Bulevirtide Acetate

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new findings from its antiviral research and development programs at IDWeek 2024 , taking place from October 16-19. The data from 31 presentations across HIV treatment and prevention, COVID-19 and viral hepatitis include one late breaker abstract and six oral presentations, reflecting Gilead’s commitment to helping address the evolving needs of a diverse range of people and communities affected by some of the world’s most challenging viruses. “ We look forward to sharing new research that highlights the breadth of our antiviral portfolio and expanding pipeline as we strive to treat, prevent, cure and help eradicate viral diseases worldwide,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head at Gilead Sciences. “ The data reflect our unwavering commitment to advance scientific innovations in virology, aimed at addressing urgent global needs.” HIV Research Continuous scientific discovery in HIV is a pillar of Gilead’s commitment to help end the HIV epidemic. Presented studies’ results and analyses will include further evaluation of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV (PWH). Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including new data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI), and a late-breaker oral presentation of Week 48 data from the Phase 2 study evaluating an investigational once-weekly oral combination regimen of islatravir and lenacapavir will also be presented. Gilead will present an overview of results from its pivotal Phase 3 PURPOSE 1 ( NCT04994509 ) and PURPOSE 2 ( NCT04925752 ) trials, which studied the efficacy and safety of lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention in a broad, diverse range of people globally. The trials were unblinded in June and September, respectively. Additionally, Gilead will present five-year outcomes in new subgroup analyses from Studies 1489 ( NCT02607930 ) and 1490 ( NCT02607956 ), which assessed the safety and efficacy of Biktarvy compared to Triumeq (ABC/DTG/3TC) and dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, DTG+F/TDF. The first analysis evaluated the safety and efficacy of Biktarvy in treatment naïve PWH aged 50 or older, providing data to inform treatment decisions in this increasing proportion of PWH with a greater burden of age-related comorbidities. The second analysis evaluated the safety and efficacy of Biktarvy in treatment-naïve Black adults, a population that has historically been underrepresented in clinical studies despite the disproportionate impact of HIV on Black communities. Gilead will also present three-year outcomes from the CAPELLA study ( NCT04150068 ), which evaluated twice-yearly subcutaneous dosing of Sunlenca ® (lenacapavir) in combination with an optimized background regimen in people with multi-drug resistant HIV. HIV prevention data will include an analysis of newly initiated pre-exposure prophylaxis (PrEP) use in priority populations with unmet needs for PrEP in the U.S. Additional HIV research findings include a presentation of survey data reporting current real-world trends for PWH with ART resistance mutations and utilization of healthcare resources in addition to the impact on efficacy, safety and clinical outcomes. COVID-19 Research Across Gilead’s 14 presentations in COVID-19, key data will highlight the dynamic nature of the SARS-CoV-2 virus and address the needs of those most susceptible to severe outcomes from COVID-19. A real-world evidence analysis will feature outcomes following treatment with Veklury ® (remdesivir, 100mg for injection), for people hospitalized with COVID-19 who have leukemia, lymphoma and multiple myeloma. Additionally, a presentation of in vitro data will demonstrate the ongoing antiviral activity of Veklury against recent Omicron subvariants. An oral presentation will discuss how investigational obeldesivir reduced SARS-CoV-2 infectious viral titers in people with COVID-19. Gilead will also present full data results from the obeldesivir BIRCH ( NCT05603143 ) and OAKTREE ( NCT05715528 ) clinical trials. Previously, Gilead announced the early termination of the BIRCH trial due to lower-than-expected COVID-19 incidence rates and related hospitalizations or all-cause death by Day 29, which were primary endpoints in the study. The decision did not reflect any safety or efficacy concerns. Gilead also previously announced top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint in people without risk factors, obeldesivir was found to have a generally well tolerated safety profile. The detailed data add to the breadth of safety data on obeldesivir. Based on results from BIRCH and OAKTREE, as well as results from preclinical studies in Respiratory Syncytial Virus (RSV), Gilead has launched a Phase 2 trial to study obeldesivir as a potential treatment for non-hospitalized adults with acute RSV. The study will evaluate if obeldesivir can help participants' symptoms improve faster. Overview of Scientific Presentations HIV Treatment Research Late Breaker Week 48 Results of a Phase 2 Study Evaluating Once-weekly Oral Islatravir Plus Lenacapavir Oral Presentation Abstract 155 Long-Acting Subcutaneous Lenacapavir in People With Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study Oral Presentation Abstract 154 Pharmacokinetics and Safety of GS-1720 Following Multiple Ascending Doses in a Phase 1a Study in People Without HIV-1 P-547 Efficacy and Safety of B/F/TAF in Treatment-Naïve People With HIV Aged ≥ 50 Years: 5-Year Follow-Up from Two Phase 3 Studies P-550 Efficacy and Safety of B/F/TAF in Black Adults With HIV who are Treatment Naïve: 5-Year Follow-Up from Two Phase 3 Studies P-474 Effects of Antiretroviral Resistance on Outcomes and Healthcare Resource Use of People With HIV in the United States and Europe – A Real-world Survey P-590 Impact of Pharmacoenhancers on the Pharmacokinetics and Safety of Lenacapavir in People With HIV P-473 Health Care Resource Use Burden Among People with HIV (PWH) and Concurrent Mental Health Disorders (MHDs): Claims Analysis of Treatment-Naïve Medicaid Population Initiating Multi-Tablet Regimens (MTRs) vs. Single-Table Regimens (STRs) P-529 Comparison of Renal Outcomes by Tenofovir Alafenamide Fumarate (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) Containing Regimens for Prevention, and Treatment of HIV and/or HBV Treatment: A Systematic Literature Review and Meta-Analysis HIV Prevention Research Oral Presentation Abstract 507 Trajectories of Newly Initiated Pre-Exposure Prophylaxis (PrEP) Use Among Priority Populations With Unmet Needs for PrEP in the USA P-512 Changes in Renal Function After Switching from Emtricitabine/Tenofovir Disoproxil Fumarate to Emtricitabine/Tenofovir Alafenamide Fumarate for HIV Pre Exposure Prophylaxis (PrEP): A Real-World Study COVID-19 Research Oral Presentation Abstract 92 Obeldesivir Reduced SARS-CoV-2 Infectious Titers in the BIRCH Phase 3 Clinical Trial (GS-US-611-6273) P-2036 The OAKTREE Study: Obeldesivir for Treatment of COVID-19 in Adults and Adolescents Without Risk Factors for Progression to Severe Disease P-2026 The BIRCH Study: Obeldesivir for the Treatment of COVID-19 in People With Comorbid Risk Factors for Progression to Severe Disease P-2030 Remdesivir and Obeldesivir Retain Potent Activity Against SARS-CoV-2 Omicron Variants P-1925 Incidence of Long COVID Symptoms During the Year Post Admission Among Patients Hospitalized for COVID-19 P-1939 Health Status and Symptom Perceptions Among Patients Diagnosed with Long COVID in the United States: An Online Survey Study P-1938 Impact of Race and Ethnicity on Patient Perspectives of Health and Symptoms Following COVID-19 Diagnosis P-2033 Patient Characteristics and Management of COVID-19 Diagnosed in the Outpatient Setting P-2020 Combination Therapy with Remdesivir and Corticosteroids is Associated With Lower Mortality Risk vs. Corticosteroids Monotherapy in Patients Hospitalised for COVID-19 P-1913 Characteristics, Clinical Management, and Outcomes of Leukemia, Lymphoma and Multiple Myeloma Patients Hospitalized With a Primary Diagnosis of COVID-19: Insights from Hospitals Across the United States P-1973 Characteristics, Clinical Management, and Outcomes of Immunocompromised Patients Diagnosed with COVID-19 in the Outpatient Setting in France P-2021 How Have COVID-19 Treatment Guidelines and the Scientific Evidence Evolved Throughout the Pandemic and Endemic Era? P-2031 Thorough QT/QTc Clinical Study to Evaluate the Effect of Remdesivir on Cardiac Repolarization in Healthy Male and Female Participants P-2025 Resistance Analyses from the Remdesivir Phase 2/3 Caravan Study in Pediatric and Neonatal Participants with COVID-19 Viral Hepatitis Research Oral Presentation Abstract 83 Predictors of Undetectable HDV RNA 48 Weeks After Completion of Finite Treatment With Bulevirtide and Pegylated-Interferon Alpha 2a P-2191 Efficacy and Safety of Bulevirtide Monotherapy for Chronic Hepatitis D in Patients With and Without Cirrhosis: Results from the Week 144 Interim Analysis of a Phase 3 Randomized Study P-2185 Community Health Worker-led Intervention to Increase Hepatitis Delta Virus Screening Among Immigrants in the Metropolitan-DC Area P-2180 Linkage to Care, Treatment Initiation, and Outcomes in Individuals with Hepatitis B Virus Infection With and Without Cirrhosis P-2322 Screening Rates and Clinical Outcomes for Hepatitis Delta in Individuals with HBV Coinfection P-2188 Hepatitis C Screening: Before and After Study of Hepatitis C Risk Score Alerts in CHORUS For more information about Gilead at IDWeek 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://idweek.org/program/ . GS-1720 is an investigational compound and not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. The use of the compound alone or in combination with other antiretrovirals is investigational. Its safety and efficacy are unknown. Lenacapavir is presently marketed as Sunlenca and approved for the treatment of adults with multi-drug resistant HIV in combination with an optimized background regimen. Lenacapavir is being studied in multiple ongoing early- and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment and prevention that could uniquely fit into the lives of PWH and individuals who need or want PrEP. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning , for Biktarvy. Please also see below for the U.S. Indication and Important Safety Information for Sunlenca and Veklury. There is currently no cure for HIV or AIDS. All uses of obeldesivir are investigational and have not been determined to be safe or efficacious and is not approved by the FDA. Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), Great Britain and Switzerland and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere. 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 Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. About Sunlenca Sunlenca (lenacapavir), 300 mg tablet and 463.5 mg/1.5 mL injection, is a first-in-class, long-acting HIV capsid inhibitor approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom, and the United States for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option. The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca 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 for HIV prevention is investigational, and its safety and efficacy for this use have not been established. 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. About Veklury Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury is the only antiviral studied in hospitalized COVID-19 patients in clinical trials and large real-world analyses that has demonstrated reduced time to recovery, as well as disease progression, mortality and readmission. Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBF, XBB.1.16, FL.22, E.G.5.1 and BA.2.86. Veklury continues to be evaluated against emerging variants of interest and concern. Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to approximately 14.5 million patients around the world, including more than 8.1 million people in middle- and low-income countries through Gilead’s voluntary licensing program. U.S. Indication for Biktarvy Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history 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. U.S. Indication for Sunlenca Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. U.S. Important Safety Information for Sunlenca Contraindications Coadministration : Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers. Warnings and precautions Immune reconstitution syndrome , including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy. Long-acting properties and potential associated risks with Sunlenca : Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection. Injection site reactions may occur, and nodules and indurations may be persistent. Adverse reactions Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%). Drug interactions Prescribing information : Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters : Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions. Dosage and administration Dosage : Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food. Initiation Option 1 : Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Initiation Option 2 : Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection. Maintenance : 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection. Missed Dose : During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2. Pregnancy and lactation Pregnancy : There is insufficient human data on the use of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation : Individuals infected with HIV-1 should informed of the potential risks of breastfeeding. U.S. Indication for Veklury Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (weighing ≥1.5 kg) who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. For more information, please see the U.S. full Prescribing Information available at www.gilead.com . U.S. Important Safety Information for Veklury Contraindication Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Warnings and precautions Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications). Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation. Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury. Adverse reactions The most common adverse reaction (≥5% all grades) was nausea. The most common lab abnormalities (≥5% all grades) were increases in ALT and AST. Drug interactions Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Dosage and administration Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Treatment duration: For patients who are hospitalized, Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19. For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days. For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use. Testing prior to and during treatment: Perform hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate. Renal impairment: No dose adjustment of Veklury is recommended in patients with any degree of renal impairment, including patients on dialysis. Veklury may be administered without regard to the timing of dialysis. Pregnancy and lactation Pregnancy: A pregnancy registry has been established for Veklury. Available clinical trial data for Veklury in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of Veklury exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy. Lactation: Veklury can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Veklury and any potential adverse effects on the breastfed child from Veklury or from an underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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, Calif. For 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 12 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 is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS. 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 or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, Sunlenca, Veklury, bulevirtide, lenacapavir, obeldesivir and GS-1720 (such as the BIRCH, CAPELLA and OAKTREE trials and Studies 1489 and 1490); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of programs for indications that are currently under evaluation, including lenacapavir, obeldesivir and GS-1720, and, as a result, these programs may never be successfully commercialized for such indications; 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, 2024, 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. Biktarvy, Sunlenca, Veklury, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s). U.S. full Prescribing Information for Biktarvy, including BOXED WARNING , U.S. full Prescribing Information for Sunlenca, and U.S. full Prescribing Information for Veklury are available at www.gilead.com . For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its second quarter 2024 results of operations. “Gilead has had another strong quarter with 6% year-over-year growth in our base business. This was driven by sales of our therapies for HIV, Oncology and Liver Disease, including 8% growth for Biktarvy,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “One of the key highlights of the quarter was interim data from the Phase 3 PURPOSE 1 trial showing 100% efficacy for lenacapavir in HIV prevention for cisgender women. We look forward to additional clinical readouts in the coming months, and to potentially launching seladelpar for primary biliary cholangitis in the United States.” Second Quarter 2024 Financial Results Total second quarter 2024 revenue increased 5% to $7.0 billion, compared to the same period in 2023, primarily due to higher product sales in HIV, Liver Disease and Oncology. Diluted earnings per share (“EPS”) was $1.29 in the second quarter 2024, compared to $0.83 in the same period in 2023. The increase was primarily driven by lower operating expenses, including a 2023 expense of $525 million for settlements with certain plaintiffs in HIV antitrust litigation which did not repeat in 2024, as well as higher revenues and lower income tax expense, partially offset by higher net unrealized losses on equity securities. Non-GAAP diluted EPS was $2.01 in the second quarter 2024, compared to $1.34 in the same period in 2023. The increase was primarily driven by lower operating expenses and higher revenues. As of June 30, 2024, Gilead had $2.8 billion of cash, cash equivalents and marketable debt securities, compared to $8.4 billion as of December 31, 2023. The decrease primarily reflects the $3.9 billion acquisition of CymaBay Therapeutics, Inc. and a $1.75 billion repayment of senior notes. During the second quarter 2024, Gilead generated $1.3 billion in operating cash flow, net of a $1.2 billion transition tax payment associated with the Tax Cuts and Jobs Act of 2017. During the second quarter 2024, Gilead paid dividends of $972 million and repurchased $100 million of common stock. Second Quarter 2024 Product Sales Total second quarter 2024 product sales increased 5% to $6.9 billion, compared to the same period in 2023. Total product sales, excluding Veklury, increased 6% to $6.7 billion in the second quarter 2024, compared to the same period in 2023, primarily due to higher product sales in HIV, Liver Disease and Oncology. HIV product sales increased 3% to $4.7 billion in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand across treatment and prevention, partially offset by lower average realized price due to channel mix. Biktarvy ® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 8% to $3.2 billion in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand. Descovy® (FTC 200mg/TAF 25mg) sales decreased 6% to $485 million in the second quarter 2024, compared to the same period in 2023, primarily driven by lower average realized price due to channel mix, partially offset by higher demand. The Liver Disease portfolio sales increased 17% to $832 million in the second quarter 2024, compared to the same period in 2023. This was primarily driven by higher average realized price due to channel mix in the United States, as well as higher demand in products for chronic hepatitis C virus (“HCV”), chronic hepatitis B virus (“HBV”) and, in Europe, chronic hepatitis D virus (“HDV”). Veklury sales decreased 16% to $214 million in the second quarter 2024, compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations. Cell Therapy product sales increased 11% to $521 million in the second quarter 2024, compared to the same period in 2023. Yescarta® (axicabtagene ciloleucel) sales increased 9% to $414 million in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the United States. Tecartus® (brexucabtagene autoleucel) sales increased 21% to $107 million in the second quarter 2024, compared to the same period in 2023, driven by higher demand in R/R mantle cell lymphoma and R/R adult acute lymphoblastic leukemia (“ALL”). Trodelvy® (sacituzumab govitecan-hziy) sales increased 23% to $320 million in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand in second-line metastatic triple negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer. Second Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 77.7% in the second quarter 2024, compared to 78.0% in the same period in 2023. Non-GAAP product gross margin was 86.0% in the second quarter 2024, compared to 86.9% in the same period in 2023. Research & development (“R&D”) expenses were $1.4 billion in the second quarter 2024 and in the same period in 2023. Non-GAAP R&D expenses were $1.3 billion in the second quarter 2024, compared to $1.4 billion in the same period in 2023. The changes were primarily driven by timing of clinical activities, including wind-down of studies. Acquired IPR&D expenses were $38 million in the second quarter 2024. Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses were $1.4 billion in the second quarter 2024, compared to $1.8 billion in the same period in 2023. The decreases in GAAP and non-GAAP SG&A expenses were primarily driven by the 2023 legal settlement expense referenced earlier which did not repeat in 2024. The effective tax rate (“ETR”) was 21.4% in the second quarter 2024, compared to 34.6% in the same period in 2023. The decrease in ETR primarily reflects a remeasurement of certain deferred tax liabilities in the prior year and a settlement with a tax authority in the second quarter 2024. Non-GAAP ETR was 17.8% in the second quarter 2024, compared to 21.0% in the same period in 2023. The decrease in non-GAAP ETR primarily reflects a settlement with a tax authority. Guidance and Outlook For the full-year 2024, Gilead expects: (in millions, except per share amounts) August 8, 2024 Guidance Low End High End Comparison to April 25, 2024 Guidance Product sales $ 27,100 $ 27,500 Unchanged Product sales, excluding Veklury $ 25,800 $ 26,200 Unchanged Veklury $ 1,300 $ 1,300 Unchanged Diluted EPS $ 0.00 $ 0.30 Previously $0.10 to $0.50 Non-GAAP diluted EPS $ 3.60 $ 3.90 Previously $3.45 to $3.85 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 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 Presented data from the Phase 3 PURPOSE 1 trial evaluating twice-yearly subcutaneous lenacapavir for HIV prevention in cisgender women at the International AIDS Conference (“AIDS 2024”). At the interim analysis, lenacapavir demonstrated 100% efficacy with zero HIV infections and superiority to both background HIV incidence and once-daily oral Truvada® (FTC 200mg and tenofovir disoproxil fumarate 300mg (“TDF”)). Lenacapavir was generally well-tolerated and no new safety concerns were identified. The use of lenacapavir for PrEP is investigational. Highlighted long-term, five-year data for Biktarvy at AIDS 2024, demonstrating virologic suppression in Hispanic/Latine people with HIV, as well as older adults with comorbidities. Additionally, presented results from Gilead’s investigational treatment pipeline, including 48-week data from the Phase 2 portion of the Phase 2/3 ARTISTRY study of once-daily oral bictegravir plus lenacapavir, once-weekly oral agents GS-1720 and GS-4182, as well as twice-yearly lenacapavir in combination with two broadly neutralizing antibodies, teropavimab and zinlirvimab. Announced U.S. Food and Drug Administration (“FDA”) approval of an updated label for Biktarvy to include additional data for the treatment of pregnant adults with HIV-1 with suppressed viral loads. Presented Phase 2b MYR201 data demonstrating potential for the investigational combination of bulevirtide 10 mg with pegylated interferon alfa-2a as finite therapy for people with chronic HDV at the European Association for the Study of the Liver (“EASL”) meeting. These data were simultaneously published in the New England Journal of Medicine . Presented 144-week follow-up data from the Phase 3 MYR301 study at EASL that reinforced bulevirtide as an efficacious and generally well-tolerated long-term treatment option as monotherapy in adults with chronic HDV. Bulevirtide 2 mg remains the only approved treatment for HDV in the EU and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally. Oncology Announced Trodelvy did not meet the primary endpoint of improvement in overall survival (“OS”) in the intention-to-treat (“ITT”) population of the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer. A numerical improvement in OS favoring Trodelvy was observed, in addition to trends in improvement for select pre-specified non-alpha controlled subgroups analyses and secondary endpoints of progression-free survival and overall response rate. In the ITT population, there was a higher number of deaths due to adverse events with Trodelvy compared to single-agent chemotherapy, which were primarily observed early in treatment and related to neutropenic complications, including infection. Presented detailed results from the Phase 3 EVOKE-01 study evaluating Trodelvy in patients with metastatic or advanced non-small cell lung cancer (“NSCLC”) that had progressed on or after platinum-based chemotherapy and anti-PD(L)1 therapy at the American Society of Clinical Oncology (“ASCO”) meeting. These data were simultaneously published in the Journal of Clinical Oncology . As announced in January 2024, EVOKE-01 did not meet its primary endpoint of overall survival. The use of Trodelvy for lung cancer is investigational. Provided a longer-term update on Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in combination with pembrolizumab in first-line advanced or metastatic squamous or non-squamous PD-L1-high NSCLC at the ASCO meeting. Announced new data from a pilot study in collaboration with Dana-Farber Cancer Institute that evaluated the safety of Yescarta in patients living with R/R primary or secondary central nervous system lymphoma, an investigational use. This data was presented at the ASCO meeting. Presented updated, four-year OS data from the pivotal Phase 2 ZUMA-3 study evaluating Tecartus in adult patients with R/R B-cell ALL at the ASCO meeting. Presented updated analysis at the ASCO meeting from Arm A1 of the Phase 2 EDGE-Gastric study evaluating domvanalimab, zimberelimab (“zim”) and FOLFOX as a potential first-line treatment for upper gastrointestinal cancers, in partnership with Arcus Biosciences, Inc. (“Arcus”). Additionally, presented Phase 1b/2 ARC-9 Cohort B data with our partner Arcus, which is evaluating etrumadenant plus zim, FOLFOX and bevacizumab in third-line metastatic colorectal cancer. These products and uses are investigational. Announced preliminary findings at the European Hematology Association (“EHA”) meeting from the Phase 2 ZUMA-24 study suggesting outpatient administration of Yescarta is feasible. Additionally, presented real-world manufacturing experience analysis demonstrating a statistically significant higher number of R/R large B-cell lymphoma patients that received second-line treatment with Yescarta achieved first-pass manufacturing success compared to patients that received treatment with Yescarta in third-line and beyond. Announced key operational updates, together with Arcellx, Inc. (“Arcellx”), for the anitocabtagene autoleucel multiple myeloma development program, including the design of the Phase 3 iMMagine-3 trial as a second- to fourth-line treatment for multiple myeloma, as well as the completion of the technical transfer to Kite. Inflammation Presented two-year interim results from the ongoing long-term Phase 3 ASSURE study evaluating seladelpar in people living with primary biliary cholangitis (“PBC”) who participated in any prior seladelpar clinical study at the Digestive Diseases Week and EASL meetings. The data demonstrated a sustained and consistent long-term efficacy and safety profile for seladelpar in PBC. Seladelpar is an investigational product and is currently under review by FDA, with a PDUFA date of August 14, 2024. Entered into an amended license agreement featuring the buy-out of global seladelpar royalties from Janssen Pharmaceutica NV for $320 million. This transaction will be reflected in Gilead’s third quarter results. Corporate Announced Gilead reached a settlement agreement in principle in the federal TDF litigation in the U.S. District Court for the Northern District of California. The agreement, which is subject to certain conditions, provides that Gilead will make a one-time payment of up to $40 million and is expected to resolve the claims of the overwhelming majority of plaintiffs in the federal TDF litigation. Announced Chief Medical Officer Merdad Parsey, MD, PhD, will leave the company in the first quarter of 2025. A search is underway for his successor. The Board declared a quarterly dividend of $0.77 per share of common stock for the third quarter of 2024. The dividend is payable on September 27, 2024, to stock holders of record at the close of business on September 13, 2024. 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 changes in tax related laws and guidelines. 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 and cancer. 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 anticipated full year 2024 financial results, including as a result of the uncertainty of the amount and timing of Veklury revenues; 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 arrangements with Arcellx and Arcus; 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, Truvada, Yescarta, bevacizumab, bictegravir, bulevirtide, anitocabtagene autoleucel, domvanalimab, etrumadenant, GS-1720, GS-4182, lenacapavir, teropavimab, seladelpar, zimberelimab, and zinlirvimab (such as the ARTISTRY-1, ASSURE, EDGE-Gastric, EVOKE-01, EVOKE-02, iMMagine-3, MYR201, MYR301, PURPOSE-1, TROPiCS-04, ZUMA-3 and ZUMA-24 studies) , 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; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, including FDA approval of the New Drug Application for seladelpar, 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 (such as the risk that the FDA may not grant full approval or may withdraw its accelerated approval for Trodelvy for the treatment of locally advanced or metastatic urothelial cancer); 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 Biktarvy; 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 June 30, 2024 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. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE TM , AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, United States. Other trademarks are the property of their respective owners. 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 Six Months Ended June 30, June 30, (in millions, except per share amounts) 2024 2023 2024 2023 Revenues: Product sales $ 6,912 $ 6,564 $ 13,559 $ 12,870 Royalty, contract and other revenues 41 35 81 81 Total revenues 6,954 6,599 13,640 12,951 Costs and expenses: Cost of goods sold 1,544 1,442 3,096 2,843 Research and development expenses 1,351 1,407 2,871 2,854 Acquired in-process research and development expenses 38 236 4,169 717 In-process research and development impairment — — 2,430 — Selling, general and administrative expenses 1,377 1,849 2,752 3,168 Total costs and expenses 4,309 4,934 15,317 9,581 Operating income (loss) 2,644 1,665 (1,678 ) 3,370 Interest expense 237 230 491 459 Other (income) expense, net 355 (152 ) 265 22 Income (loss) before income taxes 2,053 1,588 (2,433 ) 2,888 Income tax expense 438 549 123 865 Net income (loss) 1,614 1,039 (2,556 ) 2,024 Net loss attributable to noncontrolling interest — (6 ) — (32 ) Net income (loss) attributable to Gilead $ 1,614 $ 1,045 $ (2,556 ) $ 2,055 Basic earnings (loss) per share attributable to Gilead $ 1.29 $ 0.84 $ (2.05 ) $ 1.65 Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,247 1,249 1,247 1,249 Diluted earnings (loss) per share attributable to Gilead $ 1.29 $ 0.83 $ (2.05 ) $ 1.63 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,251 1,258 1,247 1,260 Supplemental Information: Cash dividends declared per share $ 0.77 $ 0.75 $ 1.54 $ 1.50 Product gross margin 77.7 % 78.0 % 77.2 % 77.9 % Research and development expenses as a % of revenues 19.4 % 21.3 % 21.0 % 22.0 % Selling, general and administrative expenses as a % of revenues 19.8 % 28.0 % 20.2 % 24.5 % Operating margin 38.0 % 25.2 % (12.3 )% 26.0 % Effective tax rate 21.4 % 34.6 % (5.1 )% 29.9 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Product sales: HIV $ 4,745 $ 4,626 3 % $ 9,088 $ 8,816 3 % Liver Disease 832 711 17 % 1,569 1,386 13 % Oncology 841 728 15 % 1,629 1,398 17 % Other 280 243 15 % 504 442 14 % Total product sales excluding Veklury 6,698 6,308 6 % 12,790 12,041 6 % Veklury 214 256 (16 )% 769 829 (7 )% Total product sales 6,912 6,564 5 % 13,559 12,870 5 % Royalty, contract and other revenues 41 35 18 % 81 81 (1 )% Total revenues $ 6,954 $ 6,599 5 % $ 13,640 $ 12,951 5 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION (1) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Non-GAAP: Cost of goods sold $ 965 $ 861 12% $ 1,939 $ 1,732 12% Research and development expenses $ 1,335 $ 1,377 (3)% $ 2,738 $ 2,816 (3)% Acquired IPR&D expenses (2) $ 38 $ 236 (84)% $ 4,169 $ 717 NM Selling, general and administrative expenses $ 1,351 $ 1,848 (27)% $ 2,646 $ 3,166 (16)% Other (income) expense, net $ (37 ) $ (83 ) (56)% $ (141 ) $ (165 ) (15)% Diluted earnings per share attributable to Gilead $ 2.01 $ 1.34 50% $ 0.70 $ 2.71 (74)% Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,251 1,258 (1)% 1,254 1,260 —% Product gross margin 86.0 % 86.9 % -84 bps 85.7 % 86.5 % -84 bps Research and development expenses as a % of revenues 19.2 % 20.9 % -167 bps 20.1 % 21.7 % -167 bps Selling, general and administrative expenses as a % of revenues 19.4 % 28.0 % -857 bps 19.4 % 24.4 % -504 bps Operating margin 47.0 % 34.5 % NM 15.7 % 34.9 % NM Effective tax rate 17.8 % 21.0 % -322 bps 51.4 % 20.0 % NM ________________________________ NM - Not Meaningful (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 Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,544 $ 1,442 $ 3,096 $ 2,843 Acquisition-related – amortization (1) (579 ) (581 ) (1,158 ) (1,110 ) Restructuring — — 1 — Non-GAAP cost of goods sold $ 965 $ 861 $ 1,939 $ 1,732 Product gross margin reconciliation: GAAP product gross margin 77.7 % 78.0 % 77.2 % 77.9 % Acquisition-related – amortization (1) 8.4 % 8.8 % 8.5 % 8.6 % Restructuring (— )% — % (— )% — % Non-GAAP product gross margin 86.0 % 86.9 % 85.7 % 86.5 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,351 $ 1,407 $ 2,871 $ 2,854 Acquisition-related – other costs (2) (3 ) (30 ) (70 ) (38 ) Restructuring (13 ) — (63 ) — Non-GAAP research and development expenses $ 1,335 $ 1,377 $ 2,738 $ 2,816 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 $ 1,377 $ 1,849 $ 2,752 $ 3,168 Acquisition-related – other costs (2) (17 ) (1 ) (84 ) (2 ) Restructuring (8 ) — (22 ) — Non-GAAP selling, general and administrative expenses $ 1,351 $ 1,848 $ 2,646 $ 3,166 Operating income (loss) reconciliation: GAAP operating income (loss) $ 2,644 $ 1,665 $ (1,678 ) $ 3,370 Acquisition-related – amortization (1) 579 581 1,158 1,110 Acquisition-related – other costs (2) 21 31 153 40 Restructuring 21 — 84 — IPR&D impairment — — 2,430 — Non-GAAP operating income $ 3,265 $ 2,277 $ 2,148 $ 4,521 Operating margin reconciliation: GAAP operating margin 38.0 % 25.2 % (12.3 )% 26.0 % Acquisition-related – amortization (1) 8.3 % 8.8 % 8.5 % 8.6 % Acquisition-related – other costs (2) 0.3 % 0.5 % 1.1 % 0.3 % Restructuring 0.3 % — % 0.6 % — % IPR&D impairment — % — % 17.8 % — % Non-GAAP operating margin 47.0 % 34.5 % 15.7 % 34.9 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ 355 $ (152 ) $ 265 $ 22 (Loss) gain from equity securities, net (392 ) 69 (405 ) (187 ) Non-GAAP other (income) expense, net $ (37 ) $ (83 ) $ (141 ) $ (165 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 2,053 $ 1,588 $ (2,433 ) $ 2,888 Acquisition-related – amortization (1) 579 581 1,158 1,110 Acquisition-related – other costs (2) 21 31 153 40 Restructuring 21 — 84 — IPR&D impairment — — 2,430 — Loss (gain) from equity securities, net 392 (69 ) 405 187 Non-GAAP income before income taxes $ 3,065 $ 2,131 $ 1,798 $ 4,226 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Income tax expense reconciliation: GAAP income tax expense $ 438 $ 549 $ 123 $ 865 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization (1) 121 120 242 227 Acquisition-related – other costs (2) 7 5 37 8 Restructuring 7 — 16 — IPR&D impairment — — 611 — Loss (gain) from equity securities, net 33 1 (6 ) 1 Discrete and related tax charges (3) (60 ) (227 ) (100 ) (256 ) Non-GAAP income tax expense $ 546 $ 448 $ 923 $ 844 Effective tax rate reconciliation: GAAP effective tax rate 21.4 % 34.6 % (5.1 )% 29.9 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments (3) (3.5 )% (13.5 )% 56.4 % (10.0 )% Non-GAAP effective tax rate 17.8 % 21.0 % 51.4 % 20.0 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,614 $ 1,045 $ (2,556 ) $ 2,055 Acquisition-related – amortization (1) 458 461 916 884 Acquisition-related – other costs (2) 14 26 117 32 Restructuring 14 — 68 — IPR&D impairment — — 1,819 — Loss (gain) from equity securities, net 359 (70 ) 412 187 Discrete and related tax charges (3) 60 227 100 256 Non-GAAP net income attributable to Gilead $ 2,519 $ 1,688 $ 874 $ 3,414 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.29 $ 0.83 $ (2.05 ) $ 1.63 Acquisition-related – amortization (1) 0.37 0.37 0.73 0.70 Acquisition-related – other costs (2) 0.01 0.02 0.09 0.03 Restructuring 0.01 — 0.05 — IPR&D impairment — — 1.46 — Loss (gain) from equity securities, net 0.29 (0.06 ) 0.33 0.15 Discrete and related tax charges (3) 0.05 0.18 0.08 0.20 Non-GAAP diluted earnings per share $ 2.01 $ 1.34 $ 0.70 $ 2.71 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 581 $ 1,157 $ 1,110 Research and development expenses adjustments 16 30 133 38 IPR&D impairment adjustments — — 2,430 — Selling, general and administrative expenses adjustments 26 1 106 2 Total non-GAAP adjustments to costs and expenses 620 612 3,826 1,150 Other (income) expense, net adjustments 392 (69 ) 405 187 Total non-GAAP adjustments before income taxes 1,012 543 4,231 1,338 Income tax effect of non-GAAP adjustments above (168 ) (126 ) (900 ) (235 ) Discrete and related tax charges (3) 60 227 100 256 Total non-GAAP adjustments to net income attributable to Gilead $ 905 $ 644 $ 3,431 $ 1,358 ______________________________ (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc., XinThera, Inc. and CymaBay Therapeutics, Inc. (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 2024 FULL-YEAR GUIDANCE (1) (unaudited) (in millions, except percentages and per share amounts) Provided February 6, 2024 Updated April 25, 2024 Updated August 8, 2024 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 76.0% - 77.0% 76.0% - 77.0% 76.0% - 77.0% Acquisition-related expenses and restructuring expenses ~ 9.0% ~ 9.0% ~ 9.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $8,700 - $9,200 $1,900 - $2,400 $2,100 - $2,500 IPR&D impairment, acquisition-related and restructuring expenses ~ 2,500 ~ 5,100 ~ 5,100 Non-GAAP projected operating income $11,200 - $11,700 $7,000 - $7,500 $7,200 - $7,600 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% ~ 65% ~ 87% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 2%) (~ 35%) (~ 57%) Non-GAAP projected effective tax rate ~ 19% ~ 30% ~ 30% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 $0.10 - $0.50 $0.00 - $0.30 IPR&D impairment, acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.70 ~ 3.35 ~ 3.60 Non-GAAP projected diluted EPS $6.85 - $7.25 $3.45 - $3.85 $3.60 - $3.90 ________________________________ (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 transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) June 30, December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 2,772 $ 8,428 Accounts receivable, net 4,663 4,660 Inventories 3,388 3,366 Property, plant and equipment, net 5,346 5,317 Intangible assets, net 22,832 26,454 Goodwill 8,314 8,314 Other assets 6,265 5,586 Total assets $ 53,579 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 10,781 $ 11,280 Long-term liabilities 24,602 28,096 Stockholders’ equity (1) 18,197 22,749 Total liabilities and stockholders’ equity $ 53,579 $ 62,125 ________________________________ (1) As of June 30, 2024 and December 31, 2023, there were 1,246 shares of common stock issued and outstanding. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 1,325 $ 2,337 $ 3,544 $ 4,082 Net cash used in investing activities (307 ) (483 ) (2,514 ) (1,309 ) Net cash used in financing activities (2,953 ) (1,101 ) (4,314 ) (2,507 ) Effect of exchange rate changes on cash and cash equivalents (11 ) 14 (29 ) 26 Net change in cash and cash equivalents (1,947 ) 768 (3,313 ) 292 Cash and cash equivalents at beginning of period 4,718 4,936 6,085 5,412 Cash and cash equivalents at end of period $ 2,772 $ 5,704 $ 2,772 $ 5,704 Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 1,325 $ 2,337 $ 3,544 $ 4,082 Capital expenditures (130 ) (139 ) (235 ) (248 ) Free cash flow (1) $ 1,195 $ 2,199 $ 3,309 $ 3,834 ________________________________ (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 Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 HIV Biktarvy – U.S. $ 2,585 $ 2,439 $ 4,900 $ 4,600 Biktarvy – Europe 370 302 735 606 Biktarvy – Rest of World 277 237 542 449 3,232 2,979 6,177 5,656 Descovy – U.S. 434 460 805 855 Descovy – Europe 25 25 51 50 Descovy – Rest of World 26 31 55 60 485 516 911 965 Genvoya – U.S. 372 455 704 872 Genvoya – Europe 45 56 95 111 Genvoya – Rest of World 23 29 44 58 440 540 843 1,041 Odefsey – U.S. 233 267 457 497 Odefsey – Europe 72 74 148 149 Odefsey – Rest of World 10 11 21 22 315 351 626 668 Symtuza - Revenue share (1) – U.S. 131 84 236 182 Symtuza - Revenue share (1) – Europe 34 33 67 70 Symtuza - Revenue share (1) – Rest of World 3 3 6 7 168 120 309 259 Other HIV (2) – U.S. 65 74 125 136 Other HIV (2) – Europe 25 31 70 63 Other HIV (2) – Rest of World 15 15 27 28 105 120 222 228 Total HIV – U.S. 3,821 3,778 7,226 7,142 Total HIV – Europe 571 521 1,167 1,049 Total HIV – Rest of World 353 326 695 624 4,745 4,626 9,088 8,816 Liver Disease Sofosbuvir / Velpatasvir (3) – U.S. 267 223 515 427 Sofosbuvir / Velpatasvir (3) – Europe 84 84 163 174 Sofosbuvir / Velpatasvir (3) – Rest of World 126 90 203 181 476 397 881 782 Vemlidy – U.S. 117 96 212 183 Vemlidy – Europe 11 10 22 19 Vemlidy – Rest of World 115 113 233 216 243 219 467 418 Other Liver Disease (4) – U.S. 47 37 89 64 Other Liver Disease (4) – Europe 47 37 94 78 Other Liver Disease (4) – Rest of World 19 21 38 44 113 95 221 186 Total Liver Disease – U.S. 431 356 816 674 Total Liver Disease – Europe 142 131 279 271 Total Liver Disease – Rest of World 259 225 474 441 832 711 1,569 1,386 Veklury Veklury – U.S. 76 97 391 349 Veklury – Europe 53 52 123 163 Veklury – Rest of World 85 107 255 317 214 256 769 829 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 Oncology Cell Therapy Tecartus – U.S. 63 56 118 114 Tecartus – Europe 37 29 73 56 Tecartus – Rest of World 7 4 16 6 107 88 207 177 Yescarta – U.S. 186 217 357 427 Yescarta – Europe 169 133 327 254 Yescarta – Rest of World 58 30 110 58 414 380 794 739 Total Cell Therapy – U.S. 250 272 475 542 Total Cell Therapy – Europe 206 162 400 310 Total Cell Therapy – Rest of World 66 34 126 65 521 469 1,001 916 Trodelvy Trodelvy – U.S. 224 189 429 351 Trodelvy – Europe 69 53 137 107 Trodelvy – Rest of World 26 17 62 23 320 260 628 482 Total Oncology – U.S. 474 462 904 893 Total Oncology – Europe 275 215 537 417 Total Oncology – Rest of World 92 51 188 88 841 728 1,629 1,398 Other AmBisome – U.S. 17 20 31 27 AmBisome – Europe 69 69 139 129 AmBisome – Rest of World 65 61 124 111 151 151 294 267 Other (5) – U.S. 98 64 156 127 Other (5) – Europe 8 10 18 22 Other (5) – Rest of World 24 17 36 26 130 92 209 175 Total Other – U.S. 115 85 188 153 Total Other – Europe 77 80 156 152 Total Other – Rest of World 88 78 160 137 280 243 504 442 Total product sales – U.S. 4,916 4,777 9,525 9,211 Total product sales – Europe 1,118 999 2,262 2,052 Total product sales – Rest of World 878 788 1,772 1,607 $ 6,912 $ 6,564 $ 13,559 $ 12,870 ______________________________ (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, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.