Thank you, Rebecca. Just after the market closed today, we issued a press release with earnings results for the first quarter of 2025. The press release, slides, and supplementary data are available on the section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Dietmar Berger, and our Chief Financial Officer, Andrew Dickinson.

After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements. Please refer to slide two regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. I'm pleased to share our first quarter results, which reflect strong commercial and clinical execution across the business. Our base business, excluding Veclury, grew 4% from the first quarter of 2024, primarily driven by growth in our HIV business. HIV sales were up 6% year over year, with Biktarvy up 7%, highlighting our demand-led volume growth that was offset in part by the expected headwinds associated with the Part D redesign.

Livedelta continues its strong launch momentum, with $40 million in sales in its second full quarter since launch. Year-over-year growth in our HIV and liver disease businesses was partially offset by softer than expected Trodelvy sales due to inventory dynamics that masked increase in demand, as well as headwinds in cell therapy. Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations.

Beyond our commercial results, we also saw impressive operational execution with strong operating margin and earnings per share results that highlight our continued focus on expense management and leverage in our business model. Our diverse pipeline continues to deliver across HIV, oncology, and inflammation. In HIV, we are now only weeks away from the anticipated FDA decision on twice-yearly lenacapavir for PrEP. We remain on track for the June 19 PDUFA date with the potential launch in the US immediately following.

As a reminder, this is one of up to nine potential HIV products we are targeting before the end of 2033, building on Gilead Sciences, Inc.'s decades of leadership in HIV innovation. In oncology, earlier this week, we announced the positive results from the phase three ASCENT-04 study of Trodelvy in combination with pembrolizumab for first-line PD-L1 positive metastatic triple-negative breast cancer. The results showed a clinically meaningful and statistically significant improvement in progression-free survival over the standard of care.

This news represents an important potential benefit for patients. Metastatic TNBC, one of the most aggressive forms of breast cancer, has historically been very difficult to treat. We expect to share the ASCENT-04 data at a medical congress in the near future and to file with global regulatory authorities as quickly as possible. We continue to expect an update later this quarter on the phase three ASCENT-03 study evaluating Trodelvy monotherapy in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-1 inhibitors.

Moving to cell therapy, we plan to provide an update on our registrational phase two IMagineOne trial later this year and remain on track to potentially launch anetocel in late-line relapsed refractory multiple myeloma in 2026. We believe that anetocel's clinical profile, combined with Kite's exceptional manufacturing capabilities and industry-leading turnaround time, puts us in a strong position to address the unmet need for patients with multiple myeloma. In inflammation, we are launching Libdelzi in additional markets following approval from the European Commission in February.

We look forward to continued momentum as we bring Libdelzi to more people seeking to manage their primary biliary cholangitis with a differentiated option. As we wrap up a strong first quarter performance, we can look forward to continuing positive momentum. We have multiple potential launches ahead, including lenacapavir, anetocel, and now Trodelvy. As a reminder, we have no major LOEs until the end of 2033 and expect to drive top-line growth over time across all three of our therapeutic focus areas of virology, oncology, and inflammation.

The overall strength of our business means we are well-positioned to adapt to a range of potential policy outcomes in the United States. It is worth noting that Gilead Sciences, Inc.'s average corporate tax rate of approximately 20% reflects the fact that the substantial majority of our intellectual property is already registered in the United States. The 2017 tax reform was instrumental in us bolstering our US investment, and Gilead Sciences, Inc. is differentiated in that almost a % of our R&D capital infrastructure is in the US.

In addition, we have been increasing our investment in US manufacturing over the last several years, with two large-scale cell therapy sites, and we have additional investment projects underway that are expected to run through 2028. Our focus is on delivering on our multiple upcoming launches and advancing our diverse pipeline. In the meantime, we continue to engage with the administration to encourage a balanced policy agenda that prioritizes innovation and the needs of patients. With that, I'll hand it over to Joanna.

Thank you, Johanna, and good afternoon, everyone. We have made a lot of progress in the first quarter, with some exciting lenacapavir updates at CROI, and our first pivotal Phase III top-line readout for Trodelvy in breast cancer since 2022. The quality of these readouts highlights the breadth and depth of clinical expertise across Gilead Sciences, Inc., with the potential to support growth in our target therapeutic areas with new commercial launches in the years ahead.

Starting with HIV on slide 15, we shared 20 abstracts at CROI, including data that showcase lenacapavir's potential even beyond the remarkable results we saw in PURPOSE 1 and PURPOSE 2 last year. For example, we shared our phase one data that showed once-yearly intermuscle injections maintained lenacapavir blood concentrations above those shown with twice-yearly subcutaneous for more than twelve months. The injections were generally well tolerated.

These data were published in The Lancet, and we look forward to initiating a phase three study for once-yearly lenacapavir for HIV prevention in the second half of this year. As a reminder, for our twice-yearly subcutaneous injection of lenacapavir for HIV prevention, we have already submitted NDA, MAA, and EU medicines for all applications with FDA and EMA. Further, we've submitted filings with regulatory bodies in South Africa and Brazil, and continue to make good progress in all our discussions with the global regulatory bodies.

In particular, we have not experienced any disruptions in our interactions with and we continue to expect a regulatory decision by June 19. In HIV treatment, we shared phase two data at CROI evaluating twice-yearly lenacapavir plus two broadly neutralizing antibodies or BNABs in biologically suppressed people with HIV genotypes that are highly susceptible to both BNABs. At week twenty-six, the combination regimen maintained biologic suppression with high efficacy similar to the stable baseline regimen comparator.

There were no infusion-related reactions to the BNABs, and no discontinuations due to injection site reactions. Lenacapavir plus BNABs has already received breakthrough therapy designation from FDA, and these phase two data further underscore the potential for this combination to be the first complete twice-yearly treatment regimen for virologically suppressed people with HIV. Phase three planning is in progress. Touching upon liver disease on slide 16, we announced the European Commission granted conditional marketing authorization for Livedelzi for the treatment of primary biliary cholangitis or PBC.

The decision reflects Livedelzi's clinical benefit across key biomarkers of PBC and related pruritus in the phase three response trial. In addition, we continue to make progress on our phase III IDEAL trial, which is evaluating the efficacy of Livedelzi in PBC patients who are partial responders to UDCA, potentially doubling the addressable patient population. Overall, we are excited by the opportunities to bring this differentiated treatment to more patients across the world.

Moving to oncology on slide 17. I'm very pleased to share Trodelvy plus pembro demonstrated highly statistically significant and clinically meaningful progression-free survival benefit over standard of care in the phase three ASCENT-04 trial in first-line PD-L1 positive metastatic triple-negative breast cancer. Triple-negative breast cancer is the most aggressive type of breast cancer that disproportionately impacts younger premenopausal women.

We look forward to being able to potentially bring the benefits of Trodelvy to these metastatic triple-negative breast cancer patients in the first line. We will be submitting these data for presentation at a future medical congress and will engage with global regulators as quickly as possible. Further, we expect to provide an update from the phase three ASCENT-03 trial, evaluating Trodelvy monotherapy in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-one inhibitors later this quarter.

We also remain focused on clinical execution of our seven other ongoing Phase III programs for Trodelvy and domvanalimab across six tumor types. Moving to slide 18, and on behalf of Cindy and the KITE team, we are pleased to be sharing new data from our next-generation products, at the upcoming ASCO meeting in June, including Phase I data from KITE-363, our 19, 20 CAR T relapsed or refractory large B cell lymphoma, and phase one data from the bisistronic EGFR IL-13 RA2 CAR T for glioblastoma in collaboration with the University of Pennsylvania, Perelman's School of Medicine. We believe KITE-363 could offer deeper, more sustained responses with a potential to overcome certain resistance mechanisms, given its ability to target both CD19 and CD20.

Additionally, we believe its dual costimulatory domains balance effects such as rapid tumor circling, and CAR T cell proliferation and persistence in an optimal way. This could result in a potentially improved overall efficacy and safety profile in B cell malignancies. Further, we believe many of these potential benefits could translate to B cell-driven autoimmune diseases, and have filed an IND to evaluate KITE-363 in this area as well.

For anetocel, our pivotal IMagine I study in fourth-line plus relapsed or refractory multiple myeloma is ongoing. And we look forward to providing an update in 2025. In the second-line plus setting, we are pleased to announce the phase three IMerge III protocol has been amended to include minimal residual disease negativity as a dual primary endpoint in addition to progression-free survival. We're excited for this positive step to potentially bring anetocel to in earlier line settings, and remain confident in anetocel's profile across efficacy and safety, combined with Kite's leading manufacturing capabilities.

Finally, on slide 19, we achieved several important milestones this year, including European Commission conditional approval of Livedelzi, positive Phase III top-line readout from ASCENT-04, and initiation of the phase three EVOQUE small cell lung cancer study. We anticipate an update from the phase three ASCENT-03 trial later this quarter. Additionally, in virology, we remain on track to provide an update of the data from our phase two one-dose one trial, our wholly owned once-weekly INSTI containing oral treatment for HIV, at an upcoming medical meeting. And now I'll hand the call over to Andy.

Thank you, Dietmar, and good afternoon, everyone. Our first-quarter results reflect both strong operating and commercial execution.

As shown on slide 21, our base business was up 4% year over year to $6.3 billion, largely driven by growth in our HIV and liver disease business, partially offset by lower oncology sales. Veclury sales were down 45% year over year, resulting in a 1% decline in our total product sales to $6.6 billion. Moving to our non-GAAP results on slide 22. For the first quarter, product gross margin was flat year over year at 85%, in line with our full-year guidance expectation of 85% to 86%.

R&D expenses were down 5% year over year, primarily due to lower clinical manufacturing activities. Acquired IPR&D expenses were $253 million, primarily driven by the LEO Pharma STAT6 collaboration we announced in January. SG&A expenses were down 6% year over year, reflecting lower corporate expenses, partially offset by incremental selling and marketing spend in the United States. First-quarter operating margin was 43%, highlighting our ongoing commitment to continue to operating expense discipline and delivering top quartile margins once again.

The non-GAAP effective tax rate was 16% this quarter, below our historic average, largely driven by tax benefits from stock-based compensation. And finally, non-GAAP diluted EPS was $1.81. Moving to our full-year guidance on slide 23, we are not making any changes to our revenue expectations or non-GAAP P&L guidance at this time. As we reflect on the tariffs that have been enacted to date, these could increase some of our indirect costs, but are expected to be manageable in 2025, in part due to potentially lighter FX headwinds than previously expected.

For 2025, therefore, we continue to expect total product sales of approximately $28.2 to $28.6 billion, product sales excluding Veclury of approximately $26.8 to $27.2 billion, 2025 HIV sales to be approximately flat compared to 2024, with demand-driven growth offset by the impact of the Medicare Part D redesign. Veclury sales of approximately $1.4 billion. While the first quarter was lighter than expected, we know this can be a highly variable business. With that in mind, and consistent with our approach last year, we do not expect to update our Veclury guidance until our third-quarter earnings call.

Moving to other parts of the P&L for full-year 2025, on a non-GAAP basis. We continue to expect product gross margin to range between 85% to 86%, R&D expenses to be roughly flat from 2024, acquired IPR&D to be approximately $400 million, including the $253 million of expenses in the first quarter, as well as known commitments and expected milestone payments. SG&A expenses to decline by a high single-digit percentage compared to 2024, operating income to be between $12.7 to $13.2 billion, effective tax rate to be approximately 19%, and finally, diluted EPS to be between $7.70 to $8.10 for the full year.

Looking ahead, we will continue to monitor the macro landscape carefully. And we expect that our disciplined approach to operating expense management positions us well to adapt as needed in the months ahead. Finally, on slide 24, our capital priorities remain unchanged. We have already returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases. And we will continue to pursue disciplined expense management and careful investment in the most promising pipeline opportunities both internally and externally.

I'm also pleased to note that S&P recently upgraded Gilead Sciences, Inc.'s long-term debt rating from BBB+ with a positive outlook to A- with a stable outlook, recognizing the outlook for our HIV franchise and other products, combined with steady revenue growth and strong cash flow generation. Overall, Gilead Sciences, Inc. is on track to continue delivering demand-led volume growth, a disciplined operating model, and strong cash flow that positions us well for the rest of 2025 and beyond. With that, I'll invite Rebecca to begin the Q&A.

But I just wanna be clear that to date, we haven't heard or seen anything that would cause us to alter our plans or expectations for the LEN for PrEP launch or adversely affect our HIV business. Obviously, we're staying very closely attuned to this. And importantly, we're having discussions with policymakers to emphasize the importance of lenacapavir for PrEP and in particular in relation to their stated goals of addressing chronic diseases in this country, and the value of prevention.

We think that LEN for PrEP is really well positioned there. You know? So specifically, relative to the government support, you know, and in particular, you mentioned CDC Carter. Obviously, responsibilities include, you know, research and surveillance of HIV. They include supporting efforts around diagnosis and linkage to care. We're also involved in those activities, but again, nothing we've seen so far suggests that those core services are in a position to change our approach to the launch. And maybe with that, I'll hand it over to Johanna if she has any other questions or if you wanna comment on FDA too.

Yeah. And then on the FDA side, at this time, you know, all our interactions with the FDA have been on track, have been as expected without any surprises, so we've not experienced any impact to our LEN for PrEP filing or any of our clinical trials actually to date. Right? And we continue to expect the lenacapavir decision by June 19. Our next question comes from James Shin at Deutsche Bank.

Great. Thanks, Salveen. Let me just start at the high level and then I'll hand it over to Andy or Johanna to comment a little more deeply. Just to emphasize what you said around the tariffs, I think at the highest level, of course, we separate them into two different categories. One is kind of indirect tariffs, which are related to, you know, all businesses. And for us, there are things like steel, lab supplies, chemicals, reagents, and, obviously, there, we have some known understanding of what those tariffs will be.

And what we see so far today, we've absorbed into our guidance without changing our guidance for the rest of the year. And Andy can comment a little further on that. And then the other category of tariffs are obviously the pharmaceutical-specific tariffs. Which are not enacted today. They've only been, you know, discussed and chatted about. We obviously haven't speculated on those nor included those. But to your point, I think that there is a difference relative to Gilead Sciences, Inc.'s makeup and setup that is important when you consider those tariffs.

And that is that the vast majority of Gilead Sciences, Inc.'s IP is in the US, and what that suggests is lower value for its pharmaceutical imports. At the end of the day, which is the value on which tariffs would be placed. In fact, more than 80% of Gilead Sciences, Inc.'s profits are recognized in the US. To your question around the supply chain, it's quite a complicated answer. We do have the strongest footprint we have is in the United States.

Like most companies, we leverage both internal and external manufacturing on a global basis. And we're always looking to adapt that to make sure that we have good continuity of supply across the world so that we can do that accordingly. I'd also say that we've invested significantly in our manufacturing infrastructure in the United States over the past many years. And our R&D infrastructure. Including, you know, opening cell therapy manufacturing sites.

And we have four large-scale US investment projects in progress that are expected to run through 2028. So it's difficult to get into the detail of every product and supply chain, but I think we're well-positioned overall. I would ask Andy to comment and maybe Andy or Johanna on the Medicare part can read his.

Sure. Hi, Salveen. It's Andy. Just to confirm what Dan said, our updated guidance does reflect the expected impact of the increase in indirect costs that we've seen from both announced tariffs, and reciprocal tariffs. As well as our general expectations for the inflationary environment that we may be moving into. And as you can expect, there are a number of puts and takes in the P&L, but as you look again at another very strong quarter of disciplined expense management, that helps us absorb some of those additional costs.

There's also a bit of a tailwind, as you've heard from our peers, as terms of the US dollar has weakened for those of us that are based in the United States. There's a tailwind relative to our budgeted FX amount. That will help offset some of those as well. So we're very confident today that with the strong growth you saw in the base business in the first quarter, despite the Part D impact, which Johanna can speak to, even with the tariffs, we're happy to reconfirm guidance for the year, and we feel like we're in a good spot.

Thank you, Geoff, for the question. Right? That's really early in our development program here. I think the important piece is that we're looking for optionality. We're really looking for the breadth and depth of the portfolio to deliver for people basically with monthly and weekly and, you know, in the PrEP setting, obviously, once every six months and potentially also once every year options. In the immediate future, obviously, we're really looking forward as discussed, right, to the len for PrEP launch.

But then we also had data at CROI, right, where we were talking about the potential of lenacapavir for once every year, PrEP, and that of course are some of our focus areas. Obviously, we will look at the overall portfolio and see with the options that we want to develop, which ones we can take forward.

Well, it's Cindy Perettie. We don't comment on the delta that they're looking for, but what I would share is that this is a dual primary endpoint. And so being able to use MRD we know today that that correlates to PFS, and it also allows us to assess you know, within months of the treatment if the patient is having a response. So our goal is to use the MRD negativity endpoint first, and then follow that up with progression-free survival, but correlation between the two is what we're talking to regulators about.

Evan, thank you for the question. I think that we have shared probably in the previous quarter and this quarter, we're seeing the dynamics from both bispecifics as well as in-class competition. And I think it depends as you look at Yescarta and Tecartus on those dynamics. We have a number of new approved indications in class within class competition outside of the US, and that's some of the dynamics you're observing outside of the US.

Within the US, in some of the more smaller markets that Tecartus is competing in. We're seeing new indications as well with in-class competitors. But we're also seeing new indications in the US and Europe with the bispecific. So it's both that we're observing right now. So hopefully that answers your question.

Thanks, Courtney, for the questions. That's very insightful. Right? We are currently looking into the different study designs, right? We have not commented exactly on what we're planning on doing at this point in time. But you're absolutely right, there are different study designs that you can utilize and potentially a PK-based approach is a possibility that we're discussing.

Thanks, Mohit. Let me start. This is Dan, and then Johanna can turn the ad as well. I just wanna repeat that we haven't seen or heard anything to date that would cause us to alter our plans or expectations. In the HIV field, including the LEN for PrEP launch. I mean, I think it's too early to speculate on anything related to Medicaid. At this stage. There's no confirmed cuts at this time. I believe the administration understands the importance of particularly chronic diseases and prevention as they approach that.

I'd also say at the CDC side, you know, we're obviously strong supporters of the CDC and also the role that NIH plays in creating a scientific community. But specifically relative to CDC, it's still too early to understand any impact on particularly CDC programs. They're generally focused on supporting PrEP utilization with community outreach, provider training, and education. Those are also things that we do as well.

Maybe I'll turn it over to Johanna to say how she sees it in terms of how some of our programs may be able to make sure that services are delivered to the people that need these medicines.

Terrific, everybody. Let me wrap up by thanking the Gilead Sciences, Inc. teams that are responsible for this great start to the year. Just say that, you know, on behalf of all of us, the strong base business growth of 4% year over year and 6% growth in our HIV business. Combined with the continued success of the Ladelzi launch and growing demand for Trodelvy, alongside the impressive operating margin and earnings share, all demonstrate that we have a strong and efficient business today, which I think is extremely important given the current environment that we're all operating in.

And moving forward, we're also excited about what's next. Our diverse pipeline and generating multiple upcoming potential launches, including lenacapavir for PrEP, which is, you know, weeks away, Libdelzi in further markets, Anetocel, and now Trodelvy based on the positive phase two results from the ASCENT-004 study all fill us with great promise as we continue on a diversification approach and confidence in our business overall. So this is an exciting time for Gilead Sciences, Inc.

The ongoing work that we all do for patients in the communities we serve. And I just wanna close by thanking you all for joining us today. We look forward to keeping you up to date on our progress as the year continues.