SEC Company Response from AGENUS INC (AGEN) (CIK 0001098972) (AGEN) — Dec 14, 2017
AGENUS INC (AGEN) (CIK 0001098972)
Date: Dec. 14, 2017 · CIK: 0001098972 · Accession: 0001193125-17-369763
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File numbers found in text: 000-29089
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CORRESP 1 filename1.htm CORRESP ROPES & GRAY LLP PRUDENTIAL TOWER 800 BOYLSTON STREET BOSTON, MA 02199-3600 WWW.ROPESGRAY.COM December 14, 2017 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Angela Connell Ibolya Ignat Re: Agenus Inc. Form 10-K for the Fiscal Year Ended December 31, 2016 Filed March 16, 2017 Form 10-Q for the Quarterly Period Ended September 30, 2017 Filed November 7, 2017 File No. 000-29089 Ladies and Gentlemen: On behalf of Agenus Inc. (“Agenus” or the “Company”), we submit via EDGAR this letter in response to the written comments of the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission, dated November 30, 2017 (the “Comment Letter”), with regard to the Company’s Form 10-K for the fiscal year ended December 31, 2016 (filed March 16, 2017), and Form 10-Q for the quarterly period ended September 30, 2017 (filed November 7, 2017), File No. 000-29089. For the convenience of the Staff’s review, we have set forth the comment contained in the Comment Letter in italics followed by the response of the Company. Form 10-Q for the Quarterly Period Ended September 30, 2017 Notes to Unaudited Condensed Consolidated Financial Statements Note H - Collaboration Agreement, page 10 1. Please provide us a full accounting analysis with reference to authoritative literature of your February 14, 2017 transactions with Incyte Corporation. Include the following in your analysis. Securities and Exchange Commission Division of Corporation Finance December 14, 2017 • With respect to the amendment to your January 9, 2015 License, Development and Commercialization Agreement, explain the basis for your accounting treatment of the $20 million in accelerated milestone payments as revenue during the nine months ended September 30, 2017. In this regard, discuss your consideration of whether the amendment should be evaluated with the remaining performance obligations from the original agreement as one arrangement. • With respect to the Stock Purchase Agreement also entered into on February 14, 2017, tell us what consideration was given to the fact that the agreements were entered into contemporaneously and how you accounted for the amount received over the fair value of the shares issued. Response: SUMMARY OF ACCOUNTING CONCLUSIONS • The License, Development and Commercialization Agreement, dated January 9, 2015, by and among Company, Agenus Switzerland Inc. (as successor to 4-Antibody AG), Incyte Corporation (“Incyte”) and Incyte Europe Sarl (the “Collaboration Agreement”) was considered a collaboration arrangement and the First Amendment to the License, Development and Commercialization Agreement, dated February 14, 2017, by and among (the “Amendment”) was considered a modification and not a new arrangement. • The Company recognized $20.0 million as revenue in Q1’17 related to milestones for the GITR and OX-40 projects. Prior to the Amendment, all work required by Agenus had been performed on these projects and there were no further performance obligations related to them. The milestone payment was considered imminent without the Amendment, however the Amendment caused the amount to be paid earlier than originally contemplated. • The Stock Purchase Agreement, dated February 14, 2017, between the Company and Incyte (the “SPA”) was separate from the Amendment and (1) the consideration received for the purchase of shares under the SPA was determined to be fair value in accordance with ASC 820 Fair Value Measurements, and (2) the transaction was recorded to equity at the fair value of the consideration exchanged. Please see below for a detailed analysis of the accounting considerations of the Amendment and the SPA, as well as a summary of key points from the Collaboration Agreement, which we have included to provide background on the Amendment accounting conclusions. 2 Securities and Exchange Commission Division of Corporation Finance December 14, 2017 ORIGINAL AGREEMENT The following sections relate to the Collaboration Agreement and are included to provide general background information on the Collaboration Agreement and associated accounting. Summary of Original Agreement On January 9, 2015, Agenus entered into the Collaboration Agreement with Incyte, effective February 19, 2015, pursuant to which Agenus granted Incyte an exclusive royalty bearing, non-transferable license or sublicense, as applicable, under Agenus intellectual property to develop, manufacture and commercialize four antibody products (targeting GITR, OX-40, TIM-3 and LAG-3) (each, a “Licensed Antibody”) worldwide in hematology and oncology. Incyte granted to Agenus a non-exclusive, royalty-free, non-transferable license or sublicense, as applicable, under Incyte intellectual property solely to the extent necessary to permit Agenus to exercise rights to perform their obligations under the Collaboration Agreement and a non-exclusive, fully paid-up sublicensable license or sublicense, as applicable, to develop, manufacture and commercialize the Licensed Antibodies worldwide outside of hematology and oncology. In accordance with the terms and conditions of the Collaboration Agreement, in November 2015, Agenus and Incyte added three undisclosed checkpoint modulator (“CPM”) targets into the collaboration. Scoping & Related Party Considerations At the time the Company entered into the Collaboration Agreement, management determined the arrangement met the US GAAP definition of a collaboration arrangement under ASC 808 as both parties were (a) active participants and (b) exposed to the significant risks and rewards dependent on the commercial success of the activity. Under the Collaboration Agreement, both parties have the right to participate in a Joint Steering Committee (“JSC”) which directs the activities to be carried out through the antibody programs. ASC 808-10-45-3 and 45-4 state that the income classification of payments between parties in a collaboration agreement shall be in accordance with other authoritative accounting literature to the extent the income classification applies based on analogy to such other accounting literature. Based on the nature of the research and development activities to be performed under the Collaboration Agreement, management considered the application of ASC 730-20 Research and Development Arrangements. ASC 730-20-25-3 states that if an entity is obligated to repay any of the funds provided regardless of the outcome of the research and development, the entity shall recognize a liability. The guidance states that repayment may be in the form of cash, securities, or other means. ASC 730-20-25-4 states that an entity may conclude that a liability does not exist when the transfer of the financial risk involved with the research and development from the entity to the other party is substantive and genuine. Management has determined that the Company is not obligated to re-pay any of the funds received under the Collaboration Agreement regardless of the outcome of the research and development. 3 Securities and Exchange Commission Division of Corporation Finance December 14, 2017 Management also considered ASC 730-20-S99 and ASC 730-20-25-6 regarding significant related party relationships. It evaluated whether Incyte’s position as a related party of the Company creates an obligation of the Company to repay the upfront payments and concluded there is no liability for the amounts received because (1) the performance obligations under the arrangement that trigger payment are similar to other non-related party relationships, (2) the Collaboration Agreement that provides an obligation for us to pay Incyte for development is also consistent with market development agreements, (3) there is no future obligation to pay Incyte royalties, and (4) there is no linkage between product development and additional equity or option purchase. We therefore concluded that the conditions to overcome the presumption that there is an obligation to repay the funds received under the Collaboration Agreement were met. Accounting for the Agreement under ASC 605 Units of Account The following chart summarizes the units of account identified based on ASC 605-25 separation criteria: Unit of Account Description 1 Perpetual license of IP to GITR antibodies and products and the related services to research and develop these licenses with the intent to manufacture and commercialize 2 Perpetual license of IP to OX-40 antibodies and products and the related services to research and develop these licenses with the intent to manufacture and commercialize 3 Perpetual license of IP to TIM-3 antibodies and products and the related services to research and develop these licenses with the intent to manufacture and commercialize 4 Perpetual license of IP to LAG-3 antibodies and products and the related services to research and develop these licenses with the intent to manufacture and commercialize 5 Access to Discovery Projects (as defined in the Collaboration Agreement) during the Discovery Period (as defined in the Collaboration Agreement). Participation in the JSC was not determined to be a unit of account as participation is optional and non-participation would not be considered a breach of contract or result in a penalty. We believe this is consistent with the accounting literature with consideration of the SEC Staff comments on Joint Steering Committees at the 2007 AICPA National Conference on Current SEC and PCAOB Developments. 4 Securities and Exchange Commission Division of Corporation Finance December 14, 2017 Management reviewed the guidance of ASC 605-25-25-1 Multiple Element Arrangements, which indicates an entity must determine whether the components of an agreement represent an individual unit of accounting and, if so, the fair value of the respective units must be determined. The total consideration is then, based on the relative fair value of each unit of accounting, allocated to the respective unit. As all payments in the Collaboration Agreement are non-refundable and there are no rights of return on any good or service, the separation criterion in ASC 605-25-25-5(b) is met for all units of account. Allocation of Consideration The allocation guidance of ASC 605-25-25-1 and 25-2 state that the total arrangement consideration, which is comprised of the fixed and determinable fees, is to be allocated based on the relative selling price method. The consideration under the Collaboration Agreement was comprised of $25 million in fixed upfront payments and contingent payments based on research and development services to be delivered and various milestones, and sales-based royalties. 5 Securities and Exchange Commission Division of Corporation Finance December 14, 2017 The Company determined that due to the unique and proprietary nature of each deliverable, neither vendor-specific objective evidence, nor third party evidence of selling price exists for the deliverables. As a result, the best estimate of selling price was used to perform the allocation under the relative selling price method. The fixed and determinable consideration is comprised of the upfront payments that have been allocated to the deliverables identified above as follows: Unit of Account Deliverables Total Fixed and Determinable Consideration Additional consideration 1 GITR antibody program and associated R&D $ 4,000,000 R&D Services, Reimbursements and potential future milestones 2 OX-40 antibody program and associated R&D $ 3,000,000 R&D Services, Reimbursements and potential future milestones 3 LAG-3 antibody program and associated R&D $ 1,500,000 R&D Services, Reimbursements and potential future milestones 4 TIM-3 antibody program and associated R&D $ 1,500,000 R&D Services, Reimbursements and potential future milestones 5 Discovery Project Access $ 15,000,000 Total $ 25,000,000 Consistent with ASC 605-25-30-5, the allocation of consideration is limited to amounts that are not contingent. Recognition Units of Account 1-4: Antibody Programs (GITR, OX-40, LAG-3, and TIM-3) The upfront consideration allocated to each of the respective antibody programs was deferred and recognized over the estimated period of service delivered by the Company, as the Company is required to perform pre-clinical R&D services for each Licensed Antibody until an investigational new drug application (an “IND”) is filed. Subsequent to the IND filing date, Incyte is responsible for all clinical research and development and commercialization activities. The Company is responsible for all manufacturing activities. R&D Services For all Licensed Antibody programs, the Company provides Incyte with full time equivalent (“FTE”) research and development personnel, at a rate of $275,000 per FTE per year. The consideration related to R&D services is recognized in the month the service is performed as revenue (not as a reduction of costs). R&D Services Reimbursements For all Licensed Antibody programs, the Company is reimbursed by Incyte for certain costs incurred during the performance of research and development activities. 6 Securities and Exchange Commission Division of Corporation Finance December 14, 2017 Under the Collaboration Agreement, some of the programs were designated as profit-share programs and others were designated as royalty-bearing programs. Profit Share Programs Prior to the Amendment, for certain Licensed Antibody programs, Agenus and Incyte split the profit and loss as earned, on a 50/50 basis, related to the R&D, manufacturing and commercialization of the related product. The amount of consideration is based on the profit or loss in a particular period. Agenus recognized profit share payments as revenue/expense in the period in which the services were provided as that was the time at which the fee became fixed and determinable. Royalty-bearing Programs On all other programs, Agenus is compensated for 100% of its R&D services and will earn royalties on sales of the related product. The amount of the royalty is based on the agreed upon tiered royalty schedule in the Collaboration Agreement. Agenus recognizes consideration related to royalty-bearing programs as revenue in the period in which the services are provided as that is the time at which the fee becomes fixed and determinable. Sales-based royalties will be recognized as revenue at the time the sale of the related product is communicated to Agenus as that is the time at which the fee becomes fixed and determinable. Milestone Payments For all Licensed Antibody programs, the Collaboration Agreement includes various milestones contingent on the initiation/completion of clinical trials, receipt of regulatory approvals, and certain sales thresholds. These milestones were evaluated and (1) determined to meet the criteria to be substantive milestones and (2) the fee paid at each milestone represented the relative selling price. Accordingly, the Company has elected the milestone method in ASC 605-28. As a result, milestones are recognized as revenue in their entirety in the period in which achieved. Unit of Account 5: Discovery Project Access Incyte has access to certain additional targets (“Discovery Projects”) during the Discovery Period, a period of approximately five years, commencing upon the effective date of the agreement (February 19, 2015) and terminating on December 31, 2019. At the mutual agreement of the parties, the Discovery Period can be extended for an additional three years with no additional consideration given. Despite the uncertainty associated with the option to extend, given the three-year extension is at no additional consideration to Incyte, management included the presumed extension in