Collaborations | 9 . Collaborations 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 December 31, 2019 and December 31, 2018, the Company’s accounts receivable and contract liabilities were primarily related to the Company’s collaborations with Novartis and Regeneron. The following table presents changes in the Company’s accounts receivable and contract liabilities during the years ended December 31, 2019 and 2018 (in thousands): Balance at Beginning of Period Additions Deductions Balance at End of Period Year Ended December 31, 2019 Accounts receivable $ 7,547 $ 15,999 $ (18,926 ) $ 4,620 Contract liabilities: Deferred revenue $ 55,932 $ 4,000 $ (31,122 ) $ 28,810 Balance at Beginning of Period Additions Deductions Balance at End of Period Year Ended December 31, 2018 Accounts receivable $ 10,471 $ 16,498 $ (19,422 ) $ 7,547 Contract liabilities: Deferred revenue $ 59,868 $ 19,000 $ (22,936 ) $ 55,932 During the years ended December 31, 2019 and 2018, the Company recognized the following revenues as a result of changes in the contract liability balance (in thousands): Revenue recognized in the period from: Year Ended December 31, 2019 Year Ended December 31, 2018 Amounts included in the contract liability at the beginning of the period $ 27,122 $ 22,936 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. Novartis Institutes for BioMedical Research, Inc. In December 2014, the Company entered into a strategic collaboration agreement with Novartis (the “2014 Novartis Agreement”), primarily focused on the research of new ex vivo Agreement Structure. Under the 2014 Novartis Agreement, the parties agreed to engage in collaborative research activities using the Company’s CRISPR/CAS9 platform to identify and research therapeutic, prophylactic and palliative products and services relating to the following applications: a) HSCs and b) CAR-T cells. In addition, in the last two years of the collaboration term, Novartis was permitted to engage in research and development of a limited number of targets using the Company’s platform. Scope of Collaboration. During the five-year research term, the parties researched potential therapeutic, prophylactic and palliative applications of CRISPR/Cas9 technology in HSCs and CAR-T cells. Research expenses incurred by the Company in support of the collaboration were reimbursed by Novartis. HSC Program. The Company and Novartis agreed to collaborate exclusively with each other during the research term to conduct research on ex vivo applications of CRISPR/Cas9 technology for HSC targets under a research plan agreed upon by both parties. At the end of the research term in December 2019, this exclusive HSC research collaboration ended. Within the ex vivo HSC therapeutic space, Novartis obtained exclusive rights to research and develop human therapeutics for a limited number of HSC targets, which were selected by Novartis in a series of selection windows. During the research term, the Company had the right to choose a limited number of HSC targets for its exclusive development and commercialization per the specified selection schedule. Following these selections by Novartis and the Company, Novartis had the right to research an additional limited number of non-selected HSC targets on a non-exclusive basis, but Novartis did not exercise this right. Because the research term has ended, the parties can no longer select additional exclusive HSC targets, and Novartis has an exclusive license to research, develop and commercialize human therapeutic products directed to its selected HSC targets. Novartis assumed sole responsibility for developing and commercializing human therapeutic products for the HSC targets it selected arising from the Company’s collaboration and is solely responsible for the costs and expenses of developing, manufacturing and commercializing its HSC products. To maintain its exclusive license on a target-by-target basis, Novartis is required to use commercially reasonable efforts to research, develop and commercialize at least one HSC product directed to each of their selected HSC targets. In 2019, Novartis announced that it had completed investigational new drug (“IND”) CAR-T Program . The Company and Novartis also agreed to collaborate exclusively with each other during the research term on research directed to applying CRISPR/Cas9 technology to CAR-T cell targets under a research plan agreed upon by both parties . At the end of the research term in December 2019, this exclusive research collaboration ended. Under the 2014 Novartis A greement, Novartis assume d sole responsibility for developing human therapeutic products for the limited number of CAR targets it select ed arising from its collaboration with the Company and is solely responsible for the costs and expenses of developing, manufacturing and commercializing its selected targets. Novartis has an exclusive license to research, develop and commercialize CAR products directed to its selected CAR-T cell targets. To maintain its exclusive license on a target-by-target basis, Novartis is required to use commercially reasonable efforts to research, develop and commercialize at least one CAR-T cell product directed to each of its selected CAR targets . Governance. The parties formed HSC and CAR-T cell steering committees with responsibility for oversight of these respective research programs and approval of the associated research plans. Beginning in December 2018, the HSC steering committee also became responsible for the OSC program (see the section below entitled “ 2018 Amendment to the Agreement”) . These steering committees in turn were overseen by a joint steering committee and comprised an equal number of representatives from each party . The steering committees terminated upon completion of the research term in December 2019. Financial Terms . The Company received an upfront technology access payment from Novartis of $10.0 million in January 2015 and was entitled to additional technology access fees of $20.0 million and quarterly research payments of $1.0 million, or up to $20.0 million in the aggregate, during the five-year Equity Investments. Additionally, at the inception of the arrangement at which time the Company was a privately held company, Novartis invested $9.0 million to purchase the Company’s Class A-1 and Class A-2 Preferred Units (the “Preferred Units”). The difference between the cash proceeds received from Novartis for the units and the $11.6 million estimated fair value of those units at the date of issuance was determined to be $2.6 million. Accordingly, $2.6 million of the upfront technology access payment was allocated to record the Preferred Units purchased by Novartis at fair value . License Grant to Novartis. In the 2014 Novartis Agreement, the Company granted to Novartis a license to its CRISPR/Cas9 platform technology, including a sublicense to certain platform rights licensed from Caribou, that is exclusive in the ex vivo HSC, CAR-T cell and in vivo fields with respect to each target selected by Novartis pursuant to the agreement and the research plan as long as Novartis continues to use commercially reasonable efforts to research, develop, and commercialize CRISPR-edited products directed to such targets. License Grant to Intellia. In the 2014 Novartis Agreement, prior to the Novartis Amendment described below, Novartis granted the Company a non-exclusive license to its IP covering a small molecule for HSC expansion and to its lipid nanoparticle (“LNP”) platform technology to research, develop and commercialize HSC and genome editing products, respectively, in the 2014 Novartis Agreement . Intellectual Property. IP that the Company develops within the collaboration related to the Company’s CRISPR/Cas9 platform will be owned solely by the Company, while all other IP developed within the collaboration, including IP covering products arising from the collaboration, will be jointly owned by the Company and Novartis. 2018 Amendment to the Agreement In December 2018, the Company entered into an amendment to this agreement with Novartis (the “Novartis Amendment”) which expanded the scope of the 2014 Novartis Agreement to include the ex vivo development of CRISPR/Cas9-based cell therapies using limbal stem cells primarily against gene targets selected by Novartis in exchange for a one-time payment of $10.0 million which the Company received in December 2018. The governance, license rights and development responsibilities, as well as milestones and royalties, associated with any OSC program and product follow those for the HSC programs and products. Because the research term has ended, as with the HSC programs, the parties’ exclusive research collaboration for limbal stem cells has ended, and Novartis has an exclusive license to research, develop and commercialize OSC products directed to a limited number of OSC targets. As part of the Novartis Amendment, Intellia rights to Novartis’ LNP technology were expanded to include use in all genome editing applications in both in vivo and ex vivo settings Term and Termination . The term of the 2014 Novartis Agreement expires on the later of (i) the expiration of Novartis’ payment obligations under the agreement and (ii) the date of expiration of the last-to-expire of the patent rights licensed to the Company or Novartis under the agreement. Novartis’ royalty payment obligations expire on a country-by-country and product-by-product basis upon the later of (i) the expiration of the last valid claim of the royalty-bearing patents covering such product in such country or (ii) ten years after the first commercial sale of such product in such country. The Company may terminate the agreement if Novartis or its affiliates institute a patent challenge against its IP rights, and all improvements thereto, licensed to Novartis under the agreement. Novartis may terminate the agreement, without cause, upon 90 days’ written notice to the Company subject to certain conditions and continuing obligations. Either party may terminate the agreement in the event of the other party’s uncured material breach or bankruptcy - or insolvency-related events. Accounting Analysis. The Company concluded that the 2014 Novartis Agreement and the Novartis Amendment are subject to ASC 606 and assessed its accounting for them accordingly . The Company evaluated the promised goods and services under the 2014 Novartis Agreement and determined that it had two performance obligations: (1) a combined performance obligation representing a series of distinct goods and services including the licenses to research, develop and commercialize HSC and LSC products and their associated research activities and the licenses to research, develop and commercialize CAR-T cell products and their associated research activities; and (2) the Preferred Units. The Company determined that the transaction price of the 2014 Novartis Agreement was $59.0 million consisting of the following consideration: (1) the upfront technology access payment of $10.0 million; (2) the additional technology access fees of $20.0 million; (3) the Company’s estimate of variable consideration of $20.0 million related to the quarterly research payments; and (4) the payment for the Preferred Units of $9.0 million. None of the clinical or regulatory milestones were included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon future regulatory progress and the licensee’s efforts. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur as they were determined to relate predominantly to the licenses granted to Novartis and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. The Company first allocated $11.6 million of the transaction price to the Preferred Units to record the Preferred Units purchased by Novartis at fair value. The Company then allocated the remaining $47.4 million of the transaction price to the remaining combined performance obligation of the licenses and associated research activities for HSC and CAR-T cell products. Revenue allocated to the combined performance obligation of the licenses and associated research activities for HSC and CAR-T cell products is being recognized using a time elapsed inputs method The Company determined that there is only one combined performance obligation identified under the Novartis Amendment, representing a series of distinct goods and services including the licenses to research, develop and commercialize products using LSCs and their associated research and development services related to the research, development and commercialization of products using LSCs, and allocated the $ 10.0 million transaction price accordingly. Revenue allocated to this performance obligation is being recognized using a time elapsed inputs method over a period of one year , which, in management’s judgment, is the best measure of progress towards satisfying the performance obligation as this method provides the most faithful depiction of the entity’s performance in transferring control of the goods and services promised to Novartis and represents the Company’s best estimate of the period of the obligation. Revenue Recognition: Collaboration Revenue. Through December 31, 2019, excluding amounts allocated to Novartis’ purchase of the Company’s Preferred Units, the Company had recorded a total of $57.4 million in cash and accounts receivable under the 2014 Novartis Agreement and the Novartis Amendment. Through December 31, 2019, the Company has recognized $57.4 million of collaboration revenue, including $18.5 million in the year ended December 31, 2019, $10.3 million in the year ended December 31, 2018, and $9.3 million in the year ended December 31, 2017, in the consolidated statements of operations and comprehensive loss related to the 2014 Novartis Agreement and the Novartis Amendment. As of December 31, 2019, the aggregate transaction price had been recognized in full. As of the periods ended December 31, 2019 and 2018, the Company had accounts receivable of $1.0 million and $6.0 million, respectively, related to this agreement. As of December 31, 2019, the Company had no deferred revenue related to this agreement . Regeneron Pharmaceuticals, Inc. In April 2016, the Company entered into a license and collaboration agreement with Regeneron (the “Regeneron Agreement”). Agreement Structure. The 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 and development 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. Scope of Collaboration. Under the terms of the six-year collaboration, Regeneron may obtain exclusive rights for up to ten targets to be chosen by Regeneron during the collaboration term, subject to a target selection process and various adjustments and limitations set forth in the agreement. Of these ten total targets, Regeneron may select up to five non-liver targets, while the remaining targets must be focused in the liver. Certain non-liver targets from the Company’s ongoing and planned research at the time, as well as any targets included in another of the Company’s collaborations, are excluded from this collaboration. At the inception of the agreement, Regeneron selected the first of its ten targets, transthyretin amyloidosis (“ATTR”), which is subject to a Co/Co agreement between the Company and Regeneron, the general terms and conditions for which were outlined within the Regeneron Agreement. Research Collaboration. Research activities under the collaboration will be governed by evaluation and research and development plans that will outline the parties’ responsibilities under, anticipated timelines of and budgets for, the various programs. The Company will assist Regeneron with the preliminary evaluation of its selected liver targets, and Regeneron will be responsible for preclinical research and conducting clinical development, manufacturing and commercialization of products directed to each of its exclusive targets. The Company may assist, as requested by Regeneron, with the later discovery and research of product candidates directed to any selected target. For each selected target, Regeneron is required to use commercially reasonable efforts to submit regulatory filings necessary to achieve IND acceptance for at least one product directed to each applicable target, and following IND acceptance for at least one product, to develop and commercialize such product. Reserved Liver Targets. The Company retains the exclusive right to solely develop products via CRISPR /Cas genome editing directed against certain specified genetic targets. During the collaboration term and subject to a target selection process, the Company has the right to choose additional liver targets for its own development using commercially reasonable efforts. Certain targets that either the Company or Regeneron select during the term may be subject to further Co/Co ag re ement s at the Company or Regeneron’s option, as applicable, which either can exercise pursuant to defined conditions . Governance. Under the Regeneron Agreement, the parties formed a joint steering committee, which is responsible for setting research objectives and overseeing the general strategies and research and development activities undertaken by the parties. Additionally, under the Co/Co agreement directed to ATTR (the “ATTR Co/Co”), the parties formed a Joint Development and Commercialization Committee (“JDCC”) to oversee all profit share products under the Co/Co agreement as discussed below. The JDCC has responsibility for overseeing the development, manufacture, regulatory matters, and commercialization (including pricing and reimbursement) of ATTR, as the first profit share product under the Regeneron agreement. Financial Terms. The Company received a nonrefundable upfront payment of $75.0 million. In addition, on Regeneron programs that are not subject to Co/Co agreements the Company may be eligible to earn, on a per-licensed target basis, (i) up to $25.0 million in development milestones, including for the dosing of the first patient in each of Phase I, Phase II and Phase III clinical trials, (ii) up to $110.0 million in regulatory milestones, including for the acceptance of a regulatory filing in the U.S., and for obtaining regulatory approval in the U.S. and in certain other identified countries, and (iii) up to $185.0 million in sales-based milestone payments. The Company is also eligible to earn royalties ranging from the high single digits to low teens, in each case, on a per-product basis, which royalties are potentially subject to various reductions and offsets and incorporate the Company’s existing low- to mid-single-digit royalty obligations under a license agreement with Caribou. Equity Investments. In connection with this collaboration, Regeneron purchased $50.0 million of the Company’s common stock in a private placement under a Stock Purchase Agreement concurrent with the Company’s initial public offering (“IPO”) . Term and Termination . The research collaboration term ends in April 2022, except that Regeneron may make a one-time payment of $25.0 million to extend the term for an additional two-year Co-Development and Co-Promotion Agreement. In July 2018, the Company and Regeneron finalized the form of the Co/Co agreement that will be used as the basis for each Co/Co agreement directed to a target. Simultaneously, the Company and Regeneron executed the Co/Co agreement directed to the first collaboration target, ATTR, for which the Company is the clinical and commercial Lead Party (see below) and Regeneron is the Participating Party (see below). Co-Development and Co-Promotion: Agreement Structure Under the Regeneron Agreement, Regeneron has the right to exercise at least five options to enter into a Co/Co agreement for the Company’s liver targets (other than the Company’s reserved liver targets), while the Company may exercise at least one option to enter into a Co/Co agreement for Regeneron’s liver targets, the exact number of options being subject to certain conditions of the target selection process. Each option to enter into a Co/Co agreement must be exercised (or forfeited) once a target reaches a defined preclinical stage. Within 15 days of exercising the option, the party exercising the option must pay $1.5 million to the other party as compensation for prior work. The ATTR program was exempted from this payment. One party will be the “Lead Party” and the other party the “Participating Party”. The Lead Party shall have control and primary responsibility for the development, manufacturing, regulatory and commercial activities. The Participating Party shall have the right to consult on these activities through its participation on the JDCC and will have the right to co-fund development and commercialization activities in exchange for a share of profits. In general, under each Co/Co agreement, the parties will share equally in worldwide development costs and profits of any future products. Prior to reaching a specific development milestone, the Participating Party may elect to reduce its share of worldwide development costs and profits by 50%. Co-Development and Co-Promotion: Termination. Either party may terminate by providing 180 days written notice. If the Company terminates, the product becomes a Regeneron product, and is subject to all future milestone and royalty payment obligations under the Regeneron Agreement. If Regeneron terminates and has contributed at least $5 million in development costs under the Co/Co agreement, the Company will pay low- to mid-single digit royalties on the net sales of the product, depending on co-funding percentage, stage at termination and, if any, Regeneron IP incorporated into the product. Accounting Analysis. The Company determined that the Regeneron Agreement is within the scope of ASC 606. The Company evaluated the promised goods and services under the Regeneron Agreement and determined that the Regeneron Agreement included three performance obligations: (1) a combined performance obligation including the licenses to targets and the associated research activities and evaluation plans; (2) a combined performance obligation including the technology collaboration and associated research activities; and (3) the common stock. The Company also concluded that the ATTR Co/Co agreement meets the definition of a collaborative arrangement per ASC 808, which is outside of the scope of ASC 606. Since ASC 808 does not provide recognition and measurement guidance for collaborative arrangements, the Company has analogized to ASC 606. As such, the Company classifies payments received or made under the cost sharing provisions of the ATTR Co/Co agreement as a component of revenues in the consolidated statements of operations and comprehensive loss. Under the Regeneron Agreement, the Company determined that the transaction price was $125.0 million, consisting of the following consideration: (1) the nonrefundable upfront payment of $75.0 million; and (2) the payment for the common stock of $50.0 million. None of the clinical or regulatory milestones were included in the transaction price, as all milestone amounts were fully constrained. As part its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future regulatory progress and the licensee’s efforts. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur as they were determined to relate predominantly to the licenses granted to Regeneron and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and when events whose outcome are resolved or other changes in circumstances occur. The Company first allocated $50.0 million of the transaction price to the common stock. . using a time elapsed inputs method as this method provides the most faithful depiction of the entity’s performance in transferring control of the goods and services promised to Regeneron using a time elapsed inputs method as this method provides the most faithful depiction of the entity’s performance in transferring control of the goods and services promised to Regeneron . Revenue Recognition: Collaboration Revenue. Through December 31, 2019, excluding the amounts allocated to Regeneron’s purchase of the Company’s common stock, the Company recorded a $75.0 million upfront payment and $24.1 million for research and development services under the Regeneron Agreement. As of December 31, 2019, there was approximately $28.8 million of the aggregate transaction price remaining to be recognized, which will be recognized ratably through April 2022. As of December 31, 2019 and 2018, the Company had deferred revenue of $28.8 million and $41.4 million, respectively, and accounts receivable of $3.6 million and $1.5 million, respectively, related to this arrangement. Through December 31, 2019, the Company has recognized $70.3 million, including $24.6 million, $20.1 million and $16.8 million of collaboration revenue in the years ended December 31, 2019, 2018 and 2017, respectively, in the consolidated statements of operations and comprehensive loss related to this arrangement. This includes $12.0 million, $7.5 million, and $4.1 million representing payments from Regeneron pursuant to the ATTR Co/Co agreement, which is accounted for under ASC 808. |