吉利德科學 (GILD) 2021 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Gilead Sciences First Quarter 2021 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference may be recorded. (Operator Instructions)

您好，感謝您的耐心等待。歡迎參加吉利德科學公司2021財年第一季財報電話會議。 （操作說明）請注意，本次會議可能會被錄音。 （操作說明）

I'd now like to hand the conference over to your speaker today, Jacquie Ross, Vice President, Investor Relations. Please go ahead.

現在我把會議交給今天的演講嘉賓，投資者關係副總裁傑奎·羅斯女士。請開始吧。

Thank you, Liz, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2021. The press release, slides, and supplementary data are available on the Investors section of our website at gilead.com.

謝謝Liz，大家下午好。今天股市收盤後，我們發布了2021年第一季財報。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看。

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 up the call to Q&A, where the team will be joined by Christi Shaw, the Chief Executive Officer 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執行長 Christy Shaw 也將加入討論。

Before we get started, let me remind you that we will be making forward-looking statements including those related to the impact of the COVID-19 pandemic on Gilead's business, financial condition, and results of operations; our plans and expectations with respect to products, product candidates, corporate strategy, financial projections and the use of capital; and our 2021 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.

在開始之前，請允許我提醒各位，我們將做出一些前瞻性聲明，包括與 COVID-19 疫情對吉利德的業務、財務狀況和經營業績的影響相關的聲明；我們關於產品、候選產品、公司策略、財務預測和資本使用的計劃和預期；以及我們 2021 年的財務指引。所有這些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聲明有重大差異。

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.

這些風險的詳細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掌握的信息，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 and our supplemental 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。

I will now turn the call over to Dan.

現在我將把通話交給丹。

Thank you, Jacquie, and good afternoon, everyone. We appreciate you taking the time to join us today. Before I hand it over to the team to go into the details of our commercial pipeline and financial results, I wanted to share our overall assessment of Gilead's first quarter. 2021 is a pivotal year for Gilead. And as you can see on Slide 4, we're off to a solid start.

謝謝Jacquie，大家下午好。感謝各位今天抽空參加我們的會議。在將發言權交給團隊，讓他們詳細介紹我們的商業產品線和財務業績之前，我想先分享一下我們對吉利德第一季的整體評估。 2021年對吉利德來說是至關重要的一年。正如您在第四張幻燈片中看到的，我們開局穩健。

Our first quarter total product sales were in line with our internal expectations. While our core business was more impacted by COVID-19 than we anticipated, this was offset by higher Veklury sales. In the United States, 1 in 2 hospitalized patients are receiving Veklury, and worldwide Veklury continues to play a key role as a standard of care treatment for patients who are hospitalized with COVID-19.

第一季產品總銷售額符合內部預期。雖然我們的核心業務受新冠疫情的影響超出預期，但Veklury的銷售額成長抵消了這一影響。在美國，每兩名住院患者中就有一名接受Veklury治療；在全球範圍內，Veklury繼續作為新冠肺炎住院患者的標準治療方案發揮關鍵作用。

Given the desperate situation in India, Gilead has been working with the Indian government, health authorities and our voluntary licensees to increase supply of remdesivir and provide donated medicine. As the trajectory of the pandemic evolves globally, we will continue to invest in multiple clinical studies of Veklury, including alternative formulations.

鑑於印度的嚴峻形勢，吉利德一直與印度政府、衛生部門以及我們的自願授權經銷商合作，增加瑞德西韋的供應並提供捐贈藥物。隨著全球疫情的發展，我們將繼續投資進行多項瑞德西韋（Veklury）的臨床研究，包括其他製劑的研究。

Earlier this month, we received 2 FDA approvals for Trodelvy The full approval for metastatic triple-negative breast cancer extended the label to second-line plus patients. This means Trodelvy could help many more patients as there are more than double the number of patients in this category as there are in the third line setting. We also received accelerated approval in second-line plus metastatic urothelial cancer.

本月初，Trodelvy獲得了FDA的兩項批准。其中一項是完全批准用於治療轉移性三陰性乳癌，這意味著該藥物的適應症擴展至二線及以上治療的患者。由於第二線及以上治療的患者數量是第三線治療患者的兩倍以上，Trodelvy有望幫助更多患者。此外，我們也獲得了第二線及以上治療轉移性尿路上皮癌的加速批准。

In March, we announced a new partnership to combine investigational lenacapavir with Merck's investigational islatravir, for long-acting HIV treatment, accelerating the path to the next wave of therapies. While many people living with HIV may prefer a daily regimen like Biktarvy, we believe that broadening their options to include weekly oral therapies and infrequent injections every 3 months or longer, addresses a significant patient need and sets up strong, sustainable HIV leadership into the late 2030s.

今年三月，我們宣布了一項新的合作計劃，將默克公司在研的lenacapavir與islatravir聯合使用，用於長效HIV治療，從而加速邁向下一代療法。雖然許多HIV感染者可能更傾向於像Biktarvy這樣的每日服藥方案，但我們相信，拓展他們的治療選擇，包括每週一次的口服藥物和每三個月或更長時間一次的注射，能夠滿足患者的重大需求，並為2030年代後期奠定堅實、可持續的HIV治療領導地位。

Long-acting formulations such as lenacapavir as monotherapy are also likely to unlock further PrEP usage and reach many more people at risk of HIV. We are also pleased with our progress in advancing lenacapavir in both treatment and prevention settings as part of our internal clinical development. This past quarter, we reported compelling long-acting efficacy data for lenacapavir in heavily treatment-experienced people with multidrug-resistant HIV.

長效製劑如單藥治療的來那卡帕韋可望進一步推廣暴露前預防（PrEP），惠及更多HIV感染風險族群。我們也很高興地看到，作為內部臨床開發的一部分，我們在治療和預防領域都取得了來那卡帕韋的進展。上個季度，我們公佈了來那卡帕韋在既往接受過多種治療的多重抗藥性HIV感染者中展現出的令人信服的長效療效數據。

We are fully confident that lenacapavir will be the foundation for our long-acting HIV treatment and prevention portfolio. And while we advanced lenacapavir, Biktarvy usage continues to grow with 1 in 2 people living with HIV, starting their treatment on Biktarvy in the U.S. In addition, Biktarvy is capturing 1 and 2 switches, and approximately half of those are switching from a regimen that includes a non-Gilead agent.

我們完全有信心，lenacapavir 將成為我們長效 HIV 治療和預防產品組合的基石。在推動 lenacapavir 研發的同時，Biktarvy 的使用量也持續成長，在美國，每兩名 HIV 感染者中就有一名最初使用 Biktarvy 進行治療。此外，Biktarvy 也吸引了大量第一線和第二線治療方案轉換，其中約一半患者是從包含非吉利德藥物的治療方案轉換而來。

In addition to securing regulatory approvals in oncology, we have already achieved several other pipeline milestones, including EMA validation of the Trodelvy MAA for metastatic triple-negative breast cancer, and submission of the supplemental biologics license application to FDA for Tecartus in relapse or refractory ALL.

除了在腫瘤領域獲得監管批准外，我們還實現了其他幾個研發管線里程碑，包括 EMA 對用於治療轉移性三陰性乳癌的 Trodelvy MAA 的驗證，以及向 FDA 提交用於治療復發或難治性 ALL 的 Tecartus 的補充生物製品許可申請。

Building on the work we did last year, we continue with the disciplined prioritization of our pipeline across Gilead. To share one example, Kite completed an optimization exercise this past quarter to ensure that resources are focused on the most promising opportunities to make a difference for patients.

在去年工作的基礎上，我們繼續在吉利德內部嚴格把控產品線優先順序。舉例來說，Kite在上個季度完成了一項優化工作，以確保資源集中用於最有希望造福患者的專案。

Finally, we're looking forward to a full year of clinical news flow for Gilead. Our pipeline list for 2021 includes over 20 milestones across therapeutic areas. While they are all important steps in Gilead's journey to serve more patients and diversify our business, Slide 5 lists the most significant items so you can track our progress more clearly.

最後，我們期待吉利德在新的一年持續發布臨床方面的新聞。我們2021年的產品線涵蓋了20多個治療領域的里程碑。雖然這些都是吉利德服務更多患者、實現業務多元化的重要步驟，但為了讓您更清晰地了解我們的進展，幻燈片5列出了其中最重要的幾項。

These include the Phase III TROPiCS-02 PFS readout for Trodelvy in hormone receptor positive HER2-negative metastatic breast cancer. Yescarta's Phase III ZUMA-7 readout for second-line DLBCL, which could result in an sBLA submission later this year. The Phase III readout for Hepcludex that could lead to BLA filing. ARC-2 domvanalimab Phase II or 7 interim readout in non-small cell lung cancer, which could inform an opt-in decision. Magrolimab's Phase Ib data readout in MDS, which could lead to a submission for accelerated approval later this year. And potential Phase II initiation of lenacapavir and islatravir as a long-acting oral HIV treatment in the second half of 2021.

這些進展包括：Trodelvy治療荷爾蒙受體陽性、HER2陰性轉移性乳癌的III期TROPiCS-02無惡化存活期（PFS）數據；Yescarta治療二線瀰漫性大B細胞淋巴瘤（DLBCL）的III期ZUM A-7數據，該數據可能促成今年稍後提交補充生物製品許可申請（sBLA）；Hepcludex的III期數據，該數據可能促成生物製品許可申請（BLA）；domvanalimab治療非小細胞肺癌的ARC-2 II期或7期中期數據，該數據可能為選擇加入（opt-in）決策提供依據；Magrolimab治療骨髓增生異常綜合徵（MDS）的Ib期數據，該數據可能促成今年晚些時候提交加速審批申請；以及lenacapavir和islatravir作為長效口服HIV治療藥物的潛在II期臨床試驗啟動時間，預計在2021年下半年啟動。

Our aspirations for patients are bold and our pipeline offers diversity across indications and risk profiles. While execution will continue to be a focus, these milestones give us a great deal of optimism about the future and our ability to deliver therapies that make a meaningful difference for patients.

我們對患者的期望遠大，我們的產品線涵蓋多種適應症和風險等級。儘管執行力仍將是我們的重點，但這些里程碑式的成就讓我們對未來充滿信心，也讓我們相信我們有能力為患者提供真正有效的治療方案。

Before I hand off, I want to take a moment to thank Dr. Bill Lee, who is retiring from his role as Executive Vice President of Research after 30 years at Gilead. On behalf of all of us, I want to offer my sincere gratitude to Bill for his outstanding contributions that have helped to benefit millions of patients around the world.

在結束演講之前，我想藉此機會感謝比爾李博士，他即將從吉利德公司研發執行副總裁的職位上退休，結束他長達30年的任期。我謹代表我們所有人，向比爾致以最誠摯的謝意，感謝他為吉利德做出的傑出貢獻，這些貢獻惠及了全球數百萬患者。

I would also like to welcome Dr. Flavius Martin, who joined Gilead as the new EVP of Research on April 12. Flavius has an impressive track record in overseeing industry-leading research and advancing new therapeutic candidates.

我還要歡迎弗拉維烏斯·馬丁博士加入吉利德公司，他於4月12日擔任新的研發執行副總裁。弗拉維烏斯在監督業界領先的研究和推進新的候選療法方面有著令人矚目的成就。

With that, I'll invite Johanna to update you on our commercial operations in the first quarter.

接下來，我將邀請 Johanna 向大家報告我們第一季的商業營運狀況。

Thanks, Dan, and good afternoon, everyone. Starting on Slide 7, it was a solid quarter of execution for the commercial team, with total product revenue of $6.3 billion, up 16% from the first quarter of last year. This was in line with our internal expectations as Veklury sales offset a more substantial pandemic-related impact on our core business than we had anticipated. Excluding Veklury, total product revenue was $4.9 billion reflecting inventory and pricing seasonality, the anticipated HIV loss of exclusivity in the U.S. and ongoing pandemic related dynamics in HIV and HCV.

謝謝丹，大家下午好。從第7張投影片開始，商業團隊本季業績穩健，產品總收入達63億美元，較去年第一季成長16%。這符合我們的內部預期，因為Veklury的銷售額抵消了疫情對我們核心業務造成的比預期更嚴重的衝擊。若不計入Veklury，產品總收入為49億美元，這反映了庫存和價格的季節性波動、預計HIV藥物在美國的獨家銷售權到期以及HIV和HCV疫情持續帶來的動態變化。

Moving to HIV on Slide 8. Revenue was down sequentially as expected, primarily due to seasonal trends. As a reminder, two things happen every year to our HIV business that contribute to a sequential decline from Q4 to Q1.

投影片 8 開始討論 HIV 業務。如預期，收入環比下降，主要受季節性因素影響。需要提醒的是，每年我們的 HIV 業務都會受到兩方面因素的影響，導致收入從第四季到第一季環比下降。

First, the channel builds inventory in the fourth quarter then draws it down in Q1. In the first quarter of 2021, this inventory impact contributed an estimated $410 million to the sequential decline.

首先，該通路在第四季度增加庫存，然後在第一季減少庫存。 2021 年第一季度，這種庫存影響估計導致季減 4.1 億美元。

Second, we've realized lower net HIV prices in the first quarter due to items such as increased co-pay support and Part D discounts, which tend to normalize throughout the rest of the year.

其次，由於共同支付支持增加和D部分折扣等因素，我們在第一季實現了HIV淨價格的下降，這些因素往往會在今年餘下的時間裡趨於正常化。

This quarter, we had 2 additional impacts. A year-over-year decline of $335 million in Truvada and Atripla revenue associated with LOEs in the U.S. And a difficult comparison in the first quarter of 2020, given the pandemic-related HIV stocking we saw in March of 2020 as well as the impact of the pandemic on HIV market demand.

本季，我們也受到兩項額外影響。一是與美國LOE相關的Truvada和Atripla收入年減3.35億美元。二是考慮2020年3月與疫情相關的HIV藥物庫存積壓以及疫情對HIV市場需求的影響，2020年第一季的業績比較基數較高。

Our focus is on share-driven by demand. Overall, 3 and 4 people living with HIV initiate or switch to Gilead products, highlighting the strength in demand for our life-changing medicines. While the pandemic dampened market size and switched volumes, we maintained share, in line with prior quarters across our total HIV portfolio despite generic erosion.

我們專注於以需求驅動的市場佔有率。整體而言，3%至4%的愛滋病毒感染者開始使用或轉用吉利德產品，凸顯了市場對我們改變生命的藥物的強勁需求。儘管疫情導致市場規模和銷售量下降，但我們仍保持了市場份額，與前幾季相比，我們的愛滋病毒產品組合整體市場份額保持穩定，即便受到仿製藥的衝擊。

In terms of product lines, Biktarvy was up 8% year-over-year but down sequentially as expected, driven by seasonal inventory and pricing dynamics. Despite the pandemic impact on the new starts and switch volume in HIV, demand fundamental for Biktarvy remains strong with 5 share point growth compared to the same time last year and 2 share point growth just in the last quarter in the United States.

就產品線而言，Biktarvy年增8%，但環比下降，符合預期，主要受季節性庫存和價格波動的影響。儘管疫情對HIV新用戶開通量和轉換量造成了影響，但Biktarvy的基本需求依然強勁，與去年同期相比增長了5個百分點，僅上一季在美國就增長了2個百分點。

As Dan mentioned earlier, 1 out of 2 people living with HIV, initiating or switching therapy is prescribed Biktarvy. Further, nearly half of Biktarvy switches come from incremental sources.

正如丹之前提到的，每兩名愛滋病毒感染者中就有一人會在開始或更換治療方案時被處方比克塔維（Biktarvy）。此外，近一半的比克塔維更換病例來自新增患者。

Descovy revenue was down sequentially and year-over-year, largely driven by seasonal inventory and pricing dynamics. Although PrEP volume continues to be impacted by the pandemic, Descovy share remains stable and strong at around 45% and positions us well as the PrEP market recovers post pandemic.

Descovy 的收入環比和年比均有所下降，主要受季節性庫存和價格波動的影響。儘管 PrEP 的銷售持續受到疫情的影響，但 Descovy 的市佔率保持穩定強勁，約 45%，這使我們在 PrEP 市場疫情後復甦之際佔據了有利地位。

Moving to Slide 9. HCV's first quarter revenue was $510 million. We continue to maintain a leading share of about 60% in the U.S. and 50% in Europe. Despite COVID continuing to impact patient starts, we did see a very modest sequential improvement overall in-patient volumes, although it remains depressed versus pre-COVID level. HCV also benefited from a pricing adjustment in France.

翻到第9頁。 HCV第一季營收為5.1億美元。我們繼續保持在美國約60%和歐洲約50%的領先市場份額。儘管新冠疫情持續影響患者就診量，但我們的住院患者總數較上季略有改善，儘管仍低於疫情前水準。 HCV在法國的價格調整也對其有所裨益。

As shown on Slide 10, in Q1, HBV and HCV sales totaled $220 million with HBV sales of $214 million, growing 15% year-over-year, driven by strong and ready demand, most notably in China and in the U.S. We continue to expect the HBV franchise sales to reach $1 billion by full year 2022.

如投影片 10 所示，第一季度，B型肝炎和C肝的銷售額總計 2.2 億美元，其中乙肝銷售額為 2.14 億美元，年增 15%，這主要得益於強勁且充足的需求，尤其是在中國和美國。我們仍預計到 2022 年全年，B型肝炎特許經營銷售額將達到 10 億美元。

With the completion of the MYR acquisition during the first quarter, our portfolio now includes Hepcludex. There are currently no available treatments for HDV making Hepcludex, which has received conditional approval by the EMA, a first-in-class treatment. This innovative drug blocks viral entry into liver cell. And we're targeting a BLA submission later this year and are excited by the opportunity to make Hepcludex more broadly available and address the unmet need for people who are infected with HDV.

隨著第一季完成對MYR的收購，我們的產品組合現已包含Hepcludex。目前尚無針對HDV的有效療法，因此Hepcludex（已獲得EMA有條件批准）成為同類首創療法。這種創新藥物能夠阻斷病毒進入肝細胞。我們計劃於今年稍後提交生物製品許可申請（BLA），並對有機會讓更多人受益於Hepcludex，滿足HDV感染者的未滿足醫療需求感到興奮。

Moving to Slide 11. Trodelvy delivered $72 million in first full quarter as part of the Gilead portfolio. In a span of just 3 weeks this month, Trodelvy received FDA full approval for second-line plus metastatic triple-negative breast cancer, received accelerated approval in second-line plus metastatic urothelial cancer, and had its ASCENT Phase III data published in the New England Journal of Medicine just a week ago.

切換到第11張投影片。作為吉利德產品組合的一部分，Trodelvy在第一個完整季度實現了7,200萬美元的營收。本月短短三週內，Trodelvy獲得了FDA對二線及以上轉移性三陰性乳癌的完全批准，獲得了二線及以上轉移性尿路上皮癌的加速批准，並且其ASCENT III期臨床試驗數據已於一周前發表在《新英格蘭醫學雜誌》上。

We can now leverage treatment efficacy data from the full trial population in our discussions with physicians and build even greater confidence to consider this potentially transformative therapy. This more than doubles the patient population, extending our reach to 6,000 second-line metastatic TNBC patients in the U.S., in addition to over 4,000 patients in the third line plus population.

現在，我們可以利用完整試驗族群的治療效果數據與醫生進行討論，從而更有信心考慮這種可能具有變革意義的療法。這使得患者群體擴大了一倍以上，除了4000多名三線以上治療的患者外，我們還將惠及美國6000名二線轉移性三陰性乳癌患者。

Given the poor prognosis and difficulty in treating both second and third-line metastatic TNBC patients, Trodelvy could extend median overall survival by almost a year, while also nearly tripling the median progression-free survival compared to chemotherapy. Outside the U.S., we submitted the TNBC marketing authorization application based on the ASCENT Phase III clinical study for an accelerated review process. We look forward to continuing discussions with the European Medicines Agency and anticipate approval as early as December of this year.

鑑於轉移性三陰性乳癌（TNBC）患者預後不良且第二線和第三線治療難度較大，Trodelvy有望將中位總存活期延長近一年，同時與化療相比，中位無惡化存活期也延長近三倍。在美國以外，我們已基於ASCENT III期臨床研究提交了TNBC上市許可申請，​​以尋求加速審批流程。我們期待繼續與歐洲藥品管理局（EMA）進行磋商，並預計最早於今年12月獲得批准。

Additionally, Trodelvy TNBC is under review with the U.K., Canada, Switzerland, and Australia as part of Project Orbis.

此外，Trodelvy TNBC 正在接受英國、加拿大、瑞士和澳洲的審查，這是 Orbis 計畫的一部分。

On Slide 12, Christi, who is on the call to answer for your questions shortly, you can see that our cell therapy business had a strong quarter with revenue of $191 million, up 36% from the same quarter last year, driven by growing adoption of Yescarta in Europe with our industry-leading 4-year 44% overall survival. The recent approval for Yescarta in follicular lymphoma will broaden our addressable patient population and support our ongoing growth. Tecartus continues to see strong launch demand as physicians and patients adopt the first and only cell therapy approved for relapsed or refractory mantle cell lymphoma.

在第12張幻燈片中，克里斯蒂（她稍後會回答大家的問題）可以看到，我們的細胞療法業務本季度表現強勁，營收達1.91億美元，較去年同期增長36%，這主要得益於Yescarta在歐洲的廣泛應用，其4年總生存率高達44%，在業內遙遙領先。 Yescarta近期獲準用於治療濾泡性淋巴瘤，這將擴大我們的目標患者群體，並支持我們持續成長。 Tecartus的上市需求依然強勁，醫生和患者都在積極採用首個也是目前唯一獲準用於治療復發或難治性套細胞淋巴瘤的細胞療法。

Moving to Veklury on Slide 13. First quarter revenue was $1.5 billion, with demand tracking to hospitalization rates. Although we saw lower hospitalization rates and increasing vaccination rates in certain parts of the world, overall progress was more gradual than expected over the first quarter. And as such, we are now assuming a slower pandemic recovery for the second quarter.

幻燈片13：Veklury。第一季營收為15億美元，需求與住院率有密切關係。儘管我們看到世界某些地區的住院率下降，疫苗接種率上升，但第一季的整體進展比預期更為緩慢。因此，我們預計第二季疫情復甦速度將放緩。

As the pace of recovery builds momentum in the second half of the year, this should contribute to the modest recovery in patient starts for HCV as well as HIV franchises. We will continue to play our part to support broader access for eligible patients in need of remdesivir. We are working with our voluntary licensees to accelerate production capacity for India, while also donating over 450,000 vials of Veklury to help patients as the supply of licensed generics increases. Our thoughts are with those who continue to tackle the worst of this pandemic.

隨著下半年復甦步伐加快，丙型肝炎和愛滋病患者數量的適度回升應該會有所促進。我們將繼續盡己所能，支持更多符合條件的患者獲得瑞德西韋。我們正與自願授權的經銷商合作，加快印度瑞德西韋的生產，同時捐贈超過45萬瓶Veklury，以幫助患者應對不斷增加的仿製藥供應。我們與那些仍在對抗疫情最嚴峻挑戰的人們同在。

And so with that, I will hand over the call to Merdad.

那麼，接下來我將把電話交給梅爾達德。

Thank you, Johanna. As both Dan and Johanna mentioned, we're off to a solid start in a catalyst-heavy 2021, and my comments today will focus on near-term events and changes to our pipeline. A comprehensive update on our broader pipeline is included in the appendix of the slide deck available on our IR website.

謝謝Johanna。正如Dan和Johanna所提到的，在充滿利好因素的2021年，我們開局穩健。我今天的發言將重點放在近期事件和產品線的變化。關於我們更廣泛的產品線的最新進展，請參閱我們投資者關係網站上提供的幻燈片附錄。

I'll start with our virology pipeline. We remain as focused as ever on driving innovation in HIV therapies, and there are no changes to the expected timelines associated with our lenacapavir programs. In HIV prevention, we're activating sites for our first Phase III study of lenacapavir as monotherapy for the prevention of HIV and will begin screening patients later this quarter.

首先，我想談談我們的病毒學研發管線。我們一如既往地專注於推動HIV療法的創新，lenacapavir計畫的預期時間表沒有任何變化。在HIV預防方面，我們正在啟動lenacapavir單一藥物預防HIV的首個III期臨床試驗，並將於本季稍後開始篩選患者。

This study will focus on preventing infection in cisgender men, transgender women and men, and gender non-binary people who have sex with men. In the second half of 2021, we plan to initiate a study looking at lenacapavir for the prevention of HIV infections in adolescent girls and young women.

本研究將聚焦在預防順性別男性、跨性別女性和男性以及與男性發生性行為的非二元性別者感染愛滋病毒。 2021年下半年，我們計畫啟動一項研究，探討使用來那卡帕韋預防青少年女孩和年輕女性感染愛滋病毒的效果。

In treatment, we presented additional data from our Phase II/III CAPELLA trial for lenacapavir at CROI and we continue to expect our first lenacapavir filing for use with other anti-retrovirals and heavily treatment-experienced individuals in the second half of this year.

在治療方面，我們在 CROI 會議上展示了 lenacapavir 的 II/III 期 CAPELLA 試驗的更多數據，我們仍然預計今年下半年將首次提交 lenacapavir 與其他抗逆轉錄病毒藥物聯合使用以及用於治療經驗豐富的患者的申請。

We anticipate data later this year from the Phase II calibrate study in the treatment-naive population to support virologically suppressed indication. And we plan to launch a Phase II trial for a long-acting oral treatment combination of Gilead's lenacapavir and Merck's islatravir in the second half of this year. Both medicines have shown long half-lives and high potency at low doses. As such, we believe that the lenacapavir plus islatravir combination is promising, and we're excited by our new partnership and working with our colleagues at Merck to bring the maximum benefit possible to people living with HIV.

我們預計今年稍後將獲得初治族群的II期校準研究數據，以支持病毒學抑制適應症。我們計劃在今年下半年啟動一項II期臨床試驗，評估吉利德公司的lenacapavir和默克公司的islatravir長效口服聯合療法的療效。這兩種藥物均顯示出較長的半衰期和低劑量下的高效性。因此，我們相信lenacapavir聯合islatravir療法前景廣闊，我們很高興能與默克公司的同事建立新的合作夥伴關係，共同努力為愛滋病毒感染者帶來最大益處。

Based on our commitment to HIV, we continue to work towards a potential cure. We have several early-stage programs evaluating combinations to understand the biology and identify path for this important mission. Leveraging our internal expertise as well as external partnerships, including Aelix and Gritstone.

基於我們對愛滋病防治的承諾，我們持續致力於尋找治癒方法。我們目前有多個早期計畫正在評估各種療法的組合，以了解其生物學特性並找到實現這一重要目標的途徑。我們將充分利用內部專業知識以及與外部合作夥伴（包括Aelix和Gritstone）的合作。

On Slide 16, moving on to the oncology pipeline, which has over 20 internal clinical stage programs, including many built around Trodelvy. We're excited to have received full FDA approval of Trodelvy in second-line plus metastatic triple-negative breast cancer based on the confirmatory basically ASCENT trial data. In the U.S. alone, this indication expands upon the accelerated approval for third line metastatic triple-negative breast cancer to now include second-line patients who've had at least 1 prior treatment for metastatic disease. Trodelvy has the potential to significantly improve overall survival and progression-free survival outcomes for patients.

在第16張幻燈片中，我們繼續介紹腫瘤產品線，該產品線擁有超過20個內部臨床階段項目，其中許多項目都圍繞著Trodelvy展開。我們很高興Trodelvy獲得FDA的完全批准，用於二線及以上轉移性三陰性乳癌的治療，該批准基於ASCENT試驗的驗證性數據。僅在美國，這種適應症是在Trodelvy已獲加速批准用於三線轉移性三陰性乳癌的基礎上擴展而來，現在也包括至少接受過一種轉移性疾病既往治療的二線患者。 Trodelvy有望顯著改善患者的總存活期和無惡化存活期。

In the U.S., there's a population of 10,000 patients who may benefit from Trodelvy. We also received FDA accelerated approval for second-line metastatic urothelial carcinoma based on positive data from the Phase II TROPHY study. With almost 1/3 of patients responding to treatment and the 7.2-month median duration of response, Trodelvy offers a much-needed new treatment option for the many patients with metastatic urothelial cancer, whose disease continues to progress despite receiving available first and second-line treatment. In the U.S. alone, we estimate there are roughly 8,000 addressable patients.

在美國，約有10,000名患者可能受益於Trodelvy。基於II期TROPHY研究的積極數據，我們也獲得了FDA加速批准，用於二線治療轉移性尿路上皮癌。近三分之一的患者對治療有反應，中位緩解持續時間為7.2個月，Trodelvy為眾多轉移性尿路上皮癌患者提供了一種急需的新治療選擇，這些患者的病情儘管接受了現有的一線和二線治療，但仍持續進展。光是在美國，我們估計就有大約8,000名潛在患者。

2021 will continue to be an exciting year for Trodelvy, and there have been no changes to the 2021 timelines we shared previously. We submitted the MAA to the EMA for Trodelvy in second-line plus metastatic TNBC in March, and it's now under accelerated review. We continue to target EU approval in the second half of this year.

2021年對於Trodelvy而言仍將是令人振奮的一年，我們先前公佈的2021年時間表沒有任何改變。我們已於3月向EMA提交了Trodelvy用於二線及以上轉移性三陰性乳癌治療的上市許可申請（MAA），目前正在進行加速審查。我們仍致力於在今年下半年獲得歐盟批准。

Later this year, we anticipate a Phase III TROPiCS-02 progression-free survival readout for hormone receptor positive HER2-negative metastatic breast cancer. Pending data, we'll evaluate and determine the appropriate next steps from a regulatory standpoint. We estimate there are roughly 17,000 patients in the U.S. who could benefit from Trodelvy in this setting.

今年晚些時候，我們預計將公佈針對荷爾蒙受體陽性、HER2陰性轉移性乳癌患者的TROPiCS-02 III期臨床試驗的無惡化存活期數據。待數據公佈後，我們將從監管角度評估並確定下一步的適當措施。我們估計，美國約有17,000名患者可能受益於Trodelvy治療。

We're now actively recruiting additional patients for the Phase II TROPiCS-03 basket study in solid tumors to expand eligibility to patients regardless of TROP-02 expression. We've already decided to initiate a Phase III trial in non-small cell lung cancer in the second half of this year, and we'll share updates on additional planned studies later this year.

我們目前正在積極招募更多患者參與實體瘤的 II 期 TROPiCS-03 籃式研究，以擴大入組範圍，使所有患者無論 TROP-02 表達如何均可納入研究。我們已決定於今年下半年啟動一項針對非小細胞肺癌的 III 期臨床試驗，並將於今年稍後公佈其他計畫研究的最新進展。

Moving on to cell therapy on Slide 17. With FDA's accelerated approval of the Yescarta for patients with third-line plus follicular lymphoma in March, we now have added a third indication for the Kite portfolio. Zuma-5 study data showed the 91% of patients responded to a single infusion with an estimated 74% of patients in continued remission at 18 months.

接下來，我們來看第17張投影片中的細胞療法部分。隨著FDA在3月加速核准Yescarta用於治療第三線及以上濾泡性淋巴瘤患者，Kite產品組合又新增了一項適應症。 Zuma-5研究數據顯示，91%的患者對單次輸注有反應，預計18個月後仍有74%的患者處於持續緩解狀態。

We're working towards making this option available to patients outside the U.S. and continue to target an MAA filing in the next several months. There are no changes to the expected timelines for the Zuma-7 study, assessing Yescarta for the second-line diffuse large B-cell lymphoma or DLBCL patients.

我們正努力讓美國以外的患者也能獲得這種治療選擇，並計劃在未來幾個月內提交上市許可申請（MAA）。評估Yescarta用於二線治療瀰漫性大B細胞淋巴瘤（DLBCL）患者的Zuma-7研究的預期時間表沒有變化。

We expect to announce the top-line Phase III outcome later this quarter, followed by sBLA and MAA submissions in the second half of the year. Additionally, the FDA has approved the inclusion of the Zuma-1 Cohort 4s updated safety data into Yescarta's label for third-line DLBCL. Cohort 4 demonstrated that early use of corticosteroids and/or tocilizumab led to reductions in cytokine release syndrome or neurological events.

我們預計本季稍後公佈III期臨床試驗的主要結果，隨後將於下半年提交補充生物製品許可申請（sBLA）和上市許可申請（MAA）。此外，FDA已批准將Zuma-1研究第四組更新的安全性數據納入Yescarta用於第三線瀰漫性大B細胞淋巴瘤（DLBCL）的適應症。第四組研究表明，早期使用皮質類固醇和/或託珠單抗可降低細胞激素釋放症候群或神經系統事件的發生率。

Moving on to Tecartus. We submitted our sBLA for relapsed or refractory adult B-cell precursor acute lymphocytic leukemia, or ALL, just after the end of the first quarter. If approved, Tecartus would add a much-needed treatment option for patients 18 and older. We plan to share the Zuma-3 data at ASCO this summer, and we continue to enroll patients for Zuma-4 to evaluate Tecartus for ALL in the pediatric population. Consistent with our ongoing diligence across both Gilead and Kite, we will continue to focus and streamline the Kite portfolio to align with our key strategic priorities and expertise in hematologic malignancies, specifically lymphoma and leukemia.

接下來談談Tecartus。我們在第一季末提交了復發或難治性成人B細胞前驅急性淋巴性白血病（ALL）的補充生物製品許可申請（sBLA）。如果獲得批准，Tecartus將為18歲及以上的患者提供一種急需的治療選擇。我們計劃在今年夏季的ASCO會議上分享Zuma-3的數據，並繼續招募Zuma-4的患者，以評估Tecartus在兒童ALL患者中的療效。秉持我們對吉利德和Kite兩家公司持續的盡職調查，我們將繼續專注於精簡Kite的產品組合，使其與我們在血液系統惡性腫瘤（特別是淋巴瘤和白血病）領域的關鍵戰略重點和專業知識保持一致。

Moving on to Slide 18. In addition to the previously mentioned milestones for virology, Trodelvy and Kite, we have several other notable upcoming events. First, I want to take a moment to highlight magrolimab's progress and outlook in myelodysplastic syndrome and acute myeloid leukemia. In MDS, we expect to see Phase Ib data in the second half of this year, pending results, those data could lead to a BLA submission before the end of the year.

接下來是第18張投影片。除了先前提到的病毒學里程碑事件，以及Trodelvy和Kite的進展之外，我們還有其他幾個值得關注的事件即將發生。首先，我想重點介紹一下magrolimab在骨髓增生異常綜合症和急性髓系白血病方面的進展和前景。在MDS方面，我們預計今年下半年將看到Ib期臨床試驗數據。如果結果符合預期，這些數據可望促成年底前提交生物製品許可申請（BLA）。

If approved, magrolimab will be the first-in-class macrophage checkpoint inhibitor targeting CD47, and Gilead's first frontline oncology indication.

如果獲得批准，magrolimab 將成為首個針對 CD47 的巨噬細胞檢查點抑制劑，也是吉利德公司首個第一線腫瘤適應症。

There's a significant unmet need for MDS with no new treatments approved in 14 years despite 15,000 new patients diagnosed each year in the U.S. alone.

儘管僅在美國每年就有 15,000 名新患者被診斷出患有 MDS，但 14 年來卻沒有任何新的治療方法獲得批准，因此 MDS 的治療需求仍然很大。

We're also exploring pivotal studies in frontline AML. Additionally, we continue to evaluate multiple solid tumor indications for magrolimab, most recently initiating a Phase Ib/II second-line plus solid tumor basket study and a randomized Phase II study for head and neck cancer in combination with chemotherapy and Merck's KEYTRUDA.

我們也正在探索第一線治療急性骨髓性白血病的關鍵性研究。此外，我們繼續評估magrolimab在多種實體瘤適應症中的應用，最近啟動了一項Ib/II期二線聯合實體瘤籃式試驗，以及一項針對頭頸癌的隨機II期試驗，該試驗將magrolimab與化療和默克公司的KEYTRUDA聯合使用。

Second, in virology, we're thrilled to officially add Hepcludex into our portfolio and look forward to Phase III data readout later this quarter, with the potential for a BLA filing in the second half of the year. As for potential opt-in programs, Arcus' ARC-7 non-small cell lung cancer study is expected to evaluate the interim data in the second quarter.

其次，在病毒學領域，我們很高興正式將Hepcludex納入我們的產品組合，並期待本季度稍後公佈其III期臨床試驗數據，並預計在下半年提交生物製品許可申請（BLA）。至於潛在的自願參與項目，Arcus的ARC-7非小細胞肺癌研究預計將於第二季評估中期數據。

We and the Arcus team have indicated that the interim analysis is targeting an ORR of 50% or greater and a clear separation in ORR from the Zimberelimab monotherapy arm when compared to the Domvanalimab plus Zimberelimab combination arm.

我們和 Arcus 團隊已表明，中期分析的目標是 ORR 達到 50% 或更高，與 Zimberelimab 單藥治療組相比，Domvanalimab 加 Zimberelimab 聯合治療組的 ORR 有明顯差異。

Last, on Slide 19, you can see our robust and diversified pipeline across oncology, virology, and inflammation. In addition to the readouts on the previous slide, we have multiple collaboration programs that we're monitoring closely, including Arcus' 8 -- ARC-8 study in pancreatic ductal adenocarcinoma and ARC-6 study for castration-resistant prostate cancer, expect -- both of which expect initial readouts later this year.

最後，在第19張投影片中，您可以看到我們在腫瘤學、病毒學和發炎領域強大且多元化的研發管線。除了上一張投影片中提到的結果外，我們還在密切關注多個合作項目，包括Arcus的8項研究——針對胰腺導管腺癌的ARC-8研究和針對去勢抵抗性前列腺癌的ARC-6研究——這兩項研究預計將於今年稍後公佈初步結果。

And the Galapagos SIK2/3 Toledo proof-of-concept trials across psoriasis, ulcerative colitis, and RA are expected to have readouts later this year.

Galapagos SIK2/3 Toledo 針對乾癬、潰瘍性結腸炎和類風濕性關節炎的概念驗證試驗預計將於今年稍後公佈結果。

In closing, we're pleased to see how our portfolio has grown from about 30 clinical stage programs 2 years ago to 47 today, while maintaining our focus on disciplined management of R&D expenses.

最後，我們很高興地看到，我們的臨床階段專案組合已從兩年前的約 30 個增加到如今的 47 個，同時我們仍然專注於嚴格管理研發費用。

We've also gone from 6 molecules approved, filed or in registrational studies to 15. Our teams have worked tirelessly to continuously evaluate and accelerate priority programs. We're thrilled to see how our portfolio is developing. And we look forward to accelerating innovation to help transform patient care.

我們核准、已提交申請或正在進行註冊研究的分子數量也從6個增加到了15個。我們的團隊不懈努力，持續評估並加速推進重點專案。我們很高興看到我們的產品組合不斷成長。我們期待加速創新，協助改善病患照護。

With that, I'd like to hand the call over to Andy.

接下來，我想把電話交給安迪。

Thank you, Merdad, and good afternoon, everyone. As you can see, we are building momentum in our clinical pipeline, and we expect to have plenty of data to share as we move through the rest of 2021.

謝謝Merdad，大家午安。如你們所見，我們的臨床試驗研發管線正在穩步推進，我們預計在2021年剩餘的時間裡將有大量數據可以分享。

Moving to Slide 21. The first quarter was a good start to the year, with total product sales in line with our internal expectations overall, as modestly higher Veklury sales offset a slower pandemic-related recovery than we had anticipated. In addition to pandemic impacts, our HIV business reflected the inventory seasonality we typically see in the first quarter. Total product sales were $6.3 billion, up 16% year-over-year, driven primarily by Veklury.

翻到第21頁。第一季開局良好，產品總銷售額整體符合我們的內部預期，Veklury銷售額的小幅成長抵消了疫情相關復甦速度低於預期的影響。除疫情影響外，我們的HIV業務也反映了第一季常見的庫存季節性波動。產品總銷售額為63億美元，年增16%，主要得益於Veklury的強勁成長。

The first quarter reflects continued growth from Biktarvy, our first full quarter of Trodelvy sales and strong growth in HBV as well as cell therapy. This growth was offset by ongoing COVID-related softness across our business in addition to the Truvada and Atripla LOEs.

第一季業績反映了Biktarvy的持續成長、Trodelvy首個完整季度的銷售以及乙肝病毒和細胞療法的強勁增長。然而，新冠疫情持續對業務造成疲軟影響，加上Truvada和Atripla的長期合約到期，部分抵消了上述成長。

As also indicated by Johanna, there is the difficult comparison to the first quarter of 2020, given the pandemic-related HIV stocking observed last year. As a result, total product sales, excluding Veklury, were $4.9 billion, down 11% year-over-year.

正如喬安娜所指出的，由於去年第一季受新冠疫情影響，愛滋病毒感染者大量囤貨，因此與2020年第一季相比，今年的業績存在較大差異。結果，不包括Veklury在內的產品總銷售額為49億美元，年減11%。

Non-GAAP product gross margin was 86.5%, 60 basis points lower year-over-year, primarily associated with product mix and a small inventory charge, partially offset by favorable royalty adjustments.

非GAAP產品毛利率為86.5%，年減60個基點，主要與產品組合和少量庫存費用有關，部分被有利的特許權使用費調整所抵銷。

Non-GAAP R&D was $1 billion, up 4% year-over-year, primarily driven by investment in new pipeline products, including Trodelvy and magrolimab, offset by timing of certain clinical studies and lower Veklury-related expenses. Non-GAAP SG&A was also $1 billion, down 4% from Q1 2020 due to timing of grants and sales and marketing activities.

非GAAP研發支出為10億美元，年增4%，主要得益於對包括Trodelvy和magrolimab在內的新產品管線的投資，但部分臨床研究的時間安排以及Veklury相關費用的減少抵消了這一增長。非GAAP銷售、管理及行政費用也為10億美元，較2020年第一季下降4%，主要原因是撥款以及銷售和行銷活動的時間表。

This was partially offset by higher commercialization investments associated with Veklury, Trodelvy, cell therapy, and HBV and HIV in China.

但這部分被與 Veklury、Trodelvy、細胞療法以及在中國的乙肝和愛滋病相關的更高商業化投資所抵消。

Moving to tax. We realized a lower rate of 18% for the quarter due to recognition of favorable settlements with tax authorities. Overall, our non-GAAP diluted earnings per share were $2.08 in the first quarter of 2021 compared to $1.68 for the same period last year. The year-over-year improvement was primarily due to Veklury revenues, flat operating expenses and a lower tax rate, offset in part by lower interest income.

接下來談談稅務方面。由於與稅務機關達成有利的和解協議，本季實際稅率降至18%。整體而言，2021年第一季非GAAP攤薄後每股收益為2.08美元，去年同期為1.68美元。年比成長主要得益於Veklury業務收入的成長、營運支出持平以及稅率的降低，但部分被利息收入的減少所抵銷。

You can see on Slide 22, that there is no change to our full year non-GAAP guidance. While the pandemic remains unpredictable, and as we realized a more substantial impact to our core business in the first quarter than we had anticipated, we are nonetheless encouraged by the lower hospitalization rates and increased vaccinations. We have modified our assumptions on the timing of pandemic recovery to allow a more gradual improvement starting in the second quarter.

如第22頁投影片所示，我們的全年非GAAP績效指引維持不變。儘管疫情情況依然難以預測，且第一季疫情對我們核心業務的影響超出預期，但我們仍然對住院率下降和疫苗接種率上升感到鼓舞。我們已調整疫情恢復時間的預期，預計從第二季開始，情況將逐步改善。

We continue to expect total product sales, excluding Veklury, of $21.7 billion to $22.1 billion. We continue to expect full year non-GAAP R&D and SG&A expenses, each to be flat to down low single-digit percentages year-over-year.

我們仍然預計，不計入Veklury，全年產品總銷售額將在217億美元至221億美元之間。我們仍預計，全年非GAAP研發費用及銷售、管理及行政費用將與上年持平或年減個位數百分比。

Given our first quarter results, you can see our R&D expenses are somewhat back-end loaded in 2021 based on the timing of clinical activities, which include the anticipated initiation of the solid tumor study with magrolimab, advancing internal long-acting combinations with lenacapavir for the treatment of HIV and other pipeline activities.

根據我們第一季的業績，可以看出，由於臨床活動的時間安排，我們的研發支出在 2021 年有所滯後，其中包括預計啟動的 magrolimab 治療實體瘤的研究、推進與 lenacapavir 聯合治療 HIV 的內部長效藥物以及其他研發管線活動。

Our work with Merck on a long-acting treatment regimen for people living with HIV is also underway, and will ramp up during 2021, although we are able to absorb this program into our current R&D expense guidance.

我們與默克公司合作開發針對 HIV 感染者的長效治療方案的工作也在進行中，並將於 2021 年加大力度，儘管我們能夠將該項目納入我們目前的研發支出指導中。

In SG&A, we are ramping up sales and marketing to support efforts such as the ongoing and expected launches of Trodelvy in the U.S. for bladder cancer and in Europe for triple-negative breast cancer.

在銷售、一般及行政費用方面，我們正在加大銷售和市場推廣力度，以支持諸如在美國持續推出用於治療膀胱癌的 Trodelvy 以及在歐洲推出用於治療三陰性乳腺癌的 Trodelvy 等舉措。

Additionally, we expect to start seeing higher travel and other costs scale up in the second half of the year as social distancing restrictions lighten up in some geographies. Despite the lighter expenses in the first quarter, we're leaving our operating expense guidance unchanged as we expect to catch up on this to some extent later in the year and for now, retain the flexibility to manage the timing of clinical and commercial investments.

此外，隨著部分地區社交隔離限制的放鬆，我們預計下半年差旅和其他成本將開始上升。儘管第一季支出較低，但我們維持營運支出預期不變，因為我們預計今年稍後會在一定程度上彌補這些支出，並且目前仍保留靈活調整臨床和商業投資時間的餘地。

We continue to expect our non-GAAP tax rate to be 21% for the year. While we are carefully monitoring the discussions on a higher corporate tax rate here in the United States, we believe any impact is more likely in 2022 and beyond, although, of course, a more immediate change could alter our current tax guidance.

我們仍預期本年度的非GAAP稅率為21%。雖然我們正在密切關注美國有關提高企業所得稅稅率的討論，但我們認為任何影響更有可能在2022年及以後顯現，當然，更直接的變化也可能會調整我們目前的稅務指引。

Finally, with no changes to our revenue or operating expense guidance, we continue to expect non-GAAP diluted EPS of $6.75 to $7.45 for the year. We have updated our GAAP diluted EPS guidance and now expect to be in the range of $4.75 to $5.45, down from $5.25 to $5.95, reflecting fair value losses for our equity holdings in the first quarter, donation expenses and other pretax charges, including upfront payments related to collaboration.

最後，在營收和營運支出預期不變的情況下，我們仍預期全年非GAAP攤薄後每股收益為6.75美元至7.45美元。我們已更新GAAP攤薄後每股收益預期，目前預計為4.75美元至5.45美元，低於此前預期的5.25美元至5.95美元，這反映了第一季股權持有的公允價值損失、捐贈支出和其他稅前費用，包括與合作相關的預付款。

On Slide 23, you can see that we remain diligent in our capital allocation priorities. Already this year, we have repaid $1.25 billion in debt, and we're on track to pay down at least $4 billion in total by the end of the year. We have also returned $1.2 billion to shareholders through dividends and repurchase of shares.

從第23頁投影片可以看出，我們始終堅持合理的資本配置優先事項。今年以來，我們已償還12.5億美元的債務，並預計在年底前償還至少40億美元的債務。此外，我們也透過派發股利和股票回購向股東返還了12億美元。

To close, we remain committed to delivering for patients and for shareholders as we look to invest in our business and R&D pipeline while paying close attention to our expenses.

最後，我們將繼續致力於為患者和股東創造價值，同時密切關注我們的支出，並投資於我們的業務和研發管線。

With that, I'll hand the call back to Dan for a few closing comments. Dan?

那麼，我把電話交還給丹，讓他做幾點總結發言。丹？

Thanks, Andy. And before we open up for questions, I'd like to thank the broader Gilead team who accomplished a great deal in the first quarter, setting the stage, I think, for quite an exciting year, rich and catalysts across our clinical portfolio.

謝謝安迪。在正式開始提問之前，我想感謝吉利德團隊的全體成員，他們在第一季取得了巨大的成就，我認為這為接下來激動人心的一年奠定了基礎，我們的臨床產品組合將迎來豐富多彩的機會和發展動力。

Of course, Gilead would not be the company it is today without the vision of John Martin, Gilead's Chief Executive Officer for 20 years, who passed away in March. Under his leadership, Gilead transformed the treatment of HIV and viral hepatitis and became a global organization firmly rooted in its commitment to science and to patients. That commitment will be a constant as we work to take John's legacy forward in Gilead's next chapter.

當然，如果沒有約翰馬丁先生的遠見卓識，吉利德就不會擁有今天的成就。馬丁先生曾擔任吉利德執行長長達20年，並於今年3月去世。在他的領導下，吉利德革新了愛滋病和病毒性肝炎的治療方式，並發展成為根植於科學和病人福祉的全球性企業。我們將秉持這項承諾，在吉利德的下一個篇章中傳承約翰先生的遺志。

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

接下來，我將邀請接線生開始問答環節。

(Operator Instructions) Our first question comes from Brian Abrahams with RBC Capital Markets.

（操作員說明）我們的第一個問題來自加拿大皇家銀行資本市場的布萊恩亞伯拉罕。

It looks like you're seeing steady growth in adoption of Trodelvy. So I'm just wondering how should we think about the potential for a near-term inflection and update now that you'd have full approval in triple-negative, the publication out and label expansion into urothelial? And I'm curious, are you starting to see some pull through. And where do you stand with respect to community physician awareness? How important is that as well for adoption?

看來Trodelvy的採用率正在穩定成長。鑑於您已獲得三陰性乳癌的完全批准，相關論文也已發表，並且適應症擴展至尿路上皮癌，我想了解一下，在短期內，Trodelvy的採用率可能會出現怎樣的變化？我想問的是，您是否已經開始看到一些實際效果？您認為目前社區醫師對該藥物的認知度如何？這對藥物的採用率有多重要？

Thanks, Brian. Johanna, please.

謝謝你，布萊恩。請叫喬安娜。

Sure. Thanks, Brian, for the question. And we're really excited with the recent news that we got with Trodelvy. It's really going to help us gain momentum, exactly what you said. We have strong awareness in academic centers above 80%. We haven't been able to break through. We're only at about 50% or so in the community. And as you well know, if 3 quarters of the patients sit in the community, that's an incredible opportunity for us to make sure that we make sure the messages come across. We haven't been in a position in the past to promote overall survival in light of the fact that we just had that conditional approval. And so now with the full approval, not only do we get to double the patient population that Trodelvy can actually help, but actually, we also get to promote the overall survival, which is the only agent with overall survival in this setting.

當然。謝謝布萊恩的提問。我們對最近Trodelvy的消息感到非常興奮。正如你所說，這確實會幫助我們獲得發展動力。我們在學術中心的認知度很高，超過80%。但我們一直未能突破。在社區，我們的認知度只有50%左右。如你所知，如果四分之三的患者都在社區，這對我們來說是一個絕佳的機會，可以確保我們的訊息能夠傳達出去。過去，由於我們只獲得了有條件批准，所以無法宣傳總生存期。現在，隨著完全批准的到來，我們不僅可以使Trodelvy實際受益的患者群體翻倍，而且還能宣傳總生存期，因為Trodelvy是目前唯一一種在此類情況下能夠改善總生存期的藥物。

So I think it's really going to help us ramp up. And the focus is still going to be despite the urothelial bladder indication. We -- the focus is really going to be more like a 90-10, 90% on second-line plus triple-negative breast cancer and then 10% from a promotional standpoint on urothelial cancer. We believe that that's going to work well because there's a high overlap. There's about 70% of physicians that overlap from bladder cancer and also treat TNBC. So we're going to be in good shape to ramp this up. This is really the opportunity for Trodelvy right now for this year.

所以我認為這確實有助於我們擴大規模。儘管新增了尿路上皮膀胱癌適應症，我們的重點仍會放在其他方面。我們的重點將更傾向90/10的比例，90%用於第二線及三陰性乳癌治療，10%用於尿路上皮癌的推廣。我們相信這種模式會很有效，因為兩者重疊度很高。約有70%的醫師既治療膀胱癌也治療三陰性乳癌。因此，我們將能夠很好地擴大規模。這確實是Trodelvy今年面臨的機會。

Our next question comes from Phil Nadeau with Cowen and Company.

我們的下一個問題來自 Cowen and Company 的 Phil Nadeau。

Merdad, I had a 2-part question for you. You highlighted a couple of oncology events happening in the second half of the year, namely the magrolimab Phase Ib data and Trodelvy data in the ER-positive HER2-negative breast cancer. On magrolimab, can you give us some sense of what data needs to be produced to support a filing? And on Trodelvy, there's been a fair amount of breast cancer data recently. Has anything that you've seen questioned the powering assumptions behind the revised design of the TROPiCS-02 trial?

Merdad，我有一個包含兩部分的問題想問你。你重點提到了今年下半年發生的幾項腫瘤學事件，分別是magrolimab Ib期臨床試驗數據和Trodelvy在ER陽性HER2陰性乳癌的數據。關於magrolimab，你能否簡單說明一下，需要哪些數據才能支持提交上市申請？至於Trodelvy，最近有很多乳癌方面的數據。你有沒有看到任何對TROPiCS-02試驗修訂設計背後的統計效力假設提出質疑的數據？

Thanks, Phil. Great questions. In terms of magro, in terms of what we think we need to see. Look, I think the challenge there is obviously that we're looking at external comparisons. So we believe that it's really around the strength of the data and its consistency with what we've seen already in that setting with magrolimab.

謝謝，菲爾。問得好。關於magro，關於我們認為需要觀察的內容。你看，我認為挑戰顯然在於我們正在進行外部比較。所以我們認為，關鍵在於數據的可靠性以及它與我們在magrolimab治療中觀察到的結果的一致性。

I think our assumption is as long as we are consistent with the data that has emerged that will give us really good grounds to go and approach regulators to discuss a potential filing. So we're -- I would say, reasonably confident there, and our expectation is as long as things continue to go the way they have been, we'll be fine.

我認為，只要我們掌握的數據與實際情況相符，我們就有充分的理由去與監管機構洽談，討論潛在的申報事宜。所以，我們——可以說——對此相當有信心，而且我們預計，只要一切繼續按照目前的情況發展，就不會有問題。

In terms of the breast cancer data for Trodelvy. Yes, I think in terms of our confidence, I think we remain confident that we're really well powered in that study to show benefit, in particular, in PFS as well as OS in that trial. So I don't think we've seen anything emerge that shakes our confidence around that.

關於Trodelvy的乳癌數據，是的，我認為就我們的信心而言，我們仍然相信該研究具有足夠的統計效力來顯示療效，尤其是在無進展生存期（PFS）和總生存期（OS）方面。因此，我認為目前還沒有出現任何動搖我們信心的跡象。

Our next question comes from Louise Pearson with Redburn.

下一個問題來自 Redburn 公司的 Louise Pearson。

On Yescarta, I was just wondering, could you find the incremental effort that would be required on your side to access the second-line DLBCL population should see the [ZUMA-7] read out positively. Just thinking in terms of any overlap, there might be in the sort of centers where these patients are treated? And kind of on a related note, has there been much COVID impact on the cell therapy franchise Germany seems to have performed pretty robustly.

關於 Yescarta，我只是想問一下，如果 [ZUMA-7] 的結果呈陽性，您能否評估一下，為了將 YELTS 納入二線 DLBCL 患者群體，您需要投入多少額外精力？我只是想了解一下，這些患者接受治療的中心之間可能有哪些重疊？另外，順便問一下，新冠疫情對細胞療法市場的影響有多大？德國的細胞療法市場似乎表現得相當強勁。

Thanks, Louise. Over to you, Christi.

謝謝你，路易絲。接下來就交給你了，克莉絲蒂。

Thank you. So I'll take the last 1 first, maybe, which is the COVID impact. We did see COVID impact and slowing of our ramp-up that we started doing well Q1 of last year, and there was a slowdown in Q3, Q4. We've seen that rebound in Q1. We do believe that that has to do with less COVID impact, especially in the U.S. Europe, in spite of the COVID impact continued to grow over those quarters. Germany and Italy being the exceptions where the COVID impact has been greater on our business there. Overall, though, we're very pleased with what we're seeing from quarter 4 to quarter 1 of this year, significant growth and coming off a couple of down quarters for Yescarta, both the U.S. and the -- and Europe up quarter-over-quarter now with Yescarta.

謝謝。那我先說最後一個問題，也就是新冠疫情的影響。我們確實看到了新冠疫情的影響，導致我們去年第一季開始的良好成長勢頭有所放緩，第三季和第四季也出現了下滑。不過，我們在第一季看到了反彈。我們認為這與新冠疫情的影響力減弱有關，尤其是在美國。儘管新冠疫情的影響持續，歐洲市場在過去幾季仍保持成長。德國和義大利是例外，新冠疫情對我們在這兩個國家的業務影響更大。總的來說，我們對今年第四季到第一季度的業績非常滿意，實現了顯著增長，此前Yescarta在美國和歐洲經歷了幾個季度的下滑，但現在Yescarta在美國和歐洲的業績都實現了環比增長。

And on the second-line DLBCL question. So the good news is the ATCs are already set up, just like with Yescarta's, we're able to launch quickly. So moving up to the second-line doubles the market opportunity, doubles the number of patients that we can serve. We also have community reps in the field already, both in Europe and in the U.S. So this referral pattern will continue to be something that we work on. But the belief or my belief is that as we look at patients in the third-line plus, those are typically patients that are going for palliative care and quality of life and short-term quantity of life is being managed, whereas with Zuma-7 in the second-line versus stem cell transplant, physicians and patients are still looking for a cure.

關於二線DLBCL治療的問題。好消息是，ATC（治療中心）已經建立，就像Yescarta一樣，我們可以快速上市。因此，進軍二線治療市場機會翻倍，我們可以服務的患者數量也翻倍。我們在歐洲和美國都已經設立了社區代表。這種轉診模式是我們持續努力的方向。但我認為，對於三線及以上治療的患者，他們通常接受的是姑息治療，旨在提高生活品質和短期生存率；而對於二線治療的Zuma-7（與乾細胞移植相比），醫生和患者仍在尋求治癒方法。

So if the study is positive, we're looking at replacing stem cell transplant as a standard of care in second-line for curative potential. Remember, stem cell only cures 20% of the patients that are sent there.

因此，如果這項研究結果積極，我們有望用其他方法取代幹細胞移植，作為二線治療方案中具有治癒潛力的標準療法。要知道，幹細胞移植的治癒率只有20%。

Our next question comes from Geoff Meacham with Bank of America.

下一個問題來自美國銀行的傑夫‧米查姆。

I wanted to ask one on Biktarvy. The adoption has been hugely successful and really for quite some time. So the question is, where do you see share maximizing in the U.S.? And what are the bigger growth opportunities? And then in the EU, what has been the primary headwind to greater share?

我想問一個關於Biktarvy的問題。它的普及應用非常成功，而且已經持續了相當長一段時間。所以我的問題是，您認為在美國，哪些地區的市佔率能夠最大化？還有哪些更大的成長機會？在歐盟，阻礙市場佔有率成長的主要因素是什麼？

Thanks, Geoff. Over to you, Johanna, please.

謝謝你，傑夫。接下來請你發言，喬安娜。

Yes. Thanks, Geoff, for the question. Yes, we're really quite pleased with Biktarvy's performance. It just continues. And obviously, there's been some ins and out because of dynamics around us from a market standpoint because of COVID and inventory, but the share growth, 8% year-over-year as well as the fact that we continue to grow share and even 2 points in the last quarter.

是的。謝謝Geoff的提問。是的，我們對Biktarvy的業績非常滿意，而且這種勢頭還在持續。當然，由於新冠疫情和庫存等市場因素的影響，業績也出現了一些波動，但我們的市佔率年增了8%，上個季度市佔率也成長了2個百分點。

We also grew 2 points, not only in the U.S., but we also grew just under 2 points in Europe and about 5 points year-over-year as well. So we are seeing solid growth in Europe, and we are seeing in other markets as well, like Japan and Canada, we're #1 with Biktarvy. So I think that as the data continues to show the benefits of the profile that Biktarvy offers for patients. I think there's no stopping us, Geoff.

我們不僅在美國成長了2個百分點，在歐洲也成長了近2個百分點，年增約5個百分點。因此，我們在歐洲看到了穩健的成長，在其他市場，例如日本和加拿大，我們也看到Biktarvy位居榜首。我認為，隨著數據不斷顯示Biktarvy為患者帶來的益處，我們勢不可擋，Geoff。

I think we need to continue to grow this business, and we are well poised to get out of this COVID-19 pandemic and hopefully, the markets reset. The market already has reset in the naive patient population. We're almost back to pre-COVID levels, which is great, and that's where Biktarvy truly differentiates itself. And in the switch business, we're not there yet. We're about 30% under pre-COVID levels. But again, with a share of close to 50%, also well poised for that to come back on track. So I think we continue to expand and continue to gain share over older agents because of the benefits that Biktarvy offers, not just in the U.S. but really around the world.

我認為我們需要繼續發展這項業務，而且我們已做好充分準備，走出新冠疫情的陰霾，並期待市場能夠重回正軌。在初次接觸疫苗的患者族群中，市場已基本恢復正常。我們幾乎已經恢復到疫情前的水平，這非常棒，而這正是Biktarvy真正的優勢所在。在轉診業務方面，我們尚未完全恢復到疫情前的水準。目前我們的市佔率比疫情前低了約30%。但即便如此，我們仍然擁有接近50%的市場份額，也完全有能力重回正軌。因此，我認為我們將繼續擴張，並憑藉Biktarvy提供的許多優勢，不斷超越老牌代理商，贏得市場份額。這些優勢不僅體現在美國，更體現在全球。

Our next question comes from Michael Yee with Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

And I appreciate the question. Going back to Trodelvy and the TROPiCS-02 study, I think it's fantastic. You guys upsized that and overpowered it. I guess I had two questions. One was, can you describe sort of what input went into your powering assumptions for that? And then also, do you guys have a view that higher CDK4/6 matters, given that, that's pretty much standard of care nowadays, and that's certainly evolved over the last few years as you think about the study?

我很感謝你的提問。回到Trodelvy和TROPiCS-02研究，我認為它非常棒。你們擴大了樣本量，並使其統計效力得到提升。我有兩個問題。第一個問題是，你們能否描述一下你們在進行統計效力假設時考慮了哪些因素？第二個問題是，鑑於目前CDK4/6水平升高幾乎已成為標準治療方案，而且在過去幾年中，隨著你們對這項研究的思考，CDK4/6水平的升高也發生了變化，你們認為CDK4/6水平升高是否重要？

Thanks, Michael. I'll take that. So two -- yes, great questions. In terms of assumptions, I think what's safe to say is we've been fairly conservative on our inputs to the assumptions in terms of looking at what the standard of care PFS looks like and using sort of that as our approach. And I'd say, actually, that's fairly our general approach.

謝謝，麥可。我接受你的建議。所以，第二個問題——是的，問得好。關於假設，我認為可以肯定的是，我們在輸入假設數據時一直相當保守，主要參考標準治療的無進展生存期（PFS）數據，並以此作為我們的方法。實際上，我認為這基本上就是我們一貫的做法。

I think we try to take a fairly conservative approach in terms of designing our trials and balance what I would say a statistically significant benefit with a clinically meaningful benefit. And I think that that's -- we keep both of those in mind when we're powering our studies to make sure that we are -- we're hitting not only statistical significance but looking for clinical significance.

我認為我們在設計試驗時力求採取較為保守的方法，努力平衡統計學上的顯著獲益和臨床意義上的益處。我們在確定研究樣本量時，會同時考慮這兩方面，以確保我們不僅達到統計上的顯著性，而且追求臨床意義上的顯著性。

In terms of prior CDK4/6, I mean, it's obviously something that's come up a fair bit appropriately. I think people are looking at some data -- there are a number of hypotheses that are going around, around what it could be there. We're trying to take a very data-driven approach on this. And I guess I would say a couple of things. One is that in our hands and what we've seen so far from the prior studies where we looked at those people who had gotten prior to CDK4/6 compared with standard of care, Trodelvy continues to bring benefit to those patients.

關於既往 CDK4/6 突變，這顯然是一個經常被提及的話題。我認為大家都在研究一些數據──目前有很多假設，都在探討其可能的作用機轉。我們正努力採取以數據為導向的方法。我想說幾點。首先，根據我們目前的研究以及先前對既往 CDK4/6 突變患者的觀察，與接受標準治療的患者相比，Trodelvy 仍然能為這些患者帶來益處。

And as a big caveat, that's a fairly small number of people in that from us when we look at it, but I think we're comfortable that that continues to be the case.

但需要特別說明的是，從我們的角度來看，這個數字相當小，但我們認為這種情況會持續下去。

And secondly, we are going to look at the data from the upcoming trial, and we will look at that that group of patients as a subgroup analysis to see if there is a difference in terms of how they respond compared to the overall population of patients that are going to be enrolled in that. So we'll make sure that we segregate those patients out to make sure we learn from that.

其次，我們將分析即將進行的試驗的數據，並將這群患者視為亞組進行分析，以了解他們的反應是否與即將入組的整體患者群體有差異。因此，我們將確保把這些患者單獨列出來，以便從中吸取經驗教訓。

Our next question comes from Terence Flynn with Goldman Sachs.

下一個問題來自高盛的 Terence Flynn。

I guess, maybe two-part for me. You mentioned a more gradual recovery now in the second quarter, but you maintained your guidance component. So just wanted to understand that a little bit more, that you baked in more of a cushion there when you initially gave the guidance? And then on the PrEP side, how are you thinking about the recovery there in the second half of the year?

我想，這或許可以分成兩個部分。您提到第二季復甦會更加緩慢，但您仍然維持了先前的業績指引。所以我想更深入地了解一下，您在最初給出業績指引時是否預留了更大的緩衝空間？另外，在關於PrEP（暴露前預防）方面，您如何看待下半年的復甦情況？

Okay. Thanks. And so Andy, why don't you start? And Johanna might want to add to the PrEP.

好的，謝謝。安迪，你先開始吧？喬安娜可能也想服用暴露前預防藥物（PrEP）。

Yes. Terence, thanks for the question. You're right. At the beginning of the year, we recognize that 2021 was likely to be more dynamic than prior years. And when we put together our guidance for the year, we looked at a range of scenarios. We're well within the range of scenarios in the first quarter. We're off to a good start. The mix was a little bit different than we expected with the additional pandemic-related headwinds that you heard about. But to be clear, when we think both about our total product revenues, including Veklury, but also our base case revenues -- our base product revenues, excluding Veklury, we're very comfortable with where we are, and we're on target for the year. We'll provide another update, of course, in the middle of the year, but that's how you should think about it at a high level, Terence.

是的，特倫斯，謝謝你的提問。你說得對。年初的時候，我們就意識到2021年可能會比往年更加多變。在製定全年業績預期時，我們考慮了一系列情境。第一季度，我們的業績完全符合預期。開局不錯。正如你所說，由於疫情帶來的額外不利因素，實際業績組成與我們預期略有不同。但要先明確的是，無論從包括Veklury在內的總產品收入，或是從不包含Veklury的基礎產品收入來看，我們都對目前的狀況非常滿意，並且能夠實現全年目標。當然，我們會在年中再次發布更新，但特倫斯，這就是你大致的了解情況。

And on the PrEP market -- yes, Johanna.

至於 PrEP 市場——是的，Johanna。

Yes. Thanks, Dan. So on the PrEP market, as I mentioned, Descovy share is holding at about 45%, 46% in the first quarter. So we're quite pleased with that. We've obviously been working closely with payers to make sure that patients and providers had choice in their prevention approach. The market is still dampened because of this pandemic, as you can appreciate with the social dynamics that we are all living with. Although we have seen some uptake in the last month or so, we'll see how that plays out.

是的，謝謝丹。正如我之前提到的，在PrEP市場，Descovy在第一季的市佔率維持在45%到46%左右，我們對此相當滿意。我們一直在與支付方密切合作，確保患者和醫療服務提供者在預防方案方面擁有選擇權。正如您所能理解的，由於疫情的影響，市場仍然受到抑制，這與我們目前面臨的社會狀況息息相關。儘管在過去一個月左右的時間裡，我們看到了一些成長，但最終結果如何，我們還需要觀察。

But again, I think it's going to be in line with what Andy said, which is going to be a bit of a gradual recovery for the PrEP market. But I think we're very well poised to make sure that once that market gets back to pre-COVID levels, I think we'll be in very good shape in light of our -- holding our share at this level.

但我認為，正如安迪所說，PrEP市場將會逐步復甦。不過，我認為我們已經做好充分準備，一旦市場恢復到新冠疫情前的水平，鑑於我們目前保持的市場份額，我們將處於非常有利的地位。

Our next question comes from Robyn Karnauskas with Truist.

下一個問題來自 Truist 的 Robyn Karnauskas。

I have a -- I just want to thank you for your outreach for India. I have a question about your guidance of $2 billion to $3 billion for Veklury. How do we think about this? I mean, it doesn't feel like this is going to go on longer outside the United States than we expect. But obviously, some places are cheaper than others.

我有個問題——我只是想感謝您對印度的關注。關於您之前提到的Veklury項目20億至30億美元的投資，我有個疑問。我們該如何看待這個問題？我的意思是，感覺這個計畫在美國以外的持續時間不會比我們預期的更長。但顯然，有些地方的成本比其他地方低。

Can you give us some estimates on how do you think of -- general trends on pricing and thanks for what you're doing over there? And then this is a very simple question. You talked a lot upfront about cell therapy. There's still, there is also off-the-shelf iPSCs. We talked about that a lot. Can you give us any sense if you're interested in augmenting our portfolio with one of those because those are different technologies?

您能否就定價的整體趨勢給予一些預估？感謝您所做的一切。還有一個很簡單的問題。您之前談了很多關於細胞療法的內容。目前還有現成的誘導性多能幹細胞（iPSCs）。我們也討論了很多。您能否透露一下您是否有興趣將其中一項納入我們的產品組合？因為這些是不同的技術。

I appreciate your kids loving us. That's terrific. And thank you for acknowledging the efforts of the company for so many countries out there that are streaking with this. Can I ask Johanna to cover the Veklury question and then Christi to cover the cell therapy?

我很感激孩子們喜歡我們，這太棒了。也感謝您認可公司為眾多國家所做的努力，這些國家都在大力推廣這項技術。我可以請Johanna回答關於Veklury的問題，然後請Christi回答關於細胞療法的問題嗎？

Absolutely. Thanks, Robyn, for your question and comment. I think what we've seen with Veklury is a really directly proportional effect with hospitalization rates. And it's kind of what we've been saying for the last couple of quarters, and we're seeing it. Yes. I mean you could literally draw the line with the hospitalizations, both in the U.S. as well as outside of the U.S. Where we've seen sales as in the first quarter, and I think that's going to continue, although to a lesser degree, we've seen hospitalizations really come down in the month of March and kind of hold steady, unfortunately.

當然。謝謝Robyn的提問和評論。我認為Veklury的療效與住院率之間有著非常直接的正比關係。這與我們過去幾個季度一直在強調的一點不謀而合，而且我們也確實看到了這一點。是的。我的意思是，無論是在美國還是在美國以外，住院率都與Veklury的療效密切相關。我們在第一季看到了銷售額的成長，我認為這種趨勢還會持續，儘管幅度會減弱。我們看到3月的住院率確實下降了，但遺憾的是，之後一直保持穩定。

And hopefully, they'll keep coming down as months go by and vaccination rates increase. But what we have seen is sales are really coming out in the U.S., of course, also within our European region as well as Asia. There's a lot of markets in Asia that are also taking full advantage of the benefits of Veklury for their patients, their appropriate patients.

希望隨著時間的推移和疫苗接種率的提高，價格能夠繼續下降。但我們目前看到的是，美國、歐洲以及亞洲的銷售額都在顯著成長。亞洲許多市場也正在充分利用Veklury的益處，為他們的患者（尤其是合適的患者）提供治療。

And so we believe -- we've always said that we think the tail is longer. I know nobody wants to hear that, but I think we think the tail is longer than anybody thought originally. And I think that's what we're seeing as we go into Q2, and it will be a gradual recovery. So we do believe that Veklury still will have an important role to play within the next couple of quarters and potentially beyond into 2022.

所以我們相信——我們一直都認為，市場尾部會更長。我知道沒人想聽這個，但我認為市場尾部比最初任何人預想的都要長。我認為，隨著我們進入第二季度，這種情況正在發生，市場將逐步復甦。因此，我們相信，Veklury 在未來幾季乃至2022年仍將發揮重要作用。

As for some of these -- for example, India or other countries that are served by our voluntary licenses. Obviously, those are royalty-free during the pandemic, and that is something at a much lower price level. So our price for Veklury hasn't moved. It's well below the value of Veklury for the developed countries. For the developing rolled up, it's obviously quite different. With that, Christi?

至於其中一些國家——例如印度或其他透過我們自願許可協議提供服務的國家。顯然，在疫情期間，這些國家的產品是免版稅的，而且價格也低得多。因此，Veklury 的價格沒有變化。它遠低於已開發國家 Veklury 的價格。但對於發展中國家來說，情況顯然截然不同。克里斯蒂，你說完了嗎？

Yes. Thanks, Robyn. Thanks for the question. So you heard a little bit in the beginning from both Merdad and Johanna and maybe Dan that we recently took a really hard look at our portfolio review. A few things are evolving or transforming, if you will.

是的，謝謝Robyn，謝謝你的提問。正如Merdad、Johanna，或許還有Dan在開頭提到的，我們最近認真地審視了我們的投資組合。一些方面正在發生變化，或者說轉型。

Kite had such a success story in bringing the first potential cure for lymphoma. We've transformed now to a company that has multiple brands -- franchise, basically, 3 indications now and with a couple more to come in the next year. As we look at that, we know a lot more now about how to affect leukemia and lymphoma in this area.

Kite公司在研發出首個淋巴瘤潛在療法方面取得了巨大成功。如今，我們已轉型為一家擁有多個品牌（​​基本上是特許經營模式）的公司，目前有三種適應症，明年還將推出另外兩種。展望未來，我們對如何治療該領域的白血病和淋巴瘤有了更深入的了解。

So really taking a focus on making sure that we double down on our life cycle management, improving the risk-benefit profile of what we have, trying to get patients with combination therapies for, et cetera, to ensure we increase the efficacy. That's really our main focus on our core. We are also looking at disrupting what we have today, whether it's iPSC, allo. We do believe eventually, the market will be, and we'll be trying to drive that way, too, towards a lower cost off-the-shelf, more convenient for patients' treatments.

因此，我們真正關注的是加倍投入生命週期管理，改善現有產品的風險效益比，努力讓患者接受聯合療法等等，以確保提高療效。這確實是我們核心工作的重點。我們也正在尋求顛覆現有模式，無論是iPSC或異體幹細胞。我們相信，最終市場將會朝著更低成本、更方便的現成療法方向發展，而我們也將努力推動這個方向。

But today, unfortunately, from what we've seen at the recent congresses and publications and study results, it's a bit further out than we had anticipated just 12 to 18 months ago.

但遺憾的是，從最近的大會、出版品和研究結果來看，這比我們 12 到 18 個月前預期的要晚一些。

So we really need to focus on improving autologous where we have it today, disrupting ourselves in the future. And lastly, to your question, beyond iPSC -- your question was iPSC, but even beyond that, as we look at solid tumor, we really are the partner of choice with our successful manufacturing process, our ability to deliver reliably in a short period of time. We are looking at transformations, really good transformations where we have proof-of-concept in solid tumors where the market will be the largest in the long-term.

所以，我們真正需要關注的是改進目前已有的自體幹細胞技術，並在未來實現顛覆性創新。最後，關於您提出的iPSC以外的問題——您的問題是關於iPSC的，但即便拋開它，當我們著眼於實體瘤時，憑藉我們成功的生產過程和在短時間內可靠交付的能力，我們無疑是首選合作夥伴。我們正在尋求變革，真正意義上的變革，我們在實體腫瘤領域已經擁有概念驗證，而實體腫瘤市場長期來看將是最大的市場。

Our next question comes from Matthew Harrison with Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

A question on Galapagos, and I guess there are 2 parts here. First part is you've got these upcoming Toledo readouts. Merdad, maybe you could just comment on what you're potentially looking to see from those readouts, given that the duration of those trials is fairly short. So maybe what you would view as sort of a positive outcome.

關於加拉巴哥群島，我有個問題，我想這個問題可以分成兩個部分。第一部分是即將公佈的托萊多試驗數據。梅爾達德，鑑於這些試驗持續時間較短，您能否談談您希望從這些數據中看到什麼？您認為什麼樣的結果才算是正面？

And then I guess second question is a more sort of broader strategic question here. But if you don't see something that's positive out of those, how do you think about the longer term relationship there? And given that you're the largest shareholder, what might you consider in terms of that relationship?

那麼，第二個問題可能更偏向更廣泛的策略層面。如果您在這些方面看不到任何正面因素，您如何看待雙方的長期關係？鑑於您是最大的股東，您會從哪些方面考慮這種關係？

Great. You want to start, Merdad, and then I'll follow.

太好了。你想先開始嗎，梅爾達德，然後我跟上。

Yes, sure. It's a great question. And I think you -- Matthew, you mentioned, I think, look, where we are now with the Toledo programs is looking for evidence of tolerability and proof-of-concept, proof of principle for that pathway in multiple indications. And I would describe these early small studies as a place to demonstrate that and look to see where the biggest impact could be.

當然可以。這是一個很好的問題。馬修，你剛才提到了，我認為，目前托萊多計畫正在尋求耐受性證據和概念驗證，也就是該療法在多種適應症中的原理驗證。我會把這些早期的小型研究描述為驗證這些研究成果並尋找可能產生最大影響的領域。

I think it's an early part of the longer journey, ranging from -- is there a particular indication that we want to pursue further to confirm and expand on the signal to -- do we have the right molecule for that. So I think we view these, together with Galapagos, I believe, we view these as sort of very early in the story of the Toledo program. So we'll be looking to see what those data look like in the near-term. Dan, do you want add.

我認為這只是漫長征程的早期階段，涵蓋了從「是否存在值得我們進一步研究以確認和擴展訊號的特定跡象」到「我們是否找到了合適的分子」等諸多方面。因此，我認為我們把這些研究，連同加拉巴哥群島的研究，都視為托萊多計畫的早期階段。所以我們將密切關注這些數據在短期內的變化。丹，你還有什麼要補充的嗎？

Sure. So maybe just to you, Matthew, to just give a little bit of context for people that may not be completely familiar with our relationship with Galapagos. So of course, there was the filgotinib relationship, but then there was a separate relationship that we went into. As you know, a couple of years ago now.

當然。馬修，或許你可以稍微解釋一下，讓那些不太了解我們與加拉巴哥群島關係的人了解一下背景。當然，我們之前有菲爾戈替尼的合作，但除此之外，我們還有另一項合作。你知道，那是幾年前的事了。

And that was really based on the research platform. And I would say that nothing has really changed in relation to that. I mean one of the reasons to do that was to diversify our approaches from a discovery research perspective across, if you like, the Gilead Group. I listened hard to the scientists at that time. I continue to listen hard to the scientists today. They think they have a very discriminated platform for screening compounds for first-in-class. And I'll remind you, that's really the approach first-in-class, which, of course, comes with some risks, some of which we've seen in the later-stage programs.

這確實是基於我們的研究平台。而且我認為，在這方面並沒有發生什麼實質的變化。我這麼做的原因之一是為了從發現研究的角度，在吉利德集團內部實現研究方法的多元化。當時我認真聽取了科學家們的意見，現在依然如此。他們認為他們擁有一個非常精準的平台，可以用來篩選首創化合物。我要提醒大家，這才是真正的首創策略，當然，這種策略也伴隨著一些風險，其中一些風險我們在後期專案中已經看到了。

And of course, Toledo is the most advanced now of those programs. But having said that, there are many others within their discovery platform that we continue to be intrigued about. I think it's an important part of our overall inflammation strategy, albeit at an earlier stage for Gilead. But when we think about our strategic approach that really focuses on immunology and virology as our core scientific skills, we have now obviously leaders in virology built up a really significant presence in oncology with inflammatory disorders, really kind of the next step and the next stage of our platform where Galapagos presents, I think 1 aspect of that, but a very important aspect in terms of first-in-class approach.

當然，目前托萊多專案是這些專案中最先進的。但即便如此，他們的研發平台還有許多其他項目也讓我們非常感興趣。我認為這是我們整體發炎策略的重要組成部分，儘管對吉利德而言，它還處於早期階段。但當我們思考我們以免疫學和病毒學為核心科學技能的策略方針時，我們顯然擁有病毒學領域的領導者，他們在腫瘤發炎性疾病領域建立了非常強大的影響力，這實際上是我們平台發展的下一步和下一階段，而加拉帕戈斯計畫則展現了其中的一個方面，但就首創療法而言，這是一個非常重要的方面。

So we continue to be working very closely with our partners at Galapagos to determine what the next screens are and what the next targets are in the concept of our -- the entirety of our inflammation strategy. So thanks, Matt.

因此，我們將繼續與 Galapagos 的合作夥伴密切合作，以確定下一步的篩選方法和靶點，從而完善我們的發炎治療策略。謝謝，Matt。

Our next question comes from Ronny Gal with Bernstein.

下一個問題來自伯恩斯坦公司的羅尼·加爾。

Just a question on Descovy. The 22% down on the year-over-year. I was wondering if you can unpack those for us. So how much of that was inventory, COVID impact in price. So when it comes to price, do you think this is a like a 1-year giveaway? Or should we expect that kind of a pricing decline every year going forward, at least when it comes to the back-class compounds?

關於Descovy，我有個問題。年比下降了22%。我想請您幫我們分析一下。其中有多少是庫存造成的，又有多少是新冠疫情對價格的影響？就價格而言，您認為這只是暫時的優惠嗎？還是說，至少對於低階化合物而言，我們預期未來每年都會出現類似的價格下跌？

Ronny, just at the very end, what did you say?

羅尼，就在最後，你說了什麼？

Yes, please.

好的，謝謝。

Are we expecting the price declines this year to be a repeating events every year? Or is this essentially expected to be a onetime decline as to Truvada generic center.

我們是否預期今年的價格下跌會成為每年的慣例？還是說，就Truvada仿製藥而言，這基本上只是一次性的下跌？

Got you. Okay. Joanna, you got it.

明白了。好的。喬安娜，你明白了。

Yes. Thank you. So, thanks for that. I didn't hear the last part of that question originally. Yes. So for Descovy, the year-over-year, obviously, it does have to do with higher payer discounts. And that was to ensure that patients and providers had choice. And make sure that we didn't have any step at it. And now we do have some step at it for some plan.

是的，謝謝。非常感謝。我一開始沒聽到問題的最後一部分。是的。對於Descovy來說，同比變動顯然與更高的支付方折扣有關。這樣做是為了確保患者和醫療服務提供者有選擇權，並確保我們之前沒有任何限制。但現在，對於某些計劃，我們確實存在一些限制。

But for most plans, access is very open to make sure that our patients and providers choose which therapeutics is best for them for prevention. And so I think that we will continue to be smart and we will continue to be disciplined in the way that we look at those discussions with our payers, but we're also looking at data that's been pretty clear, that shows that if you basically put a step at it, you don't actually get the patient on a Truvada generic, you actually just lose your patient.

但對於大多數計劃而言，准入途徑非常開放，以確保我們的患者和醫療服務提供者能夠選擇最適合他們的預防性治療方案。因此，我認為我們將繼續保持謹慎和嚴謹的態度，與支付方進行討論。同時，我們也關註一些非常明確的數據，這些數據表明，如果你設置障礙，實際上並不會讓患者使用特魯瓦達（Truvada）的仿製藥，反而會失去這位患者。

And I think as we think about ending the epidemic, prevention is a big piece of that. And so that's why choice is so important, and that we keep people at risk of HIV, making sure that we keep those folks on the medicines that they're on without creating any access restrictions. And so if that's what we need to do moving forward to ensure that that might impact the price as we go. Our intent is obviously to keep the balance between what we do from a payer standpoint, but also what we do from a share standpoint.

我認為，在思考如何終結愛滋疫情時，預防至關重要。因此，選擇權非常重要，我們要確保高風險族群能夠繼續服用他們正在服用的藥物，並且不設定任何獲取限制。如果我們需要這樣做來確保藥物價格能夠控制，那麼我們未來的目標顯然是在支付方和患者群體之間保持平衡。

And that's why we're proud of the fact that we've been able to manage the payer dynamics and actually hold and even grow share in the last quarter.

正因如此，我們才感到自豪，因為我們能夠掌控支付方的動態變化，並在上個季度保持甚至擴大市場份額。

Our last question comes from Hartaj Singh with Oppenheimer.

最後一個問題來自奧本海默公司的哈塔吉·辛格。

And I just want to also echo what Robyn said. I think people forget we donated almost 1 million vials of remdesivir last year around this time, which very few companies have done. Just a quick question on your partnership with Merck. What's the logic behind Gilead, I guess, leading the U.S. development for the oral and then Merck on the injectable?

我還要附和Robyn的說法。我覺得大家可能忘了，去年這個時候我們捐了近100萬瓶瑞德西韋，很少公司能做到這一點。關於你們和默克的合作，我有個問題。吉利德主導美國口服瑞德西韋的研發，而默克則負責注射劑，背後的邏輯又是什麼呢？

What was the thinking that went into sort of the parameters of that and then also the cost-sharing and the revenue sharing assumptions? Any color on that would really help.

制定這些參數以及成本分攤和收益分攤假設時，背後的考量是什麼？任何細節都將非常有幫助。

Hartaj, and believe me, it means a lot for you to comment on that for all the colleagues at Gilead, who I think feel very strongly about the intrinsic work we do for patients and donations is just one piece of that, it's part of our DNA. Andy, I think you're going to answer the question.

哈塔吉，相信我，你對此發表的評論對吉利德的所有同事意義重大。我認為他們都非常重視我們為患者所做的工作，而捐贈只是其中的一部分，它已經融入了我們的基因。安迪，我想你會回答這個問題。

Sure. Hartaj, thank you for the question. Look, it was relatively simple. You have 2 outstanding organizations that are deeply experienced at formulation and drug development. Gilead, obviously, is one of the leading companies globally in terms of coformulating orals. For a single tablet regimen, especially in the HIV arena, and it made sense, I think, to both companies that have us take the lead there.

當然。哈塔吉，謝謝你的提問。其實很簡單。你們有兩家在製劑和藥物研發方面經驗豐富的傑出公司。吉利德顯然是全球口服藥物復配領域的領導者之一。對於單片複方製劑，尤其是在愛滋病領域，我認為，讓我們牽頭負責這方面的研發，對兩家公司來說都是明智之舉。

And at the same time, we recognize that to keep both programs moving forward quickly, it probably made the most sense to have Merck also lead a program and the injectable formulation program is one that was in their sweet spot. So this is a win-win. Both companies will be involved in both programs.

同時，我們也意識到，為了確保兩個專案都能快速推進，由默克公司主導其中一個專案可能是最合理的選擇，而注射製劑專案正是默克公司的優勢領域。因此，這是一個雙贏的局面。兩家公司都將參與這兩個項目。

And we think by doing that, we're going to be able to advance these programs more quickly than we could individually. As far as the cost sharing, we took on more of the cost-sharing because we have more of the upside, right? So it was a relatively simple.

我們認為，透過這種方式，我們能夠比各自為政更快地推進這些計畫。至於成本分攤，我們承擔了更多的成本，因為我們擁有更大的收益，對吧？所以這相對來說比較簡單。

I think we are both bringing great molecules to the collaboration. We're both very excited about what we think these combinations can do in the treatment market, both in oral and the SubQ injectable formulations. And we recognize that when you looked at the patent life of the 2 products, for instance, was different. The franchise that we have in HIV, the impact of these on our existing franchise. When we put it all into the mix, I think there was a clear alignment between the 2 companies that it made sense at certain revenue levels for Gilead to share disproportionately and more of the revenue or the profits, I should say.

我認為我們雙方都為這次合作帶來了非常優秀的分子。我們都對這些組合療法在治療市場上的潛力感到非常興奮，無論是口服製劑還是皮下注射製劑。我們也意識到，例如，如果檢視兩種產品的專利期限，就會發現它們並不相同。我們在愛滋病領域的業務範圍，以及這些組合療法對我們現有業務的影響，都至關重要。綜合所有因素，我認為兩家公司之間存在著明確的共識：在一定的收入水平下，吉利德公司獲得不成比例的更多收入或利潤分成是合理的。

But in exchange for that, fairly, we had to agree to take a little bit more of the R&D expense, which we are happy to do. So that should, I think, Hartaj, that should answer your question.

但作為交換，公平起見，我們必須同意承擔更多研發費用，我們很樂意這樣做。所以，哈塔伊，我想這應該可以回答你的問題了。

And Hartaj, I just want to end by thanking our colleagues at Merck. It's terrific. When you get 2 companies to come together to put patients first to accelerate treatment options for patients in need. And we have a lot of respect for our Merck colleagues. And happy to say that already the collaboration is getting off to a very strong and rapid start. So we look forward to moving fast to make a difference for patients with different treatment options.

哈塔吉，最後我想感謝默克公司的同事們。這真是太棒了！兩家公司攜手合作，以患者為先，加速為有需要的患者提供治療方案，這本身就意義非凡。我們對默克公司的同事們充滿敬意。令人欣慰的是，雙方的合作已經取得了非常強勁且迅速的進展。我們期待著快速推進，為患者提供更多不同的治療選擇，從而真正改變他們的生活。

That concludes today's question-and-answer session. I'd like to turn the call back to Jacquie Ross for closing remarks.

今天的問答環節到此結束。現在請杰奎·羅斯女士作總結發言。

Thank you, Liz, and thank you all for joining us today. We appreciate your continued interest in Gilead and look forward to updating you on our continued progress.

謝謝莉茲，也謝謝各位今天蒞臨。我們非常感謝大家一直以來對吉利德的關注，並期待向大家報告我們的最新進展。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您可以斷開連線了。