Teropavimab

– New Data Showcase Safety Profile of Twice-Yearly Lenacapavir for Pre-Exposure Prophylaxis (PrEP) with Other Medications and Recruitment Strategies for PURPOSE 5 – – Five-Year BICSTaR Results Offer Insights into Long-Term Treatment with Biktarvy®, Helping Inform the Future of Coordinated, Person-Centered HIV Care – – Latest Results on Novel Long-Acting Combination Regimens, Including Once-Weekly and Twice-Yearly Treatment Options – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the 20th European AIDS Conference (EACS) to be held in Paris, France from October 15-18. As the leader in HIV innovation, Gilead will provide an update on its strategic initiatives, key collaborations, and share new scientific data from its HIV research and development programs. The research that will be presented at EACS 2025, along with the Gilead-led symposia and supported community forums, reflect the company’s person-centered approach to advancing scientific discovery and underscores its focus on community partnership to help end the HIV epidemic. “It is fitting that thousands of scientists and community stakeholders will gather in Paris for EACS 2025,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “The first Declaration on Fast-Track Cities to end the HIV epidemic was signed in Paris on World AIDS Day in 2014. Fueled by Gilead’s longstanding commitment to develop and deliver HIV prevention and treatment options tailored to the individual’s needs, my colleagues and I continue to strive for a future without HIV, in Europe and around the world.” Gilead’s EACS 2025 program highlights include: HIV Prevention Research Expanding reach to populations in Europe not currently using PrEP: Researchers will present the strategies that supported the recruitment of people in high-priority populations across France and the UK for the Phase 2 PURPOSE 5 trial (N06513CT312), which is evaluating the persistence of twice-yearly lenacapavir among people who need or want PrEP but who have not previously engaged with existing HIV prevention options. Through collaboration with community advisory groups, thoughtful site selection and targeted recruitment goals for understudied populations, the study team achieved its enrollment goals and established a model for future HIV prevention studies. Safety data build understanding around concomitant use of lenacapavir: Further data from the PURPOSE 2 trial examined the concomitant use of lenacapavir by people also taking statins administered to lower cholesterol and PDE-5 inhibitors to treat erectile dysfunction. Lenacapavir is a moderate inhibitor of the enzyme CYP3A4 and could potentially increase levels of these classes of drugs. The accumulated data suggests that lenacapavir, like other moderate CYP3A4 inhibitors, can be co-administered with statins and PDE5 inhibitors with appropriate monitoring and dose adjustment. HIV Treatment Research Five-year outcomes from the BICSTaR (NCT03580668) Study: Long-term, real-world data were analyzed from individuals with HIV who were enrolled in Canada, France and Germany. The five-year outcomes are consistent with the results observed from multiple Phase 3 clinical trials evaluating the treatment responses of people with HIV on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. These benefits were seen in both treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. The results underscore the importance of patient-reported outcomes as a person-centered approach to HIV research and can help us to better understand the impact on health-related quality of life and specifically, mental health status of people with HIV. This could help inform treatment strategies for these groups. Demographic profile of ARTISTRY-1 participants: Baseline characteristics from the Phase 3 portion of an ongoing study (NCT05502341) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily oral regimen of bictegravir and lenacapavir. The results contextualize the unmet need for people living with HIV on complex regimens who may benefit from a single-tablet regimen. In September, the last patient completed their Week 48 visit in the Phase 3 portion of ARTISTRY-1. A topline data readout for the primary endpoint is anticipated to be announced before the end of the year. Late-breaking: Week 96 outcomes of an oral combination of Islatravir and Lenacapavir: Data from an ongoing, randomized, open-label Phase 2 study (NCT05052996) demonstrate that switching to an investigational once-weekly combination regimen of islatravir and lenacapavir enabled people living with HIV to maintain viral suppression to two years. At 96 weeks, based on the Missing = Failure and Missing = Excluded analyses, respectively, 88.5% (46/52) and 100% (n=46/46) of adults treated with the novel investigation combination maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) demonstrating the potential of the combination, which could become the first weekly oral HIV treatment option. Two Phase 3 studies - ISLEND-1 and ISLEND-2 are ongoing. Week 52 results of twice-yearly regimen of Lenacapavir and broadly neutralizing antibodies (bNAbs): The Phase 2 (NCT05729568) open-label study from Gilead’s long-acting treatment pipeline demonstrated that twice-yearly lenacapavir in combination with bNAbs (teropavimab [GS-5423, TAB] and zinlirvimab [GS-2872, ZAB]) maintained viral suppression in people with HIV with susceptible viruses out to 52 weeks and was generally well tolerated. The investigational combination has the potential to be the first twice-yearly complete regimen. The novel treatment combination is now progressing to Phase 3 clinical development. Gilead’s symposia at EACS are focused on exploring the treatment needs of women with HIV throughout life, plus long-acting PrEP options and opportunities to address unmet HIV prevention needs: Overview of Scientific Presentations HIV PREVENTION RESEARCH Recruitment of Disproportionately Affected Populations in the PURPOSE 5 Study Evaluating Lenacapavir for PrEP in France and the UK Analysis of Barriers to Testing for HIV Prevention and Linkage to Care Among Migrants in Europe Commonly Prescribed Concomitant Medications and Clinical Safety Findings with Lenacapavir for PrEP in PURPOSE 2 Annual Persistence to Twice-Yearly Lenacapavir vs Daily Oral F/TDF for PrEP in the PURPOSE 2 Trial HIV TREATMENT RESEARCH Efficacy and Safety of a Twice-Yearly Regimen of Lenacapavir, Teropavimab, and Zinlirvimab: Phase 2 Week 52 Results Oral Weekly ISL/LEN in VS PWH: 96 Week Outcomes from a Phase 2 Study Five-Year Extended Follow-Up of the Observational BICSTaR Cohort: Final Analysis in PWH Receiving B/F/TAF in Routine Clinical Practice Demographics and Clinical Characteristics of Phase 3 Participants in ARTISTRY-1, An Open- Label Study Comparing a BIC/LEN STR With Complex ART Regimens For more information about Gilead at EACS 2025, including a complete list of abstracts and their corresponding oral and poster sessions, please visit: https://eacs-conference.com Lenacapavir for PrEP is not approved by any regulatory authority outside of the U.S. and the EU. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established in combination. The combination of islatravir and lenacapavir is investigational. Use in combination for the treatment of HIV has not been approved by any regulatory authority. Teropavimab and zinlirvimab are investigational compounds. The use of these compounds in combination with lenacapavir are investigational, are not approved by any regulatory authority, and their safety and efficacy has not been established. The use of lenacapavir in virologically suppressed people with HIV is investigational and the safety and efficacy of this use have not been established. There is currently no cure for HIV or AIDS. Please see below for U.S. and E.U. Indications and Important Safety Information, including Boxed Warning, for Yeztugo and Yeytuo. Please see below for U.S. Indications and Important Safety Information, including Boxed Warning, for Biktarvy. About Lenacapavir Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.” EU Indication for Yeytuo® Yeytuo® injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk weighing at least 35kg. U.S. Indication for Yeztugo® Yeztugo® (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Adverse reactions Most common adverse reactions(≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg with no antiretroviral treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration: Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Prior to or when initiating: Test patients for HBV infection. Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population. Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy, lenacapavir, teropavimab and zinlirvimab (such as ARTISTRY-1, BICsTaR, EMPOWER, PURPOSE 2 and PURPOSE 5); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of the programs for the indications currently under evaluation and, as a result, the programs may never be successfully commercialized for such indications; Gilead’s ability to effectively manage its global health equity access strategy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. Full Prescribing Information for Truvada, Yeztugo, and Biktarvy including Boxed Warning, are available at www.gilead.com. Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Biktarvy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs. Blair Baumwell, Media public_affairs@gilead.com Jacquie Ross, Investors Investor_relations@gilead.com

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2025 results of operations. “Gilead had a strong start to the year driven by excellent commercial and clinical execution along with disciplined expense management,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Our base business grew 4% year-over-year, primarily led by Biktarvy’s continued strength, and we announced positive topline Phase 3 results for Trodelvy plus pembrolizumab in first line PD-L1+ metastatic triple negative breast cancer. With the upcoming June PDUFA date for lenacapavir for HIV prevention, and continued progress across our diverse pipeline, we look forward to building on our positive momentum throughout the year.” First Quarter 2025 Financial Results Total first quarter 2025 revenue of $6.7 billion remained flat compared to the same period in 2024, with lower Veklury® (remdesivir) and Oncology sales offset by higher HIV and Liver Disease sales. Diluted earnings (loss) per share (“EPS”) was $1.04 in the first quarter 2025 compared to $(3.34) in the same period in 2024. The increase was primarily driven by prior year charges that did not repeat, including the impact of a $3.9 billion acquired in-process research and development ("IPR&D") expense related to the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), as well as a pre-tax IPR&D impairment of $2.4 billion related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020. This increase was partially offset by higher tax expense and higher net unrealized losses on equity investments in the first quarter 2025. Non-GAAP diluted EPS was $1.81 in the first quarter 2025 compared to $(1.32) in the same period in 2024. The increase was primarily driven by the prior year IPR&D expense related to the CymaBay acquisition. As of March 31, 2025, Gilead had $7.9 billion of cash and cash equivalents compared to $10.0 billion as of December 31, 2024. During the first quarter 2025, Gilead generated $1.8 billion in operating cash flow. During the first quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $730 million of common stock. In addition, Gilead repaid $1.8 billion of Senior Notes in February 2025. First Quarter 2025 Product Sales Total first quarter 2025 product sales decreased 1% to $6.6 billion compared to the same period in 2024. Total first quarter 2025 product sales excluding Veklury increased 4% to $6.3 billion compared to the same period in 2024, primarily due to higher HIV and Liver Disease sales, partially offset by lower Oncology sales. HIV product sales increased 6% to $4.6 billion in the first quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and demand. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.1 billion in the first quarter 2025 compared to the same period in 2024, primarily driven by higher demand. Descovy® (FTC 200mg/TAF 25mg) sales increased 38% to $586 million in the first quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and higher demand. The Liver Disease portfolio sales increased 3% to $758 million in the first quarter 2025 compared to the same period in 2024. This was primarily driven by increased demand in products for primary biliary cholangitis (“PBC”), chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower average realized price for chronic hepatitis C virus (“HCV”) products. Veklury sales decreased 45% to $302 million in the first quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19 related hospitalizations across regions. Cell Therapy product sales decreased 3% to $464 million in the first quarter 2025 compared to the same period in 2024. Yescarta® (axicabtagene ciloleucel) sales increased 2% to $386 million in the first quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and increased rest of world demand, partially offset by lower demand in the United States. Tecartus® (brexucabtagene autoleucel) sales decreased 22% to $78 million in the first quarter 2025 compared to the same period in 2024, primarily reflecting lower demand in the United States. Trodelvy® (sacituzumab govitecan-hziy) sales decreased 5% to $293 million in the first quarter 2025 compared to the same period in 2024, primarily driven by inventory dynamics and lower average realized price, partially offset by higher demand. First Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 76.7% in the first quarter 2025 compared to 76.6% in the same period in 2024. Non-GAAP product gross margin was 85.5% in the first quarter 2025 compared to 85.4% in the same period in 2024. Research and development (“R&D”) expenses were $1.4 billion in the first quarter 2025 compared to $1.5 billion in the same period in 2024, primarily due to lower clinical manufacturing activities and prior year CymaBay acquisition-related expenses that did not repeat. Non-GAAP R&D expenses were $1.3 billion in the first quarter 2025 compared to $1.4 billion in the same period in 2024, primarily due to lower clinical manufacturing activities. Acquired IPR&D expenses were $253 million in the first quarter 2025, primarily reflecting expenses related to the strategic partnership with LEO Pharma A/S (“LEO Pharma”) announced in January 2025. Selling, general and administrative (“SG&A”) expenses were $1.3 billion in the first quarter 2025 compared to $1.4 billion in the same period in 2024, primarily driven by prior year CymaBay acquisition-related expenses that did not repeat as well as lower corporate expenses, partially offset by incremental selling and marketing expenses in the United States. Non-GAAP SG&A expenses were $1.2 billion in the first quarter 2025 compared to $1.3 billion in the same period in 2024. This was primarily driven by lower corporate expenses, partially offset by incremental selling and marketing expenses in the United States. The effective tax rate (“ETR”) was 20.2% in the first quarter 2025 compared to 7.0% in the same period in 2024, and the non-GAAP ETR was 16.3% in the first quarter 2025 compared to (29.8)% in the same period in 2024. These changes primarily reflect the prior year non-deductible acquired IPR&D charge related to the CymaBay acquisition, and higher tax benefits from stock-based compensation. Guidance and Outlook For the full-year, Gilead expects: (in millions, except per share amounts) April 24, 2025 Guidance Low End High End Comparison to Prior Guidance Product sales $ 28,200 $ 28,600 Unchanged Product sales excluding Veklury $ 26,800 $ 27,200 Unchanged Veklury $ 1,400 $ 1,400 Unchanged Diluted EPS $ 5.65 $ 6.05 Previously $5.95 to $6.35 Non-GAAP diluted EPS $ 7.70 $ 8.10 Unchanged Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Announced FDA accepted New Drug Application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a PDUFA date of June 19, 2025. Announced the European Medicines Agency validated the Marketing Authorization Application and EU-Medicines for All application for twice-yearly lenacapavir for HIV prevention, which will undergo parallel reviews under an Accelerated Assessment timeline. Presented initial Phase 1 data evaluating investigational once-yearly lenacapavir for HIV prevention at the Conference on Retroviruses and Opportunistic Infections (“CROI”), and announced plans to launch a Phase 3 study in the second half of 2025. Presented HIV treatment research data at CROI, including long-term outcomes evaluating the use of Biktarvy in people with HIV/HBV coinfection and the primary results of a Phase 2 study evaluating the investigational combination regimen of lenacapavir and broadly neutralizing antibodies teropavimab and zinlirvimab. Oncology Announced Trodelvy plus Keytruda® (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in progression free survival in patients with previously untreated PD-L1+ unresectable locally advanced or metastatic triple-negative breast cancer in the Phase 3 ASCENT-04 trial. The use of Trodelvy plus Keytruda is investigational in this setting. Inflammation Received conditional marketing authorization from the European Commission for seladelpar for the treatment of PBC in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Corporate The Board declared a quarterly dividend of $0.79 per share of common stock for the second quarter of 2025. The dividend is payable on June 27, 2025, to stockholders of record at the close of business on June 13, 2025. Future dividends will be subject to Board approval. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2025 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues, the impact of the Inflation Reduction Act, changes in U.S. regulatory or legislative policies, and changes in U.S. trade policies, including tariffs; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the acquisitions of CymaBay and Immunomedics, and the arrangement with LEO Pharma; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy, Trodelvy, lenacapavir, teropavimab and zinlirvimab, and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines, including for lenacapavir for HIV PrEP; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, including for lenacapavir for PrEP, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies and may therefore be reluctant to prescribe the products, including Livdelzi/Lyvdelzi; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended March 31, 2025 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Additional information is available on our Investor Relations website, https://investors.gilead.com. Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten (10) days after the end of each quarter. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE™, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LIVDELZI®/LYVDELZI®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended March 31, (in millions, except per share amounts) 2025 2024 Revenues: Product sales $ 6,613 $ 6,647 Royalty, contract and other revenues 54 39 Total revenues 6,667 6,686 Costs and expenses: Cost of goods sold 1,540 1,552 Research and development expenses 1,379 1,520 Acquired in-process research and development expenses 253 4,131 In-process research and development impairments — 2,430 Selling, general and administrative expenses 1,258 1,375 Total costs and expenses 4,430 11,008 Operating income (loss) 2,237 (4,322 ) Interest expense 260 254 Other (income) expense, net 328 (91 ) Income (loss) before income taxes 1,649 (4,486 ) Income tax expense (benefit) 334 (315 ) Net income (loss) 1,315 (4,170 ) Net income attributable to noncontrolling interest — — Net income (loss) attributable to Gilead $ 1,315 $ (4,170 ) Basic earnings (loss) per share attributable to Gilead $ 1.06 $ (3.34 ) Diluted earnings (loss) per share attributable to Gilead $ 1.04 $ (3.34 ) Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,246 1,247 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,259 1,247 Supplemental Information: Cash dividends declared per share $ 0.79 $ 0.77 Product gross margin 76.7 % 76.6 % Research and development expenses as a % of revenues 20.7 % 22.7 % Selling, general and administrative expenses as a % of revenues 18.9 % 20.6 % Operating margin 33.6 % (64.6 )% Effective tax rate 20.2 % 7.0 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended March 31, (in millions, except percentages) 2025 2024 Change Product sales: HIV $ 4,587 $ 4,342 6% Liver Disease 758 737 3% Oncology 757 789 (4)% Other 209 224 (7)% Total product sales excluding Veklury 6,311 6,092 4% Veklury 302 555 (45)% Total product sales 6,613 6,647 (1)% Royalty, contract and other revenues 54 39 37% Total revenues $ 6,667 $ 6,686 —% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended March 31, (in millions, except percentages) 2025 2024 Change Non-GAAP: Cost of goods sold $ 961 $ 974 (1)% Research and development expenses $ 1,338 $ 1,403 (5)% Acquired IPR&D expenses(2) $ 253 $ 4,131 (94)% Selling, general and administrative expenses $ 1,222 $ 1,295 (6)% Other (income) expense, net $ (98 ) $ (104 ) (6)% Diluted earnings (loss) per share attributable to Gilead $ 1.81 $ (1.32 ) NM Shares used in non-GAAP diluted earnings (loss) per share attributable to Gilead calculation 1,259 1,247 1% Product gross margin 85.5 % 85.4 % 12 bps Research and development expenses as a % of revenues 20.1 % 21.0 % -91 bps Selling, general and administrative expenses as a % of revenues 18.3 % 19.4 % -104 bps Operating margin 43.4 % (16.7 )% NM Effective tax rate 16.3 % (29.8 )% NM (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended March 31, (in millions, except percentages and per share amounts) 2025 2024 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,540 $ 1,552 Acquisition-related – amortization(1) (579 ) (579 ) Non-GAAP cost of goods sold $ 961 $ 974 Product gross margin reconciliation: GAAP product gross margin 76.7 % 76.6 % Acquisition-related – amortization(1) 8.8 % 8.7 % Non-GAAP product gross margin 85.5 % 85.4 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,379 $ 1,520 Acquisition-related – other costs(2) (2 ) (66 ) Restructuring (38 ) (50 ) Non-GAAP research and development expenses $ 1,338 $ 1,403 IPR&D impairment reconciliation: GAAP IPR&D impairment $ — $ 2,430 IPR&D impairment — (2,430 ) Non-GAAP IPR&D impairment $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,258 $ 1,375 Acquisition-related – other costs(2) — (67 ) Restructuring (36 ) (13 ) Non-GAAP selling, general and administrative expenses $ 1,222 $ 1,295 Operating income (loss) reconciliation: GAAP operating income (loss) $ 2,237 $ (4,322 ) Acquisition-related – amortization(1) 579 579 Acquisition-related – other costs(2) 2 133 Restructuring 74 63 IPR&D impairment — 2,430 Non-GAAP operating income (loss) $ 2,893 $ (1,117 ) Operating margin reconciliation: GAAP operating margin 33.6 % (64.6 )% Acquisition-related – amortization(1) 8.7 % 8.7 % Acquisition-related – other costs(2) — % 2.0 % Restructuring 1.1 % 0.9 % IPR&D impairment — % 36.3 % Non-GAAP operating margin 43.4 % (16.7 )% Other (income) expense, net reconciliation: GAAP other (income) expense, net $ 328 $ (91 ) Loss from equity securities, net (426 ) (14 ) Non-GAAP other (income) expense, net $ (98 ) $ (104 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 1,649 $ (4,486 ) Acquisition-related – amortization(1) 579 579 Acquisition-related – other costs(2) 2 133 Restructuring 74 63 IPR&D impairment — 2,430 Loss from equity securities, net 426 14 Non-GAAP income (loss) before income taxes $ 2,731 $ (1,267 ) GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended March 31, (in millions, except percentages and per share amounts) 2025 2024 Income tax expense (benefit) reconciliation: GAAP income tax expense (benefit) $ 334 $ (315 ) Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 120 121 Acquisition-related – other costs(2) — 30 Restructuring 14 10 IPR&D impairment — 611 Loss (gain) from equity securities, net 20 (39 ) Discrete and related tax charges(3) (42 ) (39 ) Non-GAAP income tax expense $ 446 $ 379 Effective tax rate reconciliation: GAAP effective tax rate 20.2 % 7.0 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(3) (3.9 )% (36.8 )% Non-GAAP effective tax rate 16.3 % (29.8 )% Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,315 $ (4,170 ) Acquisition-related – amortization(1) 459 458 Acquisition-related – other costs(2) 2 103 Restructuring 61 54 IPR&D impairment — 1,819 Loss from equity securities, net 406 53 Discrete and related tax charges(3) 42 39 Non-GAAP net income (loss) attributable to Gilead $ 2,285 $ (1,644 ) Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.04 $ (3.34 ) Acquisition-related – amortization(1) 0.36 0.37 Acquisition-related – other costs(2) — 0.08 Restructuring 0.05 0.04 IPR&D impairment — 1.46 Loss from equity securities, net 0.32 0.04 Discrete and related tax charges(3) 0.03 0.03 Non-GAAP diluted earnings (loss) per share $ 1.81 $ (1.32 ) Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 579 Research and development expenses adjustments 40 117 IPR&D impairment adjustments — 2,430 Selling, general and administrative expenses adjustments 36 80 Total non-GAAP adjustments to costs and expenses 656 3,205 Other (income) expense, net, adjustments 426 14 Total non-GAAP adjustments before income taxes 1,082 3,219 Income tax effect of non-GAAP adjustments above (154 ) (732 ) Discrete and related tax charges(3) 42 39 Total non-GAAP adjustments to net income attributable to Gilead $ 970 $ 2,526 (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses and contingent consideration fair value adjustments associated with Gilead’s recent acquisitions. (3) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2025 FULL-YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 11, 2025 Updated April 24, 2025 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% 77.0% - 78.0% Acquisition-related expenses ~ 8.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $10,200 - $10,700 $10,200 - $10,700 Acquisition-related and restructuring expenses ~ 2,500 ~ 2,500 Non-GAAP projected operating income $12,700 - $13,200 $12,700 - $13,200 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 20% ~ 21% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 1%) (~ 2%) Non-GAAP projected effective tax rate ~ 19% ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.95 - $6.35 $5.65 - $6.05 Acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.75 ~ 2.05 Non-GAAP projected diluted EPS $7.70 - $8.10 $7.70 - $8.10 (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) March 31, December 31, (in millions) 2025 2024 Assets Cash and cash equivalents $ 7,926 $ 9,991 Accounts receivable, net 4,388 4,420 Inventories 3,778 3,589 Property, plant and equipment, net 5,421 5,414 Intangible assets, net 19,355 19,948 Goodwill 8,314 8,314 Other assets 7,253 7,319 Total assets $ 56,434 $ 58,995 Liabilities and Stockholders’ Equity Current liabilities $ 12,344 $ 12,004 Long-term liabilities 25,012 27,744 Stockholders’ equity(1) 19,078 19,246 Total liabilities and stockholders’ equity $ 56,434 $ 58,995 (1) As of March 31, 2025 and December 31, 2024, there were 1,245 and 1,246 shares of common stock issued and outstanding, respectively. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended March 31, (in millions) 2025 2024 Net cash provided by operating activities $ 1,757 $ 2,219 Net cash used in investing activities (415 ) (2,207 ) Net cash used in financing activities (3,426 ) (1,361 ) Effect of exchange rate changes on cash and cash equivalents 19 (18 ) Net change in cash and cash equivalents (2,065 ) (1,367 ) Cash and cash equivalents at beginning of period 9,991 6,085 Cash and cash equivalents at end of period $ 7,926 $ 4,718 Three Months Ended March 31, (in millions) 2025 2024 Net cash provided by operating activities $ 1,757 $ 2,219 Purchases of property, plant and equipment (104 ) (105 ) Free cash flow(1) $ 1,653 $ 2,114 (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) Three Months Ended March 31, (in millions) 2025 2024 HIV Biktarvy – U.S. $ 2,474 $ 2,315 Biktarvy – Europe 375 365 Biktarvy – Rest of World 301 265 3,150 2,946 Descovy – U.S. 538 371 Descovy – Europe 21 26 Descovy – Rest of World 27 29 586 426 Genvoya – U.S. 305 332 Genvoya – Europe 40 49 Genvoya – Rest of World 19 21 364 403 Odefsey – U.S. 215 223 Odefsey – Europe 57 76 Odefsey – Rest of World 10 11 281 310 Symtuza - Revenue share(1) – U.S. 82 104 Symtuza - Revenue share(1) – Europe 29 33 Symtuza - Revenue share(1) – Rest of World 3 3 114 141 Other HIV(2) – U.S. 50 60 Other HIV(2) – Europe 31 45 Other HIV(2) – Rest of World 10 12 91 117 Total HIV – U.S. 3,664 3,405 Total HIV – Europe 553 596 Total HIV – Rest of World 370 342 4,587 4,342 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 166 248 Sofosbuvir / Velpatasvir(3) – Europe 80 79 Sofosbuvir / Velpatasvir(3) – Rest of World 99 78 346 405 Vemlidy – U.S. 100 95 Vemlidy – Europe 12 11 Vemlidy – Rest of World 140 119 252 225 Other Liver Disease(4) – U.S. 68 42 Other Liver Disease(4) – Europe 76 47 Other Liver Disease(4) – Rest of World 17 19 161 107 Total Liver Disease – U.S. 335 385 Total Liver Disease – Europe 168 137 Total Liver Disease – Rest of World 256 215 758 737 Veklury Veklury – U.S. 199 315 Veklury – Europe 22 70 Veklury – Rest of World 82 169 302 555 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended March 31, (in millions) 2025 2024 Oncology Cell Therapy Tecartus – U.S. 40 55 Tecartus – Europe 31 36 Tecartus – Rest of World 8 8 78 100 Yescarta – U.S. 160 170 Yescarta – Europe 149 158 Yescarta – Rest of World 77 52 386 380 Total Cell Therapy – U.S. 200 225 Total Cell Therapy – Europe 180 195 Total Cell Therapy – Rest of World 84 60 464 480 Trodelvy Trodelvy – U.S. 181 206 Trodelvy – Europe 75 68 Trodelvy – Rest of World 37 36 293 309 Total Oncology – U.S. 381 431 Total Oncology – Europe 255 262 Total Oncology – Rest of World 121 96 757 789 Other AmBisome – U.S. 5 14 AmBisome – Europe 67 70 AmBisome – Rest of World 66 60 139 144 Other(5) – U.S. 47 59 Other(5) – Europe 9 9 Other(5) – Rest of World 14 12 70 80 Total Other – U.S. 52 73 Total Other – Europe 76 79 Total Other – Rest of World 81 71 209 224 Total product sales – U.S. 4,631 4,609 Total product sales – Europe 1,073 1,144 Total product sales – Rest of World 909 894 $ 6,613 $ 6,647 (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada and Tybost. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Livdelzi/Lyvdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis and Zydelig.