October 2025
FOR INVESTOR USE ONLY; NOT FOR PROMOTIONAL USE.
Gilead's Mission
To discover, develop, and deliver innovative therapeutics for people with life-threatening diseases.
Our AmbitionsBring 10+ transformative therapies to patients
by 2030¹
Be a biotech employer and partner of choice
Deliver shareholder value in a sustainable, responsible manner
Strategic PrioritiesMaximize near-term revenue growth
Maximize impact of long-acting HIV therapies
Expand and deliver on oncology programs
1. Six new transformative therapies have been delivered to date since January 2020: Hepcludex (bulevirtide) in the EU, Livdelzi (seladelpar), Sunlenca/Yeztugo/Yeytuo (lenacapavir), Veklury (remdesivir), Tecartus (brexucabtagene autoleucel), and Trodelvy (sacituzumab govitecan-hziy).
Welcome to our Gilead Investor Resource Book. This book is a collection of materials intended to streamline the reader's initial review of Gilead materials. Of course, there is no substitute for our SEC filings, and our most recent disclosures may be found on our Investor Relations page at https://http://investors.gilead.com. As a supplement, however, we have pulled together materials designed to help bring you up to speed on Gilead's products, strategy, team, and performance to date. Any financial data included is available in Microsoft Excel, on request.
As you get to know Gilead, please reach out to the Investor Relations team if you have questions or feedback. In the meantime, and on behalf of the management team, thank you for your interest in Gilead.
Jacquie Ross, CFA
Senior Vice President, Treasury & Investor Relations Email: investor_relations@gilead.com
Contents
5 | About Gilead |
7 | Our Business |
8 | Our Therapeutic Areas of Focus |
41 | Key Corporate Transactions and Partnerships |
42 | ESG at Gilead |
46 | Press Releases: Corporate & Regulatory |
47 | Press Releases: Data Updates |
48 | Our Leadership Team |
51 | Our Board of Directors |
55 | Analyst Coverage and Largest Investors |
56 | Capital Allocation |
57 | Debt and Credit Facility |
58 | Financials |
1987
Gilead is founded
About GileadGilead was founded in 1987 as a biopharmaceutical company focused on viral diseases, cardiovascular disease, and cancer. The company was named after a Middle Eastern medication known as the balm of Gilead, which founder
Michael Riordan considered the world's first pharmaceutical product. Gilead has consistently been a leader in virology, starting with its first HIV therapy approval in 2001, which was followed by the development of HBV treatments, the first single tablet regimen for HIV, and a transformational cure for HCV.
In 2024, Gilead presented remarkable clinical data from the PURPOSE 1 and 2 trials evaluating lenacapavir as an investigational twice-yearly regimen for
long-acting HIV pre-exposure prophylaxis (PrEP). Approved as Yeztugo by FDA in June 2025 and as Yeytuo by the European Commission in August 2025, we believe that it could help more people than ever before benefit from HIV PrEP. Additionally, we are also evaluating new lenacapavir-based combinations for daily, weekly, monthly, quarterly, and twice-yearly options for HIV treatment. This pipeline is expected to support up to 7 HIV treatment launches by the end of 2033, extending Gilead's HIV leadership well beyond Biktarvy's projected U.S. LOE in April 2036.
Our oncology business has grown to more than $3 billion sales annually, including sales of Trodelvy, the first-approved TROP2 ADC, and our cell therapies, Yescarta and Tecartus. We continue to evaluate Trodelvy in new indications and have a wide range of other promising clinical stage oncology programs. In cell therapy, we are expanding our Kite family of products, including through the Arcellx-partnered BCMA CAR T therapy, anito-cel, expected to potentially launch in the
U.S. for late-line multiple myeloma in 2026.
We continue to build our third therapeutic area of focus, inflammation, most recently with the addition of Livdelzi, which received FDA accelerated approval in August 2024 as a second-line treatment for PBC. In earlier stages, we have a broad range of promising inflammation collaborations and programs underway.
In summary, we have a robust pipeline of over 120 pre-IND and clinical programs, including 33 in Phase 3. Combined with disciplined operating expense management, Gilead is well-positioned to deliver long-term growth across all three therapeutic areas.
1992
Gilead completes its IPO
1996
John Martin appointed CEO
Focus on Virology
2012
Gilead acquires Pharmasset
2013
Sovaldi, first oral combination HCV cure, approved by FDA
2016
John Milligan appointed CEO
Building a Diversified Portfolio
2001
Viread for HIV approved by FDA
2003
Gilead acquires Triangle Pharmaceuticals
2006
Atripla, first single tablet regimen for HIV, approved by FDA
Leadership in HIV and HCV
2017
Yescarta, our first cell therapy, approved by FDA
2018
Biktarvy, market leading daily pill regimen for HIV, approved by FDA
2019
Daniel O'Day appointed Chairman and CEO
2020
First FDA approval for Veklury in COVID-19
2021
Trodelvy receives full FDA approval for 2L mTNBC
2022
Sunlenca (lenacapavir) receives U.S. FDA and European MAA authorizations
2024
Gilead acquires CymaBay; Livdelzi (seladelpar) receives accelerated FDA approval for primary biliary cholangitis
2025
Yeztugo (lenacapavir) approved as first twice-yearly HIV PrEP injectable
Progress on Gilead's Transformation
Chief Executive Officer and Chairman Daniel O'Day joined Gilead in March 2019, and announced a new strategic direction in January 2020. In the years since, Gilead has made strong progress on its strategic clinical and commercial goals, as well as diversifying and strengthening the early pipeline through internal and external innovation and collaboration.
New Products with 11 Approved Indications¹
75% Increase in Clinical Portfolio²
Oncology
Virology Inflammation
32
8
12
12
9
17
30
56
Pipeline Bolstered with M&A and Partnerships
Q119 Q325
Since Q1 2019. Approved indications reflects first approval or accelerated approval in a major market or new indications: Trodelvy in metastatic triple-negative breast cancer (2021), and HR+/HER2- metastatic breast cancer (2023); Yescarta in follicular lymphoma (2021), and large B-cell lymphoma (2022); Veklury in COVID-19 (2020); Tecartus in mantle cell lymphoma (2020, accelerated), and acute lymphoblastic leukemia (2021); Hepcludex in hepatitis Delta virus (2020 Europe, not approved in U.S.); Sunlenca in heavily treatment-experienced HIV (2022); Livdelzi in primary biliary cholangitis (2024); and Yeztugo/Yeytuo as a pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV (2025). Does not include line extensions (e.g., expanded pediatric label). 2. Program count does not include potential partner opt-in programs or programs that have received both FDA and EC approval.
Gilead is best known for pioneering therapies in HIV and HCV. Over
the last several years, we have extended our reach into new therapeutic areas through strategic partnerships and acquisitions to create the foundation for a more sustainable and diversified business. With the launch of Yeztugo for HIV PrEP, Gilead is well positioned to continue diversifying in business.
72% HIV
11% Liver Disease
TOTAL Q325 PRODUCT SALES
$7.3B-2% YOY
11% Oncology
3% Other1
3% COVID-19
Virology
HIV Q325 Revenue of $5.3B, +4% YoY
Sales increase primarily driven by increased demand and favorable inventory dynamics, partially offset by lower average realized price.
Q325 Yeztugo Sales of $39M Reflect Strong Performance in First Full Quarter
$54M in sales since launching in the U.S. in June 2025.
Liver Disease Q325 Revenue of $819M, +12% YoY
Sales driven almost entirely by Livdelzi for primary biliary cholangitis, which exceeded
$100M in quarterly revenue for the first time in Q325.
Oncology
In Q325, Oncology Revenue was $788M, -3% YoY
Cell Therapy Q325 Revenue of $432M, -11% YoY
Sales decrease reflects ongoing competitive headwinds.
Trodelvy Q325 Revenue of $357M, +7% YoY, -2% QoQ
Sales increase YoY primarily driven by higher demand, with continued strength in metastatic breast cancer more than offsetting lower YoY sales due to the withdrawl of the accelerated approval indication for metastatic urothelial cancer in the U.S.
Other Q325 Revenue of $184M, -8% YoY, reflects sales from AmBisome, Gilead's cardiopulmonary portfolio, and other revenues.
Our Therapeutic Areas of FocusThe next section of this Resource Book will address our therapeutic focus areas in more detail. Throughout the Resource Book, investigational products and programs that are part of Gilead's pipeline are discussed. Please note that investigational products or uses are not approved by the FDA, and their safety and efficacy have not been established.
Virology Inflammation
HIV Prevention, Treatment, and Cure
Biktarvy
Long-Acting HIV Regimens
HIV Launch Timelines
COVID-19
Liver Disease
HCV
HBV
HDV
Livdelzi in PBC
21 Viral and Liver Disease Pipeline
22 Early Inflammation Pipeline
23 Novel Mechanisms
Oncology
24 Oncology Strategy
25 Oncology Program Summary
26 Cell Therapy
33 Trodelvy
37 Arcus Collaboration
Early Oncology
Oncology Pipeline
HCV - hepatitis C virus; HBV - hepatitis B virus; HDV - hepatitis D virus; PBC - primary biliary cholangitis.
Driving Innovation in HIV Treatment, Prevention, and CureGilead is a pioneer in HIV treatment and prevention and remains committed to bringing the most innovative therapeutics to market to support people with HIV (PWH) and people who could benefit from HIV PrEP. HIV and insufficient use of antiretrovirals (ARVs) remains a challenge with 1.3M new HIV infections annually, 41M people living with HIV, and ~25% of PWH not receiving treatment globally⁵.
Gilead's Portfolio of HIV Treatment and Prevention Products
Launched % Q325
Patent Expiry2
Product Description
Treatment Prevention
Revenue1
U.S. EU
First twice-yearly subcutaneous treatment for PWH who are MDR
2022
-
0.3%
2037
Most prescribed HIV treatment regimen in the United States3
2018
-
52.2% 20364,62033
TAF-based HIV prevention option and HIV treatment
2016
2019
9.9% 20314,62027
First approved TAF-based STR
2015
-
5.3% 202942028
TDF-based STR
2011
-
0.3% 202542026
TDF-based treatment; first medication approved for prevention
2004
2012
0.1% 2020 2017
First approved STR 2006 - 0.0% 2020 2017
First STR with an integrase inhibitor 2012 - 0.2% 20294 2028
Smallest tablet size STR when launched 2016 - 3.9% 20324 2027
First twice-yearly subcutaneous PrEP - 2025 0.6% 2037⁶
Gilead's Market Leadership Today
The HIV treatment market is growing at 2-3% annually, and is expected to continue at this rate through the mid-2030s. The current HIV treatment market consists of mostly daily oral regimens led by Biktarvy, which is considered a standard of care given its high bar of tolerability, efficacy, and high barrier to resistance.
Well-Positioned for the Future
Gilead is well-positioned to maintain its leadership in HIV treatment, driving innovation focused on person-centric dosing options. Gilead anticipates that its ~75% share of the U.S. branded market today will grow to ~80% by the mid-2030s.
1. Total product sales excluding Veklury. 2. As of 2024 10-K filing. See Page 69 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 3. As of Q325, see Page 10 for further details. 4. Reflects settlement/license agreements with generic manufacturers. MDR - multi-drug resistant. 5. UNAIDS 2024 Global AIDS Update. 6. As of Q325 10Q.
Biktarvy: Most Prescribed HIV Treatment RegimenWith a proven track record in HIV treatment, Biktarvy continues to set the standard for efficacy and safety, reinforcing Gilead's commitment to delivering innovative and durable therapies for people with HIV.
Overview
Biktarvy is a complete, single pill, once-a-day prescription medicine used to treat HIV-1 infection in adults and children¹, virologically suppressed individuals with known or suspected M184 resistance. Biktarvy can be used in both people who are initiating HIV treatment (treatment-naïve) and people with prior treatment history who are replacing their current HIV medicines (switch). As Gilead continues to address unmet needs in HIV across a broad range of preferences, we expect that daily orals will remain widely used, with Biktarvy playing a critical role.
Powerful Medicines Working Together to Suppress the Virus
bictegravir emtricitabine tenofovir alafenamide
The HIV Treatment Market Leader
#1
in Naïve in all G9 markets2,8
#1
in Switch in 7 of G9 markets2,8
~52%
U.S. treatment market share2
$3.7B
Q325 Revenue,
+6% YoY
13.4
11.8
10.4
8.6
7.3
4.7
1.2
FY18 FY19 FY20 FY21 FY22 FY23 FY24
Revenue ($B)
BIKTARVY PROJECTED U.S. LOE EXTENDED TO 2036
On October 6, Gilead announced that it has entered into a settlement agreement to resolve the patent litigations with the generic manufacturers that filed abbreviated new drug applications with the U.S. FDA to market generic versions of Biktarvy. Under
the Agreements, which are subject to standard acceleration provisions, no generic entry is expected prior to April 1, 2036 in the United States for Biktarvy tablets containing bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg).
Durable Viral Suppression at Five Years3
In two Phase 3 studies4, ≥98% of participants on Biktarvy for 240 weeks maintained an undetectable viral load (HIV-1 RNA <50 copies/ mL) through five years of follow-up (M=E analysis⁵).
Zero cases of treatment failure due to emergent resistance were detected among the final resistance analysis population of both studies, demonstrating the efficacy and tolerability profile of Biktarvy in treatment-naïve adults3.
The ongoing BICSTaR real-world observational study showed statistically significant improvement in treatment satisfaction at Month 12 following the switch to Biktarvy6,7.
Biktarvy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg. 1. Children who weigh at least 25 kg. 2. Source: IQVIA LAAD. 3. Sax P.E., et al. j.eclinm. 2023; 59. 4. Phase 3 Study 1489 and Study 1490. 5. Missing = Excluded (M=E) analysis; study participants with missing data were excluded when calculating the proportion of study participants with HIV-1 RNA <50 copies/m. 6. Brunetta J, et al. European AIDS, Poster PE2/50, 2021; 7. Brunetta J, et al. European AIDS, Supplement, 2021. 8. G9 markets defined as U.S., Canada, China, France, Germany, Italy, Japan, Spain and UK.
Lenacapavir: Long-Acting Option for Treatment and PrEP66%
30%
40%
Over the past several decades, the optimization of antiretroviral therapy has dramatically improved HIV treatment outcomes and prevention efforts globally. Still, ~55% of people with HIV have identified less frequent dosing as the greatest need1. Lenacapavir, with its potential for flexible dosing, is the latest example of Gilead's person-centered approach to long acting (LA) innovation.
29%
of PWH miss 5+ doses2
of PWH are concerned with missing their HIV Tx daily dose3
of PWH miss 1+ dose2
of PWH fear taking medication could reveal HIV status1
In June 2025, Yeztugo (lenacapavir) was approved in the U.S. as the first twice-yearly injectable for HIV prevention.
In December 2022, Sunlenca (lenacapavir) was approved for HTE adults with MDR HIV, in combination with other antiretroviral(s).
What is Lenacapavir?
Lenacapavir (LEN) is a first-in-class, small molecule long-acting HIV-1 capsid inhibitor for HIV treatment and prevention. While most antivirals act on only one stage of viral replication, LEN has a unique multimodal mechanism designed to inhibit HIV
at multiple stages of its lifecycle. LEN disrupts nuclear transport, viral assembly and release, and capsid core formation, resulting in an abnormal structure of the virus and, thus, inhibiting HIV-1 replication.
What Options are Being Developed with Lenacapavir?
We expect Biktarvy will remain the preferred treatment option in the once-daily oral setting for most individuals, including the treatment-naive population. That said, we are developing a novel once-daily oral BIC/LEN to increase options for PWH switching therapy, including those on complex regimens. Many PWH also seek a longer-acting option, and our pipeline includes novel combinations of weekly and monthly orals, as well as quarterly and twice-yearly injectables.
In HIV prevention, in addition to the recently approved twice-yearly Yeztugo we are also working to develop once-yearly injections and potentially a monthly or weekly oral option.
Capsid Inhibitors
Capsid inhibitors target the capsid shell of HIV, preventing the virus from uncoating and releasing its genetic material into
the host cell as well as the formation of a maturation capsid.
Examples: GS-4182, GS-3107
NRTTI
Nucleoside reverse transcriptase translocation inhibitors (NRTTIs) block the reverse transcriptase enzyme, preventing the conversion of RNA into DNA and terminating DNA synthesis.
Examples: GS-1614, Islatravir
11 1. 2024 Global PWH Research (N=340). 2. IQVIA LAAD; data on missed doses per month. 3. 2024 Global Demand Research (N=341). HTE - heavily treatment experienced; MDR - multi-drug resistant; PWH - people with HIV; TAB - Teropavimab; ZAB - Zinlirvimab; bNAbs - Broadly neutralizing antibodies; INSTI - integrase strand transfer inhibitors; NRTTI - Nucleoside reverse transcriptase translocation inhibitor.
INSTI
Integrase strand transfer inhibitors (INSTIs) block the action of integrase which prevents integration of viral DNA into the host cell's DNA, thereby stopping the virus from replicating.
Examples: GS-1720, GS-1219, GS-3242
bNAbs
Broadly neutralizing antibodies (bNAbs) recognize and block the entry of various HIV strains into healthy cells and can also activate other immune cells to destroy HIV-infected cells.
Examples: TAB, ZAB
Investor Resource Book
Yeztugo Approved as First Twice-Weekly HIV PrEPPre-exposure prophylaxis (PrEP) is the use of antiretroviral medication by HIV-negative individuals to prevent HIV infection. In June 2025, Yeztugo (lenacapavir) was approved in the U.S. as the first twice-yearly injectable for HIV prevention. Marketing authorization of Yeytuo (lenacapavir) by the EC followed in August 2025, with other regulatory filings ongoing globally.
Subcutaneous Injection Allows for Biannual Dosing
Following initiation dosing, Yeztugo is delivered in two 1.5 mL SC injections 2x/year, and can
be administered in the abdomen or thigh. In PURPOSE 1 and 2, lenacapavir was generally well-tolerated with 0.2% (4/2138) and 1.2% (26/2183) of participants discontinuing due to ISRs, respectively. Subsequent injections can be administered 24-28 weeks after the last dose, offering a 4-week window for greater
flexibility. Prodrugs of lenacapavir have enabled the
Yeztugo Launch Update
$39M
$54M
Q325 revenue Revenue since launch
Yeztugo has recieved updated
recommendations in clinical guideline for HIV prevention:
Payer coverage achieved almost three months ahead of schedule
75%
90%
Payer coverage target by the end of 1H26
Gilead has agreed with the Global Fund and the U.S. State Department, through the President's Emergency Plan for AIDS
development of investigational oral options for once-
weekly and once-monthly HIV treatment, to the recently approved twice-yearly Yeztugo/Yeytuo. A prodrug is a compound that, although not
Lenacapavir as "Breakthrough of the Year"
The International AIDS Society (IAS)
World Health Organization (WHO)
NY Department of Health
U.S. Center of Disease Control
Relief (PEPFAR) to supply enough doses of lenacapavir for PrEP for up to 2 million people over three years in certain low-and middle-income countries.
active in its original form, is metabolized in the body to produce an active drug,
allowing for lower doses and potentially smaller pill sizes. LEN is combined with other agents for HIV treatment as the virus quickly adapts to single-drug therapies. In HIV prevention, Yeztugo has been approved as a monotherapy, as the risk of resistance is lower when preventing initial infection.
Unprecedented Phase 3 Results in HIV Prevention
0.00 per 100 PY
Expanding into New & Existing U.S. Populations
Yeztugo is expected to accelerate U.S. PrEP adoption from 500K+ individuals today, to 1M+ in the mid-2030s. To achieve this goal, Gilead is focused on maximizing the current consumer base while expanding to new populations who could benefit from PrEP
PURPOSE 1
100% of lenacapavir participants did not acquire HIV
(n=0/2,138)
100% efficacy vs bHIV, p<0.0001 p<0.0001 vs. Truvada
Consumer Population
People on PrEP;
People with long-acting injectable preference
Black/Latine Men;
Cisgender women; Gender diverse people1
Individuals with bacterial STI; People who inject drugs
99.9% of lenacapavir
0.10 per 100 PY (n=2/2,179)
HCP
Population
Current PrEP Providers Non-PrEP providers in
areas of high need
New specialties (i.e., OBGYN); New settings (i.e., colleges);
PURPOSE 2
participants did not acquire HIV
96% efficacy vs bHIV, p<0.0001 p=0.00245 vs. Truvada
At Launch (2025) Expansion Normalizing
1. Trans-women, Trans-men, and non-binary people. PrEP - pre-exposure prophylaxis; SC - subcutaneous; ISR - injection site reaction; bHIV - background HIV incidence; PY - person years; PEPFAR - President's Emergency Plan for AIDS Relief; OBGYN - obstetrician and gynecologist.
Multiple Potential Launches by 2030 in Treatment & PreventionPrEP
Lenacapavir and its prodrugs are foundational in our treatment and prevention programs. Gilead has seven ongoing clinical programs evaluating daily, weekly, monthly, quarterly, and twice-yearly regimens based on lenacapavir or one of its prodrugs. We have confidence in both the breadth and quality of our innovative pipeline, as well as the speed at which we can progress development.
Latest Disclosure | Expected Updates in 2025 | Launch | ||||
LEN for PrEP | Phase 3 | Ph3 PURPOSE 365 FPI | Potential Filing 2027 | |||
BIC/LEN | Phase 3 | Ph2 ARTISTRY-1 Update AIDS24 Ph3 ARTISTRY-1 and -2 LPI 2H24 | Phase 3 ARTISTRY-1 and -2 Update 2H25 | Potential Filing 2026 | |||
LEN/ISL¹ | Phase 3 | Ph2 Update CROI24 Ph3 ISLEND-1 and -2 FPI 2H24 | - | Potential Filing 2026 | |||
GS-4182 + GS-1720 | Phase 2 | Ph1 Update AIDS24 Ph2 WONDERS-1² LPI 2H24 Ph2 WONDERS-2 FPI 2H24 | On clinical hold | Potential Filing 2028 Targeting Launch 2029 | |||
GS-3107 | Phase 1 | Ph1 FPI 2H24 | - | ||||
Undisclosed INSTI #1 or 2 | Preclinical | - | - | Targeting Launch 2030+ | |||
GS-1614 | Phase 1 | - | - | Targeting Launch 2030+ | |||
LEN + TAB + ZAB | Phase 2 | Ph2 Update 2H24 | - | Targeting Launch 2030+ | |||
GS-1219 or GS-3242 | Phase 1 | Ph1 FPI 2H24 | Phase 1 Update 2H25 | Targeting Launch 2030+ |
Treatment
Note: Timeline estimates are as of 30 September, 2025 and subject to change. Planned data readouts and regulatory submissions not necessarily in chronological order. For non-registrational studies, data readouts listed may be interim readouts. The use of lenacapavir for once-yearly prevention and the combinations and investigational candidates shown are investigational; the safety and efficacy of these uses have not been established. 1. Lenacapavir + Islatravir is being developed in collaboration with our partner, Merck. 2. WONDERS-1 is a Phase 2/3 trial. CROI - Conference on Retroviruses and Opportunistic Infections; AIDS - International AIDS Conference; FPI - first patient in; LPI - last patient in; Inj - Injection; INSTI - Integrase strand transfer inhibitor; PrEP - Pre-exposure prophylaxis; SubQ -Subcutaneous; TAB - Teropavimab; ZAB - Zinlirvimab.
Leveraging Virology Expertise for COVID-19We are continuously innovating potential treatments for viral diseases, leveraging our extensive expertise in virology. This innovation is exemplified by Veklury (remdesivir), which has become the antiviral standard-of-care for hospitalized COVID-19 patients1,2.
Veklury: Continued Benefit in COVID-19, Including in Variants of Concern
Veklury (remdesivir) played a crucial role during the COVID-19 pandemic, significantly reducing hospitalization, shortening time to recovery, and slowing disease progression. The pivotal Phase 3 ACTT-1 trial demonstrated 5 days shorter recovery time versus placebo³.
Stable Amid Dynamic Environment
Following the peak of COVID-19, sales of Veklury have decreased and stabilized, reflecting trends in hospitalization. Although the virus' severity has
lessened, hospitalization and mortality from the virus continue. The environment remains dynamic, with expected quarter-to-quarter variability from seasonal spikes. Veklury's share of treated hospitalized patients in the U.S. has remained consistently strong at over 60%, reinforcing its clinical benefit and position as
the antiviral standard of care for hospitalized patients treated for COVID-19. For full-year 2025, Gilead expects ~$1B in Veklury revenues5.
Remdesivir vials donated globally6
~2M
127
Countries with distribution access from voluntary licenses6
14.5M
Patients have access to Veklury and generic remdesivir6
>60%
Share of U.S. treated hospitalized patients with COVID-197
5.6
3.9
2.8
2.2
1.8
FY20 FY21 FY22 FY23 FY24
Revenue ($B)
Gilead at IDWeek 2025
At IDWeek 2025, Gilead presented new analyses of Veklury from the Phase 3 REDPINE study, which investigated viral load dynamics in individuals hospitalized with COVID-19 who have severely impaired renal function or have undergone solid organ transplantation - two groups at elevated risk for prolonged infection. In addition, complementary real-world evidence further illuminated
treatment patterns among older adults with compromised health and immunocompromised individuals hospitalized with COVID-19 in the United States, highlighting persistent gaps in care and areas
of unmet needs.
1. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines, NIH. 2. Veklury. Prescribing Information. Gilead Sciences, Inc.; 2022. 3. Reduced mortality did not reach statistical significance n the ACTT-1 trial. 4. Mozaffari E, et al. CROI 2024. 5. Guidance as of August 7, 2025. Financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section on Page 70 for further information. 6. Based on global Veklury, global remdesivir, and licensed generic remdesivir volume donated and shipped for distribution. 7. Actuals based on HealthVerity Hospital Chargemaster + Premier Hospital Data.
Expanding Impact in Liver Disease Management
Gilead has been a leader in liver disease research and treatment for over three decades. Our therapies have transformed liver disease treatment, addressing large gaps in need and improving patient outcomes.
About Liver Diseases
Despite significant advancements in liver disease treatment, there remains a substantial global unmet need, with millions of people affected by chronic liver disease.
Chronic infection with HBV, HCV, or HDV can lead to serious and life-threatening liver damage, including liver cirrhosis (scarring), liver cancer, and the need for liver transplant. Gilead's medicines have transformed the lives of those living with viral hepatitis. We have also made significant investments in testing and linkage to care to support governments globally aligning with WHO's goal to eliminate viral hepatitis as a public health threat by 2030.
Leveraging our extensive experience, we recently received FDA accelerated approval for Livdelzi for certain adults with primary biliary cholangitis (PBC). Livdelzi is the first treatment option for PBC to significantly improve both key PBC lab results and chronic itch (pruritus).
Regulatory Approvals¹ Liver Revenue Poised for Growth
HBV
HCV HDV PBC
2002
Hepsera
2008
Viread
2013
Sovaldi
2014
Harvoni
2016
Vemlidy Epclusa
2017
Vosevi
2021
Hepcludex2
2024
Livdelzi
Liver Disease
3.7
2.9 2.9
2.8
2.8
3.0
2019 2020 2021 2022 2023 2024
Revenue ($B)
$819M
Q325 Revenue
+12%
~60%
Q325 YoY Revenue Q325 U.S. HCV
$8M IN GRANTS; 115,000 INDIVIDUALS EXPECTED FOR VIRAL HEPATITIS SCREENING
Many people diagnosed with viral hepatitis have fallen out of the care cascade - up to 50% of infected people remain diagnosed but untreated. ReLink is one program that reflects Gilead's efforts to create a healthier world for all.
Market Share
>50%
Market Share in 4 of EU4/UK
At Gilead, we understand that making the world a healthier place for all people means going beyond the medicine to help remedy health inequities and other barriers to care. HepConnect is one way that we are working to improve the lives of those with hepatitis C.
Dedication to Patient-Centric Innovation
Since our first approval in HBV in 2002, Gilead has consistently delivered innovative therapies for liver disease. This includes the approval of our first HCV cure in 2013, the first approved HDV treatment in Europe in 2021, and most recently, the accelerated approval of Livdelzi for PBC in 2024. Our commitment to liver disease remains steadfast as we work towards developing a functional cure for HBV, new therapeutics for HDV, and the elimination of HCV.
1. First global approval. 2. Hepcludex (bulevirtide) is authorized by the European Commission, MHRA, SwissMedic, and Australia TGA for treatment of chronic HDV. Its safety and efficacy have not been established in the United States or in other regions where it has not received regulatory approval. WHO - World Health Organization.
Delivering HCV Cure: Achievements and ImpactAs a leader in liver disease innovation, Gilead has delivered curative treatment to approximately 11M HCV patients globally.
ABOUT HCV
HCV is a viral liver infection that can lead to serious and life-threatening liver damage, including liver cirrhosis, liver cancer, and the need for liver transplantation. Since launch, ~11M people have been treated with Gilead HCV
medications, but it is estimated that >50M people7are living with chronic HCV infection globally.
About 30% of people infected will clear the virus without any treatment, but the remainder could develop chronic HCV infection. Of those with chronic HCV infection, the risk of cirrhosis ranges from 15% to 30% within 20 years⁷.
There are still almost 250,0007 deaths from HCV-related complications including cirrhosis and liver cancer each year.
Gilead acquired Pharmasset in 2012, adding sofosbuvir which was further developed by Gilead and approved by FDA in 2013 as Sovaldi (sofosbuvir) for the treatment of chronic HCV in combination with other antivirals.
Before Sovaldi, HCV treatment was historically difficult and ineffective, and Gilead continued to build on Sovaldi's success with Harvoni (ledipasvir / sofosbuvir), the first single tablet regimen (STR) for HCV with a cure rate of more than 95%. Epclusa (sofosbuvir / velpatasvir), the first STR to treat all genotypes, followed in 2016.
Gilead's HCV Portfolio
Product U.S. Launch Description
Q325¹ Patent Expiry2
% U.S. EU
2017
First pan-genotypic regimen following direct
acting antiviral failure
0.6% 2034 2033
2016 First HCV STR to treat all genotypes 4.4%3 2033 2032
2014 First HCV STR for genotypes 1, 4, 5, or 6
0.1%4 2030 2030
2013 Backbone of all Gilead HCV therapies
0.2% 2029 2029
HCV Contribution to Total Revenue1
enabling cure
$35
HCV Revenue
Since HCV therapies are curative, and given the large number of patients treated using a Gilead-based regimen between 2014 and 2017, the number of patient starts has trended down over time. Since 2021, the number of patients treated with direct-acting antivirals (including sofosbuvir-based regimens) has stabilized. In 2024, HCV revenues were $1.8B, or 6% of total revenues, compared to a peak of 50-60% of revenues between 2014 and 2016.
Despite a WHO goal to eliminate HCV by 2030, few countries remain on track to do so, with estimates that overall HCV elimination in the U.S. will only be reached by 2037⁵, and 60% of high-income countries are off-track by at least 20 years⁶. As such, there is an ongoing need for curative HCV therapies as well as screening and linkage to care.
$30
Total Revenue
$25
$ Billions
$20
$15
$10
$5
$0
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1. Total product sales excluding Veklury. 2. As of 2023 10-K filing. See Page 69 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 3. Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead's subsidiary, Asegua. 4. Rounds down to 0%. Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead's subsidiary, Asegua. 5. Sulkowski M et al, Adv Ther. 2021;38(1):423-440. 6. Gamkrelidze I, et al, Liver Int. 2021;41(3):456-463. 7. https://www.who.int/news-room/fact-sheets/detail/ hepatitis-c.
Delivering Healthier Futures: Commitment to Innovation in HBVWe've been advancing the science of HBV for more than three decades, helping transform how chronic HBV is treated for millions of people globally. Our therapies have helped set new standards in patient care and continue to drive progress in the fight against HBV.
Extensive History in HBV Innovation
Gilead therapies have helped transform chronic HBV into a long-term manageable condition. Vemlidy (tenofovir alafenamide) received FDA approval in 2016 as a once-daily treatment for adults with chronic HBV and compensated liver disease. In 2024, FDA expanded its approval to include pediatric patients aged six and older and weighing at least 25 kg.
We continue to work towards a functional HBV cure, collaborating with our partners to explore innovative targets, and expanding into new populations.
Global Prevalence of HBV1
How does Vemlidy work?
Vemlidy (tenofovir alafenamide) is a nucleotide reverse transcriptase inhibitor (NRTI) that targets the hepatitis B virus (HBV). It works by inhibiting the reverse transcriptase enzyme, which is essential for the replication of HBV. By blocking this enzyme, Vemlidy prevents the virus from replicating in the liver. Vemlidy's patent expiration date is 2031 in the U.S.² and 2027 in the EU.
96-week results from two pivotal Phase 3 trials demonstrated that 73% of HBeAg-positive, and 90% of HBeAg-negative patients receiving Vemlidy achieved virological suppression. Additionally, Vemlidy demonstrated improved renal and bone density safety profiles compared to patients receiving TDF3.
Vemlidy Sales
959
814
842
862
657
488
321
122
3
2016 2017 2018 2019 2020 2021 2022 2023 2024
Revenue ($M)
Gilead's HBV and HDV Clinical Pipeline
SPOTLIGHT ON COMMITMENT TO PATIENT ACCESS: HAIVN
Gilead is part of a four-year public-private academic institution collaboration initiative with the Partnership for Health Advancement in Vietnam (HAIVN) to address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in a country with high burdens of HBV and HCV.
HBV Cure selgantolimod + NCT04891770 | Phase 2 | Vir | Fully enrolled |
HBV GS-2829; Vaccine GS-6779 NCT05770895 | Phase 1 | Hookipa | Update expected at |
AASLD 2025 |
Indication Program Trial Name Stage Partner Status
VIR-22184
1. Razavi-Shearer., et al. Lancet Gastroenterol Hepatol, 8(10)(2023). 2. As of 2023 10-K filing. See Page 69 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. Reflects settlement/license agreements with generic manufacturers. 3. Agarwal K., et al. J Hepatol. 2018 Apr;68(4):672-681. 4. Combination trial of selgantolimod, VIR-2218, and anti-PD1. FPI -
17 first patient in (screening + consent); AASLD - American Association for the Study of Liver Disease.
Investor Resource Book
Ongoing Advancements in HDV TreatmentIn March 2021, Gilead completed the acquisition of MYR GmbH for approximately €1.3B, adding Hepcludex, a first-in-class entry inhibitor.
About HDV
HDV is the most severe form of viral hepatitis, and is likely under-diagnosed. HDV has a global prevalence of 12M¹, affecting
01 | BLV 2mg (144 weeks, n=49) | 29% | 18% | 16% | 20% |
YR 3 | BLV 10mg (144 weeks, n=50) | 50% | 26% | 24% | 22% |
M | BLV 10mg delayed treatment (96 weeks, n=50) | 52% | 18% | 16% | 20% |
BLV 10mg (96 weeks, n=50) | 22% | 12% | 12% | - | |
204 | BLV 10mg + PEG-IFNα (96 weeks, n=50) | 70% | 46% | 46% | - |
YR | BLV 2mg + PEG-IFNα (96 weeks, n=50) | 44% | 32% | 26% | - |
PEG-IFNα (48 weeks, n=24) | 21% | 17% | 25% | - |
an estimated 2% of people living with chronic HBV. HDV is a defective virus that requires the HBV surface antigen (HBsAg) for its replication and assembly. Thus, HDV occurs as a co-infection in individuals who have HBV, and significantly increases the risk of poor outcomes compared to HBV infection alone, which includes a more aggressive and rapid progression of disease towards
Pooled Analysis of MYR301 and Phase 2b MYR204 Data at EASL 2025
The pooled analysis presented at EASL25 showed the potential benefit of bulevirtide therapy even after treatment has stopped. The analysis showed that almost half (48.5%) of people treated with 10 mg bulevirtide monotherapy or in combination with pegylated interferon had undetectable HDV RNA at the end of treatment. Data showed that 36% of participants treated with either the 2mg or 10mg dose maintained virologic suppression almost two years after stopping treatment through achieving undetectable HDV RNA at the end of treatment. Based on the results from the Phase 3 MYR301 trial, Hepcludex is approved in the EU, UK, Canada, Switzerland, and Australia for the treatment of chronic HDV.
hepatocellular carcinoma and liver-related death2.
How does Hepcludex work?
M
Hepcludex (bulevirtide) is an entry inhibitor that binds to sodium taurocholate cotransporting polypeptide (NTCP), a receptor which normally facilitates the uptake of bile acids into hepatocytes, the chief functional cells of the liver. In individuals with HBV and HDV, NTCP is the critical receptor for viral entry into the liver cells. By binding to NTCP, Hepcludex inactivates NTCP and inhibits the entry of HBV and HDV into hepatocytes. This inhibition disrupts the viral life cycle, thereby reducing viral replication. The patent expiry for Hepcludex is 2029 in the EU⁶.
Treatment Regimen EOT
EOT
+24 weeks
EOT
+48 weeks
EOT
+96 weeks
HEPCLUDEX REGULATORY APPROVAL IN THE EU
In July 2023, Gilead received full marketing authorization from the European Commission for Hepcludex in the treatment of chronic HDV. EASL guidelines5recommend all HBsAg+ patients to be screened for HDV. Hepcludex was fully approved in the UK in August 2023, in Switzerland in February 2024, in Australia in July 2024, and in Candada in August 2025.
HEPCLUDEX REGULATORY FILINGS IN THE U.S.
On October 27 2022, Gilead received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) of bulevirtide, citing concerns regarding the manufacturing and delivery of bulevirtide. No new studies to evaluate the safety and efficacy of bulevirtide were requested. Gilead has recently submitted a BLA for bulevirtide for the treatment of chronic HDV and is awaiting FDA feedback, with a decision expected in 2026.
Hepcludex (bulevirtide) is authorized by the European Commission, MHRA, SwissMedic, Australia TGA, and Health Canada for treatment of chronic HDV. Its safety and efficacy have not been established in the United States or in other regions where it has not received regulatory approval. 1. Stockdale et al. J Hepatol. 2020 Sep;73(3):523-532. 2. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d. 3. Wedemeyer H., et. al. N Engl J Med 2023;389:22-32. 4. Asselah T. et al. N Engl J Med 2024;391:133-143. 5. Brunetto, Maurizia Rossana et al. Journal of Hepatology, Volume 79, Issue 2, 433 - 460, 2023. 6. See Page 69 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. ALT - alanine aminotransferase; BLV - bulevirtide; CRL - complete response letter; HBsAg -hepatitis B surface antigen; LoD - level of detection; PegIFNα - pegylated interferon alpha; EASL - European Association for the Study of the Liver; EOT - end of treatment.
Livdelzi: Addressing High Unmet Need in 2L PBCIn March 2024, Gilead acquired CymaBay for approximately $4.3B, expanding Gilead's liver portfolio to include Livdelzi (seladelpar), an PPAR∂ agonist, which received FDA accelerated approval for treatment of primary biliary cholangitis (PBC) in August 2024.
About Primary Biliary Cholangitis
PBC is a chronic, autoimmune, cholestatic, and fibrotic liver disease that frequently leads to impaired quality and quantity of life. It causes progressive destruction of the bile ducts in the liver, leading to bile buildup, inflammation, and scarring. PBC impacts ~130K people in the
U.S. and ~125K people in Europe¹. Treatments for PBC aim to normalize serum levels of biochemical markers of disease progression (e.g., alkaline phosphatase (ALP) and bilirubin) and minimize symptom burden (e.g., fatigue, pruritus, generalized abdominal pain).
Pruritis: A Key Symptom of PBC
Pruritus, or chronic itching, is an extremely severe and debilitating symptom for patients with PBC. Patients often experience sleep disturbances, fatigue, and secondary skin lesions from constant scratching. Prior to Livdelzi's approval, there were no other treatment options that reduced pruritus with statistical significance for PBC.
What is the current treatment paradigm?
Livdelzi was granted accelerated approval for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as a monotherapy in patients who are unable to tolerate UDCA. Livdelzi is not recommended in patients who have or develop decompensated cirrhosis.
UDCA is the only FDA approved agent for 1L PBC, but the majority of patients do not achieve normalization of ALP and/or bilirubin levels despite treatment². For patients with inadequate response to or intolerant to UDCA, two treatments are currently FDA approved, including Livdelzi (seladelpar, approved Aug'24) and Iqirvo (elafibranor, approved June'24). In September 2025, Intercept announced the voluntary withdrawl of Ocaliva (previously approved under accelerated approval for 2L PBC in the U.S.) following a request from the FDA.
U.S. 2L PBC Market Opportunity
2L Prevalence: ~130K
Diagnosed: ~80K
Treated: ~72K
UDCA 1L Treatment
Adequate
Responders
Inadequate Responders
(~21K - 23K)
Partial Responders
(~21K - 23K)
~42 - 46K
Gilead is leveraging its existing commercial infrastructure in liver diseases, which includes a large liver sales team that covers ~80% of the estimated U.S. prescribers for PBC. Separately, Kaken retains the rights to exclusively develop and commercialize Livdelzi in Japan, and Gilead will receive milestone payments and royalties on gross sales.
LAUNCH UPDATE
#1
Treatment for 2L
PBC in the U.S.
+35% Q325 QoQ Revenue
Livdelzi QoQ revenue growth was driven by
strong commercial execution (including some new launches outside of the U.S.) and a competitor product withdrawl.
We are pleased to see strong levels of patient persistence. We believe in Livdelzi's differentiation and value to those with PBC.
1. Lu et al., Clinical Gastroenterology and Hepatology. 2018; 2. de Veer RC, et al. Aliment Pharmacol Ther. 2022;56(9):1408-1418. 3. Jones D, et al. Hepatol Commun. 2023;7(3):e0057. EC - European Commission; EMA - European Medicines Agency; CHMP - committee for medicinal products for human use; PPAR∂ - peroxisome proliferator-activated receptor delta; UDCA - Ursodeoxycholic acid.
Livdelzi: New Treatment with Notably Differentiated ProfileIn August 2024, FDA granted Livdelzi accelerated approval based on the pivotal Phase 3 RESPONSE study, which demonstrated statistically significant improvements in key biomarkers and pruritus. In February 2025, The EMA granted Lyvdelzi conditional marketing authorization.
About Livdelzi
RESPONSE
Inadequate responders
(ALP > 1.67)
~21-23K
Phase 3 FDA approved
EC approved
Livdelzi (seladelpar) is a potent selective peroxisome proliferator-activated receptor (PPAR)-delta ∂ agonist. PPAR∂ is a nuclear receptor expressed in most tissues, including the liver. Activation of PPAR∂ reduces accumulation of bile acids and pro-inflammatory cytokines, and increases lipid metabolism. The reduction of bile acid synthesis occurs through Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the
PBC Clinical Pipeline
RESPONSE evaluates Livdelzi in 2L patients inadequately responsive to UDCA with ALP > 1.67 x ULN. IDEAL assesses a separate 2L population, of those partially responsive to UDCA with ALP 1 - 1.67 x ULN. AFFIRM (confirmatory) evaluates 2L PBC patients that were either partial or inadequate responders to UDCA with compensated cirrhosis and ALP < 10 x ULN for EFS. ASSURE evaluates Livdelzi's long-term safety and efficacy which is important for PBC, as it is a chronic disease.
2L U.S.
synthesis of bile acids from cholesterol. The safety and efficacy profile of
Livdelzi is based on the Phase 3 RESPONSE study including data on liver enzyme elevations. Livdelzi is intended as a chronic, indefinite therapy for PBC.
Trial Name Population
Population Stage Status
Livdelzi's Impact on Pruritus
In the pivotal RESPONSE study, Livdelzi showed a statistically significant reduction in pruritus. While the exact cause of pruritus in PBC isn't fully known, the reduction of bile acids through activation of PPAR∂ is associated with a
IDEAL Partial responders (ALP 1 - 1.67)
~21-23K
Phase 3
Enrollment completed
ASSURE Open-label, long-term study - Phase 3 Active
decrease in IL-31, a known pruritogenic cytokine. The RESPONSE trial data is reflected in Livdelzi's label, making it the only currently available therapy which uniquely demonstrated statistically significant improvements for both the key biomarkers of PBC, along with this key symptom.
AFFIRM Patients with compensated
LIVDELZI'S IP PROFILE
Seladelpar's composition of matter patents are set to expire in 2026 in the U.S. Orphan Drug Exclusivity provides regulatory exclusivity for 7 years in the U.S. and 10 years in the EU⁵.
cirrhosis (Child-Pugh A & B)
- Phase 3 Active
✓
ALP
Normalization
Positive ALP & Bilirubin Response
Statistically Significant Pruritus Reduction
✓
✓
Phase 3 Results
ENHANCE2RESPONSE3 (Pivotal) ASSURE4 (Open-Label, Long-Term)
Patient Population
intolerance to UDCA (n=265)
intolerance to UDCA (n=193) from RESPONSE) (n=97)
Inadequate response to or Inadequate response to or Prior study patients (not | RESPONSE patients receiving continuous treatment (n=103) | RESPONSE patients receiving placebo crossing over to seladelpar (n=52) |
Composite ALP & Month 3 (10mg) Month 12 (10 mg) Month 24: 70% | Month 24: 72% | Month 24: 94% |
ALP Normalization (%) Month 3 (10mg) Month 12 (10 mg) Month 24: 42% | Month 24: 17% | Month 24: 50% |
Change in Pruritus (NRS) Month 3 (10mg) Month 6 (10 mg) Month 24: -3.1 | Month 18: -3.8 | Month 6: -3.8 |
Bilirubin Response (%)
78.2% vs. Placebo 12.5% (p<0.0001)
61.7% vs. Placebo 20% (p<0.0001)
27% vs. Placebo 0% (p<0.0001) 25% vs. Placebo 0% (p<0.0001)
-3.01 vs. Placebo -1.44 (p=0.0164) -3.2 vs Placebo -1.7 (p<0.005)
1. Kremer, A.E., et. al, Hepatology 80(1):p 27-37, July 2024. 2. Kremer, A.E., et al, The Liver Meeting 2023. 3. Hirschfield, G.M, et al. NEJM 2024;390:783-794. 4. Trivedy PJ, et al. Long-term efficacy and safety of open-label seladelpar in patients with primary biliary cholangitis (PBC): interim results for 2 years from the ASSURE study, EASL 2024. 5. See Page 69 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. ALP - alkaline phosphatase; EC - European Commission; EFS - event free survival; ULN - upper limit normal.
Viral and Liver Diseases PipelinePHASE 1
PHASE 2
PHASE 3
FILED
Updates since Q2'25
HIV Prevention | Yeztugo® (PURPOSE 1 & 2) Lenacapavir (PURPOSE 365) | HIV PrEP LAI HIV PrEP LAI ★ | NDA approve | d and EC approved | EC Approved Phase 3 FPI | |||
HIV Trreatment | Bictegravir/lenacapavir oral combination (ARTISTRY-1 & -2) Islatravir/lenacapavir oral combination (ISLEND-1 &-2)1 HIV INSTI/capsid inhibitor (GS-1720/GS-4182) (WONDERS-1 & -2)2 HIV capsid inhibitor (GS-3107) Lenacapavir + teropavimab + zinlirvimab3HIV INSTI (GS-1219) HIV INSTI (GS-3242) HIV NRTTI (GS-1614)1 | HIV Oral HIV LAO HIV LAO HIV LAI HIV LAI HIV LAI HIV LAI HIV LAI | Clinical hold | Breakthrough Therapy Designation | ||||
HIV Cure | Teropavimab + zinlirvimab3,4Vesatolimod (FRESH) HIV bispecific T-cell engager (GS-8588) | HIV Cure HIV Cure HIV Cure | ||||||
HDV | HEPCLUDEX® (MYR301) HDV pre-S1 nAb (GS-4321) | HDV HDV | ★ | BLA Submitte | d; MAA approved | BLA submitted Phase 1 FPI | ||
HBV Cure | Selgantolimod | HBV Cure | ||||||
HBV therapeutic vaccine (GS-2829 + GS-6779) | HBV Cure | |||||||
Opt-ins | Assembly Biosciences | HBV, HDV, HSV | 4 clinical stage programs | |||||
★ New listing since Q225
Pipeline shown above as of end of Q3'25. 1. Subject to Gilead and Merck co-development and co-commercialization agreement. 2. Program timelines pending resolution of GS-1720 and GS-4182 clinical holds.
3. Teropavimab and zinlirvimab are broadly neutralizing antibody (bNAbs). 4. Non-Gilead sponsored trial(s) ongoing. BLA - biologics license application; HBV - hepatitis B virus; HDV - hepatitis delta virus; HIV - human immunodeficiency virus; HSV - herpes simplex virus; INSTI - integrase strand transfer inhibitor; LAI - long-acting injectable; LAO - long-acting oral; MAA - marketing authorization application; NDA - new drug application; NRTTI - nucleoside reverse transcriptase translocation inhibitor; PrEP - pre-exposure prophylaxis; FPI - first patient in.
Inflammation: Early Stage PipelineGilead is developing therapies for inflammatory and fibrotic diseases through internal programs and collaborations. Our pipeline spans many mechanisms of action as we advance our understanding in this field of high unmet need to bring transformative therapies to market.
INFLAMMATION: PRIMED FOR THERAPEUTIC INNOVATION
Inflammatory diseases are widespread and complex, posing a significant burden to the healthcare system and to patients impacted.
Gilead is committed to understanding the pathways and biologies of inflammation and fibrosis. We have
a broad portfolio developed both in-house and through partnerships
and collaborations, spanning multiple mechanisms of action with potential to be applicable across various indications.
Leveraging Acquisitions and Collaborations:
LEO Partnership (January 2025): Gilead acquired global rights to develop, manufacture, and commercialize LEO's oral STAT6 program for inflammatory diseases which includes small molecule inhibitors and targeted protein degraders.
Tentarix Collaboration (August 2023): A research collaboration with equity investment and options for up to three programs co-developed using Tentarix's proprietary Tentacles platform.
Arcus Partnership Expansion (May 2023): A research collaboration with options to exclusively license candidates on up to four undisclosed inflammatory disease targets.
Nurix's IRAK4 License (March 2023): A research collaboration with option to license multiple protein degrader molecules from Nurix. GS-6791 is the first licensed development candidate.
EVOQ Collaboration (December 2022): A research collaboration with an option to license EVOQ's NanoDisc technology to develop and commercialize products for RA and SLE.
Clinical Program
Indication
PHASE 1
PHASE 2
PHASE 3
FILED
Updates since Q2'25
Metabolic Disease
GLP-1R agonist (GS-4571)
Tilpisertib fosmecarbil (PALEKONA) IBD
α4β7 inhibitor (SWIFT) IBD
FXR agonist (GS-8670) IBD
BTLA agonist (GS-0272) Inflammatory Diseases
CD200R agonist (GS-5305) Inflammatory Diseases
PD1 agonist (GS-0151) Inflammatory Diseases
IRAK4 Degrader (GS-6791) Inflammatory Diseases
Lupus
Edecesertib (COSMIC)
Inflammatory Disease
Rich and Diverse Pipeline of Inflammation Assets
P PRIME Designation
Metabolic Disease
Pipeline shown above as of end of Q3'25. BTLA - B- and T-lymphocyte attenuator; GLP-1 - glucagon-like peptide-1; IBD - inflammatory bowel disease; MAA - marketing authorization application; NASH - nonalcoholic steatohepatitis; NDA - new drug application; PBC - primary biliary cholangitis; PD1 - program cell death protein 1.
Showcasing Novel Mechanisms in Our Inflammation PipelineGilead's inflammation pipeline includes promising therapies across novel targets and pathways. Covering multiple mechanisms of action and indications, this rich pipeline contains assets with potential for broad applicability across many inflammatory diseases. Below we highlight a few therapies from our pipeline.
Tolerize Immune Response
BTLA
Acquired (Mirobio) in 2022
GS-0272 (subcutaneous/IV)
Modulates the activity of T cells,
B cells, and dendritic cells
Phase 1b (Inflammatory Diseases)
Monotherapy
Highly selective agonist of BTLA, a critical
immune tolerance checkpoint, with the potential to modulate immune responses by significantly attenuating the activation of
T and B lymphocytes.
-
Block Immune Activation,
Infiltration, and Cytokines
TPL2
Developed in-house and wholly owned
tilpisertib fosmecarbil (oral)
Inhibits activation of pro-inflammatory
cytokines and cellular proliferation
Phase 2 (IBD)
Monotherapy
Potent inhibitor that suppresses MEK-ERK
inflammatory signaling and proinflammatory cytokine production in primary human monocytes, potentially enabling modulation of the immune response.
-
Block Immune Activation,
Infiltration, and Cytokines
α4β7
Developed in-house and wholly owned
GS-1427 (oral)
Prevents homing of pro-inflammatory
T-cells to the intestine
Phase 2 (IBD)
Monotherapy and in combination with IL-12/IL-23
α4β7 integrin inhibitor with the potential
to reduce gastrointestinal inflammation by blocking the migration of leukocytes to the gut, with possibility of combination with various anti-inflammatory agents.
IL-12/IL-23 (ustekinumab1)
Approach
Target
Program
Mechanism of Action
Clinical Phase (Indication)
Pathway Opportunity
Potential Combinations
1. Stelara (ustekinumab) is marketed by Janssen. BTLA - B and T lymphocyte attenuator; IBD - inflammatory bowel disease; NASH - nonalcoholic steatohepatitis; PSC - primary sclerosing cholangitis; TPL2 -Tumor Progression Locus 2; IV - intravenous therapy.
Gilead and Kite's Oncology StrategyGilead has driven significant scientific advancement for life-threatening illnesses like HIV and HCV, and continues to build on this legacy to deliver innovative therapies, including Yescarta and Trodelvy, to patients with cancer.
Key Approvals in Gilead Oncology
Oct 2017 | Apr 2020 | Dec 2020 | Apr 2021 | Apr 2022 | Oct 2022 | Jul 2023 |
Yescarta FDA | Trodelvy FDA | Tecartus EMA | Trodelvy FDA | Yescarta FDA | Yescarta EMA | Trodelvy EMA Approval |
Approval for | Accelerated Approval | Conditional Approval in | Full Approval in | approval for | approval for | for pre-treated HR+/ |
3L+ R/R LBCL | 3L+ mTNBC | R/R MCL | 2L+ mTNBC | 2L R/R LBCL | 2L R/R LBCL | HER2- mBC |
Aug 2018
Yescarta EMA Approval for 3L+ R/R LBCL
Jul 2020
Tecartus FDA Accelerated Approval in R/R MCL
Mar 2021
Yescarta FDA Accelerated Approval for 3L R/R FL
Oct 2021
Tecartus FDA Approval in R/R Adult ALL
Sep 2022
Tecartus EMA Conditional Approval in R/R adult ALL
Feb 2023
Trodelvy FDA Approval in pre-treated HR+/ HER2- mBC
Our Oncology Therapies
Our commercial oncology portfolio includes three approved therapies which are collectively available
Oncology Revenue Now >$3B
in over 50 countries. Our therapies include: Trodelvy for 2L+ mTNBC and pre-treated HR+/HER2- mBC; Yescarta for R/R 2L+ LBCL and accelerated approval for 3L R/R FL; and Tecartus for R/R adult ALL and accelerated approval for R/R MCL. In addition to these approved indications, we have multiple late-stage trials initiated or planned to investigate multiple types of cancers for these programs.
>110KPatients treated
$3.3BFY24 revenues
Product Class Key Trials (Indication)
ASCENT (2L+ mTNBC)
Patent Expiry1Launched U.S. EU
Antibody Drug
Conjugate (ADC)
TROPiCS-02
(pre-treated HR+/HER2- mBC)
2020 20282 20292
CAR T-cell Therapy
ZUMA-7 (2L R/R LBCL) ZUMA-1 (3L+ R/R LBCL) ZUMA-5 (3L R/R FL)
2017 2031 -
CAR T-cell Therapy ZUMA-2 (R/R MCL)
ZUMA-3 (R/R adult ALL)
2020 2027 -
Oncology as % Product Sales
Oncology Sales
11%
11%
8%
5%
3%
2%
$1.3B
1%
0%
$656M
$456M
$264M
$7M
2017 2018 2019 2020 2021 2022 2023 2024
$2.1B
$2.9B
$3.3B
As of 2024 10-K filing. See Page 69 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 2. Regulatory exclusivity in the U.S. and EU expires in 2032. ADC - antibody drug conjugate; ALL - acute lymphoblastic leukemia; FL - follicular lymphoma; LBCL - large B-cell lymphoma; mBC - metastatic breast cancer; MCL - mantle cell lymphoma; mTNBC - metastatic triple-negative breast cancer; OS - overall survival.
Broad Range of Oncology ProgramsGilead has leveraged internal development, M&A, and partnerships to build a broad pipeline of oncology programs that include an array of targets and mechanisms of action, further diversified by clinical phase.
Approach Select Targets and Mechanism of Actions Program Lead / Partner
Cell Therapy with Kite: Transformational Cancer TreatmentTRIGGER TUMOR-INTRINSIC
TROP-2
PARP1
Delivers & releases SN-38 (DNA damaging payload) following hydrolysis of linker
Blocks cells from repairing damaged DNA, causing cancer cell death
Trodelvy
GS-0201
PROMOTE IMMUNE-MEDIATED TUMOR KILLING
Drive expansion, differentiation, and activation of T-cells, natural killer (NK) cells, and macrophages resulting in robust tumor cell killing and release of proinflammatory factors.
CD19/CD20 CD19/IL-18 GPC2
EGFR / IL13Ra2
Engineered T cells that target tumor cells expressing CD19 and/ or CD20 IL-18 armored engineered T cells that target tumor cells expressing CD19 Engineered T cells that target tumor cells expressing GPC2
Engineered T cells that target tumor cells expressing EGFR and/or IL13Ra2
KITE-363/-753
Not disclosed Not disclosed Not disclosed
BCMA
Engineered T cells that target tumor cells expressing BCMA
Anito-cel
TIGIT
PD-1
Allows T cells to target tumor cells
Allows T cells to target tumor cells (inhibits PD-1 to PD-L1)
domvanalimab
zimberelimab
IL-2
Variant IL-2 molecule to stimulate anti-tumor immune response
GS-4528
Masked IL-12
Stimulates anti-tumor immunity in both innate and adaptive immune system
XTX301
IL-18BP
Enable pro-inflammatory IL-18 to activate anti-tumor effector cells
GS-0321
REMODEL TUMOR-PERMISSIVE MICROENVIRONMENT
Modulate immunosuppressive and tumor-permissive cell types and pathways to promote immune responses and inhibit tumor growth.
CCR8 CD73
A2aR/A2bR
Regulatory T cell depletion via ADCC activity
Inhibits CD73 activity, preventing formation of adenosine Inhibits adenosine receptors to reverse immunosuppression
GS-1811
quemliclustat etrumadenant
Kite joined the Gilead family in 2017, and has the largest in-house dedicated cell therapy manufacturing network to support both clinical programs and commercial expansion.
What is Cell Therapy?
CAR T-cell therapy is a custom-made cancer treatment that is designed to work by engineering a patient's own white blood cells and harnessing their immune system to treat
certain kinds of blood cancer. Unlike most cancer treatments, CAR T is a one-time treatment and may have curative potential as supported by the overall survival benefit we have seen
with Yescarta in ZUMA-7. Today, CAR T is available through Authorized Treatment Centers (ATCs).
Our Cell Therapy Approvals To Date
Indication
Trial(s)
U.S. Approval
EU Approval
2L R/R LBCL
ZUMA-7
Apr 2022
Oct 2022
3L+ R/R LBCL
ZUMA-1
Oct 2017
Aug 2018
3L R/R FL
ZUMA-5
Accelerated Mar 2021
Jun 2022
R/R MCL
ZUMA-2
Accelerated Jul 2020
Conditional Dec 2020
R/R adult ALL
ZUMA-3
Oct 2021
Sep 2022
Therapy
1,973
1,869
1,459
$432M Q325
Revenue
871
-11%
Q325 YoY
Revenue
607
456
264
-11%
7
FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24
Revenue ($M)
Q325 QoQ
Revenue
Kite Global Leadership Enabled by Core Capabilities
Kite has pioneered both CAR T development and approval, as well as established strengths in manufacturing reliability and clinical execution. Today, Kite remains at the forefront of Cell Therapy, supported by:
Strength of Our Data - overall survival benefit seen across 2L and 3L+ R/R LBCL. In addition, with more than 32,000 patients treated to date, Kite has the largest translational dataset in the industry, providing unique insights to develop the next generation therapies.
Comprehensive Network - with highly rated field teams, seamless end-to-end patient logistical support, and the largest ATC network globally.
Manufacturing Excellence - setting the standard for Cell Therapy, with 96% manufacturing success and 14 days average turnaround for Yescarta in the U.S.
Broad Research and Clinical Pipeline - advancing next generation constructs, technology, and targets across autologous, allogeneic and in vivo, as well as expansion into multiple myeloma and other hematologic malignancies, solid tumors, and autoimmune diseases.
>573
Global ATCs
5
Approved Indications
>40
Global Approvals
>32K
Patients
B-ALL - B-cell acute lymphoblastic leukemia; FL - follicular lymphoma; LBCL - large B-cell lymphoma; MCL - mantle cell lymphoma; R/R - relapsed or refractory.
Largest Cell Therapy Manufacturing Network in the World
Maximizing the potential of cell therapy on a global scale requires a highly specialized and coordinated team that includes Kite's research and development, specialized manufacturing and supply chain, in addition to our Authorized Treatment Center partners.
CAR T-cell therapy manufacturing is unique, with every manufacturing batch representing a single cell therapy designed for one patient. With some advanced and aggressive cancers, the patient's condition may rapidly deteriorate, so manufacturing quality, reliability, and speed are critical to patient outcomes.
Collect Isolate Engineer Grow Infuse
A patient's white blood cells are collected through an IV line at an ATC.
The T-cells are isolated from the white blood cells and sent to a Kite facility.
Kite adds the CAR gene to the T-cells to enable the cells to target the cancer.
Kite grows the new CAR T-cells to create enough to fight the cancerous cells.
New engineered CAR T-cells are sent to the ATC to be infused into the patient's bloodstream.
>32,000 Patients Treated to Date, Supported by:
96%
Manufacturing success rate
Quality, Speed, & Reliability
14
Days U.S. TAT for Yescarta
Infrastructure Built for Growth
Committed to Maintaining Manufacturing Leadership Through:
Further Automation - to enable greater capacity and cost efficiencies, including automation of manufacturing and quality control processes.
TAT Reduction - through manufacturing enhancements, the median TAT in the U.S. is now 14 days.
Novel CAR T Constructs - KITE-197 and KITE-753 are rapid manufacturing CAR Ts, designed to harvest a more naïve, less differentiated T-cell population.
Global Footprint to Expand CAR T Reach
>1M
Square feet of manufacturing and R&D space
>24K
Potential manufacturing capacity by 2026
Kite Manufacturing Countries with Kite ATCs
~80%
Target product gross margin in the U.S. by 2030
50%
Reduction in COGS¹ 2019-2023
Disciplined Cost Management
Opportunity to Grow CAR T Class Penetration
While more than 32,000 patients have been treated with a Kite cell therapy to date, there are many more patients globally that could benefit from cell therapy, including our CAR Ts, Yescarta and Tecartus.
CAR T Remains Under-utilized Today
Despite cell therapy offering durable responses and a potential one-time treatment for many patients in a challenging treatment landscape, class penetration as a whole is still low. Today in the U.S., just 2 in 10 second-line plus R/R LBCL eligible patients are receiving CAR T, with substantial numbers of eligible patients remaining unaddressed.
Indication | Product | 2030 CAR T Population¹ |
3L R/R LBCL | Yescarta | 13K |
2L R/R LBCL | Yescarta | 16K |
3L+ FL | Yescarta | 5K |
2L MCL | Tecartus | 4K |
2L B-ALL | Tecartus | 2K |
1L HR LBCL2 | Yescarta | 17K |
HR 2L+ FL2 | Yescarta | 3K |
Lymphoma Treatment Landscape
In addition to CAR T, the lymphoma treatment paradigm includes stem cell transplant and targeted therapies + chemo, as well as ADCs and bispecific antibodies. In Cell Therapy, Kite's Yescarta and Tecartus have both demonstrated statistically significant overall survival rates following a one-time treatment (see box). We are confident that the deep and durable responses seen with our therapies, combined with the reliability of Kite's manufacturing, will ensure cell therapies remain compelling treatment options, including in earlier-line settings.
Expanding the Use of Cell Therapies Globally
Our work continues to expand the reach of Yescarta and Tecartus to more eligible patients. This includes:
Refreshed U.S. strategy includes: working with physicians and institutions to raise awareness of the curative potential of cell therapy and the strength of our data (see box); and ensuring access for those patients who could benefit from CAR T.
COMPELLING OVERALL SURVIVAL DATA
Yescarta is the first therapy to show a statistically significant OS benefit versus standard of care in 2L R/R LBCL in almost 30 years. Key survival data includes:
2L R/R LBCL - In ZUMA-7, Yescarta demonstrated a 55% 4-year OS
3L R/R LBCL - In ZUMA-1, Yescarta demonstrated a 43% 5-year OS
R/R NHL - In ZUMA-5, Yescarta demonstrated a 69% 5-year OS
R/R B-ALL - In ZUMA-3, Tecartus demonstrated a 40% 4-year OS
1L HR LBCL - In ZUMA-12, Yescarta demonstrated an 81% 3-year OS²
Expanding into community practices where the majority (~80%) of lymphoma patients in the U.S. are treated today. We're making important in-roads with key community practices, and we are continuing to refine this "blueprint" as we work to onboard new centers and patients. Our work includes working with national payers to unlock broader commercial reimbursement.
Continuing to extend our reach into new geographies. Our revenue growth includes both new markets, such as Japan, Saudi Arabia, Brazil, and Singapore more recently, and expansions within existing markets such as in Europe.
1. 2030 eligible (on label) population in U.S, EU4, UK, and Japan. 2. The use of Yescarta in 1L HR LBCL, HR 2L+ FL is investigational and it has not been approved anywhere globally. B-ALL - adult B-cell acute lymphoblastic leukemia; FL - follicular lymphoma; HR - higher risk; LBCL - large B-cell lymphoma; MCL - mantle cell lymphoma; NHL - non-Hodgkin's lymphoma; OS - overall survival.
Unlocking the Full Potential of CAR T in Multiple Myeloma
In collaboration with Arcellx, Kite is co-developing and co-commercializing anito-cel, a differentiated and potentially best-in-class BCMA CAR T for use in multiple myeloma, addressing an underserved patient population.
The Multiple Myeloma Landscape
Multiple myeloma, arising from aberrant plasma cell expansion in the bone marrow, is among the most common forms of blood cancer. It is estimated that there are ~176K new cases globally of multiple myeloma reported each year¹. For newly diagnosed multiple myeloma patients, treatments include autologous stem cell transplant, chemotherapy, and combination therapies including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies.
In addition, in the 2L+ R/R setting, there are a number of BCMA-targeted therapies, including bispecific antibodies and CAR Ts. B-cell maturation antigen (BCMA) has demonstrated highly selective expression on malignant plasma cells, with limited expression on other cells. Anito-cel (anitocabtagene autoleucel) is a novel BCMA-targeting CAR T currently in pivotal trials.
Anito-cel: Built with Uniquely Designed Domain Binder
D-Domain
Anito-cel uses a novel D-Domain binder, which is designed to optimize binding affinity. The D-Domain is a small, stable, fully synthetic antigen-binding domain with a hydrophobic core.
The Kite-Arcellx Collaboration
Based in Redwood City, California, Arcellx was founded in 2014, starting with the novel D-domain binder and lead clinical asset anito-cel. Kite and Arcellx entered into a collaboration agreement in 2022, partnering Arcellx's potentially best-in-class anito-cel, with its unique domain and overall construct, with Kite's globally-leading manufacturing, clinical, and commercial capabilities.
Gilead ownership of Arcellx is currently ~12%³.
Collaboration Milestones
December 2022 Partnership to co-develop and co-commercialize anito-cel
for R/R MM. Terms included:
$225M upfront, $100M equity,
LOW TOTAL CELL DOSE: Small D-Domain construct facilitates high transduction efficiency and CAR positivity, which permit a low total cell dose2.
LACK OF TONIC SIGNALING: Rapid folding, lack of disulfide bonds, and a hydrophobic core enables D-Domain stability and lack of tonic signaling.
OPTIMAL TUMOR CELL KILLING: The D-Domain has a fast off-rate and high CAR surface expression. This combination may allow optimal tumor cell killing without prolonged inflammation.
Combining the unique D-Domain binder with Kite's market leading manufacturing capabilities and commercial infrastructure, we believe anito-cel can offer a differentiated and potentially best-in-class multiple myeloma therapy.
shared development and commercialization costs, Kite responsible for manufacturing.
December 2023 ASH presentation of Phase 1 anito-cel data in 4L+ R/R MM, median follow-up of 26.5 months.
December 2024 Initial data from the pivotal Phase 2 iMMagine-1 trial in 4L+ R/R MM. Updated Phase 1 data at 38 months median follow-up.
November 2023 Partnership scope expanded to include lymphomas for anito-cel,
and option exercised to negotiate for ARC-SparX program, ACLX-001, in MM. Terms included:
$200M equity, $85M non-dilutive upfront.
August 2024
Arcellx receives $68M milestone payment in relation to iMMagine-1 enrollment.
October 2024
First patient dosed in Phase 3 iMMagine-3 trial in 2L+ R/R MM.
Anito-cel (anitocabtagene autoleucel) is an investigational product and has not been approved anywhere globally. Its safety and efficacy have not been established. 1. Huang, Junjie et al. The Lancet Haematology, Volume 9, Issue 9, e670 - e677. 2. Supported by preclinical and clinical translational data. 3. At June 30, 2025.
Anito-cel's Differentiated Profile
With 38 months follow-up from the Phase 1 study and supported by initial data from the Phase 2 iMMagine-1 study, we believe anito-cel has demonstrated a differentiated profile. We expect to launch anito-cel initially in 4L+ MM in 2026.
Compelling Data Across Phase 1 and 2 Trials Substantial Multiple Myeloma Opportunity
ASH 2024 ASH 2024
Trial Phase1 trial iMMagine-1
We believe the multiple myeloma market is sizeable, with sufficient opportunity for multiple CAR T treatment options. We estimate that the overall global total addressable market in 2L+ multiple myeloma is ~$12B for CAR T in 2030+.
Stage Phase 1 Phase 2 | ||
Size | n=38 | n=86 |
Median Follow-Up | 38.1 months | 9.5 months |
ORR | 100% | 97% |
CR/sCR, n (%) | 30 (79) | 53 (62) |
MRD evaluable, n | 28 | 58 |
MRD negativity (10-⁵) | 89% | 93% |
mPFS | 30.2 months | Not reached |
mOS | Not reached | Not reached |
Given the capacity constraints and challenges in manufacturing speed and reliability by products available today, we believe there is significant opportunity for anito-cel given:
The unique D-Domain and overall construct
Its efficacy and safety profile seen to date
Kite's world leading manufacturing, clinical, and commercial capabilities
Data from the pivotal Phase 2 iMMagine-1 is expected to enable filing, and if successful, we expect to launch anito-cel in 4L+ R/R MM in 2026. Initial data from the trial was presented at
6-mo. PFS / OS | 92% / 97% | 93% / 97% | ASH 2024, and we expect to provide updated data in 2025. The Phase 3 iMMagine-3 trial in |
12-mo. PFS / OS | 76% / 95% | 79% / 97% | 2L+ R/R MM achieved FPI in October 2024, and we will share further updates when available. |
18-mo. PFS / OS | 65% / 82% | - |
24-mo. PFS / OS | 57% / 79% | - |
30-mo. PFS / OS | 50% / 75% | - |
Advancing Anito-cel Manufacturing
The data across Phase 1 and 2 trials of anito-cel continue to indicate deep and durable responses. This includes in patients with high-risk features¹, such as in the Phase 1 trial where the 30-month PFS rate was 60% for this patient population. Adverse events in anito-cel trials were generally manageable. In addition, no delayed or non-ICANS neurotoxicities have been observed2 across all anito-cel trials and spanning >150 patients, including no Parkinsonism, no cranial nerve palsies, and no Guillain Barré syndrome.
The tech transfer from Arcellx was completed in Q224. We are working to launch anito-cel with a similar TAT as other Kite products, leveraging Kite's expertise in manufacturing excellence, which includes a 96% reliability rate across >27K cell therapy patients treated.
Anito-cel Mulitple Myeloma Clinical Pipeline
Indication | Trial Name | Stage | Status |
4L+ R/R MM | Phase 1 | Phase 1 | Update provided at ASH 2024 |
4L+ R/R MM | iMMagine-1 | Phase 2 | Data at ASH 2024; update expected 2025 |
2L+ R/R MM | iMMagine-3 | Phase 3 | FPI achieved Q424 |
Anito-cel (anitocabtagene autoleucel) is an investigational product and has not been approved anywhere globally. Its safety and efficacy have not been established. 1. Defined as a patient with EMD (characterized by the presence of non-bone based plasmacytoma), ISS Stage III (B2M>/=5.5), high-risk cytogenetics (Del17p, t(14;16), or t(4;14)), or BMPC>/=60%. 2. At May 1, 2025. B2M - Beta-2-microglobulin; BMPC - bone marrow plasma-cell; EMD - extramedullary disease; FPI - first patient in (dosed); ISS - International Staging System; ORR - overall response rate; mDOR - median duration of response; mPFS -median progression-free survival; mOS - median overall survival; (s)CR: (stringent) complete response; VGPR: very good partial response; TAT - turnaround time, the time from date of leukapheresis to date of quality release of final product.
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Gilead Sciences Inc. published this content on October 30, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on October 30, 2025 at 22:05 UTC.
