Gilead Sciences, Inc.

and welcome to Gilead's second 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, please press star one. To withdraw your question, press star two. Now I'll hand the call over to Jackie Ross, Senior Vice President of Treasury and Investor Relations.

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the second 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, Joanna 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 Peretti, 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. The team and I are pleased to be here with you today to share the results of a very successful second quarter. This quarter had special significance, of course, with the FDA approval of Lenincapivir, or yes, Tugo, for twice-yearly HIV prevention. I want to take this opportunity to thank the many people who contributed to this remarkable achievement, from the Gilead teams who discovered and developed Lenincapivir, to the participants in the PURPOSE studies, as well as the KOLs, advocates, community partners, and others who have been part of the Lenincapivir journey. This is truly a milestone moment in the history of HIV, with the launch of a groundbreaking innovation that could bend the arc of the epidemic. Moving to the quarterly results, we had another very strong quarter of clinical, commercial, and operational execution. Excluding VicLurie, base business sales of $6.9 billion grew 4% year over year, driven by robust growth across Biktarvy, Dyskovy, Levdelsi, and Tridelvi. Product sales of $7.1 billion grew 2% year over year. The strong base business performance was partially offset by lower VicLurie sales due to fewer -19-related hospitalizations. HIV had a very strong second quarter, with demand-driven growth of 7% year over year, more than offsetting the anticipated headwinds from the Medicare Part D redesign. Biktarvy grew 9% year over year to $3.5 billion, and Dyskovy grew 35% year over year to $653 million. This was Dyskovy's strongest quarter ever, highlighting the growth of the HIV prevention market, into which we are now launching Yes2Go. It is now seven weeks since FDA approval of Yes2Go, and we are very pleased with what we're seeing so far. Joanna and Andy will take you through our results in more detail, but overall, the strong commercial execution and operating expense discipline year to date support higher expectations for the second half of 2025. As a result, we are increasing our revenue and EPS guidance for the full year. From a clinical perspective, the second quarter was one of the strongest in Gilead's history. In addition to the FDA approval of Yes2Go, we received a positive CHMP opinion from the European Medicines Agency. With more than one million new HIV infections globally each year, and over 600,000 HIV-related deaths, we believe Lenincapivir is one of the most important scientific breakthroughs of our time, which brings a sense of urgency and responsibility to reach the communities most in need as quickly as possible. At the same time, we continue to fully evaluate Lenincapivir's potential in the clinic. For example, we have just initiated Purpose 365, a phase three trial evaluating once yearly Lenincapivir for PrEP. Additionally, we continue to develop seven combination regimens that utilize Lenincapivir-based molecules for HIV treatment. In the second half of this year, we plan to share updates from Artistry I and Artistry II. These phase three trials are evaluating a potential new single tablet regimen, combining Bictegravir plus Lenincapivir, that could further extend the reach of Gilead's current HIV treatment business. Moving to oncology, we announced -to-back positive phase three results for Tridelvi with the top line data from Ascento III and the detailed data from Ascento IV. We now have data that show highly statistically significant and clinically meaningful benefit for Tridelvi across first line metastatic triple negative breast cancer. Tridelvi is already the leading therapy for second line metastatic TMBC, and with these data, we look forward to potentially advancing Tridelvi to the first line setting where it could benefit twice as many patients. In cell therapy, we expect to provide a pivotal update from the phase two Imagine I trial, evaluating a NIDA cell for multiple myeloma later this year. Given the compelling efficacy and safety data seen to date, combined with Kite's industry-leading manufacturing capabilities, we believe a NIDA cell is well positioned as a potential -in-class therapy for multiple myeloma. In summary, this is a very special time for Gilead that's underscored with our second quarter results. This highlights the strength of our R&D engine and the level of excellence in our commercial and operational execution. Having built this positive momentum, we're excited by what's to come with continued innovation that will benefit patients and drive growth across our therapeutic areas. With that, I'll hand over to Joanna.

Thanks, Dan, and good afternoon, everyone. We had another very strong quarter of commercial execution, culminating with the launch of Yes2Go following FDA approval in late June. Second quarter product sales, excluding Veclurie of $6.9 billion, were up 4% year over year, primarily driven by 9% growth in Diktarvy and 35% growth in Discovy. We also delivered encouraging contributions from LibDelzy in its third full quarter of commercial launch and in Cherdelvy, partially offset by lower HCV sales following a very strong second quarter in 2024. Sequentially, sales in our base business were up 10% driven by growth in HIV, oncology, and liver disease. Including Veclurie, total product sales of $7.1 billion were up 2% year over year. While Veclurie's share of US hospitalized patients treated for COVID-19 remains well over 60%, the number of patients impacted by the pandemic continues to decline. This is reflected in second quarter sales of $121 million for Veclurie, and also in our updated full year guidance. Moving to slide eight, HIV sales of $5.1 billion represented very strong 7% year over year growth, primarily driven by increased demand in addition to higher average realized price. Sequentially, sales were up 11% reflecting inventory build and higher average realized price, both typical second quarter seasonal dynamics as well as higher demand. On slide nine, Viktarvy sales of $3.5 billion were up 9% year over year with commercial execution supporting a strong increase in demand. Sequentially, sales were up 12% reflecting seasonal inventory build and higher average realized price as well as higher demand. Viktarvy once again expanded its US market share and increased two percentage points year over year to over 51%. Viktarvy continues to lead and share in major markets around the world. Further strengthening Viktarvy's differentiation, FDA recently granted a label expansion to include the treatment of HIV in people with antiretroviral history who are not virologically suppressed with no known or suspected resistance. This new indication addresses an important unmet need for people with HIV, specifically those who come off therapy and then restart treatment. This label expansion reinforces confidence in Viktarvy to get such individuals to sustain viral suppression. Moving to Discovy, second quarter sales of $653 million increased 35% year over year with growing awareness of PrEP and unrestricted access driving both higher average realized price and higher demand. Sequentially, sales were up 11% reflecting seasonal inventory dynamics and higher demand. Partly driven by strong execution from our commercial team and continued growth ahead of the Estugo launch, the US PrEP market has now expanded to more than half a million active users. This market continues to grow in the mid teens year over year highlighting progress on our goal of expanding the HIV prevention market. Additionally, Discovy for PrEP share grew once again this quarter representing more than 40% of the US market. Moving to slide 10, we received FDA approval of Estugo as the first twice yearly injection for HIV prevention in mid June and the team has been executing what I consider to be the best planned commercial launch I have seen to date. Revenue in the first days of launch right at the end of the second quarter reflected planned inventory build as we expected. While it's still early days, we're extremely pleased with the feedback from both clinicians and consumers as well as the progress of our early discussions with payers and the effectiveness of our launch preparations and execution to date. Notably, the first Estugo prescription was written within hours of approval, with the first product shipped within 24 hours and the first dose administered within days well ahead of our expectations. Prior to launch or any commercial engagement, Estugo's unaided awareness among healthcare providers was at 72%, more than twice the typical pre-launch awareness with aided awareness at 95%. I look forward to sharing more about Estugo's early performance in the coming quarters. We are well on our way to achieving our target of 75% access for Estugo within six months of launch and 90% within 12 months. Outside the US, we have just received a positive CHMP opinion and expect a European Commission decision on Lena Capovir in the next two months. Our launch preparations in our initial target European territories are underway. Gilead is committed to facilitating access to Lena Capovir for those who could benefit from HIV prevention, regardless of where they live. With that in mind, we recently announced a partnership with the Global Fund to bring Lena Capovir to approximately two million people in primarily low and lower middle income countries over the next three years. We were also pleased that the World Health Organization and the International Aid Society both recently announced new HIV prevention guidelines, recommending the use of Lena Capovir. As we look at the rest of 2025 on slide 11, it's clear that we are seeing very strong performance in both HIV treatment and prevention. With that in mind, we're increasing our full year sales guidance and now expect HIV sales to grow approximately 3% in 2025, up from our prior assumption of flat revenue year over year. This updated HIV guidance is driven by strong BIC-TARVY and DISCOV performance so far this year and our expectations for the second half. Some additional consideration. First, we've made no change to our assumption regarding the impact of Medicare Part D redesign, which at the start of the year, we expected to impact our HIV business by approximately $900 million in 2025. Excluding this headwind, HIV growth this year would be more than 7%. Second, given the recency of launch, we have made no changes to launch assumptions surrounding Yes2Go. And finally, given a broad range of possible policy outcomes, our updated HIV guidance assumes no changes to the current landscape. Moving to liver disease on slide 12, sales of $795 million were down 4% year over year following a particularly strong second quarter of 2024. This reflects lower average realized price and lower patient starts in HCV, partially offset by the very strong launch of LSDLZ, as well as demand for HDV and HBV products. For HCV, US pricing has been impacted year over year by Medicare Part D redesign, while volume was driven by the timing of purchases in both the US and internationally. In primary biliary cholangitis, we continue to be pleased with LSDLZ's performance in the US, as well as the early launches in Europe following approval last quarter. Overall, revenue almost doubled from $40 million in the first quarter to $78 million in the second, driven by growing second line PBC market share with our focus on both market expansion and persistence of therapy. Looking ahead, we are particularly encouraged by the demand we're seeing for LSDLZ in new patient starts. That said, and after a tremendously strong second quarter, we do expect sequential growth to be more moderate in the third quarter, reflecting continued growth in new patients, but a slower uptake among switch patients where cadence of physician visits remains a gating factor. Moving to slide 13, Toedelby sales of $364 million were up 14% year over year and 24% sequentially, reflecting Toedelby's continued strength in metastatic breast cancer and more than offsetting on a year over year basis, the expected decline associated with the withdrawal of the bladder cancer indication in the US. Internationally, we have seen strong demand growth both year over year and sequentially, where launch momentum and share gains continue across major markets. Building on our market leadership in second line metastatic triple negative breast cancer, we're working towards filing for approval in the first line setting based on the potentially practice changing results from the ASENTO3 and ASENTO4 trials. As a reminder, there are almost twice as many patients in the first line metastatic setting compared to second line, as well as longer duration of therapy, and we look forward to expanding the options available for patients in this earlier line setting. For cell therapy on slide 14, and on behalf of Cindy and the Kite team, second quarter sales of $485 million were down 7% year over year, primarily driven by lower demand, partially offset by higher average realized price. As expected, our Kite cell therapies continue to face competitive headwinds, although sales were up 5% sequentially, helped by favorable FX impact, in addition to higher demand for Yascarta in the US and Ticardis globally. It's taking time to reduce the barriers to broaden adoption of cell therapy, but we're making progress. For example, FDA recently removed the CAR T class requirement for a REMS program, which we believe will reduce the burden of CAR T administration for healthcare providers, patients, and caregivers, and we're pleased to see these changes starting to be rolled out across authorized treatment centers. FDA also made additional changes to the CAR T product labels, that will have meaningful impact on patient and caregiver quality of life. This included a 50% reduction in the time patients need to remain near their treating center, and a 75% reduction in driving restrictions. We continue to believe that outpatient delivery remains key to broader cell therapy adoption. With that in mind, new real world data shared at ASCO highlighted the viability of outpatient administration for Yascarta. This is also reflected in increasing outpatient adoption over time, suggesting growing physician comfort with the use of Yascarta in this setting. Our efforts to educate physicians and patients on the potential benefits of a one-time CAR T treatment are also ongoing. Most recently, we highlighted new five-year overall survival analysis from Ticardis in B-cell acute lymphoblastic leukemia at EHA, the longest follow-up of any CAR T therapy in this indication. Together, these new data support our goals of bringing cell therapy closer to patients and increasing adoption. Wrapping up our second quarter, I want to thank the commercial teams for delivering yet another strong quarter of impact for patients and financial results for Gilead. Any commercial organization is energized by new product launches, and we are so fortunate to have several new, exciting, and impactful products in our portfolio. The Yes2Go launch marks a unique moment for Gilead, and I know the commercial teams share a sense of both excitement and responsibility, given the potential to truly transform the HIV landscape in the coming years. And so with that, I'll hand the call over to Dietmar.

Thank you, Joanna, and good afternoon, everyone. I'd like to start on slide 16 by recognizing the years of tireless effort across many research and development teams at Gilead, Kite, and our partners that contributed to a spectacular quarter of clinical results. In April and May, we announced positive top line results from ASCEND 04 and ASCEND 03 that showed Tordelby regimens demonstrated highly statistically significant and clinically meaningful efficacy with the potential to be practice changing in first line metastatic triple negative breast cancer. In May and June, we shared promising early results from our next generation, bicistronic carotids in lymphoma and glioblastoma. In June, we shared updated data from our pivotal Imagine One trial in fourth line and later relapsed and or refractory multiple myeloma that further reinforce our belief in a needle cells best in class potential. And also in June, we achieved FDA approval of Yes2Go, our breakthrough twice yearly injectable for HIV prevention, which we truly believe has transformative potential. We believe Lana Capovir will help bring us closer to our goal of ending the HIV epidemic in the years ahead. You have heard Johanna's excitement about the commercial launch in the US. And in July, we were pleased CHMP adopted positive opinions for our EU marketing authorization application and for EU medicines for all, which enables a streamlined assessment for WHO pre-qualification and additional global regulatory reviews. These are critical advances in our plans to help make Lana Capovir available to people who need to be protected from HIV globally. This is a moment of pride for this Gilead team and has given me personal pause as I recognize and appreciate the brilliance of the team of scientists that we have here and the determination to keep out innovating ourselves to achieve the best possible experience and outcomes for those we serve. With that in mind, our work in HIV continues. As you can see on slide 17, with the approval of Yes2Go, we continue to target up to eight additional HIV product launches before the end of 2033, including five that would come to market by the end of 2030. In HIV prevention, we have initiated our phase three trial evaluating once yearly intermuscular injections of Lana Capovir for HIV prevention, now called Purpose 365. If successful, this could launch as early as 2028. In HIV treatment, we continue to expect an update on our new daily oral combination of Bigtegravia and Lana Capovir in the second half of the year from ARTIS 3.1 in people with HIV on complex regimens. In addition to ARTIS 3.1, we now expect to provide an update for ARTIS 3.2, the second phase three trial for Biglen for virally suppressed people with HIV or people looking to switch regimens. Looking at our weekly HIV treatment programs, we expect a phase three update on the Lana Capovir plus Isolatravir combination in 2026 with a view to potential launch in 2027. As we announced, our wholly owned weekly Wonders program evaluating the combination of GS4182, one of our Lana Capovir Pro drugs, and GS1720, one of our long acting integrase inhibitors, is on clinical hold pending further analysis. We're making progress on our other oral long acting candidates and continue to expect our wholly owned once weekly program to be moving forward with a delay of three to six quarters. Among the rest of our leading HIV programs, three are in phase one, namely our monthly oral and our quarterly and twice yearly injectables. We look forward to sharing updates on these in due course. Finally, we continue to plan for our phase three study evaluating Lana Capovir plus broadly neutralizing antibodies or BNAPs as a potential twice yearly injectable treatment. We continue to target commercial launch in 2030. Moving to oncology on slide 18, Trodelvi's impact in metastatic triple negative breast cancer was reinforced with highly statistically significant and clinically meaningful results in the phase three ASCENT03 and ASCENT04 studies in the first line setting. At ASCO, we presented potentially practice changing detailed data from ASCENT04, showing treatment with Trodelvi plus Pembrolizumab resulted in an 11.2 months median progression free survival, a 35% improvement versus chemo plus Pembro for first line PDL1 positive metastatic triple negative breast cancer. We saw an early trend for improvement in overall survival with Trodelvi plus Pembro, though we would note these data are immature. Still, these results are remarkable given the high share of patients who crossed over to Trodelvi following disease progression in the control arm, which would be expected to mask a potential overall survival benefit. We will be filing for full approval based on the primary median PFS endpoint for both ASCENT03 and ASCENT04 with a potential FDA regulatory decision expected in 2026. We plan to share detailed phase three ASCENT03 data at an upcoming medical meeting, which will allow it to be considered for future guideline updates. These results are encouraging as we continue to evaluate Trodelvi in earlier lines of breast cancer. In addition to ASCENT03 and ASCENT04, our other phase three breast cancer programs include ASCENT07 in chemo-naive hormone receptor positive HER2 negative metastatic breast cancer, evaluating Trodelvi following endocrine and CDK4-6 inhibitor therapies. This is an event-driven trial and we will update you in due course. And ASCENT05 in high risk early triple negative breast cancer evaluating adjuvant Trodelvi plus Pembro, as would be expected with an earlier line trial in a potentially curative setting, it will be several years before we are able to provide an update. We also remain focused on clinical execution of our five other ongoing phase three programs for Trodelvi and DombeneliMAP across lung, endometrial and upper GI cancers. Moving to slide 19, and on behalf of Cindy and the Kite team, we were pleased to present new data from across our cell therapy pipeline at the ASCO and EHA Congresses. In partnership with Arcelics, data from the Imagine One trial at EHA demonstrated the consistent and compelling efficacy and safety profile of a needle cell. We continue to believe a needle cell has the potential to offer a best in class profile and we look forward to presenting pivotal data from this trial towards the end of the year. As a reminder, we continue to target 2026 for a commercial launch. From our next generation construct at ASCO, we presented initial data from the biocistronic CD19, CD20, Kite363 CAR-T, which we believe has shown a promising profile in B-cell malignancies, and we have selected Kite363 to be evaluated in phase one trials of autoimmune and neuroinflammatory conditions. In the second half of this year, we will decide which program to advance in hematology, choosing between our three next generation CAR-T constructs. Additionally, in collaboration with the University of Pennsylvania Perelman School of Medicine, ASCO data on the biocistronic EGFR IL-13 RA2 CAR-T strengthens proof of concept for expanding CAR-Ts to treat solid tumors. Overall, we remain excited in the potential of our next generation therapies to offer improved efficacy and safety profiles and to reach patients faster, as we work towards our goal of bringing potentially curative therapies to patients. Finally, moving to our pipeline milestones on slide 20, we have had an extremely productive and successful quarter overall. Looking to the rest of the year, we expect the pivotal update from our imagine one trial, evaluating a needle cell in fourth line or later, relapsed or refractory multiple myeloma, the European Commission decision on Lanakapivir for PrEP, following the recent positive CHMP opinion and a phase three update for ARTIS3-1, evaluating big LAN in people with HIV on complex regimens. We have also added a new milestone, a phase three update for ARTIS3-2, evaluating big LAN in virologically suppressed people with HIV. Together, ARTIS3-1 and ARTIS3-2 have the potential to support global regulatory filings that could expand the reach of Gilead's HIV treatment business. With that, I'll turn the call over to Andy.

Thank you, Dietmar, and good afternoon, everyone. Starting on slide 22, our second quarter results show continued strength in execution across the company. Our base business was up 4% year over year to $6.9 billion, driven by growth in Biktarvy, Discovy, Livdelzy, and Tridelvy. Reflecting fewer COVID-related hospitalizations, Vecluri sales were down 44% year over year, resulting in total product sales of $7.1 billion, up 2% year over year. Moving to our non-GAAP results on slide 23, second quarter product gross margin was up 1% from the same quarter last year to 87%, driven by a more favorable product mix. R&D expenses were up 9% compared to a relatively low second quarter of 2024, reflecting investments in clinical manufacturing and study activities. I'll highlight that we continue to expect full year R&D expenses to be roughly flat on a dollar basis from 2024, and year to date R&D expenses are tracking in line with our internal expectations. Acquired IP R&D expenses were $61 million in the second quarter, primarily driven by the Chimera collaboration we announced in June. SG&A expenses were flat year over year, with higher sales and marketing expenses primarily related to our HIV franchise, offset by lower G&A expenses. Second quarter operating margin was 46% or 47% excluding acquired IP R&D. The non-GAAP effective tax rate was 19% this quarter, in line with our expectations. And finally, non-GAAP diluted EPS was $2.01 for the quarter. Moving to our full year guidance on slide 24, we had an extremely strong first half of 2025, driven by our HIV portfolio, and bolstered by the encouraging momentum in both Livdelzi and Tridelvi. With that in mind, we are updating our full year 2025 guidance as follows. We now expect product sales, excluding VecLury of approximately $27.3 billion to $27.7 billion, representing an increase of half a billion dollars in our base business expectations for 2025. This update reflects HIV growth of approximately 3% year over year, driven by the outperformance of Biktarvy and Discovi year to date, FX tailwinds, and softer cell therapy expectations, where we now expect a modest decline for full year 2025 versus full year 2024. I'll note that our assumptions have not changed in the following areas. Firstly, our assumptions for the impact of Medicare Part D redesign remain unchanged from the beginning of the year, and we expect approximately $1.1 billion of impact to our business. Secondly, while we're very encouraged by the launch dynamics of Yes2Go to date, we are not updating our assumptions for Yes2Go revenue in the second half of 2025 at this time. And finally, we have not updated our expectations for the impact of potential tariffs or other changes to the broader policy environment. We continue to expect the impact of known tariffs to be manageable in 2025. Moving to slide 25, we are reducing our full year 2025 expectations for Baclurri by $400 million to approximately $1 billion, reflecting the current path of the COVID-19 pandemic, including lower hospitalization rates in the first half and the trends we've seen in the first month of the third quarter. As a result, total product sales is expected to be in the range of $28.3 to $28.7 billion, with half a billion dollar increase in base business expectations partially offset by lower COVID-19 related sales. For other items in the P&L, on a non-GAAP basis, we now expect product gross margin to be approximately 86%, reflecting strong performance year to date and a more favorable product mix. We expect R&D expenses to be roughly flat on a dollar basis from 2024, which is consistent with our expectations at the start of the year. And we expect acquired IPR&D to be approximately $400 million, reflecting $315 million of expenses so far this year, in addition to known commitments and expected milestone payments. SG&A expenses are now expected to decline by a mid to high single digit percentage compared to 2024, updated to reflect higher HIV sales and marketing expenses and other corporate expenses associated with higher 2025 base business expectations. Rounding out the P&L, we expect operating income to be between $13 billion and $13.4 billion, our effective tax rate to be approximately 19%, consistent with our prior guidance, and we expect our full year diluted EPS to be between $7.95 and $8.25, an increase of 20 cents at the midpoint compared to our prior guidance. Looking ahead, we will continue to monitor the macro landscape carefully, and we expect that our disciplined approach to operating expense management positions as well to adapt as needed in the months ahead. On slide 26, our capital priorities remain unchanged, and we returned $1.5 billion to shareholders in the second quarter. This included $527 million of share repurchases, currently being executed under our 2020 plan. We expect to complete the 2020 program over the next several quarters, and our board recently approved a new $6 billion program to support continued 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 half of 2025. Overall, Gilead delivered another very strong quarter of clinical and commercial execution, supported by our disciplined operating model. As we look to the second half of the year, we believe that Gilead is 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. Our first question comes from Tyler Van Buren at TD Cowan. Tyler, go ahead, your line is open.

Great, hey there, thanks very much, and congratulations on the progress. I know you'll be shocked to hear this question, but can you please elaborate on the early uptake with the Estudo and whether you expect early prescriptions to trend linearly from here, or if it's still very early in what is expected to be more of an exponential launch curve? Yeah, go ahead,

Joanna, please. Thanks. Hi, Tyler. We are very surprised to get that question.

Shocked. Tyler, thanks for the question, it's Joanna. Yeah, we're really pleased with the launch so far, and you're right, it's still early days for about six weeks in, but super thrilled to see what's been going on. I think, number one, a lot of that has to do with the readiness of the cross-functional teams. As the day that we got, or I should say the hour we got the approval, everything was basically ready to turn key and get going. So the teams have hit the ground running, and just really proud to see how they're working together in pods across the US to make sure that this happens. We've already had over about 25,000 customer calls executed in the field, and just understanding that our target base is about 15,000. So many of those customers have seen either a representative or a medical sales representative more than once, and that's how we see the uptake and the excitement. When we think about the awareness at launch, it was already double what we usually see in industry at launch. You were looking at about a 72% unaided awareness, usually those numbers in the 30s or so, and then of course our aided awareness was 95 plus. So we really knew that as we were going into this, we were ready, and now it's up to us to pull it through. You heard me say a couple of early data points around first script within hours, injection within a couple of days, and tracking that super closely. The piece that maybe is important to understand as well is how access is playing out here. We've always said about 70, you should expect 75% or so access at six month time point, and then about 90% at 12. And the medical exceptions are basically the way people are working through this. And we have a great field reimbursement team that is there to provide that end to end reimbursement support to make sure we can pull through those scripts as quickly as possible. But different plans will take different times, and that's what we're obviously very conscious of. At the same time, I will say we have a couple of early wins that we're really proud of. One I would say is the J code, which sometimes is, having a miscellaneous J code is great, but having the J code come through is actually really important. And just simplified the whole billing and reimbursement process. And we got confirmation that our J code is coming through for October 1st. You probably know from other launches, usually that takes at least two to three quarters. And so that's a little bit ahead of our expectations. And then we've had some early commercial wins. We are some plans have come in as of August 1st. And then we've had also some state Medicaid wins. And namely, I just wanna highlight, we have a couple more than this, but two out of the four biggest prep states, prevention states are California and Florida. And both of those are on formally as of August 1st. So we're really pleased to see that more and more lives are getting access and working through kind of those medical exceptions as we go. And really high interest from a lot of our payers to make sure we can have those discussions. So we've engaged with multiple accounts, over 200 accounts we've engaged with to make sure they have all the information they need to make those formular decisions. And so that's what we're working through. And that's obviously gonna take a little bit of time, as you know, but I think we're very well on our way to achieve our goals. So super excited, hopefully you can hear it and see all the data to the proof points to support it. I think we have the right team, the right attitude and the responsibility to make sure we really make a difference here with Yes to Go and then the curve of this epidemic. So stay tuned as a little bit more data comes through in the next quarter and more to come.

Thanks, Joanna. Thanks, Tyler, for the question. I just wanna add, I'm really impressed with the team's early launch support here. And we look forward to updating you in quarters to come. Can we have the next question, please?

Our next question comes from Terrence Flynn at Morgan Stanley. Go ahead, Terrence, your line is open.

Great, thanks so much for taking the question and congrats on all the progress as well. Joanna, you mentioned Discovy had one of its best quarters ever. I think if you look at the growth trajectory there, it's obviously been very robust and looks to be tracking well above the 8% rate that I think is implied in your longer term guidance for the prep market when you guys look out to 2030. So just wondering how durable this kind of a growth rate is given what you're seeing out there in the market and a lot of the work you're doing you've done ahead of the Yes to Go launch. And then just one clarification, can you just comment on the accuracy of Yes to Go IQ via data for us if you have any visibility there? Thank you.

Sure, thanks, Terrence. So a couple of things. One is the prep market is growing nicely double digit, right? About 15% or so year on year. And that obviously has to do with a lot of the work that we've been pulling through a lot of initiatives in the field to increase awareness about prevention and the importance of prevention. And that's why we were excited to share that those numbers are growing quite actively and we're at about 500,000 or so active users in prep, which is well on our way to kind of those goals that you were referring to of over a million by mid 30s. We do think that there's an opportunity for us to basically continue that growth in the marketplace, especially with the excitement with Yes to Go. I think the purpose one and purpose two data are just so powerful that they're really having impact in the field. So we will continue to drive that. To your comment around Discovy and the incredible performance that we've been seeing with Discovy and right, that 35% share, a lot of that has to do with basically continued favorable access that we've seen over the last six to nine months or so, where we're seeing the copays come down to $0 in many cases, our access basically jumped up a little bit. And we're now at about, if you think about unrestricted restricted access, we're at about 88% of total lives covered and we are about 98% total covered lives. So about 10% still have a little bit of restrictions, either step at it or prior off, but that's actually a big jump. And then the teams have done an incredible job with those plans that had those changes is really to increase those shares of Discovy in those plans. So that's what you're seeing in the uptake. What I would suggest though, is as Yes to Go gets traction and ramps up over the next coming quarters, you will probably see a little bit of a decline because the intent with Yes to Go is obviously to look at the total prep market and make sure that we're differentiating there across all the Orals as well as other long acting. So you will see a little bit of a shift in the mix, right as we go forward. Hopefully that addressed that question and your quick comment on IQVIA data. Listen, it's still really early, but we do believe IQVIA data is directionally aligned. It just some accounts, some channels are not represented in IQVIA as you well know, so they're not reflected in the data. I think we're gonna need a couple of more quarters to stabilize as you've seen in the past with other launches. Having said that, we were so pleased kind of with what we're seeing in the initial uptake, the customer response. I think I will tell you the excitement's palpable internally, externally, and I would also say that we're also tracking really closely kind of the customer uptake as well, right? So as it goes through into the reimbursement because our teams are making sure that we can pull those scripts through and what really matters through IQVIA is users that are getting the injection. So we're tracking both of those really closely. So stay tuned, but I think a couple more quarters will help us kind of normalize that data.

As a reminder, we ask that you please limit yourself to one question so we can get to as many analysts as possible on today's call. Our next question comes from Umar Rafat at PEPR-Corps. Umar, go ahead, your line is open.

Hi, guys, thanks for taking my question and congrats on all the progress with you, Tugo. I figured I'll go in a different direction on potentially a risk factor for the business. In a scenario where the industry does converge around an MFN proposal, which is focused on Medicaid, how do you see the impact of Gilead business from a revenue perspective and obviously inclusive of the mandatory and CPI rates if you do pay to Medicaid already? Thank you very much.

Yeah, thanks, Umar. Maybe I'll start and then I'll hand it over to Joanna to talk specifically about the Medicaid portion of it. I just wanna be clear that obviously we are having discussions and working with the administration on the whole topic of MFN. I would say just as a backdrop to all this, given the general business uncertainty in the country and also some of the sector-specific uncertainty, it's even more important to talk about the fact that it's even more important that we're at this stage in Gilead's history of driving forward with all these new launches, controlling operating expenses. And I remind you, as you know, we have very limited patent exposure until the end of 2033 with a very strong clinical development plan to be able to support the patients with that medicine prior to 2033. So I'll just put that in the backdrop. Obviously, we very much support the concept of finding ways to have patients better afford their medicine in this country while also preserving the right ecosystem here. Now, specifically related to your Medicaid question, I'll hand it over to Joanna to talk about how that could or could not impact us.

Right, I mean, so you know Medicaid business for us in HIV. I'm gonna focus on HIV, biggest piece of our business is around mid to lower 20s. And so that is something that is important to us. Remember, the co-pays, so the patient -of-pocket cost for Medicaid is incredibly low. It's either zero dollars or a couple of dollars per script and there's a lot of support for that. I mean, obviously what we're tracking is also not just potential demo projects and things like that with MFM, but we're also tracking the current legislation with Medicaid as to the big, beautiful bill. And we are tracking that, realizing that most of those have implications late 26 into 27, so no immediate impact at this point in time. Having said that, all of that said, HIV is very different. And it is a disease that obviously if you don't treat it, I think the repercussions and the consequences are not just that individual patient. It could be much broader, such as a local epidemic of HIV in the United States. And so that's why many individuals, or most individuals that are diagnosed with HIV, there's really always a safety net program to support them in their treatment. And whether that state programs, ADAP programs, foundations, or even Gilead's patient access programs, these are all pieces of the puzzle that we're thinking through to make sure we wrap around to make sure that those patients get coverage and access to the medicines they need.

Our next question comes from Evan Singerman at CMO Capital Markets. Evan, go ahead, your line is open.

Well, thank you for the question and really congrats on the progress. Given the importance of the S2GO launch and the recent changes to the HHS Preventative Task Force, if PrEP is removed as a preventative medicine broadly, how does this change your approach to commercialization and is there a potential also impact to the community? Thank you so much.

I heard most of that. It's Joanna, Evan, I'll pick that one. Yeah, so listen, let me start by saying the USPSPS guidance is something we truly support. We believe in preventative services. We think it's very important across all diseases, but namely in HIV when you think about prevention. The current guidelines are well enforced. They support the $0 copay and without access restrictions or step edits or whatnot for HIV prevention. And we believe that also includes the S2GO as we're going forward with those conversations with the plans. As I mentioned earlier, DISCOVIA is well covered, 88% of access with no restrictions. Having said all of that, if there was to be a change in the future, not that we foresee that, if there was to be change, I just wanna remind you that these guidelines didn't really have legs until probably less than a year ago, probably about two, three quarters ago. And before that, the prevention market was still growing very strong, same rates basically that we're seeing today. And we were very successful with DISCOVIA at about a 40% share or so. We're now closer to about a little bit towards the 44, 45% share now and the market's still growing at around the same rate. So we do believe that whether we have UFPS-TF, that's ideal, if it was to change in any way, we still believe we could work through it and just work closer with our payers to make sure that people have access to HIV prevention moving forward, just as they do today.

Our next question comes from Chris Schott at JPMorgan. Chris, go ahead, your line is open.

All right, great, thanks so much. And yeah, congrats on the progress. I just wanted to ask about the treatment pipeline and specifically just elaborating your confidence on the 4182-1720, the weekly treatment combo, the WONDERS program following the clinical hold announced earlier this year. I guess just kind of next updates we should be watching for on that combo and just how does that stack up relative to some of the other treatment combos that you're working on? Thank you.

Hey Chris, we'll get deep Mars, Boris here. Yeah, thanks Chris for the question. Our confidence in the treatment pipeline is high, right? And remember, we not only work on a weekly approach, we also work on daily, monthly, every three months and every six months approaches. So the pipeline is deep, we have a variety of different molecules. And if you look at 4182 and 1720, one of them is a Lena Capovia ProDRAC, the other one is an INSTY and we have several other molecules of those classes in our portfolio. So what we're currently doing is we're trying to understand the data further, we're doing preclinical and clinical analysis to really isolate the observation that we had to make sure we understand which of the molecules led to that observation. And then to move forward expeditiously with one of our other molecules that we have in the portfolio in a new combination to really get that weekly treatment opportunity to patients. I also wanna mention that we obviously have our Phase III Island Program, is Latravia and Lena Capovia ongoing, which is currently in Phase III, the next update on that program is coming 2026 and the estimated launch for that one is in 27. With regards to our wholly owned program, kind of the wonder program and the succession of that, we will update you in due course.

Our next question comes from Jeff Meacham at Citibank. Jeff, go ahead, your line is open.

All right, great, hey guys, thanks for the question. You had another one on yes to go. It seems like the OUS contribution, I think it's gonna be much bigger when you compare to Discovia or Truvada in PrEP. Joanne, I'm not asking for guidance, but when you think about the US versus OUS contribution for HIV treatment, could that ultimately mirror what you will see in PrEP kind of at the peak? I guess that's what I'm asking is that outside the US market is one that's sort of novel and new for you guys and wanna get some context there, thanks.

Thanks, Jeff. I do think that you're right. I think there's a broader opportunity with yes to go ex-US and a lot of that has to do with Discovia, we were kind of challenged in many markets, the comparator was Truvada and Truvada was generic in many of those markets. With yes to go, I think with the innovation, the transformational value that we are bringing for markets that truly recognize the need for something else in HIV prevention and recognize the value of Lenin-Kaffir and what it brings to their populations or their specific target populations where you see an HIV incidence that is very high. I really do think there's an opportunity for us to have broader footprint than just where we are today with Discovia, for example. And so I think at, to your point at steady state or at peak, I do think maybe that'll take a little bit of time because I think the challenge from a reimbursement standpoint will not be simple, but I do think for the countries that have literally said and did very outspoken that they wanna bend the curve or that they're not meeting their 2030 targets, which nobody is, this is really an opportunity for us to partner with those stakeholders and make sure that yes to go is available for those countries.

Our next question comes from Mohit Bansal at Wells Fargo. Mohit, go ahead, your line is open.

Great, thank you very much. And Johanna, you are very popular today, so one more for you. So the question is regarding the logistics as well as the safety side of it. So just wanted to understand for yes to go, the logistics dynamic, because this is a base, this is a prescriber base that is used to oral and now they're going to use an injection which is also at doctor's offices. So how are you navigating that and would it take some time to help understand prescribers the entire dynamic? We'd love to understand that, thank you.

Sure, sure. And as we were preparing for this launch, we were leveraging a lot of the learnings of past launches in this space or launches that went from an oral to injectable just to understand what we needed to do to prepare for it. And one of the key things was education and making sure that was optionality flexibility for where they go. So at launch, we were able to offer our customers, RHCPs, the clinics to make sure that they understood that they could prescribe it and do buy and bill in their office. We also offered them to make sure that if they could prescribe it and then send the script to specialty pharmacy and they would do all the background work and then send the product back for the injection with the user, the consumer. Or if they didn't want any of that, they could go to an alternate site of care and basically just send with the script, the consumer to that alternate site of care for their injection and do all the reimbursement background work. So I think we set it up with a lot of flexibility and what we're seeing, although very early, what we're seeing is exactly kind of what we thought. We thought at the beginning, we're gonna see a lot heavier towards specialty pharmacy. The buy and bill would be more the clinics that were already doing buy and bill in the past and a little bit of alternate site of care is happening as well, but few and far between. And so I think it's still very early to kind of assess where that's looking for. But I will say one of the biggest differentiation is I talked a little bit earlier around cross-functional network and partnerships. The teams are set up across the US so that they have a full cross-functional team, whether it comes with nurse educators, field reimbursement, the medical representative, the commercial sales representative and they work together in pods. So what they've done is actually set up meetings with a lot of these clinics around the country together so that they could answer all the questions at the same time to navigate the process, the logistics for Yes2Go. And that has apparently had incredible success. Our customers aren't used to that and they've been incredibly appreciative and satisfied with what we've been bringing so that they have all their answers when they need it so that they can put pen to paper and prescribe for their patients. And so I think we're managing it incredibly cross-functionally and making sure that we understand the complexity of the logistics, but making sure the customers see it as simple. And so that's our goal.

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

Hi, well, thanks so much for taking my question today. Probably another one for Joanna, I think. You spoke a little bit about kind of you've been surprised positively so far in the Yes2Go launch around access and around kind of the connecting of the dots that the team has been able to achieve and the scripts and the actual injection rates. Why didn't you raise the launch expectations or the guidance as you thought about kind of the Yes2Go launch for the remainder of this year? What are the things that are still question marks in your mind that would give you confidence to kind of raise your own expectations in terms of this launch for the early parts and what we might see this year? Thank you.

Courtney, great question. And I think I would answer it with two ways. One is it's still very early, right? We're six weeks into the launch, so that's one. Two is access is critical here. And so we're managing one-offs on medical exceptions every time our field reimbursement team hears that there is a little bit of a block somewhere and we're working through it with the plan. But I think more importantly, we really need to see the number of covered lives increase over the next quarter or two to really see that momentum and really pull through those intake calls into scripts and injections. And so that's kind of the piece that we're waiting to see. And so I think you can ask me that question again in a couple of quarters and we'll go from there. Our

last question comes from Carter Gold at Tantor. Carter, go ahead, your line is open.

Great, thank you. Good afternoon, congrats on all the Yes2Go progress. Maybe to switch things up, I just wanted to ask on sort of your continued confidence on a need to sell approvability based on a single arm study. I'm familiar with the feedback your partner received some time ago, but since then there's been buy specific approvals. Competitor Cartese have had confirmatory data coupled with obviously no shortage of disruption across CBER and FDA. So just how you get comfortable with the feedback from years past still applies and if there's been ongoing feedback that bolsters that confidence, thank you.

Yeah, I know we're not communicating our regulatory strategy other than to say that we are continuing to have conversations with the FDA and are looking forward to launching in 2026. We don't have any major shifts in the things that we've communicated before and are looking forward to filing a need to sell.

Thank you. Great, this is Dan. I just wanna thank everybody for your questions today and for joining the call. Maybe just a couple of closing comments from my side. You know, as we've shared today, this has been a really successful second quarter with growth drivers from all three of our therapy carriers contributing to the 4% growth in the base business, more than offsetting the anticipated headwinds we have from the Medicare Part D redesign. Just to remind you all, we're incredibly proud, you know, of and much of the call was devoted to this to have delivered the world's first twice yearly prevention for HIV with Lenin-Capivir in the US. It's really off to a very strong start. We'll continue to update on the quarters with that. But in addition, of course, we had the positive CHMP opinion on yes to go and a great start overall with the launch. So we're incredibly impressed and proud of where we believe this will go. And overall, it's also been one of our strongest clinical quarters we've ever had. You know, we didn't speak about it so much today, but in addition to that, we had the -to-back positive phase three results for Tridelby, and we just finished with the last question on the needle cell and cell therapy and the broader cell therapy pipeline, I would say. And, you know, this top line performance is transforming down to the bottom line. And it's a really special time at Gilead with so many launches, imminent launches. Yes to go to the Delvey, Tridelby first line potentially coming up as well as a needle cell. So it's a strong time for the team. So I just want to take this opportunity to thank the Gilead team for the incredible efforts they're putting into driving this level of innovation. I want to thank all of you for joining us today. As usual, our IR team is available for follow-up and any questions that you have. We wish you a great rest of your day and thank you for your interest in Gilead.