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Last update 24 Mar 2025

Remdesivir

Last update 24 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryRemdesivir,also known by its trade name VEKLURY®,is a RNA-dependent RNA polymerase (RdRp) inhibitor developed by Gilead Sciences it was first approved by PMDA in Japan on May 7th, 2020, followed by EMA in the European Union on July 3rd, 2020, and then by FDA in US on October 22nd, 2020. indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients who are hospitalized or not hospitalized but at high risk for progression to severe COVID-19, including hospitalization or death, and are at least 28 days of age and weigh at least 3 kg. The drug is intended to inhibit the replication of the SARS-CoV-2 virus by interfering with its ability to make copies of itself, thus reducing the severity of the disease.

Drug Type

Small molecule drug

Synonyms

Captisol-enabled remdesivir, Redyx, Remdesivir (JAN/USAN)

+ [5]

Target

RdRp

Action

inhibitors

Mechanism

RdRp inhibitors(RNA-directed RNA polymerase inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19Respiratory Syncytial Virus InfectionsRespiratory Tract Infections

Inactive Indication

Hemorrhagic Fever, EbolaRespiratory Distress Syndrome

Originator Organization

Gilead Sciences, Inc.

Active Organization

Gilead Sciences Ireland UC

Gilead Sciences, Inc.

Gilead Sciences Canada, Inc.

+ [3]

Inactive Organization

National Institute of Allergy & Infectious Diseases

Drug Highest PhaseApproved

First Approval Date

Japan (07 May 2020),

COVID-19

RegulationFast Track (United States), Emergency Use Authorization (United States), Orphan Drug (United States)

Structure/Sequence

Molecular FormulaC27H35N6O8P

InChIKeyRWWYLEGWBNMMLJ-YSOARWBDSA-N

CAS Registry1809249-37-3

100

Clinical Trials associated with Remdesivir

NCT06817889

/ Not yet recruitingPhase 2

An Open-Label Study to Assess the Safety and Efficacy of Remdesivir for Treatment of Symptomatic Laboratory-Confirmed Respiratory Syncytial Virus Infection of the Upper Respiratory Tract in Patients Receiving Cellular or Bispecific Antibody Therapies

This phase II trial tests how well remdesivir works for treatment of respiratory syncytial virus (RSV) infection of the upper respiratory tract in patients receiving cellular or bispecific antibody therapy. Cellular or bispecific antibody therapies cause suppression of the immune system, making infections more frequent and reducing the body's ability to fight the infections. RSV infections are one of the most common respiratory infections in immunocompromised individuals and can cause significant pneumonia and even death. Remdesivir is in a class of medications called antivirals. It works by stopping viruses from spreading in the body.

Start Date01 Aug 2025

Sponsor / Collaborator

Fred Hutchinson Cancer Center

[+1]

NCT06873633

/ Not yet recruitingPhase 2

A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir in Hospitalized Children Aged 0 to Less Than 2 Years with Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.

THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.

Start Date01 Jun 2025

Sponsor / Collaborator

Penta Global Blockchain Foundation, Inc.

[+1]

NCT06792214

/ RecruitingPhase 4IIT

Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD (DEFEND) Clinical Trial

The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.

Start Date03 Jan 2025

Sponsor / Collaborator

Mount Sinai Hospital (Canada)

[+3]

100 Clinical Results associated with Remdesivir

100 Translational Medicine associated with Remdesivir

100 Patents (Medical) associated with Remdesivir

6,569

Literatures (Medical) associated with Remdesivir

31 Dec 2025·ANNALS OF MEDICINE

Early combination of sotrovimab with nirmatrelvir/ritonavir or remdesivir is associated with low rate of persisting SARS CoV-2 infection in immunocompromised outpatients with mild-to-moderate COVID-19: a prospective single-centre study

Article

Author: Cuccurullo, F. ; Buonomo, A. R. ; Scotto, R. ; D’Agostino, A. ; Palmieri, S. ; Viceconte, G. ; Silvitelli, M. ; Grimaldi, F. ; Moccia, M. ; Mercinelli, S. ; Gentile, I. ; Pietroluongo, D. ; Gravetti, A. ; Trastulli, F.

BACKGROUND:

Immunocompromised patients are at high risk of developing persisting/prolonged COVID-19. Data on the early combined use of antivirals and monoclonal antibodies in this population are scarce.

RESEARCH DESIGN AND METHODS:

We performed an observational, prospective study, enrolling immunocompromised outpatients with mild-to-moderate COVID-19, treated with a combination of sotrovimab plus one antiviral (remdesivir or nirmatrelvir/ritonavir) within 7 days from symptom onset. Primary outcome was hospitalization within 30 days. Secondary outcomes were: needing for oxygen therapy; development of persistent infection; death within 60 days and reinfection or relapse within 90 days.

RESULTS:

We enrolled 52 patients. No patient was hospitalized within 30 days of disease onset, required oxygen administration, died within 60 days, or experienced a reinfection or clinical relapse within 90 days.The clearance rates were 67% and 97% on the 14th day after the end of therapy and at the end of the follow-up period, respectively.Factors associated with longer infection were initiation of therapy 3 days after symptom onset and enrollment for more than 180 days from the beginning of the study. However, only the latter factor was independently associated with a longer SARS-CoV-2 infection, suggesting a loss of efficacy of this strategy with the evolution of SARS-CoV-2 variants.

CONCLUSIONS:

Early administration of combination therapy with a direct antiviral and sotrovimab seems to be effective in preventing hospitalization, progression to severe COVID-19, and development of prolonged/persisting SARS-CoV-2 infection in immunocompromised patients.

01 May 2025·Journal of Infection and Public Health

Prognostic factors of disease progression in patients with mild-to-moderate COVID-19 on early remdesivir treatment in Taiwan

Article

Author: Liu, Szu-Yu ; Wu, Chia-Ying ; Ho, Yu-Chien ; Lin, Wen-Ying ; Chuang, Chien ; Juan, Chih-Han ; Chang, Min-Chi ; Lin, Yi-Tsung ; Liu, Chia-Jen

BACKGROUND:

An early 3-day course of remdesivir treatment was recommended for high risk patients with mild-to-moderate COVID-19. We investigated the prognostic factors of disease progression and mortality in patients with mild-to-moderate COVID-19 on early remdesivir treatment in Taiwan.

METHODS:

Adult patients with mild-to-moderate COVID-19 treated with a 3-day course of remdesivir at Taipei Veterans General Hospital from April-July 2022 were identified. The main outcomes were 14-day disease progression (defined as increased oxygen requirement compared with the baseline condition or mortality) and 28-day mortality. Cox regression model was used to identify independent variables associated with poor outcomes.

RESULTS:

Among the 342 patients on early remdesivir treatment, 41 patients (12 %) had 14-day disease progression, and 6 patients (1.8 %) died within 28 days. Seventy-nine patients (23.1 %) did not receive COVID-19 vaccine before the diagnosis of COVID-19. Charlson Comorbidity Index (CCI) ≥ 7 was the only independent factor associated with 14-day disease progression, and nosocomial COVID-19, initial neutrophil-to-lymphocyte ratio, and C-reactive protein (CRP) > 10 mg/dL were independent factors associated with 28-day mortality. In 231 patients (67.5 %) administered at least two doses of COVID-19 vaccine, 26 patients (11.3 %) had 14-day disease progression, and 5 patients (2.2 %) died within 28 days. CCI score ≥ 7 was the only independent factor for 14-day disease progression, and CRP level > 10 mg/dL was the independent factor associated with 28-day mortality.

CONCLUSIONS:

Multiple comorbidities and nosocomial COVID-19 predisposed these patients to poor outcomes. Therefore, infection prevention and control measures are important in the fight against COVID-19.

01 May 2025·ANTIVIRAL RESEARCH

Assessment of repurposed compounds against coronaviruses highlights the antiviral broad-spectrum activity of host-targeting iminosugars and confirms the activity of potent directly acting antivirals

Article

Author: Hill, Michelle L ; Gileadi, Carina ; Brun, Juliane ; Kiappes, J L ; Witt, Karolina D ; Dwek, Raymond A ; von Delft, Annette ; Rangel, Victor ; Arman, Benediktus Yohan ; Makower, Laetitia L ; Zitzmann, Nicole ; Alonzi, Dominic S

The COVID-19 pandemic highlights the need for novel antiviral drug discovery approaches that could dramatically shorten timelines from compound discovery to clinical development. At the beginning of the pandemic, repurposing approaches were at the forefront of early research efforts to screen for antiviral activity against SARS-CoV-2 in over 2500 compounds. Here, we report cellular screening results of 100 FDA-approved and experimental compounds against SARS-CoV-2 in the human Calu-3 cell line. We observed 13 compounds showing antiviral activity against SARS-CoV-2, including seven FDA-approved compounds (remdesivir, boceprevir, amiloride, nafamostat, cisplatin, silmitasertib, and miglustat), and six compounds in pre-clinical and clinical development (tarloxotinib, lucerastat (NB-DGJ), MON-DNJ, NAP-DNJ, NN-DGJ and NN-DNJ). Further, we observed that our screening hits include several host-targeting antivirals, namely iminosugars, that are largely non-toxic and offer a large therapeutic window. The most-developed iminosugar MON-DNJ (UV-4B), which has been evaluated in a Phase 1 clinical trial, shows antiviral activity against SARS-CoV-2 wild type as well as alpha, beta, gamma, delta, and Omicron variants. Its activity also extended to another betacoronavirus HCoV OC43, but not alphacoronavirus HCoV 229E. Our cellular screening results add to the body of knowledge on antivirals against coronaviruses and confirm the antiviral efficacy of iminosugars in cellular assays using the human lung-cell line Calu-3.

622

News (Medical) associated with Remdesivir

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

23 Dec 2024

·www.accesswire.com

NanoViricides is in a Great Position to Fight Potential Bird Flu Pandemic with a Drug that the Mercurial H5N1 Influenza A Virus is Unlikely to Escape

SHELTON, CT / ACCESSWIRE / December 23, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), says that its broad-spectrum antiviral drug candidate NV-387 is the best weapon to fight a potential bird flu pandemic because the mercurial H5N1 Influenza A virus would not be able to escape the drug."Despite all changes, the H5N1 Influenza A virus should remain susceptible to NV-387 because NV-387 mimics the very essential host-side feature that H5N1 continues to use even as it changes," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding "This drug puts us in a great position to be able to fight a bird flu pandemic should it happen."WHO has stated "Available virus sequences from human cases [of H5 infection] have shown some genetic markers that may reduce susceptibility to neuraminidase inhibitors (antiviral medicines such as oseltamivir) [NAIs] or endonuclease inhibitors (such as baloxavir marboxil) [PBIs]" in their updated public health assessment of recent Influenza A H5 infections, dated December 20, 2024[1].NAIs and PBIs[2] are the only classes of drugs that currently exist for influenza treatment, and as the virus evolves, they are very likely to be rendered ineffective in the field, since already strains with reduced susceptibility are circulating.While the US Government has already sourced and stockpiled two different H5N1 vaccines, the Biden administration has currently no plans to authorize their use.Influenza viruses change far more rapidly than SARS-CoV-2 ever did in the COVID-19 pandemic[3]. At least one mutation in the H5 coat protein would be required for efficient infection of humans, and a few more changes that would still be required for rapid human-to-human transmission, in order for the H5N1 virus to turn into a pandemic virus; changes that have not happened yet.Nevertheless, any currently designed H5N1 vaccines are unlikely to be of much use, or possibly very limited use, from public health perspective to protect from a potential pandemic strain of H5N1 that has not appeared yet.In any case, vaccine against a rapidly changing virus is a game of chasing a rapidly moving target, as we have all learned from the experience during the COVID-19 pandemic[4].It is thus clear that a drug that the virus cannot escape is the only appropriate tool to fight a potential pandemic.We have already developed such a drug. NV-387 is a broad-spectrum antiviral that mimics the very host-side features that the virus continues to require no matter how much it changes in the field. It is highly unlikely that a susceptible virus would escape such a drug.The ultra-broad antiviral spectrum of NV-387, which encompasses a large number of diverse kinds of viruses including COVID, RSV, Influenza and even Orthopoxviruses (i.e. MPox, Smallpox), further substantiates that it is unlikely that a susceptible virus would escape this drug.What is more, NV-387 has demonstrated substantially superior activity to existing influenza drugs in a lethal lung infection animal study, as we have previously reported (reproduced below):Survival Lifespan of Lethally Infected Mice - Lung Infection with Influenza A H3N2TreatmentSurvival, DaysIncrease in Survival, DaysIncrease in Survival, %NV-387, Oral15788%Oseltamivir, Oral10225%Peramivir, I.V.11338%Baloxivir, Oral11338%Vehicle800%In this animal study, we also found that NV-387 treatment led to significant lung protection in the infected animals: lung destroying immune cell infiltration was substantially reduced, and the amount of mucus in the lungs was also substantially reduced, indicating that NV-387 protected the lungs and the animal from advancing into pneumonia.We believe that any H5N1 highly pathogenic virus is likely to be even more susceptible to NV-387 than the seasonal H3N2 influenza A virus. This is because all High-Path Avian Influenza A viruses are known to possess a poly-basic site that is much longer than the corresponding sequence in seasonal influenza viruses. The virus uses this poly-basic site to bind to sulfated proteoglycans prior to entry into cells. NV-387 displays a copious amount ligands that mimic this sulfated structure, which is how this drug (NV-387) entraps the virus. Thus a longer poly-basic site would be expected to cause a stronger interaction between the H5N1 High Path viruses and NV-387 in contrast to the interaction between NV-387 and seasonal influenza viruses.NV-387 has completed a Phase I human clinical trial with no reported adverse events and no drop-outs, indicating excellent safety and tolerability. We are now preparing for a Phase II clinical trial for the treatment of MPox which is currently an epidemic in Central Africa. We are also working on a Phase II clinical trial of NV-387 for the treatment of respiratory virus infections (including Influenza viruses, Coronaviruses, and RSV, among others).Thus we believe that we are in a strong position to combat a potential bird flu pandemic, being one of very few companies globally that is developing a broad-spectrum antiviral drug with the promise that viruses would be highly unlikely to escape the drug.[1] https://www.who.int/publications/m/item/updated-joint-fao-who-woah-assessment-of-recent-influenza-a(h5n1)-virus-events-in-animals-and-people_dec2024[2] NAIs = Neuraminidase inhibitors. These include Oseltamivir (Tamiflu®), Peramivir (Rapivab®), Zanamivir (Relenza®). They inhibit the exit of the virus particle from cell after the virus has already replicated into copious quantities inside the cell. PBIs = Viral Polymerase (B) inhibitors. Currently only Baloxavir (Xofluza) is licensed. They inhibit the production of new copies of viral genomic RNA. However, resistant virus to baloxavir was created in patients treated with baloxavir in its clinical trial itself. Further, the toxicity of this drug limits its use to a single dose.[3] Influenza viruses change very rapidly because they have many more tools to change themselves compared to other viruses. Firstly, an influenza virus is made up of eight separate segments of RNA, that it can simply swap with other influenza viruses (called "Re-assortment"). Secondly, segments of RNA can hop from one RNA to another (Called "Recombination"), and thirdly, single point mutations occur all the time across the entire RNA, because the virus lacks "proof-reading" capability (i.e. ability to ensure that the RNA is copied correctly).[4] The COVID vaccines did not protect the vaccinated from getting sick, and they did not even stop the vaccinated from transmitting the virus to others. The benefit of vaccination is thought to be in persons with other morbidities who would have been likely to contract severe disease from infection with hospitalization and possible death. However, the vaccines always lagged behind in time, developed against a strain that was already overtaken by a different one in the field even before rollout of the vaccine.About NanoViricidesNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:NanoViricides, Inc.[email protected]Public Relations Contact:[email protected]SOURCE: NanoViricides, Inc.

VaccineLicense out/inPhase 2Phase 1

10 Dec 2024

·www.businesswire.com

Ligand Hosts 2024 Investor and Analyst Day and Introduces 2025 Guidance

JUPITER, Fla.--( BUSINESS WIRE )--Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) will host its Investor and Analyst Day in Boston today. The event will feature presentations from Ligand CEO Todd Davis, CFO Tavo Espinoza, and other members of the senior management team who will provide an in-depth review of the company’s growth strategy, portfolio, platform technologies, and long-term financial outlook. “2023 marked the beginning of a new chapter in Ligand's history, and I could not be prouder of our team and their incredible accomplishments over the past two years. We set ambitious yet attainable goals, and I am confident that we have the right people, processes, and infrastructure in place to continue executing our strategy. We are focused on investing in highly differentiated assets and operating royalty-generating platform technologies that we believe will generate significant long-term shareholder value,” said Todd Davis, CEO of Ligand. At today’s event, Ligand’s senior management team will highlight: Ligand’s transformation over the past two years into a profitable, diversified, and infrastructure light organization that enables investors to participate in the innovation and promise of the biotech industry while avoiding concentrated binary risk The company’s robust financial performance in 2024, driven by an expected 27% increase in full year royalty revenue and a 38% increase in full year core adjusted earnings per diluted share; Ligand increased guidance twice this year based on the strength of new and existing commercial-stage assets Filspari (Travere Therapeutics), Capvaxive (Merck), Ohtuvayre (Verona Pharma plc), Qarziba (Recordati S.p.A.), and Veklury (Gilead Sciences, Inc.) as key drivers of royalty revenue growth in 2025 Ligand has had the most active dealmaking years in its recent history, deploying $192 million across eight investments, and is currently evaluating more than $1 billion in actionable opportunities The company’s royalty-generating technology platforms—Captisol® and NITRICIL™— that Ligand believes offer broad applicability and significant revenue growth Financial Overview and Outlook Today, Ligand will reiterate its 2024 guidance outlined in November: Total revenue of $160 million to $165 million comprised of $105 million to $108 million in royalty revenue, $27 million to $29 million of Captisol sales, and $28 million of contract revenue 1 Core adjusted earnings per diluted share of $5.50 to $5.70 Ligand will also introduce its 2025 guidance: Total revenue of $180 million to $200 million, comprised of $135 million to $140 million in royalty revenue, $35 million to $40 million of Captisol sales, and $10 million to $20 million of contract revenue Core adjusted earnings per diluted share of $6.00 to $6.25 Ligand will also provide an updated 5-year outlook: Long–term royalty receipts expected to deliver at least a 22% compound annual growth rate (CAGR) Existing commercial programs and late-stage pipeline (“Pharm Team”) support royalty revenue CAGR of 18% Total royalty receipts of approximately $285 million in 2029 Event Webcast The event will be broadcast live starting at 10:30 a.m. Eastern Time. The webcast and today’s presentation can be accessed at: https://investor.ligand.com/news-and-events/events-and-presentations/default.aspx . A replay of the webcast will be available on the website after the event. Adjusted Financial Measures Ligand reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, amortization of financial royalty assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, Pelthos operating loss, impairment of financial royalty assets, loss from equity method investment in Primrose Bio, income tax effect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included in its prior earnings releases. A reconciliation of forward-looking non-GAAP core adjusted earnings per diluted share to the most directly comparable GAAP measures is not available without unreasonable effort, as certain items cannot be reasonably predicted because of their high variability, complexity and low visibility. Specifically, non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items, directly impact the calculations of our core adjusted earnings per diluted share, which we expect to have a significant impact on our future GAAP financial results. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences, and Baxter International. For more information, please visit www.ligand.com . Follow Ligand on X @Ligand_LGND. We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts. Forward-Looking Statements This news release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, statements regarding the outlook or guidance regarding the final 2024 financial results and expectations for near-term and future revenue and expenses, and the breakdown of such revenue, growth in revenue and adjusted earnings; outlooks or guidance regarding the financial results and guidance for fiscal 2025 as well as potential growth over the next five years; statements regarding market position and competition for royalty transactions; expectations regarding internal and partners’ research and development programs, including the timing of the initiation or completion of clinical trials, the potential for and timing of regulatory approval and product launch by Ligand and its partners; expectations regarding future sales of products by Ligand's partners and the durability of Ligand's royalties; the ability for current and future technology platforms to generate license deals and royalties; Ligand's strategy to deploy capital including the size of the potential pipeline of transactions; and anticipated near-term milestones. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: the inherent risks of clinical development and regulatory approval of product candidates, including that the total addressable market for our partner’s products may be smaller than estimated; Ligand faces competition including with respect to royalty acquisition transactions, which may result in fewer transactions projected or may increase the cost of acquiring new programs, and our technology platforms, which may demonstrate greater market acceptance or superiority; partnered commercial products may not perform as expected; Ligand relies on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections; the possibility that Ligand’s and its partners’ drug candidates might not be proved to be safe and efficacious and FDA may not agree with our or our partners’ conclusions regarding the results of clinical trials; uncertainty regarding the commercial performance of Ligand’s and/or its partners’ products; Ligand may not achieve its guidance for 2024, 2025 or beyond; disruption to Ligand's and its partners' business, including delaying manufacturing, preclinical studies and clinical trials and product sales, and impairing global economic activity, all of which could materially and adversely impact Ligand's results of operations and financial condition; changes in general economic conditions, including as a result of geopolitical events (including the U.S. 2024 presidential and congressional elections); there may not be a market for the product(s) even if successfully developed and approved; Ligand is currently dependent on a sole supplier for Captisol® and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Ligand's partners may terminate their agreements in certain circumstances or discontinue development or commercialization of any of their products; Ligand or its partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the company; and other risks and uncertainties described in its public filings with the Securities and Exchange Commission, available at www.sec.gov . The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional license fees and milestone revenues we may receive. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Information regarding partnered products and programs comes from information publicly released by Ligand partners. Ligand’s trademarks, trade names, and service marks referenced herein include Ligand and Captisol. Each other trademark, trade name or service mark appearing in this press release belongs to its owner. 1 2024 guidance excludes the $60 million realized gain from short-term investments on the sale of Viking Therapeutics stock.

100 Deals associated with Remdesivir

External Link

KEGG	Wiki	ATC	Drug Bank
D11472	Remdesivir	J05AB	DB14761

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	Japan	Gilead Sciences, Inc.	07 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Distress Syndrome	Phase 3	United States	Gilead Sciences, Inc.	20 Apr 2021
Hemorrhagic Fever, Ebola	Phase 3	United States	National Institute of Allergy & Infectious Diseases	21 Nov 2018
Hemorrhagic Fever, Ebola	Phase 3	Republic of the Congo	National Institute of Allergy & Infectious Diseases	21 Nov 2018
Respiratory Syncytial Virus Infections	Phase 2	United States	Gilead Sciences, Inc.	01 Aug 2025
Respiratory Tract Infections	Phase 2	United States	Gilead Sciences, Inc.	01 Aug 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04292899 (EUPAS34303, Pubmed \| Clin Infect Dis)	Phase 3	COVID-19 SARS-CoV-2	-	Remdesivir plus standard-of-care (SOC)	ixgoltoutl(wjrvwjyzyw): HR = 1.64 (95% CI, 1.43 - 1.87)	Positive	22 Nov 2024
				Standard-of-care (SOC) alone
NCT04280705 (Adaptive COVID-19 Treatment Trial 1, Pubmed \| J Infect Dis)	Phase 3	COVID-19 SARS-CoV-2 RNA \| Nucleocapsid Antigen	642	Remdesivir	eztktitjtv(nzwtxrqava): recovery rate ratio = 1.95 (95% CI, 1.4 - 2.71)	Positive	24 Apr 2024
				Placebo
NCT04431453 (CARAVAN, CTgov)	Phase 2/3	COVID-19	59	Remdesivir (Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg)	kiwkfknqcd = ylvnswcytt nhqveasvyk (slpdddcyya, qgdovzspwz - rshobnumlc) View more	-	22 Dec 2023
				Remdesivir (RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg)	kiwkfknqcd = oooqtbnxdo nhqveasvyk (slpdddcyya, whxejvautq - fjdoxkswps) View more
NCT05041907 (PLATCOV, Pubmed \| J Infect Dis)	Phase 2	COVID-19	131	Remdesivir 200 mg followed by 100 mg daily for 5 days	wssfhgfxzt(sxqizubvwh) = zmfizozxyt jxdlzzscsb (duhekpnhfm, 18 - 73)	Positive	11 Nov 2023
NCT04280705 (ACTT-1, Pubmed \| J Infect Dis)	Phase 3	COVID-19 SARS-CoV-2 genomes	-	Remdesivir	tesfhvtfku(urnudnyjlc) = xaurcuvyri bmlqcapwac (gtepfadnqt )	Positive	02 Nov 2023
NCT04847622 (Pubmed \| Infect Dis Now)	Not Applicable	COVID-19	448	remdesivir (No supplemental oxygen (NSO))	fltxxnaemn(tafpfricny) = ksvmbfdlrw cxezqhrgeh (adnfgqyyhd ) View more	Positive	01 Oct 2023
				remdesivir (Low flow oxygen ≤ 6 litres (l)/minute (LFO))	fltxxnaemn(tafpfricny) = hgtriuwfgh cxezqhrgeh (adnfgqyyhd ) View more
NCT04391309 (CaTT, CTgov)	Phase 2	COVID-19 \| Severe Acute Respiratory Syndrome	49	IC14+remdesivir (IC14)	cjqpzdwtke(fzeicroinb) = agbbuxslmq fkzruaagkt (jzxrxhpaug, gmvmunovko - slqdeftbhe) View more	-	15 Jun 2023
				Sodium Chloride+remdesivir (Placebo)	cjqpzdwtke(fzeicroinb) = fflvecqrcx fkzruaagkt (jzxrxhpaug, irpsbvkmdt - gyttdbffft) View more
NCT04583969 (ACTIV-5/BET-B, CTgov)	Phase 2	COVID-19	527	Remdesivir+Lenzilumab (Remdesivir + Lenzilumab)	xoimcgrodh = uuvkixzqap pxqadrblgy (omqdaxyiti, iikflqqdge - oayfknaiuy) View more	-	05 Jun 2023
				Placebo+Remdesivir (Remdesivir + Placebo)	xoimcgrodh = jonmvuawkw pxqadrblgy (omqdaxyiti, gcitshufnx - oxvbiwdkwq) View more
ATS2023	Not Applicable	-	-	Remdesivir administration	okfjfkkhqm(hakqeghfgs): OR = 2.72 (95% CI, 1.13 - 6.55)	Negative	21 May 2023
				Remdesivir (Non-ventilated patients)
ATS2023	Not Applicable	COVID-19	5,004	Remdesivir	dbajgtoasq(jdmfwqdrki) = wbssgwrhhc prkzgsssaj (zndfkameoh )	Negative	21 May 2023
				No Remdesivir	dbajgtoasq(jdmfwqdrki) = xofjvnekgo prkzgsssaj (zndfkameoh )

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