License and Collaboration Agreements | License and Collaboration Agreements BeiGene Agreement Terms of Agreement On January 7, 2018, the Company and BeiGene Ltd, ("BeiGene") entered into a Collaboration and License Agreement (the “BeiGene Agreement”), pursuant to which the Company and BeiGene agreed to collaboratively develop sitravatinib in Asia (excluding Japan and certain other countries), Australia and New Zealand (the “Licensed Territory”). Under the BeiGene Agreement, the Company granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, with the Company retaining exclusive rights for the development, manufacture and commercialization of sitravatinib outside the Licensed Territory. As consideration for the rights granted to BeiGene under the BeiGene Agreement, BeiGene paid the Company a non-refundable, non-creditable up-front fee of $10.0 million. BeiGene is also required to make milestone payments to the Company of up to an aggregate of $123.0 million upon the first achievement of specified clinical, regulatory and sales milestones. The BeiGene Agreement additionally provides that BeiGene is obligated to pay to the Company royalties at tiered percentage rates ranging from mid-single digits to twenty percent on annual net sales of licensed products in the Licensed Territory, subject to reduction under specified circumstances. The BeiGene Agreement also provides that the Company will supply BeiGene with sitravatinib for use in BeiGene’s development activities in the Licensed Territory. The BeiGene Agreement will terminate upon the expiration of the last royalty term for the licensed products, which is the latest of (i) the date of expiration of the last valid patent claim related to the licensed products under the BeiGene Agreement, (ii) 10 years after the first commercial sale of a licensed product and (iii) the expiration of any regulatory exclusivity as to a licensed product. BeiGene may terminate the BeiGene Agreement at any time by providing 60 days prior written notice to the Company. Either party may terminate the BeiGene Agreement upon a material breach by the other party that remains uncured following 60 days after the date of written notice of such breach or upon certain bankruptcy events. In addition, the Company may terminate the BeiGene Agreement upon written notice to BeiGene under specified circumstances if BeiGene challenges the licensed patent rights. Revenue Recognition The Company evaluated the BeiGene Agreement under Topic 606. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under the BeiGene Agreement, the Company performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price, including any constraints on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v) recognized revenue when (or as) the Company satisfied each performance obligation. The Company determined the transaction price is equal to the up-front fee of $10.0 million. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. As such, of the up-front fee, the Company allocated $9.5 million to the license to the Company's intellectual property, bundled with the associated know-how, and $0.5 million to the initial obligation to supply sitravatinib for clinical development in the Licensed Territory. Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to BeiGene during the three months ended March 31, 2018, therefore during 2018 the Company recognized the full revenue amount of $9.5 million related to this performance obligation as license and collaboration revenues in its condensed consolidated statements of operations and comprehensive loss; no revenue related to this performance obligation was recorded during the three and nine months ended September 30, 2020 or 2019. Manufacturing Supply Services. The Company's initial obligation to supply sitravatinib for clinical development in the Licensed Territory represents a distinct performance obligation. The Company recognizes revenue when BeiGene obtains control of the goods, upon delivery, over the period of the obligation, which began in late 2018 and will continue into 2020. No revenue related to this performance obligation was recognized for the three months ended September 30, 2020. The Company recognized $1.0 million as license and collaboration revenues for this performance obligation for the three months ended September 30, 2019, primarily consisting of cost-sharing payments due from BeiGene. The Company recognized $0.3 million as license and collaboration revenues for this performance obligation for the nine months ended September 30, 2020, primarily consisting of cost-sharing payments due from BeiGene. The Company recognized $2.8 million as license and collaboration revenues for this performance obligation for the nine months ended September 30, 2019, of which $2.6 million relates to cost-sharing payments due from BeiGene and $0.2 million relates to recognition from the deferred revenue balance. Milestone Payments. The Company is entitled to development milestones under the BeiGene Agreement. The next clinical development milestone is for BeiGene initiating the first pivotal clinical trial in the Licensed Territory upon which the Company will be paid a $5.0 million milestone payment. The Company is also entitled to certain regulatory milestone payments which are paid upon receipt of regulatory approvals within the Licensed Territory. No milestone payments were earned during the three and nine months ended September 30, 2020 or 2019. The Company evaluated whether the remaining milestones are considered probable of being reached and determined that their achievement is highly dependent on factors outside of the Company's control. Therefore, these payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect the reported amount of license and collaboration revenues in the period of adjustment. Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize revenue when the related sales occur. No royalty revenue was recognized during the three and nine months ended September 30, 2020 or 2019. The following table presents a summary of the activity in the Company's contract liabilities during the nine months ended September 30, 2020 (in thousands): Opening balance, January 1, 2020 $ (172) Revenue from performance obligations satisfied during reporting period 29 Closing balance, September 30, 2020 $ (143) The closing balance represents deferred revenue and was classified within current liabilities at September 30, 2020. Pfizer Agreement In October 2014, the Company entered into a drug discovery collaboration and option agreement with Array BioPharma, Inc. ("Array," acquired by Pfizer Inc. ("Pfizer") during 2019) whereby Array provided services to facilitate the discovery, optimization and development of small molecule compounds that bind and specifically inhibit KRAS G12C. In June 2017, the two parties entered into a second, separate discovery collaboration and option agreement whereby Array provided services to facilitate the discovery, optimization and development of small molecule compounds that bind and specifically inhibit KRAS G12D. Both agreements established an option mechanism which enabled the Company to elect an exclusive worldwide license under the technology for the development and commercialization of certain products based on such compounds. Under the agreements, following the joint discovery periods which have concluded, the Company executed its options to retain exclusive worldwide licenses to develop, manufacture and commercialize inhibitors of KRAS G12C and KRAS G12D, including but not limited to, MRTX849 (adagrasib is the provisionally filed name for MRTX849) and MRTX1133. Under each agreement, Pfizer is entitled to potential development milestone payments of up to $9.3 million, and tiered sales milestone payments of up to $337.0 million based upon worldwide net sales, and tiered royalties in the high single digits to mid-teens on worldwide net sales of products arising from the collaborations. Under the agreements, the Company has incurred $4.5 million in development milestone payments from inception through September 30, 2020. The royalty term for each agreement shall be payable on a country-by-country and product-by-product basis, and separately will terminate at the later of (i) the date of expiration of the last valid patent claim within the collaboration patent rights or the Pfizer background technology covering such product in the country in which such product is sold at the time of such sale, or (ii) 10 years after the first commercial sale of such product in such country. The Company may terminate each agreement at any time by providing 60 days prior written notice to Pfizer. Either party may terminate each agreement upon a material breach by the other party that remains uncured following 60 days after the date of written notice of such breach or upon certain bankruptcy events. For the three months ended September 30, 2020, the Company incurred expenses under these agreements with Pfizer of $0.3 million relating to a milestone payment for initiation of the first regulatory toxicology study for MRTX1133. For the nine months ended September 30, 2020, the Company incurred expenses under these agreements with Pfizer of $4.8 million, consisting of a $3.0 million milestone payment for initiation of the first Phase 2 trial for MRTX849, a $0.3 million milestone payment for initiation of the first regulatory toxicology study for MRTX1133, and $1.5 million in research and development services. For the three months ended September 30, 2019, the Company incurred expense of $1.5 million, consisting of research and development services. For the nine months ended September 30, 2019, the Company incurred expense of $5.5 million, consisting of a $1.0 million milestone payment for initiation of the first Phase 1 trial for MRTX849, and $4.5 million in research and development services. ORIC Pharmaceuticals Agreement Terms of Agreement On August 3, 2020, the Company entered into a license agreement with ORIC Pharmaceuticals, Inc. ("ORIC") pursuant to which the Company granted to ORIC an exclusive, worldwide license to develop and commercialize the Company's allosteric polycomb repressive complex 2 (PRC2) inhibitors for all indications (the "ORIC License Agreement"). In accordance with the terms of the ORIC License Agreement, in exchange for such license, ORIC issued 588,235 shares of its common stock (the "Shares") to the Company on August 3, 2020. The Shares were issued under a stock issuance agreement entered into between ORIC and the Company, dated August 3, 2020. During the eighteen Unless terminated earlier, the ORIC License Agreement will continue in effect on a country-by-country and licensed product-by-licensed product basis until the later (a) the expiration of the last valid claim of a licensed patent covering such licensed product in such country or (b) ten years after the first commercial sale of such licensed product in such country. Following the expiration of the ORIC License Agreement, ORIC will retain its licenses under the intellectual property the Company licensed to ORIC on a royalty-free basis. The Company and ORIC may each terminate the ORIC License Agreement if the other party materially breaches the terms of such agreement, subject to specified notice and cure provisions, or enters into bankruptcy or insolvency proceedings. The Company may terminate the agreement if ORIC challenges any of the patent rights licensed to ORIC by the Company or if ORIC discontinues development of licensed products for a specified period of time. ORIC also has the right to terminate the ORIC License Agreement without cause by providing prior written notice to the Company. Revenue Recognition The Company accounted for the ORIC License Agreement under Topic 606 and identified the granting of an exclusive, worldwide license to develop and commercialize the Company's allosteric PRC2 inhibitors for all indications as a distinct performance obligation since ORIC can benefit from the license on its own by developing and commercializing the underlying product using its own resources. In determining the transaction price, the Company received the Shares as non-cash consideration. The transaction price was determined by utilizing a Level 3 fair value measurement as further described in Note 5. The Company determined the transaction price was equal to $11.4 million. The Company allocated the entire transaction price to the distinct performance obligation described above, and the license and related know-how was transferred to ORIC during the third quarter of 2020. Therefore, the Company recognized the entire transaction price of $11.4 million as license and collaboration revenues in its condensed consolidated statements of operations and comprehensive loss. |