吉利德科學 (GILD) 2023 Q3 法說會逐字稿

Hello, everyone, and welcome to the Third Quarter 2023 Gilead Sciences Earnings Conference Call. My name is Nadia, and I'll be coordinating the call today. (Operator Instructions)

大家好，歡迎參加吉利德科學公司2023年第三季財報電話會議。我是Nadia，今天將由我主持這次電話會議。 （操作說明）

I will now hand over to your host, Jacquie Ross, Vice President of Investor Relations to begin. Jacquie, please go ahead.

現在我將把發言權交給主持人，投資者關係副總裁傑奎·羅斯，請她開始。杰奎，請開始吧。

Thank you, and good afternoon, everyone.

謝謝大家，大家下午好。

Just after market close today, we issued a press release with earnings results for the third quarter of 2023. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com.

今天股市收盤後不久，我們發布了2023年第三季獲利報告。新聞稿、投影片和補充資料可在我們網站gilead.com的投資人關係欄位中查閱。

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, Merdad Parsey; 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 (Daniel O'Day)；首席商務官喬安娜·默西埃 (Johanna Mercier)；首席醫療官默達德·帕西 (Merdad Parsey)；以及首席財務官安德魯·迪金森 (Andrew Dickinson)。之後，我們將進入問答環節，屆時Kite執行副總裁辛迪佩雷蒂 (Cindy Perettie) 也將加入。

Before we get started, let me remind you that we will be making forward-looking statements, including those related to Gilead's business, financial condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital and 2023 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

在正式開始之前，請允許我提醒各位，我們將做出一些前瞻性陳述，包括與吉利德的業務、財務狀況和經營業績、產品計劃和預期、候選產品、公司策略、業務和營運、財務預測和資本運用以及2023年財務指引相關的陳述。所有這些陳述都涉及某些我們無法控制的假設、風險和不確定性，這些因素可能導致實際結果與這些陳述有重大差異。有關這些風險的描述，請參閱獲利新聞稿和我們最新的美國證券交易委員會（SEC）揭露文件。所有前瞻性陳述均基於吉利德目前可獲得的信息，吉利德不承擔更新任何此類前瞻性陳述的義務。

Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet as well as on the Gilead website.

我們將使用非公認會計準則（Non-GAAP）財務指標來幫助您了解公司的基本業務表現。公認會計準則（GAAP）與非公認會計準則（Non-GAAP）的調節表已在獲利新聞稿、補充資料表以及吉利德公司網站上提供。

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

接下來，我會把電話交給丹。

Thank you, Jacquie, and good afternoon, everyone.

謝謝你，杰奎琳，大家下午好。

I'm pleased to share that Gilead teams have delivered another strong quarter that rounds out 2 years of continuous growth for our base business. Our track record of commercial execution continued in the third quarter with our base business up 5% compared to the third quarter of 2022 and up 10% year-over-year for the first 9 months of 2023.

我很高興地宣布，吉利德團隊又取得了一個強勁的季度業績，為我們基礎業務連續兩年的成長畫上了圓滿的句號。我們在商業執行方面的良好記錄在第三季度得以延續，基礎業務較2022年第三季度增長5%，2023年前9個月同比增長10%。

In the third quarter, our growth was driven by our leading therapies across Virology and Oncology. Biktarvy had another very strong quarter, up 12% from the same quarter in 2022 and contributing to 9% growth overall in HIV in the first 9 months of 2023. Oncology is also driving growth and was up 33% in the third quarter compared to last year. Revenue is now annualizing at more than $3 billion with growing adoption of Trodelvy, the only approved TROP2-directed ADC and our industry-leading cell therapies.

第三季度，病毒學和腫瘤學領域的領先療法推動了我們的成長。 Biktarvy 再次表現強勁，較 2022 年同期成長 12%，並協助 2023 年前 9 個月 HIV 業務整體成長 9%。腫瘤學領域也實現了成長，第三季較去年同期成長 33%。隨著唯一獲準的 TROP2 標靶抗體偶聯藥物 Trodelvy 以及我們業界領先的細胞療法的應用不斷拓展，該公司年收入已超過 30 億美元。

This was also another very good quarter for clinical execution as we continued to advance our 60 clinical programs across virology, oncology and inflammation. Some of the highlights for the quarter included the European Commission approval of Trodelvy for pretreated hormone receptor positive HER2-negative metastatic breast cancer, allowing us to extend Trodelvy's reach to many more patients globally. The first data for Trodelvy in combination with pembro for first-line metastatic non-small cell lung cancer presented at World Lung. Our Phase II EVOKE-02 trial showed a strong objective response rate in the PD-L1 high cohort, which supports proof-of-concept for our ongoing Phase III EVOKE-03 trial.

本季在臨床執行方面也取得了顯著成效，我們在病毒學、腫瘤學和發炎領域持續推進60個臨床計畫。本季亮點包括：Trodelvy獲得歐盟委員會批准用於治療先前接受過治療的荷爾蒙受體陽性、HER2陰性轉移性乳癌，使Trodelvy能夠惠及全球更多患者。 Trodelvy合併帕博利珠單抗第一線治療轉移性非小細胞肺癌的首批數據已在世界肺病大會上發表。我們的II期EVOKE-02試驗在PD-L1高表達組中顯示出較高的客觀緩解率，為正在進行的III期EVOKE-03試驗提供了概念驗證支持。

Important new data at ESMO for Trodelvy's Phase II TROPiCS-03 basket trial in our small cell lung cancer and head and neck squamous cell carcinoma cohorts. All of these milestones reinforce our conviction in Trodelvy as our cornerstone oncology asset with pan tumor potential.

在ESMO大會上，我們發表了Trodelvy在小細胞肺癌和頭頸部鱗狀細胞癌隊列中開展的II期TROPiCS-03籃式試驗的重要新數據。所有這些里程碑事件都進一步鞏固了我們對Trodelvy作為我們具有泛腫瘤治療潛力的腫瘤核心資產的信心。

Staying with oncology. Today, we presented positive data from our Phase II EDGE-Gastric trial in partnership with Arcus, which further establishes proof of concept for the ongoing Phase III STAR-221 trial in first-line metastatic upper GI cancers.

繼續關注腫瘤學。今天，我們公佈了與 Arcus 合作進行的 II 期 EDGE-Gastric 試驗的積極數據，這進一步證實了正在進行的 III 期 STAR-221 試驗（一線治療轉移性上消化道癌症）的概念。

Additionally, we're encouraged by the continued strong data emerging from the ongoing Phase I study of CART-ddBCMA in multiple myeloma. Together with our partner, Arcellx, we look forward to providing even more data during next month's ASH conference.

此外，我們對正在進行的 CART-ddBCMA 治療多發性骨髓瘤的 I 期研究持續取得的強勁數據感到鼓舞。我們期待與合作夥伴 Arcellx 在下個月的 ASH 大會上公佈更多數據。

The clinical momentum continues in virology. In HIV treatment, we reviewed promising data from the Phase I study of GS-1720 or once-weekly long-acting oral integration inhibitor to be combined with lenacapavir and Phase II ARTISTRY-I trial evaluating a once-daily oral lenacapavir and bictegravir combination. We expect to share the data with you at a medical conference in early 2024.

病毒學領域的臨床進展勢頭強勁。在HIV治療方面，我們回顧了GS-1720（一種每週一次的長效口服整合抑制劑）聯合來那卡帕韋的I期研究的令人鼓舞的數據，以及評估每日一次口服來那卡帕韋聯合比克替拉韋的II期ARTISTRY-I試驗的數據。我們預計將於2024年初的醫學會議上與您分享這些數據。

In HIV prevention, we completed enrollment ahead of schedule in our Phase III PURPOSE-I trial, investigating once every 6-month lenacapavir subcutaneous injection and announced plans to initiate the Phase II PURPOSE 5 trial in 2024 to support access in Europe. In COVID-19, we completed enrollment in our Phase III OAKTREE trial evaluating obeldesivir in standard-risk nonhospitalized COVID-19 patients. We look forward to providing an update early next year.

在愛滋病預防領域，我們提前完成了 III 期 PURPOSE-I 試驗的患者招募工作，該試驗旨在研究每 6 個月皮下注射一次來那卡帕韋的療效。同時，我們宣布計劃於 2024 年啟動 II 期 PURPOSE 5 試驗，以支持歐洲地區的用藥。在新冠肺炎領域，我們完成了 III 期 OAKTREE 試驗的患者招募工作，該試驗旨在評估奧貝地西韋在標準風險非住院新冠肺炎患者中的療效。我們期待在明年初發布最新進展。

Veklury remains an important therapeutic option for hospitalized patients with COVID-19. We recently received approvals from both the FDA and the European Commission to extend use of Veklury in patients with mild to severe hepatic impairment. Looking at our pipeline overall, our aggregate progress in 2023 is such that we have already completed most of the milestone events as shown on Slide 6. Our clinical pipeline now includes 27 programs in Phase II and 19 in Phase III. We are looking forward to a busy period of updates from many of these studies in 2024 including those evaluating lenacapavir, Trodelvy and obeldesivir.

Veklury 仍然是 COVID-19 住院患者的重要治療選擇。我們近期已獲得美國 FDA 和歐盟委員會的批准，可將 Veklury 的使用範圍擴大至輕度至重度肝功能損害患者。縱觀我們的整體研發管線，2023 年的整體進展表明，我們已經完成了大部分里程碑事件（如幻燈片 6 所示）。目前，我們的臨床研發管線包括 27 個處於 II 期臨床試驗階段的項目和 19 個處於 III 期臨床試驗階段的項目。我們期待在 2024 年公佈其中許多研究的最新進展，包括評估 lenacapavir、Trodelvy 和 obeldesivir 的研究。

In summary, it's been another strong quarter of commercial and clinical execution, resulting in an important progress for Gilead and the people and communities we aim to serve.

總而言之，本季在商業和臨床執行方面又取得了強勁的進展，為吉利德以及我們旨在服務的民眾和社區帶來了重要的進步。

With that, I'll hand the call over to Johanna to cover our commercial results. Johanna?

那麼，我把電話交給喬安娜，讓她來報告我們的商業表現。喬安娜？

Thanks, Dan, and good afternoon, everyone.

謝謝你，丹，大家下午好。

I'm pleased to share the details of another strong quarter for Gilead and would like to thank the teams that have delivered 10% growth in our base business in the first 9 months of 2023.

我很高興與大家分享吉利德又一個強勁季度的詳細情況，並感謝團隊在 2023 年前 9 個月實現了我們基礎業務 10% 的成長。

Our third quarter results represent the eighth consecutive quarter of year-over-year growth in our base business, illustrated strong commercial execution and revenue growth as our virology and oncology products impact more patient lives. In the third quarter of 2023, total product sales, excluding Veklury, were up 5% to $6.4 billion as shown on Slide 8, with notable growth in our oncology and HIV businesses partially offset by lower HCV sales.

我們第三季的業績標誌著我們基礎業務連續第八個季度實現同比增長，這體現了我們強勁的商業執行力和收入增長，我們的病毒學和腫瘤學產品正在惠及更多患者。如幻燈片8所示，2023年第三季度，不包括Veklury在內的產品總銷售額增長5%至64億美元，其中腫瘤學和HIV業務的顯著增長被HCV銷售額的下降部分抵消。

Total product sales including Veklury, were $7 billion with a solid base business performance contributing $305 million of growth offset - as we expected - by lower Veklury sales compared to the same quarter last year.

包括 Veklury 在內的產品總銷售額為 70 億美元，穩健的業務表現貢獻了 3.05 億美元的成長，但正如我們預期的那樣，Veklury 的銷售額比去年同期有所下降，抵消了這一增長。

Moving to HIV on Slide 9. The treatment market continued to grow in line with our expectations of 2% to 3% annually. And as we've discussed previously, the favorable pricing dynamics in recent quarters have begun to normalize, with HIV sales growth more closely mirroring market and demand growth. This was evident in the third quarter where HIV sales were up 4% year-over-year to $4.7 billion, driven by higher treatment and prevention demand and higher channel inventory, partially offset by lower average realized price due to a shift in channel mix. Sequentially, sales were up 1%. Looking to the full year, we continue to expect HIV product sales to grow slightly more than the 5% reported in 2022.

投影片9：愛滋病治療市場持續成長，符合我們先前2%至3%的年增長率預期。正如我們之前討論過的，近幾季有利的定價策略已開始趨於正常化，愛滋病產品銷售成長與市場和需求成長的匹配度更高。第三季的情況尤其明顯，愛滋病產品銷售額年增4%至47億美元，主要得益於治療和預防需求的成長以及通路庫存的增加，但部分被通路組合變化導致的平均實際售價下降所抵消。環比來看，銷售額成長了1%。展望全年，我們仍預期愛滋病產品銷售額的成長將略高於2022年報告的5%。

Turning to Slide 10. Third quarter Biktarvy sales were $3.1 billion, up 12% year-over-year, driven by higher demand as well as higher channel inventory. Sequentially, sales were up 4%. Once again, Biktarvy gained market share up over 2% year-over-year in the U.S. to over 47% share in the third quarter. Thanks to its robust clinical profile, Biktarvy remains the #1 prescribed regimen for new starts and #1 in treatment switches across most major markets, including the U.S.

請參閱第10張投影片。第三季Biktarvy的銷售額為31億美元，年增12%，主要得益於需求成長和通路庫存增加。季增4%。 Biktarvy在美國的市佔率再次較去年同期成長超過2%，第三季市佔率超過47%。憑藉其強大的臨床療效，Biktarvy仍然是大多數主要市場（包括美國）新患者首選的治療方案，也是治療方案轉換的首選。

Descovy sales in the third quarter were $511 million, up 2% year-over-year, with strong year-over-year growth in demand for Descovy for PrEP, offset by less favorable pricing dynamics to ensure broad access ahead of the potential launch of lenacapavir as early as late 2025. The U.S. PrEP market grew about 15% year-over-year and Descovy for PrEP continues to maintain more than 40% market share due to its strong clinical profile and despite the availability of other regimens, including generics.

第三季度，Descovy的銷售額為5.11億美元，年增2%。 Descovy用於PrEP的需求年增長強勁，但為確保在lenacapavir最早於2025年底上市前實現廣泛供應，其定價策略略顯不利，部分抵消了這一增長。美國PrEP市場年增約15%，Descovy用於PrEP的市佔率持續維持在40%以上，這得益於其強大的臨床療效，且儘管有其他治療方案（包括仿製藥），Descovy仍保持著這一份額。

Moving to the liver disease portfolio on Slide 11. Sales were down 10% year-over-year to $706 million, primarily due to the resolution of a rebate claim in HCV recognized in the third quarter of 2022 as well as other pricing dynamics. From a demand perspective, HCV new starts increased compared to the third quarter of 2022 in both the U.S. and Europe, driven by our continued efforts to link HCV patients to care. Given the curative nature of our treatment, we expect HCV new starts to trend down over time, but are pleased that we are maintaining 50% to 60% market share in the U.S. and Europe and that our liver portfolio more broadly has stabilized from a revenue perspective.

幻燈片11展示了肝病產品組合的情形。銷售額年減10%至7.06億美元，主要原因是2022年第三季確認的丙型肝炎（HCV）回扣索賠的解決以及其他定價因素。從需求角度來看，與2022年第三季相比，美國和歐洲的丙型肝炎新發病例均有所增加，這得益於我們持續努力將丙型肝炎患者與治療聯繫起來。鑑於我們療法的治癒性，我們預計丙型肝炎新發病例將隨著時間的推移而呈下降趨勢，但我們很高興在美國和歐洲保持了50%至60%的市場份額，並且從整體上看，我們的肝病產品組合的收入也趨於穩定。

On to Slide 12, Veklury sales continue to be highly variable and declined 31% year-over-year in the third quarter to $636 million. On a quarter-over-quarter basis, sales were up 149%, driven by an uptick in hospitalizations during the third quarter. And over the last few weeks, we have seen a slowdown in COVID-related hospitalization. Veklury's strong clinical profile continues to be recognized, most recently by the FDA and the European Commission for use in patients with mild to severe hepatic impairment. While the COVID environment remains ever-changing, Veklury's performance in the third quarter further reinforces its established role as a key part of the standard of care for patients hospitalized with COVID-19.

翻到第12張投影片，Veklury的銷售額依然波動較大，第三季較去年同期下降31%至6.36億美元。環比來看，銷售額增加了149%，主要得益於第三季住院人數的增加。而過去幾週，我們觀察到與新冠肺炎相關的住院人數有所下降。 Veklury的卓越臨床療效持續獲得認可，最近美國食品藥物管理局（FDA）和歐盟委員會批准其用於治療輕度至重度肝功能損害患者。儘管新冠疫情情勢瞬息萬變，但Veklury在第三季的表現進一步鞏固了其作為新冠肺炎住院患者標準治療方案關鍵組成部分的地位。

Moving to Slide 13. Our oncology business achieved another strong quarter, with sales up 33% year-over-year to $769 million, representing an annual run rate that now exceeds $3 billion. With clear momentum and a solid infrastructure in place, in addition to our compelling clinical pipeline, we look forward to providing more patients with potentially new and effective options.

翻到第13頁。我們的腫瘤業務又迎來了一個強勁的季度，銷售額年增33%至7.69億美元，年化銷售額現已超過30億美元。憑藉著清晰的發展動能、穩固的基礎設施以及極具吸引力的臨床研發管線，我們期待為更多患者提供潛在的全新有效治療方案。

Looking at Trodelvy on Slide 14. Sales were up 58% year-over-year and 9% sequentially to $283 million. As a reminder, Trodelvy is the only approved TROP2-directed antibody drug conjugate. And to date, we have delivered this therapy to more than 20,000 patients, reinforcing the clinically meaningful benefit Trodelvy can provide across multiple tumor types.

請看第14張投影片中的Trodelvy。其銷售額年增58%，季增9%，達到2.83億美元。需要指出的是，Trodelvy是目前唯一核准的標靶TROP2的抗體藥物偶聯物。迄今為止，我們已為超過2萬名患者提供了這種療法，這進一步證實了Trodelvy在多種腫瘤類型中具有顯著的臨床療效。

Trodelvy remains the leading regimen in second-line metastatic triple-negative breast cancer across both the U.S. and Europe. In pretreated HR-positive, HER2-negative metastatic breast cancer, Trodelvy is showing particular strength in the IHC0 setting and as a later line treatment in the HER2 low setting consistent with expectations. Altogether, these dynamics reflect the notable work the team has done to raise awareness in both indications as well as the strength of Trodelvy's clinical profile.

在美國和歐洲，Trodelvy 仍然是第二線轉移性三陰性乳癌的首選治療方案。在先前接受過治療的 HR 陽性、HER2 陰性轉移性乳癌中，Trodelvy 在 IHC0 患者中表現出特別的優勢，並且在 HER2 低表達患者的後續治療中也展現出與預期相符的療效。總而言之，這些進展反映了該團隊在提高大眾對這兩種適應症的認知度方面所做的顯著工作，以及 Trodelvy 強大的臨床療效。

Turning to Slide 15, and on behalf of Cindy and the Kite team. Cell Therapy sales in the third quarter were $486 million, up 22% year-over-year and 4% quarter-over-quarter, reflecting strong demand with particular strength outside the U.S. in the third quarter. Yescarta sales grew 23% year-over-year to $391 million, primarily driven by strong growth ex U.S. in second and third-line relapsed or refractory large B-cell lymphoma. Tecartus sales were $96 million, up 18% year-over-year, reflecting increased demand in both the U.S. and Europe for relapsed or refractory mantle cell lymphoma as well as adult acute lymphoblastic leukemia.

翻到第15頁投影片，我謹代表Cindy和Kite團隊報告：第三季細胞療法銷售額為4.86億美元，年成長22%，季增4%，反映出強勁的需求，尤其是在美國以外地區。 Yescarta銷售額年增23%至3.91億美元，主要得益於美國以外地區在二線和第三線復發或難治性大B細胞淋巴瘤治療方面的強勁增長。 Tecartus銷售額為9,600萬美元，年成長18%，反映出美國和歐洲在復發或難治性套細胞淋巴瘤以及成人急性淋巴性白血病治療的需求增加。

Given the strong clinical data, it's surprising that only about 10% of eligible second-line large B-cell lymphoma patients in the U.S. are treated with the Cell therapy, and it is clear that there is still a significant opportunity to drive adoption. As cell therapies are offered and delivered to more and more patients, we are confident that Kite remains well positioned to benefit from this expansion with its differentiated overall survival data for Yescarta and industry-leading manufacturing capabilities.

鑑於強有力的臨床數據，令人驚訝的是，美國僅有約10%符合條件的二線大B細胞淋巴瘤患者接受了細胞療法治療，顯然，該療法的普及應用仍有巨大的提升空間。隨著越來越多的患者接受細胞療法，我們相信，憑藉Yescarta顯著的總體生存期數據和行業領先的生產能力，Kite將繼續保持優勢，從這一市場擴張中獲益。

We understand the importance of delivering these potentially curative medicines as quickly as possible to patients with severe and challenging diseases. And to that end, we continue to identify opportunities to bring our therapies to patients faster and are actively working on initiatives to shorten even further our industry-leading 16-day medium turnaround time in the U.S.

我們深知盡快將這些可能具有治癒作用的藥物送到患有嚴重困難疾病的患者手中至關重要。為此，我們不斷尋找機會，加快將療法帶給患者，並積極推進各項舉措，以進一步縮短我們在美國業內領先的16天平均週轉時間。

Wrapping up the third quarter, I'd like to recognize the strong execution of commercial teams and our cross functional partners across Gilead and Kite. Thanks to their efforts, our therapies are positively impacting more and more people, driven by growing market share and expanding reach as we bring our therapies to new geographies around the world.

第三季即將結束，我要特別感謝吉利德和凱特公司各業務團隊以及跨職能合作夥伴的出色執行力。正因為有了他們的努力，隨著市場份額的增長和業務範圍的擴大，我們的療法正在惠及越來越多的患者，並將我們的療法推廣到世界各地的新地區。

And with that, I will hand the call over to Merdad for an update on our pipeline.

接下來，我將把電話交給梅爾達德，讓他報告我們管道的最新進展。

Thank you, Johanna.

謝謝你，喬安娜。

The clinical highlight of our third quarter was the release of our promising Phase II data for Trodelvy in combination with pembrolizumab in first-line metastatic non-small cell lung cancer, highlighting Trodelvy's potential to bring a much-needed treatment alternative for patients. More broadly, we continue to progress our increasingly diverse pipeline of 60 ongoing clinical programs, spanning virology, oncology and inflammation.

第三季臨床亮點是發布了Trodelvy合併帕博利珠單抗第一線治療轉移性非小細胞肺癌的II期臨床試驗數據，這些數據令人鼓舞，凸顯了Trodelvy有望為患者帶來亟需的治療選擇。更廣泛地說，我們持續推動日益多元化的研發管線，目前共有60個在研臨床項目，涵蓋病毒學、腫瘤學和發炎等領域。

Starting with our virology programs on Slide 17, we have 10 clinical programs with our long-acting capsid inhibitor, lenacapavir including 2 Phase III studies underway in PrEP. I'm pleased to share that we have completed enrollment earlier than anticipated for our Phase III PURPOSE-I trial, evaluating lenacapavir for prevention in adolescent girls and young women. Our Phase III PURPOSE-II trial in cis-man and transwomen and men and non-binary people continues to enroll well, and we could have an opportunity to share data from one or both PURPOSE trials in late 2024 ahead of schedule. We are targeting our first approval for lenacapavir in prevention in late 2025 potentially making lenacapavir the first 6 monthly dosing regimen available for PrEP.

從幻燈片17所示的病毒學計畫開始，我們有10個臨床計畫正在進行，研究長效衣殼抑制劑lenacapavir，其中包括兩項正在進行的PrEP III期研究。我很高興地宣布，我們評估lenacapavir用於預防青少年女孩和年輕女性感染的III期PURPOSE-I試驗已提前完成受試者招募。我們針對順性別男性、跨性別女性、男性和非二元性別者的III期PURPOSE-II試驗的受試者招募工作進展順利，我們預計在2024年底提前公佈一項或兩項PURPOSE試驗的數據。我們計劃在2025年底獲得lenacapavir用於預防感染的首個批准，屆時lenacapavir有望成為第一個可用於PrEP的每6個月給藥方案。

Turning to treatment, we continue to make strong progress on evaluating 9 candidate partners for lenacapavir. Of the remaining candidates, 6 are already in Phase 1 or 2. We expect to share updates on at least 4 of these in 2024, including data from our Phase I trial of GS-1720, our once-weekly long-acting oral integrase inhibitor to be combined with lenacapavir. And from our Phase II ARTISTRY-I trial, evaluating a once-daily oral combination of lenacapavir and bictegravir for biologically suppressed treatment-experienced people living with HIV. We plan to share results from both trials at a conference in early 2024, and we look forward to advancing these programs into the next phase of development. We're also pleased to share the enrollment for our Phase II program evaluating our lenacapavir+bNAbs combination dosed every 6 months is progressing very well and is another program we expect to update you on next year.

在治療方面，我們持續推進對9種與lenacapavir合併用藥候選藥物的評估工作，並取得了顯著進展。其餘候選藥物中，有6種進入I期或II期臨床試驗。我們預計將在2024年分享其中至少4種藥物的最新進展，包括GS-1720（一種每週一次的長效口服整合酶抑制劑，將與lenacapavir聯合使用）的I期臨床試驗數據，以及評估lenacapavir和bictegravir每日一次口服聯合用藥方案在生物抑制的、既往接受過治療的HIV感染者中的療效的HIVRY-IART42227222222年接受治療的HIV-IART。我們計劃在2024年初的會議上分享這兩項試驗的結果，並期待推動這些項目進入下一階段的研發。此外，我們很高興地宣布，評估lenacapavir+廣譜中和抗體（bNAbs）聯合用藥方案（每6個月給藥一次）的II期臨床試驗項目進展順利，我們也計劃在明年向您匯報該項目的最新進展。

Putting this all together, our data continues to support our confidence that lenacapavir has the potential to transform HIV treatment and prevention globally.

綜上所述，我們的數據繼續支持我們的信心，即 lenacapavir 有潛力改變全球 HIV 的治療和預防。

Turning to oncology on Slide 18, to date, Trodelvy has been delivered to more than 20,000 patients across 3 approved indications since our launch 3 years ago. Trodelvy remains the first and only marketed TROP-2 antibody-drug conjugate to achieve meaningful overall survival benefit in 2 of its indications. With that said, we're seeing both growing real-world evidence and clinical trial data supporting not only the approach we're taking for Trodelvy's clinical developments across tumor types, but also Trodelvy's unique ADC construct. In particular, Trodelvy is the only ADC to have a high 7-to-8 drug-to-antibody ratio that is able to deliver a highly potent SN-38 payload directly into the tumor microenvironment through its hydrolyzable linker.

在第18張投影片中，我們轉向腫瘤學領域。自三年前上市以來，Trodelvy已在三個核准適應症中用於治療超過20,000名患者。 Trodelvy仍然是第一個也是目前唯一一個在兩個適應症中實現顯著總生存期獲益的上市TROP-2抗體藥物偶聯物。此外，我們看到越來越多的真實世界證據和臨床試驗數據不僅支持我們針對Trodelvy在不同腫瘤類型中所進行的臨床開發策略，也支持Trodelvy獨特的ADC結構。尤其值得一提的是，Trodelvy是唯一藥物與抗體比例高達7:8的ADC，它能夠透過其可水解連接子將高效的SN-38有效載荷直接遞送至腫瘤微環境。

As a result, in our studies to date, Trodelvy has shown a potentially differentiated safety profile with regards to ILD and stomatitis. We look forward to sharing more emerging Trodelvy data in 2024 as we continue to expand Trodelvy across tumor types and lines of therapy.

因此，在我們迄今為止的研究中，Trodelvy 在間質性肺病和口腔炎方面展現出潛在的差異化安全性。隨著我們繼續拓展 Trodelvy 在不同腫瘤類型和治療方案中的應用，我們期待在 2024 年分享更多 Trodelvy 的最新數據。

Our comprehensive clinical development program for Trodelvy consists of more than 30 active or planned clinical trials across 8 tumor types. In 2023, we've shared several data sets demonstrating clear signals of activity for Trodelvy across several indications. For example, in the ASCO meeting, this past June, we presented data for Trodelvy that demonstrated encouraging preliminary ORR and PFS data in relapsed or refractory endometrial cancer patients in the Phase II TROPiCS-03 basket trial.

我們針對Trodelvy所進行的全面臨床開發項目包括30多項正在進行或計畫中的臨床試驗，涵蓋8種腫瘤類型。 2023年，我們分享了多項數據，這些數據清楚地顯示了Trodelvy在多種適應症中的療效。例如，在今年6月的ASCO年會上，我們展示了Trodelvy的數據，這些數據表明，在II期TROPiCS-03籃式試驗中，Trodelvy在復發或難治性子宮內膜癌患者中取得了令人鼓舞的初步客觀緩解率（ORR）和無進展生存期（PFS）數據。

More recently, at the ESMO meeting, we presented additional early data from TROPiCS-03, showing promising ORR in both relapsed or refractory head and neck squamous cell carcinoma and previously treated extensive-stage small cell lung cancer.

最近，在 ESMO 會議上，我們展示了 TROPiCS-03 的更多早期數據，結果顯示，對於復發或難治性頭頸部鱗狀細胞癌和先前接受過治療的廣泛期小細胞肺癌，ORR 均有良好的療效。

We reported strong data from EVOKE-02 at World Lung in September shown on Slide 19, establishing clear proof of concept for Trodelvy plus pembro in first-line metastatic non-small cell lung cancer. In the PD-L1 high cohort, Trodelvy plus pembro demonstrated an ORR of 69%, including unconfirmed responses. This compares favorably to the historical pembro monotherapy benchmark with response rates of 45% and 39% in KEYNOTE-024 and KEYNOTE-042, respectively. As a reminder, we are currently enrolling patients with first-line PD-L1high metastatic non-small cell lung cancer in our registrational Phase III EVOKE-03 study. Preliminary data from the PD-L1 TPS less than 50% cohort has also been encouraging, demonstrating an ORR of 44%, similar to previous trials that evaluated pembro plus chemotherapy.

我們在9月的世界肺癌大會上發表了EVOKE-02研究的強大數據（見投影片19），該研究明確驗證了Trodelvy合併帕博利珠單抗一線治療轉移性非小細胞肺癌的療效。在PD-L1高表達隊列中，Trodelvy聯合帕博利珠單抗的客觀緩解率（ORR）為69%，其中包括未確認的緩解。此結果優於既往帕博利珠單抗單藥治療的基準，KEYNOTE-024和KEYNOTE-042研究中帕博利珠單抗的ORR分別為45%和39%。值得一提的是，我們目前正在招募第一線PD-L1高表達轉移性非小細胞肺癌患者參與註冊性III期研究EVOKE-03。 PD-L1 TPS低於50%隊列的初步數據也令人鼓舞，ORR為44%，與先前評估帕博利珠單抗合併化療的試驗結果相似。

These results inform our plans to expand into broader first-line non-small cell lung cancer patient populations across all PD-L1 expression levels. We're looking forward to sharing further analysis from EVOKE-02 that will highlight the efficacy of Trodelvy and pembro across both squamous and non-squamous histologies in first-line metastatic non-small cell lung cancer patients.

這些結果為我們制定計劃提供了依據，即擴大一線非小細胞肺癌患者人群的範圍，涵蓋所有PD-L1表達量。我們期待分享EVOKE-02研究的進一步分析結果，該分析將重點展示Trodelvy和pembro在轉移性非小細胞肺癌一線治療中，無論鱗狀細胞癌或非鱗狀細胞癌的療效。

Moving to our TIGIT program on Slide 20, an initial update of 1 arm of the Phase II EDGE-Gastric study was presented in an ASCO plenary session earlier today. The study found that the addition of dom and zim to a FOLFOX chemo regimen showed an encouraging 77% 6-month PFS and 59% ORR, including unconfirmed responses in first-line metastatic upper GI cancer. In patients with PD-L1 high tumors, the ORR was an impressive 80% and the 6-month PFS was 93%. We're pleased to see that dom and zim added to the standard of care was generally well tolerated with an adverse event profile similar to anti-PD-1 plus FOLFOX.

接下來，我們來看投影片20的TIGIT專案。今天早些時候，我們在ASCO全體會議上公佈了II期EDGE-Gastric研究其中一個治療組的初步結果。研究發現，在FOLFOX化療方案中加入多巴胺能藥物（dom）和齊美沙芬（zim）後，一線轉移性上消化道癌患者的6個月無惡化存活期（PFS）達到77%，客觀緩解率（ORR）達到59%，其中包括未確認的緩解。在PD-L1高表達腫瘤患者中，ORR高達80%，6個月PFS達93%。我們很高興地看到，在標準治療方案中加入多巴胺能藥物和齊美沙芬整體耐受性良好，其不良事件特徵與抗PD-1抗體合併FOLFOX方案相似。

These results increase our confidence in the ongoing registrational Phase III STAR-221 trial in the similar first-line gastric gastroesophageal junction and esophageal adenocarcinoma population and our broader anti-TIGIT program. Although anti-TIGIT will not work in every tumor type, we're excited to see that dom has shown encouraging efficacy and tolerability in the tumor types we have advanced into Phase III studies including first-line non-small cell lung cancer and upper GI cancer.

這些結果增強了我們對正在進行的註冊性 III 期 STAR-221 試驗的信心，該試驗針對的是類似的胃食道交界處癌和食道腺癌一線治療人群，以及我們更廣泛的抗 TIGIT 計畫。儘管抗 TIGIT 療法並非對所有腫瘤類型都有效，但我們很高興地看到，dom 在我們已推進至 III 期研究的腫瘤類型中展現出了令人鼓舞的療效和耐受性，這些腫瘤類型包括一線非小細胞肺癌和上消化道癌。

Turning to cell therapy on Slide 21. We are continuing to work to expand the benefits of cell therapy to even more patients with 8 ongoing trials in earlier lines, new indications or new settings. We also have an extensive early-stage pipeline where we are exploring allogeneic CARTs, including healthy donor and iPSC-derived cell therapies as well as natural killer and invariant natural killer T cell therapies.

請參閱第21張投影片，了解細胞療法。我們正持續努力，透過8項正在進行的臨床試驗，在早期治療、新適應症或新治療環境中，將細胞療法的益處惠及更多患者。此外，我們還擁有廣泛的早期研發管線，正在探索異體CAR-T細胞療法，包括健康捐贈者和iPSC衍生細胞療法，以及自然殺手細胞和不變自然殺手T細胞療法。

Beyond therapies, we continue to invest in manufacturing innovation to maintain our position as the world's leading cell therapy manufacturer and drive more rapid treatment for patients. We will continue to explore emerging disease areas in cell therapy, where we have the potential to apply our expertise to the treatment of difficult diseases. This includes multiple myeloma where we are pleased that the Phase II IMAGINE-1 trial, CART-ddBCMA has resumed enrollment, and we share in our Arcellx's confidence in the therapeutic profile of CART-ddBCMA to be able to deliver benefit to patients.

除了療法之外，我們持續投資於生產製造創新，以保持我們作為全球領先細胞療法製造商的地位，並推動患者更快地獲得治療。我們將繼續探索細胞療法領域的新興疾病，在這些領域，我們有能力運用我們的專業知識來治療疑難雜症。這包括多發性骨髓瘤，我們很高興看到 II 期 IMAGINE-1 試驗（CART-ddBCMA）已恢復患者招募，我們與 Arcellx 一樣，對 CART-ddBCMA 的治療前景充滿信心，相信它能夠為患者帶來益處。

To that end, the data unveiled in last week's abstract release of the upcoming American Society of Hematology meeting further reinforce CART-ddBCMA's robust efficacy and safety profile where a 22 months follow-up in the ongoing Phase I trial, 2/3 of patients continue to respond and median survival has not yet been reached. We look forward to additional data and even longer median follow-up next month. In the meantime, we are further strengthening the body of clinical evidence highlighting the long-term durability and survival benefits of both Yescarta and Tecartus at the ASH meeting in December.

為此，上週即將召開的美國血液學會（ASH）年會上公佈的摘要數據進一步強化了CART-ddBCMA的顯著療效和安全性。在正在進行的I期臨床試驗中，22個月的追蹤結果顯示，三分之二的患者持續有效，且尚未達到中位存活期。我們期待下個月獲得更多數據以及更長的中位追蹤期。同時，我們將在12月的ASH年會上進一步補充臨床證據，強調Yescarta和Tecartus的長期療效和存活率獲益。

Finally, and before I hand over to Andy, the team's progress on key 2023 clinical milestones is shown on Slide 22. As is expected with a diverse and large clinical portfolio, not all our programs will benefit patients the way we hope they will. And the ENHANCE and ENHANCE-2 programs evaluating magrolimab have both been discontinued based on futility analyses. The ENHANCE-3 study remains under partial clinical hold in frontline, unfit AML, and we continue to evaluate the progress of this and other Phase II solid tumor trials for magrolimab.

最後，在將發言權交給安迪之前，投影片 22 展示了團隊在 2023 年關鍵臨床里程碑方面的進展。如預期，由於臨床計畫種類繁多且規模龐大，並非所有計畫都能如我們所願地造福病患。基於無效性分析，評估 magrolimab 的 ENHANCE 和 ENHANCE-2 計畫都已終止。 ENHANCE-3 研究目前仍處於部分臨床暫停狀態，該研究針對第一線不適合接受治療的急性髓性白血病 (AML) 患者，我們將繼續評估該研究以及其他 magrolimab II 期實體瘤試驗的進展。

With regards to some of the remaining milestones for 2023, as referenced previously, we look forward to sharing data from ARTISTRY-I at a medical conference in 2024. For our HIV prevention studies, we continue to expect to have our first patient in for the PURPOSE-III and PURPOSE-IV clinical trials by the end of this year. Additionally, we remain on track to initiate our Phase II PALEKONA trial evaluating our potential first-in-class TPL-2 inhibitor for ulcerative colitis later this year. Our TPL-2 inhibitor represents one of our many oral agents for inflammation.

關於2023年剩餘的一些里程碑，如前所述，我們期待在2024年的醫學會議上分享ARTISTRY-I試驗的數據。在HIV預防研究方面，我們仍預計在今年年底前完成PURPOSE-III和PURPOSE-IV臨床試驗的首例患者入組。此外，我們仍按計劃於今年稍後啟動II期PALEKONA試驗，該試驗旨在評估我們潛在的首創TPL-2抑制劑治療潰瘍性結腸炎的療效。我們的TPL-2抑制劑是我們眾多口服抗發炎藥物之一。

Looking beyond 2023, we will share our target 2024 milestones in due course, but it's already clear that it will be a rich year for data updates for Gilead, including potential updates or regulatory filings for obeldesivir, lenacapavir, Trodelvy and CART-ddBCMA.

展望 2023 年後，我們將在適當的時候分享我們 2024 年的目標里程碑，但很明顯，這將是吉利德資料更新的豐收年，包括 obeldesivir、lenacapavir、Trodelvy 和 CART-ddBCMA 的潛在更新或監管文件。

With that, I'll hand the call over to Andy. Andy?

這樣，我就把電話交給安迪了。安迪？

Thank you, Merdad, and good afternoon, everyone.

謝謝你，梅爾達德，大家下午好。

We had another solid quarter, as shown on Slide 24, with total product sales, excluding Veklury, up 5% year-over-year, driven by growth across oncology and HIV, partially offset by lower HCV sales.

如投影片 24 所示，我們又迎來了一個穩健的季度，除 Veklury 外，產品總銷售額年增 5%，這主要得益於腫瘤學和 HIV 領域的成長，但部分被 HCV 銷售額的下降所抵消。

Total product sales were $7 billion, flat year-over-year with lower Veklury sales offsetting more than $300 million of growth in our base business. Our non-GAAP results are shown on Slide 25. Product gross margin was 86%, down 85 basis points from last year. R&D was $1.5 billion, up 24% year-over-year, reflecting ongoing clinical trial activities. Third quarter R&D expenses also reflected some sizable wind-down costs related to the discontinuation of 2 Phase III magrolimab ENHANCE studies and faster-than-anticipated enrollment in our Phase III PURPOSE-I and Oaktree studies both of which have recently completed enrollment and could accelerate timelines for data readouts in due course.

產品總銷售額為70億美元，與去年同期持平，其中Veklury銷售額下降抵消了基礎業務超過3億美元的成長。我們的非GAAP業績請見第25頁幻燈片。產品毛利率為86%，較去年下降85個基點。研發支出為15億美元，年增24%，反映了正在進行的臨床試驗活動。第三季研發支出也反映了一些與終止兩項III期magrolimab ENHANCE研究相關的較大額收尾成本，以及我們III期PURPOSE-I和Oaktree研究的入組速度超出預期，這兩項研究近期均已完成入組，有望加快數據公佈的進程。

Acquired IPR&D was $91 million, reflecting the Tentarix collaboration announced in August, in addition to other payments associated with ongoing partnerships. SG&A was $1.3 billion, up 7% year-over-year, primarily driven by increased commercial investments, namely in oncology.

收購的智慧財產權及研發支出為9,100萬美元，其中包括8月宣布的與Tentarix的合作，以及其他與現有合作關係相關的款項。銷售、管理及行政費用為13億美元，年增7%，主要得益於商業投資的增加，尤其是腫瘤領域。

Moving to tax. Our effective tax rate in the third quarter was 7%, primarily reflecting a decrease in tax reserves as a result of reaching an agreement with a tax authority on certain tax position. Excluding this settlement, our non-GAAP effective tax rate would have been approximately 16%. Our non-GAAP diluted earnings per share were $2.29 compared to $1.90 for the same period last year. This was primarily driven by growth in our base business, lower tax and lower acquired IPR&D expenses compared to the third quarter of 2022, partially offset by lower Veklury sales and higher R&D and commercial investments.

接下來談談稅務方面。第三季我們的實際稅率為7%，主要原因是由於與稅務機關就某些稅務問題達成和解，導致稅務準備金減少。若不計入此項和解，我們的非GAAP實際稅率約為16%。我們的非GAAP攤薄後每股收益為2.29美元，去年同期為1.90美元。這主要得益於我們基礎業務的成長、稅收減少以及收購智慧財產權和研發支出較2022年第三季有所下降，但部分被Veklury銷售額下降以及研發和商業投資增加所抵銷。

Moving to Slide 26. Year-to-date base business revenue has grown 10% year-over-year, highlighting strong performance across virology and oncology. From an OpEx perspective, the investment we have made this year in R&D is notable with a robust and diverse clinical pipeline and with our commercial sales and marketing organization scaled to meet growing demand for our on-market oncology portfolio, we continue to expect a moderation of expense growth in 2024 and beyond.

翻到第26頁。今年迄今為止，基礎業務收入年增10%，病毒學和腫瘤學領域表現強勁。從營運支出角度來看，我們今年在研發方面的投入顯著，擁有強大且多元化的臨床產品線；同時，我們的商業銷售和行銷團隊也已擴大規模，以滿足市場對我們現有腫瘤產品組合日益增長的需求。因此，我們預計2024年及以後的支出成長將趨於緩和。

Moving to Slide 27. We are updating many of our guidance ranges to reflect our year-to-date performance and our expectations for the rest of the year. Total product sales is now expected to be in the range of $26.7 billion to $26.9 billion, up from $26.3 billion to $26.7 billion previously. We are increasing total product sales, excluding Veklury at the midpoint. We now expect the range to be between $24.8 billion to $25 billion, up from $24.6 billion to $25 billion previously. This range represents growth of 7% to 8% for our base business year-over-year and an increase of $650 million at the midpoint from the initial guidance we issued in February.

請翻至第27頁。我們更新了多項業績指引範圍，以反映我們年初至今的業績表現以及對今年剩餘時間的預期。目前預計產品總銷售額將在267億美元至269億美元之間，高於先前預測的263億美元至267億美元。我們上調了不計入Veklury的整體產品銷售額預期範圍，目前預計該範圍將在248億美元至250億美元之間，高於先前預測的246億美元至250億美元。此範圍代表我們基礎業務年增7%至8%，較2月發布的初始指引範圍中位數增加了6.5億美元。

On Veklury, based on our results year-to-date, we now expect full year Veklury sales of approximately $1.9 billion. As always, this remains highly variable and correlated with COVID-related hospitalization.

根據我們今年迄今的業績，我們預計Veklury全年銷售額約為19億美元。但與以往一樣，這一數字仍存在較大波動，並且與新冠肺炎相關住院人數密切相關。

Moving to the rest of the P&L. We continue to expect non-GAAP gross margin to be approximately 86%. On R&D, reflecting the accelerated enrollments and magrolimab discontinuation expenses, our full year non-GAAP R&D expense is now expected to grow approximately 15% in 2023 compared to 2022. Excluding these items, our full year R&D expense is consistent with our prior guidance in the low double digits.

接下來來看損益表的其他部分。我們仍預期非GAAP毛利率約為86%。研發方面，考慮到加速的病患招募和magrolimab停用費用，我們預計2023年全年非GAAP研發費用將比2022年增加約15%。剔除這些項目後，我們全年研發費用與我們先前的預期一致，仍維持在兩位數低點成長。

Reflecting the Tentarix collaboration closed in the third quarter as well as previously committed acquired IPR&D amounts and known milestone payments from existing collaborations, we now expect non-GAAP acquired IPR&D of approximately $1 billion in 2023. Similar to prior quarters, we will update expected acquired IP R&D expenses if they are incurred during the fourth quarter.

考慮到第三季完成的與Tentarix的合作，以及先前承諾的收購智慧財產權研發支出和現有合作項目已知的里程碑付款，我們現在預計2023年非GAAP收購智慧財產權研發支出約為10億美元。與前幾季類似，如果第四季產生收購智慧財產權研發支出，我們將更新預期支出。

We continue to expect non-GAAP SG&A expenses to increase by a high single-digit percentage compared to 2022. As a reminder, this includes a onetime legal settlement accrual of $525 million in the second quarter. Excluding this, we continue to expect non-GAAP SG&A expense for 2023 to be down a low single-digit percentage compared to 2022.

我們仍預計，與2022年相比，非GAAP銷售、管理及行政費用將以接近兩位數的百分比成長。需要注意的是，這其中包含第二季一次性法律和解費用提列的5.25億美元。剔除此項費用後，我們仍預計，與2022年相比，2023年非GAAP銷售、管理及行政費用將以接近兩位數的百分比下降。

Non-GAAP operating income is expected to be $10.5 billion to $10.8 billion as compared to $10.4 billion to $10.9 billion previously, driven by higher R&D expenses, offset by higher product sales. Given certain onetime tax benefits in 2023, we now expect our non-GAAP effective tax rate to be approximately 16% for the full year. Altogether, we now expect our non-GAAP diluted EPS to be between $6.65 and $6.85 per share as compared to $6.45 and $6.80 per share previously.

預計非GAAP營業收入為105億美元至108億美元，高於先前預期的104億美元至109億美元，主要受研發支出增加的影響，但部分被產品銷售成長所抵銷。考慮到2023年可享有的某些一次性稅收優惠，我們目前預計全年非GAAP實際稅率約為16%。綜上所述，我們目前預計非GAAP攤薄後每股收益為6.65美元至6.85美元，高於先前預期的6.45美元至6.80美元。

As shown on Slide 28, the chart highlights the continued strength of our business with higher total product sales guidance flowing into the bottom line, which, together with a lower expected tax rate, more than offset the higher R&D expenses in the third quarter. On a GAAP basis, our diluted EPS is expected to be in the range of $4.55 and $4.75 per share.

如投影片28所示，圖表顯示我們業務持續強勁，更高的產品銷售總額預期將轉化為淨利成長，加之預期稅率降低，足以抵銷第三季研發費用增加的影響。以美國通用會計準則（GAAP）計算，我們預計稀釋後每股盈餘將在4.55美元至4.75美元之間。

Moving to Slide 29. Our capital allocation priorities remain focused and unchanged. In the third quarter, we returned $1.3 billion to shareholders through our dividend and repurchase of shares totaling $3.7 billion year-to-date. In the third quarter, we repaid $2.25 billion of senior notes and issued $2 billion in senior notes maturing in 2033 and 2053.

翻到第29頁。我們的資本配置重點依然明確，未作任何改變。第三季度，我們透過派發股利和回購股票向股東返還了13億美元，年初至今的股票回購總額為37億美元。第三季度，我們償還了22.5億美元的優先票據，並發行了20億美元的優先票據，分別於2033年和2053年到期。

Overall, the third quarter was another solid quarter of commercial and clinical execution in an extremely strong 2023 for Gilead so far. Our planning for 2024 is well underway and we've taken steps in the third quarter to continue to evolve our business model and expense structure to set us up for strong execution next year. 2023 has been a year of considerable investment, notably in R&D, and we are excited to finally be at the point where many of our key programs will start reading out data. With that in mind, we are preparing for a catalyst-rich 2024, and we look forward to sharing more early next year.

總體而言，第三季吉利德在商業和臨床執行方面又取得了穩健的成績，2023年至今吉利德的整體表現非常強勁。我們2024年的規劃工作正在穩步推進，並在第三季採取措施，持續優化業務模式和費用結構，為明年的強勁發展奠定基礎。 2023年，我們投入了大量資金，尤其是在研發方面。我們很高興看到許多關鍵項目終於開始公佈數據。有鑑於此，我們正積極籌備迎接充滿機會的2024年，並期待明年初與大家分享更多資訊。

With that, I'll invite the operator to open the Q&A.

接下來，我將邀請接線生開啟問答環節。

(Operator Instructions) Our first question today goes to Geoff Meacham of Bank of America.

（操作員說明）我們今天的第一個問題來自美國銀行的傑夫·米查姆。

I guess this is for maybe Johanna or for Merdad. Just on lenacapavir, your competitor highlighted some of the derm pot. I wanted to get your perspective on what you've seen in clinical studies really as well as the early commercial experience. I wasn't sure if you guys view that as a nonissue or something to navigate as you develop lenacapavir for PrEP or various doublets in HIV treatment?

我想這可能是給Johanna或Merdad的。關於lenacapavir，你們的競爭對手重點提到了一些皮膚病。我想了解你們在臨床研究以及早期商業經驗方面的看法。我不確定你們是否認為這無關緊要，還是在開發lenacapavir用於PrEP或HIV治療的各種雙聯療法時需要注意的問題？

Sure. GEOff, this is Merdad. Thanks for the question. I would say that our ddI profile has been pretty well characterized and is in our label and laid out, as you noted, lenacapavir is metabolized by CYP3A and like many other drugs in the class. And we -- that's been available on the label for quite some time. We don't anticipate any changes to our programs based on that. There are no adaptations that we are making in our clinical development program based on that. As you know, we're well on our way in our PURPOSE-I and II Lenacapavir PrEP studies and have the approval in highly treatment-experienced people and have not made any modifications based on any DDI concerns in those trials. And I'd encourage folks to take a look at the label. You can see what's laid out fairly clearly there.

當然。 GEOff，我是Merdad。謝謝你的提問。我想說的是，我們的藥物交互作用（ddI）特性已經相當明確，並且已經在我們的藥品說明書中列出。正如你所提到的，lenacapavir 和同類藥物一樣，都是經由 CYP3A 代謝的。而且，這一點已經在藥品說明書中明確列出一段時間了。我們預計不會因此對我們的項目做出任何改變。我們的臨床開發項目也沒有因此做出任何調整。如你所知，我們的 PURPOSE-I 和 II lenacapavir PrEP 研究進展順利，並且已經獲準用於治療經驗豐富的患者，在這些試驗中也沒有因為任何藥物交互作用問題而做出任何修改。我建議大家仔細閱讀藥品說明書。你可以清楚地看到上面的內容。

Yes. And maybe just to add to what Merdad said. So we launched Sunlenca, lenacapavir for heavily treatment experienced earlier this year. As per Merdad's comments, the label has no contraindications specific to what you were referring to opioids or ED drugs, and the launch so far is well underway and access is increasing every day across the U.S. but also other markets, including Japan and Europe. And we're excited to have an option for these patients that unfortunately have really no other option at this point in time. So a very small market opportunity today with the potential for lenacapavir for PrEP as early as late '25. So very excited as we continue our plan for that.

是的。或許可以補充一下Merdad剛才說的話。今年早些時候，我們推出了Sunlenca，也就是用於治療重度接受過治療患者的lenacapavir。正如Merdad所說，該藥的標籤上沒有您提到的阿片類藥物或ED藥物的禁忌症。目前，該藥的上市進展順利，在美國以及包括日本和歐洲在內的其他市場，其可及性每天都在增加。我們很高興能為這些目前別無選擇的患者提供新的選擇。目前，lenacapavir的市場機會雖然很小，但預計在2025年底前用於PrEP。我們對此感到非常興奮，並將繼續推進相關計劃。

Our next question goes to Michael Yee of Jefferies.

下一個問題請傑富瑞集團的麥可葉提問。

Great. I appreciate the question. Maybe for Merdad, coming away from ESMO and some of the recent conferences, obviously, a ton of TROP-2 data. And there's a lot of talk around the benefit, particularly in lung for non-squamous versus squamous and some of your competitors have modified their studies to be more focused on non-squamous. Can you maybe just talk about how you see the benefits here in the different populations and whether you would consider emphasizing or modifying to be in non-squamous as well to improve probability of success?

好的，感謝您的提問。 Merdad，或許您從ESMO和最近的一些會議中了解了大量TROP-2數據。目前有許多關於其益處的討論，尤其是在非鱗狀細胞癌與鱗狀細胞癌的肺癌治療方面。您的一些競爭對手已經調整了他們的研究，更加專注於非鱗狀細胞癌。您能否談談您如何看待不同人群的益處，以及您是否會考慮加強或調整研究，將非鱗狀細胞癌也納入其中，以提高治療成功率？

Thanks, Michael, for the question.

謝謝你的提問，麥可。

Yes. Look, we had a really interesting ESMO, I think, for all concerned. And I think something that we've been saying for quite some time is that not all TROP-2 ADCs are equivalent, right? It's really important to note that there are differences between Trodelvy and the other TROP-2 ADCs in all 3 components. The affinity of the antibody is two orders of magnitudes better. We have a different linker and we have a different payload. That has played out in many ways along the safety spectrum where we have different adverse event profiles of the 2 drugs that have clearly emerged and it's possible now that we're starting to see divergence on the efficacy side as well.

是的。你看，我認為對所有相關人員來說，我們這次ESMO大會都非常精彩。我們一直以來都在強調，並非所有TROP-2抗體偶聯藥物（ADC）都相同，對吧？需要特別注意的是，Trodelvy與其他TROP-2 ADC在所有三個方面都存在差異。抗體的親和力提高了兩個數量級。我們使用了不同的連接子和不同的有效載荷。這些差異在安全性方面體現在許多方面，兩種藥物的不良反應譜明顯不同，現在看來，它們在療效方面也可能出現分歧。

Recall that we have shared our EVOKE-02 data, which comprise both squam and non-squamous patients. We have enrolled both squamous and non-squamous patients in our trials. And as one would expect, we do stratify those patients in our -- in the studies, and we'll continue to do so. We're very confident in our approach and with what we've seen so far and really look forward to being able to share more data from EVOKE-01 next year.

請記住，我們已分享了EVOKE-02的數據，其中包括鱗狀細胞癌和非鱗狀細胞癌患者。我們的試驗也同時納入了鱗狀細胞癌和非鱗狀細胞癌患者。正如大家所預期的，我們在研究中對這些患者進行了分層，並將繼續這樣做。我們對目前的研究方法和所觀察到的結果非常有信心，並期待明年能分享更多EVOKE-01的數據。

Our next question goes to Daina Graybosch of Leerink Partners.

我們的下一個問題將由 Leerink Partners 的 Daina Graybosch 提出。

A question about Kite. I wonder if you can talk through the specific barriers that are limiting uptake of CART in the second-line large B cell lymphoma indication? And what do you think will be required to upshift the earlier line demand for cell therapy in large B-cell lymphoma and maybe even in multiple myeloma as well?

關於Kite，我想問一個問題。能否具體談談限制CAR-T細胞療法在二線大B細胞淋巴瘤治療中應用的具體障礙？您認為需要做些什麼才能提高大B細胞淋巴瘤（甚至可能是多發性骨髓瘤）早期治療對細胞療法的需求？

Thank you very much for the question, Daina. I think some of the specific barriers that we're observing are more in the U.S. So I like first talk about what we're observing in Europe where we have socialized medicine, we're seeing uptake as soon as we are granted access and reimbursement, and it goes very quickly into the system because it's a non-fragmented health care system.

非常感謝你的提問，黛娜。我認為我們觀察到的一些具體障礙在美國更為常見。所以我想先談談我們在歐洲觀察到的情況，那裡實行的是公費醫療，一旦獲得准入和報銷，我們就能看到人們積極接受，而且由於醫療保健系統較為完整，所以很快就能融入到醫療體系中。

In the U.S., things look a little bit different given the fragmentation of the health care system. So the barriers that we're observing in the U.S. are really our ability to treat patients where they are, so moving into community oncology. Today, 80% of oncology patients are seen in the community, most of our authorized treatment centers exist in large academic hospitals. And so what we're doing for the future and what we think is going to be very important is that we're able to have authorized treatment centers in the community closer to patients. So that's one important piece. And we continue to open up new treatment centers in the United States. And in fact, this year, we should end with somewhere around 140 treatment centers in the U.S., and that will continue to grow in 2024.

在美國，由於醫療保健系統的碎片化，情況略有不同。我們目前在美國面臨的障礙在於，我們能否在患者所在的地方提供治療，也就是如何推進社區腫瘤治療。目前，80%的腫瘤患者在社區接受治療，我們的大部分授權治療中心都設在大型教學醫院。因此，我們未來正在努力的方向，也是我們認為至關重要的方向，就是在社區設立更多授權治療中心，讓病人更方便地就醫。這是非常重要的一點。我們也持續在美國開設新的治療中心。事實上，今年年底，我們在美國應該會擁有約140家治療中心，而且到2024年，這個數字還會持續成長。

I think the second piece for barriers is converting stem cell transplant, so physicians who are transplanting patients, they will have a better outcome via the data if they have CART, and so we're working with transplanters on education and really making sure those patients have access to CART in the earlier lines. I think those are 2 of the larger barriers that we're observing today.

我認為第二個障礙是幹細胞移植的轉化，也就是說，如果患者接受CAR-T細胞療法，移植醫生就能獲得更好的治療效果（數據支持CAR-T細胞療法），因此我們正在與移植醫生合作，開展教育培訓，確保患者在早期階段就能獲得CAR-T細胞療法。我認為這是目前我們觀察到的兩大主要障礙。

And the last piece I would say is the excitement with multiple myeloma therapies coming forward. You can imagine the ATCs now are seeing both lymphoma patients as well as multiple myeloma patients, and that's causing a crunch within those authorized treatment centers. And that's why it's important in the academic medical centers that we're able to expand the number of beds and secondly, open new authorized treatment centers that can serve both lymphoma and multiple myeloma.

最後一點是，多發性骨髓瘤療法的不斷湧現令人振奮。您可以想像，現在獲得授權的治療中心（ATC）既要接診淋巴瘤患者，也要接診多發性骨髓瘤患者，這導致這些中心的床位非常緊張。因此，對於學術醫療中心來說，增加床位數量至關重要；其次，開設新的授權的治療中心，能夠同時服務淋巴瘤和多發性骨髓瘤患者。

Our next question goes to Chris Schott of JPMorgan.

我們的下一個問題來自摩根大通的克里斯·肖特。

Can you just elaborate a little bit more on HIV channel mix dynamics this quarter and how you're thinking about that for 4Q and beyond? I know channel has been a bit of a tailwind over the past year or two- it seems like we're now maybe starting to see some headwinds, at least sequentially. And I just was wondering how you think about that progressing from here?

您能否詳細談談本季愛滋病毒通路組合的動態變化，以及您對第四季及以後的發展有何看法？我知道過去一兩年通路發展一直是利好因素，但現在看來，至少從環比來看，我們可能開始看到一些不利因素。我想知道您如何看待接下來的發展趨勢？

Sure, Chris. Thanks for the question.

當然可以，克里斯。謝謝你的提問。

So you're right, right. As expected, we've seen some of those favorable pricing dynamics that we've seen in the last couple of quarters, including in 2022, due to the channel mix kind of begin to normalize. And you should expect to see kind of the same play from Q3 into Q4. One of the reasons for that had to do with some of the channel -- specifically around the channel mix to what you referenced, having to do with some of our government channels being less utilized, where we have higher rebates, and therefore, we had pricing variability. We believe a lot of that has due to stabilization post COVID around employment rates, inflation, et cetera. So we had a benefit that we saw over that, probably, I would say, 4 to 6 quarters or so. And as we kind of shared with you in Q2, we are seeing that normalize out for the second half of this year. And I think you should expect that not only for the next quarter, but then as we go into 2024.

你說得對。如預期，由於通路組合開始趨於正常化，我們看到了過去幾季（包括2022年）以來一些有利的價格動態。預計從第三季到第四季，情況也會大致相同。其中一個原因與通路有關——特別是你提到的通路組合，由於一些政府通路的使用率較低，而這些通路的返利較高，因此價格波動較大。我們認為這很大程度是由於新冠疫情後就業率、通貨膨脹等因素趨於穩定。因此，我們享受到了大約4到6個季度的利好。正如我們在第二季度與你分享的那樣，我們看到這種情況在今年下半年趨於正常化。我認為不僅在下一個季度，而且在2024年，這種情況都會持續下去。

The -- and therefore, because of all that, we believe that our HIV sales growth is closely mirroring now more of the market and the demand growth where we're seeing real strength both from a market standpoint, in treatment and prevention. We're seeing about 2 to 3 points growth in the market when you look at retail and non-retail market, and then, of course, 15% growth in the PrEP market. And then from a demand standpoint, I think, obviously, with Biktarvy growing at 12 points year-on-year and Descovy continuing to hold on to a very strong share over 40% or so in a competitive market with generics and of course, new formulations. So more to come as we go into Q4, but hopefully that gives you better picture some of the mix of channels.

因此，基於以上所有因素，我們相信我們的HIV產品銷售成長與市場和需求成長更加緊密地同步，我們看到市場在治療和預防方面都呈現出強勁的成長勢頭。零售和非零售市場整體成長約2%至3%，而PrEP市場則成長了15%。從需求角度來看，Biktarvy年增12%，Descovy在競爭激烈的市場中持續保持超過40%的強勁份額，這無疑推動了市場成長，尤其是在仿製藥和新配方藥物不斷湧現的挑戰下。隨著第四季度的到來，我們將發布更多信息，但希望以上內容能讓您更好地了解渠道組合的情況。

Our next question goes to Tim Anderson of Wolfe Research.

我們的下一個問題將由 Wolfe Research 的 Tim Anderson 提出。

This is Adam on for Tim Anderson at Wolfe Research. Also on TROP-2, just in light of competitor data, can you provide some more color on just latest thoughts on the competitive dynamics within the class? For example, if AstraZeneca get the label for HR-positive breast cancer in the second line, and Trodelvy only has a label for the third line, won't that displace Trodelvy?

這裡是Wolfe Research的Adam，代表Tim Anderson。關於TROP-2，鑑於競爭對手的數據，您能否進一步闡述您對該類藥物競爭格局的最新看法？例如，如果阿斯特捷利康的TROP-2獲準用於HR陽性乳癌的第二線治療，而Trodelvy僅獲準用於第三線治療，這是否會取代Trodelvy的市場地位？

Good question, Adam. So I'm assuming you're referring to some of the data we saw at ESMO with Dato-DXd. We don't believe there is a material impact for now anyway or even in the future for Trodelvy. And the reason for that really has to do with the data itself and the lines of therapy, to your point, I think we've proven very clearly with Trodelvy in second-line TNBC and beyond around the overall survival data that we've shown. And then, of course, showing OS, again, in HR-positive, HER2 negative, although in later lines. I think what we're seeing today in the marketplace is -- not only are we the leaders in TNBC, we're also leading from an IHC0 population. And then, of course, looking at sequencing of ADCs post-Enhertu as expected in the HR-positive HER2-negative population. So quite pleased with our positioning, and we don't believe the data that we've seen thus far is going to have the direct impact there.

問得好，Adam。我猜您指的是我們在ESMO大會上看到的Dato-DXd的一些數據。我們認為，就目前而言，甚至未來，這些數據對Trodelvy都不會產生實質影響。原因在於數據本身以及治療方案。正如您所說，我們已經非常清楚地證明了Trodelvy在二線及後續治療中，尤其是在總生存期（OS）方面的優勢。當然，我們也展示了HR陽性、HER2陰性患者的OS數據，儘管在後續治療中。我認為我們目前在市場上看到的是——我們不僅在TNBC領域處於領先地位，而且在IHC0人群中也處於領先地位。當然，我們也關注HR陽性、HER2陰性患者在Enhertu治療後ADC的序貫治療，正如預期的那樣。因此，我們對目前的市場定位非常滿意，我們認為目前為止看到的數據不會對此產生直接影響。

Yes, I would just add that we continue to expand our programs and continue to want to generate additional data for Trodelvy. So we are very comfortable with where we are. And I think our ability to interact with our caregivers and patients now having been on the market for quite some time, it's really helping us make sure that we get Trodelvy to as many patients who could benefit from it as possible.

是的，我還要補充一點，我們正在不斷拓展項目，並持續收集Trodelvy的相關數據。因此，我們對目前的進展非常滿意。我認為，Trodelvy上市一段時間後，我們與醫護人員和患者的互動能力得到了顯著提升，這確實有助於我們確保盡可能多的患者都能從中受益。

Our next question goes to Salveen Richter of Goldman Sachs.

下一個問題請高盛的薩爾文·里希特回答。

Just a question here on the pipeline, just given 2 data releases that came out. So on the TIGIT gastric data that was presented today, how do we think -- or how do you think about the terms -- had the opportunity, the competitiveness versus standard of care combos and next steps? And then with regard to the multiple myeloma for Arcellx that was presented, it's looking to -- it looks to be tracking a CARVYKTI profile in relapsed/refractory multiple myeloma. Could you just walk us through next steps path to market competitive positioning here?

關於研發管線，我有個問題，因為剛剛發布了兩項數據。今天公佈的TIGIT胃癌數據，您認為（或您如何看待）該藥物在市場上的競爭力，以及它與標準療法組合的競爭前景和下一步計劃是什麼？另外，Arcellx的多發性骨髓瘤數據也已公佈，它似乎在復發/難治性多發性骨髓瘤的治療中與CARVYKTI類似。您能否簡要介紹一下該藥物的下一步市場競爭定位？

Sure. Maybe I'll start with TIGIT, and I'll hand it off to Cindy for the multiple myeloma discussion. Yes, I think -- look, we find the data that we presented today at the ASCO plenary to really be promising for continued momentum for TIGIT. The data from an ORR standpoint, and I think importantly, the landmark PFS analysis are very promising. It's early data. It's single-arm data, and I think those are all caveats that are appropriate when looking at these. But when you think about the context around what the standard of care, PFS and OSR, we think there's certainly promising signals that we could do better than that.

當然。或許我可以先講TIGIT療法，然後把多發性骨髓瘤的討論交給Cindy。是的，我認為——你看，我們今天在ASCO全體會議上公佈的數據確實很有希望，預示著TIGIT療法將繼續保持發展勢頭。從客觀緩解率（ORR）的角度來看，以及我認為非常重要的里程碑式的無惡化存活期（PFS）分析，這些數據都非常令人鼓舞。這些數據還處於早期階段，是單臂研究數據，我認為這些都是在解讀這些數據時需要考慮的注意事項。但是，考慮到標準治療方案、PFS和總緩解率（OSR）的背景，我們認為這些數據確實顯示出一些令人鼓舞的訊號，表明我們有可能做得更好。

So obviously, what we need to do next is allow these data to mature in ARC-21. And then, of course, we have the 221 study that is our Phase III study where we will be comparing to standard of care in a randomized Phase III trial. We think the data shown today really will help us with momentum in accruing that trial and hopefully demonstrating the promise of TIGIT added on to standard of care -- a standard of care like regimen with zim and FOLFOX, we were excited about that Phase III outcome. And it really gives us the opportunity to be, we think, ahead on that indication compared to the competition in TIGIT.

顯然，接下來我們需要做的是讓這些數據在ARC-21研究中進一步改進。當然，我們還有221研究，這是一項III期臨床試驗，我們將在隨機III期試驗中將TIGIT與標準療法進行比較。我們認為今天發表的數據將有助於我們加快該試驗的受試者招募，並有望證明TIGIT聯合標準療法（例如齊美替尼聯合FOLFOX方案）的療效，我們對該III期試驗的結果感到非常興奮。我們認為，這確實讓我們有機會在該適應症領域領先TIGIT的競爭對手。

And Cindy, do you want to...

辛迪，你想…

Yes. Happy to. Thank you.

是的，樂意效勞，謝謝。

So this is early days, obviously, for the ddBCMA molecule. We have 38 patients worth of data. If I compare it to CARVYKTI, it's the population looks more like the LEGEND-2 population. We have a 34% extramedullary disease, which is a high-risk prognosis patients. And if you look at the LEGEND-2 data, they had 30%. Our overall response rate to date in those 38 patients at 22 months is 100%. And in the LEGEND-2 data is 88% to 25 months. So I do think there is a potential to differentiate on efficacy.

顯然，ddBCMA分子目前還處於早期階段。我們只有38例患者的數據。如果與CARVYKTI相比，我們的患者族群更接近LEGEND-2研究的患者族群。我們的患者中髓外病變佔34%，這類患者預後風險較高。而LEGEND-2研究的髓外病變比例為30%。截至目前，這38例患者22個月的總緩解率為100%。 LEGEND-2研究25個月的緩解率為88%。因此，我認為ddBCMA在療效方面具有差異化的潛力。

We're seeing a differentiation as it relates to the safety profile around the Parkinson's syndrome. We are not observing that in any of our patients to date. Obviously, we're going to continue to watch that as we enroll the IMAGINE-1 study and move into our next studies as well. Multiple myeloma is a large market. There is enough room in multiple myeloma to have multiple competitors but we also feel like we will have a differentiated molecule with Arcellx. So we're looking forward to generating more data and talking to folks about it at ASH.

我們發現，在帕金森氏症候群的安全性方面存在差異。迄今為止，我們尚未在任何患者中觀察到這種情況。當然，隨著IMAGINE-1研究的開展以及後續研究的推進，我們將繼續密切關注這一情況。多發性骨髓瘤是一個巨大的市場。多發性骨髓瘤領域有足夠的空間容納多個競爭對手，但我們相信Arcellx將是一款具有差異化優勢的分子。因此，我們期待獲得更多數據，並在ASH會議上與大家分享。

Our next question goes to Tyler Van Buren of TD Cowen.

下一個問題請問TD Cowen公司的Tyler Van Buren。

I have another question actually on the myeloma program. So assuming that Arcellx CART-ddBCMA data continue to look great at ASH and the IMAGINE-1 trial that's later next year leads to approval. How prepared have you guys gotten on the manufacturing front in the past year? And do you expect the launch to have a similar trajectory to Yescarta in terms of supply or be significantly better?

關於多發性骨髓瘤項目，我還有一個問題。假設Arcellx CART-ddBCMA在ASH會議上的數據持續表現良好，並且明年晚些時候進行的IMAGINE-1試驗最終獲得批准，那麼過去一年你們在生產方面做了哪些準備？你們預計該藥物的上市供應情況會與Yescarta類似，還是會顯著更好？

See, there's a number of things that we have learned over the course of the years with Yescarta and around manufacturing, all of which we're applying that knowledge to the manufacturing of the ddBCMA CART. So we plan to launch that out of our facilities at Kite and expect to have a strong launch. Again, we will be applying Yescarta learnings. So our goal is to be significantly better than we were at the launch of Yescarta.

你看，這些年來，我們在Yescarta計畫和製造領域累積了不少經驗，我們將把這些經驗應用到ddBCMA CART的生產中。我們計劃在Kite工廠推出這款產品，並期待它能達到良好的開端。同樣，我們會運用在Yescarta計畫上累積的經驗。我們的目標是比Yescarta發佈時做得更好。

Our next question goes to Brian Abrahams of RBC Capital Markets.

下一個問題請問加拿大皇家銀行資本市場的布萊恩亞伯拉罕。

It seems like the long-acting HIV combos are moving ahead really well. I was wondering if you could talk a little bit more about the strategic role that the lenacapavir, bictegravir daily oral or the weekly 1720 based combo could play in the HIV competitive landscape? Do you think this could move beyond treatment experienced patients on complex regimen into the earlier lines?

看來長效HIV合併療法進展非常順利。我想請您詳細談談以利那卡帕韋、比克替拉韋每日口服或以1720為基礎的每週一次的聯合療法在HIV治療領域可能發揮的戰略作用？您認為這種療法能否從接受過複雜治療方案的成熟患者推廣到早期治療？

Sure. Maybe, Johanna, do you want to talk about bict lena, and I'll do the weekly?

當然可以。喬安娜，你想聊聊bict lena嗎？我來做每週例行報告。

Sure. Thanks for the question, Brian. I think the way we're looking at lenacapavir bictegravir in the virologically suppressed really has to do with -- we set the standard of care with Biktarvy and the opportunity now is to ensure that if, for some reason, there was a reason to switch Biktarvy from a tolerability profile or anything else that they have an option to go to that has a really interesting combination, right? When you think about a capsid inhibitor as well as an integrase inhibitor. So for us, it's really about the optionality for patients and making sure that this could offer something a little bit different in the daily oral market. And I do think that this will also be a longer-term strategy for us as we think about beyond Biktarvy's LOE in 2033. So I would go there. And on the weekly, just to start, and then I'll kick it over to Merdad to share with you our plans there.

當然。謝謝你的提問，布萊恩。我認為我們之所以考慮在病毒學抑制的患者中使用lenacapavir和bictegravir，是因為我們用Biktarvy確立了治療標準，而現在的機會在於確保，如果出於某種原因，比如耐受性或其他原因需要更換Biktarvy，患者可以選擇一種具有非常吸引人的聯合療法，對吧？這種療法同時具有衣殼抑制劑和整合酶抑制劑的特性。所以對我們來說，這真正關乎患者的選擇權，並確保這種療法能在每日口服藥物市場中帶來一些不同的選擇。而我認為，在我們考慮Biktarvy的研發有效期（2033年）之後，這也會是我們一項長期策略。所以我會先談談這方面。先從每週的方案開始，然後我會把話題交給Merdad，讓他和你分享我們的計畫。

On the weekly oral, it's clear from the patient research that we've done in treatment that we really do see benefit not only the daily oral market, but also in the oral weekly or even potentially even a little bit longer as we think about what patients are asking for today. So as much as we're very interested in the long acting that are every 3 months or every 6 months, we are also making sure that we meet the needs of patients and their request as they're looking at for some really don't like any injectables or sub-q and really looking at that weekly oral as potentially extending a little bit the time they don't think about the fact that they have HIV.

就每週一次的口服給藥方案而言，我們從治療中進行的患者研究中清楚地看到，我們不僅看到了每日口服給藥方案的益處，而且每週一次甚至更長時間的口服給藥方案也確實有效，因為我們考慮到了患者目前的需求。因此，儘管我們對每3個月或每6個月一次的長效給藥方案非常感興趣，但我們也確保滿足患者的需求和要求，因為有些患者確實不喜歡注射或皮下注射，他們正在考慮每週一次的口服給藥方案，希望能夠延長他們不再想起自己感染愛滋病毒的時間。

Yes, just minor things to add. I would say we have been focusing our development on what people living with HIV and people who are looking for PrEP options are -- have told us that they're interested in. And that's longer-acting oral options and injectable options that are every 3 months, every 6 months, and that's what we've been focusing our development program on. And we want to make sure that we provide that optionality to different folks.

是的，還有一些補充。我想說的是，我們一直專注於研發那些感染愛滋病毒的人以及正在尋找暴露前預防（PrEP）方案的人——他們告訴我們他們感興趣的是長效口服藥物和注射藥物，例如每3個月或每6個月注射一次的方案。這正是我們研發項目的重點。我們希望確保為不同人群提供這種選擇。

The other thing about the bict lena, remember is, remember that lena is a new class of antiretroviral and that provides caregivers the option to leverage that new class for the appropriate people living with HIV. So our goal as the leader in HIV is to continue to provide as many of the relevant options to people living with HIV and people looking for prevention options as we think are going to be reasonable and valuable. And remember that we think the weekly oral is important enough that we have 2 programs. So you mentioned 1720. Remember, we also have the program with islatravir and lenacapavir. So we're very happy with the progress we've made, as you noted and really on track to provide better options.

關於利那卡帕韋（Lena），請記住，它是一種新型抗逆轉錄病毒藥物，這使得醫護人員可以選擇為合適的愛滋病毒感染者使用這種新型藥物。作為愛滋病領域的領導者，我們的目標是繼續為愛滋病毒感染者和尋求預防方案的人們提供盡可能多的相關選擇，我們認為這些選擇合理且有價值。請記住，我們認為每週口服一次非常重要，因此我們設立了兩個項目。您提到了1720方案。請記住，我們還有伊斯拉曲韋和利那卡帕韋的聯合方案。正如您所指出的，我們對已取得的進展感到非常滿意，並且正朝著提供更好的治療方案的目標穩步前進。

Our next question go to Terence Flynn of Morgan Stanley.

下一個問題請摩根士丹利的特倫斯弗林提問。

I was just wondering if you can provide any preliminary thoughts on 2024 spend or margins, Andy?

安迪，我想問你能否對2024年的支出或利潤率提供一些初步看法？

Terence, thanks for the question. Happy to take that.

特倫斯，謝謝你的提問。我很樂意回答這個問題。

Obviously, in late January or early February, as we customarily do, we'll provide very specific guidance in 2024. What we've said, and I would continue to reiterate is that, as you've seen, our expenses increase over the last couple of years as our portfolio has increased, and again, from our perspective, a very necessary, an appropriate increase as we developed a -- what we feel is one of the best and broadest pipelines in the industry, both in virology, oncology across cell therapy, and at Gilead, we're finally at the level where we're spending on par with our peers, especially on the R&D side, as you saw that in the third quarter. So as you think about expenses going forward, we expect that you will see more moderate growth in expenses over time. We're doing a lot to manage our expenses, as you heard on the last couple of quarters.

顯然，我們將在1月下旬或2月初，按照慣例，提供2024年的具體指引。如您所見，過去幾年我們的支出隨著產品組合的擴大而增加。我們認為，這種成長非常必要且合理，因為我們開發了業內最優秀、最全面的產品線之一，涵蓋病毒學、腫瘤學和細胞療法等領域。吉利德的支出水準終於與同業持平，尤其是在研發方面，正如您在第三季所見。因此，展望未來，我們預期支出成長將趨於溫和。正如您在過去幾季所了解到的，我們正在採取許多措施來控制支出。

Maybe the best evidence of that, Terence, is if you look at our first quarter R&D expenses, our third quarter R&D expenses are essentially flat. So you saw a little bit of a step down from the first quarter, in the second quarter and the third quarter were flat. So you already see that we're kind of, as we said, we're approaching kind of the peak spend, recognizing that we have 60 different clinical programs. If I remember correctly, we have 27 programs in Phase II, 19 programs in Phase III. That is very different than the Gilead of prior years that you remember and it's part of what makes us so excited about where we're going as a company.

特倫斯，或許最好的證明就是，如果你看我們第一季的研發支出，你會發現第三季的研發支出基本上持平。也就是說，第二季的研發支出比第一季略有下降，而第三季則基本持平。正如我們之前所說，我們已經接近研發支出的峰值，因為我們目前有60個不同的臨床項目。如果我沒記錯的話，其中27個項目處於II期，19個項目處於III期。這和吉利德以往的研發支出水準截然不同，也正是這一點讓我們對公司的未來發展充滿信心。

And the final thing I'd say is you're already seeing the benefits of those investments and the commercial performance that we've talked about for the last 2 years. So we expect that you'll continue to see those benefits in our commercial performance across the entire business, and you're going to see a moderation of expense growth. And again, we'll provide much more specific detail early next year and look forward to talking about this further.

最後我想說的是，您已經看到了這些投資帶來的收益，以及我們過去兩年一直在討論的商業業績成長。因此，我們預期這些收益將繼續體現在我們整個業務的商業業績中，同時費用成長也將趨於緩和。我們將在明年初提供更具體的細節，並期待與您就此進行更深入的探討。

Our next question goes to Evan Seigerman of BMO Capital Markets.

下一個問題請BMO資本市場的Evan Seigerman提問。

One on kind of capital allocation as a function of competitiveness in your respective markets. For example, you have a great moat in virology. How do you think about investment there, say, versus oncology where it's a more competitive marketplace and where we're seeing incremental kind of benefit over time? Maybe some thoughts there.

一種觀點認為，資本配置應取決於各自市場的競爭程度。例如，你們在病毒學領域擁有強大的競爭優勢。那麼，你們如何看待在該領域的投資，與腫瘤學領域相比呢？腫瘤學領域的市場競爭更為激烈，我們看到的是隨著時間的推移而逐步增長的利益。或許你們可以就此分享一些想法。

Evan, it's Andy. I'll start and others may want to jump in as well. Look, I mean, what we've said historically and I'd reiterate is we're always going to follow the science. So we are completely committed to virology, not just HIV, but virology broadly. You see that, for instance, with our progress with obeldesivir as well as other programs. We've also said in virology that a lot of what happens in virology happens in our internal research and that there's a less -- there are less opportunities externally to invest in. That doesn't mean that we won't continue to look for them. And we're going to continue to invest in oncology. We have a much larger oncology organization today. We've increased our internal research and development, and we're still very focused as the third pillar on inflammation. So I would remind people that we have a number of early inflammation programs, including a number in Phase II that we're excited about, Merdad highlighted the TPL2 program in his remarks earlier. But that's just one of the programs that we expect to build out over time.

埃文，我是安迪。我先來，其他人也可以補充。我們一直以來都強調，我還要重申，我們會一直遵循科學。因此，我們完全致力於病毒學，不僅是愛滋病毒，而是整個病毒學領域。例如，我們在奧貝地西韋以及其他專案上取得的進展就證明了這一點。我們也說過，病毒學領域的許多進展都來自我們的內部研究，外部投資機會相對較少。但這並不意味著我們不會繼續尋找機會。我們將繼續投資腫瘤學。如今，我們的腫瘤學部門規模更大。我們增加了內部研發投入，我們仍然非常重視發炎治療，將其作為我們的第三大支柱。因此，我想提醒大家，我們有許多早期發炎治療項目，包括一些我們非常看好的第二期臨床試驗項目。 Merdad 在先前的演講中重點提到了 TPL2 專案。但這只是我們計劃隨著時間推移逐步完善的眾多項目之一。

So we'll follow the science. We're going to apply capital to each of those areas. If you look back, our capital investment has risen and fallen over time in each of those areas as we've looked at different opportunities. And of course, we're going to continue to invest in cell therapy as part of oncology and more broadly, I should have highlighted that earlier. So the short summary is we'll follow the science, but all of the areas will receive additional capital over time.

所以我們會遵循科學。我們會將資金投入各個領域。回顧過去，隨著我們對不同機會的關注，我們在各個領域的投資額都曾出現過波動。當然，我們將繼續投資細胞療法，將其作為腫瘤學以及更廣泛的領域的一部分——我應該早點強調這一點。簡而言之，我們會遵循科學，但隨著時間的推移，所有領域都會獲得額外的資金投入。

Merdad, do you want to add anything to that?

Merdad，還有什麼要補充的嗎？

I would just add that our goal has been to diversify the portfolio. We remain committed and think one of our key competitive advantages is our track record and strength in virology. And we -- I would agree with you, Evan, and that's critical to our continued success and growth. And we also believe that having more diversity in our portfolio, whether it's oncology or inflammation is going to be really important to our long-term future. So we are -- our capital allocation will happen on where the best data are, and we make those trade-offs virtually every day.

我只想補充一點，我們的目標一直是實現投資組合多元化。我們始終致力於此，並認為我們在病毒學領域的過往業績和實力是我們的關鍵競爭優勢之一。我同意你的看法，埃文，這對我們持續的成功和發展至關重要。我們也相信，投資組合的多元化，無論是腫瘤學還是發炎領域，對我們的長遠未來都至關重要。因此，我們的資本配置將基於最佳數據，我們幾乎每天都在權衡利弊。

Our final question goes to Joe Catanzaro of Piper Sandler.

最後一個問題請Piper Sandler公司的Joe Catanzaro提問。

I actually had one on Trodelvy within bladder cancer, and I appreciate this is a smaller proportion of Trodelvy sales. But I just wanted to ask about the potential impact of PADCEV EV-302 data it and moving into the front line and what you could potentially see there with Trodelvy, both maybe in the near term and longer term?

我之前確實有一位患者在膀胱癌領域使用過Trodelvy，我知道這部分患者在Trodelvy的銷售額中所佔比例較小。但我只是想了解PADCEV EV-302的數據及其對Trodelvy一線治療的潛在影響，以及您在短期和長期內可能看到的Trodelvy療效？

So maybe I'll start and then throw to Merdad from a clinical standpoint, what we're thinking. From a commercial standpoint, with the data that we saw, I think the standard of care is going to change in first line, clearly with that data. And we see that as a potential opportunity to actually move up Trodelvy in lines of therapy. So right now in the U.S., we do have accelerated approval in the U.S., and we're seeing about 15%, 16% share in bladder cancer, but later lines of therapy. So third line plus. I think with the opportunity to have PADCEV kind of move up in the first-line setting with pembro, I think it will be interesting to see how Trodelvy kind of moves up as we've seen a lot of sequencing from ADCs here as well. So that's in the here and now.

所以，我先從臨床角度談，然後把話題引到Merdad身上，說說我們的想法。從商業角度來看，根據我們看到的數據，我認為第一線治療的標準將會改變，這一點從數據上可以明顯看出。我們認為這是一個潛在的機會，可以把Trodelvy的治療線數提前。目前，在美國，Trodelvy已經獲得了加速批准，在膀胱癌的治療中，它的市佔率約為15%到16%，但主要用於三線及以後的治療。我認為，隨著PADCEV有機會與帕博利珠單抗（pembro）一起用於一線治療，Trodelvy的治療線數也會隨之增加，這很值得關注，因為我們也看到了許多抗體偶聯藥物（ADC）的序貫治療。以上就是目前的情況。

And maybe, Merdad, do you want to comment on the clinical development?

梅爾達德，您是否想對臨床進展發表一些看法？

Yes. Look, I think it's great news for patients with the data that's come out, and we think it does change the paradigm for bladder cancer. I think the other thing I would add to what Johanna said is that we're looking with interest. We don't have data on sequencing, but we're certainly hearing about sequencing. And there were data that were shown in ESMO around combining PADCEV and Trodelvy, where the tolerability profile looked good and the responses look good. It's a small study, but we think there continues to be opportunity there for us. And having this clarity will help us design where we're going to go from here after our confirmatory trial in second line completes.

是的。我認為，根據已發表的數據，這對患者來說是個好消息，我們認為它確實改變了膀胱癌的治療模式。我想補充Johanna的觀點，我們對此很感興趣。我們目前還沒有測序方面的數據，但我們確實聽到了很多關於測序的資訊。在ESMO會議上公佈的數據顯示，PADCEV和Trodelvy合併用藥的耐受性和療效都很好。雖然這是一項小型研究，但我們認為這方面仍有機會。有了這些明確的訊息，將有助於我們在二線確證性試驗完成後，制定下一步的治療方案。

Thank you. That's all the questions that we have time for today. I will now hand back to Dan for any closing comments.

謝謝。今天的問題就這些問題了。現在我把麥克風交給丹，請他做最後的總結發言。

Well, I just want to thank the team here and all of you for joining. And just maybe end with this reflection, which is, at Gilead, I don't think we could be more excited about as we wrap up 2023 and head into 2024, about the evolution of our commercial and clinical execution. In particular, 2024 will be a year that's full of key clinical catalysts across our portfolio. And that's really been a culmination over the past several years of investing in a robust and diversified portfolio, many of which were Phase II studies that led to Phase III studies, that we'll be reading out over the course of not only next year but the years to come. We'll provide more details on all of our 2024 clinical milestones early next year. But in the meantime, maybe just a couple to highlight in a busy year.

首先，我要感謝團隊以及各位的參與。最後，我想分享我對吉利德的展望：在即將告別2023年、邁入2024年之際，我們對商業和臨床執行的進展感到無比振奮。尤其值得一提的是，2024年將是我們產品組合中許多關鍵臨床進展的一年。這其實是過去幾年我們持續投資於穩健且多元化的產品組合的成果，其中許多計畫都始於II期研究，並由此進入III期研究階段。我們將在明年以及未來幾年陸續公佈這些研究結果。明年年初，我們將公佈2024年所有臨床里程碑的更多細節。在此之前，我想先重點介紹幾個方面，因為今年我們將迎來一個繁忙的年份。

Obviously, on Trodelvy, where the clinical data increasingly highlight that all Trop-2 ADCs are not alike. We'll be rolling out data across a variety of disease states in oncology, and we're excited to share data on lung cancer in the first half of 2024. And then maybe to highlight one other one, lenacapavir will have a rich year of data on the treatment combination candidates. And we continue to target being first to market with our 6-month long-acting preps starting with readouts next year on our Phase III trials and a commercial launch as early as late 2025.

顯然，在Trodelvy上，臨床數據日益表明，並非所有Trop-2抗體偶聯藥物都相同。我們將陸續公佈在多種腫瘤疾病領域的數據，並很高興能在2024年上半年分享肺癌的數據。此外，lenacapavir的聯合治療候選藥物也將迎來豐碩的一年。我們將繼續致力於搶佔市場先機，推出6個月長效製劑，預計明年將公佈III期臨床試驗結果，並於2025年底前商業化上市。

With that, as always, feel free to reach out to the IR team here at Gilead if you have any questions or feedback for our team and we look forward to updating you again early in the New Year. Thank you for joining.

如有任何問題或回饋，歡迎隨時聯繫吉利德的投資者關係團隊。我們期待在新的一年伊始再次與您分享最新進展。感謝您的參與。

Thank you. This now concludes today's call. Thank you all for joining. You may now disconnect your lines.

謝謝。今天的電話會議到此結束。感謝各位的參與。現在可以掛斷電話了。