吉利德科學 (GILD) 2022 Q1 法說會逐字稿

Thank you for standing by, and welcome to the Gilead Sciences First Quarter 2022 Earnings Conference Call. (Operator Instructions) Please be advised that today's call is being recorded. (Operator Instructions)

感謝您的耐心等待，歡迎參加吉利德科學公司2022年第一季財報電話會議。 （操作說明）請注意，本次電話會議正在錄音。 （操作說明）

I would now like to hand the call over to your host for today's program, Jacquie Ross, Vice President, Investor Relations. Please go ahead.

現在我將把電話交給今天節目的主持人，投資者關係副總裁傑奎·羅斯女士。請開始吧。

Thank you, Jonathan, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2022. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com.

謝謝喬納森，大家下午好。今天股市收盤後，我們發布了2022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·梅西耶 (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, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital, and 2022 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、產品計劃和預期、候選產品、公司戰略、業務和運營、財務預測和資本使用以及 2022 年財務指引相關的聲明。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, in our supplementary data sheet as well as on the Gilead website.

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

Now I'll turn the call over to Dan.

現在我把電話交給丹。

Thank you, Jacquie, and good afternoon, everybody. We appreciate you taking the time with Gilead today, and I also want to thank those of you who joined our Virology and Oncology Deep Dives over the last few months. These 2 events provided a more in-depth view of our portfolio, our strategy and the teams behind them. We shared a much broader view of our growing clinical pipeline than we had in the past, highlighting its potential to deliver a number of new therapies to address unmet needs for patients across a diverse range of conditions.

謝謝Jacquie，大家下午好。感謝各位今天抽出時間與吉利德交流，我也要感謝過去幾個月參加我們病毒學和腫瘤學深度研討會的各位。這兩場活動讓我們更深入地了解了我們的產品組合、策略以及背後的團隊。我們分享了比以往更全面的臨床研發管線，重點介紹了其為滿足不同疾病患者未被滿足的醫療需求提供多種新療法的潛力。

For those of you who joined, I hope you got a deeper sense of why we're confident of sustaining our leadership in virology and growing our oncology revenue so that it becomes more than 1/3 of our total revenue in 2030.

對於參加本次會議的各位，我希望你們能更深入地了解我們為什麼有信心保持我們在病毒學領域的領先地位，並不斷提高我們的腫瘤學收入，使其在 2030 年占我們總收入的三分之一以上。

I'll turn now to our performance this quarter, and I'm pleased to share that the year is off to a strong start in line with guidance, as shown on Slide 4. Total product revenue was up 3% from last year to USD 6.5 billion, with cell therapy, VEKLURY, TRODELVY and HIV driving growth. HIV grew 2% year-over-year, primarily driven by BIKTARVY, which grew 18%, and reported more than 4% market share growth compared to the first quarter of 2021. This is notable given the impact of our TRUVADA LOE. Sequentially, HIV was down 18%, primarily as a result of first quarter seasonality. Our growing oncology portfolio performed well, with TRODELVY revenue doubling compared to the first quarter of 2021 and cell therapy delivering another strong quarter of growth.

接下來我將介紹本季的業績，我很高興地告訴大家，正如投影片4所示，今年開局強勁，符合預期。產品總收入年增3%，達到65億美元，其中細胞療法、VEKLURY、TRODELVY和HIV業務是成長的主要驅動力。 HIV業務年增2%，主要得益於BIKTARVY的強勁成長，其成長幅度達18%，市佔率較2021年第一季成長超過4%。考慮到TRUVADA的剩餘合約期限的影響，這一成績尤其顯著。 HIV業務較上季下降18%，主要受第一季季節性因素的影響。我們不斷成長的腫瘤產品組合表現良好，TRODELVY的營收較2021年第一季翻了一番，細胞療法也實現了另一個強勁的季度成長。

We recently expanded our portfolio of marketed cancer therapies following the FDA approval of Yescarta for second-line relapsed and refractory LBCL. I'm also pleased to highlight the FDA approval of our new cell therapy facility in Maryland, which is part of the expected 50% increase in our manufacturing capacity by the end of 2022. The new facility will support our cell therapy growth expectations over the next several years.

繼Yescarta獲FDA核准用於二線復發/難治性大B細胞淋巴瘤（LBCL）治療後，我們近期進一步拓展了已上市癌症療法的產品組合。此外，我很高興地宣布，我們位於馬裡蘭州的新細胞療法生產設施也已獲得FDA批准。該設施的投產是我們預計在2022年底產能提升50%計畫的一部分。新設施將在未來幾年內幫助我們實現細胞療法業務的成長目標。

Moving to the pipeline. We shared the Phase III top line readout from TROPiCS-02 in March showing that the study met its primary endpoint with a statistically significant improvement in progression-free survival versus physician's choice in chemotherapy. Additionally, the first interim analysis of the key secondary endpoint of overall survival demonstrated a trend in improvement. As you know, we are exploring potential pathways for approval with regulatory authorities to bring TRODELVY to these later-stage patients. The details of the study results will be shared at ASCO in June.

接下來談談研發管線。我們在三月公佈了TROPiCS-02 III期臨床試驗的主要結果，結果顯示該研究達到了主要終點，與醫生選擇的化療方案相比，患者的無進展生存期（PFS）有統計學意義上的顯著改善。此外，關鍵次要終點－總存活期（OS）的首次中期分析也顯示出改善趨勢。如您所知，我們正在與監管機構探討可能的審批途徑，以便將TRODELVY用於這些晚期患者。該研究結果的詳細資訊將於六月的ASCO年會上公佈。

At the Oncology Deep Dive earlier this month, we highlighted the broad potential for TRODELVY across multiple tumor types and lines of therapy, with plans to initiate 13 more TRODELVY trials through 2023, including 4 more in 2022.

在本月初的腫瘤學深度研討會上，我們重點介紹了 TRODELVY 在多種腫瘤類型和治療方案中的廣泛潛力，並計劃在 2023 年前啟動 13 項 TRODELVY 試驗，其中包括 2022 年的 4 項試驗。

Turning to Slide 5. As you know, the timing for TROPiCS-02 and the NDA decision for CAPELLA are subject to change. In the case of CAPELLA, this is due to the biocompatibility issue that we're working to resolve, and we're fully confident in lenacapavir itself. Other than that, we are on track with the remaining targeted milestones we shared with you in January.

請看幻燈片5。如您所知，TROPiCS-02的研發時間和CAPELLA的新藥申請（NDA）決定可能會有所變動。就CAPELLA而言，這是由於我們正在努力解決的生物相容性問題，我們對lenacapavir本身充滿信心。除此之外，我們在1月與您分享的其他目標里程碑均按計畫進行。

We've added some of the newly disclosed trials from our Oncology Deep Dive as well on this slide. Additionally, we're pleased to note that the partial clinical hold for the pivotal magrolimab trials, including ENHANCE-3 for first-line unfit AML shown on the slide have been lifted. I'm also pleased to share that despite the hold, there's no change to the timing of the first interim readout for ENHANCE for first-line high-risk MDS, which we expect in the first half of 2023. Merdad will share more pipeline details later in the call.

我們在這張投影片中也加入了一些來自我們腫瘤學深度分析的最新揭露的試驗。此外，我們很高興地宣布，關鍵性magrolimab試驗（包括幻燈片中展示的一線不適合接受治療的AML患者的ENHANCE-3試驗）的部分臨床暫停已解除。同時，我也很高興地宣布，儘管試驗暫停，但一線高風險MDS患者的ENHANCE試驗的首次中期結果公佈時間不變，我們預計將在2023年上半年公佈。 Merdad將在稍後的電話會議中分享更多研發管線詳情。

Before I pass it over to Johanna, I just want to take a moment to thank the Gilead and Kite teams who are putting the full way to their expertise, passion and commitment behind all of this work that you're seeing. It's thanks to our 14,000 employees across the world that were delivering for patients with diverse conditions and diseases today and advancing a pipeline of innovative new therapies for the future. We have some bold ambitions for the coming years, and we're confident of achieving them given the level of innovation and capabilities that we have in place today.

在將發言權交給喬安娜之前，我想藉此機會感謝吉利德和凱特團隊，他們傾注了全部的專業知識、熱情和奉獻精神，才成就了大家今天所看到的這一切。這要感謝我們遍佈全球的14,000名員工，他們不僅為患有各種疾病的患者提供治療，還持續推動面向未來的創新療法研發。我們對未來幾年有著宏偉的目標，並且憑藉著目前所擁有的創新能力和實力，我們有信心實現這些目標。

Now I'll invite Johanna to share an update on our first quarter commercial performance. Over to you, Johanna.

現在我請喬安娜向大家報告我們第一季的商業表現。喬安娜，請開始。

Thanks, Dan, and good afternoon, everyone. So turning to Slide 7. We had a solid start to the year with total product sales, excluding VEKLURY, of USD 5 billion for the quarter, up 2% year-over-year driven by cell therapy, TRODELVY and HIV, and offset in part by HCV pricing dynamics. Quarter-over-quarter, total product sales, excluding VEKLURY, were down 14% as a result of the seasonality we typically see in the first quarter of the year, primarily in our HIV business.

謝謝丹，大家下午好。現在來看第七張幻燈片。今年開局不錯，第一季產品總銷售額（不包括VEKLURY）達到50億美元，年增2%，主要得益於細胞療法、TRODELVY和HIV業務的成長，但部分被HCV定價策略所抵銷。由於每年第一季通常存在的季節性因素（主要體現在我們的HIV業務上），第一季產品總銷售額（不包括VEKLURY）環比下降14%。

On Slide 8, you can see that HIV sales were down 18% quarter-over-quarter to $3.7 billion, consistent with our guidance, given the seasonality we customarily experienced in the first quarter of every year. First, the channels build their inventories over the fourth quarter and then draw them down during Q1. On a dollar basis, the majority of the sequential decline was associated with inventory drawdown. Second, we realized lower net prices in part due to increased copay support, Part D discounts and other efforts to maintain access and affordability of our HIV medicines as patients' insurance plans reset. This is a customary Q1 dynamic that we expect to normalize throughout the rest of this year.

如幻燈片8所示，HIV藥物銷售額較上季下降18%至37億美元，這與我們的預期一致，因為每年第一季通常都會出現季節性波動。首先，通路會在第四季增加庫存，然後在第一季減少庫存。以美元計算，季減的主要原因是庫存減少。其次，由於患者保險計劃調整，我們提高了共付額支持、D部分折扣以及其他旨在維持HIV藥物可及性和可負擔性的措施，導致淨價下降。這是第一季的常見情況，我們預計這種情況將在今年剩餘時間內恢復正常。

Year-over-year, HIV sales were up 2% driven by market growth for both treatment and PrEP, offset in part by the impact of the loss of exclusivity for TRUVADA in 2020. The year-over-year impact of this LOE is expected to be minimal starting in the second quarter of this year. And excluding the LOE impact, HIV sales increased 5%.

受治療和暴露前預防（PrEP）市場成長的推動，HIV藥物銷售額年增2%，但部分被TRUVADA於2020年失去獨家銷售權的影響所抵銷。預計從今年第二季開始，該獨家銷售權喪失對年比銷售額的影響將微乎其微。若不計獨家銷售權喪失的影響，HIV藥物銷售額成長5%。

Overall, we're encouraged by the signs of recovery seen in the HIV treatment market despite screening and diagnosis rates still below pre-pandemic levels and the continued impact on market growth due to the Omicron surge in Q1. As a result, both the U.S. and European HIV treatment markets were down slightly on a sequential basis. On a year-over-year basis, the European market was roughly flat, and the U.S. market grew a little over 3%.

總體而言，儘管篩檢和診斷率仍低於疫情前水平，且第一季奧密克戎（Omicron）銷量激增持續影響市場成長，但我們對愛滋病治療市場復甦的跡象感到鼓舞。因此，美國和歐洲的愛滋病治療市場較上季均略有下降。與去年同期相比，歐洲市場基本持平，而美國市場成長略高於3%。

The PrEP market grew 33% year-over-year and 3% sequentially. Notably, DESCOVY continues to hold approximately 45% market share, and we'll continue to engage with payers to ensure those who benefit from PrEP have access to their preferred regimen. We believe Gilead remains well positioned in PrEP. And as highlighted during our Virology Deep Dive in February, we expect the market to double by 2030, catalyzed by the launch of long-acting regimens such as lenacapavir. DESCOVY sales in the first quarter were $374 million, up 4% year-over-year, driven by continued PrEP market growth and partially offset by generic competition and switches to newer treatment medicines such as BIKTARVY.

PrEP市場較去年成長33%，較上季成長3%。值得注意的是，DESCOVY繼續保持約45%的市場份額，我們將繼續與支付方合作，確保PrEP受益者能夠獲得其首選的治療方案。我們相信吉利德在PrEP領域仍處於有利地位。正如我們在2月的病毒學深度分析報告中所強調的，我們預計到2030年，在lenacapavir等長效治療方案上市的推動下，該市場規模將翻倍。 DESCOVY第一季銷售額為3.74億美元，較去年同期成長4%，這主要得益於PrEP市場的持續成長，但部分被仿製藥競爭以及患者轉向BIKTARVY等新型治療藥物所抵銷。

Turning to Slide 9. BIKTARVY sales of $2.2 billion in the first quarter were up 18% year-over-year driven by U.S. market growth, and notably, continued share gains in both the U.S. and in Europe. BIKTARVY remains the leading regimen for new starts and switches in the U.S. and new starts in Europe. In fact, BIKTARVY share is up 4.5% year-over-year to 43% share in the U.S., almost 8x larger than the next leading promoted medicine and representing the highest share of any complete regimen for the treatment of HIV.

請看投影片9。 BIKTARVY第一季銷售額達22億美元，年增18%，主要得益於美國市場的成長，尤其值得一提的是，其在美國和歐洲的市佔率均持續提升。 BIKTARVY仍然是美國新發和轉換治療方案以及歐洲新發治療方案的首選。事實上，BIKTARVY在美國的市佔率年增4.5%，達到43%，幾乎是排名第二的領先推廣藥物的8倍，在所有HIV治療方案中市佔率最高。

Moving to Slide 10 in HCV. We maintained steady market share, and the 22% decline year-over-year was primarily driven by unfavorable pricing dynamics. Sequentially, HCV was up 2%, while the overall market and new patient starts continue to be impacted by the pandemic.

接下來是丙型肝炎（HCV）部分的幻燈片10。我們維持了穩定的市場份額，年減22%主要是由於不利的價格因素。環比來看，C型肝炎的銷售量成長了2%，而整體市場和新患者數量仍受到疫情的影響。

HBV and HDV on Slide 11 were up 7% year-over-year due to higher demand for Vemlidy, namely in Asia. Sequentially, HBV and HDV declined 11% driven by the same HBV seasonal inventory and pricing dynamics impacting HIV.

第11張投影片顯示，HBV和HDV銷量年增7%，主要原因是Vemlidy的需求增加，尤其是在亞洲地區。環比來看，HBV和HDV銷量下降11%，原因與影響HIV的HBV季節性庫存和價格波動相同。

Hepcludex sales were $11 million for the quarter, primarily reflecting sales in Germany and France where full reimbursement has been established. Our discussions with regulatory bodies and other countries across Europe are ongoing. And of course, we look forward to potential approval in the U.S. in the second half of this year.

Hepcludex本季銷售額為1,100萬美元，主要來自德國和法國，這兩個國家已實現全額醫保報銷。我們正與歐洲各國監管機構進行磋商。當然，我們也期待今年下半年在美國獲得批准。

VEKLURY revenues in the first quarter were $1.5 billion, as shown on Slide 12. VEKLURY utilization tracks hospitalization rates, and therefore, due to the timing of Omicron surges, was lower in the U.S. after January but higher in Europe and Asia later in the quarter. We're optimistic that there will not be another surge this year in the U.S. And overall, we will maintain our readiness to support hospitalized and nonhospitalized patients. There's no change to our commitment to COVID-19 patients globally. And in that regard, we were very pleased to receive the World Health Organization's revised COVID-19 guidelines.

如投影片12所示，VEKLURY第一季營收為15億美元。 VEKLURY的使用率與住院率密切相關，因此，由於Omicron的用藥高峰期，1月後美國地區的VEKLURY使用率較低，但本季後期歐洲和亞洲地區的VEKLURY使用率較高。我們樂觀地認為，今年美國不會再出現另一波疫情高峰。總體而言，我們將繼續做好準備，為住院和非住院患者提供支援。我們對全球新冠肺炎患者的承諾並沒有改變。在這方面，我們非常高興地收到了世界衛生組織修訂後的新冠肺炎指南。

These guidelines now conditionally recommend VEKLURY for the treatment of patients with nonsevere COVID-19 at highest risk of hospitalization. And earlier this week, VEKLURY received FDA approval for the treatment of certain pediatric patients for at least 28 days old, highlighting our ongoing commitment to extend the reach of VEKLURY where we can.

這些指引目前有條件地建議使用VEKLURY治療非重症COVID-19患者，尤其是那些住院風險最高的患者。本週早些時候，VEKLURY獲得了FDA批准，用於治療至少28天大的某些兒科患者，這凸顯了我們持續致力於盡可能擴大VEKLURY適用範圍的承諾。

Now turning to oncology. TRODELVY sales were up 103% year-over-year and 24% sequentially, as shown on Slide 13. We're encouraged by adoption not just in the U.S., but notably, in Germany and France, and continue to work with health authorities and reimbursement bodies to extend TRODELVY's reach to patients globally. We've completed the expansion of our field force to support the U.S. and Europe and believe we are now at right scale to support physicians and make TRODELVY available across all approved indications to patients who could benefit from it.

現在我們來談談腫瘤領域。如投影片13所示，TRODELVY的銷售額年增103%，季增24%。我們很高興地看到，TRODELVY不僅在美國，而且在德國和法國也取得了顯著的市場認可。我們將繼續與衛生監管機構和醫保機構合作，將TRODELVY的惠及範圍擴大到全球患者。我們已完成美國和歐洲銷售團隊的擴充，並相信目前的規模足以支持醫生，使TRODELVY能夠惠及所有獲準適應症的患者。

We're extremely excited by the feedback from physicians about TRODELVY's impact on patients, both those who are prescribing TRODELVY today and those who expect to have access to it soon. With strong physician uptake and our expanded field footprint starting in April, we believe TRODELVY will benefit more than the 1 in 4 second-line metastatic TNBC patients we're reaching in the U.S. today. We look forward to sharing more updates as we progress throughout the year.

我們對醫生們關於TRODELVY對患者影響的回饋感到非常振奮，無論是目前正在使用TRODELVY的醫生，還是即將使用該藥物的醫生。隨著醫生們積極採納，以及我們從四月開始擴大推廣範圍，我們相信TRODELVY將惠及更多患者，而不僅僅是目前在美國接受二線治療的四分之一轉移性三陰性乳癌（TNBC）患者。我們期待在今年後續進展中與大家分享更多最新資訊。

Turning to Slide 14. And on behalf of Christi and the Kite team, cell therapy sales for the first quarter of 2022 were $274 million, up 43% year-over-year and 15% sequentially. For the quarter, Yescarta sales of $211 million were up 32% year-over-year and 16% sequentially driven by continued global demand in relapsed or refractory large B-cell lymphoma as well as in follicular lymphoma. This highlights the growing recognition of the durable long-term survival benefit showcased at last December's American Society of Hematology Meeting.

請翻到第14張投影片。我謹代表Christi和Kite團隊報告，2022年第一季細胞療法銷售額為2.74億美元，年增43%，季增15%。其中，Yescarta的銷售額為2.11億美元，較去年同期成長32%，較上季成長16%，主要得益於全球對復發或難治性大B細胞淋巴瘤以及濾泡性淋巴瘤的持續需求。這凸顯了人們對Yescarta在去年12月美國血液學會年會上展示的持久長期生存獲益的日益認可。

For Tecartus, sales of $63 million were up 103% year-over-year due to strong demand in relapsed or refractory mantle cell lymphoma. We're pleased with the strong early uptake for adult acute lymphoblastic leukemia in the U.S. following approval last October, which contributed to the 11% sequential growth in Tecartus. The strong momentum we've seen across our cell therapy portfolio continued with the approval of Yescarta in second-line relapsed or refractory LBCL earlier this month as well as FDA's approval for our new Maryland manufacturing facility announced just last week. Through capacity improvements across our existing in-house CAR-T manufacturing site in addition to the new Maryland site, we expect our manufacturing capacity to increase by up to 50% and support our aspiration to serve a cumulative 25,000-plus patients by the end of 2025.

Tecartus 的銷售額達到 6,300 萬美元，年增 103%，這主要得益於復發或難治性套細胞淋巴瘤的強勁需求。我們很高興 Tecartus 的成人急性淋巴性白血病療法自去年 10 月獲批以來，在美國市場早期表現強勁，這推動了 Tecartus 銷售額較上季成長 11%。本月初 Yescarta 已獲批用於二線復發或難治性大B細胞淋巴瘤 (LBCL) 治療，以及上週 FDA 批准我們位於馬裡蘭州的新生產基地，都延續了我們細胞療法產品組合的強勁增長勢頭。透過提升現有 CAR-T 細胞療法生產基地以及馬裡蘭州新基地的產能，我們預計產能將提升高達 50%，從而支持我們實現到 2025 年底累計服務超過 25,000 名患者的目標。

Second-line orders started coming in the day after the FDA approval and have been steady ever since. It is truly heartening to see the immediate help we can provide for patients. Given the Yescarta second-line inclusion in the NCCN guidelines and robust clinical data, we expect Yescarta to shift the paradigm in the standard of care for LBCL patients.

FDA批准Yescarta的第二天，二線治療訂單就開始湧入，並且從那時起一直保持穩定成長。看到我們能夠為患者提供如此及時的幫助，我們深感欣慰。鑑於Yescarta已被納入NCCN指引的二線治療方案，且擁有可靠的臨床數據，我們預期Yescarta能夠改變大B細胞淋巴瘤（LBCL）患者的標準治療模式。

Christi is here with the team and is available to take any questions on cell therapy during our Q&A. And so with that, I will hand over the call to Merdad for an update on our clinical pipeline.

克里斯蒂和團隊一起在這裡，她會在問答環節回答關於細胞療法的任何問題。接下來，我將把電話交給梅爾達德，請他介紹我們的臨床研發管線。

Thank you, Johanna, and hi, everyone. 2022 is full of clinical activity here at Gilead, and I hope the Virology and Oncology Deep Dives were helpful in highlighting the breadth and depth of our portfolio.

謝謝 Johanna，大家好。 2022 年吉利德的臨床活動非常豐富，我希望病毒學和腫瘤學深度講座能幫助大家更了解我們產品組合的廣度和深度。

By the end of 2022, we expect to have more than 90 clinical trials underway across oncology, virology and inflammation. With such a broad portfolio, our focus is firmly on innovation and execution to ensure that we fully leverage its potential.

到2022年底，我們預計將在腫瘤學、病毒學和發炎領域進行超過90項臨床試驗。憑藉如此廣泛的產品組合，我們將重點放在創新和執行上，以確保充分發揮其潛力。

Moving to HIV on Slide 16. We shared exciting 1-year data from the CAPELLA trials at CROI in February, reporting 83% virologic suppression in heavily treatment-experienced people living with multidrug-resistant HIV. Given the significant unmet need of this patient population, the lenacapavir NDA was designated Priority Review by the FDA, and we're planning to resubmit the NDA as soon as we resolve the clinical hold and complete response letter.

接下來是第16張投影片，內容是關於HIV。我們在2月的CROI會議上分享了CAPELLA試驗令人振奮的1年數據，結果顯示，在接受過大量治療的多重抗藥性HIV感染者中，病毒抑制率達到了83%。鑑於該患者群體存在巨大的未滿足需求，FDA已將lenacapavir新藥申請（NDA）指定為優先審評，我們計劃在解決臨床暫停和完整回复函的問題後，盡快重新提交NDA。

As you know, the basis of these FDA actions was the compatibility of lenacapavir with vials in use at that time, not lenacapavir itself. We're in ongoing dialogue with the agency to consider an alternative vial and look forward to updating you of our progress in due course. Separately, we're on track for the HTE MAA approval in Europe in the second half of the year.

如您所知，FDA採取這些行動的依據是lenacapavir與當時使用的藥瓶的兼容性，而非lenacapavir本身。我們正與FDA保持溝通，探討使用替代藥瓶的可能性，並期待在適當的時候向您報告進度。此外，我們正按計畫推進lenacapavir在歐洲的上市許可申請（HTE MAA），預計今年下半年獲得批准。

At our Virology Deep Dive in February, we shared details of the 8 internal candidates that could partner with lenacapavir for treatment and highlighted the additional early development or discovery assets shown on Slide 17. In addition to our PrEP programs, these assets give us a high degree of confidence that Gilead will sustain its leadership in HIV through the 2020s and beyond.

在二月份的病毒學深度研討會上，我們分享了8種可與lenacapavir聯合用於治療的內部候選藥物的詳細信息，並重點介紹了幻燈片17中展示的其他早期開發或發現資產。除了我們的PrEP項目外，這些資產讓我們高度確信，吉利德將在2020年代及以後繼續保持其在HIV領域的領先地位。

In the immediate term, we continue to generate very strong data for BIKTARVY. At CROI, we showed virologic suppression at or above 98% in the M=E analysis and 0 cases of treatment failure due to resistance to any components of the single-tablet regimen in two 5-year Phase III trials. Of note, this 5-year duration is unprecedented for an HIV regimen.

短期內，我們持續獲得BIKTARVY的強有力數據。在CROI會議上，我們證實，在M=E分析中，病毒抑制率達到或超過98%，並且在兩項為期5年的III期臨床試驗中，未出現因對單片複方製劑任何成分產生抗藥性而導致的治療失敗病例。值得注意的是，5年的療程對於HIV治療方案而言是前所未有的。

Moving to Slide 18. VEKLURY is playing an important role in the fight against COVID-19 and is the only antiviral approved for use in both hospitalized and non-hospitalized patients. Just in the past few days, the FDA approved an sNDA for VEKLURY for the treatment of pediatric patients who are at least 28 days old and either hospitalized with COVID-19 or with mild-to-moderate COVID-19 and considered high risk for progression to severe COVID-19.

切換到第18張投影片。 VEKLURY在對抗COVID-19疫情中發揮重要作用，是唯一獲準用於住院和非住院患者的抗病毒藥物。就在幾天前，FDA批准了VEKLURY的補充新藥申請（sNDA），用於治療至少28天大的COVID-19住院患兒，或患有輕度至中度COVID-19且被認為有發展為重症COVID-19高風險的患兒。

In addition to VEKLURY, we have an ongoing Phase I trial of GS-5245, our investigational oral COVID-19 nucleoside that once metabolized works in the same way as remdesivir. Results from this study could lead to a registrational trial. So even while we hope the worst of this pandemic is behind us, we will continue to work to ensure that COVID-19 therapies are available to as many patients as possible.

除了VEKLURY之外，我們目前正在進行一項GS-5245的I期臨床試驗。 GS-5245是一種正在研究的口服COVID-19核苷類藥物，其代謝後的作用機轉與瑞德西韋相同。這項研究的結果可能會促成註冊性試驗。因此，即使我們希望疫情最糟糕的時期已經過去，我們仍將繼續努力，確保盡可能多的患者能夠獲得COVID-19治療。

Moving to oncology, and specifically TRODELVY, on Slide 19, we'll share more detailed data from the TROPiCS-02 study at ASCO in June. As a reminder, we announced that the study met its primary endpoint with statistically significant PFS versus physician's choice of chemotherapy in late-line patients. And that results are consistent with the TRODELVY arm in the Immunomedics-132-01 Phase I/II trial. OS showed a trend in improvement at the first interim analysis, and we're now targeting a final OS analysis in 2024, depending on the timing of events.

接下來，我們將討論腫瘤學，特別是TRODELVY。在第19張投影片中，我們將分享TROPiCS-02研究的更多詳細數據，該研究將於6月在ASCO會議上舉行。我們先前宣布，該研究達到了主要終點，在晚期患者中，TRODELVY組的無惡化存活期（PFS）與醫師選擇的化療方案相比具有統計學意義。此結果與Immunomedics-132-01 I/II期試驗中TRODELVY組的結果一致。在首次中期分析中，總存活期（OS）顯示出改善趨勢，我們目前計劃在2024年進行最終的OS分析，具體時間取決於事件發生的時間。

In the meantime, we're engaging with regulatory authorities to explore potential pathways given the high unmet need. As a reminder, TROPiCS-02 targeted a more advanced patient population than DESTINY-Breast04. The encouraging clinical data we've seen in this more challenging patient group has strengthened our excitement in exploring earlier-stage patients. As we shared 2 weeks ago, we're planning a pivotal study for frontline HR-positive/HER2-negative patients, and we'll share more information in due course.

同時，鑑於目前龐大的未滿足醫療需求，我們正與監管機構接洽，探索潛在的治療途徑。需要指出的是，TROPiCS-02 研究針對的是比 DESTINY-Breast04 研究更為晚期的患者群體。我們在這更具挑戰性的患者群體中觀察到的令人鼓舞的臨床數據，更加激發了我們探索早期患者治療的熱情。正如我們兩週前所分享的，我們正在計劃一項針對第一線 HR 陽性/HER2 陰性患者的關鍵性研究，並將適時分享更多資訊。

In addition to TROPiCS-02, we're targeting First Patient In, or FPI, for a number of new TRODELVY trials this year. In the first half of 2022, this includes front-line studies for non-small cell lung cancer and PD-L1-positive and PD-L1-negative metastatic TNBC. In the second half of the year, we're targeting FPI for the EVOKE-03 Phase III trial for first-line non-small cell lung cancer. TROPiCS-04 for metastatic urothelial carcinoma is ongoing, and we anticipate a readout in the 2023, 2024 time frame.

除了 TROPiCS-02 之外，我們今年還將啟動多項新的 TRODELVY 試驗，並爭取首例患者入組（FPI）。 2022 年上半年，這些試驗包括針對非小細胞肺癌以及 PD-L1 陽性和 PD-L1 陰性轉移性三陰性乳癌的第一線治療研究。下半年，我們將重點放在 EVOKE-03 III 期臨床試驗（針對第一線非小細胞肺癌）的首例患者入組。 TROPiCS-04（針對轉移性尿路上皮癌）試驗正在進行中，預計 2023 年至 2024 年間發表結果。

As you can see on this slide, shared for the first time in our Oncology Deep Dive earlier this month, we are in the earliest stages of evaluating how TRODELVY, either alone or in combination, could bring new options to people with cancer. In total, we're studying more than 25 combinations, including 7 Phase III combination studies.

正如您在本月初的腫瘤學深度研討會上首次分享的這張幻燈片所示，我們目前正處於評估 TRODELVY（單藥或聯合用藥）如何為癌症患者帶來新治療方案的早期階段。我們總共在研究超過 25 種合併用藥方案，其中包括 7 項 III 期合併用藥研究。

On behalf of my Kite colleagues and on Slide 20, I'm pleased to highlight the FDA approval of Yescarta for the second-line treatment of relapsed or refractory large B-cell lymphoma earlier this month. The approval is based on the ZUMA-7 trial data that showed that 2.5x more patients receiving Yescarta were alive at 2 years without disease progression or need for additional cancer treatment versus the standard of care. This was the first cell therapy approved by FDA for initial treatment of refractory or relapsed LBCL and within 12 months of initial treatment. Yescarta was also added to the NCCN's B-cell lymphoma treatment guidelines for these patients.

我謹代表Kite公司的同事，在第20張投影片中，很高興地向大家介紹本月初FDA批准Yescarta用於復發或難治性大B細胞淋巴瘤二線治療的消息。此核准是基於ZUMA-7試驗的數據，數據顯示，與標準治療相比，接受Yescarta治療的患者在2年內無疾病進展或無需額外癌症治療的生存率是其2.5倍。這是FDA批准的首個用於難治性或復發性大B細胞淋巴瘤一線治療且在初始治療後12個月內起效的細胞療法。 Yescarta也被納入NCCN（美國國家綜合癌症網絡）針對此類患者的B細胞淋巴瘤治療指南。

Moving to magrolimab on Slide 21. We're very pleased that the FDA lifted the partial clinical holds for our MDS and AML trials, and we resumed enrollment in our 3 pivotal studies. I'll note that the remaining partial clinical holds on DLBCL and multiple myeloma are being reviewed by a different division of the FDA, and we're actively working to resolve them as quickly as possible. In the meantime, the impact of these remaining partial holds is limited since the DLBCL trial was already fully enrolled at the time of the partial clinical hold and the multiple myeloma trial had just initiated.

接下來，我們來看看投影片 21 中的 magrolimab。我們非常高興 FDA 解除了我們 MDS 和 AML 試驗的部分臨床試驗暫停，我們已恢復了 3 項關鍵性研究的患者招募。需要說明的是，DLBCL 和多發性骨髓瘤試驗剩餘的部分臨床試驗暫停正在由 FDA 的另一個部門進行審查，我們正在積極努力盡快解決這些問題。同時，由於 DLBCL 試驗在部分臨床試驗暫停時已完成全部患者招募，而多發性骨髓瘤試驗也剛啟動，因此這些剩餘部分臨床試驗暫停的影響有限。

Overall, we're excited by magrolimab's potential to be the first new treatment for first-line high-risk MDS patients in 15 years and have completed patient enrollment for the first interim analysis that we expect to share in early 2023. In the meantime, we look forward to sharing data from our Phase Ib trial for high-risk MDS and first-line TP53 AML with more patients and longer follow-up at ASCO in June.

總體而言，我們對magrolimab有望成為15年來首個用於一線治療高風險MDS患者的新療法感到興奮，並且已經完成了首次中期分析的患者招募，預計將於2023年初公佈結果。同時，我們期待在6月的ASCO會議上分享我們針對高風險MDS和第一線TP53 AML的Ib期試驗數據，該試驗納入了更多患者，並進行了更長時間的追蹤。

Finally, on Slide 22 and noting that the timing for the potential submission of TROPiCS-02 and the NDA decision for CAPELLA are subject to change, there are no updates to the targeted milestones shared with you in January. With our partner, Arcus, we're targeting a number of data readouts in the second half of the year and have added some new trials, including STAR-121, evaluating zimberelimab and domvanalimab in combination with chemotherapy for front-line non-small cell lung cancer and ARC-21 to evaluate the same combination of upper GI malignancies.

最後，在第22張投影片中，考慮到TROPiCS-02的潛在提交時間和CAPELLA的新藥申請（NDA）決定時間可能會有所變動，因此，我們1月份與您分享的目標里程碑沒有更新。我們與合作夥伴Arcus計劃在今年下半年公佈多項數據，並新增了一些試驗，包括STAR-121（評估zimberelimab和domvanalimab聯合化療一線治療非小細胞肺癌）和ARC-21（評估相同聯合療法治療上消化道惡性腫瘤）。

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

這樣，我就把電話交給安迪了。

Thank you, Merdad, and good afternoon, everyone. Before I get into the Q1 P&L review and the guidance update, I wanted to touch on the $2.7 billion partial in-process R&D impairment related to assets acquired from Immunomedics in 2020. This had a $1.63 per share impact on our Q1 GAAP results and on our full year GAAP EPS guidance. There is no impact to our non-GAAP EPS in Q1 or to our non-GAAP EPS guidance for the full year.

謝謝Merdad，大家午安。在進行第一季損益回顧和業績指引更新之前，我想先談談與2020年從Immunomedics收購的資產相關的27億美元在研項目減值。這導致我們第一季GAAP業績和全年GAAP每股收益指引分別減少了1.63美元。第一季非GAAP每股盈餘和全年非GAAP每股盈餘指引均未受到影響。

With the TROPiCS-02 data readout in March, we have reassessed the value of the assets acquired. While no final decisions have been made pending discussions with regulatory authorities, as a result of the data, we have taken a $2.7 billion impairment to reflect the likelihood of a delayed launch of TRODELVY for third-line plus HR-positive/HER2-negative breast cancer in the United States as well as Europe and the possibility of a reduced market share in late-line patients given the emerging competitive landscape.

隨著3月TROPiCS-02數據公佈，我們重新評估了所收購資產的價值。雖然在與監管機構進行磋商後尚未做出最終決定，但根據這些數據，我們已計提27億美元的減值準備，以反映TRODELVY在美國和歐洲用於治療三線及以上HR陽性/HER2陰性乳腺癌的上市可能延遲，以及鑑於當前競爭格局的變化，其在後期競爭格局中可能下降。

Prior to today's update, Gilead was carrying $14.7 billion for the IP R&D indefinite-lived intangible assets acquired with Immunomedics. This now values these assets at $12 billion. Recall that the carrying value of TRODELVY reflected 4 potential indications in progress at the time of the acquisition, triple-negative breast cancer and hormone receptor-positive/HER2-negative breast cancer, bladder cancer and non-small cell lung cancer. At that time, we knew that TRODELVY's potential extended beyond these indications, but for accounting purposes did not assign value for the incremental opportunities that we are exploring in prostate, endometrial and other solid tumors as well as potential combinations such as with magrolimab, domvanalimab and PD-1s like pembrolizumab.

在今天的更新之前，吉利德為從Immunomedics收購的智慧財產權研發無形資產提列了147億美元的帳面價值。現在，這些資產的價值為120億美元。回顧一下，TRODELVY的帳面價值反映了收購時正在研發的4個潛在適應症：三陰性乳癌、荷爾蒙受體陽性/HER2陰性乳癌、膀胱癌和非小細胞肺癌。當時，我們知道TRODELVY的潛力遠不止於這些適應症，但出於會計目的，我們並未將我們正在探索的前列腺癌、子宮內膜癌和其他實體瘤的增量機會，以及與magrolimab、domvanalimab和PD-1抑製劑（如pembrolizumab）等潛在聯合用藥的機會計入價值。

As you saw at our Oncology Deep Dive earlier this month, there are 13 TRODELVY programs targeted for initiation through 2023, including a number of incremental opportunities. As a result, we remain confident TRODELVY will deliver an attractive return to our shareholders over time.

正如您在本月初的腫瘤學深度研討會上所看到的，TRODELVY計劃在2023年前啟動13個項目，其中包括一些新增項目。因此，我們仍然相信TRODELVY將在未來為股東帶來可觀的回報。

Moving to Slide 24. The first quarter was a strong start to the year despite the expected seasonality observed in our HIV business and was stronger-than-expected VEKLURY sales. Total product sales were $6.5 billion, up 3% year-over-year, with growth in cell therapy, VEKLURY, TRODELVY and HIV, offset in part by lower HCV revenue. Of note, FX negatively impacted first quarter revenue by almost $100 million, net of hedges, representing approximately 160 basis points of growth. Total product sales, excluding VEKLURY, were up 2% from the first quarter of 2021 to $5 billion.

翻到第24頁。儘管HIV業務受到預期季節性因素的影響，但第一季仍保持強勁的開局，其中VEKLURY的銷售額超出預期。產品總銷售額為65億美元，年增3%，其中細胞療法、VEKLURY、TRODELVY和HIV業務均實現成長，但部分被HCV收入的下降所抵消。值得注意的是，匯率波動對第一季營收造成了近1億美元的負面影響（扣除對沖收益後），相當於約160個基點的成長。若不計入VEKLURY，產品總銷售額較2021年第一季成長2%，達到50億美元。

In HIV, on a sequential basis, we were impacted, as expected, by the normal seasonality associated with Q1 inventory burn following a build in Q4 in addition to the typical first quarter pricing headwinds that improve throughout the rest of the year. With Q1 now behind us, we expect sequential growth in HIV throughout the rest of the year.

在愛滋病毒業務方面，正如預期，我們受到第一季庫存消耗的正常季節性影響（此前第四季度庫存有所增加），以及第一季常見的定價不利因素（這些不利因素會在下半年有所改善）。隨著第一季結束，我們預計愛滋病毒業務在今年剩餘時間內將保持季比成長。

Non-GAAP product gross margin was 87.4% for Q1, up 90 basis points year-over-year, primarily due to lower inventory reserve adjustment. First quarter non-GAAP operating expenses were largely consistent with our expectations as we support the expansion of our oncology business. Non-GAAP R&D was $1.2 billion, up 10% year-over-year. And non-GAAP SG&A was $1.1 billion, up 5% year-over-year, both primarily due to higher costs associated with TRODELVY.

第一季非GAAP產品毛利率為87.4%，較去年成長90個基點，主要由於存貨準備金調整減少。第一季非GAAP營運費用基本上符合預期，這得益於我們為腫瘤業務擴張所做的努力。非GAAP研發支出為12億美元，較去年成長10%。非GAAP銷售、管理及行政費用為11億美元，年增5%，這兩項支出均主要由於TRODELVY相關成本增加所致。

Moving to tax. Our non-GAAP effective tax rate in the first quarter was 18.4%. Overall, our non-GAAP diluted earnings per share were $2.12 in the first quarter of 2022 compared to $2.04 for the same period last year, reflecting the higher revenue and higher gross margin, offset in part by higher operating expenses.

接下來談談稅務方面。我們第一季的非GAAP實際稅率為18.4%。整體而言，我們2022年第一季的非GAAP稀釋後每股收益為2.12美元，而去年同期為2.04美元，這主要得益於更高的收入和更高的毛利率，但部分被更高的營運費用所抵銷。

On a GAAP basis, our effective tax rate and earnings per share were impacted by the $2.7 billion impairment. We are excited about the strong start to the year. And as you can see on Slide 25, the only revision to our outlook is to our GAAP EPS, primarily to reflect the $1.63 share impact of the impairment discussed earlier. We now expect GAAP EPS in the range of $3 to $3.50 per share from $4.70 to $5.20.

以美國通用會計準則（GAAP）計算，我們的實際稅率和每股盈餘受到27億美元減損的影響。我們對今年的強勁開局感到振奮。正如您在第25頁幻燈片中所見，我們對業績展望的唯一調整是GAAP每股收益，主要是為了反映先前討論的減損對每股1.63美元的影響。我們現在預計GAAP每股收益將介於3美元至3.50美元之間，先前預期為4.70美元至5.20美元。

On VEKLURY, we note the strong revenue start to the year, but also, fortunately, the significant drop-off in U.S. hospitalizations during the first quarter and into the second quarter so far. With that in mind, we will monitor demand through the second quarter and evaluate our full year guidance in the middle of the year.

關於威立雅（VEKLURY），我們注意到其年初營收表現強勁，但令人欣慰的是，美國住院人數在第一季和第二季迄今均顯著下降。有鑑於此，我們將密切注意第二季的需求情況，並在年中評估全年業績預期。

One housekeeping item before we wrap up. Following recent guidance from the SEC, beginning in the first quarter and similar to many of our peers, Gilead will no longer exclude acquired in-process R&D expenses from non-GAAP financial measures. Prior period results have been updated to reflect this new methodology and are shared in our supplementary data posted on the Investor Relations website.

在結束之前，還有一項重要事項需要說明。根據美國證券交易委員會（SEC）的最新指導，從第一季開始，吉利德將不再從非GAAP財務指標中剔除收購的在研研發費用，此舉與許多同業公司的做法類似。我們已更新前期業績以反映此新方法，相關數據已發佈在投資者關係網站的補充資料中。

As a reminder, our full year guidance does not include the impact of any future upfront payments related to the normal course of business partnerships or licensing deals. Going forward, we plan to update our guidance on a quarterly basis to reflect the impact of any new corporate development transactions closed in the prior quarter.

再次提醒，我們的全年業績指引並未包含未來與正常業務合作或授權交易相關的任何預付款的影響。今後，我們將按季度更新業績指引，以反映上一季完成的任何新的企業發展交易的影響。

Moving to Slide 26. You can see there is no change to our capital allocation priorities. In the first quarter, we repaid $500 million in debt. Additionally, we returned $1.3 billion to shareholders through our dividend and repurchase of shares.

請看第26張投影片。可以看到，我們的資本配置優先事項沒有改變。第一季度，我們償還了5億美元的債務。此外，我們透過派發股利和股票回購向股東返還了13億美元。

Finally, on M&A, there is no change to our philosophy here either. We are very comfortable with the breadth and the quality of the pipeline that we have built, acquired or partnered, and the growth that it will enable in the coming years. With that in mind, you can expect us to continue to opportunistically access high-quality assets through partnerships or make smaller acquisitions in the normal course of business.

最後，關於併購，我們的理念也未有任何改變。我們對已建立、收購或合作的項目儲備的廣度和質量，以及這些項目將在未來幾年帶來的成長潛力感到非常滿意。基於此，您可以預期我們將繼續透過合作或在日常業務中進行小規模收購，抓住機會獲取優質資產。

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

接下來，我將邀請接線生開啟問答環節。

(Operator Instructions) Our first question comes from the line of Michael Yee from Jefferies.

（操作說明）我們的第一個問題來自 Jefferies 的 Michael Yee。

Maybe I could ask about the planned or potential TRODELVY filing. You note that it's subject to change. Maybe you could just describe what you think the conversation is with FDA. Is it a combination of a modest PFS and OS trend? And is there a magnitude of OS trend that you think will be attractive and allow a green light to a filing? Maybe just talk a little bit about that and what would drive a filing.

或許我可以問問關於TRODELVY的計畫或潛在申請。您提到申請可能會有變動。您能否描述一下您認為與FDA的溝通內容？是否是基於適度的PFS和OS趨勢？您認為OS趨勢達到什麼程度才算有吸引力，足以獲得FDA的核准？能否簡單談談這方面，以及哪些因素會推動申請的提交？

Thanks, Michael. I'll turn it over to Merdad in just a second, but I'll just remind folks that we will be discussing the data more at ASCO coming up there in early June. We look forward to engaging with regulatory authorities in the coming months to further discuss the data and the path forward. I'll see if Merdad has anything to add on that at this stage, but...

謝謝，麥可。我馬上把麥克風交給梅爾達德，不過我先提醒大家，我們將在六月初舉行的ASCO會議上更詳細地討論這些數據。我們期待在未來幾個月與監管機構溝通，進一步探討這些數據和後續方案。我看看梅爾達德目前還有什麼補充，不過…

Yes. Michael, I think as a normal course of business, we'll always discuss the data, the totality of the data with the agency prior to a filing and have that conversation with them. As we've said, the primary endpoint was statistically significant. And so we will have that conversation with them looking at all the data and come to a conclusion based on the feedback we get.

是的，邁克爾，我認為按照正常的業務流程，在提交申請之前，我們總是會與監管機構討論所有數據，並與他們溝通。正如我們所說，主要終點具有統計意義。因此，我們會與他們討論所有數據，並根據我們收到的回饋得出結論。

Right. And we continue to look at earlier lines of therapy and plan those trials to move up in lines of therapy given the results we saw in TROPiCS-02 as well and hormone receptor-positive. So thanks a lot, Michael, for that.

沒錯。我們會繼續關注早期療法，並計劃根據我們在TROPiCS-02試驗中看到的結果，以及激素受體陽性患者的情況，推進相關試驗的開展。非常感謝你，麥可。

Certainly. Our next question comes from the line of Matthew Harrison from Morgan Stanley.

當然。我們的下一個問題來自摩根士丹利的馬修·哈里森。

This is Charlie Yang on for Matthew. So I guess my question is, is VEKLURY being -- currently being used in China and then actually benefit from the COVID outbreak there? And maybe if that's the case, can you talk about what the economics look like over there?

這裡是查理楊，替馬修提問。所以我想問的是，VEKLURY目前是否在中國使用，並且是否真的從那裡的COVID-19疫情中受益？如果是這樣的話，您能否談談那裡的經濟狀況？

Thanks for the question. We'll go right to Johanna.

謝謝你的提問。我們這就去找喬安娜。

Thanks for your question. So VEKLURY has been used now with over 11 million patients worldwide, which I think is really impressive. And it's still 1 out of 2 hospitalized patients in the U.S. What we are seeing, though, is trends of less severe disease, and therefore, less hospitalizations, but also less treatments.

感謝您的提問。目前，全球已有超過1,100萬名患者使用過VEKLURY，我認為這非常了不起。在美國，仍有一半的住院病患使用VEKLURY。不過，我們觀察到的趨勢是，病情較輕，因此住院人數減少，但接受的治療也相應減少。

Specific to your question to China, we don't have approval in China at this point in time. And we're continuing those discussions with health authorities in light of the fact that what's going on in China with the pandemic, obviously. I do think the WHO guidelines being updated just most recently is also going to help those discussions as well. So more to come on that, but not currently in play at this point in time in China. Thank you.

關於您提出的中國相關問題，目前我們尚未獲得中國的批准。鑑於中國當前的疫情情勢，我們正與衛生部門繼續進行磋商。我認為世衛組織最近更新的指導方針也將有助於這些諮詢。後續會有更多消息，但目前在中國尚未實施。謝謝。

Our next question comes from the line of Brian Abrahams from RBC Capital Markets.

下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。

Sticking with the COVID theme. Anything new that you're seeing that increases your level of confidence in 5245's potential for success? And are there any ways to potentially expedite future development of that asset?

繼續討論新冠疫情相關的議題。您觀察到哪些新情況，能夠增強您對5245計畫未來成功潛力的信心？是否有任何方法可以加快該專案未來的開發？

Thanks, Brian. I'll hand over to you, Merdad.

謝謝你，布萊恩。接下來交給你了，梅爾達德。

Yes. Nothing new to report, Brian. It's a great question. We continue to move along really well in our Phase I study that's moving forward expeditiously. And we are working with the agency to design a Phase II/III program and really moving as fast as possible. We've got a great partnership with the agency and others and are really ready to count. So right now, so far, so good.

是的，布萊恩，沒什麼新進展。你問得好。我們的一期臨床試驗進展非常順利，並且正在快速推進。我們也正在與相關機構合作設計二期/三期臨床試驗方案，並盡可能加快進度。我們與相關機構和其他合作夥伴建立了良好的合作關係，一切準備就緒。所以目前為止，一切順利。

Our next question comes from the line of Simon Baker from Redburn.

我們的下一個問題來自雷德本的西蒙·貝克。

On HIV, Johanna, you alluded to the market dynamics. I just wondered if you could give us a little bit more color and update us on how diagnosis rates are now compared to the beginning of the year. And also if you are seeing any initial impact from perhaps this launch of CABENUVA.

關於愛滋病，Johanna，你提到了市場動態。我想請你更詳細地介紹一下，並更新一下目前的診斷率與年初相比的情況。另外，CABENUVA的上市是否產生了任何初步影響？

Sure. So both market and CABENUVA. Thanks, Simon, for your question. So let me start with the market. So if you look at the screening and diagnosis levels, they're still somewhat below prepandemic, but they're definitely catching up. I think what we saw in the first half '21 was a really depressed market and started picking back up in Q3 and Q4 of last year. What we saw in Q1 of this year despite the Omicron surge that obviously impacts, what we saw quarter-over-quarter pretty much flat in the U.S. and overall Europe as well. Year-on-year change, though, we have about a 3.6% growth.

當然。所以，市場和CABENUVA都是如此。謝謝Simon的提問。那麼，我先來說說市場。如果你看一下篩檢和診斷水平，它們仍然比疫情前略低，但肯定正在迎頭趕上。我認為我們在2021年上半年看到的是一個非常低迷的市場，直到去年第三季和第四季才開始回升。今年第一季度，儘管Omicron的激增顯然產生了影響，但我們看到美國和整個歐洲的季度環比基本持平。不過，年成長率約為3.6%。

And I think that's really -- that's the signal that we need to watch for and continue to focus on. And since Gilead has close to 75% market share of the total HIV market, I think it's really -- it's part of our responsibility to ensure that we get screening and diagnosis up and make sure we end this pandemic. So more to come on that, but there's a lot of activities the team is taking on to ensure that we get people back in and screened so that we don't have full-fledge case rebate, which, unfortunately, we've seen in the recent past, and you've seen that anecdotally.

我認為這才是我們真正需要關注和持續關注的訊號。由於吉利德在愛滋病市場佔據了近75%的市場份額，我認為確保篩檢和診斷工作順利開展，最終終結這場疫情，是我們義不容辭的責任。關於這一點，我們稍後會詳細說明。目前，團隊正在進行多項工作，以確保患者能夠重新接受篩檢，從而避免嚴重的病例反彈。不幸的是，這種情況在近期已經出現過，你們也從一些案例中了解到。

On the prevention market, it's a little bit different. Prevention market bounces back a lot faster post this pandemic, and we've seen that time and time again after every single surge. So what we've seen quarter-over-quarter was about a 3% growth in the U.S. for prevention. So slightly modest growth, which declined a little bit, but that's because of the Omicron surge in January. Year-over-year, the growth was 33%. And so I think that's really telling in the sense of how it bounces back much faster post these surges. And that's been kind of consistent year-on-year as we've seen the different, I guess, variants.

預防市場的情況略有不同。預防市場在疫情後反彈速度更快，我們在每次疫情高峰過後都看到了這一點。因此，我們看到美國預防市場較上季成長約3%。成長幅度略為溫和，略有下降，但這主要是由於1月Omicron疫苗的銷售量激增所致。年比來看，成長率為33%。我認為這充分說明了預防市場在疫情高峰過後反彈速度非常快。而且，正如我們所看到的，這種趨勢在每年的疫情高峰期都保持穩定。

On your question around CABENUVA, specific to CABENUVA, treatment share in CABENUVA is 0.6%. So no, we haven't seen an impact. What we see is new entrants coming into the market. You always see a little bit of switching going on, which is normal. I do think that there's an ask from a patient standpoint, this is the first long-acting, so it is exciting. What we're also seeing is a higher-than-usual drop-off rate with CABENUVA as well. And a lot of that share is going to BIKTARVY back. So I do think it's interesting to watch. And I think the more agents on the market, the better, but definitely one that at this point in time very limited impact to the HIV market share for Gilead. Thanks for your questions.

關於您提到的CABENUVA，具體來說，CABENUVA的治療份額為0.6%。所以，我們目前還沒有看到任何影響。我們看到的是新藥進入市場。總是會有一些藥物轉換，這很正常。我認為從患者的角度來看，CABENUVA是首個長效HIV治療藥物，所以它令人興奮。我們也注意到CABENUVA的停藥率高於平常。而且很多流失的份額都流向了BIKTARVY。所以我認為這值得關注。我認為市場上的藥物越多越好，但就目前而言，CABENUVA對吉利德HIV市場份額的影響非常有限。感謝您的提問。

Our next question comes from the line of Geoff Meacham from Bank of America.

我們的下一個問題來自美國銀行的傑夫·米查姆。

I had an HIV question for Merdad or maybe even Dan. So you built an increasingly broad pipeline around lenacapavir. And I know getting long-acting right is strategically very important to Gilead. So the question is, what's been the main bottleneck so far? Is it a matter of matching up the PK/PD for lena? And would you wait to go into a larger scale trial if there is a candidate that may make an optimal doublet with lenacapavir?

我有一個關於HIV的問題想問Merdad或Dan。你們圍繞著lenacapavir構建了一個越來越廣泛的產品線。我知道，對吉利德來說，研發出合適的長效藥物在策略上至關重要。所以我的問題是，到目前為止，主要的瓶頸是什麼？是lenacapavir的藥物動力學/藥效學（PK/PD）匹配問題嗎？如果有一種候選藥物可能與lenacapavir形成最佳的雙藥療法，你們會等待一段時間再進行更大規模的臨床試驗嗎？

Yes. Thanks, Geoff. Appreciate it. I'm going to turn it over to Merdad in a second here. But just remind -- for those of you that didn't have the chance to look at the Virology Deep Dive Day, we really did spend a lot of time in the entirety of the portfolio and the many shots on goal we have along with lenacapavir. Lenacapavir is a truly unique molecule and presents opportunities and challenges to find exactly the right partner. But we certainly have many that will be progressing to the clinic. But Merdad, maybe you want to give a little more meat to the...

是的，謝謝，Geoff。非常感謝。我馬上就把麥克風交給Merdad。不過提醒一下——對於那些沒有機會觀看病毒學深度研討會的朋友們，我們確實花了很多時間詳細介紹了我們所有的產品組合，以及包括lenacapavir在內的眾多潛在候選藥物。 Lenacapavir是一種非常獨特的分子，在尋找合適的合作夥伴方面既充滿機會也面臨挑戰。但我們有許多候選藥物將會進入臨床試驗階段。 Merdad，或許你想再詳細說…

Sure. Yes. I mean maybe I'll start by saying on the PrEP side, we obviously don't need to wait for a partner molecule. And really, at this point, it's about resolving the issues with the clinical hold. Once that gets resolved, we'll be back in business with the trials and we'll move as fast as possible to get the PrEP studies completed and get our filing done.

當然。是的。我的意思是，或許我可以先說說PrEP方面，我們顯然不需要等待合適的分子。實際上，目前最重要的是解決臨床試驗暫停的問題。一旦這個問題解決，我們就能恢復試驗，並儘快完成PrEP研究和申報工作。

In treatment, you're absolutely right. And again, I think you're right, we've built the portfolio to provide us numerous options to then combine with lenacapavir for treatment in a long-acting mode. And that's a mix of oral approaches where we could have an oral long-acting molecule or a parenteral long-acting agent. And for parenteral, we're trying to go for longer than 2 months. And for oral, we are looking at, hopefully, getting to weekly or thereabouts.

在治療方面，您說得完全正確。而且，我認為您說得對，我們已經建立了豐富的藥物組合，可以提供多種選擇，與來那卡帕韋聯合使用，實現長效治療。這包括口服和腸外給藥兩種途徑。對於腸外給藥，我們力求超過兩個月的療程。對於口服藥物，我們希望能夠達到每週一次或更短的給藥頻率。

So we have a number of candidates that are progressing to show us -- essentially, you said it right, which is do they have the right properties from a PK/PD standpoint for an oral agent? And do they have the right properties parenterally, including things like injection site reactions and tolerability? So it's less about the ability to inhibit HIV replication. It's more about the molecule and the formulation characteristics that allow us to get to long-acting therapy. And I'll just say again that lenacapavir is a very unique and special molecule that enables us to do that. Finding another molecule that has those sorts of characteristics is the challenge that we're undertaking.

所以，我們有一些候選藥物正在進行研究，它們需要向我們展示——正如您所說，本質上來說，就是它們是否具備口服藥物所需的藥物動力學/藥效學特性？以及它們是否具備適當的腸外給藥特性，包括注射部位反應和耐受性？因此，關鍵不在於抑制HIV複製的能力，而是能夠實現長效治療的分子和製劑特性。我再次強調，lenacapavir是一種非常獨特且特殊的分子，它使我們能夠做到這一點。尋找另一種具有類似特性的分子是我們正在面臨的挑戰。

Certainly. Our next question comes from the line of Do Kim from Piper Sandler.

當然。我們的下一個問題來自Piper Sandler飾演的Do Kim的台詞。

I wanted to ask about Yescarta and the launch in second-line LBCL. Was hoping you could provide some first impressions of the launch and whether your sense of the demand out there is matching with your expectations?

我想問Yescarta在二線LBCL的上市狀況。希望您能分享上市的初步印象，以及您對市場需求的判斷是否符合預期？

Yes. Thanks, Do. We're delighted to have Christi here with us. So we'll hear it from the source here. Over to you, Christi.

是的，謝謝，杜。我們很高興克里斯蒂能來到這裡。那麼，我們就聽聽她本人怎麼說。克里斯蒂，請你來吧。

Thanks, Do. So we're very encouraged. First, before the approval, the NCCN guidelines that changed and now put Yescarta for LBCL second-line as Category 1 which, as you may know, physicians and providers use to identify standard of care. So that happened a month before approval, which is unusual in these times. And then with the approval -- right after the approval, our manufacturing site was approved in Maryland. So we really feel like we're hitting on all cylinders in terms of really bringing this important therapy to patients. And so the second-line launch was approved on a Friday at about 3 p.m. And on Saturday, orders started to come in. So we're already manufacturing commercial product in our site in the Maryland facility. So definitely, it's really early days, obviously, but the demand was building up, I think, when the data came out at ASH in December, and we're starting to see the orders come in as soon as we get approval.

謝謝，Do。我們感到非常鼓舞。首先，在核准之前，NCCN指南進行了更新，將Yescarta用於LBCL二線治療列為1類藥物，正如您可能知道的，醫生和醫療機構通常用1類藥物來界定標準治療方案。這項更新發生在核准前一個月，目前情況下實屬罕見。獲批後不久，我們在馬裡蘭州的生產基地也獲得了批准。因此，我們感覺在將這種重要的療法帶給患者方面，一切都進展順利。二線治療方案的上市是在周五下午3點左右獲得批准的。週六，訂單就開始湧入。我們已經在馬裡蘭州的工廠開始生產商業產品。當然，現在還處於早期階段，但我認為，自從12月份ASH會議上公佈數據以來，市場需求就一直在增長，而且我們一獲得批准就開始收到訂單。

Our next question comes from the line of Cory Kasimov from JPMorgan.

我們的下一個問題來自摩根大通的科里·卡西莫夫。

It's Gavin, on for Cory. Just on TRODELVY label expansion opportunities and lung cancer, in particular, with the EVOKE-02 study. It looks like there's multiple cohorts in the study. And we're just curious if, one, is there evidence of synergy with PD-1 inhibitors and do you plan on sharing any of that this year? And then two, are you going to utilize a Trop-2 biomarker in any of these cohorts?

我是 Gavin，替 Cory 發言。我想談談 TRODELVY 的適應症擴展機會，特別是針對肺癌的 EVOKE-02 研究。這項研究似乎包含多個隊列。我們想問的是：第一，是否有證據顯示 TRODELVY 與 PD-1 抑制劑有協同作用？今年是否計劃分享這方面的資訊？第二，您是否會在這些隊列中使用 Trop-2 生物標記？

Thanks for the question. Merdad, why don't you cover that probably in lung?

謝謝你的提問。梅爾達德，為什麼不把這部分內容歸類到肺部疾病裡呢？

Sure. Yes. On the biomarker side, we continue to evaluate the role of Trop-2 expression in responses. And as we discussed, actually, for the breast cancer study in our experience so far, we are not seeing a big impact of Trop-2 expression on responsiveness. So we'll -- but we'll keep looking because lung cancer may behave differently than what we're seeing. And we do expect expression patterns to be different. So maybe there'll be a different cutoff in a different tumor type. So that remains to be seen.

當然。是的。在生物標記方面，我們仍在評估Trop-2表現在治療反應中的作用。正如我們之前討論的，就我們目前在乳癌研究中的經驗而言，我們並未發現Trop-2表現對治療反應有顯著影響。因此，我們會繼續觀察，因為肺癌的臨床表現可能與我們目前觀察到的不同。我們預期不同腫瘤類型的表達模式也會有所不同。所以，在不同的腫瘤類型中，或許會有不同的臨界值。這還有待觀察。

In terms of synergy, we are -- I think that's the nature of where we're going with the studies. And that in order to see additive benefit, we need to conduct the larger clinical trials. We do think that coming at the tumors with the 2 different approaches will add. I'm always careful about using the term synergy. I think that implies a different mechanistic approach. So I do think we expect additivity of the 2 components. And yes, we do feel that we will have additivity that TRODELVY should bring additional benefit to patients over and above what the immuno-oncology agents, PD-1, PD-L1 inhibitors, bring to the treatment of those patients.

就協同作用而言，我認為這正是我們研究的方向。為了觀察到疊加效應，我們需要進行更大規模的臨床試驗。我們確實認為，採用兩種不同的方法來治療腫瘤會產生疊加效應。我一直很謹慎地使用「協同作用」這個詞。我認為它暗示著不同的機制。因此，我們預期這兩種成分會產生疊加效應。是的，我們相信TRODELVY能為患者帶來額外的益處，超越免疫腫瘤藥物、PD-1抑制劑和PD-L1抑制劑的療效。

Our next question comes from the line of Robyn Karnauskas from Truist Securities.

我們的下一個問題來自 Truist Securities 的 Robyn Karnauskas。

Congrats on the Yescarta data, by the way. So I just want to maybe play double a little bit on your comments around M&A. I think some investors believe that you have all these great programs, but we're not going to see them read out. And I think you did a good job highlighting that in the oncology day. So for near-term growth, are you thinking about -- would you be open to acquiring something that would provide some near-term growth to gap you before a lot of your TRODELVY trials and your magro trials like start reading out? How are you thinking about that as a company?

順便祝賀你們的Yescarta數據。我想就你們關於併購的發言再補充一點。我認為一些投資者覺得你們有很多很棒的項目，但我們可能看不到它們的結果公佈。我覺得你們在腫瘤學日上很好地強調了這一點。那麼，就近期成長而言，你們是否考慮過收購一些能夠帶來短期成長的項目，以便在你們的TRODELVY試驗和類似MAGR的試驗結果公佈之前彌補差距？作為一家公司，你們是如何看待這個問題的？

Thanks, Robyn, and I'll start and then maybe Andy can add. But I appreciate you bringing that up. I think it's been a really purposeful strategic approach that we've taken over the past -- last 3 years to build our oncology portfolio beyond cell therapy, which is obviously now has a history with us for almost 5 years. And I'd just remind the folks on the phone that in addition to whatever is acquired at the time of the acquisition in terms of trials and potential and capability of that size organization, naturally, when a large organization acquires particularly these pan-tumor potential molecules, you begin really the process of extending the potential for that medicine alone in late lines, earlier lines and in combinations and thoughtful combinations.

謝謝Robyn，我先來，然後Andy可以補充。感謝你提出這一點。我認為過去三年我們採取的策略方針非常有目的性，旨在拓展我們的腫瘤產品組合，使其超越細胞療法——當然，細胞療法我們已經開展了近五年。我想提醒電話那頭的各位，除了收購時獲得的臨床試驗、潛力以及該規模機構的能力之外，當一家大型機構收購這些具有泛腫瘤治療潛力的分子時，自然而然地，他們就開始著手拓展該藥物在後期治療、早期治療以及聯合治療和精心設計的聯合療法中的應用潛力。

I think actually, Kite is a terrific example of that, going back now 5 years post the acquisition, and I appreciate, Robyn, that you started out with congratulations on Yescarta. But to see the potential for a technology like cell therapy and the leadership that Kite took by bringing this up into earlier lines of therapy and the number of patients, of course, then that you can impact on with a potentially curative therapy is exactly kind of the playbook that we will be -- we are pursuing right now with TRODELVY, with magrolimab, and obviously, with the combination of Arcus assets, which -- albeit a bit earlier in the process. So I think we always have to remember the time frame and which one evaluates the success of M&A.

我認為，Kite 就是一個很好的例子，尤其是在收購五年後。 Robyn，我很感謝你一開始就祝賀 Yescarta 的成功。但要看到細胞療法這類技術的潛力，以及 Kite 將其引入早期治療方案所展現出的領導力，還有由此可能造福的患者數量，這都值得我們關注。而這正是我們目前正在努力的方向——我們正在研發 TRODELVY、magrolimab，以及整合 Arcus 的資產，儘管目前還處於早期階段。所以我認為，我們必須時時牢記時間因素，並以此評估併購的成功與否。

The other thing I would just say is that, of course, we constantly are looking to complement that. I mean the bar is much higher now for Gilead than it was several years ago because the number of possibilities and opportunities we have and the bandwidth that any one company can do, but you see on the bandwidth side, we're also doing a lot of collaborations with other companies, including folks like Merck who are operationalizing, in fact, a study of ours with TRODELVY. So there's different ways, I think, to work on the bandwidth. But we will constantly be looking at different types of opportunities out there that complement our virology, our oncology and our early inflammation program to add those to the growth story that we are creating here at Gilead.

我還要補充一點，當然，我們一直在尋求補充。我的意思是，吉利德現在面臨的標準比幾年前高得多，因為我們擁有的可能性和機會數量，以及任何一家公司所能承擔的資源和能力。但就資源方面而言，我們也與其他公司進行了大量合作，包括像默克這樣的公司，他們實際上正在將我們的一項關於TRODELVY的研究投入實際應用。所以我認為，提升資源能力的方式有很多種。我們將持續尋找各種能夠補充我們病毒學、腫瘤學和早期發炎計畫的機會，從而為吉利德的發展故事錦上添花。

I'll just -- I know Andy spends a lot of time thinking about this. I'd love Andy's additional thoughts on this as well.

我知道安迪花了很多時間思考這個問題。我也想聽聽安迪對此的補充想法。

Thanks, Dan. And thank you, Robyn, for the question. Look, I would just go back to start with fundamentally, we have a lot of confidence in where we are in our growth profile today. And I think it's fair to say that the market maybe under appreciates the growth. Even, Robyn, if you look at our first quarter results, especially when you adjust for the impact of LOE and FX, there's really reasonably strong growth in our business. And this is just the beginning from our perspective. So there are always things that we can do to work on our growth profile. But when you look at the strength of the HIV business, what we're seeing in our oncology business, hopefully, that gives you a sense of why we as a management team have so much confidence about not only where we are today, but where we're going. And we recognize, to your question, that the growth profile should get meaningfully better in the next couple of years as the portfolio matures in the way that Dan was describing.

謝謝丹。也謝謝羅賓的提問。首先，我想從根本上說起，我們對目前的成長前景非常有信心。我認為市場可能低估了我們的成長潛力。羅賓，即使你看一下我們第一季的業績，尤其是在調整了營運支出和匯率的影響之後，你會發現我們的業務成長確實相當強勁。而這只是個開始。所以我們總是能找到方法來提升成長前景。但是，看看我們在愛滋病業務和腫瘤業務方面的成就，希望這能讓你明白，為什麼我們管理團隊不僅對目前的狀況充滿信心，也對未來的發展充滿信心。至於你提到的成長前景，我們承認，隨著產品組合像丹所描述的那樣日益成熟，未來幾年我們的成長前景應該會顯著改善。

So while we will look at things, including commercial assets, as you know, those are far and few between. Many of them are expensive, and that's not really where our focus is. We really genuinely believe we have everything that we need today to be a leading growth company in the sector, and it's just going to take a little more time. But we're definitely seeing all the right signs that we are looking for as a management team. So you should not expect that we're going to go out chasing commercial assets or large deals. The guidance is very clear. It's ordinary course partnerships, maybe smaller commercial acquisitions. Again, we'll be opportunistic. But that's not where our focus is today. Thank you.

所以，雖然我們會關注各種機會，包括商業資產，但如您所知，這類機會非常有限。很多商業資產價格昂貴，而這並非我們目前的重點。我們真心相信，我們擁有成為業界領先成長型公司所需的一切，只是還需要一些時間。但作為管理團隊，我們確實看到了所有我們所期待的積極跡象。因此，您不必指望我們會去追逐商業資產或進行大型交易。我們的方向非常明確：我們將進行常規的合作關係，或許會進行一些規模較小的商業收購。再次強調，我們會抓住機會。但這並非我們目前的重點。謝謝。

Thanks, Andy. And the last thing I'd say in addition to the molecules and the medicines, the expertise that we're bringing into Gilead is second to none. And hopefully, you saw some of that. And it's just really the -- some representation of that at both Virology and Oncology Deep Dive days because that's really critical in any company that we've all -- as the leadership team worked in is really getting the right teams together at the right time to make sure we're making the right choices and decisions on the portfolios as we move forward. So that's a really big focus for us, and we're really pleased with the progress we're making there.

謝謝安迪。除了分子和藥物之外，我最後想說的是，我們為吉利德帶來的專業知識也是首屈一指的。希望你們已經有所體會。在病毒學和腫瘤學深度研討會上，我們都充分展現了這一點，因為對於任何一家公司來說，這一點都至關重要。正如我們領導團隊所秉持的理念，在適當的時間組建合適的團隊，確保我們在推動產品組合的過程中做出正確的選擇和決策。因此，這是我們工作的重中之重，我們對目前的進展感到非常滿意。

Certainly. It comes from the line of Umer Raffat from Evercore.

當然。它源自Evercore的Umer Raffat的系列。

I just wanted to expand on a prior question on remdesivir. And Dan, Merdad, it feels like the pace at which this program is moving forward and sort of the timeline to the pivotal trial start and the amount of time it will take, it feels materially slower than how PAXLOVID and molnupiravir were moved. So I guess my question is, what are the expedited pathways you guys are thinking about when talking to FDA? Because presumably, a 505(b)(2) path is not unreasonable given the public health emergency and/or maybe even an active comparator trial versus PAXLOVID established non-inferiority relatively fast given the pace at which infections are happening right now. So there's a path where this could all wrap up this summer. Is that too accelerated in your view?

我只是想就之前關於瑞德西韋的問題補充一下。丹、默達德，感覺這個計畫的推進速度，以及關鍵性試驗的啟動時間表和所需時間，都比帕克洛維和莫努匹拉韋的推進速度慢得多。所以我想問的是，你們在與FDA溝通時，考慮過哪些加快審核的途徑？因為考慮到當前的公共衛生緊急狀況，走505(b)(2)途徑或許並非不合理，或者，考慮到目前感染的快速蔓延，或許可以開展一項與帕克洛維進行對照試驗，以相對快速地證明瑞德西韋的非劣效性。這樣一來，整個專案有可能在今年夏天完成。你們覺得這樣是不是太快了？

Yes. Umer, I'll start, and then I'll hand it over to Merdad. So first of all, I mean, just to reinforce this message for everybody on the phone, I mean, we are absolutely moving with tremendous focus and speed. And of course, we have great lessons within our organization. Remdesivir was arguably the fastest development of an antiviral that's ever occurred from standing still essentially to an approval in the United States. So -- and as you know, we've got a lot of experience from that in terms of working both property groups around accelerating trials, with the FDA around pursuing unique regulatory path. And those learnings and those lessons I just want to say are certainly being put to use now for 5245.

是的。烏默，我先說，然後交給默達德。首先，我想再次強調一點，讓所有電話那頭的人都明白，我們正在以極大的專注度和速度推進專案。當然，我們公司內部也累積了寶貴的經驗。瑞德西韋可以說是迄今為止研發速度最快的抗病毒藥物，從幾乎停滯到在美國獲得批准，整個過程進展迅速。如你所知，我們在與兩個智慧財產權團隊合作加速臨床試驗，以及與FDA合作尋求獨特的監管途徑方面，都累積了豐富的經驗。我想強調的是，這些經驗教訓現在正被運用到5245的研發中。

Having said that, we're, of course, at a very different stage of the pandemic at this stage. And therefore, both from a regulatory perspective and also our ability to recruit clinical trials, particularly with a somewhat raining pandemic in the developed world, has implications on the path we'll take.

話雖如此，我們目前所處的疫情階段當然與之前截然不同。因此，無論從監管角度或從我們招募臨床試驗參與者的能力來看，尤其是在已開發國家疫情仍在持續蔓延的情況下，都會對我們未來的發展路徑產生影響。

And with that, maybe I'll turn it over to Merdad on any other details he wants to add.

這樣一來，或許我會把這個問題交給梅爾達德，讓他補充其他細節。

Yes. I mean not much to add other than I think our Phase I study is moving very quickly. It's moving very nicely without any issues. I know, Umer, you've asked about the 505(b)(2) approach in the past. As you can imagine, those are all -- the avenues you've mentioned are all avenues that we've thought about and explored. And so we will move with the fastest pathway available to us, and that's the nature of the discussions we're having with the agency.

是的。我沒什麼要補充的，只是覺得我們的一期臨床試驗進展非常迅速，一切順利，沒有任何問題。我知道，Umer，你之前問過關於505(b)(2)途徑的問題。正如你所想，你提到的這些途徑，我們都考慮過，也探索過。所以我們會選擇最快的途徑，這也是我們和監管機構討論的內容。

Our next question comes from the line of Evan Seigerman from BMO Capital Markets.

我們的下一個問題來自 BMO 資本市場的 Evan Seigerman。

It might be a combo one for Andy and Merdad. So can you walk me through some of the math behind the $2.7 billion write-down? Maybe how some of the data you've seen inform the magnitude of the impairment? I'm just trying to square how your assumptions may have changed from August 2020 to now based on data updates that we've had.

這可能是安迪和默達德共同負責的問題。所以，你可以給我解釋一下27億美元減損背後的計算過程嗎？或者說說你看到的數據是如何影響減損規模的？我只是想弄清楚，根據我們掌握的最新數據，你從2020年8月至今的假設可能發生了哪些變化。

Evan, it's Andy. Thanks for the question. It's a great question. Look, it's relatively simple. And just to back up, remember, this is an accounting construct that we are required to reassess the value even before we have the discussions with the regulatory authorities. So I just want to back up and reiterate what we said when the data came out. The study was positive. This is strong data. There was a range of outcomes that we expected when we did the deal. This was within the range of outcomes, but it wasn't at the point that we had modeled specifically because we are required to when we put together the intangible indefinite-lived asset schedule after the acquisition. So it's a very simple model, too.

埃文，我是安迪。謝謝你的提問。這是一個很好的問題。其實這相對簡單。我再補充一點，記住，這是一個會計概念，即使在與監管機構討論之前，我們也必須重新評估其價值。所以我想重申一下數據公佈時我們說過的話。這項研究結果是正面的。這是強而有力的數據。我們在進行交易時預期會出現一系列結果。最終的結果在我們預期的範圍內，但並沒有達到我們模型中設定的具體數值，因為在收購完成後編制無形無限期使用壽命資產清單時，我們必須這樣做。所以，這也是一個非常簡單的模型。

So the key, by the way, is our valuation when we have discussions in the coming months with the FDA could change again, of course. And we'll have to continue to look at the valuation of the assets that are still sitting on the balance sheet, which is the valuation attributed to hormone receptor-positive/HER2-negative breast cancer and non-small cell lung cancer over the coming years, as you'd expect, consistent with any business combination transaction. But it's relatively simple.

所以，關鍵在於，未來幾個月我們與FDA討論時的估值當然可能會再次改變。而且，我們還需要繼續評估資產負債表上現有資產的估值，也就是未來幾年內荷爾蒙受體陽性/HER2陰性乳癌和非小細胞肺癌的估值，正如您所預期的，這與任何企業合併交易的情況一致。但其實相對簡單。

It's your standard probability-weighted discounted cash flow analysis where you look at the probability of approval. We are assuming, Evan, I think this is the key for you. We took a conservative approach, and we were looking at this and assume that there is not a path forward based on the PFS data and that we need to wait for overall survival, even though we're not certain that that's the case and we will know more in the coming months. So for purposes -- for the accounting treatment, we had to make a call, and that's the call that we made, and that leads to the $2.7 billion.

這是標準的機率加權折現現金流分析，主要考察核准的機率。埃文，我認為這才是關鍵。我們採取了保守的做法，基於無惡化存活期（PFS）數據，我們假設目前沒有可行的方案，需要等待總生存期數據，儘管我們並不確定最終結果，未來幾個月我們會獲得更多資訊。因此，出於會計處理的目的，我們必須做出判斷，而我們也確實做出了這樣的判斷，最終得出了27億美元的結論。

The other thing I would add is we had TRODELVY-related IPR&D of $14.7 billion at the end of 2021, a little over half of that or $8.8 billion of it related to hormone receptor-positive/HER2-negative breast cancer. The remainder was non-small cell lung cancer. And again, we're already -- in the other indications that are approved, we're already amortizing that. Those are now some finite-lived assets. So now we have $6.1 billion relating to the cash flows expected from third line plus as well as the earlier line, hormone receptor positive breast cancer indication. But hopefully, that gives you a little bit of color.

我還要補充一點，截至2021年底，我們與TRODELVY相關的研發支出為147億美元，其中略多於一半，即88億美元，用於治療荷爾蒙受體陽性/HER2陰性乳癌。其餘部分用於治療非小細胞肺癌。此外，我們已經在其他已核准的適應症中攤銷了這部分支出。這些資產現在都屬於有限期限資產。因此，目前我們有61億美元與第三線及以上適應症以及早期荷爾蒙受體陽性乳癌適應症的預期現金流量有關。希望這些資訊能讓您更清楚地了解情況。

And again, I'd reiterate what we said on the call, which is when we did this originally, when we did the acquisition, we highlighted explicitly that we were going to explore other tumor types and combinations that were not part of our deal model. There is no need to build them into the deal model from bottoms up. So when you step back, more importantly, outside of the accounting construct, we continue to believe that there are many, many paths forward to create a lot of value for patients and for our shareholders with this. So I'm happy to take it off-line if it's helpful to give you more color.

我再次重申我們在電話會議上所說的話，也就是當初我們進行收購時，我們明確指出，我們將探索其他腫瘤類型和組合療法，這些並不在我們最初的交易模式之內。沒有必要從頭開始將它們納入交易模式。所以，更重要的是，拋開會計框架，我們仍然相信，有很多途徑可以為病人和股東創造巨大的價值。如果需要更詳細的說明，我很樂意私下討論。

Yes. Thanks a lot, Andy. I mean, Evan, I think the bottom line is that, again, we took a somewhat conservative approach in the absence of having regulatory discussions so far. We thought it was a prudent thing to do. And to Andy's point, I mean, this is an evaluation of value at the time of the transaction, which, of course, several years later in terms of the indications, the combinations, the potential for TRODELVY is never, as you know, reflective in the initial accounting treatment of it. So hopefully, there's plenty of information in there in our press release and more than happy to take it up with you as well. So thanks, Evan, for that.

是的，非常感謝，安迪。我的意思是，埃文，我認為關鍵在於，鑑於目前還沒有與監管機構進行過討論，我們採取了一種較為保守的做法。我們認為這是謹慎的做法。至於安迪的觀點，我的意思是，這是對交易時價值的評估，當然，幾年後，就適應症、聯合用藥以及TRODELVY的潛力而言，正如你所知，這些都無法在最初的會計處理中得到體現。所以，希望我們的新聞稿中包含了足夠的訊息，我也非常樂意與你進一步探討。所以，謝謝你，埃文。

Our next question comes from the line of Tyler Van Buren from Cowen.

我們的下一個問題來自 Cowen 公司的 Tyler Van Buren。

Can you please give us your latest thoughts regarding a successful outcome for the domvanalimab ARC-7 trial when we get the Phase II PFS data later in the year? And related to the readout for the upcoming Roche results, what are you most interested in seeing other than the primary endpoint?

您能否在今年稍後獲得domvanalimab ARC-7試驗的II期PFS數據後，談談您對該試驗能否取得成功的最新看法？另外，關於即將公佈的羅氏公司試驗結果，除了主要終點之外，您最想看到哪些方面？

Thanks a lot, Tyler. So over to Merdad, please.

非常感謝，泰勒。那麼，請把鏡頭交給梅爾達德吧。

Sure. Hi, Tyler. Yes. I think our thinking has been that domvanalimab as a TIGIT agent will add to the ORR. But to your point, it's not only that, that we would be looking for. And what we would be hoping for in addition to the overall response rate is going to be the depth of the responses and the durability of responses, right? So those are the factors that we'll be looking for. We will also be looking to see what the Roche data looks like when they -- when it comes out at ASCO to see what they've seen is sort of a benchmark, if you will. But those are the various factors we'll be looking for. Obviously, tolerability is going to be in there as well and the overall profile.

當然。嗨，泰勒。是的。我認為我們一直認為，作為TIGIT抑制劑的domvanalimab能夠提高客觀緩解率（ORR）。但正如你所說，我們關注的不僅僅是ORR。除了整體緩解率之外，我們還希望看到緩解的深度和持久性，對吧？所以這些都是我們關注的因素。我們也會關注羅氏在ASCO會議上公佈的數據，看看他們的研究結果，這可以算是基準。以上就是我們關注的各種因素。當然，耐受性和整體療效也是我們考慮的重點。

Our next question comes from the line of Mohit Bansal from Wells Fargo.

我們的下一個問題來自富國銀行的莫希特·班薩爾。

Maybe a question for Andy regarding FX. So Andy, you mentioned that in 1Q, there was a $100 million impact. And then since you provided the guidance, I mean, U.S. dollar has been strong, about 7% U.S. dollar to European -- Euro decline. So just what I'm trying to understand is how much of the FX impact you are absorbing in this guidance which you are maintaining right now. From my math, it could be $300 million plus. But that means that this base business is really stronger than you anticipated, if you could help us understand where this strength is coming from.

或許我想問安迪一個關於外匯的問題。安迪，你提到第一季外匯影響了1億美元。而且，自從你發布業績指引以來，美元一直走強，美元兌歐元下跌了約7%。所以我想了解的是，你目前維持的績效指引中，外匯影響究竟有多大？我估計可能超過3億美元。這意味著公司的基本面比你預期的強勁得多，你能幫我們分析一下這種強勁勢頭來自哪裡嗎？

Sure. That's a great question, Mohit. I'm happy to take it. The -- look, it's relatively simple. And that you're absolutely right. And even in April, we've seen a continued deterioration of exchange rates or strengthening of the dollar, which impacts the revenues coming from our European business. So to be clear, the $100 million impact was a year-over-year comparison Q1 to Q1. Johanna and I are watching the budget impact of the exchange rates very carefully. And part of the confidence in maintaining the guidance is that, yes, there are FX headwinds. There are also, for instance -- related to your question, there's also this change in the accounting treatment of in-process R&D, which will lead to additional expenses from upfront payments that weren't previously part of how we reported non-GAAP earnings.

當然。莫希特，你問得好。我很樂意回答。其實，這相對簡單。你說得完全正確。即使在四月份，我們也看到匯率持續走弱，美元走強，這影響了我們歐洲業務的收入。所以要明確一點，1億美元的影響是比第一季與去年同期相比的。我和喬安娜正在密切關注匯率對預算的影響。我們之所以有信心維持業績指引，部分原因在於，外匯市場確實有不利因素。此外，例如——與你的問題相關——在研發項目的會計處理方式也發生了變化，這將導致一些額外的預付款支出，而這些支出之前並未計入我們的非GAAP收益報告。

On the flip side, there are parts of our business that are outperforming. Again, you think of the strength of VEKLURY that we've seen so far. So Johanna and I and the rest of the management team will look at the puts and takes of this in the middle of the year, and we'll provide a more thoughtful update. But I think the key for you is recognizing the couple of things that have changed that could impact negatively are EPS GAAP and non-GAAP EPS. There are also things that will have additional strength we expect over the course of the year that will offset that to some extent. And so we'll give you additional color later in the year, but we're very comfortable maintaining our guidance where we are today. Hopefully, that helps.

另一方面，我們業務的某些部分錶現優異。例如，我們目前看到的VEKLURY的強勁表現。因此，我和Johanna以及其他管理團隊成員將在年中仔細評估這些因素，並提供更詳細的更新。但我認為，關鍵在於要意識到一些變化可能會對GAAP和非GAAP每股盈餘產生負面影響。同時，我們預計今年還有一些其他因素會表現強勁，在一定程度上抵消這些負面影響。因此，我們將在今年稍後提供更詳細的信息，但我們非常有信心維持目前的業績指引。希望這些資訊對您有所幫助。

Our next question comes from the line of Colin Bristow from UBS.

我們的下一個問題來自瑞銀集團的 Colin Bristow。

Just a quick one, just following on, on the TIGIT and adenosine asset. The -- I just wanted to really understand where your -- what is it you're most enthused about and how you're just thinking about this strategically? Is it the TIGIT and PD-1 doublet that you really see the value, but there's some concern about market timing? Or are you absolutely excited about the triplet data? Can you just help me through that?

關於TIGIT和腺苷資產，我還有一個問題想快速解答。我只是想了解一下，您最重視的是什麼？您是如何從策略角度來考慮這個問題的？您是看好TIGIT和PD-1雙藥組合的價值，但又擔心市場時機的問題嗎？還是您對三藥組合的數據非常看好？您能幫我解答一下嗎？

Thanks, Colin. Merdad, go ahead.

謝謝，科林。梅爾達德，你繼續。

Sure. Look, I think we obviously are going to be looking across all the data across all the assets. Maybe the way I would say it is that we're seeing the TIGIT/PD-1 combination as likely to be sort of the benchmark or the basis for treatment at least in lung cancer and potentially more broadly. And as such, our hope is to have a great combination there to make sure that we then have something to which we can add other potential agents that could bring us to even better responsiveness. So whether that's adenosine or TRODELVY or something else in our pipeline, I think those are all options for us to consider. But we're seeing -- I would say the floor is being raised is our belief and that TIGIT/PD-1 combination becomes sort of the baseline that we need to aim for.

當然。你看，我認為我們顯然會全面分析所有資產的所有數據。或許可以說，我們認為TIGIT/PD-1聯合療法很可能成為肺癌治療的基準或基礎，甚至可能適用於更廣泛的領域。因此，我們希望找到一種有效的聯合療法，以便在此基礎上添加其他潛在藥物，從而獲得更好的療效。無論是腺苷、TRODELVY還是我們研發管線中的其他藥物，我認為這些都是我們可以考慮的選擇。但我們看到——我認為，我們認為治療的底線正在提高，TIGIT/PD-1聯合療法將成為我們努力的目標。

Thanks. Very nice conceptual there. So out of respect for everybody's time, we'll take one last question. Jonathan, can we have the last question, please?

謝謝。這個想法很棒。為了尊重大家的時間，我們再回答最後一個問題。喬納森，請問最後一個問題好嗎？

Certainly. Our final question for today comes from the line of Salveen Richter from Goldman Sachs.

當然。我們今天的最後一個問題來自高盛的薩爾文·里希特。

This is [Matt] for Salveen. Just to go back to TIGIT real quick. You and Arcus have previously noted that you'd want to see an ORR greater than 50%, but what would you like to see on PFS and, most importantly, OS? It seems like 30-plus months might be sufficient on OS given KEYTRUDA mono data and maybe a year plus for PFS. Just would be great to hear your thoughts on this.

我是Salveen的Matt。簡單來說，我想回到TIGIT的話題。您和Arcus之前提到過，你們希望ORR大於50%，那麼你們希望PFS和最重要的OS達到什麼水準呢？考慮到KEYTRUDA單藥治療的數據，OS方面30個月以上似乎就足夠了，PFS方面可能一年以上。非常想聽聽你們的看法。

Well, what I would say is those milestones -- I would agree with the milestones that you've got there. And it's important to remember that those milestones will take time to play out. And we are going to make our bets without being able to look at OS for 30 months, right? We're going to have a less mature data set from which to make that decision. So you're absolutely right that we will be looking at all of those things.

嗯，我想說的是，我同意你列出的那些里程碑。重要的是要記住，這些里程碑需要時間才能實現。而且，我們將在30個月內無法觀察操作系統的情況下做出決定，對吧？我們只能依靠不夠成熟的資料集來做決定。所以你說得完全正確，我們會考慮所有這些因素。

The driver will be to see that, again, tolerability and a benefit as far as the overall response rate is concerned and look for benefits in the depth and duration of response that we can garner from the data set at the maturity that we will have when we look at it. And there, I would just say we'll be, in a sense, watch our actions because you'll be seeing the studies will be getting underway, and that should give you a sense of our confidence in those assets.

關鍵在於觀察藥物的耐受性和整體療效，以及在療效深度和持續時間方面，能否從我們掌握的成熟資料集中獲得益處。因此，我們將密切關注相關進展，因為研究即將啟動，這應該能讓您感受到我們對這些藥物的信心。

With that, I just want to thank everybody. I really appreciate the attention today for the couple of deep dives we've had. We look forward to chatting with you at ASCO and beyond to keep you updated on our progress for the year. And with that, I'll turn it over to Jacquie for some final comments.

最後，我要感謝大家。非常感謝大家今天對我們這幾次深入探討的關注。我們期待在ASCO會議及其他場合與大家交流，並向大家報告我們今年的最新進展。接下來，我將把發言權交給Jacquie，請她做最後的總結發言。

Thank you all for joining us today. We do appreciate your continued interest in Gilead and look forward to updating you throughout the year, as Dan said. Have a great rest of your day.

感謝各位今天蒞臨。正如丹所說，我們非常感謝大家對吉利德的持續關注，並期待在今年繼續為大家帶來最新消息。祝您今天餘下的時間愉快。

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

感謝各位女士、先生參加今天的會議。本次會議到此結束，您可以斷開連線了。祝您今天愉快。