吉利德科學 (GILD) 2023 Q1 法說會逐字稿

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

大家好，歡迎參加吉利德科學公司2023年第一季財報電話會議。我是Nadia，今天將由我主持這次電話會議。 （操作說明）

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

現在我將把發言權交給投資者關係副總裁傑奎·羅斯，由她來開始。杰奎，請開始吧。

Thank you, operator, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2023. The press release, slides and supplemental data are available on the Investors section of our website at gilead.com.

謝謝接線員，大家下午好。今天收盤後，我們發布了2023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.

今天電話會議的發言人包括：董事長兼首席執行官丹尼爾·奧戴；首席商務官喬安娜·默西埃；首席醫療官默達德·帕爾西；以及首席財務官安德魯·迪金森。

Before we get started, let me remind you that we will be making forward-looking statements, including those related to Gilead's business, financial condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital and 2023 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

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，包括與吉利德的業務、財務狀況和經營業績、產品計劃和預期、候選產品、公司策略、業務和營運、財務預測和資本使用以及 2023 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. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliation is provided in the earnings press release in our supplemental data sheet as well as on the Gilead website.

這些風險的描述可在獲利新聞稿和我們最新的美國證券交易委員會（SEC）揭露文件中找到。所有前瞻性陳述均基於吉利德目前可獲得的信息，吉利德不承擔更新任何此類前瞻性陳述的義務。我們將使用非GAAP財務指標來幫助您了解公司的基本業務表現。 GAAP與非GAAP的調節表可在盈利新聞稿的補充資料表以及吉利德網站上找到。

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

接下來，我會把電話交給丹。

Thank you, Jacquie, and good afternoon, everyone. The Gilead team continued its track record of strong commercial and clinical execution in the first quarter of 2023. Our base business grew at 15% excluding Veklury with total product sales of $6.3 billion, reflecting outperformance across the portfolio. On year-over-year basis, roughly 2/3 of the $735 million increase in our base business sales were driven by HIV, and the other 1/3 was driven by oncology.

謝謝Jacquie，大家下午好。吉利德團隊在2023年第一季持續保持了強勁的商業和臨床執行力。剔除Veklury後，我們的基礎業務成長了15%，產品總銷售額達63億美元，反映了我們全線產品的優異表現。與去年同期相比，我們基礎業務銷售額成長的7.35億美元中，約三分之二來自HIV領域，其餘三分之一來自腫瘤領域。

Once again, we're seeing the tangible impact of our transformation and the successful diversification of our business. We saw year-over-year growth in HIV, up 13%; liver disease, which includes therapies for HCV, HBV and HDV, up 6%; cell therapy, up 64%; and Trodelvy, up 52%. As expected, Veklury revenues continue to track lower rates of COVID-19 hospitalizations. As a result, revenue of $573 million was down 63% from the first quarter of last year.

我們再次看到了轉型帶來的實際影響以及業務多元化的成功。 HIV 業務年增 13%；肝病業務（包括 HCV、HBV 和 HDV 療法）較去年同期成長 6%；細胞療法年增 64%；Trodelvy 年成長 52%。正如預期，Veklury 的收入繼續與 COVID-19 住院率的下降趨勢一致。因此，其營收為 5.73 億美元，較去年第一季下降 63%。

On the clinical side, we received another FDA approval for Trodelvy in early February. This latest approval was for a third indication: pretreated HR-positive/HER2-negative metastatic breast cancer. It's early days, but this has been a very strong commercial launch for Trodelvy in the U.S. so far. This further highlights the critical patient need that Trodelvy is addressing in this late-stage population as well as the effectiveness of our commercial oncology team. We continue to prepare for Trodelvy's approval in pretreated HR-positive/HER2-negative metastatic breast cancer in Europe in the second half of this year.

在臨床方面，我們在2月初獲得了FDA對Trodelvy的另一項批准。此核准的適應症新增至第三種：用於治療先前接受過治療的HR陽性/HER2陰性轉移性乳癌。目前尚處於早期階段，但Trodelvy在美國的商業上市迄今表現非常強勁。這進一步凸顯了Trodelvy在晚期乳癌患者族群中滿足的迫切需求，以及我們商業腫瘤團隊的卓越能力。我們正積極籌備Trodelvy今年下半年在歐洲獲準用於治療先前接受過治療的HR陽性/HER2陰性轉移性乳癌。

Another key milestone for the quarter was the announcement of the primary overall survival data from the landmark Phase III ZUMA-7 study. Yescarta is now the first-and-only treatment in nearly 30 years to show a statistically significant improvement in overall survival for initial treatment of relapsed or refractory large B-cell lymphoma patients versus historical standard of care in a curative setting. Full results will be presented at this year's ASCO.

本季度另一個重要里程碑是公佈了具有里程碑意義的III期ZUMA-7研究的主要總生存期數據。 Yescarta是近30年來首個也是唯一一個在復發或難治性大B細胞淋巴瘤患者的初始治療中，與既往標準治療相比，在治癒性治療方面顯示出具有統計學意義的總生存期改善的療法。完整結果將在今年的ASCO年會上公佈。

Turning to clinical progress in virology. We continue to add to the body of evidence for lenacapavir's effectiveness as part of a 6-month subcutaneous therapy. At this year's CROI, the team shared positive Phase Ib data on the investigational lenacapavir and bNAb combination. The bNAb combination is, of course, just 1 of the 8 long-acting combination options that we're exploring for lenacapavir, and we are pleased with our progress so far.

接下來談談病毒學的臨床進展。我們持續累積證據，證明lenacapavir作為6個月皮下療法的有效性。在今年的CROI會議上，團隊分享了lenacapavir聯合廣譜中和抗體（bNAb）的Ib期臨床試驗的積極數據。當然，bNAb聯合療法只是我們正在探索的lenacapavir的8種長效聯合療法之一，我們對目前的進展感到滿意。

In the meantime, following our first approval of lenacapavir as Sunlenca for heavily treatment-experienced people living with HIV, we are seeing strong engagement from KOLs and physicians who are interested in the full potential of lenacapavir for prevention and treatment. As you know, this first approval addresses a significant unmet need for a small number of people living with HIV who have very limited options available to them, and we look forward to making lenacapavir available to many more people beginning with the potential approval and prevention in the 2025 time frame.

同時，繼我們首次批准lenacapavir（商品名Sunlenca）用於治療既往接受過大量治療的HIV感染者之後，我們看到KOL和醫生們積極參與，他們對lenacapavir在預防和治療方面的全部潛力表現出濃厚的興趣。如您所知，此批准滿足了少數HIV感染者的重要未滿足需求，他們可選擇的治療方案非常有限。我們期待lenacapavir能夠惠及更多人群，尤其是在2025年左右，隨著lenacapavir獲批用於預防，我們將努力實現這一目標。

We see lenacapavir as having the most promising potential yet in the ongoing efforts to end the HIV epidemic, and we're looking forward to working with others to make it broadly available as soon as possible.

我們認為，在持續努力終結愛滋病流行的過程中，lenacapavir 具有最有希望的潛力，我們期待與其他人合作，盡快使其廣泛應用。

With that, I'll hand over to Johanna for a review of our first quarter commercial performance. Johanna?

接下來，我將把時間交給喬安娜，讓她為我們回顧第一季的商業表現。喬安娜？

Thanks, Dan, and good afternoon, everyone. The commercial organization delivered a very strong start to the year and continue to build on the momentum we saw in 2022 to set a firm foundation for continued execution and growth in 2023.

謝謝丹，大家下午好。商業部門今年開局強勁，並將繼續保持2022年的發展勢頭，為2023年的持續發展和成長奠定堅實基礎。

As our results show on Slide 7, each of our core franchises delivered year-over-year growth, led by HIV and oncology. And total product sales excluding Veklury totaled $5.7 billion, up 15% year-over-year. Including Veklury, total product sales were $6.3 billion, down 3%, driven by lower Veklury sales associated with fewer COVID-19 hospitalizations.

如幻燈片7所示，我們所有核心業務板塊均實現了同比增長，其中以愛滋病和腫瘤業務表現最為強勁。不計入Veklury，產品總銷售額達57億美元，較去年成長15%。計入Veklury後，產品總銷售額為63億美元，較去年同期下降3%，主要原因是Veklury銷售額因新冠肺炎住院人數減少而下降。

On Slide 8, HIV sales were up 13% year-over-year to $4.2 billion driven by favorable pricing dynamics, higher demand and lower inventory drawdowns. Quarter-over-quarter, sales were down 12% associated with the normal seasonality we typically experience in the first quarter.

根據投影片8，受有利的價格策略、更高的需求和更低的庫存消耗推動，HIV產品銷售額年增13%至42億美元。環比來看，銷售額下降12%，這與我們通常在第一季遇到的季節性波動有關。

As a reminder, at the start of the year, patient co-pays and deductibles reset, which have an impact on average realized prices and market growth. We expect these pricing impacts to normalize through the remainder of the year. And we also see typically a buildup in inventory in the fourth quarter, followed by meaningful inventory drawdowns in the first quarter.

提醒各位，年初時患者的自付額和免賠額會重置，這會影響平均實際價格和市場成長。我們預計這些價格影響將在今年剩餘時間內恢復正常。此外，我們通常還會觀察到第四季度庫存增加，隨後在第一季出現顯著的庫存下降。

Following a focused effort to better manage this dynamic, we're pleased to see less of an impact than we have historically on both a quarter-over-quarter and year-over-year basis, highlighting our goal of better matching product delivery with end-user demand. We expect these efforts to contribute to a more stable quarter-over-quarter growth in our HIV business as compared to prior years.

經過我們集中精力更好地應對這一動態變化，我們欣喜地看到，無論從季度環比還是同比來看，其影響都比以往有所降低，這凸顯了我們致力於更好地將產品交付與終端用戶需求相匹配的目標。我們預計，與往年相比，這些努力將有助於我們的愛滋病業務實現更穩定的季度環比成長。

Turning to Sunlenca. First quarter sales of $4 million were very much in line with our expectations. Sunlenca is an important option for the small number of people living with HIV who have developed resistance and have few, if any, other options. We're leveraging the launch to engage with providers and the community ahead of lenacapavir's potential launches in prevention and treatment.

接下來來談談Sunlenca。第一季銷售額為400萬美元，與我們的預期基本相符。對於少數已產生抗藥性且幾乎沒有其他治療選擇的HIV感染者來說，Sunlenca是一個重要的選擇。我們正利用Sunlenca的上市契機，在lenacapavir可能用於預防和治療之前，與醫療服務提供者和社區進行溝通。

Overall, the HIV treatment market grew approximately 2% year-over-year in the U.S. and almost 4% in Europe, tracking in line with our expectations for annual growth of 2% to 3%. And in prevention, awareness continues to grow with the U.S. PrEP market up over 19% year-over-year.

整體而言，美國愛滋病治療市場年增約2%，歐洲年增率近4%，與我們先前2%至3%的年增長率預期相符。在預防方面，民眾意識持續提高，美國PrEP市場年增超過19%。

Moving to Slide 9. Biktarvy sales of $2.7 billion were up 24% year-over-year driven by higher demand as well as favorable pricing and inventory dynamics. Biktarvy continues to cement itself as a therapy of choice for people living with HIV, now capturing a treatment market share of 46% in the U.S., up 3% year-over-year and representing a growth rate that has impressively outpaced new and existing regimens.

切換到第9張投影片。 Biktarvy的銷售額達到27億美元，年增24%，主要得益於更高的需求以及有利的價格和庫存動態。 Biktarvy持續鞏固其作為愛滋病患者首選療法的地位，目前在美國的治療市場份額已達46%，同比增長3%，這一增長率顯著超過了其他新療法和現有療法。

Moreover, Biktarvy has maintained its leading position for new starts across the U.S., Europe and other major markets as well as in treatment switches across most major markets, including the U.S.

此外，Biktarvy 在美國、歐洲和其他主要市場的新病例以及包括美國在內的大多數主要市場的治療轉換方面都保持著領先地位。

On Descovy, sales were $449 million in the quarter, up 20% year-over-year. Demand for Descovy for PrEP remained strong, up 14% year-over-year. Descovy for PrEP once again maintained its greater than 40% market share. The continued resilience of our PrEP business despite availability of other prevention options, including generics, provides a solid foundation as we make progress towards the potential approval and launch of lenacapavir for PrEP.

Descovy本季銷售額達4.49億美元，年增20%。用於PrEP的Descovy需求依然強勁，較去年同期成長14%。 Descovy用於PrEP的市佔率再次維持在40%以上。儘管有其他預防方案（包括仿製藥）可供選擇，但我們的PrEP業務仍保持韌性，這為我們推進lenacapavir用於PrEP的潛在審批和上市奠定了堅實的基礎。

Moving to Slide 10. The liver disease portfolio was up 6% year-over-year to $675 million, highlighting the continuing contribution of our viral hepatitis medicines to patients and the Gilead portfolio. In HCV, sales were $445 million, up 12% year-over-year, driven by favorable pricing dynamics and timing of purchases by the Department of Corrections. HBV and HDV sales were $230 million, down 2% year-over-year, primarily due to pricing dynamics outside of the U.S.

切換到第10張投影片。肝病產品組合年增6%至6.75億美元，凸顯了我們的病毒性肝炎藥物對患者和吉利德產品組合的持續貢獻。丙型肝炎（HCV）藥物銷售額為4.45億美元，年增12%，主要得益於有利的價格動態以及懲教部門的採購時機。乙型肝炎（HBV）和丁型肝炎（HDV）藥物銷售額為2.3億美元，較去年同期下降2%，主要原因是美國以外地區的定價動態。

We continue to expect HCV starts to trend down over time given the curative nature of therapy with some offset from HBV and HDV. In the meantime, we're pleased to observe solid and stable market shares across all of our liver portfolio.

我們仍然預期，鑑於丙型肝炎治療的治癒性，丙型肝炎市場份額會隨著時間推移而下降，同時乙型肝炎和丁型肝炎也會在一定程度上抵消丙型肝炎市場份額的下降。同時，我們欣喜地看到，我們所有肝臟疾病產品組合的市佔率都保持穩健穩定。

On to Slide 11 and as we expected, Veklury sales of $573 million were down year-over-year and sequentially as COVID-related infections became less severe and hospitalizations remain below peak levels. As a reminder, the winter surge occurred earlier than we had expected beginning in the fourth quarter and lasting only through the beginning of Q1. As [Veklury's] use tracks hospitalizations, its sales are volatile and highly subject to surges and the overall path of the pandemic.

接下來是第11張投影片。正如我們預期的那樣，Veklury的銷售額為5.73億美元，同比和環比均有所下降，原因是與新冠病毒相關的感染病例有所減少，住院人數也低於峰值水平。需要提醒的是，冬季疫情高峰比我們預期的來得更早，從第四季開始，一直持續到第一季初。由於Veklury的使用量與住院人數密切相關，其銷售額波動較大，極易受到疫情高峰和整體發展趨勢的影響。

Veklury is backed by clinical data and real-world evidence that reinforces its clinical profile and despite the lower hospitalization rates in the quarter, Veklury's share of hospitalized patients treated for COVID-19 grew modestly, maintaining well over 50% share in the United States.

Veklury 擁有臨床數據和真實世界證據的支持，這強化了其臨床特性。儘管本季住院率較低，但 Veklury 在 COVID-19 住院患者治療中所佔份額略有增長，在美國保持了 50% 以上的份額。

Moving to oncology and beginning with Trodelvy on Slide 12. Sales of $222 million were up 52% year-over-year and 14% sequentially driven by strong growth both in the U.S. and Europe. Following U.S. approval in early February, we're off to a strong start with Trodelvy in pretreated HR-positive/HER2-negative metastatic breast cancer as some clinicians move quickly to make this new option available for patients in this setting. We look forward to extending Trodelvy's reach to these patients in Europe where a decision is expected later this year.

接下來我們來看看腫瘤領域，首先是第12頁投影片中的Trodelvy。其銷售額達2.22億美元，年增52%，季增14%，主要得益於美國和歐洲市場的強勁成長。在2月初獲得美國批准後，Trodelvy在先前接受過治療的HR陽性/HER2陰性轉移性乳癌患者中取得了良好的開端，一些臨床醫生正迅速將這項新療法應用於此類患者。我們期待Trodelvy能夠惠及歐洲的這些患者，預計歐洲市場將在今年稍後做出最終決定。

Of course, our efforts here are underpinned by the successes and learnings in metastatic triple-negative breast cancer or TNBC. From our expansion of sales force last year and a strong body of data across a number of tumor types, more physicians are recognizing Trodelvy's clinically meaningful overall survival benefit. This recognition is not just in metastatic TNBC, but also in HR-positive/HER2-negative metastatic breast cancer regardless of HER2-negative status.

當然，我們在此所做的努力都建立在轉移性三陰性乳癌（TNBC）領域的成功經驗和寶貴教訓之上。去年，我們擴大了銷售團隊，並累積了涵蓋多種腫瘤類型的大量數據，越來越多的醫生認識到Trodelvy在臨床上具有顯著的總生存獲益。這種認可不僅體現在轉移性TNBC中，也體現在HR陽性/HER2陰性的轉移性乳癌中，無論HER2狀態如何。

Now on to Slide 13. Cell therapy sales in the first quarter were $448 million, up 64% year-over-year and 7% quarter-over-quarter. We're pleased with the continued growth of Yescarta with sales up 70% year-over-year to $359 million primarily driven by growth in the second- and third-line setting for relapsed or refractory large B-cell lymphoma. Sequentially, sales were up 6%, driven in part by strong demand and favorable pricing dynamics both primarily in Europe.

現在來看第13張投影片。第一季細胞療法銷售額為4.48億美元，年增64%，季增7%。我們對Yescarta的持續成長感到滿意，其銷售額年增70%至3.59億美元，主要得益於復發或難治性大B細胞淋巴瘤二線和三線治療的增長。環比成長6%，部分原因是強勁的需求和有利的價格策略，尤其是在歐洲。

Turning to Tecartus. Sales were $89 million, up 40% year-over-year and 8% sequentially, driven by growing demand for both relapsed or refractory mantle cell lymphoma and adult acute lymphoblastic leukemia.

再來看看 Tecartus 公司。銷售額為 8,900 萬美元，年增 40%，較上季成長 8%，主要得益於復發或難治性套細胞淋巴瘤和成人急性淋巴性白血病需求的成長。

Looking ahead, we continue to work to raise awareness of cell therapies and increase class share. We believe that compelling data, including ZUMA-7's recent positive overall survival results in addition to [peer] data set in the cell therapy space, will support broader adoption over time.

展望未來，我們將繼續努力提高大眾對細胞療法的認知度，並擴大其市場份額。我們相信，包括ZUMA-7近期積極的總生存期結果以及細胞療法領域其他同類療法的數據在內的有力數據，將有助於細胞療法在未來得到更廣泛的應用。

In summary, it's been a positive start to the year with our current product portfolio of virology and oncology medicines delivering strong performance. We look forward to maintaining this momentum through the rest of the year and beyond.

總而言之，今年開局良好，我們現有的病毒學和腫瘤學藥物產品組合表現強勁。我們期待在今年餘下的時間以及未來幾年保持這一發展勢頭。

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

那麼，接下來我將把電話交給梅爾達德，讓他報告我們管道的最新情況。梅爾達德？

Thank you, Johanna. We are off to a strong start in 2023 with our first regulatory approval of the year for Trodelvy for certain HR-positive/HER2-negative metastatic breast cancer patients in the U.S. and an additional 10 trials initiated so far this year, including 4 Phase III studies. This brings our clinical pipeline to 61 ongoing clinical programs.

謝謝Johanna。 2023年伊始，我們便取得了強勁的開局。今年，我們的首個監管審批計畫——Trodelvy——已在美國獲準用於治療部分HR陽性/HER2陰性轉移性乳癌患者。此外，今年迄今已啟動10項臨床試驗，其中包括4項III期研究。目前，我們的在研臨床項目已達61個。

Starting with virology on Slide 15. We presented late-breaking data among 83 abstracts at CROI in Seattle in February, highlighting Gilead's continued expertise and leadership across HIV, viral hepatitis and COVID-19.

從第 15 張投影片上的病毒學開始。我們在 2 月於西雅圖舉行的 CROI 會議上，在 83 篇摘要中展示了最新數據，重點介紹了吉利德在 HIV、病毒性肝炎和 COVID-19 領域的持續專業知識和領導地位。

In HIV, we shared several data readouts from our lenacapavir-based development programs in prevention and treatment. In prevention, we presented preclinical in vivo data providing further validation that a subcutaneous injection of lenacapavir can confer long-acting protection in an animal model. We believe lenacapavir as a single agent has the potential to be the first once every 6-month option for HIV prevention. We're currently testing this in our pivotal Phase III purpose trials.

在愛滋病防治領域，我們分享了基於勒那卡帕韋的預防和治療研發計畫的多項數據。在預防方面，我們展示了臨床前體內數據，進一步驗證了皮下注射勒那卡帕韋可在動物模型中提供長效保護。我們相信，勒那卡帕韋作為單一藥物，可望成為第一個每6個月一次的愛滋病預防方案。目前，我們正在關鍵的III期臨床試驗中驗證此方案。

In treatment, we shared Phase Ib proof-of-concept data on twice-yearly lenacapavir in combination with 2 investigational broadly neutralizing antibodies. At week 26, 90% of trial participants receiving this combination maintained virologic suppression. Further, treatment with the investigational regimen was generally well tolerated.

在治療方面，我們分享了每年兩次使用lenacapavir合併兩種在研廣譜中和抗體的Ib期概念驗證數據。在第26週，接受此聯合療法的試驗參與者中有90%維持了病毒抑制。此外，此試驗方案的耐受性整體良好。

Moving to COVID-19 on Slide 16. We also shared positive data from 3 retrospective real-world analysis of Veklury at CROI. These analyses showed that initiation of Veklury within the first 2 days of hospital admission reduced death and hospital readmission rates among all patients with COVID-19.

投影片16將轉向新冠肺炎。我們也分享了CROI的3項回顧性真實世界分析的正面數據，這些分析都是針對Veklury。這些分析表明，在新冠肺炎患者入院後的前兩天內開始使用Veklury可降低死亡率和再入院率。

The right-hand side of the slide highlights that both of our oral Phase III trials evaluating GS-5245 or obeldesivir, our investigational oral COVID nucleoside in standard-risk patients and in high-risk patients, are now enrolling. Given uncertainties in the global epidemiology of COVID-19, we continue to be cautious with regards to the length of time it could take to fully enroll these trials.

投影片右側重點介紹了我們兩項評估GS-5245或奧貝地西韋（一種在研口服新冠核苷類藥物）的III期口服臨床試驗，這兩項試驗分別針對標準風險患者和高風險患者，目前均已開始招募患者。鑑於新冠疫情在全球流行病學方面存在不確定性，我們對完成這些試驗所需的時間仍持謹慎態度。

Moving on to Slide 17. Trodelvy continues to build momentum as the cornerstone of our solid tumor portfolio. As expected, the FDA approved Trodelvy for its third indication. Trodelvy is now approved in adults with HR-positive/HER2-negative metastatic breast cancer who previously received endocrine-based therapy and at least 2 additional systemic therapies for metastatic disease. This FDA approval is based on the overall survival benefit seen in the Phase III TROPiCS-02 trial. We've already received acceptance of our European filing and continue to expect a regulatory decision from the European Commission in the second half of this year.

接下來是第17張投影片。 Trodelvy作為我們實體瘤產品組合的基石，持續保持強勁勢頭。如預期，FDA批准了Trodelvy的第三個適應症。 Trodelvy現已獲準用於治療先前接受過內分泌治療以及至少兩種其他全身性轉移性疾病治療的HR陽性/HER2陰性轉移性乳癌成人患者。 FDA的這項批准是基於III期TROPiCS-02試驗中觀察到的總存活期獲益。我們已收到歐洲監管機構的受理申請，並繼續期待歐盟委員會在今年下半年做出監管決定。

The Phase III EVOKE-01 trial evaluating the potential for Trodelvy in second-line non-small cell lung cancer is ongoing. Additionally, we recently had FPI for the Phase III EVOKE-03 study, also known as KEYNOTE-D46. This trial is being led by Merck to evaluate Trodelvy in combination with pembrolizumab in first-line, PD-L1-high, non-small cell lung cancer.

評估Trodelvy在二線非小細胞肺癌治療中潛力的III期EVOKE-01試驗正在進行中。此外，我們近期完成了III期EVOKE-03研究（又稱KEYNOTE-D46）的首次臨床試驗。該試驗由默克公司主導，旨在評估Trodelvy合併帕博利珠單抗第一線治療PD-L1高表達非小細胞肺癌的療效。

Additionally, we're excited to announce that over 30 abstracts, including an oral presentation of the updated ARC-7 trial data, have been accepted at ASCO this year. Not only do these data highlight elements of our investigational Trodelvy and domvanalimab programs in breast, bladder and lung cancers, the abstracts include new insights on many of our promising targets, including our cell therapy portfolio.

此外，我們很高興地宣布，今年ASCO會議已接收超過30篇摘要，其中包括一篇關於更新後的ARC-7試驗數據的口頭報告。這些數據不僅重點介紹了我們在乳癌、膀胱癌和肺癌領域正在研究的Trodelvy和domvanalimab項目，摘要還包含了關於我們許多有前景的標靶（包括我們的細胞療法產品組合）的新見解。

Speaking of which, on Slide 18, I'm pleased to discuss the clinical progress we've made within cell therapy. Recently, we highlighted new overall survival data from the Phase III ZUMA-7 trial evaluating Yescarta for the initial treatment of adults with relapsed or refractory large B-cell lymphoma. These data will be presented as an oral late-breaker at ASCO. Yescarta is the first-and-only therapy of any kind to show a statistically significant overall survival benefit versus standard of care in almost 30 years.

說到這裡，我很高興在第18張幻燈片中討論我們在細胞療法領域的臨床進展。最近，我們重點介紹了評估Yescarta用於復發或難治性大B細胞淋巴瘤成人患者一線治療的III期ZUMA-7試驗的最新總生存期數據。這些數據將在ASCO會議上以口頭報告的形式進行展示。 Yescarta是近30年來首個也是唯一一個在總存活期方面顯示出優於標準療法的統計學顯著療效的療法。

As we work to extend our leadership in cell therapy within our current portfolio, we're also building out our earlier-stage programs. As mentioned in our last earnings call, we closed our agreement to co-develop and co-commercialize Arcellx's CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma.

在努力鞏固我們現有產品組合在細胞療法領域的領先地位的同時，我們也積極拓展早期研發項目。正如我們在上次財報電話會議上提到的，我們已完成與 Arcellx 的合作開發和商業化協議，共同開發和商業化 Arcellx 的 CART-ddBCMA，用於治療復發或難治性多發性骨髓瘤患者。

Also, we closed our acquisition of Tmunity Therapeutics in February, extending our preclinical and clinical pipeline in blood cancers and solid tumors. We're currently working to integrate the Tmunity team with their assets into our broader innovation pipeline.

此外，我們在2月完成了對Tmunity Therapeutics的收購，進一步擴大了我們在血液腫瘤和實體瘤領域的臨床前和臨床研發管線。目前，我們正致力於將Tmunity團隊及其資產整合到我們更廣泛的創新研發管線中。

Wrapping up on Slide 19. We're sharing the updated key pipeline milestones that we expect in 2023, which, as you can see, span FPIs, data readouts, updates and regulatory approvals across oncology, virology and inflammation. Overall, this highlights the progress that Gilead has made on its transformation journey, the 61 clinical programs that are well diversified across indication and stage.

投影片19總結完畢。我們將分享預計在2023年實現的最新關鍵研發管線里程碑，如您所見，這些里程碑涵蓋了腫瘤學、病毒學和發炎領域的首款候選藥物、數據解讀、最新進展和監管批准。總而言之，這凸顯了吉利德在轉型之旅中的進展，以及其在適應症和研發階段方面多元化的61個臨床計畫。

We have an ambitious clinical program, and I'd like to thank the Gilead team that has worked tirelessly to execute and accelerate the progress of our portfolio. We look forward to updating you as we progress through 2023.

我們有一個雄心勃勃的臨床項目，我要感謝吉利德團隊為推進和加速我們的產品組合所付出的不懈努力。我們期待在2023年期間向您報告最新進展。

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

那麼，我就把電話交給安迪了。安迪？

Thank you, Merdad, and good afternoon, everyone. Starting on Slide 21. The first quarter was a strong commercial start to the year with total product sales excluding Veklury up 15% year-over-year despite continued FX headwinds. Overall, our base business demonstrated growth in each of our product families, including almost 60% growth in oncology and 13% growth in HIV.

謝謝Merdad，大家午安。從第21張投影片開始。儘管持續受到匯率不利因素的影響，但第一季仍取得了強勁的商業開局，不包括Veklury在內的產品總銷售額年增15%。總體而言，我們的基礎業務在所有產品系列中均實現了成長，其中腫瘤產品成長近60%，HIV產品成長13%。

Total product sales were $6.3 billion, down 3% due to lower Veklury sales, partially offset by growth in our base business. FX negatively impacted first quarter total product sales by $106 million, representing approximately 160 basis points of growth.

第一季產品總銷售額為63億美元，年減3%，主要原因是Veklury銷售額下降，但部分被基礎業務的成長所抵銷。匯率波動對第一季產品總銷售額造成了1.06億美元的負面影響，相當於約160個基點的成長。

Turning to Slide 22. Non-GAAP product gross margin was 86.2%, down 1.2 percentage points from last year due to, among other things, the timing of the Biktarvy royalty initiation in the first quarter of 2022 and product mix, partially offset by inventory benefits.

翻到第 22 頁。非 GAAP 產品毛利率為 86.2%，比去年下降 1.2 個百分點，原因包括 Biktarvy 特許權使用費在 2022 年第一季開始收取以及產品組合的變化，部分被庫存收益所抵消。

Moving to OpEx. Expenses were higher than we anticipated in the first quarter due to R&D investments and inflationary pressures. Non-GAAP R&D was $1.4 billion, up 25% year-over-year due to higher expenses, including the acceleration of certain late-stage clinical studies as well as about $50 million in onetime items.

接下來談談營運支出。由於研發投入和通膨壓力，第一季的支出高於預期。非GAAP研發支出為14億美元，年增25%，主要原因是支出增加，包括加速推進某些後期臨床研究以及約5000萬美元的一次性項目。

As Merdad mentioned, we have started 10 new trials so far this year, including 4 Phase III programs. This brings the total number of ongoing Phase III studies to 22, highlighting the investment we are making in Gilead's future growth. Clinical trial enrollment for a number of new and ongoing Trodelvy and lenacapavir trials was faster than we expected with a notable acceleration, for example, in certain lenacapavir trials in March.

正如Merdad所提到的，今年迄今為止，我們已啟動了10項新的臨床試驗，其中包括4項III期臨床試驗。這使得正在進行的III期臨床試驗總數達到22項，凸顯了我們對吉利德未來發展的投入。多項新的和正在進行的Trodelvy和lenacapavir臨床試驗的入組速度超出預期，例如，3月份某些lenacapavir試驗的入組速度顯著加快。

Our clinical team has been working hard to rapidly advance our studies and bring new therapeutic options to patients as fast as we can. This includes working to close the gap that some peers have in certain programs. And we believe we are starting to see the impact of these acceleration efforts in our trials, although this did contribute to higher R&D expenses in the first quarter.

我們的臨床團隊一直努力加快研究進度，力求盡快為患者帶來新的治療方案。這包括努力縮小與一些同行在某些項目上的差距。我們相信，這些加速措施已開始在臨床試驗中產生影響，儘管這也導致第一季的研發支出增加。

Consistent with past practice, we will continue to manage expenses carefully, including the ongoing process of prioritizing programs based on potential impact and data. We have taken the last several years to build the most diverse and robust clinical pipeline in Gilead's history now with well over 100 trials across our 3 targeted therapeutic areas. We are excited to see so many of these programs in later-stage trials with a number of data readouts building momentum over the next several years.

秉承以往的做法，我們將繼續謹慎管理各項支出，包括持續根據潛在影響和數據對項目進行優先排序。過去幾年，我們打造了吉利德史上最多元化、最強大的臨床研發管線，目前在三大目標治療領域進行了超過100項試驗。我們很高興看到其中許多項目已進入後期試驗階段，預計未來幾年將陸續公佈相關數據，推動研發進程。

Non-GAAP acquired IPR&D was $481 million primarily driven by expenses related to our acquisition of Tmunity as well as upfront and milestone payments associated with the Arcellx and Nurix collaboration. Non-GAAP SG&A was $1.3 billion, up 22% year-over-year, primarily due to the commercial expansion and investments in our oncology business in addition to higher branded prescription drug fee expenses and higher corporate expenses that continue to be impacted by inflation.

非GAAP收購IPR&D支出為4.81億美元，主要來自對Tmunity的收購相關費用，以及與Arcellx和Nurix合作相關的預付款和里程碑付款。非GAAP銷售、管理及行政費用為13億美元，年增22%，主要由於腫瘤業務的商業擴張和投資，以及品牌處方藥費用和受通貨膨脹持續影響的企業支出增加。

Moving to tax. Our non-GAAP effective tax rate in the first quarter was 18.9%, lower than expected, driven by discrete tax benefits recorded in the first quarter. Overall, our non-GAAP diluted earnings per share was $1.37 in the first quarter of 2023 compared to $2.12 for the same period last year, reflecting higher operating expenses and lower product gross margin.

接下來談談稅務方面。我們第一季的非GAAP實際稅率為18.9%，低於預期，這主要得益於第一季確認的一次性稅收優惠。整體而言，我們2023年第一季的非GAAP稀釋後每股收益為1.37美元，而去年同期為2.12美元，反映出營運費用增加和產品毛利率下降。

I'll move now to guidance for the full year 2023 on Slide 23. There is no change to our revenue guidance. We continue to expect total product sales in the range of $26 billion to $26.5 billion, and we continue to expect total product sales excluding Veklury in the range of $24 billion to $24.5 billion, representing growth of 4% to 6% for our base business year-over-year.

接下來，我將在第23頁介紹2023年全年業績展望。我們的營收預期維持不變。我們仍預期產品總銷售額在260億美元至265億美元之間，剔除Veklury後的產品總銷售額在240億美元至245億美元之間，這意味著我們基礎業務的年增長率將達到4%至6%。

On Veklury, the first quarter was modestly below our internal expectations, and our $2 billion full year guidance assumes an increase in infections at some point later this year, not dissimilar from what we saw in 2022. We know from experience that COVID-19-related sales are extremely volatile and are leaving our guidance unchanged pending additional data points as we move through the year.

關於Veklury，第一季業績略低於我們的內部預期，我們20億美元的全年業績預期是基於今年稍後感染人數可能增加的假設，這種情況與2022年類似。我們根據經驗知道，與新冠疫情相關的銷售額波動極大，因此在獲得更多數據後，我們將維持業績預期不變。

Moving to the rest of the P&L. We continue to target non-GAAP product gross margin of approximately 86%. As discussed, we now expect full year 2023 non-GAAP R&D expenses to increase a low double-digit percentage compared to 2022. This results in an overall R&D investment for the full year in the low 20s as a percentage of total revenue. We believe this is a more appropriate level of investment for a company with a broad late-stage clinical portfolio that is targeting attractive opportunities and sustainable revenue growth.

接下來來看損益表的其他部分。我們繼續將非GAAP產品毛利率目標設定在86%左右。如同先前所討論的，我們現在預計2023年全年非GAAP研發費用將比2022年成長兩位數百分比。這將使全年研發投入佔總收入的比例達到20%左右。我們認為，對於一家擁有廣泛的後期臨床產品組合、並致力於把握極具吸引力的機會和實現可持續收入成長的公司而言，這是一個更合適的投資水平。

We continue to expect non-GAAP acquired IPR&D to be approximately $700 million, reflecting previously committed acquired IP R&D amounts. Similar to prior quarters, we will continue to include expected acquired IPR&D expenses as we announce additional transactions over the course of the year.

我們仍預期非GAAP收購智慧財產權研發支出約為7億美元，這反映了先前承諾的收購智慧財產權研發金額。與前幾季類似，我們將繼續在年內宣布其他交易時計入預計的收購智慧財產權研發支出。

Moving to non-GAAP SG&A. There is no change to our prior guidance, where we expect a full year decline by a low single-digit percentage compared to 2022, although we will continue to look for opportunities to partially offset the higher R&D investments we now plan for this year.

調整為非GAAP會計準則下的銷售、管理及行政費用。我們之前的預期不變，預計全年銷售額將比2022年下降個位數百分比，但我們將繼續尋找機會，以部分抵消我們今年計劃增加的研發投資。

Overall, there is no change to our expectations for non-GAAP operating income in the range of $11 billion to $11.6 billion. Additionally, there is no change to our tax guidance, and we continue to target a non-GAAP effective tax rate of approximately 20%.

整體而言，我們對非GAAP營業收入的預期保持不變，仍為110億美元至116億美元。此外，我們的稅務指引也保持不變，我們繼續將非GAAP實際稅率目標設定在20%左右。

And finally, we continue to expect non-GAAP diluted EPS in the range of $6.60 and $7 per share, reflecting, first, that the initial guidance model we shared with you in early February allowed for a broad range of potential revenue and expense scenarios; and second, that we're committed to finding room in our overall P&L to absorb the higher R&D investments that we are choosing to prioritize in 2023. On a GAAP basis, we expect diluted EPS to be in the range of $4.75 to $5.15.

最後，我們仍然預期非GAAP稀釋後每股盈餘在6.60美元至7美元之間。這首先反映了我們在2月初與您分享的初步績效指引模型涵蓋了廣泛的潛在收入和支出情境；其次，也反映了我們致力於在整體損益表中留出空間，以消化我們選擇在2023年優先考慮的更高研發投資。以GAAP準則計算，我們預期稀釋後每股盈餘在4.75美元至5.15美元之間。

Moving to Slide 24. You can see there is no change to our capital allocation priorities. We returned $1.4 billion to shareholders in the first quarter through our dividend and repurchase of shares.

請看第24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，我們透過派發股利和股票回購向股東返還了14億美元。

Finally, on business development, there's no change to our philosophy. We are very comfortable with the breadth and the quality of the pipeline that we've built, acquired or partnered and the growth 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 to make smaller acquisitions in the normal course of business.

最後，關於業務拓展，我們的理念保持不變。我們對已建立、收購或合作的項目儲備的廣度和質量，以及這些項目儲備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運營中進行小型收購，抓住機會獲取優質資產。

And now I'll hand it over to Dan for some closing remarks.

現在我把麥克風交給丹，讓他做些總結發言。

Thanks, Andy. Before we open for Q&A, I'll just summarize our prepared remarks by noting that this is another quarter where we demonstrated the continued impact of our transformation.

謝謝安迪。在正式進入問答環節之前，我先總結我們準備好的發言稿，指出本季我們再次證明了轉型帶來的持續影響。

Going forward, we are committed to building on the track record of strong commercial and clinical execution that we've shown in recent quarters, thanks to the dedication of the Gilead and Kite teams around the world. With this positive momentum, we look forward to delivering our portfolio while maintaining financial discipline.

展望未來，我們將繼續鞏固近幾個季度以來在商業和臨床執行方面取得的強勁成績，這得益於吉利德和凱特全球團隊的辛勤付出。憑藉這一積極勢頭，我們期待在保持財務穩健的同時，順利交付我們的產品組合。

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

接下來，我將邀請接線生開啟問答環節。

(Operator Instructions) Our first question today goes to Michael Yee of Jefferies.

（操作說明）我們今天的第一個問題來自傑富瑞集團的邁克爾葉。

This is Dennis Ding on for Mike. Two from us. Maybe number one, what are your expectations for the competitor Trop-2 data that's coming imminently? And what would you like to see? And how would you differentiate? And could you perhaps look at PFS like your competitor? And then number two, can you just talk about the progress of your long-acting oral integrated inhibitors for HIV. Are they in the clinic yet?

這裡是丹尼斯·丁，他替麥克發言。我們有兩個問題。第一個問題，您對即將公佈的競爭對手Trop-2的數據有何預期？您希望看到什麼？您將如何進行差異化？能否像競爭對手一樣分析一下無惡化存活期（PFS）？第二個問題，您能否談談貴公司用於治療HIV的長效口服整合抑制劑的進展？它們是否已進入臨床試驗階段？

Thanks for the questions. So in terms of the competitor Trop-2 data, I think it's a little early for us to be doing comparisons across data we haven't seen yet. We're really comfortable with the data we've already shown and have certainly led to approvals in breast cancer with OS benefits. So you can see from the uptake of Trodelvy in the breast cancer market that being approved and having those OS data have had an impact for patients, and we're very comfortable with where we are. Of course, we'll keep an eye on those emerging data as they become available in every indication.

感謝您的提問。關於競爭對手Trop-2的數據，我認為現在就進行數據比較還為時過早，因為我們還沒有看到相關數據。我們對已發表的數據非常有信心，這些數據也確實促成了乳癌治療中總存活期（OS）獲益的核准。從Trodelvy在乳癌市場的接受度可以看出，核准並擁有OS數據對患者產生了積極影響，我們對目前的進展非常滿意。當然，我們會密切關注所有適應症的最新數據。

And then in terms of the long-acting orals, we -- as you know, we have a number of programs in the clinic for our long-acting portfolio, both oral and injectable. And we've moved several of them, including an oral program into the clinic, and we'll be sharing those data as they become available. Very excited about that portfolio. We remain committed to and really excited about our long-acting portfolio to do -- to leverage lenacapavir's unique profile to go into both oral long-acting as well as parenteral long-acting formulation. So stay tuned. As those data develop, we'll gladly share.

至於長效口服製劑，如您所知，我們目前有多個長效製劑計畫正在進行臨床試驗，涵蓋口服和注射劑型。其中一些項目，包括口服製劑項目，已經進入臨床試驗階段，我們將在獲得相關數據後及時分享。我們對這些產品組合感到非常興奮。我們將繼續致力於長效製劑的研發，並對其充滿信心，充分利用來那卡帕韋的獨特優勢，開發口服長效製劑和注射長效製劑。敬請關注。一旦數據更新，我們將樂於分享。

(Operator Instructions)

（操作說明）

The next question goes to Brian Abrahams of RBC.

下一個問題交給加拿大皇家銀行的布萊恩·亞伯拉罕。

Regarding Trodelvy, I was wondering if you can talk a little bit about what you're seeing with regards to its use across the different lines of therapy post HR-positive/HER2-negative approval. And I guess, along those lines, as you think about moving this to earlier lines in this indication, what's your latest thoughts on the potential trial design for ASCENT-07 to optimize in terms of optimizing the right patient population to expedite trial enrollment and support a meaningful commercial expansion?

關於Trodelvy，我想請您談談在HR陽性/HER2陰性乳癌核准後，您在不同治療方案中的應用情況。另外，考慮到您將Trodelvy推廣至此適應症的早期治療方案，您對ASCENT-07試驗設計有何最新想法？如何優化試驗方案，以篩選出合適的患者群體，加快試驗入組速度，並支持其商業化擴張？

Thanks so much, Brian. Dan O'Day here. I'm going to have Johanna answer the first part of your question and then Merdad the second. Thank you.

非常感謝，布萊恩。我是丹·奧戴。我會讓喬安娜回答你問題的第一部分，然後讓梅爾達德回答第二部分。謝謝。

Thanks, Brian. So basically, we're really pleased with the early launch results that we've seen so far in HR-positive/HER2-negative. And what we've been seeing is strong initial uptake basically in fourth line plus with some share even in third line. And I think that's really important for us as we think about even earlier trials moving up lines of therapy.

謝謝，布萊恩。總的來說，我們對目前在HR陽性/HER2陰性患者中觀察到的早期上市結果感到非常滿意。我們看到，該產品在四線及以上治療中取得了強勁的初期應用，甚至在三線治療中也有一定份額。我認為這對我們來說非常重要，因為我們正在考慮進行更早期的試驗，以支持更高線數的治療。

But I think the data with the overall survival that we've shown, in addition to the work that we've done in metastatic TNBC also showing overall survival, has really helped because we've had strong awareness, obviously, of Trodelvy in the community as well as in academic centers. And the extended field team work that we did last year has really helped us make sure that we solidify the launch of HR-positive/HER2-negative.

但我認為，我們展示的整體存活率數據，以及我們在轉移性三陰性乳癌（TNBC）方面取得的整體存活率數據，都起到了很大的幫助，因為很明顯，Trodelvy 在社區和學術中心都獲得了很高的知名度。此外，我們去年開展的拓展性現場團隊工作也確實幫助我們鞏固了 HR 陽性/HER2 陰性乳癌的上市。

So still early, we only have a couple of months in, but definitely on the right track. And we're really seeing physicians understand the benefits of Trodelvy and what they can bring for their patients in this setting. Merdad?

所以現在還處於早期階段，我們才進行了幾個月，但肯定走在正確的道路上。我們確實看到醫生們開始理解 Trodelvy 的益處，以及它在這種情況下能為患者帶來的益處。 Merdad？

Yes. And then in terms of ASCENT-07, as we design and move into earlier lines of therapy -- in that study, as you know, we're going to be looking at the chemo-naive population. And we do anticipate that study getting started in the second half of this year. So things are moving along very nicely, and we are really excited about that program.

是的。至於ASCENT-07，隨著我們設計並推進到更早期的治療方案——正如您所知，在該研究中，我們將關注未接受過化療的患者群體。我們預計研究將於今年下半年啟動。所以一切進展順利，我們對這個專案感到非常興奮。

But final details in terms of design will be rolled out. I think we're crossing the Ts and dotting the Is right now in terms of that final protocol. So you'll see that posted and available in short order.

但最終的設計細節將會陸續公佈。我認為我們目前正在對最終協議進行最後的敲定工作。所以不久之後您就會看到相關文件發佈並可供查閱。

The next question goes to Chris Schott of JPMorgan.

下一個問題交給摩根大通的克里斯·肖特。

I just had one on OpEx. Can you just talk a little bit about how we should be thinking about Gilead's operating costs going forward? It sounds like you're obviously accelerating some R&D programs, and you've got this double-digit step-up in R&D this year. But as we think about operating margin dynamics kind of going forward, I guess off of the 2023 levels, can we start to think about margin expansion going forward? Or do we need to maybe think about another year or 2 of investment before we can think about margin expansion for the company?

我剛剛問了一個關於營運支出的問題。您能否談談我們應該如何看待吉利德未來的營運成本？聽起來你們顯然正在加速一些研發項目，而且今年的研發投入實現了兩位數的成長。但是，當我們展望未來的營運利潤率動態時，我想以2023年的水準為基準，我們是否可以開始考慮利潤率的提升？還是我們需要考慮再投入一兩年的時間，才能考慮公司利潤率的提升？

Chris, it's Andy Dickinson. Thanks for the question. It's a great question. Maybe just stepping back, again, highlight and reinforce that we've built a large and diverse portfolio that really positions us for significant growth both in the short term as well as in the long run. As you heard in our prepared remarks, we're really investing and kind of leaning into that. We had an accelerated -- or significant focused efforts to accelerate some of our clinical development, which is starting to pay dividends.

克里斯，我是安迪‧迪金森。謝謝你的提問，這是一個很好的問題。我想再次強調，我們已經建立了一個龐大且多元化的投資組合，這使我們能夠在短期和長期內實現顯著成長。正如你在我們的發言稿中聽到的，我們正在大力投資並積極推動這方面的工作。我們加快了部分臨床研發的步伐，這些努力已經開始發揮成效。

You're also seeing the validation of this approach in our commercial results that Johanna highlighted and the strength across our base business. So to your point, we are now -- this year, I think we already have 22 Phase III trials underway, which is significantly more than we have as a company historically. It's actually, frankly, a healthy level. I highlighted in my comments that this year, we're targeting kind of low 20s percentage point of revenue for our R&D investment. And that's a reasonably good place to be. We believe it's in line with peers over the long run.

正如Johanna所強調的，我們的商業業績和基礎業務的強勁表現也驗證了這項策略的有效性。正如您所說，今年我們已經啟動了22項三期臨床試驗，遠超公司以往的歷史水準。坦白講，這確實是一個相當健康的水平。我在演講中提到，今年我們計劃將研發投入佔營收的比例控制在20%左右。這是一個相當不錯的水平。我們相信，從長遠來看，這與同行的水平相當。

There will be years when we have expenses that are greater than that and years lower. But over the cycle, I think that's kind of what we're targeting. So -- and then maybe to your question on operating margin, we still have a very healthy operating margin, as you know. Again, there's apples-and-oranges comparison with the new IPR&D rules. But we do expect to see our operating margin strengthen again over time as we get through this bolus of Phase III trials that we have underway, and that drives growth above and beyond what you've already seen in the last 18 months, which we think is off to a great start.

未來幾年，我們的支出可能會高於這個數字，也會低於這個數字。但就整個週期而言，我認為這正是我們努力的目標。至於您所提到的營業利潤率，如您所知，我們目前的營業利潤率仍然非常健康。當然，與新的智慧財產權和研發規則相比，情況有所不同。但我們預計，隨著目前正在進行的這批三期臨床試驗的推進，我們的營業利潤率將進一步提升，這將推動我們實現超過過去18個月的成長，而我們認為這18個月的開局已經非常出色。

So more to come. It's going to take a little more time to get through it, to your point, but we're in a very good spot from our perspective.

所以還有更多消息。正如你所說，這還需要一些時間才能完成，但從我們的角度來看，我們目前處境非常有利。

The next question goes to Salveen Richter of Goldman Sachs.

下一個問題交給高盛的薩爾文·里希特。

This is [Anna Guan] on for Salveen. Just on the TIGIT combo data at ASCO, how do you view this update? Is it more incremental? And then just on the Roche OS data, which is now expected in 3Q, how much read-through do you anticipate on that front?

這裡是Salveen的Anna Guan。關於ASCO會議上公佈的TIGIT聯合療法數據，您如何看待這次更新？是增量式的嗎？還有，關於羅氏OS療法的數據，預計將在第三季公佈，您預計這方面的解讀會有多大影響？

Yes. Thanks. What we have said and I think what we're planning is we'll have an updated data set from a more recent cut. So there'll be additional data compared with what was presented -- what we talked about last year at the ASCO plenary. And so there should be more mature data with a larger patient population. And so that should help reinforce our confidence.

是的，謝謝。我們之前說過，而且我認為我們正在計劃的是，我們會使用來自最新資料組的更新資料集。因此，與去年我們在ASCO全體會議上討論的數據相比，我們會獲得更多資訊。這樣一來，數據將更加成熟，涵蓋的患者群也更大。這應該有助於增強我們的信心。

In terms of the Roche data, I think it's a great question. Look, I think we believe in our own data as well as all of the other public data that are out there in terms of TIGIT bringing benefit certainly in terms of response rates and other parameters. Certainly in our data set, we've seen those PFS benefits. And our expectation is that the Roche data will continue to demonstrate benefit adding TIGIT to PD-1 inhibitors, so PD-L1 inhibitors in their case.

關於羅氏的數據，我認為這是一個很好的問題。我們相信我們自身的數據以及所有其他已公開的數據，這些數據都表明TIGIT在緩解率和其他指標方面確實具有益處。當然，在我們的資料集中，我們已經觀察到了無惡化存活期（PFS）的益處。我們預期羅氏的數據將繼續證明，在PD-1抑制劑（在他們的案例中是PD-L1抑制劑）的基礎上加用TIGIT具有益處。

So we will be looking forward to seeing those OS data, and I think that should help to provide additional confidence to all the TIGIT antibodies out there.

因此，我們期待看到這些作業系統數據，我認為這應該有助於增強人們對所有 TIGIT 抗體的信心。

The next question goes to Geoff Meacham of Bank of America.

下一個問題交給美國銀行的傑夫‧米查姆。

Merdad, you guys have been very successful commercially with Kite, and it looks like the pipeline has some logical next steps in terms of liquid tumors. I guess what I wanted to ask you is, what's your appetite for leveraging the expertise to look at non-oncology indications like rare diseases or maybe towards solid tumors? And why do you think the field has mostly evaluated the same targets in myeloma, lymphoma, leukemia, et cetera?

Merdad，你們的Kite在商業上非常成功，而且看起來在血液腫瘤領域，你們的研發管線也有一些合乎邏輯的下一步發展方向。我想問的是，你們是否有興趣利用你們的專業知識，將研發重點放在非腫瘤適應症上，例如罕見疾病，或是實體腫瘤？另外，你認為為什麼目前在多發性骨髓瘤、淋巴瘤、白血病等領域，大部分研究的標靶都相同？

Thanks, Geoff. Yes, it's a very complicated question. I'll try to give a very brief answer. Look, I think that leveraging the engineered T cells so far in hematology has demonstrated really great efficacy and a reasonable tolerability profile for that patient population. I think it's all about therapeutic index.

謝謝，傑夫。是的，這確實是個很複雜的問題。我盡量簡明扼要地回答。你看，我認為目前在血液病學領域，利用基因工程改造的T細胞已經展現出非常顯著的療效，並且對該類患者群體來說也具有良好的耐受性。我認為關鍵在於治療指數。

As you start to go into broader indications where treatment options are different and the disease state is different, I think there are different considerations for therapeutic index. So as we look into different populations, we're going to keep a very close eye on the appropriate therapeutic index for a given patient, whether you're talking about lupus or anything else in -- outside of oncology related to your question.

隨著適應症範圍的擴大，治療方案和疾病狀態也會有所不同，我認為治療指數的考量也會有所不同。因此，在研究不同人群時，我們會密切注意特定患者的合適治療指數，無論您討論的是狼瘡還是其他任何疾病——與您問題中涉及的腫瘤學以外的疾病。

From our perspective, maybe the broader perspective that I would offer is that we do believe that modulating the immune system will lead to better outcomes in patients, whether you're talking about agonizing or antagonizing. And in immunologic disorders, we do believe that getting to better and more targeted immune blockade is going to be better for patients.

從我們的角度來看，或許我更願意從更廣泛的角度來看待這個問題：我們相信，調節免疫系統能夠改善患者的預後，無論採用的是抑制還是拮抗療法。在免疫系統疾病方面，我們相信，更有效、更有針對性的免疫阻斷療法對患者更有益。

And so from our perspective, there is not only cell therapy in play. And I think that's what we like about our portfolio is that we have -- we're not modality-restricted. And you've seen the deals we've done. We have our BTLA antibody and the rest of our portfolio in inflammation. So we are going to be pursuing the best outcome for patients regardless of modality. And certainly, cell therapy will be one of those.

因此，從我們的角度來看，我們關注的不僅僅是細胞療法。我認為我們產品組合的優勢就在於此——我們不受治療方式的限制。您也看到了我們達成的交易。我們擁有BTLA抗體，以及其他針對發炎領域的產品。因此，我們將致力於為患者尋求最佳治療效果，無論採用何種治療方式。當然，細胞療法也將是其中之一。

The next question goes to Terence Flynn of Morgan Stanley.

下一個問題交給摩根士丹利的特倫斯·弗林。

Just one for me on Yescarta. I was wondering if you can give us any more color in terms of the breakdown between second line versus third line right now. Obviously, you're seeing some nice momentum. And then on the manufacturing footprint, maybe just any color there in terms of total number of patients you can supply in a year. Obviously, that's been an issue for some of the other CAR-T therapies out there, but just want to understand kind of longer-term supply dynamics.

關於Yescarta，我還有一個問題。我想請教一下，您能否更詳細地介紹一下目前二線療法和三線療法的具體情況？顯然，Yescarta的發展勢頭良好。另外，關於生產規模，您能否提供一些關於一年內可滿足多少患者需求的資訊？顯然，這對於其他一些CAR-T療法來說也是一個問題，但我只是想了解更長期的供應動態。

Sure. So let me start and then maybe Andy can touch on the manufacturing piece of the puzzle. So thanks for your question, Terence. I think what we've seen is really strong growth across second line and third line and obviously a little slower coming into second line, but we're seeing nice momentum into second line as well. And I think the OS data from ZUMA-7 coming through that will be presented at ASCO will only help continue that and really differentiate it versus current standard of care.

當然。那我先開始，然後安迪可以談談生產製造的問題。謝謝你的提問，特倫斯。我認為我們看到的是二線和三線療法的強勁增長，二線療法的增長速度顯然稍慢一些，但我們也看到二線療法的發展勢頭良好。我認為即將在ASCO會議上公佈的ZUMA-7研究的OS數據將有助於延續這一趨勢，並使其與目前的標準療法真正區分開來。

And -- but what we have seen is growth that has really picked up quite nicely, and you're seeing it both in the U.S. as well as Europe. And really happy to say, actually, we're -- although we just got recent approval for second line in Europe late last year, we're getting a lot of markets coming in from reimbursement, accelerating reimbursement because of the importance of this data for patients. And actually one example of that is actually just today with the NICE approval for second-line therapy with Yescarta.

我們看到的是成長勢頭強勁，而且在美國和歐洲都是如此。非常高興的是，儘管我們去年底才在歐洲獲得二線治療的批准，但由於這些數據對患者的重要性，我們正在加快許多市場的醫保報銷進程。事實上，今天NICE批准Yescarta用於二線治療就是一個例子。

So we're very excited about where this is going. There's still a lot of growth opportunity in second line. And obviously, the team is really working diligently to make sure that physicians are well educated to make sure that they understand the benefit and the overall survival over long term for these patients. So more to come on that.

我們對這項技術的未來發展方向感到非常興奮。二線治療領域仍蘊藏著巨大的成長潛力。顯然，團隊正在努力確保醫生接受充分的培訓，從而了解這些療法對患者的長期益處和整體存活率。更多相關資訊敬請期待。

And with that, I'll just turn it over to Andy for manufacturing.

這樣一來，我就把它交給安迪生產了。

Yes. Thanks, Johanna. Terence, on manufacturing, what I would say is that's a real area of competitive strength for Kite and for us. As you know, we have 3 approved manufacturing centers globally: 2 in the United States, 1 on each coast and then the 1 in the Netherlands. All of them are fully operational. We're already moving in our Maryland facility to partial automation of our manufacturing process, which is a off to a great start, and we just have an outstanding team.

是的，謝謝，喬安娜。特倫斯，關於生產製造，我想說，這對Kite和我們來說都是真正的競爭優勢領域。如你所知，我們在全球擁有3個經認證的生產中心：2個在美國，分別位於東西海岸，還有1個在荷蘭。所有中心都已全面運作。我們位於馬裡蘭州的工廠已經開始逐步實現生產流程的部分自動化，目前進展順利，而且我們擁有一支非常優秀的團隊。

So we have not had capacity constraints either on the manufacturing of the cells or on the viral vector. So remember, we have both an outsourced and an internal viral vector supply. We manufacture our own viral vector at our Oceanside, California biologics facility. So I don't think, Terence, we've shared specifically the capacity of our manufacturing footprint. But rest assured, we have adequate capacity to serve the market today.

因此，無論是細胞生產或病毒載體生產，我們都沒有遇到產能限制。請記住，我們既有外包的病毒載體供應，也有內部生產的。我們在加州奧申賽德的生物製劑工廠生產自己的病毒載體。所以，特倫斯，我認為我們還沒有具體透露過我們的生產規模。但請放心，我們目前的產能足以滿足市場需求。

Our team does a great job of forecasting where the market is going. We're always 1 or 2 steps ahead, and we don't expect that to change. So from a manufacturing standpoint, the Kite team has just really done an outstanding job.

我們的團隊在預測市場走向方面做得非常出色。我們總是能領先一兩步，而且我們預計這種情況不會改變。因此，從製造角度來看，Kite團隊確實做得非常出色。

The next question goes to Tim Anderson of Wolfe Research.

下一個問題交給 Wolfe Research 的 Tim Anderson。

This is Adam on behalf of Tim. So on Biktarvy, it doesn't lose exclusivity until the next decade, but it's possible to get targeted by the IRA before then. We know that Medicare only accounts for a limited portion of Biktarvy's volume. And is it possible that the pricing impact extends to commercial patients? Also, what other aspects of the IRA that you think investors are discounting beyond the negotiation piece?

我是亞當，代表提姆。關於Biktarvy，它的獨家銷售權要到下一個十年才會失效，但在此之前，它有可能成為IRA的目標。我們知道，Medicare（聯邦醫療保險）只佔Biktarvy銷售的一小部分。那麼，價格影響是否也會波及商業保險患者呢？此外，除了談判環節之外，您認為投資人在考慮IRA的其他哪些方面時，也忽略了這些影響？

I'll take that one, Adam. So yes, we do believe that the IRA will have an impact on Biktarvy, although we do believe it will be later this decade, and probably the earliest could be 2028 or so.

我來回答這個問題，亞當。所以，是的，我們確實認為愛爾蘭共和軍會對Biktarvy產生影響，儘管我們認為這種影響會在本十年末期出現，最早可能也要到2028年左右。

The -- again, what you said is absolutely true. It is only on our Medicare business. And obviously, there's a lot of things that can happen between now and then. It's still early in understanding exactly how it's going to play out, including the [present] negotiations that will happen.

——再說一遍，您說的完全正確。這僅限於我們的醫療保險業務。當然，從現在到那時可能會發生很多事情。現在要確切了解事情最終會如何發展還為時過早，包括即將進行的談判。

As to the spillover effect that you mentioned, we believe that -- we've had situations, obviously, in other channels today where we have higher discounts than in our commercial channels. And we've been able to manage that specific to the patient populations within those channels. And so we believe we'll be able to do that again and mitigate the risk of spillover.

關於您提到的溢出效應，我們認為——顯然，目前我們在其他管道也遇到過折扣高於商業管道的情況。我們已經能夠針對這些管道內的特定患者群體進行有效管理。因此，我們相信我們能夠再次做到這一點，並降低外溢效應的風險。

And -- so yes, so I think that, that's kind of what we're managing in addition to the fact that our portfolio as much as Biktarvy is out to 2033 and that will, I think, really continue to be the standard of care for daily orals. We're also expanding our portfolio as you think about where we're going with lenacapavir with different combinations in treatment and obviously, with our prevention work.

是的，我認為，除了Biktarvy之外，我們目前也在努力應對這些問題。 Biktarvy的研發週期將持續到2033年，我認為它將繼續成為每日口服藥物的標準療法。同時，我們也在拓展產品組合，考慮lenacapavir與其他藥物聯合用於治療以及預防方面的應用。

So more to come on that, but I think we're more than prepared to manage the situation and have a couple more years to figure out some of the different dynamics within the IRA.

關於這一點，以後還會有更多消息，但我認為我們已經做好了充分的準備來應對這種情況，並且還有幾年的時間來弄清楚 IRA 內部的一些不同動態。

The next question goes to Umer Raffat of Evercore.

下一個問題交給Evercore公司的Umer Raffat。

I want to touch up on Trodelvy real quick in terms of how the prescription trends are tracking in TNBC in particular, especially in light of your competitor, Daiichi, saying they now have #1 patient share in HER2-low and growing. So I'm just curious how that's shaking out because I know you've got a new indication this quarter.

我想快速談談Trodelvy在三陰性乳癌（TNBC）領域的處方趨勢，特別是考慮到你們的競爭對手第一三共株式會社（Daiichi）聲稱他們在HER2低表達型乳癌患者群體中佔據了第一的市場份額，並且還在不斷增長。我很想知道這方面的情況如何，因為我知道你們本季推出了新的適應症。

And secondly also, there's a lot of renewed interest in CAR-T, especially as it relates to immunology. But as I think of immunology and the price points, maybe 3x HUMIRA, so that will be $150,000. But conversely, I would imagine each cell therapy dose would be at least $100,000. So how do you think about economics as you head into potentially immunology indications?

其次，人們對CAR-T療法的興趣再次高漲，尤其是在免疫學領域。但考慮到免疫學和價格因素，CAR-T療法的價格可能是阿達木單抗（HUMIRA）的三倍，也就是15萬美元。反過來，我估計每次細胞療法的劑量至少也要10萬美元。那麼，當您考慮將CAR-T療法應用於潛在的免疫學適應症時，您是如何看待經濟效益的呢？

Umer, I'll take the first part of that specific to Trodelvy and what we're seeing in TNBC and metastatic TNBC. So what we've seen is actually continued growth in TNBC for Trodelvy, and really that has a lot to do with the expansion of our field of course but also the continued data that comes through, right? The OS data in TNBC is one piece of the puzzle. The other piece is obviously the OS that we've shown also in HR-positive. So really, the breast cancer community understanding Trodelvy better in that space.

Umer，我先具體談談Trodelvy在三陰性乳癌（TNBC）和轉移性TNBC的應用。 Trodelvy在TNBC的應用持續成長，這當然與我們研究領域的拓展以及不斷湧現的數據密切相關，對吧？ TNBC的OS數據是其中的一部分。另一部分則顯然是我們已證實的HR陽性乳癌的OS數據。因此，乳癌領域對Trodelvy在這一領域的應用有了更深入的了解。

We haven't split the market and neither have physicians at this point really split the market between HER2-low kind of population. So what we look at is each indication, TNBC and HR-positive/HER2-negative. And what we're seeing in metastatic TNBC in the lines of therapy that is second line plus is really Trodelvy established itself as the standard of care in this setting, and it continues to do that.

我們尚未將市場細分，目前醫生也尚未真正將市場細分為 HER2 低表現族群。因此，我們關注的是每種適應症，即三陰性乳癌 (TNBC) 和荷爾蒙受體陽性/HER2 陰性乳癌。在轉移性 TNBC 的二線及以上治療方案中，Trodelvy 已確立了其在該領域的標準治療地位，且這一地位仍在持續。

So I do think, just remembering in TNBC, the split between IHC 0 and IHC 1 and 2 is 65-35. So much more represented -- so less represented by maybe some of our competitors. Having said that, we work across a spectrum, which I think is really important to remember. So that's the Trodelvy dynamics right now in metastatic TNBC.

所以我認為，在三陰性乳癌（TNBC）中，IHC 0 與 IHC 1 和 2 的比例是 65:35。我們的代表性遠高於某些競爭對手。話雖如此，我們的治療範圍涵蓋了整個治療光譜，我認為這一點非常重要。這就是 Trodelvy 目前在轉移性 TNBC 領域的動態。

Great, Umer. This is Dan O'Day. To -- I think -- I appreciate your question. On the second one, I'll dovetail on to what Merdad said before about the importance of therapeutic index. But before I do that, let me just articulate the tremendous benefit that CAR-T is providing a large B-cell lymphoma from a pharmaeconomic standpoint. The fact that we now have patients in very late-stage disease, 50% of them surviving up to 5 years and essentially a flatline survival curve, you can imagine the benefit from both a mortality perspective and cost of the system of the current price point in large B-cell lymphoma.

太好了，Umer。我是Dan O'Day。我想說的是，我很感謝你的提問。關於第二個問題，我會呼應Merdad之前提到的治療指數的重要性。但在那之前，我想先從藥物經濟學的角度闡述CAR-T療法為大B細胞淋巴瘤患者帶來的巨大益處。我們現在有許多晚期患者，其中50%的人能存活長達5年，而且存活曲線基本上呈現平穩狀態。你可以想像，無論從降低死亡率或目前大B細胞淋巴瘤治療的成本角度來看，CAR-T療法都帶來了多麼巨大的益處。

I think any price point in other therapeutic areas would be based upon the clinical benefit that, that brings to those particular patients. Of course, we understand that this wouldn't necessarily be a broad-scale use across all different types of patients. There will be patient segments where the therapeutic index is more important. And for those patients, we would look at the level of benefit that brings both to the patient and to the health care system and then price it accordingly, of course.

我認為其他治療領域的定價應基於該療法為特定患者帶來的臨床效益。當然，我們也明白，這種療法未必適用於所有類型的患者。對於某些患者族群，治療指數更為重要。對於這些患者，我們會綜合考慮該療法為患者和醫療保健系統帶來的益處，並據此定價。

So I think it's hypothetical at this stage. But given the given the benefit that we're seeing in cancer, we would take the same approach to other disease states.

所以我覺得目前這只是假設。但鑑於我們在癌症治療中看到的益處，我們會對其他疾病採取同樣的方法。

(Operator Instructions) We do have 10 folks still hoping to ask a question on the call, and we'd like to get to as many as possible.

（操作員說明）目前還有 10 位朋友希望在通話中提問，我們希望盡可能回答他們的問題。

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

下一個問題交給TD Cowen公司的Tyler Van Buren。

I guess given Legend's tremendous top line data leak in the second line, I figured I would ask for your latest thoughts on that opportunity and how you plan to differentiate in that setting with the Arcellx program.

鑑於 Legend 在第二行中洩露了大量重要數據，我想問您對這個機會的最新看法，以及您計劃如何透過 Arcellx 專案在這個環境中脫穎而出。

Tyler, it's Andy Dickinson. I'll take the question on behalf of the Kite team. Obviously, we and others want to see the full data set. We read the same releases that you've read. And we continue to believe that Arcellx and now Kite have a very interesting program that has the potential to be very competitive in that area to get on par or better potentially than the J&J Legend product.

泰勒，我是安迪‧迪金森。我代表Kite團隊回答這個問題。顯然，我們和其他人一樣，都希望看到完整的資料集。我們和你一樣，也閱讀了同樣的新聞稿。我們仍然認為，Arcellx以及現在的Kite擁有一個非常有趣的項目，該項目有潛力在該領域極具競爭力，甚至有可能與強生Legend產品持平或更勝一籌。

And as Dan said earlier, it doesn't come as a surprise to us that cell therapy is delivering that magnitude of benefit to patients across different disease areas. And it's exciting to see where cell therapy may go in terms of becoming the standard of care in second-line BCMA potentially over time, which, of course, increases the size of the potential opportunity for the Arcellx and Kite team.

正如丹之前所說，細胞療法能為不同疾病領域的患者帶來如此巨大的益處，這並不讓我們感到驚訝。令人興奮的是，細胞療法未來有望成為二線BCMA治療的標準療法，這無疑也為Arcellx和Kite團隊帶來了更大的發展機會。

So look forward to seeing more on the data, look forward to carrying our program for it together with Arcellx team and to updating you over time. But certainly, looks like a fantastic data set and great for patients.

所以，敬請期待更多數據，期待與 Arcellx 團隊共同推動我們的項目，並會持續更新資訊。可以肯定的是，這看起來是一套非常棒的數據集，對患者來說意義重大。

Our next question goes to Hartaj Singh of Oppenheimer & Co.

下一個問題請奧本海默公司的哈塔吉·辛格回答。

I just had a quick question on Trodelvy in non-small cell lung cancer. I know those trials are still about a year or 2 years from reading out. But Merdad, can you just remind us of the scientific rationale behind Trodelvy in non-small cell lung cancer and just to opine a little bit on just the EVOKE-01 and 03 trials?

我有個關於Trodelvy治療非小細胞肺癌的問題想請教一下。我知道這些試驗的結果還需要一到兩年才能公佈。 Merdad，您能否簡單介紹一下Trodelvy治療非小細胞肺癌的科學原理，並就EVOKE-01和EVOKE-03試驗談談您的看法？

Sure, Hartaj. Yes, I think there are several things that we -- give us a lot of confidence in terms of moving forward in non-small cell lung cancer. Certainly, the distribution of Trop-2 has demonstrated broad expression in non-small cell lung cancer, not too dissimilar from breast cancer. And so I think that gives us a lot of incentive to believe that the expression of Trop-2 in those tumors is going to give us efficacy by delivering the payload to those cells.

當然，Hartaj。是的，我認為有幾點讓我們對非小細胞肺癌的治療充滿信心。首先，Trop-2在非小細胞肺癌中的分佈已證實廣泛表達，與乳癌的情況非常相似。因此，我認為這讓我們更有理由相信，Trop-2在這些腫瘤中的表現能夠將有效載荷遞送至這些細胞，從而提高治療效果。

Secondly, we've seen both internal and external data for Trop-2-targeted ADCs that support the value of bringing Trop-2-directed antibody-drug conjugate to non-small cell lung cancer. So our approach, which has been broad and we're very excited about, I think, is going really well is we are, as you know, in EVOKE-01 going into second-line non-small cell lung cancer, and that study is going very well.

其次，我們已經看到了針對Trop-2靶向抗體偶聯藥物（ADC）的內部和外部數據，這些數據支持將Trop-2靶向抗體藥物偶聯物應用於非小細胞肺癌的價值。因此，我們採取的策略非常廣泛，我們對此感到非常興奮，我認為目前進展非常順利。如您所知，我們正在進行的EVOKE-01研究，旨在開發二線非小細胞肺癌治療方案，該研究進展非常順利。

We are then as well looking in front-line lung cancer in our other trials and looking at combinations of PD-1s with Trodelvy in those tumors in non-small cell. And we think that the potential for Trodelvy in those tumors is very high. We believe that we'll start to see those data start to roll out from our second-line studies first, as you would imagine. And then we'll continue to build on that as we go.

此外，我們也在其他臨床試驗中研究第一線肺癌治療，探討PD-1抑制劑與Trodelvy合併治療非小細胞肺癌的療效。我們認為Trodelvy在這些腫瘤中的潛力非常高。正如您所料，我們相信首先會從二線研究中獲得相關數據。然後，我們會在此基礎上繼續推進研究。

Our next question goes to Brian Skorney of RW Baird.

下一個問題請問RW Baird公司的Brian Skorney。

This is Charlie Moore on for Brian. I had a question about lenacapavir. So with regards to the recent data with the bNAbs, it seemed like 1 case out of 20 experienced a viral rebound. So I was wondering how that might inform which combinations you are thinking about moving forward with regarding overcoming resistance. And kind of along that same line, what kind of expectations do you have for the size of the long-acting market in HIV?

我是查理·摩爾，替布萊恩提問。我有個關於來那卡帕韋的問題。根據最近關於廣譜中和抗體（bNAbs）的數據，似乎每20例患者中就有1例出現病毒反彈。我想知道這會如何影響您考慮採用哪些聯合療法來克服抗藥性。另外，您對HIV長效藥物的市場規模有何預期？

Yes. Very important that, that breakthrough was not associated with lenacapavir resistance, right? And I think that's really important to keep in mind. Look, bNAbs are relatively new clinical tools to look for, options for people in terms of treating HIV. And it's one of the many approaches we're taking.

是的。非常重要的一點是，這項突破與勒那卡帕韋抗藥性無關，對吧？我認為這一點非常重要，必須牢記。你看，廣譜中和抗體（bNAbs）是相對較新的臨床工具，是治療愛滋病患者的新選擇。這也是我們正在採取的眾多方法之一。

Our approach has been to move a broader portfolio of small molecules to complement that early foray into long-acting with bNAbs, where we believe that the tried-and-true mechanisms that we have used, again, both orally or parenterally, should provide us with an opportunity to bring treatment options to people living with HIV that will be associated with low resistance rates and high efficacy.

我們採取的策略是，擴大小分子藥物組合，以補充早期對長效廣譜中和抗體的探索。我們相信，我們採用的行之有效的機制，無論是口服還是腸外給藥，都應該能夠為 HIV 感染者提供治療選擇，這些治療選擇具有低抗藥性和高療效。

So that's what we're testing out. As we find the ideal partners, and I use the plural intentionally, we will be moving that forward. And so I would look at those -- the bNAb data as early -- an early first approach to a long-acting treatment for people living with HIV.

所以這就是我們正在測試的內容。一旦找到理想的合作夥伴（我特意用了複數），我們就會推進這項工作。因此，我會把這些——廣譜中和抗體（bNAb）數據——視為早期針對愛滋病毒感染者的長效治療方案的初步嘗試。

And maybe just to cover, Charlie, the second part of your question around the size of the market. So I'm going to split it out. When you think about the market from a treatment standpoint, we do believe that the long-acting market, probably by the end of this decade, will look about 50-50 or so. We think that there are definitely patients out there that are looking for us not to be reminded that they have HIV and an opportunity to think about the next-generation long-acting to really bring to patients what they're looking for. I think that's the kind of the last unmet medical need in this space at this point in time.

查理，關於你問題的第二部分，也就是市場規模，我再補充兩點。從治療的角度來看，我們認為到本十年末，長效製劑市場可能會達到50/50左右。我們認為，確實有一些病人希望我們不要總是提醒他們自己感染了愛滋病毒，並希望有機會研發出真正能滿足他們需求的下一代長效製劑。我認為這是目前這個領域最後一個尚未滿足的醫療需求。

I also think Biktarvy will continue to be the standard of care in the daily oral market, where there's still a lot of patients that actually do want to take their medicine every single day to make sure that they know that they're taking something to put at bay their HIV.

我也認為 Biktarvy 將繼續成為每日口服藥物市場的標準治療方案，因為仍有許多患者希望每天服用藥物，以確保他們知道自己正在服用藥物來控制 HIV 感染。

Just to touch on the expansion from a PrEP standpoint, I just wanted -- the prevention market, very different in our view. And some discussions we've had with community partners and people that are at risk of HIV, what we're seeing here is probably the split is different, but the market expansion is also very different. So the split is probably going to go towards 70-30 by the end of this decade is what we assume.

從暴露前預防（PrEP）的角度來看，我想談談市場擴張的問題。在我們看來，預防市場與傳統療法市場截然不同。我們與社區夥伴和愛滋病毒感染高風險族群進行了一些討論，發現目前的市場格局可能有所不同，市場擴張也大相徑庭。我們預計，到本十年末，市場格局可能會趨向於70:30。

That has a lot to do with the fact that these are not patients, these are people at risk, and they don't necessarily want to take a pill a day for something they don't have. And so that makes a lot of sense. So something every 6 months aligned with physician visits could be an ideal scenario in this setting.

這很大程度是因為這些人並非患者，而是高風險族群，他們未必願意每天服用藥物來治療自己沒有的疾病。所以這樣做很有道理。因此，每六個月進行一次與醫生就診相結合的檢查，在這種情況下可能是理想的方案。

And then from an expansion standpoint, as you all know, we've talked about this a lot. If you look at the CDC assumptions around the number of people that are at risk in the U.S., we've only kind of captured about 25% of those folks that are currently under medication. And unfortunately, there's still 75% that are not and that are at risk. And so there's an incredible opportunity, especially with something every 6 months, to really expand in this marketplace and make sure that we truly work together to end this epidemic.

從拓展的角度來看，如大家所知，我們已經多次討論過這個問題。如果參考美國疾管中心對美國高危險群數量的估計，就會發現我們目前只涵蓋了約25%正在接受治療的人。不幸的是，還有75%的人沒有接受治療，他們仍然面臨風險。因此，這是一個絕佳的機會，尤其是在每六個月就推出新冠疫苗的情況下，我們可以真正拓展市場，確保我們攜手合作，最終戰勝這場疫情。

So very exciting times to come. And within the next 2 years, hopefully, we'll have lenacapavir as the data reads out and approvals in prevention and then just a bit after that in treatment with different partners that Merdad was just mentioning. So very exciting time.

所以未來令人振奮。希望在未來兩年內，隨著數據公佈和預防方面的審批，我們能夠看到lenacapavir獲批用於預防，之後不久，它就能與Merdad剛才提到的不同合作夥伴一起用於治療。真是令人興奮！

The next question goes to Steve Seedhouse of Raymond James.

下一個問題交給 Raymond James 公司的 Steve Seedhouse。

This is Ryan Deschner on for Steve Seedhouse. Just curious what the current non-hospitalized versus hospitalized usage split for Veklury is? And do you anticipate a large amount of potential cannibalization in the non-hospitalized usage coming from obeldesivir if its clinical development is successful?

這裡是 Ryan Deschner，替 Steve Seedhouse 發言。我想了解目前 Veklury 在非住院患者和住院患者中的使用比例是多少？如果 obeldesivir 的臨床開發成功，您是否預期它會對非住院病患市場造成很大的蠶食？

Thanks. So Ryan, I'll take that question. So what we have seen in the last year or so is somewhat of a lessening of the severity of infections, and therefore, from a hospitalization standpoint, obviously, less hospitalizations as well. So we've seen a couple of different things. So obviously, much more non-hospitalizations of late, and we've seen that obviously in the numbers because as you well know, that Veklury tracks very closely to hospitalization.

謝謝。瑞恩，我來回答這個問題。過去一年左右，我們看到感染的嚴重程度減輕，因此，從住院的角度來看，住院人數也明顯減少了。所以我們看到了幾個不同的現象。顯然，最近非住院病例大幅增加，這一點我們從數據中也明顯看出，因為如你所知，Veklury 與住院率密切相關。

And what we've seen is despite the fact that hospitalizations have come down versus our expectations in Q1, the actual usage of Veklury has gone up. And that's super interesting. And a lot of that has to do with the strength of the data that keeps delivering for Veklury around the updates of guidelines, the strength of our data, real-world data that's come out continuously showing reduction in mortality and reduction in readmissions to hospitalization. So very powerful data, but definitely a bit of a play there.

我們看到，儘管第一季住院人數低於預期，但Veklury的實際使用量卻有所上升。這非常有趣。這很大程度上歸功於Veklury持續更新的指南數據，以及我們不斷發布的真實世界數據，這些數據持續顯示死亡率和再入院率的降低。這些數據非常有力，但其中也存在著一定的主觀因素。

This is -- our outpatient use with Veklury is still quite small, in the single digit or so. Having said that, it is growing. But it's really the only antiviral that is approved in hospitalized setting for COVID-19. And so that continues to drive.

目前，Veklury在門診的使用率仍然很低，只有個位數左右。儘管如此，它的使用率正在增長。而且，它是目前唯一獲準用於住院治療新冠肺炎的抗病毒藥物。因此，它的使用率持續成長。

I think as we think about our oral COVID program, I think we are thinking more [than] non-hospitalized setting, which I think would then complement what we have in our portfolio that works really nicely both in the non-hospitalized setting and the hospitalized setting to make sure that patients at risk have what they need if they do get infected.

我認為，當我們考慮口服新冠藥物計畫時，我們考慮的不僅僅是非住院環境，我認為這將補充我們現有的產品組合，這些產品在非住院環境和住院環境中都能很好地發揮作用，以確保有風險的患者在感染時能夠獲得所需的藥物。

The next question goes to Olivia Brayer of Cantor Fitzgerald.

下一個問題交給 Cantor Fitzgerald 公司的 Olivia Brayer。

Have you guys started to think through a commercial rollout strategy for magrolimab, especially when you look beyond the initial academic centers? And is there anything you can do to help drive initial adoption for -- of transfusion guidelines in that community setting specifically?

你們是否已經開始考慮magrolimab的商業推廣策略，尤其是在最初的學術中心之外？你們能否採取一些措施來幫助推動社區環境中輸血指南的初步應用？

So I'll take that one, Olivia. As we think about magro, we are excited, obviously. We're waiting for the data to read out. But we are excited, and we have started thinking about our commercial model for sure. I think a couple of pieces to that one.

那我就來回答這個問題吧，奧莉維亞。說到magro，我們當然很興奮。我們正在等待數據結果。但我們確實很興奮，而且肯定已經開始考慮我們的商業模式了。我認為這其中有幾個方面需要考慮。

One is the strength of the community and making sure we understand kind of what that looks like, but also the strength that Kite brings in this play as well. So we're not starting from scratch, right? We are going to -- we partner very closely with our Kite colleagues to make sure that there's a lot of learnings there that I think we can apply and a lot of overlap from a physician standpoint that also that we've been working through. So a lot of those pieces are in play.

一方面是社區的力量，我們要確保了解這種力量的具體體現；另一方面是Kite在這項工作中帶來的優勢。所以我們並非從零開始，對吧？我們會與Kite的同事們緊密合作，確保能夠借鑒他們的經驗並加以應用；同時，從醫生的角度來看，我們也有很多共同之處，這些我們一直在努力。所以，很多因素都在發揮作用。

And the last piece I would say, just to add to the commercial model and our thinking, also has to do with the fact that we're also trying to get ahead of the game and better understanding, right? These are diseases that sometimes community physicians will not see on a regular basis and how do we make sure that we understand the when and where and making sure that the commercial model support that timing as well and being a little bit smarter in our approach from an execution standpoint. So all those pieces are coming into play. But obviously, we're excited and anxious for the data. But we will be sure that we are ready for not only the data, but the approvals as well.

最後一點，我想補充的是，在商業模式和我們的思考基礎上，我們也在努力搶佔先機，更了解這些疾病。這些疾病有時是社區醫生不常遇到的，我們如何確保了解它們的發病時間和地點，並確保商業模式也能支持這種時機把握，同時在執行層面採取更明智的策略？所有這些因素都在發揮作用。顯然，我們對數據既興奮又焦慮。我們將確保不僅做好迎接數據的準備，也做好迎接審批的準備。

The next question goes to Colin Bristow of UBS.

下一個問題交給瑞銀集團的柯林布里斯托。

This is Ting for Colin. So on magrolimab, can you specify how many interims were planned in total for the ENHANCE trial? And for the interim update in the back half of the year, will there be actual data disclosure or just a high-level update? And for -- and what's your expectation -- also, what's your expectation of the CR and overall survival for the azacitidine control arm? There were some chatters around azacitidine arm outperformed Tekada's Phase III trial, where they used a more intensive dosing regimen. So what's your thought over this?

我是Ting，問Colin。關於magrolimab，您能否具體說明ENHANCE試驗計畫進行多少次中期追蹤？下半年的中期更新會公佈具體數據還是只提供概要資訊？另外，您對阿札胞苷對照組的完全緩解率（CR）和總存活期（OS）有何預期？有傳言說阿札胞苷組的療效優於Tekada的III期試驗，而Tekada的試驗則採用了更強的給藥方案。您對此有何看法？

Sure. Thanks for the question. So the -- in terms of the interim analysis, it's a good reminder that the study is powered for the final analysis. And so our expectation for any study that has interim analyses is that we run to the final analysis, which I think we've guided to occurring next year.

當然。謝謝你的提問。關於中期分析，它提醒我們，這項研究的統計效力是為最終分析而設計的。因此，我們對任何包含中期分析的研究的預期都是，最終分析能夠順利完成，而我們預計最終分析將在明年進行。

When an interim analysis occurs, we generally will not see the data. Generally, what happens is that the DSMB will tell us to either continue or potentially discontinue. If -- obviously, we discontinue, we'd share that. But if it's just continue, we would continue the trial, and there will be nothing other than that to share because we don't have any data to share since we won't have seen it. So our expectation is that we run to the end of the trial. It would certainly be upside if we saw something earlier than that.

當進行中期分析時，我們通常看不到數據。一般情況下，資料安全監察委員會 (DSMB) 會指示我們繼續試驗或可能終止試驗。顯然，如果我們終止試驗，我們會分享相關資訊。但如果只是繼續試驗，我們會繼續試驗，除此之外沒有其他資訊可以分享，因為我們沒有數據可以分享。因此，我們預期試驗會持續到結束。如果我們能提前看到一些結果，那當然是好事。

And then I think in terms of the expectations, you're absolutely right. I think everyone has looked at the Takeda data and are wary as to the efficacy of azacitidine in performing in that patient population. And so we're going to have to wait and see what that looks like at the end of the trial.

至於預期方面，我認為您說得完全正確。我想大家都看過武田的數據，對阿札胞苷在該患者族群的療效持謹慎態度。所以我們只能等待試驗結束，看看結果如何。

I'm, I guess, buttressed by the fact that we have -- the DSMB has told us to continue the trial, gives me a little bit of more confidence that we are going to see a treatment effect. But that's a very indirect assessment. So we're going to have to see. But we are powered for -- we've made some assumptions in terms of how we power the trial. So hopefully, we'll be able to detect the difference between the 2.

我想，讓我感到欣慰的是，資料安全監察委員會（DSMB）已經指示我們繼續進行試驗，這讓我更有信心看到治療效果。但這只是非常間接的評估，所以我們還需要觀察。不過，我們已經根據試驗的統計效力做出了一些假設，希望能夠檢測出兩種治療方案之間的差異。

Our final question goes to Mohit Bansal of Wells Fargo.

最後一個問題請富國銀行的莫希特·班薩爾回答。

And maybe a question on BD at this point. I mean, how are you thinking about BD? I know in the past, you talked about there's no urgency there, and you could be thinking about tuck-in. But has anything changed at this point now that you're in a good position with the growth coming back? Is there an updated thought there?

現在或許可以問一個關於業務拓展的問題。我的意思是，您是如何看待業務拓展的？我知道您之前說過目前並不急於推進業務拓展，而且您可能正在考慮進行業務整合。但現在隨著業務成長的復甦，您的處境有所好轉，您的想法是否有所改變？您對此是否有新的見解？

Mohit, it's Andy. Thank you for the question. Nothing's changed from our recent updates. I mean we think that BD is an important part of the puzzle for us going forward. It's important to continue to bring new and exciting innovation and products into our portfolio over time. We don't expect that to stop.

莫希特，我是安迪。謝謝你的提問。我們最近的更新內容沒有任何變化。我的意思是，我們認為業務拓展（BD）是我們未來發展策略的重要組成部分。隨著時間的推移，不斷為我們的產品組合引入令人興奮的創新和產品至關重要。我們預計這一進程不會停止。

That said, and to your point, we have made extraordinary progress over the last 4 years that we're really proud of. And so the breadth -- given the breadth and depth of our pipeline, you should expect that we will do less over the coming years than we did over the last 3 or 4 years. But we will still be active. And what we've said recently and I'd reinforce is that we will do ordinary course licensing deals.

話雖如此，正如您所說，過去四年我們取得了令人矚目的進步，我們為此感到非常自豪。鑑於我們專案儲備的廣度和深度，您應該預料到，未來幾年我們的業務量將比過去三、四年有所減少。但我們仍將保持活躍。我們最近已經說過，而且我還要重申，我們會繼續進行常規的課程授權交易。

Obviously, you saw the Tmunity and Arcellx deals last year. We've talked about the MiroBio deal, all of which we're very excited about. And then we expect from time to time to do small acquisitions. But our portfolio, to your point, is in a great spot. We're very excited about what that's going to do to drive growth, and we will always look for opportunities to add to it, if we can, in a thoughtful way that we think will benefit patients and our shareholders. But that's the way I would think about it at this point.

顯然，您去年已經看到了Tmunity和Arcellx的收購交易。我們也討論過MiroBio的收購，所有這些交易都讓我們感到非常興奮。此外，我們預計會不時進行一些小型收購。但正如您所說，我們的投資組合目前狀況良好。我們對這將推動成長感到非常興奮，並且我們將始終尋找機會，以我們認為對患者和股東都有益的方式，進一步拓展我們的投資組合。這就是我目前的想法。

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

謝謝。今天的問題就這些問題了。現在我把麥克風交給丹，請他做最後的總結發言。

Thank you so much. I just want to thank you all for joining today for your continued interest in Gilead. Look, bottom line is, we've had a very strong start to the year building on the momentum from 2022. And we collectively at Gilead and Kite believe we have a very strong and firm foundation for continued growth in 2023.

非常感謝。我只想感謝各位今天蒞臨，感謝你們一直以來對吉利德的關注。總而言之，今年我們開局非常強勁，延續了2022年的發展動能。吉利德和Kite的全體員工都相信，我們已經為2023年的持續成長奠定了堅實的基礎。

As usual, if we didn't get to your questions or you have additional follow-up questions, please reach out to Jacquie and the IR team, and we'd be more than happy to support you. Thank you very much for joining.

像往常一樣，如果您的問題沒有得到解答，或者您還有其他後續問題，請聯絡Jacquie和投資者關係團隊，我們非常樂意為您提供協助。非常感謝您的參與。

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

謝謝。今天的電話會議到此結束。非常感謝您的參與。您可以掛斷電話了。