吉利德科學 (GILD) 2023 Q2 法說會逐字稿

Hello, everyone. Thank you for attending Gilead Sciences Second Quarter 2023 Earnings Conference Call. My name is Siera, and I'll be your moderator today. (Operator Instructions)

大家好。感謝各位參加吉利德科學公司2023年第二季財報電話會議。我是主持人Siera。 （操作說明）

I would now like to pass the conference over to our host, Jacquie Ross, VP of Investor Relations. Please proceed.

現在我將把會議交給我們的主持人，投資者關係副總裁傑奎·羅斯。請開始。

Thank you, operator, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the second quarter of 2023. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Merdad Parsey, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A where the team will be joined by Cindy Perettie, the Executive Vice President of Kite.

謝謝接線員，大家下午好。今天收盤後，我們發布了2023年第二季財報。新聞稿、投影片和補充資料可在吉利德官網 (gilead.com) 的投資者關係欄位中查看。今天電話會議的發言人包括：董事長兼首席執行官丹尼爾·奧戴 (Daniel O'Day)、首席商務官喬安娜·默西埃 (Johanna Mercier)、首席醫療官默達德·帕西 (Merdad Parsey) 和首席財務官安德魯·迪金森 (Andrew Dickinson)。之後，我們將進入問答環節，屆時Kite執行副總裁辛迪佩雷蒂 (Cindy Perettie) 也將加入討論。

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 reconciliations are provided in the earnings press release, in our supplementary 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、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. As always, we appreciate you taking the time to catch up with Gilead in the midst of a busy earnings period. This was another very strong quarter for Gilead in terms of both business performance and clinical execution. Thank you to the Gilead teams that drove this progress with their dedication to improving the health of individuals and communities worldwide.

謝謝Jacquie，大家下午好。一如既往，感謝您在繁忙的財報季抽出時間與吉利德交流。吉利德本季在業務表現和臨床執行方面都取得了非常強勁的成績。感謝吉利德團隊為改善全球個人和社區健康所做的貢獻，正是他們的努力推動了這項進展。

Total product sales, excluding Veklury, grew 11% year-over-year and closed a very strong first half performance in the base business. As we look to the full year, we are increasing guidance for total product sales. We now expect even stronger growth in our base business of 6.5% to 8% and which is expected to more than offset our revised expectations for Veklury. As a result, our guidance for base business product sales has increased $550 million at the midpoint.

不計入Veklury，產品總銷售額年增11%，基礎業務上半年業績表現強勁。展望全年，我們上調了產品總銷售額預期。我們預期基礎業務將實現更強勁的成長，增幅達6.5%至8%，預計這將足以抵銷我們先前對Veklury銷售額預期的調整。因此，我們基礎業務產品銷售額預期中位數上調了5.5億美元。

In the second quarter, HIV contributed about 2/3 of the $615 million growth in our core business, growing 9% year-over-year. Oncology grew 38% year-over-year and with product sales of $728 million in the second quarter, now has an annual run rate of approximately $3 billion.

第二季度，HIV業務貢獻了我們核心業務6.15億美元成長的約三分之二，年增9%。腫瘤業務年增38%，第二季產品銷售額達7.28億美元，目前年化銷售額約30億美元。

Moving to clinical progress. The second quarter was very active on the regulatory front with approvals, positive opinions, or recommendations for 6 of our therapies, Trodelvy, Yescarta, Tecartus, Sunlenca, Hepcludex and Veklury. This regulatory progress highlights the strength of our increasingly diverse portfolio. It also reflects the ability of our teams to successfully navigate regulatory processes across the therapeutic areas and key geographies with speed and efficiency.

臨床進展方面，第二季我們在監管方面非常活躍，旗下六款療法——Trodelvy、Yescarta、Tecartus、Sunlenca、Hepcludex 和 Veklury——獲得了批准、積極意見或推薦。這些監管進展凸顯了我們日益多元化的產品組合的實力，也反映了我們團隊在各個治療領域和關鍵地區快速有效地完成監管流程的能力。

In addition to this progress, we shared positive pipeline updates at ASCO, which included overall survival data for Yescarta, the only large B-cell lymphoma cell therapy, to demonstrate significant overall survival benefit versus standard of care in the second-line setting. Promising Trodelvy data in endometrial cancer, reinforcing our belief in Trodelvy as a cornerstone asset with pan-tumor potential and updated TIGIT data from the full study population of ARC-7, establishing domvanalimab's proof-of-concept in lung cancer.

除了上述進展外，我們在ASCO會議上分享了積極的研發管線更新，其中包括Yescarta（目前唯一一種大B細胞淋巴瘤細胞療法）的總生存期數據，該數據表明，在二線治療中，Yescarta相比標準療法具有顯著的總生存獲益。此外，我們也發表了Trodelvy在子宮內膜癌治療中令人鼓舞的數據，這進一步增強了我們對Trodelvy作為具有泛腫瘤治療潛力的基石藥物的信心。同時，我們也更新了ARC-7研究全人群的TIGIT數據，證實了domvanalimab在肺癌治療中的概念驗證。

We have also shared long-term data for Hepcludex for hepatitis delta virus showing improved response rates at week 96 compared to week 48. These data support new guidelines recommending Hepcludex from people living with chronic HDV in the EU. With a broad portfolio of novel mechanisms and a commitment to pursuing areas of high unmet need, we know that some pipeline setbacks are to be expected. As we announced last month, we have discontinued the Phase III ENHANCE study in higher-risk MDS due to futility and a second interim analysis.

我們也分享了Hepcludex治療丁型肝炎病毒感染的長期數據，結果顯示第96週的回應率較第48週有所提高。這些數據支持歐盟新指引推薦Hepcludex用於治療慢性丁型肝炎病毒感染患者。我們擁有廣泛的新型作用機制產品組合，並致力於滿足尚未充分滿足的醫療需求，因此我們深知研發管線中出現一些挫折在所難免。正如我們上個月宣布的那樣，由於療效不佳以及第二次中期分析的結果，我們已終止了針對高風險骨髓增生異常綜合徵（MDS）患者的III期ENHANCE研究。

As you know, MDS is one of the most intractable forms of blood cancer, and we are disappointed that the study was not able to deliver new hope for patients with the disease. We will take a thorough data-driven approach regarding next steps as we carry out the ongoing analysis of magrolimab. Overall, we are executing well on our clinical commitments, and our current performance speaks to the strength of our combined oncology portfolio. We have a rich pipeline of activity in the second half, including an initial look at a subset of EVOKE-02 data on Trodelvy plus pembro in first-line metastatic non-small cell lung cancer.

如您所知，MDS是最難治癒的血液癌症之一，我們對這項研究未能給該疾病患者帶來新的希望感到失望。我們將採取以數據為導向的全面方法，繼續對magrolimab進行分析，以製定下一步計劃。整體而言，我們在履行臨床承諾方面進展順利，目前的表現也反映了我們腫瘤產品組合的實力。下半年，我們擁有豐富的研發管線，其中包括對EVOKE-02研究中Trodelvy合併帕博利珠單抗一線治療轉移性非小細胞肺癌的部分數據進行初步分析。

Before I hand over to Johanna, I'd like to welcome Cindy Perettie, our Head of Cell Therapy to our first Gilead earnings conference call. Cindy has now been with Gilead for 2 months and brings a wealth of oncology and leadership experience from Roche, Foundation Medicine and the Sarah Cannon Research Institute. We're delighted to have Cindy join our Gilead leadership team, and it's great to have her with us on the call today.

在將發言權交給喬安娜之前，我謹代表吉利德歡迎細胞療法負責人辛迪佩雷蒂女士參加我們首次吉利德財報電話會議。辛蒂加入吉利德已有兩個月，她擁有豐富的腫瘤學和領導經驗，曾任職於羅氏、Foundation Medicine 和莎拉·坎農研究所。我們非常高興辛蒂加入吉利德領導團隊，也很榮幸她今天能與我們一同參加這場電話會議。

With that, I'll hand the call over to Johanna for a discussion of our commercial results. Johanna?

那麼，我將把電話交給喬安娜，讓她和我們討論我們的商業表現。喬安娜？

Thanks, Dan, and good afternoon, everyone. The second quarter was another strong quarter for Gilead with solid performance across our commercial portfolio, leading to an increase in our full year expectations for both the base and overall business. For the second quarter of 2023, as shown on Slide 7, total product sales, excluding Veklury, grew 11% year-over-year to $6.3 billion with year-over-year growth in each of our core franchises. This represents the seventh consecutive quarter of year-over-year growth for our base business, reinforcing the strength of our virology and oncology portfolios. This strong growth more than offset the decline in Veklury sales which were as expected, given the lower hospitalizations. Altogether, total product sales, including Veklury, was $6.6 billion, up 7% year-over-year.

謝謝丹，大家下午好。吉利德第二季業績依然強勁，所有商業產品組合均表現穩健，因此我們提高了全年基礎業務和整體業務的預期。如投影片7所示，2023年第二季度，不包括Veklury在內的產品總銷售額年增11%至63億美元，所有核心業務均實現年成長。這是我們基礎業務連續第七個季度實現同比增長，進一步鞏固了我們在病毒學和腫瘤學領域的實力。這一強勁成長足以抵銷Veklury銷售額的下滑，而Veklury銷售額的下滑也在預期之中，因為住院人數減少。總而言之，包括Veklury在內，產品總銷售額為66億美元，較去年同期成長7%。

Starting with HIV on Slide 8. Second quarter sales of $4.6 billion were up 9% year-over-year, driven by higher average realized price in part due to channel mix and higher demand, partially offset by lower channel inventory. Quarter-over-quarter, sales were up 10%, driven by favorable pricing and inventory build following the typical first quarter dynamics. Overall, the global HIV treatment market continues to grow in line with our expectations of 2% to 3% annually. Specifically in the U.S. the market overall grew more than 2% in the first half of the year compared to the first half of 2022, reflecting growth in the non-retail channels more than offsetting a roughly flat retail market.

從投影片 8 的 HIV 部分開始。第二季銷售額達 46 億美元，年增 9%，主要得益於平均實際售價的提高（部分原因是通路組合優化和需求成長），但部分被通路庫存下降所抵銷。環比來看，銷售額成長 10%，主要得益於有利的定價策略以及延續第一季典型趨勢的庫存增加。整體而言，全球 HIV 治療市場持續維持成長，符合我們每年 2% 至 3% 的預期。具體到美國，今年上半年市場整體成長超過 2%，與 2022 年上半年相比，這反映出非零售通路的成長足以抵銷零售市場基本持平的影響。

HIV product sales grew 11% in the first half of 2023 compared to the first half of 2022, helped by favorable pricing dynamics, including the phasing of certain government purchases and channel mix. Looking forward, we expect HIV product sales growth to more closely mirror market growth in the second half. Therefore, we are increasing our full year expectations for HIV and now expect full year HIV product growth for 2023 to be modestly higher than the 5% we reported in 2022.

2023年上半年，HIV產品銷售額較2022年上半年成長11%，這主要得益於有利的價格策略，包括部分政府採購的分階段實施以及通路組合的最佳化。展望未來，我們預期下半年HIV產品銷售額的成長將更接近市場整體成長。因此，我們上調了2023年全年HIV產品銷售額預期，預計全年成長率將略高於2022年報告的5%。

Turning to Slide 9. Biktarvy sales of $3 billion were up 17% year-over-year, driven by higher demand and favorable pricing dynamics partially offset by lower channel inventory. With the market share up almost 3% year-over-year in the U.S., Biktarvy remains the treatment of choice for HIV with more than 46% market share. This represents the 20th consecutive quarter of share gains in the U.S. with a year-over-year growth rate that has once again outpaced new and existing regimens. Similarly, we continue to see solid share gains across other major markets as Biktarvy maintains its leading position for new starts as well as for those switching therapies.

請看投影片9。 Biktarvy的銷售額達到30億美元，年增17%，主要得益於更高的需求和有利的價格策略，但部分被通路庫存下降所抵銷。在美國，Biktarvy的市佔率年增近3%，仍是治療HIV的首選藥物，市佔率超過46%。這標誌著Biktarvy在美國市場連續第20個季度實現市場份額增長，其同比增長率再次超過了其他新療法和現有療法。同樣，在其他主要市場，Biktarvy的市場份額也持續穩定成長，在新患者和轉換療法的患者中均保持領先地位。

Descovy sales were $516 million, up 12% year-over-year. With awareness and utilization of HIV prevention higher than ever, the U.S. market grew once again. And amidst this growth, we're pleased to see strong demand for Descovy for PrEP, up 14% year-over-year in the U.S. with a strong market share that has remained over 40%. With this strong foundation, we look forward to potentially adding lenacapavir as a 6-monthly subcutaneous option for prevention as early as 2025.

Descovy 的銷售額為 5.16 億美元，較去年同期成長 12%。隨著人們對 HIV 預防的認知度和使用率達到前所未有的高度，美國市場再次實現成長。在這一成長趨勢中，我們很高興看到 Descovy 用於暴露前預防 (PrEP) 的需求強勁，在美國同比增長 14%，市場份額保持在 40% 以上。憑藉這一堅實的基礎，我們期待最早在 2025 年將 lenacapavir 作為一種每 6 個月一次的皮下注射預防方案納入產品線。

Moving to the liver disease portfolio on Slide 10. Sales were up 4% year-over-year and 5% quarter-over-quarter to $711 million. We remain committed to eliminating HCV globally with our market-leading portfolio of medicines, and our efforts to increase awareness contributed to higher patient starts in the U.S., Europe and Asia in the second quarter. HBV and HDV also contributed to growth in the liver disease portfolio driven by higher demand.

接下來是投影片10中關於肝病產品組合的內容。銷售額年增4%，季增5%，達7.11億美元。我們始終致力於透過我們市場領先的藥品組合在全球範圍內消除丙型肝炎病毒（HCV），並且我們為提高公眾認知所做的努力促成了第二季度美國、歐洲和亞洲患者新發用藥數量的增加。乙型肝炎病毒（HBV）和丁型肝炎病毒（HDV）的需求成長也推動了肝病產品組合的成長。

Liver disease remains an important part of our portfolio, benefiting hundreds of thousands of patients. We're pleased to have received full marketing authorization for Hepcludex in HDV in Europe. A further recognition of the benefit this medicine brings to patients who have very limited therapeutic options.

肝病仍然是我們產品組合的重要組成部分，惠及數十萬名患者。我們很高興Hepcludex在歐洲獲得用於治療丁型肝炎病毒感染的全面上市許可。這進一步肯定了該藥物為治療選擇非常有限的患者帶來的益處。

Across our portfolio of HCV, HBV and HDV products, the liver disease contribution to our commercial performance continues to stabilize overall to a run rate of more than $2.5 billion in sales a year.

在我們涵蓋 HCV、HBV 和 HDV 產品的產品組合中，肝病對我們商業績效的貢獻總體上持續穩定，年銷售額超過 25 億美元。

On to Slide 11. Veklury sales declined in the second quarter, as expected, reflecting lower hospitalization rates with sales of $256 million, down 43% year-over-year. For those patients hospitalized and treated for COVID-19, a majority continue to receive Veklury, a testament to Veklury's robust clinical profile. Most recently, this has included decisions by the U.S. FDA and the European Commission to expand Veklury's indication to reach patients with renal impairment, including those on dialysis.

接下來是第11張投影片。如預期，Veklury第二季銷售額有所下降，反映出住院率降低，銷售額為2.56億美元，較去年同期下降43%。對於因新冠肺炎住院治療的患者，大多數仍在接受Veklury治療，證明了Veklury強大的臨床療效。最近，美國FDA和歐盟委員會決定擴大Veklury的適應症，使其適用於腎功能不全患者，包括接受透析的患者。

Moving to oncology on Slide 12. It is remarkable to observe that in less than 5 years, our oncology business has grown from less than $300 million and is now approaching an annualized run rate of $3 billion. With tens of thousands of patients treated with Gilead and Kite oncology therapies to date. Beyond our well-established leadership in cell therapy, we have the only TROP2-directed ADC on the market with Trodelvy, and combined, our oncology portfolio extends the option for patients in 8 indications.

幻燈片12：腫瘤業務。值得注意的是，在不到5年的時間裡，我們的腫瘤業務規模從不到3億美元成長到如今接近30億美元的年化收入。迄今為止，已有數萬名患者接受了吉利德和凱特的腫瘤療法治療。除了我們在細胞療法領域穩固的領先地位外，我們還擁有市場上唯一的TROP2標靶抗體偶聯藥物（ADC）—Trodelvy。綜合來看，我們的腫瘤產品組合已為8種適應症的患者提供了更多選擇。

Looking in more detail at Trodelvy on Slide 13. Sales were up 63% year-over-year, and 17% sequentially to $260 million, representing an annual run rate that exceeds $1 billion. We continue to be very pleased with the launch in pretreated HR+/HER2- metastatic breast cancer, with strong awareness of our approval in the U.S. We look forward to reaching even more patients in Europe following last week's marketing authorization from the European Commission. Additionally, we're beginning discussions with health authorities in Japan with plans to file for approval in metastatic triple-negative breast cancer later this year.

在第13張投影片中，我們將更詳細地了解Trodelvy的情況。銷售額年增63%，季增17%至2.6億美元，年化銷售額超過10億美元。我們對Trodelvy在HR+/HER2-轉移性乳癌預處理藥物領域的成功上市感到非常滿意，並高度認可其在美國的認可。繼上週獲得歐盟委員會的上市許可後，我們期待在歐洲惠及更多病患。此外，我們正與日本衛生部門展開磋商，並計劃於今年稍後提交Trodelvy在轉移性三陰性乳癌領域的上市申請。

With a strong field force in place and robust data sets across multiple tumor types, Trodelvy remains well positioned to maintain and expand its reach. And Gilead continues to build on our experience in breast and bladder cancers with a view to other indications over time as the development program evolves.

憑藉強大的市場推廣團隊和涵蓋多種腫瘤類型的可靠數據，Trodelvy 仍處於有利地位，能夠維持並擴大其市場覆蓋範圍。吉利德將持續累積在乳癌和膀胱癌領域的經驗，並隨著研發計畫的推進，著眼於未來拓展至其他適應症。

Turning to cell therapy on Slide 14. Sales in the second quarter were $469 million, up 27% year-over-year and 5% quarter-over-quarter. Yescarta showed continued growth with sales up 29% year-over-year to $380 million, primarily driven by strong underlying demand in the second and third-line settings for relapsed or refractory large B-cell lymphoma, both in existing as well as new markets. Tecartus sales were $88 million, up 21% year-over-year, reflecting increased demand for relapsed or refractory adult acute lymphoblastic leukemia as well as mantle cell lymphoma, primarily outside of the U.S.

請參閱第14張投影片，了解細胞療法的情況。第二季銷售額為4.69億美元，年增27%，季增5%。 Yescarta持續成長，銷售額年增29%至3.8億美元，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強勁潛在需求，無論是在現有市場還是新市場。 Tecartus銷售額為8,800萬美元，年增21%，反映出復發或難治性成人急性淋巴性白血病以及套細胞淋巴瘤的需求增加，主要來自美國以外的市場。

We are excited about the opportunity ahead as the body of evidence supporting broader adoption of cell therapies continues to grow. The work that Kite has been leading to raise awareness in adoption of cell therapy will be accelerated by other providers as they ramp up their manufacturing capabilities. This overall expansion in supply will predictably impact our market share in the near term, but overall class share is the most important driver of our business over time. As cell therapy is offered and delivered to more patients, we are confident that Kite cell therapies will remain differentiated in terms of our manufacturing reliability and efficacy.

隨著越來越多的證據支持細胞療法的廣泛應用，我們對未來的機會感到振奮。 Kite 一直致力於提高人們對細胞療法的認知度，而隨著其他供應商提升生產能力，這項工作也將加速推進。預計短期內，供應量的整體成長將對我們的市佔率產生一定影響，但從長遠來看，整體市佔率才是我們業務發展的最重要驅動因素。隨著越來越多的患者接受細胞療法，我們相信 Kite 的細胞療法在生產可靠性和療效方面將保持差異化優勢。

Wrapping up the second quarter, I'd like to acknowledge the commercial teams and our partners across Gilead and Kite that once again delivered an extremely strong performance, reflecting both solid execution and the compelling portfolio of Gilead products that positively impacts millions of people around the world.

在第二季即將結束之際，我要感謝吉利德和凱特公司的商業團隊和合作夥伴，他們再次取得了非常優異的業績，這既體現了紮實的執行力，也反映了吉利德強大的產品組合，這些產品對世界各地數百萬人產生了積極的影響。

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. I'm pleased to highlight the ongoing progress our teams have made with 64 ongoing clinical programs and 21 Phase III trials. Notably, we presented multiple positive data readouts at medical conferences in the second quarter such as updated overall survival data for Trodelvy in pretreated HR+/HER2- metastatic breast cancer, OS data for Yescarta in second-line relapsed or refractory large B-cell lymphoma and long-term data from bulevirtide in HDV.

謝謝 Johanna。我很高興地向大家介紹我們團隊在 64 個正在進行的臨床項目和 21 項 III 期試驗方面取得的持續進展。值得一提的是，我們在第二季度的醫學會議上公佈了多項積極的數據，例如 Trodelvy 在既往接受過治療的 HR+/HER2- 轉移性乳癌患者中更新的總生存期數據、Yescarta 在二線復發或難治性大 B 細胞淋巴瘤患者中的總生存期數據，以及 bulevirtide 在 HDV 患者中的長期數據。

As we move into the second half of 2023, we remain focused on execution, investing in capabilities to increase our productivity and portfolio prioritization. We also look forward to sharing an update on Trodelvy in non-small cell lung cancer, including EVOKE-02 data at World Conference on Lung Cancer in September.

進入2023年下半年，我們將繼續專注於執行，增加對自身能力的投入，以提高生產力並優化產品組合優先順序。我們也期待在9月的世界肺癌大會上分享Trodelvy在非小細胞肺癌治療的最新進展，包括EVOKE-02研究數據。

Turning first to virology on Slide 16. We're proud of the role Gilead has played in transforming HIV care. We continue to innovate based on our commitment to both the HIV community and to those who could benefit from a prevention regimen with our ongoing work to deliver new, effective and convenient options. The unique profile of lenacapavir, our first-in-class capsid inhibitor enables the 8 prevention and treatment clinical programs we're focused on.

首先，我們來看第16張投影片中的病毒學部分。吉利德在改變愛滋病治療領域所扮演的角色令我們感到自豪。我們始終致力於為愛滋病患者群體以及那些可能受益於預防方案的人群提供新的、有效的、便捷的治療選擇，並以此為基礎不斷創新。我們首創的衣殼抑制劑lenacapavir具有獨特的特性，這使得我們目前重點關注的8個預防和治療臨床計畫得以順利進行。

In HIV treatment, the ARTISTRY-1 trial evaluating an oral once-daily bictegravir and lenacapavir combination regimen is progressing well. We expect to provide an update on the Phase II portion of the study later this year. This novel regimen aims to provide an effective and simpler regimen for the 6% to 8% of virologically suppressed individuals who are currently on complex multi-tablet regimens to manage their HIV.

在HIV治療領域，評估每日一次口服比克替拉韋和來那卡帕韋合併方案的ARTISTRY-1試驗進展順利。我們預計將於今年稍晚發布該研究II期部分的最新進展。這種新型方案旨在為目前服用複雜多片藥物方案以控制HIV感染的6%至8%病毒學抑制患者提供一種有效且更簡便的治療方案。

We continue to advance in our goal of providing longer-acting HIV treatment options through the development of lenacapavir combination regimens with integrase inhibitors, NRTIs and NNRTI as well as the Phase II study of our 2 broadly neutralizing antibodies. In HIV prevention, recruitment for our Phase III PURPOSE-I and II clinical trials evaluating every 6 months single-agent subcutaneous lenacapavir continues to exceed our expectations in the second quarter. We look forward to potentially providing a data update in the late 2024 to early 2025 time frame as we target approval in late 2025.

我們正持續推進提供長效HIV治療方案的目標，包括開發lenacapavir合併整合酶抑制劑、核苷類逆轉錄酶抑制劑（NRTI）和非核苷類逆轉錄酶抑制劑（NNRTI）的方案，以及進行我們兩種廣譜中和抗體的II期臨床研究。在HIV預防方面，我們評估每6個月皮下注射一次lenacapavir單藥的III期臨床試驗PURPOSE-I和II的受試者招募情況在第二季度持續超出預期。我們期待在2024年底至2025年初期間提供最新數據，目標是在2025年底獲得批准。

Moving on to Slide 17. I'm pleased to note that the European Association for the Study of the Liver, or EASL, has updated its HDV guidelines to recommend that all patients in the EU with chronic HDV infection should be considered for antiviral treatment. Recently, Hepcludex was granted full approval by the European Commission and remains the only approved therapy for chronic HDV infection in the EU. The updated guidelines were supported by Hepcludex's 48-week data, which were published in the New England Journal of Medicine in June.

接下來是第17張投影片。我很高興地註意到，歐洲肝臟研究協會（EASL）更新了其HDV指南，並建議歐盟所有慢性HDV感染患者都應考慮接受抗病毒治療。最近，Hepcludex獲得了歐盟委員會的全面批准，目前仍是歐盟唯一獲準用於治療慢性HDV感染的藥物。此指南更新得到了Hepcludex 48週數據的支持，這些數據已於6月發表在《新英格蘭醫學雜誌》上。

Gilead also presented data demonstrating that 96-week treatment with bulevirtide improved virologic and biochemical responses with no evidence of treatment-emergent resistance including in those who were previously non or partial-responders. These data reinforce our confidence in bulevirtide and its potentially longer-term benefit for patients with HDV. As a reminder, bulevirtide is not yet approved in the U.S.

吉利德公司也發表了數據，顯示使用布列維肽治療96週可改善病毒學和生化反應，且未發現治療期間出現的抗藥性，包括那些先前無回應或部分回應的患者。這些數據增強了我們對布列維肽及其對HDV患者潛在長期療效的信心。需要提醒的是，布列維肽尚未在美國核准。

Turning to oncology on Slide 18. Trodelvy remains the first and only approved TROP2-directed ADC with indications across 3 tumor types. It's also the only TROP2-directed ADC to show overall survival benefit versus chemotherapy in 2 tumor types. We have now treated over 20,000 patients and evaluated more than 2,300 patients in our clinical trials. Trodelvy's robust dataset informs a well-characterized safety profile with low discontinuation rates observed across multiple indications and no required increasing monitoring for severe interstitial lung disease.

在第18張投影片中，我們轉向腫瘤學領域。 Trodelvy仍然是第一個也是目前唯一核准的標靶TROP2的抗體偶聯藥物（ADC），其適應症涵蓋三種腫瘤類型。它也是唯一在兩種腫瘤類型中均顯示出優於化療的總生存期獲益的靶向TROP2的ADC。目前，我們在臨床試驗中治療了超過20,000名患者，並評估了超過2,300名患者。 Trodelvy強大的數據支持了其明確的安全性特徵，在多種適應症中觀察到較低的停藥率，且無需針對嚴重間質性肺病進行加強監測。

At ASCO, we presented additional data demonstrating Trodelvy's potential, including in pretreated HR+/HER2- metastatic breast cancer. We presented the final analysis from our Phase III TROPiCS-02 trial, supporting the marketing authorization we just received from the European Commission last week. In bladder cancer, we shared an analysis of TROPHY-U-01, supporting Trodelvy's efficacy in post-platinum, post-IO metastatic urothelial cancer across a range of TROP2 expression.

在ASCO會議上，我們展示了更多數據，進一步證明了Trodelvy的潛力，包括在先前接受過治療的HR+/HER2-轉移性乳癌中的應用。我們公佈了III期TROPiCS-02試驗的最終分析結果，該結果支持了我們上週剛從歐盟委員會獲得的上市許可。在膀胱癌方面，我們分享了TROPHY-U-01試驗的分析結果，該結果支持Trodelvy對鉑類化療後、免疫治療後轉移性尿路上皮癌在不同TROP2表達水平下的療效。

With our accelerated approval in bladder cancer, we hope to provide a data update from the ongoing confirmatory Phase III TROPiCS-04 trial and initiate global filings for Trodelvy in metastatic urothelial cancer by the end of next year. In heavily pretreated endometrial cancer, we presented promising efficacy data from our Phase II TROPiCS-03 basket trial, demonstrating the expanding pan-tumor potential of Trodelvy.

隨著我們在膀胱癌領域獲得加速批准，我們希望能夠提供正在進行的III期確證性試驗TROPiCS-04的最新數據，並在明年年底前啟動Trodelvy用於轉移性尿路上皮癌的全球申報。在先前接受過大量治療的子宮內膜癌患者中，我們公佈了II期TROPiCS-03籃式試驗中令人鼓舞的療效數據，證明了Trodelvy在多種腫瘤類型上的廣泛應用潛力。

Moving to Slide 19. Our comprehensive clinical development program in non-small cell lung cancer includes several signal seeking and ongoing Phase III clinical trials. We know non-small cell lung cancer is not only an area of significant unmet need as the number 1 cause of cancer-related deaths, but also an area we believe Trodelvy has the potential to transform standard of care as a combination partner to an IO backbone in the first-line setting as well as a single agent in the post-IO setting.

切換到第19張投影片。我們在非小細胞肺癌領域開展的綜合臨床開發項目包括多項訊號探索性試驗和正在進行的III期臨床試驗。我們深知，非小細胞肺癌不僅是癌症相關死亡的首要原因，也是亟待解決的重大醫療需求領域，我們相信，Trodelvy有望改變該領域的標準治療方案。它既可以作為第一線免疫療法的聯合用藥，也可以作為免疫療法後的單藥治療。

On Slide 20, we highlight the growing number of lung-related catalysts. I'm particularly excited to highlight that we've added a new milestone with a preliminary readout from our Phase II EVOKE-02 trial at the World Conference on Lung Cancer. This study is evaluating Trodelvy plus pembrolizumab with or without chemo in first-line non-small cell lung cancer. We will be sharing data from the first 2 cohorts evaluating Trodelvy in combination with pembro in PD-L1 high and PD-L1 low patients.

在第20張投影片中，我們重點介紹了與肺癌相關的催化劑數量不斷增長的情況。我特別興奮地宣布，我們在世界肺癌大會上公佈了II期EVOKE-02試驗的初步結果，這標誌著我們又邁出了新的一步。研究正在評估Trodelvy合併帕博利珠單抗（加或不加化療）第一線治療非小細胞肺癌的療效。我們將分享前兩個隊列的數據，這兩個隊列分別評估了Trodelvy合併帕博利珠單抗在PD-L1高表達和PD-L1低表達患者的療效。

The abstract expected to be released later in August will be an initial subset of a small number of patients. Our presentation scheduled for Sunday, September 10 at World Lung will include data at a later cutoff date with more patients.

預計八月下旬發布的摘要將僅包含少量患者的初步數據。我們定於9月10日（週日）在世界肺臟大會上發表的報告將包含更多患者的後續數據。

Turning to domvanalimab, or dom, on Slide 21, we presented data from the last interim analysis of the full 150 patients enrolled in the Phase II ARC-7 study at ASCO in June. The data continue to show consistent and clinically meaningful improvement in progression-free survival in first-line PD-L1 high non-small cell lung cancer when dom, our FC-silent anti-TIGIT is combined with an investigational anti-PD-1 agent as compared to the PD-1 inhibitor alone. These data form the basis for our dom program, encompassing Phase III trials in first-line non-small cell lung cancer and upper GI cancers.

在第21張投影片中，我們展示了domvanalimab（簡稱dom）的最新中期分析數據，涵蓋了6月在ASCO會議上入組的150名患者。數據顯示，與單獨使用PD-1抑制劑相比，dom（一種FC沉默的抗TIGIT藥物）與一種在研的抗PD-1藥物聯合使用，在PD-L1高表達的一線非小細胞肺癌患者中，持續且具有臨床意義的無進展生存期改善。這些數據構成了我們dom計畫的基礎，該計畫包括針對第一線非小細胞肺癌和上消化道腫瘤的III期臨床試驗。

Moving to cell therapy on Slide 22. Yescarta continues to strengthen its position as the cell therapy of choice for large B-cell lymphoma. At ASCO in June, we presented overall survival data from the landmark Phase III ZUMA-7 trial of Yescarta in second-line relapsed or refractory large B-cell lymphoma. At a median follow-up of 4 years, a onetime treatment with Yescarta demonstrated a statistically significant longer overall survival compared to standard of care with a 27% reduction in risk of death, representing a 38% relative improvement.

幻燈片 22 介紹了細胞療法。 Yescarta 作為大 B 細胞淋巴瘤首選細胞療法的地位持續鞏固。在 6 月的 ASCO 會議上，我們公佈了 Yescarta 治療二線復發或難治性大 B 細胞淋巴瘤的里程碑式 III 期 ZUMA-7 試驗的總生存期數據。中位追蹤 4 年後，單次 Yescarta 治療與標準治療相比，總存活期顯著延長，死亡風險降低 27%，相對改善達 38%。

Moreover, a majority of the patients in the standard of care arm eventually received a cell therapy off protocol. And of those, 77% received Yescarta. Overall, Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival for this patient population, and these data add to the growing body of evidence that position the cell therapy is potentially curative in some populations.

此外，標準治療組的大多數患者最終接受了方案外細胞療法。其中，77%的患者接受了Yescarta治療。總體而言，Yescarta是近30年來首個能夠顯著提高該患者群體生存率的療法，這些數據進一步證實了細胞療法在某些人群中具有潛在的治癒作用。

With a strong pipeline of 6 ongoing Phase II and III trials across lines of therapy, new tumor types and earlier-stage assets, Kite continues to innovate and execute on expanding the potential benefit of cell therapies to new patients, both through internal or acquired innovation and through collaborations. We're working closely with 1 of these partners, Arcellx, to support their efforts regarding the iMMagine-1 clinical hold.

Kite擁有強大的研發管線，目前有6項正在進行的II期和III期臨床試驗涵蓋多種治療方案、新的腫瘤類型以及早期階段的候選藥物。本公司持續創新，致力於透過內部研發、收購創新以及合作，將細胞療法的潛在益處惠及更多患者。我們正與合作夥伴之一Arcellx緊密合作，支持他們應對iMMagine-1臨床試驗暫停的相關工作。

We remain confident in the therapeutic profile for CART-ddBCMA and the iMMagine-1 trial based on the data demonstrated to date and share in Arcellx's commitment to delivering this novel therapy to multiple myeloma patients.

根據目前已證實的數據，我們對 CART-ddBCMA 的治療前景和 iMMagine-1 試驗充滿信心，並認同 Arcellx 致力於為多發性骨髓瘤患者提供這種新型療法的承諾。

Turning to Slide 23. We highlight our progress against key clinical milestones for 2023 so far. We are, of course, disappointed by the outcome of the interim analysis of the ENHANCE trial evaluating magrolimab in higher-risk MDS given the need for treatment options. We will continue to monitor and report on the other magrolimab trials. Importantly, while not every trial will be positive, our efforts at building a well-diversified portfolio gives us multiple opportunities to improve the lives of patients. We're excited about our momentum in making oncology and inflammation important contributors to our future and continue to make strong progress on delivering our key clinical catalysts for this year.

請翻到第23頁投影片。我們重點介紹迄今為止在2023年關鍵臨床里程碑方面取得的進展。當然，鑑於治療方案的迫切需求，我們對評估magrolimab治療高風險MDS的ENHANCE試驗中期分析結果感到失望。我們將繼續監測並報告其他magrolimab試驗的結果。重要的是，雖然並非所有試驗都會取得積極結果，但我們致力於建立多元化的產品組合，這為我們提供了多種改善患者生活的機會。我們對在腫瘤學和發炎領域的進展感到振奮，這些領域將成為我們未來發展的重要組成部分，並且我們將繼續在實現今年的關鍵臨床目標方面取得顯著進展。

Beyond our near-term milestones, I'd also like to highlight our growing pipeline of early-stage inflammation assets, including our oral alpha 4, beta 7 and the progression of our IRAK4 inhibitor, edecesertib into Phase II as well as the advancement of the BTLA agonist program from the MiroBio acquisition into Phase I. We're excited by this differentiated inflammation pipeline and the potential to impact important gaps in the treatment of inflammatory diseases.

除了近期取得的里程碑之外，我還想重點介紹我們不斷增長的早期發炎治療產品線，包括我們的口服α4β7受體激動劑、IRAK4抑制劑edecesertib進入II期臨床試驗，以及從MiroBio收購的BTLA激動劑計畫進入I期臨床試驗。我們對這一差異化的發炎治療產品線及其在填補發炎性疾病治療領域重要空白的潛力感到振奮。

Overall, we believe we have a very ambitious clinical portfolio that is well diversified across indication and stage. We look forward to updating you as we progress through 2023.

整體而言，我們相信我們擁有一個雄心勃勃的臨床產品組合，涵蓋多種適應症和研發階段。我們期待在2023年取得進展後及時向您報告最新情況。

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

好了，我把電話交給安迪。安迪？

Thank you, Merdad, and good afternoon, everyone. Turning to Slide 25. And as you heard from Dan and Johanna, our base business continued to perform very well in the second quarter, with total product sales, excluding Veklury, up 11% year-over-year driven by growth across all of our product families. FX was still a headwind, albeit more modest, impacting growth by approximately 1 percentage point. Total product sales were $6.6 million, up 7% year-over-year and strong execution in our base business more than offset the lower Veklury sales as well as FX impact of $82 million.

謝謝Merdad，大家午安。請看第25張投影片。正如Dan和Johanna剛才所說，我們的基礎業務在第二季度繼續表現強勁，除Veklury外，產品總銷售額同比增長11%，這主要得益於我們所有產品系列的增長。匯率波動仍是一個不利因素，但影響較小，對成長造成了約1個百分點的影響。產品總銷售額為660萬美元，年增7%，基礎業務的強勁表現足以抵銷Veklury銷售額的下降以及8,200萬美元的匯率影響。

Moving to the rest of the P&L. On a non-GAAP basis on Slide 26. Product gross margin was 86.9%, up 131 basis points from last year. R&D was $1.4 billion, up 25% year-over-year due to higher expenses associated with our broad clinical pipeline, including the acceleration of certain late-stage clinical studies. As a reminder, we have 21 ongoing Phase III trials, highlighting the investment we continue to make in Gilead's near- and long-term growth profile.

接下來來看損益表的其他部分。根據第26頁投影片中的非GAAP準則，產品毛利率為86.9%，較去年成長131個基點。研發支出為14億美元，年增25%，主要原因是與我們廣泛的臨床產品線相關的支出增加，包括加速推進某些後期臨床研究。需要提醒的是，我們目前有21項正在進行的III期臨床試驗，這凸顯了我們對吉利德近期和長期成長的持續投入。

As mentioned earlier this year, we will continue to manage expenses carefully. And in R&D, with a number of significant mid- to late-stage trials ongoing, we'll continue to follow the science, pivoting investment if and when the data warrants. Acquired IPR&D was $236 million, reflecting the XinThera acquisition and expansion of the Arcus collaboration into inflammation, in addition to milestone payments associated with ongoing partnerships.

正如今年稍早所述，我們將繼續謹慎控制支出。在研發方面，目前有多項重要的中後期臨床試驗正在進行中，我們將繼續遵循科學發展方向，並根據數據狀況調整投資方向。收購的智慧財產權和研發支出為2.36億美元，其中包括對XinThera的收購以及將與Arcus的合作拓展至發炎領域，此外還包括與現有合作關係相關的里程碑付款。

SG&A was $1.8 billion, up 45% year-over-year, including the $525 million legal accrual for settlements with certain plaintiffs in the HIV antitrust litigation, as well as increased commercial activities in oncology and HIV. Excluding the legal settlement accrual, non-GAAP SG&A expense was $1.3 billion, up 4% year-over-year.

銷售、管理及行政費用為18億美元，年增45%，其中包括因與愛滋病反壟斷訴訟中的部分原告達成和解而提列的5.25億美元法律費用，以及腫瘤和愛滋病領域商業活動的增長。剔除此法律和解費用提列後，非GAAP下的銷售、管理及行政費用為13億美元，較去年同期成長4%。

Moving to tax. Our effective tax rate in the second quarter was 21%. Our non-GAAP diluted earnings per share was $1.34 in the second quarter of 2023 including approximately $0.32 of expense associated with the legal settlement accrual, partially offset by higher product sales. This compared to $1.58 of earnings for the same period last year.

接下來談談稅務方面。我們第二季的實際稅率為21%。 2023年第二季度，我們的非GAAP攤薄後每股收益為1.34美元，其中包括約0.32美元的法律和解費用，部分被產品銷售額的成長所抵銷。相比之下，去年同期每股收益為1.58美元。

Overall, we had a very strong first half, and as highlighted on Slide 27, with solid performance in each of our core franchises across virology and oncology driving 13% year-over-year growth, excluding Veklury. Given these strong first half results, we have updated our full year sales guidance.

整體而言，我們上半年業績表現非常強勁，正如第27頁幻燈片所示，病毒學和腫瘤學兩大核心業務板塊均表現穩健，推動了同比增長13%（不包括Veklury）。鑑於上半年強勁的業績，我們已更新了全年銷售預期。

Moving to Slide 28. We now expect total product sales in the range of $26.3 billion to $26.7 billion, up from $26 billion to $26.5 billion previously. We expect total product sales, excluding Veklury, in the range of $24.6 billion to $25 billion, up from $24 billion to $24.5 billion, previously. This new range represents growth of 6.5% to 8% for our base business year-over-year compared to 4% to 6% previously.

翻到第28頁。我們現在預計產品總銷售額將在263億美元至267億美元之間，高於先前預測的260億美元至265億美元。我們預計，不計入Veklury的產品總銷售額將在246億美元至250億美元之間，高於先前預測的240億美元至245億美元。這項新的預測區間意味著我們基礎業務的年成長率為6.5%至8%，而先前的預測為4%至6%。

On Veklury, the second quarter and first half were below our internal expectations. Based on COVID-19 infections and hospitalizations to date, we have lowered our guidance for the full year to approximately $1.7 billion to bring second half expectations more in line with our first half experience. As a reminder, Veklury is highly correlated with COVID-related hospitalizations, and as such, its utilization remains variable. We will share another update with you on our third quarter call.

關於Veklury，第二季和上半年的業績均低於我們的內部預期。根據迄今為止的COVID-19感染和住院情況，我們將全年業績預期下調至約17億美元，以使下半年的預期與上半年的實際情況更加一致。需要提醒的是，Veklury的用量與COVID-19相關的住院人數高度相關，因此其使用仍存在波動。我們將在第三季財報電話會議上與您分享最新進展。

Moving to the rest of the P&L. We continue to expect non-GAAP gross margin to be approximately 86%. There is also no change to our non-GAAP R&D guidance where we expect expenses to increase by a low double-digit percent compared to 2022. Reflecting the onetime legal settlement accrual of $525 million in the second quarter, we now expect non-GAAP SG&A expense to increase a high single-digit percent compared to 2022. Excluding this legal settlement accrual, non-GAAP SG&A expense for 2023 is expected to be down a low single-digit percent compared to 2022, consistent with our prior guidance.

接下來來看損益表的其他部分。我們仍預期非GAAP毛利率約為86%。我們對非GAAP研發支出的預期也保持不變，預計研發支出將比2022年成長兩位數百分比。考慮到第二季提列的5.25億美元的一次性法律和解費用，我們現在預計非GAAP銷售、管理及行政費用將比2022年增長個位數百分比。剔除此法律和解費用後，我們預期2023年非GAAP銷售、管理及行政費用將比2022年下降個位數百分比，與我們先前的預期一致。

Non-GAAP acquired IPR&D has been updated to reflect the XinThera acquisition and expanded Arcus collaboration, adding about $200 million or $0.17 per share. For 2023, we now expect acquired IPR&D to be approximately $900 million, reflecting previously committed acquired IPR&D amounts as well as known milestone payments from existing collaborations. Similar to prior quarters, we will continue to include expected acquired IPR&D expenses if we announce additional transactions over the course of the year.

非GAAP收購智慧財產權及研發支出已更新，以反映對XinThera的收購以及與Arcus擴大合作的情況，新增約2億美元，即每股0.17美元。我們目前預計2023年收購智慧財產權及研發支出約為9億美元，其中包括先前承諾的收購智慧財產權及研發支出以及現有合作項目中已知的里程碑付款。與前幾季類似，如果我們在年內宣布其他交易，我們將繼續計入預計的收購智慧財產權及研發支出。

We now expect non-GAAP operating income in the range of $10.4 billion to $10.9 billion or roughly $650 million lower at the midpoint due to the $525 million onetime legal settlement accrual and $200 million in additional acquired IPR&D expense, neither of which were reflected in our previous full year guidance.

我們現在預計非GAAP營業收入在104億美元至109億美元之間，或按中間值計算減少約6.5億美元，原因是5.25億美元的一次性法律和解費用以及2億美元的額外收購IPR&D支出，這兩項費用均未反映在我們之前的全年指導中。

Moving to tax. We now expect our non-GAAP effective tax rate to be approximately 17% reflecting an expected decrease in our tax reserves for the second half of the year. Altogether, we now expect non-GAAP diluted EPS in the range of $6.45 and $6.80 per share, down from $6.60 and $7.00 previously, as shown on Slide 29. The chart illustrates the underlying strength of our business with the higher product sales guidance flowing through to the bottom line in addition to lower expected tax rate. This is, however, offset by both acquired IPR&D at $0.17 per share and the legal settlement accrual at $0.32 per share, a non-recurring cost. On a GAAP basis, we expect diluted EPS to be in the range of $4.50 and $4.85.

接下來談談稅務方面。我們現在預計非GAAP有效稅率約為17%，這反映了我們下半年稅務準備金的預期下降。綜上所述，我們現在預期非GAAP稀釋後每股盈餘在6.45美元至6.80美元之間，低於先前預測的6.60美元至7.00美元（見投影片29）。圖表顯示了我們業務的潛在強勁勢頭，更高的產品銷售預期以及更低的預期稅率都對最終利潤產生了積極影響。然而，每股0.17美元的收購智慧財產權及研發成本以及每股0.32美元的法律和解費用（均為非經常性成本）抵銷了部分利多。以GAAP準則計算，我們預期稀釋後每股盈餘在4.50美元至4.85美元之間。

Moving to Slide 30. You can see that there is no change to our capital allocation priorities. We returned $1.1 billion to shareholders in the second quarter through our dividend and repurchase of shares.

請看第30張投影片。可以看到，我們的資本配置優先事項沒有改變。第二季度，我們透過派發股利和股票回購向股東返還了11億美元。

We believe we have built a strong pipeline that will enable Gilead to deliver near- and long-term growth. And of course, we'll continue to remain opportunistic as we look to access high-quality assets through partnerships or make smaller acquisitions in the normal course of business. We remain committed to growing our dividend, and to using share repurchases primarily to offset equity dilution, although we will also be opportunistic from time to time.

我們相信，我們已建立起強大的產品線，這將助力吉利德實現近期和長期的成長。當然，我們將繼續保持敏銳的市場嗅覺，尋求透過合作獲取優質資產，或在正常業務過程中進行小型收購。我們始終致力於提高股息，並將股票回購主要用於抵消股權稀釋，但也會不時抓住機會進行其他收購。

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 Geoff Meacham with Bank of America.

（操作員說明）我們的第一個問題來自美國銀行的傑夫·米查姆。

Just maybe a quick one for Dan or for Andy. You guys have had an aspiration to have about 1/3 of total revenue from hematology and oncology. I wasn't sure how big of a role of magrolimab played in those assumptions? And if it was a small amount, where do you see opportunities in the pipeline that you think the Street perhaps is underappreciating?

或許可以問丹或安迪一個問題。你們的目標是血液腫瘤業務的收入佔總收入的三分之一左右。我不確定magrolimab在這些預期中佔多大比重？如果佔比很小，你們認為目前研發管線還有哪些機會被市場低估了？

Geoff, I'll start and then turn it over to Andy. But thank you very much for the question. I want to be clear that we continue to be on track to meet our goal of oncology representing 1/3 of our 2030 revenues, and that's on top of a growing HIV business overall.

傑夫，我先來，然後交給安迪。非常感謝你的提問。我想明確一點，我們仍然有望實現2030年腫瘤業務收入佔總收入三分之一的目標，而且這還是在愛滋病業務整體成長的基礎上實現的。

I'll just remind the team here that our portfolio is very broad. It's more than doubled since a few years ago in quantity and many folds on a quality risk-adjusted basis as well. We have novel mechanisms and technologies and approaches across many indications precisely to allow for the fact that not every clinical card is going to turn over favorably.

我只想提醒各位團隊成員，我們的產品組合非常廣泛。與幾年前相比，產品數量翻了一番還多，品質和風險調整後的價值也提升了數倍。我們針對多種適應症發展了創新機制、技術和方法，正是為了因應並非所有臨床試驗都能成功的情況。

And Andy, why don't -- I'll let you add on to that in terms of what we -- what our initial assumptions were around the 1/3.

安迪，為什麼不——我讓你補充我們——我們最初對三分之一的假設是什麼。

Geoff, I'm good to hear from you, and thank you for the question. You may recall that historically, when we've talked about this, we've highlighted that, that assumption is really tied to the cell therapy business and to Trodelvy and that we have a complete belief that we're going to get there based on those 2 franchises alone. Magrolimab and TIGIT and the rest of the oncology pipeline provide additional upside.

傑夫，很高興收到你的來信，謝謝你的提問。你可能還記得，我們​​之前討論這個問題時，曾強調過，這種假設實際上與細胞療法業務和Trodelvy密切相關，我們堅信僅憑這兩個產品線就能實現目標。 Magrolimab、TIGIT以及其他腫瘤產品線則提供了額外的成長潛力。

So -- just reiterating what Dan said, we continue to be on track to meet the goal of our oncology business, representing 1/3 of our total revenue by 2030 and we remain excited about the breadth of our oncology portfolio and the exceptional progress that you see in cell therapy and Trodelvy, which combined, as you heard in the prepared remarks, are on track to produce $3 billion of revenue roughly this year.

所以——我再次重申丹所說的，我們繼續朝著實現腫瘤業務目標穩步前進，到 2030 年，腫瘤業務收入將占我們總收入的三分之一。我們對腫瘤產品組合的廣度以及細胞療法和 Trodelvy 的卓越進展感到興奮，正如你們在準備好的發言稿中聽到的那樣，這兩項業務加起來今年有望創造大約 30 億美元的收入。

Our next question comes from Chris Schott with JPMorgan.

我們的下一個問題來自摩根大通的克里斯·肖特。

Just on Trodelvy and the EVOKE-02 data, can you just help set some expectations for the profile that we'll see from that at World Lung. I guess, specifically, would just be interested in your thoughts on what we should anticipate in terms of the ILD profile in the setting as well as your thoughts on a potential TROP2 expression biomarker-driven approach that I think your competitor has alluded to post their data.

關於Trodelvy和EVOKE-02的數據，您能否幫助我們預測在世界肺臟大會上將會看到的臨床特徵？具體來說，我想了解您對該背景下ILD特徵的看法，以及您對潛在的基於TROP2表達生物標誌物的研究方法的看法——我認為您的競爭對手在公佈數據時已經暗示過這種方法。

Thanks, Chris. Over to Merdad, please.

謝謝，克里斯。接下來請梅爾達德發言。

Yes. We're looking forward to sharing those data. And as you can imagine, we're under embargo, so I can't share too many details until the presentation comes up. And the abstract itself will come out, I think, in mid-August, so very shortly. And that initial abstract will represent a relatively small data set from EVOKE-02, and then there'll be more data at the time of the presentation in September. So in terms of what's coming.

是的，我們很期待分享這些數據。正如您所想，我們目前處於保密期，所以在正式發布之前，我無法透露太多細節。摘要本身應該會在八月中旬發布，也就是很快了。這份初步摘要將展示EVOKE-02專案中相對較小的資料集，到九月正式發佈時，我們將展示更多數據。以上就是即將發布的內容。

In terms of ILD, across our programs, including all the clinical trials, we have not seen ILD to date. We don't screen for ILD in our clinical trials nor in the clinical practice. So at this time, we have not seen anything from -- in an ILD standpoint.

就ILD而言，在我們所有的項目中，包括所有臨床試驗，迄今為止我們尚未發現ILD病例。我們在臨床試驗和臨床實踐中均不進行ILD篩檢。因此，目前我們尚未發現任何ILD病例。

And then in terms of TROP2 expression, as a matter of course, we are measuring TROP2 expression in all of our trials as we go forward and looking to see if we see correlations between TROP2 expression and efficacy. And to date, we've not seen a correlation. We've seen great efficacy across TROP2 expression levels in the tumors that we've studied to date. Now that may change with different tumor types. But to date, we have not seen a correlation with TROP2 expression levels. So we're optimistic for that to keep -- to continue I would not expect to see TROP2 data in this upcoming data set. It's -- this is an early data set and those data usually trail -- the TROP2 expression data usually trail the clinical trials.

至於TROP2表達，我們通常會在所有試驗中檢測TROP2表達，並觀察其與療效之間是否有相關性。到目前為止，我們尚未發現相關性。在我們目前研究的腫瘤中，無論TROP2表現量如何，我們都觀察到了顯著的療效。當然，不同腫瘤類型可能會有所不同。但就目前而言，我們尚未發現療效與TROP2表現量之間存在相關性。因此，我們對此持樂觀態度－預計在即將發布的資料集中不會出現TROP2相關數據。這是一個早期資料集，這類資料通常會落後於臨床試驗的結果。

Our next question comes from Tyler Van Buren with TD Cowen.

下一個問題來自 TD Cowen 公司的 Tyler Van Buren。

Another one on Trodelvy. It looks like we're seeing a bit of a quarter-over-quarter inflection. So would you say this is attributed primarily to the HR+/HER2- launch? And do you believe this is the beginning of a new sustainable trend?

關於Trodelvy的另一則消息。看起來我們看到了一個季度環比拐點。您認為這主要歸因於HR+/HER2-的上市嗎？您認為這是永續發展新趨勢的開端嗎？

Great, Tyler. Yes, over to Johanna, please.

太好了，泰勒。好的，請把麥克風交給喬安娜。

Yes, we're very pleased with the results and the early signs that we've seen from the recent launch of HR+/HER2- in the U.S. We've definitely seen, as you say, an inflection point. So we've seen a really strong uptake in this setting. We've also kind of building on foundation of triple-negative breast cancer, where we are the standard of care here as well. And we're excited about the fact that Europe, the EC just gave approval for HR+/HER2- in Europe. So building on the success of TNBC and we've seen strong uptake in Europe for TNBC. So there's also a piece of that for the Trodelvy business performance. And we're excited to see what we can do with HR+/HER2- in Europe as well. So we do think this is definitely on the right path from a growth standpoint and very exciting times for Trodelvy and breast cancer patients.

是的，我們對近期在美國推出的HR+/HER2-療法所取得的成果和早期跡象感到非常滿意。正如您所說，我們確實看到了一個轉折點。該療法在這一領域獲得了非常強勁的市場認可。同時，我們也在三陰性乳癌領域奠定了基礎，該療法在該領域也是標準療法。我們很高興地宣布，歐盟委員會剛剛批准了HR+/HER2-療法在歐洲的上市。這建立在三陰性乳癌（TNBC）療法成功的基礎上，我們在歐洲也看到了TNBC療法的強勁市場接受度。這也對Trodelvy的業務表現有所貢獻。我們期待HR+/HER2-療法在歐洲的發展前景。因此，我們認為從成長的角度來看，這無疑是正確的方向，對於Trodelvy和乳癌患者來說，這是一個令人振奮的時刻。

Our next question comes from Terence Flynn with Morgan Stanley.

下一個問題來自摩根士丹利的特倫斯·弗林。

This one is for Johanna. I read that there's -- CMS could propose to have Medicare cover PrEP. Just wondering if you have any insight on the likelihood here and timing? And then could you help us think about the size of that population?

這個問題是問Johanna的。我看到有報告說，CMS可能會提議讓Medicare承保PrEP。我想問您對這件事發生的可能性和時間有什麼看法？另外，您能否幫我們估算一下這部分人群的規模？

Yes. So thanks for the question. I think you're referring to the national coverage determination, the NCD, right, for prevention for PrEP?

是的。謝謝你的提問。我想你指的是國家覆蓋範圍決定（NCD），也就是針對暴露前預防（PrEP）的那項決定，對嗎？

Yes.

是的。

I'm assuming. And that's really just because right now, it currently only supports oral drugs and there's an opportunity for us to add injectable drugs, and I think that was a ViiV request to CMS. And so we're very supportive of course. We believe PrEP is actually quite central to ending HIV epidemic and fully support the CMS proposal.

我只是猜測。這主要是因為目前該計劃僅支持口服藥物，而我們有機會將注射藥物也納入其中，我認為這是ViiV向CMS提出的請求。所以我們當然非常支持。我們認為PrEP對於終結愛滋流行至關重要，並完全支持CMS的提案。

As from a timing standpoint, that's probably, hopefully, in the coming quarters that we should see something come out, but I don't have details on that. But I do think it can only help what we're trying to do in HIV prevention, let alone support as we think of launching the potential launch for lenacapavir in 2025.

從時間安排來看，我們可能（希望）會在接下來的幾季看到一些成果，但我目前還沒有具體細節。但我認為這肯定有助於我們進行愛滋病預防工作，更不用說它還能為我們考慮在2025年推出lenacapavir提供支持了。

Next question comes from Robyn Karnauskas with Truist.

下一個問題來自 Truist 的 Robyn Karnauskas。

This is Billal Jahangiri on for Robyn. Congrats on all the progress. I had a question about TIGIT. And since you began the ARC studies, have you learned anything by way of expression of TIGIT CD155 or any other potential prognostic biomarkers in the tumor microenvironment that would warrant further development of dom in the upper GI indications even if SKYSCRAPER-1 were to fail?

我是 Billal Jahangiri，代表 Robyn 演講。祝賀你們取得的所有進展。我有一個關於 TIGIT 的問題。自從你們開始 ARC 研究以來，你們是否透過 TIGIT CD155 的表達或其他任何潛在的腫瘤微環境預後生物標誌物，了解到即使 SKYSCRAPER-1 研究失敗，這些發現是否足以支持在上消化道適應症方面進一步開發 dom 療法？

Thanks for the question. As I understand it, I think the question is around predictors of response as it relates to the upper GI setting. What I would say is we, of course, are following biomarkers, as I mentioned with TROP2. We are looking for biomarkers of responsiveness to various markers that could predict TIGIT responsiveness. Our interest in the upper GI is, of course, based on TIGIT-expression levels in tumor samples and things like that outside of the clinical trials, more based on clinical data that we've seen and others have seen for the efficacy of TIGIT in upper GI tumors. And so we'll, of course, across the programs, be looking for any potential markers for predictive response.

感謝您的提問。據我理解，您的問題是關於上消化道治療反應的預測因子。正如我之前提到的TROP2，我們當然會專注於生物標記。我們正在尋找能夠預測TIGIT療效的各種生物標記。我們對上消化道的關注，當然是基於腫瘤樣本中TIGIT的表達水平以及其他臨床試驗之外的指標，更多地是基於我們和其他研究人員觀察到的TIGIT治療上消化道腫瘤的臨床數據。因此，我們當然會在所有項目中尋找任何潛在的預測反應的標記。

Our next question comes from Brian Abrahams with 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。

Congrats on the quarter. Maybe a question on magrolimab. Do you have any preliminary thoughts on why the trial in high-risk MDS was not successful, just given the encouraging early data? And I guess what indications are you most optimistic the drug could still be successful in going forward?

恭喜你本季取得佳績。關於magrolimab，我有個問題。鑑於早期數據令人鼓舞，你對高風險MDS患者的試驗為何失敗有何初步看法？另外，你認為該藥物未來在哪些方面最有可能成功？

Thanks, Brian. Well, I mean, I think you can imagine, we are looking thoroughly at the data. And the trigger for this was a futility analysis centered on overall survival. We will, of course, update as we generate data and look at all those, we'll make those -- that information publicly available. To your point, the -- we're fairly far along in our AML trials. And as you know, we have some studies going on in solid tumors. And we believe that there are a number of factors that could -- that determine success or failure in these various settings. And each of these settings represents a slightly different biological experiment.

謝謝，布萊恩。嗯，我想你應該可以想像到，我們正在仔細研究數據。這次研究的起因是以總存活期為中心的無效性分析。當然，我們會隨著數據的產生和分析不斷更新，並將所有資訊公開。正如你所說，我們的急性骨髓性白血病（AML）試驗已經取得了相當大的進展。你也知道，我們還有一些實體瘤的研究正在進行中。我們認為，有許多因素可能決定這些不同情況下治療的成敗。每一種情況都代表著一個略有不同的生物學實驗。

So we are going to continue to look broadly at what we've learned from the initial data. We're going to continue to talk with the regulators and the IRBs in the near term. And then we'll update you as we proceed down that path with where we're going to go. But we continue our efforts right now, hoping that magrolimab could have an effect in other diseases outside of MDS. MDS is a uniquely challenging indication, and we feel -- we were hoping we could bring a benefit to those patients and we're disappointed that we can't do that.

因此，我們將繼續全面審視從初步數據中獲得的經驗。近期，我們將繼續與監管機構和倫理審查委員會（IRB）進行溝通。之後，我們會根據進展及時更新資訊。目前，我們仍在努力，希望magrolimab能夠對MDS以外的其他疾病產生療效。 MDS是一種極具挑戰性的適應症，我們原本希望能為這些患者帶來益處，但很遺憾未能實現這一目標。

Our next question comes from Carter Gould with Barclays.

下一個問題來自巴克萊銀行的卡特·古爾德。

As you talked about sort of the hematology portfolio, one thing you guys didn't talk on much today is sort of the ddBCMA and it being on clinical hold. Your partner has talked about investigator conduct and bridging therapy being issues? Are you sort of in agreement with that characterization? And to what extent is sort of timely addressing of the clinical hold critical to your underlying thesis behind the product?

剛才你們談到了血液學產品組合，但今天你們沒有過多提及ddBCMA及其臨床試驗暫停的情況。您的合夥人提到研究者行為和橋接治療是問題所在？您是否同意這種說法？及時解決臨床試驗暫停問題對您產品背後的基本概念有多重要？

Thanks, Carter. This gives us a chance. Well, all a chance to hear from Cindy for the first time with Gilead so Cindy over to you, please.

謝謝你，卡特。這給了我們一個機會。嗯，確切地說，是所有人第一次有機會聽到辛迪在基列國的講話，所以辛迪，請你發言吧。

Thanks a lot, Carter for the question. I think first, it might be helpful if I can provide a little context associated with the clinical hold. On June 16, the FDA did notify Arcellx that it was placing the CART-ddBCMA IND on clinical hold. So that was following patient death. The patient was treated with the ddBCMA, our CART. And despite becoming ineligible for treatment under the trial protocol due to the fact that they developed a secondary malignancy before the time of infusion. So they would have not been allowed technically to be on protocol. After infusing that patient, they subsequently mismanaged, I would say, the manner in which the protocol specifies the treatment of adverse events.

非常感謝Carter的提問。首先，我想先簡單介紹一下臨床試驗暫停的背景。 6月16日，FDA通知Arcellx公司，暫停了CART-ddBCMA的IND臨床試驗申請。這是因為一名患者去世了。該患者接受了ddBCMA（即我們的CART療法）的治療。儘管由於在輸注前出現了繼發性惡性腫瘤，他已經不符合試驗方案的治療條件，從技術上講，他本來就不應該參與試驗。但在輸注該患者後，Arcellx公司在處理不良事件方面，可以說是違反了試驗計畫的規定。

And so we are continuing to partner with Arcellx on this. We are very confident in the molecule. We're confident in the iMMagine-1 study design, and we're looking at ways in which we can partner with Arcellx to enhance protocol adherence. All of the clinical sites to date have been retrained so that we can again ensure that protocol adherence.

因此，我們將繼續與Arcellx公司就此展開合作。我們對該分子充滿信心，對iMMagine-1研究設計也充滿信心，並且正在探索如何與Arcellx公司合作，以提高方案的依從性。迄今為止，所有臨床試驗中心都已接受再培訓，以便我們能夠再次確保方案的依從性。

And additionally, the FDA has allowed Arcellx to dose patients who had gone through lymphodepletion while on clinical hold. So again, we remain confident that the therapeutic profile of ddBCMA, CART and the iMMAGINE-1 trial, is going to be successful, I think, based on the data demonstrated to date. So our commitment in delivering that therapy to patients globally is still there for multiple myeloma.

此外，FDA已允許Arcellx公司在臨床試驗暫停期間對接受過淋巴清除治療的患者進行給藥。因此，基於目前已獲得的數據，我們仍然對ddBCMA、CAR-T細胞療法以及iMMAGINE-1試驗的治療前景充滿信心，我認為這些療法將會成功。我們致力於為全球多發性骨髓瘤患者提供這種療法的承諾仍然不變。

Our next question comes from Salveen Richter with Goldman Sachs.

下一個問題來自高盛的薩爾文·里希特。

We are expected to...

我們需要…

Salveen, we're not hearing you very well. Maybe just try one more time? Salveen -- maybe you can try and dial in a different line.

薩爾文，我們聽不太清楚你的聲音。能不能再試一次？薩爾文－或許你可以試試撥另一條線。

Jacquie, can you hear me? This is Matt on for Salveen.

傑奎琳，妳聽得到我說話嗎？我是馬特，替薩爾文報的。

Yes. We can hear you perfectly.

是的，我們聽得很清楚。

Okay. Great. So Daiichi expects to share full data from the Phase III TROPION-Lung 1 study later this year. Could you guys just share what you're focused on from a competitive standpoint and then in terms of read-through to Trodelvy.

好的，太好了。第一三共預計將於今年稍後公佈 TROPION-Lung 1 III 期研究的完整數據。能否請你們從競爭角度以及對 Trodelvy 的解讀角度，談談你們的重點？

Sure. This is Merdad. Thanks for the question. So as you know, our program is relatively broad and pushing forward in lung cancer as well. As I mentioned earlier, we'll be presenting our frontline data in EVOKE-02 -- preliminary frontline data from the EVOKE-02 study. And I think that will help provide everyone sort of benchmarking in terms of how Trodelvy is doing in that setting. And then what we'll be looking for, I think, is consistent with what our belief is for Trodelvy in the second line, which is, look, the patients in second line are sicker. They tend to have -- they're more difficult to manage, and they're more challenging in terms of outcomes. So we are hopeful that we will see a benefit in those patients in terms of outcomes, particularly PFS and OS. So we will keep our -- keep you updated on the progress of the EVOKE-01 study in the second line as well. And we're pretty confident that we'll be in where we want to be.

當然。我是Merdad。謝謝你的提問。如你所知，我們的計畫範圍比較廣，在肺癌領域也取得了進展。正如我之前提到的，我們將發表EVOKE-02研究的第一線數據——EVOKE-02研究的初步第一線數據。我認為這將有助於大家了解Trodelvy在該領域的療效。接下來，我們將關注與我們對Trodelvy二線治療的預期一致的結果，因為二線患者病情更重，治療難度更大，預後也更具挑戰性。因此，我們希望這些患者能夠從治療中獲益，尤其是在無惡化存活期（PFS）和總存活期（OS）方面。我們也會持續向你報告EVOKE-01二線治療研究的進展。我們非常有信心能夠達到預期目標。

Our underlying hypothesis remains that we will have comparable efficacy and that we will have a better tolerability profile with Trodelvy. So we're very confident with where we're headed.

我們的基本假設仍然是，Trodelvy 將具有相當的療效，並且耐受性更好。因此，我們對未來的發展方向非常有信心。

Our next question comes from Colin Bristow with UBS.

下一個問題來自瑞銀集團的柯林布里斯托。

Congrats on the quarter. So the TROPION-Breast01 trial is expected to read out in the near term. I'm just curious on to get your thoughts really on how you view this from a sort of competitive-threat standpoint.

恭喜你本季業績出色。 TROPION-Breast01試驗預計近期就會公佈結果。我很好奇你從競爭威脅的角度對此有何看法。

I think we may just have answered that question.

我想我們或許已經回答了這個問題。

In breast...

在乳房方面…

In breast -- I'm sorry.

乳房方面——我很抱歉。

So maybe I'll pick it up -- so thanks for the question, Colin. We are -- we have been expecting that data. We're also very pleased with what we've seen thus far with Trodelvy. And I think that's the piece that's important here. I think Trodelvy is positioning in the marketplace, both in metastatic triple-negative breast cancer in the second line as the standard of care in that setting, is very well established with an opportunity to continue to make sure people move up the lines of therapy because they're still usage in the third, fourth line setting when there's still an opportunity to displace chemotherapies.

所以也許我會注意一下——謝謝你的提問，科林。我們一直在期待這些數據。我們對目前為止Trodelvy的表現也非常滿意。我認為這才是關鍵。 Trodelvy在市場上的定位非常明確，它在二線轉移性三陰性乳癌治療中已確立了標準治療的地位，並且有機會繼續確保患者能夠接受更高階的治療，因為在三線和四線治療中，它仍然有機會取代化療。

I think as we've seen with other ADCs in the breast cancer market, I think it does -- it really help the awareness of the benefits of ADCs. And with Trodelvy's overall survival, both in triple-negative breast cancer as well as in HR+/HER2-, I do think it sets up Trodelvy incredibly well, and we've seen also ADC sequencing either in HER2 to Trodelvy or Trodelvy to -- in HER2. I think at a third ADC -- market, I think it might be a little bit more challenging in light of some of the positioning that's already there, but I do think for patients, this is a great thing.

我認為，正如我們在其他乳癌抗體偶聯藥物（ADC）市場所見，這確實有助於提高人們對ADC益處的認識。 Trodelvy在三陰性乳癌和HR+/HER2-乳癌中的總存活期均表現出色，我認為這為其奠定了非常有利的地位。我們也看到一些ADC序貫療法，例如從HER2陽性乳癌序貫Trodelvy，或從Trodelvy序貫HER2陰性乳癌。我認為，在第三代ADC市場，鑑於現有藥物的市場定位，可能會面臨一些挑戰，但我認為這對患者來說是一件好事。

I also think the safety profile that Merdad mentioned just a little bit earlier, is also something to consider. When you think about a safety profile with Trodelvy, where you're looking at neutropenia and diarrhea, which are very much in line with other chemotherapies already in the marketplace. So physicians are very confident in how to treat versus bringing in something like ILD is going to be a little bit more concerning. So more to come, and I guess we wait to see the data, but today -- in the field today, I think Trodelvy is definitely making a difference for these patients.

我認為默達德剛才提到的安全性也是一個值得考慮的因素。就Trodelvy的安全性而言，其主要不良反應是嗜中性白血球減少症和腹瀉，這與其他已上市的化療藥物非常相似。因此，醫生們對如何治療這些不良反應很有信心，而像間質性肺病（ILD）這樣的併發症則更令人擔憂。所以，我們還需要等待更多數據，但就目前而言，我認為Trodelvy確實正在為這些患者帶來改變。

Merdad, did you want to add anything?

Merdad，還有什麼要補充的嗎？

No, you hit it all.

不，你全都擊中了。

Thank you, Johanna.

謝謝你，喬安娜。

Our next question comes from Evan Seigerman with BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Evan Seigerman。

With, I believe it's the third anniversary of the Immunomedics deal nearing us. Can you walk us through how you look forward to BD. You digested this asset. Are you looking at oncology, inflammation elsewhere?

我相信，Immunomedics收購案三週年紀念日即將到來。您能否談談您對BD的未來展望？您已經消化了這項資產。您是否正在關注腫瘤、發炎等其他領域？

Andy, do you want to start with that?

安迪，你想從那件事開始嗎？

Look, I'd say we continue to be very active in BD as you'd expect, across both Gilead and Kite and that's across all of our areas of focus. So again, oncology, inflammation and virology. As we've said before, there are fewer virology opportunities externally. We have an incredibly robust pipeline and extraordinary research group. We're building out our research groups at Kite and at Gilead in oncology and inflammation. We're excited about the progress that we're making there.

正如您所預期的，我們在業務拓展方面仍然非常活躍，吉利德和Kite兩家公司都積極開展業務拓展，涵蓋我們所有重點領域。例如，腫瘤學、發炎和病毒學。正如我們之前所說，外部病毒學領域的機會相對較少。我們擁有極為強大的研發管線和卓越的研究團隊。我們正在Kite和吉利德兩家公司擴大腫瘤學和發炎領域的研究團隊。我們對目前的進展感到非常興奮。

We're still going to be active in the outside. That being said, what you should expect over the next 5 years is different than what you saw over the last 5 years. So using Immunomedics as an example. That's a deal that we continue to be very excited about. You've heard all the excitement about Trodelvy and where we are today with the franchise, where we see it going. But that was a unique point in time where we really needed an anchor molecule to build our oncology business around. We will continue to look at commercial assets, but you should expect consistent with what you saw last year, that our focus is predominantly on ordinary course partnerships and smaller acquisitions.

我們仍將積極拓展外部業務。不過，未來五年的發展趨勢與過去五年有所不同。以Immunomedics為例，我們對這筆交易依然充滿信心。您可能已經了解了Trodelvy的種種進展，以及我們目前在品牌上的成就和未來發展方向。但當時的情況比較特殊，我們需要一個核心分子來建構我們的腫瘤業務。我們將繼續專注於商業資產，但與去年一樣，我們的重點仍將放在常規的合作關係和小規模收購上。

Again, we will be opportunistic. We will look for ways to build our franchise and to create value for shareholders, but that's the base case expectation.

我們依然會抓住機會。我們會尋找各種途徑來發展我們的品牌，並為股東創造價值，但這只是基本預期。

Our next question comes from Joe Catanzaro with Piper Sandler.

下一個問題來自喬·卡坦扎羅和派珀·桑德勒。

I actually had a question on the XinThera acquisition. I'm just wondering if you could share your thoughts around the plans and timelines for their PARP1 selective inhibitor. And whether in the future, there's opportunity to potentially combine it with Trodelvy given some preclinical data that supports that approach.

我其實有個關於XinThera收購案的問題。我想請您談談他們PARP1選擇性抑制劑的研發計畫和時間表。鑑於一些臨床前數據支持這種聯合療法，未來是否有可能將其與Trodelvy聯合使用？

Yes. That's -- I think you hit the nail on the head. We're moving forward aggressively. I'm not sure we've disclosed the time lines yet, but we're moving forward aggressively with our efforts to move that program into the clinic. And as you say, I think a key potential for that PARP inhibitor is in combination with Trodelvy and combining those 2 agents to hopefully bring better outcomes to patients. So we'll update as we go along. I think things are progressing very nicely there.

是的，你說的很對。我們正在積極推進。雖然我不確定我們是否已經公佈了具體的時間表，但我們正在全力以赴地推進該計畫進入臨床試驗階段。正如你所說，我認為這種PARP抑制劑的一個關鍵潛力在於與Trodelvy聯合使用，這兩種藥物結合起來有望為患者帶來更好的療效。我們會隨時更新進展。我認為目前一切進展順利。

Our next question comes from Mohit Bansal with Wells Fargo.

下一個問題來自富國銀行的莫希特·班薩爾。

Welcome and congrats Cindy on your new role. Maybe if I can ask a question to Andy. Regarding -- so you have a lot of clinical trials going on in oncology, especially. How should we think about the operating margin evaluation from here, if I take out the onetime items as well as IPR&D, it seems like about 45% in the first half of the year. Is that a good number, a good proxy to go with? Or how should we think about it in the next few years?

歡迎辛迪履新，並祝賀你！我可以問安迪一個問題嗎？你們在腫瘤領域進行了許多臨床試驗，尤其是在腫瘤方面。如果剔除一次性專案和研發投入，上半年的營業利潤率似乎在45%左右，我們該如何評估？這個數字合理嗎？或者說，我們該如何看待未來幾年的營業利益率？

Thanks for the question. This is an important point. What we said and we continue to believe is we have an exceptionally strong business with a lot of leverage, a highly efficient structure, a lot of leverage in our model. We've historically had industry-leading operating margins, and we certainly expect to have that in the future.

感謝您的提問。這一點非常重要。我們過去說過，現在也依然堅信，我們擁有實力雄厚的業務，槓桿效應顯著，組織結構高效，我們的商業模式也極具優勢。我們歷來擁有業界領先的營業利潤率，而且我們預計未來也將繼續保持這一優勢。

We also have said and acknowledge that we're in a unique point in time as we've built out both our R&D portfolio and our sales and marketing team with the move into oncology, where our expenses have increased in the short run, and we expect over the coming years, so the expense increases to moderate, and we expect that you'll continue to see the strong growth that you've seen in our base business the last couple of years. So again, this is kind of our strategy playing out where you see the extraordinary progress in the base business growth last year, certainly through this year. You see that with the raised guidance for the base business. We expect to carry that momentum going forward. Of course, we don't provide long-term guidance.

我們也承認，我們正處於一個特殊的時期，因為我們拓展了研發組合，並組建了銷售和行銷團隊，進軍腫瘤領域，這導致我們的短期支出增加。我們預計未來幾年支出成長將趨於緩和，同時我們預計，您將繼續看到過去幾年我們基礎業務的強勁成長。因此，這正是我們策略的體現，您可以看到去年基礎業務的成長取得了非凡的進展，尤其是在今年。這一點也體現在我們提高了基礎業務的業績預期。我們預計未來將保持這一成長勢頭。當然，我們不提供長期業績預期。

And we -- as we've highlighted, have 21 late-stage Phase III clinical studies underway. We will get to a point over the coming quarters and years where our expense growth moderates, and you should see a lot of that carry to the bottom line. So -- and I think the way that you characterize the operating margin in the second quarter is entirely consistent with the way that I see it. And we don't provide long-term guidance beyond saying that we expect to have a top-tier operating margin going forward, and we think we're in a great place to achieve that goal.

正如我們先前強調的，我們目前有21項處於後期III期臨床試驗階段。未來幾季和幾年內，我們的支出成長將會放緩，而這部分節省也將轉化為利潤成長。因此，我認為您對第二季營業利潤率的描述與我的看法完全一致。我們不提供長期業績指引，只是表示我們預計未來將維持一流的營業利潤率，並且我們認為我們目前處於實現這一目標的有利位置。

Our last question today comes from Simon Baker with Redburn.

今天最後一個問題來自 Redburn 的 Simon Baker。

Given the recent developments within the CART space in non-oncology indications such as lupus. So I was just interested to know what your perspectives are on the strategic clinical and commercial opportunities for cell therapy outside oncology?

鑑於CAR-T細胞療法在非腫瘤適應症（例如狼瘡）方面的最新進展，我想了解您對腫瘤以外細胞療法的策略性臨床和商業機會有何看法？

Similar to you, we are very intrigued also by the data that we're seeing in spaces like autoimmune disease and lupus, and it's something of great interest to us. We have established ourselves in oncology, certainly and expanded into multiple myeloma with the Arcellx collaboration, and we are also looking at autoimmune disease going forward.

和您一樣，我們也對自體免疫疾病和狼瘡等領域的數據非常感興趣，這對我們來說意義重大。我們在腫瘤學領域已經站穩腳跟，並透過與Arcellx的合作拓展了多發性骨髓瘤領域，未來也將關注自體免疫疾病。

Terrific. So this is Dan. I just want to close this call by thanking you all for joining. And maybe just relay some of the enthusiasm of both the team here in the room and colleagues throughout Gilead and Kite, we're really seeing continued positive momentum, and this is just another quarter of that related to our strategy that we set out several years ago.

太棒了。我是丹。最後，我要感謝各位的參與。我想轉達一下在座各位以及吉利德和凱特公司全體同事的熱情：我們看到了持續的積極勢頭，而這只是我們幾年前製定的戰略取得的又一個季度成果。

I mean the first thing is the business is performing well and on a consistent basis. This is our seventh consecutive quarter of year-on-year growth for our business, excluding Veklury. Secondly, we're much further ahead than we expected to be with our pipeline delivery. Now -- we have now 64 ongoing clinical programs, 21 in Phase III and that -- you saw that in the newsflow for the second quarter.

首先，公司業務表現良好且持續成長。這已經是我們連續第七個季度實現同比增長（不包括Veklury）。其次，我們的研發管線交付進度遠超預期。目前，我們有64個在研臨床項目，其中21個處於III期臨床試驗階段—您在第二季的新聞稿中已經看到了這一點。

And then finally, we have a lot to look forward to in the second half of the year and beyond. We're particularly excited about the potential to transform beyond the diseases that we're helping patients with today in lung cancer and continuing to help the epidemic for HIV then to end the epidemic for HIV.

最後，我們對下半年及以後的發展充滿期待。我們尤其興奮的是，我們有望在目前幫助肺癌患者之外，進一步拓展治療領域，並持續協助對抗愛滋病疫情，最終終結愛滋病疫情。

So I just want to take this opportunity on behalf of all us to thank you for joining. As usual, if you have questions that we haven't been able to handle here today, please get in touch with Jacquie and the IR team, and we're more than happy to support you. Thank you, everybody, and thanks for joining today.

所以，我謹代表大家感謝各位的參與。像往常一樣，如果您有任何我們今天未能解答的問題，請聯絡Jacquie和投資者關係團隊，我們非常樂意為您提供協助。謝謝大家，謝謝你們今天的參與。

That will conclude today's conference call. Thank you all for your participation. You may now disconnect your lines.

今天的電話會議到此結束。感謝各位的參與。現在可以掛斷電話了。