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Collaboration Agreements And Business Development Activities | 9 Months Ended
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Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
COLLABORATION AGREEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES | COLLABORATION AGREEMENTS 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 collaborations, in-licensing arrangements and other strategic transactions 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 and Business Development Activities” of the “Notes to Consolidated Financial Statements” included in Part II, Item 8 of our Fiscal 2021 Form 10-K, as further described below, for additional information on certain of our collaboration agreements and in-licensing arrangements. Cabozantinib Commercial 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. Revenues under the collaboration agreement with Ipsen were as follows (in thousands):
| Three Months Ended September 30, |  | Nine Months Ended September 30,
| 2022 |  | 2021 |  | 2022 |  | 2021 |  |
License revenues | $ | 27,607 |  |  | $ | 25,139 |  |  | $ | 103,389 |  |  | $ | 81,246 |  |  |
Collaboration services revenues | 7,211 |  |  | 12,956 |  |  | 28,196 |  |  | 81,576 |  |  |
Total | $ | 34,818 |  |  | $ | 38,095 |  |  | $ | 131,585 |  |  | $ | 162,822 |  |  |
During the nine months ended September 30, 2022, we recognized $25.8 million in revenues in connection with two regulatory milestones totaling $27.0 million upon approval by the European Commission and Health Canada, of cabozantinib as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to RAI who have progressed during or after prior systemic therapy. As of September 30, 2022, $49.3 million of the transaction price for this collaboration was allocated to our research and development services performance obligations that have 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,
| 2022 |  | 2021 |  | 2022 |  | 2021 |  |
License revenues | $ | 2,690 |  |  | $ | 20,078 |  |  | $ | 7,755 |  |  | $ | 23,476 |  |  |
Collaboration services revenues | 3,661 |  |  | 2,656 |  |  | 11,148 |  |  | 10,815 |  |  |
Total | $ | 6,351 |  |  | $ | 22,734 |  |  | $ | 18,903 |  |  | $ | 34,291 |  |  |
As of September 30, 2022, $33.8 million of the transaction price for this collaboration was allocated to our research and development services performance obligations that have not yet been satisfied. Royalty Pharma In October 2002, we established a product development and commercialization collaboration agreement with GlaxoSmithKline (GSK), that required us to pay a 3% royalty to GSK on the worldwide net sales of any product incorporating cabozantinib sold by us and our collaboration partners. Effective January 1, 2021, Royalty Pharma plc (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 Royalty Pharma in connection with our sales of cabozantinib are included in cost of goods sold and in connection with sales by our collaboration partners are included as a reduction of collaboration services revenues. Such royalties were $14.9 million and $42.6 million during the three and nine months ended September 30, 2022, respectively, as compared to $11.5 million and $33.7 million for the corresponding prior year periods. Other Commercial Collaborations 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,
| 2022 |  | 2021 |  | 2022 |  | 2021 |  |
Profits on U.S. commercialization | $ | 1,504 |  |  | $ | 1,743 |  |  | $ | 5,325 |  |  | $ | 5,697 |  |  |
Royalty revenues on ex-U.S. sales | $ | 1,494 |  |  | $ | 1,576 |  |  | $ | 4,011 |  |  | $ | 3,309 |  |  |
Research Collaborations, In-Licensing Arrangements and Other Business Development Activities Our research collaborations, in-licensing arrangements and other strategic transactions include upfront payments, which are generally paid upon the closing of the transaction, and also milestone payments (in connection with development, regulatory or commercial achievements) and royalty payments, which are contingent upon the occurrence of certain future events linked to the success of the asset in development. Certain of our research collaborations and in-licensing arrangements provide us exclusive options that give us the right to license programs developed under the research collaborations for further discovery and development. When we decide to exercise an option, we are required to pay an exercise fee and then, in most instances, we will assume the responsibilities for all subsequent clinical development, manufacturing and commercialization of the licensed asset. In June 2022, we entered into an exclusive option and license agreement with BioInvent International AB (BioInvent), upon which we paid an upfront payment of $25.0 million. Upon option exercise, we will pay BioInvent an option exercise fee, and BioInvent will be eligible for additional payments from us for future development and commercial milestones, as well as royalties on our future net product sales. In July 2022, we entered into an exclusive license agreement with Ryvu Therapeutics S.A. (Ryvu) and paid an upfront payment of $3.0 million. Ryvu is eligible for potential future development and commercial milestones as well as royalties on future net product sales. As of September 30, 2022, in conjunction with each of our research collaborations and in-licensing arrangements, and an asset purchase agreement entered into in 2021, we are subject to contingent payments for potential future development milestones of up to $364.7 million, regulatory milestones of up to $453.4 million and commercial milestones of up to $2,443.4 million, each in the aggregate per product or target, as well as royalties on future net product sales.

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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 https://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 https://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 https://asc.fasb.org/topic&trid=5833765 + Details
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