Gilead Sciences, Inc (NASDAQ: GILD) Q4 2025 Earnings Call dated Feb. 10, 2026
Corporate Participants:
Jacquie Ross — Senior Vice President of Treasury and Investor Relations
Daniel O’Day — Chairman and Chief Executive Officer
Johanna Mercier — Chief Commercial & Corporate Affairs Officer
Dietmar Berger — Chief Medical Officer
Andrew Dickinson — Chief Financial Officer
Cindy Perettie — Executive Vice President, Kite
Analysts:
Chris Schott — Analyst
Louise Alesandra Chen — Analyst
Tazeen Ahmad — Analyst
Michael Yee — Analyst
Brian Abrams — Analyst
Umer Raffat — Analyst
Geoff Meacham — Analyst
Daina Graybosch — Analyst
Tyler Van Buren — Analyst
Courtney Breen — Analyst
Presentation:
operator
Good afternoon everyone and welcome to Gilead’s fourth quarter and full year 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 and A session. To ask a question, please press star 1. To withdraw your question, press star 2. Now I’ll hand the call over to Jackie Ross, Senior Vice President of Treasury and Investor Relations.
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 fourth quarter and full year 2025. The press release slides and supplementary data are available on the Investors section of our website@gilead.com the speakers on today’s call will be our Chairman and Chief Executive Officer Daniel o’, Day, our Chief Commercial and Corporate Affairs Officer Joanna Mercier, our Chief Medical Officer Dimar Berger, and our Chief Financial Officer Andrew Dickinson.
After that, we’ll open the call to Q and A where the team will be joined by Cindy Peretti, the Executive Vice President of kite. Let me remind you that we will be making forward looking statements. Please Refer to slide 2 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.
Daniel O’Day — Chairman and Chief Executive Officer
Thank you, Jackie and good afternoon everyone. I’m pleased to share another very strong set of results for Gilead, closing out a remarkable year for the company with clinical, commercial and operational achievements that set the stage for a very promising 2026. Starting with our full year results, our HIV business grew 6% year over year driven by 7% growth in Biktarvy and 47% growth in our HIV prevention portfolio. This was despite an estimated $900 million headwind in 2025 associated with the Part D redesign. Absent this headwind, our HIV business growth was 10% in 2025. Yes to go.
Our twice yearly HIV prevention injectable has already exceeded our coverage goals and is rapidly gaining market share. In addition to expanding the reach of HIV prevention to new users with its unique potential to bend the curve of the HIV epidemic, Yes2Go is a transformative medicine that we expect to drive durable, steady and long term growth in our HIV prevention business in the coming quarters and years. Our liver business grew 6% in 2025 compared to 2024, largely driven by the rapid adoption of Levdelzi for primary biliary cholangitis and in oncology. Trondelvy also grew 6% in 2025 driven by momentum in metastatic triple negative breast cancer following positive phase three updates and cell therapy was down about 7% year over year, largely in line with our expectations and reflecting continuing competitive headwinds.
Moving to clinical progress following a very productive year in 2025, we have a catalyst rich year ahead including Phase 3 updates from Illin 1 and 2 trials evaluating aslatrevir plus lanacapavir, the potential first once weekly oral treatment for people with virologically suppressed HIV. Two Phase 3 updates for Tridelvi including the Evoke trial and metastatic non small cell lung cancer and the ASCENT GYN01 trial in advanced endometrial cancer. Lastly, we expect an Update on the Phase 3 IDEAL study evaluating Libdelzi in second line primary biliary cholangitis patients with only incomplete response to udca. The strength and the pace of progress in our clinical pipeline is driving a steady cadence of product launches and on the heels of Libdelze in 2024 and yes to go in 2025, we are targeting four commercial launches this year including Tridelvi for first line metastatic triple negative breast cancer extending beyond second line treatment for which Trdelvy is a standard of care.
Following positive results from the Phase 3 Ascent O3 and Ascent O4 studies, a new daily oral combination of Bictegravir and Lenacaprevir for HIV treatment following positive Updates from the Phase 3 Artistry 1 and Artistry 2 trials Annidocel or potential best in disease BCMA Car T for 4th line or later relapsed or refractory multiple Myeloma and Bilabirtide in the US following approval in the EU for treatment of chronic Hepatitis Delta. These commercial and clinical milestones reflect the success of our diversification strategy that has been shaping Gilead over the last six years. We have up to 10 ongoing and potential new launches through 2027 and the strongest pipeline in our almost 40 year history.
the same time, we remain committed to operating expense and MA discipline, continued delivery of exceptional operating results and growing returns to shareholders. With many of the policy related uncertainties behind us and no major product loes until 2036, Gilead is entering 2026 in a position of strength. With that I will hand it over to Joanna.
Johanna Mercier — Chief Commercial & Corporate Affairs Officer
Thanks Dan and Good afternoon everyone. 2025 was another strong year of commercial execution with base business sales up 4% compared to 2024 or nearly 8% excluding impact from Medicare Part D redesign. This underscores the durability of our base business and our sustained launch momentum with up to 10 ongoing and potential through 2027 beginning on slide 7, fourth quarter total product sales excluding vecalry were $7.7 billion up 7% year over year and 9% sequentially, primarily driven by higher sales across HIV and Levdel C including vecalry sales of $212 million. Fourth quarter total product sales were 7.9 billion, up 5% year over year and 8% sequentially.
Turning to the full year on Slide 8, total product sales excluding Viclory were $28 billion in 2025, more than $300 million above the high end of our full year guidance range driven by outperformance in our HIV business and partially offset by lower cell therapy sales including Vecleri. Total product sales were $28.9 billion up 1% compared to 2024 or 5% excluding Medicare Part D redesign impact highlighting the strength of our overall business moving to Slide 9, our HIV business delivered record sales of $5.8 billion for the fourth quarter, up 6% year over year driven by higher demand for Biktarvy and Descovy as well as the launch of yes to go sequentially.
Hiv sales were up 10% primarily driven by seasonal inventory dynamics and higher average realized price due to favorable channel mix in addition to demand for the full year. HIV sales of $20.8 billion were up 6% year over year driven by strong underlying demand growth. Our exceptional commercial performance and higher than expected average realized price exceeded our updated guidance of 5% growth. Excluding the estimated $900 million headwind associated with the Medicare Part D redesign, our HIV business grew 10% year over year. Looking at HIV treatment in more detail on slide 10, Biktarvy fourth quarter sales were $4 billion up 5% year over year and full year sales were $14.3 billion up 7% year over year, both driven by higher demand partially offset by lower average realized price.
This demand led growth reflects 2 to 3% treatment market growth annually and continued Biktarvy share gains. In the US for example, Biktarvy’s share is more than 52% with year over year gains every quarter since launch. It’s clear biktarvy continues to set the bar for HIV treatment and remains the number one prescribed regimen for both treatment naive and switch across major markets. We are rapidly advancing towards the launch of bicled, our investigational once daily oral combining bictecrevir, the most prescribed integrase inhibitor with our breakthrough capsid inhibitor Lenacapavir in virologically suppressed people with HIV including those on complex regimens.
Biclen could further expand our lead in the switch market following potential launch in the second half of this year. This regimen represents the first of up to seven potential HIV product launches through 2033. Now moving to slide 11, we’ve had another exceptional quarter for our HIV prevention business which grew 53% year over year, driven by favorable access, strong commercial execution and continued US market growth of approximately 13% year over year. Our fourth quarter sales of Descovy were up an impressive 33% year over year. For the full year, Descovy sales were $2.8 billion, up 31% year over year, driven by increased demand in HIV prevention and higher average realized price.
Descovy’s performance in HIV prevention, which accounts for roughly 80% of its sales, continues to exceed expectations with record US market share greater than 45%. Similarly, Yes2Go continues to perform strongly across several key launch indicators. Yes2Go fourth quarter sales were $96 million and full year Yes2Go sales were $150 million. In line with our guidance we shared in the third quarter. Building upon this early success, we recently launched our Yastugo Branded Direct to consumer campaign highlighting Yes2Go’s dosing schedule and efficacy and reflecting the broad diversity represented in our purpose trials. We expect this DTC campaign to broaden awareness of yes to Go and contribute to a consistent build in yes to Go sales in the coming quarters.
Coverage for yes to Go continues to grow and I’m thrilled to share that we have achieved our goal of 90% coverage on well ahead of our one year target. This includes all major payers. Additionally, approximately 90% of covered individuals can access Yes2Go with $0 copay. We continue to work on an account by account basis to support pull through as quickly as possible. While we have more to do, we are making great progress here as we support clinicians and their offices navigate the new logistics associated with a twice yearly injectable regimen. Given our expectations for a steady, durable and long term build in sales, we expect full year 2026 yes to go revenue of approximately $800 million compared to 150 million in 2025, highlighting that yes2go is well on its way to achieving blockbuster status.
We continue to offer the most compelling HIV prevention portfolio available including the six monthly Yes2Go injectable with its transformative potential on the HIV epidemic. In addition to Descovy for Prep, the current market leading branded oral Our goal this year is to continue to drive rapid adoption of HIV prevention and we expect both brands to demonstrate robust growth in 2026 for 2026, we expect total HIV sales, including both treatment and prevention, to grow approximately 6% compared to 2025, as shown on slide 12. Looking at quarterly trends and as a reminder, we expect our normal HIV seasonal inventory drawdown in the first quarter of 2026.
As announced in December, there are manageable headwinds associated with the drug pricing agreement with the US Government to lower Medicaid pricing for some of our products, including genvoya and odefc. Additionally, our guidance reflects some potential shifts into lower priced channels associated with proposed changes to the Affordable Care Act. In total, these headwinds are expected to impact HIV growth by about 2% in 2026 compared to 2025. Absent these headwinds, our HIV business is expected to grow 8% in 2026, highlighting the underlying strength of our HIV business. Turning to liver Disease on slide 13, full year sales of $3.2 billion were up 6% year over year, primarily driven by higher demand and partially offset by lower average realized price.
In the fourth quarter liver sales were $844 million, up 17% year over year and 3% sequentially driven by another quarter of continued strength for Luvdelzi. In primary biliary cholangitis or PBC, Luvdelzi grew a remarkable 42% sequentially to $150 million driven by strong patient demand, further accelerated by the withdrawal of a competitor product in the US with much of this switching activity now behind us, we are pleased to start 2026 as the US market share leader with more than 50% in second line PBC moving to Jadelvi on slide 14. Full year 2025 sales increased 6% to $1.4 billion primarily driven by higher demand in metastatic breast cancer treatment which more than offset the expected impact from the bladder cancer withdrawal in the US at the end of 2024.
In the fourth quarter TruDelvi sales were $384 million, up 8% both year over year and sequentially driven by higher demand. Building on Tredelvi’s strong 2025 performance, we shared back to back positive phase three, Ascento 3 and Ascento 4 readouts. These results contribute to the strong body of evidence for Trudelvi across lines of therapy and metastatic triple breast cancer and continue to drive demand growth. In both these studies, the investigational Trudelvi regimens demonstrated a highly statistically significant and clinically meaningful progression free survival benefit over the standard of care. These potentially practice changing data have now been published in the New England Journal of Medicine and have been recognized by the NCCN in their updated breast cancer guidelines.
Trudelvi is now the only antibody drug conjugate to be recommended by the NCCN for first line PD L1 positive and PD L1 negative as well as second line metastatic triple negative breast cancer as the leading regimen in second line. Trudelvi is already well established with oncologists and these updates build momentum for Trudelvi ahead of potential first line launches expected later this year. Moving to cell therapy on slide 15 and on behalf of Cindy and the Kite team, full year cell Therapy sales were $1.8 billion, down 7% year over year, reflecting ongoing in and out of class competition.
For the fourth quarter, cell therapy sales were $458 million, up 6% sequentially due to higher than expected patient treatments in advance of holidays. In addition to one time pricing adjustments year over year, fourth quarter cell therapy sales were down 6%, consistent with the trends we have discussed throughout 2025. For 2026 we continue to expect these competitive headwinds, including in several countries outside the US where we expect new entrants this year. Additionally, cell therapy volumes are being impacted by a growing number of clinical trials, which is exciting for our industry and for the patients who could benefit from innovative new therapies from K.
That said, this represents another near term headwind. Overall, we expect Kite revenue to decline approximately 10% in 2026 compared to 2025. Looking to the second half of the year, the team is preparing for the potential launch of AnnidoCell in 4th line and later relapsed or refractory multiple myeloma. We believe Inidocell’s potential best in disease profile combined with Kite’s exceptional manufacturing capabilities and industry leading turnaround times puts us in a favorable position ahead of a potential commercial launch. Wrapping up our fourth quarter and 2025 on slide 16, I’d like to highlight the exceptional strength of our existing commercial portfolio as well as our robust launch pipeline.
With the potential for four launches later this year, we are committed to remaining focused on our ongoing launches of Livdelzi and Yastugo. In addition to ensuring that we are prepared to have an immediate impact with the potential launches of AnnidoCell in multiple myeloma, TruDelvi in first line metastatic triple negative breast cancer, Biclen in HIV treatment and bilivertide in chronic Hepatitis D. The addition of these potentially transformative therapies to our portfolio is incredibly energizing for our teams. We look forward to extending the reach of Gilead therapies to many more patients who can benefit from them in 2026.
And with that, I’ll hand the call over to Dietmar.
Dietmar Berger — Chief Medical Officer
Thank you Joanna and good afternoon everyone. I’d like to start by reflecting on 2025 and thanking the research and development teams and partners for an exceptional year of clinical execution. As shown in our 2025 milestones on slide 18, we received regulatory approvals for lenacapavir, our first in class capsid in for HIV prevention in the US, EU and 12 other countries. Additionally, we provided updates on seven phase three or pivotal phase two trials including positive updates for bictegravir plus lanacapavir, Chudelvi and Adidocell. Looking ahead to 2026 and beyond, we are well positioned to progress our clinical programs across our three core therapeutic areas, starting with HIV on Slide 19, we continue to advance a comprehensive pipeline with Lana Capivir as the backbone.
Our HIV pipeline could support up to seven additional daily, weekly, monthly, twice yearly or yearly HIV product launches by the end of 2033. In the fourth quarter, we announced positive top line results from Artistry 1 and 2 evaluating once daily bictegravir, the most prescribed integrase inhibitor, with lenacapavir, our breakthrough capsid inhibitor. We expect to share detailed results from our positive phase three trials at the CROI meeting in February with a potential FDA decision by the end of the year. Looking at our long acting programs, we plan to share phase three updates from our Island 1 and Island 2 trials evaluating is Latrivir plus Lanacapavir in the first half of 2020 and for our twice yearly treatment program, we plan to initiate our phase 3 trial evaluating lenacapavir plus broadly neutralizing antibodies in the second half of the year.
Further, we have now completed our evaluation of the phase one data for our long acting insti candidates GS3242 and GS1219 as well as GS1614 and is Latrevir prodrug. Consistent with the timeline shared during our HIV Analyst event in December 2024, we have identified GS 3242 as the most promising program with Lena Capavir and prioritized its development as a potential twice yearly HIV treatment. As a result, and as a reminder, we have discontinued the development of a twice yearly regimen with GS1219 and a quarterly regimen with GS1614. Turning to liver disease on slide 20, we remain committed to further evaluating Livdelzi to potentially improve the standard of care for more patients with PBC.
the LIVR meeting in November, we presented late breaking real world data showing that Lifdelzi is an effective and well tolerated alternative for PBC patients. Switching from obeticholic acid. Later this year we expect to provide an Update from our Phase 3 IDEAL study evaluating Luftelzi in PBC patients with ALP levels between 1 and 1.67 times the upper limit of normal patients typically excluded from phase 3 studies. If positive, these data could support the expansion of Luvdelzy to incomplete responders to UDCA and potentially enable even more second line PBC patients to achieve better biochemical and symptomatic control of their PBC.
Moving to oncology on slide 21 Trudelvi has demonstrated clinically meaningful survival benefit in two phase three trials establishing it as a leading regimen in its approved indications. Most recently, Trudelvi has demonstrated highly statistically significant and clinically meaningful progression free survival benefits across first line metastatic triple negative breast cancer patients. Full Data from the Phase 3 ASCENT O3 and ASCENT 04 trials were published in the New England Journal of Medicine in October 2025 and January 2026. We expect FDA decisions for TruDelvi in first line metastatic TNBC patients who are not candidates for PD1 inhibitors and for TruDelvi plus pembrolizumab in first line PD L1 positive metastatic TNBC in the second half of 2026 ahead of the FDA decisions.
The NCCN updated their breast cancer guidelines to reflect the practice changing nature of these results reinforcing our confidence in Trudelvi’s clinical profile. We also have four phase three studies that continue to evaluate Trudelvi’s potential in additional tumor types. Notably, we Expect updates from two of the phase 3 trials this year, including ASCENT GYNO evaluating TruDelvi in second line metastatic endometrial cancer in the second half of this year as well as Evoke 03 exploring TruDelvi plus Pembro in first line metastatic PD L1 high non small cell lung cancer Moving to cell therapy on slide 22 and on behalf of Cindy and the Kite team, I will touch upon some of our updates on our annidocell program.
Notably, we have filed a needle cell based on our Update from the Phase 2 Imagine one trial in fourth line or later relapsed or refractory multiple myeloma at ASH in December. A needle cell demonstrated clinically meaningful efficacy with 96% overall response including 74% complete response and 95% measurable residual disease negativity. Additionally, Adneedocell demonstrated a predictable and manageable safety profile with no delayed or non icans neurotoxicities and no immune effector cell associated enterocolitis. Based on these exciting data, we are energized to potentially bring AdidoCell to patients in the second half of this year. Longer term, we see additional opportunity for oneidocell with our phase 3 imagine 3 study in 2nd, 3rd and 4th line relapsed or refract refractory multiple myeloma enrolling in record time.
We are also planning a pivotal program in newly diagnosed multiple myeloma. With our broader and rapidly advancing clinical development program, we expect AnnidoCell to potentially reach more patients earlier in the treatment paradigm. Wrapping up on slide 23 our key milestones for 2026 include five phase three readout as well as five FDA decisions for Bulebrotide for chronic hepatitis Delta, Big Len for virologically suppressed people with HIV, Trudelvi in first line PD L1 positive and negative metastatic triple negative breast cancer and a needle cell in fourth line and later relapsed or refractory multiple myeloma. While these pipeline milestones reflect some of our later stage catalysts, I would like to remind you we have 53 ongoing clinical programs and will continue our progress across our portfolio including kite753, our next generation CD19 CD20 bicistronic car T enrolling for its pivotal trial for third line large B cell lymphoma GS1427, a once daily oral alpha 4 beta 7 inhibitor for inflammatory bowel disease and it is a sirtib, our Irek 4 inhibitor for cutaneous lupus erythematosus.
And with that I’ll turn over the call to Andy.
Andrew Dickinson — Chief Financial Officer
Thank you Dietmar and good afternoon everyone. Starting on slide 25 full year 2025 total product sales of $28.9 billion were up 1% from 2024 and above our 28.4 billion to 28.7 billion guidance range driven by demand led HIV sales growth that more than offset the $1.1 billion headwind related to Part D redesign and 900 million lower VEC Luri revenue. Excluding the Part D redesign impact, our total product sales grew nearly 5%. Base business revenue, which reflects total product sales excluding Veclory was $28 billion, up nearly $1.2 billion or 4% from 2024 exceeding our 27.4 billion to 27.7 billion guidance range.
Excluding the impact of the Part D redesign, our base business grew 8%. Our strong revenue results reflected HIV growth of 6% or $1.1 billion to $20.8 billion, driven by strong growth for Biktarvy and Descovy, which grew 7% and 31% respectively from 2024 as well as the launch of yes to Go. And our liver business grew 6% to $3.2 billion, reflecting growing demand primarily driven by Libdelzi. Full year 2025 Vecaluri revenue was 911 million, a decline of 900 million or 49% from 2024 and mostly in line with our expectations given lower COVID 19 related hospitalization trends Moving to our full year non GAAP results on Slide 26 Product Gross Margin was 86.4% in line with our guidance of 86%.
R&D expenses of 5.7 billion were down 1% compared to 2024 and in line with our guidance of R and D flat on a dollar basis. For 2025, acquired IPRD expenses were approximately $1 billion in line with our expected annual investment in earlier stage opportunities that are part of our normal course of business development and SGA expenses of 5.6 billion were down 5% compared to 2024 within our guidance range, reflecting lower general and administrative expenses partially offset by sales and marketing investments to Support yes to Go’s launch. Overall, our operating margin for full year 2025 was 45% excluding acquired IPRD and the 400 million non recurring other revenue related to the IP asset sale in the third quarter, our operating margin was roughly 48% for the full year.
This underscores our ability to continue expense discipline while increasing investment in new and ongoing launches. The non GAAP effective tax rate was 18.3%, roughly in line with our guidance of approximately 19% and down from 25.9% in 2024, primarily driven by the prior year non deductible acquired IPR and D charge for the acquisition of SIMA Bay. And finally non GAAP diluted EPS was $8.15 in line with our 2025 guidance of $8.05 to $8.25 and driven by lower acquired IPR and D expenses, higher revenues and lower SGA expenses. Excluding the approximately $3.14 per share impact related to the SIMA Bay transaction, non GAAP diluted EPS increased by $0.4 compared to 2024.
To quickly recap the fourth quarter on slide 27 total product sales were $7.9 billion, up 5% year over year, with base business growth partially offset by the expected decline in Vec Lurie sales. Excluding Vec Lurie, total product sales were $7.7 billion, up 7% from the same period in 2024, primarily driven by higher sales for our HIV and liver disease products. Moving to the fourth quarter PL on slide 28, R&D expenses were $1.6 billion, down 3% relative to the same period in 2024 and SGA expenses were $1.7 billion, down 9% year over year primarily due to lower G and A expenses.
Overall, our non GAAP diluted earnings per share was $1.86 in the fourth quarter of 2025 compared to $1.90 in the same period 2024, primarily due to higher acquired IPR and D expenses, partially offset by higher product sales and lower SGA expenses. Looking at our full year guidance on Slide 29, we expect 2026 total product sales between $29.6 and $30 billion. We expect total VEC Lurie sales of approximately $600 million, highlighting a $300 million headwind that we expect to more than offset in our base business. We therefore expect base business sales between 29 and $29.4 billion growth of 4 to 5% compared to 2025.
Moving to the non GAAP P and L for the full year 2026, we expect product gross margin of approximately 87% R&D expenses to increase a low single digit percentage from 2025 acquired IPR and D investments of approximately $300 million reflecting known commitments associated with prior collaborations and partnerships. Consistent with our approach in 2025 we will highlight incremental acquired IPR and D expenses as we announce new transactions throughout the year and SGA expenses to increase by a mid single digit Percentage relative to 2025 reflecting higher investments in sales and marketing to support our commercial launches, offset in part by lower G and A expenses.
We expect full year 2026 non GAAP operating income of between 13.8 billion and and $14.3 billion, a tax rate of approximately 20% and non GAAP diluted EPS in the range of $8.45 and $8.85 per share. As Joanna mentioned and as shown on Slide 30, we expect an approximate 2% headwind to growth in 2026 primarily associated with the impact of the drug pricing agreement announced in December 2025 and the expected impact of updates to the Affordable Care Act. I’ll note that absent these updates Our full year growth would be in the range of 6 to 7%.
Additionally, we expect HIV to grow approximately 6% in 2026. And within HIV, we expect 2026 yes to go revenue of approximately $800 million. In cell therapy, we expect full year 2026 revenues to decline approximately 10% compared to 2025, reflecting continued competitive headwinds related to our KITE portfolio. On slide 31, we returned $5.9 billion to shareholders in 2025 and we remain committed to returning on average at least 50% of our free cash flow to shareholders in 2025. This included $1.9 billion of share repurchases primarily intended to offset equity dilution at a minimum. In addition to opportunistic repurchases combined with our dividend, we returned approximately 63% of our free cash flow to shareholders in 2025.
In terms of business development, we are confident that we have built a robust and diverse portfolio that can support Gilead’s growth. At the same time, we are carefully strengthening our early stage pipeline to position Gilead well for the long term, typically investing about $1 billion annually in smaller licensing deals, partnerships and acquisitions. Additionally, we are proactive and disciplined in our approach to later stage acquisitions that support our strategic goals and add new growth opportunities. Overall, we are pleased with Gilead’s consistent, strong performance 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 and A.
Questions and Answers:
operator
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. Our first question comes from Chris Schott at jpm. Chris, go ahead. Your line is open.
Chris Schott
Great. Thanks so much. Just wanted to kick off with a question on yes2go. Can you just elaborate a little bit more on the assumptions driving the $800 million guidance? And maybe as part of that, as we start to think about patients now needing to be redosed on the drug, what type of refill rates are you anticipating as we think about kind of going through 20, 26 and beyond? Thank you.
Daniel O’Day
Thanks, Chris. Dan O’, Day, welcome to the call. I’d invite Joanna to cover that point. Thank you.
Johanna Mercier
Thanks, Dan. And thanks Chris for the question. So, yeah, so one, let me start with how excited we are with Yes2Go. I think as we closed out 2025 and really building momentum coming into 2026, all of our key launch indicators are basically tracking or exceeding our expectation. And that includes of course access, which is where it starts, with about 90% payer coverage. So all major payers are now covering Yes2Go, about 90% of those with $0Co pay. So that’s really important for people that want to have access to this medicine. I would just remind everyone that as we pull through this great access, it takes a little bit of time, right, because you do it by account by account and you’re basically navigating logistics for HCPs and their clinics around an injectable versus a very oral market to begin with.
So that scheduling, coordination, administration. So that just takes a little bit of time and the teams are working diligently to make sure that happens as quickly as possible. We also launched, you might have seen a very recent DTC campaign. Our whole campaign is 12 prep campaign, which is really meant to increase awareness for HIV prevention and of course brand recognition for Yes2Go is it really differentiates itself both from its efficacy as well as its dosing and really intended to appeal to a much broader audience than past HIV prevention campaigns. And hopefully folks are seeing that it’s a very consumer friendly campaign and we expect that to kind of pull through as well and make sure that people are talking to their physicians about the potential opportunities of yes2go.
So all of our indicators, intakes, access, HCP awareness, conversion rates are all tracking in the right direction. So we’re excited about that and looking ahead, we really expect to drive very durable, sustained long term growth of Yes2Go. So that’s not just 2026. Continued growth and momentum’s quarter on quarter will build on, but also well beyond 2026 as we expand the HIV and normalize HIV prevention for everyone. To your point around persistency, we don’t have an assumption at this point in time because it’s still really quite early. As you think about a late launch in June of last year with very little access.
As we launched and building access into Q3, there’s really only a small number of individuals that are eligible for that second dose or second injection. But we’re really quite encouraged by early data. We’re tracking it closely and continue to focus on ensuring that individuals return for their second injection. And then well beyond that, we have a lot of activities planned that are ongoing and have started ever since we started the launch of Yes2Go around making sure HCPs are thinking about that auto refill script, making sure that our specialty pharmacy partners are reaching out proactively to all of their individuals that are on prep and making sure they’re reminding them as well as the work that we do here at Gilead, both with digital reminders as well.
Proactive outreach with our Access program. So more to come on that. But we’re excited about what yes2go has to offer for individuals looking or wanting to need and need HIV prep. So more to come.
operator
Our next question comes from Louise Chen at Scotiabank. Louise, go ahead. Your line is open.
Louise Alesandra Chen
Hi, thank you for taking my question. I wanted to ask you what type of share gains you would expect for a needle cell in the fourth line setting if you’re approved, especially in light of competition from entrenched players. Thank you.
Daniel O’Day
Thanks Louise. Dan here. I’ll turn it over to Cindy who’s with us here.
Cindy Perettie
Thanks Louise. Just as a reminder, our expectation is that we would be launching the second half of next of this year and once we have approval there’s a period of time where we turn on our qualified authorized treatment centers so that they’re able to treat so that there’s that component right after approval. The market for fourth line multiple myeloma is a $3.5 billion market we expect because the launch is the second half of the year and we need to turn on our authorized treatment centers modest contributions in 2026. However, in 2027 we will have a full year of sales.
We expect over time to become the market leader given our excellent efficacy profile and differentiated safety profile in particular with the delayed neurotoxicities and enter. I think the last piece I would add is that we are bringing forward our world class manufacturing and so we are ready for launch. We will have the ability to serve the market at launch with 99% reliability and 16 day turnaround time, which again is very differentiated from the existing products on the market today.
operator
Our next question comes from Tazeen Ahmad at Bank of America. Tazeen, go ahead. Your line is open.
Tazeen Ahmad
Okay, great. Thanks for taking my questions. Anya Estuko, how should we be thinking about the growth outlook? Are you expecting to begin to see cannibalization of descovy prep sales as early as this year? And then connected to that, how should we be thinking about the evolution of net price for Yasdugo throughout the launch? Should we expect to see a decay over time like we’ve seen with other HIV therapies? Thanks.
Johanna Mercier
Sure. Hi, it’s Joanna again. Thanks Suzanne, for the question.
So we do expect as we come into 2026, we have strong growth momentum already. So Q1 will be, we’ll start with modest growth and then kind of build on that quarter after quarter in light of all the different pieces, including access, including the DTC awareness campaign, including a lot of the work that we’re doing in the field to drive Yes2Go awareness. So all of that will build on that growth moment. In addition to that, we’re also doing market expansion strategies as well with very targeted communities. And so we do believe that ES2GO is going to be the strong performance.
And over time we believe that Yes2Go will be the market leader in HIV prevention just because of the incredible profile that it offers for folks. Having said that, in 2026 we believe that Descovy continues to grow through in 2026. As you saw, in 2025 we had the high share for Descovy we’ve ever seen. This is driven by many factors, namely commercial execution, really strong market, of course, but also unrestricted access. So all the pieces are coming together and all the votes are rising. And it has a lot to do with the awareness in HIV prep because of the purpose 1 and purpose 2 trials for yes 2 go really building up the market.
So we believe descovy will continue to grow through 2026 and over time, of course that will erode as Yes2Go takes the leading share in HIV prevention. I think the final point you were asking about was gross to nets. We obviously don’t discuss gross to nets for our products, but I would say that Yes2Go’s value proposition is quite differentiated and we feel strongly that that is being recognized and that’s in line with the 90% access in less than six months that we’ve been able to achieve. So really pleased so far with what we’ve been seeing and making sure that value continues to get recognized for HIV prep users.
Tazeen Ahmad
Thank you.
operator
Our next question comes from Michael Yee at ubs. Michael, go ahead. Your line is open.
Michael Yee
Great, thank you guys. Maybe a question for Dietmar or the team. Your long acting Q6 month treatment drug, which I guess could be a Super Bictgravir, long acting 3242 I think you said, entered phase two. So can you tell us a little bit about the profile of that drug and what you’re seeing in phase one to get you excited? Is that going to be at Chlori, I guess coming up in a week or two. And how do you compare that to? I think Shionogi’s product, which their investment into Vive. And I’m sure you’re aware that they’re also excited about their Q6M as well.
So maybe compare and contrast and what gets you excited about your product. Thank you.
Dietmar Berger
Yeah, thank you Michael, for the question. I mean, first of all, I really want to say that I’m excited about the breadth of the program that we have, right? Not only the Q6 month, also the upcoming, for example weekly treatment that we have with isletravir and then acapavir and really the options between the daily, weekly, monthly and then every six months treatments that we’re developing specifically for the ones every six months. I also want to point out that we have two programs in development. One is for Lenacapavir plus broadly neutralizing antibodies. Obviously that is an infusion and comes with everything that you need to do from an infusion perspective.
However, there’s a real unmet need and the study, the interest in the study is really high. So we feel that will be an important addition and that will come even a little earlier than the 3242 based combination. Now, 3242 is obviously a long acting insti. We firmly believe that an integrase inhibitor is important in this combination and I think that also sets it apart from some of the other options that are out there. And you know, all the benefits of the instis, starting with for example the tolerability, but then also really the resistance profile and the forgiveness.
And we feel that that translates also into the once every six month treatment and then obviously the combination with Enacapir. So you have the insti again plus the capsid inhibitor, which we feel is a really important combination. So yes, you will see more data, more information about 3,242 during the year and we’re really looking forward to detail that. I don’t want to go too much into the comparison to the competitors, but please keep in mind that they cannot base once every six month treatment on one product only. They also need a combination. So we need to look at the overall development program that they have and that they’ll put together to then really bring their products forward as compared to the two options that I’ve laid out that we have in development.
operator
Our next question comes from Brian Abrams at RBC Capital Markets. Brian, go ahead. Your line is open.
Brian Abrams
Hey guys, congrats on the quarter. Thanks for taking my question. We noticed a little bit more detail on your once yearly injectable Lenacapavir for prep on the slides today and I was wondering if you could maybe just talk about what you need to show out of purpose365 in order to support approval. And how are you planning to position that in the market of successful. Thanks.
Daniel O’Day
Thanks, Brian. Go back to Dietmar.
Dietmar Berger
Yeah, I’ll start with the profile. And really what is so great about Lena Capivir is that it’s such a versatile product. Right. And we do understand the pharmacokinetics and the target coverage and some of the scientific underpinnings of Lena Capivir 4 Prevention really well. So the study purpose 365 is a PK based study. It’s a smaller study. Obviously it has been recruiting very well and continues to recruit very well. But it’s a smaller study where we basically need to demonstrate target coverage and the right pharmacokinetics saying peak levels, trough levels, et cetera, so that we can demonstrate effective prevention.
That’s how the study has been designed. Obviously we’re looking forward to see the data looking at pk, looking at safety. It will be an intramuscular injection, which is also an important differentiation that we’re looking forward to demonstrate. But we feel it can. Really bring. In a very important benefit with a longer term interval to patients. I’ll hand over to Joanna for the market.
Johanna Mercier
Yeah, thanks, Brian. I would just add to what Dietmar was saying is the fact that it’s 12 months. We’ve been very clear with the market research that we’ve seen that frequency or less frequency in the HIV prep setting specifically is the most important. And that’s why yes, two go. Being such an important innovation to this marketplace every six months, let alone the potential of going to every 12 months really would potentially attract a larger population if you were thinking that you just had to go to the physician’s office once a year for that injection. So I think there’s an opportunity to broaden the addressable population as well as there are some folks as well that might have unstable housing or situations that once a year would also be ideal for them.
So it’s a real market expansion opportunity for us as we see this, with that potential with 360.
Daniel O’Day
Great. And Brian, I would just remind what we’ve already stated, which is this could be available as early as 2028. The trial is recruiting well.
Brian Abrams
Thank you.
operator
Our next question comes from Umer Rafat at Evercore Umar. Go ahead, your line is open.
Umer Raffat
Hi guys. Thanks for taking my question. I was quite intrigued by your mention of the Trudelvi Phase 3 in endometrial perhaps in second half of this year, which makes me wonder. It’s probably an interim analysis you’re effectively guiding to. Can you speak to your confidence overall heading into this interim and is it fair to say that the size of the indication is generally similar to triple negative breast? Thank you.
Dietmar Berger
So let me just talk about the study and then later on Johanna can chime in. Thanks for the question, Umer. Obviously we are primarily intrigued about endometrial because of the earlier study. Right. Because of the phase 2 tropics 03 study, the basket trial that we did where we saw a median OS of 15 months in that population. That data was published at ESMO 2024. We feel with data like that this would be a really important addition to the treatment options for second line endometrial cancer patients. We’re not providing details regarding the exact evaluation that we’re going to do, but we’re really looking forward to seeing the data later this year.
I want to say second line endometrial cancer is of course more of an incremental opportunity, but I’ll hand over to Johanna if she wants to comment on that further.
Johanna Mercier
Yeah, sure. So I think you’re right, Umer. It’s basically in line with second line metastatic tnbc. So more or less about 5000 or so addressable population in the US so small opportunity but very important unmet medical need as well for us. So this is where the focus and just the breadth of data for Trudelvi just expands. In addition to Ascent guide that Dietmar was talking about, we also have a potential with Evoco3 earlier this year in our PD L1 high non small cell lung cancer setting as well, which we would be a much larger market expansion for Treadelby as well if that was to play out.
So we’re excited about what’s to come for Tridelvi.
operator
Next we have Jeff Meacham at Citibank. Jeff, go ahead. Your line is open.
Geoff Meacham
Oh great. Hey guys. Afternoon. Thanks so much for the question. I had a bigger picture one for Andy or Dan. You guys have done a ton of phase three cards of turnover this year and also some launches. You know, you haven’t done a larger scale deal in a while. So I guess I wanted to get a sense from you guys as to what voids you think you need to fill. Is it further diversification of safe therapeutic areas? Is it a new product cycle looking to the maybe mid-2030s or is there no real BD urgency from you guys at this point? Thank you.
Daniel O’Day
Thanks a lot, Jeff. I’ll start and certainly invite Andy to add. You know, I think we’ve all been reflecting here at Gilead about the progress that’s made over the past five or six years. And I think some of the greatest evidence of that is the fact that, you know, we have up to 10 launches now, either ongoing or to be, to be introduced between now and 2027. That includes four additional launches this year that have already been articulated and five phase three readouts. And importantly, back to your question, Jeff. That’s across really all therapeutic areas, which is exactly the design.
So we’re building this very robust internal portfolio that’s been built through original research, early stage partnerships and collaborations and M and A. So what I would say is that as we approach additional partnerships and M and A, there’s two pieces to that, of course. The first one is that we have to stay active in what we call kind of earlier stage transactions, sometimes referred to as normal course. And we spend roughly around billion dollars every year on that. Again, we can be agnostic to the three therapeutic areas and go for the most interesting science. And that’s what we’ve been doing to build this portfolio that is now coming through to us.
And as we approach later stage acquisitions, we do it in the context of the fact that we have the most robust clinical and launch pipeline in our company’s history with no major loes until 2026. So we’re uniquely positioned, we’re very ready, we’re very proactive and disciplined. But we may not have the urgency of other companies in this sector. So we’re going to be disciplined around that. But I would say that we very much want to continue to add to our pipeline with appropriate M and A over the course of the coming years as well. If I haven’t said everything, Andy, would you like to add anything to that?
Andrew Dickinson
I think you covered it well. I mean if you look at the growth that’s ahead of us and the cycle that, that we’re entering with all of the launches that are underway or the additional launches that are coming, you know, a reasonable portion of that is driven by our corporate development activities historically. And we, we continue to want to supplement both, as Dan said, the early stage, late preclinical early clinical pipeline through more of the ordinary course deals. And we would like to add synergistic E risk late stage assets that will further, you know, I define it as Turbocharger, our top line growth and drive even more outsized bottom line growth.
And you know, and we will be discip in that. But We’ve been very active in this space. We’ll continue to be active and I’m confident that we’ll add exciting new products over time when we find the right ones.
operator
Our next question comes from Dana Graybosch at Lee Ring Partners. Dana, go ahead. Your line is open.
Daina Graybosch
Yeah, one on a needle cell for me. I wonder, and maybe I’m being presumptuous, but what gives you confidence in a second half launch? Does that assume priority review for FDA. For needle cel and then for your 2027 filing from Imagine3? Is that going to be on the MRD endpoint or on a survival endpoint? Thank you.
Cindy Perettie
Thanks Shana. Cindy. So for the confidence in Anita cell second half launch, we can’t say today if we have priority review or not. Obviously that would come with the BLA acceptance and we’ll be sure to let you know as soon as as we can on that. But we have confidence in our conversations with the agency around the filing and look forward to being able to share more soon. The second component you asked about around Imagine 3, we have a dual endpoint which is both MRD and PFS on the Imagine 3 study and that’s in line with the guidance that you heard from the FDA not too long ago ago.
operator
Our next question comes from Tyler Van Buren, Tyler at TD Cowan. Tyler, go ahead. Your line is open.
Tyler Van Buren
Great. Thanks so much for TRO Delby. Are you guys starting to see off label use in the front line in advance of formal approval given the very positive readouts and the NCCN recommendation in particular? And what do you expect the opportunity. In the front line to be versus the current indicator?
Johanna Mercier
Sure, Ty, I’ll take that one. It’s Joanna. Yeah, so post essential 4 presentation at ASCO last June. That’s when we started actually seeing a little bit more spontaneous use of Tridelvi both in the first line setting, but also strengthening our position, our leadership position in the second line setting as well. So that’s been kind of building obviously that spontaneous use. There’s no promotion against first line. There’s only education from our medical team, field teams around the data publications in the New England Journal of Medicine and you highlighted as well the NCCN guidelines. We are Trudelvi is now the only ADC that is recommended both in first line PD L1 positive and PD L1 negative metastatic TNDC as well as second line setting.
So we’re excited about that and the impact it can have on patients because disease is such an aggressive form of breast cancer to your market Opportunity, it’s about double or so. If you think about the second line setting into the first line setting, there’s about 10,000 or so women in the first line setting that are looking for care and really an opportunity for Trudelvi to have an impact here, both in PD L1 negative and PD L1 positive with Pembro. The other opportunity, of course, if you think about it, is dot. Your duration of treatment basically doubles.
Right. Line setting because of the aggressiveness of this disease is four to five months. And so therefore, as you think about first line, it’s about double. It’s nine to 10 months, which gives a little bit more hope to these women. So definitely an important advancement in triple negative breast cancer with Trudelvi at the lead.
operator
Our last question comes from Courtney Breen at Bernstein. Courtney, go ahead. Your line is open.
Courtney Breen
Hi, Gilead team. Thanks so much for squeezing me in at the end. I’m going to point us back to yes, Tuga again and just kind of really trying to get our arms around the 2026 guide.
By our calculations, you have to believe that there’s no growth in new patient starts compared to what we’ve seen kind of through January for the rest of this year, and a more than 10% price cut year on year to kind of get to that $800 million guide for 2026. Given that, should we be thinking about the $800 million as a floor or as kind of a guide for 2026? Thanks so much.
Johanna Mercier
Thanks, Courtney, for your question. I’m not sure I’m tracking your modeling because we are definitely assuming continued strong momentum for Yes2Go. I know all of you are looking at weeklies.
We’re obviously looking at weeklies, but we’re also looking at monthlies and making sure that we’re creating new growth numbers month to month. And so we do see that as an acceleration of our growth as we go into 2026. A lot of those pieces are supported by making sure that we’re adding new patients on Yes2Go, new individuals on Yes2Go, and also bringing back people for their second injection. So those two pieces are considered in that guide guidance. And I think we’re excited thus far about where we stand today with Yes2Go, and all the pieces are coming together.
We are just making sure that as much as the access is strong right now, and I’m really proud of the team that pulled that through, we also need to pull it through at an account level. So we’re doing that account by account and making sure People are navigating the logistics of an injectable and oral market and all of that takes a little bit of time. But the intent is we expect strong, consistent, durable growth for the long term for yes2go. So we’re excited about what’s to come. And I guess DTC will also have a pretty big impact, we believe to bring people in asking and talking about yes2go.
operator
That completes the time that we have for questions. I’ll now invite Dan to share any closing remarks.
Daniel O’Day
Thanks everybody. First of all, let me thank the Gilead teams again. It’s such a pleasure to work with them and to see them deliver these really strong full year performance measures and reinforcing that. This is a time of impacting growth for the company. You know, our performance from last year gives us a really strong foundation for the coming year where we have a lot to deliver for the patients and communities we serve. Coming off of a year where we had just, you know, a really strong yes2go launch. As Joanna mentioned, several key launch indicators have exceeded our expectations.
We’re firmly committed to continuing to drive that launch. But in addition, we have four potential launches this year and five pivotal phase three readouts across all three therapeutic areas. Hiv, oncology, liver disease. So you can expect us to show the same strong commercial and clinical execution you’ve seen in the past and disciplined focus on expense management as you’ve seen from us quarter after quarter. And with no major LOEs until 2036, the next 10 years and a really proactive approach to business development, Gilead’s business is secure, growing and with the potential for much more to come.
So thanks again for your time today. Today we look forward to keeping you informed on our progress. And as usual, if you have any follow up questions, our investor relations teams is very happy to support you with the answers to your questions. Thank you everybody. Have a good rest of your day.