GILD
Published on 05/07/2026 at 07:41 pm EDT - Modified on 05/07/2026 at 07:45 pm EDT
May 2026
FOR INVESTOR USE ONLY; NOT FOR PROMOTIONAL USE.
To discover, develop, and deliver innovative therapeutics for people with life-threatening diseases.
Bring 10+ transformative therapies to patients
by 2030¹
Be a biotech employer and partner of choice
Deliver shareholder value in a sustainable, responsible manner
Maximize impact of long-acting HIV therapies
Accelerate pipeline build in oncology and inflammation
Adopt and scale AI to transform how we work
Prioritize investments for highest impact
Strengthen collaboration to accelerate innovation
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 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: [email protected]
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.
About Gilead
Q126 Financial Results
HIV
HIV PrEP, Treatment, and Cure
Biktarvy
Long-Acting HIV Regimens
HIV Launch Timelines
Liver Disease
Liver Disease
HCV
HBV
HDV
Livdelzi in PBC
HIV and Liver Disease Pipeline
Inflammation
Early Inflammation Pipeline
Novel Mechanisms
Oncology
Oncology Strategy
Oncology Program Summary
Cell Therapy
Trodelvy
Oncology Pipeline
COVID-19
Veklury
Key Corporate Transactions and Partnerships
ESG at Gilead
Press Releases: Corporate & Regulatory
Press Releases: Data Updates
Our Leadership Team
49 Our Board of Directors
Analyst Coverage and Largest Investors
Capital Allocation
Debt and Credit Facility
Financials
4 PrEP - pre-exposure prophylaxis; HCV - hepatitis C virus; HBV - hepatitis B virus; HDV - hepatitis D virus; PBC - primary biliary cholangitis; ESG - environmental, social, and governance.
Investor Resource Book
1987
Gilead is founded
1992
Gilead completes its IPO
Gilead 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, 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 a 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 investigational lenacapavir-based combinations for daily, weekly, monthly, and twice-yearly options for HIV treatment. Our pipeline is expected to support up to 7 potential
HIV product 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, and includes Trodelvy, the first-approved TROP2 ADC, and our cell therapies, Yescarta and Tecartus. We continue to evaluate Trodelvy in new indications, and, following the recently announced definitive agreement to acquire Tubulis, we look forward to further exploring their promising ADC portfolio and next-generation platform. In cell therapy, we are expanding our Kite family of products, including our BCMA CAR T therapy, anito-cel, expected to launch in the U.S. for late-line multiple myeloma in December 2026.
We continue to expand our third therapeutic area of focus, inflammation, with the launch of Livdelzi, which received FDA accelerated approval in August 2024 as a second-line treatment for PBC. Building on our promising early stage inflammation collaborations and programs, Gilead recently announced a definitive agreement to acquire Ouro Medicines, a company with a portfolio of potential best-in-class T cell engager therapies under evaluation for certain autoimmune conditions.
In summary, we have a robust pipeline of 47 clinical programs, including 14 in Phase 3. Combined with disciplined operating expense management, Gilead is well-positioned to deliver long-term growth across all 3 therapeutic areas.
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
2026
Gilead acquires Arcellx; announces agreements to acquire Tubulis and Ouro Medicines
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 Transformative Therapies1 and 11 New Approved Indications Since 20192
Acquisitions and Collaborations Contributing to our Robust and Diverse Portfolio
>45% Increase in Clinical Portfolio3
Oncology
Virology Inflammation
32
8
12
12
10
16
21
47
Q119 Q126
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). 2. 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 with multidrug resistance (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). 3. 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 portfolio through both internal
R&D as well as through strategic partnerships and acquisitions
to create the foundation for an even more sustainable and diversified business, spanning our three therapeutics areas of focus: virology, oncology, and inflammation.
11% Liver Disease
2% COVID-19
3% Other1
12% Oncology
TOTAL Q126 PRODUCT SALES
+5% YOY
72% HIV
HIV
HIV Q126 Revenue of $5B, +10% YoY
Driven by strong demand across Biktarvy, Yeztugo, and Descovy, as well as pricing favorability
Biktarvy Q126 Revenue of $3.4B, +7% YoY
Driven by higher demand and average realized price
Descovy Q126 Revenue of $807M, +38% YoY Driven by higher average realized price and demand growth
U.S. PrEP Business Grew +87% YoY
Driven by commercial execution and the strong product portfolios of Descovy and Yeztugo
Descovy for PrEP Revenue Grew +50% YoY
Accounting for ~80% of Descovy sales
Yeztugo Q126 Revenue of $166M, +72% QoQ Strong performance across key launch metrics, including access, market share, and persistence
Oncology
Trodelvy Q126 Revenue of $402M, +37% YoY
Reflecting growing demand in breast cancer
Cell Therapy Q126 Revenue of $407M -12% YoY
Reflecting ongoing in- and out-of-class competition
Liver Disease
Livdelzi Q126 Revenue of $133M, +230% YoY Launch continues to generate strong and growing demand in the U.S. and Europe
Total Liver Q126 Revenue of $767M, +1% YoY
Primarily reflecting Livdelzi's continued PBC launch
For FY26, HIV business revenues are expected to grow +8% YoY and Yeztugo revenues are expected to be ~$1B2.
1. Other Q126 Revenue of $196M, -6% YoY, reflects sales from AmBisome, Cayston, Jyseleca, Letairis, and Zydelig. 2. Guidance as of May 7, 2026. Financial
guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section on Page 69 for further information. PrEP - pre-exposure
prophylaxis; PBC - primary biliary cholangitis.
Investor Resource Book
Gilead 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.
Gilead's Portfolio of HIV Treatment and Prevention Products
Launched % Q126
Patent Expiry2
Gilead's Market Leadership Today
The HIV treatment market is growing at 2-3%
First twice-yearly subcutaneous PrEP - 2025 ~2% 2037
Most prescribed HIV treatment regimen in the United States3
2018
-
~49% 20364 2033
First twice-yearly subcutaneous treatment for PWH who are MDR
2022
-
<1%
2037
TAF-based HIV prevention option and HIV treatment
2016
2019
~12% 20314 2027
First approved TAF-based STR
2015
-
~4% 20294 2028
TDF-based STR
2011
-
<1% 20254,6 2026
TDF-based treatment; first medication approved for prevention
2004
2012
<1% 20206 2017
First approved STR 2006 - <1% 20206 2017
First STR with an integrase inhibitor 2012 - <1% 20294,6 2028
Smallest tablet size STR when launched 2016 - ~3% 20325 2027
Product Description
41M
People Living with HIV
HIV and Insufficient Use of Antiretrovirals Remains a Challenge7
Treatment Prevention
Revenue1
U.S. EU
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
~73% share of the U.S. branded treatment market today will grow to ~80% by the mid-2030s. With up to seven potential treatment and prevention launches by 2033, we are well positioned to extend our HIV leadership into the 2040s.
~1.3M
New HIV Infections Annually
>25%
PWH Not Receiving Treatment
8
1. Total product sales excluding Veklury. 2. As of our latest 10-K filing, unless otherwise noted. See Page 68 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 3. As of Q126, see Page 9 for further details. 4. Reflects settlement/license agreements with generic manufacturers. 5. In February 2025, Gilead reached an agreement with one generic manufacturer to settle patent litigation concerning certain patents relating to our Genvoya product. The agreement provides a non-exclusive license to those patents beginning on August 6, 2032, or earlier in certain circumstances. 6. As of our 2024 10-K filing. 7. UNAIDS 2024 Global AIDS Update. PrEP - pre-exposure prophylaxis; MDR - multi-drug resistant; TAF - tenofovir alafenamide; STR - single-tablet regimen; TDF - tenofovir disoproxil fumarate.
Investor Resource Book
With a proven track record in HIV treatment, and over 1 million users worldwide, Biktarvy continues to display robust efficacy and safety, reinforcing Gilead's commitment to delivering innovative and durable therapies for people with HIV.
What is Biktarvy?
Approved in 2018, Biktarvy is a complete, single pill, once-a-day prescription medicine used to treat HIV-1 infection in adults and children¹. Biktarvy can be used in people who are initiating HIV treatment (treatment-naïve), people with prior treatment history who are replacing their current HIV medicines (switch), and people restarting antiretroviral treatment. As Gilead continues to address unmet needs in HIV treatment across a broad range of preferences, we expect that daily orals will remain widely used, with Biktarvy playing a critical role.
Powerful Medicines Work Together to Suppress the Virus
>52%
#1
#1
bictegravir emtricitabine tenofovir alafenamide
The HIV Treatment Market Leader
13.4
14.3
11.8
10.4
8.6
7.3
4.7
FY19 FY20 FY21 FY22 FY23 FY24 FY25
Biktarvy Revenue ($B)
$3.4B
Q126 Revenue
-15%
Q126 QoQ Revenue
+7%
Q126 YoY Revenue
Durable Viral Suppression at Five Years2
In two Phase 3 studies3, ≥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 analysis4).
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 adults2.
The BICSTaR real-world observational study showed statistically significant improvement in treatment satisfaction at Month 12 following the switch to Biktarvy5,6.
U.S. Treatment Market Share7
in NaÏve in all G9 Markets7,8
in Switch in 5 of G9 Markets and Australia7,8
BIKTARVY PROJECTED U.S. LOE SECURED THROUGH 2036
On October 6, 2025, Gilead announced that it has entered into a settlement agreement to resolve the patent litigations with the generic manufacturers that filed abbreviated NDAs 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).
Biktarvy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg. 1. Children who weigh at least 25 kg. 2. Sax P.E., et al. j.eclinm. 2023; 59. 3. Phase 3 Study 1489 and Study 1490. 4. 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. 5. Brunetta J, et al. European AIDS, Poster PE2/50, 2021; 6. Brunetta J, et al. European AIDS, Supplement, 2021. 7. Source: IQVIA LAAD. 8. G9 markets defined as U.S., Canada, China, France, Germany, Italy, Japan, Spain and UK. NDA - new drug application.
9 Investor Resource Book
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 long-acting dosing, is the latest example of Gilead's person-centered approach to long acting (LA) HIV innovation.
66%
of PWH Miss 1+ Dose2
30%
of PWH are Concerned with Missing Their HIV Tx Daily Dose3
What is Lenacapavir?
of PWH Fear Taking Medication Could Reveal HIV Status1
40%
~30%
of PWH Miss 5+ Doses Per Month2
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 bictegravir and lenacapavir combination ("BIC/LEN") to increase options for PWH switching therapy, including those on complex regimens.
~5-6%
~20%
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
of PWH are on Complex Regimens (~2-11 Pills/Day)
of PWH Switch HIV Therapy Annually
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.
Many PWH also seek a longer-acting option, and our pipeline includes novel combinations of weekly and monthly orals, as well as twice-yearly and yearly injectables.
Approved in Treatment and PrEP
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.
Example: Islatravir4
INSTI
Integrase strand transfer inhibitors (INSTIs) block the action of integrase preventing integration of viral DNA into the host
cell's DNA, thereby stopping the virus from replicating.
Examples: GS-1720, 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
Before its approval as Yeztugo for PrEP, lenacapavir was approved in 2022 as Sunlenca for HIV treatment in treatment-experienced individuals who have HIV that is resistant to many medications and whose current treatment may be failing.
1. 2024 Global PWH Research (N=340). 2. IQVIA LAAD; data on missed doses per month. 3. 2024 Global Demand Research (N=341). 4. Lenacapavir + Islatravir is
10 being developed in collaboration with our partner, Merck. PWH - people with HIV; Tx - treatment; HTE - heavily treatment experienced; MDR - multi-drug resistant;
TAB - Teropavimab; ZAB - Zinlirvimab; INSTI - integrase strand transfer inhibitors; NRTTI - Nucleoside reverse transcriptase translocation inhibitor; bNAbs - Broadly neutralizing antibodies.
Investor Resource Book
Pre-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 additional regulatory approvals and filings ongoing globally.
$166M
+72%
~95%
#1
Subcutaneous Injection Allows for Biannual Dosing
Following initiation dosing, Yeztugo is delivered in two 1.5 mL subcutaneous
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
Q126 Revenue
Q126 QoQ Revenue
Payer Coverage
PrEP Injectable for Switches from an Oral Regimen
the last dose, offering a 4-week window for greater flexibility.
Unprecedented Phase 3 Results in HIV Prevention
100% of lenacapavir participants did not acquire HIV
99.9% of lenacapavir participants did not acquire HIV
0.00 per 100 PY (n=0/2,134)
100% efficacy vs. bHIV, p<0.0001 p<0.0001 vs. Truvada
0.10 per 100 PY (n=2/2,179)
96% efficacy vs. bHIV, p<0.0001 p=0.00245 vs. Truvada
Clinical Recommendations for Yeztugo
Yeztugo has received recommendations in clinical guidelines for HIV prevention from the Center for Disease Control and Prevention (CDC), World Health Organization (WHO), International Antiviral Society - USA (IAS-USA), and New York State Department of Health (NYSDOH) AIDS Institute.
Expanding into New & Existing U.S. Populations
U.S. PrEP adoption is expected to grow from 500K+ individuals today, to 1M+ in the mid-2030s. To support this goal, Gilead is focused on maximizing the current consumer base while expanding to new populations who could benefit from PrEP.
Gilead's Expanded Collaboration with PEPFAR
In April 2026, Gilead announced that the U.S. State Department, the United States President's Emergency Plan for AIDS Relief (PEPFAR), and The
Consumer Population
HCP
People on PrEP; People with long-acting injectable preference
Black/Latine Men; Cisgender women; Gender diverse people1
Non-PrEP providers in
Individuals with bacterial STI; People who inject drugs
New specialties (i.e., OBGYN);
Global Fund will further invest in lenacapavir, to expand access for up to an additional 1 million people, bringing the total commitment up to 3 million
Population Current PrEP providers
areas of high need
New settings (i.e., colleges)
people in high-incidence, resource-limited countries through 2028.
At Launch (2025) Expansion Normalizing
1. Trans-women, Trans-men, and non-binary people. PrEP - pre-exposure prophylaxis; PY - person years; bHIV - background HIV incidence; ISR - injection site reaction; PEPFAR - President's Emergency Plan for AIDS Relief; STI - sexually-transmitted infection; HCP - healthcare provider; OBGYN - obstetrician and gynecologist.
Lenacapavir and its prodrugs are foundational in our treatment and prevention programs. Gilead has seven ongoing clinical programs evaluating daily, weekly, monthly, twice-yearly, and 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.
Building Dosing Flexibility Through Prodrugs
PrEP
A prodrug is a compound that, although not active in its original form, is metabolized in the body to produce an active drug. Optimized prodrugs can increase bioavailability, leading to lower doses and potentially smaller pill sizes. Prodrugs of lenacapavir, including GS-3107, have enabled the development of oral options for once-weekly and once-monthly HIV treatment.
Latest Disclosure
Updates
Potential Launch
Once-Yearly Injectable
LEN for PrEP
Phase 3
Ph3 PURPOSE 365 FPI
Enrollment Complete
2028
Daily Oral
BIC/LEN
Phase 3
ARTISTRY-1 and -2 Full Readouts at CROI25
FDA Decision 2H26
2H26
Weekly Oral
LEN/ISL¹
Phase 3
Ph2 Update CROI24
Ph3 ISLEND-1 and -2 FPI 2H24
Ph3 ISLEND-1 and -2 Update 1H26
2027
LEN Prodrug + INSTI
Phase 2
Ph1 Update AIDS24
New Ph2 FPI 2H26
2030
Monthly Oral
GS-3107 + INSTI
Phase 1
Ph1 FPI 2H24
Ph1 GS-3107 Update 2H26
2031 - 2033
Twice-Yearly Injectable
LEN + TAB + ZAB
Phase 2
Ph2 Update 2H24
Ph3 FPI 2H26
2030
LEN + GS-3242
Phase 1
Ph1 GS-3242 Update at CROI
Ph2 FPI 2H26
2031 - 2033
Treatment
Note: Timeline estimates are as of May 1, 2026 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. LEN - lenacapavir; PrEP - pre-exposure prophylaxis; FPI - first patient in; BIC - bictegravir; ISL -islatravir; CROI - Conference on Retroviruses and Opportunistic Infections; AIDS - International AIDS Conference; INSTI - Integrase strand transfer inhibitor; TAB - teropavimab; ZAB - zinlirvimab.
Gilead has been a leader in liver disease research and treatment for more than 30 years. 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
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
(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.
We received FDA accelerated approval in 2024 for Livdelzi for certain adults with primary biliary cholangitis (PBC). Livdelzi has the potential to help people living with PBC as the first and only treatment that achieved statistically significant improvements across biochemical response, ALP normalization, and pruritus versus placebo.
Dedication to Patient-Centric Innovation
Since our first approval of therapies for 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.
U.S. HCV
~60%
Market Share
EU4/UK HCV
>50%
Market Share
3.2
3.0
2.9 2.9
FY20 FY21 FY22 FY23 FY24 FY25
Liver Disease Revenue ($B)
2.8 2.8
$767M
Q126 Revenue
+1%
Q126 YoY
Revenue
-9%
Q126 QoQ
Revenue
$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 are diagnosed but remain untreated. ReLink is one program that reflects Gilead's efforts to create a healthier world for all.
13
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; ALP - alkaline phosphatase.
Investor Resource Book
As 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. It is estimated that >50M people1 are 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 years1. There are still almost 250,0002 deaths from HCV-related complications including cirrhosis and liver cancer each year.
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 20372, and 60% of high-income countries are off-track by at least 20 years8.
While curative therapy has reduced incident starts, persistent diagnosis gaps and delayed elimination timelines sustain ongoing demand. As such, there is an ongoing need for screening and linkage to care.
HCV Contribution to Total Revenue3
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.
% Q126
Gilead's HCV Portfolio Revenue3 Patent Expiry4
$35
Total Revenue
HCV Revenue
$30
$ Billions
$25
$20
$15
$10
$5
2017
First pan-genotypic regimen following direct
acting antiviral failure
<1%5
2034
2033
2016
First HCV STR to treat all genotypes
~4%6
2033
2032
2014
First HCV STR for genotypes 1, 4, 5, or 6
<1%5
2030
2030
Product U.S. Launch Description
2013
Backbone of all Gilead HCV therapies enabling cure
% U.S. EU
<1%7 2029 2029
$0
2005 2007 2009 2011 2013 2015 2017 2019 2021 2023 2025
Since HCV therapies have become 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 2025, HCV revenues were $1.5B, or 5% of total revenues, compared to a peak of 50-60% of revenues between 2014 and 2016.
1. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c. 2. Sulkowski M et al, Adv Ther. 2021;38(1):423-440. 3. Total product sales excluding Veklury. 4. As of our latest 10-K filing, unless otherwise noted. See Page 68 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 5. As of our 2024 10-K filing. See Page 68 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 6. Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead's subsidiary, Asegua. 7. As of our 2017 10-K filing. See Page 68 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 8. Gamkrelidze I, et al, Liver Int. 2021;41(3):456-463. STR - single tablet regimen. WHO - World Health Organization.
14 Investor Resource Book
We've been advancing the science of HBV treatment 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 expected patent expiration date is 2031 in the U.S. and 2027 in the EU2.
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 reduced impact on renal and bone density safety profiles compared to patients receiving TDF3.
1,070
959
814
842 862
657
488
321
3
122
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25
Vemlidy Revenue ($M)
Gilead's HBV Clinical Pipeline
Indication Program Trial Name Stage Partner Status
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 GS-2829;
NCT05770895 Phase 1 Hookipa Update at
GS-6779 AASLD 2025
1. Razavi-Shearer., et al. Lancet Gastroenterol Hepatol, 8(10)(2023). 2. As of our latest 10-K filing, unless otherwise noted. See Page 68 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. TDF - tenofovir disoproxil fumarate;
15 AASLD - American Association for the Study of Liver Disease.
Investor Resource Book
In 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
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, including
a more aggressive and rapid progression of disease towards hepatocellular carcinoma and liver-related death2.
How does Hepcludex work?
Hepcludex (bulevirtide) is an entry inhibitor that binds to sodium taurocholate co-transporting 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 anticipated patent expiry for Hepcludex is 2029 in the EU3.
Meaningful Virologic and Biochemical Benefit
Phase 3 data demonstrate that bulevirtide (BLV) monotherapy delivers meaningful virologic and biochemical benefit when used as ongoing treatment for chronic hepatitis D. In the MYR301 trial, continued BLV therapy maintained and progressively improved HDV RNA suppression and ALT normalization over the three years of treatment, including in patients with suboptimal early response. These results support BLV as a foundational, disease-modifying treatment, with continued treatment being a central consideration to helping achieve and maintain disease control. Hepcludex is approved for the treatment of chronic hepatitis D with compensated liver disease in the EU, UK, Canada, Switzerland, and Australia.
BLV 2mg
BLV 10mg
Control
BLV 2mg
BLV 10mg
BLV 2mg
BLV 10mg
n=49
n=50
n=51
n=49
n=50
n=49
n=50
Week 48
Week 96
Week 144
Combined response
45%
48%
2%
55%
56%
57%
54%
Virologic response
73%
76%
4%
76%
82%
73%
76%
Undetectable HDV RNA
12%
20%
0%
20%
36%
29%
50%
ALT Normalization
51%
56%
12%
63%
64%
59%
60%
HEPCLUDEX REGULATORY APPROVAL IN THE EU
In July 2023, Gilead received full marketing authorization from the European Commission for Hepcludex for the treatment of chronic HDV. EASL guidelines4 recommend all patients with chronic HDV and compensated liver disease should be considered for treatment with Hepcludex. Hepcludex was fully approved in the UK in August 2023, in Switzerland in February 2024, in Australia in July 2024, and in Canada 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. In September 2025, Gilead submitted a BLA for bulevirtide for the treatment of chronic HDV and is awaiting FDA feedback, with a decision expected in 1H26.
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.
See Page 68 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 4. Asselah T. et al. N Engl J Med 2024;391:133-143. HBsAg - hepatitis B surface antigen; NTCP - sodium taurocholate co-transporting polypeptide; EASL - European Association for the Study of the Liver; CRL - complete response letter; BLA - biologics license application; EOT - end of treatment; BLV -bulevirtide; PegIFNα - pegylated interferon alpha.
16 Investor Resource Book
In March 2024, Gilead acquired CymaBay for approximately $4.3B, expanding Gilead's liver portfolio to include Livdelzi (seladelpar), a 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 pruritus.
Pruritus: A Key Symptom of PBC
Pruritus, or chronic itching, can be an extremely severe and debilitating symptom for up to 70% of 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 PBC treatment options that reduced pruritus with statistical significance.
Current PBC 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.
U.S. PBC Market Opportunity
Prevalence: ~130K
Diagnosed: ~80K
Treated: ~72K
UDCA 1L Treatment
Adequate Responders
Inadequate Responders Incomplete Responders ALP ≥ 1.67x ULN ALP 1.0-1.67x ULN
(~21K - 23K)
2L : ~42 - 46K
(~21K - 23K)
PBC Clinical Pipeline
RESPONSE evaluates Livdelzi in 2L patients inadequately responsive to UDCA with ALP > 1.67 x ULN. IDEAL assesses 2L patients with ALP 1.0-1.67x ULN. AFFIRM (confirmatory) evaluates 2L PBC patients 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.
ASSURE Open-label, long-term study - 3 Active
completed
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 intolerance to UDCA, two treatments are currently FDA approved, including Livdelzi
2L U.S.
RESPONSE Inadequate responders (ALP > 1.67)
~21-23K
3
FDA approved EC approved
Trial Name Population Population
Phase Status
(seladelpar, approved Aug'24). In September 2025, a competitor product (previously approved under accelerated approval for 2L PBC in the U.S.) was voluntarily withdrawn following a request from the FDA.
IDEAL Incomplete responders (ALP 1 - 1.67) ~21-23K 3 Enrollment AFFIRM Patients with compensated cirrhosis4 - 3 Active
17
1. Lu et al., Clinical Gastroenterology and Hepatology. 2018; 2. de Veer RC, et al. Aliment Pharmacol Ther. 2022;56(9):1408-1418. 3. IQVIA LAAD, 10/2024 through 6/2025. 4. (Child-Pugh A & B). PPAR∂ - peroxisome proliferator-activated receptor delta; PBC - primary biliary cholangitis; UDCA - ursodeoxycholic acid; ALP - alkaline phosphatase; 1L - first line; 2L - second line.
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In August 2024, FDA granted Livdelzi accelerated approval based on the 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
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 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.
Livdelzi Launch Update
Gilead is leveraging its existing commercial infrastructure in liver diseases, which includes a 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.
$133M
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 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.
#1
Q126 Revenue
-11%
Q126 QoQ
Revenue
+230%
Q126 YoY
Revenue
Prescribed PBC Treatment for New 2L Starts3
>50%
U.S. 2L PBC
Market Share
✓
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 EU1.
ALP
Normalization
Positive ALP & Bilirubin Response
Statistically Significant Pruritus Reduction
Phase 3 Results
ENHANCE2 RESPONSE3 (Pivotal) ASSURE4 (Open-Label, Long-Term)
Patient Population
Inadequate response to or intolerance to UDCA (n=265)
Inadequate response to or intolerance to UDCA (n=193)
Prior study patients (not from RESPONSE) (n=97)
RESPONSE patients receiving continuous treatment (n=103)
RESPONSE patients receiving placebo crossing over to seladelpar (n=52)
Composite ALP & Bilirubin Response (%)
Month 3 (10mg)
78.2% vs. Placebo 12.5% (p<0.0001)
Month 12 (10 mg)
61.7% vs. Placebo 20% (p<0.0001)
Month 24: 70% Month 24: 72% Month 24: 94%
ALP Normalization (%)
Month 3 (10mg)
27% vs. Placebo 0% (p<0.0001)
Month 12 (10 mg)
25% vs. Placebo 0% (p<0.0001)
Month 24: 42%
Month 24: 17%
Month 24: 50%
Change in Pruritus (NRS)
Month 3 (10mg)
-3.01 vs. Placebo -1.44 (p=0.0164)
Month 6 (10 mg)
-3.2 vs. Placebo -1.7 (p<0.005)
Month 24: -3.1 Month 18: -3.8 Month 6: -3.8
1. See Page 68 for a summary of the methodologies and assumptions underlying estimated patent expiry dates presented. 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. EMA - European Medicines Agency; PBC - primarily biliary cholangitis; ALP - alkaline phosphatase; UDCA - ursodeoxycholic acid; NRS - numerical rating scale; EC - European Commission; EFS -
18 event free survival; ULN - upper limit normal.
Investor Resource Book
PHASE 1
PHASE 2
PHASE 3
FILED
Clinical Program Indication
Q126 Updates
HIV PrEP
Lenacapavir (PURPOSE 365)
HIV PrEP LAI
HIV Treatment
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
HIV capsid inhibitor (GS-3107) Lenacapavir + teropavimab + zinlirvimab3 HIV INSTI (GS-1219)
HIV INSTI (GS-3242)
HIV Oral HIV LAO
HIV LAO
HIV LAO HIV LAI HIV LAI
HIV LAI
NDA Submitted
HIV Cure
Teropavimab + zinlirvimab3,4 Vesatolimod (FRESH)
HIV bi-specific T-cell engager (GS-8588)
HIV Cure HIV Cure
HIV Cure
HDV
HEPCLUDEX® (MYR301)
HDV pre-S1 nAb (GS-4321)
HDV
HDV
BLA Filed
HBV
Cure
HBV therapeutic vaccine (GS-2829 + GS-6779)
HBV Cure
HSV
HSV HPI5
HSV
ID
CoV Mpro Inhibitor (GS-1701)
NEVPP
★
Phase 1 FPI
Opt-
Assembly Biosciences
HDV
1 clinical stage program
ins
★ New listing in Q126
Pipeline shown above as of May 1, 2026. Removed program: Phase 2 selgantolimod for HBV Cure. 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. 5. Gilead exercised the option for the combined HSV program (ABI-1179 and ABI-5366) in December 2025. FPI - first patient in, HIV - human immunodeficiency virus, INSTI - integrase strand transfer inhibitor, LAI - long-acting injectable, LAO - long-acting oral, NDA - new drug application, NRTTI - nucleoside reverse transcriptase translocation inhibitor, PrEP - pre-exposure prophylaxis, BLA - biologics license application, CoV - covid, HBV - hepatitis B virus, HDV - hepatitis delta virus, HPI - helicase-primase inhibitor, ID - infectious diseases, HSV - herpes simplex virus, MAA - marketing authorization application, NEVPP - neglected and emerging viruses and pandemic preparation.
19 Investor Resource Book
Gilead 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 patients.
INFLAMMATION: PRIMED FOR THERAPEUTIC INNOVATION
Inflammatory diseases are widespread and complex, posing a significant burden to patients impacted and the healthcare system.
Gilead is committed to understanding the pathways and mechanisms 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.
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.
MiroBio Acquisition (August 2022): Added a proprietary discovery platform and portfolio of immune inhibitory receptor agonists.
Clinical Program
Indication
PHASE 1
PHASE 2
PHASE 3
FILED
Q126 Updates
Metabolic Disease
GLP-1R agonist (GS-4571)
Inflammatory Diseases
Inflammatory Diseases Inflammatory Diseases
CD200R agonist (GS-5305)
IRAK4 Degrader (GS-6791) PD1 agonist (GS-0151)
IBD IBD
IBD
Tilpisertib fosmecarbil (PALEKONA) Emvistegrast (SWIFT)1
FXR agonist (GS-8670)
Lupus
Edecesertib (COSMIC)
Rich and Diverse Pipeline of Inflammation Assets
P PRIME Designation
Inflammation
Pipeline shown above as of May 1, 2026. Removed program: Phase 1 BTLA agonist (GS-0272) for inflammatory diseases. 1. Previously GS-1427. STAT6 - signal transducer and activator of transcription 6; RA - rheumatoid arthritis; SLE - systemic lupus erythematosus; IBD - inflammatory bowel disease; FXR - farnesoid x receptor; BTLA - B-
20 and T-lymphocyte attenuator; PD1 - programmed cell death protein 1; IRAK4 - interleukin-1 receptor-associated kinase 4; GLP-1 - glucagon-like peptide-1.
Investor Resource Book
Gilead'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.
Approach
Target
α4β7
Block Immune Activation, Infiltration, and Cytokines
TPL2
IRAK4 Degrader
Developed in-house and wholly owned
Developed in-house and wholly owned
Exclusive development license1
Program emvistegrast (formerly GS-1427; oral) tilpisertib fosmecarbil (oral) GS-6791 (oral)
Mechanism of Action
Prevents homing of pro-inflammatory T-cells to the intestine
Inhibits activation of pro-inflammatory cytokines and cellular proliferation
Inhibits innate immune activation and proinflammatory cytokine production
Clinical Phase (Indication)
Phase 2 (Inflammatory Bowel Disease)
Monotherapy
Phase 2 (Inflammatory Bowel Disease)
Monotherapy
Phase 1 (Inflammatory Diseases)
Monotherapy
Pathway Opportunity
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
Potent inhibitor that suppresses MEK-ERK inflammatory signaling and proinflammatory cytokine production in primary human monocytes, potentially enabling modulation of the immune response
Potent IRAK4 degrader that suppresses inflammatory activation downstream of IL-1 family and toll-like receptors in immune and non-immune cells, blocking an early driver of immune activation
Potential Combinations
Internal NME - -
21 1. Following opt-in from Nurix research collaboration. IBD - inflammatory bowel disease; NME - new molecular entity; TPL2 - tumor progression locus 2.
Investor Resource Book
Gilead has driven significant scientific advancement for life-threatening illnesses like HIV and HCV, and continues to build on this legacy to deliver our innovative therapies - Trodelvy, Yescarta, and Tecartus - to patients.
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
Apr 2026
Tecartus FDA Full Approval in R/R MCL
Our Oncology Therapies
Our commercial oncology portfolio includes three approved therapies that are collectively available in over 60 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 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.
Oncology Revenue >$3B
Patients treated
FY25 revenues
Product Class Key Trials (Indication)
Patent Expiry1 Launched U.S. EU
Antibody Drug ASCENT (2L+ mTNBC) Conjugate (ADC) TROPiCS-02
2020
20282
20292
ZUMA-7 (2L R/R LBCL)
CAR T-cell Therapy ZUMA-1 (3L+ R/R LBCL)
2017
2031
-
ZUMA-5 (3L R/R FL)
(pre-treated HR+/HER2- mBC)
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%
11%
8%
5%
3%
$656M
FY20 FY21 FY22 FY23 FY24 FY25
$1.3B
$2.1B
$2.9B
$3.2B
$3.3B
1. As of our latest 10-K filing, unless otherwise noted. See Page 68 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. HCV - hepatitis C virus; R/R - relapsed or refractory; LBCL - large B-cell lymphoma; FL - follicular lymphoma; mTNBC - metastatic triple negative breast cancer; MCL - mantle cell lymphoma; ALL - acute lymphoblastic leukemia; EMA - European Medicines Agency; mBC - metastatic breast cancer; ADC - antibody drug conjugate.
Gilead 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
TRIGGER TUMOR-INTRINSIC CELL DEATH
Target key pathways within tumor cells to induce cell death, resulting in potentiation of an immunogenic response.
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
CD19/CD20
Engineered T cells that target tumor cells expressing CD19 and/ or CD20
KITE-363/-753
CD19/IL-18
IL-18 armored engineered T cells that target tumor cells expressing CD19
Not disclosed
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 pro-inflammatory factors.
EGFR / IL13Ra2
BCMA
Engineered T cells that target tumor cells expressing EGFR and/or IL13Ra2
Engineered T cells that target tumor cells expressing BCMA
Not disclosed
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
REMODEL TUMOR-PERMISSIVE MICROENVIRONMENT
Modulate immunosuppressive and tumor-permissive cell types and pathways to promote immune responses and inhibit tumor growth.
IL-18BP
Enable pro-inflammatory IL-18 to activate anti-tumor effector cells
GS-0321
CCR8
Regulatory T cell depletion via ADCC activity
GS-1811
CD73
Inhibits CD73 activity, preventing formation of adenosine
quemliculstat
The global cell therapy leader, Kite joined the Gilead family in 2017, and has the largest in-house dedicated cell therapy manufacturing network in the world to support both clinical programs and commercial expansion.
What is CAR T-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. Today, CAR T is available through Authorized Treatment Centers (ATCs), which are independent facilities that dispense Kite CAR T therapies.
Our Cell Therapy Approvals To Date
Therapy 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 Full Approval Apr 2026 Conditional Dec 2020 R/R adult ALL ZUMA-3 Oct 2021 Sep 2022
Global Leadership Enabled by Core Capabilities
Kite has pioneered both CAR T development and approval, as well as established strengths in
$407M
-11%
-12%
Q126 Revenue
Q126 QoQ
Revenue
Q126 YoY
Revenue
manufacturing reliability and clinical execution. Today, Kite remains at the forefront of cell therapy, supported by:
1,869
1,973
1,839
1,459
871
456
607
264
7
FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25
Kite Revenue ($M)
Strength of Our Data - overall survival benefit seen across 2L and 3L+ R/R LBCL. In addition, 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.
For FY26, Cell Therapy revenues are expected to decline approximately 10% YoY, reflecting continued competitive headwinds1.
1. Guidance as of May 7, 2026. Financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section on Page 69 for further information. CAR - chimeric antigen receptor; ATC - Authorized Treatment Center; R/R - relapsed or refractory; LBCL; large B-cell lymphoma; FL - follicular lymphoma; MCL - mantle cell lymphoma; ALL - acute lymphoblastic
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
A patient's white blood cells are collected through an IV line at an ATC.
Isolate
The T cells are isolated from the white blood cells and sent to a Kite facility.
Engineer
Grow
Kite adds the CAR gene to Kite grows the new CAR T cells the T cells to enable the cells to create enough to fight the
to target the cancer.
cancerous cells.
Infuse
New engineered CAR T cells are sent to the ATC to be infused into the patient's bloodstream.
>35,000 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.
Turnaround Time (TAT) Reduction - through manufacturing enhancements, the median TAT in the U.S. is now 14 days.
Novel CAR T Constructs - KITE-753 is a rapid manufacturing CAR T, 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
1. COGS in this instance refers to cost per patient to produce. TAT - turnaround time, the time from date of leukapheresis to date of quality release of final product; R&D - research and development; ATC - Authorized Treatment Center.
Investor Resource Book
While more than 35,000 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 approved CAR Ts, Yescarta and Tecartus.
CAR T Remains Under-Utilized Today Expanding the Use of Cell Therapies Globally
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., only 2 in 10 eligible patients are receiving CAR T, with substantial numbers of eligible patients remaining unaddressed.
Population¹
Therapy Indication 2030 CAR T
1L HR LBCL2
17K
2L R/R LBCL
16K
3L R/R LBCL
13K
HR 2L+ FL2
3K
3L+ FL
5K
2L MCL
4K
2L B-ALL
2K
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 has demonstrated statistically significant overall survival rates following a one-time treatment. 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.
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 strength of our data (see box) and that Yescarta offers the best chance at a cure; and ensuring access for 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.
2L R/R LBCL - In ZUMA-7, Yescarta demonstrated a 55% 4-year OS
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 approach also 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.
>600
Global ATCs
5
Approved Indications
>40
Global Approvals
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. R/R - relapsed or refractory; LBCL - large B-cell lymphoma; HR - higher risk; FL - follicular lymphoma; MCL - mantle cell lymphoma; B-ALL - adult B-cell acute lymphoblastic leukemia; ADC - antibody-drug conjugate; OS -overall survival.
Investor Resource Book
Kite has the largest and longest cell therapy dataset in the industry, enabling us to leverage translational learnings in the development of next generation, paradigm changing cell therapies.
Research Programs Advancing Next-Generation Kite CAR Technology
Single antigen and costimulatory domain
Yescarta, Tecartus, Anito-cel
Mono-CAR
Bicistronic-CAR
Multiple antigens and 2 costimulatory domains
KITE-363
Kite DuoCore™
Mono or bicistronic enriched for juvenile T-cells
KITE-753
Allogeneic-CAR
Using donor cells to create CARs (e.g. iPSC)
CAR-NKs for autoimmune
In vivo-CAR
Capable of generating CARs in system
Novel delivery technology
Approach
Bicistronic-CAR
Kite DuoCoreTM
Program KITE-363 KITE-753¹
Description
Clinical Phase (Indication)
Targets CD19 and CD20 antigens on B-cell malignancies Rapid and enhanced manufacturing process
Phase 1 (neuroinflammatory); Phase 1 (autoimmune) Phase 2 (DLBCL)
Pathway Opportunity
Bicistronic CAR may prevent CD19 antigen escape by minimizing selective pressure through upfront therapeutic dual targeting.
Potential to overcome certain resistance mechanisms as the loss of either antigen on tumor cells can be compensated for by the other CAR.
Potentially provides deeper and more sustained responses, and could improve the overall efficacy/safety profile of the CAR T.
For patients with very aggressive tumors, improving speed to treatment is a key unmet need.
Kite's rapid and enhanced process harvests the product early to enrich a more naïve T cell population.
Potentially improves product potency, manufacturing success rates, reducing turn-around-time and lowering cost of goods.
With KITE-753, there are additional dual-targeting potential benefits of the bicistronic construct.
1. KITE-753 is also a bicistronic CAR T. CAR - chimeric antigen receptor; LBCL - large B-cell lymphoma.
27
Investor Resource Book
Anito-cel is a potentially differentiated and one-time treatment 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
The Journey to the Arcellx Acquisition
In 2022, Kite and Arcellx entered into a collaboration agreement, 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. Following the acquisition of Arcellx, Gilead now has full control of anito-cel, eliminating future profit-share, milestone, and royalty obligations.
December 2022 Partnership to co-develop and co-commercialize anito-cel
for R/R MM. Terms included:
$225M upfront, $100M equity,
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.
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 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
FPI in Phase 3 iMMagine-3 trial in 2L+ R/R MM.
April 2026
Gilead completes acquisition of Arcellx ahead of Dec. 2026 PDUFA date for iMMagine-1.
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. BCMA - B-cell maturation antigen; CAR - chimeric antigen receptor; R/R - relapsed or refractory; MM -multiple myeloma; ASH - American Society of Hematology.
With ~38 months follow-up from the Phase 1 study and supported by data from the Phase 2 iMMagine-1 study, we believe anito-cel has a potentially differentiated profile. We have filed with FDA and target potential launch of anito-cel in 4L+ R/R multiple myeloma in 2H26.
Compelling Data Across Phase 1 and 2 Trials Substantial Multiple Myeloma Opportunity
ASH 2024
ASH 20251
Trial
Phase 1 Trial
iMMagine-1
Stage
Phase 1
Phase 2
Size
n=38
n=117
Median Follow-Up
38.1 months
15.9 months
ORR
100%
96%
CR/sCR
79%
74%
MRD negativity (10-⁵)
89%
95%
mPFS
30.2 months
Not reached
mOS
Not reached
Not reached
6-mo. PFS / OS
92% / 97%
93% / 96%
12-mo. PFS / OS
76% / 95%
82% / 88%
18-mo. PFS / OS
65% / 82%
67% / 88%
24-mo. PFS / OS
57% / 79%
62% / 83%
30-mo. PFS / OS
50% / 75%
-
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+, and ~$3.5B in 4L+.
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
The Phase 3 iMMagine-3 trial in 2L+ R/R MM, which achieved FPI in October 2024, is enrolling ahead of schedule, and the FDA filing is expected as early as 2027.
Rapid and Reliable 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 features2. 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.
The tech transfer from Arcellx was completed in Q224. We are working to launch anito-cel with a similar turnaround time (TAT)3 as other Kite products, leveraging Kite's expertise in manufacturing excellence, which includes a 96% reliability rate.
Anito-cel Multiple 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
Update provided at ASH 2025; Filed with FDA
2L+ R/R MM
iMMagine-3
Phase 3
FPI Q424; Enrolling
Anito-cel (anitocabtagene autoleucel) is an investigational product and has not been approved anywhere globally. Its safety and efficacy have not been established. 1. Data cutoff of October 7, 2025. 2. 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%. 3. At May 1, 2025. 3. turnaround time: the time from date of leukapheresis to date of quality release of final product. R/R - relapsed or refractory; ASH - American Society of Hematology; ORR - overall response rate; (s) CR: (stringent) complete response; MRD - measurable residual disease; mPFS - median progression-free survival; mOS - median overall survival; PFS - progression-free survival; OS - overall survival; ICANS -immune effector cell-associated neurotoxicity syndrome; FPI - first patient in (dosed).
Lymphoma
Kite's broad clinical pipeline spans indication expansion in our core areas of lymphoma and leukemia, as well as expansion into multiple myeloma with anito-cel. Additionally, we are developing a range of next generation constructs, technology improvements, and new targets for use across hematologic and solid tumors, with potential to expand into autoimmune diseases as well.
Clinical Program
Axicabtagene ciloleucel (ZUMA-22) Axicabtagene ciloleucel (ZUMA-23) Brexucabtagene autoleucel (ZUMA-4) CD19/CD20 bicistronic (KITE-753)1 Anitocabtagene autoleucel (iMMagine-1) Anitocabtagene autoleucel (iMMagine-3)
CD19/CD20 bicistronic (KITE-363) CD19/CD20 bicistronic (KITE-363)
Anitocabtagene autoleucel
Indication
2L+ HR FL
1L HR LBCL
Pediatric ALL/NHL R/R DLBCL
4L + R/R MM
2-4L R/R MM
Rheumatology Neurology gMG
PHASE 1
PHASE 2
PHASE 3
FILED
Q126 Updates
BLA Filed
P1 → P2
Acquired from Arcellx Acquired from Arcellx
★
★
P1 FPI
Acquired from Arcellx
Autoimmune
MM
Diseases
★ New listing in Q126
AUTOIMMUNE CELL THERAPY
Our Phase 1 study evaluating KITE-363 in participants with autoimmune neurologic diseases (chronic inflammatory demyelinating polyneuropathy, myasthenia gravis, and multiple sclerosis) is
currently enrolling.
We believe that our bicistronic construct offers more comprehensive targeting of the B cells, given its ability to target both CD19 and CD20, as well as the dual co-stimulatory domains which aims to balance effects such as rapid tumor killing and cell proliferation / persistence in an optimal way.
Leveraging Acquisitions & Collaborations to Accelerate Innovation
April 2026 October 2025 September 2025 December 2022
Acquisition
anito-cel; D-Domain binder platform
Collaboration in vivo CAR-T
Acquisition
in vivo platform
Acquisition Manufacturing technologies;
Pre-clinical & clinical programs
Pipeline shown above as of May 1, 2026. Removed programs: Phase 1 CD19 CAR (KITE-197) for R/R DLBCL. Phase 1 CD19/CD20 bicistronic (KITE-363) for R/R DLBCL. 1. Manufacturing innovation. ALL - acute lymphocytic leukemia, BLA - biological license application, DLBCL - diffuse large B-cell lymphoma, FL - follicular lymphoma, FPI - first patient in, gMG - generalized myasthenia gravis, HR - high risk, LBCL -large B cell lymphoma, MDS - myelodysplastic syndrome, MM - multiple myeloma, NHL - non-Hodgkin's lymphoma, R/R - relapsed or refractory, RMAT - regenerative medicine advanced therapy.
Gilead acquired Trodelvy, a first-in-class TROP-2 directed ADC as part of the Immunomedics acquisition in October 2020. Between Gilead's clinical development program and post-approval, more than 79,000 people across multiple cancers have been treated with Trodelvy.
TRODELVY ADDED TO NCCN GUIDELINES FOR 1L mTNBC
Ahead of the FDA decisions and based on positive ASCENT-03 and ASCENT-04 data, Trodelvy has been added to the NCCN Guidelines as a category 1 recommendation across 1L mTNBC. FDA regulatory decisions for 1L mTNBC are expected 2H 2026.
What is Trodelvy?
Trodelvy (sacituzumab govitecan-hziy) is a TROP-2 directed antibody-drug conjugate approved in the U.S. for 2L+ metastatic triple-negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.
What are ADCs?
Antibody-drug conjugates (ADCs) are biological drugs built using a distinct platform that attaches a potent anti-cancer drug to an antibody via a linker. The antibody is designed to target a specific receptor that is expressed on cancer cells in order to deliver the anti-cancer drug directly to the cells.
How does Trodelvy work?
Trodelvy targets TROP-2 (trophoblast cell-surface antigen 2), which is an epithelial antigen highly expressed on many solid cancer cells that promotes tumor cell growth and metastasis. After Trodelvy (antibody, linker, and drug) binds to TROP-2 on the cell surface, Trodelvy is internalized by the cell. Once inside of the cell, the linker is hydrolyzed, releasing SN-38, leading to DNA damage and eventual cell death.
TROP-2 antibody targets protein highly expressed in multiple tumor types
Trodelvy Strategy
Advancing into earlier lines - Positive back-to-back results from ASCENT-03 and -04 potentially allow for expansion into 1L mTNBC. Exploring Trodelvy in combination with pembrolizumab in ASCENT-05 for high-risk early TNBC.
Expanding approvals globally - For 2L+ mTNBC and pre-treated HR+/HER2- mBC, Trodelvy is approved in over 60 countries (between both indications).
Extending potential benefits to new tumor types - Phase 3 data updates from EVOKE-03 in 1L PD-L1≥50% mNSCLC and ASCENT-GYN in 2L metastatic endometrial cancer are expected in 2H26. EVOKE-04, evaluating Trodelvy in ES-SCLC is currently enrolling.
1,315 1,397
1,063
680
380
49
FY20 FY21 FY22 FY23 FY24 FY25
Trodelvy Revenue ($M)
$402M
Trodelvy's Revenue Growth
Q126 Revenue
+5%
Q126 QoQ Revenue
SN-38 is a potent topoisomerase I inhibitor with a short systemic half-life that causes DNA damage, leading to cell death; uniquely designed with high drug-to-antibody ratio of ~8:1
Hydrolysable linker allows release of SN-38 directly into the tumor microenvironment to kill neighboring cells (bystander effect)
+37%
Q126 YoY Revenue
Note: The use of Trodelvy for lung cancer, endometrial cancer, high-risk early TNBC, and 1L mTNBC is investigational. The safety and efficacy for these uses have not been established. The mechanism of action is based on preclinical data, which may not correlate with clinical outcomes. TROP2 - trophoblast cell surface antigen 2; NCCN - National Comprehensive Cancer Network; mTNBC - metastatic triple negative breast cancer; mBC - metastatic breast cancer; HR - hormone receptor; HER2 - human epidermal growth factor receptor 2; SCLC - small-cell lung cancer.
Breast cancer is the second most common cancer in the world1, accounting for approximately 30% of all new female cancer diagnoses in the U.S. each year2.
TNBC
~538,000 U.S. and EU4 Breast Cancer Annual Incidence, 20262
HR+/HER2-
HER2+
10% (~54K) of Breast Cancers are TNBC
74% (~400K) of Breast Cancers are HR+/HER2-
16% (~86K) of Breast Cancers are HER2+
Early2
Trodelvy Being Explored in This Indication
~32K Patients, ~4K (~12%) Trodelvy Addr. Pop.
~170K Patients
All Lines - Not Trodelvy Addressable
Advance to Metastatic Disease
Trodelvy Approval Pending in This Indication
★
~18K Patients, ~18K Trodelvy Addr. Pop.
1L
30% PD-L1-4 70% PD-L1+4
~100K Patients
★ Trodelvy Approved in This Indication
2L 2L+ : ~20K Patients, ~20K Trodelvy Addressable Population
2L+ opportunity could decline if more
3L patients are able to access Trodelvy in 1L
~76K Patients
★
Trodelvy Approved in This Indication
3L+ : ~90K Patients,
~27K (~30%) Trodelvy Addressable Pop.5,6
~60% HER2 Low ~40% HER2 IHC 0
★ Trodelvy recommended by NCCN in this indication
1. World Health Organization (WHO). Cancer. Updated April 16, 2025. https://www.who.int/news-room/fact-sheets/detail/cancer. 2. American Cancer Society. Key
Statistics for Breast Cancer. https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html. 3. Global breast cancer patient flow model v2.2; 4. Stage II-IIIB patients treated in adjuvant setting; 5. Re-treatment with Trodelvy not expected to occur; 6. i.e., satisfy ET + 2 chemo label requirement.
Investor Resource Book
With two positive Phase 3 trials, Trodelvy has potential as the first and only ADC to be a backbone standard of care for all first-line metastatic TNBC patients regardless of PD-L1 status, as monotherapy in PD-L1- patients and in combination with pembrolizumab in PD-L1+ patients.
Gilead has filed Trodelvy across 1L mTNBC based on Phase 3 ASCENT-03 and ASCENT-04 trials, and is expecting FDA decisions in 2H26.
About Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer and has historically been difficult to treat. TNBC cells do not have estrogen and progesterone receptors and have limited HER2.
HER2 is a growth promoting receptor on the outside of breast cells. Cells with higher-than normal levels of HER2 are considered HER2+ and may be treated
with HER2-targeted therapies. Additionally, for HER2-patients, without hormone receptors on the cancer cells, endocrine therapies are not likely to be effective. Prior to the availability of Trodelvy, treatment options were very limited for metastatic TNBC (mTNBC).
Phase 3 Trodelvy Results in mTNBC
HR, (95% CI)
Trial
ASCENT
ASCENT-03
ASCENT-04
Indication
2L+ mTNBC
1L PD-L1- mTNBC
1L PD-L1+ mTNBC
Regimen
Trodelvy (n=235)
TPC (n=267)
Trodelvy (n=279)
TPC T
(n=279)
rodelvy + Pembro (n=221)
TPC + Pembro (n=222)
mPFS, months
5.6
1.7
9.7
6.9
11.2
7.8
HR, (95% CI)
0.41
(0.32-0.52), P<0.001
0.62
(0.50-0.77), P<0.001
0.65
(0.51-0.84), P<0.001
mOS, months
12.1
6.7
21.5
20.2
-
-
0.48
ORR, % 35 5 48 46 60 53
(0.38-0.59), P<0.001
0.98 0.89
How does PD-L1 Status Influence Treatment?
Programmed cell death ligand 1 (PD-L1) is a protein found on the surface of some cancer cells. When PD-L1 on
The descriptive median overall survival data for ASCENT-03 and ASCENT-04 provided in the table above is
immature. The ASCENT-03 data are based off the ESMO 2025 presentation with an OS data maturity of 37% at time of data cutoff of April 2, 2025. The ASCENT-04 data are based off the ASCO 2025 presentation with an OS data maturity of 26% at the time of data cutoff of March 3, 2025. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned. See footnote for SARs information1.
mTNBC Clinical Opportunity and Potential Patient Reach
cancer cells binds to programmed cell death protein 1 (PD-1) on the surface of T cells, the T cell is prevented from killing the cancer cell. For TNBC patients that are PD-L1 positive, immunotherapy options are available that block the PD-L1/PD-1 interaction, thereby helping
Line of Therapy
Addressable
Population Trial Name Stage Status
to prevent the cancer cell from evading destruction by immune cells. Chemo remains the mainstay of treatment in first-line mTNBC patients who are not candidates for PD-1/PD-L1 inhibitors, and the need to improve outcomes continues to be high.
ASCENT-03
Early
ASCENT-05 Phase 3 Ongoing Collaboration
~32K ADAPT-TN-III (WSG Collaboration) Phase 32 Ongoing Collaboration ADAPT-TN-IV (WSG Collaboration) Phase 32 Ongoing Collaboration
2L+ ~20K ASCENT Phase 3 FDA/EMA Approved 2021
1L ~18K
ASCENT-04 (Merck collaboration)
Phase 3
Phase 3
FDA Decision Expected 2H26 FDA Decision Expected 2H26
Note: Addressable population reflects an estimate of 2030 incidence rates in the U.S., EU4, and UK. Based on internal model. 1. In the ASCENT trial, the most frequent SARs (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SARs were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. 2. This is not a registrational trial. PD-L1 - programmed cell death ligand 1; mTNBC - metastatic triple negative breast cancer; 1L - first-line; WSG - West German Study Group; TPC - treatment of physician's choice; mPFS - progression-free survival; HR - hazard ratio; mOS - median overall survival; ORR - overall response rate; ASCO - American Society of Clinical Oncology; ESMO - European Society for medical Oncology; SAR - serious adverse reactions; GBG - German Breast Group.
In 2023, FDA and the European Commission approved Trodelvy for adult patients with pretreated HR+/HER2- mBC¹, based on the Phase 3 TROPiCS-02 study which demonstrated statistically significant and clinically meaningful median overall survival.
What Does HER2- Mean?
HR+/HER2- breast cancer is the most common type of breast
TROPiCS-023 Study in HR+/HER2- mBC (June 2023)
cancer, accounting for approximately 74% of all breast cancers. Patients who are HER2-negative do not overexpress HER2.
HER2-negative is defined per ASCO/CAP guidelines as IHC
Median PFS, months
HR
Trodelvy (n=272) 5.5
0.65
TPC (n=271) 4.0
3X
More patients remained
0, IHC 1 or IHC 2/ISH-. There are currently no HER2 directed therapies approved for patients with HER2 IHC 0 expression. Patients with HER2 IHC 0, 1, or 2/ISH- expression may be eligible for Trodelvy. Trodelvy has shown a statistically significant and clinically meaningful OS and PFS benefit versus standard of
care chemotherapy in HER2-negative patients in its Phase 3 TROPiCS-02 and Phase 3 ASCENT study in 2L+ mTNBC.
HR+/HER2- Treatment
(95% CI)
Median OS, months 14.5 11.2
HR
ORR, n (%) 58 (21) 38 (14)
(95% CI)
Odds Ratio
Median DoR, months (95% CI)
8.1
(6.7-8.9)
5.6
(3.8-7.9)
(95% CI)
(0.53-0.81), nominal P=0.0001
0.79
(0.65-0.95), nominal P=0.01
1.66
(1.06-2.61), P=0.03
progression free and alive at 12 months
3.3
More months of overall survival versus chemotherapy
21%
Reduction in the risk of death compared to TPC
The standard of care for patients with HR+/HER2- mBC is endocrine-based therapy with or without CDK4/6 inhibitors. Eventually endocrine-based therapies and CDK4/6 inhibitors will stop working for all patients. There is no clearly defined treatment sequence after patients are no longer responsive to endocrine therapies2, though historically it has often been followed by chemo. These patients have historically poor survival and quality of life becomes a key consideration, where later-line chemotherapy is associated with substantial toxicity and poor quality of life.
NCCN Category 1 Preferred Treatment
The most frequent Grade >3 treatment-related adverse events were neutropenia (52%), diarrhea (10%), and anemia (7%).
HR+/HER2- mBC Opportunity and Potential Patient Reach
Addressable
Line of Therapy
Population
Trial Name
Stage
Status
Early
~180K
SASCIA (GBG Collab)
Phase 34
Ongoing
2+ Prior Chemo
~27K
TROPiCS-02
Phase 3
FDA/EMA Approved 2021
Trodelvy is recommended as a Category 1 preferred treatment option for adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received prior treatment, including endocrine therapy, a CDK4/6 inhibitor, and at least 2 lines of chemotherapy (one of which was a taxane), at least one of which was in the metastatic setting5.
Addressable population reflects an estimate of 2030 incidence rates in the U.S., EU4, and UK. Based on internal model. 1. Adult patients with HR+/HER2- mBC who have received endocrine based therapy and at least 2 additional systemic therapies in the metastatic setting 2. Moy B, et al. J Clin Oncol 2021;39(35):3938-3958. 3. Tolaney S, et al. Journal of Clinical Oncology. 2023. 4. Not a registrational trial. 5. This NCCN recommendation differs from the Trodelvy Prescribing Information. mBC - metastatic breast cancer; ADC - antibody-drug conjugate; ASCO - American Society of Clinical Oncology; CAP - College of American Pathologists; IHC - immunohistochemistry; PFS - progression-free survival; HR - hazard ratio; OS - overall survival; ORR - objective response rate; DoR - duration of response; TPC - treatment of physicians choice; DCFI - Dana-Farber Cancer Institute; GBG - German Breast Group; EMA - European Medicines Agency.
Lung cancer is the most common cancer and the leading cause of cancer death worldwide, with ~2.5M new lung cancer diagnoses and ~1.8M deaths annually. Up to 85% of lung cancers are NSCLC and 10-15% are SCLC, with both having poor prognosis1.
What is Gilead Developing for Lung Cancer?
Gilead aims to improve long-term survival in lung cancer through exploring the development of a targeted antibody-drug conjugate (ADC) in combination with immunotherapy. In particular, Gilead is evaluating Trodelvy plus pembro for 1L PD-L1 high mNSCLC, with promising data from the Phase 2 EVOKE-02 study in 1L advanced or mNSCLC. Additionally, based on data from the Phase 2 TROPiCS-03 basket study, Trodelvy received FDA Breakthrough Therapy designation for 2L+ ES-SCLC, and initiated EVOKE-SCLC-04 in March 2025.
Clinical Opportunity and Potential Reach
Addressable
1L Stage IV (All-comers)
~190K2
EVOKE-02 VELOCITY-Lung
Phase 2 WCLC 2024
Phase 2 -
Line of Therapy Population Trial Name Stage Status
1L Stage IV ~35K
EVOKE-03
Phase 3
Update Expected in
2H26
2L SCLC 25K3
EVOKE-SCLC-04
Phase 3
Enrolling
(PD-L1≥50%)
Established Proof-of-Concept in 1L mNSCLC
Gilead shared updated data from Cohort A of the Phase 2 EVOKE-02 study at ASCO 2024, following initial presentation at WCLC 2023 along with preliminary data from Cohort
B. Additionally, Cohorts C and D data were shared at WCLC 2024 demonstrating similar efficacy and safety results across both nonsquamous and squamous patients. These data reinforce Trodelvy + pembro's potential in 1L mNSCLC, such as in the PD-L1 high population currently being studied in the Phase 3 EVOKE-03 study. EVOKE-03 is ongoing and evaluating Trodelvy + pembro as compared to pembro alone.
Phase 2 EVOKE-024,5 Interim Analysis
Trodelvy plus pembro continued to demonstrate promising activity in the 1L setting in patients with PD-L1 high (TPS ≥ 50%) mNSCLC without actionable genomic alterations (AGAs). In Cohort A, Trodelvy's mPFS of ~13 months compared favorably to the historical performance of current treatment options in 1L PD-L1 high mNSCLC in Phase 3 trials6.
(Target Size) Histology
PD-L1 Status
Treatment
N
ORR
mDOR
mPFS
Cohort A Nsq or Sq
TPS ≥ 50%
Trodelvy + Pembro
30
67%
20mo
13mo
Cohort B Nsq or Sq
TPS < 50%
Trodelvy + Pembro
32
44%
NR
NR
Cohort
Established Proof-of-Concept in 2L+ ES-SCLC
directed therapy.
All Patients
Platinum Resistant
Platinum Sensitive
(n=43)
(n=20)
(n=23)
ORR, %
41.9
35.0
47.8
Median DOR, months
4.7
6.3
4.4
Median PFS, months
-
3.8
5.0
Median OS, months
-
6.6
14.7
TROPiCS-03 is a phase 2 open-label basket study of Trodelvy in patients with metastatic solid tumors. The ES-SCLC cohort includes patients that have progressed after prior platinum-based chemotherapy and anti-PD-(L)1
(n=30)
(n=60)
Cohort C (n=40)
+ Chemo
Nsq only All-comers Trodelvy + Pembro
51 45% NR 8mo
Cohort D (n=40)
Sq only All-comers
Trodelvy + Pembro
+ Chemo
41 39% 12mo 8mo
Note: The use of Trodelvy for the treatment of lung cancer is investigational, and the efficacy and safety for this use have not been established. 1. World Health Organization (WHO). Lung Cancer. https://www.who.int/news-room/ fact-sheets/detail/lung-cancer. 2. All-comer includes PD-L1≥ 50% population. 3. U.S. and EU addressable population. 4. Cho B, et al. presented at the World Conference on Lung Cancer 2023. 5. Grey J, eta al. presented at the World
Conference on Lung Cancer 2024. 6. KEYNOTE-189, KEYNOTE-407. NSCLC - non-small cell lung cancer; SCLC - small cell lung cancer; ADC - antibody-drug conjugate; mNSCLC - metastatic non-small cell lung cancer; WCLC - World Conference on Lung Cancer; FPI - first patient in; ES-SCLC - extensive-stage small cell lung cancer; ORR - objective response rate; DOR - duration of response; PFS - progression-free survival; OS - overall survival; ASCO - American Society of Clinical Oncology; TPS - tumor proportion score.
Gilead's oncology pipeline includes promising therapies across novel targets and pathways. With advanced assets, including Trodelvy and domvanalimab serving as potential key backbone treatments, the earlier stage development pipeline includes programs with unique combination potential and broad applicability across tumor types. Below we highlight a few examples.
Approach
Trigger Tumor-Intrinsic Cell Death Remodel Tumor-Permissive Microenvironment
Target
PARP1
Acquired from XinThera in May 2023
IL-18BP
Licensed from Compugen in December 2023
CCR8
Acquired from Jounce in December 2022
via ADCC activity
Program GS-0201 GS-0321 denikitug (GS-1811)
Mechanism of
Action
Blocks cells from repairing damaged DNA
Amplify cytokine effects Regulatory T cell depletion
Clinical Phase (Indication)
Pathway Opportunity
Phase 1 (Solid Tumors) Monotherapy and in combination with Trodelvy
PARP1 selective inhibitors may potentially mitigate the hematological toxicities seen in first-generation, dual PARP1/2 inhibitors, enabling combination with DNA-damaging agents, including systemic chemotherapy and targeted agents like Trodelvy
Phase 1 (Solid Tumors) Monotherapy and in combination with zimberelimab
IL-18 is present in high levels in the tumor microenvironment, where it activates anti-tumor effector cells. IL-18 binding protein prevents IL-18 anti-tumor activity. GS-0321 could block IL-18 and IL-18BP activity, allowing IL-18 tumor suppression activity
Phase 1 (Solid Tumors) Monotherapy and in combination with zimberelimab
CCR8 is highly expressed on Tregs in a broad range of solid tumors and may be an important mechanism of resistance to PD(L)1 inhibitors, but is not on most circulating Tregs. Treg depletion could
alleviate immuno-suppression and activate effector T cells
Potential Combinations
PD-1 (zimberelimab)
TROP2 (Trodelvy) PD-1 (zimberelimab) TROP2 (Trodelvy) SoC chemotherapy
ADCC - antibody-dependent cellular cytotoxicity; CCR8 - chemokine Receptor 8; PARP - poly ADP ribose polymerase; Tregs - regulatory T cells; PD-L1 - programmed death-ligand 1; TIGIT - T cell immunoreceptor with Ig and ITIM domains SoC - standard of care.
PHASE 1
PHASE 2
PHASE 3
FILED
cology
Clinical Program Indication Q126 Updates
Breast
Sacituzumab govitecan-hziy (ASCENT-03)
Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-04)1 Sacituzumab govitecan-hziy + pembrolizumab (ASCENT-05)
1L mTNBC (PD-L1-)
1L mTNBC (PD-L1+)
High risk adjuvant TNBC
BLA Filed BLA Filed
Lung & Thoracic
Sacituzumab govitecan-hziy + pembrolizumab (EVOKE-03)1 Sacituzumab govitecan-hziy (EVOKE-SCLC-04)
Lung cancer platform (VELOCITY-Lung2)
1L mNSCLC (PD-L1+, TPS≥50%) ES-SCLC
NSCLC
Genito-urinary
Sacituzumab govitecan-hziy + combinations (TROPHY U-01)
1L mUC
Gyne-
Sacituzumab govitecan-hziy (ASCENT-GYN-01)3
2L mEC
Advanced Cancers
Denikitug (GS-1811) PARP1 inhibitor (GS-0201) Anti-IL-18BP (GS-0321)4 Masked IL-12 (XTX301)5 GS-2121
GS-5319
Advanced Cancers Advanced Cancers Advanced Cancers Advanced Cancers Advanced Cancers
Advanced Cancers
Opt-ins
Arcus
MacroGenics
Advanced Cancers
Advanced Cancers
2 clinical stage programs
1 clinical stage program
Pipeline shown above as of May 1, 2026. Removed programs: Phase 2 Sacituzumab govitecan-hziy + combinations (VELOCITY-HNSCC) for 1L HNSCC. Phase 3 Domvanalimab + zimberelimab + chemo (STAR-121) for 1L mNSCLC. Phase 2 sacituzumab govitecan-hziy (TROPiCS-03) for basket (solid tumors). Phase 1 GS-4528 for advanced tumors 1. In collaboration with Merck. 2. VELOCITY-Lung includes combinations of domvanalimab, etrumadenant (recruitment closed), zimberelimab, and sacituzumab govitecan-hziy. 3. In collaboration with the GOG Foundation (GOG) and European Network of Gynecological Oncological Trial Groups (ENGOT). 4. Operationalized by Compugen. 5. Operationalized by Xilio. ES-SCLC - extensive stage - small cell lung cancer, mEC - metastatic endometrial cancer, mNSCLC - metastatic non-small cell lung cancer, mTNBC - metastatic triple-negative breast cancer, mUC - metastatic urothelial carcinoma, NSCLC - non-small cell lung cancer, PD-L1 - programmed death-ligand 1, sBLA - supplemental biologics license application, TNBC - triple-negative breast cancer, PARP1 - poly (ADP-ribose) polymerase 1.
The #1 prescribed antiviral for patients hospitalized with COVID-191, Veklury (remdesivir) is an example of Gilead's virological expertise driving innovation.
~2M
Continued Benefit in COVID-19, Including 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, Veklury demand declined and subsequently stabilized, reflecting evolving disease severity, vaccination uptake, and changes in hospitalization patterns. Although the virus3 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 2026, Gilead expects
~$600M in Veklury revenues4.
5.6
3.9
2.8
2.2
1.8
0.9
FY20 FY21 FY22 FY23 FY24 FY25
Veklury Revenue ($B)
$144M
Q126 Revenue
-32%
Q126 QoQ Revenue
-52%
Q126 YoY Revenue
Remdesivir Vials Donated Globally5
127
Countries with Distribution Access From Voluntary Licenses5
14.5M
Patients Have Access to Veklury and Generic Remdesivir5
>60%
Share of Hospitalized Patients with COVID-19 Treated in the U.S.6
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. Data on file; January 2023 to January 2025. Gilead Sciences, Inc. 2. Reduced mortality did not reach statistical significance n the ACTT-1 trial. 3. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines, NIH. 4. Guidance as of May 7, 2026. Financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section on Page 69 for further information. 5. Based on global Veklury, global remdesivir, and licensed generic remdesivir volume donated and shipped for distribution. 6. Actuals based on HealthVerity Hospital Chargemaster + Premier Hospital Data.
Name Date Detail
M&A
Tubulis
Apr-26
Acquisition to add potential best-in-class ADC and next generation platform to further strengthen oncology pipeline ($3.15B)
Ouro
Mar-26
Acquisition to advance first-in-class T cell engager platform for autoimmune diseases ($1.675B)
Arcellx
Feb-26
Acquisition to maximize long-term potential of anito-cel (closed April 2026 for $7.1B, which excludes shares already owned by Gilead)
Interius
Aug-25
Acquisition to add in vivo cell therapy platform to add to existing Kite capabilities ($350M)
CymaBay
Feb-24
Acquisition to add investigational seladelpar to Liver Disease and Inflammation portfolio (closed March 2024) ($3.9B)
XinThera
May-23
Acquisition to add early pipeline in oncology and inflammation, including PARP1 asset (~$200M)
Tmunity
Dec-22
Acquisition to pursue next generation CAR T-cell therapy advancements in cancer (closed February 2023) (~$300M)
MiroBio
Aug-22
Acquisition adding investigational inflammation therapies to the Gilead portfolio (closed September 2022) ($414M)
MYR
Dec-20
Acquisition to add Hepcludex (bulevirtide) for certain HDV infections (closed March 2021) (€1.3B)
SELECT COLLABORATIONS AND/ OR LICENSES
Assembly
Dec-25
Gilead Sciences exercises option to license Assembly Biosciences' helicase-primase inhibitor programs for recurrent genital herpes
PreGene
Oct-25
Kite enters licensing and collaboration agreement with Shenzhen PreGene Biopharma to research and develop in vivo CAR-T ($120M)
Kymera
Jun-25
Exclusive option and license agreement to develop novel oral molecular glue CDK2 degraders ($85M)
LEO Pharma
Jan-25
Strategic partnership to accelerate development of oral STAT6 program with potential in multiple inflammatory diseases ($250M)
Terray
Dec-24
Multi-target research collaboration to discover and develop novel small molecule therapies
Tubulis
Dec-24
Exclusive option and license agreement to develop ADC candidate for select solid tumor target ($20M)
Genesis
Sep-24
Collaboration to discover and develop novel therapies using GEMS AI Platform ($35M)
Janssen
Aug-24
Buy-out of global seladelpar royalties from Janssen Pharmaceutica NV ($320M)
Xilio
Mar-24
Exclusive license agreement for tumor-activated IL-12 program ($44M)
Merus
Mar-24
Collaboration to discover novel antibody-based trispecific T-cell engagers ($81M)
Arcus
Jan-24
Amended collaboration agreement to refocus TIGIT program and further equity investment ($320M)
Compugen
Dec-23
Exclusive license agreement for later-stage development and commercialization of pre-clinical anti-IL18 binding protein antibodies ($60M)
Arcellx
Nov-23
Expansion of existing partnership to include ARC-SparX ACLX-001in MM, anito-cel lymphoma, and further equity investment ($200M)
Galapagos
Oct-23
Amended collaboration agreement in relation to the development cost sharing and tiered royalties on Jyseleca sales in Europe
Assembly Bio
Oct-23
Collaboration for research and development of novel antiviral therapies, including in herpesviruses, HBV, and HDV ($100M)
Tentarix
Aug-23
Collaboration to discover and develop novel therapies across cancer and inflammation ($66M)
Arcus
May-23
Expansion of existing partnership to include research programs in inflammation ($35M)
Nurix
Mar-23
Exercised option to license IRAK4 targeted protein degrader for inflammation
EVOQ
Dec-22
Collaboration to advance immunotherapies in treatment of RA and lupus
Note: amounts listed represent equity and upfront payments, and may not reflect amounts charged as acquired IPR&D. Future milestones and other contingent payments are not included. ADC - antibody-drug conjugate; CAR - chimeric antigen receptor; HDV - hepatitis delta virus; CDK2 - cyclin-dependent kinase 2; STAT6
39 - signal transducer and activator of transcription 6; TIGIT - T-cell immunoreceptor with Ig and ITIM domains; MM - multiple myeloma; HBV - hepatitis B virus; IRAK4 -interleukin-1 receptor-associated kinase 4; RA - rheumatoid arthritis.
Investor Resource Book
Gilead collaborates with organizations and communities across the globe to strengthen health systems, tackle stigma and discrimination, educate patients and providers, and ensure that diverse populations are represented in clinical trials and public health initiatives.
Voluntary Licensing
Beginning with Viread in 2006, Gilead has been an industry leader in voluntary licensing for two
decades. Gilead's voluntary licensing program enables
Partnerships and Grants
Bringing together patients, stakeholders, advocates and communities in order to go where the need is greatest, and developing trust and long-term relationships with the communities we serve.
technology transfer to vetted generic manufacturers and promotes best practices to enable rapid and safe production of medicines necessary to support those who need them.
Voluntary Licensing Access
3M+
8.5M
21.6M
Sofosbuvir-based HCV treatments made available since 2015
Remdesivir treatments made available since 2020
Gilead-developed HIV and HBV treatments made available in 2025
Lenacapavir for PrEP
In September 2025, Gilead announced a partnership with the U.S. State Department and PEPFAR to deliver twice-yearly lenacapavir for HIV prevention for up to two million people in primarily low- and lower-middle-income countries. In April 2026, Gilead announced an enhanced partnership increasing to up to three million deliveries over three years. This partnership brings together the resources and expertise of both PEPFAR and the Global Fund. The Global Fund is a partnership designed to accelerate the end of AIDS, tuberculosis and malaria as epidemics. Gilead is actively consulting with global aid organizations, including
the Global Fund, to understand product demand and collaborate on distribution.
HIV Support in Eastern Europe
Supported by Gilead in partnership with the Elton Johns AIDS Foundation, RADIAN helps grassroots organizations and partners in Eastern Europe and Central Asia (EECA) to address the HIV-related challenges in the region. Since its launch in 2019, RADIAN has provided HIV tests, treatment and healthcare worker training across EECA.
Screening and Linkage to Care
Since 2010, FOCUS has partnered with hundreds of institutions in Portugal, Spain and the U.S.
to strengthen health systems and share best practices for routine screening, diagnosis and linkage to care across HIV, HBV and HCV. The FOCUS model is data driven, efficient and scalable.
Addressing HIV in Southern U.S.
The Gilead COMPASS Initiative® is a 10-year, $100 million+ program to support organizations working to address the HIV/AIDS epidemic in the Southern United States. Organizations use funding to help improve access to, and quality of, healthcare services for people living with HIV, increase
local leadership and advocacy, and reduce HIV-related stigma.
people reached with direct services
~376K
>36K
~19K
PWH linked to care
front-line workers trained
~25M
186
116
blood-borne virus tests (2010-2025)
active partnerships
cities / countries
1M
462
~450K
individuals reached
community-based partners
people trained
40 HCV - hepatitis C virus; HBV - hepatitis B virus; PrEP - pre-exposure prophylaxis; PEPFAR - President's Emergency Plan for AIDS Relief; PWH - people with HIV.
Investor Resource Book
Disclaimer
Gilead Sciences Inc. published this content on May 07, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 07, 2026 at 23:35 UTC.