A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects (8 to <18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.
Approximately 80 subjects from 8 to <18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to <12 years of age, will be enrolled in this study.
During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food).
Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study.
Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.

Start Date01 May 2025

Sponsor / Collaborator

Alfasigma SpA

NCT06687551

/ Not yet recruitingPhase 4IIT

JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

This study aims to assess the feasibility of tapering JAK inhibitors in rheumatoid arthritis patients in low disease activity by comparing a group of patients tapering the JAK inhibitor dosage to a group of patients continuing the full-dose.
Participants will:
* Either take
1. JAK inhibitor dose-tapering strategy.
2. JAK inhibitor continuous therapy strategy.
* Visit the clinic once every 3 months for checkups and tests
* Keep a diary of their treatment intake and symptoms

Start Date01 Jan 2025

Sponsor / Collaborator

Toulouse University Hospital

NCT06625242

/ RecruitingPhase 4

A Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Efficacy and Safety of Filgotinib in Korean Patients With Rheumatoid Arthritis

The primary purpose of this study is to assess the percentage of participants achieving an American College of Rheumatology (ACR) 20 percent (%) Improvement (ACR20) response at Week 12 of the administration of the investigational product.

Start Date22 Oct 2024

Sponsor / Collaborator

Eisai Korea, Inc.

100 Clinical Results associated with Filgotinib Maleate

100 Translational Medicine associated with Filgotinib Maleate

100 Patents (Medical) associated with Filgotinib Maleate

353

Literatures (Medical) associated with Filgotinib Maleate

13 Feb 2025·Cureus

Dynamics of Serum Cytokines and Chemokines in Patients With Idiopathic Multicentric Castleman Disease: From a Phase Ib Investigator-Initiated Trial of Filgotinib

Article

Author: Tsunoda, Shinichiro ; Migita, Kiyoshi ; Morimoto, Shimpei ; Masaki, Yasufumi ; Hosogaya, Naoki ; Sato, Shuzo ; Katsube, Atsushi ; Koga, Tomohiro ; Kawakami, Atsushi ; Yano, Shingo ; Fukui, Shoichi ; Sumiyoshi, Remi ; Narita, Sawana ; Yano, Hiroshi

Background Idiopathic multicentric Castleman disease (iMCD) is a chronic inflammatory condition for which Janus kinase (JAK) inhibition has been hypothesized to be a potential treatment. However, filgotinib, a JAK1 preferential inhibitor, did not show apparent efficacy for iMCD in a clinical trial at eight weeks. This study aimed to compare the serum cytokine and chemokine profiles of patients treated with filgotinib with those of patients treated with tocilizumab to speculate why filgotinib was not effective at eight weeks. Methods This study included five patients treated with filgotinib who participated in a phase Ib single-arm clinical trial of filgotinib for iMCD and five tocilizumab-treated patients whose data were collected retrospectively. Serum levels of 41 cytokines/chemokines before and after treatment were measured. Results The tocilizumab group showed improvement in C-reactive protein, hemoglobin, and albumin levels after treatment while the filgotinib group showed no changes in these markers. The tocilizumab group showed significant changes in 12 cytokines/chemokines from baseline to after treatment, whereas the filgotinib group showed only a decrease in IL-18 and IL-27 levels. After treatment, significant differences were observed between the two groups for 10 cytokines/chemokines. Five cytokines (FGF-2, IL-4, IL-6, TNF-β, and VEGF-A) showed significant changes after tocilizumab treatment and differences between the tocilizumab and filgotinib groups after treatment. Conclusion This study identified FGF-2, IL-4, IL-6, TNF-β, and VEGF-A as potential factors that could explain the lack of apparent efficacy of filgotinib in iMCD treatment at eight weeks. These findings may contribute to future drug development for iMCD.

04 Feb 2025·Journal of Crohn's and Colitis

Janus kinase inhibitors in the management of acute severe ulcerative colitis: a comprehensive review

Article

Author: Gisbert, Javier P ; Chaparro, María

AbstractBackgroundOne-third of patients with acute severe ulcerative colitis (ASUC) are steroid-refractory. Cyclosporine and infliximab are currently the mainstays of salvage therapy. Janus kinase inhibitors (JAKi) could play a role in the treatment of ASUC.AimTo review the evidence on JAKi in the management of ASUC.MethodsWe performed a bibliographic search to identify studies focusing on the treatment of ASUC with JAKi.ResultsPotential advantages of JAKi for the management of ASUC include their oral administration, rapid onset of action, short half-life, lack of immunogenicity, and effectiveness in patients with prior biologic exposure. Thirty studies (including 373 patients) have evaluated the efficacy of tofacitinib in ASUC, with a response rate (avoidance of colectomy) ranging between 43% and 100%, with a weighted mean of 82%. Experience with upadacitinib is more limited (only 10 studies and 74 patients are available) but also encouraging: mean colectomy-free rate ranging between 67% and 100%, with a weighted mean of 79%. However, experience with filgotinib in ASUC is currently nonexistent. Regarding safety, the available data does not reveal any new safety concerns when JAKi are used in ASUC, although follow-up periods are still short.ConclusionJAKi seems to be a promising treatment option for ASUC, with both tofacitinib and upadacitinib achieving colectomy-free rates of approximately 80%. Further studies are essential to define whether JAKi can replace cyclosporine/infliximab as second-line therapy for the medical management of ASUC, or whether they can even be used as initial treatment in place of intravenous corticosteroids.

01 Feb 2025·The Lancet Gastroenterology & Hepatology

Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial

Article

Author: Santermans, Eva ; Gietka, Piotr ; Watanabe, Mamoru ; Ritter, Timothy ; Hospodarskyy, Ihor ; Beales, Ian ; Hibi, Toshifumi ; Kwon, Paul ; Roblin, Xavier ; Schreiber, Stefan ; Masior, Tomasz ; D'Haens, Geert ; Reinisch, Walter ; Danese, Silvio ; Mehta, Rajiv ; Rubin, David T ; Vermeire, Séverine ; Le Brun, Franck-Olivier ; Genovese, Mark C ; Barron, Rahul

BACKGROUNDThere is a need for efficacious therapies for patients with Crohn's disease that are better tolerated and more durable than available treatments. We aimed to evaluate the efficacy and safety of filgotinib, an oral Janus kinase 1 preferential inhibitor, for treating Crohn's disease.METHODSThis phase 3, double-blind, randomised, placebo-controlled trial was conducted in 371 centres in 39 countries. Eligible patients were aged 18-75 years with moderately to severely active Crohn's disease for at least 3 months before enrolment. Patients were enrolled into one of two induction studies on the basis of their experience with biological agents (induction study A included biologic-naive and later biologic-experienced patients and induction study B included biologic-experienced patients). In both induction studies, patients were randomly assigned (1:1:1), using an interactive web response system, to receive oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily for 11 weeks. Patients who received filgotinib and had two-item patient-reported outcome (PRO2) clinical remission or an endoscopic response at week 10 were re-randomised (2:1) to receive their induction dose or placebo orally, once daily to the end of week 58 in the maintenance study. Co-primary endpoints were PRO2 clinical remission and an endoscopic response at week 10 (induction studies) and week 58 (maintenance study). PRO2 clinical remission was defined as an abdominal pain subscore of not more than 1 and a liquid or very soft stool frequency subscore of not more than 3 (from eDiary data) and endoscopic response was defined as a reduction of at least 50% in Simple Endoscopic Score for Crohn's disease from induction baseline (from central reading of endoscopy). For the induction studies, efficacy was assessed in all randomly assigned patients who received at least one dose of study drug. For the maintenance study, efficacy was assessed in all patients from either filgotinib treatment group in the induction studies who reached PRO2 clinical remission or an endoscopic response at week 10, and who were re-randomised and received at least one dose of study drug in the maintenance study. Patients who received placebo throughout the induction and maintenance studies were not included in the full analysis set for the maintenance study. Safety was assessed in all patients who received at least one dose of study drug. This trial is complete and is registered with ClinicalTrials.gov, NCT02914561.FINDINGSBetween Oct 31, 2016, and Nov 11, 2022, 2634 patients were screened, of whom 1372 were enrolled (induction study A: n=707, induction study B: n=665, and maintenance study: n=481). There were 346 (49%) women and 358 (51%) men in induction study A, 356 (54%) women and 303 (46%) men in induction study B, and 242 women (51%) and 236 men (49%) in the maintenance study. Significantly more patients had PRO2 clinical remission at week 10 with filgotinib 200 mg than with placebo in induction study B (29·7% vs 17·9%, difference 11·9%; 95% CI 3·7 to 20·2, p=0·0039) but not induction study A (32·9% vs 25·7%, 6·9%; -1·4 to 15·2, p=0·0963); there was no significant difference for endoscopic response (induction study A: 23·9% vs 18·1%, difference 5·5%; 95% CI -2·0 to 12·9, p=0·1365; induction study B: 11·9% vs 11·4%, 0·1%; -6·5 to 6·6, p=0·9797). At week 58, both co-primary endpoints were reported in greater proportions of patients who received filgotinib 200 mg than in those who received placebo (PRO2 clinical remission: 43·8% vs 26·4%, difference 16·8%; 95% CI 2·0 to 31·6, p=0·0382; endoscopic response: 30·4% vs 9·4%, difference 20·6%; 95% CI 8·2 to 33·1, p=0·0038). Co-primary endpoints were not met for filgotinib 100 mg in any study. In the induction studies, the most frequently reported treatment-emergent adverse events (TEAEs; ≥5% of patients in any group) were abdominal pain; arthralgia; an exacerbation, flare, or worsening of Crohn's disease; headache; nasopharyngitis; nausea; and pyrexia. In the maintenance study, the most frequently reported TEAEs (≥5% of patients in any filgotinib or associated placebo group) were those reported in the induction studies (except for headache) and abdominal distension, upper abdominal pain, anaemia, and flatulence. Serious TEAEs were reported in 49 patients in induction study A (18 [8%]) of 222 patients in the filgotinib 200 mg group, 16 [7%] of 245 patients in the filgotinib 100 mg group, and 15 [6%] of 237 patients in the placebo group), 81 patients in induction study B (19 [9%] of 202 patients in the filgotinib 200 mg group, 36 [16%] of 228 patients in the filgotinib 100 mg group, and 26 [11%] of 229 patients in the placebo group), and 49 patients in the maintenance study (13 [11%] of 118 patients in the filgotinib 200 mg-filgotinib 200 mg group, five [9%] of 56 patients in the filgotinib 200 mg-placebo group, 14 [13%] of 104 patients in the filgotinib 100 mg-filgotinib 100 mg group, three [5%] of 55 patients in the filgotinib 100 mg-placebo group, and 14 [10%] of 145 patients in the placebo-placebo group). No deaths were reported during the induction and maintenance studies.INTERPRETATIONFilgotinib 200 mg did not meet the co-primary endpoints of clinical remission and an endoscopic response at week 10, but did meet the co-primary endpoints at week 58. Filgotinib treatment was well tolerated, and no new safety signals were reported.FUNDINGGalapagos.

News (Medical) associated with Filgotinib Maleate

11 Feb 2025

·www.gilead.com

Gilead Sciences Announces Fourth Quarter and Full Year 2024 Financial Results

Product Sales Excluding Veklury Increased 8% Year-Over-Year to $26.8 billion for Full Year 2024 Biktarvy Sales Increased 13% Year-Over-Year to $13.4 billion for Full Year 2024 Oncology Sales Increased 12% Year-Over-Year to $3.3 billion for Full Year 2024 FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024. “Gilead delivered another exceptionally strong full year and fourth quarter, with growth in our base business product sales of 8% for 2024 and 13% year-over-year for the fourth quarter,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “From this foundation of commercial strength, we are planning for the potential launch of lenacapavir for HIV PrEP in Summer 2025, with its unique opportunity to extend the reach of HIV prevention. This potential in HIV, along with our strong and diverse portfolio, and improved operational efficiencies, positions Gilead to deliver increasing patient impact and compelling shareholder returns in the years ahead.” Fourth Quarter 2024 Financial Results Total fourth quarter 2024 revenue increased 6% to $7.6 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease, partially offset by lower sales of Veklury® (remdesivir). Diluted Earnings Per Share (“EPS”) increased to $1.42 in the fourth quarter 2024 compared to $1.14 in the same period in 2023, primarily driven by lower costs of goods sold, higher product sales and lower acquired in-process research and development ("IPR&D") expenses, partially offset by higher operating expenses as well as unrealized losses on equity investments in 2024 compared to gains in 2023. Non-GAAP diluted EPS increased to $1.90 in the fourth quarter 2024 compared to $1.72 in the same period in 2023. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher operating expenses. As of December 31, 2024, Gilead had $10.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023. During the fourth quarter 2024, Gilead generated $3.0 billion in operating cash flow. During the fourth quarter 2024, Gilead issued senior unsecured notes in an aggregate principal amount of $3.5 billion, paid cash dividends of $973 million and utilized $350 million to repurchase common stock. Fourth Quarter 2024 Product Sales Total fourth quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total product sales excluding Veklury increased 13% to $7.2 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 16% to $5.5 billion in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favorable inventory dynamics. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 21% to $3.8 billion in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, favorable inventory dynamics and higher average realized price. Descovy® (FTC 200mg/TAF 25mg) sales increased 21% to $616 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favorable inventory dynamics. The Liver Disease portfolio sales increased 4% to $719 million in the fourth quarter 2024 compared to the same period in 2023. This was primarily driven by the launch of Livdelzi® (seladelpar) in primary biliary cholangitis (“PBC”), and increased demand in products for chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower demand and average realized price in products for chronic hepatitis C virus (“HCV”). Veklury sales decreased 53% to $337 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations, particularly in the United States. Cell Therapy product sales increased 5% to $488 million in the fourth quarter 2024 compared to the same period in 2023. Yescarta® (axicabtagene ciloleucel) sales increased 6% to $390 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher average realized price and increased demand outside of the United States, partially offset by lower demand in the United States. Tecartus® (brexucabtagene autoleucel) sales of $98 million in the fourth quarter 2024 were flat compared to the same period in 2023, reflecting increased demand outside of the United States, offset by lower demand in the United States. Trodelvy® (sacituzumab govitecan-hziy) sales increased 19% to $355 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by increased demand in all regions, as well as higher average realized price. Fourth Quarter 2024 Product Gross Margin, Operating Expenses and Tax Product gross margin was 79.0% in the fourth quarter 2024 compared to 70.4% in the same period in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.7% in the fourth quarter 2024 compared to 86.1% in the same period in 2023. Research and development (“R&D”) expenses were $1.6 billion in the fourth quarter 2024 compared to $1.4 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio and the impact of a prior year valuation adjustment to the MYR-related contingent consideration that did not repeat. Non-GAAP R&D expenses were $1.6 billion in the fourth quarter 2024 compared to $1.5 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio. Acquired IPR&D expenses were $(11) million in the fourth quarter 2024, reflecting expenses related to the Terray Therapeutics, Inc. (“Terray”) and Tubulis GmbH (“Tubulis”) collaborations, offset by a favorable adjustment related to the CymaBay Therapeutics, Inc. (“CymaBay”) acquisition. Selling, general and administrative (“SG&A”) and non-GAAP SG&A expenses were $1.9 billion in the fourth quarter 2024 compared to $1.6 billion in the same period in 2023, primarily driven by a litigation accrual and higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV pre-exposure prophylaxis (“PrEP”) as well as for Livdelzi. The effective tax rate (“ETR”) was 17.8% in the fourth quarter 2024 compared to 14.3% in the same period in 2023, primarily due to prior year settlements with tax authorities and non-taxable unrealized gains and losses on equity investments. Non-GAAP ETR was 19.2% in the fourth quarter 2024 compared to 17.1% in the same period in 2023, primarily due to prior year settlements with tax authorities. Full Year 2024 Financial Results Total full year 2024 revenue increased 6% to $28.8 billion compared to 2023, primarily due to higher sales in HIV, Oncology and Liver Disease, partially offset by lower sales of Veklury. Diluted EPS decreased to $0.38 in the full year 2024 compared to $4.50 in 2023. The decrease was primarily driven by a pre-tax IPR&D impairment charge of $4.2 billion, or $2.49 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020, and acquired IPR&D charges of $3.9 billion, or $3.14 per share, in the first quarter 2024 related to the acquisition of CymaBay, partially offset by higher product sales. Non-GAAP diluted EPS decreased to $4.62 in the full year 2024 compared to $6.72 in 2023. This was primarily driven by higher acquired IPR&D expenses related to the CymaBay acquisition and higher income tax expense, partially offset by higher product sales. Full Year 2024 Product Sales Total full year 2024 product sales increased 6% to $28.6 billion compared to 2023. Total product sales excluding Veklury increased 8% to $26.8 billion in the full year 2024 compared to 2023, primarily driven by higher sales in HIV, Oncology and Liver Disease. HIV product sales increased 8% to $19.6 billion in the full year 2024 compared to 2023, primarily driven by higher demand, as well as the impact of higher average realized price. Biktarvy sales increased 13% to $13.4 billion in the full year 2024 compared to 2023, primarily driven by higher demand. Descovy sales increased 6% to $2.1 billion in the full year 2024 compared to 2023, primarily driven by higher demand, partially offset by lower average realized price. The Liver Disease portfolio sales increased 9% to $3.0 billion in the full year 2024 compared to 2023. The increase was primarily due to higher demand across all liver diseases. Veklury sales decreased 18% to $1.8 billion in the full year 2024 compared to 2023, primarily driven by lower rates of COVID-19 related hospitalizations. Cell Therapy product sales increased 6% to $2.0 billion in the full year 2024 compared to 2023. Yescarta sales increased 5% to $1.6 billion in the full year 2024 compared to 2023, primarily driven by increased demand outside of the United States and higher average realized price, partially offset by lower demand in the United States. Tecartus sales increased 9% to $403 million in the full year 2024 compared to 2023, primarily driven by increased demand outside of the United States, partially offset by lower demand in the United States. Trodelvy sales increased 24% to $1.3 billion in the full year 2024 compared to 2023, primarily driven by increased demand in all regions. Full Year 2024 Product Gross Margin, Operating Expenses and Tax Product gross margin was 78.2% in the full year 2024 compared to 75.9% in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.2% in the full year 2024 compared to 86.3% in 2023. R&D expenses were $5.9 billion in the full year 2024 compared to $5.7 billion in 2023, primarily driven by restructuring costs and integration expenses related to the CymaBay acquisition. Non-GAAP R&D expenses of $5.7 billion in the full year 2024 were flat compared to 2023. Acquired IPR&D expenses were $4.7 billion in the full year 2024 compared to $1.2 billion in 2023, primarily reflecting the acquisition of CymaBay. SG&A expenses of $6.1 billion in the full year 2024 were flat compared to 2023, reflecting higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV PrEP as well as for Livdelzi, integration costs related to the acquisition of CymaBay, and restructuring expenses, offset by lower expenses related to legal matters. Non-GAAP SG&A expenses were $5.9 billion in the full year 2024 compared to $6.1 billion in 2023, primarily driven by lower expenses related to legal matters, partially offset by higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV PrEP as well as for Livdelzi. The ETR was 30.5% in the full year 2024 compared to 18.2% in 2023, primarily driven by the non-deductible acquired IPR&D charge for CymaBay and prior year decrease in tax reserves that did not repeat, partially offset by the tax impact of a legal entity restructuring and Immunomedics IPR&D impairment expense, as well as current year settlements with tax authorities and remeasurement of certain deferred tax liabilities. Non-GAAP ETR was 25.9% in the full year 2024 compared to 15.2% in 2023, primarily due to the non-deductible acquired IPR&D charge for CymaBay and a prior year decrease in tax reserves that did not repeat, partially offset by current year settlements with tax authorities. Guidance and Outlook For the full-year 2025, Gilead expects: (in millions, except per share amounts) February 11, 2025 Guidance Low End High End Product sales $ 28,200 $ 28,600 Product sales excluding Veklury $ 26,800 $ 27,200 Veklury $ 1,400 $ 1,400 Diluted EPS $ 5.95 $ 6.35 Non-GAAP diluted EPS $ 7.70 $ 8.10 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Presented new HIV data at the International Congress on Drug Therapy in HIV Infection (“HIV Glasgow 2024”). This included full results from the Phase 3 PURPOSE 2 trial evaluating investigational twice-yearly lenacapavir for HIV prevention among cisgender men and gender-diverse people, with data published in theNew England Journal of Medicine. Additionally at HIV Glasgow 2024, presented new HIV treatment research data from Biktarvy, as well as for investigational regimens with once-daily, once-weekly and twice-yearly dosing frequencies. Completed the New Drug Application submissions to U.S. Food and Drug Administration (“FDA”), as well as a marketing authorization application and an EU-Medicines for All application to the European Medicines Agency (“EMA”), for twice-yearly lenacapavir for HIV prevention. Lenacapavir named by Science Magazine as its 2024 “Breakthrough of the Year,” based in part on the PURPOSE 1 and PURPOSE 2 trial results. Oncology Our partner, Arcellx, Inc. (“Arcellx”), presented new data evaluating investigational anitocabtagene autoleucel (“anito-cel”) in relapsed or refractory (“R/R”) multiple myeloma at the American Society of Hematology 2024 Annual Meeting (“ASH 2024”). This included preliminary data from the registrational Phase 2 iMMagine-1 trial, as well as updated Phase 1 data. Presented new data at ASH 2024 including long-term follow-up of Yescarta in R/R non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Yescarta in R/R large B-cell lymphoma and Tecartus in B-cell precursor adult acute lymphoblastic leukemia. Granted Breakthrough Therapy Designation by FDA to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer (“ES-SCLC”) whose disease has progressed on or after platinum-based chemotherapy. The use of Trodelvy in ES-SCLC is investigational. Entered into a single-asset focused collaboration, license, and option agreement with Tubulis to develop an antibody-drug conjugate candidate for a solid tumor target using Tubulis’ Tubutecan and Alco5 platforms. Inflammation Received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use recommending seladelpar for the treatment of PBC in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Received marketing authorization from the Medicines and Healthcare products Regulatory Agency in the UK for seladelpar for treatment of PBC, including pruritus, in adults in combination with UDCA who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Presented new data evaluating seladelpar in PBC at the American Association for the Study of Liver Diseases’ The Liver Meeting. This included longer-term follow-up data from the ASSURE trial, as well as additional analyses from the RESPONSE trial. Announced a strategic partnership to develop and commercialize the pre-clinical oral STAT6 program of LEO Pharma A/S (“LEO Pharma”) for the potential treatment of inflammatory diseases. Corporate Appointed Dietmar Berger, MD, PhD, as Chief Medical Officer effective January 2025. Entered into a strategic research collaboration with Terray to discover and develop novel, small molecule therapies across multiple targets using Terray’s artificial intelligence tNOVA platform. Reached a final settlement agreement with the U.S. Department of Justice and the U.S. Department of Health and Human Services on patents that the government alleged covered Truvada® (FTC 200mg/tenofovir disoproxil fumarate (“TDF”) 300mg) and Descovy for HIV PrEP. Issued $3.5 billion aggregate principal amount of senior unsecured notes in a registered offering. The Board declared a quarterly dividend of $0.79 per share of common stock for the first quarter of 2025. The dividend is payable on March 28, 2025, to stockholders of record at the close of business on March 14, 2025. Future dividends will be subject to Board approval. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2025 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues; 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, LEO Pharma, Terray and Tubulis; 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, Tecartus, Trodelvy, Yescarta, anito-cel, lenacapavir and seladelpar (such as the ASSURE, iMMagine-1, PURPOSE 1 and 2, and RESPONSE 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 and seladelpar for PBC; 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 December 31, 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®, KITETM , 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 Twelve Months Ended December 31, December 31, (in millions, except per share amounts) 2024 2023 2024 2023 Revenues: Product sales $ 7,536 $ 7,070 $ 28,610 $ 26,934 Royalty, contract and other revenues 33 45 144 182 Total revenues 7,569 7,115 28,754 27,116 Costs and expenses: Cost of goods sold 1,581 2,090 6,251 6,498 Research and development expenses 1,641 1,408 5,907 5,718 Acquired in-process research and development expenses (11 ) 347 4,663 1,155 In-process research and development impairments — 50 4,180 50 Selling, general and administrative expenses 1,906 1,608 6,091 6,090 Total costs and expenses 5,118 5,503 27,092 19,511 Operating income 2,451 1,612 1,662 7,605 Interest expense 248 252 977 944 Other (income) expense, net 35 (293 ) (6 ) (198 ) Income before income taxes 2,168 1,653 690 6,859 Income tax expense 385 236 211 1,247 Net income 1,783 1,417 480 5,613 Net loss attributable to noncontrolling interest — (12 ) — (52 ) Net income attributable to Gilead $ 1,783 $ 1,429 $ 480 $ 5,665 Basic earnings per share attributable to Gilead $ 1.43 $ 1.15 $ 0.38 $ 4.54 Shares used in basic earnings per share attributable to Gilead calculation 1,248 1,248 1,247 1,248 Diluted earnings per share attributable to Gilead $ 1.42 $ 1.14 $ 0.38 $ 4.50 Shares used in diluted earnings per share attributable to Gilead calculation 1,259 1,256 1,255 1,258 Supplemental Information: Cash dividends declared per share $ 0.77 $ 0.75 $ 3.08 $ 3.00 Product gross margin 79.0 % 70.4 % 78.2 % 75.9 % Research and development expenses as a % of revenues 21.7 % 19.8 % 20.5 % 21.1 % Selling, general and administrative expenses as a % of revenues 25.2 % 22.6 % 21.2 % 22.5 % Operating margin 32.4 % 22.7 % 5.8 % 28.0 % Effective tax rate 17.8 % 14.3 % 30.5 % 18.2 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Product sales: HIV $ 5,452 $ 4,693 16% $ 19,612 $ 18,175 8% Liver Disease 719 691 4% 3,021 2,784 9% Oncology 843 765 10% 3,289 2,932 12% Other 184 201 (8)% 889 859 3% Total product sales excluding Veklury 7,198 6,350 13% 26,811 24,750 8% Veklury 337 720 (53)% 1,799 2,184 (18)% Total product sales 7,536 7,070 7% 28,610 26,934 6% Royalty, contract and other revenues 33 45 (26)% 144 182 (21)% Total revenues $ 7,569 $ 7,115 6% $ 28,754 $ 27,116 6% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Non-GAAP: Cost of goods sold $ 1,002 $ 980 2% $ 3,936 $ 3,697 6% Research and development expenses $ 1,612 $ 1,452 11% $ 5,732 $ 5,720 —% Acquired IPR&D expenses(2) $ (11 ) $ 347 NM $ 4,663 $ 1,155 NM Selling, general and administrative expenses $ 1,852 $ 1,597 16% $ 5,903 $ 6,060 (3)% Other (income) expense, net $ (91 ) $ (104 ) (13)% $ (279 ) $ (365 ) (24)% Diluted EPS $ 1.90 $ 1.72 10% $ 4.62 $ 6.72 (31)% Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,259 1,256 —% 1,255 1,258 —% Product gross margin 86.7 % 86.1 % 56 bps 86.2 % 86.3 % -3 bps Research and development expenses as a % of revenues 21.3 % 20.4 % 89 bps 19.9 % 21.1 % -116 bps Selling, general and administrative expenses as a % of revenues 24.5 % 22.4 % 203 bps 20.5 % 22.3 % -182 bps Operating margin 41.1 % 38.5 % 265 bps 29.6 % 38.7 % -903 bps Effective tax rate 19.2 % 17.1 % 210 bps 25.9 % 15.2 % 1075 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 Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,581 $ 2,090 $ 6,251 $ 6,498 Acquisition-related – amortization(1) (579 ) (580 ) (2,316 ) (2,271 ) Restructuring — (479 ) — (479 ) Other(2) — (51 ) — (51 ) Non-GAAP cost of goods sold $ 1,002 $ 980 $ 3,936 $ 3,697 Product gross margin reconciliation: GAAP product gross margin 79.0 % 70.4 % 78.2 % 75.9 % Acquisition-related – amortization(1) 7.7 % 8.2 % 8.1 % 8.4 % Restructuring — % 6.8 % (— )% 1.8 % Other(2) — % 0.7 % — % 0.2 % Non-GAAP product gross margin 86.7 % 86.1 % 86.2 % 86.3 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,641 $ 1,408 $ 5,907 $ 5,718 Acquisition-related – other costs(3) — 59 (78 ) 22 Restructuring (30 ) (15 ) (98 ) (20 ) Non-GAAP research and development expenses $ 1,612 $ 1,452 $ 5,732 $ 5,720 IPR&D impairment reconciliation: GAAP IPR&D impairment $ — $ 50 $ 4,180 $ 50 IPR&D impairment — (50 ) (4,180 ) (50 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,906 $ 1,608 $ 6,091 $ 6,090 Acquisition-related – other costs(3) (8 ) — (97 ) (2 ) Restructuring (46 ) (11 ) (91 ) (28 ) Non-GAAP selling, general and administrative expenses $ 1,852 $ 1,597 $ 5,903 $ 6,060 Operating income reconciliation: GAAP operating income $ 2,451 $ 1,612 $ 1,662 $ 7,605 Acquisition-related – amortization(1) 579 580 2,316 2,271 Acquisition-related – other costs(3) 8 (59 ) 174 (20 ) Restructuring 76 505 188 527 IPR&D impairment — 50 4,180 50 Other(2) — 51 — 51 Non-GAAP operating income $ 3,114 $ 2,739 $ 8,520 $ 10,484 Operating margin reconciliation: GAAP operating margin 32.4 % 22.7 % 5.8 % 28.0 % Acquisition-related – amortization(1) 7.6 % 8.1 % 8.1 % 8.4 % Acquisition-related – other costs(3) 0.1 % (0.8 )% 0.6 % (0.1 )% Restructuring 1.0 % 7.1 % 0.7 % 1.9 % IPR&D impairment — % 0.7 % 14.5 % 0.2 % Other(2) — % 0.7 % — % 0.2 % Non-GAAP operating margin 41.1 % 38.5 % 29.6 % 38.7 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ 35 $ (293 ) $ (6 ) $ (198 ) (Loss) gain from equity securities, net (126 ) 189 (274 ) (167 ) Non-GAAP other (income) expense, net $ (91 ) $ (104 ) $ (279 ) $ (365 ) GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Income before income taxes reconciliation: GAAP income before income taxes $ 2,168 $ 1,653 $ 690 $ 6,859 Acquisition-related – amortization(1) 579 580 2,316 2,271 Acquisition-related – other costs(3) 8 (59 ) 174 (20 ) Restructuring 76 505 188 527 IPR&D impairment — 50 4,180 50 Loss (gain) from equity securities, net 126 (189 ) 274 167 Other(2) — 51 — 51 Non-GAAP income before income taxes $ 2,956 $ 2,591 $ 7,822 $ 9,905 Income tax expense reconciliation: GAAP income tax (benefit) expense $ 385 $ 236 $ 211 $ 1,247 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 121 119 484 466 Acquisition-related – other costs(3) 2 1 41 9 Restructuring 16 90 37 95 IPR&D impairment — 15 1,051 15 Loss (gain) from equity securities, net 13 (18 ) (39 ) (14 ) Discrete and related tax charges(4) 29 (12 ) 243 (326 ) Other(2) — 11 — 11 Non-GAAP income tax expense $ 566 $ 442 $ 2,028 $ 1,503 Effective tax rate reconciliation: GAAP effective tax rate 17.8 % 14.3 % 30.5 % 18.2 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(4) 1.4 % 2.8 % (4.6 )% (3.0 )% Non-GAAP effective tax rate 19.2 % 17.1 % 25.9 % 15.2 % Net income attributable to Gilead reconciliation: GAAP net income attributable to Gilead $ 1,783 $ 1,429 $ 480 $ 5,665 Acquisition-related – amortization(1) 458 460 1,832 1,805 Acquisition-related – other costs(3) 6 (59 ) 134 (29 ) Restructuring 59 414 151 431 IPR&D impairment — 35 3,129 35 Loss (gain) from equity securities, net 113 (171 ) 313 180 Discrete and related tax charges(4) (29 ) 12 (243 ) 326 Other(2) — 40 — 40 Non-GAAP net income attributable to Gilead $ 2,390 $ 2,161 $ 5,795 $ 8,454 Diluted earnings per share reconciliation: GAAP diluted earnings per share $ 1.42 $ 1.14 $ 0.38 $ 4.50 Acquisition-related – amortization(1) 0.36 0.37 1.46 1.43 Acquisition-related – other costs(3) — (0.05 ) 0.11 (0.02 ) Restructuring 0.05 0.33 0.12 0.34 IPR&D impairment — 0.03 2.49 0.03 Loss (gain) from equity securities, net 0.09 (0.14 ) 0.25 0.14 Discrete and related tax charges(4) (0.02 ) 0.01 (0.19 ) 0.26 Other(2) — 0.03 — 0.03 Non-GAAP diluted earnings per share $ 1.90 $ 1.72 $ 4.62 $ 6.72 Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 1,110 $ 2,315 $ 2,801 Research and development expenses adjustments 29 (44 ) 176 (2 ) IPR&D impairment adjustments — 50 4,180 50 Selling, general and administrative expenses adjustments 54 11 188 30 Total non-GAAP adjustments to costs and expenses 663 1,127 6,858 2,879 Other (income) expense, net, adjustments 126 (189 ) 274 167 Total non-GAAP adjustments before income taxes 789 938 7,132 3,046 Income tax effect of non-GAAP adjustments above (152 ) (218 ) (1,574 ) (583 ) Discrete and related tax charges(4) (29 ) 12 (243 ) 326 Total non-GAAP adjustments to net income attributable to Gilead $ 607 $ 732 $ 5,315 $ 2,789 (1) Relates to amortization of acquired intangibles. (2) Relates to a write-off of an intangible asset related to the restructuring of our collaboration with Galapagos NV during the fourth quarter of 2023. (3) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s recent acquisitions. (4) 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 2025 FULL YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 11, 2025 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% Acquisition-related expenses ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $10,200 - $10,700 Acquisition-related and restructuring expenses ~ 2,500 Non-GAAP projected operating income $12,700 - $13,200 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 20% Income tax effect of above non-GAAP adjustments, and discrete and related tax adjustments (~ 1%) Non-GAAP projected effective tax rate ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.95 - $6.35 Acquisition-related and restructuring expenses, and discrete and related tax adjustments ~ 1.75 Non-GAAP projected diluted EPS $7.70 - $8.10 (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 9,991 $ 8,428 Accounts receivable, net 4,420 4,660 Inventories 3,589 3,366 Property, plant and equipment, net 5,414 5,317 Intangible assets, net 19,948 26,454 Goodwill 8,314 8,314 Other assets 7,319 5,586 Total assets $ 58,995 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 12,004 $ 11,280 Long-term liabilities 27,744 28,096 Stockholders’ equity(1) 19,246 22,749 Total liabilities and stockholders’ equity $ 58,995 $ 62,125 (1) As of December 31, 2024 and 2023, there were 1,246 shares of common stock issued and outstanding. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 2,975 $ 2,168 $ 10,828 $ 8,006 Net cash used in investing activities (225 ) (726 ) (3,449 ) (2,265 ) Net cash used in financing activities 2,260 (1,100 ) (3,433 ) (5,125 ) Effect of exchange rate changes on cash and cash equivalents (55 ) 37 (40 ) 57 Net change in cash and cash equivalents 4,954 380 3,906 673 Cash and cash equivalents at beginning of period 5,037 5,705 6,085 5,412 Cash and cash equivalents at end of period $ 9,991 $ 6,085 $ 9,991 $ 6,085 Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 2,975 $ 2,168 $ 10,828 $ 8,006 Capital expenditures (147 ) (214 ) (523 ) (585 ) Free cash flow(1) $ 2,828 $ 1,954 $ 10,305 $ 7,421 (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 Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 HIV Biktarvy – U.S. $ 3,129 $ 2,588 $ 10,855 $ 9,692 Biktarvy – Europe 400 333 1,509 1,253 Biktarvy – Rest of World 246 188 1,060 905 3,774 3,109 13,423 11,850 Descovy – U.S. 563 457 1,902 1,771 Descovy – Europe 25 25 100 100 Descovy – Rest of World 28 28 110 114 616 509 2,113 1,985 Genvoya – U.S. 410 447 1,498 1,752 Genvoya – Europe 42 48 180 205 Genvoya – Rest of World 18 22 84 103 470 517 1,762 2,060 Odefsey – U.S. 252 258 957 1,012 Odefsey – Europe 74 71 290 294 Odefsey – Rest of World 11 11 41 44 336 340 1,288 1,350 Symtuza - Revenue share(1) – U.S. 112 104 450 382 Symtuza - Revenue share(1) – Europe 30 32 130 133 Symtuza - Revenue share(1) – Rest of World 3 3 12 13 144 139 592 529 Other HIV(2) – U.S. 67 46 257 238 Other HIV(2) – Europe 33 25 129 116 Other HIV(2) – Rest of World 11 9 48 47 111 79 434 401 Total HIV – U.S. 4,532 3,899 15,918 14,848 Total HIV – Europe 603 533 2,339 2,102 Total HIV – Rest of World 317 261 1,355 1,226 5,452 4,693 19,612 18,175 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 185 216 922 859 Sofosbuvir / Velpatasvir(3) – Europe 69 74 299 323 Sofosbuvir / Velpatasvir(3) – Rest of World 75 89 374 355 330 378 1,596 1,537 Vemlidy – U.S. 148 115 486 410 Vemlidy – Europe 11 10 44 38 Vemlidy – Rest of World 100 92 428 414 260 217 959 862 Other Liver Disease(4) – U.S. 58 39 192 152 Other Liver Disease(4) – Europe 54 38 202 150 Other Liver Disease(4) – Rest of World 18 19 73 83 130 96 467 385 Total Liver Disease – U.S. 391 370 1,601 1,421 Total Liver Disease – Europe 134 121 545 511 Total Liver Disease – Rest of World 194 200 876 852 719 691 3,021 2,784 Veklury Veklury – U.S. 108 364 892 972 Veklury – Europe 80 181 284 408 Veklury – Rest of World 150 175 623 805 337 720 1,799 2,184 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 Oncology Cell Therapy Tecartus – U.S. 53 66 234 245 Tecartus – Europe 36 27 138 110 Tecartus – Rest of World 10 5 31 15 98 98 403 370 Yescarta – U.S. 161 187 662 811 Yescarta – Europe 156 140 666 547 Yescarta – Rest of World 72 42 242 140 390 368 1,570 1,498 Total Cell Therapy – U.S. 213 253 896 1,055 Total Cell Therapy – Europe 193 167 804 658 Total Cell Therapy – Rest of World 82 46 274 156 488 466 1,973 1,869 Trodelvy Trodelvy – U.S. 247 226 902 777 Trodelvy – Europe 77 48 294 217 Trodelvy – Rest of World 31 24 119 68 355 299 1,315 1,063 Total Oncology – U.S. 461 479 1,798 1,833 Total Oncology – Europe 269 216 1,098 875 Total Oncology – Rest of World 113 70 393 224 843 765 3,289 2,932 Other AmBisome – U.S. 7 4 44 43 AmBisome – Europe 66 68 276 260 AmBisome – Rest of World 36 39 212 189 109 111 533 492 Other(5) – U.S. 51 64 255 261 Other(5) – Europe 8 9 34 40 Other(5) – Rest of World 16 17 68 66 76 90 356 367 Total Other – U.S. 59 68 299 304 Total Other – Europe 74 77 310 301 Total Other – Rest of World 52 56 280 255 184 201 889 859 Total product sales – U.S. 5,550 5,180 20,508 19,377 Total product sales – Europe 1,160 1,128 4,576 4,197 Total product sales – Rest of World 826 762 3,526 3,361 $ 7,536 $ 7,070 $ 28,610 $ 26,934 (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, Stribild, Sunlenca, 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. Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com

Clinical ResultBreakthrough TherapyPhase 2License out/inPhase 1

08 Jan 2025

·medcitynews.com

Galapagos Keeps Focus on Cancer Cell Therapy, Spins Out Rest of Biz Into NewCo Backed by €2.4B - MedCity News

The Galapagos pipeline spans both oncology and immunology, but in recent years, the company has invested heavily in cancer cell therapy. The firm is now fully embracing the modality, announcing on Wednesday a business separation that leaves legacy Galapagos focused on cell therapy and a spin-off company able to independently develop a variety of new medicines. The transaction will result in two separate publicly traded companies. The yet-to-be named new company, called SpinCo for now, will be capitalized with €2.45 billion (about $2.5 billion) from Belgium-based Galapagos, which will retain its name. The plan is for SpinCo to deploy that cash across business deals to build a pipeline of drug candidates with clinical proof-of-concept in oncology, immunology, and virology. But SpinCo will start out with a partner. It is inheriting a collaboration agreement with Gilead Sciences signed in 2019. Galapagos started out in 1999 as a developer of small molecule drugs for inflammatory disorders. The company’s top-selling product was Jyseleca, a pill for rheumatoid arthritis and ulcerative colitis. This drug was initially developed in partnership with Gilead, and it won regulatory approvals in Japan and Europe. But after the FDA rejected the drug in 2020, Gilead walked away from it, leaving Galapagos to commercialize it alone. Last year, Galapagos transferred the Jyseleca business to Alfasigma, enabling the company to devote more resources to cell therapy. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions In cell therapy, Galapagos is chasing bigger companies, including Gilead, that have commercialized these treatments made by engineering a patient’s immune cells into targeted cancer fighters. But the multi-step manufacturing process can take a month or more; beyond actual manufacturing time, it takes time to transport cells to and from the lab where the engineering is done. Meanwhile, a patient’s cancer can advance, making it harder to treat. Galapagos aims to get cell therapies to patients more quickly by bringing manufacturing time down to about a week. In 2022, Galapagos acquired CellPoint, a company whose software enables remote monitoring of cell therapy manufacturing. CellPoint was partnered with contract drug manufacturing giant Lonza, whose Cocoon system enables manufacturing at the hospital where a patient is receiving care. During the 2023 annual meeting of the American Society of Hematology, Galapagos presented encouraging early results for its cell therapies made with Cocoon. Galapagos has since posted additional data supportive of a one-week manufacturing time, but not everyone is fully convinced Cocoon gives the company an advantage. Bristol Myers Squibb and Novartis are both developing new platforms that could enable a seven-day turnaround time, Leerink Partners analyst Faisal Khurshid wrote in a note sent to investors during the ASH 2024 conference last month. He also pointed to AstraZeneca’s $1 billion acquisition of Gracell Biotechnologies, whose appropriately named FasTCAR technology is designed to offer next-day turnaround times. To Khurshid, a key question is whether the new structure enables SpinCo to be better at business development than Galapagos was. At the legacy company, business development has been stymied by the emphasis on developing CAR T-cell therapies, he said in a Wednesday research note. Galapagos faced challenges finding good deals and its longstanding collaboration with Gilead came with limitations, such as requiring the company to give away half of a partnered asset after Phase 2 for a fixed $150 million. Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health “We eagerly await whether the new structure better allows for BD (business development),” Kurshid said. “The challenging issue of the [Gilead] collaboration structure remains, but a new team in place to oversee BD should definitely help the prospects here.” The 2019 collaboration with Gilead partnered multiple programs and included a $1.1 billion equity investment. Galapagos and Gilead are now amending the agreement. Galapagos regains full global rights to its pipeline and will pay royalties to Gilead on sales of certain products. But those drug candidates will not be developed within Galapagos. The company’s renewed focus on cell therapy brings a corporate restructuring that will lead to the discontinuation of small molecule programs in both oncology and immunology. These programs still offer value through potential partnerships, Galapagos said in an investor presentation. The company also said it will look to partner GLPG3667, a small molecule TYK2 inhibitor in mid-stage development for dermatomyositis and systemic lupus erythematosus. The corporate shakeup will result in the layoff of about 300 workers — about 40% of the company’s headcount, Galagapos said. Most of the job cuts will happen in Belgium and Galapagos will also shutter a site in France. After the reorganization and the business separation, the company expects to have about €500 million (about $515.6 million), which it expects will support the company into at least 2028. “The planned reorganization is a difficult but necessary step, but one that will position Galapagos for sustainable growth and value creation and for future success in its renewed focus on cell therapies,” Galapagos CEO Paul Stoffels said in a prepared statement. “Gaining full global development and commercialization rights from Gilead to our robust discovery and development pipeline supports our commitment to executing our strategy for accelerated growth and value creation.” As for SpinCo, that company will apply to list its shares on the Euronext exchange. Galapagos expects the business separation will be complete by mid-2025. When that happens, Gilead will have a 25% ownership stake in each company; two Gilead directors will step down from the Galapagos board and two Gilead directors will join SpinCo’s board. The 2019 agreement that gave Gilead the right to license and develop programs outside of Europe will now apply solely to SpinCo.

Cell TherapyAcquisitionDrug ApprovalASH

06 Nov 2024

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Gilead Sciences Announces Third Quarter 2024 Financial Results

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.

Clinical ResultPhase 2Phase 3Breakthrough TherapyDrug Approval

100 Deals associated with Filgotinib Maleate

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KEGG	Wiki	ATC	Drug Bank
D11106	Filgotinib Maleate	-	DB14845

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	European Union	Alfasigma SpA	24 Sep 2020
Colitis, Ulcerative	Iceland	Alfasigma SpA	24 Sep 2020
Colitis, Ulcerative	Norway	Alfasigma SpA	24 Sep 2020
Colitis, Ulcerative	Liechtenstein	Alfasigma SpA	24 Sep 2020
Rheumatoid Arthritis	Iceland	Alfasigma SpA	24 Sep 2020
Rheumatoid Arthritis	Liechtenstein	Alfasigma SpA	24 Sep 2020
Rheumatoid Arthritis	Norway	Alfasigma SpA	24 Sep 2020
Rheumatoid Arthritis	European Union	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active moderate	Norway	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active moderate	Liechtenstein	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active moderate	Iceland	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active moderate	European Union	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active severe	Norway	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active severe	Iceland	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active severe	European Union	Alfasigma SpA	24 Sep 2020
Ulcerative colitis, active severe	Liechtenstein	Alfasigma SpA	24 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	NDA/BLA	Canada	Gilead Sciences Canada, Inc.	01 Jan 2021
Crohn Disease	Phase 2	Georgia	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 2	Italy	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 2	South Korea	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 2	Ireland	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 1	Italy	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 1	Ireland	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 1	Georgia	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 1	Argentina	Galapagos NV	31 Oct 2016
Crohn Disease	Phase 1	South Korea	Galapagos NV	31 Oct 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02914522 (SELECTION, Pubmed \| United European Gastroenterol J)	Phase 2/3	Colitis, Ulcerative	-	Filgotinib 200 mg	sjcjijyijz(rsacwojfwt) = rmcxzqsgmw hlhlwnyxeg (rmmtjdokvr )	Positive	25 Oct 2024
				Filgotinib 100 mg	sjcjijyijz(rsacwojfwt) = estgesnwum hlhlwnyxeg (rmmtjdokvr )
UEGW2024	Not Applicable	-	-	Filgotinib 200 mg	fnrtyoylcz(cjyyxlgtzz) = joghxtylmg qwyvtbushl (uwnhshgsbl ) View more	-	13 Oct 2024
STEER STUDY (UEGW2024)	Not Applicable	Colitis, Ulcerative	20	Filgotinib	kjcoqwysun(twasxomxak) = jpwplxawfs ahkkitssym (ydafdpklhc, 3.2 - 6.2)	Positive	13 Oct 2024
NCT02914535 (SELECTIONLTE, UEGW2024)	Phase 3	Colitis, Ulcerative	-	Filgotinib 200 mg	bkfziogrgz(riqvktjhum) = AEs and AESIs in patients treated with open-label FIL200 (2464.7 PYE) showed no new safety signals, and safety events were comparable to those seen in previous analyses bixbiqtiff (tivzcjrilm )	Positive	13 Oct 2024
				Placebo
NCT05479058 (CAPYBARA, CTgov)	Phase 3	Colitis, Ulcerative	22	Placebo+Filgotinib (Filgotinib 200 mg)	hfuxbvcvco(ukfpuqqewz) = cdmqvckmqp bgooocahxm (somsapyqmp, fzgkvzlpxy - jayusviqxk) View more	-	04 Oct 2024
				Placebo+Filgotinib (Filgotinib 100 mg)	hfuxbvcvco(ukfpuqqewz) = nyntyzhxii bgooocahxm (somsapyqmp, pguglxmjfg - qhonvcdpic) View more
NCT02889796 (FINCH 1, Pubmed \| Rheumatology (Oxford)) Manual	Phase 3	Rheumatoid Arthritis	-	Filgotinib 200 mg	(cnzxdbjgxh) = ufklpacdnf glyfixcnyi (kovuwpmxai )	Positive	27 Sep 2024
				Filgotinib 100 mg	(cnzxdbjgxh) = swcgbexhsj glyfixcnyi (kovuwpmxai )
NCT02914535 (SELECTIONLTE, Pubmed) Manual	Phase 2/3	Colitis, Ulcerative inflammatory biomarkers	622	Filgotinib 200 mg	rxvboufxhl(eqgpaghwsc) = vzjnyygrqz zzlftjmxpx (tghsnstpfv ) View more	Positive	31 Jul 2024
				Filgotinib 200 mgFilgotinib 200 mg (non-responders)	rxvboufxhl(eqgpaghwsc) = klcrokhuiu zzlftjmxpx (tghsnstpfv ) View more
NCT02914600 (DIVERSITY LTE, CTgov)	Phase 3	Crohn Disease	1,188	Filgotinib (Filgotinib 200 mg)	hqsdzqajrz(ocysnjlifm) = qptdewerai srwqrwczdx (cnujfvobgi, cyvqvyflrm - btcgzjjgfs) View more	-	10 Jul 2024
				Filgotinib (Filgotinib 100 mg)	hqsdzqajrz(ocysnjlifm) = mtfdzcusas srwqrwczdx (cnujfvobgi, yeqdwvvsyh - dwpspxbeid) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Filgotinib	(obycekxuem) = tuxqapiqiv iwfnumogus (jmoklkfhyb ) View more	-	05 Jun 2024
				bDMARDs	(obycekxuem) = alqqxaubub iwfnumogus (jmoklkfhyb ) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Filgotinib 100mg	(lrwdsxpdme) = jhumnrmxiv vcattckstp (idxhwxarod, 1.8 - 2.6) View more	-	05 Jun 2024
				Filgotinib 200mg	(lrwdsxpdme) = ybeovoicqu vcattckstp (idxhwxarod, 1.5 - 2.0) View more

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