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Collaboration Agreements, In-Licensing Arrangements And Business Development Activities | 9 Months Ended
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Oct. 01, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
COLLABORATION AGREEMENTS, IN-LICENSING ARRANGEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES | COLLABORATION AGREEMENTS, IN-LICENSING ARRANGEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES We have established multiple collaborations with leading pharmaceutical companies for the commercialization and further development of our cabozantinib franchise. Additionally, we have entered into several research collaboration and in-licensing arrangements to further enhance our early-stage pipeline and expand our ability to discover, develop and commercialize novel therapies with the goal of providing new treatment options for cancer patients and their physicians. Historically, we also entered into other collaborations with leading pharmaceutical companies pursuant to which we out-licensed other compounds and programs in our portfolio. See “Note 3. Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2020, or as further described below, for additional information on each of our collaboration agreements and in-licensing arrangements. Cabozantinib Collaborations Ipsen Collaboration In February 2016, we entered into a collaboration agreement with Ipsen for the commercialization and further development of cabozantinib. Under the terms of the collaboration agreement, as amended, Ipsen received exclusive commercialization rights for current and potential future cabozantinib indications outside of the U.S. and Japan. We have also agreed to collaborate with Ipsen on the development of cabozantinib for current and potential future indications. The parties’ efforts are governed through a joint steering committee and appropriate subcommittees established to guide and oversee the collaboration’s operation and strategic direction; provided, however, that we retain final decision-making authority with respect to cabozantinib’s ongoing development. During the second quarter of 2021, Ipsen opted into and is now co-funding the development costs for COSMIC-311, our phase 3 pivotal trial evaluating cabozantinib versus placebo in patients with RAI-refractory DTC who have progressed after up to two VEGF receptor-targeted therapies. Under the terms of the collaboration agreement, Ipsen i s now obligated to reimburse us for their share of COSMIC-311 global development costs, as well as an additional payment calculated as a percentage of such costs, triggered by the timing of the exercise of its option. We determined that the decision to opt in and co-fund the development costs for COSMIC-311 represented a contract modification for additional distinct services at their standalone selling price and therefore was treated as a separate contract under Topic 606. Accordingly, collaboration services revenues for the nine months ended September 30, 2021, includes a cumulative catch up for Ipsen’s share of global development costs incurred since the beginning of the study and through the end of the period. Revenues under the collaboration agreement with Ipsen were as follows (in thousands):
| Three Months Ended September 30, |  | Nine Months Ended September 30,
| 2021 |  | 2020 |  | 2021 |  | 2020 |  |
License revenues | $ | 25,139 |  |  | $ | 19,910 |  |  | $ | 81,246 |  |  | $ | 71,456 |  |  |
Collaboration services revenues | 12,956 |  |  | 16,096 |  |  | 81,576 |  |  | 46,503 |  |  |
Total | $ | 38,095 |  |  | $ | 36,006 |  |  | $ | 162,822 |  |  | $ | 117,959 |  |  |
Milestone revenues for the nine months ended September 30, 2021 included $11.9 million recognized in connection with a $12.5 million regulatory milestone we determined was probable of achievement in the second quarter of 2021. The milestone was achieved in the third quarter of 2021 upon submission of a variation application to the European Medicines Agency for CABOMETYX as a treatment for patients with previously treated RAI-refractory DTC. As of September 30, 2021, $44.8 million of the tr ansaction price was allocated to our research and development services performance obligations that has not yet been satisfied. Takeda Collaboration In January 2017, we entered into a collaboration and license agreement with Takeda for the commercialization and further development of cabozantinib. Pursuant to this collaboration and license agreement, as amended, Takeda has exclusive commercialization rights for current and potential future cabozantinib indications in Japan, and the parties have agreed to collaborate on the clinical development of cabozantinib in Japan. The operation and strategic direction of the parties’ collaboration is governed through a joint executive committee and appropriate subcommittees. Revenues under the collaboration agreement with Takeda were as follows (in thousands):
| Three Months Ended September 30, |  | Nine Months Ended September 30,
| 2021 |  | 2020 |  | 2021 |  | 2020 |  |
License revenues | $ | 20,078 |  |  | $ | 9,780 |  |  | $ | 23,476 |  |  | $ | 32,726 |  |  |
Collaboration services revenues | 2,656 |  |  | 13,204 |  |  | 10,815 |  |  | 16,468 |  |  |
Total | $ | 22,734 |  |  | $ | 22,984 |  |  | $ | 34,291 |  |  | $ | 49,194 |  |  |
Milestone revenues for the three and nine months ended September 30, 2021 included $18.8 million recognized in connection with a $20.0 million milestone we achieved upon Takeda’s first commercial sale in Japan of CABOMETYX in combination with OPDIVO for the treatment of patients with unresectable, advanced or metastatic RCC. As of September 30, 2021, $41.7 million of the transaction price was allocated to our research and development services performance obligations that has not yet been satisfied. GSK and Royalty Pharma In October 2002, we established a product development and commercialization collaboration agreement with GSK, that required us to pay a 3% royalty to GSK on the worldwide net sales of any product incorporating cabozantinib by us and our collaboration partners. As disclosed in Note 2, we received notification that, effective January 1, 2021, Royalty Pharma acquired from GSK all rights, title and interest in royalties on net product sales containing cabozantinib for non-U.S. markets for the full term of the royalty and for U.S. market through September 2026, after which time U.S. royalties will revert back to GSK. Royalties earned by GSK and Royalty Pharma in connection with our sales of cabozantinib are included in cost of goods sold and as a reduction of collaboration services revenues for sales by our collaboration partners. Such royalties were $11.5 million and $33.7 million during the three and nine months ended September 30, 2021, respectively, as compared to $7.9 million and $23.7 million in the corresponding periods in 2020. Genentech Collaboration In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech under a worldwide collaboration agreement. In November 2015, the FDA approved cobimetinib, under the brand name COTELLIC, in combination with Genentech’s ZELBORAF® (vemurafenib) for the treatment of patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with ZELBORAF has also been approved in the European Union and multiple additional countries for use in the same indication. In July 2020, the FDA also approved COTELLIC for use in combination with ZELBORAF and TECENTRIQ® (atezolizumab) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma in previously untreated patients. License revenues under the collaboration agreement with Genentech were as follows (in thousands):
| Three Months Ended September 30, |  | Nine Months Ended September 30,
| 2021 |  | 2020 |  | 2021 |  | 2020 |  |
Profits on U.S. commercialization | $ | 1,743 |  |  | $ | 1,595 |  |  | $ | 5,697 |  |  | $ | 4,378 |  |  |
Royalty revenues on ex-U.S. sales | $ | 1,576 |  |  | $ | 1,370 |  |  | $ | 3,309 |  |  | $ | 3,804 |  |  |
Research Collaborations, In-Licensing Arrangements and Other Business Development Activities During the nine months ended September 30, 2021, in support of our development pipeline, we entered into collaboration and in-licensing arrangements with Adagene Inc. (Adagene), WuXi Biologics Ireland Limited (WuXi Bio), expanded our collaboration with Invenra, Inc. (Invenra), and amended our existing collaboration agreement with StemSynergy Therapeutics, Inc. (StemSynergy). In conjunction with each of these arrangements we have made aggregate upfront payments totaling $28.0 million and will make payments for potential future development milestones of up to $98.0 million, regulatory milestones of up to $229.0 million and commercial milestones of up to $802.5 million, each in the aggregate per product or target, as well as royalties on future net product sales. In addition to the upfront and future milestone payments, we will also pay Invenra, in three equal annual installments, an exclusivity payment of up to $15.0 million to nominate up to 20 additional oncology targets and up to $30.0 million in research program funding in equal quarterly payments over a three-year period, as well as additional fees. As of September 30, 2021, we have paid the first exclusivity installment of $5.0 million and $2.5 million for the first quarterly research and development funding installment. We have the ability to opt in to certain of Invenra’s other internal research programs in exchange for an option exercise payment of $3.0 million per program. Additionally, in May 2021, we entered into an asset purchase agreement with GamaMabs Pharma SA (GamaMabs), pursuant to which we made an upfront payment of $5.0 million for the initial technology transfer, and subject to certain conditions, will make a $9.0 million payment upon the completion of an initial technology transfer of certain materials and documents specified in the asset purchase agreement. We will also make payments for potential future development milestones of up to $42.0 million and regulatory milestones of up to $22.5 million, per product.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (a) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (b) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -URI http://asc.fasb.org/topic&trid=5833765 + Details
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