Revenue from Contracts with Customers | Note J - Revenue from Contracts with Customers Gilead Collaboration Agreement On December 20, 2018, we entered into a series of agreements with Gilead Sciences, Inc. (“Gilead”) focused on the development and commercialization of up to five novel immuno-oncology therapies. Pursuant to the terms of the license agreement, the option and license agreements and the stock purchase agreement we entered into with Gilead (each defined below and, collectively, the “Gilead Collaboration Agreements”), at the closing of the transaction on January 23, 2019 (the “Effective Date”), we received an upfront cash payment from Gilead of $120.0 million and Gilead made a $30.0 million equity investment in Agenus. We are also eligible to receive up to $1.7 billion in aggregate potential milestones. License Agreement Pursuant to the terms of a license agreement between the parties (the “License Agreement”), we granted Gilead an exclusive, worldwide license under certain of our intellectual property rights to develop, manufacture and commercialize our preclinical bispecific antibody, AGEN1423 (now GS-1423), in all fields of use. Pursuant to the License Agreement, Gilead is responsible for all of the development, manufacturing and commercialization costs for any products that Gilead may develop under the License Agreement. In addition, Gilead also received the right of first negotiation for two of our undisclosed antibody programs. The License Agreement will continue until all of Gilead’s applicable payment obligations under the License Agreement have been performed or have expired, or the agreement is earlier terminated. Under the terms of the License Agreement, each party has the right to terminate the agreement for material breach by, or insolvency of, the other party. Gilead may also terminate the License Agreement in its entirety, or on a product-by-product or country-by-country basis, for convenience upon ninety (90) days’ notice. Pursuant to the terms of the License Agreement, we are eligible to receive potential development and commercial milestones of up to $552.5 million in the aggregate, as well as tiered royalty payments on aggregate net sales ranging from the high single digit to mid-teen percent, subject to certain reductions under certain circumstances as described in the License Agreement. We filed an investigational new drug (“IND”) application for AGEN1423 (now GS-1423) in February 2019, and the IND was accepted by the FDA in March 2019. Option and License Agreements Pursuant to the terms of two separate option and license agreements between the parties (each, an “Option and License Agreement” and together, the “Option and License Agreements”), we granted Gilead exclusive options to license exclusively (“License Option”) our bispecific antibody, AGEN1223, and our monospecific antibody, AGEN2373 (together, the “Option Programs”), during the respective Option Periods (defined below). Pursuant to the terms of the Option and License Agreements, we agreed to grant Gilead an exclusive, worldwide license under our intellectual property rights to develop, manufacture and commercialize AGEN1223 or AGEN2373, as applicable, in all fields of use upon Gilead’s exercise of the applicable License Option. Gilead is entitled to exercise its License Option for either or both Option Programs at any time up until ninety (90) days following Gilead’s receipt of a data package with respect to the first complete Phase 1b clinical trial for each Option Program (the “Option Period”). During the Option Period, we are responsible for the costs and expenses related to the development of the Option Programs. After Gilead’s exercise of a License Option, if at all, Gilead would be responsible for all development, manufacturing and commercialization activities relating to the relevant Option Program at Gilead’s cost and expense. During the Option Period, we are eligible to receive milestones of up to $30.0 million in the aggregate. If Gilead exercises a License Option, it would be required to pay an upfront license exercise fee of $50.0 million for each License Option that is exercised. Following any exercise of a License Option, we would be eligible to receive additional development and commercial milestones of up to $520.0 million in the aggregate for each such Option Program, as well as tiered royalty payments on aggregate net sales. For either, but not both, of the Option Programs, we will have the right to opt-in to share Gilead’s development and commercialization costs in the United States for such Option Program in exchange for a profit (loss) share on a 50:50 basis and revised milestone payments. If we opt-in under one Option and License Agreement, our right to opt-in under the other Option and License Agreement automatically terminates. Unless earlier terminated, each Option and License Agreement will continue until the earlier of (i) the expiration of the Option Period, without Gilead’s exercise of the License Option; and (ii) the date all of Gilead’s applicable payment obligations under the Option and License Agreement have been performed or have expired. Under the terms of each Option and License Agreement, we and Gilead each have the right to terminate the agreement for material breach by, or insolvency of, the other party. Gilead may also terminate an Option License Agreement in its entirety, or on a product-by-product or country-by-country basis for convenience upon ninety (90) days’ notice. Stock Purchase Agreement Pursuant to the terms of a stock purchase agreement between the parties (the “Stock Purchase Agreement”), Gilead purchased 11,111,111 shares of Agenus common stock (the “Shares”) for an aggregate purchase price of $30.0 million, or $2.70 per share. Gilead owned approximately 8.5% of the outstanding shares of Agenus common stock after such purchase. Under the Stock Purchase Agreement, Gilead has agreed (i) not to dispose of any of the Shares for a period of 12 months, (ii) to certain standstill provisions that generally preclude it from acquiring more than 15% of Agenus’ outstanding voting stock after taking into account the purchase of the Shares and (iii) to vote the Shares in accordance with the recommendations of the Agenus board of directors in connection with certain equity incentive plan or compensation matters for a period of 12 months. We have agreed to register the Shares for resale under the Securities Act of 1933. Collaboration Revenue We identified the following performance obligations under the Gilead Collaboration Agreements: (1) the license that we granted to Gilead pursuant to the License Agreement (the “AGEN1423 License”), (2) our obligation to complete manufacturing and know-how tech transfer activities to Gilead pursuant to the License Agreement to enable Gilead or its third party contract manufacturing organization to manufacture the licensed antibody (the “AGEN1423 Technology Transfer”), (3) our obligation to advance development of AGEN1223 to the option exercise point pursuant to the AGEN1223 Option and License Agreement (such development activities, the “AGEN1223 R&D Services”), and (4) our obligation to advance development of AGEN2373 to the option exercise point pursuant to the AGEN2373 Option and License Agreement (such development activities, the “AGEN2373 R&D Services”). We determined that the AGEN1423 License was both capable of being distinct and distinct within the context of the contract given both the advanced stage of development and that the IND was anticipated to be accepted within a short period of time after the Effective Date. Gilead can begin deriving benefit from the license prior to the AGEN1423 Technology Transfer being completed. The technology transfer plan includes an extensive list of items to be transferred over time and is separate from the transfer of the AGEN1423 License which occurred at contract inception. As a result, we concluded that the AGEN1423 License and AGEN1423 Technology Transfer are separate performance obligations. We considered whether the AGEN1223 R&D Services and AGEN2373 R&D Services were distinct from one another and from the performance obligations related to AGEN1423. We determined that the research and development services related to each antibody were both capable of being distinct and distinct within the context of the contract given that each program is governed by a separate option agreement with a separate development plan. The services performed to develop each program are independent of one another, and the antibodies are in different stages of development. We concluded that the AGEN1223 R&D Services and AGEN2373 R&D Services are separate performance obligations. We determined that there were no significant financing components, noncash consideration, or amounts that may be refunded to the customer, and as such the total upfront fixed consideration of license and research and development fees totaling $120.0 million would be included in the total transaction price. In addition to the fixed consideration, the variable consideration milestones related to IND acceptance for each of the three antibodies was also included in the transaction price. We determined that based on the likelihood of the triggering event occurring for the acceptance of each IND filling, the most likely amount for each of the three milestones was the stated value, totaling $22.5 million. The variable consideration related to each performance obligation will be allocated entirely to that specific performance obligation. The remaining fixed consideration will be allocated using the relative standalone selling price method. We determined the estimated standalone selling price of the AGEN1423 License by applying a risk adjusted, net present value, estimate of future cash flow approach. We determined the estimated standalone selling price of the AGEN1423 Technology Transfer, and AGEN1223 R&D Services and AGEN2373 R&D Services by using the estimated costs of satisfying these performance obligations, plus an appropriate margin for such services. Revenue attributable to the AGEN1423 License was recognized at a point-in-time, upon delivery of the license to Gilead at the Effective Date. The AGEN1423 Technology Transfer, AGEN1223 R&D Services and AGEN2373 R&D Services are satisfied over time and revenue attributable to these performance obligations will be recognized as the related services are being performed using the input of costs incurred over total costs expected to be incurred. We believe this is the best measure of progress because other measures do not reflect how we transfer our performance obligations to Gilead. A cost-based input method of revenue recognition requires management to make estimates of costs to complete our performance obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete our performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods. For the three months ended June 30, 2019, we recognized $3.8 million of license and collaboration revenue related to the Gilead Collaboration Agreement. This amount included $3.8 million of the transaction price recognized based on the partial satisfaction of the over time performance obligations as of quarter end. For the six months ended June 30, 2019, we recognized $74.1 million of license and collaboration revenue related to the Gilead Collaboration Agreement. This amount included $8.6 million of the transaction price recognized based on the partial satisfaction of the over time performance obligations as of period end. We expect to recognize deferred research and development revenue of $13.2 million, $34.4 million, and $20.8 million for the remainder of 2019, 2020, and 2021, respectively, related to performance obligations that are unsatisfied or partially unsatisfied as of June 30, 2019. Incyte Collaboration Agreement For the three months ended June 30, 2019, we recognized approximately $0.6 million of research and development revenue. This amount included $0.1 million of the transaction price for the collaboration agreement (“Incyte Collaboration Agreement”) we entered into with Incyte Corporation (“Incyte”) recognized based on the partial satisfaction of the over time performance obligations as of quarter end and $0.5 million for research and development services. For the three months ended June 30, 2018, we recognized approximately $6.5 million of research and development revenue. This amount included $0.3 million of the transaction price for the Incyte Collaboration Agreement recognized based on the partial satisfaction of the over time performance obligations as of quarter end, $5.0 million for the achievement of a milestone For the six months ended June 30, 2019, we recognized approximately $1.2 million of research and development revenue. This amount included $0.3 million of the transaction price for the Incyte Collaboration Agreement recognized based on the partial satisfaction of the over time performance obligations as of period end and $0.9 million for research and development services. For the six months ended June 30, 2018, we recognized approximately $8.1 million of research and development revenue. This amount included $0.8 million of the transaction price for the Incyte Collaboration Agreement recognized based on proportional performance, $5.0 million for the achievement of a milestone and $2.3 million for research and development services. We expect to recognize deferred research and development revenue of $0.6 million and $1.2 million for the remainder of 2019 and 2020, respectively, related to performance obligations that are unsatisfied or partially unsatisfied as of June 30, 2019. These amounts exclude amounts (milestones, research and development services and royalties) where we have a right to invoice the customer in the amount that corresponds directly with the value of the performance completed to date. Disaggregation of Revenue The following tables present revenue (in thousands) for the three and six months ended June 30, 2019 and June 30, 2018, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations. Three months ended June 30, 2019 United States Europe Total Revenue Type Research and development services $ 486 $ — $ 486 Recognition of deferred revenue 3,913 — 3,913 Recognition of deferred grant revenue 231 55 286 Manufacturing services 1,767 — 1,767 Non-cash royalty revenue 9,263 — 9,263 $ 15,660 $ 55 $ 15,715 Three months ended June 30, 2018 Revenue Type Research and development services $ 1,144 $ — $ 1,144 License and collaboration milestones 5,000 4,000 9,000 Recognition of deferred revenue 329 — 329 Non-cash royalty revenue 5,422 — 5,422 $ 11,895 $ 4,000 $ 15,895 Six months ended June 30, 2019 United States Europe Total Revenue Type Research and development services $ 901 $ — $ 901 License fee revenue 65,500 — 65,500 Recognition of deferred revenue 8,870 — 8,870 Recognition of deferred grant revenue 646 55 701 Manufacturing services 1,767 — 1,767 Non-cash royalty revenue 17,869 — 17,869 $ 95,553 $ 55 $ 95,608 Six months ended June 30, 2018 Revenue Type Research and development services $ 2,307 $ — $ 2,307 License and collaboration milestones $ 5,000 $ 4,000 9,000 Recognition of deferred revenue $ 802 $ — 802 Non-cash royalty revenue 5,422 — 5,422 $ 13,531 $ 4,000 $ 17,531 Contract Balances Contract assets primarily relate to our rights to consideration for work completed in relation to our research and development services performed but not billed at the reporting date. The contract assets are transferred to receivables when the rights become unconditional. We had no asset impairment charges related to contract assets in the period. The contract liabilities primarily relate to contracts where we received payments but have not yet satisfied the related performance obligations. The advance consideration received from customers for research and development services or licenses bundled with other promises is a contract liability until the underlying performance obligations are transferred to the customer. The following table provides information about contract assets and contract liabilities from contracts with customers (in thousands): Six months ended June 30, 2019 Balance at beginning of period Additions Deductions Balance at end of period Contract assets: Unbilled receivables from collaboration partners $ - $ - $ - $ - Contract liabilities: Deferred revenue $ 2,052 $ 62,000 $ (8,870 ) $ 55,182 The change in contract liabilities is primarily related to the addition of $62.0 million of deferred revenue from the Gilead Collaboration Agreement, offset by the recognition of $8.6 million of revenue related to this same agreement and $0.3 million of revenue related to the Incyte Collaboration Agreement during the six months ended June 30, 2019. Deferred revenue related to the Gilead Collaboration Agreement of $53.4 million ($68.4 million net of a $15.0 million contract asset) as of June 30, 2019, which was comprised of the $142.5 million initial transaction price, less $74.1 million of license and collaboration revenue recognized from the effective date of the contract, will be recognized as the combined performance obligation is satisfied. Deferred revenue related to our Incyte Collaboration Agreement of $1.8 million as of June 30, 2019, which was comprised of the $25.0 million upfront payment, less $23.2 million of license and collaboration revenue recognized from the effective date of the contract, will be recognized as the performance obligation is satisfied. We also recorded a $2.2 million receivable as of June 30, 2019 for research and development and manufacturing services provided. During the six months ended June 30, 2019, we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods. None of the costs to obtain or fulfill a contract were capitalized. |