길리어드 사이언스 2026년 3분기 실적 발표 요약

핵심 요약

• 길리어드 사이언스(GILD)의 베클루리 제외 2026년 3분기 제품 매출은 82억 달러로, 전년 동기 대비 16% 증가하며 10년 만에 가장 강력한 주력 사업 성장세를 기록했습니다.
• 전체 제품 매출은 13% 증가한 83억 달러를 기록했습니다. Non-GAAP 희석 EPS는 2.55달러였으며, Non-GAAP 영업이익률은 50%에 달했습니다.
• HIV 치료제 매출은 18% 증가한 62억 달러를 기록했습니다. 빅타르비 매출은 41억 달러를 기록했으며, 미국 치료제 시장 점유율은 사상 최고치인 53%에 달했습니다.
• 트로델비 매출은 42% 증가한 5억 600만 달러를 기록했고, 리브델지 매출은 93% 증가한 2억 300만 달러를 기록했습니다. 세포 치료제 매출은 18% 감소한 3억 5,500만 달러를 기록했습니다.
• 경영진은 2026년 주력 사업 매출 전망치를 307억~310억 달러로 상향 조정했으며, 이는 지난 8월 전망치의 중간값 대비 9억 달러 늘어난 수준입니다.
• 길리어드는 빅타르비의 새로운 메디케어 약가 적용으로 2028년에 약 15억 달러의 순매출 영향이 발생할 것으로 예상하지만, 경영진은 2027년 대비 해당 연도의 전체 HIV 매출, 제품 매출 및 EPS가 여전히 성장할 것으로 전망하고 있습니다.

핵심 재무 데이터

사업 및 경영 실적

HIV

HIV 매출은 62억 달러에 달해, 약 10억 달러 또는 전년 동기 대비 18% 증가했다. 경영진은 이러한 성장의 원인으로 실현 가격 상승, 수요 증가 및 유리한 재고 이동을 꼽았으며, 이는 연말까지 정상화될 것으로 예상하고 있다.

빅타르비 매출은 10% 증가하여 41억 달러를 기록했다. 미국 내 치료제 점유율은 사상 최고치인 53%에 도달했으며, 이는 신규 환자 유입, 유지율 상승 및 플로리다주 ADAP 프로그램 변경에 따른 접근성 개선에 힘입은 것이다.

HIV 예방제 매출은 전년 대비 거의 두 배로 늘어났다. 예즈투고 매출은 3억 500만 달러를 기록해 전분기 대비 31% 증가했으며, 경영진은 연간 매출 목표치인 약 10억 달러를 유지했다. 투여자의 70% 이상이 2차 투여를 위해 재방문했다.

데스코비 매출은 49% 증가했다로 10억 달러에 달했으며, PrEP 제품이 매출의 약 80%를 차지했다. 예즈투고(Yeztugo)와 프렙용 데스코비(Descovy)는 합산 50%의 점유율을 기록하며 연간 40억 달러 규모의 런레이트를 달성했다고 경영진은 설명했다.

종양학 및 세포 치료제

트로델비 매출은 42% 증가한 5억 600만 달러를 기록해 연간 약 20억 달러의 런레이트 수준을 나타냈다. 미국과 유럽에서 전이성 삼중음성 유방암 및 HR 양성/HER2 음성 유방암 치료제 수요가 증가했다.

세포 치료제 매출은 18% 감소한 3억 5,500만 달러에 그쳤으며, 이는 경쟁 압박에 따른 영향이다. 길리어드는 4차 이상 재발성 또는 불응성 다발골수종 치료제인 아네토셀(Anetocell)의 12월 23일 PDUFA 심사 기한을 준비하고 있다.

소수 환자에게서 관찰된 3등급 및 4등급 ICANS 차이를 조사하는 동안 PALISADE 1 및 2 임상시험이 부분 임상 보류 조치를 받았다. 경영진은 환자 사망이나 5등급 이상 반응은 없었다고 밝혔다.

간 질환 및 염증 질환

립델지 매출은 93% 증가한 2억 300만 달러를 기록하며 미국과 유럽에서의 수요 증가를 반영했다. 전체 간 질환 매출은 13% 증가한 9억 2,700만 달러를 나타냈다.

길리어드는 긍정적인 12주 염증성 장질환 데이터를 발표한 후, 2027년에 엠비스테그라스트(emvistegrast)의 궤양성 대장염 3상 임상시험을 진행할 계획이다. 현재 염증 파이프라인에는 13개의 임상 프로그램이 포함되어 있다.

경영진 가이드언스

약 주당 9.95달러의 인수 IP R&D, 관련 자금조달 비용 및 비경상 기타 매출 관련 항목을 제외한 경영진의 예시적인 연간 비GAAP 희석 EPS 범위는 8.75~9.10달러이며, 상·하단 모두 0.25달러 상향 조정되었습니다.

리스크 및 주시해야 할 요인

• CMS는 빅타비 가격을 30일 공급량당 2,600달러로 책정했으며, 이는 메디케어 채널 표시 가격 대비 약 38% 낮은 수준으로 2028년부터 적용됩니다.
• 길리어드의 예비 추산에 따르면 약 15억 달러의 순영향이 2028년 빅타비 매출에 미칠 것으로 예상되며, 여기에는 메디케어와 메디케이드, 340B 및 기타 미국 지불자 부문 전반에 걸친 파급 효과가 포함됩니다.
• 3분기 HIV 치료제 매출은 평소보다 높은 재고 수준의 수혜를 입었습니다. 경영진은 4분기 계절적 재고 축적 규모가 줄어들 것으로 예상합니다.
• 세포 치료제 부문은 경쟁 압력이 지속되고 있으며, PALISADE 임상 연구는 여전히 부분적 임상 보류 상태입니다.
• 월 1회 복용하는 경구용 HIV 치료제 프로그램 GS-3107은 예상치 못한 대사산물 영향으로 임상 보류 상태에 있습니다. 길리어드는 백업 물질을 개발하는 한편, 임상 보류 해제를 위해 대응하고 있다고 밝혔습니다.

애널리스트 Q&A 주요 내용

• 빅타비 약가: 경영진은 15억 달러 추정치가 메디케어 약가와 기타 미국 채널의 영향을 주로 반영한 종합적인 순영향이라고 설명했습니다. 여기에는 2028년 메디케어 파트 D 개편 영향의 반전 효과도 포함됩니다.
• 2028년 HIV 성장률: 회사의 HIV 매출 성장 예상치에는 치료제와 예방제 부문이 모두 포함됩니다. 경영진은 더 넓은 HIV 포트폴리오와 잠재적 완화 조치를 언급했으나 세부 연결 내역(bridge)은 제시하지 않았습니다.
• 주 1회 복용 경구용 PrEP: 길리어드는 주사 없이 더 긴 지속 효과를 원하는 이들에게 이 제품이 매력적일 것으로 기대하고 있습니다. 경영진은 약 70% 수준인 예즈투고(Yeztugo)의 기존 약제비 관리(pharmacy-benefit) 접근성을 바탕으로 시장을 확대할 수 있다고 밝혔습니다.
• 마진(수익성): 경영진은 영업비용 통제에 힘입어 2027년 이후에도 마진이 견조하게 유지될 것으로 예상하지만, 공식 가이던스는 해당 시점에 임박하여 제공될 예정이라고 밝혔습니다.
• 포트폴리오 다각화: 길리어드는 기존 HIV 프랜차이즈를 뛰어넘는 다각화의 주요 축으로 6개의 장기 지속형 HIV 치료 프로그램, 7개의 임상 단계 항암 ADC 프로그램, 13개의 염증 질환 프로그램을 강조했습니다.

실적발표 컨퍼런스 콜 전문

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전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good afternoon, everyone, and welcome to Gilead's Third Quarter 2026 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. [Operator Instructions]

Now I'll hand the call over to Jacquie Ross, Senior Vice President, Treasurer and Head of Investor Relations.

Jacquie Ross

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the third quarter of 2026. The press release, slides and supplementary data are available on the Investors 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 and Corporate Affairs Officer, Joanne Mercier; our Chief Medical Officer, Demar 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 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially.

With that, I'll turn the call over to Dan.

Daniel O'Day

Thank you, Jacquie, and thanks, everyone, for joining us on today's call. Gilead delivered an exceptional third quarter that highlights the strength, breadth and durability of the business. Third quarter base business sales were up 16% year-over-year, Gilead's strongest growth in more than a decade, driven by Biktarvy, Descovy and Yeztugo and HIV, Trodelvy in metastatic breast cancer and Livdelzi in and TBC.

At the same time, we continue to advance our diverse pipeline as we prepare for the next phase of launches. In HIV, we continue to lead across treatment and prevention. In the third quarter, HIV sales grew 18% year-over-year. Biktarvy achieved an all-time high U.S. market share, and we had a modest initial contribution from Bixlenvo, which launched in August. HIV prevention sales nearly doubled year-over-year. As expected, Yeztugo has rapidly established itself as the leading long-acting injectable option for HIV prevention. Yeztugo and Descovy for PrEP combined have 50% market share today and a $4 billion annual run rate.

As Dietmar will cover later, we believe we have the most comprehensive and diverse HIV pipeline in the industry as well as in Gilead's history. Across daily and long-acting dosing, we are advancing a portfolio that will deliver new options for many years to come. The most near-term example is the [indiscernible] plus lenacapavir. We expect to file this year, and if approved, this would be the first once-weekly oral treatment regimen for virally suppressed people with HIV. In oncology, Trodelvy delivered another very strong quarter. Sales were up 42% year-over-year and with growing demand across triple-negative and HR-positive HER2-negative metastatic breast cancer Trodelvy reached an approximately $2 billion annual run rate.

In the third quarter, we received European approval of Trodelvy in combination with pembro for first-line PD-L1-positive metastatic triple-negative breast cancer, extending Trodelvy's benefits to patients earlier in treatment. Beyond Trodelvy in metastatic breast cancer, we now have 7 clinical stage antibody drug conjugate programs in oncology. In cell therapy, we are approaching an important catalyst with the potential approval of a needle cell toward the end of the year. This would bring our total number of approvals to 4 in 2026 alone.

In inflammation, our third strategic area of focus, we are advancing and expanding our broad and differentiated pipeline that we believe will establish a durable new growth area for the company. We recently shared promising 12-week data for emvistegrast in inflammatory bowel disease, and we expect to advance the program into Phase III studies in ulcerative colitis in 2027. Emvistegrast has the potential to be a backbone therapy for inflammatory bowel diseases as a monotherapy or in combination with other mechanisms, including the oral IL-23 receptor inhibitor we recently agreed to acquire.

Beyond IBD, we have our IRAK4 inhibitor for which we plan to share data at the upcoming ACR meeting as well as Gangertemig, which represents a promising approach to B-cell-driven autoimmune diseases with additional data expected later this year. Overall, our inflammation pipeline now includes 13 clinical programs, giving us multiple opportunities to deliver meaningful advances for patients.

In summary, the third quarter continues what is proving to be a stellar year of execution and performance. This has enabled us to raise our 2026 base business revenue guidance by $1.6 billion over the course of the year, while advancing our robust pipeline and preparing for the next wave of potential launches. This fundamental strength in our business means we are well placed to adapt to potential policy headwinds.

As you know, Biktarvy was selected for the maximum fair price determination process. That process is now complete, and CMS have informed us of the price they have set. As we have previously shared, this will have an impact on Biktarvy revenues in 2028. Andy will share details in his section of the call. And as the third quarter has reinforced again our strategy of diversification has reshaped our business and is expected to continue to drive sustainable growth.

Looking forward, the multiple opportunities to drive growth across all 3 of our therapeutic areas, the strength and diversity of our pipeline within and beyond HIV and a disciplined operating model all give us confidence in the trajectory of the company.

With that, I'll hand it over to Joanna.

Johanna Mercier

Thanks, Dan, and good afternoon, everyone. Starting on Slide 7. Total product sales, excluding Veklury, of $8.2 billion were up 16% year-over-year, driven by strong HIV performance, Trodelvy and Lively. This is the highest year-over-year growth for our base business since 2015. Sequentially, sales were up 8%, driven by growth in HIV, Trodelvy and Biktarvy. Including Veklury, third quarter total product sales were $8.3 billion, up 13% year-over-year and 9% sequentially. Moving to HIV on Slide 8. And Third quarter HIV sales of $6.2 billion were up nearly $1 billion or 18% year-over-year and represented the highest year-over-year growth since the fourth quarter of 2018.

This strong performance was driven by higher average realized price, higher demand and favorable inventory dynamics. Sequentially, HIV sales were up 10% and primarily driven by higher inventory, demand and average realized price. We expect these inventory dynamics to normalize by year-end. Looking at HIV treatment in more detail on Slide 9. Biktarvy sales of $4.1 billion were up 10% year-over-year, driven by higher demand and average realized price in addition to favorable inventory dynamics. Sequentially, Biktarvy sales increased 8%, driven by favorable inventory dynamics and higher demand, partially offset by lower average realized price due to channel mix.

Biktarvy reached an all-time high treatment market share of 53% in the U.S., supported by continued gains among new patients strong retention and improving access following adjustments to the Florida ADAP program earlier in the year. While we have not yet seen the HIV treatment market return to its typical 2% to 3% growth, we have seen signs of stabilization. Biktarvy has also demonstrated continued resilience amid changes related to the Affordable Care Act reflecting the strength of the product profile and of our commercial teams to help people living with HIV maintain access to treatment.

Bixlenvo our new daily oral combination of bictegravir and lenacapavir for virally suppressed adults with HIV was launched late into the third quarter following U.S. approval in August. While it's still early days for the launch, we're pleased with the uptake we are seeing in virally suppressed people on complex regimens, which has been in line with our expectations. Overall, we remain focused on expanding coverage and bringing this new option for people who want to switch or simplify their HIV treatment.

Moving to HIV prevention or prep on Slide 10, sales nearly doubled year-over-year in the third quarter, once again outpacing overall U.S. market growth of 14% year-over-year. This is a clear testament to Gilead's strong commercial execution. Building on our leadership, now with 50% pre market share, our innovative portfolio has accounted for the vast majority of market growth since 2025. Additionally, demand in the long-acting injectable market doubled year-over-year, and we're pleased to share Yeztugo now the leading injectable prevention regimen with sales of $305 million, up 31% sequentially and on track to deliver full year sales of approximately $1 billion.

Importantly, we continue to see that more than 70% of users have returned for their second injection, resulting in combined protection of up to a full year. This continues to reinforce Yeztugo's best-in-pe persistency profile as defined by patients returning for their reinjections after 6 months. We are particularly encouraged by the mix of new starts with the majority continuing to come from individuals switching from other PrEP regimens, while the share of PrEP naive individuals increased during the quarter.

Looking ahead, -- we believe the potential launch of once weekly oral Yeztugo could further expand choice and support continued growth by reaching additional individuals who could benefit from PrEP. Looking at Descovy, total sales of $1 billion were up 49% year-over-year, driven by higher average realized price and favorable inventory dynamics. Prep sales continue to account for approximately 80% of total Descovy sales. Sequentially, Total Descovy sales were up 8%, driven by higher-than-usual inventory build and higher demand. In just 3 quarters, Descovy sales have already exceeded that of full year 2025 and driven primarily by strong demand and pricing favorability.

Moving to Livdelzi on Slide 11. Sales of $203 million were up 93% year-over-year and 21% sequentially driven by increased demand in both the U.S. and Europe. Livdelzi is the market leader in the U.S. and is helping to drive expansion of the second-line PBC market. Looking ahead, we're excited to share the detailed results from Livdelzi's Phase III IDEAL study at the upcoming ASLD Liver Meeting. The study evaluated Livdelzi in PBC patients with ALP between 1 and 1.67x the upper limit of normal, which account for approximately half of the second-line eligible population and remain associated with an increased risk of disease progression.

We are working towards global filings to update Livdelzi's label to include data from the IDEAL study and expect a U.S. label update in 2027. Together with sales in our viral hepatitis portfolio, Liver disease sales were $927 million, up 13% year-over-year, reflecting increased demand for Livdelzi in PBC as well as favorable pricing dynamics for HCV and HBV partially offset by lower HCV starts.

Sequentially, sales were up 6%, reflecting higher average realized price and inventory dynamics, partially offset by lower demand for HCV products. Moving to Slide 12. Trodelvy sales of $506 million for the quarter, now a $2 billion annual run rate was up 42% year-over-year and 11% sequentially and driven by strong demand growth in both metastatic triple-negative and HR-positive HER2-negative breast cancer across the U.S. and Europe.

Following the first-line approvals in the U.S. and Europe earlier this year, Trodelvy is establishing itself as the backbone of treatment in metastatic triple-negative breast cancer and we're working to expand Trodelvy's first-line opportunity further into new markets. Triple-negative breast cancer remains 1 of the most aggressive and challenging forms of breast cancer to treat. Bringing Trodelvy into the first-line setting represents an important opportunity to reach significantly more patients earlier in their treatment journey when the potential impact of treatment may be the greatest. We are incredibly pleased with the first-line metastatic TNBC uptake thus far.

Moving to Slide 13. And on behalf of Cindy and the Kite team, Third quarter cell therapy sales of $355 million were down 18% year-over-year, reflecting ongoing competitive headwinds. Looking ahead, we're also focused on the next potential chapter of growth for our cell therapy business. Our launch preparations are in full force as we approach Nedocell's December 23 PDUFA date in fourth line plus relapsed or refractory multiple myeloma. This includes conducting preactivation efforts within our authorized treatment centers network with a target activation of 80% of our ATCs within the first 6 months of launch.

Detailed launch planning across sales, medical and access teams as well as engaging with a range of payers with a target of 90% payer coverage within the first 12 months of launch. Coupling our steadfast preparations with the level of health care provider and patient enthusiasm we have seen for netocells profile ahead of launch, we are targeting brand leadership in the fourth line plus setting with 18 months of approval.

As we head into the final months of the year, we remain focused on delivering strong performance across our portfolio and preparing for the upcoming launch of Anetocell. In HIV, we are building on our leadership in treatment and prevention through the early launch of Bixlenvo and the continued performance of Biktarvy, Yeztugo and Descovy. Beyond HIV, Live else continues to gain share as the PBC market expands, while Trodelvy is delivering strong growth across triple-negative and HR-positive HER2-negative metastatic breast cancer. Our outstanding performance this quarter once again reflects the incredible work of our teams across the organization, and I want to thank them for their unwavering commitment to patients.

And with that, I'll hand the call over to Dietmar.

Dietmar Berger

Thank you, Joanna, and good afternoon, everyone. The third quarter was another productive period across all 3 of our therapeutic areas. We received FDA approval of Bixlenvo, advanced our twice yearly HIV treatment programs and shared promising early data from our emerging inflammation portfolio, including our investigational oral alpha 4 beta 7 -- we're making strong progress across our diverse portfolio of 49 clinical programs.

Beginning with HIV treatment on Slide 16. We're advancing the most comprehensive HIV portfolio in both the industry and in Gilead's history. While Biktarvy sets the standard for daily single-tablet regimens in people with HIV, we continue to innovate across daily and long-acting treatment options to address the diverse needs of the greater than 40 million people living with HIV globally. Building on Bixlenvo's approval, we are making progress in 6 long-acting treatment programs encompassing both orals and injectables. We expect to file eslaterovir plus lenacapavir with FDA this year with a regulatory decision in 2027.

If approved, is Len would be the first once-weekly oral treatment regimen for virally suppressed people with HIV. Beyond this lens, we remain on track to initiate our Phase II trials for our wholly owned weekly oral regimens, combining lenacapavir with our investigational long-acting integrase inhibitors. Earlier this month, we started the Phase II trial for the lenacapavir combination with GS-3242, and the Phase II trial for the combination with GS-1720 is expected to start in early 2027. We will select the most promising candidate for Phase III development in treatment naive and virally suppressed people with HIV.

The selected program will have the potential to be the first insty-containing weekly regimen. We're also advancing 2 distinct long-acting injectable treatment options. First, we initiated the newly named Phase III Daybreak I and II trials for lenacapavir plus our investigational broadly neutralizing antibodies teropevumab and sellerizumab during the third quarter. This has the potential to be our first complete twice-yearly HIV treatment regimen for the virally suppressed population with susceptibility to both [indiscernible].

In parallel, we initiated the also newly named Phase II PULSAR I and II trials, evaluating injectable GS3242-plus lenacapavir, our first insty-based long-acting injectable treatment program. These studies have already begun dosing our every 4-month cohort. We expect to initiate the twice-yearly dosing cohort following additional Phase I data.

Overall, we continue to believe that this portfolio across both long-acting oral and injectable treatments positions us well to expand choice, support Gilead's continued leadership and reach more of the 44% of people with HIV who are not virally suppressed.

Turning to HIV prevention. We continue to build upon the unprecedented clinical profile demonstrated by lenacapavir in the purpose studies with twice [indiscernible], establishing a new benchmark for HIV prevention efficacy. Building on the successful commercial launch of twice yearly Yeztugo, our application of once weekly oral lenacapavir for prep is under review with the FDA with a regulatory decision expected in early February 2027. If approved, once weekly lenacapavir could become the first long-acting oral prep regimen, complementing twice yearly -- Yeztugo for people who prefer an oral option.

Looking further ahead, we continue to expect an update from the Phase III purpose 365 study evaluating once yearly intramuscular lenacabivir for PrEP in 2027. Aligning with annual preventative care visits, this option could be even more transformative in reaching more people who could benefit from PrEP and we are targeting potential launch in 2028. Turning to oncology on Slide 17. We remain focused on advancing differentiated therapies for cancers with large unmet needs. Our acquisition of [indiscernible] is earlier this year adds 4 promising clinical stage programs as well as next-generation ADC technology that further strengthened our existing ADC expertise.

Among our ADC programs, we look forward to providing an update from our Phase III ASCENT-GYN study around the end of the year. The study is evaluating Trodelvy in advanced or recurrent endometrial cancer, where patients whose disease progresses following prior treatment continue to have limited effective options. Beyond Trodelvy, we continue to advance GS-8D824, our investigational NaPi2b directed ADC in platinum-resistant ovarian cancer. The encouraging Phase I activity observed in heavily pretreated patients without biomarker selection reinforces our belief in its potential to offer a differentiated treatment option in this challenging disease.

At the same time, we're exploring GS-8824's potential more broadly in our Phase I program for platinum-sensitive ovarian cancer. We have also initiated a new trial in advanced or recurrent endometrial cancer. Our commitment to oncology extends further into our earlier stage pipeline, where we are advancing several programs designed to address high unmet needs in solid tumors. This includes a focused effort in MTAP deleted cancers, which represent approximately 10% to 15% of solid tumors with GS-5319, our investigational MTA cooperative PRMT5 inhibitor and GS-2426, our investigational MAT2A inhibitor, which targets a complementary pathway, both currently in Phase I clinical trials.

Moving to inflammation on Slide 18. We're excited to be at the stage where we're starting to share clinical data. As our third strategic area of focus, we have been building and leveraging deep expertise across immunological pathways and mechanisms to develop a pipeline of potential first-in-class or best-in-class approaches to target various severe immune-mediated inflammatory conditions with high unmet need.

In inflammatory bowel disease, we shared promising 12-week data for emvistegrast, our investigational once-daily oral small molecule inhibitor of alpha 4 beta 7 at the United European Gastroenterology meeting earlier this month. The data demonstrate the potential for best-in-class oral efficacy with a generally well-tolerated safety profile. We believe that emvistegrast could provide a much-needed oral treatment option for IBD patients who currently cycle through burdensome injectable therapies.

Following these results, we expect to advance emvistegrast's monotherapy into Phase III studies in ulcerative colitis in 2027. We -- in addition, we are exploring its potential as an oral backbone for combination regimens designed to break through the efficacy ceiling seen with approved monotherapies. We are also planning a Phase IIb/III study to evaluate emvistegrast in Crohn's disease. These programs will be conducted in both advanced therapy naive as well as advanced therapy experience populations in line with FDA guidance.

In addition to these programs, we agreed to acquire an oral peptide IL-23 receptor inhibitor which we believe adds a potentially differentiated oral approach for inflammatory bowel disease to our growing inflammation and immunology portfolio. The program known as HCXT2001 may potentially be used alone or in combination with invistigrast as a daily oral treatment for people living with IBD. This reinforces our approach to build depth and optionality in selected immune-mediated diseases through multiple complementary mechanisms and modalities.

Beyond our inflammatory bowel disease programs, we are also excited by the early-stage portfolio of T cell engager therapies acquired in our overall Medicine acquisition in partnership with Lake front. As a reminder, Gamgerdamic is a potential best-in-class BCMA/CD3 bispecific T cell engager that demonstrated robust clinical activity in early Phase I studies across autoimmune conditions. We will be presenting additional Phase I data for gamgordamic in immune thrombocytopenia at a medical congress later this year.

Additionally, we are looking forward to sharing a detailed update from our Phase IIa COSMIC study at the upcoming American College of Rheumatology meeting on November 8. While still early, the study provided the first clinical proof-of-concept signal for idesasertib, our investigational IRAK4 inhibitor in cutaneous lupus erithermatosis. Further, at the upcoming AASLD meeting, we're excited to present detailed results from our Phase III IDEAL study of Livdelzi.

This study evaluated patients with alkaline phosphatase between 1 and 1.67x the upper limit of normal or intolerant to ursodeoxycholic acid. Following positive top line results shared earlier this year. This presentation will provide a fuller view of the findings and their potential benefit for patients with PBC and an opportunity to deepen our understanding of where Livdelzi can potentially address remaining treatment needs.

Overall, our inflammation pipeline now includes 13 clinical programs led by our inflammatory bowel disease and B-cell depleting programs. We believe our portfolio gives us multiple opportunities to deliver meaningful advances for patients and establish inflammation as a potentially significant new growth area for Gilead.

Moving to cell therapy on Slide 19. And on behalf of Cindy and the Kite team, we are now less than 2 months away from Anidocell's December 23 PDUFA date and potential launch in fourth line or later relapsed or refractory multiple myeloma. The filing was supported by data from our Phase II IMEGEN-1 study for which we expect to share additional follow-up data inclusive of the Kaplan-Meier curve for PFS at an upcoming Medical Congress this year. We're excited to deliver what we believe could be an important new treatment option for patients reinforced by Anetocell's deep durable efficacy, differentiated safety profile and targeted manufacturing turnaround time of less than 3 weeks.

In addition to the fourth line plus setting, the broad [indiscernible] program adds the potential to establish a new standard of care across the multiple myeloma landscape reaching more patients earlier in treatment. We look forward to IMAGINE 3 data in second to fourth line with a potential BLA filing as early as 2027. We are pleased to share that we expect to initiate our IMAGINE 6 and IMAGINE-4 studies in transplant eligible and noneligible newly diagnosed patients in early 2027, and and plan to share data from the GEM nedofirst safety lead-in study for newly diagnosed multiple myeloma at an upcoming medical congress later this year.

Beyond the needle cell, KITE 512, our GPC3 targeted dual armored CAR T cell therapy has been cleared for clinical studies by FDA, and we look forward to enrolling the Phase I trial in patients with advanced GPC3 positive hepatocellular carcinoma soon. This marks an important milestone for extending the reach of the transformative potential of Kite cell therapies into solid tumors.

Turning to our next-gen cell therapies PALISADE 1 and 2, evaluating Kite 753 in patients with second line and third line plus relapsed or refractory diffuse large B-cell lymphoma have been placed on a partial clinical hold while we investigate safety differences we've noted between Phase I and Phase II.

Lastly, we are pleased to share that in collaboration with pre-gene we've begun dosing patients with our in vivo BCMA CAR-T therapy in an investigator-initiated trial in China. Leveraging Kite's extensive cell therapy expertise and manufacturing capabilities, our in vivo program aims to address existing class challenges and unlock broader applications across oncology and autoimmune diseases. Our advancement in the clinic is an encouraging milestone, and we look forward to providing additional updates in due course.

Moving now to our milestones on Slide 20. And I'd like to thank our research and development teams at Gilead and Kite for their dedication and execution across our clinical portfolio. We are on track for our remaining 2026 milestones, including the Phase III update for ASCENT GYN, evaluating Trodelvy in advanced or recurrent endometrial cancer and the FDA decision on Aniducel in fourth line or later relapsed or refractory multiple myeloma.

Along with our planned acquisition of an oral IL-23 receptor inhibitor program, we entered 2 new collaborations that further strengthen our solid tumor portfolio. With BioNTech, we will evaluate Trodelvy in combination with pumitamic, an investigational PD-L1 VEGF-A bispecific in first-line metastatic triple-negative breast cancer and with Vera Biotechnology, we will develop 3 novel dual mast T cell engagers for solid tumors. Taken together, these updates reflect the strength of the portfolio we have built and the opportunities that lie ahead.

Now I will turn over the call to Andy.

Andrew Dickinson

Thank you, Dietmar, and good afternoon, everyone. Gilead's third quarter results demonstrate outstanding commercial and clinical execution reinforced by continued operating expense discipline. As shown on Slide 22, our base business grew 16% year-over-year to $8.2 billion, driven by continued growth across Biktarvy, Descovy and Yeztugo in HIV, Trodelvy in metastatic breast cancer and Livdelzi in PBC, partially offset by lower sales of cell therapy products. Sequentially, sales were up 8%, driven by higher HIV, liver disease and Trodelvy sales, partially offset by lower sales of cell therapy products.

Total product sales of $8.3 billion were up 13% year-over-year, reflecting lower Veklury sales due to fewer COVID-19-related hospitalizations. Moving to our non-GAAP third quarter results on Slide 23. Product gross margin was 88% in the third quarter of 2026, up from 86% in the third quarter of 2025, primarily driven by the expiration of a TAF-related royalty obligation in November of 2025. R&D expenses were $1.6 billion, up 19% year-over-year and 11% sequentially, reflecting higher compensation accruals on related to our financial outperformance year-to-date as well as higher clinical costs.

SG&A expenses were $1.5 billion, up 14% year-over-year primarily reflecting HIV promotional activities that supported our strong commercial performance in addition to legal expenses and higher compensation accruals related to financial outperformance year-to-date. The operating margin was 50% in the third quarter and 49% year-to-date, excluding acquired IP R&D associated with the Arcellx, Tubulus and oral medicines acquisitions, firmly in the top quartile of our peer group and underscoring the leverage in our business model, resulting from our expense discipline.

The non-GAAP effective tax rate was 19% in the third quarter in line with our full year expectation for an effective tax rate of approximately 20%, excluding acquired IP R&D expenses related to our 2026 acquisitions. And finally, our non-GAAP diluted EPS was $2.55, primarily driven by higher product sales and lower acquired IP R&D expenses, partially offset by higher operating expenses compared to $2.47 in the same period in 2025.

Recall, as shown on Slide 24, our third quarter 2025 benefited from an approximately $400 million or $0.25 per share contribution reported in royalty contract and other revenue related to an IP asset sale from 2018. Excluding this, non-GAAP EPS increased 15% year-over-year and compares to 13% total product sales growth. Moving to our full year guidance on Slide 25, we are updating our full year sales and EPS guidance to reflect our outstanding third quarter results. We now expect base business sales to range between $30.7 billion and $31 billion. This represents an increase of $900 million at the midpoint compared to our August guidance and an increase of $1.65 billion at the midpoint compared to our initial 2026 guidance.

Within HIV, and reflecting our strong performance year-to-date, we now expect full year sales to grow approximately 12% year-over-year, driven by Biktarvy for HIV treatment as well as Yeztugo and Descovy for PrEP. Given larger inventory build than is typical for the third quarter, we expect the Q4 inventory build to be smaller than we have historically seen in the fourth quarter. We continue to expect Yeztugo sales of approximately $1 billion for the full year, allowing for more modest sequential growth reflecting holiday seasonality. And we continue to expect cell therapy sales to decline mid-teens percentage year-over-year.

Moving to total product sales. We now expect sales in the range of $31 billion to $31.3 billion. Included in total product sales, we continue to expect Veklury sales of approximately $300 million for the full year, reflecting lower COVID-19-related hospitalizations. With regards to our non-GAAP P&L, we now expect acquired IP R&D of approximately $12.9 billion, reflecting the $1.4 billion in upfront payments expected in the fourth quarter associated with the acquisition of an oral IL-23 R inhibitor program from PepStar Therapeutics and the recently announced VR research collaboration.

Moving to operating expenses. We now expect full year 2026 R&D expenses to increase a mid- to high single-digit percentage on a dollar basis compared to 2025 and SG&A expenses to increase by a high single-digit percentage on a dollar basis compared to 2025, both reflecting higher costs related to the significant increase in our expected full year financial performance.

Moving to tax. We now expect full year 2026 effective tax rate to be between 220% and 165%, reflecting the nondeductible acquired IP R&D expenses associated with the Arcellx, tubulus and oral medicines transactions as well as the expected acquired IP R&D expense associated with the Pepstar Therapeutics transaction.

Excluding these transactions, our effective tax rate would be 20%, no change from our February guidance. Overall, we expect full year non-GAAP loss per share between $1.20 and $0.85. Turning to Slide 26. Excluding approximately $9.95 per share related to the acquired IP R&D expense and full year financing costs associated with the acquisitions this year and nonrecurring other revenue, our full year non-GAAP diluted EPS would be $8.75 to $9.10, raised $0.25 on both ends from our illustrative August guidance due to higher base sales partially offset by higher operating expenses.

Looking beyond 2026, I wanted to share an update on our discussions with CMS regarding Biktarvy pricing. As a reminder, Biktarvy was selected for the maximum fair price determination process that will impact Biktarvy revenue starting in 2028. CMS has informed us that it has set pricing for Biktarvy at $2,600 per 30-day supply, which represents an approximate 38% discount from the list price in the Medicare channel.

Based on our preliminary analysis, we currently expect full year 2028 Biktarvy revenue to decline from 2027. More specifically, we expect a total net impact to Biktarvy revenue of approximately $1.5 billion in 2028, reflecting the lower price in Medicare in addition to related impacts across other U.S. channels, including Medicaid, 340B and other payer segments. Reflecting growth from other innovations across our HIV portfolio, we continue to expect total HIV revenue to grow in 2028 compared to 2027.

Further, our growing HIV business is expected to be complemented by additional growth across our innovative oncology and inflammation portfolios. As a result, we expect both total product sales and earnings per share to grow in 2028 compared to 2027. Note that these statements are based on our current assumptions that may change and could be updated at any time, including when we share formal guidance in early 2028.

Taking a step back, Gilead has demonstrated its ability to address policy impacts over the last few years, including the $1.1 billion headwind associated with Medicare Part D redesign in 2025 and a greater than $500 million headwind associated with the Affordable Care Act and other government policies in 2026. With more than a year before the new Biktarvy pricing takes effect, we will continue to work diligently to potentially mitigate some of the impact.

Back to 2026 and on Slide 27, you can see we returned approximately $1.4 billion to shareholders in the third quarter, including $370 million of share repurchases. Combined with our dividend, we have returned approximately 40% of our free cash flow to shareholders in the first 3 quarters of 2026.

In closing and building on our track record of execution so far, we remain focused on a strong finish to a remarkable year for Gilead and believe we are better positioned than ever with robust clinical and commercial pipelines and a strong business model that sets us up well in 2027 and 2028 and beyond.

And with that, I'll invite Rebecca to start our Q&A session.

Operator

[Operator Instructions] Our first question comes from Umer Raffat at Evercore.

질의응답

Umer Raffat

I wanted to spend a quick second on your recently acquired oral IL-23 and the potential for combo with some of the recent data sets for the [indiscernible]. And my question is, if the alpha 4 beta 7 requires dosing as fasted and the IL-23, which is presumably a cyclic peptide requires overnight fasting and perhaps waiting another 30 minutes post the dose practically speaking, for a patient, how would the co-administration or the combo actually work? Is there a way to be able to give them simultaneously or close enough while still being practically feasible. .

Dietmar Berger

Yes, Umer. Thank you for the question. This is Dietmar. I mean first of all, let me say, we're really excited about the portfolio that we're building in inflammatory bowel disease. And there's obviously really the opportunity for various types of combinations, both internal and external. The IL-23 is very early. So we're still working on different types of formulations. So please stay tuned, and we'll inform you more about those details as we move along.

Operator

Our next question comes from Akash Tewari at Jefferies.

Akash Tewari

Can you go over the moving pieces on the $1.5 billion IRA impact for Biktarvy pricing? How much of that is a net pricing impact for Medicare specifically versus the downstream impact on your kind of Medicaid best price and then the 340B impact. I want to make sure we just get those moving pieces right..

Daniel O'Day

Yes. Thanks, Akash. This is Dan, and then I'll turn it over to my colleagues for some more detailed framing of your question. But before we do, just I wanted to elaborate a little bit on what was in my script and share my perspectives on the CMS price setting. First, I'd just like to say that the price set by CMS does not reflect the value of Biktarvy, the medicine that has transformed HIV treatment and widely recognized as a standard of care. And I think this is an example of how price setting approach under the IRA, especially for highly differentiated medicines like Biktarvy in the middle of their life cycle can put investment in new medicines at risk. .

We firmly believe there are ways to improve affordability for patients in America without damaging policies that undermine U.S. patent system and the innovation and support. I'll just go on to say that there are certain diseases that can only be addressed by small molecule medicines like HIV and others. And many of these diseases disproportionately impact underserved patients for what Gilead is firmly committed to supporting in so many ways. And so this pill penalty, which has now been applied to Biktarvy discourages investment in these medicines.

So I just want to end with these 2 concepts, both can be true. As I said earlier, our business is strong. The quarter has been exceptional. The portfolio that you just saw that Dietmar outlined really has never been stronger ideally yet. And we've built a business for patients and communities we serve that can respond to these policy headwinds. And I just want to say we firmly oppose policies like this that undermine innovation. Relative to the $1.5 billion, we wanted to give you some color on our preliminary analysis and what we think the impact will be in 2028 to guide you. I'm going to turn it over to Joanna to give a little bit more detail on how that $1.5 billion breaks out and what we anticipated, including in it. So over to you, Johanna.

Johanna Mercier

Thanks, Dan. Yes. So again, obviously, this is a preliminary analysis and subject to change as we get closer to 2028. But we expect the $1.5 billion that Andy mentioned earlier, really, that's a net impact on Biktarvy revenues in 2028. So that is inclusive of the Medicare piece and all other skill overs to other channels in the U.S. And so to your question around kind of the split on that, we're not going to give all the details at this point in time, it's still very early. But having said that, it's primarily Medicare and then you have this spillover effect. It really is a net impact, and that's why we're giving you the total number. And this is also net of, of course, the Part D redesign, impact that we saw for Biktarvy in 2025 that goes away in 2028. So the 1.5% is all encompassing.

Operator

Our next question comes from Mohit Bansal at Wells Fargo.

Mohit Bansal

And I want to turn that thing to the anitcell trial for newly diagnosed multiple myeloma, the Imagine big trial. And I couldn't help but notice that it does have a co-primary endpoint of MRD negativity at 12 months. So I would love to understand your thought process behind this? And what discussions you had with the FDA? And is there a possibility of early filing on the basis of 1 month MRD negativity here? .

Cindy Perettie

Thanks, Mohit. This is Cindy. If you look at both our IMAGINE-3 trial as well as our newly diagnosed trials, they are co-primary endpoints looking at MRD followed by PFS or the Gemini first, and then I think you were referring to the IMAGINE 4 IMAGINE 6 trial, those are MRD-negative CR rate. And those are discussions that we had with global regulatory agencies as we were designing the trial. I think the thing I would point out uniquely about the files for IMAGINE-4 and IMAGINE 6 is they're in transplant ineligible, IMAGINE-4 and transplant eligible for IMAGINE 6, where we're looking at quad therapy upfront followed by a [indiscernible] and maintenance in the IMAGIN-4 trial, we're also looking at MRD guided maintenance so that patients could have treatment-free intervals.

Operator

Our next question comes from Brian Abrahams at RBC.

Brian Abrahams

Congrats on the strong quarter. I really appreciate the details on the potential IRA impact in [indiscernible], that's really helpful. Can you clarify, does your expectation to be able to grow the HIV franchise through that. Does that include -- is that inclusive of prep? And then I guess I'm curious what sort of would need to happen in terms of overall market growth, new products and switches in order to be able to offset that $1.5 billion IRI impact to [indiscernible].

Daniel O'Day

Yes. Johanna, why don't you start? .

Johanna Mercier

Yes. Thanks, Brian, for the question. Yes, so your question about our HIV, -- of course, we look at HIV holistically. We look at our portfolio across both treatment and prevention. And so that is inclusive of all of our portfolio today, and of course, the portfolio to come as we think about the very strong pipeline that's going to support the next 10 to 15 years of growth and leadership in HIV. The other piece of your question around sorry, the offset for the $1.5 billion. And what we've said is obviously, we will look to -- we have about a year or so, we will look at different opportunities to mitigate as much as possible the $1.5 billion, but that's in addition to the overall portfolio and, of course, other strategies that we can look at. So more to come on that one. .

Operator

Our next question comes from Chris Schott at JPMorgan.

Christopher Schott

I just want to dig into the weekly oral prep launch as we head into next year. I guess, can you just help frame out what portion of the market do you think this could appeal to? And maybe just compare and contrast a little bit how you're thinking about that launch relative to what we've seen with S2G over the last year or so?

Johanna Mercier

Sure. Chris, it's Johanna again. I'll take that one. We're really excited about the Q weekly. This will be the first long-acting oral in the prevention market potentially. And so we're excited about the opportunity. As we think about that launch, we are thinking that, that's going to really appeal to a population that might want the longer acting, but might not like injectables, for example. And if you think about the current market today despite the very strong growth of go because I think people are really moving towards that long acting as much as possible because it's truly prevention at the Q6 monthly and that is a preference. There are some people that don't like the injection and there's still a very strong oral market, both with Descovy as well as generic Truvada. And so we do think there's going to be a strong appeal for folks that are already on a daily oral to move to a 2 weekly oral, and we're excited about that opportunity.

And I would just add 1 more concept that's maybe a little bit different than a new launch. -- because this is an extension based on Yeztugo in the weekly, we're going to be building off the access we already have on Yeztugo, specifically around the access we have in the pharmacy benefit space, which is about 70% or so. And so we do think that as of launch, it will really help support kind of effect vast potential ramp-up as we go forward. And of course, we'll continue to expand our access over the months to follow our launch, so more to come on that.

But we're excited about that mix. And of course, to your question about, yes, to go and how that plays out, -- we still believe longer-acting is going to be preferred in the HIV prevention space, not only with our Q6 monthly but even with the potential of an annual injection with our Q12 potentially in 2028. So excited about what's to come in our HIV market.

Operator

Our next question comes from Michael Yee at UBS.

Michael Yee

On the HIV treatment pipeline, you had a disclosure around 3107 monthly oral with a clinical hold. Maybe you could just give us an update on that program and what was going on there. .

Daniel O'Day

For the question. For 3107, this is one of our prodrug compounds. And with some of the product compounds, as you know, we saw metabolites that have unexpected impact, and that is really the reason for the clinical hold at this point. We're working through that clinical hold. At the same time, broader portfolio really in the background, right, resemolecules coming out of research into the early development that are also aiming at the monthly space. So monthly oral treatment is still a key objective for us. We're following that working through 3107 and we're also in parallel working on backup molecules.

Operator

Our next question comes from Terence Flynn at Morgan Stanley.

Terence Flynn

I was just wondering, Andy, if you can help us think about margin progression here. into 2027. Obviously, you have done some business development deals. There's going to be some R&D spend behind those programs. And then also, as we think about the Biktarvy impact in 28 -- maybe just help us think high level about impact to margins there, knowing it's a little early to give guidance, but just maybe directionally.

Andrew Dickinson

Terence, thanks for the question. It's Andy. Look, at a high level, we continue to expect to have very strong margins not only in '27, but for the foreseeable future. And of course, we'll provide guidance on '27 and '28 as we get into those calendar years. You've seen this year our ability to do 3 acquisitions earlier this year and to absorb most of that spend. So when you look at our updated guidance this year, we were right on track.

When you parse out both our R&D spend as well as our SG&A spend, right on track for the expenses that we are targeting at the beginning of the year in our initial guidance. And then we added in the additional compensation accruals and expenses tied to our significant outperformance this year as our expected bonus payments have gone up. So we're really pleased with our ability to bring in these additional assets and fold them into the portfolio and absorb those expenses this year. And that's certainly our goal in future years as well.

We are really focused, as you heard in my comments on continued disciplined operating expense management and a very strong margin profile, both in terms of our gross margin as well as our operating margin. So we'll give you more specifics as we go forward. But we think the business is really set up nicely to continue to have a very strong margin.

Operator

Our next question comes from Daina Graybosch at Leerink Partners.

Daina Graybosch

I wonder if you could talk more about the PALISADE partial clinical hold and whether taking that amongst some of the other competitive clinical holds, particularly with the SaaS manufacturing, how you're thinking about fast manufacturing? And if there's any risk you see for Kite an autoimmune disease as well and sort of the timing for when we might better understand the risk for both of these programs.

Cindy Perettie

Thanks a lot, Daina, it's Cindy. So maybe I'll start with KITE363 in autoimmune because we're not using rapid manufacturing with that, and that program does continue. We expect both the rheumatology and the neurology Phase I to continue and remain excited about that program. The second question that you had around PALISADE 1 and 2, that does have a rapid manufacturing. It's a 3-day manufacturing process that we shared with you. That's different than what I think you were referring to, to the other manufacturers in this space to have rapid manufacturing is a 1-day manufacturing. Ours is a 3-day manufacturing.

When you look at the partial clinical hold, we have made a decision to take a look at differences that we're seeing specifically with Grade 3 and Grade 4 ICANs in a small number of patients. And we have decided to take some time, pause and investigate that before we move forward. This is not -- there's no patient death. There's no Grade 5. So as soon as we have more information, we'll continue to keep you informed.

Operator

Our next question comes from Louise Chen at Scotiabank.

Louise Chen

I wanted to ask you about sort of a more long-term view on things. Currently, around 70% of your commercial franchise is HIV. And just curious if you think out in the next couple of years, how do you expect this to change as you develop these new verticals?

Daniel O'Day

And maybe I'll start and I'll invite others to add, Louise, this is Dan. Our strategy has always been over the past 8 years or so to diversify our portfolio from a variety of different angles. I mean, first of all, within and that includes both HIV treatment and prep and my colleagues have spoken about that. I think you'll continue to hear how our longer-acting treatment programs continue to evolve over time, but we really are incredibly enthusiastic about how that is progressing.

Of course, the prep options that allow for even longer [indiscernible] intervals are in our pipeline and our portfolio. And then we've always said that as that provides great robustness of our HIV business that we're very interested in diversify and then, of course, outside of HIV and into oncology and inflammation. And I think the call here has really, I think, emphasized how much progress we made on that front, both in oncology, cell therapy and our non-cell therapies in that growing portfolio.

But also, I think this has really been a quarter where the inflammation and autoimmune pipeline has started to reveal itself. And you can see that we're going after a highly differentiated mechanisms and a chance to really kind of break through efficacy barriers and bring different options for people with autoimmune diseases across all of our therapeutic platforms. I'd invite others to add as well.

Dietmar Berger

I mean, this is Dietmar, -- Dan you said a lot of it, right? But I'm really similarly excited about both the diversification in the HIV portfolio. You look at it, we've got 6 long-acting programs currently ongoing. We're looking at up to 5 launches before 2033 in HIV therapy, which will help us to really address the needs of people with HIV and the different options that they appreciate.

On the prevention side. I'm also really excited about the weekly oral option that we have, but then also about once every year, which so well aligns with other preventative visits that is really, I think, a broader opportunity there. In oncology. We now have the 7 ongoing ADC programs. We look at the broader tubules technology that has brought applicability also together with our medicinal chemistry capabilities -- and I think with the PRMT5 [indiscernible] programs, we have another interesting program really focusing on [indiscernible], which is very broadly present in different types of tumors.

And then finally, the inflammation program currently with 13 different projects is really starting to reveal itself. And I think we have very differentiated mechanisms and really drugs there. that have the potential to address large unmet medical needs, whether it's an inflammatory bowel disease, whether it's in B cell depletion, which is a broad set of different types of diseases or even in type 2 inflammation. So stay tuned, but I think that trajectory is starting to reveal itself.

Operator

Our next question comes from Carter Gould at Cantor Fitzgerald.

Carter Gould

On [indiscernible] and the update we're going to get on that front. [indiscernible], can you kind of help set the stage there, the number of dosing cohorts we see -- we might see or the number of patients with over 6 months follow-up and clarify that things are still on track to enter registrational studies next year. .

Unknown Executive

So you're going to have to wait for the exact data release, right, that is coming at a conference later this year. But we're really looking forward to present more data, especially in the autoimmune cytopenia setting, also very much on the immune thrombocytopenia. I think that data is exciting. So stay tuned for that. Obviously, there's a much broader opportunity with B-cell depletion, as you know. And we're staying firm in our commitment to bring Gambertamic into a Phase III study next year in autoimmune cytopenia.

Operator

Our last question comes from Geoff Meacham at Citigroup.

Geoffrey Meacham

I get the IRA impact longer term to HIV, but maybe can you talk about the trends you're seeing in 3Q? I wasn't sure the reason why you guys are now recognizing a stronger realized price. And then related, can you talk a little bit about if there's any discernible growth trends and just the number of new patients entering the HIV treatment market? .

Johanna Mercier

Yes. Sure, Geoff. It's Johanna. Yes. So what we're seeing -- and I'll just take the Taby, right, a 10% year-on-year growth Overall, HIV is 18% year-on-year, and that's obviously inclusive of Biktarvy, but also Yestugo and Descovy. But if you think about the treatment and what's going on there, a lot of that has to do with obviously, demand, but also inventory. And we saw a little bit of a higher Q3 inventory that we usually see across all of our HIV portfolio, which is obviously something that we're conscious of and understand that, that might mean that the seasonal -- the typical seasonal Q4 inventory that plays out in Q4 usually might be a little softer than usual, but you'll still see a ramp-up of buildup and that's part of our guidance, of course.

So there was an inventory play. There was also favorable pricing and the favorable pricing has to do with the channels. So as I think I've shared before, but 1% of 1 channel is the channel moves if there's less of a discount in that channel versus a heavier discounting channel and play a big fluctuation in your pricing on a quarter-over-quarter kind of basis. And so that's what's kind of playing out there.

And of course, the demand piece. You see that the share for Biktarvy continues to grow. It's at an all-time high at 53%. So incredibly proud. We are #1 across naive, switch, we start and I think the team has just done an incredible job, and this is obviously not only in the U.S. but really worldwide and very proud of that work, let alone the big Flen launch that we haven't really touched on, and I just closed the call on that. The [indiscernible] launch is absolutely on track versus expectations. It's very early. We launched late August, but really pleased to see incredible awareness of this molecule. And really, if you compare at similar time points post launch, we are well ahead competitor launches. So we feel very strongly that this is on the right track, and we just need to continue to build access and awareness in the field, both for complex regimen as well as viral suppressed switch patients.

Operator

That completes the time we have for questions. I'll now invite Dan to share any closing remarks.

Daniel O'Day

Well, first of all, I mean, I can't let a quarter go by. I like this without thanking the extraordinary Gilead team. We're delivering on this really exceptional third quarter. It's the strongest base business growth we've seen in more than 10 years. And at the same time, just the incredible advancement in our pipeline, which is getting diverse, as you can see, and we're preparing for even more launches into the future. So I'm incredibly proud of the progress that we made as a team and the impact -- and the impact that we're creating for the communities and the patients we serve. .

As we look ahead, the multiple opportunities to drive growth across all of our therapeutic areas, the strength of our commercial and clinical execution and the discipline in operating model that we are following all give us tremendous confidence in the trajectory of the company and really the fact that we can do even more for the patients and communities and shareholders that we serve. So thank you so much for joining today. As usual, we hear for your questions and comments, and we look forward to keeping you informed on our progress. Thank you again.