Tenofovir Alafenamide Fumarate

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infection ( HIV Glasgow 2024 ), taking place from November 10-13. The results from more than 40 studies across HIV treatment and prevention include late-breaking data and seven oral presentations. These findings reflect a robust portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV and help end the epidemic. “ We look forward to presenting new research from our broad and innovative HIV portfolio and pipeline as we strive to help end the epidemic through continuous scientific discovery,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “ Our contributions to HIV Glasgow 2024 demonstrate that people are at the center of all we do at Gilead. The breadth and depth of Gilead’s work underscore our commitment to driving the next wave of transformational innovations in HIV research.” HIV Prevention Research A late-breaking oral presentation at HIV Glasgow will be the first in-depth look at the full results from the PURPOSE 2 trial ( NCT04925752 ), including data not presented last month at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 2 is a pivotal Phase 3 trial evaluating twice-yearly lenacapavir, Gilead’s injectable HIV-1 capsid inhibitor for the investigational use of HIV prevention, among a broad and geographically diverse range of cisgender men and gender-diverse people. The trial is part of a comprehensive program assessing lenacapavir in a variety of populations who need or want pre-exposure prophylaxis (PrEP) and, if approved, would be the first and only twice-yearly HIV prevention choice. Prevention research presented at HIV Glasgow will also include a systematic review and meta-analysis of real-world data mapping HIV prevalence against PrEP uptake, health economic data on the impact of PrEP in France and the return on investment that HIV prevention has yielded for the French healthcare system. Data will also be presented from a study examining same-day PrEP initiation and its effect on PrEP uptake at a Canadian clinic. HIV Treatment Research Continuous scientific discovery in HIV treatment is a pillar of Gilead’s commitment to help end the epidemic. At HIV Glasgow, presented study 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 who may also have common comorbidities and other specific health needs. Outcomes from pipeline research studies will provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, late-breaking data from the Phase 2 study ( NCT05052996 ) evaluating an investigational once-weekly oral combination regimen of lenacapavir and islatravir will be presented during an oral session. Specifically, Biktarvy presentations will include four-year outcomes from BICSTaR, ( NCT03580668 ) an ongoing global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. As the average age of people with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform what the future of coordinated person-centered HIV care could look like. Additional research studies evaluating Biktarvy include three-year outcomes from ALLIANCE, an ongoing Phase III study ( NCT03547908 ) evaluating the efficacy and safety of the single-tablet regimen versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV/hepatitis B (HBV) coinfection who were initiating therapy. Gilead will also present outcomes from the Phase 2 portion of the ARTISTRY-1 study ( NCT05502341 ) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily regimen of lenacapavir and bictegravir. Additional lenacapavir data to be presented at HIV Glasgow will evaluate the efficacy and safety of the novel antiviral agent in combination with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment regimen with twice-yearly dosing. HIV treatment research pipeline findings also include a presentation of new pharmacokinetic and resistance data on GS-1720, a selective integrase strand transfer inhibitor (INSTI). The agent is being evaluated as a component of a novel, investigational, once-weekly oral INSTI/capsid-inhibitor combination regimen with GS-4182 aimed at providing new long-acting treatment options for people with HIV. A late-breaker presentation will compare the rate of treatment emergent resistance associate mutations (TE-RAMs) in people with HIV taking three-drug single tablet regimens and cabotegravir+rilpivirine. A separate late-breaker oral presentation will explore clinical features and resistance patterns during second-generation INSTI failure from the ROSETTA-registry. Overview of Scientific Presentations HIV TREATMENT RESEARCH (B/F/TAF) Oral Presentation Randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from dolutegravir/lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in people with HIV, good virologic control and neuropsychiatric comorbidities: Week 24 results from the MIND Study. Poster Four-year outcomes from the BICSTaR study: Observational analysis of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV in Canada, France and Germany Poster Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve people with both HIV-1 and hepatitis B: 3-year outcomes from ALLIANCE Poster Global survey to evaluate engagement in care and treatment experiences of people with HIV Poster Rapid Start (RS) with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with HIV-1 (PWH): A systematic literature review (SLR) of clinical and patient-reported outcomes (PROs) Poster Persistence, safety, and virologic outcomes of B/F/TAF as a baseline or switch regimen in HIV-infected people living with advanced HIV disease in the real world: the BIC-CD4 study. Poster Real-world effectiveness in treatment-experienced (TE) people with HIV (PWH) switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) with distinct patterns of self-reported adherence Poster Multicentre, prospective cohort study of same-day initiation of antiretroviral therapy with BIC/FTC/TAF among antiretroviral-naïve people with HIV Poster Real-World Persistence of Bictegravir- versus Dolutegravir-based Single Tablet Regimens in a Large Urban Canadian HIV Centre Poster Incidence of comorbidities over 18 months with BIC/FTC/TAF, DTG/ABC/3TC or DTG/3TC in real life settings in the ANRS-CO3 - AquiVIH-NA cohort. Poster Effectiveness of switching to B/F/TAF in virologically suppressed people with HIV and with preexisting resistance-associated mutations in Italy: the BIC-BARRIER Study Poster Evaluation of T-cell immunosenescence in +60 years PLWH virologically suppressed on 3DR with BIC/FTC/TAF or 2DR with DTG/3TC: the Collateral-2 study. LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR) Oral Presentation (late breaker) Once-Weekly Islatravir Plus Lenacapavir in Virologically Suppressed PWH: Week 48 Safety, Efficacy, and Metabolic Changes Oral Presentation (late breaker) Persistence in use of twice-yearly lenacapavir versus daily oral PrEP in the PURPOSE 1 Phase 3 trial Oral Presentation (late breaker) Twice-yearly lenacapavir PrEP in cisgender gay men, transgender women and men, and gender-diverse people (PURPOSE 2) Poster Pharmacokinetic/Pharmacodynamic and Resistance Analyses of GS-1720, a Once-Weekly Oral Integrase Strand Transfer Inhibitor Poster Pharmacokinetics of oral islatravir (ISL) plus lenacapavir (LEN) given once weekly in an open-label, active-controlled, phase 2 study of virologically suppressed people with HIV HIV TREATMENT PIPELINE RESEARCH Oral Presentation Efficacy and safety analysis of lenacapavir with broadly neutralising antibodies, teropavimab and zinlirvimab, in people with HIV-1 highly sensitive to one or both broadly neutralising antibodies Poster Pharmacokinetic (PK) analysis of oral once-daily bictegravir (BIC) plus lenacapavir (LEN) administered separately (BIC 75mg + LEN 25mg; BIC 75mg + LEN 50mg) and as a single-tablet BIC/LEN 75/50mg fixed-dose combination (FDC) to support Phase 3 dose selection Poster Effect of acid reducing agents on the pharmacokinetics of oral GS-4182 Poster Safety and immunogenicity of GS-1966+GS-1144 vaccines in virally suppressed adults living with HIV-1: a phase 1b, randomised, placebo-controlled study Poster Metabolic changes at 48 weeks in virologically suppressed people with HIV switching from complex antiretroviral regimens to bictegravir plus lenacapavir: ARTISTRY-1 trial HIV PREVENTION RESEARCH Poster Estimating return on investment (ROI) with increased utilisation of HIV pre-exposure prophylaxis (PrEP) among key populations in France from a national health payer perspective Poster PrEP cascade improvement through same-day PrEP initiation Poster Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used Pre-exposure Prophylaxis in Europe; the PrEPaRe study. Poster HIV-1 prevalence and pre-exposure prophylaxis uptake among key populations in high-income economies (2017-2023): a systematic review and meta-analysis of real-world studies ADDITIONAL HIV RESEARCH Oral Presentation (late breaker) Clinical features and resistance patterns during second-generation INSTI failure: The ROSETTA-registry Oral Presentation (late breaker) Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia Poster (late breaker) Comparison of treatment-emergent resistance associated mutations among three-drug single tablet regimens and cabotegravir+rilpivirine for the treatment of virologically suppressed people with HIV: A Systematic Literature Review and Network Meta-Analysis Poster (late breaker) The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period Poster Replication-competent HIV-1 harbouring resistance-associated mutations is present in the viral reservoir Poster Treatment Patterns in Virologically Suppressed, Treatment-Experienced People with HIV; a US Real-World Database Study Poster Demographic and clinical characteristics of treatment naïve people with HIV, and their healthcare professionals’ reasons for treatment choice: findings from a real-world survey in five European countries Poster Understanding knowledge and attitudes regarding HIV amongst secondary care healthcare professionals in the United Kingdom: A national survey Poster The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study For more information about Gilead at HIV Glasgow 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://hivglasgow.org/programme/ . The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally. Islatravir in combination with lenacapavir is investigational and not approved anywhere globally. The safety and efficacy of the combination of islatravir and lenacapavir have not been established. Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established. The use of Biktarvy in individuals with HIV/HBV co-infection is investigational and the safety and efficacy of this use have not been established. GS-5423, GS-2872, GS-1720 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning , for Biktarvy. There is currently no cure for HIV or AIDS. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. 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. 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 (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. Lactation : Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead Sciences in HIV 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 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 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, bictegravir, lenacapavir, teropavimab, zinlirvimab and GS-1720 (such as the ALLIANCE, ARTISTRY, BICSTaR, PURPOSE 2 and NCT05052996 studies); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation, such as 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 programs for indications that are currently under evaluation, including bictegravir, lenacapavir 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, 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 , and U.S. full Prescribing Information for lenacapavir 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 , or contact Gilead Public Affairs at public_affairs@gilead.com , 1-800-GILEAD-5 or 1-650-574-3000.

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its third quarter 2024 results of operations. “Gilead’s third quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this very strong topline growth and disciplined operating expense management, we are increasing our full year revenue, operating income, and earnings per share guidance,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “We are excited to further increase our impact for patients and communities in the months ahead. This includes building on the momentum from the U.S. launch of Livdelzi for primary biliary cholangitis and preparing for the potential launch of the first twice-yearly option for HIV prevention option, lenacapavir.” Third Quarter 2024 Financial Results Total third quarter 2024 revenue increased 7% to $7.5 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Veklury ® (remdesivir), Oncology and Liver Disease. Diluted earnings per share (“EPS”) was $1.00 in the third quarter 2024 compared to $1.73 in the same period in 2023. The decrease was primarily driven by a pre-tax in-process research and development (“IPR&D”) impairment of $1.75 billion, or $1.04 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020, as well as higher acquired IPR&D expense. This was partially offset by higher product sales and higher net unrealized gains on equity securities. Non-GAAP diluted EPS was $2.02 in the third quarter 2024 compared to $2.29 in the same period in 2023. The decrease was primarily driven by higher acquired IPR&D and tax expense, partially offset by higher product sales. As of September 30, 2024, Gilead had $5.0 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. During the third quarter 2024 Gilead generated $4.3 billion in operating cash flow. During the third quarter 2024 Gilead paid dividends of $983 million and repurchased $300 million of common stock. Third Quarter 2024 Product Sales Total third quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total third quarter 2024 product sales, excluding Veklury, increased 7% to $6.8 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Oncology and Liver Disease. HIV product sales increased 9% to $5.1 billion in the third quarter 2024 compared to the same period in 2023, driven by higher average realized price, primarily due to shifts in channel mix, and higher demand, partially offset by inventory dynamics. Biktarvy ® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 13% to $3.5 billion in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics. Descovy ® (FTC 200mg/TAF 25mg) sales increased 15% to $586 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics. The Liver Disease portfolio sales increased 4% to $733 million in the third quarter 2024 compared to the same period in 2023. This was primarily driven by higher demand in viral hepatitis medicines, partially offset by unfavorable pricing dynamics. Veklury sales increased 9% to $692 million in the third quarter 2024 compared to the same period in 2023, primarily driven by increased rates of COVID-19 related hospitalizations, particularly in the United States. Cell Therapy product sales of $485 million in the third quarter 2024 were relatively flat compared to the same period in 2023. Yescarta ® (axicabtagene ciloleucel) sales decreased 1% to $387 million in the third quarter 2024 compared to the same period in 2023, reflecting increased in- and out-of-class competition in the United States, partially offset by increased demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) in other regions. Tecartus ® (brexucabtagene autoleucel) sales increased 2% to $98 million in the third quarter 2024 compared to the same period in 2023, driven by increased demand in adult acute lymphoblastic leukemia (“ALL”). Trodelvy ® (sacituzumab govitecan-hziy) sales increased 17% to $332 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand across all regions. Third Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 79.1% in the third quarter 2024 compared to 77.6% in the same period in 2023. Non-GAAP product gross margin was 86.8% in the third quarter 2024 compared to 85.9% in the same period in 2023. The increases in GAAP and non-GAAP were primarily driven by product mix. Research & development (“R&D”) expenses and non-GAAP R&D expenses were $1.4 billion in the third quarter 2024 compared to $1.5 billion in the same period in 2023. The decreases were primarily driven by the timing of clinical activities, including the wind-down of the magrolimab and obeldesivir COVID programs. Acquired IPR&D expenses were $505 million in the third quarter 2024, primarily driven by a $320 million charge related to the buy-out of global Livdelzi ® (seladelpar) royalties from Janssen Pharmaceutica NV, as well as payments related to ongoing collaborations. IPR&D impairment was $1.75 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023. Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses were $1.4 billion in the third quarter 2024 compared to $1.3 billion in the same period in 2023. The increases reflect the timing of commercial activities, including the launch of Livdelzi in the United States, and other corporate activities. The effective tax rate (“ETR”) was (31.1)% in the third quarter 2024 compared to 6.3% in the same period in 2023. The decrease in ETR primarily reflects the impact of a legal entity restructuring and the aforementioned Immunomedics IPR&D impairment expense, partially offset by a prior year decrease in tax reserves that did not repeat. Non-GAAP ETR was 17.5% in the third quarter 2024 compared to 7.0% in the same period in 2023, primarily reflecting the impact of the prior year decrease in tax reserves. Guidance and Outlook For the full-year 2024, Gilead expects: (in millions, except per share amounts) November 6, 2024 Guidance Low End High End Comparison to August 8, 2024 Guidance Product sales $ 27,800 $ 28,100 Previously $27,100 to $27,500 Product sales, excluding Veklury $ 26,000 $ 26,300 Previously $25,800 to $26,200 Veklury $ 1,800 $ 1,800 Previously $1,300 Diluted EPS $ 0.05 $ 0.25 Previously $0.00 to $0.30 Non-GAAP diluted EPS $ 4.25 $ 4.45 Previously $3.60 to $3.90 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 Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference. In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with 2 incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada ® (FTC 200mg and tenofovir disoproxil fumarate 300mg; 89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. Gilead expects to file for U.S. Food and Drug Administration (“FDA”) approval before the end of the year, with global filings to follow. The use of lenacapavir for the prevention of HIV is investigational. Presented HIV treatment data at the Infection Disease Week (“IDWeek”) meeting, including Week 48 data from the Phase 2 study evaluating the investigational oral once-weekly combination regimen of lenacapavir with Merck’s, known as MSD outside of the United States and Canada (“Merck”), islatravir. In addition, Phase 1a data of the investigational once-weekly GS-1720 and 3-year follow up from the Phase 2/3 CAPELLA trial of twice-yearly lenacapavir in people with multi-drug resistant HIV were also highlighted. Signed royalty-free voluntary licensing agreements with six manufacturers to make and sell generic lenacapavir for HIV prevention and for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV in 120 high-incidence, resource-limited countries, subject to regulatory approval of lenacapavir in those markets. Presented data at IDWeek from the Phase 3 BIRCH and OAKTREE trials of investigational obeldesivir in non-hospitalized participants at high-risk or standard-risk for severe COVID-19, respectively. Previously, Gilead announced the early termination of the BIRCH trial and top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint, obeldesivir was found to have a generally well tolerated safety profile. The detailed data presented add to the breadth of safety data on obeldesivir. Donated approximately 5,000 vials of remdesivir to the Rwanda Medical Supply in response to the Marburg Virus Disease (“MVD”) outbreak for emergency use. Remdesivir is not approved for the treatment of MVD anywhere globally, and the safety and efficacy of this use is not known. Oncology Announced abstracts for the American Society of Hematology 2024 Annual Meeting (“ASH”), including preliminary data from the registrational Phase 2 iMMagine-1 trial evaluating the Arcellx, Inc. (“Arcellx”) partnered investigational CAR T anito-cel (anitocabtagene autoleucel) in R/R multiple myeloma, as well as updated results from the Phase 1 trial. Additionally, the first patient has been dosed in the Phase 3 iMMagine-3 trial in 2L+ R/R multiple myeloma. Announced ASH abstracts for long-term follow-up of Yescarta in R/R indolent non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Tecartus in B-cell precursor ALL. Presented Trodelvy data at the International Association for the Study of Lung Cancer World Conference on Lung Cancer across first- and second-line advanced or metastatic non-small cell lung cancer, as well as in extensive-stage small cell lung cancer. The use of Trodelvy for lung cancer is investigational. Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024. Received FDA Regenerative Medicine Advanced Therapy Designation for the evaluation of Yescarta as first-line treatment for adult patients with newly diagnosed, high-risk LBCL, an investigational use. Inflammation Received FDA accelerated approval for Livdelzi for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis. Corporate Announced a strategic collaboration with Genesis Therapeutics, Inc. (“Genesis”) to discover and develop novel small molecule therapies across multiple targets using Genesis’ GEMS AI platform. The Board declared a quarterly dividend of $0.77 per share of common stock for the fourth quarter of 2024. The dividend is payable on December 30, 2024, to stockholders of record at the close of business on December 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 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 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, Genesis and Merck; 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 Trodelvy, anito-cel, GS-1720, lenacapavir, and obeldesivir (such as the BIRCH, CAPELLA, iMMagine-1, iMMagine-3, OAKTREE, and PURPOSE-2 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, including for lenacapavir for HIV PrEP; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, 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; 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 September 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 ® , LIVDELZI ® , 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 Nine Months Ended September 30, September 30, (in millions, except per share amounts) 2024 2023 2024 2023 Revenues: Product sales $ 7,515 $ 6,994 $ 21,074 $ 19,864 Royalty, contract and other revenues 30 56 111 138 Total revenues 7,545 7,051 21,185 20,002 Costs and expenses: Cost of goods sold 1,574 1,565 4,670 4,408 Research and development expenses 1,395 1,457 4,266 4,310 Acquired in-process research and development expenses 505 91 4,674 808 In-process research and development impairment 1,750 — 4,180 — Selling, general and administrative expenses 1,433 1,315 4,184 4,482 Total costs and expenses 6,657 4,428 21,975 14,009 Operating income (loss) 888 2,623 (790 ) 5,993 Interest expense 238 232 728 692 Other (income) expense, net (306 ) 72 (41 ) 95 Income (loss) before income taxes 956 2,318 (1,477 ) 5,206 Income tax (benefit) expense (297 ) 146 (174 ) 1,010 Net income (loss) 1,253 2,172 (1,303 ) 4,196 Net loss attributable to noncontrolling interest — (8 ) — (40 ) Net income (loss) attributable to Gilead $ 1,253 $ 2,180 $ (1,303 ) $ 4,236 Basic earnings (loss) per share attributable to Gilead $ 1.00 $ 1.75 $ (1.04 ) $ 3.39 Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,247 1,248 1,247 1,249 Diluted earnings (loss) per share attributable to Gilead $ 1.00 $ 1.73 $ (1.04 ) $ 3.37 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,254 1,257 1,247 1,259 Supplemental Information: Cash dividends declared per share $ 0.77 $ 0.75 $ 2.31 $ 2.25 Product gross margin 79.1 % 77.6 % 77.8 % 77.8 % Research and development expenses as a % of revenues 18.5 % 20.7 % 20.1 % 21.5 % Selling, general and administrative expenses as a % of revenues 19.0 % 18.6 % 19.8 % 22.4 % Operating margin 11.8 % 37.2 % (3.7 )% 30.0 % Effective tax rate (31.1 )% 6.3 % 11.8 % 19.4 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Product sales: HIV $ 5,073 $ 4,667 9% $ 14,160 $ 13,482 5% Liver Disease 733 706 4% 2,302 2,093 10% Oncology 816 769 6% 2,446 2,167 13% Other 201 216 (7)% 705 658 7% Total product sales excluding Veklury 6,823 6,358 7% 19,613 18,400 7% Veklury 692 636 9% 1,461 1,465 —% Total product sales 7,515 6,994 7% 21,074 19,864 6% Royalty, contract and other revenues 30 56 (46)% 111 138 (19)% Total revenues $ 7,545 $ 7,051 7% $ 21,185 $ 20,002 6% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION (1) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Non-GAAP: Cost of goods sold $ 995 $ 985 1% $ 2,933 $ 2,717 8% Research and development expenses $ 1,382 $ 1,453 (5)% $ 4,120 $ 4,268 (3)% Acquired IPR&D expenses (2) $ 505 $ 91 NM $ 4,674 $ 808 NM Selling, general and administrative expenses $ 1,405 $ 1,298 8% $ 4,051 $ 4,464 (9)% Other (income) expense, net $ (48 ) $ (96 ) (50)% $ (189 ) $ (261 ) (28)% Diluted earnings per share attributable to Gilead $ 2.02 $ 2.29 (12)% $ 2.72 $ 5.00 (46)% Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,254 1,257 —% 1,254 1,259 —% Product gross margin 86.8 % 85.9 % 84 bps 86.1 % 86.3 % -24 bps Research and development expenses as a % of revenues 18.3 % 20.6 % -229 bps 19.4 % 21.3 % -189 bps Selling, general and administrative expenses as a % of revenues 18.6 % 18.4 % 21 bps 19.1 % 22.3 % -320 bps Operating margin 43.2 % 45.7 % -255 bps 25.5 % 38.7 % -1320 bps Effective tax rate 17.5 % 7.0 % 1052 bps 30.0 % 14.5 % 1552 bps ________________________________ 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 Nine Months Ended September 30, September 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,574 $ 1,565 $ 4,670 $ 4,408 Acquisition-related – amortization (1) (579 ) (581 ) (1,737 ) (1,691 ) Restructuring — — 1 — Non-GAAP cost of goods sold $ 995 $ 985 $ 2,933 $ 2,717 Product gross margin reconciliation: GAAP product gross margin 79.1 % 77.6 % 77.8 % 77.8 % Acquisition-related – amortization (1) 7.7 % 8.3 % 8.2 % 8.5 % Restructuring — % — % (— )% — % Non-GAAP product gross margin 86.8 % 85.9 % 86.1 % 86.3 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,395 $ 1,457 $ 4,266 $ 4,310 Acquisition-related – other costs (2) (9 ) 1 (78 ) (37 ) Restructuring (5 ) (5 ) (68 ) (5 ) Non-GAAP research and development expenses $ 1,382 $ 1,453 $ 4,120 $ 4,268 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 1,750 $ — $ 4,180 $ — IPR&D impairment (1,750 ) — (4,180 ) — Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,433 $ 1,315 $ 4,184 $ 4,482 Acquisition-related – other costs (2) (5 ) — (88 ) (2 ) Restructuring (23 ) (17 ) (45 ) (17 ) Non-GAAP selling, general and administrative expenses $ 1,405 $ 1,298 $ 4,051 $ 4,464 Operating income (loss) reconciliation: GAAP operating income (loss) $ 888 $ 2,623 $ (790 ) $ 5,993 Acquisition-related – amortization (1) 579 581 1,737 1,691 Acquisition-related – other costs (2) 13 (1 ) 167 39 Restructuring 28 22 112 22 IPR&D impairment 1,750 — 4,180 — Non-GAAP operating income $ 3,258 $ 3,224 $ 5,406 $ 7,745 Operating margin reconciliation: GAAP operating margin 11.8 % 37.2 % (3.7 )% 30.0 % Acquisition-related – amortization (1) 7.7 % 8.2 % 8.2 % 8.5 % Acquisition-related – other costs (2) 0.2 % — % 0.8 % 0.2 % Restructuring 0.4 % 0.3 % 0.5 % 0.1 % IPR&D impairment 23.2 % — % 19.7 % — % Non-GAAP operating margin 43.2 % 45.7 % 25.5 % 38.7 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (306 ) $ 72 $ (41 ) $ 95 Gain (loss) from equity securities, net 258 (168 ) (148 ) (356 ) Non-GAAP other (income) expense, net $ (48 ) $ (96 ) $ (189 ) $ (261 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 956 $ 2,318 $ (1,477 ) $ 5,206 Acquisition-related – amortization (1) 579 581 1,737 1,691 Acquisition-related – other costs (2) 13 (1 ) 167 39 Restructuring 28 22 112 22 IPR&D impairment 1,750 — 4,180 — (Gain) loss from equity securities, net (258 ) 168 148 356 Non-GAAP income before income taxes $ 3,068 $ 3,088 $ 4,866 $ 7,314 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Income tax (benefit) expense reconciliation: GAAP income tax (benefit) expense $ (297 ) $ 146 $ (174 ) $ 1,010 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization (1) 121 120 363 347 Acquisition-related – other costs (2) 2 — 39 8 Restructuring 4 5 21 5 IPR&D impairment 440 — 1,051 — (Gain) loss from equity securities, net (46 ) 4 (52 ) 5 Discrete and related tax charges (3) 314 (58 ) 214 (314 ) Non-GAAP income tax expense $ 538 $ 216 $ 1,461 $ 1,061 Effective tax rate reconciliation: GAAP effective tax rate (31.1 )% 6.3 % 11.8 % 19.4 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments (3) 48.6 % 0.7 % 18.2 % (4.9 )% Non-GAAP effective tax rate 17.5 % 7.0 % 30.0 % 14.5 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,253 $ 2,180 $ (1,303 ) $ 4,236 Acquisition-related – amortization (1) 458 461 1,374 1,345 Acquisition-related – other costs (2) 11 (1 ) 128 31 Restructuring 24 17 92 17 IPR&D impairment 1,310 — 3,129 — (Gain) loss from equity securities, net (212 ) 164 200 351 Discrete and related tax charges (3) (314 ) 58 (214 ) 314 Non-GAAP net income attributable to Gilead $ 2,531 $ 2,879 $ 3,405 $ 6,293 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.00 $ 1.73 $ (1.04 ) $ 3.37 Acquisition-related – amortization (1) 0.37 0.37 1.10 1.07 Acquisition-related – other costs (2) 0.01 — 0.10 0.02 Restructuring 0.02 0.01 0.07 0.01 IPR&D impairment 1.04 — 2.51 — (Gain) loss from equity securities, net (0.17 ) 0.13 0.16 0.28 Discrete and related tax charges (3) (0.25 ) 0.05 (0.17 ) 0.25 Difference in shares used for GAAP vs. Non-GAAP — — (0.01 ) — Non-GAAP diluted earnings per share $ 2.02 $ 2.29 $ 2.72 $ 5.00 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 581 $ 1,736 $ 1,691 Research and development expenses adjustments 13 4 146 42 IPR&D impairment adjustments 1,750 — 4,180 — Selling, general and administrative expenses adjustments 28 17 133 19 Total non-GAAP adjustments to costs and expenses 2,370 602 6,196 1,752 Other (income) expense, net adjustments (258 ) 168 148 356 Total non-GAAP adjustments before income taxes 2,113 770 6,343 2,108 Income tax effect of non-GAAP adjustments above (521 ) (129 ) (1,421 ) (364 ) Discrete and related tax charges (3) (314 ) 58 (214 ) 314 Total non-GAAP adjustments to net income attributable to Gilead $ 1,278 $ 699 $ 4,708 $ 2,057 ________________________________ (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 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. 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 Updated November 6, 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% 78.0% Acquisition-related expenses and restructuring expenses ~ 9.0% ~ 9.0% ~ 9.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% 85.0% - 86.0% 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 $1,100 - $1,400 IPR&D impairment, acquisition-related and restructuring expenses ~ 2,500 ~ 5,100 ~ 5,100 ~ 6,900 Non-GAAP projected operating income $11,200 - $11,700 $7,000 - $7,500 $7,200 - $7,600 $8,000 - $8,300 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% ~ 65% ~ 87% ~ 56% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 2%) (~ 35%) (~ 57%) (~ 29%) Non-GAAP projected effective tax rate ~ 19% ~ 30% ~ 30% ~ 27% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 $0.10 - $0.50 $0.00 - $0.30 $0.05 - $0.25 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 ~ 4.20 Non-GAAP projected diluted EPS $6.85 - $7.25 $3.45 - $3.85 $3.60 - $3.90 $4.25 - $4.45 ________________________________ (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) September 30, December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 5,037 $ 8,428 Accounts receivable, net 4,587 4,660 Inventories 3,435 3,366 Property, plant and equipment, net 5,391 5,317 Intangible assets, net 20,546 26,454 Goodwill 8,314 8,314 Other assets 7,215 5,586 Total assets $ 54,525 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 11,725 $ 11,280 Long-term liabilities 24,409 28,096 Stockholders’ equity (1) 18,390 22,749 Total liabilities and stockholders’ equity $ 54,525 $ 62,125 ________________________________ (1) As of September 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 Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 4,309 $ 1,756 $ 7,853 $ 5,837 Net cash used in investing activities (710 ) (229 ) (3,224 ) (1,538 ) Net cash used in financing activities (1,379 ) (1,518 ) (5,693 ) (4,026 ) Effect of exchange rate changes on cash and cash equivalents 44 (7 ) 15 20 Net change in cash and cash equivalents 2,265 1 (1,049 ) 293 Cash and cash equivalents at beginning of period 2,772 5,704 6,085 5,412 Cash and cash equivalents at end of period $ 5,037 $ 5,705 $ 5,037 $ 5,705 Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 4,309 $ 1,756 $ 7,853 $ 5,837 Capital expenditures (140 ) (122 ) (376 ) (370 ) Free cash flow (1) $ 4,169 $ 1,633 $ 7,478 $ 5,467 ________________________________ (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 Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 HIV Biktarvy – U.S. $ 2,826 $ 2,504 $ 7,726 $ 7,104 Biktarvy – Europe 375 313 1,110 920 Biktarvy – Rest of World 272 268 814 717 3,472 3,085 9,649 8,741 Descovy – U.S. 534 460 1,339 1,314 Descovy – Europe 24 25 75 75 Descovy – Rest of World 28 26 82 86 586 511 1,496 1,475 Genvoya – U.S. 384 433 1,088 1,305 Genvoya – Europe 44 47 138 157 Genvoya – Rest of World 21 23 66 81 449 503 1,292 1,544 Odefsey – U.S. 248 257 705 754 Odefsey – Europe 69 74 217 223 Odefsey – Rest of World 9 11 30 33 326 343 952 1,011 Symtuza - Revenue share (1) – U.S. 103 96 338 278 Symtuza - Revenue share (1) – Europe 33 32 101 101 Symtuza - Revenue share (1) – Rest of World 3 3 9 10 139 131 448 390 Other HIV (2) – U.S. 65 56 190 192 Other HIV (2) – Europe 26 28 96 91 Other HIV (2) – Rest of World 9 9 36 38 100 94 322 321 Total HIV – U.S. 4,161 3,807 11,386 10,949 Total HIV – Europe 570 519 1,737 1,568 Total HIV – Rest of World 342 341 1,038 965 5,073 4,667 14,160 13,482 Liver Disease Sofosbuvir / Velpatasvir (3) – U.S. 222 215 737 643 Sofosbuvir / Velpatasvir (3) – Europe 67 76 230 250 Sofosbuvir / Velpatasvir (3) – Rest of World 96 85 299 266 385 377 1,266 1,159 Vemlidy – U.S. 126 112 338 295 Vemlidy – Europe 11 9 33 28 Vemlidy – Rest of World 95 106 328 322 232 228 699 645 Other Liver Disease (4) – U.S. 45 49 134 113 Other Liver Disease (4) – Europe 54 33 148 112 Other Liver Disease (4) – Rest of World 17 20 55 64 116 102 337 289 Total Liver Disease – U.S. 393 376 1,210 1,051 Total Liver Disease – Europe 132 119 411 390 Total Liver Disease – Rest of World 207 211 682 652 733 706 2,302 2,093 Veklury Veklury – U.S. 393 258 784 607 Veklury – Europe 81 65 204 227 Veklury – Rest of World 219 313 473 630 692 636 1,461 1,465 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 Oncology Cell Therapy Tecartus – U.S. 63 64 181 179 Tecartus – Europe 29 27 102 83 Tecartus – Rest of World 6 4 22 11 98 96 305 272 Yescarta – U.S. 145 197 502 624 Yescarta – Europe 182 154 509 408 Yescarta – Rest of World 60 40 170 99 387 391 1,181 1,130 Total Cell Therapy – U.S. 208 261 683 802 Total Cell Therapy – Europe 211 181 611 491 Total Cell Therapy – Rest of World 66 45 192 109 485 486 1,485 1,402 Trodelvy Trodelvy – U.S. 226 201 655 551 Trodelvy – Europe 80 62 217 169 Trodelvy – Rest of World 26 21 88 44 332 283 960 764 Total Oncology – U.S. 433 462 1,338 1,354 Total Oncology – Europe 291 243 828 660 Total Oncology – Rest of World 92 65 280 153 816 769 2,446 2,167 Other AmBisome – U.S. 6 12 37 39 AmBisome – Europe 71 63 210 192 AmBisome – Rest of World 52 39 176 150 130 115 424 381 Other (5) – U.S. 47 69 203 197 Other (5) – Europe 8 9 26 31 Other (5) – Rest of World 16 23 52 49 71 101 281 277 Total Other – U.S. 53 82 241 236 Total Other – Europe 80 72 236 224 Total Other – Rest of World 68 62 228 199 201 216 705 658 Total product sales – U.S. 5,433 4,985 14,958 14,196 Total product sales – Europe 1,154 1,017 3,416 3,069 Total product sales – Rest of World 928 992 2,700 2,599 $ 7,515 $ 6,994 $ 21,074 $ 19,864 ________________________________ (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, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.