吉利德科學 (GILD) 2022 Q3 法說會逐字稿

Ladies and gentlemen, thank you for your patience, and thank you for attending today's Third Quarter 2022 Gilead Sciences Earnings Conference Call. My name is Amber, and I will be your operator for today's call. (Operator Instructions) It is now my pleasure to hand the conference over to our host, Jacquie Ross, VP of Investor Relations. Jacquie, please proceed.

女士們、先生們，感謝各位的耐心等待，也感謝各位參加今天吉利德科學公司2022年第三季財報電話會議。我是Amber，將擔任本次電話會議的接線生。 （接線生操作說明）現在，我很高興將會議交給我們的主持人，投資者關係副總裁Jacquie Ross女士。 Jacquie，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 third quarter of 2022. 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 up the call to Q&A where the team will be joined by Christi Shaw, the Chief Executive Officer of KITE.

謝謝接線員，大家下午好。今天收盤後，我們發布了2022年第三季財報。新聞稿投影片和補充資料可在吉利德官網（gilead.com）的投資人關係欄位查看。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）以及首席財務官安德魯·迪金森（Andrew Dickinson）。之後，我們將進入問答環節，屆時KITE執行長克里斯蒂·肖（Christi Shaw）也將加入。

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 2022 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

在開始之前，請允許我提醒各位，我們將做出一些前瞻性聲明，包括與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 2022 年財務指引相關的聲明。所有這些都涉及某些我們無法控制的假設、風險和不確定性，這些因素可能導致實際結果與這些聲明有重大差異。

A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

這些風險的詳細描述請參閱獲利新聞稿和我們最新的美國證券交易委員會（SEC）揭露文件。所有前瞻性陳述均基於吉利德目前掌握的信息，吉利德不承擔更新任何此類前瞻性陳述的義務。

Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release and our supplemental data sheet, as well as on the Gilead website.

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

Now I'll turn the call over to Dan.

現在我把電話交給丹。

Thank you, Jacquie, and good afternoon, everybody. We're pleased to connect with all of you today to share the details of another very strong quarter. Thanks to strong commercial and clinical execution by our teams, the positive momentum continues to build.

謝謝Jacquie，大家下午好。我們很高興今天能與大家分享另一個業績強勁的季度詳情。由於我們團隊在商業和臨床方面的出色執行，這一積極勢頭仍在持續增強。

Total product sales, excluding Veklury were $6.1 billion, growing 6% sequentially and 11% year-over-year. The total, including Veklury, was $7 billion. If we exclude the impact of foreign currency fluctuations and the tail end of the loss of exclusivity for Truvada and Atripla and HIV, total product sales excluding Veklury grew 15% from the third quarter of last year. The majority of this growth was driven by HIV, and over 40% of the $620 million increase in sales came from oncology.

不計入Veklury，產品總銷售額為61億美元，季增6%，年增11%。計入Veklury，總銷售額為70億美元。若剔除匯率波動以及Truvada和Atripla（HIV治療藥物）專利到期後的影響，不計入Veklury，產品總銷售額較去年第三季成長15%。這一成長主要由HIV治療藥物推動，而6.2億美元的銷售額成長中，超過40%來自腫瘤治療領域。

The team will share more details, but this has been a great quarter for commercial execution, including continued share gains for Biktarvy, growing momentum for Trodelvy, another impressive quarter for cell therapy and a strong quarter for Veklury. We also saw continued clinical momentum this quarter. Some of the highlights include the FDA priority review granted to Trodelvy for late-line HR-positive/HER2-negative metastatic breast cancer, the EU approvals for Yescarta for second-line relapsed/refractory large B-cell lymphoma; and Tecartus in adult acute lymphoblastic lymphoma.

團隊將分享更多細節，但本季在商業執行方面取得了巨大成功，包括Biktarvy市場份額持續增長，Trodelvy發展勢頭強勁，細胞療法又迎來一個令人矚目的季度，以及Veklury表現強勁。本季我們也看到了臨床的持續進展。其中一些亮點包括：Trodelvy獲得FDA優先審查資格，用於治療晚期HR陽性/HER2陰性轉移性乳癌；Yescarta獲得歐盟批准，用於治療二線復發/難治性大B細胞淋巴瘤；以及Tecartus獲得批准，用於治療成人急性淋巴細胞淋巴瘤。

And in virology, lenacapavir received its first regulatory approval in Europe. Marketed as Sunlenca, it is approved for heavily treatment-experienced people living with multidrug-resistant HIV, making it the first approved casted inhibitor and the first therapy with a 6-month dosing schedule for HIV treatment.

在病毒學領域，lenacapavir 在歐洲獲得了首個監管批准。該藥以 Sunlenca 的商品名上市，獲準用於治療先前接受大量治療的多重抗藥性 HIV 感染者，使其成為首個獲準的 CAST 抑制劑，也是首個採用 6 個月給藥方案的 HIV 治療藥物。

We are taking multiple important steps to advance our ambitious clinical pipeline; including, in oncology, we are expanding our lung program with 8 trials now active and 3 more planned to start in the coming months. We plan to resume our Phase II trial investigating a once-weekly oral combination of Merck's Islatravir and our Lenacapavir. This will be one of many ongoing combination studies we have for long-acting HIV treatment in addition to our extensive program for prevention.

我們正在採取多項重要措施推進我們雄心勃勃的臨床研發管線；其中包括，在腫瘤領域，我們正在擴大肺癌項目，目前已有8項試驗正在進行，另有3項計劃在未來幾個月內啟動。我們計劃重啟一項II期臨床試驗，該試驗旨在研究默克公司的伊斯拉曲韋（Islatravir）和我們公司的萊那卡帕韋（Lenacapavir）每週一次的口服聯合用藥方案。除了我們廣泛的預防項目外，我們還在進行多項針對長效HIV治療的聯合用藥研究，這將是我們眾多正在進行的研究之一。

And we continue to further strengthen our early-stage portfolio, adding a BTLA agonist for inflammation from MiroBio and an option for a bispecific antibody for oncology for MacroGenics.

我們將繼續進一步加強我們的早期產品組合，新增來自 MiroBio 的用於治療發炎的 BTLA 激動劑，以及來自 MacroGenics 的用於腫瘤治療的雙特異性抗體的選擇權。

Moving to our clinical goals for 2022 on Slide 5. We're on track to start the 2 remaining Phase III trials, namely EVOKE-03 for first-line non-small cell lung cancer and ZUMA-23 for first-line high-risk LBCL. We continue to expect another interim readout for the Phase II R7 study in first-line non-small cell lung cancer before the end of the year.

接下來，我們將介紹投影片5中提到的2022年臨床目標。我們正按計畫啟動剩餘的兩項III期臨床試驗，分別是用於第一線治療非小細胞肺癌的EVOKE-03和用於第一線治療高風險大B細胞淋巴瘤的ZUMA-23。我們預計在年底前將公佈用於一線治療非小細胞肺癌的II期R7研究的另一項中期結果。

Overall, this has been another very strong quarter and a very strong year for Gilead. We're seeing impressive growth of our base business with continued share gains for Biktarvy and excellent performance for cell therapy, and growing demand for Trodelvy. On the clinical side, we've had the first approval for lenacapavir, a foundational asset for the future of our HIV franchise.

整體而言，吉利德本季和今年業績均表現強勁。我們的基礎業務成長顯著，Biktarvy市佔率持續提升，細胞療法表現優異，Trodelvy需求不斷成長。在臨床方面，lenacapavir獲得了首個上市許可，這是我們HIV產品線未來發展的基礎資產。

Trodelvy is now in a priority review for HR-positive/HER2-negative breast cancer in the U.S., and we're executing on an extensive development program across virology, oncology and inflammation. Finally, the recent TAF settlement is expected to significantly extend the exclusivity of key components of our HIV franchise in the U.S.

Trodelvy目前正處於美國HR陽性/HER2陰性乳癌的優先審查階段，我們正在病毒學、腫瘤學和發炎領域開展廣泛的研發計畫。此外，近期與TAF達成的和解協議預計將顯著延長我們HIV產品線關鍵成分在美國的獨家銷售期。

I'd like to take this opportunity to thank the Gilead and KITE teams for their outstanding clinical and commercial execution. This consistent execution of our strategy, along with a very robust portfolio, has led to some terrific progress in 2022, and we look forward to building on that momentum through the rest of the year and beyond.

我想藉此機會感謝吉利德和KITE團隊在臨床和商業化方面的卓越成就。正是由於我們策略的持續有效執行，以及我們強大的產品組合，才使得我們在2022年取得了令人矚目的進展。我們期待在今年餘下的時間以及未來繼續保持這一發展勢頭。

With that, I'll invite Johanna to share an update on our third quarter commercial performance.

接下來，我將邀請 Johanna 為我們介紹第三季的商業表現。

Thanks, Dan, and good afternoon, everyone.

謝謝你，丹，大家下午好。

Before I jump into the commercial results for the third quarter, I wanted to begin by acknowledging our team for another exceptional quarter. We're making important progress in our goals of ensuring the strength and sustainability of our virology franchise while also continuing to build our expertise and market presence in oncology.

在深入探討第三季的商業業績之前，我想先感謝我們的團隊，感謝他們又一個季度的出色表現。我們在確保病毒學業務的實力和永續發展方面取得了重要進展，同時也不斷提升我們在腫瘤學領域的專業水平和市場份額。

Turning to Slide 7. We had a very strong quarter with total product sales, excluding Veklury of $6.1 billion, up 11% year-over-year or 15% excluding FX and the residual impact of the HIV LOEs, with growth in each of our core franchise areas and notable strength in HIV and oncology. Sequentially, total product sales, excluding Veklury grew 6%, driven by HIV, HCV and oncology. Growth excluding FX impact and the LOEs was 8%.

請看幻燈片7。本季業績非常強勁，不計Veklury，產品總銷售額達61億美元，年增11%；若不計匯率及HIV產品延期付款的剩餘影響，則較去年同期成長15%。我們所有核心業務領域均實現成長，其中HIV和腫瘤領域表現尤為突出。環比來看，不計Veklury，產品總銷售額成長6%，主要得益於HIV、HCV和腫瘤領域的成長。若不計匯率及延期付款的影響，則增長率為8%。

On Slide 8, HIV sales of $4.5 billion were up 7% year-over-year. Excluding the impact of both FX and the LOEs, HIV revenue grew 10% year-over-year. Similar to last quarter, this was primarily channel mix-driven by U.S. government utilization leading to higher average realized price in addition to higher demand. Overall, despite the quarter-over-quarter shift in average realized price, government plans continue to represent approximately 60% of our U.S. HIV treatment prescriptions, including Medicare in the low 20s.

根據投影片8，HIV產品銷售額達45億美元，年增7%。剔除匯率和營運支出的影響，HIV產品收入年增10%。與上季類似，這主要是由於通路組合的變化，美國政府健保的使用率上升，導致平均實際價格上漲，同時也帶動了需求成長。總體而言，儘管平均實際價格較上季有所變化，但政府健保計畫仍占我們美國HIV治療處方量的約60%，其中聯邦醫療保險（Medicare）佔比約為20%。

HIV revenue growth was driven by the U.S. while Europe was down year-over-year due to FX and less favorable pricing dynamics, offset in part by higher demand. Quarter-over-quarter, HIV sales were up 6%, similarly driven by channel mix and inventory dynamics as well as higher demand.

HIV 收入成長主要由美國市場推動，而歐洲市場由於匯率波動和定價策略不利等因素導致同比下降，但部分被更高的需求所抵消。環比來看，HIV 銷售額成長了 6%，同樣得益於通路組合和庫存動態的變化以及更高的需求。

Turning to the market more broadly. We are encouraged that on a year-over-year basis, the HIV treatment market across the U.S. and Europe has grown for 5 consecutive quarters. This reflects the work we have been doing with our partners to bring people living with HIV and people at risk of HIV back into care following the pandemic. The market growth we are seeing suggests that activity has returned to pre-COVID trends.

從更廣泛的市場角度來看，我們欣喜地看到，美國和歐洲的愛滋病治療市場已連續五個季度實現同比增長。這反映了我們與合作夥伴共同努力，在疫情後幫助愛滋病毒感染者和高風險族群重返治療體系的成效。我們所看到的市場成長表明，市場活動已恢復到新冠疫情前的水平。

In the third quarter of 2022, the market grew 2% year-over-year, both in the U.S. and Europe. Looking forward, we continue to expect annual treatment market growth in the 2% to 3% range.

2022年第三季度，美國和歐洲市場均較去年同期成長2%。展望未來，我們預期治療市場年增率仍將維持在2%至3%之間。

Descovy sales were $500 million, up 16% year-over-year and 9% sequentially, and perhaps market share remains stable despite generic and other entrants. For the quarter, the PrEP market continues to demonstrate robust growth largely driven by the growing awareness for PrEP and demand well above pre-pandemic levels. Overall, the PrEP market grew 19% year-over-year and 6% sequentially.

Descovy的銷售額為5億美元，年增16%，季增9%，儘管面臨仿製藥和其他新進者的挑戰，其市佔率或許仍保持穩定。本季度，PrEP市場持續保持強勁成長，這主要得益於人們對PrEP認知度的不斷提高以及遠高於疫情前水準的需求。整體而言，PrEP市場年增19%，季增6%。

On to Slide 9. Third quarter Biktarvy sales were $2.8 billion, up 22% year-over-year, driven by higher demand in both the U.S. and Europe and favorable pricing dynamics. Sequentially, sales were up 8% due to higher demand as well as favorable inventory and pricing dynamics. Once again, Biktarvy continues to command a leading position in the treatment of HIV with another record quarter growing to 45% market share in the U.S., up 4 percentage points year-over-year. Moreover, Biktarvy remains the leading medicine for those seeking to switch to a new regimen in the U.S. as well as those starting treatment in both the U.S. and Europe, most notably, capturing 10 new starts for every 1 person prescribed another medicine in the U.S.

接下來是投影片9。第三季Biktarvy的銷售額為28億美元，年增22%，主要得益於美國和歐洲市場需求的成長以及有利的價格策略。環比來看，銷售額成長了8%，這同樣得益於需求的成長以及有利的庫存和價格策略。 Biktarvy再次鞏固了其在HIV治療領域的領先地位，其在美國的市場份額再次創下新高，達到45%，同比增長4個百分點。此外，Biktarvy仍然是美國尋求更換治療方案的患者以及美國和歐洲新開始接受治療的患者的首選藥物，尤其值得注意的是，在美國，每有10位患者開始使用Biktarvy，而其他藥物的處方量則為1:1。

Looking to the fourth quarter, I'd like to call out a few points. First, given the historic trend towards a significant inventory build in the fourth quarter followed by inventory drawdown in the first quarter, we are renewing our focus on inventory management in an effort to better align the timing of product delivery with end user demand.

展望第四季度，我想強調幾點。首先，鑑於以往第四季庫存大幅增加，而第一季庫存下降的趨勢，我們將重新聚焦庫存管理，力求更好地使產品交付時間與終端用戶需求相匹配。

Second, while we continue to see strong market share gains for Biktarvy in addition to solid growth in both the treatment and prevention market, we will remind you that some of our second and third quarter performance has been driven by shifts in channel mix that have had a favorable impact on average realized price. Given the favorable trends we observed over the last 2 quarters, we do expect the channel mix to be more stable in the fourth quarter.

其次，儘管我們看到Biktarvy的市佔率持續強勁成長，治療和預防市場也保持穩健成長，但我們仍需提醒您，第二季和第三季的部分業績成長得益於通路組合的變化，這些變化對平均售價產生了正面影響。鑑於過去兩個季度觀察到的良好趨勢，我們預計第四季度通路組合將更加穩定。

With these factors in mind and also allowing for further FX impact, we expect fourth quarter HIV sales to be roughly flat on a sequential basis, noting that full year 2022 HIV growth is therefore expected to be approximately 4% or 7% excluding the LOEs and FX headwinds year-to-date.

考慮到這些因素，並考慮到匯率的進一步影響，我們預計第四季度 HIV 銷售額將與上一季大致持平，並指出，因此，2022 年全年 HIV 銷售額預計將增長約 4% 或 7%，不包括年初至今的 LOE 和匯率不利因素。

In summary, we're extremely proud of the portfolio we have built in HIV and excited about the way Gilead is positioned for 2023 and beyond. Specifically, the Biktarvy's clinical profile continues to impress, evidenced by ongoing strong growth rates, even though its annual revenue run rate is now in excess of $10 billion. Descovy for PrEP maintained over 40% market share despite competition and generic entrants. And most recently, lenacapavir approval as Sunlenca for heavily treatment-experienced people living with multidrug-resistant HIV in the EU.

總而言之，我們對在愛滋病領域所建構的產品組合感到無比自豪，並對吉利德在2023年及以後的發展前景充滿信心。具體而言，Biktarvy的臨床表現持續令人矚目，其強勁的成長率是最好的證明，即便其年收入已超過100億美元。用於暴露前預防（PrEP）的Descovy，儘管面臨激烈的競爭和仿製藥的衝擊，仍保持了40%以上的市場份額。此外，最近，lenacapavir（商品名Sunlenca）在歐盟獲準用於治療先前接受過大量治療的多重抗藥性愛滋病患者。

This is an important option for a group that has very few treatment options and is a great opportunity for physicians and the HIV community to get more familiar with a 6 monthly subcutaneous HIV therapy. We believe this sets the stage well for our other planned lenacapavir-based treatment and prevention regimens.

對於治療選擇非常有限的族群而言，這是一個重要的選擇，也是醫生和愛滋病防治團體更了解每6個月一次的皮下注射愛滋病療法的絕佳機會。我們相信，這將為我們計劃開展的其他基於來那卡帕韋的治療和預防方案奠定良好的基礎。

All of this, combined with the treatment and prevention market showing solid recovery, the impact of the loss of exclusivity of Truvada and Atripla now behind us and the recent task settlement extending projected U.S. LOEs for Descovy and into the early 2030s and Genvoya's patent to 2029 in the U.S. All of this truly underpins our confidence that Gilead is well positioned for growth and continued leadership in the HIV market.

所有這些因素，再加上治療和預防市場呈現穩健復甦，Truvada 和 Atripla 專利到期帶來的影響已經過去，以及最近達成的和解協議將 Descovy 在美國的預計有效期延長至 2030 年代初，並將 Genvoya 在美國的專利期限延長至 2029 年，所有這些都真正增強了我們對吉利德在 HIV 市場實現增長和信心。

Now on to Slide 10. HCV sales for the third quarter were $524 million, up 22% year-over-year and 17% sequentially, primarily due to the favorable resolution of a prior year rebate claim in Europe and other favorable pricing dynamics in the U.S. Offsetting these benefits, there were fewer patient starts in both the U.S. and Europe, consistent with our expectations for both the quarter and the general trend that you should expect in HCV going forward.

現在就來看第 10 張投影片。第三季 HCV 銷售額為 5.24 億美元，年增 22%，季增 17%，主要得益於歐洲上一年回扣索賠的有利解決以及美國其他有利的定價動態。抵銷這些利好因素的是，美國和歐洲的患者起始數量均有所減少，這與我們對本季的預期以及您未來應該預期的 HCV 整體趨勢相符。

Despite the trend in patients start, we're pleased to maintain HCV market share of more than 50% in both the U.S. and Europe and third quarter share increased on a year-over-year basis. For HBV and HDV on Slide 11, sales were up 7% year-over-year and 13% quarter-over-quarter, primarily driven by favorable inventory dynamics.

儘管患者數量呈下降趨勢，但我們很高興地看到，丙型肝炎病毒（HCV）疫苗在美國和歐洲的市場份額均保持在50%以上，且第三季度市場份額同比增長。如第11頁投影片所示，乙型肝炎病毒（HBV）和丁型肝炎病毒（HDV）疫苗的銷售額年增7%，較上季成長13%，主要得益於有利的庫存動態。

Moving to Veklury on Slide 12. Third quarter revenues were $925 million. As expected, sales were down year-over-year, given lower U.S. hospitalizations as compared to the same period last year. Indeed, though hospitalizations are below the peak seen at the start of the year, it's clear with the sequential increase that the path of the pandemic remains difficult to predict. Nonetheless, we're proud of the role Veklury continues to play in the fight against COVID-19.

接下來是投影片 12 中的 Veklury。第三季營收為 9.25 億美元。正如預期，由於美國住院人數較去年同期下降，銷售額較去年同期下滑。的確，儘管住院人數已低於年初的峰值，但環比增長表明，疫情的走向仍然難以預測。儘管如此，我們仍為 Veklury 在對抗 COVID-19 疫情中持續發揮的作用感到自豪。

In the U.S., Veklury is used in approximately 60% of hospitalized patients who are being treated for COVID. Now outside the U.S., Veklury's benefit to patients continues to be recognized by health authorities, including the World Health Organization and the European Medicines Agency based in part on the Pine Trees data, which demonstrated a significant reduction in the risk of hospitalization after 3-day IV treatment in the outpatient setting. These factors continue to support the clear utilization where it's needed.

在美國，約有60%的新冠肺炎住院患者使用Veklury進行治療。目前，在美國以外地區，Veklury對患者的益處也持續得到包括世界衛生組織和歐洲藥品管理局在內的衛生機構的認可，部分依據是「松樹計畫」（Pine Trees）的數據，該計畫顯示，在門診進行為期3天的靜脈注射治療後，患者的住院風險顯著降低。這些因素繼續支持在需要的地方合理使用Veklury。

Moving to oncology and beginning with Trodelvy on Slide 13. Sales of $180 million grew 78% year-over-year and 13% quarter-over-quarter, and we continue to work with regulators, payers and clinicians around the world to broaden access. Since its approval in second-line metastatic TNBC late last year in Europe, Trodelvy is now reimbursed in 13 countries outside the U.S. with additional markets in Europe and elsewhere expected to come online shortly.

接下來我們來看看腫瘤領域，首先是第13頁提到的Trodelvy。其銷售額達1.8億美元，年增78%，季增13%。我們將繼續與全球監管機構、支付方和臨床醫生合作，擴大Trodelvy的覆蓋範圍。自從去年底在歐洲獲準用於二線轉移性三陰性乳癌治療以來，Trodelvy目前已在美國以外的13個國家獲得健保報銷，預計不久後歐洲及其他地區的更多市場也將陸續上線。

We've also begun work on establishing the right infrastructure to support a potential launch into pretreated HR-positive/HER2-negative metastatic breast cancer, reinforcing the significant unmet need in this population and the clinically meaningful overall survival data demonstrated in the Phase III TROPiCS-02 study. FDA has accepted our supplemental biologics license application as priority review, and we look to a decision in February of next year. We're excited by the potential for many more patients to benefit from Trodelvy.

我們已開始著手建立必要的基礎設施，以支持未來針對既往接受過治療的HR陽性/HER2陰性轉移性乳癌患者的潛在上市，這凸顯了該人群中巨大的未滿足醫療需求，以及在III期TROPiCS-02研究中展現出的具有臨床意義的總生存期數據。 FDA已受理我們的補充生物製品許可申請，​​並將其列為優先審查項目，我們期待明年2月獲得批准結果。我們對Trodelvy有望惠及更多患者感到無比興奮。

Now on to Slide 14 and on behalf of Christi and the KITE team, I'm pleased to share that cell therapy sales in the third quarter were $398 million, up 79% year-over-year and up 8% sequentially. These strong results were driven by continued growth in large B-cell lymphoma and KITE's ability to reliably meet customer demand. Together with our recently FDA-approved viral vector manufacturing facility in Oceanside, KITE remains well-positioned to ensure clinical and commercial supply availability, while it continues to execute on its geographic expansion.

現在請看第14張投影片。我謹代表Christi和KITE團隊，高興地宣布，第三季細胞療法銷售額達3.98億美元，年增79%，季增8%。這一強勁的業績得益於大B細胞淋巴瘤治療的持續成長以及KITE可靠滿足客戶需求的能力。憑藉我們位於Oceanside、近期獲得FDA批准的病毒載體生產設施，KITE在確保臨床和商業供應方面仍處於有利地位，同時公司也在繼續推進地域擴張。

For the quarter, Yescarta sales of $317 million were up 81% year-over-year and 8% quarter-over-quarter, driven by a continued successful launch in second-line LBCL in the U.S. and partially offset by FX headwinds in Europe. Just last week, Yescarta was approved in the EU for second-line LBCL, and we look forward to launching there in the months ahead. Tecartus grew 72% year-over-year to deliver $81 million in sales, driven by growth in adult acute lymphoblastic leukemia. In early September, the European marketing authorization for Tecartus in relapsed or refractory ALL was granted.

本季度，Yescarta 的銷售額為 3.17 億美元，年增 81%，環比增長 8%，主要得益於其在美國二線 LBCL 治療領域持續成功的上市，但部分被歐洲市場的匯率波動所抵消。就在上週，Yescarta 已獲准在歐盟用於二線 LBCL 治療，我們期待在未來幾個月內將其推向市場。 Tecartus 的銷售額年增 72%，達到 8,100 萬美元，主要得益於成人急性淋巴性白血病 (ALL) 治療領域的成長。 9 月初，Tecartus 獲准在歐洲用於復發或難治性 ALL 治療。

We continue to broaden awareness and access to our cell therapy through indication and authorized treatment center expansion in existing markets as well as through geographic expansion, as demonstrated by our most recent regulatory applications in Brazil, Singapore and Saudi Arabia. As always, Christi is available for Q&A later on the call.

我們持續擴大細胞療法的認知度和可及性，透過在現有市場拓展適應症和授權治療中心，以及透過地理擴張來實現，正如我們最近在巴西、新加坡和沙烏地阿拉伯提交的監管申請所體現的那樣。和往常一樣，Christi 將在稍後的電話會議中回答問題。

Overall, this was an incredibly strong quarter for Gilead Oncology with revenue of $578 million, up 10% from last quarter and 79% from last year. This represents an almost $2.4 billion annual run rate as we move into the last few months of 2022 and hint that the possibilities ahead as we continue to execute on our commercial and clinical oncology goals.

整體而言，吉利德腫瘤業務本季表現強勁，營收達5.78億美元，較上季成長10%，較去年同期成長79%。這意味著，在2022年最後幾個月，我們的年化營收將接近24億美元，這預示著隨著我們繼續推動商業和臨床腫瘤目標，未來發展潛力巨大。

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

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進展。

Thank you, Johanna. Before I start, I'd like to recognize the strong execution of our internal team and external partners across a broad range of activities that's diversified across therapeutic area and clinical stage with milestones spanning study initiations, the sBLA submission for Trodelvy, 2 EC approvals in cell therapy and our first approval for lenacapavir in the EU.

謝謝 Johanna。在開始之前，我想表揚一下我們內部團隊和外部合作夥伴在廣泛的活動中展現出的強大執行力，這些活動涵蓋了不同的治療領域和臨床階段，里程碑事件包括啟動研究、Trodelvy 的補充生物製品許可申請 (sBLA) 提交、細胞療法的兩項歐盟批准以及 lenacapavir 在歐盟的首次批准。

On Slide 16, you can see that we've made a lot of progress so far this year, meeting nearly all of our milestones. Regarding our BLA filing for Hepcludex, we received a complete response letter from the FDA, citing concerns about the manufacture and delivery of Hepcludex. We will take the time to fully digest the CRL, but note that no new safety or efficacy clinical trials were requested by the FDA. We plan to resubmit as quickly as possible, and we'll work with the agency on the path forward. We remain confident in Bulevirtide and the potential benefits it can bring to people living with HDV, and we'll share an update on the U.S. regulatory pathway when we can.

從第16張投影片可以看出，我們今年迄今取得了顯著進展，幾乎實現了所有里程碑目標。關於我們提交的Hepcludex生物製品許可申請（BLA），我們收到了FDA的完整回覆函（CRL），其中提到了對Hepcludex生產和交付的擔憂。我們將仔細研究CRL，但需要注意的是，FDA並未要求進行新的安全性和有效性臨床試驗。我們計劃盡快重新提交申請，並將與FDA合作，共同推進後續工作。我們對Bulevirtide及其可能為HDV感染者帶來的益處仍然充滿信心，並將在條件允許時分享美國監管審批流程的最新進展。

Moving on to HIV on Slide 17. We're thrilled that lenacapavir received its first marketing authorization from the European Commission as Sunlenca for people living with multidrug-resistant HIV in combination with other antiretrovirals. Sunlenca is a first-in-class capsid inhibitor. It's the first and only twice yearly subcutaneous HIV treatment and as a much-needed option for those people living with HIV with limited alternatives.

接下來是第17張投影片，內容是關於HIV的。我們非常高興地宣布，lenacapavir獲得了歐盟委員會的首個上市許可，商品名為Sunlenca，用於治療多重抗藥性HIV感染者，需與其他抗逆轉錄病毒藥物聯合使用。 Sunlenca是一種首創的衣殼抑制劑，也是目前唯一一種每年兩次皮下注射的HIV治療藥物，為那些治療選擇有限的HIV感染者提供了一種急需的治療方案。

We continue to expect a decision on our NDA from lenacapavir from FDA in late December of this year. In the meantime, this first regulatory approval from the EC is an important validation while we continue to progress our other lenacapavir-based treatment and prevention programs.

我們仍然期待FDA在今年12月底對我們lenacapavir的新藥申請做出決定。同時，歐盟委員會的首次批准是對我們其他基於lenacapavir的治療和預防計畫的重要認可。

For HIV treatment, a new clinical development plan, allowing a lower dose of islatravir, Merck's investigational NRTTI is moving forward after FDA review. As such, we're planning to resume the Phase II trial investigating oral once-weekly lenacapavir and islatravir combination.

針對HIV治療，默克公司正在推進一項新的臨床開發計劃，該計劃允許降低islatravir的劑量。在獲得FDA批准後，默克正在推動其正在開發的NRTTI藥物的研發。因此，我們計劃恢復II期臨床試驗，該試驗旨在研究每週一次口服lenacapavir和islatravir聯合用藥的療效。

Our internal combination programs are also ongoing and we expect to share data next year from the Phase Ib proof-of-concept study for lenacapavir in 2 broadly neutralizing antibodies or bNAb, directed at HIV. In prevention, our clinical development continues to progress with 4 in process or planned clinical trials evaluating every 6-month subcutaneous lenacapavir.

我們的內部合併用藥計畫也在進行中，預計明年將發表lenacapavir合併兩種針對HIV的廣譜中和抗體（bNAb）的Ib期概念驗證研究數據。在預防方面，我們的臨床開發也在持續推進，目前有4項正在進行或計畫中的臨床試驗，評估每6個月皮下注射一次lenacapavir的療效。

Moving to Slide 18. Veklury continues to be recognized as the standard of care for patients with severe COVID-19 with updated guidelines for Veklury from the World Health Organization. Additionally, the CHMP issued a positive opinion on the use of Veklury for the treatment of pediatric patients with COVID-19. Although novel treatments and vaccinations have improved the COVID-19 outlook, there is a continued need for effective and convenient oral treatment options for patients. I'm pleased to share that the FDA has just granted our novel oral nucleoside GS-5245 Fast Track designation which aims to expedite development of promising new medicines. We continue to be in active discussions with the FDA and other global regulators on potential clinical pathways, including a Phase III study that we expect to start within the next several months, either globally or outside the U.S.

切換到第18張投影片。世界衛生組織更新了Veklury的治療指南，Veklury仍然被公認為重症COVID-19患者的標準治療方案。此外，人用藥品委員會（CHMP）也對Veklury用於治療兒童COVID-19患者發表了正面意見。儘管新型療法和疫苗改善了COVID-19的預後，但患者仍需要有效且便利的口服治療方案。我很高興地宣布，美國食品藥物管理局（FDA）剛剛授予我們新型口服核苷類藥物GS-5245快速通道資格，旨在加速有前景的新藥的研發。我們正與FDA和其他全球監管機構就潛在的臨床路徑積極磋商，包括一項預計將在未來幾個月內啟動的III期臨床試驗，該試驗可能在全球範圍內或美國以外地區開展。

On Slide 19, we show the Phase III TROPiCS-02 results in patients with HR-positive/HER2-negative metastatic breast cancer. It was a late breaking presentation at ESMO in September. Trodelvy demonstrated a statistically significant and clinically meaningful 3.2-month overall survival benefit. Patients with metastatic HR-positive/HER2-negative breast cancer who progressed on endocrine-based therapies in chemotherapy have limited options. As a reminder, the patients enrolled in TROPiCS-02 were heavily pretreated with a meeting of 3 prior chemotherapy regimens in addition to prior CDK4/6 inhibitors.

第19張投影片展示了TROPiCS-02 III期臨床試驗在HR陽性/HER2陰性轉移性乳癌患者的結果。該結果於9月在ESMO會議上發布為最新報告。 Trodelvy試驗顯示，患者的總存活期延長了3.2個月，這項結果具有統計學意義和臨床意義。對於接受過內分泌治療後病情進展的HR陽性/HER2陰性轉移性乳癌患者，化療選擇有限。需要指出的是，TROPiCS-02試驗的入組患者均接受過大量預處理，包括至少3種化療方案以及既往的CDK4/6抑制劑治療。

Importantly, the FDA recently accepted our sBLA for Trodelvy in HR-positive/HER2-negative metastatic breast cancer and granted it a priority review. The PDUFA date is currently set for February 2023. We continue to work with regulatory agencies outside the U.S. to potentially make this medicine available to eligible patients. Additionally, following the acquisition of Trodelvy's Asian commercialization and development rights from Everest Medicines, we expect data from our Phase III metastatic TNBC China bridging trial in the next few months and our Phase III HR-positive/HER2-negative metastatic breast cancer study in mid-2023.

值得注意的是，FDA近期已受理我們針對HR陽性/HER2陰性轉移性乳癌的Trodelvy補充生物製品許可申請（sBLA），並授予其優先審查資格。目前，PDUFA日期暫定為2023年2月。我們正持續與美國以外的監管機構合作，以期盡快讓符合條件的患者能夠使用這款藥物。此外，在從Everest Medicines收購Trodelvy在亞洲的商業化和開發權益後，我們預計將在未來幾個月內獲得Trodelvy在中國開展的III期轉移性三陰性乳癌橋接試驗的數據，並於2023年中期獲得HR陽性/HER2陰性轉移性乳癌III期研究的數據。

Moving to lung cancer on Slide 20. You can see that we expect to have at least 9 active clinical trials in non-small cell lung cancer by the end of 2022, including 5 with Trodelvy, as well as programs with Zimberelimab and Domvanalimab and Etruma; Merck's KEYTRUDA; AstraZeneca's Durvalumab and our own magrolimab. 8 trials are already underway, including the Phase III EVOKE-01 study and second to third line non-small cell lung cancer and our Phase II EVOKE-02 study in first-line non-small cell lung cancer without actionable mutations.

接下來是第20張投影片，內容是關於肺癌的。您可以看到，到2022年底，我們預計至少有9項非小細胞肺癌的在研臨床試驗，其中包括5項與Trodelvy合作的試驗，以及與Zimberelimab、Domvanalimab和Etruma合作的項目；默克的KEYTRUDA；阿斯特捷利康的Durvalumab以及我們自主研發的magrolb。目前已有8項試驗正在進行中，包括針對二線或三線非小細胞肺癌的III期EVOKE-01研究，以及針對一線無標靶突變的非小細胞肺癌的II期EVOKE-02研究。

Our partner, Merck, also plans to initiate the Phase III EVOKE-03 study later this year to evaluate the combination of Trodelvy and KEYTRUDA in first-line patients with non-small cell lung cancer whose tumors express high levels of PD-L1. Additionally, with our partner, Arcus, we're looking forward to the fourth interim analysis of the Phase II ARC-7 trial, evaluating ZIM and DOM in PD-L1 high non-small cell lung cancer before the end of the year. Data from ARC-7 are expected to support our ongoing Phase III studies for DOM-based combinations in lung cancer, including STAR-121, which just achieved first patient in.

我們的合作夥伴默克公司計劃於今年稍後啟動III期EVOKE-03研究，以評估Trodelvy合併KEYTRUDA一線治療PD-L1高表達非小細胞肺癌患者的療效。此外，我們與合作夥伴Arcus公司正期待在年底前完成II期ARC-7試驗的第四次中期分析，該試驗旨在評估ZIM和DOM在PD-L1高表達非小細胞肺癌中的療效。 ARC-7試驗的數據有望支持我們正在進行的基於DOM的肺癌聯合療法III期研究，包括剛完成首例患者入組的STAR-121試驗。

Lung cancer is a disease area with high unmet need, and we believe we have multiple promising MOAs and potential combinations that could help bring additional new treatment options to patients. To explore these opportunities, we plan to initiate 2 Phase II signal-seeking platform studies, VELOCITY and the Arcus led Edge 1 in the coming months. Overall, we have initiated a comprehensive evaluation of the assets in our portfolio to address the significant unmet need in lung cancer and look forward to sharing updates in the coming years.

肺癌領域存在著巨大的未滿足醫療需求，我們相信我們擁有多種前景廣闊的作用機制和潛在聯合療法，能夠為患者帶來更多新的治療選擇。為了探索這些機遇，我們計劃在未來幾個月內啟動兩項II期訊號探索平台研究：VELOCITY研究和由Arcus主導的Edge 1研究。總體而言，我們已啟動對產品組合中所有候選藥物的全面評估，旨在滿足肺癌領域巨大的未滿足醫療需求，並期待在未來幾年分享最新進展。

Moving to Slide 21. And on behalf of Christi and the KITE team, we're highlighting our expanding clinical pipeline as we build on the growing momentum and adoption of cell therapy based on the significant survival benefit that Yescarta and Tecartus are delivering to patients. We believe there are still opportunities to bring Yescarta and Tecartus to more patients by moving into earlier lines as well as new indications. As you can see, we have recently enrolled patients in several studies, including ZUMA-24, a Phase II study to evaluate Yescarta in an outpatient setting for second-line LBCL and ZUMA-22, a Phase III study for Yescarta in second-line plus high-risk follicular lymphoma.

接下來是第21張投影片。我謹代表Christi和KITE團隊，重點介紹我們不斷擴展的臨床研發管線。 Yescarta和Tecartus為患者帶來了顯著的生存獲益，推動了細胞療法的蓬勃發展和廣泛應用。我們相信，透過將Yescarta和Tecartus應用於更早期的治療方案以及新的適應症，仍有更多機會讓更多患者受益。如您所見，我們近期已在多項研究中招募了患者，其中包括ZUMA-24（一項評估Yescarta在門診治療二線LBCL療效的II期研究）和ZUMA-22（一項評估Yescarta在二線及高危險濾泡性淋巴瘤治療中療效的III期研究）。

We also expect to begin screening for patients for the ZUMA-23 study of Yescarta in Q4. The decision to initiate a Phase III trial in first-line HR LBCL was based on the encouraging data from ZUMA-12 where Yescarta demonstrated 89% ORR and 78% CR.

我們也預計將於第四季開始對Yescarta的ZUMA-23研究進行患者篩選。啟動第一線HR LBCL III期試驗的決定是基於ZUMA-12研究的令人鼓舞的數據，該研究顯示Yescarta的客觀緩解率（ORR）為89%，完全緩解率（CR）為78%。

Additional studies include an evaluation of Tecartus in rare B-cell malignancies and KITE 363 is evaluating a CD19/20 bicistronic CAR-T in post-CD19 third line plus LBCL. We're committed to continuously improving the safety and efficacy of our cell therapies through both internal pipeline and external partnerships.

其他研究包括對 Tecartus 在罕見 B 細胞惡性腫瘤中的療效評估，以及 KITE 363 研究，該研究正在評估 CD19/20 雙順反子 CAR-T 療法在 CD19 治療後三線治療及 LBCL 中的療效。我們致力於透過內部研發管線和外部合作，不斷提升細胞療法的安全性和有效性。

On Slide 22, we turn to hematology and highlight the breadth of our programs across MDS and AML. For magrolimab, we fully enrolled our Phase III ENHANCE study in MDS ahead of schedule. Our discussions with the FDA and other regulators continue, and we expect to share an update in early 2023. Moreover, enrollment for the 2 AML trials, ENHANCE-2 and 3 is well underway, and we're targeting top line data in 2024.

在第22張投影片中，我們將重點放在血液學領域，並專注於我們在MDS和AML方面的計畫概況。關於magrolimab，我們已提前完成MDS III期ENHANCE研究的全部入組。我們與FDA和其他監管機構的討論仍在繼續，預計2023年初發布最新進展。此外，兩項AML試驗ENHANCE-2和ENHANCE-3的入組工作正在順利進行，我們計劃於2024年公佈初步數據。

A few weeks ago, we announced our oncology collaboration with MacroGenics to develop bispecific antibodies. This includes the exclusive option to license MGD024, a bispecific antibody that binds to CD123 and CD3, currently in Phase I, as well as 2 additional research programs. This complements magrolimab and furthers our work as we explore therapies that could translate into better clinical outcomes for patients with AML and MDS.

幾週前，我們宣布與MacroGenics公司在腫瘤領域合作，共同開發雙特異性抗體。該合作包括獨家授權MGD024（一種結合CD123和CD3的雙特異性抗體，目前處於I期臨床試驗階段）以及另外兩項研究項目。這項合作是對magrolimab的補充，並推進了我們探索能夠改善AML和MDS患者臨床療效的療法的工作。

Finally, we were pleased that FDA granted KITE-222 orphan drug designation at the end of September. It's the first CLL1 targeted CAR-T and is currently enrolling patients in a Phase I study.

最後，我們很高興地宣布，FDA於9月底授予KITE-222孤兒藥資格認定。它是首個標靶CLL1的CAR-T療法，目前正在進行I期臨床試驗並招募患者。

On Slide 23, I want to take a moment to welcome MiroBio to Gilead. We completed the acquisition a few weeks ago and pleased to add the MiroBio team to the Gilead Research family and bring their proprietary discovery platform an immune inhibitory receptor agonist to our portfolio. This acquisition complements our inflammatory disease cornerstones, including IBD, RA and systemic lupus and opens opportunities in other indications. We're excited to continue to explore and develop these antibody agonists, which we believe have the potential to induce immunosuppressive signaling and restore tolerance in autoimmunity.

在第23張投影片上，我想藉此機會歡迎MiroBio加入吉利德。我們幾週前完成了MiroBio的收購，很高興MiroBio團隊加入吉利德研發大家庭，並將他們專有的發現平台——一種免疫抑制受體激動劑——納入我們的產品組合。此次收購完善了我們在發炎性疾病領域的核心產品，包括發炎性腸道疾病（IBD）、類風濕性關節炎（RA）和系統性紅斑狼瘡，並為其他適應症領域開闢了新的機會。我們期待繼續探索和開發這些抗體激動劑，我們相信它們具有誘導免疫抑制信號傳導並恢復自身免疫耐受性的潛力。

Wrapping up, I'll note that we now have 60 clinical programs underway here at Gilead, spanning a broad range of indications across virology, oncology and inflammation. We've accomplished a lot in 2022 and yet feel we're really just getting started in exploring the possibilities offered by our portfolio.

最後，我想指出，吉利德目前有60個臨床計畫正在進行中，涵蓋病毒學、腫瘤學和發炎等多個領域。我們在2022年取得了豐碩的成果，但我們仍然覺得，在探索我們產品組合所蘊含的無限可能方面，我們才剛起步。

With that, Andy?

就這樣，安迪？

Thank you, Merdad, and good afternoon, everyone.

謝謝你，梅爾達德，大家下午好。

We are pleased to share another strong quarter of results, with sequential and year-over-year growth in every franchise across our core business. As shown on Slide 25, product sales, excluding Veklury, grew 11% year-over-year despite a $130 million headwind from FX. If we exclude this FX impact, in addition to the impact of previous HIV LOEs, total underlying sales growth year-over-year was 15%.

我們很高興地宣布又一個強勁的季度業績，核心業務所有產品線均實現了環比和同比增長。如第25頁投影片所示，儘管受到1.3億美元的匯率波動影響，但除Veklury外，產品銷售額仍年增11%。若剔除匯率影響以及先前HIV藥物研發投入的影響，則總銷售額年增15%。

Moving to Slide 26. You can see that Veklury was down as expected year-over-year, although it more than doubled on a sequential basis from the second quarter. I'll note that with the continued strengthening of the U.S. dollar, the total FX impact on revenue, net of hedges, was higher than expected at approximately $200 million compared to the third quarter of last year.

翻到第26張幻燈片。可以看到，Veklury的營收年減，符合預期，但季增超過一倍。需要指出的是，由於美元持續走強，扣除對沖後，外匯對營收的總影響高於預期，約2億美元，與去年第三季相比有所增加。

Non-GAAP product gross margin was 87%, down 320 basis points from last year, primarily due to the third quarter 2021 reversal of a previously recorded litigation reserve. Additionally, non-GAAP product gross margin was impacted by higher Biktarvy-related royalty expense and lower Veklury sales. Non-GAAP product gross margin improved sequentially due to higher HIV and Veklury product sales. Non-GAAP R&D, excluding acquired IPR&D expenses was $1.2 billion, up 10% year-over-year primarily due to investments in oncology. Sequentially, R&D excluding acquired IPR&D expenses was up 6%, driven by investments in oncology and COVID treatments. Acquired IPR&D, reflecting acquisitions milestones and upfront payments for the quarter was $448 million and includes $389 million of expense related to the MiroBio acquisition.

非GAAP產品毛利率為87%，較去年同期下降320個基點，主因是2021年第三季衝回了先前提列的訴訟準備金。此外，Biktarvy相關特許權使用費支出增加和Veklury銷售額下降也對非GAAP產品毛利率造成了影響。由於HIV和Veklury產品銷售額成長，非GAAP產品毛利率較上季有所改善。不計收購IPR&D費用的非GAAP研發支出為12億美元，較去年成長10%，主要得益於腫瘤領域的投資。不計收購IPR&D費用的研發支出較上季成長6%，主要得益於對腫瘤和COVID治療領域的投資。本季收購IPR&D支出（反映了收購里程碑付款和預付款）為4.48億美元，其中包括與收購MiroBio相關的3.89億美元費用。

Non-GAAP SG&A was $1.2 billion, up 3% year-over-year. Non-GAAP operating margin was 47%, down year-over-year and driven primarily by higher acquired IPR&D expenses and lower Veklury sales. Sequentially, non-GAAP operating margin increased 400 basis points due to higher HIV and Veklury sales, partially offset by higher acquired IPR&D expenses. Non-GAAP effective tax rate in the third quarter was 22.4%, higher than normal due to the nondeductibility of the upfront MiroBio payment. Overall, our non-GAAP diluted earnings per share was $1.90 in the third quarter of 2022 compared to $2.65 for the same period last year. Of note, the MiroBio transaction impacted post-tax EPS by $0.31 a share and this was not reflected in the full year guidance we shared back in August.

非GAAP銷售、管理及行政費用為12億美元，較去年同期成長3%。非GAAP營業利潤率為47%，年減，主要受收購IPR&D費用增加及Veklury銷售額下降的影響。環比來看，非GAAP營業利潤率成長400個基點，主要得益於HIV和Veklury銷售額的成長，但部分被收購IPR&D費用增加所抵銷。第三季非GAAP實際稅率為22.4%，高於正常水平，原因是預付的MiroBio款項不可抵扣。整體而言，2022年第三季非GAAP稀釋後每股收益為1.90美元，去年同期為2.65美元。值得注意的是，MiroBio交易使稅後每股盈餘減少了0.31美元，這並未反映在我們8月發布的全年業績指引中。

On Slide 27, we take a quick look at our performance year-to-date, which shows total product sales, excluding Veklury at $16.7 billion, up 7% year-over-year. If we exclude the approximately $385 million of FX headwinds year-to-date as compared to the same period last year, in addition to the impact of the HIV LOEs, the underlying growth year-to-date is 11%. Veklury, as expected, is down year-to-date highlighting the lower demand for COVID-19 treatment in this stage of the pandemic.

在第27頁投影片中，我們快速回顧年初至今的業績，數據顯示，不包括Veklury在內，產品總銷售額為167億美元，較去年同期成長7%。若我們剔除年初至今約3.85億美元的匯率不利影響（與去年同期相比），以及HIV研發投入的影響，則年初至今的實際成長率為11%。如預期，Veklury年初至今的銷售額有所下降，這凸顯了在疫情的現階段，COVID-19治療藥物的需求較低。

Moving to Slide 28. We are increasing our full year sales guidance to reflect our year-to-date results and our expectations for Q4, including our latest view of FX. For revenues, we now expect total product sales of $25.9 billion to $26.2 billion, up from our previous range of $24.5 billion to $25 billion. This reflects the strong performance year-to-date, notably very strong growth in HIV, Veklury in cell therapy and incorporates our expectations for the broader macro environment, including FX, which will once again be a headwind in the fourth quarter.

翻到第28頁。我們上調了全年銷售預期，以反映年初至今的業績以及我們對第四季度的預期，其中包括我們對匯率的最新看法。營收方面，我們現在預期產品總銷售額為259億美元至262億美元，高於先前預期的245億美元至250億美元。這反映了年初至今的強勁業績，特別是HIV和細胞療法藥物Veklury的強勁增長，同時也包含了我們對更廣泛的宏觀環境的預期，包括匯率波動，匯率波動將在第四季度再次構成不利因素。

In HIV, as Johanna discussed, we expect HIV revenue in Q4 to be roughly flat on a sequential basis. In cell therapy, we expect slower growth on a sequential basis, primarily due to stabilizing demand following the second-line LBCL launch and FX headwinds. Additionally, we are taking a cautious view with regards to both the current shortage of fludarabine, which we expect to be partially mitigated later in the fourth quarter, and the competitive landscape as our peers improve their manufacturing reliability.

正如Johanna所討論的，我們預計第四季度HIV業務收入將與上一季基本持平。細胞療法方面，我們預期環比成長將放緩，主要原因是二線LBCL療法上市後需求趨於穩定以及外匯市場不利因素。此外，我們對目前氟達拉濱的短缺情況持謹慎態度（我們預計第四季度後期供應將有所緩解），同時，隨著同業提高生產可靠性，競爭格局也將發生變化。

Moving to Veklury. And with year-to-date revenue of $2.9 billion, we are increasing our expectations to approximately $3.4 billion for the full year. Note that we expect Veklury sales to continue to track hospitalization rates, and our guidance assumes no significant increase in hospitalization rates from the third quarter levels. Excluding Veklury, we expect our total product sales to be $22.5 billion to $22.8 billion, representing growth of 5% to 6% year-over-year compared to our prior range of $22 billion to $22.5 billion.

接下來談談Veklury。截至目前，Veklury的營收為29億美元，因此我們將全年營收預期上調至約34億美元。需要注意的是，我們預計Veklury的銷售額將繼續與住院率保持同步，且我們的業績指引假設住院率不會較第三季水準顯著成長。剔除Veklury的營收，我們預期公司總銷售額將達到225億美元至228億美元，較先前預測的220億美元至225億美元年增5%至6%。

As for the rest of the non-GAAP P&L, product gross margin is now expected to be in the 86% to 87% range compared to our prior guidance of approximately 85% to 86%. There is no change to our R&D guidance, where we expect full year R&D expense to increase by a mid-single-digit percentage compared to the 2021 baseline of $4.5 billion.

至於其他非GAAP損益表項目，產品毛利率預計在86%至87%之間，高於我們先前約85%至86%的預期。研發預期維持不變，我們預期全年研發支出將比2021年的基準值45億美元成長中個位數百分比。

Moving to acquired IPR&D, we are not issuing guidance for the full year. And similar to what we did with MiroBio this quarter, we'll update our EPS guidance quarterly as needed to reflect any relevant activity during the quarter. What we've included here is the year-to-date acquired IPR&D amount, including approximately $0.04 per share associated with the MacroGenics collaboration that we announced last week. The guidance shared today does not include any upfront payments related to normal course of business partnerships or licensing deals that we might close in the fourth quarter.

關於已收購的知識產權及研發項目，我們不提供全年業績指引。與本季對MiroBio的處理方式類似，我們將根據季度內的相關活動，按需更新每股收益指引。此處包含的是年初至今已收購的智慧財產權及研發項目金額，其中包括上週宣布的與MacroGenics合作相關的約0.04美元/股。今天發布的業績指引不包括任何與我們可能在第四季度完成的正常業務合作或授權交易相關的預付款。

For SG&A, with our continued investment across our commercial organization and expectations for higher costs as a result of inflation, we continue to expect SG&A expenses to grow by a low single-digit percentage compared to 2021. Altogether, we expect operating income to be $11.8 billion to $12.2 billion for the full year, up from $11 billion to $11.6 billion previously.

就銷售、管理及行政費用而言，鑑於我們持續增加對商業機構的投資，以及通膨預期導致成本上升，我們仍然預期銷售、管理及行政費用將比 2021 年增長個位數百分比。總而言之，我們預計全年營業收入將達到 118 億美元至 122 億美元，高於先前預測的 110 億美元至 116 億美元。

And finally, we now expect our non-GAAP diluted earnings per share to range between $6.95 to $7.15 per share, up from $6.35 to $6.75 previously. This EPS guidance range is approaching our 2021 non-GAAP EPS results despite an expected $2.2 billion decline in Veklury revenue and a more than $0.5 billion in total FX headwinds anticipated through the end of the year as compared to 2021 rates.

最後，我們現在預計非GAAP稀釋後每股盈餘將在6.95美元至7.15美元之間，高於先前預期的6.35美元至6.75美元。儘管Veklury的營收預計將下降22億美元，且預計到年底將面臨超過5億美元的匯兌損失（與2021年匯率相比），但這一每股收益預期範圍仍接近我們2021年的非GAAP每股收益預期。

This highlights the strength of our core business, which is now expected to grow in the 5% to 6% range in 2022. On a GAAP basis, we expect our diluted earnings per share to range between $3.35 and $3.55 per share compared to $2.90 and $3.30 per share previously.

這凸顯了我們核心業務的強勁實力，預計2022年該業務將成長5%至6%。以美國通用會計準則計算，我們預計稀釋後每股收益將在3.35美元至3.55美元之間，而先前的預期為每股2.90美元至3.30美元。

Finally, on Slide 29, you can see that there is no change to our capital allocation priorities. In the quarter, we returned over $1.1 billion to shareholders, including $928 million in dividend payments and $180 million in share repurchases. As we announced previously, we repaid $1 billion of debt early in the third quarter and have returned to the same debt level we were at prior to the Immunomedics acquisition.

最後，在第29張投影片中，您可以看到我們的資本配置優先事項沒有改變。本季度，我們向股東返還了超過11億美元，其中包括9.28億美元的股息支付和1.8億美元的股票回購。正如我們之前宣布的，我們在第三季初償還了10億美元的債務，目前債務水平已恢復到收購Immunomedics之前的水平。

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 Chris Schott with JPM.

（操作說明）我們的第一個問題來自摩根大通的克里斯·肖特。

My question was on lenacapavir and in treatment. I want to talk a little bit about -- maybe first, islatravir and the lift of the clinical hold. How interesting is that as a partnered asset relative to your internal programs? And then the second part of that, just a bigger picture one in treatment. Do you see the portfolio with lenacapavir resulting in, I guess, a number of different combos that serve different segments of the market? Or is it more likely you're going to end up with one of these combos that really separates from the other and becomes an anchor type asset like we see with Biktarvy?

我的問題是關於lenacapavir及其在治療中的應用。我想先談談islatravir以及臨床試驗暫停的解除。作為一項合作資產，它相對於貴公司內部專案而言有多大優勢？其次，我想從更宏觀的角度來看lenacapavir在治療領域的應用。您認為lenacapavir的研發組合最終會衍生出多種不同的組合，分別服務於不同的市場區隔嗎？或者更有可能的是，最終會有一種組合脫穎而出，成為像Biktarvy那樣的錨定資產？

Chris, this is Merdad. Let me first start by saying that we are really excited about the recent approval for lenacapavir in this -- in the highly treatment-experienced population. Obviously, as a group of people who have limited options, and I think lenacapavir as a new class provides a new opportunity for them. In terms of islatravir, what we like about islatravir is that it is fairly late in its development. We are able to be in Phase II with that.

克里斯，我是默達德。首先，我想說我們對最近lenacapavir獲批用於治療經多種治療的患者群體感到非常興奮。顯然，對於這部分患者來說，治療選擇非常有限，而lenacapavir作為一種新型藥物，為他們提供了新的希望。至於islatravir，我們看好islatravir的一點是，它的研發階段相對較晚，目前已經進入了II期臨床試驗。

And I think it provides us a relatively near-term opportunity to launch a partner in treatment for lenacapavir that could be given in a long-acting way. And I think that's really important in terms of where the market is going and what our goal is in terms of, as we've said before, providing a long-acting parenteral option that is longer than in the 3 months or longer time frame. And we're optimistic about our ability to do that.

我認為這為我們提供了一個相對近期的機會，可以推出一個長效的來那卡帕韋治療方案。我認為這對於市場發展方向以及我們的目標都至關重要，正如我們之前所說，我們希望提供一種比3個月或更長療程的長效腸外給藥方案。我們對實現這一目標的能力充滿信心。

So for that, we have our internal pipeline assets that are really providing our options there. For islatravir, that's part of our oral program. And for us, we do think that we have a number of opportunities in terms of oral programs to provide weekly oral treatment options for people using lenacapavir.

因此，我們擁有內部研發管線資源，這些資源確實為我們提供了多種選擇。例如，伊斯拉曲韋（islatravir）是我們口服藥物計畫的一部分。我們認為，在口服藥物計畫方面，我們有許多機會為使用來那卡帕韋（lenacapavir）的患者提供每週一次的口服治療方案。

And right now is a potential. Certainly islatravir is an option there, and we have other options in our pipeline that could potentially get that -- get to that level. So the way I look at it, just to answer directly your last question, we do think that there will be a lenacapavir partner, and there will be probably 1 partner that will achieve our therapeutic goals in oral, potentially a different partner in parenteral.

目前來看，這確實是一種可能性。當然，伊斯拉曲韋（islatravir）是一個選擇，我們研發管線中還有其他藥物有可能達到那個水平。所以，就我而言，直接回答你最後一個問題，我們認為會有一個萊那卡帕韋（lenacapavir）的合作夥伴，而且很可能只有一個合作夥伴能夠實現我們在口服給藥方面的治療目標，而注射給藥方面則可能由另一個合作夥伴來實現。

And as we go forward, if we can make improvements whether that's lenacapavir and being able to provide even longer than 6-month therapy or to the partner that we could extend the duration of therapy with a different molecule or a different formulation we'll always try to get to that longer exposure. So over time, I expect us to continue to try to innovate and move forward.

展望未來，如果我們能夠取得改進，無論是萊那卡帕韋的療效能否延長至6個月以上，還是能否透過其他分子或製劑延長療程，我們都會努力實現更長的治療時間。因此，我預計我們會繼續創新並不斷進步。

So maybe just to add to that, Chris, in light of what Merdad was just referring to, we've done a lot of patient market research to really understand the segments within the oral market, but also with the long-acting market, specifically in treatment, which is quite different to your point to prevention.

所以，克里斯，我想補充一點，鑑於默達德剛才提到的情況，我們已經做了很多患者市場調查，以真正了解口腔市場的各個細分領域，以及長效市場，特別是治療方面，這與你提到的預防方面有很大不同。

And in the treatment setting, it is clear that you will always have a market for that daily oral, which we believe Biktarvy has really set the standard there. And then there are others that the weekly oral will be more preferred. Some people just want to make sure they're taking something every single day. Others don't want to be reminded that they have HIV.

在治療領域，每日口服藥物顯然始終有市場，我們認為Biktarvy在這方面樹立了標竿。當然，也有人更傾向於每週口服一次。有些人只是想確保每天都準時服藥，有些人則不想被提醒自己感染了愛滋病毒。

And then you have, obviously, the injectables or the subcu with lenacapavir combinations every 3 months or potentially even every 6 months that will be very appealing to some, but don't want to be reminded at all. And so those are kind of the segments we're trying to play out. So I do think is a long acting, there will be more of a split segment than we've seen in the daily oral.

當然，還有註射劑或皮下注射，每3個月甚至可能每6個月一次的來那卡帕韋聯合療法，這對某些人來說非常有吸引力，但他們可能完全不想被提醒用藥。所以，這些就是我們正在努力拓展的市場區隔。因此，我認為長效製劑的細分市場會比每日口服製劑更加分散。

Amber, you ready for the next question, please?

Amber，你準備好回答下一個問題了嗎？

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。

On the TIGIT program, what is the likelihood that we'll see PFS data at this point? And if we don't, when could that come? And then based on the interim updates, it does seem like you already have clear benefit on ORR at least on the doublet arm versus monotherapy. So would love to see if you could just walk us through the possible scenarios with this data readout? And if there's any outcome that could impact the recently initiated Phase III studies.

關於TIGIT項目，目前來看，我們有多大可能看到PFS數據？如果看不到，大概什麼時候看得到？根據中期更新，雙藥治療組的ORR似乎已經比單藥治療組有明顯的效益。能否請您詳細解釋一下這些數據解讀可能帶來的各種情況？以及是否有任何可能影響近期啟動的III期研究的結果？

Salveen, this is Merdad again. Yes, maybe I'll start by saying that really -- nothing has really changed in terms of the ARC-7 study and where we're headed. And the reminder make is that this is going to be the fourth interim analysis for the ongoing Phase II study and enrollment was only recently completed over the summer. And so when we look at that, if you think about it in that context, to your point, we continue to look for consistency in the DOM and ZIM combination as a doublet in the ORR to bolster our ongoing Phase III program, right, just to underline our confidence in the TIGIT and DOM combination. Based on the data we've seen already, and this should continue to support that.

Salveen，我是Merdad。是的，我想先說明一點——ARC-7研究及其未來方向實際上並沒有任何變化。需要提醒的是，這將是正在進行的II期研究的第四次中期分析，而受試者招募工作直到今年夏天才剛剛完成。因此，從這個角度來看，正如您所說，我們將繼續關注DOM和ZIM聯合用藥在客觀緩解率（ORR）方面的穩定性，以支持我們正在進行的III期項目，對吧？這也再次印證了我們對TIGIT和DOM合併用藥的信心。基於我們目前掌握的數據，這次分析應該會繼續支持這個觀點。

In terms of PFS, I think PFS is -- as I tried to allude to, given the fact that enrollment went on until fairly recently, the likelihood is that PFS is going to be fairly immature and may not be informative. And certainly, when we think about the triplet there as well, it's unlikely that PFS is going to be informative, but it may be. And so we'll look at that, and our plan is to evaluate the data and then decide with our partners at Arcus what the data and how we approach it.

就無惡化存活期（PFS）而言，正如我之前提到的，考慮到入組工作持續到最近，PFS數據可能還不夠成熟，可能無法提供有效資訊。當然，當我們考慮三聯體模型時，PFS數據可能也難以提供有效信息，但並非完全沒有可能。因此，我們會對此進行研究，我們的計劃是評估數據，然後與Arcus的合作夥伴共同決定如何處理這些數據。

And certainly, as we've said before, making sure that we are sharing the data at a medical conference next year. And exactly to your point, it's really about confirming the confidence we already have in TIGIT and moving into Phase III with our -- with the lead programs that we're moving with. So I hope that answers your question.

當然，正如我們之前所說，我們會確保明年在醫學會議上分享這些數據。正如您所說，這確實是為了鞏固我們對TIGIT的信心，並推進我們正在推進的主要項目進入III期臨床試驗。希望我的回答能解答您的問題。

Our next question comes from Brian Abrahams with RBC.

下一個問題來自加拿大皇家銀行的布萊恩亞伯拉罕。

Congrats on the quarter. A question on Trodelvy. With the maturing TROPiCS-02 overall survival data and the evolving competitive landscape, I'm curious on your latest views on where you see Trodelvy fitting in, in the HR-positive/HER2-negative population. Any updates on market research on how it might be used, your commercial strategy to align with that? And curious also your latest expectations on how effective it could be post in HER2 in certain patients who may receive that first?

恭喜本季業績！關於Trodelvy，我有個問題。隨著TROPiCS-02整體生存期數據的不斷改進以及競爭格局的演變，我想了解您對Trodelvy在HR陽性/HER2陰性人群中的定位有何最新看法。關於其潛在用途的市場研究是否有更新？您的商業策略又將如何與之配合？另外，對於某些可能先接受HER2治療的患者，您對Trodelvy在HER2治療後的療效有何預期？

Brian, it's Johanna. Thanks for the question. So basically, let me start by saying with Trodelvy, the performance for the quarter has been really strong. We're seeing 78% year-on-year growth, 13% quarter-over-quarter. And we're seeing markets add in every week basically. And reimbursement kind of playing out. We have now over 13 countries ex U.S. that have gotten reimbursement. So we're seeing really strong launches, namely France, Germany right now, and other markets coming in as we're speaking. So strong foundations there.

布萊恩，我是喬安娜。謝謝你的提問。首先，我想說的是，Trodelvy 本季的業績非常強勁。我們實現了 78% 的同比增長，環比增長 13%。而且，幾乎每週都有新的市場加入。健保報銷也逐步落實。目前，除美國外，已有超過 13 個國家/地區獲得了醫療保險報銷。我們看到市場推廣勢頭強勁，尤其是法國和德國，以及其他正在加入的市場。總之，我們擁有非常穩固的基礎。

I think having OS data in both triple-negative breast cancer as well as now with TROPiCS-02 in the HR-positive/HER2-negative, patient population really helps the foundation for Trodelvy, but really helps across breast cancer. To your specific question around kind of where do we position ourselves, obviously, with TROPiCS-02, we're in previously treated -- heavily-treated lines of therapy, right, when you think about this patient population, so a little bit different than some of our competitors.

我認為，在三陰性乳癌以及現在在HR陽性/HER2陰性患者群體中，TROPiCS-02的OS數據都為Trodelvy奠定了堅實的基礎，而且對整個乳癌治療領域都大有裨益。至於您提出的關於我們自身定位​​的具體問題，顯然，TROPiCS-02針對的是既往接受過多種治療方案的患者，對吧？考慮到這部分患者群體，我們與一些競爭對手略有不同。

And so we're excited actually because these patients have very limited options. And so now with Trodelvy, there is a real potential for overall survival in these late-line patients. So we do think that as we're playing it out, as we're doing our market research, we feel very confident that Trodelvy will be very well-positioned in the marketplace, and we'll build on the success that we've seen thus far in triple-negative breast cancer as well in how we're playing that out.

因此，我們感到非常興奮，因為這些患者的治療選擇非常有限。而現在有了Trodelvy，這些晚期患者的整體存活率有望顯著提高。因此，隨著我們持續推動市場調查，我們非常有信心Trodelvy將在市場上佔據有利地位，並且我們將借鑒目前在三陰性乳癌領域取得的成功經驗，進一步拓展Trodelvy在三陰性乳癌領域的應用。

So we expect continued momentum in our base business. And I might have mentioned before in one of the previous calls, how we've expanded our footprint, specifically in the U.S. to prepare for both, not only the expansion of what we need to do in triple-negative breast cancer, but also what we need to do in HR-positive. And so we're well poised to make sure that we're ready for that PDUFA date coming up in February to make sure that we're successful.

因此，我們預計基礎業務將繼續保持成長勢頭。我之前可能在電話會議中提到過，我們已經擴大了商業版圖，尤其是在美國，以應對三陰性乳癌和HR陽性乳癌領域業務拓展的需求。我們已做好充分準備，確保在2月的PDUFA截止日期前取得成功。

And maybe -- this is Merdad. Maybe I'll add to that. We're not done, right? And I think we're excited about how much we've been able to achieve with Trodelvy so far, and you've seen consistent positive data across tumor types. And in particular, I think, as Johanna highlighted, the late-line therapy, certainly, those are patients who may now -- there's a potential that some of them will be getting in HER2 beforehand.

或許——這是梅爾達德。或許我還會補充一些。我們還沒說完，對吧？我們對目前為止在Trodelvy方面取得的成就感到非常興奮，而且你們也看到了各種腫瘤類型中持續的正面數據。特別是，正如喬安娜所強調的那樣，我認為，對於後期治療，尤其是那些可能——其中一些患者有可能在HER2陽性之前就接受治療——這些患者現在或許有機會。

We don't have data on sequencing, but I do believe that there may be those who decide to treat for those patients who may not respond adequately to in HER2 to later lines, right? So that's kind of where, certainly, there's an opportunity there. The other thing I would add is that we've got really strong data in triple-negative breast, including the HER2 -- sorry, in HR-positive breast cancer, including the HER2 0 population. And I think that's a very important distinction and really important to remember.

我們沒有關於定序的數據，但我相信，對於那些對後續治療反應不佳的HER2陽性患者，可能會有人選擇進行定序治療，對吧？所以，這方面確實存在著機會。另外，我想補充的是，我們在三陰性乳癌（包括HER2陽性）方面擁有非常可靠的數據——抱歉，是HR陽性乳癌（包括HER2 0人群）。我認為這是一個非常重要的區別，請務必牢記。

And then finally, based on what we've seen so far and the clinical benefit we've brought, we certainly believe that there's an opportunity for us to move to earlier lines of therapy as well in breast cancer in triple negative, in HR-positive and in other tumor types. I think that's -- our excitement about Trodelvy has always been the ability to go into broad tumor types, and our strategy has always been to advance into earlier lines of therapy as we generate positive data.

最後，基於我們目前所觀察到的情況以及我們所取得的臨床效益，我們堅信有機會將Trodelvy應用於三陰性乳癌、荷爾蒙受體陽性乳癌以及其他腫瘤類型的早期治療。我認為－我們對Trodelvy的興奮點始終在於它能夠應用於多種腫瘤類型，而我們的策略也始終是隨著正面數據的積累，逐步推進到更早期的治療階段。

Our next question comes from Michael Yee with Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

Congrats on a great quarter. I also wanted to ask Merdad a question on Trodelvy and lung cancer. I mean, I would think that this is an even bigger opportunity than breast cancer on EVOKE-01 which is ongoing. Can you confirm you think you would update next year and how you think about that opportunity versus second-line docetaxel? I know there's some early response rates based on the basket study when you acquired Immunomedics. And I was wondering if you had more data in lung cancer that you've been observing to give you more confidence there? And then you commented on EVOKE-02 and EVOKE-03, which is first line. I just wanted to understand if you think we would update on EVOKE-02 next year. I would think that's pretty big trying to replace chemo. So maybe comment on EVOKE-01 and EVOKE-02.

恭喜你們季度表現出色。我還想問Merdad一個關於Trodelvy和肺癌的問題。我的意思是，我認為這比正在進行的EVOKE-01乳癌研究更有發展潛力。您能否確認明年是否會更新相關數據，以及您如何看待Trodelvy與二線多西他賽相比的優勢？我知道根據你們收購Immunomedics時進行的籃子研究，Trodelvy已經有一些早期緩解率。我想知道你們是否掌握了更多肺癌數據，以增強你們的信心？您也提到了EVOKE-02和EVOKE-03，它們是第一線治療藥物。我想了解一下您是否認為明年會更新EVOKE-02的數據。我認為嘗試用Trodelvy取代化療意義重大。所以，能否也談談EVOKE-01和EVOKE-02？

Yes, Michael, Merdad, thanks for the question. I think just to follow on, it's a great follow-on to the prior question around our ability to really look across tumor types and earlier lines. And in particular, I think what you're referencing is our confidence in going into early line lung cancer and starting those studies. To your point, we've seen data, as you know, very well from our early Phase Ib study in lung cancer.

是的，Michael，Merdad，謝謝你們的提問。我想接著之前的問題繼續，這個問題很好地引出了我們能否真正研究不同腫瘤類型和早期肺癌治療的問題。特別是，我認為你們指的是我們對早期肺癌治療的信心，以及我們進行相關研究的決心。如你們所知，我們已經從早期肺癌Ib期研究中獲得了非常充分的數據。

And we continue to enroll and we've initiated now studies looking at both the second- and third-line setting and we and then as well as in the frontline setting. As you know, we're doing a study in combination with OCO III with the PD-1 and the PD-L1 high population, which I think is really an important trial for us to proceed on.

我們仍在持續招募患者，目前已啟動針對二線、三線以及第一線治療的研究。如您所知，我們正在進行一項針對PD-1和PD-L1高表達族群的OCO III聯合研究，我認為這對我們來說是一項非常重要的試驗。

So I think what I would say is that the timing of the data, Michael, is always difficult to predict. We have to see how the study enrollment goes, and it's early days. But we're really excited about the opportunity to bring a meaningful therapy to a group with a very high unmet need.

所以我想說的是，邁克爾，數據的發佈時間總是很難預測。我們得看看研究的招募情況如何，現在還處於早期階段。但我們非常興奮有機會為這個亟需治療的團體帶來有效的療法。

Our next question comes from Brian Skorney with Baird.

下一個問題來自 Baird 公司的 Brian Skorney。

Maybe perhaps for Merdad, just kind of jumping off on the long-acting HIV discussion. I noticed in the pipeline slides, long-acting bictegravir has been removed from the pipeline. Obviously, it would have been nice to have a known entity like the bictegravir part of the combo. I was just wondering, may be give us any insight to what happened in the Phase I there? Is it sort of bictegravir missing a PK threshold? Or is it something that you're seeing with the 6212 or 589 for -- that gives you more confidence there?

或許可以藉著Merdad的話題，順便聊聊長效HIV藥物。我注意到在研發管線幻燈片中，長效比克替拉韋已經從研發管線中移除。顯然，如果能保留像比克替拉韋這樣已知的有效成分作為組合療法的一部分就更好了。我想問的是，能否透露一下I期臨床試驗中發生了什麼事？是不是比克替拉韋的藥物動力學指標沒有達到閾值？或者，您是否在6212或589上也觀察到了類似的情況，從而對它們更有信心？

Yes. Thanks for the question. Happy to expand on that. Yes, look, bictegravir is an amazing molecule and has done a lot for patients. And one of the opportunities we looked at is in addition to thinking about bictegravir for long-acting oral was to see if we could give it as a long-acting subcutaneous. And really, what happened is we had tolerability issues just given that molecule subcu in terms of injection site reactions. So it's not about the molecule itself.

是的，謝謝你的提問。我很樂意詳細解釋一下。是的，比克替拉韋是一種非常棒的分子，它為患者帶來了許多好處。我們研究的一個方向是，除了考慮開髮長效口服製劑外，我們也嘗試將其製成長效皮下注射劑。但實際上，我們發現皮下注射比克替拉韋有耐受性問題，主要是注射部位反應。所以問題不在於分子本身。

One of the challenges of developing long-acting subcutaneous therapies is tolerability. And so I want to make sure that it's clear that bictegravir is an oral agent continues to be a huge part of where we want to go. And then maybe just to step back to your point, the way I think about it, maybe the way to think about is from a PrEP standpoint, long-acting, we are lenacapavir, it's prep for long-acting and that -- those studies are underway, moving along nicely.

開髮長效皮下療法的一大挑戰是耐受性。因此，我想強調的是，口服比克替拉韋仍然是我們未來發展方向的重要組成部分。回到您剛才的觀點，我的想法是，或許應該從暴露前預防（PrEP）的角度來看，長效藥物，例如我們正在研發的來那卡帕韋，是為長效藥物做準備——相關研究正在進行中，進展順利。

From a treatment standpoint, as I mentioned earlier, lenacapavir is a huge part of our backbone therapy for us. And now we are looking at a number of different opportunities to get to long-acting oral and long-acting parenteral. And molecules like lenacapavir don't come along every day. We are looking for a number of -- at a number of molecules.

從治療角度來看，正如我之前提到的，lenacapavir 是我們核心療法的重要組成部分。現在，我們正在探索多種途徑，以期獲得長效口服製劑和長效注射製劑。像 lenacapavir 這樣的分子並非每天都會出現。我們正在尋找多種分子。

We think we have the world-class expertise in chemistry and preclinical development that gives us a leg up on the competition to get to those molecules that will really get to the need that Johanna has laid out, which is to get to the subcutaneous or every 3-month dosing or even longer, and that's what we're looking for.

我們認為我們在化學和臨床前開發方面擁有世界一流的專業知識，這使我們在競爭中佔據優勢，能夠研發出真正滿足 Johanna 提出的需求的分子，即實現皮下注射或每 3 個月給藥一次，甚至更長時間的給藥，而這正是我們所追求的。

Our next question comes from Matthew Harrison with Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

I just wanted to ask a question on 5245. Can you just talk a little bit about the range of possibilities you might be thinking about in terms of what a Phase III might look like? And then just sort of where you see commercially, what sort of data you might need to compete just given the fact that it may be hard to have the same kind of data set as some of those pills that were developed earlier in the pandemic.

我只是想問一個關於5245的問題。您能否談談您正在考慮的III期臨床試驗的各種可能性？另外，考慮到可能難以獲得與疫情早期研發的一些藥物相同的數據集，您認為在商業上需要哪些數據才能參與競爭？

Matthew, Dan O'Day here. So we'll have Merdad take the first part of your question, and then Johanna compete into the second.

馬修，我是丹‧奧戴。我們先讓梅爾達德回答你問題的第一部分，然後喬安娜回答第二部分。

Yes. Thanks, Dan. Yes. Thanks, Matthew. So 5245 has, as you know, we started those trials in Phase I earlier this year. Things are going well. And as you know, the pandemic has changed a lot. And I think you make an excellent point that looking at high-risk patients is a challenge right now in looking at high-risk patients who may get hospitalized as a challenge right now, giving vaccination, other treatment options.

是的，謝謝，丹。是的，謝謝，馬修。如你所知，我們今年稍早啟動了5245的I期臨床試驗。一切進展順利。你也知道，疫情帶來了許多變化。我認為你提出的觀點非常中肯，目前對於高風險患者來說，尤其是那些可能需要住院的高風險患者，在接種疫苗和其他治療方案方面都面臨挑戰。

So exactly to your point, I think the discussion we're having internally and with our regulators is what's the best population for us to establish the benefit of 5245. And how does that anticipate what might come down the road, which has been the unpredictable part, whether that is resistance to other agents, the need for combination agents, new variants that may increase the hospitalization rates.

所以，正如您所說，我認為我們內部以及與監管機構討論的重點是，哪個人群最適合我們確定 5245 的益處。以及如何預測未來可能出現的情況，這才是不可預測的部分，例如對其他藥物的抗藥性、合併用藥的需求，以及可能導致住院率上升的新變種。

Those are all the things that we have to be prepared for. And we really see 5245 as a way -- as we move forward with that and move into clinical trials once we demonstrate its efficacy as an important tool should the pandemic start to pick up again, heaven forbid, but that's how we think about it. So both combinations and treating resistance or a new surge.

這些都是我們必須做好準備應對的情況。我們確實將5245視為一種途徑——隨著我們推進該計畫並進入臨床試驗，一旦我們證明其療效，它將成為應對疫情再次爆發的重要工具（但願不會如此），我們就是這麼考慮的。因此，它既可以用於聯合治療，也可以用於治療抗藥性或應對新一輪疫情。

Yes. So in line with that, Matthew, it's Johanna. I would just add to what Merdad was saying. So I think from a commercial standpoint, what we're thinking is the fact that it doesn't have a boosting agent is a real plus here, as well as the fact that we're going to look at rebound effects as we've seen with current marketed products right now have that issue. And so -- in addition to the antiviral activity.

是的。所以，馬修，我是喬安娜。我只想補充一下默達德剛才說的話。我認為從商業角度來看，我們認為它不含增效劑是一個真正的優勢，而且我們還要關注反彈效應，因為我們目前看到的市售產品都存在這個問題。所以——除了抗病毒活性之外。

So I think those pieces are kind of what we're thinking about as well as you well know, drug-drug interactions has been a bit of an issue with some of the current agents today. So I think if you -- without the boosting agent, I think those will just open up a little bit more for a broader patient population potentially to really benefit. And as we've seen with this pandemic, it's not over. We've seen hospitalizations go up and down. We've seen a little bit of an increase most recently, and we're tracking that very closely with hospitalizations, of course, because of Veklury. But we do believe that there's still opportunity for more options here to make sure that we curve this pandemic.

所以我覺得這些正是我們正在考慮的問題。您也知道，藥物交互作用一直是目前一些藥物存在的問題。因此，我認為如果不用增效劑，這些藥物就能惠及更廣泛的患者群體，讓他們真正受益。正如我們在這次疫情中所看到的，疫情尚未結束。我們看到住院人數有增有減。最近住院人數略有上升，我們當然會密切關注住院人數的變化，這主要是因為Veklury的出現。但我們相信，我們仍有機會開發更多治療方案，以確保我們能夠控制住這場疫情。

And Matthew, this is Dan. I'll just add one other thing in addition to my colleagues, which is in our conversations with the U.S. government, particularly the recent Fast Track designation that was applied to GSV-245, -- there's 3 major things that they're interested in to. Number one is more oral antivirals. Number two, to the points that both Merdad and Johanna made, working across the variance as the virus continues to mutate. And then thirdly, lack of DDI, lack of boosting and this rebound issue.

馬修，我是丹。除了我的同事們提到的，我還要補充一點，在我們與美國政府的討論中，特別是最近GSV-245獲得的快速通道資格認定，他們主要關註三個方面。第一，更多口服抗病毒藥物。第二，正如默達德和喬安娜所提到的，隨著病毒的持續變異，如何應對這種變異。第三，缺乏藥物交互作用、缺乏增強作用、反彈問題。

So I think it's a recognition of the fact that there is a need for the ongoing pandemic/endemic, whatever you want to call it with COVID for additional options. And I think that's expressed in the way the U.S. government wants to work closely with us as we continue to develop this program.

所以我認為這表明人們認識到，在當前新冠疫情（或者說流行病，不管你怎麼稱呼它）的影響下，我們需要更多的應對方案。我認為，美國政府希望與我們密切合作，共同推動這個項目，也體現了這一點。

Our next question comes from Tyler Van Buren with Cowen.

下一個問題來自 Cowen 公司的 Tyler Van Buren。

Congratulations on the results. Great quarter. I had a follow-up, a high-level question on Biktarvy. So the product continues to see very impressive uptake, and it looks like it will be around 60% of HIV product revenues this year. So where do you expect the product to peak out as a percentage of HIV sales over the next several years?

恭喜取得如此佳績！本季表現出色。我還有一個關於Biktarvy的後續問題，這是一個比較高層次的問題。該產品的市場接受度持續保持強勁成長，預計今年將佔HIV產品總收入的60%左右。那麼，您預計未來幾年內，該產品在HIV產品銷售額中的佔比會達到怎樣的高峰呢？

Tyler, it's Johanna. Thanks for the question. I would say that we're really proud of the Biktarvy performance, but I would say even the increased momentum that we're seeing, and this is not just in the U.S., this is really around the globe. And so we're just about 45% market share with Biktarvy. We've seen 4% share gain year-on-year. And now we're looking at an annual run rate in excess of about $10 billion.

泰勒，我是喬安娜。謝謝你的提問。我們為Biktarvy的業績感到非常自豪，而且我們看到的成長勢頭也十分強勁，這不僅限於美國，而是遍及全球。目前Biktarvy的市佔率約45%，較去年同期成長4%。我們預計年收入將超過100億美元。

So I do think we're very well poised for the future. The -- we're looking at both the naive share, obviously, just about under 60% of that share right now with Biktarvy, so really setting the standard for new patients coming into HIV. And obviously, the switch share, and you can't -- switch share is obviously a little bit lower because you can switch to Biktarvy if you're already on Biktarvy.

所以我認為我們已經為未來做好了充分準備。我們目前主要關注的是初治患者群體，顯然，Biktarvy 目前佔比接近 60%，這確實為新感染 HIV 的患者樹立了標竿。而轉換治療的患者群體佔比則略低一些，因為如果您已經在使用 Biktarvy，則可以轉換到 Biktarvy。

So therefore, we're tracking that very closely as well, but making sure that when there is opportunity either from older drugs or when there's been some issues for patients to really come on to Biktarvy just because it really does have a profile from an efficacy standpoint and safety standpoint. So we do believe that continued growth with Biktarvy is on the agenda.

因此，我們也密切關注這種情況，確保在出現機會時，無論是老藥停用還是患者出現問題，都能讓患者真正開始使用Biktarvy，因為它在療效和安全性方面都表現出色。所以我們相信，Biktarvy的持續成長動能依然強勁。

And I would also add just a little bit of a note around the market as well, which also helps, right, because where the market goes, Biktarvy goes; and where Biktarvy goes, the market goes. We've seen market stabilization actually back to pre-pandemic levels and growing at about 2% or so year-on-year, both in the U.S. as well as in Europe. And so that also really helps our momentum continue and Biktarvy is driving that as well, of course, in a lot of our efforts.

我還想補充一點關於市場的情況，這也很重要，因為市場走向決定了Biktarvy的走向；反之亦然。我們已經看到市場穩定，並已恢復到疫情前的水平，而且無論在美國還是歐洲，都保持著約2%的同比增長。因此，這也有助於我們保持成長勢頭，當然，Biktarvy自身也在為此做出許多努力。

The teams have worked very closely with community partners and physicians and advocacy groups to make sure that we get patients back into clinics, back into care, both from a screening standpoint and diagnosis standpoint. Now that we're -- and you really see those numbers back to pre-pandemic. So I think we're in good place moving forward and well-poised for the future to continue this leadership in HIV driven by Biktarvy.

團隊與社區夥伴、醫生和倡導團體密切合作，確保患者能夠重返診所，重新接受治療，包括篩檢和診斷。現在，我們——而且您確實可以看到這些數字已經恢復到疫情前的水平。所以我認為我們目前處境良好，並且已經做好充分準備，在未來繼續引領愛滋病防治工作，而這一切都離不開Biktarvy的推動。

Amber, we'll squeeze in just 2 more, please. Maybe go to the next caller.

安珀，我們再擠出兩個名額吧。或許可以先接下一個電話了。

Our next question comes from Umer Raffat with Evercore.

我們的下一個問題來自 Evercore 公司的 Umer Raffat。

I wanted to touch up on a slightly different topic today, and I have a 2-part question for Dan and Andy. And this is on the tenofovir litigation that's been ongoing. And then I guess my question really was there's a very unusual amount of plaintiffs aggregated up in this case. And I'm curious, is it something you guys are looking to take to a final judgment? Or would you be open to a settlement?

今天我想談談一個稍微不同的主題，我有一個分成兩部分的問題想問丹和安迪。這個問題是關於正在進行的替諾福韋訴訟案。我想問的是，這個案子涉及的原告人數非常多，這很不尋常。我很好奇，你們打算堅持到最終判決嗎？還是願意接受和解？

And that brings me to sort of the second part, Andy, how much of a legal charge have you taken on this litigation to date? Because I know you've been doing that on the Biktarvy and other litigations in the past. And is there something more significant that has to happen for a more prominent charge to show up? I ask because every company handles the accounting differently. So I was just curious.

這就引出了我的第二個問題，安迪，到目前為止，你在這場訴訟中承擔了多少法律費用？因為我知道你過去在Biktarvy和其他訴訟中也承擔過類似的費用。是否需要發生更重大的事件才會產生更顯著的費用？我這麼問是因為每家公司的會計處理方式都不一樣，所以我只是好奇。

Thanks, Umer. Let me just start before I hand it over to Andy to say, obviously, with any litigation, we're -- we don't comment on ongoing litigation in any level of detail. I do want to emphasize the confidence we have in our overall patent portfolio in general. And maybe with that, I'll hand it over to Andy to answer some more specifics of your question as well.

謝謝，烏默。在把麥克風交給安迪之前，我先聲明一下，顯然，對於任何訴訟，我們——我們不會對正在進行的訴訟做任何細節評論。但我確實想強調，我們對整體的專利組合充滿信心。或許說完這些，我就可以把麥克風交給安迪，讓他更詳細回答你的問題了。

Yes. Thanks, Dan. Umer, thanks for the question. Happy to touch base on this. This is a topic, as you know, that we've been getting a lot of questions on with the Zantac litigation. So a number of things that I can provide some background and context. So first of all, like most companies, anyone operating in the U.S., we are routinely managing a lot of different litigation matters, as you know.

是的。謝謝，丹。烏默，謝謝你的提問。很高興能就此談談。如你所知，關於善胃得（Zantac）的訴訟，我們收到了很多相關問題。所以我可以提供一些背景資訊。首先，和大多數在美國經營的公司一樣，我們常常要處理各種各樣的訴訟案件，你也知道。

Many of those are from our perspective, meritless or baseless. As a matter of practice, we don't typically -- or usually comment on specific litigation cases. What I can say stepping back is that we have won to resolve the 3 material litigation -- or 3 material litigation matters over the past year, as you know, on terms that were favorable to the company and to our shareholders that is the Juno KITE IP litigation, the ViiV IP litigation around bictegravir, then the third was the TAF litigation with generic companies.

在我們看來，其中許多指控毫無根據或毫無道理。通常情況下，我們不會對具體的訴訟案件發表評論。但我可以肯定的是，在過去一年中，我們已經成功解決了三起重大訴訟——正如您所知，這些訴訟的條件對公司和股東都非常有利。這三起訴訟分別是：Juno KITE 智慧財產權訴訟、圍繞比克替拉韋的 ViiV 智慧財產權訴訟，以及與仿製藥公司就 TAF 提起的訴訟。

We have an outstanding legal team, both internally and externally. And then maybe to your specific question, I mean, we have complete confidence in the merits of the defense on the ongoing product liability case. So it is very different than the Zantac litigation case. So just to your question on the number of plaintiffs, for instance, if I remember correctly in the Zantac cases, there were 250,000 patients in our case -- I'm sorry, plaintiffs. There were 25,000 in ours.

我們擁有一支傑出的法律團隊，無論內部或外部。至於您提出的具體問題，我們對正在進行的這起產品責任訴訟的辯護理由完全有信心。這與善胃得（Zantac）訴訟案截然不同。就您提到的原告人數而言，如果我沒記錯的話，善胃得案有25萬名患者——抱歉，應該是25萬名原告。我們這起案件只有2.5萬名原告。

But the key difference is that the issues at hand here, I mean, our TDF-based products are life-saving products that really transform care for HIV. And the side effects of the products were in the label from day 1. The labels in the U.S. and Europe were slightly different, but the labels were there. These were well known, well disclosed potential side effects, and I think that's an important piece of it.

但關鍵差異在於，我們在這裡討論的是基於替諾福韋酯（TDF）的產品，這些產品是救命藥，真正改變了愛滋病治療的現狀。而且，這些產品的副作用從一開始就標示在標籤上。美國和歐洲的標籤略有不同，但副作用資訊都存在。這些都是眾所周知、充分揭露的潛在副作用，我認為這至關重要。

So it's a very different case. Zantac, if I remember correctly was taken off the market and reformulated. So I'd be careful about drawing too many parallels between what you saw with Zantac and some of the companies that were affected by that in this litigation. That doesn't mean that we don't take it seriously. We do take it very seriously. And as I said, we have a great team that's working on it.

所以情況截然不同。如果我沒記錯的話，善胃得（Zantac）後來被撤出市場並重新配方。因此，我建議不要將善胃得的案例與本訴訟中受其影響的其他公司的情況進行過多類比。但這並不意味著我們不重視此事。我們非常重視。正如我所說，我們有一個優秀的團隊正在處理此事。

The last thing, Umer, maybe the last 2 things, there are a number of amicus briefs that have been filed. Those are all publicly available. This is in the California state litigation that I would encourage you to read. I think there are 4 or 5 Amicus briefs that really speak to how different this cause of action is relative to what you would typically expect to see in a case. And then finally, on the charge, no, we have not taken a charge. And as I said, we feel very strongly about the merits of our case and look forward to proceeding with the litigation over the coming months and years. So good question. Thank you.

最後一點，烏默，或許應該說最後兩點，是已經提交了一些法庭之友意見陳述書。這些陳述書都是公開的。我建議你閱讀一下加州州級訴訟中的相關文件。我認為有四、五份法庭之友意見陳述書充分說明了本案的訴訟理由與通常案件的不同之處。最後，關於指控，不，我們沒有被指控。正如我所說，我們對本案的勝訴充滿信心，並期待在未來幾個月甚至幾年內繼續推動訴訟。所以，問得好。謝謝。

Amber, may we go to our last question, please.

Amber，我們可以問最後一個問題了嗎？

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

最後一個問題來自美國銀行的傑夫‧米查姆。

And Merdad, I want to follow up on a few questions that you've gotten on long-acting HIV. I know it's been tricky to develop a doublet that has a comparable profile to lenacapavir, but is there a mechanism that you have either in-house or that you've seen in HIV that looks like it's more straightforward to develop long-acting? I wasn't sure if Integrace would be better than new versus non-new, something of that category?

Merdad，我想就你收到的一些關於長效HIV藥物的問題做個後續討論。我知道開發一種與lenacapavir療效相當的雙藥療法很棘手，但你公司內部或你在HIV領域觀察到的，是否存在某種機制，看起來更容易開發出長效藥物？我不確定Integrace是否比新藥或非新藥更好，或類似的問題？

Thanks, Geoff. This is Merdad. Yes, we're -- I think our chemistry and our virology team do favor the entities as a class where we believe that we have a better shot at getting to a long-acting partner for the capsid inhibitors. So I would say a fair bit of our effort is going into those. But -- and we are open to looking at a variety of mechanisms to achieve our goal. We just think that the entities are more likely to get there.

謝謝，Geoff。我是Merdad。是的，我們——我認為我們的化學和病毒學團隊確實更傾向於這類化合物，因為我們相信它們更有可能成為衣殼抑制劑的長效配體。所以，我們投入了相當多的精力。但是──我們也願意探索各種不同的機制來實現我們的目標。我們只是認為這類化合物更有可能最終成功。

I will remind you this may have gone under the radar, but we do have the program where we are looking at the BNAB. I did mention it in the script and that does provide us another option for people from a long-acting standpoint where we're looking at every 6 months potentially there. So we are pretty open and committed to finding the right partner that will achieve our goals.

我提醒各位，這件事可能不太為人所知，但我們確實有一個項目正在考察BNAB（英國國家美容營養師協會）。我在劇本裡提到過，從長遠角度來看，這確實為我們提供了一個新的選擇，我們考慮每六個月進行一次。所以，我們非常開放，並且致力於找到合適的合作夥伴來實現我們的目標。

Terrific with that. This is Dan. I just want to thank all of you for joining today. And I just wanted to emphasize how we believe our third quarter performance demonstrates the tangible impact of delivering on our strategy. After putting the right foundation in place over the past 3 years, we're now seeing the positive momentum that continues to build. It's an exciting time for the company as we realize our potential to do more, to reach further to help more patients and the communities we serve.

太棒了！我是丹。感謝各位今天蒞臨。我想強調的是，我們相信第三季的業績充分體現了我們策略實施的實際成效。過去三年，我們打下了堅實的基礎，如今，我們正看到這股正向動能持續增強。對於公司而言，這是一個令人興奮的時刻，因為我們意識到自身擁有更大的潛力，能夠為更多患者和我們服務的社區帶來更大的福祉。

So I just want to take this opportunity to thank all the colleagues again at Gilead and KITE, to thank all of you for joining your interest in Gilead. And as usual, if you have any additional questions, please reach out to our Investor Relations team. As you know, they're more than happy to help. And thank you for joining today.

所以，我想藉此機會再次感謝吉利德和KITE的所有同事，感謝大家對吉利德的關注。像往常一樣，如果您有任何其他問題，請聯絡我們的投資者關係團隊。他們非常樂意為您提供協助。感謝您今天的參與。

This concludes today's Third Quarter 2022 Gilead Sciences Earnings Conference Call. Thank you for your participation. You may now disconnect your line.

吉利德科學公司2022年第三季財報電話會議到此結束。感謝您的參與。您可以掛斷電話了。