吉利德科學 (GILD) 2025 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon, everyone, and welcome to Gilead's third-quarter 2025 earnings conference call. My name is Rebecca, and I'll be today's host. (Operator Instructions)

    各位下午好,歡迎參加吉利德2025年第三季財報電話會議。我叫麗貝卡,我將擔任今天的主持人。(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 - Senior Vice President - Treasury and Investor Relations

    Jacquie Ross - Senior Vice President - Treasury and Investor Relations

  • Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the third quarter of 2025. The press release, slides, and supplemental data are available on the Investors section of our website at gilead.com.

    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 年第三季的獲利結果。新聞稿、投影片和補充資料可在吉利德公司網站 gilead.com 的投資者關係部分取得。

  • The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day; our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Dietmar Berger; and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A where the team will be joined by Cindy Perettie, the Executive Vice President of Kite.

    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;首席商務官喬安娜·梅西耶;首席醫療官迪特馬爾·伯格;以及首席財務官安德魯·迪金森。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. We appreciate you joining today as we take you through another very strong set of quarterly results. Our third-quarter earnings underscore the growing momentum you're seeing from Gilead today which is driven by our strong portfolio and the impressive execution of our teams. As you'll hear during the call, our progress is visible in both our quarterly results and in our strong clinical pipeline.

    謝謝你,杰奎琳,大家下午好。感謝您今天收看,我們將帶您了解另一份非常亮眼的季度業績報告。我們第三季的收益凸顯了吉利德目前不斷增長的發展勢頭,這得益於我們強大的產品組合和我們團隊出色的執行力。正如您將在電話會議中聽到的那樣,我們的進展在季度業績和強大的臨床研發管線中都有所體現。

  • Highlights of our third quarter include commercial outperformance across our HIV therapies and Livdelzi. This resulted in 6% year-over-year growth for Biktarvy, 20% year-over-year growth for Descovy, and 35% sequential growth for Livdelzi. Disciplined operating expense management contributed to 22% year-over-year growth in non-GAAP EPS. Even excluding a $0.25 benefit from a nonrecurring accounting item, non-GAAP EPS grew 10% compared to 4% base business growth year over year, highlighting the leverage in our business model.

    第三季亮點包括我們的 HIV 療法和 Livdelzi 的商業表現優異。這使得 Biktarvy 年比成長 6%,Descovy 年比成長 20%,Livdelzi 環比成長 35%。嚴格的營運費用管理使非GAAP每股收益年增22%。即使不計入非經常性會計項目帶來的 0.25 美元收益,非 GAAP 每股收益也同比增長 10%,而基本業務同比增長僅為 4%,這凸顯了我們商業模式的槓桿作用。

  • As a reflection of our strong performance year to date, we are increasing our full year HIV revenue growth expectations to approximately 5%. This is despite the $900 million headwind for our HIV business in 2025 associated with the Medicare Part D redesign.

    鑑於我們今年迄今的強勁業績,我們將全年 HIV 收入成長預期提高至約 5%。儘管 2025 年 Medicare Part D 改革為我們的 HIV 業務帶來了 9 億美元的不利影響,但我們依然取得了成功。

  • Our newest addition to the HIV portfolio, Yeztugo, for HIV prevention delivered third-quarter sales of $39 million or $54 million, including the first few weeks of launch in June. Of course, our initial priority has been securing payer coverage, and I'm very pleased to share that we've already achieved our 75% coverage goal nearly three months ahead of our target. This sets a strong foundation for continued growth in 2026.

    我們最新推出的 HIV 預防產品 Yeztugo 在第三季度實現了 3,900 萬美元的銷售額,如果算上 6 月上市後的前幾週的銷售額,則達到 5,400 萬美元。當然,我們首要任務是確保支付方的覆蓋,我很高興地宣布,我們已經提前近三個月實現了 75% 的覆蓋率目標。這將為2026年的持續成長奠定堅實的基礎。

  • Our confidence in our HIV business comes from both our existing on-market product leadership and our innovative pipeline. We look forward to sharing progress on one of our next-generation HIV treatments before the end of the year with an update on the ARTISTRY-1 and ARTISTRY-2 studies.

    我們對愛滋病業務的信心源自於我們現有的市場領先產品和創新研發管線。我們期待在年底前分享我們下一代 HIV 療法之一的進展,並更新 ARTISTRY-1 和 ARTISTRY-2 研究的最新情況。

  • These Phase 3 programs are evaluating an investigational single tablet regimen of bictegravir and lenacapavir, and we continue to target a product launch in early 2027.

    這些 3 期臨床試驗計畫正在評估比克替拉韋和來那卡帕韋的單片試驗性治療方案,我們將繼續以 2027 年初推出產品為目標。

  • As I mentioned, Livdelzi was a standout of the quarter, contributing to 12% year-over-year growth in our liver portfolio. Livdelzi exceeded $100 million in quarterly sales for the first time and is already the number one treatment for second-line PBC in the US.

    正如我之前提到的,Livdelzi 在本季度表現出色,為我們的肝臟產品組合帶來了 12% 的同比增長。Livdelzi 的季度銷售額首次突破 1 億美元,並且已經成為美國二線 PBC 治療藥物的首選。

  • We're also pleased to share that we have filed for FDA approval of bulevirtide for the treatment of chronic hepatitis delta virus. This therapy has been available in Europe since 2020 under the brand name of Hepcludex and we expect to bring it to patients in the US in 2026.

    我們也很高興地宣布,我們已向美國食品藥物管理局 (FDA) 提交了布列維肽用於治療慢性丁型肝炎病毒的核准申請。該療法自 2020 年起在歐洲以 Hepcludex 的品牌名稱上市,我們預計將於 2026 年將其引入美國,造福患者。

  • Turning to oncology. We continue to make significant clinical progress, most recently with the presentation of our ASCENT-03 detailed data at ESMO and simultaneous publication in the New England Journal of Medicine. Given the particularly aggressive nature of this disease, we are moving as quickly as we can to bring Trodelvy to first-line metastatic triple-negative breast cancer patients.

    轉向腫瘤學。我們持續取得重大的臨床進展,最近在 ESMO 上展示了我們的 ASCENT-03 詳細數據,並同時在《新英格蘭醫學雜誌》上發表。鑑於這種疾病的侵襲性特別強,我們正在盡最大努力盡快將 Trodelvy 應用於第一線轉移性三陰性乳癌患者。

  • We have submitted SBLAs with the FDA and are targeting a potential commercial launch in 2026 that could extend Trodelvy's leadership in breast cancer. We also continue to target commercial launch for anito-cel for multiple myeloma in 2026 and look forward to sharing an update from the Pivotal iMMagine-1 study before the end of this year.

    我們已向 FDA 提交了 SBLA 申請,目標是在 2026 年實現潛在的商業化上市,這可能會鞏固 Trodelvy 在乳癌領域的領先地位。我們也將繼續以 2026 年為目標,推出用於治療多發性骨髓瘤的 anito-cel,並期待在今年年底前分享關鍵性 iMMagine-1 研究的最新進展。

  • In summary, we are very pleased with our performance in the third quarter, building on a very strong 2025 overall. And just as importantly, we have significant potential ahead. The quality, breadth, and diversity we built into the portfolio over the past years is now presenting us with multiple opportunities to drive benefits for patients. With several just launched or soon-to-be-launched products across HIV, oncology, and liver disease and clinical readouts on the horizon with further commercial potential, this continues to be an exciting phase of growth.

    總而言之,我們對第三季的業績非常滿意,這建立在2025年整體強勁業績的基礎上。同樣重要的是,我們未來還有巨大的發展潛力。過去幾年,我們在產品組合中建構的品質、廣度和多樣性,現在為我們提供了多種機會,可以為患者帶來福祉。該公司在 HIV、腫瘤和肝病領域推出了多款新產品或即將推出多款產品,並且即將公佈具有更大商業潛力的臨床結果,這仍然是一個令人興奮的成長階段。

  • The fact that we now have no major LOEs until 2036, reinforces our strong position. My thanks as always to the Gilead team for their incredible work this quarter and their continued dedication to doing more for the communities we serve.

    2036 年之前我們沒有重大的 LOE(支出目標),這一事實鞏固了我們的強大地位。一如既往地感謝吉利德團隊在本季度做出的傑出貢獻,以及他們為我們所服務的社區持續做出更多貢獻的奉獻精神。

  • With that, I'll hand it over to Johanna.

    這樣,我就把它交給喬安娜了。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Dan, and good afternoon, everyone. I'm pleased to share our third-quarter results representing another strong quarter of commercial execution, with exciting momentum in our most recently launched products, Yeztugo and Livdelzi, in addition to continued robust Biktarvy and Descovy growth.

    謝謝你,丹,大家下午好。我很高興地與大家分享我們第三季度的業績,這代表著我們又一個強勁的商業執行季度,我們最新推出的產品 Yeztugo 和 Livdelzi 都取得了令人振奮的發展勢頭,此外,Biktarvy 和 Descovy 也繼續保持強勁增長。

  • Starting on slide 7. Third-quarter product sales, excluding Veklury, were $7.1 billion, up 4% year over year and up 2% sequentially driven by strength across our HIV portfolio, offset in part by lower oncology revenue. Including Veklury sales of $277 million, third-quarter total product sales were $7.3 billion, up 4% sequentially and down 2% year over year, primarily reflecting lower Veklury sales associated with fewer COVID-19-related hospitalizations.

    從第7張投影片開始。第三季產品銷售額(不包括 Veklury)為 71 億美元,年成長 4%,季增 2%,主要得益於 HIV 產品組合的強勁表現,但部分被腫瘤業務收入的下降所抵銷。第三季度,包括 Veklury 的 2.77 億美元銷售額在內,產品總銷售額為 73 億美元,季增 4%,年減 2%,主要反映與 COVID-19 相關住院人數減少相關的 Veklury 銷售額下降。

  • Moving to slide 8. HIV sales of $5.3 billion represented 4% growth versus prior year and prior quarter, primarily driven by higher demand and favorable inventory dynamics partially offset by lower average realized price. Year to date, our HIV business has grown more than 5%, which is particularly impressive as we manage through a $900 million headwind for the full year related to the Medicare Part D redesign. Consistent with our performance year to date, we are increasing our guidance for full year HIV revenue growth to approximately 5%, up from 3% last quarter.

    切換到第8張投影片。HIV產品銷售額達53億美元,較上年同期和上一季成長4%,主要得益於更高的需求和有利的庫存動態,但部分被較低的平均實現價格所抵銷。今年迄今為止,我們的 HIV 業務成長超過 5%,考慮到我們全年都面臨著與 Medicare Part D 改革相關的 9 億美元的不利因素,這一成績尤其令人印象深刻。與我們今年迄今的業績一致,我們將全年 HIV 收入成長預期從上一季的 3% 上調至約 5%。

  • On slide 9, Biktarvy sales of $3.7 billion were up 6% year over year and 4% sequentially due to higher demand, reflecting continued market growth of 2% to 3% and strong commercial execution. Biktarvy's year-over-year market share in the US has grown every quarter since launch and achieved a record high of approximately 52% in the third quarter. Given Biktarvy's clear differentiation and market leadership, we're pleased that the expected loss of exclusivity in the US for Biktarvy has been extended into 2036.

    投影片 9 顯示,由於需求增加,Biktarvy 的銷售額為 37 億美元,年成長 6%,環比成長 4%,這反映了市場持續成長 2% 至 3%,以及強勁的商業執行。自推出以來,Biktarvy 在美國的市佔率逐年成長,並在第三季達到了約 52% 的歷史新高。鑑於 Biktarvy 的明顯差異化和市場領導地位,我們很高興 Biktarvy 在美國失去獨家銷售權的預期期限已延長至 2036 年。

  • Moving to Descovy. Third-quarter sales were a record $701 million, increasing 20% year over year, primarily due to higher demand for Descovy for PrEP. Sequentially, sales were up 7% driven by higher demand and average realized price due to channel mix, partially offset by inventory dynamics. As a reminder, roughly 3/4 of Descovy sales are for HIV prevention. This highlights the incredible momentum in the prevention market driven by the growing awareness and increasing unrestricted access as well as excellent commercial execution.

    遷移到 Descovy。第三季銷售額創下 7.01 億美元的紀錄,年增 20%,主要原因是 PrEP 藥物 Descovy 的需求增加。環比來看,受通路組合帶來的更高需求和平均實現價格的推動,銷售額成長了 7%,但部分被庫存動態所抵銷。提醒大家,Descovy 銷售額的約 3/4 用於預防 HIV。這凸顯了預防市場令人難以置信的發展勢頭,這得益於人們意識的提高、日益普及的無限制獲取途徑以及出色的商業執行。

  • Descovy for PrEP achieved a new record market share of more than 45% in the US in the third quarter. This reflects the strength of our PrEP team and the impact they're having in ensuring HIV PrEP reaches more of the people who could benefit from it. Overall, the PrEP market grew approximately 14% year over year.

    第三季度,用於 PrEP 的 Descovy 在美國的市佔率創下新紀錄,超過 45%。這反映了我們 PrEP 團隊的實力,以及他們在確保 HIV PrEP 惠及更多可能從中受益的人群方面所發揮的影響。總體而言,PrEP 市場年增約 14%。

  • Moving to slide 10 and one quarter in, we are really excited with the initial positive reception to our Yeztugo launch across consumers, clinicians, and payers. Yeztugo is increasingly recognized in clinical guidelines, including most recently the US CDC. This strong endorsement of Yeztugo offers healthcare providers, public health leaders, and communities clear guidance on an innovation that could help shift the trajectory of the HIV epidemic.

    翻到第 10 張幻燈片,四分之一處,我們對 Yeztugo 的推出在消費者、臨床醫生和支付方中獲得的初步積極反響感到非常興奮。Yeztugo 在臨床指引中越來越受到認可,包括最近的美國疾病管制與預防中心 (CDC)。Yeztugo 的這項強有力認可,為醫療保健提供者、公共衛生領導者和社區提供了明確的指導,幫助他們了解這項可能有助於改變 HIV 疫情發展軌蹟的創新。

  • As we've discussed previously, expanding payer coverage is a critical indicator in our initial launch and we're working with every payer to accelerate access. I am thrilled that we have already achieved 75% access in the US, almost three months ahead of our target. This includes coverage by UnitedHealthcare and Express Scripts as well as 20 of the top 25 state Medicaid plans. In most cases, payers do not require prior authorization or co-pays.

    正如我們之前討論過的,擴大支付方覆蓋範圍是我們初期推廣的關鍵指標,我們正在與每一位支付方合作,以加快推廣速度。我很高興我們在美國已經實現了 75% 的市場准入率,比我們的目標提前了近三個月。這包括 UnitedHealthcare 和 Express Scripts 的保險,以及前 25 名的州醫療補助計劃中的 20 個。大多數情況下,付款方不需要事先授權或共同支付費用。

  • Keep in mind that much of our progress to the 75% access goal has been made in the last several weeks. We continue to work on an account-by-account basis to help clinicians navigate the new logistics and reimbursement process and the benefits of this access will pull through in 2026. Looking forward, we're moving quickly to expand access beyond 75% and continue to target 90% by the end of the first half of 2026.

    請記住,我們實現 75% 訪問目標的大部分進展都是在過去幾週內取得的。我們將繼續逐一帳戶幫助臨床醫生了解新的物流和報銷流程,這種便利措施的好處將在 2026 年顯現。展望未來,我們將迅速擴大覆蓋範圍,使覆蓋率超過 75%,並繼續以 2026 年上半年末達到 90% 為目標。

  • Altogether, Yeztugo is off to a strong start, delivering $39 million in sales in the third quarter. From launch in the middle of June to the end of the third quarter, Yeztugo revenue was $54 million, including $15 million of new launch-related stocking at the end of the second quarter. As we expected, most early prescribers are existing HIV PrEP clinicians who are leveraging white bagging to simplify the logistics and reimbursement arrangements.

    總的來說,Yeztugo 開局強勁,第三季銷售額達到 3,900 萬美元。從 6 月中旬推出到第三季末,Yeztugo 的營收為 5,400 萬美元,其中包括第二季末與新產品上市相關的 1,500 萬美元庫存收入。正如我們所預期的,大多數早期開處方者都是現有的 HIV PrEP 臨床醫生,他們利用白袋包裝來簡化物流和報銷安排。

  • In August, the European Commission approved lenacapavir for PrEP under the name Yeytuo. We look forward to further regulatory decisions across other geographies.

    8 月,歐盟委員會批准了 lenacapavir 用於 PrEP,商品名為 Yeytuo。我們期待其他地區推出更多監管決定。

  • Additionally, as part of our broader commitment to access, Gilead has agreed with the global fund and the US State Department through PEPFAR to supply enough doses of lenacapavir for PrEP to reach up to 2 million people over three years in certain low and lower middle-income countries.

    此外,作為我們更廣泛的普及承諾的一部分,吉利德已與全球基金和美國國務院透過 PEPFAR 達成協議,在三年內向某些低收入和中低收入國家提供足夠劑量的 lenacapavir 用於 PrEP,使多達 200 萬人受益。

  • Moving to liver disease on slide 11. Sales of $819 million were up 12% year over year and 3% sequentially, driven almost entirely by Livdelzi for primary biliary cholangitis. Livdelzi grew 35% sequentially driven by strong commercial execution, including some new launches outside the US and withdrawal of a competitor's product in the US. We are particularly pleased to see strong levels of persistence among users and believe that Livdelzi shows clear differentiation and value to those with PBC.

    第 11 張幻燈片將講解肝臟疾病。銷售額達 8.19 億美元,年增 12%,環比增長 3%,幾乎完全得益於用於治療原發性膽汁性膽管炎的利維德爾齊 (Livdelzi)。由於強勁的商業執行,包括在美國以外地區推出一些新產品以及在美國撤回競爭對手的產品,Livdelzi 的業績環比增長了 35%。我們尤其高興地看到使用者表現出強烈的堅持性,並相信 Livdelzi 對 PBC 患者來說具有明顯的差異化優勢和價值。

  • Livdelzi is now the market leader in second-line PBC in the US and quarterly revenue topped $100 million for the first time.

    Livdelzi 現在是美國二線 PBC 市場的領導者,季度收入首次突破 1 億美元。

  • Moving to slide 12. Trodelvy sales of $357 million were up 7% year over year, primarily due to higher demand and down 2% sequentially with higher demand, offset by unfavorable inventory dynamics and lower ex-US average realized price. Trodelvy's continued strength in the US and international markets across metastatic breast cancer, more than offset on a year-over-year basis, the expected impact from the bladder cancer withdrawal in the US.

    切換到第12張投影片。Trodelvy 的銷售額為 3.57 億美元,年增 7%,主要原因是需求增加;環比下降 2%,儘管需求增加,但不利的庫存動態和美國以外地區的平均實現價格下降抵消了這一增長。Trodelvy 在美國和國際轉移性乳癌市場持續強勁的表現,與去年同期相比,足以抵消其在美國撤出膀胱癌治療市場所帶來的預期影響。

  • With Trodelvy's potential launch in first-line metastatic TNBC following the potentially practice-changing ASCENT-03 and ASCENT-04 this year, we look forward to expanding the options available for patients in this earlier line setting. There are almost twice as many patients in the first-line metastatic setting compared to second line and patients typically have a longer duration of therapy.

    繼今年可能改變臨床實踐的 ASCENT-03 和 ASCENT-04 研究之後,Trodelvy 預計將在轉移性 TNBC 的一線治療中上市,我們期待著為早期治療的患者擴大治療選擇。一線轉移性治療的患者人數幾乎是第二線治療患者的兩倍,而且患者的治療持續時間通常更長。

  • For cell therapy on slide 13, and on behalf of Cindy and the Kite team, third-quarter sales of $432 million were down 11% both year over year and sequentially with continued competitive headwinds from in and out of class therapies. We anticipate these headwinds to continue in the near future. We remain committed to increasing the adoption and utilization of cell therapies given their curative potential for many patients. Year to date, we've added more than 40 authorized treatment centers and now have more than 570 globally.

    關於幻燈片 13 中的細胞療法,代表 Cindy 和 Kite 團隊,第三季銷售額為 4.32 億美元,同比和環比均下降 11%,持續面臨同類療法和非同類療法帶來的競爭阻力。我們預計這些不利因素在不久的將來還會持續。鑑於細胞療法對許多患者俱有治癒潛力,我們將繼續致力於提高細胞療法的採用率和利用率。今年以來,我們新增了 40 多個授權治療中心,目前全球共有 570 多個治療中心。

  • As shared in prior quarters, our efforts to lower the hurdles to community adoption are progressing but it's clear that we have more to do before all eligible patients have the opportunity to benefit from these cell therapies. In addition to the team's work to expand the reach of cell therapies, Kite is also progressing its next-generation pipeline to offer similar efficacy with better safety, which would result in enhanced outpatient usage potential.

    正如前幾季所分享的,我們為降低社區採用這些療法的門檻所做的努力正在取得進展,但很明顯,在所有符合條件的患者都有機會從這些細胞療法中受益之前,我們還有更多工作要做。除了致力於擴大細胞療法的應用範圍外,Kite 團隊還在推進其下一代產品線的研發,以期在提供類似療效的同時提高安全性,從而增強其在門診應用方面的潛力。

  • Additionally, we're very excited by the development of anito-cel, which continues to show potential best-in-class safety and efficacy as a BCMA CAR T therapy for late-line relapsed refractory multiple myeloma. We look forward to providing an update from the iMMagine-1 study later this year.

    此外,我們對anito-cel的研發進展感到非常興奮,它作為一種BCMA CAR T療法,在治療晚期復發難治性多發性骨髓瘤方面,持續展現出同類最佳的安全性和有效性。我們期待在今年稍後提供 iMMagine-1 研究的最新進展。

  • Wrapping up our third quarter, I'd like to thank the commercial teams who are executing relentlessly across both our in-line portfolio as well as our newer opportunities like Yeztugo and Livdelzi. Looking to 2026, we're preparing for a number of additional potential launches across our therapeutic areas of focus and are excited by the opportunity to extend our reach and impact on the patients and communities we serve.

    在第三季即將結束之際,我要感謝我們的商業團隊,他們不懈努力,不僅在我們現有的產品組合中執行任務,還在 Yeztugo 和 Livdelzi 等新機遇中努力工作。展望 2026 年,我們正在為在重點治療領域推出更多潛在產品做準備,並很高興有機會擴大我們對所服務患者和社區的影響範圍。

  • 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 - Chief Medical Officer

    Dietmar Berger - Chief Medical Officer

  • Thank you, Johanna, and good afternoon, everyone. In the third quarter, the team progressed 56 clinical programs across our three therapeutic focus areas with four additions since last quarter as we advance our research with the most meaningful potential scientific and patient impact into the clinic.

    謝謝你,喬安娜,大家下午好。第三季度,團隊在三大治療重點領域推進了 56 個臨床項目,比上一季度新增了 4 個,我們正將最具意義的潛在科學和患者影響的研究推進到臨床階段。

  • Building on Johanna's comments on our Yeztugo launch, we continue to lead HIV innovation with 10 clinical programs across treatment and prevention. Lenacapavir and its prodrugs are foundational in our treatment and prevention programs, and in July, we initiated the registration of Phase 3 PURPOSE-365 trial, evaluating lenacapavir as HIV prevention with once yearly injections. This is a single-arm PK and safety study, which, along with the unprecedented efficacy seen in the Phase 3 PURPOSE 1 and 2 studies is expected to support a regulatory filing with potential for approval in 2028.

    繼 Johanna 對我們 Yeztugo 計畫的評價之後,我們繼續引領 HIV 創新,在治療和預防方面開展了 10 個臨床計畫。Lenacapavir 及其前藥是我們治療和預防計劃的基礎,今年 7 月,我們啟動了 3 期 PURPOSE-365 試驗的註冊,該試驗評估 lenacapavir 作為 HIV 預防藥物,每年註射一次。這是一項單臂藥物動力學和安全性研究,結合 3 期 PURPOSE 1 和 2 研究中觀察到的前所未有的療效,預計將支持向監管機構提交申請,並有可能在 2028 年獲得批准。

  • Moving to treatment. We have seven ongoing clinical programs evaluating daily, weekly, monthly, quarterly and twice-yearly regimens based on lenacapavir or one of its prodrugs. Beginning with our next-generation daily oral regimen, BIC/LEN, we continue to expect an update from our Phase 3 ARTISTRY studies later in the year.

    進入治療階段。我們有七個正在進行的臨床項目,評估基於 lenacapavir 或其前藥的每日、每週、每月、每季和每年兩次的給藥方案。從我們的下一代每日口服方案 BIC/LEN 開始,我們將繼續期待在今年稍後獲得 ARTISTRY 3 期研究的最新進展。

  • ARTISTRY-1 and ARTISTRY-2 are evaluating the potential of Gilead's investigational complete regimen that combines bictegravir, the key integrase inhibitor in Biktarvy and lenacapavir, our breakthrough capsid inhibitor. The regimen is a potential option for virologically suppressed people with HIV, including many people currently on complex regimens.

    ARTISTRY-1 和 ARTISTRY-2 正在評估吉利德公司正在研究的完整療法的潛力,該療法結合了 Biktarvy 中的關鍵整合酶抑製劑比克替拉韋和我們突破性的衣殼抑製劑來那卡帕韋。對於病毒學上受到抑制的 HIV 感染者來說,這種治療方案可能是一種選擇,包括許多目前正在接受複雜治療方案的人。

  • Further, we have a suite of long-acting oral and injectable agents in development for a range of dosing frequencies from once-weekly oral to twice-yearly injectables. Our strategy has been to set up our pipeline for multiple shots on goal and then choose the best option for each dosing frequency.

    此外,我們正在開發一系列長效口服和注射劑,給藥頻率從每週一次口服到每年兩次注射不等。我們的策略是建立一套能夠多次嘗試的方案,然後針對每種給藥頻率選擇最佳方案。

  • Notably, for our development of a twice-yearly treatment regimen combining a novel integrase inhibitor with lenacapavir, we took two [insteagents] to Phase 1, GS-1219 and GS-3242. Aligned with the guidance we shared at our HIV analyst event last year, we have now chosen to prioritize the development of GS-3242 over GS-1219, and we expect to share more details on GS-3242 at a virology conference in 2026.

    值得一提的是,為了開發一種將新型整合酶抑制劑與 lenacapavir 結合的每年兩次的治療方案,我們選擇了兩種[替代藥物] GS-1219 和 GS-3242 進入 1 期臨床試驗。根據我們去年在 HIV 分析師活動上分享的指導意見,我們現在選擇優先開發 GS-3242 而不是 GS-1219,我們預計將在 2026 年的病毒學會議上分享更多有關 GS-3242 的細節。

  • On slide 16, I'm pleased to highlight that we have completed the BLA filing for bulevirtide in chronic hepatitis delta virus or HDV. We're excited by the potential to bring bulevirtide to HDV patients in the US with a potential regulatory decision in 2026.

    在第 16 張投影片中,我很高興地強調,我們已經完成了布列維肽治療慢性丁型肝炎病毒或 HDV​​ 的生物製品許可申請。我們對預計在 2026 年獲得監管部門批准,將 bulevirtide 帶給美國 HDV 患者感到興奮。

  • As a reminder, HDV affects approximately 2% of patients with HBV or about 40,000 people in the US. Patients with chronic untreated HDV infection can experience accelerated development of cirrhosis or severe scarring of the liver and have higher risk of liver cancer and potentially end-stage liver disease and failure.

    提醒大家,HDV 感染者約佔 HBV 感染者的 2%,在美國約有 4 萬人感染。未治療的慢性 HDV 感染患者可能會加速發展為肝硬化或肝臟嚴重疤痕,且罹患肝癌的風險更高,甚至可能發展為末期肝病和肝衰竭。

  • Beyond bulevirtide, we are also evaluating next-generation approaches to HDV treatment. Specifically, we have advanced GS-4321 a pre-S1 neutralizing antibody into Phase 1 clinical development. We believe GS-4321 has significant potential, given its preclinical safety profile and long half-life with potentially quarterly subcutaneous dosing.

    除了布列維肽之外,我們還在評估下一代 HDV 治療方法。具體來說,我們已將 GS-4321(一種前 S1 中和抗體)推進到 1 期臨床開發階段。鑑於 GS-4321 的臨床前安全性良好,且半衰期長,可能每季進行一次皮下給藥,我們認為它具有巨大的潛力。

  • Moving to Trodelvy on slide 17. Earlier this month at the ESMO meeting, we presented detailed potentially practice-changing Phase 3 ASCENT-03 data in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-L1 inhibitors.

    第 17 張投影片切換到 Trodelvy。本月初在 ESMO 會議上,我們詳細介紹了可能改變臨床實踐的 3 期 ASCENT-03 數據,該數據針對的是不適合接受 PD-L1 抑製劑治療的一線轉移性三陰性乳癌患者。

  • Specifically, Trodelvy demonstrated a 9.7-month median progression-free survival compared to 6.9 months for standard of care chemotherapy. This reflects a statistically significant and clinically meaningful 38% reduction in disease progression or death versus standard of care chemotherapy. As we expected when we initiated the study, the median overall survival data are not yet mature. These results were simultaneously published in the New England Journal of Medicine.

    具體而言,Trodelvy 的中位無惡化存活期為 9.7 個月,而標準治療化療的中位無惡化存活期為 6.9 個月。這反映出與標準治療化療相比,疾病進展或死亡風險降低了 38%,具有統計意義和臨床意義。正如我們在啟動這項研究時所預期的那樣,中位總存活期數據尚未成熟。這些研究結果同時發表在《新英格蘭醫學雜誌》。

  • Additionally, the detailed results from ASCENT-04 were shared at the ASCO meeting in May. These data, combined with ASCENT-03, highlight the potential for Trodelvy to be a backbone treatment across first-line metastatic triple-negative breast cancer.

    此外,ASCENT-04 的詳細結果已於 5 月在 ASCO 會議上公佈。這些數據與 ASCENT-03 結合,突顯了 Trodelvy 有潛力成為第一線轉移性三陰性乳癌的骨幹治療藥物。

  • Based on these positive Phase 3 update from ASCENT-03 and 04, we have submitted two supplemental biologics license applications for Trodelvy in first-line metastatic TNBC and expect regulatory decisions in 2026. This is incredibly important for patients as metastatic TNBC is the most aggressive subtype of breast cancer with limited treatment options and poor prognosis. Historically, progress in first-line therapy has been minimal, and nearly half of patients do not progress beyond first-line treatment, meaning they may never access Trodelvy if it remains a later line option.

    基於 ASCENT-03 和 04 的積極 3 期更新結果,我們已提交了兩份 Trodelvy 用於一線轉移性 TNBC 的補充生物製品許可申請,​​並預計在 2026 年獲得監管部門的決定。這對患者來說極為重要,因為轉移性三陰性乳癌是最具侵襲性的乳癌亞型,治療選擇有限,預後較差。從歷史上看,一線治療的進展微乎其微,近一半的患者無法接受第一線治療,這意味著如果 Trodelvy 仍然是後續治療方案,他們可能永遠無法獲得藥物。

  • Similarly, we are currently exploring Trodelvy for first-line post endocrine hormone receptor positive HER2-negative metastatic breast cancer patients in the Phase 3 ASCENT-07 trial. We now expect to provide an update from this trial before the end of the year.

    同樣,我們目前正在進行 ASCENT-07 3 期試驗,探索 Trodelvy 用於第一線治療內分泌激素受體陽性、HER2 陰性轉移性乳癌患者的療效。我們預計在年底前提供此次試驗的最新進展。

  • On slide 18, we are highlighting overall survival results shared at ESMO earlier this month, from Arm A1 of the Phase 2 EDGE-Gastric study, evaluating domvanalimab, our Fc-Silent Anti-TIGIT plus zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic upper gastrointestinal cancers.

    在第 18 張幻燈片中,我們重點介紹了本月早些時候在 ESMO 上分享的總體生存結果,這些結果來自 2 期 EDGE-Gastric 研究的 A1 組,該研究評估了 domvanalimab(我們的 Fc-Silent Anti-TIGIT)加 zimberelimab 和化療在局部晚期消化性治療中的療效道。

  • In the 41 patients who received the novel regimen in this analysis, the median overall survival was 26.7 months. These findings were simultaneously published in Nature Medicine. These data are in a small number of patients. Survival results for this patient population still need to be confirmed in our ongoing Phase 3 STAR-221 trial evaluating domvanalimab plus zimberelimab and chemotherapy in patients with metastatic upper gastrointestinal cancers.

    在本分析中,接受新療法的 41 名患者的中位總存活期為 26.7 個月。這些研究結果同時發表在《自然醫學》期刊。這些數據來自少數患者。對於轉移性上消化道癌症患者,多瓦那利單抗合併齊貝利單抗和化療的 3 期 STAR-221 試驗仍需證實該患者族群的存活結果。

  • We continue to expect an update from the event-driven STAR-221 trial in 2026.

    我們仍然期待在 2026 年獲得 STAR-221 事件驅動試驗的最新結果。

  • We also continue to develop domvanalimab plus zimberelimab and chemotherapy in first-line metastatic non-small cell lung cancer in the Phase 3 STAR-121 trial.

    我們也將繼續在 STAR-121 3 期試驗中開發 domvanalimab 合併 zimberelimab 和化療一線治療轉移性非小細胞肺癌的方案。

  • Moving to cell therapy on slide 19. And on behalf of Cindy and the Kite team, you can see that we have strengthened our in vivo capabilities. The in vivo cell therapies are potentially off-the-shelf products that could shorten the time it takes to treat patients. and are also expected to have more simplified and cost-effective manufacturing processes. Given these potential advantages over autologous CAR-T, we believe in vivo could unlock broad access to cell therapies.

    第 19 張幻燈片將介紹細胞療法。我代表 Cindy 和 Kite 團隊向大家展示,我們已經加強了體內實驗能力。體內細胞療法有望成為現成的產品,可以縮短患者的治療時間,並且預期其生產過程也將更加簡化、成本更低。鑑於這些相對於自體 CAR-T 的潛在優勢,我們相信體內療法可以實現細胞療法的廣泛應用。

  • With that in mind, we have welcomed the Interius team into the Kite family adding a novel in vivo platform and a strong IP portfolio. We have also entered into a new research and licensing collaboration with Pregene Biopharma. It's early days for in vivo but we're excited to accelerate our exploration of the opportunities these technologies could bring to patients.

    考慮到這一點,我們歡迎 Interius 團隊加入 Ki​​​​te 大家庭,為公司帶來了全新的體內平台和強大的智慧財產權組合。我們也與 Pregene Biopharma 達成了一項新的研究和授權合作協議。雖然體內試驗還處於早期階段,但我們很高興能夠加快探索這些技術可能為患者帶來的機會。

  • As we step up our investment in in vivo therapies, we remain committed to our current Yescarta and Tecartus portfolios. For example, FDA recently granted priority review Yescarta in primary CNS lymphoma with a PDUFA date in February 2026.

    在增加對體內療法的投資的同時,我們仍然致力於我們現有的 Yescarta 和 Tecartus 產品組合。例如,FDA 最近授予 Yescarta 治療原發性中樞神經系統淋巴瘤的優先審查資格,PDUFA 日期為 2026 年 2 月。

  • Primary CNS lymphoma is a rare, yet aggressive subtype of non-Hodgkin's lymphoma that affects the central nervous system. Additionally, CD19 CAR-T products, including Yescarta, have recently received a category 2A recommendation from the NCCN for Richter's transformation. We are pleased with these review and guideline decisions, which will provide HCPs with additional opportunities to prescribe Yescarta.

    原發性中樞神經系統淋巴瘤是一種罕見但具有侵襲性的非何杰金氏淋巴瘤亞型,會影響中樞神經系統。此外,包括 Yescarta 在內的 CD19 CAR-T 產品最近獲得了 NCCN 2A 類推薦,用於治療 Richter 轉換。我們對此審查和指南決定感到滿意,這將為醫療保健專業人員提供更多開立 Yescarta 處方的機會。

  • For our next-generation CAR-Ts, we look forward to sharing Phase 1 data from KITE-753 and KITE-363 in lymphoma at an upcoming medical congress later this year, as well as pivotal Phase 2 initiation of KITE-753 for third-line large B-cell lymphoma in the first quarter of 2026.

    對於我們的下一代 CAR-T 療法,我們期待在今年稍後舉行的醫學大會上分享 KITE-753 和 KITE-363 在淋巴瘤治療中的 1 期數據,以及在 2026 年第一季度啟動 KITE-753 用於三線大 B 細胞淋巴瘤的關鍵性 2 期試驗。

  • In autoimmune diseases, KITE-363 is enrolling patients for its Phase 1 trial in rheumatology and a Phase 1 study in neuro-inflammatory conditions is expected to start in the first quarter of 2026. We look forward to providing updates from these earlier stage programs.

    在自體免疫疾病方面,KITE-363 正在招募患者進行風濕病學的 1 期試驗,預計在 2026 年第一季開始進行神經發炎性疾病的 1 期研究。我們期待為大家帶來這些早期階段專案的最新進展。

  • Together with our partner, Arcellx, we plan to share additional follow-up data from the pivotal iMMagine-1 trial of anito-cel at an upcoming medical meeting. We continue to believe anito-cel has the potential to offer a best-in-class efficacy and safety profile for patients with relapsed and/or refractory multiple myeloma. The target commercial launch in fourth line plus relapsed and/or refractory multiple myeloma remains in 2026.

    我們計劃與合作夥伴 Arcellx 一起,在即將舉行的醫學會議上分享 anito-cel 的關鍵性 iMMagine-1 試驗的更多後續數據。我們仍然相信,anito-cel 有潛力為復發和/或難治性多發性骨髓瘤患者提供一流的療效和安全性。針對四線以上復發和/或難治性多發性骨髓瘤的商業化上市目標仍定於 2026 年。

  • On slide 20, I will quickly highlight the key milestone updates. First, we have received European Commission Marketing Authorization of Yeytuo and remain on track to provide updates for our Phase 3 ARTISTRY-1 and ARTISTRY-2 trials for BIC/LEN and for our pivotal Phase 2 iMMagine-1 trial for anito-cel in the fourth quarter. Finally, we now also expect ASCENT-07 data in the fourth quarter.

    在第 20 張投影片中,我將快速專注於關鍵里程碑更新。首先,我們已獲得歐盟委員會對 Yeytuo 的上市許可,並將繼續按計劃在第四季度提供 BIC/LEN 的 3 期 ARTISTRY-1 和 ARTISTRY-2 試驗以及 anito-cel 的關鍵性 2 期 iMMagine-1 試驗的最新進展。最後,我們現在也預計在第四季獲得 ASCENT-07 數據。

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

    這樣,我就把電話交給安迪了。

  • Andrew Dickinson - Chief Financial Officer

    Andrew Dickinson - Chief Financial Officer

  • Thank you, Dietmar, and good afternoon, everyone. Starting on slide 22. Our third-quarter results showed continued strong execution across the company. Our base business was up 4% year over year to $7.1 billion, driven by growth in Biktarvy, Descovy, and Livdelzi.

    謝謝你,迪特馬爾,大家下午好。從第22張投影片開始。第三季業績顯示,公司各部門持續保持強勁的執行力。我們的基礎業務年增 4%,達到 71 億美元,這主要得益於 Biktarvy、Descovy 和 Livdelzi 的成長。

  • Veklury sales were down 60% year over year to $277 million which continue to reflect fewer COVID-related hospitalizations. Including Veklury sales, total product sales were $7.3 billion.

    Veklury 的銷售額年減 60% 至 2.77 億美元,這繼續反映出與 COVID 相關的住院人數減少。包括 Veklury 的銷售額在內,產品總銷售額為 73 億美元。

  • Moving to slide 23. You can see we benefited from a $400 million contribution in royalty, contract, and other revenues in the third quarter. This relates to an IP asset sale from 2018. Given we are now able to reasonably estimate future royalty and milestone payments, we are required to recognize this revenue in the third quarter. This is a nonrecurring accounting item and does not reflect cash received during the quarter.

    切換到第23張投影片。您可以看到,我們在第三季度獲得了 4 億美元的特許權使用費、合約費和其他收入。這與 2018 年的一項智慧財產權資產出售有關。鑑於我們現在能夠合理估計未來的特許權使用費和里程碑付款,我們需要在第三季確認這筆收入。這是一個非經常性會計項目,並不反映本季收到的現金。

  • As a reminder, this contribution was not part of our product sales and therefore, did not impact our product gross margin in the third quarter. But it does otherwise flow through to the bottom line, contributing approximately $0.25 after tax.

    需要提醒的是,這筆捐款不屬於我們的產品銷售額,因此不會影響我們第三季的產品毛利率。但除此之外,它確實會影響最終利潤,稅後大約貢獻 0.25 美元。

  • Moving to our non-GAAP results on slide 24. Third-quarter product gross margin was 86%, in line with 87% in the third quarter of 2024. R&D expenses of $1.3 billion were down 3% compared to the third quarter of 2024. Year to date, 2025 R&D expenses were $4.1 billion, in line with 2024 suggesting we are on track for our full year goal.

    接下來請看第 24 頁的非 GAAP 財務表現。第三季產品毛利率為 86%,與 2024 年第三季的 87% 持平。研發支出為 13 億美元,比 2024 年第三季下降 3%。截至目前,2025 年研發支出為 41 億美元,與 2024 年持平,顯示我們正朝著全年目標穩步前進。

  • Acquired IPR&D expenses were $170 million in the third quarter, including a $120 million upfront payment to Pregene for a research and licensing collaboration in the in vivo cell therapy space.

    第三季收購的智慧財產權和研發費用為 1.7 億美元,其中包括向 Pregene 支付的 1.2 億美元預付款,用於在體內細胞治療領域進行研究和授權合作。

  • SG&A expenses of $1.4 billion were down 4% compared to the third quarter of 2024, modestly lower than we expected due to the timing of spending. Third-quarter operating margin was 50%, reflecting the continued focus on operating expense discipline and leverage. The non-GAAP effective tax rate was 18% this quarter, slightly below our expectations due to a $79 million tax settlement.

    銷售、一般及行政費用為 14 億美元,比 2024 年第三季下降 4%,由於支出時間的原因,略低於我們的預期。第三季營業利益率為 50%,反映出公司持續專注於控制營運費用和提高槓桿率。本季非GAAP實際稅率為18%,略低於我們的預期,原因是7,900萬美元的稅務和解。

  • And finally, non-GAAP diluted EPS was $2.47 for the quarter. Excluding the $400 million nonrecurring other revenue, non-GAAP diluted EPS would have been $2.22 for the third quarter.

    最後,本季非GAAP稀釋後每股收益為2.47美元。如果排除 4 億美元的非經常性其他收入,第三季非 GAAP 稀釋後每股收益將為 2.22 美元。

  • Moving to our full year guidance on slide 25. We are raising the low end of our product sales range by $100 million to reflect our strong performance year to date. As a reminder, the $400 million included in our royalty contracts and other revenue in the third quarter does not impact our full year guidance as we do not guide to total revenue.

    接下來,我們將在第25頁介紹全年業績指引。為了反映我們今年迄今的強勁業績,我們將產品銷售額的下限提高了 1 億美元。需要提醒的是,第三季我們收到的 4 億美元特許權使用費合約和其他收入不會影響我們全年的業績指引,因為我們不會對全年總收入做出指引。

  • We now expect total product sales, excluding Veklury, to be between $27.4 billion and $27.7 billion primarily reflecting higher HIV growth. Driven by the outperformance of both Biktarvy and Descovy year to date, we now anticipate our HIV franchise will grow approximately 5% year over year versus our prior guidance of 3%.

    我們現在預計,不包括 Veklury 在內的產品總銷售額將在 274 億美元至 277 億美元之間,這主要反映了 HIV 產品銷售的更高成長。受 Biktarvy 和 Descovy 今年迄今表現優異的推動,我們現在預計我們的 HIV 產品線將同比增長約 5%,而我們之前的預期為 3%。

  • Consistent with last quarter, I'll note that our assumptions for the impact of the Medicare Part D redesign remained unchanged from the beginning of the year, and we continue to expect approximately $900 million of impact to our HIV business in 2025. Our 2025 assumptions for Yeztugo also remain unchanged, and we remain very encouraged by the launch so far, particularly the accelerated timeline for payer coverage.

    與上個季度一致,我要指出,我們對 Medicare Part D 改革影響的假設與年初相比沒有變化,我們仍然預計到 2025 年,這將對我們的 HIV 業務產生約 9 億美元的影響。我們對 Yeztugo 2025 年的假設也保持不變,我們對目前的推出情況感到非常鼓舞,特別是支付方覆蓋範圍的加速推進。

  • In other parts of our business, strength in HIV is expected to be partially offset by weaker cell therapy estimates where we now forecast approximately a 10% decline for full year 2025 versus full year 2024.

    在我們業務的其他部分,HIV 業務的強勁成長預計將被細胞療法業務預期的疲軟部分抵消,我們現在預測 2025 年全年業務量將比 2024 年全年下降約 10%。

  • For Veklury, we continue to expect full year revenue of approximately $1 billion. As a result, total product sales are anticipated to be in the range of $28.4 billion to $28.7 billion. As noted earlier, this reflects a $100 million increase at the low end of the range from our previous guidance. Finally, we continue to expect the impact of known tariffs to be manageable in 2025.

    對於 Veklury,我們仍然預計全年營收約 10 億美元。因此,預計產品總銷售額將在 284 億美元至 287 億美元之間。如前所述,這比我們先前預期的範圍下限增加了 1 億美元。最後,我們仍然預計到 2025 年,已知關稅的影響將是可控的。

  • Moving to the rest of the P&L. There is no change to our prior non-GAAP guidance for product gross margin, R&D, and SG&A expenses. We continue to expect product gross margin of approximately 86%, R&D expenses to be roughly flat on a dollar basis from 2024, and SG&A expenses to decline by a mid- to high-single-digit percentage compared to 2024.

    接下來來看損益表的其餘部分。我們先前發布的非GAAP產品毛利率、研發費用及銷售、管理及行政費用指引沒有變動。我們繼續預期產品毛利率約為 86%,研發費用從 2024 年起將基本持平(以美元計),銷售、一般及行政費用將比 2024 年下降中高個位數百分比。

  • Similar to last year, we expect a step-up in both R&D and SG&A expenses in the fourth quarter, reflecting normal end-of-year trends. We have updated our IPR&D expectations for the full year to reflect our actuals through the third quarter and our known fourth-quarter commitments, including $300 million relating to the Interius acquisition.

    與去年類似,我們預計第四季度研發和銷售、一般及行政費用都將增加,這反映了正常的年末趨勢。我們已更新了全年的智慧財產權和研發預期,以反映截至第三季的實際情況以及我們已知的第四季度承諾,其中包括與收購 Interius 相關的 3 億美元。

  • We now expect full year acquired IPR&D to be $900 million.

    我們現在預計全年收購的智慧財產權和研發支出將達到 9 億美元。

  • Rounding out the P&L, we expect operating income to be between $13.1 billion and $13.4 billion, reflecting an increase of $100 million at the low end of the prior guidance range. We continue to expect our effective tax rate to be approximately 19%. And finally, we expect non-GAAP EPS in the range of $8.05 and $8.25, raising non-GAAP EPS by $0.10 at the low end of the range. GAAP EPS is expected to be in the range of $6.65 to $6.85.

    綜上所述,我們預期損益表營業收入將在 131 億美元至 134 億美元之間,比先前預期範圍的下限增加了 1 億美元。我們仍然預計實際稅率約為 19%。最後,我們預期非GAAP每股盈餘在8.05美元至8.25美元之間,這意味著在區間下限時,非GAAP每股盈餘將增加0.10美元。GAAP每股收益預計介於6.65美元至6.85美元之間。

  • On slide 26, our capital priorities remain unchanged, and we returned $1.4 billion to shareholders in the third quarter, which included $435 million of share repurchases. These repurchases are intended to offset equity dilution at a minimum but can also be used opportunistically, as you've seen in the first three quarters of 2025.

    在第 26 頁,我們的資本優先事項保持不變,我們在第三季向股東返還了 14 億美元,其中包括 4.35 億美元的股票回購。這些回購旨在至少抵消股權稀釋,但也可以像你在 2025 年前三個季度看到的那樣,伺機利用。

  • Overall, we are pleased with the strong performance this quarter, 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,我們對本季強勁的業績感到滿意,這主要得益於我們的臨床和商業執行,以及我們嚴謹的營運模式的支持。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 Rebecca 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) Geoff Meacham, Citigroup.

    (操作員說明)Geoff Meacham,花旗集團。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Congrats on the quarter. On Yeztugo, I know it's early, I wanted to see if you had any color on patients switching from Descovy versus those that were brand new to PrEP? And then related, but just looking to the balance of the year, are there any demand drivers that could give you some momentum going into 2026?

    恭喜你本季取得佳績。Yeztugo,我知道現在還為時過早,我想了解一下從 Descovy 轉用 PrEP 的患者與那些剛開始使用 PrEP 的患者相比,您有什麼看法?另外,展望今年剩餘時間,有哪些需求驅動因素可以推動公司在 2026 年取得發展動能?

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Thanks, Geoff, and welcome. I'll hand it right over to Johanna.

    謝謝傑夫,歡迎你。我會立刻把它交給喬安娜。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Great. Thanks, Geoff. Yes, so we're really excited about the launch so far and really much in line with our expectations of an injectable into an oral market.

    偉大的。謝謝你,傑夫。是的,所以我們對目前的上市情況感到非常興奮,這與我們對注射劑進入口服市場的預期非常吻合。

  • To your point about where the Yeztugo sourcing is coming from, it's really across the board. So it's more switches, as you'd expect, in this marketplace versus naive. But really across the switches, what we're really pleased to see is that we're getting -- the source of business is actually coming from the long-acting injectable currently on the market, also the oral branded such as Descovy, but also oral generics. And so you're seeing a real nice balance mix across the board for switches, and we expect that to continue.

    關於您提到的 Yeztugo 原料來源,它實際上來自四面八方。正如你所預料的那樣,在這個市場中,使用開關的人比使用天真的人要多得多。但實際上,在各種轉換過程中,我們真正高興地看到,業務來源實際上來自目前市場上的長效注射劑,以及像 Descovy 這樣的口服品牌藥,還有口服仿製藥。因此,您可以看到開關產品的整體平衡性非常好,我們預計這種情況會持續下去。

  • And of course, as the market grows and continues to grow the awareness of Yeztugo increases, we also believe that the naive patient population will also grow with time as well.

    當然,隨著市場的發展和 Yeztugo 知名度的不斷提高,我們也相信,隨著時間的推移,尚未接觸過 Yeztugo 的患者群體也會隨之增長。

  • Operator

    Operator

  • Umer Raffat.

    烏麥爾·拉法特。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • Quick question. I noticed a $39 million sales number in 3Q. And I'm trying to make sense of it. By my rough math, it sounds like about 3,000 patients initiated in 3Q. Is that consistent with how you see it?

    問個問題。我注意到第三季銷售額為 3900 萬美元。我正在努力理解這件事。根據我的粗略計算,第三季大約有 3000 名患者開始接受治療。這和你的看法一致嗎?

  • And I ask because IMS was implying something like 2,300 patients. So I'm just trying to get a sense of it all.

    我這麼問是因為IMS暗示可能有2300名病患。我只是想了解這一切。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Umer, for the question. Maybe I'll give a little bit more context to Yeztugo in light of your question. And not that we've been sharing patients per se, but we do have year to date about -- year to date as of the Q3 quarter, about $54 million in sales. Some of that was in early June, right, in late June for inventory purposes, about $15 million of that. And we've really seen that inventory flow through.

    謝謝 Umer 的提問。有鑑於你的問題,或許我可以再補充一些關於 Yeztugo 的背景資訊。雖然我們並沒有分享病人訊息,但截至第三季度,我們的銷售額約為 5400 萬美元。其中一部分是在 6 月初,對吧?還有一部分是在 6 月下旬,是為了盤點庫存,大約有 1500 萬美元。我們已經看到庫存週轉非常順暢。

  • So there's really no more stocking left in the system. We've been tracking a lot of different indicators to make sure that our launch is on the right track. And so we're really excited because we see the access piece as one of the most important indicators for the future and meeting the 75% coverage for access, almost three months ahead of schedule with very limited prior (inaudible) and basically zero co-pays, it really sets us up nicely actually as you think about 2026 and beyond.

    所以系統裡真的已經沒有庫存了。我們一直在追蹤許多不同的指標,以確保我們的產品發布走上正確的軌道。因此我們感到非常興奮,因為我們認為醫療服務覆蓋率是未來最重要的指標之一,而我們提前近三個月實現了 75% 的醫療服務覆蓋率目標,而且事先幾乎沒有任何費用(聽不清楚),基本上無需支付任何費用,這實際上為我們展望 2026 年及以後的發展奠定了良好的基礎。

  • The UnitedHealth, ESI, many other commercial plans are on board. We have about 20 out of the 25 large PrEP states for Medicaid that represents just over 80% of the PrEP Medicaid volume. So that's really been our focus. And of course, the J-code coming on as of October 1, all of this would support buy-and-bill modeling as well. And so these access wins are recent.

    UnitedHealth、ESI 以及許多其他商業保險計劃都已加入。在 25 個 PrEP 大州中,我們大約有 20 個州為 Medicaid 提供 PrEP 服務,佔 PrEP Medicaid 總量的 80% 以上。所以這確實是我們關注的重點。當然,從 10 月 1 日起推出的 J 代碼也將支援購買和計費模式。因此,這些准入方面的勝利都是近期取得的。

  • And obviously, it's going to take a little bit of time account by account to pull it through and integrate it within the practices. But I think it really provides that platform for us to accelerate the uptake for Yeztugo.

    顯然,要逐一帳戶落實並將其融入實踐中,需要一些時間。但我認為這確實為我們加速 Yeztugo 的普及提供了平台。

  • We've also seen conversion rates basically from script to approval really dropped dramatically. And so we continue to focus on the logistics to make sure we get the drug and the patient schedules aligned shortly after the reimbursement approval.

    我們也發現,從腳本到審批的轉換率確實大幅下降了。因此,我們繼續專注於物流,以確保在獲得報銷批准後儘快將藥物和患者的治療計劃協調一致。

  • And so I would say from an overall standpoint, super pleased about the -- what we track are the intakes, the access, HCP awareness and interest, the conversion rates that I just referred to and everything is going in the right direction. So we do expect full year Yeztugo sales of around $150 million or so, including the $54 million year to date. So I hope that gives you a bit of perspective.

    因此,從整體上看,我對我們追蹤的數據——包括接收量、訪問量、醫療保健專業人員的認知度和興趣、我剛才提到的轉換率——感到非常滿意,一切都在朝著正確的方向發展。因此,我們預計 Yeztugo 全年銷售額約為 1.5 億美元,其中包括今年迄今的 5,400 萬美元。希望這能給你一些啟發。

  • And then as you get the full year, you can have a better understanding of patient numbers.

    然後,等到全年數據統計完畢,你就能更了解患者人數了。

  • Operator

    Operator

  • Mohit Bansal.

    莫希特·班薩爾。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Congrats on all the progress. Switching a little bit to HIV treatment. Now that you are guiding for 5% year-over-year growth, combined that with the $900 million of Part D redesign impact you are taking, it does seem like HIV is growing at, what, 9% to 10%. I mean, can you talk a little bit about that?

    祝賀你們取得的所有進展。稍微轉向愛滋病治療。既然你們預計年增長率為 5%,再加上你們正在投入 9 億美元用於 D 部分重新設計,那麼 HIV 的成長速度似乎達到了 9% 到 10%。我的意思是,您能稍微談談這方面嗎?

  • How should we think about it going forward given that you have had such an impressive growth this year?

    鑑於貴公司今年取得如此令人矚目的成長,我們該如何展望未來?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Mohit, for that. I do agree with you. I think we've had such an impressive growth, and it's really driven by a couple of things. It's driven by the market both in treatment and in PrEP and real demand-driven growth, specifically Biktarvy, Descovy are really the ones that are impacting this year's growth.

    謝謝你,莫希特。我同意你的看法。我認為我們取得了令人矚目的成長,這主要得益於以下兩點。治療和 PrEP 市場的推動作用以及真正的需求驅動成長,特別是 Biktarvy 和 Descovy,才是真正影響今年成長的因素。

  • So as you think about Biktarvy growing year on year, about 6% and is, to your point, is despite Part D redesign and those assumptions have not changed and Biktarvy growing at 6 points, but also Descovy growing at about 20%. And if you think about just for PrEP, when if you think about the 3/4 of that product being driven by prevention, you're looking at almost over 30% growth for Descovy let alone, if you think about HIV prevention at, Gilead is over 40%.

    所以,當你考慮到 Biktarvy 每年增長約 6% 時,正如你所指出的,儘管 Part D 進行了重新設計,但這些假設並沒有改變,Biktarvy 仍然增長了 6 個百分點,而 Descovy 則增長了約 20%。如果只考慮 PrEP,考慮到該產品 3/4 的銷售量都來自預防,Descovy 的成長率就接近 30% 以上,更不用說 HIV 預防領域,吉利德的成長率更是超過 40%。

  • So both HIV treatment and HIV prevention are really driving the growth. And you could assume that actually, if Part D redesign hadn't played out, we would probably be around the numbers you were talking about, 8% to 9%.

    因此,愛滋病治療和愛滋病預防都是推動成長的主要因素。你可以假設,如果 D 部分的重新設計沒有發生,我們實際上可能會達到你所說的數字,即 8% 到 9%。

  • Operator

    Operator

  • Salveen Richter, Goldman Sachs.

    薩爾文·里克特,高盛。

  • Salveen Richter - Analyst

    Salveen Richter - Analyst

  • Could you just comment on the inventory impact for Yeztugo in the third quarter and also how the [CVS] pricing discussions are progressing?

    您能否談談 Yeztugo 第三季的庫存影響,以及 [CVS] 定價談判的進展?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure, Salveen. It's Johanna again. A couple of things. One is, in the Q3, there's really no inventory buy-in. It really happened in the first two weeks -- the last two weeks of June, first two weeks of our launch. And that really got pulled through in the first month of Q3. And then what you're seeing in the [$39 million] is really true demand coming through. So that's the inventory piece of the puzzle.

    當然可以,薩爾文。又是喬安娜。有幾件事。一是第三季其實沒有庫存採購。這確實發生在最初的兩週——六月的最後兩週,也就是我們產品發布的前兩週。而這在第三季的第一個月就真正實現了。然後,你看到的這 3900 萬美元確實反映了真實的市場需求。這就是庫存盤點部分的問題。

  • From a CVS access standpoint, payers all have different timelines as to how they make formulary decisions. And we're working with every single one of the payers to make sure we go as quickly as possible to secure access while also ensuring that the innovative value of Yeztugo gets recognized.

    從 CVS 准入的角度來看,所有支付方在製定處方集決策方面都有不同的時間表。我們正在與每位付款方合作,以確保我們盡快獲得存取權限,同時確保 Yeztugo 的創新價值得到認可。

  • And so our discussions with the remaining 25% of payers, including CVS, are ongoing, and we're very confident about our ability to reach the goals that we've set forth, which is the 90% at the first year of launch. So we're very confident that we are on track to reach those numbers.

    因此,我們與包括 CVS 在內的其餘 25% 的支付方的討論仍在進行中,我們非常有信心實現我們設定的目標,即在推出後的第一年達到 90% 的目標。因此,我們非常有信心能夠實現這些目標。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    Evan Seigerman,BMO資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Livdelzi continues to perform exceptionally well and appears to be succeeding as a clear strategic fit to your business. Can you just talk to you about the level of appetite for additional BD and liver-focused indications such as NASH?

    Livdelzi 的表現持續非常出色,並且顯然與貴公司的策略高度契合。您能否談談您對更多 BD 和以肝臟為中心的適應症(例如 NASH)的興趣程度?

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Andy, why don't you start there?

    安迪,為什麼不從那裡開始呢?

  • Andrew Dickinson - Chief Financial Officer

    Andrew Dickinson - Chief Financial Officer

  • Sure. Hi, Evan, thanks for the question. Look, I mean, as we said, we don't comment specifically on any subsectors. We are looking actively at opportunities across the BD spectrum in all of our areas of strategic interest. That includes liver disease as well as oncology, cell therapy broadly, virology and immunology.

    當然。嗨,Evan,謝謝你的提問。你看,我的意思是,正如我們所說,我們不對任何細分行業發表具體評論。我們正在積極尋找所有策略關注領域內的業務拓展機會。這包括肝病、腫瘤學、細胞療法(廣義)、病毒學和免疫學。

  • And we've said consistently and continue to believe that we would like to add more therapies just like Livdelzi that are best-in-class therapies that serve patients in need on a regular basis. And we would look for those late-stage derisked assets every two to three years at a minimum to kind of add them to our portfolio.

    我們一直表示,並且仍然相信,我們希望增加更多像 Livdelzi 這樣的一流療法,這些療法能夠定期為有需要的患者提供服務。我們至少每兩到三年就會尋找那些後期降低風險的資產,並將它們加入我們的投資組合中。

  • So when you step back, I think we are really pleased with the size and shape of our portfolio, all of the growth drivers that we have, the additional launches that you heard Dietmar talked about in his prepared remarks and we would like to add growth -- additional growth drivers. And of course, we'll be disciplined in doing that. But yes, you should expect that we're going to be looking at deals across all of our sectors, including liver disease.

    所以,從整體來看,我們對目前的投資組合規模和結構,以及我們擁有的所有成長動力,還有迪特馬爾在事先準備好的發言中提到的其他產品發布,都非常滿意。我們希望增加成長——更多的成長動力。當然,我們會嚴格遵守紀律來做到這一點。是的,你們應該預料到,我們將關注我們所有領域的交易,包括肝病領域。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    克里斯‧肖特,摩根大通。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Can I just dig into Yeztugo in 4Q and heading into '26 in a little bit more detail? I mean, it seems like you're pointing to a step-up in sales next quarter, but we're getting obviously a lot of coverage. I'm just trying to understand a little bit more about how you're envisioning the shape of the curve. Is this kind of like a gradual acceleration or a bigger step function as we move into 2026? I'm just trying to get, again, a little bit more color on that dynamic.

    我可以更詳細地分析一下 Yeztugo 在第四季度以及即將進入 2026 年的情況嗎?我的意思是,你似乎預示著下個季度的銷售額將會成長,但顯然我們也獲得了大量的媒體關注。我只是想更了解你對曲線形狀的想像。隨著我們邁入 2026 年,這更像是一種漸進式的加速,還是更大的階躍函數?我只是想再次為這種動態增添一些色彩。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • So Chris, it's Johanna. I think that's a fair question. I think what we're seeing is a lot of the access to get us to the 75% goal most recently, really happened in the last couple of weeks. And so it's important to understand that those don't turn on just overnight. And so practices need to actually integrate these changes into their working practices.

    克里斯,我是喬​​安娜。我認為這是個很合理的問題。我認為我們看到的是,最近幾週,為了實現 75% 的目標,許多資源的取得都取得了進展。因此,我們需要明白,這些功能不會一夕之間就啟動。因此,各機構需要將這些變化實際融入他們的工作流程中。

  • And so we're working with them to make sure that happens. Things can go for the J-code. Some people will update right away, some people update biannually. And so January 1 could be kind of for some that update to really help the buy and bill, folks that are interested in buy and bill. And so we do believe it's going to be a gradual ramp-up.

    因此,我們正在與他們合作,確保這種情況發生。事情可以朝著 J 程式碼的方向發展。有些人會立即更新,有些人則每半年更新一次。因此,1 月 1 日的更新可能會對一些用戶有所幫助,特別是那些對購買和帳單支付感興趣的用戶。所以我們相信這將是一個逐步增加的過程。

  • And then for us, it really sets up the platform for the ramp for Yeztugo in 2026. And so that's what we're kind of focusing on.

    對我們來說,這確實為 2026 年 Yeztugo 的崛起奠定了基礎。所以這就是我們目前關注的重點。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    James Shin,德意志銀行。

  • James Shin - Research Analyst

    James Shin - Research Analyst

  • Johanna, could you just give us an update on Yeztugo's buy-and-bill and white-bagging mix? And does reaching this 75% ahead of schedule equate to reaching bigger portion of white bagging sooner?

    Johanna,你可以為我們介紹一下 Yeztugo 的買入結算和白袋包裝業務的最新進展嗎?提前 75% 完成是否意味著能更快完成更大比例的白袋包裝?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure. So the white bagging and the buy and bill you'd expect, and if you remember, at our HIV Day in 2024, we did kind of share that would be heavier to the white bagging and buy and bill over time, and that's exactly what we're seeing. So much more in -- coming through the scripts are going to specialty pharmacy, going through that process and then white bagging back to the clinic. Probably more towards about 3/4 range in the 70% to 80%, and then the rest of that is buy and bill.

    當然。所以,你會看到白色包裝袋和購買後結算的情況,如果你還記得的話,在我們 2024 年的愛滋病日上,我們確實說過,隨著時間的推移,白色包裝袋和購買後結算的情況會越來越嚴重,而這正是我們現在所看到的。還有很多其他藥品──透過處方送到專科藥房,經過處理後,再用白袋包裝送回診所。可能更接近 70% 到 80% 之間的 3/4 範圍,剩下的部分是購買和帳單。

  • That's not steady state, obviously, and that's going to change over time as people get more comfortable and get -- and as they integrate the J-code as well into their practice. So all of those things will evolve. But for right now, that's what we're seeing.

    顯然,這並非穩定狀態,隨著人們越來越熟悉並逐漸將 J 代碼融入他們的實踐中,這種情況會隨著時間的推移而改變。所以所有這些都會不斷發展變化。但就目前而言,這就是我們所看到的。

  • Operator

    Operator

  • Daina Graybosch, Leerink Partners.

    Daina Graybosch,Leerink Partners。

  • Daina Graybosch - Analyst

    Daina Graybosch - Analyst

  • And another one on Yeztugo. I mean, you've said several times that in the 75% covered lives, you've been pleased by the level of restriction. I wonder if you could give us a little more detail to how much of the lives have prior offs or copay? Or any other restrictions like to certain types of practices, for instance?

    Yeztugo 上還有另一個。我的意思是,你曾多次說過,在 75% 的受保人群中,你對限製程度感到滿意。我想請您詳細說明一下,有多少人有過停工或自付費用?或者有其他限制嗎,例如某些類型做法的限制?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • So what we're seeing thus far, and it's still early, right, because we're trying to see how this all plays out. But most of the plans so far have added Yeztugo to their formulary with zero co-pays (inaudible). If you're looking for a number and a very few step edits and prior offs and if they are, they're very simple. And so we do think it's really important. It's one thing to have access.

    所以,到目前為止我們看到的情況還很早,對吧,因為我們正在努力觀察這一切將如何發展。但到目前為止,大多數計劃都已將 Yeztugo 添加到其藥品目錄中,且無需支付任何費用(聽不清楚)。如果你正在尋找一些數字和極少的步驟編輯和先前的關閉,如果是這樣的話,它們就非常簡單。所以我們認為這非常重要。擁有這種權限是一回事。

  • The quality of the access is also very important for us and to make sure that the people who may want or need PrEP can have access to it. And that's very much in line. I mean, those goals were set because of Descovy. And Descovy is as of September, access is at about 99% of lives covered with about 88% un-restriction, no restrictions. And so that gives you a little bit of a flavor of kind of the direction of where Yeztugo is going.

    對我們來說,獲取途徑的品質也非常重要,我們要確保那些可能需要或想要獲得 PrEP 的人能夠獲得它。這與預期完全吻合。我的意思是,這些目標都是因為 Descovy 才設定的。截至 9 月,Descovy 的覆蓋率約為 99%,其中約 88% 的人享有無限服務。這樣你就能對 Yeztugo 的發展方向有個大致的了解了。

  • Not there yet, but definitely well on its way.

    還沒完全實現,但肯定進展順利。

  • Operator

    Operator

  • Brian Abrahams, RBC Capital Markets.

    Brian Abrahams,加拿大皇家銀行資本市場。

  • Brian Abrahams - Managing Director

    Brian Abrahams - Managing Director

  • Maybe just another one on Yeztugo. Johanna, can you maybe talk bigger picture about what the patient journey is like here for getting an appointment with the physician obtaining and getting Yeztugo administered? Maybe how that's comparing to your expectations? How that could evolve? And really just wondering like what are the biggest barriers for a patient wanting to switch to do so?

    或許只是 Yeztugo 上的另一個例子。Johanna,你能否從更宏觀的角度談談病人在這裡從預約醫生到獲得 Yeztugo 藥物並接受治療的整個過程?或許你想問這和你的預期相比如何?這種情況會如何演變?我真的很想知道,對於想要轉換治療方案的患者來說,最大的障礙是什麼?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure, Brian. Happy to do so. And they're changing, right? So I'm going to share with you kind of where we're at, but it's been an evolution even from July on. We're seeing a big difference in the time it takes from prescription.

    當然可以,布萊恩。我很樂意這樣做。它們正在改變,對吧?所以我想和大家分享我們目前的狀況,但從七月開始,情況一直在不斷變化。我們發現從開處方到拿到藥品所需的時間發生了很大的變化。

  • So as a physician writes a prescription for someone for Yeztugo and the prescription goes to specialty pharmacy, for example, and go through the process, I mean, the approval process used to take over a month, and so it could take four or five, six weeks. Now it's more than half down from that time frame because the access is starting to play in.

    例如,醫生為某人開立 Yeztugo 處方,然後該處方會送到專科藥房,並經過審批流程,我的意思是,審批流程過去需要一個多月的時間,所以可能需要四到五週,甚至六週。現在比當時下降了一半以上,因為准入條件開始發揮作用。

  • But then you also have the piece that you just said, which is then how do you make sure that the logistics play out where you get the approval and make sure that the drug gets to the office at the same time as the patient gets back into the office as well. And so that obviously can take a week or two, sometimes more depending on the patient's availability and the doctor's availability, of course.

    但正如你剛才所說,還有另一個問題,那就是如何確保物流順利進行,獲得批准,並確保藥物在患者返回診室的同時送到診間。因此,這顯然可能需要一到兩週的時間,有時甚至更久,當然,這取決於患者和醫生的時間安排。

  • And so that's kind of what we're playing out. So that is definitely something that was part of our assumptions. But those conversion rates both from prescription to approval, but approval to offset to injection because that's really when it gets shipped is when it gets captured by IQVIA, for example, that's really what we've been tracking to make sure we minimize that time and support the offices in the logistics of doing so.

    所以,這就是我們正在上演的戲碼。所以這絕對是我們之前考慮過的問題之一。但無論是從處方到審批,還是從審批到結算再到注射的轉化率,因為只有在藥物真正發貨的時候,IQVIA 等公司才能捕捉到相關信息,這正是我們一直在跟踪的,以確保我們最大限度地縮短時間,並在物流方面為各辦事處提供支持。

  • So we're seeing benefits every single month. and seeing those numbers come down. And obviously, as people get more in tune with the practice, it's going to get easier.

    所以我們每個月都能看到成效,而且這些數字都在下降。顯然,隨著人們對這種做法越來越熟悉,就會變得越來越容易。

  • On the flip side, I would say buy and bill is obviously, it cuts out one piece of that because then it's directly within the doctor's office, they get approval, they get product. And then they can kind of start -- as buy-and-bill builds, you're going to see a little bit faster turnaround there as well.

    另一方面,我認為「先買後付」顯然可以省去一個環節,因為這樣一來,所有流程都在醫生辦公室內完成,他們獲得批准,然後拿到產品。然後他們就可以開始——隨著採購和結算模式的建立,你也會看到週轉速度加快一些。

  • Hopefully, that helps give you a little bit of a picture of the patient's journey.

    希望這能讓您對患者的治療過程有大致的了解。

  • Operator

    Operator

  • Carter Gould, Cantor Fitzgerald.

    卡特·古爾德,坎托·菲茨杰拉德。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • I hope you'll indulge me on a relatively short-term minded question here on Yeztugo. But we've seen pretty volatile scripts over here in the past couple of weeks. And I guess my question is, are the TRx that we're seeing reflective of what you're seeing? Is that impacted by third-party PrEP campaigns or more standard demand growth? Or early impacts from the J-code?

    希望您能容我在這裡(Yeztugo)提出一個相對短期的問題。但過去幾週,我們看到這裡的腳本波動相當劇烈。我想問的是,我們看到的 TRx 是否與你們所看到的相符?這是否受到第三方PrEP推廣活動的影響,還是受到更常規的需求成長的影響?或者說是 J 程式碼帶來的早期影響?

  • Any color would be appreciated.

    任何顏色都可以。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • There's a lot of week-to-week variability with IQVIA versus what we're seeing. Obviously, we track as well. And it really depends on the reports that you're looking at within IQVIA as well. I think it's going to take a couple of quarters for this to stabilize a little bit. I think it's a good directional indicator.

    IQVIA 的數據與我們看到的數據相比,每週的波動性都很大。顯然,我們也會進行追蹤。這其實也取決於你在 IQVIA 內部查看的是哪些報告。我認為這種情況需要幾個季度才能稍微穩定下來。我認為這是一個很好的方向性指標。

  • And depending on the report, just make sure you're looking at both the SP intakes, but also the buy and bill and kind of merging those two pieces together.

    根據報告,確保你既查看 SP 的進貨量,也查看買入量和出貨量,並將這兩部分合併在一起。

  • Those two pieces together, although sometimes accounts are missing directionally are in line with the overall of what we're seeing. But the volatility with IQVIA is definitely real right now, and I think it's going to take a little while to settle. We've seen that before with other products as well.

    雖然有時在方向上有所缺失,但這兩部分結合起來與我們所看到的整體情況是一致的。但IQVIA目前的波動性確實存在,我認為需要一段時間才能穩定下來。我們之前在其他產品上也遇到過這種情況。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    Terence Flynn,摩根士丹利。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Johanna, just wondering if you can comment at all high level about how we should think about overall PrEP market growth? Obviously, it's been very strong the last couple of quarters, 14% this quarter, 15% last quarter. Is that kind of the level we should think about at a franchise for you guys as we head into 2026?

    Johanna,我想請你從宏觀層面談談我們該如何看待 PrEP 市場的整體成長?顯然,過去幾季表現非常強勁,本季為 14%,上季為 15%。對你們來說,展望2026年,這種程度的特許經營模式是我們該考慮的嗎?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure, Terence. I think that's the right way to think about it. I think 14%, 15% is the right approach for this market growth. This is obviously fueled by many of us to make sure that there is increased awareness of the options within PrEP, and I think that will continue to be fueled as the noise kind of increases as we go into 2026 whether it's through social media or direct-to-consumer advertising. And so I would assume about a 14% to 15% growth continuing with PrEP.

    當然可以,特倫斯。我認為這是正確的思考方式。我認為14%、15%是這個市場成長的合適速度。顯然,我們許多人都在努力提高人們對 PrEP 方案的認識,我認為隨著 2026 年到來,無論是透過社群媒體還是直接面向消費者的廣告,相關聲音都會不斷增加,這種努力也將持續下去。因此,我預計 PrEP 的使用率將繼續保持 14% 至 15% 的成長。

  • Operator

    Operator

  • Tyler Van Buren, TD Cowen.

    泰勒·範·布倫,TD·考恩。

  • Tyler Van Buren - Analyst

    Tyler Van Buren - Analyst

  • Congratulations on the good quarterly results. So for anito-cel, could the filing happen any day or in the very near future? What is left that's required for the filing? And we're excited for the data at ASH. So should the expectation be similar efficacy to [Carvykti] with improved safety?

    恭喜貴公司取得良好的季度業績。那麼,對於anito-cel公司來說,申請文件會隨時提交,還是會在不久的將來提交?提交申請還需要哪些資料?我們非常期待ASH大會上公佈的數據。那麼,我們是否可以預期它在療效上與 [Carvykti] 相似,但安全性更高?

  • Or do you believe there's still room to improve on efficacy?

    還是您認為療效方面還有進步空間?

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Tyler, we'll hand it over to Cindy to give Johanna a break.

    泰勒,我們把工作交給辛迪,讓喬安娜休息一下。

  • Cindy Perettie - Executive Vice President

    Cindy Perettie - Executive Vice President

  • So with anito-cel, we haven't communicated what our filing dates are nor will we. But what we have communicated is that we're very much looking forward to a launch second half of next year, and we're definitely on track for that. As Dan spoke to and Dietmar earlier, we will be sharing a data cut of anito-cel at ASH. And I would say we're looking forward to sharing that data with everyone in there.

    所以對於anito-cel,我們沒有公佈我們的申請日期,以後也不會公佈。但我們已經傳達的訊息是,我們非常期待明年下半年推出產品,而且我們目前正按計劃推進。正如 Dan 和 Dietmar 之前所說,我們將在 ASH 上分享 anito-cel 的資料切片。我想說,我們期待與在場的所有人分享這些數據。

  • You were asking particularly about similar efficacy and improved safety. We continue to see -- we're continuing to be impressed with the safety we're seeing similar to what we shared at EHA, and we look forward to sharing that data cut at ASH.

    您特別詢問了在保持療效的同時提高安全性的問題。我們繼續看到——我們繼續對我們在EHA上分享的類似安全情況印象深刻,我們期待在ASH上分享這些數據。

  • Operator

    Operator

  • Simon Baker, Rothschild & Co.

    西蒙貝克,羅斯柴爾德公司

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Sorry, back to Johanna after that very short break. Back on Yeztugo, I just wondered if you could give us some of your feedback on the patient and physician experience and reaction to Yeztugo. Obviously, your competitor has been suggesting a preference for their product over yours, but I've been treated to hear what you're actually experiencing on the ground.

    抱歉,短暫休息後,又回到喬安娜的故事了。回到 Yeztugo,我想問問您能否就病人和醫生對 Yeztugo 的體驗和反應給我們一些回饋。顯然,你的競爭對手一直在暗示他們更傾向於他們的產品而不是你的產品,但我很榮幸能聽到你在實際使用中的真實體驗。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Absolutely. Happy to do so. Yes, so listen, as we look at -- I think you're referring to any ISRs or any injection site reactions which is kind of normal when you have an injectable. And so that is common with any injection. Having said that, we've done a really nice job, I think, in making sure that we educated not only the HCPs but obviously, everybody in their practice to make sure that they know how to give the injection, they know how to pre and post treat basically just a short-term [ICE] helps the whole situation.

    絕對地。我很樂意這樣做。是的,所以聽著,當我們觀察——我想你指的是任何注射部位反應(ISR)或註射部位反應,這在使用注射劑時是比較正常的。所以,任何注射都會出現這種情況。話雖如此,我認為我們做得非常好,不僅確保我們教育了醫療保健專業人員,而且顯然也教育了他們診所裡的每個人,確保他們知道如何注射,知道如何進行注射前和注射後治療,基本上短期[ICE]有助於整個情況。

  • And so we've had over 7,000 HCPs that have been trained over [1,500] accounts to date with 98% satisfaction rate with their training.

    因此,到目前為止,我們已經培訓了超過 7,000 名 HCP,涵蓋了超過 1,500 個帳戶,培訓滿意度高達 98%。

  • And so this is led by our nurse educator team basically across the board, across the country, making sure we get to every single clinic. And I think that's been incredibly helpful for those that why use Yeztugo. We really believe that it just with a little bit of information, it can go a long way to make sure that patient and HCP experience is very smooth.

    因此,這項工作基本上是由我們遍布全國的護理教育團隊牽頭開展的,以確保我們能夠涵蓋每個診所。我認為這對於使用 Yeztugo 的人來說非常有幫助。我們堅信,只要掌握一點訊息,就能大大有助於確保病患和醫護人員獲得非常順暢的體驗。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    Courtney Breen,Bernstein。

  • Courtney Breen - Equity Analyst

    Courtney Breen - Equity Analyst

  • Thank you so much for taking the time for our questions today. I want to, I guess, zoom out a little bit to the White House deals and drug pricing, but particularly in the context of our HIV portfolio and higher Medicaid exposure.

    非常感謝您今天抽出時間回答我們的問題。我想稍微把目光從白宮的交易和藥品定價上移開一些,但尤其是在我們愛滋病毒防治組合和更高的醫療補助風險敞口的背景下。

  • Obviously, this year, you've dealt with the Part D redesign have grown through that. As you're looking at potential flexibility and any sort of deal with this administration on direct pricing, can you give any context kind of the scale that you're preparing for or your actions or flexibility that you're looking to Ghana in a deal that might ensure that that impact is less than what you're experiencing with the Part D redesign this year?

    顯然,今年你們經歷了D部分的重新設計,並從中成長。鑑於您正在考慮與本屆政府就直接定價達成任何形式的協議以及潛在的靈活性,您能否提供一些背景信息,說明您正在準備的規模,或者您正在採取的行動,或者您正在尋求與加納達成的協議的靈活性,以確保其影響小於您今年在D部分重新設計中遇到的影響?

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Thanks, Courtney. This is Dan. I'll take that one as well, and thank you for the question. So I think it's important to note that we continue to have really ongoing good constructive engagements with the administration, across the administration on a number of topics.

    謝謝你,考特尼。這是丹。我也選這個,謝謝你的提問。所以我認為有必要指出,我們與政府各部門就許多議題持續保持良好且富有建設性的溝通。

  • And I would say a couple of things that every meeting that I and the team are in, I think the administration has been very clear that they want the US to remain a leading innovator in the space, in the biotech pharma space. And at the same time, addressing the issues relative to US outpatient costs and having countries outside the US do more to appropriately value innovation. Those are the principles that address our conversations, and I think we're making very, very good progress.

    我想說的是,我和我的團隊參加的每一次會議,政府都非常明確地表示,他們希望美國繼續保持生物技術製藥領域的創新領先地位。同時,也要解決美國門診費用問題,並讓美國以外的國家更重視創新。這些原則貫穿我們的對話中,我認為我們取得了非常非常好的進展。

  • Relative to any Gilead-specific information, I can only point to that, that's publicly disclosed. But I would say that recently, we had -- as a part of an example of this constructive dialogue, we had an announcement with the US State Department related to PEPFAR and our partnership to bring lenacapavir to low and low- and middle-income countries.

    關於吉利德的具體信息,我只能指出那些已經公開披露的信息。但我想說,最近,作為這種建設性對話的一個例子,我們與美國國務院就 PEPFAR 以及我們為低收入和中低收入國家提供 lenacapavir 的合作發表了聲明。

  • So I think this concept of Gilead's unique role in an epidemic globally, connecting with administration objectives, whether that be national defense, whether that be any epidemics is something that I think has been very much appreciated by the administration and continues to be a cornerstone in our conversation.

    所以我認為,吉利德在全球疫情中扮演的獨特角色,與政府目標(無論是國防還是應對任何疫情)的聯繫,我認為政府對此非常重視,並且這仍然是我們討論的基石。

  • And then I was just lastly, just to remind, Courtney, things we've said in the past. But I would remind you that as we have broader conversations with the agency that -- I'm sorry, with the administration, again, the vast majority of our IP is in the United States. As such, tariffs is related to transfer pricing. It may have more of a limited impact on Gilead versus our peers. We recognize more than 80% of our IP in the United States, 90% of our taxes are paid here.

    最後,我只是想提醒考特尼,我們過去說過的一些話。但我要提醒各位,當我們與該機構——抱歉,是與政府——進行更廣泛的對話時,再次強調,我們絕大多數的智慧財產權都在美國。因此,關稅與轉移定價相關。與同行相比,它對吉利德的影響可能較為有限。我們80%以上的智慧財產權都在美國,90%的稅金都在美國繳納。

  • We have a strong footprint in the United States. We have almost 100% of our R&D capital infrastructure here. We've committed to significant additional investments in the United States of the magnitude of $32 billion.

    我們在美國擁有強大的業務基礎。我們幾乎100%的研發資本基礎設施都位於此。我們已承諾在美國追加巨額投資,總額達 320 億美元。

  • So these conversations are wide, and I think that we will continue to update you as we have different announcements just like we did with the State Department. But I'd say we feel very good about the constructive nature of them and where they're going.

    所以這些討論範圍很廣,我認為我們會像之前向國務院報告那樣,在發布不同公告時繼續向大家通報最新情況。但我認為我們對它們的建設性性質和發展方向感到非常滿意。

  • Operator

    Operator

  • Joseph Stringer, Needham.

    約瑟夫·斯特林格,尼德姆。

  • Joseph Stringer - Analyst

    Joseph Stringer - Analyst

  • Question on Hepcludex or HDV. You put a lot of effort into getting that resubmitted since the CRL. So I guess, one, what gives you confidence that you'll get approval from FDA this time around? And two, what do you think the market opportunity for the drug and is an HDV just keeping in mind that there are two competitors in Phase 3 development?

    關於Hepcludex或HDV的問題。自 CRL 以來,你為重新提交該申請付出了很多努力。所以我想問,第一,是什麼讓你有信心這次能獲得FDA的批准?第二,您認為這種藥物的市場機會如何?考慮到目前還有兩款同類藥物處於 3 期研發階段,您認為它是否屬於 HDV 類藥物?

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Great. So we'll start with Dietmar. Welcome, Dietmar.

    偉大的。那我們就從迪特馬爾開始吧。歡迎你,迪特瑪。

  • Dietmar Berger - Chief Medical Officer

    Dietmar Berger - Chief Medical Officer

  • And another quick break. Yes, so thank you for the question. I mean, we're not, of course, commenting in depth on the regulatory strategy but different factors give us confidence. When we have additional data with regards to how is the medicine injected, what's the experience also that patients would have with the injection. And also, we have really the experience from Europe where the drug is used now for some time, and that gives us additional data from the real-world setting that we can also utilize.

    再休息一會兒。是的,謝謝你的提問。我的意思是,我們當然不會深入評論監管策略,但不同的因素讓我們充滿信心。當我們獲得更多關於藥物注射方式以及患者註射體驗的數據時,我們就能更了解情況。此外,我們在歐洲也累積了豐富的經驗,這種藥物已經在歐洲使用了一段時間,這為我們提供了來自真實世界環境的額外數據,我們也可以利用這些數據。

  • So overall, these additional data sets, plus then further work on the filing for the US gives us the confidence that we can move forward here.

    總的來說,這些額外的數據集,加上進一步向美國提交申請的工作,讓我們有信心繼續推進這項工作。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • So maybe I'll just close and talk about the market opportunity. It kind of goes back to the comment that was made earlier about the strategic fit with Livdelzi and how perfect it is. This is kind of the same with Hepcludex. This is -- obviously, these are people that have hepatitis B and it's a very small percentage. It is rare disease.

    所以,我可能就此結束,談談市場機會吧。這其實又回到了先前關於利夫德爾齊的策略契合度以及這種契合度多麼完美的評論。Hepcludex的情況也類似。顯然,這些人患有B型肝炎,而且比例非常小。這是一種罕見疾病。

  • Small percentage of these hep-B patients have also hep-D, but much unfortunately worse we're seeing with liver cirrhosis and potentially even liver cancers and [death]. And so therefore, important to get to these patients as quickly as possible.

    這些B肝患者中只有一小部分同時患有丁肝,但更令人遺憾的是,我們看到更多患者患有肝硬化,甚至可能患有肝癌。[死亡]。因此,盡快趕到這些患者身邊至關重要。

  • And so we do believe that because of our footprint in hep-B, it's a really good fit for us to make a difference for these patients across the board. So much smaller, but again, a little change in our footprint overall. So I think that's why we think Hepcludex is important, let alone the unmet need that is out there, as there is nothing else out there today.

    因此我們相信,由於我們在乙肝領域擁有一定的影響力,我們完全有能力為所有患者帶來改變。雖然規模小了許多,但整體而言,我們的足跡還是略有變化。所以我覺得這就是我們認為 Hepcludex 很重要的原因,更不用說它滿足了目前市場上尚未滿足的需求,因為目前市場上還沒有其他同類產品。

  • Jacquie Ross - Senior Vice President - Treasury and Investor Relations

    Jacquie Ross - Senior Vice President - Treasury and Investor Relations

  • 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

  • Terrific. So let me, first of all, thank all of you for joining today. We really appreciate your interest and time. I also would be remiss not to thank the Gilead team for another great quarter in our growth journey here.

    了不起。首先,我要感謝各位今天到場。我們非常感謝您的關注和時間。我還要感謝吉利德團隊,感謝他們為我們公司的發展歷程又帶來了一個精彩的季度。

  • And as you've seen, I just want to point this out, strong commercial and clinical execution along with disciplined expense management, in a consistent way quarter to quarter is what you have seen from us and what you should continue to expect from us. So we believe we're very well positioned as we go into 2026 not only with the current and upcoming product launches that we have today, (inaudible) spoke about a lot today, but also the strong clinical pipeline.

    正如你們所看到的,我只想指出一點,我們一直以來都以強勁的商業和臨床執行力以及嚴格的費用管理,每個季度都保持穩定,這也是你們應該繼續期待我們做到的。因此,我們相信,展望 2026 年,我們不僅擁有目前和即將推出的產品(今天我們談到了很多),而且擁有強大的臨床研發管線,因此我們處於非常有利的地位。

  • And I just want to point out, we have some important readouts coming up in oncology and HIV in this quarter and into next year. And I just would remind you again that really, we're in a relatively unique position with no patent expiries before 2036.

    我還要指出,本季以及明年,我們在腫瘤學和愛滋病領域有一些重要的數據公佈。我還要再次提醒各位,實際上,我們處於一個相對獨特的地位,因為在 2036 年之前沒有任何專利到期。

  • So for that, I'd like to again thank you for your time today. Jacquie and team, as usual, are here to follow up with you on any of the questions that you have. Please don't hesitate to reach out, and I wish you all a good rest of your day. Thank you.

    因此,我再次感謝您今天抽出時間。Jacquie 和她的團隊一如既往地隨時準備解答您的任何問題。如有任何疑問,請隨時與我聯繫,並祝大家今天餘下的時間過得愉快。謝謝。