License and Collaboration Agreements | Note 7. License and Collaboration Agreements The following table summarizes the revenues for the three and nine months ended September 30, 2021 and 2020 received as a result of the Company’s collaboration agreements with Gilead Sciences, Inc. (Gilead) and Taiho Pharmaceutical Co., Ltd. (Taiho): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 License revenue $ - $ 55,096 $ - $ 55,096 Collaboration revenue 9,461 9,434 28,383 12,934 Total revenues $ 9,461 $ 64,530 $ 28,383 $ 68,030 The following table summarizes details of revenues for the three and nine months ended September 30, 2021 and 2020 by collaboration and by category of revenue: Three Months Ended September 30, Nine Months Ended September 30, Revenues recognized: Over time Point in time 2021 2020 2021 2020 Gilead license to zimberelimab * $ - $ 55,096 $ - $ 55,096 Gilead access rights related to the * 7,711 7,684 23,133 7,684 Taiho collaboration agreement * 1,750 1,750 5,250 5,250 Total revenues $ 9,461 $ 64,530 $ 28,383 $ 68,030 The Company recognized the following revenue as a result of changes in the deferred revenue balance during the period below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Revenue recognized in the period from: 2021 2020 2021 2020 Amounts included in deferred revenue at the beginning of the period $ 9,461 $ 1,750 $ 28,383 $ 5,250 Performance obligations satisfied in previous period - - - - Gilead Sciences, Inc. On May 27, 2020, the Company entered into an Option, License and Collaboration Agreement (Gilead Collaboration Agreement), Common Stock Purchase Agreement (the Stock Purchase Agreement), and Investor Rights Agreement, (collectively, the Gilead Agreements), each with Gilead Sciences, Inc. (Gilead). The transaction closed on July 13, 2020 following expiration of the antitrust waiting period. Upon closing, Gilead made an upfront payment of $ 175 million pursuant to the Gilead Collaboration Agreement, and made an equity investment of approximately $ 200 million in the Company by purchasing 5,963,029 shares of Arcus common stock at a per share price of $ 33.54 pursuant to the Stock Purchase Agreement. Pursuant to the Investor Rights Agreement, the Company appointed two Gilead designees to the Company’s Board of Directors. See Note 12 for further discussion of the agreements with Gilead. Pursuant to the terms of the Gilead Collaboration Agreement, Gilead has an exclusive license to develop and commercialize zimberelimab in certain markets and obtained exclusive options to acquire an exclusive license to develop and commercialize all of the Company’s current and future clinical programs during the 10-year collaboration term, contingent upon Gilead’s access rights payments of up to $ 400 million and, for those programs that enter clinical development prior to the end of the collaboration term, for up to an additional three years thereafter. Gilead's option, on a program-by-program basis, will expire after a proscribed period, following the achievement of a development milestone in such program and the Company's delivery to Gilead of the requisite data package. If Gilead exercises its option in a timely manner, after obtaining any applicable anti-trust approvals, Gilead shall pay the Company an option fee that ranges from $ 200 million to $ 275 million per program for the Company’s clinical programs in existence at the date of the agreement, and $ 150 million per program for all other programs that enter clinical development thereafter should Gilead elect to exercise its options. Gilead may exercise its option to any program at any time prior to expiration of the option. The Company may incur consulting fees to a third party if Gilead exercises its option to certain programs on or before December 31, 2022, ranging from $ 2.0 million to $ 4.5 million for those programs. Upon closing of Gilead’s exercise of its option to a program, the two companies will co-develop and equally share global development costs for the joint development program, subject to certain opt-out rights of the Company, and expense caps on the Company’s spending and related subsequent adjustments. For each optioned program, provided the Company has not exercised its opt-out rights, the Company has an option to co-promote in the United States with equal sharing of related profits and losses. Gilead has the right to exclusively commercialize any optioned programs outside of the U.S., subject to the rights of the Company’s existing partners to any territories, and Gilead will pay to the Company tiered royalties as a percentage of revenues ranging from the high teens to the low twenties. Pursuant to the Stock Purchase Agreement and the Investor Rights Agreement, Gilead has the right, at its option, to purchase additional shares from the Company, up to a maximum of 35 % of the Company’s then-outstanding voting common stock, from time to time over a five-year period from closing of the initial transaction, at a purchase price equal to the greater of a 20 % premium to market (based on a trailing five-day average closing price) at the time Gilead exercises such option, and the $ 33.54 initial purchase price. Based on the value of the Company’s common stock at the contract closing, the right to purchase additional shares had no value. In January 2021, the Company and Gilead entered into an Amended and Restated Common Stock Purchase Agreement, which amended and restated in its entirety the Common Stock Purchase Agreement, pursuant to which Gilead purchased 5,650,000 shares of the Company’s common stock at a purchase price of $ 39.00 per share for total gross proceeds of $ 220.4 million. All other terms of the original Stock Purchase Agreement remain unchanged. The Investor Rights Agreement also includes a three-year standstill and a two-year lockup and provides Gilead with registration rights commencing at the end of the lockup period, pro rata participation rights in certain future financings and the right to designate two individuals to be appointed to the Company’s Board of Directors. The Company’s assessment of the transaction price included an analysis of amounts it expected to receive, which at contract inception consisted of the upfront cash payment of $ 175.0 million due upon contract closing in July 2020, the $ 100.0 million payment related to the research and development access rights due in 2022, and the $ 90.6 million premium resulting from Gilead’s purchase of common stock. All payments to date have been made by Gilead as they became due and payable. Given this successful collection history, the Company considers the entire $ 365.6 million outlined above to be the initial transaction price. The Company evaluated the Gilead Agreements under ASC 606 and determined that the performance obligations at the contract inception consisted of the following: Zimberelimab license Effective on closing, Gilead obtained an exclusive license to zimberelimab. The standalone selling price of this license was determined using a discounted cash flow method. The Company recognized the full revenues associated with this performance obligation on the date the transaction closed. Etrumadenant option Gilead has the right to exercise an option for exclusive rights to etrumadenant, the Company’s adenosine receptor program, in exchange for an option payment of $ 250.0 million, that expires after a proscribed period following the Company’s achievement of certain development milestones. The Company calculated the standalone selling price of this program using a discounted cash flow method and concluded that it exceeded the price of the option, creating a material right and a distinct performance obligation. If the option is exercised, the performance obligations associated with the option will be identified and the Company will determine the accounting for the option’s transaction price. If the exercise occurs on or before December 31, 2022, the Company will also incur $ 4.5 million in consulting fees to a third party. If the option is allowed to lapse, the Company will recognize any deferred revenue allocated to the option at the time of the lapse. At September 30, 2021, the Company had $ 127.0 million of deferred revenue on its condensed consolidated balance sheets related to this performance obligation. The Company has evaluated the program’s status as of the balance sheet date and believes that some or all of the revenue associated with the opt-in will be recognized within the minimum four-year term of the Gilead Collaboration Agreement. Domvanalimab option Gilead has the right to exercise an option for exclusive rights to domvanalimab, the Company’s anti-TIGIT monoclonal antibody, in exchange for an option payment of $ 275.0 million, that expires after a proscribed period following the Company’s achievement of certain development milestones. In addition to the option payment, the Company has the right to receive clinical and regulatory milestones totaling up to $ 500 million. The Company calculated the standalone selling price of this program using a discounted cash flow method and concluded that it exceeded the price of the option, creating a material right and a distinct performance obligation. If the option is exercised, the performance obligations associated with the option will be identified and the Company will determine the accounting for the option’s transaction price. If the exercise occurs on or before December 31, 2022, the Company will also incur $ 4.5 million in consulting fees to a third party. If the option is allowed to lapse, the Company will recognize any deferred revenue allocated to the option at the time of the lapse. At September 30, 2021, the Company had $ 36.7 million of deferred revenue on its condensed consolidated balance sheets related to this performance obligation. The Company has evaluated the program’s status and believes that revenue associated with the opt-in will be recognized within one year . As of September 30, 2021, Gilead's option rights remained outstanding and no clinical or regulatory milestones had been achieved under this agreement. Access rights related to the Company’s research and development pipeline Gilead receives exclusive access to the Company’s current programs as well as the future programs for a period of ten years , contingent upon Gilead’s payment of $ 400 million, with the first payment of $ 100 million in 2022 , and an additional $ 100 million payment due at Gilead’s option on each of the fourth, sixth, and eighth anniversaries of the agreement. The standalone selling price of this ongoing research and development pipeline access was determined using an expected cost-plus margin approach. The Company evaluated its rights and obligations in the Gilead Collaboration Agreement and determined that Gilead is contractually obligated to make the $ 100 million payment due in 2022 resulting in a minimum term of four years for this performance obligation. As a result, the amount was included in the transaction price. The Company uses a time-elapsed input method to measure progress toward satisfying this obligation, which is the method the Company believes most faithfully depicts the Company’s performance in transferring the promised services during the time period in which Gilead has access to the Company’s research and development pipeline. Accordingly, the revenue allocated to the performance obligation is being recognized using this input method over the minimum four-year period. The Company further determined that Gilead is not obligated to pay the remaining $ 300 million due over the remainder of the term. Failure to pay the non-obligatory payments will result in Gilead’s loss of certain rights to access and obtain licenses to the programs arising from the Company’s research and development pipeline. At September 30, 2021, the Company had $ 98.6 million of deferred revenue on its consolidated balance sheets related to this performance obligation, classified between current and noncurrent based on the amortization of the revenue. Development and commercialization services for zimberelimab monotherapy In conjunction with the license, the Company determined there existed a separate obligation to perform further development and commercialization services for Gilead related to zimberelimab monotherapy. The standalone selling price of this obligation was determined using an expected cost-plus margin approach. This obligation includes a 50/50 share of the costs associated with all future development and commercialization of zimberelimab as a monotherapy. The portion of the transaction price allocated to this performance obligation has been allocated in accordance with the total costs forecast for the development and commercialization of zimberelimab as a monotherapy. The Company will recognize the amounts allocated to these services as the performance obligation is satisfied. Any additional payments received from or payments made to Gilead for the 50/50 cost share will be recognized as a reduction or an increase to R&D expense, respectively. At September 30, 2021, the Company had $ 9.7 million of contract liabilities on its consolidated balance sheets related to this performance obligation. The Company has evaluated the program’s status and believes that revenue associated with these services will be recognized over the full term of the contract. As of September 30, 2021, no revenue had been recognized from this performance obligation. Gilead was also granted option rights to programs not yet in development. These programs were not determined to be performance obligations at contract inception, as there are no identified programs, revenues, or costs to compare against the option price. Prepaid expenses The Company incurred $ 7.3 million in expenses to obtain the contract, which consisted of consultant and legal fees that were directly connected to the successful completion of the Gilead Agreements. The Company determined that $ 1.9 million of these expenses were related to the Stock Purchase Agreement and recorded them as offering costs. The Company allocated the remaining expenses between the various performance obligations, to be recognized when the underlying revenue is recognized. The portion allocated to the delivery of zimberelimab was recognized immediately, and the portion allocated to the remaining performance obligations will be recognized with timing consistent with the associated performance obligation. During the three and nine months ended September 30, 2021, the Company recognize d $ 0.1 million and $ 0.3 million, respectively, in expense from the amortization of these assets. At September 30, 2021, the Company had $ 3.9 million in prepaid expenses from costs to obtain the Gilead Agreements, of which $ 1.0 million was recorded in prepaid expenses and other current assets and $ 2.9 million was recorded in other long-term assets. Taiho Pharmaceutical Co., Ltd In September 2017, the Company and Taiho entered into an option and license agreement (the Taiho Agreement) to collaborate on the potential development and commercialization of certain investigational products from the Company’s portfolio in Japan and certain other territories in Asia (excluding China) (the Taiho Territory). The Taiho Agreement provides Taiho with exclusive options, over a five-year period ending September 2022 (the Option Period), to obtain an exclusive development and commercialization license to clinical stage investigational products from the Company’s programs (each, an Arcus Program). In consideration for the exclusive options and other rights contained in the Taiho Agreement, Taiho agreed to make non-refundable, non-creditable cash payments to the Company totaling $ 35.0 million, of which the Company received $ 25.0 million during 2017. An additional $ 5.0 million was received in 2018 and the remaining $ 5.0 million was received in 2019. For each option that Taiho elects to exercise, it will be obligated to make an option exercise payment of between $ 3.0 million to $ 15.0 million, depending on the development stage of the applicable Arcus Program for which the option is exercised. In addition, the Taiho Agreement provides that the Company is eligible to receive additional clinical and regulatory milestones totaling up to $ 130.0 million per Arcus Program, and it will be eligible to receive contingent payments of up to $ 145.0 million per Arcus Program associated with the achievement of specified levels of Taiho net sales in the Taiho Territory. In addition, the Company will receive royalties ranging from high single-digits to mid-teens on net sales of licensed products in the Taiho Territory. Royalties will be payable on a licensed product-by-licensed product and country-by-country basis during the period of time commencing on the first commercial sale of a licensed product in a country and ending upon the later of: (a) ten (10) years from the date of first commercial sale of such licensed product in such country; and (b) expiration of the last-to-expire valid claim of the Company’s patents covering the manufacture, use or sale or exploitation of such licensed product in such country (the Royalty Term). The Company determined that the identified performance obligations, which include the combined performance obligation of the research and development services and the obligation to participate on the joint steering committee, are satisfied over time. The Company uses a time-elapsed input method to measure progress toward satisfying its performance obligation, which is the method the Company believes most faithfully depicts the Company’s performance in transferring the promised services during the time period in which Taiho has access to the Company’s research and development activities. Accordingly, the transaction price of $ 35.0 million is being recognized using this input method over the estimated performance period of five years . Based on the nature of the clinical and regulatory milestones, such as the regulatory approvals which are not within the Company’s control, the Company will not consider achievement of such milestones to be probable until the uncertainty associated with the milestones has been resolved. When it is probable that a significant reversal of revenue will not occur, the milestone payment will be added to the transaction price, which will then be allocated to each performance obligation, on a relative standalone selling price basis, for which the Company recognizes revenue. As of September 30, 202 1, no clinical or regulatory milestones had been achieved under the Taiho Agreement. The Company also considers the contingent payments due from Taiho upon the achievement of specified sales volumes to be similar to royalty payments. The Company considers the license to be the predominant item to which the royalties relate. The Company will 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). As of September 30, 2021, no sales milestone or royalty revenue has been recognized. The Taiho Agreement shall remain in effect until expiry of all Royalty Terms for the licensed products, in each case subject to certain exceptions. WuXi Biologics License Agreements The Company entered into a license agreement (the WuXi PD-1 Agreement) with WuXi Biologics in August 2017, as subsequently amended, in which it obtained an exclusive license to develop, use, manufacture, and commercialize products including an anti-PD-1 antibody worldwide except for Greater China. From the inception of the WuXi PD-1 Agreement through September 30, 2021, the Company has made upfront and milestone payments of $ 41.0 million and incurred sub-license fees of $ 11.3 million. These payments were recorded as research and development expense, as the products had not reached technological feasibility and did not have an alternative future use. The WuXi PD-1 Agreement also provides for clinical and regulatory milestone payments, commercialization milestone payments of up to $ 375.0 million, and tiered royalty payments to be made to WuXi Biologics that range from the high single-digits to low teens of net sales by the Company of licensed products. The Company incurred zero and $ 10.0 m illion, respectively, in development milestone expense under the WuXi PD-1 Agreement during the three and nine months ended September 30, 2021. In December 2020, the Company entered into a separate license agreement (the WuXi CD-39 Agreement) with WuXi Biologics to develop anti-CD39 antibodies. Under the agreement, the Company was granted exclusive worldwide rights to anti-CD39 antibodies discovered under the collaboration and will be responsible for the further development and commercialization of those antibodies. From the inception of the WuXi CD-39 Agreement through September 30, 2021, the Company has paid $ 0.5 million in upfront payments which was recorded in research and development expense, as the products are still in research stage. The WuXi CD-39 Agreement provides for clinical and regulatory milestone payments totaling $ 16.5 million, and royalty payments in the low single digits of net sales by the Company of licensed products. The Company incurred no development milestone expense under the WuXi CD-39 Agreement during the three and nine months ended September 30, 2021. Abmuno License Agreement In December 2016, the Company entered into a license agreement (the Abmuno Agreement) with Abmuno Therapeutics LLC (Abmuno) in which it obtained a worldwide exclusive license to develop, use, manufacture, and commercialize products that include an anti-TIGIT antibody, including domvanalimab (formerly referred to as AB154). Under the Abmuno Agreement, the Company has made upfront and milestone payments totaling $ 14.6 m illion as of September 30, 2021. The Abmuno Agreement also provides for additional clinical, regulatory and commercialization milestone remaining payments of up to $ 93.0 million as of September 30, 2021. The Company incurred zero and $ 5.0 million in development milestone expense under the Abmuno Agreement during the three and nine months ended September 30, 2021. The Company incurr ed $ 3.0 million in development milestone expense under the Abmuno Agreement during the three and nine months ended September 30, 2020. Strata Collaboration Agreement On April 30, 2019, the Company and Strata Oncology, Inc. (Strata) entered into a Co-Development and Collaboration Agreement (the Strata Agreement) to pursue a clinical development collaboration utilizing Strata’s precision drug development platform and proprietary biomarkers to evaluate zimberelimab, the Company’s clinical-stage anti-PD-1 antibody, in patients in a tumor-agnostic fashion. Under the terms of the Strata Agreement, the parties share a portion of development costs for the clinical collaboration. From the inception of the Agreement through September 30, 2021, the Company has made a milestone payment of $ 2.5 million and has incurred expenses of $ 4.5 million, of which $ 0.9 million had b een reimbursed by Strata as development cost sharing. Net expenses related to this co-development agreement were recorded within research and development expenses. As further consideration in connection with the Strata Agreement, the Company issued to Strata 1,257,651 restricted shares of its common stock in April 2019 with an initial measured fair value of $ 15.0 million, which were subject to vesting based upon the achievement of specified regulatory milestones within certain timelines. In September 2021, the Company and Strata agreed to cancel the full amount of the restricted shares upon final determination that the biomarker indications were unlikely to be successful given the evolution of the competitive landscape. For the three and nine months ended September 30, 2021, the Company incurred expenses p ursuant to the Strata Agreement of $ 0.7 million and $ 1.8 million, respectively. Of these expenses, $ 0.1 million and $ 0.3 mi llion, respectively, were reimbursed by Strata. For the three and nine months ended September 30, 2020, the Company incurred expenses pursuant to the Strata Agreement of $ 0.3 million and $ 1.2 million, respectively. Of these expenses, $ 0.1 and $ 0.2 million, respectively, were reimbursed by Strata. AstraZeneca Agreement On October 29, 2020 the Company announced a collaboration with AstraZeneca to evaluate domvanalimab, the Company’s investigational anti-TIGIT antibody, in combination with AstraZeneca’s Imfinzi (durvalumab) in a registrational Phase 3 clinical trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC). Under the terms of the agreement, 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 its respective anti-cancer agent to support the trial. Under the terms of the agreement and subject to the parties’ approval of a final budget for the clinical trial, the Company may be obligated to reimburse AstraZeneca for a portion of the costs incurred. Consistent with the terms of the Gilead Collaboration Agreement, Gilead maintains an option to co-develop and co-commercialize domvanalimab. If Gilead exercises its option to domvanalimab, the trial from this AstraZeneca collaboration is expected to form part of the Arcus and Gilead joint development program and Arcus’s portion of the trial costs would be shared with Gilead. For the three and nine months ended September 30, 2021, the Company incurred $ 0.3 million and $ 0.6 million, respectively, of expenses pursuant to the AstraZeneca Agreement. Expenses from this co-development agreement are recorded within research and development expenses. Genentech Collaboration Agreement In December 2019, the Company and Genentech, through F. Hoffmann-La Roche Ltd (collectively, Genentech) entered into a Master Clinical Collaboration Agreement (the Genentech Agreement) pursuant to which the parties may conduct combination clinical studies involving Genentech’s monoclonal antibody, atezolizumab, and the Company’s investigational products. Pursuant to the Genentech Agreement, the parties entered into Trial Supplements for the evaluation of etrumadenant and atezolizumab utilizing the MORPHEUS platform in two separate study indications: second and third line metastatic colorectal cancer and first line metastatic pancreatic cancer. The Company and Genentech each supply their respective investigational products for use in the collaboration studies and share a portion of the development costs under specific terms as set forth in the agreement. For each of the three and nine months ended September 30, 2021 and 2020, the Company recorded immaterial n et expenses related to this co-development agreement within research and development expenses. |