Effective December 2021, under the Amended Gilead Collaboration Agreement, Gilead exercised the option and obtained an exclusive license to etrumadenant and we were also obligated to perform further R&D services for Gilead related to etrumadenant. We determined that the license and R&D services were combined based on an evaluation of the delivery of the license, due to the early stage of the technology and the specialized nature of our know-how. We determined the standalone selling price of the license using a discounted cash flow method and the R&D services using an expected cost-plus margin approach. We recognize the amounts allocated to the combined license and services as the performance obligation is satisfied, calculated as an estimated percentage of completion based on management's estimated total effort for the program. We recognized $34 million in license and R&D services revenue in the year ended December 31, 2022 and no revenue was recognized in 2021 as the R&D services had not yet commenced. At December 31, 2022 we had $185 million of deferred revenue remaining on our Consolidated Balance Sheet related to this performance obligation. Quemliclustat – License and R&D services Under the Gilead Collaboration Agreement Gilead obtained an option to the exclusive rights to the Company's CD73 program, quemliclustat, in exchange for an option payment of $200 million, if exercised. Prior to the closing of the Amended Gilead Collaboration Agreement, we had no deferred revenue on our Consolidated Balance Sheet related to this performance obligation. Effective December 2021, under the Amended Gilead Collaboration Agreement, Gilead exercised the option and obtained an exclusive license to quemliclustat and we were also obligated to perform further R&D services for Gilead related to quemliclustat. We determined that the license and R&D services were combined based on an evaluation of the delivery of the license, due to the early stage of the technology and the specialized nature of our know-how. We determined the standalone selling price of the license using a discounted cash flow method and the R&D services using an expected cost-plus margin approach. We recognize the amounts allocated to the combined license and services as the performance obligation is satisfied, calculated as an estimated percentage of completion based on management's estimated total effort for the program. We recognized $26 million in license and R&D services revenue in the year ended December 31, 2022 and no revenue was recognized in 2021 as the R&D services had not yet commenced. At December 31, 2022 we had $149 million of deferred revenue remaining on our Consolidated Balance Sheet related to this performance obligation. Zimberelimab – License Effective July 2020, under the Gilead Collaboration Agreement, Gilead obtained an exclusive license to zimberelimab. We determined that this license was distinct based on an evaluation of the delivery of the license, noting that the program was in the later stages of development and it met the criteria for being distinct from the R&D services required under the Gilead Collaboration Agreement. We determined the standalone selling price of this license using a discounted cash flow method. We recognized the full $55 million of the allocated transaction price as revenue in the year ended December 31, 2020. Zimberelimab – R&D and commercialization services We determined that we retained separate performance obligations to perform further R&D and commercialization services for Gilead related to zimberelimab, as a monotherapy and in combination with other agents. Prior to the closing of the Amended Gilead Collaboration Agreement, we had $10 million of deferred revenue on our Consolidated Balance Sheet, related to these performance obligations. The standalone selling price of these obligations were determined using an expected cost-plus margin approach. We recognize the amounts allocated to these services as the performance obligations are satisfied, calculated as an estimated percentage of completion based on management's estimated total effort for the program. We recognized $9 million and $1 million for R&D and commercialization services in the year ended December 31, 2022 and 2021, respectively. At December 31, 2022, we had $1 million of deferred revenue remaining on our Consolidated Balance Sheet related to these performance obligations. Access rights and option continuation periods Under the Amended Gilead Collaboration Agreement, Gilead has exclusive access to our current programs as well as the future programs for a period of ten years, contingent upon option continuation payments totaling $300 million, consisting of a $100 million payment on each of the fourth, sixth, and eighth anniversaries of the agreement. Prior to the closing of the Amended Gilead Collaboration Agreement, we had $92 million deferred revenue on our Consolidated Balance Sheet related to this performance obligation. The standalone selling price of this ongoing R&D pipeline access was determined using an expected cost-plus margin approach. We use a time-elapsed input method to measure progress toward satisfying this obligation, which is the method we believe most faithfully depicts the Company’s performance in transferring the promised services during the time period in which Gilead has access to our R&D pipeline. Accordingly, the revenue allocated to this performance obligation is being recognized using this input method over the minimum four-year period. We determined that Gilead is not obligated to pay the remaining $300 million due over the remainder of the term and excluded these payments from the transaction price. Failure to pay the non-obligatory option continuation payments will result in Gilead’s loss of certain rights to access and obtain licenses to the programs arising from our R&D pipeline. We recognized as revenue $33 million, $31 million and $16 million associated with this obligation in the years ended December 31, 2022, 2021 and 2020, respectively under the Gilead Collaboration Agreement and the Amended Gilead Collaboration Agreement. At December 31, 2022, we had $87 million of deferred revenue on our Consolidated Balance Sheet related to this performance obligation. Capitalized costs to obtain a contract We incurred $7 million in costs to obtain the Gilead Agreements in 2020, which consisted of consultant and legal fees. We determined that $2 million of these costs were related to the Stock Purchase Agreement which were recognized as offering costs and we allocated the remaining costs to the various performance obligations, to be recognized as the underlying performance obligation is satisfied and revenue is recognized. We incurred $4 million in costs to obtain the Amended Gilead Collaboration Agreement in 2021, which consisted of fees to a third party. These fees were combined with the $4 million of capitalized fees that remained from the original agreement at the amendment closing date, and the total $8 million was allocated to the performance obligations identified under the Amended Gilead Collaboration Agreement, to be recognized as expense as the underlying performance obligation is satisfied and revenue is recognized. For the years ended December 31, 2022, 2021 and 2020, we recognized expense related to these capitalized costs of $1 million, $4 million and $1 million, respectively, which was recorded in G&A expense. As of December 31, 2022, we had $4 million in capitalized costs to obtain the contract, of which $1 million was recorded as Prepaid and other current assets and $3 million was recorded as Other noncurrent assets in our Consolidated Balance Sheet. |
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| Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Taxes | Note 6. Income taxes Income (loss) before income taxes included the following (in millions):
The provision for income taxes included the following (in millions):
The 2022 income tax expense considers the impact of the capitalization of R&D expenses for income tax purposes due to changes in U.S. legislation. The reconciliation between the federal statutory income tax rate and our effective tax rate was as follows:
Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards. Significant components of our deferred tax assets and liabilities were as follows (in millions):
The accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of net deferred tax assets. We considered factors such as our history of operating losses, the nature of our deferred tax assets, and the timing, likelihood and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible, including amounts that may arise under the collaboration agreement with Gilead entered into in 2020 and the 2021 program opt-ins. As a result of our evaluation of these factors, including the uncertainty that exists with respect to the option fees and milestone payments, we do not believe that it is more likely than not that the deferred tax assets will be realized. Accordingly, a full valuation allowance has been established and no deferred tax asset is shown in the accompanying Consolidated Balance Sheets. The valuation allowance increased by approximately $67 million for the year ended December 31, 2022 and decreased by approximately $1 million for the year ended December 31, 2021. The United States enacted the Tax Cuts and Jobs Act in December 2017, which requires companies to capitalize all of their R&D costs for U.S. tax purposes, including software development costs, incurred in tax years beginning after December 21,2021. Beginning in 2022, for tax purposes we began capitalizing and amortizing R&D costs over a five-year period for domestic research and a fifteen-year period for international research rather than expensing these costs immediately. At December 31, 2022, we had total net operating loss carryforwards (NOLs) of $109 million that have no expiration date and federal research tax credits of approximately $18 million that begin to expire in 2039. We also have state NOLs of approximately $19 million that begin to expire in 2035, and state research tax credits of approximately $12 million that have no expiration date, and foreign research tax credits of approximately $3 million that have no expiration date. Use of the U.S. federal and state NOLs and credit carryforwards may be subject to a substantial annual limitation due to the ownership change provisions of U.S. tax law, as defined in Section 382 and 383 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitation may result in the expiration of NOLs and credits before use. We have determined that an ownership change, as defined under IRC Section 382, occurred in previous years. While we do not expect these ownership changes to result in the expiration of net operating loss and credit carryforwards prior to utilization, we are subject to an annual limitation on the use of its tax attributes. The limitation on the use of net operating loss and credit carryforwards could reduce our ability to use a portion of the tax attributes to offset future taxable income. We have not been audited by the Internal Revenue Service, any state or foreign tax authority. We are subject to taxation in the United States and in Australia. Due to net operating loss and research credit carryforwards, all of our tax years, from 2015 to 2022, remain open to U.S. federal and California state tax examinations. In addition, our fiscal years from 2018 to 2022 are open to examination in Australia. Uncertain Tax Positions We follow the provisions of FASB Accounting Standards Codification (ASC 740-10), Accounting for Uncertainty in Income Taxes. ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of uncertain tax positions that have been taken or are expected to be taken on a tax return. No liability related to uncertain tax positions is recorded in the Consolidated Financial Statements. The reserve for unrecognized tax benefits was approximately $8 million and $5 million at December 31, 2022, and 2021, respectively. Due to the full valuation allowance at December 31, 2022 and 2021, current adjustments to the unrecognized tax benefit will have no impact on our effective income tax rate; any adjustments made after the valuation allowance is released will have an impact on the tax rate. Interest and penalties related to unrecognized tax benefits are included in the provision for income taxes. There were no interest or penalties accrued at December 31, 2022 or 2021. The following table summarizes the activity related to our unrecognized tax benefits (in millions):
As of December 31, 2022, the total amount of gross unrecognized tax benefits was $8 million, of which, if recognized, none would impact our effective tax rate. We do not anticipate material changes to our uncertain tax positions through the next 12 months. |
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Net Income (Loss) per Share |
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| Net Income (Loss) per Share | Note 7. Net income (loss) per share The computation of basic net income (loss) per share is based on the weighted-average number of our common shares outstanding during the period. The computation of diluted net income (loss) per share is based on the weighted-average number of our common shares and dilutive potential common shares, which primarily include shares that may be issued under our stock option, restricted stock award, and ESPP programs (collectively, dilutive securities) as determined under the treasury stock method. The following table sets forth the computation of basic and diluted net income (loss) per share (in millions, except per share data):
The following table summarizes potentially dilutive securities excluded from the computation of diluted net income (loss) per share calculations because they would have been antidilutive (in millions):
We have also excluded the effect of Gilead's right to purchase additional shares of our common stock from the calculation as these rights had no intrinsic value at either December 31, 2022, 2021 or 2020. |
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Stock-Based Compensation |
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| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | Note 8. Stock-based compensation Stock-based compensation expense The following table reflects the components of stock-based compensation expense recognized in our Consolidated Statements of Operations (in millions):
As of December 31, 2022, unrecognized compensation costs related to non-vested stock option awards and RSUs totaled $90 million and $37 million, respectively, and is expected to be recognized over a weighted average period of 2.2 years and 2.4 years, respectively. Stock Plans We grant awards to employees and nonemployees under a series of equity incentive plans (collectively, the Stock Plans). Awards under our Stock Plans are made with newly issued shares reserved for this purpose. 2020 Stock Plan In January 2020, we adopted the 2020 Inducement Plan (2020 Stock Plan). Under this plan, an initial 3.0 million shares of our common stock were authorized by the Board of Directors for the award of stock options and other equity-based awards as an inducement to eligible individuals to enter into employment with us. During the years ended December 31, 2021 and 2020, the Board of Directors authorized an increase of 5.0 million shares and 1.0 million shares, respectively. As of December 31, 2022, there were 3.2 million shares available for grant under this plan. 2018 Stock Plan In March 2018, we adopted the 2018 Equity Incentive Plan (2018 Stock Plan), which replaced the 2015 Stock Plan. Under this plan, an initial 3.6 million shares were reserved together with 0.7 million shares that remained available for issuance at adoption under the 2015 Stock Plan. Any outstanding awards under the 2015 Stock Plan that subsequently expire, lapse unexercised or are forfeited to or repurchased by us are also added to the 2018 Stock Plan. The number of shares reserved for issuance will automatically increase on January 1 of each year by a number equal to or the smaller of (i) 3.6 million shares, (ii) 4% of the shares of common stock outstanding on the last business day of the prior fiscal year, or (iii) an amount as determined by the Board of Directors. As of December 31, 2022, there were 3.6 million shares available for grant under this plan. On January 1, 2023, the number of shares available for issuance under this Plan automatically increased by 2.9 million. 2015 Stock Plan Our amended 2015 Stock Plan, which was in place prior to our public offering in March 2018, allowed option holders to exercise stock options prior to vesting, subject to certain limitations. Any exercised unvested shares were subject to repurchase by us at the original exercise price in the event the option holder’s service with the Company was terminated either voluntarily or involuntarily. Employee Stock Purchase Plan In March 2018, we adopted the 2018 Employee Stock Purchase Plan (2018 ESPP). The 2018 ESPP provides eligible employees with the opportunity to purchase shares of common stock through payroll deductions at a price equal to 85% of the lower of the fair market value per share on the first trading day of the applicable 24-month offering period or on the applicable purchase date. Employees are limited to a maximum purchase limit of 3,000 shares on each purchase date or $25,000 of shares purchased in a calendar year. The 2018 ESPP is intended to constitute an “employee stock purchase plan” under Section 423(b) of the Internal Revenue Code of 1986, as amended. The 2018 ESPP may be terminated by our board of directors at any time. Under this plan, an initial 0.7 million shares were reserved for issuance. The number of shares reserved for issuance will automatically increase on January 1 of each year by a number equal to or the smaller of (i) 1.1 million shares, (ii) 1% of the shares of common stock outstanding on the last business day of the prior fiscal year, or (iii) an amount as determined by the Board of Directors. As of December 31, 2022, there were 2.0 million shares available for purchase under this plan. On January 1, 2023, the number of shares available for purchase under this Plan automatically increased by 0.7 million shares. The number of shares issued under the 2018 ESPP during the years ended December 31, 2022, 2021 and 2020 was 0.3 million, 0.2 million, and 0.2 million, respectively. Restricted Stock Units We grant restricted stock units (RSUs) to our employees and directors under the 2018 Plan. The RSUs vest annually or quarterly over four years for employees and annually for directors. The following table summarizes information regarding our RSUs for the year ended December 31, 2022:
The total grant date fair value of shares vested during the years ended December 31, 2022, 2021 and 2020 was $15 million, $12 million and $0.1 million, respectively. Stock Options The exercise price of stock options is set at the closing price of our common stock on the grant date, and the related number of shares granted is fixed at that point in time. Awards expire 10 years from the date of grant. The following table summarizes information regarding our stock options for the year ended December 31, 2022:
During the years ended December 31, 2022, 2021 and 2020, the intrinsic value of shares exercised was $26 million, $17 million, and $7 million, respectively, and the fair value of shares vested during the same period was $48 million, $40 million, and $17 million, respectively. Valuation Assumptions for Stock Options and ESPP We utilize the Black-Scholes pricing model to estimate the fair value of stock options and shares issued under our ESPP. The following table summarizes the key assumptions used to calculate the fair value and the resulting weighted-average grant date fair value of stock options granted:
Closing price of our common stock on grant date — The exercise price of our stock options is set as the closing price of our common stock on the grant date. Risk-free interest rate — The risk-free rate assumption is based on the U.S. treasury yield in effect at the time of grant for instruments with maturities similar to the expected term of our stock options. Expected term — We have opted to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years). Volatility — Due to our limited operating history and a lack of company specific historical and implied volatility data, our estimate of expected volatility is based on the historical volatility of a group of similar publicly traded companies. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. Dividend yield — We have not issued any dividends in our history and do not expect to issue dividends over the life of the options. |
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Employee Benefit Plan |
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Dec. 31, 2022 | |
| Retirement Benefits [Abstract] | |
| Employee Benefit Plan | Note 9. Employee benefit plan We have a 401(k) defined contribution plan for all our employees which allows tax-deferred salary deductions. The Company matches, at its discretion, employee contributions. For the years ended December 31, 2022 and 2021, we made contributions of $2 million and $1 million to the plan. We made no contributions to the plan for the year ended December 31, 2020. |
Cash, Cash Equivalents and Marketable Securities |
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| Cash, Cash Equivalents and Marketable Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash, Cash Equivalents and Marketable Securities | Note 10. Cash, cash equivalents and marketable securities The following table summarizes amortized cost, gross unrealized gains and losses and the fair value of our cash, cash equivalents and marketable securities, all of which are considered available for sale, by type of securities:
The following table summarizes the fair values of our cash, cash equivalents and marketable securities by location in the Consolidated Balance Sheets and contractual maturity:
Realized gains or losses recognized on the sale of available-for-sale marketable securities were not material for the years ended December 31, 2022, 2021 and 2020. Realized gains and losses are included in Interest and other income, net, in the Consolidated Statements of Operations. The cost of a security sold is determined using the specific-identification method. We limit the credit risk associated with our investments by placing them with banks and institutions it believes are highly credit worthy and investing in highly rated investments. We held a total of 219 and 165 positions in securities which were in unrealized loss positions as of December 31, 2022 and 2021, respectively. We do not intend to sell our securities with unrealized loss positions and have concluded we will not be required to sell the securities before recovery of the amortized cost for the investment at maturity. No credit related losses have been recognized for any of the periods presented. The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the Consolidated Balance Sheets to the total shown in the Consolidated Statements of Cash Flows (in millions):
Restricted cash at December 31, 2022 and 2021 represents cash balances held as security in connection with our facility lease agreements. |
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Property and Equipment |
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| Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and equipment | Note 11. Property and equipment Property and equipment, net was all located in the United States and consisted of the following (in millions):
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Consolidated Balance Sheet Components |
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| Balance Sheet Related Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Consolidated balance sheet components | Note 12. Consolidated balance sheet components Prepaid and Other Current Assets Prepaid and other current assets consisted of the following (in millions):
Other Current Liabilities Other current liabilities consisted of the following (in millions):
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Leases |
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| Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases | Note 13. Leases We lease our corporate headquarters, which includes approximately 151,000 square feet of executive offices, research and development, and business operations, in Hayward, California. This includes approximately 14,500 square feet of leased space that commenced in April 2022, with related tenant improvement allowances totaling approximately $6 million. We also lease approximately 109,000 square feet in Brisbane, California. Both leases: are non-cancelable; extend through 2031; have two options, at our sole discretion, to extend the lease terms for a period of eight years each; and require monthly lease payments that are subject to annual increases throughout the lease term. In October 2022, we entered into an agreement to sublease approximately 31,000 unfinished square feet of our Brisbane office to another company. This sublease includes a tenant improvement allowance to be paid by us of $9 million. Under the terms of the agreement, we will receive sublease income of approximately $3 million per year which will be recognized on a straight-line basis over the lease term. This sublease is non-cancelable, is expected to commence in 2023 and extends through 2028, with the sublessee having options to extend the lease term and/or to lease additional space within the building. At December 31, 2022 and 2021, our lease portfolio had a weighted average remaining term of 9.0 years and 10.0 years, respectively, and a weighted average discount rate of 5.2% and 5.1%, respectively. The following table summarizes information related to our leases, all of which are classified as operating (in millions):
For the years ended December 31, 2022, 2021 and 2020, the Company incurred lease expense of $18 million, $7 million, and $3 million, respectively. Lease costs include rent expense, which consists primarily of our proportionate share of operating expenses, property taxes, and insurance which we have elected to include in lease costs. The following table summarizes our cash and non-cash information related to our operating leases (in millions):
The following table summarizes our future minimum lease payments at December 31, 2022 (in millions):
As of December 31, 2022, we have a tenant allowance receivable of $6 million expected to be received within one year. This amount is included as offset to our lease liability in Other current liabilities on the Consolidated Balance Sheet. As of December 31, 2022, we have provided deposits for letters of credit totaling $3 million to secure our obligations under our leases, which are included in Other noncurrent assets on the Consolidated Balance Sheet. |
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Stockholders' Equity |
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Dec. 31, 2022 | |
| Stockholders' Equity Note [Abstract] | |
| Stockholders' Equity | Note 14. Stockholders’ equity Common Stock We are authorized to issue up to 400.0 million shares of common stock. Public Offering In 2020, under our shelf registration statement that was filed with the SEC in May 2020, we issued 12.7 million shares of our common stock at $27.50 per share in an underwritten public offering. The total number of shares sold consisted of 11.0 million base shares and an additional 1.7 million shares sold pursuant to the underwriters’ option exercise. Proceeds from the public offering were approximately $326 million net of underwriting discounts, commissions and other offering expenses. Gilead Stock Purchase Agreement In 2020, we closed a private offering under the Stock Purchase Agreement pursuant to which Gilead purchased 6.0 million shares of our common stock at a price of $33.54 per share for a total investment of approximately $200 million. Approximately $91 million of Gilead’s investment was determined to be a premium on the fair value of the common stock and was allocated to the revenue related performance obligations under the Gilead Collaboration Agreement. See Note 3, Related party - Gilead Sciences, Inc., and Note 5, Revenues, for further discussion of these agreements with Gilead. Net proceeds allocated to the equity investment were approximately $108 million after deducting the premium and direct offering expenses of $2 million. In February 2021, we closed a second private offering under the Amended Stock Purchase Agreement, pursuant to which Gilead made an equity investment of approximately $220 million in the Company by purchasing 5.7 million shares of our common stock at a price of $39.00 per share. Preferred Stock We have 10.0 million shares of preferred stock issuable in series. There was no preferred stock outstanding as of December 31, 2022 and 2021. |
Fair Value Measurements |
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| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Measurements | Note 15. Fair value measurements We determine 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 include unadjusted quoted prices in active markets for identical assets or liabilities; • Level 2 inputs include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar assets or liabilities 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 asset or liability; and • Level 3 inputs include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Our Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The following tables summarizes the types of assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in millions):
Liability for sale of future royalties In 2021, we entered into an agreement with BVF Partners L.P. (BVF), under which BVF will fund the discovery and development of compounds for the treatment of inflammatory diseases (the Program) for $15 million in non-refundable payments paid in 2021 and 2022. In return, we are obligated to perform research and development activities in the Program, to make contingent payments upon the achievement of certain clinical and regulatory milestones of up to $73 million or $160 million depending on whether the program is solely developed by us or with Gilead if they opt-in pursuant to the Gilead Collaboration Agreement. We will also pay mid- to high-single digit royalties on any net product sales generated by the Program. We account for the BVF Agreement as a liability primarily because we have significant continuing involvement in generating the cash flows due to BVF. The liability is recorded at fair value by using probability-adjusted discounted cash flows, and we revalue this liability each reporting period until the related contingencies have been resolved. The fair value measurement of this liability is based on significant unobservable inputs reviewed quarterly by management. The inputs include, as applicable, estimated probabilities and the timing of achieving specified development, regulatory and commercial milestones as well as estimated annual sales. Significant changes that increase or decrease the probabilities of achieving the related development, regulatory and commercial events or that shorten or lengthen the time required to achieve such events or that increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of the obligations, as applicable. Changes in the fair value of this liability related to interest accretion are recognized in Non-operating income (expense) in the Consolidated Statements of Operations. The imputed effective interest rate on the unamortized portion of the liability was approximately 20.6% as of December 31, 2022. The liability for sale of future royalties is reported in Other noncurrent liabilities in the Consolidated Balance Sheets and changes were as follows (in millions):
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Commitments |
12 Months Ended |
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Dec. 31, 2022 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments | Note 16. Commitments Standby Letters of Credit We have standby letters of credit up to an aggregate of $3 million provided as collateral for our leases. The letters of credit are secured by $3 million in deposits classified as restricted cash and included in Other noncurrent assets on the Consolidated Balance Sheet. At December 31, 2022 the standby letters of credit were not drawn down. Purchase Commitments We have contractual arrangements with CROs and suppliers. These contracts are generally cancelable on 30 days’ notice and the obligations under these contracts arise as the services are performed. Indemnification As permitted under Delaware law and in accordance with our bylaws, we are required to indemnify our officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. We are also party to indemnification agreements with our directors and officers. We believe the fair value of the indemnification rights and agreements is minimal and accordingly, we have not recorded any liabilities as of December 31, 2022 and 2021. |
Summary of Significant Accounting Policies (Policies) |
12 Months Ended |
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Dec. 31, 2022 | |
| Accounting Policies [Abstract] | |
| Basis of Presentation | Basis of Presentation The Consolidated Financial Statements, which include the accounts of Arcus as well as its wholly owned subsidiary, have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. All intercompany transactions and balances have been eliminated in consolidation. We assess whether we are the primary beneficiary of a variable interest entity (“VIE”) at the inception of the arrangement and at each reporting date. This assessment is based on our power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE. We do not have any significant interests in any variable interest entities of which we are the primary beneficiary. |
| Use of Estimates | Use of Estimates The preparation of the Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Actual results may differ materially from those estimates. |
| Collaborative Arrangements | Collaborative Arrangements We assess whether our licensing and other agreements are collaborative arrangements based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. For arrangements that we determine are collaborations, we identify each distinct performance obligation, and then determine whether a customer relationship exists for that distinct performance obligation. If we determine a performance obligation within the collaborative arrangement to be with a customer, we apply our revenue accounting policy. If a portion of a distinct bundle of goods or services within the collaborative arrangement is not with a customer, we apply recognition and measurement based on an analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. |
| Revenues | Revenues We recognize revenue when a customer obtains control of promised goods or services in a contract for an amount that reflects the consideration we expect to receive in exchange for those goods or services. For contracts with customers, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. As part of the accounting for contracts with customers, we develop assumptions that require judgment to determine the standalone selling price of We currently do not have product sales and our revenues are derived from arrangements for the development of our investigational products. Such arrangements may require us to deliver various rights, services and/or goods, including intellectual property rights/licenses, R&D services, manufacturing services and/or commercialization services. The underlying terms of these arrangements may generally include consideration to Arcus in the form of one or more of the following: (i) nonrefundable, up-front license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; (iii) royalties on net sales of licensed products; (iv) fees attributable to options to intellectual property; and (v) profit sharing. In arrangements involving more than one performance obligation, each performance obligation is evaluated to determine whether it qualifies as distinct based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects our best estimate of what the selling price would be if the deliverable was regularly sold by us on a stand-alone basis or by using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods is transferred or services are performed. We evaluate each performance obligation to determine if it can be satisfied at a point in time or over time as services are performed. For performance obligations that are determined to be satisfied over time we determine an appropriate method of measuring progress for purposes of recognizing revenue. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. For arrangements that include sales-based royalties, including milestone payments based on sales thresholds, and for which the license is deemed to be the predominant item to which the royalties relate, we recognize 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). To date, we have not recognized any royalty revenue resulting from any of our arrangements. The accounting for these arrangements requires us to develop estimates and assumptions that require judgment. These estimates may include items such as forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. Actual results may differ materially from those estimates. See Note 5, Revenues, for more information. |
| Research and Development Expenses | Research and Development Expenses Research and development (“R&D”) costs are expensed as incurred and primarily include: salaries, benefits and other staff-related costs; facilities and overhead costs; third-party service provider costs for preclinical and clinical studies; laboratory supplies and equipment maintenance costs; consulting; payments under collaborative and other arrangements including milestone payments, licenses and fees; expense reimbursements to collaboration partners; and other related expenses. Under certain collaborative arrangements, we are reimbursed for a portion of the research and development expenses, including costs of drug supplies. When these R&D expenses are incurred under a reimbursement or cost sharing model with a collaboration partner, we record the related reimbursements as a reduction of R&D expense in our Consolidated Statements of Operations. Acquired in-process research and development projects with no alternative future use are recorded in R&D expense upon acquisition. Net payment or reimbursement of R&D costs is recognized when the obligations are incurred or as we become entitled to the cost recovery. See Note 4, License and collaboration agreements, for more information. Clinical study costs are a significant component of R&D expenses. Our clinical studies are primarily performed by third-party contract research organizations (“CROs”). We monitor levels of performance under each significant contract including the extent of patient enrollment and other activities and accrue costs for clinical studies performed over the service periods specified in the contract. We adjust our estimates, if required, based upon our ongoing review of the level of effort and costs actually incurred by the CROs. All of our material CRO contracts are terminable by us upon written notice, and we are generally only liable for actual services completed by the CRO and certain noncancelable expenses incurred at termination. |
| General and Administrative Expenses | General and Administrative Expenses General and administrative (“G&A”) expenses relate to: finance; human resources; legal and other administrative activities which consist primarily of personnel costs; facilities and overhead costs; legal expenses; and other general and administrative costs. G&A expenses also include cost recoveries associated with collaborative R&D arrangements. |
| Stock-Based Compensation | Stock-Based Compensation We provide share-based compensation in the form of various types of equity-based awards, including restricted stock units (“RSU”s) and stock options. The fair values of RSU’s and stock options, which are subject to service conditions and vesting, are recognized as compensation expense on a straight-line basis over the service period net of forfeitures as they occur. See Note 8, Stock-based compensation, for more information. |
| Income Taxes | Income Taxes We provide for income taxes under the asset and liability method. Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards, measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when we determine it is more likely than not that some or all of the tax benefits will not be realized. We recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by tax authorities. We assess all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and we will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. We include any penalties and interest expense related to income taxes as a component of other expense and interest income, net, as necessary. See Note 6, Income taxes, for more information. |
| Cash Equivalents | Cash Equivalents Cash equivalents consist of marketable securities having an original maturity of three months or less at the time of purchase. |
| Marketable Securities | Marketable securities We consider our interest-bearing securities investment portfolio as available-for-sale, and accordingly, these investments are recorded at fair value, with unrealized gains and losses recorded in Accumulated Other Comprehensive Income (AOCI). See Note 10, Cash, cash equivalents and marketable securities, and Note 15, Fair value measurements, for more information. |
| Property and Equipment | Property and Equipment Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets, ranging from to ten years. Leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease term. We review property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. See Note 11, Property and equipment, for more information. |
| Leases | Leases We determine whether an arrangement is or contains a lease at contract inception. Operating lease right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of the lease payments over the lease term, which is the non-cancelable period stated in the contract adjusted for any options to extend or terminate when it is reasonably certain that we will exercise that option. Right-of-use assets are adjusted for prepaid lease payments, lease incentives and initial direct costs incurred. Operating lease expense for the minimum lease payments is recognized on a straight-line basis over the lease term. When our operating leases do not provide an implicit interest rate, we generally utilize our incremental borrowing rate, based on the information available at the commencement date to determine the lease liability. We do not recognize the right-of-use assets and liabilities for leases with lease terms of one year or less with payments recognized as operating expenses on a straight-line basis over the lease term. See Note 13, Leases, for more information. |
| Fair Value of Financial Instruments | Fair Value of Financial Instruments We apply fair value accounting for all financial and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. We define fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities which are required to be recorded at fair value, we consider the principal or most advantageous market in which we would transact and the market-based risk measurements or assumptions that market participants would use in pricing the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risks. See Note 15, Fair value measurements, for more information. |
| Other Significant Accounting Policies | Other Significant Accounting Policies Our other significant accounting policies are described in the remaining appropriate notes to the Consolidated Financial Statements. |
| Recent Accounting Pronouncements | Recent Accounting Pronouncements There have been no new accounting pronouncements issued or adopted during the year ended December 31, 2022 with a significant impact to our financial statements. |
Revenues (Tables) |
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| Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Revenues by Collaboration, Category of Revenue and Method of Recognition | The following table summarizes our revenues by collaboration, category of revenue, and the method of recognition (in millions):
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| Summary of Revenue Recognized as a Result of Changes in Deferred Revenue | The following table summarizes the revenue recognized as a result of changes in the deferred revenue balance (in millions):
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| Summary of Transaction Price and Allocation of Transaction Price to the Performance Obligations | The following table summarizes the transaction price and the allocation of the transaction price to the performance obligations (in millions):
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Income Taxes (Tables) |
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| Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Loss Before Provision for Income Taxes | Income (loss) before income taxes included the following (in millions):
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| Schedule of Components of Provision for Income Taxes | The provision for income taxes included the following (in millions):
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| Schedule of Effective Tax Rate of Provision for Income Taxes Differs from Federal Statutory Rate | The reconciliation between the federal statutory income tax rate and our effective tax rate was as follows:
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| Schedule of Significant Components of Deferred Tax Assets for Federal and State Income Taxes | Significant components of our deferred tax assets and liabilities were as follows (in millions):
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| Summary of Activity Related to Unrecognized Tax Benefits | The following table summarizes the activity related to our unrecognized tax benefits (in millions):
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Net Income (Loss) per Share (Tables) |
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| Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Computation of Basic and Diluted Net Income (Loss) Per Share | The following table sets forth the computation of basic and diluted net income (loss) per share (in millions, except per share data):
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| Summary of Outstanding Potentially Dilutive Securities Excluded from Computation of Diluted Net Income (Loss) per Share | The following table summarizes potentially dilutive securities excluded from the computation of diluted net income (loss) per share calculations because they would have been antidilutive (in millions):
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Stock-Based Compensation (Tables) |
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Dec. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Stock-Based Compensation Expense | The following table reflects the components of stock-based compensation expense recognized in our Consolidated Statements of Operations (in millions):
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| Summary of Restricted Stock Units Activity | We grant restricted stock units (RSUs) to our employees and directors under the 2018 Plan. The RSUs vest annually or quarterly over four years for employees and annually for directors. The following table summarizes information regarding our RSUs for the year ended December 31, 2022:
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| Summary of Information Regarding Stock Options | The following table summarizes information regarding our stock options for the year ended December 31, 2022:
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| Schedule of Assumptions Used to Calculate Fair Value and the Weighted-Average Grant Date Fair Value of Stock Options Granted | The following table summarizes the key assumptions used to calculate the fair value and the resulting weighted-average grant date fair value of stock options granted:
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Cash, Cash Equivalents and Marketable Securities (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash, Cash Equivalents and Marketable Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Amortized Cost, Gross Unrealized Gains and Losses and Fair Value of Our Cash, Cash Equivalents and Marketable Securities Considered as Available for Sale by Type of Securities | The following table summarizes amortized cost, gross unrealized gains and losses and the fair value of our cash, cash equivalents and marketable securities, all of which are considered available for sale, by type of securities:
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| Schedule of Fair Values of Our Cash, Cash Equivalents and Marketable Securities by Location in Consolidated Balance Sheets and Contractual Maturity | The following table summarizes the fair values of our cash, cash equivalents and marketable securities by location in the Consolidated Balance Sheets and contractual maturity:
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| Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the Consolidated Balance Sheets to the total shown in the Consolidated Statements of Cash Flows (in millions):
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Property and Equipment (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Property and Equipment, Net | Property and equipment, net was all located in the United States and consisted of the following (in millions):
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Consolidated Balance Sheet Components (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance Sheet Related Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Prepaid and Other Current Assets | Prepaid and Other Current Assets Prepaid and other current assets consisted of the following (in millions):
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| Summary of Other Current Liabilities | Other current liabilities consisted of the following (in millions):
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Leases (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Information Related to Operating Leases | The following table summarizes information related to our leases, all of which are classified as operating (in millions):
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| Summary of Cash and Non-cash Information Related to Operating Leases | The following table summarizes our cash and non-cash information related to our operating leases (in millions):
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| Summary of Future Minimum Lease Payments | The following table summarizes our future minimum lease payments at December 31, 2022 (in millions):
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Fair Value Measurements (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables summarizes the types of assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in millions):
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| Summary of Changes of Liabilities for Sale of Future Royalties | The liability for sale of future royalties is reported in Other noncurrent liabilities in the Consolidated Balance Sheets and changes were as follows (in millions):
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Organization, Liquidity and Capital Resources - Additional Information (Details) $ in Millions |
12 Months Ended |
|---|---|
|
Dec. 31, 2022
USD ($)
Segment
| |
| Organization [Line Items] | |
| Number of reportable segments | 1 |
| Number of operating segments | 1 |
| Cash, Cash Equivalents and Investments in Marketable Securities | |
| Organization [Line Items] | |
| Cash and investments | $ | $ 1,140 |
Summary of Significant Accounting Policies - Additional Information (Details) |
12 Months Ended |
|---|---|
Dec. 31, 2022 | |
| Minimum | |
| Significant Accounting Policies [Line Items] | |
| Property and equipment, estimated useful lives | 3 years |
| Maximum | |
| Significant Accounting Policies [Line Items] | |
| Property and equipment, estimated useful lives | 10 years |
License and Collaborations - Schedule of Payments Allocated to Performance Obligations (Details) - USD ($) $ in Millions |
Dec. 12, 2021 |
Dec. 21, 2021 |
|---|---|---|
| Allocation of transaction price | ||
| Deferred revenues as of 12/21/2021 | $ 165 | |
| Option payment for Domvanalimab | $ 275 | |
| Option payment for Etrumadenant | 250 | |
| Option payment for Quemliclustat | 200 | |
| Total transaction price allocated to performance obligations | 890 | |
| Allocation to performance obligations | ||
| Domvanalimab license | 329 | |
| Total allocated transaction price | $ 890 |
Revenues - Summary of Revenues by Collaboration, Category of Revenue and Method of Recognition (Details) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | $ 112 | $ 383 | $ 78 |
| Gilead Collaboration License to Domvanalimab | |||
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | 329 | ||
| Gilead Collaboration, License to Zimberelimab | |||
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | 55 | ||
| Gilead Collaboration, License and R&D services | |||
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | 74 | 1 | |
| Gilead Collaboration, Access Rights | |||
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | 33 | 31 | 16 |
| Taiho Collaboration, License to Domvanalimab | |||
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | 15 | ||
| Taiho Collaboration, Access Rights | |||
| License And Collaboration Agreements [Line Items] | |||
| Total revenues | $ 5 | $ 7 | $ 7 |
Revenues - Summary of Revenue Recognized as a Result of Changes in Deferred Revenue (Details) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| License And Collaboration Agreements [Abstract] | |||
| Amounts included in deferred revenue at the beginning of the period | $ 112 | $ 202 | $ 7 |
Revenue - Summary of Transaction Price and Allocation of Transaction Price to the Performance Obligations (Details) - USD ($) $ in Millions |
Dec. 12, 2021 |
Dec. 21, 2021 |
|---|---|---|
| Allocation Of Transaction Price [Abstract] | ||
| Deferred revenues as of 12/21/2021 | $ 165 | |
| Option payment for Domvanalimab | $ 275 | |
| Option payment for Etrumadenant | 250 | |
| Option payment for Quemliclustat | 200 | |
| Total transaction price | 890 | |
| Revenue, Performance Obligation [Abstract] | ||
| Domvanalimab license | 329 | |
| Domvanalimab - R&D services | 34 | |
| Etrumadenant - License and R&D services | 219 | |
| Quemliclustat - License and R&D services | 176 | |
| Zimberelimab - R&D and commercial services | 11 | |
| Access rights | 84 | |
| Option continuation periods | 37 | |
| Total allocated transaction price | $ 890 |
Income Taxes - Schedule of Loss Before Provision for Income Taxes (Details) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Income Tax Disclosure [Abstract] | |||
| Domestic | $ (267) | $ 54 | $ (123) |
| Foreign | 1 | 1 | |
| Income (loss) before income taxes | $ (266) | $ 55 | $ (123) |
Income Taxes - Schedule of Components of Provision for Income Taxes (Details) - USD ($) $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| Current | ||
| Federal | $ 1 | |
| State | $ 1 | 1 |
| Total income tax expense | $ 1 | $ 2 |
Income Taxes - Schedule of Effective Tax Rate of Provision for Income Taxes Differs from Federal Statutory Rate (Details) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Income Tax Disclosure [Abstract] | |||
| Federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
| State taxes, net of federal benefit | (0.10%) | 0.80% | |
| Equity investment | 0.90% | (4.10%) | 4.20% |
| Research and development credits | 3.10% | (11.90%) | 3.10% |
| Change in valuation allowance | (24.50%) | (2.60%) | (27.40%) |
| Stock based compensation | 0.10% | (0.80%) | (0.20%) |
| Non-deductible expenses and other | (0.60%) | 0.90% | (0.70%) |
| Provision for income taxes | (0.10%) | 3.30% | 0.00% |
Income Taxes - Schedule of Significant Components of Deferred Tax Assets for Federal and State Income Taxes (Details) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Deferred tax assets: | ||
| Federal and state net operating loss carryforwards | $ 24 | $ 24 |
| Research and development credits carryforwards | 22 | 13 |
| Stock-based compensation | 16 | 10 |
| Depreciation and amortization | 6 | 6 |
| Deferred revenue | 19 | 24 |
| Lease liability | 25 | 25 |
| Capitalized research and development costs | 53 | |
| Other | 7 | 4 |
| Total deferred tax assets | 172 | 106 |
| Deferred tax liabilities: | ||
| Right-of-use assets | (22) | (23) |
| Total deferred tax liabilities | (22) | (23) |
| Less valuation allowance | $ (150) | $ (83) |
Income Taxes - Summary of Activity Related to Unrecognized Tax Benefits (Details) - USD ($) $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
| Beginning balance | $ 5 | $ 3 |
| Additions for tax positions taken in current year | 3 | 2 |
| Ending balance | $ 8 | $ 5 |
Net Income (Loss) per Share - Computation of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Net income (loss) (Numerator): | |||
| Net income (loss) | $ (267) | $ 53 | $ (123) |
| Weighted-average shares (Denominator): | |||
| Outstanding | 72.0 | 70.3 | 56.4 |
| Less: Subject to vesting | (1.0) | (1.6) | |
| Weighted-average shares for basic EPS | 72.0 | 69.3 | 54.8 |
| Effect of dilutive securities | 4.7 | ||
| Weighted-average shares for diluted EPS | 72.0 | 74.0 | 54.8 |
| Net income (loss) per share | |||
| Basic | $ (3.71) | $ 0.76 | $ (2.24) |
| Diluted | $ (3.71) | $ 0.71 | $ (2.24) |
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
| Total stock-based compensation | $ 65 | $ 55 | $ 22 |
| Research and Development | |||
| Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
| Total stock-based compensation | 33 | 29 | 11 |
| General and Administrative | |||
| Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
| Total stock-based compensation | $ 32 | $ 26 | $ 11 |
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - 2018 Equity Incentive Plan - Restricted Stock Units |
12 Months Ended |
|---|---|
|
Dec. 31, 2022
$ / shares
shares
| |
| Total Restricted Stock Units | |
| Nonvested at December 31, 2021 | shares | 1,100,000 |
| RSUs granted | shares | 900,000 |
| RSUs vested | shares | (500,000) |
| RSUs forfeited or canceled | shares | (200,000) |
| Nonvested at December 31, 2022 | shares | 1,300,000 |
| Weighted Average Grant Date Fair Value | |
| Nonvested at December 31, 2021 | $ / shares | $ 32.23 |
| RSUs granted | $ / shares | 30.22 |
| RSUs vested | $ / shares | 32.27 |
| RSUs forfeited or canceled | $ / shares | 30.65 |
| Nonvested at December 31, 2022 | $ / shares | $ 31.09 |
Employee Benefit Plan - Additional Information (Details) - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Retirement Benefits [Abstract] | |||
| Defined contribution plan, cost | $ 2,000,000 | $ 1,000,000 | $ 0 |
Cash, Cash Equivalents and Marketable Securities - Schedule of Fair Values of Our Cash, Cash Equivalents and Marketable Securities by Location in Consolidated Balance Sheets and Contractual Maturity (Details) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Fair Value Disclosures [Abstract] | ||
| Cash and cash equivalents | $ 206 | $ 148 |
| Marketable securities | 803 | 351 |
| Long-term marketable securities | 129 | 182 |
| Total | $ 1,138 | $ 681 |
Cash, Cash Equivalents and Marketable Securities - Additional Information (Details) |
12 Months Ended | ||
|---|---|---|---|
|
Dec. 31, 2022
USD ($)
Positions
|
Dec. 31, 2021
USD ($)
Positions
|
Dec. 31, 2020
USD ($)
|
|
| Cash, Cash Equivalents and Marketable Securities [Abstract] | |||
| Number of positions in securities in unrealized loss | Positions | 219 | 165 | |
| Credit related losses | $ | $ 0 | $ 0 | $ 0 |
Cash, Cash Equivalents and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
Dec. 31, 2019 |
|---|---|---|---|---|
| Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract] | ||||
| Cash and cash equivalents | $ 206 | $ 148 | ||
| Restricted cash (included in Other noncurrent assets) | $ 3 | $ 3 | ||
| Restricted Cash, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Assets, Noncurrent | Other Assets, Noncurrent | ||
| Cash, cash equivalents and restricted cash | $ 209 | $ 151 | $ 174 | $ 58 |
Consolidated Balance Sheet Components - Summary of Prepaid and Other Current Assets (Details) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Prepaid Expense and Other Assets, Current [Abstract] | ||
| Prepaids and other assets | $ 15 | $ 16 |
| Accrued interest receivable | 4 | 2 |
| Total prepaid and other current assets | $ 19 | $ 18 |
Consolidated Balance Sheet Components - Summary of Other Current Liabilities (Details) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Accrued Liabilities, Current [Abstract] | ||
| Accrued research and development | $ 45 | $ 30 |
| Accrued personnel expenses | 25 | 17 |
| Income taxes payable | 2 | |
| Other | 6 | 5 |
| Total other current liabilities | $ 76 | $ 54 |
Leases - Summary of Information Related to Operating Leases (Details) - USD ($) $ in Millions |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Assets: | ||
| Right-of-use assets | $ 100 | $ 105 |
| Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other Assets, Noncurrent | Other Assets, Noncurrent |
| Prepaid expenses and other current assets - net tenant receivable | $ 3 | |
| Liabilities: | ||
| Net current operating lease liabilities | $ 3 | |
| Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Current | Other Liabilities, Current |
| Other noncurrent liabilities | $ 117 | $ 117 |
| Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Leases - Summary of Cash and Non-cash Information Related to Operating Leases (Details) - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
|
| Leases [Abstract] | |||
| Cash paid for amounts included in measurement of lease liabilities | $ 11 | $ 5 | $ 2 |
| Cash received from tenant improvement allowances | 8 | 3 | |
| Right-of-use assets obtained in exchange for new operating lease liabilities | 3 | 95 | 8 |
| Recognition of tenant improvement allowance receivable included in Other current liabilities | $ 6 | $ 11 | $ 1 |
Leases - Summary of Future Minimum Lease Payments (Details) $ in Millions |
Dec. 31, 2022
USD ($)
|
|---|---|
| Leases [Abstract] | |
| 2023 | $ 15 |
| 2024 | 16 |
| 2025 | 16 |
| 2026 | 17 |
| 2027 | 18 |
| Thereafter | 77 |
| Total undiscounted future minimum lease payments | 159 |
| Less: Imputed interest | (33) |
| Total present value of lease liabilities | $ 126 |
Liability for Sale of Future Royalties - Additional Information (Details) - BVF Partners L.P. - BVF Agreement - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
| Imputed effective rate of interest on unamortized portion of liability | 20.60% | |
| Maximum | ||
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
| Contingent payments upon achievement of certain clinical and regulatory milestones | $ 73,000,000 |
Fair Value Measurements - Additional Information (Details) - BVF Partners L.P. - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| BVF Agreement | ||
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
| Non-refundable payments received | $ 15,000,000 | $ 15,000,000 |
| Imputed effective rate of interest on unamortized portion of liability | 20.60% | |
| BVF Agreement | Maximum | ||
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
| Contingent payments upon achievement of certain clinical and regulatory milestones | 73,000,000 | |
| Gilead Collaboration Agreement | Maximum | ||
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
| Contingent payments upon achievement of certain clinical and regulatory milestones | $ 160,000,000 | |
Fair Value Measurements - Summary of Changes of Liabilities for Sale of Future Royalties (Details) - BVF Partners L.P. - BVF Agreement - USD ($) $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
| Beginning balance | $ 5 | |
| Cash received | 10 | $ 5 |
| Interest accretion | 2 | |
| Ending balance | $ 17 | $ 5 |
Commitments - Additional Information (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| Loss Contingencies [Line Items] | ||
| Purchase commitments cancellation notice period | 30 days | |
| Liabilities for Indemnification rights and agreements | $ 0 | $ 0 |
| Restricted cash | 3,000,000 | $ 3,000,000 |
| Standby Letters of Credit [Member] | ||
| Loss Contingencies [Line Items] | ||
| Line of credit | 3,000,000 | |
| Restricted cash | $ 3,000,000 |