Gilead Sciences Inc.

"As a result of the recent acquisitions completed or announced above, we expect to record related charges of approximately $11.5 billion to Acquired in-process research and development expenses in the second quarter of 2026, which we expect to result in a net loss for the second quarter and full year 2026."

"HIV product sales increased 10% to $5.0 billion for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand and average realized price, partially offset by unfavorable inventory dynamics."

"Cell Therapy product sales decreased 12% to $407 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower demand reflecting ongoing competitive headwinds."

"During 2025, we delivered growth in our HIV product sales, introduced Yeztugo, the first and only twice-yearly HIV pre-exposure prophylaxis option available in the U.S., and expanded Livdelzi's market share in the treatment of primary biliary cholangitis."

"As we look to 2026, we expect to see continued growth for our product sales overall, bolstered by increased demand in our HIV business. We anticipate that such growth will be partially offset by the impact of various policy-related developments in the U.S."

"In December 2025, Gilead reached an agreement with the administration to (1) pause the imposition of Section 232 tariffs on Gilead for three years, (2) implement MFN prices in Medicaid for select existing and future launched products, (3) set a new direct-to-patient price for Epclusa and (4) return a portion of increased international revenues to the U.S."

"In June 2023, the jury returned a complete verdict in Gilead's favor on the remaining plaintiffs' Phase I allegations [in antitrust litigation]"

"We recorded a partial impairment charge of $190 million...related to certain acquired in-process research and development assets [for bulevirtide] due to additional competitive clinical data becoming available indicating a potentially more competitive market"

"In October 2025, we closed an agreement to acquire all outstanding shares of Interius BioTherapeutics, Inc. for approximately $350 million in cash consideration"

"In March 2025, we completed the acquisition of CymaBay Therapeutics, Inc. for total consideration of $3.9 billion, net of cash acquired."

"Based on our evaluation of the data, and in connection with the preparation of the financial statements for the second quarter, 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."

"In January 2025, we entered into a strategic partnership with LEO Pharma A/S to accelerate the development and commercialization of LEO Pharma's small molecule oral signal transducer and activator of transcription 6 programs."

"Total revenues of $6.7 billion remained relatively flat for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to lower Veklury and Oncology sales being mostly offset by higher HIV and Liver Disease sales."

"HIV product sales increased 6% to $4.6 billion for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to higher demand and higher average realized price, inclusive of the impact of the redesign of the U.S. Medicare Part D program."

"If future events result in adverse changes in the key assumptions used in determining fair value, including the timing of product launches, information on the competitive landscape of treatments in this indication, changes to the probability of technical or regulatory success, failure to obtain anticipated regulatory approval or discount rate, among others, additional impairments may be recorded and could be material to our financial statements."

"We anticipate that strong, demand-led volume growth in 2025 will be offset by: (i) the effects of the Inflation Reduction Act, which is expected to increase our payment obligations under the redesigned Medicare Part D discount program; (ii) an expected decrease in our Veklury product sales reflecting lower rates of COVID-19-related hospitalizations; and (iii) the impact of the U.S. dollar strengthening against major foreign currencies."

"Total revenues increased 6% to $28.8 billion in 2024, compared to 2023, primarily due to higher sales in HIV, Oncology and Liver Disease, partially offset by lower sales of Veklury."

"Net income attributable to Gilead was $480 million...The decrease was primarily due to: A pre-tax IPR&D partial impairment charge of $4.2 billion related to Trodelvy IPR&D assets"

"In January 2024, we received data from our Phase 3 EVOKE-01 study of Trodelvy evaluating SG indicating that the study did not meet its primary endpoint of overall survival in previously treated metastatic NSCLC, thus triggering a review for potential impairment"

"In September 2024, based on discussions with regulators and external opinion leaders and the completed evaluation of the Phase 3 EVOKE-01 study data, we made a strategic decision to discontinue our clinical development program in metastatic NSCLC for Trodelvy"

"In August 2024, FDA granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid"

"We completed the acquisition of CymaBay Therapeutics, Inc. for $4.3 billion in total equity value...adding investigational candidate seladelpar for the treatment of primary biliary cholangitis"

"We performed an interim impairment test and determined that the revised estimated fair value of the NSCLC IPR&D intangible asset was below its carrying value...we recognized a partial impairment charge of $2.4 billion"

"Total revenues increased 5% to $7.0 billion and $13.6 billion for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily due to higher product sales in HIV, Oncology and Liver Disease"

"In January 2024, we received data from our Phase 3 EVOKE-01 study of Trodelvy evaluating SG indicating that the study did not meet its primary endpoint of overall survival in previously treated metastatic NSCLC, thus triggering a review for potential impairment"

"We completed the acquisition of CymaBay Therapeutics, Inc. for total consideration of $3.9 billion, net of cash acquired...seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta agonist with Orphan Drug Designation"

"During the three months ended March 31, 2024, we incurred restructuring charges of $63 million primarily related to the initiation of reductions in our commercial and research and development workforce"

"Generic manufacturers have sought and may continue to seek FDA approval for a similar or identical drug through an abbreviated new drug application ('ANDA'), the application form typically used by manufacturers seeking approval of a generic drug. The sale of generic versions of our products prior to their patent expiration would have a significant negative effect on our revenues and results of operations."

"In May 2023, we settled claims with the direct purchaser class and the retailer opt-out plaintiffs for $525 million...The settlement agreements are not an admission of liability or fault by us."

"While we believe the Phase II claims are without merit, we cannot predict the ultimate outcome. If the plaintiffs are successful in their Phase II claims, we could be required to pay monetary damages or could be subject to permanent injunctive relief in favor of the plaintiffs."

"In May 2023, the District Court held a trial regarding the government's patent infringement claims, and the jury rendered a full defense verdict in favor of Gilead, finding that the asserted claims of the HHS Patents are invalid and not infringed."

"In March 2023, we settled claims with the direct purchaser class and the retailer opt-out plaintiffs for $525 million, which we have agreed to pay in the second half of 2023."

"In February 2023, FDA granted approval of Trodelvy for use in adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer"