INTANGIBLE ASSETS |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| INTANGIBLE ASSETS | INTANGIBLE ASSETS The following table summarizes our Intangible assets, net:
_______________________________ (1) In May 2026, FDA granted accelerated approval of Hepcludex (bulevirtide) for treatment of adults living with chronic hepatitis delta virus infection. Accordingly, the related IPR&D intangible asset of $550 million was reclassified to finite-lived assets in the second quarter of 2026. (2) During the second quarter of 2026, we recorded an impairment for the remaining $1.75 billion IPR&D intangible asset balance related to sacituzumab govitecan-hziy (“SG”) for NSCLC. See “2026 Impairment” below. Impairment Assessments We did not identify any indicators of impairment resulting in an adjustment to the carrying value of intangible assets during the three and six months ended June 30, 2026 and 2025, except as described in “2026 Impairment” and “2025 Impairment” below. 2026 Impairment In June 2026, we announced the discontinuation of our Phase 3 EVOKE-03 study of Trodelvy evaluating SG in combination with pembrolizumab in certain patients with previously untreated metastatic NSCLC. In consideration of this decision, and in connection with the preparation of the financial statements for the second quarter of 2026, we determined that no future cash flows were expected to be generated in relation to the NSCLC IPR&D intangible asset, and therefore, no value was attributed to the asset. As a result, we recognized an impairment charge of the remaining balance of $1.75 billion in In-process research and development impairments on our Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2026. 2025 Impairment During the three months ended June 30, 2025, additional data became available indicating a more competitive market for bulevirtide where it was not yet approved. Based on our evaluation of the data, and in connection with the preparation of the financial statements for the second quarter of 2025, we performed an interim impairment test and determined that the revised estimated fair value of the bulevirtide IPR&D intangible asset was below its carrying value. As a result, we recognized a partial impairment charge of $190 million in In-process research and development impairments on our Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025. To arrive at the revised estimated fair value as of June 30, 2025, we used a probability-weighted income approach that discounts expected future cash flows to present value, which requires the use of Level 3 fair value measurements and inputs, including critical estimated inputs, such as: revenues and operating profits related to the planned utilization of bulevirtide outside of the European Union (“EU”), which includes inputs such as addressable patient population, projected market share, treatment duration, and the life of the potential commercialized product; the probability of technical and regulatory success; the time and resources needed to complete the development and approval of bulevirtide outside of the EU; an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile; and risks related to the viability of and potential alternative treatments in any future target markets. We used a discount rate of 8.25%, which is based on the estimated weighted-average cost of capital for companies with profiles similar to ours.
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