Collaborations and Other Arrangements | 7. Collaborations and Other Arrangements To accelerate the development and commercialization of CRISPR/Cas9-based products in multiple therapeutic areas, the Company has formed, and intends to seek other opportunities to form, strategic alliances with collaborators who can augment its leadership in CRISPR/Cas9 therapeutic development. As of March 31, 2023, the Company’s accounts receivable were related to its collaborations with Regeneron Pharmaceuticals, Inc. (“Regeneron”), AvenCell Therapeutics, Inc. (“AvenCell”), SparingVision SAS (“SparingVision”) and ONK Therapeutics, Ltd. (“ONK”), and the Company’s contract liabilities were related to its collaborations with Regeneron, AvenCell and SparingVision. As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron, AvenCell, SparingVision and ONK and the Company’s contract liabilities were related to its collaborations with Regeneron, AvenCell, SparingVision and Kyverna Therapeutics, Inc. (“Kyverna”). The following table presents changes in the Company’s accounts receivable and contract liabilities during the three months ended March 31, 2023 and 2022 (in thousands): Balance at Additions Deductions Balance at End Three Months Ended March 31, 2023 Accounts receivable $ 3,768 $ 4,488 $ ( 3,350 ) $ 4,906 Contract liabilities - deferred revenue $ 63,771 $ - $ ( 14,566 ) $ 49,205 Balance at Additions Deductions Balance at End Three Months Ended March 31, 2022 Accounts receivable $ 2,031 $ 1,801 $ ( 2,031 ) $ 1,801 Contract liabilities - deferred revenue $ 127,235 $ - $ ( 13,995 ) $ 113,240 During the three months ended March 31, 2023 and 2022, the Company recognized the following revenues as a result of changes in the contract liability balance (in thousands): Three Months Ended March 31, Revenue recognized in the period from: 2023 2022 Amounts included in the contract liability at the beginning of the period $ 11,753 $ 11,183 Costs to obtain and fulfill a contract The Company did not incur any expenses to obtain collaboration agreements and costs to fulfill those contracts do not generate or enhance resources of the Company. As such, no costs to obtain or fulfill a contract have been capitalized in any period. Regeneron Pharmaceuticals, Inc. License and Collaboration Agreement In April 2016, the Company entered into a license and collaboration agreement with Regeneron (the “2016 Regeneron Agreement”). The 2016 Regeneron Agreement has two principal components: i) a product development component under which the parties will research, develop and commercialize CRISPR/Cas-based therapeutic products primarily focused on genome editing in the liver, and ii) a technology collaboration component, pursuant to which the Company and Regeneron will engage in research-related activities aimed at discovering and developing novel technologies and improvements to CRISPR/Cas technology to enhance the Company’s genome editing platform. Under this agreement, the Company also may access the Regeneron Genetics Center and proprietary mouse models to be provided by Regeneron for a limited number of the Company’s liver programs. At the inception of the 2016 Regeneron Agreement, Regeneron selected the first of its 10 targets, transthyretin (“ATTR”) amyloidosis, which is subject to a co-development and co-promotion agreement between the Company and Regeneron (the “ATTR Co/Co”). On May 30, 2020, the Company entered into (i) amendment no. 1 (the “2020 Regeneron Amendment”) to the 2016 Regeneron Agreement, (ii) co-development and co-funding agreements for the treatment of hemophilia A and hemophilia B (the “Hemophilia Co/Co”) agreements and (iii) a stock purchase agreement. The collaboration expansion builds upon the jointly developed targeted transgene insertion capabilities designed to durably restore missing therapeutic protein, and to overcome the limitations of traditional gene therapy. The collaboration was extended until April 2024, at which point Regeneron has an option to renew for an additional two years. The 2020 Regeneron Amendment also grants Regeneron exclusive rights to develop products for five additional in vivo CRISPR/Cas-based therapeutic liver targets and non-exclusive rights to independently develop and commercialize up to 10 ex vivo gene edited products made using certain defined cell types. Since December 31, 2022, there have been no material changes to the key terms of the 2016 Regeneron Agreement and the 2020 Regeneron Amendment (the “Amended Agreements”). For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022. Revenue Recognition – Collaboration Revenue. Through March 31, 2023, excluding amounts allocated to Regeneron’s purchase of the Company’s common stock, the Company recorded $ 145.0 million in upfront payments under the Amended Agreements and $ 40.7 million for research and development services, primarily under the ATTR Co/Co agreement. Through March 31, 2023 , the Company has recognized $ 179.9 million of collaboration revenue under all arrangements, including $ 6.8 million and $ 5.9 million during the three months ended March 31, 2023 and 2022, respectively , in the condensed consolidated statements of operations and comprehensive loss. This includes $ 4.2 million and $ 1.8 million during the three months ended March 31, 2023 and 2022, respectively, primarily representing payments due from Regeneron pursuant to the ATTR Co/Co agreement. These revenues are offset in part by contra-revenue related to the Hemophilia Co/Co agreements amounting to $ 2.9 million and $ 1.5 million during the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023, there was approximately $ 23.3 million of the aggregate transaction price of the Amended Agreements remaining to be recognized, which the Company expects to be recognized during the research term through April 2024. As of March 31, 2023 and December 31, 2022, the Company had accounts receivable of $ 4.2 million and $ 3.2 million, respectively, and deferred revenue of $ 23.3 million and $ 28.8 million respectively, related to the Amended Agreements. AvenCell Therapeutics, Inc. On July 30, 2021 (the “Effective Date”), the Company entered into two agreements with AvenCell, a privately held chimeric antigen receptor T (“CAR-T”) cell therapy company formed on that date in a joint venture between the Company, Cellex Cell Professionals GmbH (“Cellex”) and funds managed by Blackstone Life Sciences Advisors L.L.C. (“BXLS”): (i) a license and collaboration agreement (the “AvenCell LCA”), under which the Company will collaborate to develop allogeneic universal CAR-T cell therapies and which granted AvenCell a license to develop and commercialize genome edited universal CAR-T cell therapies (limited to its use with their switchable, universal CAR-T cell UniCAR and RevCAR platforms); and (ii) a co-development and co-funding agreement (the “AvenCell Co/Co”), under which the Company would co-develop and co-commercialize allogeneic universal CAR-T cell products for an immuno-oncology indication. In November 2022, the Company decided to re-prioritize its ex vivo programs and terminated the AvenCell Co/Co, effectively turning over control of the program to AvenCell. The Company expects that its obligations under the terminated agreement will be completed in the second quarter of 2023. The Company will also have one option to enter into an additional co-development and co-funding agreement for a payment of $ 30.0 million to AvenCell. Since December 31, 2022, there have been no other material changes to the key terms of the AvenCell LCA and AvenCell Co/Co agreements. For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company ’s Annual Report for the year ended December 31, 2022. Revenue Recognition – Collaboration Revenue. The Company recognized $ 5.6 million in revenue related to the AvenCell LCA for each of the three month periods ended March 31, 2023 and 2022, after eliminating $ 2.8 million in intra-entity profits during each of those respective periods. The elimination of intra-entity profits results in the deferral of revenue that will be recognized if and when AvenCell commercializes a product with the Company ’ s license or abandons the related project. Until such time, this revenue is indefinitely deferred and excluded from the results of operations of the Company. The Company recognized $ 0.7 million and $ 0.2 million in contra-revenue in the three months ended March 31, 2023 and 2022, respectively, related to the AvenCell Co/Co agreement. As of March 31, 2023, there was approximately $ 11.4 million of the aggregate transaction price of the AvenCell LCA remaining to be recognized, which the Company expects to recognize through July 2023. As of both March 31, 2023 and December 31, 2022, the Company had $ 0.3 million in accounts receivable related to the AvenCell agreements. The Company had deferred revenue of $ 11.4 million and $ 19.9 million as of March 31, 2023 and December 31, 2022, respectively, related to the AvenCell LCA. SparingVision SAS In October 2021, the Company and SparingVision, a genomic medicine company developing vision saving treatments for ocular diseases, entered into a license and collaboration agreement (the “SparingVision LCA”) to develop novel genomic medicines utilizing CRISPR/Cas9 technology for the treatment of ocular diseases. Since December 31, 2022, there have been no material changes to the key terms of the SparingVision LCA agreement. For further information on the terms and conditions of this agreement, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022. Revenue Recognition – Collaboration Revenue. The Company recognized $ 0.4 million in revenue related to the SparingVision LCA for the three months ended March 31, 2023. The Company did no t recognize collaboration revenue in the three months ended March 31, 2022 related to the SparingVision LCA. As of March 31, 2023 and December 31, 2022, the Company had $ 0.2 million and $ 0.1 million in accounts receivable, respectively, related to the SparingVision LCA. As of March 31, 2023 and December 31, 2022, the Company had deferred revenue of $ 14.5 million and $ 14.7 million related to the SparingVision LCA, which is expected to be recognized over a six to nine year period from the signing of the agreement. Kyverna Therapeutics, Inc. In December 2021, the Company and Kyverna, a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases, entered into a license and collaboration agreement (the “Kyverna LCA”), for the development of an allogeneic CD19 CAR-T cell therapy for the treatment of a variety of B cell-mediated autoimmune diseases. Since December 31, 2022, there have been no material changes to the key terms of the Kyverna LCA agreement. For further information on the terms and conditions of this agreement, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022. Revenue Recognition – Collaboration Revenue. The Company recognized $ 0.4 million in revenue for the three months ended March 31, 2023 related to the Kyverna LCA. The Company did no t recognize collaboration revenue in the three months ended March 31, 2022 related to the Kyverna LCA. As of March 31, 2023 and December 31, 2022, the Company did no t have accounts receivable related to the Kyverna LCA. As of March 31, 2023, the Company had recognized all revenue related to the Kyverna LCA. As of December 31, 2022, the Company had deferred revenue of $ 0.4 million related to the Kyverna LCA. ONK Therapeutics, Ltd. On February 12, 2022 the Company entered into a license, collaboration and option agreement (the “ONK LCA”) with ONK, an innovative company dedicated to developing optimally engineered natural killer (“NK”) cell therapies to cure patients with cancer. Since December 31, 2022, there have been no material changes to the key terms of the ONK LCA agreement. For further information on the terms and conditions of this agreement, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022. Revenue Recognition – Collaboration Revenue. The Company recognized $ 0.1 million in revenue for the three months ended March 31, 2023 related to materials shipped in accordance with the ONK LCA. There was no revenue recognized in the three months ended March 31, 2022 related to the ONK LCA. T he Company had $ 0.1 million in accounts receivable related to the ONK LCA at March 31, 2023 and December 31, 2022. |