On February 11, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy (Press release, Regeneron, FEB 11, 2025, View Source [SID1234650174]). The target action date for the FDA decision is July 10, 2025.

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Acceptance of the BLA resubmission follows the resolution of third-party fill/finish manufacturing issues, which was the sole approvability issue identified by the FDA in the previous submission. The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM, and linvoseltamab is also under review by the European Medicines Agency (EMA) for the same patient population.

Linvoseltamab is investigational and has not been approved by any regulatory authority.

About Multiple Myeloma
As the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

About the Linvoseltamab Clinical Development Program
Linvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in 282 enrolled patients with relapsed/refractory MM. The Phase 1 dose-escalation portion of the trial – which is now complete – primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab and explored different administration regimens. The ongoing Phase 2 dose expansion portion is assessing the safety and anti-tumor activity of linvoseltamab, with the primary endpoint of objective response rate. Key secondary endpoints include duration of response, progression-free survival, rate of minimum residual disease negative status and overall survival.

Eligibility in the Phase 2 portion requires patients to have received at least three prior lines of therapy or have triple-class refractory MM. Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose administered weekly. At week 16, all patients transition to every two-week dosing. A response-adapted regimen further enables patients to shift to every four-week dosing if they achieve a very good partial response or better and have completed at least 24 weeks of therapy. The regimen requires a total of two 24-hour hospitalizations for safety monitoring.

Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders. They include evaluating linvoseltamab in a Phase 1b trial (LINKER-MM2) in combination with other cancer treatments in R/R MM as well as a Phase 3 confirmatory trial (LINKER-MM3) as a monotherapy in R/R MM. For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 844-734-6643.

On February 11, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, FEB 11, 2025, View Source [SID1234650173]):

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TD Cowen 45th Annual Health Care Conference at 11:50 a.m. ET on Tuesday, March 4, 2025
Leerink Partners 2025 Global Healthcare Conference at 8:00 a.m. ET on Tuesday, March 11, 2025

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

On February 11, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has received first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108) (Press release, Moleculin, FEB 11, 2025, https://moleculin.com/moleculin-receives-first-country-approval-in-europe-to-begin-recruiting-for-the-miracle-phase-3-r-r-acute-myeloid-leukemia-aml-pivotal-trial/ [SID1234650172]). In Ukraine the final necessary regulatory approvals from the Ministry of Health were received last week. This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US, Europe and the Middle East.

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"We continue to make solid progress across our site initiation and enrollment efforts. Achieving this important milestone of receiving our first country’s approval puts us another step closer to getting this study well underway and further bolsters our confidence that we’re on track for unblinded preliminary data from the first 45 subjects in the second half of this year. Our team remains committed to operational execution and face-to-face meetings with investigators, over 30 investigators in 11 countries of which I personally have met," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Building on this momentum, we are focused on getting more of the initial 25 sites we have selected to date on board and enrolling for the study."

The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting. The amended protocol allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). This early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

For Part B of the trial, approximately 244 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative. This increase from 240 to 244 subjects represents the statistical "cost" of the additional interim unblinding.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).

On February 11, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported encouraging new clinical data from the ongoing Phase 1 investigator-sponsored trial of INB-100, an allogeneic gamma-delta T cell therapy designed to help patients with complex leukemias, including AML (Press release, In8bio, FEB 11, 2025, View Source [SID1234650171]). INB-100, given following hematopoietic stem cell transplantation (HSCT), is demonstrating the potential to achieve durable long-term remissions and improved survival. The data will be presented at the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, hosted in Honolulu, HI.

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Highlights

100% of AML patients remain relapse-free
All treated AML patients in both the original and expansion cohorts through January 17, 2025 remain in complete remission. The original cohort of AML patients has reached a median CR of 23.3 months, with several patients in remission for over three years. The median duration across all treated AML patients (N=9) is 20.1 months.
Trial displays improved survival outcomes vs. standard treatment
When compared with real-world historical data, INB-100 demonstrated significantly higher survival rates:
INB-100:
All patients – 90.9% PFS and OS of 100% at one-year; and
AML patients – 100% PFS and OS of 100% at one-year.
Historical controls in AML:
Center for International Blood and Marrow Transplant Research (CIBMTR) demonstrate a PFS of 67.8% and OS of 74.7% at one-year; and
Kansas University Cancer Center (KUCC) PFS of 57.4% and OS of 66.7% at one-year.
Results demonstrate activity even with older, high-risk patients receiving reduced intensity conditioning (RIC)
Relapse is the most significant challenge leading to mortality for patients undergoing HSCT.
Many of the patients enrolled in the study were older (median age = 68), had complex, high-risk disease or had failed multiple prior therapies, including CAR-T treatments, yet they achieved durable, long-term remission with manageable side effects.
Therapy appears to be well-tolerated without significantly impacting patient Quality of Life
No cytokine release syndrome (CRS) or neurotoxicity; (ICANs)
Tolerable graft-versus-host disease (GvHD) in-line with historical data that is managed with steroids; and
Limited, mild infections.
Dr. Joseph P. McGuirk, Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics Medical Director, Blood and Marrow Transplant, The University of Kansas Cancer Center, commented, "These data suggest that the addition of allogeneic INB-100 gamma-delta T cells appears to have the potential to support durable relapse-free remissions in high-risk leukemia patients, with 100% of treated AML patients remaining in remission after a median follow-up of almost two years post-transplant. Typically, patients receiving reduced-intensity conditioning face substantial risks of relapse within a year, and those who relapse are often left with very few treatment options. INB-100 is not only helping patients avoid this common relapse timeline but is doing so while helping to preserve their quality of life. These results are truly exciting. We are seeing something we rarely encounter in high-risk leukemia patients: sustained, durable remissions with minimal side effects to date. These continued results of INB-100, with the manageable toxicity profile, suggest it could become an attractive cellular therapy with the potential to extend survival in this difficult-to-treat patient population."

William Ho, Chief Executive Officer and co-founder of IN8bio, added, "We’re incredibly pleased with our efforts to continue to deliver consistent, long-term remission results with INB-100. It’s rare to see 100% relapse-free survival in high-risk AML patients, especially over a prolonged period. For patients who may not have had a clear path forward in the past, INB-100 is providing hope, extending survival, and demonstrating the potential to change the standard-of-care. What makes this even more exciting is the safety profile we’ve observed. Gamma-delta T cells are showing that they can do the job of fighting residual cancer cells without causing significant side effects like CRS or neurotoxicity—issues that often plague other cell therapies. As we continue to enroll patients and expand the trial network, we are working diligently to lay the groundwork for the future regulatory pathway towards a potential registrational trial. The IN8bio team is working hard to de-risk the future path to approval and to bring this innovative therapy towards broader patient access. We are committed to providing further updates later this year as we build momentum toward this goal."

Conference Call Details

IN8bio will host a conference call and webcast today, Tuesday, February 11, 2025, at 8:30 am ET. The webcast can be accessed by clicking this link and can also be accessed on the Events & Presentations page of the Company’s website. To participate in the live call, please register using this link. It is recommended that participants register at least 5 minutes in advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.

For more information about the study – including detailed findings, conclusions and next steps – please visit the Company’s poster being presented at the American Society of Transplantation and Cellular Therapy conference: View Source

On February 11, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2024 (Press release, Gilead Sciences, FEB 11, 2025, View Source [SID1234650170]).

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"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 the New 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 (ASH) (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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 View Source and will be archived on www.gilead.com for one year.