吉利德科學 (GILD) 2024 Q2 法說會逐字稿

Good afternoon, everyone, and welcome to Gilead's second-quarter 2024 earnings conference call. My name is Rebekah, and I'll be your host for today. (Operator Instructions)

各位下午好，歡迎參加吉利德2024年第二季財報電話會議。我叫麗貝卡，今天由我來主持節目。（操作說明）

I'll now hand the call over to Jacquie Ross, Vice President of Investor Relations and Corporate Strategic Finance.

現在我將把電話交給投資者關係和企業策略財務副總裁傑奎·羅斯。

Thank you, Rebekah. Just after market close today, we issued a press release with earnings results for the second quarter of 2024. The press release, slides, and supplementary 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 2024 年第二季的獲利結果。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, 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：董事長兼執行長 Daniel O'Day；商務長 Johanna Mercier；首席醫療官 Merdad Parsey；以及財務長 Andrew Dickinson。之後，我們將開啟問答環節，屆時 Kite 的執行副總裁 Cindy Perettie 將加入我們的團隊。

Before we get started, 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.

在我們開始之前，請允許我提醒各位，我們將做出一些前瞻性陳述。有關前瞻性陳述的風險和不確定性，請參閱第 2 頁，這些陳述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.

好了，接下來我將把電話交給丹。

Thank you, Jacquie, and good afternoon, everyone.

謝謝你，杰奎琳，大家下午好。

I’m pleased to share that this was another strong quarter of commercial execution with growth across HIV, liver disease, and oncology. BIKTARVY for HIV treatment was up 8% year over year, TRODELVY was up 23%, and cell therapy was up 11%. In addition, we continued to demonstrate disciplined operating expense management and delivered exceptional bottom‐line growth, highlighting the leverage in our business model.

我很高興地宣布，本季商業執行情況依然強勁，HIV、肝病和腫瘤領域均實現了成長。HIV 治療藥物 BIKTARVY 年​​成長 8%，TRODELVY 年成長 23%，細胞療法較去年同期成長 11%。此外，我們繼續展現出嚴格的營運費用管理，並實現了卓越的淨利潤成長，凸顯了我們商業模式的槓桿作用。

Given the results for the first half of the year, we are raising our non‐GAAP operating income and EPS guidance for the full year. Moving to clinical updates, this is an important time for our virology and inflammation therapeutic areas. A key highlight of the quarter was the readout of our Phase 3 PURPOSE 1 trial evaluating lenacapavir for HIV prevention.

鑑於上半年的業績，我們提高了全年非GAAP營業收入和每股盈餘預期。接下來是臨床進展，對於我們的病毒學和發炎治療領域來說，這是一個重要的時期。本季的一大亮點是我們評估 lenacapavir 用於 HIV 預防的 3 期 PURPOSE 1 試驗的結果。

The results showed 100% efficacy with zero HIV infections in cisgender women. The presentation of these results at AIDS 2024 in Munich generated considerable excitement, and we’re delighted to have reached this milestone with such a positive outcome. Lenacapavir, with its twice‐yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen.

結果顯示，此方法有效率達100%，且在順性別女性中未發現HIV感染病例。在慕尼黑舉行的 AIDS 2024 大會上公佈這些結果引起了相當大的轟動，我們很高興能夠以如此積極的結果達到這一里程碑。Lenacapavir 每年只需服用兩次，這可能會為 HIV 預防樹立新的標準，並使 PrEP 能夠惠及更多可以從預防方案中受益的人群。

The PURPOSE program, which is expected to include more than 9,000 participants in over 10 countries, is designed to highlight the efficacy of HIV prevention in a wide range of groups, including cisgender women, transgender men and women, Black and Latino individuals, and young adults. We expect an update for PURPOSE 2 late this year or early next year, with a commercial launch as early as late 2025.

PURPOSE 計畫預計將有超過 10 個國家的 9000 多名參與者，旨在突出 HIV 預防在包括順性別女性、跨性別男性和女性、黑人和拉丁裔人士以及年輕人在內的廣泛群體中的有效性。我們預計 PURPOSE 2 將於今年底或明年年初發布更新，最快可能在 2025 年底進行商業發布。

The PURPOSE data were part of several updates at AIDS 2024 that highlight the strength of Gilead’s innovation in HIV, for both prevention and treatment. Our pipeline has the promise to extend our HIV leadership well into the late 2030s and beyond.

PURPOSE 數據是 AIDS 2024 上發布的幾項更新的一部分，這些更新突顯了吉利德在 HIV 預防和治療方面的創新實力。我們的研發管線有望使我們在愛滋病防治領域的領先地位延續到 2030 年代末及以後。

Updates at AIDS 2024 included data from our daily oral combination of bictegravir and lenacapavir, which is now in pivotal Phase 3 trials for people with HIV, including those on complex regimens. We also shared data from our broad long‐acting program, including our once‐weekly orals GS‐4182 and GS‐1720. We plan to start the Phase 2 study evaluating these in combination before the end of the year. This is in addition to the once‐weekly oral combination of lenacapavir and islatravir in partnership with Merck that will begin Phase 3, also before the end of the year.

在 AIDS 2024 大會上公佈的最新數據包括我們每日口服比克替拉韋和來那卡帕韋組合藥物的數據，該藥物目前正處於針對 HIV 感染者（包括接受複雜治療方案的患者）的關鍵性 3 期試驗階段。我們也分享了我們廣泛的長效計劃的數據，包括我們每週一次的口服GS4182和GS1720。我們計劃在年底前啟動第二階段研究，評估這些藥物合併使用的效果。此外，與默克公司合作研發的每週一次口服的lenacapavir和islatravir組合藥物也將在今年底前開始進行3期臨床試驗。

On the immediate horizon, our PDUFA date for seladelpar is next week. The body of clinical evidence behind seladelpar for the treatment of primary biliary cholangitis, or PBC, continues to grow, most recently with the Phase 3 ASSURE data shared at EASL. The Gilead team is excited by the opportunity to launch seladelpar and bring a promising new treatment to the patients who could benefit.

就目前而言，seladelpar 的 PDUFA 日期是下週。seladelpar 用於治療原發性膽汁性膽管炎 (PBC) 的臨床證據不斷增加，最近在 EASL 上分享了 3 期 ASSURE 數據。吉利德團隊很高興有機會推出 seladelpar，為可能受益的患者帶來這種有前景的新療法。

Moving to Oncology, we are ready to manufacture anito‐cel for multiple myeloma at our Maryland Kite facility, and we are preparing to support the Phase 3 iMMagine‐3 trial from the site starting later this year. The iMMagine‐3 trial is expected to reach a broader set of second‐ to fourth‐line multiple myeloma patients with our potentially best‐in‐class BCMA CAR T.

轉向腫瘤領域，我們已準備好在馬裡蘭州 Kite 工廠生產用於治療多發性骨髓瘤的 anitócel，並且我們正準備從今年晚些時候開始在該工廠支持 3 期 iMMagine 試驗。iMMagine™3 試驗有望使更多二線至四線多發性骨髓瘤患者受益，我們潛在的同類最佳 BCMA CAR T 療法將發揮作用。

At ASCO, we shared new data from our Phase 2 EVOKE‐02 program evaluating TRODELVY in combination with pembro in first‐line metastatic non‐small cell lung cancer. The results showed meaningful efficacy compared to the historical standard‐of‐care, supporting the Phase 3 EVOKE‐03 trial currently underway. We continue to assess the path for TRODELVY in second‐line metastatic non‐small cell lung cancer and metastatic bladder cancer following the EVOKE‐01 and TROPiCS‐04 readouts earlier this year.

在 ASCO 上，我們分享了來自 2 期 EVOKE™02 計畫的新數據，該計畫評估了 TRODELVY 與帕博利珠單抗聯合用於一線轉移性非小細胞肺癌的療效。結果顯示，與歷史標準治療相比，療效顯著，支持目前正在進行的 3 期 EVOKE™03 試驗。繼今年稍早的 EVOKE™01 和 TROPiCS™04 數據公佈後，我們繼續評估 TRODELVY 在二線轉移性非小細胞肺癌和轉移性膀胱癌中的應用前景。

In the meantime, I’d highlight the strong commercial results this quarter in breast cancer where TRODELVY remains the first and only approved TROP2‐directed ADC on the market and is the standard of care for second‐line metastatic triple‐negative breast cancer. To date, we have served over 40,000 cancer patients, and remain confident that TRODELVY will continue to be an important treatment option.

同時，我想重點介紹本季乳癌領域強勁的商業成果，其中 TRODELVY 仍然是市場上第一個也是唯一一個獲批的 TROP2 標靶 ADC，並且是二線轉移性三陰性乳癌的標準療法。迄今為止，我們已為超過 40,000 名癌症患者提供服務，並且仍然相信 TRODELVY 將繼續是一種重要的治療選擇。

We also shared Phase 2 EDGE‐Gastric data at ASCO for domvanalimab plus zimberelimab and chemotherapy in first‐line upper GI cancers. These results showed compelling efficacy that supports the Phase 3 STAR‐221 program, which has completed enrollment.

我們也在美國臨床腫瘤學會 (ASCO) 上分享了 domvanalimab 聯合 zimberelimab 和化療一線治療上消化道癌症的 2 期 EDGE™ 胃癌數據。這些結果顯示出令人信服的療效，支持已完成招募的 STARâft221 3 期項目。

Moving to our 2024 key milestones on slide 6, we look forward to the upcoming updates from the Phase 3 ASCENT‐03 trial and Phase 2 iMMagine‐1 trial. ASCENT‐03 is an event‐driven trial evaluating TRODELVY in first‐line PD‐L1 negative metastatic triple‐negative breast cancer patients. A positive progression‐free survival outcome would support global filings, potentially moving TRODELVY into earlier lines of triple‐ negative breast cancer. Our iMMagine‐1 trial could support regulatory filings for anito‐cel in later‐line relapsed or refractory multiple myeloma.

接下來，我們來看看第 6 頁幻燈片中提到的 2024 年的關鍵里程碑，我們期待即將發布的 ASCENT™03 期試驗和 iMMagine™1 期試驗的最新消息。ASCENT03 是一項以事件驅動的試驗，旨在評估 TRODELVY 在第一線 PD-L1 陰性轉移性三陰性乳癌患者中的療效。無惡化存活期的正面結果將支持全球申請，並有可能將 TRODELVY 推向三陰性乳癌的早期治療階段。我們的 iMMagine™1 試驗可能支持 anito™cel 在晚期復發或難治性多發性骨髓瘤中的監管申請。

Overall, the second quarter was a strong performance for the Gilead team, with the highlights including some remarkable clinical results in HIV, solid revenue growth across therapeutic areas, tangible impact from our disciplined cost management initiatives, and planning for the imminent launch of seladelpar.

總體而言，吉利德團隊在第二季度表現出色，亮點包括 HIV 治療領域取得的一些顯著臨床成果、各治療領域的穩健收入增長、嚴格的成本管理措施帶來的切實影響，以及為即將推出的 seladelpar 所做的規劃。

With that, I will hand it over to Johanna.

然後，我就把它交給喬安娜了。

Thanks Dan, and good afternoon, everyone. I’m very pleased to report the continued momentum we saw in the second quarter, and would like to thank the Gilead teams who contributed to another strong quarter of execution.

謝謝丹，大家下午好。我非常高興地報告我們在第二季度看到的持續成長勢頭，並感謝吉利德團隊為另一個強勁的季度業績做出的貢獻。

As shown on slide 8, total product sales, excluding VEKLURY were $6.7 billion in the second quarter, up 6% year over year, with growth across HIV, liver disease, and oncology. Including VEKLURY, total product sales were $6.9 billion, up 5% year over year.

如投影片 8 所示，第二季產品總銷售額（不包括 VEKLURY）為 67 億美元，較去年同期成長 6%，HIV、肝病和腫瘤領域均成長。包括 VEKLURY 在內，產品總銷售額為 69 億美元，較去年同期成長 5%。

Starting with HIV on slide 9, sales of $4.7 billion were up 3% year over year, driven by strong demand across treatment and prevention, partially offset by lower average realized price due to channel mix. Quarter over quarter, sales were up 9%, reflecting favorable pricing and inventory build following the typical first quarter dynamics, as well as higher demand. Looking to the full year, we remain on track to deliver HIV sales growth of approximately 4%.

從幻燈片 9 中的 HIV 開始，銷售額為 47 億美元，年增 3%，這主要得益於治療和預防方面的強勁需求，但部分被通路組合導致的平均實際價格下降所抵消。與上一季相比，銷售額成長了 9%，這反映了有利的定價和庫存累積（遵循典型的第一季動態），以及更高的需求。展望全年，我們仍有望實現 HIV 銷售額成長約 4%。

Turning to slide 10, total second quarter BIKTARVY sales of $3.2 billion were up 8% year over year, primarily due to higher demand. Sequentially, sales were up 10%, largely reflecting favorable pricing and inventory following the typical first-quarter dynamics.

翻到第 10 張投影片，BIKTARVY 第二季總銷售額為 32 億美元，較去年同期成長 8%，主要原因是需求增加。銷售額環比成長 10%，主要反映了有利的定價和庫存，符合典型的第一季市場動態。

Highlighting our leadership position, BIKTARVY represents more than 49% share of the treatment market in the US This was up almost 3% year over year, our 24th consecutive quarter of year‐over‐year market share gain. With a meaningful share lead over all other branded regimens for HIV treatment, BIKTARVY firmly remains the HIV treatment of choice, particularly for those starting or switching regimens in the US, as well as across other major markets. Overall, the HIV treatment market continues to grow in‐line with our expectations of 2% to 3% annually.

BIKTARVY 在美國治療市場佔有超過 49% 的份額，凸顯了我們的領先地位。這比去年同期成長了近 3%，這是我們連續第 24 個季度實現市場份額同比增長。BIKTARVY 在 HIV 治療領域擁有顯著的市場份額優勢，領先所有其他品牌的 HIV 治療方案，仍然是 HIV 治療的首選，尤其是在美國以及其他主要市場，對於開始或更換治療方案的患者而言更是如此。整體而言，愛滋病治療市場持續成長，符合我們每年 2% 至 3% 的預期。

Turning to DESCOVY, we continued to see higher demand with sales of $485 million in the second quarter. Year over year, sales were down 6% as demand growth was more than offset by lower average realized price due to channel mix. As a reminder, shifts in channel mix will continue to impact average realized price, in addition to our ongoing efforts to ensure people who want or need PrEP have access to the prevention regimen of their choice.

再來看 DESCOVY，我們看到需求持續走高，第二季銷售額達到 4.85 億美元。由於通路組合變化導致平均實際售價下降，需求成長被抵消，銷售額較去年同期下降 6%。再次提醒大家，通路組合的變化將繼續影響平均實際價格，此外，我們將繼續努力確保想要或需要 PrEP 的人能夠獲得他們選擇的預防方案。

Sequentially, sales were up 14%, reflecting favorable inventory and pricing following typical first-quarter seasonality, in addition to the higher demand. DESCOVY for PrEP once again maintained its over 40% PrEP market share in the US, despite the availability of other regimens, including generics. We’re particularly excited to note that the HIV PrEP market in the US continues to expand, with total volumes up more than 12% in the second quarter of 2024 compared to the same period last year.

與上一季相比，銷售額成長了 14%，這反映了第一季典型的季節性因素之後，庫存和定價狀況良好，以及更高的需求。儘管有其他治療方案（包括仿製藥）可用，但 DESCOVY 在美國 PrEP 市場仍保持了 40% 以上的份額。我們特別興奮地註意到，美國 HIV PrEP 市場持續擴張，2024 年第二季總銷售量比去年同期成長超過 12%。

With that in mind, we are thrilled with the unprecedented results seen in our pivotal Phase 3 PURPOSE 1 trial, achieving 100% efficacy with zero cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating. This is just the beginning of our larger, landmark PURPOSE program which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, Black and Latino individuals, and young adults.

考慮到這一點，我們對關鍵的 3 期 PURPOSE 1 試驗中取得的空前成果感到非常興奮，在包括懷孕或哺乳期女性在內的廣大順性別女性人群中，實現了 100% 的療效，且無一例 HIV 感染病例。這只是我們規模更大、具有里程碑意義的 PURPOSE 計劃的開始，該計劃涵蓋了目前 PrEP 使用不足或更難獲得的多個群體和社區，例如順性別女性、跨性別男性和女性、黑人和拉丁裔人士以及年輕人。

Overall, we expect lenacapavir will emerge as the regimen of choice for those who want or need prevention as the first and only long‐acting option with twice‐yearly subcutaneous dosing. We are preparing for potential launch as early as late 2025.

總體而言，我們預計 lenacapavir 將成為那些想要或需要預防的人的首選方案，因為它是第一個也是唯一一個長效選擇，每年兩次皮下注射。我們正在為最早於 2025 年底的可能發布做準備。

Moving to the liver disease portfolio on slide 11, sales were up 17% year over year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the US. Our liver disease franchise continues to differentiate itself, with leading share in HCV despite fewer HCV starts year over year, together with growing demand in HBV and HDV.

在第 11 張投影片中，我們來看肝病產品組合，銷售額年增 17%，較上季成長 13%，這主要得益於美國通路組合帶來的更高需求和更高平均實現價格。我們的肝病業務持續保持差異化優勢，儘管丙型肝炎病例逐年減少，但我們仍佔據丙型肝炎市場份額領先，同時乙型肝炎和丁型肝炎的需求也在不斷增長。

As you know, our PDUFA date for seladelpar is next week, and we stand ready to launch commercially in the US. We are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring seladelpar to many of the 130,000 people impacted by PBC in the US who progress after initial treatment. Outside the US, commercial preparations are well underway, and we look forward to the European regulatory decision in early 2025.

如您所知，seladelpar 的 PDUFA 日期是下週，我們已準備好在美國進行商業推廣。我們能夠利用我們在肝病領域現有的商業佈局，並繼續鞏固這些關係，迅速將 seladelpar 帶給美國 13 萬名受 PBC 影響、在初始治療後病情惡化的患者。在美國以外，商業準備工作正在順利進行，我們期待歐洲監管機構在 2025 年初做出決定。

Turning to slide 12, while severity of COVID infections and hospitalization rates remain variable, VEKLURY continues to be recognized as an important part of the standard of care for hospitalized patients treated for COVID‐19. This includes the US where VEKLURY has maintained well over 60% share in this setting. For the second quarter, VEKLURY sales were down 16% year over year and down 61% sequentially, as expected.

翻到第 12 張幻燈片，儘管 COVID 感染的嚴重程度和住院率仍然存在差異，但 VEKLURY 仍然被認為是 COVID-19 住院患者標準護理的重要組成部分。這其中包括美國，VEKLURY 在該市場的份額一直保持在 60% 以上。如預期，第二季 VEKLURY 的銷售額年減 16%，季減 61%。

Moving to Oncology on slide 13, sales were up 15% year over year and up 7% quarter over quarter to $841 million. With over 60,000 patients treated with a Gilead or Kite therapy to date, we’re proud of the positive impact our oncology medicines have made across multiple cancer types.

在第 13 張投影片中，腫瘤業務的銷售額年增 15%，季增 7%，達到 8.41 億美元。迄今為止，已有超過 60,000 名患者接受了吉利德或凱特療法的治療，我們為我們的腫瘤藥物在多種癌症類型中產生的積極影響感到自豪。

Looking in more detail at TRODELVY on slide 14, sales for the second quarter were $320 million, up 23% year over year and up 4% sequentially, primarily driven by higher demand in the US and Europe across its metastatic breast cancer indications. TRODELVY is the only approved and available TROP2‐directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancers. And with increasing awareness amongst physicians, TRODELVY has remained the leading regimen in the US and Europe for second‐line metastatic triple‐negative breast cancer, with growing adoption in the pre‐treated HR+/HER2‐ metastatic breast cancer setting.

在第 14 張投影片中更詳細地查看 TRODELVY，第二季銷售額為 3.2 億美元，年成長 23%，環比成長 4%，主要得益於美國和歐洲市場對其轉移性乳癌適應症的需求增加。TRODELVY 是唯一獲準且可用的 TROP2 標靶 ADC，在兩種類型的轉移性乳癌中均顯示出具有臨床意義的生存獲益。隨著醫生們的認識不斷提高，TRODELVY 仍然是美國和歐洲二線轉移性三陰性乳癌的主要治療方案，並且在已接受過治療的 HR+/HER2 轉移性乳癌治療中也得到了越來越廣泛的應用。

We are working to expand TRODELVY’s reach beyond the 40,000‐plus patients treated to date across multiple tumor types as we look to new and existing markets, as well as new indications. In bladder cancer, we are planning to further discuss the results of TROPiCS‐04 and next steps with FDA. At this time, TRODELVY continues to be available under an accelerated approval in the US for second‐line plus metastatic or advanced bladder cancer.

我們正在努力擴大 TRODELVY 的適用範圍，使其超越迄今為止已治療的 40,000 多名患者（涵蓋多種腫瘤類型），同時我們也著眼於新的和現有的市場以及新的適應症。在膀胱癌方面，我們計劃與 FDA 進一步討論 TROPiCSâf04 的結果和下一步措施。目前，TRODELVY 在美國仍獲加速核准，用於治療第二線及以上轉移性或晚期膀胱癌。

Turning to slide 15, and on behalf of Cindy and the Kite team, cell therapy sales in the second quarter were $521 million, up 11% year over year and up 9% quarter over quarter, with solid growth in all regions. In the US, sales were up 11% sequentially as we've begun to see momentum from our focused efforts at the authorized treatment centers, including further educating providers and patients on the curative potential of our cell therapies. Despite these efforts, in‐class and out‐of‐class competition remain a near‐term headwind in the US.

翻到第 15 張投影片，我代表 Cindy 和 Kite 團隊表示，第二季細胞療法銷售額為 5.21 億美元，年成長 11%，季增 9%，所有地區均實現了穩健成長。在美國，銷售額環比增長了 11%，因為我們開始看到在授權治療中心集中精力所取得的進展，包括進一步教育醫療服務提供者和患者了解我們細胞療法的治癒潛力。儘管做出了這些努力，但在美國，同級和超級競爭仍然是近期的一大阻力。

As we extend the reach of cell therapy, we are making important in‐roads with key community practices, including working with national payers to unlock broader commercial reimbursement, and as a reminder, expect impact from these initiatives towards the end of 2024. We’ll continue to refine this blueprint as we work to onboard new centers and patients over time.

隨著我們擴大細胞療法的覆蓋範圍，我們正在與關鍵的社區實踐取得重要進展，包括與國家支付者合作，以獲得更廣泛的商業報銷。在此提醒大家，預計這些措施將在 2024 年底產生影響。我們將隨著新中心和病患的陸續加入，不斷改進這項藍圖。

Outside the US, demand for YESCARTA and TECARTUS across Europe and other international geographies remains strong, and we’re encouraged by the solid progress in our newly launched markets such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market: first with seladelpar for PBC next week; and then, lenacapavir for HIV prevention as early as late next year.

在美國以外，歐洲和其他國際地區對 YESCARTA 和 TECARTUS 的需求依然強勁，我們在日本和沙烏地阿拉伯等新推出的市場取得了穩步進展，這令我們倍感鼓舞。總體而言，我們的商業產品組合在第二季度表現強勁，團隊上下都充滿熱情，期待著將另外兩種變革性療法推向市場：首先是下週推出用於治療原發性膽汁性膽管炎的 seladelpar；然後是最早於明年年底推出用於預防 HIV 的 lenacapavir。

And with that, I’ll hand the call over to Merdad.

就這樣，我把電話交給梅爾達德。

Thank you, Johanna. We were very pleased to wrap up the second quarter with two New England Journal of Medicine publications and a number of important readouts across our portfolio. Most exciting was the readout of our Phase 3 PURPOSE 1 trial evaluating twice‐yearly, subcutaneous lenacapavir for the prevention of HIV infection in cisgender women.

謝謝你，喬安娜。我們很高興在第二季末取得了兩篇發表在《新英格蘭醫學雜誌》上的文章，以及我們投資組合中多項重要成果的公佈。最令人興奮的是我們 3 期 PURPOSE 1 試驗的結果，該試驗評估每年兩次皮下注射 lenacapavir 預防順性別女性 HIV 感染的效果。

As you can see on slide 17, this was the first Phase 3 HIV prevention trial to ever achieve 100% efficacy. We have since shared data at the International AIDS Society meeting in July, where our presentation was the highlight of the plenary session. The data were simultaneously published in the New England Journal of Medicine.

正如你在第 17 張投影片上看到的那樣，這是第一個達到 100% 療效的 3 期 HIV 預防試驗。此後，我們在 7 月舉行的國際愛滋病協會會議上分享了數據，我們的報告是全體會議的亮點。這些數據同時發表在《新英格蘭醫學雜誌》。

Our second registrational trial for lenacapavir, PURPOSE 2, has enrolled approximately 3,300 men, transwomen, and non‐binary people who have sex with men. This trial completed enrollment globally in December 2023, approximately four months after PURPOSE 1.

我們針對 lenacapavir 的第二次註冊試驗 PURPOSE 2 招募了約 3,300 名與男性發生性關係的男性、跨性別女性和非二元性別者。該試驗於 2023 年 12 月完成全球招募，約在 PURPOSE 1 之後四個月。

As a result, we expect to provide an update in late 2024 or early 2025. Assuming positive data from PURPOSE 2, we plan to file based on data from both trials, with the goal of bringing transformative HIV prevention to people at risk of HIV as early as late 2025.

因此，我們預計將在 2024 年底或 2025 年初提供最新進展。假設 PURPOSE 2 的數據是正面的，我們計劃根據這兩項試驗的數據提交申請，目標是在 2025 年底之前為有 HIV 感染風險的人群帶來變革性的 HIV 預防。

Beyond our registrational trials, we are generating Phase 2 data from the PURPOSE 3, 4, and 5 trials in key populations across the US, UK, and France, including people who inject drugs. These trials reflect our commitment to evaluate lenacapavir across diverse populations that could benefit. These studies are also intended to drive greater awareness amongst physicians and patients, including geographies where prevention options have not been effective historically.

除了註冊試驗之外，我們還在美國、英國和法國的關鍵人群（包括注射毒品的人群）中開展 PURPOSE 3、4 和 5 試驗，並產生 2 期數據。這些試驗體現了我們致力於評估 lenacapavir 對可能受益的不同族群的療效的承諾。這些研究也旨在提高醫生和患者的意識，包括那些預防措施歷來無效的地區。

In addition to HIV prevention, we are of course intensely focused on next generation HIV treatment options, and slide 18 highlights our comprehensive HIV treatment pipeline. Our recent updates at the AIDS Society meeting included: longer‐term Phase 2 data from our once‐daily oral combination of bictegravir and lenacapavir that showed the regimen was highly effective at maintaining viral suppression. These results further support our ongoing Phase 3 studies in people with HIV, including those on complex regimens.

除了預防愛滋病毒感染外，我們當然也高度關注下一代愛滋病毒治療方案，第 18 張投影片重點介紹了我們全面的愛滋病毒治療研發管線。我們在愛滋病協會會議上的最新進展包括：我們每日一次口服比克替拉韋和來那卡帕韋組合的長期 II 期數據表明，該方案在維持病毒抑制方面非常有效。這些結果進一步支持了我們正在進行的針對 HIV 感染者（包括接受複雜治療方案的患者）的 3 期研究。

We also reported safety and PK data for both GS‐4182, an oral pro‐drug of lenacapavir designed to provide two‐ to three‐times greater oral bioavailability, and GS‐1720, our long‐acting oral integrase inhibitor. Initiation of the Phase 2 trial evaluating the combination of these agents as a once‐weekly oral regimen is expected later this year.

我們也報告了 GS4182（一種口服的 lenacapavir 前藥，旨在提供兩到三倍的口服生物利用度）和 GS1720（我們的長效口服整合酶抑制劑）的安全性和藥物動力學數據。預計今年稍後啟動評估這些藥物組合作為每週一次口服方案的 2 期試驗。

Additionally, we are on‐track to initiate our Phase 3 ISLEND‐1 and ISLEND‐2 trials evaluating once‐weekly lenacapavir in combination with Merck's islatravir. This regimen is expected to be the first once‐weekly oral treatment option.

此外，我們正按計畫啟動 3 期 ISLEND1 和 ISLEND2 試驗，評估每週一次的 lenacapavir 與默克公司的 islatravir 合併用藥的療效。預計該療法將成為首個每週一次的口服治療方案。

Looking at our longer‐duration treatments, we expect to provide Phase 1 updates from our every three‐ month injectable programs and to initiate the Phase 1 studies for our potentially every six‐month integrase inhibitors in the second half of the year.

展望我們持續時間更長的治療方案，我們預計將在今年下半年提供每三個月注射一次的治療方案的 1 期更新，並啟動我們可能每六個月注射一次的整合酶抑製劑的 1 期研究。

Moving to our liver disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the EASL Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open‐label Phase 3 ASSURE study of seladelpar for PBC were consistent with the pivotal RESPONSE study that formed the basis of our global regulatory filings.

接下來談談我們的肝病產品組合。在第 19 張幻燈片中，我們在 6 月的 EASL 會議上展示了 25 篇關於病毒性和發炎性肝病的摘要，突顯了我們持續的領先地位。重要的是，如幻燈片右側所示，seladelpar 治療 PBC 的開放標籤 3 期 ASSURE 研究的最新中期結果與構成我們全球監管申報基礎的關鍵性 RESPONSE 研究的結果一致。

As you know, we expect an FDA regulatory decision shortly, with a decision from European regulators to follow in early 2025.

如您所知，我們預計美國食品藥物管理局（FDA）很快就會做出監管決定，歐洲監管機構也將在2025年初做出決定。

In viral hepatitis, Gilead shared final Week 144 results of the Phase 3 MYR301 trial at EASL. These data continue to support monotherapy bulevirtide 2 milligrams as a chronic treatment for HDV. Additionally, we presented promising Phase 2b data evaluating bulevirtide 10 milligrams with interferon alfa‐2a as a finite regimen. The post‐treatment response rates were the highest ever posted in HDV and were simultaneously published in the New England Journal of Medicine. We’re encouraged by the data and continue to be engaged with KOLs and health authorities, including FDA, as we work to bring bulevirtide to patients as quickly as possible.

在病毒性肝炎方面，吉利德在 EASL 上分享了 MYR301 3 期試驗第 144 週的最終結果。這些數據繼續支持布列維肽 2 毫克單藥治療作為 HDV 的慢性治療。此外，我們也展示了有希望的 2b 期數據，評估了 10 毫克布列維肽與乾擾素 α-2a 作為有限方案的療效。治療後反應率是迄今為止在HDV中報導的最高值，並同時發表在《新英格蘭醫學雜誌》上。我們對這些數據感到鼓舞，並將繼續與關鍵意見領袖和衛生當局（包括 FDA）保持溝通，努力盡快將 bulevirtide 帶給患者。

Switching to oncology, on slide 20, we’re pleased with the progress across our mid- to late-stage programs. In the front‐line setting, we shared mature Cohort A data at ASCO from our Phase 2 EVOKE‐02 trial with TRODELVY plus pembro, demonstrating a median progression‐free survival of 13.1 months. These data exceeded the historical performance of PD‐1 monotherapy in first‐line PD‐L1 high non‐small cell lung cancer and support our ongoing Phase 3 EVOKE‐03 trial where enrollment is going well.

轉到腫瘤學方面，在第 20 張投影片中，我們對中後期專案的進展感到滿意。在第一線治療方面，我們在 ASCO 上分享了我們 2 期 EVOKE™02 試驗中 TRODELVY 加帕博利珠單抗治療的成熟 A 組數據，結果顯示中位無惡化存活期為 13.1 個月。這些數據超過了 PD-1 單藥療法在 PD-L1 高表達非小細胞肺癌一線治療中的歷史療效，並支持我們正在進行的 3 期 EVOKE-03 試驗，該試驗的入組進展順利。

In an all‐comer non‐small cell lung cancer population, our Phase 3 STAR‐121 study evaluating dom plus zim is ongoing. Our Phase 3 STAR‐221 study in upper GI cancers evaluating dom with zim and chemo has completed enrollment. The updated Phase 2 EDGE‐Gastric data presented at ASCO supported the use of this combination. If successful, dom plus zim and chemo would be the first TIGIT‐based regimen for upper GI cancer patients.

我們正在對非小細胞肺癌患者進行 STAR121 期 3 研究，評估 dom 加 zim 的療效。我們正在進行針對上消化道癌症的 STARâft221 3 期研究，評估 dom 與 zim 和化療的療效，目前已完成入組。在 ASCO 上公佈的最新 2 期 EDGE™胃數據支持使用這種組合。如果成功，dom plus zim 和化療將成為第一個基於 TIGITâf 的上消化道癌症患者治療方案。

In addition, we have several Phase 3 programs underway in earlier settings of breast cancer, including ASCENT‐03 evaluating TRODELVY in PD‐L1 negative metastatic triple‐negative breast cancer.

此外，我們在乳癌早期階段還有幾個 3 期計畫正在進行中，包括 ASCENT™03，該試驗評估 TRODELVY 在 PD™L1 陰性轉移性三陰性乳癌中的療效。

Turning to our second‐line programs, we have discussed the results of EVOKE‐01 in metastatic non‐small cell lung cancer with regulators, and as expected, have confirmed there is no immediate regulatory path based on EVOKE‐01 alone. We are currently assessing next steps for TRODELVY in this setting. We will also provide updates on our bladder cancer program, including the full trial results at a future scientific conference, after discussions with FDA and KOLs.

談到我們的二線項目，我們已經與監管機構討論了 EVOKE™01 在轉移性非小細胞肺癌中的療效，並且正如預期的那樣，已經確認僅憑 EVOKE™01 本身沒有直接的監管途徑。我們目前正在評估 TRODELVY 在此環境下的下一步措施。我們還將在與 FDA 和 KOL 討論後，在未來的科學會議上提供有關我們膀胱癌計畫的最新信息，包括完整的試驗結果。

Moving to slide 21, and on behalf of Cindy and the Kite team, we shared updates for YESCARTA and TECARTUS at both ASCO and the European Hematology Association meeting.

翻到第 21 張投影片，我代表 Cindy 和 Kite 團隊，在 ASCO 和歐洲血液學協會會議上分享了 YESCARTA 和 TECARTUS 的最新進展。

At ASCO, we shared encouraging new efficacy data from a pilot study of YESCARTA in 18 patients with relapsed or refractory primary or secondary central nervous system lymphoma in collaboration with the Dana‐Farber Cancer Institute. YESCARTA demonstrated greater than 26 months median overall survival with no reported treatment‐limiting toxicities and no apparent additional risk of adverse events in these patients with high unmet need.

在 ASCO 會議上，我們與 Dana-Farber 癌症研究所合作，分享了 YESCARTA 在 18 名復發或難治性原發性或繼發性中樞神經系統淋巴瘤患者中進行的試點研究的令人鼓舞的新療效數據。YESCARTA 顯示超過 26 個月的中位總存活期，沒有報告治療限制性毒性，也沒有明顯的額外不良事件風險，對於這些未滿足需求較高的患者而言。

Based on these results, we are engaging with regulators to expand the use of YESCARTA to include these patients. Additionally, we reported that treatment with TECARTUS resulted in a 40% four‐year overall survival rate and median overall survival of almost 26 months in the pivotal ZUMA‐3 trial in relapsed or refractory adult B‐cell acute lymphoblastic leukemia.

基於這些結果，我們正在與監管機構接洽，以擴大 YESCARTA 的使用範圍，將這些患者納入其中。此外，我們報告稱，在關鍵的 ZUMA3 試驗中，對於復發或難治性成人 B 細胞急性淋巴細胞白血病，TECARTUS 治療的四年總生存率為 40%，中位總生存期接近 26 個月。

At EHA, we shared preliminary analysis from the Phase 2 ZUMA‐24 trial further supporting outpatient use of YESCARTA in relapsed or refractory large B‐cell lymphoma with the use of prophylactic steroids and other early intervention strategies. Real‐world manufacturing experience of YESCARTA for second‐ and third‐line large B‐cell lymphoma, reinforces our strong manufacturing success rate of 96%.

在歐洲血液學協會 (EHA) 上，我們分享了 2 期 ZUMA™24 試驗的初步分析，進一步支持在復發或難治性大 B™ 細胞淋巴瘤中使用 YESCARTA 進行門診治療，同時配合預防性類固醇和其他早期幹預策略。YESCARTA 在二線和三線大 B 細胞淋巴瘤治療中的實際生產經驗，鞏固了我們 96% 的強大生產成功率。

Further, on slide 22, I will highlight our promising clinical development program for anito‐cel, a potential best‐in‐class BCMA CAR T that we are developing in partnership with Arcellx. Notably, we shared our study design for our Phase 3 iMMagine‐3 trial that will include a broader set of earlier‐line, relapsed, or refractory multiple myeloma patients. We expect to have first patient in for this trial in the second half of this year.

此外，在第 22 張投影片中，我將重點介紹我們與 Arcellx 合作開發的、具有潛力的同類最佳 BCMA CAR T 的 anito®cel 的有前景的臨床開發計劃。值得一提的是，我們分享了我們的 3 期 iMMagine™3 試驗的研究設計，該試驗將納入更廣泛的早期、復發或難治性多發性骨髓瘤患者。我們預計今年下半年迎來該試驗的首例患者。

We are pleased to note that the tech transfer and transfer of the US IND of anito‐cel to Kite are now complete. The Kite manufactured product will be used in the iMMagine‐3 trial, and we anticipate the turnaround time for anito‐cel to be on par with Kite’s commercially available products.

我們很高興地註意到，anitoâfcel 的技術轉移和美國 IND 轉讓現已完成。Kite 生產的產品將用於 iMMagine™3 試驗，我們預計 anito™cel 的周轉時間將與 Kite 的商業化產品持平。

Wrapping up with our key 2024 milestones on slide 23, we completed all of our first half milestones, and are pleased with our program execution overall. We’re off to a good start for the second half with the readout of PURPOSE 1 occurring ahead of our committed timeline. We look forward to the FDA decision next week for seladelpar in PBC, as well as an update from the pivotal Phase 2 iMMagine‐1 trial in later‐line relapsed or refractory multiple myeloma, in addition to an update on the pivotal Phase 3 ASCENT‐03 study in first‐line PD‐L1 negative metastatic triple‐negative breast cancer.

在第 23 頁投影片中，我們總結了 2024 年的主要里程碑，我們完成了上半年的所有里程碑，並且對我們的整體專案執行情況感到滿意。下半年開局良好，PURPOSE 1 的成果發布比我們承諾的時間表提前完成。我們期待 FDA 下週對 seladelpar 在 PBC 中的應用做出決定，以及針對晚期復發或難治性多發性骨髓瘤的關鍵性 2 期 iMMagine™1 試驗的最新進展，此外，我們還期待針對一線 PD™L1 陰性轉移性三陰性乳腺癌的關鍵性 3 期 ASCENT™03 研究的最新進展。

Along with these updates, we have a maturing inflammation pipeline that includes several Phase 2 programs, such as a once‐daily oral alpha‐4‐beta‐7 integrin inhibitor and an oral TPL2 inhibitor for inflammatory bowel disease.

除了這些更新之外，我們還有一個日趨成熟的發炎治療產品線，其中包括幾個 2 期項目，例如每日一次口服 α4β7 整合素抑制劑和用於治療發炎性腸道疾病的口服 TPL2 抑制劑。

And now, I’ll hand the call over to Andy.

現在，我把電話交給安迪。

Thank you, Merdad, and good afternoon, everyone.

謝謝你，梅爾達德，大家下午好。

Starting on slide 25, the team delivered an excellent quarter, with our base business up 6% year over year to $6.7 billion. Product sales growth across HIV, liver disease, and oncology more than offset the expected decline in VEKLURY, with total product sales up 5% year over year.

從第 25 頁開始，團隊取得了優異的季度成績，我們的基礎業務年增 6%，達到 67 億美元。HIV、肝病和腫瘤領域的產品銷售成長超過了 VEKLURY 的預期下降幅度，產品總銷售額較去年同期成長 5%。

Moving to our non‐GAAP results on slide 26, product gross margin was 86%, down 84 basis points from last year. R&D expenses were down 3% year over year, primarily due to the wind‐down of certain magrolimab, obeldesivir, and TRODELVY studies following recent data and regulatory updates. Sequentially, R&D was down 5%, primarily due to the timing of clinical and manufacturing activities, partially offset by the initiation of new studies. These savings reflect disciplined management of R&D resources towards the most meaningful opportunities.

接下來是第 26 頁的非 GAAP 業績，產品毛利率為 86%，比去年下降了 84 個基點。研發費用年減 3%，主要是由於近期數據和監管更新後，某些 magrolimab、obeldesivir 和 TRODELVY 研究的逐步停止。研發投入較上季下降 5%，主要原因是臨床和生產活動的進度安排，但部分被新研究的啟動所抵銷。這些節省體現了對研發資源進行嚴格管理，以抓住最有意義的機會。

Acquired IPR&D was $38 million, reflecting new and ongoing collaboration payments in the second quarter. SG&A was down 27% year over year, primarily due to the $525 million legal settlement in 2023 that did not repeat in 2024. Excluding this payment, SG&A was up 2% year over year, and includes commercial investments ahead of the launch of seladelpar.

第二季收購的智慧財產權和研發支出為 3,800 萬美元，反映了新的和持續的合作付款。銷售、一般及行政費用年減 27%，主要是因為 2023 年支付的 5.25 億美元法律和解金在 2024 年沒有再支付。除此款項外，銷售、一般及行政費用年增 2%，其中包括在 seladelpar 上市前進行的商業投資。

Operating margin for the second quarter was 47%, our strongest operating margin since the third quarter of 2022, highlighting the leverage we have in our business model. Turning to tax, our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the second quarter.

第二季營業利益率為 47%，是自 2022 年第三季以來最高的營業利潤率，凸顯了我們商業模式的優勢。就稅收而言，我們的實際稅率約為 18%，這反映了我們在第二季與稅務機關達成的和解。

On a reported basis, our non‐GAAP diluted EPS grew 50% year over year from $1.34 to $2.01 per share. As mentioned earlier, we had a $525 million legal settlement, representing $0.32 per share, in the second quarter of 2023 that did not repeat in the second quarter of 2024. Excluding this settlement, EPS grew 21% year over year, reflecting higher product sales and lower expenses including acquired IPR&D expenses.

按報告數據，我們的非GAAP稀釋後每股收益年增50%，從每股1.34美元增至每股2.01美元。如前所述，我們在 2023 年第二季達成了一項 5.25 億美元的法律和解協議，相當於每股 0.32 美元，但 2024 年第二季沒有再次達成類似協議。不計入此次和解，每股收益年增 21%，反映產品銷售額成長和支出減少，包括收購智慧財產權和研發費用。

As highlighted on slide 27, we had a strong first half of the year, with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year over year, which is at the upper end of our full‐year guidance of 4% to 6%.

正如幻燈片 27 中所強調的那樣，我們今年上半年業績強勁，病毒學和腫瘤學等各個核心業務都取得了穩健的業績，推動基礎業務同比增長 6%，這達到了我們全年 4% 至 6% 指導目標的上限。

Switching to our expectations for 2024 on slide 28, we continue to expect total product sales in the range of $27.1 billion to $27.5 billion, and total product sales, excluding VEKLURY, in the range of $25.8 billion to $26.2 billion. Given the inherent variability experienced historically, and as stated previously, we are not updating our VEKLURY guidance at this time.

在第 28 頁投影片中，我們繼續預測 2024 年的總產品銷售額將在 271 億美元至 275 億美元之間，不包括 VEKLURY 在內的總產品銷售額將在 258 億美元至 262 億美元之間。鑑於歷史上固有的波動性，以及先前所述，我們目前不會更新 VEKLURY 的指導意見。

As we think about the second half of the year, here are some of the factors that we are continuing to monitor. First, we continue to expect the normal, quarter‐to‐quarter variability in our HIV business that we have always experienced relative to average realized price associated with channel mix. Second, we expect quarterly variability in cell therapy due to continued in‐class and out‐of‐class competition.

展望下半年，以下是我們持續關注的一些因素。首先，我們預計 HIV 業務仍將像以往一樣，按季度波動，這與通路組合相關的平均實現價格有關。其次，由於同類產品和同類產品以外產品的持續競爭，我們預期細胞療法會出現季度波動。

Third, there is some uncertainty associated with TRODELVY bladder revenue following TROPiCS‐04. As a reminder, bladder represents less than 10% of total TRODELVY sales today. And finally, there is a possibility of incremental FX headwinds in the second half of the year.

第三，TROPiCSâve04 之後，TRODELVY 膀胱收入有些不確定性。需要提醒的是，目前膀胱尿布的銷售額僅佔 TRODELVY 總銷售額的不到 10%。最後，今年下半年外匯市場可能面臨進一步的不利因素。

For the rest of 2024, we continue to expect to deliver strong volume growth across all therapeutic areas, and assuming approval, seladelpar as an incremental contributor to revenue growth. Continued HIV volume and revenue growth, consistent with our full-year expectation to grow HIV product sales by approximately 4% and continued focus on disciplined operating expense management.

2024 年剩餘時間裡，我們繼續預期所有治療領域的銷售將實現強勁增長，並假設獲得批准，seladelpar 將成為收入成長的增量貢獻者。HIV產品銷售和收入持續成長，符合我們全年HIV產品銷售額成長約4%的預期，並持續專注於嚴格的營運費用管理。

Moving to the non‐GAAP guidance, there is no change to our non‐GAAP gross margin range of 85% to 86%. For R&D, we now expect total R&D expense to increase by a low- to mid‐single‐digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024, despite absorbing the late‐stage seladelpar program.

就非GAAP準則而言，我們的非GAAP毛利率範圍仍為85%至86%，沒有變動。就研發而言，我們現在預計研發總支出將比 2023 年增長個位數百分比，低於先前預期，儘管吸收了後期 seladelpar 專案。

For SG&A, there is no change to our prior guidance pointing to a mid‐single digit decline compared to 2023. Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the CymaBay transaction.

對於銷售、一般及行政費用，我們先前的預期沒有改變，預計與 2023 年相比將出現中等個位數的下降。與上個季度的預期一致，我們已經能夠消化與 CymaBay 交易相關的額外費用。

For acquired IPR&D, we now expect full‐year expenses of $4.7 billion, up from $4.4 billion last quarter to reflect a $320 million transaction with Janssen to buy out the global seladelpar royalty. This expense will be included in our third-quarter results.

對於收購的智慧財產權和研發，我們現在預計全年支出為 47 億美元，高於上一季的 44 億美元，這反映了與 Janssen 達成的 3.2 億美元交易，以收購全球 seladelpar 特許權使用費。這筆費用將計入我們第三季的業績。

Finally, with the strong operational expense control demonstrated in both the first and second quarters, and despite this new $320 million acquired IPR&D expense, we are increasing our operating income guidance to $7.2 billion to $7.6 billion, and increasing our non‐GAAP diluted EPS guidance to $3.60 to $3.90.

最後，鑑於第一季和第二季都展現了強勁的營運費用控制，儘管新增了 3.2 億美元的收購智慧財產權研發費用，我們仍將營業收入預期上調至 72 億美元至 76 億美元，並將非 GAAP 稀釋後每股收益預期上調至 3.60 美元至 3.90 美元。

Slide 29 highlights that the increase to our EPS guidance fully absorbs the $320 million, or approximately $0.20 per share, expense associated with the buy‐out of the seladelpar royalty from Janssen. This transaction removes Gilead’s royalty obligation to pay 8% of seladelpar sales.

第 29 頁投影片強調，我們提高每股盈餘預期完全抵銷了與從 Janssen 收購 seladelpar 特許權使用費相關的 3.2 億美元（約每股 0.20 美元）支出。這項交易免除了吉利德公司支付 seladelpar 銷售額 8% 的特許權使用費義務。

Excluding this transaction, our EPS guidance increase would have been even more significant today, up $0.30 or 8% at the midpoint, again highlighting the financial discipline that has translated into operating leverage.

如果排除這筆交易，我們今天的每股盈餘預期上調幅度會更大，中位數為 0.30 美元或 8%，再次凸顯了財務紀律轉化為營運槓桿的作用。

Moving to slide 30, we continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities. In the second quarter, we returned $1.1 billion to shareholders, repaid $1.75 billion of senior notes, and paid $1.2 billion as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017. The remaining transition tax payment of $1.3 billion is scheduled for April 2025.

翻到第 30 頁，我們的資產負債表仍有足夠的彈性來執行我們的資本配置優先事項。第二季度，我們向股東返還了 11 億美元，償還了 17.5 億美元的高級票據，並支付了 12 億美元作為與 2017 年減稅和就業法案相關的聯邦過渡稅的一部分。剩餘的13億美元過渡稅計畫於2025年4月支付。

Overall, we believe that Gilead is well‐positioned for near‐ and long‐term growth, and we continue to be focused on commercial execution, expense management discipline, and to delivering on our strategic commitments.

總體而言，我們相信吉利德已為近期和長期成長做好了充分準備，我們將繼續專注於商業執行、費用管理紀律以及履行我們的策略承諾。

And now, I’ll invite Rebekah to begin the Q&A.

現在，我邀請麗貝卡開始問答環節。

(Operator Instructions)

（操作說明）

Hi there, this is Evan Seigerman from BMO Capital Markets. I wanted to touch on TIGIT. There's been a lot of updates in the TIGIT space in ASCO. We had the Roche update. And most recently, Merck discontinued their KeyVibe study in small cell lung cancer.

大家好，我是BMO資本市場的Evan Seigerman。我想談談TIGIT。ASCO 的 TIGIT 領域有許多更新。我們收到了羅氏的最新進展報告。最近，默克公司終止了針對小細胞肺癌的 KeyVibe 研究。

So Merdad, maybe you could walk us through how you think about the opportunity for TIGIT? And what looks good -- what good would look like for you in terms of safety and efficacy with the STAR-121 program? Thank you so much.

Merdad，您能否跟我們談談您如何看待TIGIT的機會？那麼，對於您而言，STAR-121 專案的安全性和有效性方面，什麼樣的表現才是好的呢？太感謝了。

Thanks, Evan, for the question. Yeah, I think, as you noted, there have been a lot of updates on TIGIT over the past six months or so. And I think that gets to our approach, which I think is somewhat differentiated from our competition in that, as we've said all along, we have a differentiated molecule first off, and that is that we have an Fc-silent molecule relative to an Fc-active molecule that the competition has.

謝謝埃文的提問。是的，正如你所指出的，在過去的六個月左右的時間裡，TIGIT 有許多更新。我認為這與我們的方法有關，我認為我們的方法與競爭對手有所不同，正如我們一直所說，首先我們擁有一個差異化的分子，那就是我們擁有一個 Fc 沉默分子，而競爭對手擁有一個 Fc 活性分子。

And we have note -- I would note that, that is demonstrating a difference in terms of the adverse event profile, including the data that we highlighted today. Additionally, I think we've tried to stay focused in areas where we believe that there is the best chance of activity. And so for example, we have not initiated any trials with small cell. We look forward to capitalizing on the data we have seen so far both in non-small cell lung cancer and gastric cancer. As you know, we provided an update on EDGE-Gastric study at Asco. And as I noted in the call, we have completed enrollment of that -- of the Phase 3 trial of that.

我們注意到——我想指出的是，這表明不良事件概況存在差異，包括我們今天重點介紹的數據。此外，我認為我們一直在努力將重點放在我們認為最有可能開展活動的領域。例如，我們還沒有進行任何小細胞試驗。我們期待利用目前在非小細胞肺癌和胃癌領域所獲得的數據。如您所知，我們在ASCO會議上提供了關於EDGE-Gastric研究的最新進展。正如我在電話會議中提到的，我們已經完成了該試驗的 3 期臨床試驗的受試者招募工作。

So we continue to be cautiously optimistic about TIGIT and are doing it in a data driven way based on the data we've generated in our trials so far.

因此，我們繼續對 TIGIT 持謹慎樂觀態度，並以數據驅動的方式，根據我們迄今為止在試驗中產生的數據來開展工作。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

Great. Thanks for taking that question. A two-part for me. Just Merdad, wondering if you can help frame expectations for the PURPOSE 2 trial, just given this is a slightly different population relative to PURPOSE 1. So just as we think about level setting their ahead of that data.

偉大的。謝謝你回答這個問題。對我來說，這分為兩個部分。Merdad，我只是想知道你是否可以幫忙確定 PURPOSE 2 試驗的預期，因為這次試驗的人群與 PURPOSE 1 略有不同。所以，當我們考慮設定水平線時，他們已經領先這些數據。

And then, the second part is for Johanna, so obviously, you guys noted that you've seen growth in the PrEP market recently, which is encouraging. But what other steps can you as a company take to maybe help alleviate some of the payer roadblocks that are really still in the way of branded PrEP use, given the still high level of generic Truvada use? Thank you.

然後，第二部分是給 Johanna 的，顯然，你們注意到最近 PrEP 市場有所成長，這令人鼓舞。但鑑於仿製藥 Truvada 的使用率仍然很高，作為一家公司，你們還可以採取哪些其他措施來幫助緩解一些仍然阻礙品牌 PrEP 使用的支付方障礙？謝謝。

Thanks, Terence. I'll start and then I'll hand it off to Joanna, as you said. It's a great question and a good thing for us to make sure that everyone remembers. Our Purpose 1 was the trial that was in cisgender women. And as I noted, PURPOSE 2 is our ongoing study in cisgender gay men, transgender women and men, and gender non-binding people. And that study is ongoing.

謝謝你，特倫斯。我先開始，然後照你說的，交給喬安娜。這是一個很好的問題，我們最好確保每個人都能記住。我們的首要目標是針對順性別女性的試驗。正如我所指出的，PURPOSE 2 是我們正在進行的針對順性別男同性戀者、跨性別女性和男性以及性別非約束人群的研究。這項研究仍在進行中。

It is the second trial that's necessary for filing. And like PURPOSE 1, PURPOSE 2 is designed to evaluate the superiority of lenacapavir against background HIV rate. That's the primary endpoint and the secondary endpoint would be similar to PURPOSE 1, will be superior to Truvada as a secondary endpoint.

這是提交申請所必需的第二次審判。與 PURPOSE 1 一樣，PURPOSE 2 旨在評估 lenacapavir 在 HIV 背景感染率下的優越性。這是主要終點，次要終點與 PURPOSE 1 類似，作為次要終點將優於 Truvada。

So once we -- if hopefully we demonstrate a positive result in PURPOSE 2, we combine those data with PURPOSE 1 and move as quickly as possible to filing those data to lenacapavir for PrEP.

因此，一旦我們——如果希望我們能在 PURPOSE 2 中取得積極成果，我們將這些數據與 PURPOSE 1 的數據結合起來，並儘快將這些數據提交給 lenacapavir 用於 PrEP。

Great. So maybe just to complete the second part of that question around the growth in PrEP and the opportunity lies ahead despite some of the payer roadblocks that you're referring to, just a couple of points on that. One is today the market for PrEP is growing at about 12% or so year on year, so nice consistent growth that we've seen over the last couple of years.

偉大的。所以，為了完成關於 PrEP 成長以及儘管存在一些支付方障礙但未來仍充滿機會的問題的第二部分，我只想就此提出幾點看法。一方面，目前 PrEP 市場正以每年約 12% 的速度成長，這是我們在過去幾年中看到的良好且持續的成長。

DESCOVY's coverage is -- over 90% of our lives are covered from an access standpoint. So today, the daily oral do not have any concerns from an access standpoint. I think maybe what you're referring to is potentially -- as we think about medical benefits versus the pharmacy benefit, that might create a little bit more access headwinds from a payer standpoint and we've seen that already with some of our competitors. As we think about lenacapavir in light of not only the data just most recently with PURPOSE 1 but also just the profile that it offers with a twice-yearly subcu, I think it really allows us to redefine the PrEP market as a whole.

DESCOVY 的覆蓋範圍——從醫療服務獲取的角度來看，我們生活中超過 90% 的內容都得到了覆蓋。所以今天，從獲取途徑的角度來看，每日口服藥物沒有任何問題。我想你可能指的是——當我們考慮醫療福利與藥品福利時，這可能會從支付方的角度造成一些准入方面的阻力，我們已經從一些競爭對手那裡看到了這一點。當我們考慮 lenacapavir 時，不僅要考慮最近 PURPOSE 1 的數據，還要考慮它提供的每年兩次的皮下注射方案，我認為它確實能夠讓我們重新定義整個 PrEP 市場。

And as much as we're seeing today maybe over 400,000 users in the US, we really see three major growth opportunities. One is around market size growth. The other ones around market share growth. And the third one is on adherence.

儘管我們今天在美國看到的用戶可能超過 40 萬，但我們真正看到的是三大成長機會。一是市場規模成長方面的問題。其他的則與市場佔有率成長有關。第三點是關於依從性。

And so if I just break those down a little bit, the market size growth is around reach more users, so well beyond just white MSMs, thinking about cisgender women, transgender men and women, Latino Black individuals, as well as young adults, reaching more prescribers in different settings than we are today and over time reaching more countries, right? Because right now, PrEP revenues are really coming primarily out of the United States.

所以，如果我稍微細分一下，市場規模的增長在於覆蓋更多用戶，遠遠超出白人男男性行為者（MSM）的範疇，還要考慮順性別女性、跨性別男性和女性、拉丁裔黑人以及年輕成年人，在不同的環境中接觸到比現在更多的處方醫生，並且隨著時間的推移，覆蓋更多國家，對吧？因為目前 PrEP 的收入主要來自美國。

From a market share growth standpoint, DESCOVY is the number one branded daily-oral today with over 40% share. And we believe lenacapavir will be number one from a long-acting standpoint. And between the two together, we believe that Gilead presence in HIV prevention will also be leading and greater than where we are today.

從市佔率成長的角度來看，DESCOVY 是目前排名第一的每日口服品牌，市佔率超過 40%。我們相信，從長效性角度來看，lenacapavir 將成為第一名。我們相信，吉利德公司與吉利德公司攜手合作，將在愛滋病預防領域佔據領先地位，並且比我們今天所取得的成就更大。

And last but not least, is higher adherence. And that just has to do with the method -- the frequency of administration. When you think about it, twice-daily subcu has much higher adherence than a daily-oral and obviously better outcomes.

最後但同樣重要的是，更高的依從性。而這僅與給藥方法有關—給藥頻率。仔細想想，每天兩次皮下注射比每天口服的依從性高得多，而且療效也明顯更好。

So all of those pieces together is what we are focused on as an opportunity for the future of prevention. And with not only DESCOVY but obviously with lenacapavir around the corner potentially and from an access standpoint, we are thinking ahead as we think about even the work that CMS is doing, when I think about making it a Part B drug for a medical benefit in PrEP to ensure greater access. But we're also thinking through how is this going to impact from both from a prescriber standpoint and how do we support that reimbursement challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

因此，我們將所有這些因素結合起來，視為未來預防工作的機會。不僅有了 DESCOVY，而且顯然 lenacapavir 也即將問世，從獲取途徑的角度來看，我們正在展望未來，甚至考慮 CMS 正在進行的工作，例如將其作為 PrEP 的醫療福利 B 部分藥物，以確保更大的可及性。但我們也正在思考，從處方醫生的角度來看，這將產生怎樣的影響，以及我們如何應對其他人面臨的報銷挑戰，以及我們如何採取高度人性化的方式，確保每個需要或想要 PrEP 的人都能獲得他們選擇的藥物。

(Operator Instructions) (technical difficulty), Leerink Partners.

（操作說明）（技術難題），Leerink Partners。

Hi, thanks for the question. I want to ask on Anito-cel, a two-part. One is just the process fact. So I wonder if you can confirm whether you have completed enrollment in Imagine 1 and that’s what kind of follow-up time we can expect from the data should it be accepted at ASH?

您好，感謝您的提問。我想問 Anito-cel 一個兩部分的問題。一個只是過程事實。所以我想知道您是否已經完成了 Imagine 1 的註冊，以及如果資料被 ASH 接受，我們可以預期需要多長時間的追蹤？

And then a deeper question on Imagine 3. I wonder what your approach is in Imagine 3 to bridging therapy so as to avoid the higher risk of death that was observed in the competitor trials soon after enrollment? Thank you.

然後是關於 Imagine 3 的一個更深層的問題。我想知道在 Imagine 3 中，你們是如何進行橋接治療的，以避免像競爭對手的試驗中那樣，在入組後不久就出現較高的死亡風險？謝謝。

Thanks Daina. We got Cindy Perettie here. We’ll turn over to her to answer that. Thanks for your question.

謝謝黛娜。辛蒂佩雷蒂今天也來了。我們將請她來回答這個問題。謝謝你的提問。

Thanks, Daina. We continue to be really excited about the potential with anito‐cel with a best-in-class profile and our enrollment target for iMMagine‐1 has been met. I think the second question you asked is what type of follow-up would we expect to see at ASH? And I think we're in the process of -- we did an initial cut. Obviously, for the abstracts, we'll do a second cut for the final sharing of the data. So I don't have the exact follow-up time, but we can certainly look to follow up with you once we have that.

謝謝你，黛娜。我們對anitoâfcel的潛力感到非常興奮，它擁有業內最佳的資質，而且我們的iMMagineâf1招生目標已經實現。我認為你提出的第二個問題是，我們預期在 ASH 會議上會看到什麼樣的後續行動？我認為我們正在進行中——我們已經完成了初步剪輯。顯然，對於摘要，我們會進行第二次篩選，以便最終共享資料。所以我現在還無法確定具體的跟進時間，但一旦確定了時間，我們一定會盡快與您聯繫。

Your second question was around iMMagine‐3 and bridging therapy. Right now, we will be moving -- so we were able to complete the tech transfer as you heard from Dan into our Maryland production facility. So we will be supplying therapy out of our Maryland facility, and we expect to apply a lot of the learnings that we have at our existing products on the market today and be able to get anito‐cel back to those patients in iMMagine‐3 as it relates to having time upfront to do bridging therapy. However, with the protocol design today, we do have the option to do bridging therapy, if necessary for patients.

你的第二個問題是關於 iMMagineâf3 和橋接療法。目前，我們將進行搬遷——正如丹所說的那樣，我們已經完成了技術轉移，將技術轉移到了我們在馬裡蘭州的生產設施。因此，我們將從我們在馬裡蘭州的工廠提供治療，我們希望應用我們目前在市場上現有產品中獲得的許多經驗，並能夠將anito™治療cel帶回給iMMagine™治療3中的患者，因為這涉及到提前進行橋接治療的時間。但是，根據目前的方案設計，如果患者需要，我們可以選擇進行橋接治療。

Umer Raffat, Evercore.

Umer Raffat，Evercore。

Hi, guys. Thanks for taking my question. I'm very intrigued about your lenacapavir plus bictegravir trial heading into Phase 3. And I'm just trying to understand could this regimen possibly replace BIKTARVY to a meaningful extent? Or would you rather have some sort of a low-dose nuke in that combination as well as a second alternative? I'm just thinking back to some of the DOVATO experience, as well. Thank you very much.

嗨，大家好。謝謝您回答我的問題。我非常關注你們的 lenacapavir 聯合 bictegravir 的 3 期臨床試驗。我只是想了解這種療法是否有可能在一定程度上取代 BIKTARVY 療法？或者，您是否更傾向於在這種組合中加入某種低劑量核彈，作為第二種替代方案？我也想起了一些在 DOVATO 的經驗。非常感謝。

So maybe I'll take that one, Ummar. So the len-bic combination is a single-treatment regimen that really combines our best-in-class integrase inhibitor with a first-in-class capsid. The studies that we are doing both Phase 2 and 3 are really -- first, that we looked at the complex regimen, which that was kind of a first step. And as we go into Phase 3, we believe we can get a broader label indication to also include all [virologically suppressed].

所以，也許我會接受這個提議，烏瑪爾。因此，len-bic 組合是一種單一治療方案，真正將我們一流的整合酶抑制劑與首創的衣殼結合在一起。我們正在進行的第二階段和第三期研究其實是——首先，我們研究了複雜的治療方案，這算是第一步。隨著我們進入第三階段，我們相信我們可以獲得更廣泛的適應症標籤，將所有內容也納入其中。[病毒學抑制]。

So as we think about that opportunity, we think it's an opportunity for an FTI to optimize, simplify for complex regimen, but also provides optionality in the viral decree to press the switch segment of the marketplace.

因此，當我們思考這個機會時，我們認為這是一個 FTI 優化、簡化複雜治療方案的機會，同時也為病毒法令提供了選擇餘地，以推動市場轉型。

So when we think about it as a portfolio perspective, we still believe that today BIKTARVY is the standard of care and will remain as the standard of care from a daily-oral standpoint, but we also see that's an opportunity in the switch segment. So naïve is a big piece -- probably the biggest piece for BIKTARVY's growth and the switch because we have such a large share, obviously, right? So from a switch segment that offers us another opportunity for us to play in a bigger market space in HIV.

因此，從投資組合的角度來看，我們仍然認為，從日常口腔護理的角度來看，BIKTARVY 目前是護理標準，並將繼續保持這一標準，但我們也看到，在轉換領域存在著機會。所以，天真（naïve）是很大一部分——可能是BIKTARVY成長和轉變的最大因素，因為我們顯然佔了很大一部分份額，對吧？因此，從轉換領域來看，這為我們提供了另一個機會，讓我們能夠在愛滋病毒領域更大的市場空間中發揮作用。

Carter Gould, Barclays.

Carter Gould，巴克萊銀行。

Great, thank you. Good afternoon. Thanks for taking the question. Maybe another one on PURPOSE 1. So again, the efficacy was very impressive. However we could see that north of 20% of patients that have nodules out to week 52. And I guess for Johanna, as you think about that profile in this setting recognizing they were only grade one, but sort of the long-term nature of those nodules, how do you see that influencing or impacting the profile, its demand, and the potential for those patients then go back and you get retreated after six months? Thank you.

太好了，謝謝。午安.感謝您回答這個問題。或許還有另一個專門針對 1 的。所以，效果再次令人印象深刻。然而，我們可以看到，超過 20% 的患者在懷孕 52 週時仍有結節。我想，對於 Johanna 來說，當你考慮到這種情況下的病情，雖然它們只是 1 級，但這些結節的長期性質，你認為這會如何影響病情、需求以及這些患者在六個月後再次接受治療的可能性？謝謝。

Sure. And Carter, just to explain a little bit, the nodules are because it's a drug depot, right? So the nodule actually get smaller over time. What we've seen is actually very little discontinuation of PURPOSE 1 due to that. That's number one.

當然。卡特，我稍微解釋一下，這些結節是因為那裡是毒品庫，對吧？所以隨著時間的推移，結節實際上會變小。我們看到的情況是，由於上述原因，PURPOSE 1 實際上並沒有出現太多停產的情況。這是第一點。

Two, if the nodules are sometimes palpable, not all -- but sometimes possible, but not visible, and generally speaking. And so we believe that actually, we will have some flexibility as well as to where those injections play out. And when -- because I think they've been studied in different places, not just in the stomach inside. And so I think that will be an opportunity as well for people to be a little bit more flexible as to where they get their injections.

第二，如果結節有時可以觸及，並非總是如此——但有時可能，但肉眼不可見，而且一般來說。因此我們相信，實際上，我們在這些注射的實施地點方面也會有一定的彈性。而且——因為我認為它們在不同的地方都得到了研究，而不僅僅是在胃裡。所以我認為這也將為人們提供一個機會，讓他們在註射地點方面更加靈活。

So we're not overly concerned there at all actually. Actually and really, we're taking it from the data that we're getting from PURPOSE 1. And hopefully, we'll have similar data to learn from PURPOSE 2.

所以實際上我們對此並不太擔心。實際上，我們是從 PURPOSE 1 獲得的數據中得出這個結論的。希望我們能從 PURPOSE 2 中獲得類似的數據來學習。

Mike Yee, Jefferies.

Mike Yee，傑富瑞集團。

Thank you, guys. We have one question on long-acting HIV, specifically the potential for [AQ] six month, which I think could be a game changer. I think you have one or two of them on your slide and they are advancing. Can you tell me your confidence level on what you have there? Because if you follow HIV development, you know that if it's generally safe and more tolerant than significant (inaudible) reduction. You're in a pretty good spot in Phase 1, 2. Thank you. Let me know.

謝謝大家。我們有一個關於長效 HIV 的問題，特別是 [AQ] 六個月的潛力，我認為這可能會改變遊戲規則。我認為你的幻燈片上有一兩個這樣的幻燈片，而且它們正在推進。你對目前掌握的資訊有多大信心？因為如果你關注 HIV 的發展，你就會知道，如果它總體上是安全的，並且比顯著的（聽不清楚）減少更耐受。你在第一階段和第二階段都處於相當有利的位置。謝謝。請告訴我。

Hi, Michael. It's Merdad. Thanks.

你好，麥可。是梅爾達德。謝謝。

Yeah, I think you raised the right question, which is that whenever we're looking at the long-acting -- new long-acting agents, we have to be cautious about the transition from preclinical to clinical. We don't -- we're not always able to predict the injection site reactions that you might get from the log-acting, in particular. We were just talking about the nodules for lenacapavir, but other more severe injection site reactions and then the human pharmacokinetics.

是的，我認為你提出的問題很正確，那就是每當我們研究長效——新型長效藥物時，我們都必須謹慎對待從臨床前到臨床的過渡。我們無法－我們並非總是能夠預測注射部位可能出現的反應，特別是對數作用的注射部位反應。我們剛才還在討論來那卡帕韋引起的結節，但其他更嚴重的注射部位反應以及人體藥物動力學。

So I think we need those to play out to allow us to move forward. And that's why you see multiple agents going into Phase 1. We have generated a number of molecules. We move them forward. We've been pretty aggressive in moving them forward in order to maintain our leadership in long-acting HIV treatment and prophylaxis. And so once we start to see those data in Phase 1, I think that will help us decide both choosing between those molecules and where we want to go forward.

所以我認為我們需要讓這些事情發生，才能讓我們繼續前進。所以你會看到很多代理商進入第一階段。我們已經合成了一系列分子。我們推動他們前進。為了維持我們在長效 HIV 治療和預防領域的領先地位，我們一直積極推動這些療法的研發。因此，一旦我們開始看到 1 期臨床試驗的數據，我認為這將有助於我們決定在這些分子之間做出選擇，以及我們未來的發展方向。

Remember, we're also moving our bNAb program forward, which will be our -- which is our most advanced long-acting program with lenacapavir plus bNAbs and we should -- we expect to get Phase 2 data from that study as well. So for those early programs, it's the usual risks and which is why we take multiple shots. And hopefully, we'll be able to advance one of them quickly.

記住，我們也在推進我們的 bNAb 項目，這將是我們最先進的長效項目，採用 lenacapavir 加 bNAb，我們應該——我們預計也會從該研究中獲得 2 期數據。所以對於這些早期專案來說，存在著通常的風險，這也是為什麼我們要多次嘗試的原因。希望我們能夠盡快推進其中一個專案。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，加拿大皇家銀行資本市場。

Hi, there. Thanks so much for taking my question. You guys have an oral GLP-1 GS-4751 in your preclinical pipeline. Are you planning to move it forward? And as you continue to diversify that portfolio, how are you guys thinking about the obesity landscape and potentially participating? Or are there other metabolic areas in adjacencies that you may be more interested in pursuing? Thanks.

你好呀。非常感謝您回答我的問題。你們的臨床前研發管線中有一種口服 GLP-1 類藥物 GS-4751。你打算推進這個專案嗎？隨著你們不斷拓展投資組合，你們如何看待肥胖問題以及可能參與其中的可能性？或者，您對鄰近的其他代謝領域更感興趣？謝謝。

Thanks, Brian. Yes, we have shared some preclinical data on 47 -- 4571. As you know, it is an internally developed oral GLP-1 agonist, which came out of our initial interest in our NASH program. And based on the data so far, both preclinical and tox data, we are planning a Phase 1 study for that molecule and that'll help us evaluate 4571 for weight management, obesity, and other metabolic diseases.

謝謝你，布萊恩。是的，我們已經分享了一些關於 47 至 4571 的臨床前數據。如您所知，這是一種內部開發的口服 GLP-1 激動劑，源自於我們最初對 NASH 計畫的興趣。根據目前為止的臨床前和毒理學數據，我們計劃對該分子進行 1 期研究，這將有助於我們評估 4571 在體重管理、肥胖症和其他代謝疾病方面的療效。

Once we generate those data, we will decide in a data-driven way how best to proceed from there and we'll just have to see how that plays out. We want to make sure if we dealt something, it's best in class and allows for a best-in-class profile. So we'll update more as the data are generated.

一旦我們產生了這些數據，我們將以數據驅動的方式決定下一步的最佳方案，然後我們只需看看結果如何。我們希望確保，如果我們處理某件事，那就是最好的，並且能夠帶來最好的效果。隨著數據的生成，我們會進行更多更新。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Great. Thanks, so much. My questions -- our question was just on the US CAR-T franchise. Just want to get your latest view on how we should be thinking about sequential growth from her? And maybe as part of that, can we just get an update on your community physician engagement with the CAR-Ts any leading indicators that you're seeing there that'll help could move the guide some of the efforts or when we could start seeing the impact from some of these efforts in the US? Thank you.

偉大的。非常感謝。我的問題——我們的問題只是關於美國的 CAR-T 特許經營權。想聽聽你對我們應該如何看待循序漸進成長的最新看法？或許作為其中的一部分，我們能否了解一下您的社區醫生參與 CAR-T 療法的最新情況？您觀察到的任何領先指標是否有助於指導一些工作，或者我們何時才能在美國開始看到這些工作的影響？謝謝。

Thanks, Chris. We are really pleased with our strong cell therapy growth this quarter and this is really part and parcel to our US refresh strategy. So as a reminder, we restructured our sales team at the end of last year and we've got our new sales team in place and trained and ready to go. And as part of that strategy, we also focused for the next couple of quarters on really -- within the authorized treatment centers making sure those referrals occur between the lymphoma specialists to the CAR-T specialists. And that's what you're seeing as part of the excellent performance that we had this quarter. And we'll continue to deliver and really focus on the referrals within the AGC.

謝謝你，克里斯。我們對本季細胞療法業務的強勁成長感到非常滿意，這確實是我們美國業務更新策略的重要組成部分。再次提醒大家，我們在去年底重組了銷售團隊，現在新的銷售團隊已經到位、訓練有素，隨時可以投入工作。作為該策略的一部分，在接下來的幾個季度裡，我們還重點關注在授權治療中心內，確保淋巴瘤專家向 CAR-T 專家進行轉診。這就是你們在本季看到的我們出色業績的一部分。我們將繼續努力，並真正專注於AGC內部的轉診。

We're also in parallel building up those community practices and spending time educating both the community practices, I'd say, regional hospitals and those institutions about the curative potential of CAR-T and why it's important to bring this into the therapy that they're offering to their patients. And we're making really good progress there, including a lot of work with national payers.

我們同時也在同步發展這些社區診所，並花時間向社區診所、地區醫院和相關機構普及 CAR-T 療法的治癒潛力，以及為什麼將這種療法引入他們為患者提供的治療方案中非常重要。我們在這方面取得了非常好的進展，包括與國家支付方進行了大量工作。

But despite all of this, as you heard earlier from both Dan and Johanna, we are facing -- it's a dynamic market. We are remaining cautious for the second half of this year as we continue to see some competitive headwinds. Both, in-class competition, so we have new indications that came out at the late May, early June timeframe, which are capturing physician mind share initially. And we're also seeing other cost competition with the bispecific.

但儘管如此，正如你之前從丹和喬安娜那裡聽到的那樣，我們面臨的是一個充滿活力的市場。鑑於我們持續面臨一些競爭阻力，我們對今年下半年仍保持謹慎態度。兩者都存在課堂競爭，因此我們在 5 月下旬至 6 月初出現了一些新的跡象，這些跡象最初引起了醫生的注意。我們也看到雙特異性抗體在成本方面也存在競爭。

But with all of that said, we are focused on execution and working with our physicians and institutions to raise awareness of the curative potential for CAR-T, and we'll continue to do so the second half of this year. As it relates to community practices, I shared last quarter that it's taking us a little bit longer than we had expected to get them up and fully operating. But we're making great progress as it relates to that and learning a lot along the way, so we're continuing to refine our blueprint as we onboard new centers.

儘管如此，我們仍專注於執行，並與我們的醫生和機構合作，提高人們對 CAR-T 療法治癒潛力的認識，我們將在今年下半年繼續這樣做。關於社區實踐方面，我上個季度曾提到，我們啟動並全面運作這些實踐所需的時間比預期要長一些。但我們在這方面取得了巨大進展，並且在過程中學到了很多東西，因此，隨著新中心的加入，我們將繼續完善我們的藍圖。

Steven Seedhouse, Raymond James.

Steven Seedhouse，Raymond James。

Yes, thank you very much. Just given some of the newer tailwinds out of oncology, so lenacapavir obviously which you indicated could redefine the PrEP market and then seladelpar, of course as well. When you just combine that with the updated view of oncology pipeline, are you still expecting the 2030 revenue mix to be about a third of oncology? Or is that more of a moving target? So when you could comment on the long-term outlook. Thank you.

是的，非常感謝。鑑於腫瘤學領域的一些新利好因素，例如您提到的可能重新定義 PrEP 市場的 lenacapavir，以及當然還有 seladelpar。如果把這些因素與更新後的腫瘤產品線情況結合起來考慮，您是否仍預期 2030 年的收入組成中腫瘤業務將佔到三分之一左右？或者說，這更像是一個不斷變化的目標？那麼，您能否就長期前景發表一下看法呢？謝謝。

Yeah. Thanks, Steven, for the question. So one-third of sales remains our target, you know, with the portfolio that we have today and which we believe is achievable without additional BD. I'll just remind you -- keep in mind that the indications in that target are probability adjusted and many of them are around 50%. So you'd expect to see puts and takes in that pipeline evolution. We certainly expected that when we set that target. So it allows for some programs to pay or fall short of initial expectations and others obviously succeed to support achieving that goal.

是的。謝謝史蒂文的提問。所以，三分之一的銷售額仍然是我們的目標，你知道，以我們目前的產品組合來看，我們認為無需額外拓展業務就能實現這一目標。我提醒一下——請記住，該目標中的指標是經過機率調整的，其中許多指標的機率都在 50% 左右。所以，你會預期在這個管道演變過程中看到賣出和賣出。我們設定目標時當然預料到了這一點。因此，有些專案可能無法達到預期效果，而有些專案則顯然能夠成功支持目標的實現。

I would just note that our oncology sales today are already more than a third of the way there. In quarter two 2024, they're about 12% of the total product sales, growing nicely. So it's highlighting the progress we're making on this on this overall goal.

我只想指出，我們目前的腫瘤產品銷售額已經超過目標的三分之一。到 2024 年第二季度，它們約佔產品總銷售額的 12%，成長勢頭良好。所以它突顯了我們在實現這一總體目標方面所取得的進展。

I think you're right to point out also the progress and as you put at the tailwinds with a virology business and lenacapavir data as well as seladelpar, obviously, as that grows, that puts even more stretch to our ambition. It's a good problem to have. But I think the ambition we have is very much along the lines of diversifying our business as well as solidifying our base in virology and we're firmly committed to that strategy.

我認為您指出取得的進展是正確的，正如您所說，病毒學業務和 lenacapavir 數據以及 seladelpar 的發展都為我們帶來了順風，顯然，隨著這些業務的增長，我們的雄心壯誌也得到了更大的拓展。這是個幸福的煩惱。但我認為，我們的雄心壯志在於實現業務多元化，同時鞏固我們在病毒學領域的基礎，我們堅定地致力於這項策略。

Tim Anderson, Wolfe Research.

提姆·安德森，沃爾夫研究公司。

Thank you. I have a question on the TROP2 space. So sometime before or around year end, we'll get your Phase 3 first-line triple-negative readout with TRODELVY from your ASCENT-03 trial and we'll also be getting Astra's TROPION-Breast02 and the design of those trials are quite similar, which will allow, probably for the best, side-by-side comparisons thus far of your drug versus Astra’s. And I'm sure you thought about this a lot.

謝謝。我有一個關於 TROP2 空間的問題。因此，在年底前後，我們將獲得您 ASCENT-03 試驗中 TRODELVY 治療三陰性乳癌的 3 期一線研究結果，同時我們還將獲得阿斯特捷利康 TROPION-Breast02 試驗的結果。這些試驗的設計非常相似，這將使我們能夠對您的藥物與阿斯特捷利康的藥物進行迄今為止最好的並排比較。我相信你肯定認真考慮過這個問題。

What's your prediction for how those results will likely stack up against each other? I'm guessing you'll show less ILD as one benefit, but how do you think efficacy and other safety metrics will compare?

你預測這些結果最終會如何比較？我猜想減少間質性肺病（ILD）會是其中一項優勢，但您認為療效和其他安全性指標會如何比較呢？

Sure. This is Merdad. Maybe -- I think you hit the highlights. We are -- TRODELVY has demonstrated great efficacy in the triple-negative breast cancer space. And we remain -- I think the only approved TROP2 ADC and that space in triple negative is definitely where TRODELVY is doing very well and has become standard of care for most physicians.

當然。這是梅爾達德。也許吧——我覺得你抓住重點了。我們證實，TRODELVY 在三陰性乳癌領域具有顯著療效。而且我們仍然是——我認為唯一獲批的 TROP2 ADC，在三陰性乳癌領域，TRODELVY 的表現非常出色，並且已經成為大多數醫生的標準治療方案。

So I think that sets us up nicely. And ASCENT-03 as we update the status of that trial as the end of the year rolls around, I think, we'll be part of the continuation of that story and our expectation for TRODELVY success in triple-negative breast cancer.

所以我覺得這給我們創造了很好的條件。隨著年底臨近，我們將更新 ASCENT-03 試驗的進展情況，我認為，我們將參與這個故事的後續發展中，並期待 TRODELVY 在三陰性乳癌治療中取得成功。

We have felt that there are areas where our programs are differentiated. And for TRODELVY, as you mentioned, our adverse event profile has remained largely predictable and very manageable on the part of physicians. We certainly both the ILD you mentioned as well as stomatitis have been very different in their manifestations. And mostly for TRODELVY, it's been neutropenia and diarrhea, which I think clinicians have gotten very comfortable with managing certainly when we speak to our KOLs.

我們認為，在某些方面，我們的專案具有差異化優勢。至於 TRODELVY，正如您所提到的，我們的不良事件情況在很大程度上仍然是可預測的，對於醫生來說也很容易控制。您提到的ILD和口腔炎在臨床表現上確實非常不同。對於 TRODELVY 而言，主要不良反應是中性粒細胞減少症和腹瀉，我認為臨床醫生在處理這些不良反應方面已經非常得心應手，尤其是在我們與 KOL 交流時。

So we'll be looking for those data, and we'll look for our data , and in particular, and I think it's a continuation of where we think TRODELVY can go and really solidify our position in triple-negative breast.

所以我們會尋找這些數據，也會尋找我們自己的數據，特別是，我認為這延續了我們對 TRODELVY 的發展方向，並真正鞏固了我們在三陰性乳癌領域的地位。

Yeah, I would just reemphasize what Merdad said. I think just the fact that we are the ones on the market today and so well established as the number one standard of care in triple-negative breast cancer second line, I do think that, that is a big differentiator as we think about some of these data points.

是的，我只想再次強調梅爾達德所說的。我認為，我們目前在市場上佔有一席之地，並且作為三陰性乳癌二線治療的一流標準療法，這一點本身就是一個巨大的優勢，尤其是在考慮這些數據點時。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Thank you. Good afternoon, everyone. With regard to the long-acting program, could you speak more about potential read through from PURPOSE 1 to PURPOSE 2 and whether they're typically any differences in responses to HIV drugs in these different patient populations? And regarding the strategy to expand the PrEP market, could you speak to specific strategies here? And why you haven't been able to reach these patients already? Thank you.

謝謝。大家下午好。關於長效治療方案，您能否詳細談談從 PURPOSE 1 到 PURPOSE 2 的潛在銜接，以及這些不同患者群體對 HIV 藥物的反應是否通常存在差異？關於擴大PrEP市場的策略，您能否談談具體的策略？為什麼你們至今未能聯絡到這些患者？謝謝。

Thanks, Salveen. It’s kind of a two-part. So I'll have Merdad start and maybe have Johanna add, as well.

謝謝你，薩爾文。它有點像是兩個部分組成的。所以我會讓梅爾達德先發，也許還會讓喬安娜加入。

Yeah, Salveen, you're absolutely right that the patient populations are different. That is why we did the broad purpose program to really get a diversity of patients early in our program to ensure that we can bring PrEP to a variety of populations early on in development. And the patient populations are different. We're talking really cisgender women relative to the PURPOSE 2 population, which is a different population. And our expectation is that those populations have different levels of awareness, different levels of compliance, and their use of PrEP otherwise for example with the oral PrEP agents.

是的，Salveen，你說得完全正確，患者群體確實不同。這就是為什麼我們開展了廣泛的項目，以便在項目早期就真正獲得各種各樣的患者，以確保我們能夠在開發初期就將 PrEP 帶給各種人群。而且患者群體也不同。我們這裡指的是相對於 PURPOSE 2 族群而言的真正順性別女性，這是一個不同的族群。我們預期這些族群對 PrEP 的認知程度、依從性程度以及使用 PrEP 的方式（例如口服 PrEP 藥物）都會有所不同。

And despite that, I think the strength of the PURPOSE 1 data and the fact that you have people who are essentially protected for six months with no infections occurring in the cisgender women so far, I think, give us a lot of confidence that with -- I would expect some variability in the background infection rate in the population. If we are able to maintain that degree of protection in PURPOSE 2, we remain really confident that the outcome will be very powerful.

儘管如此，我認為 PURPOSE 1 數據的可靠性，以及人們基本上受到六個月的保護，而且到目前為止順性別女性中還沒有發生感染，這讓我們很有信心——儘管我預計人群中的背景感染率會有一些波動。如果我們能夠保持 PURPOSE 2 中那種程度的保護，我們仍然非常有信心，結果將會非常顯著。

And maybe, to pick up on the second part of that, Salveen. So just to take a step back, I think, it’s important to understand how much we have moved the needle actually when you think about the penetration in the prevention market. Just a couple of years ago, you were about 25% penetrating when you -- if you consider it from a CDC standpoint estimate. We're now over a third of that.

或許，接下來我想說的是薩爾文。所以，退一步來看，我認為，重要的是要了解，當我們考慮預防市場的滲透率時，我們實際上已經取得了多大的進展。就在幾年前，如果你從美國疾病管制與預防中心 (CDC) 的估計來看，你的滲透率大約是 25%。我們現在已經完成了三分之一以上。

So we have really grown this market and expanded it. I think one of the challenges has definitely been this is not a typical market that you -- it's not HIV treatment. It is a market where these are individuals that are not sick. They have no -- asymptomatic. Obviously, they have nothing. And so therefore, it's very challenging when you think about a daily oral pill, which today over 95% of the total market where you think about current generics or DESCOVY share. And taking a pill every single day is incredibly challenging.

因此，我們確實發展壯大了這個市場。我認為其中一個挑戰肯定是，這不是一個典型的市場——它不是愛滋病治療市場。這是一個顧客並非病人的市場。他們沒有——無症狀。顯然，他們一無所有。因此，當你想到每日口服藥片時，你會發現這是一個非常具有挑戰性的問題，因為如今超過 95% 的市場份額都被目前的仿製藥或 DESCOVY 佔據了。每天吃藥真的非常困難。

So many use PrEP on demand. And I do think -- and in that, the biggest population that we see are actually white MSMs, so very much a high commercial market here. And we believe that there is a real opportunity to whip something that has the profile of lenacapavir with a twice-yearly subcu that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future.

很多人按需使用PrEP。而且我認為——其中最大的群體實際上是白人男男性行為者，所以這是一個非常高的商業市場。我們相信，如果能研發出像 lenacapavir 這樣每年兩次皮下注射的藥物，就能真正擴大其適用人群，讓更多人受益於未來的預防。

And so, so that's kind of the step. So I think it's an ongoing growth that we've been seeing. I think we have to do a step change here as we think about the future of prevention. I think we have to think completely differently about what lenacapavir could offer all of these people and really make a dent in this HIV epidemic.

所以，這就是關鍵的一步。所以我認為我們一直看到的是一種持續成長的趨勢。我認為，在思考預防的未來時，我們必須做出根本性的改變。我認為我們必須徹底改變對來那卡帕韋能為所有這些人帶來什麼，以及它能真正對愛滋病流行產生多大影響的看法。

Olivia Brayer, Cantor Fitzgerald.

奧利維亞·布雷耶，坎托·菲茨杰拉德。

James Shin, Deutsche Bank.

James Shin，德意志銀行。

Hey guys, thanks for the question. For PrEP, is the move to PARPi a net positive to access? And when len is eventually proved for PrEP, do you expect the markets remain mostly buy and bill? Thank you.

嘿，各位，謝謝你們的提問。對PrEP而言，轉向PARPi是否有利於藥物取得？當 len 最終被證實可用於 PrEP 時，你認為市場會繼續以買入和報銷為主嗎？謝謝。

Sure. I’ll take that one. So the move -- the entity for PrEPs that CMS is working on, I do think it's positive. I think it's really around providing greater access and potentially providing also the services that go with it. So a D2B could actually be a nice move, despite the fact that today Medicare is a very small piece of the total prevention market.

當然。我選那個。所以，我認為CMS正在努力建立的PrEP實體這項措施是積極的。我認為這實際上是為了提供更大的便利，並可能提供與之相關的服務。因此，儘管如今醫療保險在整個預防市場中所佔份額非常小，但D2B模式實際上可能是一個不錯的舉措。

As we think about lenacapavir, I think it'll be both. I think there's probably opportunities for it to be both a pharmacy benefit as well as a medical benefit and be a buy and bill. And I think we just need to think very differently because buy and bill in the current users of prevention, this is not something that they're familiar with. And so this is something we're really thinking about today for tomorrow is to setting up that system to make sure they understand how to do this, if they want to do it. But that they have an option if they don't want to do it. And I think that's what we're kind of planning for us as we think about the future of lenacapavir.

當我們考慮 lenacapavir 時，我認為它兩者兼具。我認為它有可能既成為藥品福利，又成為醫療福利，並且可以採用先買後付的方式。我認為我們需要換個角度思考，因為對於目前的預防使用者來說，購買和計費並不是他們熟悉的。所以，我們今天真正思考的是，為了明天能夠建立這樣的系統，確保他們明白如何做這件事（如果他們想做的話）。但如果他們不想這樣做，他們還有其他選擇。我認為，這就是我們在考慮 lenacapavir 的未來時所製定的計劃。

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

提問環節到此結束。我會邀請丹來做總結發言。

Thank you, everybody. In closing, we the team here would like to summarize the quarter as follows. We had a very strong quarter, a revenue growth, and impressive bottom line growth, that highlights the leverage in our model.

謝謝大家。最後，我們團隊想對本季進行以下總結。我們本季業績非常強勁，營收成長，淨利也實現了顯著成長，這凸顯了我們模式的槓桿效應。

Secondly, we made progress that should enable us to build on that growth in the future, including really remarkable data from the PURPOSE 1 trial and from across the HIV portfolio with the promise to extend our HIV leadership well into the late-2030s and beyond; the imminent launch of seladelpar in the US; and continued progress in oncology. And all this leaves us well positioned for the second half of 2024 when we will continue to focus on quarter after quarter of strong clinical commercial and financial execution.

其次，我們取得了一些進展，這些進展將使我們能夠在未來繼續保持成長，包括來自 PURPOSE 1 試驗和整個 HIV 產品組合的非常顯著的數據，預計將我們在 HIV 領域的領先地位延續到 2030 年代後期及以後；seladelpar 即將在美國上市；以及在腫瘤學領域取得的持續進展。所有這些都讓我們為 2024 年下半年做好了充分準備，屆時我們將繼續專注於每季強勁的臨床、商業和財務執行。

My thanks to the Gilead team and to all of you for joining today. I want to hand it over to Jacquie Ross for some final comments.

感謝吉利德團隊，也感謝今天到場的各位。我想把發言權交給杰奎·羅斯，請她做一些最後的總結。

Thank you, Dan, and thank you all for joining us today.

謝謝丹，也謝謝各位今天蒞臨現場。

One final housekeeping item. I can share that we are tentatively planning to release our third-quarter 2024 earnings results on Thursday, November 7. Please note that this day is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of the third quarter.

最後還有一件需要處理的事情。我可以透露，我們暫定於11月7日（星期四）發布2024年第三季財報。請注意，此日期為暫定日期，可能會因屆時出現的日程衝突而更改。像往常一樣，我們將在第三季結束後公佈最終確定的日期。

We appreciate your continued interest in Gilead and look forward on updating you on our progress throughout the quarter.

我們感謝您一直以來對吉利德的關注，並期待在本季向您報告我們的進展。