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Operator
Operator
Good afternoon, everyone, and welcome to Gilead's fourth-quarter and full year 2025 earnings conference call. My name is Rebekah, and I'll be today's host. In a moment, we'll begin our prepared remarks, followed by our Q&A session. (Operator Instructions)
各位下午好,歡迎參加吉利德2025年第四季及全年業績電話會議。我叫麗貝卡,我將擔任今天的主持人。稍後我們將開始發表準備好的講話,之後是問答環節。(操作說明)
Now I'll hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.
現在我將把電話交給財務和投資者關係高級副總裁傑奎·羅斯。
Jacquie Ross, CFA - Senior Vice President of Treasury and Investor Relations
Jacquie Ross, CFA - Senior Vice President of Treasury and Investor Relations
Thank you, Rebekah. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year 2025. The press release, slides and supplemental 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, 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.
謝謝你,麗貝卡。今天股市收盤後不久,我們發布了一份新聞稿,公佈了 2025 年第四季和全年的獲利結果。新聞稿、投影片和補充資料可在吉利德公司網站 gilead.com 的投資者關係欄位中查閱。今天電話會議的發言人包括:董事長兼首席執行官丹尼爾·奧戴 (Daniel O'Day);首席商務及企業事務官喬安娜·默西埃 (Johanna Mercier);首席醫療官迪特馬爾·伯格 (Dietmar Berger);以及首席財務官安德魯·迪金森 (Andrew Dickinson)。之後,我們將開啟問答環節,屆時 Kite 的執行副總裁 Cindy Perettie 將加入團隊。
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.
我在此提醒各位,我們將發表一些前瞻性聲明。有關前瞻性陳述的風險和不確定性,請參閱第 2 頁,這些風險和不確定性可能導致實際結果與預期結果有重大差異。
With that, I'll turn the call over to Dan.
接下來,我會把電話交給丹。
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share another very strong set of results for Gilead, closing out a remarkable year for the company with clinical, commercial, and operational achievements that set the stage for a very promising 2026.
謝謝你,杰奎琳,大家下午好。我很高興地宣布吉利德公司又取得了一系列非常強勁的業績,為公司輝煌的一年畫上了圓滿的句號。公司在臨床、商業和營運方面都取得了顯著成就,為充滿希望的 2026 年奠定了基礎。
Starting with our full year results. Our HIV business grew 6% year over year driven by 7% growth in Biktarvy and 47% growth in our HIV prevention portfolio. This was despite an estimated $900 million headwind in 2025 associated with the Part D redesign. Absent this headwind, our HIV business growth was 10% in 2025.
首先是我們的全年業績。我們的 HIV 業務年增 6%,這主要得益於 Biktarvy 成長 7% 以及 HIV 預防產品組合成長 47%。儘管預計到 2025 年,與 Part D 重新設計相關的成本將高達 9 億美元,但這仍然發生了。如果沒有這種不利因素,到 2025 年,我們的 HIV 業務成長率將達到 10%。
Yeztugo, our twice-yearly HIV prevention injectable has already exceeded our coverage goals and is rapidly gaining market share in addition to expanding the reach of HIV prevention to new users. With its unique potential to bend the curve of the HIV epidemic, Yeztugo is a transformative medicine that we expect to drive durable, steady and long-term growth in our HIV prevention business in the coming quarters and years.
Yeztugo 是我們每年註射兩次的 HIV 預防藥物,其覆蓋率已超過預期目標,並且正在迅速擴大市場份額,同時也擴大了 HIV 預防的覆蓋範圍,吸引了新的用戶。Yeztugo 具有扭轉 HIV 疫情曲線的獨特潛力,是一種具有變革意義的藥物,我們預計它將在未來幾個季度和幾年內推動我們 HIV 預防業務的持久、穩定和長期成長。
Our Liver business grew 6% in 2025 compared to 2024, largely driven by the rapid adoption of Livdelzi for primary biliary cholangitis. And in oncology, Trodelvy also grew 6% in 2025 driven by momentum in metastatic triple-negative breast cancer following positive Phase III updates. And cell therapy was down about 7% year over year, largely in line with our expectations and reflecting continuing competitive headwinds.
與 2024 年相比,我們的肝臟業務在 2025 年增長了 6%,這主要得益於 Livdelzi 在原發性膽汁性膽管炎治療中的快速普及。在腫瘤領域,Trodelvy 2025 年也成長了 6%,這得益於轉移性三陰性乳癌在 III 期臨床試驗中取得的積極進展。細胞療法年減約 7%,基本上符合我們的預期,反映出持續的競爭逆風。
Moving to clinical progress, following a very productive year in 2025, we have a catalyst-rich year ahead, including: Phase III updates from ISLEND-1 and 2 trials evaluating islatravir plus lenacapavir, the potential first once-weekly oral treatment for people with virologically suppressed HIV. Two Phase III updates for Trodelvy, including the EVOKE-03 trial in metastatic non-small cell lung cancer and the ASCENT GYN-01 trial in advanced endometrial cancer. Lastly, we expect an update on the Phase III IDEAL study, evaluating Livdelzi in second-line primary biliary cholangitis patients with only incomplete response to UDCA.
展望臨床進展,繼 2025 年碩果累累之後,我們迎來充滿催化劑的一年,其中包括:ISLEND-1 和 2 試驗的 III 期更新,該試驗評估了 islatravir 加 lenacapavir,這可能是首個針對 HIV 病毒抑制患者的每週一次口服治療方案。Trodelvy 的兩項 III 期最新進展,包括轉移性非小細胞肺癌的 EVOKE-03 試驗和晚期子宮內膜癌的 ASCENT GYN-01 試驗。最後,我們期待 III 期 IDEAL 研究的最新進展,該研究旨在評估 Livdelzi 對僅對 UDCA 有不完全反應的二線原發性膽汁性膽管炎患者的療效。
The strength and the pace of progress in our clinical pipeline is driving a steady cadence of product launches and on the heels of Livdelzi in 2024 and Yeztugo in 2025, and we are targeting four commercial launches this year, including: Trodelvy for first-line metastatic triple-negative breast cancer, extending beyond second-line treatment for which Trodelvy is a standard of care following positive results from the Phase III ASCENT-03 and ASCENT-04 studies; a new daily oral combination of bictegravir and lenacapavir for HIV treatment following positive updates from the Phase III ARTISTRY-1 and ARTISTRY-2 trials; Anito-cel our potential best-in-disease BCMA CAR-T for fourth line or later relapsed or refractory multiple myeloma; and bulevirtide in the US following approval in the EU for treatment of chronic hepatitis delta. These commercial and clinical milestones reflect the success of our diversification strategy that has been shaping Gilead over the last six years. We have up to 10 ongoing and potential new launches through 2027 and the strongest pipeline in our almost 40-year history.
我們臨床研發管線的實力和進展速度推動著產品穩步上市,繼 2024 年的 Livdelzi 和 2025 年的 Yeztugo 之後,我們今年的目標是推出四款商業產品,包括:用於一線轉移性三陰性乳腺癌的 Trodelvy,在 III 期 ASCENT-03 和 ASCENT-04 研究取得積極性乳癌的 Trodelvy,在 III 期 ASCENT-03 和 ASCENT-04 研究取得積極治療結果,Cdelvyvy 已作為標準治療後;治療的每日口服比克替拉韋和來那卡帕韋新組合,此前 III 期 ARTISTRY-1 和 ARTISTRY-2 試驗取得了積極進展;用於四線或更晚期復發或難治性多發性骨髓瘤的潛在最佳 BCMA CAR-T 療法 Anito-cel;以及在歐盟獲批用於治療慢性丁型肝炎後,在美國上市的 bulevirtideide。這些商業和臨床里程碑反映了我們過去六年來塑造吉利德的多元化策略的成功。到 2027 年,我們共有多達 10 個正在進行且潛在的新產品發布項目,這是我們近 40 年歷史上最強大的產品線。
At the same time, we remain committed to operating expense in M&A discipline, continued delivery of exceptional operating results and growing returns to shareholders.
同時,我們將繼續致力於控制併購營運費用,持續取得卓越的經營業績,並為股東帶來不斷增長的回報。
With many of the policy-related uncertainties behind us and no major product LOEs until 2036, Gilead is entering 2026 in a position of strength.
由於許多與政策相關的不確定因素已經過去,而且在 2036 年之前沒有重大產品停產,吉利德以強勁的勢頭進入 2026 年。
With that, I will hand it over to Johanna.
然後,我就把它交給喬安娜了。
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Thanks, Dan, and good afternoon, everyone. 2025 was another strong year of commercial execution with base business sales up 4% compared to 2024 or nearly 8% excluding impact from Medicare Part D redesign. This underscores the durability of our base business and our sustained launch momentum with up to 10 ongoing and potential new launches through 2027.
謝謝丹,大家下午好。 2025年商業執行方面又取得了強勁的成績,基礎業務銷售額比2024年增長了4%,若不計入Medicare Part D改革的影響,增幅接近8%。這凸顯了我們基礎業務的持久性和持續的推出勢頭,到 2027 年,我們還有多達 10 個正在進行和潛在的新產品推出。
Beginning on slide 7. Fourth quarter total product sales, excluding Veklury, were $7.7 billion, up 7% year over year and 9% sequentially, primarily driven by higher sales across HIV and Livdelzi. Including Veklury sales of $212 million, fourth quarter total product sales were $7.9 billion, up 5% year over year and 8% sequentially.
從第7張投影片開始。第四季產品總銷售額(不包括 Veklury)為 77 億美元,較去年同期成長 7%,較上季成長 9%,主要得益於 HIV 和 Livdelzi 銷售額的成長。包括 Veklury 的 2.12 億美元銷售額在內,第四季產品總銷售額為 79 億美元,年增 5%,季增 8%。
Turning to the full year on slide 8. Total product sales, excluding Veklury, were $28 billion in 2025, more than $300 million above the high end of our full year guidance range, driven by outperformance in our HIV business and partially offset by lower cell therapy sales. Including Veklury, total product sales were $28.9 billion, up 1% compared to 2024 or 5%, excluding Medicare Part D redesign impact, highlighting the strength of our overall business.
接下來請看第 8 張投影片,了解全年情況。2025 年,除 Veklury 外,產品總銷售額為 280 億美元,比我們全年預期範圍的上限高出 3 億美元以上,這主要得益於 HIV 業務的出色表現,但部分被細胞療法銷售額的下降所抵消。包括 Veklury 在內,產品總銷售額為 289 億美元,比 2024 年成長 1%,或 5%(不包括 Medicare Part D 重新設計的影響),這凸顯了我們整體業務的強勁勢頭。
Moving to slide 9. Our HIV business delivered record sales of $5.8 billion for the fourth quarter, up 6% year over year, driven by higher demand for Biktarvy and as well as the launch of Yeztugo. Sequentially, HIV sales were up 10%, primarily driven by seasonal inventory dynamics and higher average realized price due to favorable channel mix in addition to demand. For the full year, HIV sales of $20.8 billion were up 6% year over year, driven by strong underlying demand growth. Our exceptional commercial performance and higher-than-expected average realized price exceeded our updated guidance of 5% growth. Excluding the estimated $900 million headwind associated with the Medicare Part D redesign, our HIV business grew 10% year over year.
切換到第9張投影片。我們的 HIV 業務第四季銷售額創下 58 億美元的紀錄,年增 6%,這主要得益於對 Biktarvy 的需求增加以及 Yeztugo 的推出。HIV 產品的銷售額季增 10%,主要受季節性庫存動態和有利的通路組合以及需求推動,導致平均實現價格上漲。全年來看,HIV產品銷售額為208億美元,較去年同期成長6%,這主要得益於強勁的潛在需求成長。我們卓越的商業表現和高於預期的平均實現價格超過了我們更新後的 5% 的成長預期。撇開與 Medicare Part D 改革相關的預計 9 億美元不利因素不談,我們的 HIV 業務年增了 10%。
Looking at HIV treatment in more detail on slide 10. Biktarvy fourth quarter sales were $4 billion, up 5% year over year and full year sales were $14.3 billion, up 7% year over year, both driven by higher demand, partially offset by lower average realized price. This demand-led growth reflects 2% to 3% treatment market growth annually and continued Biktarvy share gains. In the US, for example, Biktarvy's share is more than 52% with year-over-year gains every quarter since launch. It's clear Biktarvy continues to set the bar for HIV treatment and remains the number one prescribed regimen for both treatment naive and switch across major markets.
第 10 張投影片將更詳細地介紹 HIV 治療。Biktarvy 第四季銷售額為 40 億美元,年增 5%;全年銷售額為 143 億美元,年增 7%,均受需求成長的推動,但部分被平均實現價格下降所抵銷。這種需求驅動的成長反映了治療市場每年 2% 至 3% 的成長以及 Biktarvy 市場份額的持續成長。例如,在美國,Biktarvy 的市佔率超過 52%,自推出以來每季都實現了年成長。很明顯,Biktarvy 繼續引領 HIV 治療的標準,並且仍然是各大市場中初治患者和轉治患者的首選治療方案。
We are rapidly advancing towards the launch of BIC/LEN, our investigational once-daily oral combining bictegravir, the most prescribed integrase inhibitor with our breakthrough capsid inhibitor lenacapavir in virologically suppressed people with HIV, including those on complex regimens. BIC/LEN could further expand our lead in the switch market following potential launch in the second half of this year. This regimen represents the first of up to seven potential HIV product launches through 2033.
我們正在快速推進 BIC/LEN 的上市,這是一種研究性每日一次口服藥物,它將處方量最大的整合酶抑製劑比克替拉韋與我們突破性的衣殼抑製劑來那卡帕韋結合,用於治療 HIV 病毒學抑制的患者,包括接受複雜治療方案的患者。BIC/LEN預計將在今年下半年上市,並進一步擴大我們在交換器市場的領先地位。該方案是 2033 年可能推出的多達七個 HIV 產品中的第一個。
Now moving to slide 11. We've had another exceptional quarter for our HIV prevention business, which grew 53% year over year, driven by favorable access, strong commercial execution and continued US market growth of approximately 13% year over year. Our fourth quarter sales of Descovy were up an impressive 33% year over year. For the full year, Descovy sales were $2.8 billion, up 31% year over year, driven by increased demand in HIV prevention and higher average realized price. Descovy performance in HIV prevention, which accounts for roughly 80% of its sales continues to exceed expectations with record US market share greater than 45%.
現在轉到第11張投影片。我們的 HIV 預防業務又迎來了一個卓越的季度,同比增長 53%,這得益於良好的市場准入、強勁的商業執行以及美國市場持續增長(同比增長約 13%)。Descovy第四季的銷售額年增了33%,成績斐然。全年來看,Descovy 的銷售額為 28 億美元,年增 31%,這主要得益於 HIV 預防需求的增加和平均實際價格的上漲。Descovy 在 HIV 預防領域的表現(約佔其銷售額的 80%)繼續超出預期,在美國的市場份額創下超過 45% 的紀錄。
Similarly, Yeztugo continues to perform strongly across several key launch indicators. Yeztugo fourth quarter sales were $96 million, and full year Yeztugo sales were $150 million, in line with our guidance we shared in the third quarter. Building upon this early success, we recently launched our Yeztugo branded direct-to-consumer campaign, highlighting Yeztugo's dosing schedule and efficacy and reflecting the broad diversity represented in our purpose trials. We expect this DTC campaign to broaden awareness of Yeztugo and contribute to a consistent build in Yeztugo sales in the coming quarters.
同樣,Yeztugo 在幾個關鍵的上市指標上也持續表現強勁。Yeztugo 第四季銷售額為 9,600 萬美元,全年銷售額為 1.5 億美元,與我們在第三季分享的預期一致。憑藉早期的成功,我們最近推出了 Yeztugo 品牌直接面向消費者的宣傳活動,重點介紹 Yeztugo 的給藥方案和療效,並體現了我們在用途試驗中所代表的廣泛多樣性。我們預計此次 DTC 活動將擴大 Yeztugo 的知名度,並有助於 Yeztugo 在未來幾季持續成長。
Coverage for Yeztugo continues to grow, and I'm thrilled to share that we have achieved our goal of 90% coverage well ahead of our 1-year target. This includes all major payers. Additionally, approximately 90% of covered individuals can access Yeztugo with $0 co-pay. We continue to work on an account-by-account basis to support pull-through as quickly as possible. While we have more to do, we are making great progress here as we support clinicians and their offices navigate the new logistics associated with a twice yearly injectable regimen.
Yeztugo 的覆蓋範圍持續擴大,我很高興地宣布,我們已提前實現了 90% 的覆蓋率目標,遠超我們 1 年的目標。這包括所有主要支付方。此外,約 90% 的受保人員可自付費用 0 美元使用 Yeztugo。我們將繼續逐一帳戶地進行工作,以盡快支持資金到位。雖然我們還有很多工作要做,但我們在支援臨床醫生及其診所應對每年兩次注射方案相關的新後勤方面取得了巨大進展。
Given our expectations for a steady, durable, and long-term build in sales, we expect full year 2026 Yeztugo revenue of approximately $800 million compared to $150 million in 2025. And highlighting that Yeztugo is well on its way to achieving blockbuster status. We continue to offer the most compelling HIV prevention portfolio available including the six monthly Yeztugo injectable with its transformative potential on the HIV epidemic, in addition to Descovy PrEP, the current market-leading branded oral. Our goal this year is to continue to drive rapid adoption of HIV prevention, and we expect both brands to demonstrate robust growth in 2026.
鑑於我們對銷售額穩定、持久和長期成長的預期,我們預計 Yeztugo 2026 年全年營收約為 8 億美元,而 2025 年為 1.5 億美元。並強調 Yeztugo 正在朝著成為票房大片的方向穩步前進。我們繼續提供最具吸引力的 HIV 預防產品組合,包括每六個月注射一次的 Yeztugo,它對 HIV 流行具有變革性的潛力,以及目前市場領先的品牌口服藥物 Descovy PrEP。我們今年的目標是繼續推動愛滋病預防的快速普及,我們預計這兩個品牌在 2026 年都將實現強勁成長。
For 2026, we expect total HIV sales, including both treatment and prevention to grow approximately 6% compared to 2025, as shown on slide 12. Looking at quarterly trends and as a reminder, we expect our normal HIV seasonal inventory drawdown in the first quarter of 2026.
如投影片 12 所示,我們預計 2026 年 HIV 產品總銷售額(包括治療和預防)將比 2025 年成長約 6%。從季度趨勢來看,需要提醒的是,我們預計 2026 年第一季將出現正常的 HIV 季節性庫存下降。
As announced in December, there are manageable headwinds associated with the drug pricing agreement with the US government to lower Medicaid pricing for some of our products, including Genvoya and Odefsey. Additionally, our guidance reflects some potential shifts into lower-priced channels associated with proposed changes to the Affordable Care Act. In total, these headwinds are expected to impact HIV growth by about 2% in 2026 compared to 2025. Absent these headwinds, our HIV business is expected to grow 8% in 2026, highlighting the underlying strength of our HIV business.
正如 12 月宣布的那樣,與美國政府達成的藥品定價協議,旨在降低我們部分產品(包括 Genvoya 和 Odefsey)的 Medicaid 價格,這其中存在一些可控的阻力。此外,我們的指導意見也反映了與《平價醫療法案》擬議變更相關的向低價管道的一些潛在轉變。總體而言,預計這些不利因素將使 2026 年 HIV 感染人數比 2025 年下降約 2%。如果沒有這些不利因素,我們的 HIV 業務預計在 2026 年將成長 8%,這凸顯了我們 HIV 業務的潛在實力。
Turning to liver disease on slide 13. Full year sales of $3.2 billion were up 6% year over year, primarily driven by higher demand and partially offset by lower average realized price. In the fourth quarter, liver sales were $844 million, up 17% year over year and 3% sequentially, driven by another quarter of continued strength for Livdelzi in primary biliary cholangitis or PBC.
接下來請看第 13 張投影片,內容是關於肝臟疾病的。全年銷售額達 32 億美元,年增 6%,主要受需求成長的推動,但部分被平均實現價格下降所抵銷。第四季度,肝臟銷售額為 8.44 億美元,年增 17%,環比增長 3%,這主要得益於 Livdelzi 在原發性膽汁性膽管炎 (PBC) 治療中持續強勁的銷售勢頭。
Livdelzi grew a remarkable 42% sequentially to $150 million, driven by strong patient demand, further accelerated by the withdrawal of a competitor product in the US. With much of this switching activity now behind us, we are pleased to start 2026 as the US market share leader with more than 50% in second-line PBC.
在強勁患者的需求推動下,Livdelzi 的銷售額環比增長了驚人的 42%,達到 1.5 億美元,而競爭對手的產品在美國的撤市進一步加速了這一增長。隨著大部分轉換活動已經結束,我們很高興地宣布,2026 年伊始,我們已成為美國市場份額的領導者,在二線 PBC 市場佔有超過 50% 的份額。
Moving to Trodelvy on slide 14. Full year 2025 sales increased 6% to $1.4 billion, primarily driven by higher demand in metastatic breast cancer treatment which more than offset the expected impact from the bladder cancer withdrawal in the US at the end of 2024. In the fourth quarter, Trodelvy sales were $384 million, up 8% both year over year and sequentially, driven by higher demand.
第 14 張投影片切換到 Trodelvy。2025 年全年銷售額成長 6% 至 14 億美元,主要得益於轉移性乳癌治療需求的增加,足以抵銷 2024 年底在美國撤出膀胱癌治療藥物的預期影響。第四季度,Trodelvy 的銷售額為 3.84 億美元,較去年同期成長 8%,較上季成長 8%,主要得益於更高的需求。
Building on Trodelvy's strong 2025 performance, we shared back-to-back positive Phase III ASCENT-03 and ASCENT-04 readouts. These results contribute to the strong body of evidence for Trodelvy across lines of therapy in metastatic triple-negative breast cancer and continue to drive demand growth. In both these studies, the investigational Trodelvy regimen demonstrated a highly statistically significant and clinically meaningful progression-free survival benefit over the standard of care. These potentially practice-changing data have now been published in the New England Journal of Medicine and have been recognized by the NCCN in their updated breast cancer guidelines.
繼 Trodelvy 2025 年的強勁表現之後,我們連續公佈了 ASCENT-03 和 ASCENT-04 III 期臨床試驗的正面結果。這些結果為 Trodelvy 在轉移性三陰性乳癌的各種治療方案中的療效提供了強有力的證據,並持續推動需求成長。在這兩項研究中,試驗性 Trodelvy 方案均顯示出比標準治療方案具有高度統計意義和臨床意義的無惡化存活獲益。這些可能改變臨床實踐的數據現已發表在《新英格蘭醫學雜誌》上,並被美國國家綜合癌症網絡(NCCN)在其更新的乳癌指南中予以認可。
Trodelvy is now the only antibody drug conjugate to be recommended by the NCCN for first-line PD-L1 positive and PD-L1 negative as well as second-line metastatic triple-negative breast cancer. As the leading regimen in second line, Trodelvy is already well established with oncologists and these updates build momentum for Trodelvy ahead of potential first-line launches expected later this year.
Trodelvy 是目前唯一被 NCCN 推薦用於第一線治療 PD-L1 陽性和 PD-L1 陰性乳癌以及二線治療轉移性三陰性乳癌的抗體藥物偶聯物。作為二線治療的領先方案,Trodelvy 已在腫瘤學家中得到廣泛認可,這些更新將為 Trodelvy 在今年稍後可能推出的一線治療方案奠定基礎。
Moving to Cell Therapy on slide 15 and on behalf of Cindy and the Kite team, full year cell therapy sales were $1.8 billion, down 7% year over year, reflecting ongoing in and out-of-class competition. For the fourth quarter, cell therapy sales were $458 million, up 6% sequentially due to higher-than-expected patient treatments in advance of holidays in addition to onetime pricing adjustments. Year over year, fourth quarter cell therapy sales were down 6%, consistent with the trends we have discussed throughout 2025. For 2026, we continue to expect these competitive headwinds including in several countries outside the US, where we expect new entrants this year. Additionally, cell therapy volumes are being impacted by a growing number of clinical trials, which is exciting for our industry and for the patients who could benefit from innovative new therapies from Kite and others.
在第 15 張投影片中,我們來看看細胞療法。我代表 Cindy 和 Kite 團隊表示,全年細胞療法銷售額為 18 億美元,年減 7%,反映了持續的產業內外競爭。第四季度,細胞療法銷售額為 4.58 億美元,較上季成長 6%,原因是假日前病患治療量高於預期,以及一次性價格調整。與去年同期相比,第四季細胞療法銷售額下降了 6%,這與我們 2025 年全年討論的趨勢一致。2026 年,我們預計這些競爭逆風將繼續存在,包括在美國以外的幾個國家,我們預計今年將有新的企業進入這些國家。此外,越來越多的臨床試驗正在影響細胞療法的銷量,這對我們行業以及可能受益於 Kite 和其他公司創新療法的患者來說都是令人興奮的。
That said, this represents another near-term headwind. Overall, we expect Kite revenue to decline approximately 10% in 2026 compared to 2025. Looking to the second half of the year, the team is preparing for the potential launch of anito-cel in fourth line and later relapsed or refractory multiple myeloma. We believe anito-cel potential best-in-disease profile combined with Kite's exceptional manufacturing capabilities and industry-leading turnaround times puts us in a favorable position ahead of a potential commercial launch.
也就是說,這代表著近期內的另一個不利因素。總體而言,我們預計 Kite 2026 年的營收將比 2025 年下降約 10%。展望下半年,該團隊正在為anito-cel在四線及以後復發或難治性多發性骨髓瘤中的應用做準備。我們相信,anito-cel 具有最佳的疾病特性,再加上 Kite 卓越的製造能力和業界領先的周轉時間,使我們在潛在的商業化推出之前處於有利地位。
Wrapping up our fourth quarter and 2025 on slide 16, I'd like to highlight the exceptional strength of our existing commercial portfolio as well as our robust launch pipeline with the potential for four launches later this year. We are committed to remaining focused on our ongoing launches of Livdelzi and Yeztugo in addition to ensuring that we are prepared to have an immediate impact with the potential launches of anito-cel in multiple myeloma, Trodelvy in first-line metastatic triple-negative breast cancer, BIC/LEN in HIV treatment, and bulevirtide in chronic hepatitis D. The addition of these potentially transformative therapies to our portfolio is incredibly energizing for our teams. We look forward to extending the reach of Gilead's therapies to many more patients who can benefit from them in 2026.
在第 16 張投影片中,我將總結我們的第四季和 2025 年,並重點介紹我們現有商業組合的卓越實力以及我們強大的產品上市管道,今年稍後有可能推出四款產品。我們將繼續專注於 Livdelzi 和 Yeztugo 的持續上市,同時確保做好準備,以便在 anito-cel(用於治療多發性骨髓瘤)、Trodelvy(用於一線轉移性三陰性乳腺癌)、BIC/LEN(用於 HIV 治療)和 bulevirtide(用於治療慢性丁型肝炎)的潛在上市中迅速產生影響。這些具有潛在變革意義的療法加入我們的產品組合,讓我們的團隊倍感振奮。我們期待在 2026 年將吉利德的療法推廣到更多能夠從中受益的患者群體。
And with that, I'll hand the call over to Dietmar.
好了,接下來我將把電話交給迪特馬爾。
Dietmar Berger, MD, PhD - Chief Medical Officer
Dietmar Berger, MD, PhD - Chief Medical Officer
Thank you, Johanna, and good afternoon, everyone. I'd like to start by reflecting on 2025 and thanking the research and development teams and partners for an exceptional year of clinical execution. As shown in our 2025 milestones, on slide 18, we received regulatory approvals for lenacapavir, our first-in-class capsid inhibitor for HIV prevention in the US, EU, and 12 other countries. Additionally, we provided updates on seven Phase III or pivotal Phase II trials, including positive updates for bictegravir plus lenacapavir, Trodelvy, and anito-cel. Looking ahead to 2026 and beyond, we are well positioned to progress our clinical programs across our three core therapeutic areas.
謝謝你,喬安娜,大家下午好。首先,我想回顧一下 2025 年,並感謝研發團隊和合作夥伴在過去一年中出色地完成了臨床執行工作。正如我們在 2025 年里程碑的第 18 頁幻燈片中所示,我們在美國、歐盟和其他 12 個國家獲得了 lenacapavir 的監管批准,lenacapavir 是我們首創的 HIV 預防衣殼抑制劑。此外,我們還提供了七項 III 期或關鍵 II 期試驗的最新進展,包括比克替拉韋加來那卡帕韋、Trodelvy 和 anito-cel 的積極進展。展望 2026 年及以後,我們已做好充分準備,推進我們在三大核心治療領域的臨床計畫。
Starting with HIV on slide 19. We continue to advance a comprehensive pipeline with lenacapavir as the backbone. Our HIV pipeline could support up to seven additional daily, weekly, monthly, twice yearly or yearly HIV product launches by the end of 2033. In the fourth quarter, we announced positive top line results from ARTISTRY-1 and 2 evaluating once-daily bictegravir, the most prescribed integrated inhibitor with lenacapavir, our breakthrough capsid inhibitor. We expect to share detailed results from our positive Phase III trials at the CROI meeting in February with a potential FDA decision by the end of the year.
從第 19 張投影片上的 HIV 開始。我們繼續推進以lenacapavir為核心的綜合研發管線。到 2033 年底,我們的 HIV 產品線可以支援每天、每週、每月、每年兩次或每年推出多達 7 種新的 HIV 產品。第四季度,我們公佈了 ARTISTRY-1 和 2 的積極頂線結果,這兩項研究評估了每日一次的 bictegravir(處方量最大的整合抑製劑)與我們突破性的衣殼抑製劑 lenacapavir 的療效。我們預計將在 2 月的 CROI 會議上分享我們積極的 III 期試驗的詳細結果,並預計在年底前獲得 FDA 的決定。
Looking at our long-acting programs. We plan to share Phase III update from our ISLEND-1 ISLEND-2 trials, evaluating islatravir plus lenacapavir in the first half of 2026. And for our twice-yearly treatment program, we plan to initiate our Phase III trial evaluating lenacapavir plus broadly neutralizing antibodies in the second half of the year. Further, we have now completed our evaluation of the Phase I data for our long-acting insti candidates GS-3242 and GS-1219 as well as GS-1614 an islatravir prodrug. Consistent with the timeline shared during our HIV analyst event in December 2024, we have identified DS-3242 as the most promising program with lenacapavir and prioritized its development as a potential twice-yearly HIV treatment.
看看我們的長效項目。我們計劃在 2026 年上半年分享 ISLEND-1 ISLEND-2 試驗的 III 期最新進展,該試驗評估了 islatravir 加 lenacapavir 的療效。對於我們每年兩次的治療計劃,我們計劃在今年下半年啟動評估 lenacapavir 加廣譜中和抗體的 III 期試驗。此外,我們現在已經完成了對長效誘導劑候選藥物 GS-3242 和 GS-1219 以及 islatravir 前藥 GS-1614 的 I 期數據的評估。根據我們在 2024 年 12 月 HIV 分析師活動中分享的時間表,我們已將 DS-3242 確定為最有前途的 lenacapavir 項目,並優先開發其作為潛在的每年兩次 HIV 治療方案。
As a result and as a reminder, we have discontinued the development of a twice yearly regimen with GS-1219 and a quarterly regimen with GS-1614. Turning to liver disease on slide 20. We remain committed to further evaluating Livdelzi to potentially improve the standard of care for more patients with PBC. At the Liver meeting in November, we presented late-breaking real-world data showing that Livdelzi is an effective and well-tolerated alternative for PBC patients switching from obeticholic acid. Later this year, we expect to provide an update from our Phase III IDEAL study, evaluating Livdelzi in PBC patients with ALP levels between 1 and 1.67 times the upper limit of normal, patients typically excluded from Phase III studies.
因此,再次提醒大家,我們已經停止開發每半年一次使用 GS-1219 的治療方案和每季一次使用 GS-1614 的治療方案。接下來請看第 20 張投影片,內容是關於肝臟疾病。我們將繼續致力於對 Livdelzi 進行進一步評估,以期提高更多 PBC 患者的治療標準。在 11 月的肝臟會議上,我們展示了最新的真實世界數據,表明 Livdelzi 是 PBC 患者從奧貝膽酸轉換到 Livdelzi 的有效且耐受性良好的替代方案。今年晚些時候,我們預計將公佈 III 期 IDEAL 研究的最新進展,該研究評估了 Livdelzi 對 ALP 水平在正常上限的 1 到 1.67 倍之間的 PBC 患者的療效,這些患者通常會被排除在 III 期研究之外。
If positive, these data could support the expansion of Livdelzi to incomplete responders to UDCA and potentially enable even more second-line PBC patients to achieve better biochemical and symptomatic control of their PBC.
如果結果為陽性,這些數據可能支持將 Livdelzi 應用於對 UDCA 反應不完全的患者,並有可能使更多二線 PBC 患者更好地控制其 PBC 的生化和症狀。
Moving to oncology on slide 21. Trodelvy has demonstrated clinically meaningful survival benefit in two Phase III trials establishing it as a leading regimen in its approved indications. Most recently, Trodelvy has demonstrated highly statistically significant and clinically meaningful progression-free survival benefit across first-line metastatic triple-negative breast cancer patients. Full data from the Phase III ASCENT-03 and ASCENT-04 trials were published in the New England Journal of Medicine in October 2025 and January 2026. We expect FDA decisions for Trodelvy in first-line metastatic TNBC patients who are not candidates for PD-1 inhibitors and for Trodelvy plus pembrolizumab in first-line PD-L1 positive metastatic TNBC in the second half of 2026.
第 21 張投影片將轉到腫瘤學部分。Trodelvy 在兩項 III 期試驗中均顯示出具有臨床意義的生存獲益,使其成為已獲批准適應症中的領先治療方案。最近,Trodelvy 在一線轉移性三陰性乳癌患者中表現出具有高度統計意義和臨床意義的無惡化存活獲益。ASCENT-03 和 ASCENT-04 III 期試驗的完整數據分別於 2025 年 10 月和 2026 年 1 月在《新英格蘭醫學雜誌》上發表。我們預計 FDA 將於 2026 年下半年對 Trodelvy 用於一線治療不適合 PD-1 抑制劑的轉移性 TNBC 患者,以及對 Trodelvy 聯合 pembrolizumab 用於一線治療 PD-L1 陽性轉移性 TNBC 患者做出決定。
Ahead of the FDA decisions, the NCCN updated their breast cancer guidelines to reflect the practice-changing nature of these results, reinforcing our confidence in Trodelvy's clinical profile.
在 FDA 做出決定之前,NCCN 更新了其乳癌指南,以反映這些結果對實踐的改變,這增強了我們對 Trodelvy 臨床表現的信心。
We also have four Phase III studies that continue to evaluate Trodelvy's potential in additional tumor types. Notably, we expect updates from two of the Phase III trials this year, including ASCENT GYN-01 evaluating Trodelvy in second-line metastatic Endometrial cancer in the second half of this year, as well as EVOKE-03, exploring Trodelvy plus pembro in first-line metastatic PD-L1 high non-small cell lung cancer.
我們還有四項 III 期研究正在繼續評估 Trodelvy 在其他腫瘤類型中的潛力。值得注意的是,我們預計今年將有兩項 III 期試驗的更新結果,包括今年下半年評估 Trodelvy 在二線轉移性子宮內膜癌中的療效的 ASCENT GYN-01,以及探索 Trodelvy 聯合帕博利珠單抗一線治療轉移性 PD-L1 高表達非小細胞肺癌的 EVOKE-03。
Moving to cell therapy on slide 22, and on behalf of Cindy and the Kite team, I will touch upon some of our updates on our anito-cel program. Notably, we have filed anito-cel based on our update from the Phase II iMMagine-1 trial in fourth line or later relapsed or refractory multiple myeloma at ASH in December. Anito-cel demonstrated clinically meaningful efficacy with 96% overall response, including 74% complete response and 95% measurable residual disease negativity. Additionally, anito-cel demonstrated a predictable and manageable safety profile with no delayed or non-ICANS neurotoxicities and no immune effector cell-associated enterocolitis. Based on these exciting data, we are energized to potentially bring anito-cel to patients in the second half of this year.
接下來,在第 22 張投影片上,我將代表 Cindy 和 Kite 團隊,談談我們的抗細胞療法計畫的最新進展。值得注意的是,我們已根據我們在 12 月 ASH 會議上公佈的針對四線或更晚期復發或難治性多發性骨髓瘤的 II 期 iMMagine-1 試驗的最新結果,提交了 anito-cel 的上市申請。Anito-cel 顯示具有臨床意義的療效,整體緩解率為 96%,其中完全緩解率為 74%,可測量殘留病灶陰性率為 95%。此外,anito-cel 也表現出可預測且可控制的安全性,沒有延遲或非 ICNS 神經毒性,也沒有免疫效應細胞相關的腸炎。基於這些令人振奮的數據,我們充滿信心,並有望在今年下半年將anito-cel帶給病患。
Longer term, we see additional opportunity for anito-cel with our Phase III iMMagine-3 study in second, third, and fourth line relapsed or refractory multiple myeloma, enrolling in record time. We are also planning a pivotal program in newly diagnosed multiple myeloma. With our broader and rapidly advancing clinical development program, we expect anito-cel to potentially reach more patients earlier in the treatment paradigm.
從長遠來看,我們看到 anito-cel 在二線、三線和四線復發或難治性多發性骨髓瘤的 III 期 iMMagine-3 研究中具有更大的發展潛力,並且正在以創紀錄的速度招募患者。我們也計劃開展一項針對新確診多發性骨髓瘤的關鍵性項目。隨著我們更廣泛、快速推進的臨床開發計劃,我們預計anito-cel預計將在治療模式的早期階段惠及更多患者。
Wrapping up on slide 23. Our key milestones for 2026 include 5 Phase III readouts as well as five FDA decisions for â bulevirtide for chronic hepatitis delta, BIC/LEN for virologically suppressed people with HIV, Trodelvy in first-line PD-L1 positive and negative metastatic triple-negative breast cancer, and anito-cel in fourth line and later relapse or refractory multiple myeloma.
第 23 張投影片內容結束。我們 2026 年的主要里程碑包括 5 項 III 期臨床試驗結果公佈,以及 FDA 對以下藥物的五項決定:用於治療慢性丁型肝炎的 bulevirtide、用於治療 HIV 病毒抑制患者的 BIC/LEN、用於一線治療 PD-L1 陽性和陰性轉移性三陰性乳腺癌的 Trodelvy,以及用於四線以後及發性骨髓瘤或複發性骨髓瘤的 celanicel-celanicel -cel讀
While these pipeline milestones reflect some of our later-stage catalysts, I would like to remind you we have 53 ongoing clinical programs and will continue our progress across our portfolio, including KITE-753, our next-generation CD19/CD20, bicistronic CAR-T, enrolling for its pivotal trial for third-line large B-cell lymphoma, GS-1427, a once daily oral alpha-4-beta-7 inhibitor for inflammatory bowel disease, and edecesertib, our IRAK4 inhibitor for cutaneous lupus erythematosus.
雖然這些研發管線里程碑反映了我們後期的一些催化劑,但我還是要提醒大家,我們目前有 53 個正在進行的臨床項目,並將繼續推進我們產品組合的各項進展,包括我們的下一代 CD19/CD20 雙順反子 CAR-T 療法 KITE-753(目前正在招募患者針對三線大 B 細胞淋巴瘤的關鍵性試驗GS-1427,以及用於治療皮膚紅斑性狼瘡的 IRAK4 抑制劑 edecesertib。
And with that, I will turn over the call to Andy.
接下來,我會把電話交給安迪。
Andrew Dickinson - Chief Financial Officer
Andrew Dickinson - Chief Financial Officer
Thank you, Dietmar, and good afternoon, everyone. Starting on slide 25, full year 2025 total product sales of $28.9 billion were up 1% from 2024 and above our $28.4 billion to $28.7 billion guidance range driven by demand-led HIV sales growth that more than offset the $1.1 billion headwind related to Part D redesign and $900 million lower Veklury revenue. Excluding the Part D redesign impact, our total product sales grew nearly 5%.
謝謝你,迪特馬爾,大家下午好。從第 25 頁開始,2025 年全年產品總銷售額為 289 億美元,比 2024 年增長 1%,高於我們先前預測的 284 億美元至 287 億美元,這主要得益於 HIV 銷售需求的增長,足以抵消與 D 部分重新設計相關的 11 億美元不利因素以及 Veklury 銷售需求的增長,足以抵消與 D 部分重新設計相關的 11 億美元不利因素以及 Veklury 收入減少因素。不計入 Part D 重新設計的影響,我們的產品總銷售額成長了近 5%。
Base business revenue, which reflects total product sales, excluding Veklury, was $28 billion up nearly $1.2 billion or 4% from 2024, exceeding our $27.4 billion to $27.7 billion guidance range. Excluding the impact of the Part D redesign, our base business grew 8%. Our strong revenue results reflected HIV growth of 6% or $1.1 billion to $20.8 billion, driven by strong growth for Biktarvy and Descovy, which grew 7% and 31%, respectively, from 2024 as well as the launch of Yeztugo. And our Liver business grew 6% to $3.2 billion, reflecting growing demand primarily driven by Livdelzi. Full year 2025 Veklury revenue was $911 million, a decline of $900 million or 49% from 2024 and mostly in line with our expectations given lower COVID-19-related hospitalization trends.
基本業務收入(反映產品總銷售額,不包括 Veklury)為 280 億美元,比 2024 年增長近 12 億美元或 4%,超過了我們 274 億美元至 277 億美元的指導範圍。不計入 Part D 重新設計的影響,我們的基礎業務成長了 8%。我們強勁的營收表現反映了 HIV 業務成長 6%(即 11 億美元)至 208 億美元,這主要得益於 Biktarvy 和 Descovy 的強勁成長,它們分別從 2024 年起成長了 7% 和 31%,以及 Yeztugo 的推出。我們的肝臟業務成長了 6%,達到 32 億美元,這主要反映了 Livdelzi 推動的需求成長。2025 年 Veklury 全年收入為 9.11 億美元,比 2024 年下降了 9 億美元或 49%,考慮到 COVID-19 相關住院趨勢的下降,這基本上符合我們的預期。
Moving to our full year non-GAAP results on slide 26. Product gross margin was 86.4%, in line with our guidance of 86%. R&D expenses of $5.7 billion were down 1% compared to 2024 and in line with our guidance of R&D flat on a dollar basis for 2025. Acquired IPR&D expenses were approximately $1 billion, in line with our expected annual investment in earlier-stage opportunities that are part of our normal course of business development. And SG&A expenses of $5.6 billion were down 5% compared to 2024 within our guidance range, reflecting lower general and administrative expenses, partially offset by sales and marketing investments to support Yeztugo's launch.
接下來請看第 26 頁的全年非 GAAP 業績報告。產品毛利率為 86.4%,與我們預期的 86% 相符。研發支出為 57 億美元,比 2024 年下降 1%,符合我們對 2025 年研發支出以美元計算保持不變的預期。收購智慧財產權和研發費用約為 10 億美元,這符合我們對早期階段機會的預期年度投資,這是我們正常業務發展的一部分。銷售、一般及行政費用為 56 億美元,比 2024 年下降 5%,符合我們的預期範圍,這反映出一般及行政費用的降低,但部分被支持 Yeztugo 上市的銷售和營銷投資所抵消。
Overall, our operating margin for full year 2025 was 45%. Excluding acquired IPR&D and the $400 million nonrecurring other revenue related to the IP asset sale in the third quarter, our operating margin was roughly 48% for the full year. This underscores our ability to continue expense discipline while increasing investment in new and ongoing launches.
整體而言,我們 2025 年全年的營業利潤率為 45%。除去收購的智慧財產權和研發收入以及第三季與智慧財產權資產出售相關的 4 億美元非經常性其他收入,我們全年的營業利潤率約為 48%。這凸顯了我們能夠在持續控製成本的同時,增加對新產品和現有產品的投入。
The non-GAAP effective tax rate was 18.3%, roughly in line with our guidance of approximately 19% and down from 25.9% in 2024, primarily driven by the prior year nondeductible acquired IP R&D charge for the acquisition of Sima Bay. And finally, non-GAAP diluted EPS was $8.15, in line with our 2025 guidance of $8.05 to $8.25 and driven by lower acquired IP R&D expenses, higher revenues, and lower SG&A expenses. Excluding the approximately $3.14 per share impact related to the CymaBay transaction, non-GAAP diluted EPS increased by $0.40 compared to 2024.
非GAAP有效稅率為18.3%,與我們約19%的指導意見大致一致,低於2024年的25.9%,主要原因是去年收購Sima Bay產生的不可抵扣的收購智慧財產權研發費用。最後,非GAAP稀釋後每股盈餘為8.15美元,符合我們2025年8.05美元至8.25美元的預期,主要得益於收購智慧財產權研發費用降低、收入增加以及銷售、一般及行政費用降低。剔除與 CymaBay 交易相關的每股約 3.14 美元的影響,非 GAAP 稀釋後每股收益比 2024 年增加了 0.40 美元。
To quickly recap the fourth quarter on slide 27. Total product sales were $7.9 billion, up 5% year over year, with base business growth partially offset by the expected decline in Veklury sales. Excluding Veklury, total product sales were $7.7 billion, up 7% from the same period in 2024, primarily driven by higher sales for our HIV and liver disease products.
快速回顧一下第 27 頁投影片上的第四季內容。產品總銷售額為 79 億美元,年增 5%,但基礎業務成長部分被 Veklury 銷售額的預期下降所抵銷。除 Veklury 外,產品總銷售額為 77 億美元,比 2024 年同期成長 7%,主要得益於 HIV 和肝病產品銷售額的成長。
Moving to the fourth quarter P&L on slide 28. We R&D expenses were $1.6 billion, down 3% relative to the same period in 2024. And SG&A expenses were $1.7 billion, down 9% year over year primarily due to lower G&A expenses. Overall, our non-GAAP diluted earnings per share was $1.86 in the fourth quarter of 2025 compared to $1.90 in the same period in 2024, primarily due to higher acquired IP R&D expenses, partially offset by higher product sales and lower SG&A expenses.
接下來請看第 28 頁的第四季損益表。我們的研發支出為 16 億美元,比 2024 年同期下降 3%。銷售、管理及行政費用為 17 億美元,較去年同期下降 9%,主要原因是一般及行政費用降低。整體而言,2025 年第四季非 GAAP 稀釋後每股收益為 1.86 美元,而 2024 年同期為 1.90 美元,主要是由於收購智慧財產權研發費用增加,部分被產品銷售額增加和銷售、一般及行政費用降低所抵銷。
Looking at our full year guidance on slide 29. We expect 2026 total product sales between $29.6 billion and $30 billion. We expect total Veklury sales of approximately $600 million, highlighting a $300 million headwind that we expect to more than offset in our base business. We, therefore, expect base business sales between $29 million and $29.4 billion growth of 4% to 5% compared to 2025.
請查看第 29 頁投影片中的全年業績指引。我們預計 2026 年產品總銷售額將在 296 億美元至 300 億美元之間。我們預計 Veklury 的總銷售額約為 6 億美元,其中 3 億美元的不利因素預計將在我們的基礎業務中得到充分抵消。因此,我們預計 2025 年基礎業務銷售額將在 2,900 萬美元至 294 億美元之間成長 4% 至 5%。
Moving to the non-GAAP P&L for the full year 2026. We expect product gross margin of approximately 87%, R&D expenses to increase a low single-digit percentage from 2025, acquired IPR&D investments of approximately $300 million, reflecting known commitments associated with prior collaborations and partnerships. Consistent with our approach in 2025, we will highlight incremental acquired IPR&D expenses as we announce new transactions throughout the year.
接下來是 2026 年全年的非 GAAP 損益表。我們預計產品毛利率約為 87%,研發費用從 2025 年起將以較低的個位數百分比成長,收購的智慧財產權和研發投資約為 3 億美元,反映了與先前合作和夥伴關係相關的已知承諾。與 2025 年的做法一致,我們將在全年宣布新交易時,重點介紹新增的收購智慧財產權和研發費用。
And SG&A expenses to increase by a mid-single-digit percentage relative to 2025, reflecting higher investments in sales and marketing to support our commercial launches, offset in part by lower G&A expenses. We expect full year 2026 non-GAAP operating income of between $13.8 billion and $14.3 billion, a tax rate of approximately 20% and non-GAAP diluted EPS in the range of $8.45 and $8.85 per share. As Johanna mentioned, and as shown on slide 30, we expect an approximate 2% headwind to growth in 2026, primarily associated with the impact of the drug pricing agreement announced in December 2025 and the expected impact of updates to the Affordable Care Act.
銷售、一般及行政費用將比 2025 年增長個位數百分比,反映出為支持我們的商業發布而對銷售和營銷投入的增加,部分被較低的一般及行政費用所抵消。我們預計 2026 年全年非 GAAP 營業收入將在 138 億美元至 143 億美元之間,稅率約為 20%,非 GAAP 稀釋後每股收益將在 8.45 美元至 8.85 美元之間。正如 Johanna 所提到的,並且如幻燈片 30 所示,我們預計 2026 年增長將面臨約 2% 的阻力,這主要與 2025 年 12 月宣布的藥品定價協議的影響以及《平價醫療法案》更新的預期影響有關。
I'll note that absent these updates, our full year growth would be in the range of 6% to 7%. Additionally, we expect HIV to grow approximately 6% in 2026. And within HIV, we expect 2026 Yeztugo revenue of approximately $800 million. In cell therapy, we expect full year 2026 revenues to decline approximately 10% compared to 2025, reflecting continued competitive headwinds related to our Kite portfolio. On slide 31, a -- we returned $5.9 billion to shareholders in 2025, and we remain committed to returning on average, at least 50% of our free cash flow to shareholders.
需要指出的是,如果沒有這些更新,我們全年的成長率將在 6% 到 7% 之間。此外,我們預計到 2026 年,愛滋病毒感染人數將增加約 6%。在 HIV 領域,我們預期 Yeztugo 2026 年的營收約為 8 億美元。在細胞療法領域,我們預計 2026 年全年收入將比 2025 年下降約 10%,這反映出我們的 Kite 產品組合持續面臨競爭逆風。在第 31 頁幻燈片中,我們—在 2025 年向股東返還了 59 億美元,我們仍然致力於平均將至少 50% 的自由現金流返還給股東。
In 2025, this included $1.9 billion of share repurchases, primarily intended to offset equity dilution at a minimum in addition to opportunistic repurchases. Combined with our dividend, we returned approximately 63% of our free cash flow to shareholders in 2025.
2025 年,其中包括 19 億美元的股票回購,主要目的是在進行機會性回購的同時,盡可能地抵銷股權稀釋。加上股息,我們在 2025 年將大約 63% 的自由現金流返還給了股東。
In terms of business development, we are confident that we have built a robust and diverse portfolio that can support Gilead's growth. At the same time, we are carefully strengthening our early-stage pipeline to position Gilead well for the long term, typically investing about $1 billion annually in smaller licensing deals, partnerships and acquisitions. Additionally, we are proactive and disciplined in our approach to later stage acquisitions that support our strategic goals and add new growth opportunities.
在業務發展方面,我們有信心建立一個強大而多元化的產品組合,能夠支持吉利德的成長。同時,我們正在精心加強早期研發管線,以使吉利德在長期發展中佔據有利地位,通常每年在較小的授權交易、合作和收購方面投資約 10 億美元。此外,我們在後期收購方面採取積極主動、嚴謹的態度,以支持我們的策略目標並增加新的成長機會。
Overall, we are pleased with Gilead's consistent strong performance highlighted by our clinical and commercial execution and supported by our disciplined operating model. We continue to be well positioned for near-term and long-term growth, and we remain focused on delivering on our strategic commitments.
整體而言,我們對吉利德持續強勁的業績感到滿意,這得益於我們在臨床和商業方面的出色執行,以及我們嚴謹的營運模式。我們依然處於有利於近期和長期成長的有利位置,並將繼續專注於履行我們的策略承諾。
With that, I'll invite Rebekah to begin the Q&A.
接下來,我將邀請麗貝卡開始問答環節。
Operator
Operator
(Operator Instructions)
(操作說明)
Chris Schott, JPM.
克里斯‧肖特,摩根大通。
Christopher Schott - Analyst
Christopher Schott - Analyst
Just wanted to kick off with a question on Yeztugo. Can you just elaborate a little bit more on the assumptions driving the $800 million guidance? And maybe as part of that, as we start to think about patients now needing to be redosed on the drug, what type of refill rates are you anticipating as we think about kind of going through 2026 and beyond?
首先想問一個關於 Yeztugo 的問題。能否再詳細解釋得出 8 億美元業績指引的假設?或許作為其中的一部分,當我們開始考慮患者現在需要重新服用該藥物時,您預計在 2026 年及以後會出現什麼樣的續藥率?
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Thanks, Chris, and a day. Welcome to the call. I'd invite Johanna to cover that point. Thank you.
謝謝你,克里斯,也謝謝你花了一天。歡迎參加通話。我會邀請喬安娜來談談這一點。謝謝。
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Thanks, Dan, and thanks, Chris, for the question. So yes, so -- one, let me start with how excited we are with Yeztugo. I think as we closed out 2025 and really building momentum coming into 2026. All of our key launch indicators are basically tracking or exceeding our expectation. And that includes, of course, access, which is where it starts with about 90% payer coverage.
謝謝丹,也謝謝克里斯的提問。所以,是的,所以——首先,讓我先說我們對 Yeztugo 有多興奮。我認為,隨著我們結束 2025 年並真正進入 2026 年,勢頭越來越強勁。我們所有關鍵的上市指標基本上都達到了或超越了我們的預期。這當然包括醫療服務獲取,而醫療服務獲取正是問題的起點,目前約有 90% 的支付方提供醫療保障。
So all major payers are now covering Yeztugo. About 90% of those with $0 co-pay. So that's really important for people that want to have access to this medicine. I would just remind everyone that as we pull through this great access, it takes a little bit of time, right, because you do it by account by account, and you're basically navigating logistics for HCPs and their clinics -- around an injectable versus a very oral market to begin with. So that scheduling coordination administration.
所以現在所有主要保險公司都承保 Yeztugo 了。約90%的人無需支付任何費用。所以這對想要獲得這種藥物的人來說非常重要。我只想提醒大家,在我們努力實現這一重大目標的過程中,需要一些時間,對吧?因為我們要逐一客戶進行操作,而且我們基本上是在為醫療保健專業人員及其診所安排物流——首先,這是一個注射劑市場,而不是一個以口服為主的市場。因此,需要進行日程協調管理。
So that just takes a little bit of time. And the teams are working diligently to make sure that happens as quickly as possible. We also launched, you might have seen a very recent DTC campaign. Our whole campaign is prep campaign, which is really meant to increase awareness for HIV prevention and, of course, brand recognition for Yeztugo is it really differentiates itself both from an efficacy as well as its dosing and really intended to appeal to a much broader audience than past HIV prevention campaigns and hopefully focus are seeing that. It is a very consumer-friendly campaign, and we expect that to kind of pull through as well and make sure that people are talking to their physicians about the potential opportunities of Yeztugo.
所以這需要一點時間。各團隊正努力確保盡快實現這一目標。我們還推出了一項新的DTC行銷活動,您可能已經看到了。我們的整個宣傳活動都是準備宣傳活動,旨在提高人們對愛滋病預防的認識,當然,也是為了提高 Yeztugo 的品牌知名度,因為它在功效和劑量方面都與其他產品截然不同,旨在吸引比以往愛滋病預防宣傳活動更廣泛的受眾,希望大家能夠看到這一點。這是一個非常注重消費者體驗的活動,我們希望它也能取得成功,並確保人們與他們的醫生討論 Yeztugo 的潛在益處。
So all of our indicators, intakes, access, HCP awareness, conversion rates are all tracking in the right direction. So we're excited about that. And looking ahead, we really expect to drive very durable, sustained long-term growth of Yeztugo. So that's not just 2026 continued growth and momentum quarter on quarter will -- we'll build on that but also well beyond 2026 as we expand the HIV and normalized HIV prevention for everyone.
因此,我們所有的指標,包括攝取量、獲取途徑、醫護人員認知度、轉換率等,都朝著正確的方向發展。我們對此感到很興奮。展望未來,我們確實期望推動 Yeztugo 實現非常持久、持續的長期成長。所以,這不僅意味著 2026 年將持續成長,並且每個季度都將保持成長勢頭——我們將以此為基礎,而且隨著我們擴大 HIV 防治範圍,使 HIV 預防常態化惠及所有人,我們的目標也將遠遠超越 2026 年。
To your point around persistency, we don't have an assumption at this point in time because it's still really quite early. As you think about a late launch in June of last year, with very little access as we launched and building access into Q3, there's really only a small number of individuals that are eligible for that dose or second injection. But we're really quite encouraged by early data. We're tracking it closely and continue to focus on ensuring that individuals return for their second injection and then well beyond that.
關於您提到的持久性問題,目前我們還沒有任何假設,因為現在還處於非常早期的階段。考慮到去年 6 月才姍姍來遲地推出,而且在推出之初准入渠道非常有限,直到第三季度才逐步建立准入渠道,因此實際上只有少數人有資格獲得第一劑或第二劑注射。但我們對早期數據感到非常鼓舞。我們正在密切關注此事,並將繼續致力於確保個人按時返回接受第二次注射,並在之後的一段時間內持續關注此事。
We have a lot of activities planned that are ongoing and have started ever since we started the launch of Yeztugo, around making sure HCPs are thinking about that auto refill script making sure that our specialty pharmacy partners are reaching out proactively to all of their individuals that are on prep and making sure they're reminding them as well as the work that we do here at Gilead both with digital reminders as well as proactive outreach with our access program.
自從 Yeztugo 上市以來,我們計劃開展許多活動,這些活動一直在進行中,旨在確保醫療保健專業人員 (HCP) 考慮自動續藥處方,確保我們的專業藥房合作夥伴主動聯繫所有正在接受準備治療的患者,並確保他們提醒患者,以及我們在吉利德所做的工作,包括數位提醒和透過我們的准入計劃進行主動聯繫。
So more to come on that, but we're excited about what Yeztugo has to offer for individuals looking or wanting to need and need HIV preps. So more to come.
關於這一點,我們還有更多消息要公佈,但我們對 Yeztugo 能為正在尋找或需要 HIV 藥物的人們提供的產品感到興奮。敬請期待更多內容。
Operator
Operator
Louise Chen, Scotiabank.
Louise Chen,加拿大豐業銀行。
Louise Chen - Analyst
Louise Chen - Analyst
I wanted to ask you what type of share gains you expect for anito-cel in the fourth-line setting if you're approved, especially in light of competition from entrenched players?
我想問一下,如果獲得批准,您預期anito-cel在第四線治療領域能獲得什麼樣的市佔率成長,尤其是在面臨根深蒂固的競爭對手的情況下?
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Thanks, Louise. Dan here. I'll turn it over to Cindy, who is with us here.
謝謝你,路易絲。我是丹。我將把麥克風交給辛迪,她現在就在我們這裡。
Cindy Perettie - Executive Vice President
Cindy Perettie - Executive Vice President
Thanks, Louise. Just as a reminder, our expectation is that we would be launching the second half of this year. And once we have approval, there's a period of time where we turn on our qualified authorized treatment centers so that they're able to treat. So there's that component right after approval. The market for fourth line multiple myeloma is a $3.5 billion market.
謝謝你,路易絲。再次提醒大家,我們預計今年下半年推出。一旦獲得批准,我們會安排一段時間啟動我們合格的授權治療中心,以便他們能夠進行治療。所以,審批之後還有這一環節。四線多發性骨髓瘤治療市場規模達35億美元。
We expect because the launch is the second half of the year, and we need to turn on our authorized treatment centers, modest contributions in 2026. However, in 2027, we will have a full year of sales. We expect over time to become the market leader, given our excellent efficacy profile and differentiated safety profile, in particular with the delayed neurotoxicities. I think the last piece I would add is that we are bringing forward our world-class manufacturing.
由於計畫啟動時間是今年下半年,我們需要啟用授權的治療中心,因此我們預計 2026 年將獲得少量捐款。然而,到 2027 年,我們將迎來完整的銷售年度。鑑於我們卓越的療效和差異化的安全性,特別是延遲性神經毒性,我們期望隨著時間的推移成為市場領導者。最後我想補充的是,我們正在推進我們世界一流的製造流程。
And so we are ready for launch. We will have the ability to serve the market at launch with 99% reliability in the 6-day turnaround time, which again is very differentiated from the existing products on the market today.
我們已經做好發射準備。我們將能夠在產品上市時以 99% 的可靠性在 6 天的周轉時間內服務市場,這與目前市場上的現有產品有很大的不同。
Operator
Operator
Tazeen Ahmad, Bank of America.
塔津·艾哈邁德,美國銀行。
Tazeen Ahmad - Analyst
Tazeen Ahmad - Analyst
Okay. Great. On Yeztugo, how should we be thinking about the growth outlook? Are you expecting to begin to see cannibalization of the sales as early as this year? And then connected to that, how should we be thinking about the evolution of net price for Yeztugo throughout the launch?
好的。偉大的。關於 Yeztugo,我們該如何看待其成長前景?您是否預計今年就會出現銷售蠶食現象?那麼,與此相關的是,我們應該如何看待 Yeztugo 在上市過程中淨價的演變呢?
Should we expect to see a over time like we've seen with other HIV therapies?
我們是否應該預期會看到像其他愛滋病療法那樣的長期效果?
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Sure. It's Johanna again. Thanks, Tazeen, for the question. So we do expect, as we come into 2026, we have strong growth momentum already. So Q1 will be -- will start with modest growth and then kind of build on that quarter after quarter in light of all the different pieces including access, including the DTC awareness campaign, including a lot of the work that we're doing in the field to drive to awareness.
當然。又是喬安娜。謝謝Tazeen的提問。因此,我們預計,進入 2026 年,我們將擁有強勁的成長動能。因此,第一季將會——以溫和成長開始,然後隨著各季度的成長,在包括市場准入、DTC 意識推廣活動以及我們在實地開展的大量提高意識工作等各種因素的影響下,逐步實現成長。
So all of that will build on that growth momentum. And in addition to that, we're also doing a market expansion strategies as well with very targeted communities. And so we do believe that Yeztugo is going to be the strong performance. And over time, we believe that Yeztugo will be the market leader in HIV prevention just because of the incredible profile that it offers for folks.
因此,所有這些都將鞏固這種成長勢頭。除此之外,我們也正在針對特定族群進行市場拓展策略。因此我們相信 Yeztugo 將會有出色的表現。我們相信,隨著時間的推移,Yeztugo 將成為 HIV 預防領域的市場領導者,因為它為人們提供了令人難以置信的優勢。
Having said that, in 2026, we believe that Descovy continues to grow through in 2026. As you saw in 2025, we had the highest performance share for Descovy we've ever seen. This is driven by many factors, namely commercial execution, really strong market, of course, but also unrestricted access. So all the pieces are coming together. And all the boats are rising, and it has a lot to do with the awareness in HIV prep.
也就是說,我們相信 Descovy 在 2026 年將繼續成長。正如您在 2025 年所看到的,Descovy 的市場份額達到了我們有史以來的最高水平。這主要受多種因素驅動,包括商業執行、強勁的市場,當然還有不受限制的准入。所以一切都開始水到渠成了。所有的船都在上升,這與人們對愛滋病毒預防的認知有很大關係。
Because of the PURPOSE 1 and PURPOSE 2 trials for Yeztugo, really building up the market. So we believe Descovy will continue to grow through 2026. And over time, of course, that will erode as Yeztugo takes the leading share in HIV prevention.
由於 Yeztugo 的 PURPOSE 1 和 PURPOSE 2 試驗,市場正在迅速發展。因此我們相信 Descovy 將在 2026 年繼續成長。當然,隨著時間的推移,隨著 Yeztugo 在愛滋病預防領域佔據領先地位,這種情況將會逐漸消失。
I think the final point you were asking about was gross to net. We obviously don't discuss gross to net for our products, but I would say that, yes, to the value proposition is quite differentiated. And we feel strongly that, that is being recognized, and that's in line with the 90% access in less than 6 months that we've been able to achieve. So really pleased so far with what we've been seeing and making sure that value continues to get recognized for HIV prep users.
我想你問的最後一點應該是毛利和淨利之間的轉換。我們顯然不會討論我們產品的毛利與淨利潤之比,但我認為,是的,我們的價值主張確實與眾不同。我們強烈感受到這一點正在得到認可,這與我們不到 6 個月內實現的 90% 的訪問率是一致的。到目前為止,我們對所看到的成果感到非常滿意,並確保愛滋病毒暴露前用藥者的價值繼續得到認可。
Operator
Operator
Michael Yee, UBS.
Michael Yee,瑞銀集團。
Michael Yee - Analyst
Michael Yee - Analyst
Maybe a question for Dietmar or the team. You were long-acting Q6 month treatment drug, which I guess could be a super bictegravir long-acting 3242. I think you said entered Phase II, can you tell us a little bit about the profile of that drug and what you're seeing in Phase I to get you excited? Is that going to be a core, I guess, coming up a week or two? And how do you compare that to, I think, Shionogi's product, which -- or their investment into And I'm sure you're aware that they're also excited about their QM as well.
或許可以問問迪特馬爾或他的團隊。你服用的是長效 Q6 個月治療藥物,我猜這可能是超級比克替拉韋長效 3242。我想您剛才提到該藥物已進入二期臨床試驗,您能否簡要介紹一下該藥物的特點以及您在一期臨床試驗中觀察到的令人振奮的現象?我猜,這會是接下來一兩週的核心內容嗎?那麼,您如何將它與鹽野義的產品進行比較呢?我認為,鹽野義的產品——或者說他們對QM的投資——而且我相信您也知道,他們也對自己的QM產品感到興奮。
So maybe compare and contrast and what gets you excited about your product.
所以,不妨比較一下,想想你的產品有哪些地方讓你感到興奮。
Dietmar Berger, MD, PhD - Chief Medical Officer
Dietmar Berger, MD, PhD - Chief Medical Officer
Yes. Thank you, Michael, for the question. I mean first of all, I really want to say that I'm excited about the breadth of the program that we have, right, not only the Q6 month, also the upcoming, for example, weekly treatment that we have with islatrovir and lenacapivir. And really the options between the daily, weekly, monthly and then every six months, treatments that we're developing specifically for the ones every six months. I also want to point out that we have two programs in development.
是的。謝謝你的提問,麥可。首先,我真的想說,我對我們計畫的廣度感到非常興奮,對吧,不僅是每六個月一次的治療,還有即將到來的,例如,我們使用伊斯拉曲韋和來那卡皮韋的每周治療。實際上,治療方案的選擇範圍很廣,包括每日、每週、每月以及每六個月一次,我們正在專門為每六個月一次的治療方案進行開發。我還想指出,我們目前有兩個項目正在開發中。
One is for lenacapavir plus broadly neutralizing antibodies. Obviously, that is an infusion and comes with everything that you need to do from an infusion perspective. However, there's a real unmet need and the study the interest in the study is really high. So we feel that will be an important addition. And that will come even a little earlier than the 3242 based combination.
其中一個方案是使用lenacapavir聯合廣譜中和抗體。顯然,這是一次輸液,並且包含了從輸液角度來看你需要做的一切。然而,目前確實存在尚未滿足的需求,而且人們對這項研究的興趣非常高。所以我們認為這將是一項重要的補充。而且,這將比基於 3242 的組合更早一些推出。
Now 3242 is obviously a long-acting INSTI, we firmly believe that an inhibitor is important in this combination and I think that also sets us apart from some of the other options that are out there. And you know all the benefits of the INSTI, starting with, for example, the tolerability, but then also really the resistance profile and the forgiveness. And then we feel that, that translates also into the once every 6-month treatment. And then obviously, the combination with lenacapavir, so you have the ins again, plus the capsid inhibitor, which we feel is a really important combination. So yes, you will see more data, more information about 3242 during the year, and we're really looking forward to detail that.
3242 顯然是一種長效 INSTI,我們堅信抑制劑在這種組合中非常重要,我認為這也使我們與其他一些選擇區分開來。您也了解 INSTI 的所有優點,例如耐受性,以及抗性特徵和容錯性。然後我們認為,這也意味著每 6 個月進行一次治療。然後很明顯,與 lenacapavir 聯合使用,這樣你又有了 ins,再加上衣殼抑制劑,我們認為這是一個非常重要的組合。所以,是的,今年您將會看到更多關於 3242 的數據和信息,我們非常期待詳細介紹這些信息。
I don't want to go too much into the comparison to the competitors. But please keep in mind that they cannot face once every 6-month treatment on one product only. They also need a combination. So we need to look at the overall development program that they have and that they have put together to then really bring their products forward as compared to the two options that I've laid out that we have in development.
我不想過度比較與競爭對手的情況。但請記住,他們不能每 6 個月只接受一次單一產品的治療。他們還需要兩者結合。所以我們需要看看他們所製定的整體發展計劃,以及他們為了真正推動產品發展而製定的計劃,並將其與我正在開發的兩種方案進行比較。
Operator
Operator
Brian Abrahams, RBC Capital Markets.
Brian Abrahams,加拿大皇家銀行資本市場。
Brian Abrahams - Analyst
Brian Abrahams - Analyst
Congrats on the quarter. Give us a little bit more detail on your once-yearly injectable lenacapavir for PrEP on the slides today. And I was wondering if you could maybe -- just talk about what you need to show out of PURPOSE-365 in order to support approval? And how are you planning to position that in the market is successful?
恭喜你本季取得佳績。請您今天在幻燈片中詳細介紹一下用於 PrEP 的每年一次注射的 lenacapavir。我想問一下,您能否談談您需要從 PURPOSE-365 中展示哪些內容才能獲得批准?你打算如何定位才能在市場上取得成功?
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Thanks, Brian. Back to Dietmar.
謝謝你,布萊恩。回到迪特馬爾。
Dietmar Berger, MD, PhD - Chief Medical Officer
Dietmar Berger, MD, PhD - Chief Medical Officer
Yes. I'll start with the profile. And really, what is so great about lenacapavir is that it's such a versatile product, right? And we do understand the pharmacokinetics and the target coverage and some of the scientific underpinnings of lenacapavir for prevention really well. So the study PURPOSE-365 is a PK-based study.
是的。我先從個人資料開始。而實際上,lenacapavir 最棒的地方就在於它是一種用途非常廣泛的產品,對吧?我們對用於預防的來那卡帕韋的藥物動力學、標靶覆蓋率以及一些科學原理確實有很好的了解。因此,PURPOSE-365 研究是一項基於藥物動力學的研究。
It's a smaller study. Obviously, it has been recruiting very well and continues to recruit very well. But it's a smaller study where we basically need to demonstrate target coverage and the right pharmacokinetics thing, peak levels, trough levels, et cetera. So that we can demonstrate effective prevention. That's how the study has been designed.
這是一項規模較小的研究。顯然,該公司過去和現在的招聘情況都非常好。但這是一項規模較小的研究,我們基本上需要證明目標覆蓋率和正確的藥物動力學特性,例如峰值水平、谷值水平等等。這樣我們就能證明預防措施的有效性。這項研究就是這樣設計的。
Obviously, we're looking forward to see the data by looking at PK, looking at safety, it will be an intramuscular injection, which is also an important differentiation that we're looking forward to demonstrate. But we feel it can really bringing a very important benefit with a longer-term interval to patients. I'll hand over to Johanna for the market.
顯然,我們期待透過觀察藥物動力學和安全性數據來了解情況,它將採用肌肉注射,這也是我們期待證明的一個重要區別。但我們認為,從長遠來看,它確實能為患者帶來非常重要的好處。我將把市場交給喬安娜負責。
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Yes. Thanks, Brian. The -- I would just add to what Dietmar was saying is the fact that it's 12 months. We've been very clear with the market research that we've seen that frequency or less frequency in the HIV prep setting specifically is the most important. And that's why Yeztugo being such an important innovation to this marketplace every 6 months, let alone the potential of going to every 12 months.
是的。謝謝你,布萊恩。我只想補充迪特馬爾所說的一點,那就是期限是 12 個月。市場調查已經非常明確地表明,我們發現,在 HIV 預防環境中,頻率或減少頻率是最重要的。這就是為什麼 Yeztugo 每 6 個月對這個市場來說都是一項重要的創新,更不用說每 12 個月一次的創新了。
Really would potentially attract a larger population if you were thinking that you just had to go to the physician's office once a year for that injection. So I think there's an opportunity to broaden the ads population as well as there are some folks as well that might have unstable housing or situations that once a year would also be ideal for them. So it's a real market expansion opportunity for us as we see this with that potential with 365.
如果人們認為只需要每年去醫生辦公室打一次針,那麼這種療法真的可能會吸引更多的人。所以我認為這裡有機會擴大廣告受眾群體,因為有些人可能住房不穩定,或者處境特殊,一年一次的廣告對他們來說也是理想的選擇。因此,我們看到了 365 的這種潛力,這對我們來說是一個真正的市場擴張機會。
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
And Brian, I would just remind what we've already stated, which is could be available as early as 2028. The trial is recruiting well. Thank you.
布萊恩,我只想再次強調我們之前說過的話,那就是最早可能在 2028 年就能實現。試驗招募工作進展順利。謝謝。
Operator
Operator
Umer Raffat, Evercore.
Umer Raffat,Evercore。
Umer Raffat - Equity Analyst
Umer Raffat - Equity Analyst
I was quite intrigued by your mention of the Trodelvy Phase III in endometrial, perhaps in second half of this year, which makes me wonder it's probably an interim analysis you're effectively guiding to. Can you speak to your confidence overall heading into this interim? And is it fair to say that the size of the indication is generally similar to triple-negative breast?
您提到的 Trodelvy III 期子宮內膜試驗,可能在今年下半年進行,這讓我很感興趣,也讓我懷疑您實際上是在引導進行中期分析。您能否談談您對即將到來的過渡期的整體信心?是否可以說,此適應症的嚴重程度與三陰性乳癌的嚴重程度大致相同?
Dietmar Berger, MD, PhD - Chief Medical Officer
Dietmar Berger, MD, PhD - Chief Medical Officer
So let me just talk about the study and then later on Johanna can chime in. Thanks for the question, Umer. Obviously, we are primarily intrigued about endometrial because of the earlier study, right, because of the Phase II TROPiCS-03 study, the basket trial that we did where we saw a median OS of 15 months in that population. That data was published at ESMO 2024. We feel with data like that, this would be a really important addition to the treatment options for second-line endometrial cancer patients.
那麼,我先談談這項研究,之後 Johanna 可以再補充。謝謝你的提問,烏默。顯然,我們主要對子宮內膜感興趣,是因為先前的研究,對吧,因為 II 期 TROPiCS-03 研究,我們進行的籃式試驗,在該研究中,我們觀察到該族群的中位總生存期為 15 個月。該數據已在 2024 年 ESMO 會議上發布。我們認為,有了這樣的數據,這將是二線子宮內膜癌患者治療方案的重要補充。
We're not providing details regarding the exact evaluation that we're going to do. But we're really looking forward to seeing the data later this year. I want to say second-line endometrial cancer is, of course, more of an incremental opportunity, but I'll hand over to Johanna, if she wants to comment on that further.
我們不會透露我們將要進行的具體評估細節。但我們非常期待今年稍後看到這些數據。我想說,二線子宮內膜癌當然是一個循序漸進的機會,但如果 Johanna 想對此做進一步評論,我會把發言權交給她。
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Yes, sure. So I think you're right, Umer, it's basically in line with second-line metastatic TNBC, so more or less about 5,000 or so -- addressable population in the US. So small opportunity, but very important unmet medical need as well for us. So this is where the focus and just the breadth of data for Trodelvy just extends. In addition to that guide that Dietmar was talking about, we also have a potential with EVOKE-03 VOO, earlier this year, in our PD-L1 high non-small cell lung cancer setting as well, which would be a much larger market expansion for Trodelvy as well as that was to play out.
當然可以。所以我覺得你說得對,Umer,這基本上與二線轉移性 TNBC 一致,所以在美國,可治療的人群大約有 5000 人左右。機會雖小,但對我們來說,這也是一個非常重要的未被滿足的醫療需求。所以,這就是 Trodelvy 的數據關注點和數據廣度所延伸的地方。除了 Dietmar 提到的那份指南之外,我們今年早些時候在 PD-L1 高表達的非小細胞肺癌領域也擁有 EVOKE-03 VOO 的潛力,這將為 Trodelvy 帶來更大的市場擴張,正如預期的那樣。
So we're excited about what's to come Trodelvy.
所以我們對 Trodelvy 的未來充滿期待。
Operator
Operator
Geoff Meacham, Citibank.
傑夫‧米查姆,花旗銀行。
Geoffrey Meacham - Analyst
Geoffrey Meacham - Analyst
Great. I had a bigger picture one for Andy or Dan. You guys have done a ton of Phase III cards at turnover this year and also some launches. You haven't done a larger scale deal in a while. So I guess I wanted to get a sense from you guys as to what voids you think you need to fill?
偉大的。我還有一張更大的照片,是給安迪或丹看的。你們今年在產品週轉期間做了很多第三階段的卡片,也推出了一些新品。你已經很久沒有做過大規模的交易了。所以我想了解大家的想法,你們覺得需要填補哪些空白?
Is it further diversification of safe therapeutic areas? Is it a new product cycle looking to the maybe mid-2030s? Or is there no real BD urgency from you guys at this point?
這是安全治療領域的進一步多元化嗎?這會是展望2030年代中期的新產品週期嗎?還是說你們現在對BD(業務拓展)並不真正著急?
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Thanks a lot, Geoff, I'll start and certainly invite Andy to add. I think we've all been reflecting here, Gilead, about the progress we've made over the past five or six years. And I think -- some of the greatest evidence of that is the fact that we have up to 10 launches now ongoing or to be introduced over -- between now and 2027. That includes four additional launches this year that have already been articulated in five Phase III readouts. And importantly, back to your question, Geoff, that's across really all therapeutic areas, which is exactly the design.
非常感謝,傑夫,我會先開始,也一定會邀請安迪加入。我想,基列的各位,我們都在反思過去五、六年我們所取得的進步。我認為——這方面最有力的證據之一就是,從現在到 2027 年,我們有多達 10 個發射項目正在進行或即將推出。這其中包括今年另外四次發射,這些發射已經在五份 III 期試驗結果中進行了闡述。回到你的問題,Geoff,這一點非常重要,它適用於所有治療領域,這正是設計的目的。
So we're building this very robust internal portfolio that's been built through original research, early-stage partnerships on collaborations and M&A. So what I would say is that as we approach additional partnerships and M&A, there's two pieces to that, of course. The first one is that we have to stay active in what we call kind of earlier stage transactions sometimes referred to as normal course. And we spend roughly around $1 billion every year on that. Again, we can be agnostic to the three therapeutic areas and go for the most interesting science, and that's what we have been doing to build this portfolio that is now coming through to us.
因此,我們正在建立一個非常強大的內部投資組合,該投資組合是透過原創研究、早期合作以及併購建立起來的。所以我想說的是,當我們尋求更多合作關係和併購時,這當然包含兩個面向。首先,我們必須積極參與我們所謂的早期階段交易,有時也稱之為正常流程。我們每年在這方面的花費約為10億美元。再次強調,我們可以不拘泥於三大治療領域,而選擇最有趣的科學,這正是我們建構現在呈現在我們面前的這個產品組合的方式。
And as we approach later-stage acquisitions, we do it in the context of the fact that we have the most robust clinical and pipeline in our company's history with no major LOEs until 2026. So we're uniquely positioned. We're very ready. We're very proactive and disciplined. We may not have the urgency of other companies in the sector.
隨著我們進入後期收購階段,我們這樣做是基於這樣一個事實:我們擁有公司歷史上最強大的臨床和研發管線,並且在 2026 年之前沒有重大的研發成果限制。因此,我們擁有得天獨厚的優勢。我們已經做好充分準備了。我們積極主動,紀律嚴明。我們可能不像業內其他公司那樣充滿緊迫感。
So we're going to be disciplined around that. But I would say that we very much want to continue to add to our pipeline with appropriate M&A over the course of the coming years as well. And -- if I haven't said everything, Andy, would you like to add?
所以我們會在這方面嚴格遵守紀律。但我認為,在未來幾年裡,我們也非常希望透過適當的併購繼續擴充我們的專案儲備。安迪,如果我還沒說完,你還有什麼要補充的嗎?
Andrew Dickinson - Chief Financial Officer
Andrew Dickinson - Chief Financial Officer
I think you covered it well. I mean if you look at the growth that's ahead of us and the cycle that we're entering with all of the launches that are underway or the additional launches that are coming, a reasonable portion of that is driven by our corporate development activities historically. And we continue to want to supplement, both, as Dan said, the early-stage late preclinical, early clinical pipeline through more of the ordinary course deals and we would like to add synergistic, e-risk, late-stage assets that will further -- I define it as turbocharge our top line growth and drive even more outsized bottom line growth. And we will be disciplined in that. But we've been very active in this space.
我覺得你解釋得很清楚。我的意思是,如果你看看我們未來的成長,以及我們正在進入的周期,包括所有正在進行或即將推出的產品,其中相當一部分成長是由我們歷史上的企業發展活動所推動的。正如丹所說,我們將繼續補充早期臨床前和早期臨床產品線,透過更多常規交易,同時我們也希望增加具有協同效應、風險較低的後期資產,這將進一步——我將其定義為加速我們的營收成長,並推動更巨大的利潤成長。我們會在這方面嚴格遵守紀律。但我們一直積極投身於這個領域。
We'll continue to be active, and I'm confident that we'll add exciting new products over time when we find the right ones.
我們將繼續保持積極進取的態度,我相信,隨著時間的推移,當我們找到合適的產品時,我們會不斷推出令人興奮的新產品。
Operator
Operator
Daina Graybosch, Leerink Partners.
Daina Graybosch,Leerink Partners。
Daina Graybosch - Analyst
Daina Graybosch - Analyst
I wonder, and maybe I'm being presumptuous, but what gives you confidence in a second half launch? Does that assume priority review for FDA for anito-cel? And then for your 20207 filing from iMMagine-3, is that going to be on the MRD endpoint or on a survival endpoint?
我想知道,也許我有點妄自尊大,但是什麼讓您對下半年的發布充滿信心?這是否意味著anito-cel將獲得FDA的優先審查?那麼,對於您在 2020 年提交的 iMMagine-3 數據,是針對 MRD 終點還是存活終點呢?
Cindy Perettie - Executive Vice President
Cindy Perettie - Executive Vice President
Thanks, Daina. It's Cindy. So for the confidence in anito-cel second half launch, we can't say today, if we have priority review or not, obviously, that would come with the BLA acceptance, and we'll be sure to let you know as soon as we can on that. But we have confidence in our conversations with the agency around the filing and look forward to being able to share more soon.
謝謝你,黛娜。是辛蒂。所以對於anito-cel下半年上市的信心,我們今天還不能說我們是否獲得了優先審查,顯然,這取決於BLA的批准,我們一定會盡快通知大家。但我們對與該機構就備案事宜進行的溝通充滿信心,並期待盡快分享更多資訊。
The second component you asked about around iMMagine-3, we have a dual endpoint, which is both MRD and PFS on the iMMagine-3 study. And that's in line with the guidance that you heard from the FDA not too long ago.
關於您詢問的 iMMagine-3 的第二個組成部分,我們有一個雙重終點,即 iMMagine-3 研究中的 MRD 和 PFS。這與不久前美國食品藥物管理局(FDA)發布的指導意見一致。
Operator
Operator
Tyler Van Buren, TD Cowen.
泰勒·範·布倫,TD·考恩。
Tyler Van Buren - Analyst
Tyler Van Buren - Analyst
Great. For Trodelvy, are you guys starting to see off-label use in the frontline in advance of formal approval given the very positive readouts and the NCCN recommendation in particular? And what do you expect the opportunity in the front line to be versus the current indication?
偉大的。對於 Trodelvy,鑑於其非常積極的療效數據,特別是 NCCN 的推薦,你們是否已經開始看到在正式批准之前將其用於一線治療的非適應症用途?那麼,與目前的跡象相比,您認為一線崗位的機會如何?
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Sure, Tyler, I'll take that one. It's Johanna. So post ASCENT-04 presentation at ASCO last June, that's when we started actually seeing a little bit more spontaneous use of Trodelvy, both in the first-line setting, but also strengthening our position -- our leadership position in the second-line setting as well. So that's been kind of building. Obviously, that spontaneous use.
當然,泰勒,我接受這個任務。是喬安娜。因此,在去年六月 ASCO 會議上 ASCENT-04 演示之後,我們開始看到 Trodelvy 的使用有所增加,不僅在一線治療中,而且在二線治療中也鞏固了我們的地位——我們的領導地位。所以這種情況一直在逐漸形成。顯然,這是自發性的使用。
There's no promotion against first line. There's only education from our medical team, field teams around the data publications in the New England Journal Medicine and you highlighted as well, the NCCN guidelines. We are Trodelvy is now the only ADC that is recommended both in first-line PD-L1-positive and PD-L1-negative metastatic TNBC as well as second-line setting. So we're excited about that and the impact it can have on patients because this disease is such an aggressive form of breast cancer.
第一線員工沒有晉昇機會。我們醫療團隊和現場團隊只能根據《新英格蘭醫學雜誌》上發表的數據進行教育,您也重點提到了 NCCN 指南。目前,Trodelvy 是唯一被推薦用於第一線 PD-L1 陽性和 PD-L1 陰性轉移性 TNBC 以及二線治療的 ADC。因此,我們對此感到興奮,並期待它能對患者產生正面影響,因為這種疾病是一種侵襲性極強的乳癌。
To your market opportunity, it's about double or so. If you think about setting into the first-line setting. There's about 10,000-or-so women in the first-line setting that are looking for care and really an opportunity for Trodelvy to have an impact here both in PD-L1 negative and PD-L1 positive with pembro. The other opportunity, of course, if you think about it is DOT, your duration of treatment basically doubles, right? Second-line setting, because of the aggressiveness of this disease is four to five months.
相對於你的市場機會而言,大約是兩倍左右。如果你考慮一下第一行的設定。大約有 10,000 名女性正在接受一線治療,這確實是一個讓 Trodelvy 發揮作用的機會,無論是在 PD-L1 陰性還是 PD-L1 陽性患者中,都可以使用帕博利珠單抗。當然,如果你仔細想想,還有另一個機會,那就是DOT(直接觀察治療),你的治療時間基本上會翻倍,對吧?由於疾病的侵襲性,二線治療方案的療程為四到五個月。
And so therefore, as you think about first line, it's about double, it's 9 to 10 months, which gives a little bit more hope to these women. So definitely an important advancement in triple-negative breast cancer with Trodelvy
因此,當你考慮第一線治療時,大約是原來的兩倍,需要 9 到 10 個月,這給了這些女性更多的希望。所以,Trodelvy 的出現無疑是三陰性乳癌治療領域的重要進展。
Operator
Operator
Courtney Breen, Bernstein.
Courtney Breen,Bernstein。
Courtney Breen - Equity Analyst
Courtney Breen - Equity Analyst
I'm going to point us back to stub again and just kind of really trying to get our arms around the 2026 guide. By our calculations, you have to believe that there's no growth in new patient starts compared to what we've seen kind of through January for the rest of this year, and a more than 10% price cut year on year to kind of get to that $800 million guide for 2026. Given that, should we be thinking about the $800 million as a floor or as kind of a guide for 2026?
我打算再次引導大家回到 stub,努力理解 2026 年的指南。根據我們的計算,你必須相信,與今年1月份的情況相比,今年剩餘時間裡,新患者數量不會增長,而且為了達到2026年8億美元的指導目標,價格將同比下降10%以上。有鑑於此,我們應該把 8 億美元視為底線,還是將其視為 2026 年的某種指導目標?
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Johanna Mercier - Chief Commercial & Corporate Affairs Officer
Thanks, Courtney, for your question. I'm not sure I'm tracking your modeling because we are definitely assuming continued strong momentum for Yeztugo. I know all of you are looking at weekly. We're obviously looking at weekly, but we're also looking at monthly and making sure that we're creating new growth numbers month-to-month. And so we do see that as an acceleration of our growth as we go into 2026.
謝謝 Courtney 的提問。我不確定我是否理解了你的模型,因為我們肯定認為 Yeztugo 將繼續保持強勁的成長勢頭。我知道你們都在關注週報。我們當然會關注每週的數據,但我們也會關注每個月的數據,並確保每個月都能創造新的成長數字。因此,我們認為,隨著我們邁入 2026 年,我們的成長速度將會加快。
A lot of those pieces are supported by making sure that we're adding new patients on Yeztugo, new individuals on Yeztugo and also bringing back people for their second injection. So those two pieces are considered in that guidance. And I think we're excited thus far about where we stand today with Yeztugo and all the pieces are coming together. We are just making sure that as much as the access is strong right now, and I'm really proud of the team that pulled that through. We also need to pull it through at an account level.
許多工作都依賴確保我們在 Yeztugo 上增加新患者、新用戶,以及讓患者回來接受第二次注射。所以,該指南中考慮了這兩方面的內容。我認為我們對 Yeztugo 目前的發展感到非常興奮,所有環節都在順利銜接。我們現在只是確保盡可能地保證訪問暢通,我為完成這項工作的團隊感到非常自豪。我們還需要將其落實到帳戶層面。
So we're doing that account by account and making sure people are navigating the logistics of an indexable and overall market and all of that takes a little bit of time. But the intent is we expect strong, consistent durable growth for the long term for Yeztugo. So we're excited about what's to come. And I guess DTC will also have a pretty big impact, we believe, to bring people in, asking and talking about Yeztugo.
所以我們正在逐個帳戶進行操作,確保人們能夠了解可指數化市場和整體市場的運作方式,而所有這些都需要一些時間。但我們的目標是期望 Yeztugo 能夠長期保持強勁、持續、可持續的成長。所以我們對未來充滿期待。我相信,DTC(直接面向消費者)模式也會產生相當大的影響,吸引人們詢問和談論 Yeztugo。
Operator
Operator
That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
提問環節到此結束。現在我請丹作總結發言。
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Daniel O'Day - Chairman of the Board, Chief Executive Officer
Thanks, everybody. First of all, let me thank the Gilead teams again. It's such a pleasure to work with them, and this then deliver these really strong full year performance measures, and reinforcing that this is a time of impact and growth for the company. Our performance from last year gives us a really strong foundation for the coming year where we have a lot to deliver for the patients and communities we serve. Coming off of a year where we had just a really strong Yeztugo launch, as Johanna mentioned several key launch indicators have exceeded our expectations.
謝謝大家。首先,請允許我再次感謝吉利德團隊。與他們合作非常愉快,這也帶來了非常強勁的全年業績指標,並進一步證明這是公司發展和成長的重要時期。我們去年的出色表現為來年奠定了非常堅實的基礎,來年我們將為我們服務的患者和社區帶來更多成果。正如 Johanna 所提到的,在 Yeztugo 成功推出的一年後,幾個關鍵的推出指標都超出了我們的預期。
We are firmly committed to continuing to drive that launch. But in addition, we have four potential launches this year in five pivotal Phase III readouts across all three therapeutic areas, HIV, oncology, liver disease. So you can expect us to show the same strong commercial and clinical execution you've seen in the past and disciplined focus on expense management, as you've seen from us quarter after quarter. And with no major LOEs until 2036, the next 10 years and a really proactive approach to business development. Delia's business is secure, growing and with the potential for much more to come.
我們堅定致力於繼續推進此次發布。此外,我們今年還有四項潛在的產品上市,涵蓋愛滋病、腫瘤和肝病這三大治療領域,共有五項關鍵的 III 期臨床試驗結果。因此,您可以期待我們展現出與過去一樣強大的商業和臨床執行力,以及對費用管理的嚴格把控,就像您每個季度都看到的那樣。而且在 2036 年之前沒有重大的 LOE,未來 10 年將採取非常積極的業務發展方式。德莉亞的生意穩定、發展迅速,未來還有很大的發展潛力。
So thanks again for your time today. We look forward to keeping you informed on our progress. And as usual, if you have any follow-up questions, our Investor Relations team is very happy to support you with the answers to your questions. Thank you, everybody. Have a good rest of your day.
再次感謝您今天抽出時間。我們將持續向您報告我們的進度。像往常一樣,如果您有任何後續問題,我們的投資者關係團隊非常樂意為您解答。謝謝大家。祝您今天餘下的時間過得愉快。