Collaboration and Licensing Agreements | 9. Collaboration and Licensing Agreements The following is a summary description of the material revenue arrangements, including arrangements that generated revenue in the three and six months ended June 30, 2020 and 2019. Genentech In February 2019, the Company entered into a collaboration and license agreement (the Genentech Agreement) with Genentech, Inc. and F. Hoffman-La Roche Ltd (collectively, Genentech) for the development and commercialization of novel IL-15 collaboration products (Collaboration Products), including XmAb24306 (also named RG6323), the Company’s IL-15/IL-15Ra candidate. The Genentech Agreement became effective March 8, 2019. Under the terms of the Genentech Agreement, Genentech received an exclusive worldwide license to XmAb24306 and other Collaboration Products, including any new IL-15 programs identified during the joint research collaboration. Genentech and the Company will jointly collaborate on worldwide development of XmAb24306 and potentially other Collaboration Products with Genentech maintaining all worldwide commercialization rights, subject to the Company having an option to co-promote in the United States. The Company has the right to perform clinical studies of Collaboration Products in combination with other therapeutic agents at its own cost, subject to certain requirements. The Company received a $120.0 million upfront payment and is eligible to receive up to an aggregate of $160.0 million in clinical milestone payments for each Collaboration Product that advances to Phase 3 clinical trials. The Company is also eligible to receive 45% share of net profits for sales of XmAb24306 and other Collaboration Products, while also sharing in net losses at the same percentage rate. The parties will jointly share in development and commercialization costs for all programs designated as a development program under the Genentech Agreement at the same percentage rate, while Genentech will bear launch costs entirely. The initial 45% profit-cost share percent is subject to ratchet down at the Company’s discretion and convertible to a royalty under certain restrictions. Pursuant to the Genentech Agreement, XmAb24306 is designated as a development program and all costs incurred for developing XmAb24306 from March 8, 2019, the effective date of the Genentech Agreement, are being shared with Genentech under the initial cost-sharing percentage of 45%. Pursuant to the Genentech Agreement, the Company and Genentech will conduct joint research activities for a two -year period to identify and discover additional IL-15 candidates developed from the Company’s cytokine and bispecific technologies. The two-year research term may be extended an additional year if both parties agree. The Company and Genentech are each responsible for their own costs in conducting the research activities. The Company is eligible for clinical milestone payments for new Collaboration Products identified from the research efforts. The Company recognized the $111.7 million allocated to the license when it satisfied its performance obligation and transferred the license to Genentech in March 2019. A total of $8.3 million of the transaction price was allocated to the research activities and is being recognized over a period of time through the end of the research term that services are rendered. A total of $0.8 million and $1.5 million of revenue related to the research activities was recognized in the three- and six-month periods ended June 30, 2020, respectively. For the three months ended June 30, 2020 and 2019, the Company recognized $0.8 million and $0.6 million of income, respectively, from the Genentech Agreement. For the six months ended June 30, 2020 and 2019, the Company recognized $1.5 million and $112.5 million of income, respectively. As of June 30, 2020, there is a $1.3 million payable related to cost-sharing development activities during the second quarter of 2020 for the XmAb24306 program. There is $4.6 million in deferred revenue as of June 30, 2020 which reflects the Company’s obligation to perform research services during the remaining research term. Astellas Effective March 29, 2019, the Company entered into a Research and License Agreement (Astellas Agreement) with Astellas Pharma Inc. (Astellas) pursuant to which the Company and Astellas will conduct a discovery program to characterize compounds and products for development and commercialization. Under the Astellas Agreement, Astellas was granted a worldwide exclusive license, with the right to sublicense products in the field created by the research activities. Pursuant to the Astellas Agreement, the Company will apply its bispecific Fc technology to research antibodies provided by Astellas to generate bispecific antibody candidates and will conduct limited testing and characterization of the bispecific candidates and return the candidates to Astellas for development and commercialization. The activities will be conducted under a research plan agreed to by both parties to the Astellas Agreement. Astellas will assume full responsibility for development and commercialization of the antibody candidate. Pursuant to the Astellas Agreement, the Company received an upfront payment of $15.0 million and is eligible to receive up to $240.0 million in milestones which include $32.5 million in development milestones, $57.5 million in regulatory milestones and $150.0 million in sales milestones. If commercialized, the Company is eligible to receive royalties on net sales that range from the high-single to low-double digit percentages. The Company recognized the $13.6 million allocated to the bispecific antibodies when it satisfied its performance obligation and transferred the bispecific antibodies to Astellas in June 2019. The $1.4 million allocated to the research activities is being recognized as the research services are being completed over the period of time the Company expects to complete the activities under the research plan. The Company completed the remaining activities under the research plan during the second quarter of 2020. For the three months ended June 30, 2020 and 2019, the Company recognized $0.7 million and $13.8 million of revenue related to the arrangement, respectively. For the six months ended June 30, 2020 and 2019, the Company recognized $0.9 million and $13.8 million of revenue, respectively. There is no deferred revenue as of June 30, 2020 related to the arrangement. Novartis In June 2016, the Company entered into a Collaboration and License Agreement (Novartis Agreement) with Novartis Institutes for BioMedical Research, Inc. (Novartis), to develop and commercialize bispecific and other Fc engineered antibody drug candidates using the Company’s proprietary XmAb technologies and drug candidates. The Company received an upfront payment of $150.0 million and is eligible to receive additional development, regulatory and sales milestones. Pursuant to the Novartis Agreement: ● The Company granted Novartis certain exclusive rights to research, develop and commercialize vibecotamab (XmAb14045) and plamotamab (XmAb13676), two development stage products that incorporate the Company’s bispecific Fc technology; ● The Company will apply its bispecific technology in up to four target pair antibodies identified by Novartis (each a Global Discovery Program); and ● The Company will provide Novartis with a non-exclusive license to certain of its Fc technologies to apply against up to ten targets identified by Novartis. Under the Novartis Agreement, the Company and Novartis are co-developing vibecotamab worldwide and sharing development costs. In December 2018, Novartis notified the Company it was terminating its rights with respect to the plamotamab program, which became effective June 2019. The Company has completed delivery of two target pair antibodies under the Agreement and in December 2019 Novartis initiated a Phase 1 study with one of the target pair antibodies. No revenue was recognized during the three and six months ended June 30, 2020 and 2019. As of June 30, 2020, there is a receivable of $1.0 million related to cost-sharing of development activities for the second quarter of 2020 for the vibecotamab program, and $40.1 million in deferred revenue related to the obligation to deliver two additional Global Discovery Programs to Novartis under the arrangement. Amgen Inc. In September 2015, the Company entered into a research and license agreement (the Amgen Agreement) with Amgen Inc. (Amgen) to develop and commercialize bispecific antibody product candidates using the Company’s proprietary XmAb bispecific Fc technology. Under the Amgen Agreement, the Company granted an exclusive license to Amgen to the rights to our CD38 x CD3 preclinical program and developed AMG 424. Amgen also applied our bispecific Fc technology to create AMG 509, a STEAP1 x CD3 XmAb 2+1 bispecific antibody. The Company has received a total of $60.5 million in upfront payments and milestone payments and is eligible to receive up to $255.0 million in future development, regulatory and sales milestone payments in total for the STEAP1 x CD3 program and is eligible to receive royalties on any global net sales of products. In May 2020, Amgen notified the Company that it was terminating its rights with respect to the CD38 x CD3 program, including AMG 424, which termination became effective July 2020. Under the terms of the Agreement, the rights to the AMG 424 program revert to the Company in connection with the termination. No revenue was recognized under the arrangement during the three and six months ended June 30, 2020 or 2019. As of June 30, 2020, there is no deferred revenue related to the arrangement. MorphoSys AG In June 2010, the Company entered into a Collaboration and License Agreement with MorphoSys AG (MorphoSys), which was subsequently amended. Under the agreement, we granted MorphoSys an exclusive worldwide license to the Company’s patents and know-how to research, develop and commercialize the XmAb5574 product candidate (subsequently renamed MOR208 and tafasitamab) with the right to sublicense under certain conditions. If certain developmental, regulatory and sales milestones are achieved, the Company is eligible to receive future milestone payments and royalties. In February 2020, the U.S. Food and Drug Administration (FDA) accepted MorphoSys’ Biologics License Application (BLA) for tafasitamab and the Company received a milestone payment of $12.5 million. The Company recognized the payment as revenue in the period that the milestone event occurred. On July 31, 2020, the FDA approved MorphoSys’ BLA for tafasitamab (now Monjuvi®). In connection with the approval, the Company will receive a milestone payment of $25.0 million. The Company will recognize the payment as revenue in the period that the milestone event occurs. No revenue was recognized under this arrangement for the three months ended June 30, 2020. The Company recognized $12.5 million of milestone revenue for the six months ended June 30, 2020. No revenue was recognized under this arrangement for the three and six months ended June 30, 2019. As of June 30, 2020, there is no deferred revenue related to this agreement. Alexion Pharmaceuticals, Inc. In January 2013, the Company entered into an option and license agreement with Alexion Pharmaceuticals, Inc. (Alexion). Under the terms of the agreement, the Company granted to Alexion an exclusive research license, with limited sublicensing rights, to make and use the Company’s Xtend technology to evaluate and advance compounds. Alexion exercised its rights to one target program, ALXN1210, which is now marketed as Ultomiris®. The Company is eligible to receive contractual milestones for certain commercial achievements and is also entitled to receive royalties based on a percentage of net sales of Ultomiris sold by Alexion, its affiliates or its sublicensees, which percentage is in the low single digits. Alexion’s royalty obligations continue on a product-by-product and country-by-country basis until the expiration of the last-to-expire valid claim in a licensed patent covering the applicable product in such country. Under ASC 606, the Company recognizes revenue for sales-based royalties upon the subsequent sale of the product. We began earning royalty revenue from the sale of Ultomiris in 2019. The Company recognized $3.8 million and $1.1 million of royalty revenue under this arrangement for the three months ended June 30, 2020 and 2019, respectively. The Company also recognized $4.0 million of milestone revenue for the three months ended June 30, 2019. The Company recognized total revenue of $7.2 million and $5.1 million for the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, there is a receivable of $7.4 million related to royalties due under the arrangement. There is no deferred revenue related to this agreement. INmune Bio, Inc. In October 2017, the Company entered into a License Agreement (Agreement) with INmune Bio, Inc. (INmune). Under the terms of the agreement, the Company provided INmune with an exclusive license to certain rights to a proprietary protein, XPRO1595. Under the agreement the Company received an upfront payment of $100,000, 1,585,000 shares of INmune common stock and an option to acquire additional shares of INmune. The Company is also eligible to receive a percentage of sublicensing revenue received for XPRO1595 and royalties in the mid-single digit percent range on the sale of approved products. The option has a six-year term from the date of the Agreement and provides the Company the option to purchase up to 10% of the fully diluted outstanding shares of INmune for $10.0 million. The Company has recorded its equity interest in INmune at cost pursuant to ASC 323. The Company did not record its share of the net loss from INmune during the three and six months ended June 30, 2020 or 2019, respectively, as the carrying value of this investment has been reduced to zero . The Company did not recognize any revenue related to the agreement for the three and six months ended June 30, 2020 and 2019. There is no deferred revenue as of June 30, 2020 related to this agreement. Vir Biotechnology, Inc. In the third quarter of 2019, the Company entered into a Patent License Agreement (the VirBio Agreement) with Vir Biotechnology (VirBio) pursuant to which the Company provided a non-exclusive license to its Xtend technology for up to two targets. Under the terms of the VirBio Agreement, the Company received an upfront payment and is eligible to receive total milestones of $155.25 million which include $5.25 million of development milestones, $30.0 million of regulatory milestones and $120.0 million of sales milestones. In addition, the Company is eligible to receive royalties on the net sales of approved products in the low single digit percent range. The Company evaluated the VirBio Agreement and determined that the single performance obligation was access to a non-exclusive license to certain patents of the Company which were transferred to VirBio upon execution of the VirBio Agreement in July 2019. VirBio initiated a Phase 1 study with a licensed antibody in 2019 and in the second quarter of 2020 it initiated a Phase 1 study with a second licensed antibody. In March 2020, the Company entered into a second Patent License Agreement (the Second VirBio Agreement) with VirBio pursuant to which the Company provided a non-exclusive license to its Xtend technology to extend the half-life of novel antibodies VirBio is investigating as potential treatments for patients with SARS-CoV-2, which causes COVID-19. Under the terms of the Second VirBio Agreement, VirBio is responsible for all research, development, regulatory and commercial activities for the antibody, and the Company is eligible to receive royalties on the net sales of approved products in the mid-single digit percent range. The Company determined that the Second VirBio Agreement was a modification of the original agreement and the transfer of the license occurred at inception of the VirBio Agreement. The total consideration under the arrangement did not change with the Second VirBio Agreement as the Company will potentially receive additional royalty revenue which is variable consideration and is not included in the transaction price. The Company recognized $0.3 million milestone revenue for the three and six months ended June 30, 2020. The Company did not recognize revenue related to the agreement for the three and six months ended June 30, 2019. There is no deferred revenue as of June 30, 2020 related to this agreement. Aimmune Therapeutics, Inc. On February 4, 2020, the Company entered into a License, Development and Commercialization Agreement (the Aimmune Agreement) with Aimmune Therapeutics, Inc. (Aimmune) pursuant to which the Company granted Aimmune an exclusive worldwide license to XmAb7195, which was renamed AIMab7195. Under the Aimmune Agreement, Aimmune will be responsible for all further development and commercialization activities for XmAb7195. The Company received an upfront payment of $5.0 million and 156,238 shares of Aimmune common stock with an aggregate value of $4.6 million on the closing date. Under the Aimmune Agreement, the Company is also eligible to receive up to $385.0 million in milestones, which include $22.0 million in development milestones, $53.0 million in regulatory milestones and $310.0 million in sales milestones, and tiered royalties on net sales of approved products from high-single to mid-teen percent range. Under the Aimmune Agreement, Aimmune received exclusive worldwide rights to manufacture, develop and commercialize XmAb7195. They also received the rights to all data, information and research materials related to the XmAb7195 program. The Company evaluated the Aimmune Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract: ● License to the rights to the XmAb7195 drug candidate; and ● Rights to material, data and information that the Company had accumulated in connection with manufacturing, testing and conducting clinical trials for the XmAb7195 program and intellectual property filings and information (XmAb7195 data). The Company considered the licenses as functional intellectual property as Aimmune has the right to use XmAb7195 at the time that the Company transfers such rights. The rights to the XmAb7195 data are not considered to be separate from the license to XmAb7195 as Aimmune cannot benefit from the license without the supporting data and documentation. The Company determined the transaction price at inception is $9.6 million which consists of the $5.0 million upfront payment and the 156,238 shares of Aimmune common stock which had a value of $4.6 million on the closing date. The Company determined that the transaction price is to be allocated to the performance obligations. The Aimmune Agreement includes variable consideration for potential future milestones and royalties that were contingent on future success factors for the XmAb7195 program. The Company used the “most likely amount” method to determine the variable consideration. None of the development, regulatory or sales milestones or royalties were included in the transaction price. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur. The Company determined the transaction price at inception of the Aimmune Agreement and allocated it to the performance obligation, delivery of the XmAb7195 license. The Company completed delivery of its performance obligations in March 2020. The license to XmAb7195 was transferred to Aimmune at inception of the Aimmune Agreement, and the XmAb7195 data was transferred to Aimmune in March 2020. No revenue was recognized in the three months ended June 30, 2020. The Company recognized $9.6 million of revenue related to the agreement for the six months ended June 30, 2020. There is no deferred revenue as of June 30, 2020 related to this agreement. Gilead Sciences, Inc. In January 2020, the Company entered into a Technology License Agreement (the Gilead Agreement) with Gilead Sciences, Inc. (Gilead), in which the Company provided an exclusive license to its Cytotoxic Fc and Xtend Fc technologies for an initial identified antibody and options for up to three additional antibodies directed to the same molecular target. The Company retains the right to grant licenses for other antibodies directed to the target, subject to the Company’s approval. Gilead is responsible for all development and commercialization activities for all target candidates. The Company received an upfront payment of $6.0 million and is eligible to receive up to $67.0 million in milestones, which include $10.0 million in development milestones, $27.0 million in regulatory milestones and $30.0 million in sales milestones for each product incorporating the antibodies selected. In addition, the Company is eligible to receive royalties in the low-single digit percentage range on net sales of approved products. In March 2020, Gilead exercised options on two additional antibody compounds and in April 2020 it exercised the option on the third antibody available under the Gilead Agreement. In April 2020, we received a total of $7.5 million in payment of the three options. The Company evaluated the Gilead Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract: ● Non-exclusive license to its Cytotoxic Fc and Xtend Fc technologies; and, ● Options for four exclusive commercial licenses to incorporate the licensed technologies on approved target compounds The Company considered the licenses as functional intellectual property as Gilead has the right to use the technologies at the time that the Company transfers such rights. Each of the four options is considered a separate performance obligation as the arrangement does not confer material rights to the options without payment of the option exercise fee. Gilead will benefit from each option upon exercise of each of the four options and payment of each option fee as Gilead has access to each technology at inception of the arrangement and the rights are transferred upon payment of each option fee. The total transaction price is $13.5 million which includes the upfront payment of $6.0 million and the option fee payment of $7.5 million which was contractually due with the exercise of the three options by Gilead. The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Gilead Agreement it is unlikely that the Company will collect such payments. The milestone payments were not included in the transaction price and the Company will review this conclusion and update at each reporting period. The Company allocated $3.5 million of the transaction price to the licenses to the cytotoxic Fc and Xtend Fc technologies and recognized income for the licenses at inception of the arrangement when Gilead began benefiting access to them. The Company allocated The Company recognized Revenue earned The revenues recorded for the three and six months ended June 30, 2020 were earned principally from the following licensees (in millions): Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Aimmune $ — $ — $ 9.6 $ — Alexion 3.8 5.1 7.2 5.1 Astellas 0.7 13.8 0.9 13.8 Genentech 0.8 0.6 1.5 112.5 Gilead 7.5 — 13.5 — MorphoSys — — 12.5 — Vir Biotechnology 0.3 — 0.3 — Total $ 13.1 $ 19.5 $ 45.5 $ 131.4 The table below summarizes the disaggregation of revenue recorded for the three and six months ended June 30, 2020 (in millions): Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Research collaboration $ 1.5 $ 14.4 $ 2.4 $ 14.7 Milestone 0.3 4.0 12.8 4.0 Licensing 7.5 — 23.1 111.6 Royalties 3.8 1.1 7.2 1.1 Total $ 13.1 $ 19.5 $ 45.5 $ 131.4 Remaining Performance Obligations and Deferred Revenue The Company’s remaining performance obligations are delivery of two Global Discovery Programs under the Novartis Agreement and conducting research activities pursuant to research plans under the Genentech Agreement. We have completed the remaining research activities pursuant to the research plan under the Astellas Agreement in the three-month period ended June 30, 2020. As of June 30, 2020 and 2019, the Company has deferred revenue of $44.7 million and $48.8 million, respectively. As of June 30, 2020, all deferred revenue is classified as current liabilities as the Company’s obligations to perform services are due on demand when requested by Novartis under the Novartis Agreement and the Company’s obligation to perform research services to Genentech will end upon expiration of the research term within one year . As of June 30, 2019, $45.5 million was classified as current liabilities for the same reason, and $3.3 million of the deferred revenue liability was classified as long-term for the portion of obligations to perform research services to Genentech after one year . |