“We continue to work towards global regulatory filings as quickly as possible with potential for launch of the first weekly oral in 2027.”

In context

“Dietmar Berger (Chief Medical Officer): Thank you, Johanna, and good afternoon, everyone. We delivered another strong quarter of clinical execution across our 53 ongoing clinical programs, reflecting both the continued growth of our pipeline and our disciplined approach to portfolio prioritization. We expanded the breadth of our innovation engine through the acquisitions of Arcellx, Tubulis and Ouro Medicines, adding differentiated and potentially best-in-class cell therapy, antibody drug conjugate and bispecific T-cell engager assets. These acquisitions further complement the broadest and most diverse pipeline in Gilead's history. Starting with HIV on Slide 16. Gilead continues to expand and advance our industry-leading HIV pipeline. In treatment, we continue to evaluate 6 potential new daily and longer-acting orals and injectables for people with HIV. We anticipate once-daily bictegravir plus lenacapavir or BIC/LEN will be the first new addition to our treatment portfolio for virally suppressed people with HIV or the switch population. Combining 2 orthogonal mechanisms of action, each with high potency, BIC/LEN has the potential to deliver long-term viral suppression for people with HIV, including those switching from complex regimens. As previously shared, FDA has granted BIC/LEN priority review, and we continue to anticipate a decision by August 27. Turning to our once-weekly oral portfolio. We are making significant progress on another novel regimen for virally suppressed people with HIV. At the International AIDS Society Conference held in Brazil last week, Gilead shared data from 54 abstracts and highlights included oral presentations with a simultaneous publication in the New England Journal of Medicine on Gilead and Merck's once-weekly oral regimen combining islatravir plus lenacapavir or ISL/LEN. In the Phase III ISLEND-1 and 2 trials, ISL/LEN met the primary endpoints of non-inferiority versus both Biktarvy and physician's choice oral antiretroviral regimens, respectively. We continue to work towards global regulatory filings as quickly as possible with potential for launch of the first weekly oral in 2027. Beyond the switch population, we are developing 2 different potential once-weekly oral combinations of lenacapavir with our investigational wholly owned long-acting integrase inhibitors or INSTIs, which we believe could be a preferred option across a broad range of people with HIV, including treatment naive. We expect to initiate new Phase II trials in both the switch and naive populations with the first study evaluating once-weekly oral lenacapavir with oral GS-3242 starting before the end of the year and the second study testing once-weekly oral lenacapavir with oral GS-1720 starting in early 2027. We are pleased that GS-1720 has recently been cleared for further clinical studies by the FDA, so we are now able to move 2 Phase II clinical programs forward. We expect to advance the combination with the most compelling profile to Phase III. Focusing on twice yearly treatment intervals, we are now initiating our Phase III trial evaluating lenacapavir with 2 broadly neutralizing antibodies, TAB and ZAB. This regimen takes a novel approach targeting the HIV viral reservoir and could be the first complete twice yearly treatment regimen for virally suppressed people with HIV. We view this as a differentiated opportunity for a subset of the virally suppressed population and with potential for launch around 2030, it could establish an important early presence in the twice yearly treatment market ahead of our INSTI-based regimen currently in development. As you may recall, we first shared Phase I data for GS-3242 injection at the CROI meeting in February. Preliminary data showed the potential for dosing intervals longer than 4 months with additional data from the higher dose cohorts expected later this year. We started our first program of GS-3242 injection in combination with lenacapavir in June. For HIV prevention or PrEP, we have the broadest and most differentiated portfolio in the industry that we believe is uniquely positioned to meet individual preferences and needs. At the same time, we are investing in the next generation of PrEP innovation that we believe could continue to broaden the reach of PrEP and potentially accelerate progress towards ending the HIV epidemic. In June, the FDA accepted our filing for once-weekly oral lenacapavir for PrEP. The submission is supported by the robust and established clinical profile of Yeztugo for PrEP from the pivotal Phase III trials in which more than 99.9% of participants did not acquire HIV infection. We anticipate a regulatory decision by February 2, 2027, and look forward to the opportunity to add the first long-acting oral prevention option to our industry-leading portfolio. Looking beyond daily, weekly and twice yearly options, we have completed recruitment for PURPOSE 365, evaluating once yearly intramuscular lenacapavir for PrEP. We expect to provide an update in 2027 with potential to launch in 2028. Taken together, we believe our HIV portfolio provides a strong foundation for long-term leadership and durable growth with multiple opportunities to expand choice across both treatment and prevention, a deep pipeline of differentiated innovations and a steady cadence of catalysts ahead, we are well positioned to create value for patients, health care systems and shareholders while advancing our vision to end the HIV epidemic. Turning to liver disease on Slide 17. We continue to build on our long-standing commitment to advancing innovative therapies and generating additional clinical data aimed at improving the lives of people living with serious liver conditions. This quarter, we reached an important milestone in HDV with the FDA's accelerated approval of Hepcludex, the first and only FDA-approved treatment of chronic hepatitis delta virus infection based on data from the Phase III MYR301 study. Chronic HDV is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure and liver-related death and impacts between 40,000 and 80,000 people in the United States. As a reminder, Hepcludex has been available in the EU since July 2020. We also announced positive top line results from the Phase III IDEAL study, evaluating Livdelzi in patients with primary biliary cholangitis, or PBC, whose disease remains inadequately controlled with alkaline phosphatase or ALP levels between 1 and 1.67x the upper limit of normal. Treatment with Livdelzi demonstrated statistically significant composite ALP normalization. This is a particularly important finding as these patients have been underrepresented in prior randomized trials. We're looking forward to sharing the detailed results at a future medical congress this year. Moving to oncology on Slide 18. We remain focused on disciplined execution of our core clinical programs and continued development of our research platforms that complement our ADC and cell therapy leadership. Specifically, we closed our acquisitions of Tubulis and Arcellx, adding Tubulis next-generation ADC platform with its novel linker and payload technologies alongside Arcellx differentiated D-Domain binder platform for future cell therapy development. At ASCO and EHA, we shared more than 25 abstracts spanning both ADCs and cell therapy that reinforce Gilead's long-term position in oncology. Focusing first on our ADC programs, we shared additional analyses from the Phase III ASCENT-03 and 04 studies, which continue to strengthen the evidence supporting Trodelvy with or without pembrolizumab in first-line metastatic triple-negative breast cancer. We are pleased that FDA have now approved Trodelvy for first-line treatment of metastatic triple-negative breast cancer based on results from the Phase III ASCENT-03 and 04 trials. These regulatory decisions provide a new potential standard of care for the most aggressive form of breast cancer in the first-line setting when it may have the greatest potential to provide a durable response and delay disease progression. Shortly following close of the Tubulis acquisition in May, we were pleased to present updated safety and efficacy data from the Phase I NAPISTAR-1-01 study, evaluating TUB-040, now known as GS-8824 in platinum-resistant ovarian cancer at ASCO. Across select doses, GS-8824, a NaPi2b directed ADC demonstrated deep and durable responses with a confirmed objective response rate of 61%, a clinically significant median progression-free survival of 11 months and a low rate of hematological toxicity. We believe GS-8824 has the potential to be transformative in ovarian cancer, given these results in biomarker unselected and heavily pretreated platinum-resistant ovarian cancer patients who have limited effective treatment options and short survival. Our pipeline now includes a Phase I/II clinical program in platinum-resistant ovarian cancer, and we continue to expect entering registrational development in platinum-resistant ovarian cancer as early as 2027. Further, we have added Phase I clinical programs in platinum-sensitive ovarian cancer and other advanced tumor types. In parallel, we are continuing to evaluate GS-8823, previously known as TUB-030, a 5T4 directed ADC as well as other potential research stage candidates utilizing Tubulis platform technologies. Altogether, Gilead is positioned to be a leader in ADC innovation long term. Moving to cell therapy on Slide 19 and on behalf of Cindy and the Kite team, with the completion of the Arcellx acquisition in April, we now have full control of anito-cel's development, enabling us to move with greater speed and focus in maximizing the long-term potential of anito-cel, including in earlier lines of multiple myeloma as well as the full potential of the D-Domain binder platform. With its deep and durable efficacy as well as a differentiated safety profile observed in the Phase II iMMagine-1 study, we continue to believe anito-cel has best-in-disease potential, and we look forward to a regulatory decision later this year. We completed enrollment of iMMagine-3 in second-line multiple myeloma this quarter and look forward to potentially filing in this indication as early as 2027. Reinforcing Kite's enduring operational and technical leadership across novel cell therapies, we presented data at ASCO showing a 98% first-pass manufacturing success rate and global median turnaround time of 18 days across anito-cel patients with multiple myeloma. As such, we are confident that we can quickly meet the needs of multiple myeloma patients that are awaiting potential anito-cel launch. In addition to our work on anito-cel, we're excited to unlock the broad potential of the D-Domain binder platform, which has applications far beyond autologous multiple myeloma CAR T. Combining Kite's extensive experience in CAR T clinical development with strategically selected business development, we are rapidly advancing our updated in vivo CAR T platform. We are developing a differentiated in vivo program that not only addresses class challenges of durability, safety and manufacturability, but also provides scalability for broad expansion across oncology and autoimmune diseases. Specifically, our smaller D-Domain binder enables bypassing payload challenges associated with viral vectors to target multiple antigens simultaneously. The plug-and-play modular interiors platform allows Kite to optimize CAR constructs and vector targets by diseases and our collaboration with Pregene enables speed to clinic, where we will start exploring our updated in vivo platform in 2 investigator-sponsored studies later this year. Moving now to our milestones on Slide 20. I'd like to recognize our research and development teams at Gilead and Kite and our partners whose tireless efforts have contributed to the significant progress we have made across our key clinical milestones. Since our last quarterly update, we shared 4 Phase III clinical trial updates and 3 FDA approvals. For the remainder of the year, we anticipate FDA regulatory decisions for BIC/LEN in virally suppressed people with HIV and anito-cel in fourth line or later relapsed and/or refractory multiple myeloma as well as a Phase III ASCENT-GYN update for Trodelvy in advanced or recurrent endometrial cancer. In addition to these milestones, we expect to share updates from our broader inflammation portfolio this year, including the Phase II SWIFT study evaluating GS-1427 or emvistegrast, our investigational oral alpha-4 beta-7 inhibitor for inflammatory bowel diseases and the Phase IIa COSMIC study evaluating edigisertib, our investigational IRAK4 kinase inhibitor in cutaneous lupus erythematosus. Taken together, these updates reflect the strength of the portfolio we have built and the opportunities that lie ahead. Now I'll turn over the call to Andy.”