Gilead completed the acquisition of CymaBay Therapeutics, Inc. for $3.9 billion net cash paid, adding investigational candidate seladelpar for the treatment of primary biliary cholangitis to Gilead's Liver Disease portfolio. Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.

Gilead amended its collaboration agreement with Arcus, acquiring 15.2 million additional shares of Arcus common stock at a premium for $320 million, increasing its ownership to 30.1 million shares, or 33% of the issued and outstanding voting stock of Arcus immediately following the closing of the transaction.

Following results and data from several magrolimab studies as well as corresponding FDA clinical holds, Gilead announced in February 2024 that it would not pursue further development of magrolimab in hematologic cancers.

Gilead received approval from the FDA to update Biktarvy's label with additional data reinforcing the safety and efficacy profile to treat pregnant people with HIV-1 with suppressed viral loads.

Gilead received approval from FDA to expand the indication for Vemlidy to include treatment of chronic hepatitis B virus (“HBV”) in children six years and older who weigh at least 25 kg with compensated liver disease.

Gilead recognized a partial impairment charge of $2.4 billion in In-process research and development impairment on its Condensed Consolidated Statements of Operations for the three months ended March 31, 2024, after the Phase 3 EVOKE-01 study of Trodelvy evaluating SG did not meet its primary endpoint.

FDA announced it is investigating the risk of T-cell malignancies in patients who received treatment with CAR T-cell therapy and determined that safety labeling issues were needed for approved CAR T-cell therapies, including a “boxed warning” about the possible risk of T-cell malignancies.

Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccines and alternative treatments for COVID-19. Future sales of Veklury in the short- and long-term remain uncertain.

There continues to be enhanced scrutiny of company-sponsored patient assistance programs, including co-pay assistance programs and manufacturer donations to third-party charities that provide such assistance. If Gilead is deemed to have failed to comply with laws, regulations or government guidance in any of these areas, it could be subject to criminal or civil sanctions.

HIV product sales increased 4% to $4.3 billion for the three months ended March 31, 2024, compared to the same period in 2023, primarily driven by higher demand. In particular, Biktarvy sales increased primarily reflecting higher demand, including patients switching from Genvoya and other Gilead HIV products.

Liver Disease product sales increased 9% to $737 million for the three months ended March 31, 2024, compared to the same period in 2023, primarily driven by favorable inventory dynamics, the timing of chronic hepatitis C virus (“HCV”) product purchases by the Department of Corrections in the United States, as well as higher demand across HBV, HCV, and in the European Union (“EU”), chronic hepatitis D virus (“HDV”) products.

Cell Therapy product sales increased 7% to $480 million for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to increased Yescarta demand for the treatment of relapsed or refractory (“R/R”) large B-cell lymphoma outside the United States and increased Tecartus demand for the treatment of R/R adult acute lymphoblastic leukemia and R/R mantle cell lymphoma, mostly in Europe.

Product gross margin decreased to 76.6% for the three months ended March 31, 2024, compared to 77.8% for the same period in 2023, primarily driven by product mix, as well as higher intangible asset amortization expenses related to the pretreated hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) metastatic breast cancer indication for Trodelvy following its approval in February 2023.

Selling, general and administrative expenses increased 4% to $1.4 billion for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to stock-based compensation expenses related to the acquisition of CymaBay and restructuring expenses.

During the three months ended March 31, 2024, Gilead incurred restructuring charges of $63 million primarily related to the initiation of reductions in its commercial and research and development workforce. $50 million of these charges were recorded in Research and development expenses and $13 million in Selling, general and administrative expenses.

Research and development expenses increased 5% to $1.5 billion for the three months ended March 31, 2024, compared to the same period in 2023. Personnel, infrastructure and other support costs increased primarily due to stock-based compensation expenses related to the acquisition of CymaBay and restructuring expenses.

Gilead announced a research collaboration, option and license agreement with Merus N.V. to discover novel antibody-based trispecific T-cell engagers in oncology.

Gilead entered into an exclusive license agreement with Xilio Therapeutics, Inc. to develop and commercialize Xilio's tumor-activated IL-12 program, including investigational candidate XTX301 in advanced solid tumors.

During the three months ended March 31, 2024, Gilead utilized cash of $400 million for common stock repurchases under repurchase programs.

During the three months ended March 31, 2024, Gilead utilized cash of $990 million for dividend payments.

During the three months ended March 31, 2024, Gilead sold all of its available-for-sale debt securities and used the proceeds to partially fund its acquisition of CymaBay.

Gilead's aspirations, goals and disclosures related to environmental, social and governance (“ESG”) matters expose it to numerous risks, including risks to its reputation and stock price. These goals are subject to risks outside of Gilead's control.

The standards for tracking and reporting on ESG matters are relatively new, have not been harmonized and continue to evolve. Gilead's selection of disclosure frameworks may change from time to time and may result in a lack of consistent or meaningful comparative data from period to period.

Regulatory authorities may impose mandatory disclosure requirements with respect to ESG matters, such as recent U.S. Securities and Exchange Commission rules requiring companies to make certain climate-related disclosures, including information about climate-related risks, greenhouse gas emissions and certain climate-related financial statement metrics.

Foreign currency exchange, net of hedges, had an unfavorable impact on Gilead's total product sales of $47 million for the three months ended March 31, 2024, based on a comparison using foreign currency exchange rates from the three months ended March 31, 2023.

The Inflation Reduction Act will increase Gilead's payment obligations under the redesigned Part D discount program, limit the prices it can charge for its products, and increase the rebates it must provide government programs for its products, thereby reducing its profitability and negatively impacting its financial results.

As Gilead's products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices.