These companies use the creative forces of capitalism to solve big problems—and do well by doing good.

<p>Gilead is a longtime leader in HIV therapeutics and prevention, including antiretroviral treatment and pre-exposure prophylaxis (PrEP) medicines, which are drugs taken to lower the risk of contracting HIV. Gilead has worked with the government of South Africa and the Global Fund to accelerate access to lenacapavir, a long-acting prevention medication that the FDA approved in 2022 to treat drug-resistant HIV. Approximately 7.8 million people in South Africa live with HIV, with an estimated 170,000 new infections each year. 
</p>

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<p>Gilead’s drugs have helped change HIV infection from a death sentence to a manageable condition. In 2012, it launched the first pre-exposure prophylaxis (PrEP) preventive drug for HIV. In June, it won FDA approval for Yeztugo, a PrEP drug requiring only two doses a year—giving it far greater potential efficacy in preventing new infections.
</p>

Almost $20 trillion in revenue—and a record-breaking $1.87 trillion in profits. Introducing the 2025 Fortune 500, the definitive list of the biggest companies in America.

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Although the southern United States represent only 33% of the U.S. population, they account for 51% of new HIV diagnoses and 47% of HIV-related deaths in the country. Gilead, which makes a variety of HIV drugs, has launched the Compass Initiative to tackle the factors fueling that disparity. In partnership with more than 390 community organizations across 16 states, Compass’s events and training programs focus on topics including stigma reduction and trauma-informed medical care, with the aim of helping those community groups do more to help combat the spread of HIV. To date, Compass has provided 300,000 people with services, trained 26,000 individuals in leadership development, and provided more than $106 million in grant funding to support outreach to those impacted by HIV.

The Fortune 500, in its 69th year in 2023, ranks the biggest U.S. companies by revenue.

This year’s Fortune 500 marks the 68th running of the list.

Total revenue for the world’s biggest companies fell 4.8% to $31.7 trillion this year—the first decline in half a decade.

The biopharmaceutical company researches and develops antiviral drugs used in the treatment of life-threatening diseases, including HIV and hepatitis. Last October, its intravenous drug remdesivir became the first treatment for COVID-19 approved for emergency use by the FDA.

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This year's Fortune 500 marks the 66th running of the list.

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California-based Gilead is a biopharmaceutical firm best known for its hepatitis C cures Sovaldi and Harvoni, though it's been making headlines more recently due to its experimental coronavirus treatment remdesivir.

This year's Fortune 500 marks the 65th running of the list.

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Wal-Mart stayed on top as its sales crept closer to half-a-trillion dollars. Apple moved into the top five. And UnitedHealth Group continued its steady climb. 

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Gilead Sciences is a biopharmaceutical company that researches, develops, and commercializes medicines. Gilead’s Veklury (remdesivir) was one of the first antiviral treatments authorized for COVID-19. Gilead also pioneered groundbreaking treatments for HIV that helped transform the fatal virus into a manageable chronic condition. The company continues to expand into oncology and other chronic conditions through acquisitions, such as CymaBay, which developed a treatment for a rare liver disease.

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Gilead Sciences (GILD): Company Profile, Stock Price, News, Rankings

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Gilead Sciences

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Good afternoon, everyone, and welcome to Gilead's third quarter 2025 earnings conference call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks, followed by our Q&A session. To ask a question, press star one. To withdraw your question, press star two. Now, I'll hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.

Thank you, Rebecca. Just after market close today, we issued a press release with earnings results for the third quarter of 2025. The press release, slides, and supplementary data are available on the investor section of our website at gilead.com.

The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Dietmar Berger, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements. Please refer to slide two regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. We appreciate you joining today as we take you through another very strong set of quarterly results. Our third quarter earnings underscore the growing momentum you're seeing from Gilead today, which is driven by our strong portfolio and the impressive execution of our teams. As you'll hear during the call, our progress is visible in both our quarterly results and in our strong clinical pipeline.

Highlights of our third quarter include commercial outperformance across our HIV therapies and Livdelzi. This resulted in 6% year-over-year growth for Biktarvy, 20% year-over-year growth for Descovy, and 35% sequential growth for Livdelzi. Disciplined operating expense management contributed to 22% year-over-year growth in non-GAAP EPS. Even excluding a $0.25 benefit from a non-recurring accounting item, non-GAAP EPS grew 10% compared to 4% base business growth year-over-year, highlighting the leverage in our business model.

As a reflection of our strong performance year to date, we are increasing our full-year HIV revenue growth expectations to approximately 5%. This is despite the $900 million headwind for our HIV business in 2025, associated with the Medicare Part D redesign. Our newest addition to the HIV portfolio, Yes To Go, for HIV prevention, delivered third quarter sales of $39 million, or $54 million, including the first few weeks of launch in June. Of course, our initial priority has been securing payer coverage, and I'm very pleased to share that we've already achieved our 75% coverage goal, nearly three months ahead of our target. This sets a strong foundation for continued growth in 2026. Our confidence in our HIV business comes from both our existing on-market product leadership and our innovative pipeline.

We look forward to sharing progress on one of our next-generation HIV treatments before the end of the year, with an update on the ARTISTRY-1 and ARTISTRY-2 studies. These phase three programs are evaluating an investigational single tablet regimen of Biktarvy and lenacapavir, and we continue to target a product launch in early 2027. As I mentioned, Livdelzi was a standout of the quarter, contributing to 12% year-over-year growth in our liver portfolio. Livdelzi exceeded $100 million in quarterly sales for the first time and is already the number one treatment for second-line PBC in the U.S. We're also pleased to share that we have filed for FDA approval of bulevirtide for the treatment of chronic hepatitis delta virus. This therapy has been available in Europe since 2020 under the brand name of Hepcludex, and we expect to bring it to patients in the U.S. in 2026.

Turning to oncology, we continue to make significant clinical progress, most recently with the presentation of our ASCENT-03 detailed data at ESMO and simultaneous publication in the New England Journal of Medicine. Given the particularly aggressive nature of this disease, we are moving as quickly as we can to bring Trodelvy to first-line metastatic triple-negative breast cancer patients. We have submitted sBLAs with the FDA and are targeting a potential commercial launch in 2026 that could extend Trodelvy's leadership in breast cancer. We also continue to target commercial launch for anito-cel for multiple myeloma in 2026 and look forward to sharing an update from the pivotal iMMagine-1 study before the end of this year. In summary, we are very pleased with our performance in the third quarter, building on a very strong 2025 overall, and just as importantly, we have significant potential ahead.

The quality, breadth, and diversity we built into the portfolio over the past years is now presenting us with multiple opportunities to drive benefits for patients. With several just launched or soon-to-be-launched products across HIV, oncology, and liver disease, and clinical readouts on the horizon with further commercial potential, this continues to be an exciting phase of growth. The fact that we now have no major LOEs until 2036 reinforces our strong position. My thanks, as always, to the Gilead team for their incredible work this quarter and their continued dedication to doing more for the communities we serve. With that, I'll hand it over to Johanna.

Thanks, Dan, and good afternoon, everyone. I'm pleased to share our third quarter results representing another strong quarter of commercial execution, with exciting momentum in our most recently launched products, Yes To Go and Livdelzi, in addition to continued robust Biktarvy and Descovy growth. Starting on slide seven, third quarter product sales, excluding Veklury, were $7.1 billion, up 4% year-over-year and up 2% sequentially, driven by strength across our HIV portfolio, offset in part by lower oncology revenue.

Including Veklury sales of $277 million, third quarter total product sales were $7.3 billion, up 4% sequentially and down 2% year-over-year, primarily reflecting lower Veklury sales associated with fewer COVID-19-related hospitalizations. Moving to slide eight, HIV sales of $5.3 billion represented 4% growth versus prior year and prior quarter, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price.

Year to date, our HIV business has grown more than 5%, which is particularly impressive as we managed through a $900 million headwind for the full year related to the Medicare Part D redesign. Consistent with our performance year to date, we are increasing our guidance for full-year HIV revenue growth to approximately 5%, up from 3% last quarter. On slide nine, Biktarvy sales of $3.7 billion were up 6% year-over-year and 4% sequentially due to higher demand reflecting continued market growth of 2% to 3% and strong commercial execution. Biktarvy's year-over-year market share in the U.S. has grown every quarter since launch and achieved a record high of approximately 52% in the third quarter. Given Biktarvy's clear differentiation and market leadership, we're pleased that the expected loss of exclusivity in the U.S. for Biktarvy has been extended into 2036.

Moving to Descovy, third quarter sales were a record $701 million, increasing 20% year-over-year, primarily due to higher demand for Descovy for PrEP. Sequentially, sales were up 7%, driven by higher demand and average realized price due to channel mix, partially offset by inventory dynamics. As a reminder, roughly three-quarters of Descovy sales are for HIV prevention. This highlights the incredible momentum in the prevention market, driven by the growing awareness and increasing unrestricted access, as well as excellent commercial execution. Descovy for PrEP achieved a new record market share of more than 45% in the U.S. in the third quarter. This reflects the strength of our PrEP team and the impact they're having in ensuring HIV PrEP reaches more of the people who could benefit from it. Overall, the PrEP market grew approximately 14% year-over-year.

Moving to slide 10, and one quarter in, we're really excited with the initial positive reception to our Yes To Go launch across consumers, clinicians, and payers. Yes To Go is increasingly recognized in clinical guidelines, including most recently the U.S. CDC. This strong endorsement of Yes To Go offers healthcare providers, public health leaders, and communities clear guidance on an innovation that could help shift the trajectory of the HIV epidemic. As we've discussed previously, expanding payer coverage is a critical indicator in our initial launch, and we're working with every payer to accelerate access. I'm thrilled that we have already achieved 75% access in the U.S., almost three months ahead of our target. This includes coverage by UnitedHealthcare and Express Scripts, as well as 20 of the top 25 state Medicaid plans. In most cases, payers do not require prior authorizations or copays.

Keep in mind that much of our progress to the 75% access goal has been made in the last several weeks. We continue to work on an account-by-account basis to help clinicians navigate the new logistics and reimbursement process, and the benefits of this access will pull through in 2026. Looking forward, we're moving quickly to expand access beyond 75% and continue to target 90% by the end of the first half of 2026. Altogether, Yes To Go is off to a strong start, delivering $39 million in sales in the third quarter. From launch in the middle of June to the end of the third quarter, Yes To Go revenue was $54 million, including $15 million of new launch-related stocking at the end of the second quarter.

As we expected, most early prescribers are existing HIV PrEP clinicians who are leveraging white bagging to simplify the logistic and reimbursement arrangements. In August, the European Commission approved lenacapavir for PrEP under the name Ye Tuo. We look forward to further regulatory decisions across other geographies. Additionally, as part of our broader commitment to access, Gilead has agreed with the Global Fund and the U.S. Department of State through PEPFAR to supply enough doses of lenacapavir for PrEP to reach up to 2 million people over three years in certain low and lower-middle-income countries. Moving to liver disease on slide 11, sales of $819 million were up 12% year-over-year and 3% sequentially, driven almost entirely by Livdelzi for primary biliary cholangitis. Livdelzi grew 35% sequentially, driven by strong commercial execution, including some new launches outside the U.S. and withdrawal of a competitor's product in the U.S.

We are particularly pleased to see strong levels of persistence among users and believe Livdelzi shows clear differentiation and value to those with PBC. Livdelzi is now the market leader in second-line PBC in the U.S., and quarterly revenue topped $100 million for the first time. Moving to slide 12, Trodelvy's sales of $357 million were up 7% year-over-year, primarily due to higher demand and down 2% sequentially, with higher demand offset by unfavorable inventory dynamics and lower ex-U.S. average realized price. Trodelvy's continued strength in the U.S. and international markets across metastatic breast cancer more than offset on a year-over-year basis the expected impact from the bladder cancer withdrawal in the U.S. With Trodelvy's potential launch in first-line metastatic TNBC following the potentially practice-changing ASCENT-03 and ASCENT-04 readouts this year, we look forward to expanding the options available for patients in this earlier line setting.

There are almost twice as many patients in the first-line metastatic setting compared to second-line, and patients typically have a longer duration of therapy. For cell therapy on slide 13, and on behalf of Cindy and the Kite team, third-quarter sales of $432 million were down 11% both year-over-year and sequentially with continued competitive headwinds from in- and out-of-class therapies. We anticipate these headwinds to continue in the near future. We remain committed to increasing the adoption and utilization of cell therapies, given their curative potential for many patients. Year to date, we've added more than 40 authorized treatment centers and now have more than 570 globally. As shared in prior quarters, our efforts to lower the hurdles to community adoption are progressing, but it's clear that we have more to do before all eligible patients have the opportunity to benefit from these cell therapies.

In addition to the team's work to expand the reach of cell therapies, Kite is also progressing its next-generation pipeline to offer similar efficacy with better safety, which would result in enhanced outpatient usage potential. Additionally, we're very excited by the development of anito-cel, which continues to show potential best-in-class safety and efficacy as a BCMA CAR-T therapy for late-line relapsed refractory multiple myeloma. We look forward to providing an update from the iMMagine-1 study later this year. Wrapping up our third quarter, I'd like to thank the commercial teams who are executing relentlessly across both our in-line portfolio as well as our newer opportunities like Yes To Go and Livdelzi. Looking to 2026, we're preparing for a number of additional potential launches across our therapeutic areas of focus and are excited by the opportunity to extend our reach and impact on the patients and communities we serve. With that, I'll hand the call over to Dietmar. 

Thank you, Johanna, and good afternoon, everyone. In the third quarter, the team progressed 56 clinical programs across our three therapeutic focus areas, with four additions since last quarter, as we advance our research with the most meaningful potential scientific and patient impact into the clinic.

Building on Johanna's comments on our Yes To Go launch, we continue to lead HIV innovation with 10 clinical programs across treatment and prevention. Lenacapavir and its prodrugs are foundational in our treatment and prevention programs, and in July, we initiated the registrational phase three PURPOSE 365 trial, evaluating lenacapavir as HIV prevention with once-yearly injections. This is a single-arm PK and safety study, which, along with the unprecedented efficacy seen in the phase three PURPOSE 1 and 2 studies, is expected to support a regulatory filing with potential for approval in 2028.

Moving to treatment, we have seven ongoing clinical programs evaluating daily, weekly, monthly, quarterly, and twice-yearly regimens based on lenacapavir or one of its prodrugs. Beginning with our next-generation daily oral regimen, bictegravir/lenacapavir, we continue to expect an update from our phase 3 ARTISTRY studies later this year. ARTISTRY-1 and ARTISTRY-2 are evaluating the potential of Gilead's investigational complete regimen that combines bictegravir, the key integrase inhibitor in Biktarvy, and lenacapavir, our breakthrough capsid inhibitor. The regimen is a potential option for virologically suppressed people with HIV, including many people currently on complex regimens. Further, we have a suite of long-acting oral and injectable agents in development for a range of dosing frequencies, from once-weekly oral to twice-yearly injectables. Our strategy has been to set up our pipeline for multiple shots on goal and then choose the best option for each dosing frequency.

Notably, for our development of a twice-yearly treatment regimen combining a novel integrase inhibitor with lenacapavir, we took two INSTI agents to phase 1, GS-1219 and GS-3242. Aligned with the guidance we shared at our HIV analyst event last year, we have now chosen to prioritize the development of GS-3242 over GS-1219, and we expect to share more details on GS-3242 at a virology conference in 2026. On slide 16, I'm pleased to highlight that we have completed the BLA filing for Bulevertide in chronic hepatitis delta virus, or HDV. We're excited by the potential to bring Bulevertide to HDV patients in the U.S. with a potential regulatory decision in 2026. As a reminder, HDV affects approximately 2% of patients with HBV, or about 40,000 people in the U.S.

Patients with chronic untreated HDV infection can experience accelerated development of cirrhosis or severe scarring of the liver and have higher risk of liver cancer and potentially end-stage liver disease and failure. Beyond Bulevertide, we are also evaluating next-generation approaches to HDV treatment. Specifically, we have advanced GS-4321, a pre-S1 neutralizing antibody, into phase 1 clinical development. We believe GS-4321 has significant potential given its preclinical safety profile and long half-life with potentially quarterly subcutaneous dosing. Moving to Trodelvy on slide 17, earlier this month at the ESMO meeting, we presented detailed potentially practice-changing phase 3 ASCENT-03 data in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-L1 inhibitors. Specifically, Trodelvy demonstrated a 9.7-month median progression-free survival compared to 6.9 months for standard-of-care chemotherapy. This reflects a statistically significant and clinically meaningful 38% reduction in disease progression or death versus standard-of-care chemotherapy.

As we expected when we initiated the study, the median overall survival data are not yet mature. These results were simultaneously published in the New England Journal of Medicine. Additionally, the detailed results from ASCENT-04 were shared at the ESMO meeting in May. These data, combined with ASCENT-03, highlight the potential for Trodelvy to be a backbone treatment across first-line metastatic triple-negative breast cancer. Based on these positive phase 3 updates from ASCENT-03 and ASCENT-04, we have submitted two supplemental Biologics License Applications for Trodelvy in first-line metastatic TNBC and expect regulatory decisions in 2026. This is incredibly important for patients as metastatic TNBC is the most aggressive subtype of breast cancer with limited treatment options and poor prognosis.

Historically, progress in first-line therapy has been minimal, and nearly half of patients do not progress beyond first-line treatment, meaning they may never access Trodelvy if it remains a later-line option. Similarly, we are currently exploring Trodelvy for first-line post-endocrine hormone receptor-positive, HER2-negative metastatic breast cancer patients in the phase 3 ASCENT-07 trial. We now expect to provide an update from this trial before the end of the year. On slide 18, we are highlighting overall survival results shared at ESMO earlier this month from arm A1 of the phase 2 EDGE-Gastric study evaluating domvanelimab, our Fc-silent anti-TIGIT, plus zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic upper gastrointestinal cancers. In the 41 patients who received the novel regimen in this analysis, the median overall survival was 26.7 months. These findings were simultaneously published in Nature Medicine.

These data are in a small number of patients. Survival results for this patient population still need to be confirmed in our ongoing phase 3 STAR-221 trial evaluating domvanelimab plus zimberelimab and chemotherapy in patients with metastatic upper gastrointestinal cancers. We continue to expect an update from the event-driven STAR-221 trial in 2026. We also continue to develop domvanelimab plus zimberelimab and chemotherapy in first-line metastatic non-small cell lung cancer in the phase 3 STAR-121 trial. Moving to cell therapy on slide 19, and on behalf of Cindy and the Kite team, you can see that we have strengthened our in vivo capabilities. The in vivo cell therapies are potentially off-the-shelf products that could shorten the time it takes to treat patients and are also expected to have more simplified and cost-effective manufacturing processes.

Given these potential advantages over autologous CAR-T, we believe in vivo could unlock broad access to cell therapies. With that in mind, we have welcomed the Interius team into the Kite family, adding a novel in vivo platform and a strong IP portfolio. We have also entered into a new research and licensing collaboration with Pregene Biopharma. It's early days for in vivo, but we're excited to accelerate our exploration of the opportunities these technologies could bring to patients. As we step up our investment in in vivo therapies, we remain committed to our current Yescarta and Tecartus portfolios. For example, FDA recently granted priority review for Yescarta in primary CNS lymphoma with a PDUFA date in February 2026. Primary CNS lymphoma is a rare yet aggressive subtype of non-Hodgkin's lymphoma that affects the central nervous system.

Additionally, CD19 CAR-T products, including Yescarta, have recently received a category 2A recommendation from the NCCN for Richter's transformation. We are pleased with these review and guideline decisions, which will provide HCPs with additional opportunities to prescribe Yescarta. For our next-generation CAR-Ts, we look forward to sharing phase one data from Kite-753 and Kite-363 in lymphoma at an upcoming medical congress later this year, as well as pivotal phase two initiation of Kite-753 for third-line large B-cell lymphoma in the first quarter of 2026. In autoimmune diseases, Kite-363 is enrolling patients for its phase one trial in rheumatology, and a phase one study in neuroinflammatory conditions is expected to start in the first quarter of 2026. We look forward to providing updates from these earlier stage programs.

Together with our partner, Arcellx, we plan to share additional follow-up data from the pivotal iMMagine-1 trial of Anito-cel at an upcoming medical meeting. We continue to believe Anito-cel has the potential to offer a best-in-class efficacy and safety profile for patients with relapsed and/or refractory multiple myeloma. The target commercial launch in fourth-line plus relapsed and/or refractory multiple myeloma remains in 2026. On slide 20, I will quickly highlight the key milestone updates. First, we have received European Commission marketing authorization of Ye Tuo and remain on track to provide updates for our phase 3 ARTISTRY-1 and ARTISTRY-2 trials for bictegravir/lenacapavir and for our pivotal phase 2 iMMagine-1 trial for Anito-cel in the fourth quarter. Finally, we now also expect ASCENT-07 data in the fourth quarter. With that, I'll turn over the call to Andy. Thank you, Dietmar, and good afternoon, everyone. 

Starting on slide 22, our third-quarter results showed continued strong execution across the company. Our base business was up 4% year-over-year to $7.1 billion, driven by growth in Biktarvy, Descovy, and Livdelzi. Veklury sales were down 60% year-over-year to $277 million, which continued to reflect fewer COVID-related hospitalizations. Including Veklury sales, total product sales were $7.3 billion.

Moving to slide 23, you can see we benefited from a $400 million contribution in royalty, contract, and other revenues in the third quarter. This relates to an IP asset sale from 2018. Given we are now able to reasonably estimate future royalty and milestone payments, we are required to recognize this revenue in the third quarter. This is a non-recurring accounting item and does not reflect cash received during the quarter.

As a reminder, this contribution was not part of our product sales and therefore did not impact our product gross margin in the third quarter, but it does otherwise flow through to the bottom line, contributing approximately $0.25 after tax. Moving to our non-GAAP results on slide 24, third-quarter product gross margin was 86%, in line with 87% in the third quarter of 2024. R&D expenses of $1.3 billion were down 3% compared to the third quarter of 2024. Year-to-date, 2025 R&D expenses were $4.1 billion, in line with 2024, suggesting we are on track for our full-year goal. Acquired IP R&D expenses were $170 million in the third quarter, including a $120 million upfront payment to Pregene for a research and licensing collaboration in the in vivo cell therapy space.

SG&A expenses of $1.4 billion were down 4% compared to the third quarter of 2024, modestly lower than we expected due to the timing of spending. Third-quarter operating margin was 50%, reflecting the continued focus on operating expense discipline and leverage. The non-GAAP effective tax rate was 18% this quarter, slightly below our expectations due to a $79 million tax settlement. And finally, non-GAAP diluted EPS was $2.47 for the quarter. Excluding the $400 million non-recurring other revenue, non-GAAP diluted EPS would have been $2.22 for the third quarter. Moving to our full-year guidance on slide 25, we are raising the low end of our product sales range by $100 million to reflect our strong performance year-to-date. As a reminder, the $400 million included in our royalty, contracts, and other revenue in the third quarter does not impact our full-year guidance, as we do not guide the total revenue.

We now expect total product sales, excluding Veklury, to be between $27.4-$27.7 billion, primarily reflecting higher HIV growth. Driven by the outperformance of both Biktarvy and Descovy year-to-date, we now anticipate our HIV franchise will grow approximately 5% year-over-year versus our prior guidance of 3%. Consistent with last quarter, I'll note that our assumptions for the impact of the Medicare Part D redesign remain unchanged from the beginning of the year, and we continue to expect approximately $900 million of impact to our HIV business in 2025. Our 2025 assumptions for Sunlenca also remain unchanged, and we remain very encouraged by the launch so far, particularly the accelerated timeline for payer coverage. In other parts of our business, strength in HIV is expected to be partially offset by weaker cell therapy estimates, where we now forecast approximately a 10% decline for full-year 2025 versus full-year 2024.

For Veklury, we continue to expect full-year revenue of approximately $1 billion. As a result, total product sales are anticipated to be in the range of $28.4-$28.7 billion. As noted earlier, this reflects a $100 million increase at the low end of the range from our previous guidance. Finally, we continue to expect the impact of known tariffs to be manageable in 2025. Moving to the rest of the P&L, there is no change to our prior non-GAAP guidance for product gross margin, R&D, and SG&A expenses. We continue to expect product gross margin of approximately 86%, R&D expenses to be roughly flat on a dollar basis from 2024, and SG&A expenses to decline by a mid- to high-single-digit percentage compared to 2024. Similar to last year, we expect a step up in both R&D and SG&A expenses in the fourth quarter, reflecting normal end-of-year trends.

We have updated our IP R&D expectations for the full year to reflect our actual through the third quarter and our known fourth-quarter commitments, including $300 million relating to the Interius acquisition. We now expect full-year acquired IP R&D to be $900 million. Rounding out the P&L, we expect operating income to be between $13.1 billion and $13.4 billion, reflecting an increase of $100 million at the low end of the prior guidance range. We continue to expect our effective tax rate to be approximately 19%. And finally, we expect non-GAAP EPS in the range of $8.05-$8.25, raising non-GAAP EPS by 10 cents at the low end of the range. GAAP EPS is expected to be in the range of $6.65-$6.85.

On slide 26, our capital priorities remain unchanged, and we returned $1.4 billion to shareholders in the third quarter, which included $435 million of share repurchases. These repurchases are intended to offset equity dilution at a minimum but can also be used opportunistically, as you've seen in the first three quarters of 2025. Overall, we are pleased with the strong performance this quarter, highlighted by our clinical and commercial execution and supported by our disciplined operating model. We continue to be well-positioned for near-term and long-term growth, and we remain focused on delivering on our strategic commitments. With that, I'll invite Rebecca to begin the Q&A.

Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call. Again, to ask a question, press star one, and to withdraw your question, press star two. First question comes from Geoff Meacham at Citi. Jeff, go ahead. Your line is open.

Oh, great. Okay. Hey, guys. Thanks so much for the question. Congrats on the quarter. On Yes To Go, I know it's early. I wanted to see if you had any color on patients switching from Descovy versus those who are brand new to PrEP. And then related, but just looking to the balance of the year, are there any demand drivers that could give you some momentum going into 2026? Thank you.

Thanks, Jeff, and welcome. I'll hand it right over to Johanna.

Great. Thanks, Jeff. Yeah, so we're really excited about the launch so far and really much in line with our expectations of an injectable into an oral market.  To your point about where the Yes To Go sourcing is coming from, it's really across the board, so it's more switches, as you'd expect, in this marketplace versus naive.

But really, across the switches, what we're really pleased to see is that we're getting the source of business is actually coming from the long-acting injectable currently on the market, also the oral branded, such as Descovy, but also oral generics, and so you're seeing a real nice balance mix across the board for switches, and we expect that to continue, and of course, as the market grows and continues to grow and the awareness of Yes To Go increases, we also believe that the naive patient population will also grow with time as well.

Our next question comes from Umer Raffat. Umer, go ahead. Your line is open.

Thank you, guys. Quick question. I noticed a $39 million sales number in 3Q, and I'm trying to make sense of it. By my rough math, it sounds like about 3,000 patients initiated in 3Q. Is that consistent with how you see it? And I ask because IMS was implying something like 2,300 patients, so I'm just trying to get a sense of it all. Thank you.

Thanks, Umer, for the question. Maybe I'll give a little bit more context to Yes To Go in light of your question, and not that we've been sharing patients per se, but we do have year-to-date as of the Q3 quarter, about $54 million in sales. Some of that was in early June, in late June for inventory purposes, about $15 million of that, and we've really seen that inventory flow through, so there's really no more stocking left in the system.

We've been tracking a lot of different indicators to make sure that our launch is on the right track. And so we're really excited because we see the access piece as one of the most important indicators for the future. And meeting the 75% coverage for access almost three months ahead of schedule with very limited prior auths and basically zero copays, it really sets us up nicely, actually, as you think about 2026 and beyond. The UnitedHealthcare, ESI, many other commercial plans are on board. We have about 20 out of the 25 large PrEP states for Medicaid. That represents just over 80% of the PrEP Medicaid volume, so that's really been our focus. And of course, the J-code coming on as of October 1st, all of this would support buy and bill modeling as well.

And so these access wins are recent, and obviously, it's going to take a little bit of time account by account to pull it through and integrate it within the practices, but I think it really provides that platform for us to accelerate the uptake for Yes To Go. We've also seen conversion rates basically from script to approval really drop dramatically, and so we continue to focus on the logistics to make sure we get the drug and the patient schedules aligned shortly after the reimbursement approval.

And so I would say from an overall standpoint, super pleased about what we track are the intakes, the access, HCP awareness and interest, the conversion rates that I just referred to, and everything is going in the right direction. So we do expect full-year Yes To Go sales of around $150 million or so, including the $54 million year-to-date. So hopefully, that gives you a bit of perspective, and then as you get the full year, you can have a better understanding of patient numbers.

Our next question comes from Mohit Bansal. Mohit, go ahead. Your line is open. 

Great. Thank you very much for taking my question and congrats on all the progress. Switching a little bit to HIV treatment, now that you are guiding for 5% year-over-year growth, combine that with the $900 million of R&D redesign impact you are taking, it does seem like HIV is growing at, what, 9%-10%. I mean, can you talk a little bit about that? How should we think about it going forward, given that you have had such an impressive growth this year?

Thanks, Mohit, for that. I do agree with you. I think we've had such an impressive growth, and it's really driven by a couple of things. It's driven by the market, both in treatment and in PrEP, and real demand-driven growth, specifically Biktarvy and Descovy, are really the ones that are impacting this year's growth, so as you think about Biktarvy growing year-on-year about 6%, and as to your point, it's despite Part D redesign, and those assumptions have not changed, and Biktarvy growing at 6 points, but also Descovy growing at about 20%, and if you think about just for PrEP, if you think about the three-quarters of that product being driven by prevention, you're looking at almost over 30% growth for Descovy, let alone if you think about HIV prevention at Gilead, it's over 40%.

So both HIV treatment and HIV prevention are really driving the growth, and you could assume that actually if Part D redesign hadn't played out, we would probably be around the numbers you were talking about, 8%-9%.

Our next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead. Your line is open.

Good afternoon. Thanks for taking my question. Could you just comment on the inventory impact for Yes To Go in the third quarter and also how the CVS pricing discussions are progressing? Thank you.

Sure. Salveen, it's Johanna again. A couple of things. One is in the Q3, there's really no inventory buy-in. It really happened in the first two weeks, the last two weeks of June, sorry, the first two weeks of our launch. And that really got pulled through in the first months of Q3. And then what you're seeing in the 39 is really true demand coming through. So that's the inventory piece of the puzzle.

From a CVS access standpoint, payers all have different timelines as to how they make formulary decisions, and we're working with every single one of the payers to make sure we go as quickly as possible to secure access while also ensuring that the innovative value of Yes To Go gets recognized. And so our discussions with the remaining 25% of payers, including CVS, are ongoing, and we're very confident about our ability to reach the goals that we've set forth, which is the 90% at the first year of launch. So we're very confident that we're on track to reach those numbers.

Our next question comes from Evan Seigerman at BMO Capital Markets. Evan, go ahead. Your line is open.

Hi, all. Thank you so much for taking my question. Livdelzi continues to perform exceptionally well and appears to be succeeding as a clear strategic fit to your business. Can you just talk to me about the level of appetite for additional BD and liver-focused indications such as MASH?

Sure.Hi, Evan. Thanks for the question. Look, I mean, as we've said, we don't comment specifically on any subsectors. We are looking actively at opportunities across the BD spectrum in all of our areas of strategic interest. That includes liver disease as well as oncology, cell therapy broadly, virology, and immunology. And we've said consistently and continue to believe that we would like to add more therapies just like Livdelzi that are best-in-class therapies that serve patients in need on a regular basis.

And we would look for those late-stage de-risked assets every two to three years at a minimum to kind of add them to our portfolio. So when you step back, I think we are really pleased with the size and shape of our portfolio, all of the growth drivers that we have, the additional launches that you heard Dietmar talk about in his prepared remarks, and we would like to add additional growth drivers. And of course, we'll be disciplined in doing that. But yes, you should expect that we're going to be looking at deals across all of our sectors, including liver disease.

Our next question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open.

Great. Thanks so much. Can I just dig into Yes To Go in 4Q and heading into 26 in a little bit more detail?I mean, it seems like you're pointing to a step up in sales next quarter, but we're getting obviously a lot of coverage. I'm just trying to understand a little bit more about how you're envisioning the shape of the curve. Is this kind of like a gradual acceleration or a bigger step function as we move into 2026? I'm just trying to get, again, a little bit more color on that dynamic. Thanks so much.

So Chris, it's Johanna. I think that's a fair question. I think what we're seeing is a lot of the access to get us to the 75% goal most recently really happened in the last couple of weeks. And so it's important to understand that those don't turn on just overnight. And so practices need to actually integrate these changes into their working practices.

And so we're working with them to make sure that happens. Same thing goes for the J-code. Some people will update right away. Some people update biannually. And so January 1st could be kind of, for some, that update to really help the buy and bill folks that are interested in buy and bill. And so we do believe it's going to be a gradual ramp-up, and then for us, it really sets up the platform for the ramp for Yes To Go in 2026. And so that's what we're kind of focusing on.

Our next question comes from James Shin at Deutsche Bank. James, go ahead. Your line is open.

Hi. Thank you for the question. Johanna, could you just give us an update on Yes To Go's buy and bill and white bagging mix? And does reaching this 75% ahead of schedule equate to reaching a bigger portion of white bagging sooner? Thank you.

Sure. So the white bagging and the buy and bill, you'd expect, and if you remember, at our HIV Day in 2024, we did kind of share that it would be heavier to the white bagging, and buy and bill would build over time. And that's exactly what we're seeing.

So much more in this coming through, the scripts are going to specialty pharmacy, going through that process, and then white bagging back to the clinic, probably more towards about three-quarter range in the 70%-80%, and then the rest of that is buy and bill. That's not steady state, obviously, and that's going to change over time as people get more comfortable and as they integrate the J-code as well into their practice. So all of those things will evolve, but for right now, that's what we're seeing.

Our next question comes from Daina Graybosch at Leerink Partners. Daina, go ahead. Your line is.

Thank you. Another one on Yes To Go. I mean, you've said several times that in the 75% covered lives, you've been pleased by the level of restriction. I wonder if you could give us a little more detail to how much of the lives have prior auths or copay or any other restrictions like to certain types of practices, for instance.

So what we're seeing thus far, and it's still early, right, because we're trying to see how this all plays out, but most of the plans so far have added Yes To Go to their formulary with zero copays. So high 80s if you're looking for a number, and very few step edits and prior auths.

And if they are, they're very simple. And so we do think it's really important. It's one thing to have access. The quality of the access is also very important for us, and to make sure that the people who may want or need PrEP can have access to it. And that's very much in line. I mean, those goals were set because of Descovy, and Descovy, as of September, access is at about 99% of lives covered with about 88% no restrictions. And so that gives you a little bit of a flavor of kind of the direction of where Yes To Go is going. Not there yet, but definitely well on its way.

Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open.

Hi there. Thanks so much for taking my question. Maybe just another one on Yes To Go. Johanna, can you maybe talk a bigger picture about what the patient journey is like here for getting an appointment with a physician, obtaining and getting Yes To Go administered, maybe how that's comparing to your expectations, how that could evolve, and really just wondering what are the biggest barriers for a patient wanting to switch to do so? Thank you.

\Yeah. Sure, Brian. Happy to do so. And they're changing, right? So I'm going to share with you kind of where we're at, but it's been an evolution even from July on. We're seeing a big difference in the time it takes from prescription. So as a physician writes a prescription for someone for Yes To Go, and the prescription goes to a specialty pharmacy, for example, and goes through the process, I mean, the approval process used to take over a month, and so it could take four or five, six weeks.

Now it's more than half down from that timeframe because the access is starting to play in. But then you also have the piece that you just said, which is then how do you make sure that the logistics play out where you get the approval and make sure that the drug gets to the office at the same time as the patient gets back into the office as well? And so that obviously can take a week or two, sometimes more, depending on the patient's availability and the doctor's availability, of course. And so that's kind of what we're playing out. So that is definitely something that was part of our assumptions, but those conversion rates, both from prescription to approval, but approval to office to injection, because that's really when it gets shipped is when it gets captured by IQVIA, for example.

That's really what we've been tracking to make sure we minimize that time and support the offices in the logistics of doing so. So we're seeing benefits every single month and seeing those numbers come down. And obviously, as people get more in tune with the practice, it's going to get easier. On the flip side, I would say buy and bill is obviously it cuts out one piece of that because then it's directly within the doctor's office. They get approval, they get product, and then they can kind of start as buy and bill builds, you're going to see a little bit faster turnaround there as well. Hopefully, that helps give you a little bit of a picture of the patient's journey.

Our next question comes from Carter Gould at Cantor Fitzgerald. Carter, go ahead. Your line is open.

Great. Thank you. Good afternoon. Thanks for taking the question. I hope you'll indulge me on a relatively short-term-minded question here on Yes To Go, but we've seen pretty volatile scripts over here the past couple of weeks, and I guess my question is, are the TRX that we're seeing reflective of what you're seeing? Is that impacted by third-party prep campaigns or more standard demand growth or early impacts from the J code? Any color would be appreciated.

Sure, Carter. There's a lot of week-to-week variability with IQVIA versus what we're seeing. Obviously, we track as well, and it really depends on the report that you're looking at within IQVIA as well. I think it's going to take a couple of quarters for this to stabilize a little bit. I think it's a good directional indicator.

And depending on the report, just make sure you're looking at both the SP intakes, but also the buy and bill and kind of merging those two pieces together. Those two pieces together, although sometimes accounts are missing, directionally are in line with the overall of what we're seeing. But the volatility with IQVIA is definitely real right now, and I think it's going to take a little while to settle. We've seen that before with other products as well.

Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open.

Hi. Thanks for taking the questions. Congrats on the quarter. Johanna, just wondering if you can comment at all high level about how we should think about overall prep market growth. Obviously, it's been very strong the last couple of quarters, 14%. This quarter, 15%. Last quarter, is that kind of the level we should think about at a franchise for you guys as we head into 2026? Thank you.

Sure, Terence. I think that's the right way to think about it. I think 14%-15% is the right approach for this market growth. This is obviously fueled by many of us to make sure that there's increased awareness of the options within prep. And I think that'll continue to be fueled as the noise kind of increases as we go into 2026, whether it's through social media or direct-to-consumer advertising. And so I would assume about a 14%-15% growth continuing with prep.

Our next question comes from Tyler Van Buren at TD Cowen. Tyler, go ahead. Your line is open.

Hey, guys. Thanks. Congratulations on the good quarterly results. For Anito-cel, could the filing happen any day or in the very near future? What is left that's required for the filing? And we're excited for the data at ASH. Should the expectation be similar efficacy to Carvykti with improved safety, or do you believe there's still room to improve on efficacy?

Tyler, we'll hand it over to Cindy to give Johanna a break.

Thanks, Tyler. With Anito-cel, we haven't communicated what our filing dates are, nor will we, but what we have communicated is that we're very much looking forward to a launch second half of next year, and we're definitely on track for that. As Dan spoke to and Dietmar earlier, we will be sharing a data cut of Anito-cel at ASH, and I would say we're looking forward to sharing that data with everyone. And you were asking particularly about similar efficacy and improved safety. We continue to see we're continuing to be impressed with the safety we're seeing, similar to what we shared at EHA, and we look forward to sharing that data cut at Ash.

Our next question comes from Simon Baker at Rothschild & Co. Simon, go ahead. Your line is open.

Thanks for taking the question. And sorry, back to Johanna after that very short break. Back on Yes To Go, I just wonder if you could give us some of your feedback on the patient and physician experience and reaction to Yes To Go. Obviously, your competitor has been suggesting a preference for their product over yours, but I'd be intrigued to hear what you're actually experiencing on the ground. Thanks so much.

Absolutely. Happy to do so. Yeah. So listen, as we look at, I think you're referring to any ISRs or any injection site reactions, which is kind of normal when you have an injectable, and so that is common with any injection. Having said that, we've done a really nice job, I think, making sure that we educated not only the HCPs, but obviously everybody in their practice to make sure that they know how to give the injection, they know how to pre and post-treat, basically just a short-term ice helps the whole situation.

And so we've had over 7,000 HCPs that have been trained over 1,500 accounts to date with 98% satisfaction rate with their training. And so this is led by our nurse educator team, basically across the board, across the country, making sure we get to every single clinic. And I think that's been incredibly helpful for those that want to use Yes To Go. We really believe that just with a little bit of information, it can go a long way to make sure that patient and HCP experience is very smooth.

Our next question comes from Courtney Breen at Bernstein. Courtney, go ahead. Your line is open.

Fantastic. Thank you so much for taking the time for a question today. I wanted to, I guess, zoom out a little bit to the white bagging deals and direct pricing, but particularly in the context of your HIV portfolio and higher Medicaid exposure. Obviously, this year, you've dealt with the Part D redesign and have grown through that. As you're looking at potential flexibility and any sort of deal with this administration on direct pricing, can you give any context to kind of the scale that you're preparing for or your actions or flexibility that you're looking to garner in a deal that might ensure that that impact is less than what you're experiencing with the Part D redesign this year?

Gilead Sciences (GILD) Q3 2025 Earnings Call Transcript

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