吉利德科學 (GILD) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the third quarter 2021 Gilead Sciences earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jacquie Ross, Vice President of Investor Relations. Please go ahead.

大家好，感謝您的耐心等待。歡迎參加吉利德科學公司2021財年第三季財報電話會議。 （操作說明）請注意，本次會議正在錄音。現在我將會議交給今天的發言人，投資者關係副總裁傑奎·羅斯女士。請開始吧。

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

謝謝凱瑟琳，大家下午好。今天收盤後，我們發布了2021年第三季財報。新聞稿、投影片和補充資料可在我們網站gilead.com的投資人關係頁面上查看。

The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day; our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Merdad Parsey; and our Chief Financial Officer, Andrew Dickinson. After that, we will open up the call to Q&A, where the team will be joined by Christi Shaw, Chief Executive Officer of Kite.

今天電話會議的發言人包括：董事長兼首席執行官丹尼爾·奧戴 (Daniel O'Day)；首席商務官喬安娜·默西埃 (Johanna Mercier)；首席醫療官默達德·帕西 (Merdad Parsey)；以及首席財務官安德魯·迪金森 (Andrew Dickinson)。之後，我們將進入問答環節，屆時Kite執行長 Christy Shaw 也將加入討論。

Before we get started, let me remind you that we will be making forward-looking statements, including those related to the impact of the COVID-19 pandemic on Gilead's business, financial condition and results of operation, plans and expectations with respect to products, product candidates, corporate strategy, financial projections and the use of capital, and 2021 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

在開始之前，請允許我提醒各位，我們將做出一些前瞻性聲明，包括與 COVID-19 疫情對吉利德的業務、財務狀況和經營業績的影響、產品計劃和預期、候選產品、公司戰略、財務預測和資本使用以及 2021 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.

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

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

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

I will now turn the call over to Dan.

現在我將把通話交給丹。

Thank you, Jacquie, and good afternoon, everyone. We appreciate you taking the time to join us here today.

謝謝Jacquie，大家下午好。感謝各位今天抽空參加我們的活動。

Starting on Slide 4, this was a very strong third quarter with significantly higher than expected demand for Veklury and positive HIV share gains as the market continues to recover. The high demand for Veklury was associated with the latest surge in cases of COVID-19. The therapy has now been provided to more than 9 million people worldwide, including 6.5 million people in 127 middle- and low-income countries through our voluntary licensing program.

從投影片4開始，第三季表現非常強勁，Veklury的需求遠超預期，隨著市場持續復甦，HIV治療市場份額也實現了積極成長。 Veklury的高需求與近期新冠肺炎病例激增密切相關。目前，全球已有超過900萬人接受了該療法，其中包括透過我們的自願許可計劃在127個中低收入國家/地區獲得治療的650萬人。

All of us at Gilead are proud of the important role that Veklury continues to play. I wanted to acknowledge the way our teams have navigated the unpredictable path of the pandemic, flexing our own operations and supporting our partners' efforts to ensure Veklury and remdesivir are available to meet patient demand.

吉利德全體員工都為Veklury持續發揮的重要作用感到自豪。我想特別感謝我們的團隊，感謝他們應對疫情帶來的種種變數，靈活調整自身運營，並全力支持合作夥伴，確保Veklury和瑞德西韋的供應，滿足患者的需求。

At the same time, we're applying our 3 decades of expertise in virology to advance new options that can be taken outside the hospital and earlier in the disease. We recently filed an sNDA for IV outpatient use of Veklury. This is based on data from our Phase III PINETREE study that demonstrated a significant reduction in the risk of hospitalizations after a 3-day IV treatment of Veklury in the outpatient setting. In order to meet additional treatment needs, we also continue to advance our oral programs to develop a novel, best-in-class therapy.

同時，我們正運用三十年來在病毒學領域的專業知識，推動可在院外及疾病早期階段實施的新療法。我們近期已提交了Veklury靜脈注射門診治療的補充新藥申請（sNDA）。該申請基於我們進行的III期PIENTREE研究的數據，該研究表明，在門診環境下，患者接受為期3天的Veklury靜脈注射治療後，住院風險顯著降低。為了滿足更多治療需求，我們也持續推動口服藥物項目，致力於開發一種新型的、同類最佳的療法。

Turning to HIV performance, we saw positive gains in the treatment market for the second quarter in a row, and reported record revenue for Biktarvy. While treatment prescription volumes remain below pre-pandemic levels, we maintained total U.S. and EU treatment market share, and we grew Biktarvy shares sequentially in both geographies. The PrEP market continues to recover and our PrEP market share is holding steady despite generic entry. Overall, our third quarter results give us confidence that the HIV market is recovering from the pandemic and our market share clearly highlights Gilead's strong market position.

在愛滋病治療領域，我們連續第二季在治療市場取得正面成長，Biktarvy 的營收也創下歷史新高。儘管治療處方量仍低於疫情前水平，但我們保持了在美國和歐盟的整體市場份額，並且 Biktarvy 在這兩個地區的市場份額均實現了環比增長。 PrEP 市場持續復甦，儘管仿製藥上市，我們的 PrEP 市佔率仍保持穩定。總體而言，第三季的業績讓我們相信愛滋病市場正在從疫情中復甦，而我們的市場份額也清晰地凸顯了吉利德強大的市場地位。

As a result of the strong quarter, we have increased our full year revenue and earnings per share guidance. Veklury now looks set to deliver close to twice the revenue we expected at the start of the year. While our base business has clearly been affected by COVID, it has also shown resilience. At the guidance midpoint, we are now expecting full year total revenue to be $1.75 billion higher than we expected at the start of the year.

由於本季業績強勁，我們提高了全年營收和每股盈餘預期。 Veklury 目前預計將達到年初預期營收的近兩倍。儘管我們的核心業務顯然受到了新冠疫情的影響，但也展現出了韌性。以預期中位數計算，我們目前預計全年總營收將比年初預期高出 17.5 億美元。

Our confidence in the longevity of our HIV business is in part based on our progress in developing the next generation of HIV therapy and prevention. Lenacapavir is the cornerstone of that work, and we have 4 clinical trials evaluating lenacapavir across treatment and prevention, highlighting our efforts to extend the options available to people living with or at risk of HIV. This quarter, lenacapavir was granted FDA priority review for the heavily treatment-experienced population. As a reminder, lenacapavir has breakthrough therapy designation and if approved, would be the first long-acting treatment for people living with HIV who have multidrug resistance as well as the first available 6-month long-acting subcutaneous injection treatment for HIV.

我們對愛滋病業務長期發展的信心部分源於我們在開發下一代愛滋病治療和預防藥物方面取得的進展。 Lenacapavir 是這項工作的基石，我們正在進行 4 項臨床試驗，評估 lenacapavir 在治療和預防方面的療效，這凸顯了我們致力於為愛滋病毒感染者或高危險群提供更多治療選擇的努力。本季度，lenacapavir 獲得了 FDA 針對先前接受過多種治療族群的優先審查資格。值得一提的是，lenacapavir 已獲得突破性療法認定，如果獲得批准，它將成為首個用於治療多重抗藥性愛滋病毒感染者的長效療法，也是首個可用於治療愛滋病毒感染的 6 個月長效皮下注射療法。

Separately, as you know, we signed an agreement with Merck earlier this year to explore combinations of lenacapavir and islatravir in long-acting treatment. Earlier this week, we announced the start of a Phase II study with Merck, evaluating a lenacapavir and islatravir long-acting oral combination treatment. Our approach to long-acting is very much shaped by people living with HIV. We've heard that they would welcome weekly oral or infrequent subcutaneous injections that could coincide with routine office visits or even be taken at home. The advantages of these options include greater convenience, the potential for stronger adherence and privacy. Lenacapavir has shown promising potential in both oral and subcutaneous injections and we'll continue to advance both options while updating you on our progress throughout.

如您所知，我們今年稍早與默克公司簽署了一項協議，共同探索lenacapavir和islatravir聯合用於長效治療的方案。本週早些時候，我們宣布與默克公司啟動一項II期臨床試驗，評估lenacapavir和islatravir長效口服聯合療法。我們研發長效療法的理念很大程度源自於HIV感染者的需求。我們了解到，他們希望每週口服一次或不頻繁皮下注射，以便配合常規門診就診，甚至可以在家服用。這些方案的優點包括更便利、更高的依從性和更佳的隱私性。 lenacapavir在口服和皮下注射方面均展現出良好的潛力，我們將繼續推進這兩種方案的研發，並隨時向您報告進展。

While extending our leadership in HIV, we are also executing on the significant potential in our broad and diverse oncology portfolio. This is potential that could bring transformational benefits for people with cancer and value for our stakeholders.

在鞏固我們在愛滋病領域的領先地位的同時，我們也在積極挖掘我們廣泛而多元化的腫瘤產品組合所蘊藏的巨大潛力。這種潛力有望為癌症患者帶來變革性的益處，並為我們的利害關係人創造價值。

Third quarter highlights include the initiation of 2 solid tumor trials for magrolimab, head and neck cancer and a multi-tumor basket study. We plan to initiate an additional Phase III study in first-line unfit acute myeloid leukemia or AML in early 2022.

第三季亮點包括啟動兩項針對magrolimab的實體腫瘤臨床試驗（頭頸癌）以及一項多腫瘤籃式研究。我們計劃於2022年初啟動一項針對第一線不適合接受其他治療的急性髓性白血病（AML）患者的III期臨床試驗。

The FDA approval of Tecartus for adult relapsed and refractory acute lymphoblastic leukemia, or ALL, is our fourth approved indication in cell therapy. Additionally, the Kite team has filed an sBLA for Yescarta in second-line LBCL which, if approved, would be the first CAR T therapy in an earlier line setting and a positive CHMP opinion for Trodelvy in second line metastatic triple-negative breast cancer earlier this month. We expect an approval decision from the European Commission later this year, and this could potentially be our sixth approval for Trodelvy in triple-negative breast cancer in 2021.

Tecartus已獲FDA核准用於治療成人復發/難治性急性淋巴性白血病（ALL），這是我們在細胞療法領域核准的第四個適應症。此外，Kite團隊已提交Yescarta用於二線大B細胞淋巴瘤（LBCL）的補充生物製品許可申請（sBLA），如果獲批，這將是首個用於早期治療的CAR-T療法。本月初，人類藥物委員會（CHMP）對Trodelvy用於第二線轉移性三陰性乳癌的治療也給予了正面意見。我們預計歐盟委員會將於今年稍後做出批准決定，這有望成為Trodelvy在2021年批准的第六個適應症，用於治療三陰性乳癌。

Additionally, we've just announced a new clinical trial collaboration and supply agreement with Merck to evaluate the combination of Gilead's Trop-2 antibody drug conjugate Trodelvy with Merck's anti-PD-1 therapy KEYTRUDA for the treatment of first-line metastatic triple-negative breast cancer. When we acquired Immunomedics last year, we said that we would explore the use of Trodelvy across a wide range of tumor types, and then we would pursue combinations with both internal and external molecules. You can see this start to play out now with this Merck partnership as an early example of our approach.

此外，我們剛宣布與默克公司達成一項新的臨床試驗合作及供應協議，旨在評估吉利德公司的Trop-2抗體偶聯藥物Trodelvy與默克公司的抗PD-1療法KEYTRUDA聯合用於一線治療轉移性三陰性乳癌的療效。去年收購Immunomedics時，我們曾表示將探討Trodelvy在多種腫瘤類型中的應用，並尋求與內部和外部分子藥物的聯合治療。如今，與默克公司的合作正是我們這項策略的早期體現。

Next, on Slide 5, I'm pleased to note that we delivered on 3 of our target milestones for the quarter. You will also note that the time lines for TROPiCS-02 and the Phase Ib magrolimab have shifted as we now expect to have the PFS readout for TROPiCS-02 in late January or early February, and the top line readout for the Phase Ib magrolimab in the first quarter of 2022.

接下來，在第5張投影片中，我很高興地指出，我們達成了本季3個目標里程碑。您還會注意到，TROPiCS-02和Ib期magrolimab試驗的時間表有所調整，我們現在預計將在1月下旬或2月初獲得TROPiCS-02的無進展生存期（PFS）數據，並在2022年第一季度獲得Ib期magrolimab試驗的主要結果數據。

Merdad will also touch on this later in the call. But as you know, these modest timeline adjustments are quite normal in oncology, especially event-driven trials like TROPiCS-02. We look forward to sharing these updates in the first quarter of 2022.

Merdad稍後也會在電話會議中談到這一點。但如您所知，在腫瘤學領域，尤其是像TROPiCS-02這樣以事件驅動的試驗中，這些時間安排上的小幅調整非常正常。我們期待在2022年第一季分享這些最新進展。

Taken as a whole, our oncology portfolio now spans some of the most promising targets in the field today. In addition to Trodelvy for Trop-2, CD47 and cell therapy, these include TIGIT, adenosine and many others. We are very encouraged by the momentum across these programs and look forward to sharing much more in the coming quarters.

總體而言，我們的腫瘤產品組合目前涵蓋了該領域一些最有前景的標靶。除了用於治療Trop-2、CD47和細胞療法的Trodelvy之外，還包括TIGIT、腺苷等多種標靶。我們對這些項目的進展勢頭感到非常鼓舞，並期待在接下來的幾個季度分享更多資訊。

The positive momentum overall in the third quarter gives us great confidence in the direction we are taking and the pace of our progress. We are well on our way with the plans to sustain our leadership in HIV. And while there is much more to come in oncology, we've already begun to execute on the potential in our highly promising portfolio. Veklury is making a significant impact as the pandemic continues to evolve, and we are well placed for when the HIV market bounces back.

第三季整體的正面動能讓我們對發展方向和進展速度充滿信心。我們正按計劃穩步推進，以鞏固我們在愛滋病領域的領先地位。雖然腫瘤領域還有許多工作要做，但我們已經開始著手開發極具潛力的產品組合。隨著疫情的持續發展，Veklury 正在發揮顯著作用，我們已做好充分準備，迎接愛滋病市場的復甦。

I want to thank all the Gilead and Kite employees around the world who are making all this possible with their passion for scientific excellence and their commitment to global public health.

我要感謝吉利德和凱特公司在全球的所有員工，正是他們對卓越科學的熱情和對全球公共衛生的承諾，使得這一切成為可能。

With that, I'll hand over to Johanna, who will share an update on the commercial performance in the third quarter.

接下來，我將把麥克風交給 Johanna，她將分享第三季商業業績的最新情況。

Thanks, Dan, and good afternoon, everyone. As you can see on Slide 7, total product sales of $7.4 billion grew 13% year-over-year, primarily driven by Veklury. Excluding Veklury, total product sales were $5.4 billion, down 3% year-over-year, primarily due to the impact of the Truvada and Triple LOEs, offset by continued growth in Biktarvy and contributions from our new medicines such as Trodelvy.

謝謝丹，大家下午好。正如您在幻燈片7中看到的，產品總銷售額為74億美元，年增13%，主要得益於Veklury的成長。若不計入Veklury，產品總銷售額為54億美元，年減3%，主要原因是Truvada和Triple LOE的影響，但Biktarvy的持續成長以及Trodelvy等新藥的貢獻抵消了部分影響。

On Slide 8, Veklury sales of $1.9 billion were up 132% sequentially and reflected strong U.S. demand consistent with the recent surge in COVID cases, including the Delta variant. Over 60% of patients hospitalized with COVID-19 in the U.S. received Veklury, and we continue to expect Veklury sales to track hospitalizations, which you can see peaked at the end of August and have been declining ever since.

在第8張幻燈片中，Veklury的銷售額達到19億美元，環比增長132%，反映了美國強勁的需求，這與近期新冠病例激增的情況相符，其中包括Delta變體。在美國，超過60%的新冠住院患者接受了Veklury治療，我們仍然預期Veklury的銷售額將與住院人數保持同步增長，正如您所看到的，住院人數在8月底達到峰值，此後一直在下降。

Moving to HIV on Slide 9. Revenue of $4.2 billion grew 6% sequentially, driven by favorable net pricing and strong demand for Biktarvy, partially offset by a continuation of the trends towards a less favorable payer mix. While sequential trends were strong, total HIV revenues were down 8% year-over-year, given the impact of the Truvada and Triple LOEs and lower channel inventory, primarily driven by pandemic-related stocking in the prior year. Excluding the impact of the LOEs, HIV revenues were up 4% year-over-year.

幻燈片9：愛滋病業務。營收達42億美元，季增6%，主要得益於有利的淨定價和Biktarvy的強勁需求，但部分被支付方結構持續惡化的趨勢所抵銷。儘管環比成長強勁，但由於Truvada和Triple LOE的影響以及渠道庫存減少（主要由上一年疫情相關的庫存積壓所致），愛滋病業務總收入同比下降8%。若剔除LOE的影響，愛滋病業務收入年增4%。

Overall, we're encouraged by the improving trends in HIV treatment. The US HIV treatment market grew about 3% sequentially, suggesting a modest pickup from the recovery that started in Q2. Our share of the overall U.S. HIV treatment market continues to hold steady at approximately 75%. And reflecting the modest pandemic recovery and strong share gains, Biktarvy revenues grew 20% year-over-year and 14% sequentially to a record $2.3 billion.

整體而言，我們對愛滋病治療領域的改善趨勢感到鼓舞。美國愛滋病治療市場較上季成長約3%，顯示自第二季開始的復甦動能有所回升。我們在美國愛滋病治療市場的整體份額持續保持穩定，約為75%。由於疫情的溫和復甦和強勁的市佔率成長，Biktarvy的營收年增20%，季增14%，達到創紀錄的23億美元。

DESCOVY revenue of $433 million was flat quarter-over-quarter, driven by increased demand and inventory offset by lower net price. We continue to see recovery year-to-date with the PrEP market growing 12% quarter-over-quarter and are encouraged to see DESCOVY share holding steady around 45% despite the availability of multisource generic versions of Truvada.

DESCOVY營收為4.33億美元，與上一季持平，主要得益於需求和庫存的成長，但部分被淨價下降所抵銷。我們持續看到今年以來PrEP市場復甦的勢頭，該市場環比增長12%，儘管Truvada有多種來源的仿製藥，DESCOVY的市場份額仍穩定在45%左右，這令人鼓舞。

Next, on Slide 10. Biktarvy continues to gain market share sequentially and year-over-year, both in the U.S. and the EU5. We are particularly pleased to see sequential quarterly growth of 1.5% in the U.S. and 1% in the EU5, especially given Biktarvy's leading market share. We're proud to see continued uptake of Biktarvy now capturing 41% of the total treatment market in the U.S., with more than 57% of people living with HIV starting treatment on Biktarvy.

接下來，請看第10頁投影片。 Biktarvy在美國和歐盟五國（EU5）的市佔率均持續成長，較上季和年比均有所提升。尤其令人欣喜的是，Biktarvy在美國和歐盟五國分別實現了1.5%和1%的季度環比增長，考慮到其領先的市場份額，這一增長尤為顯著。我們很自豪地看到，Biktarvy的市佔率持續成長，目前已佔據美國治療市場41%的份額，超過57%的HIV感染者選擇使用Biktarvy作為初始治療藥物。

On Slide 11, HCV revenue of $429 million was down 8% year-over-year, primarily driven by favorable settlement in the third quarter of 2020 that did not repeat, fewer patient starts outside of the U.S. and the timing of the Department of Corrections purchases on a relative basis. Sequentially, HCV revenue declined 22% due to inventory dynamics, including a sizable purchase by the Department of Corrections in the prior quarter and fewer patient starts. Although starts improved in some geographies year-over-year, we saw sequential declines in the U.S. and Europe, driven by continued pandemic-related impact on patient visits and lower testing volumes in additional -- in addition to normal seasonality. However, we continue to be pleased that Gilead HCV market share is holding steady around 60% in the U.S. and just above 50% in the EU5.

根據第11頁投影片，C型肝炎（HCV）收入為4.29億美元，年減8%，主要原因是2020年第三季有利的結算情況未能重現，美國以外地區的新患者數量減少，以及懲教部門採購的時間安排相對而言。環比來看，HCV收入下降22%，主要原因是庫存動態變化，包括懲教部門在上一季的大額採購以及新患者數量減少。儘管部分地區的新患者數量同比有所改善，但美國和歐洲的新患者數量環比下降，這主要是由於疫情持續影響患者就診量，以及檢測量下降——此外，正常的季節性因素也是原因之一。然而，我們仍欣喜地看到，吉利德HCV在美國的市佔率穩定在60%左右，在歐盟五國（EU5）的市佔率略高於50%。

Moving to Slide 12. HBV and HDV revenues of $247 million were up 17% year-over-year, driven by Vemlidy demand in the international markets and the addition of Hepcludex to our portfolio. Q3 revenue for Hepcludex was $12 million, reflecting sales now in Germany, France, Austria and Greece. We are actively working with government authorities to secure full reimbursement in the major European markets in 2022.

翻到第12頁。 HBV和HDV的營收為2.47億美元，年增17%，主要得益於Vemlidy在國際市場的需求以及Hepcludex的加入。 Hepcludex第三季的營收為1,200萬美元，反映了目前在德國、法國、奧地利和希臘的銷售情況。我們正積極與政府部門合作，爭取2022年獲得歐洲主要市場的全額報銷。

Moving to Trodelvy on Slide 13. Third quarter revenue of $101 million grew 13% quarter-over-quarter, driven by increased share in metastatic TNBC in part due to the expansion to second line. Trodelvy was approved for second-line metastatic TNBC in the U.S. in April, and we already estimate that approximately 15% of second-line patients are receiving Trodelvy. In the third line or later setting, we estimate that about 1/3 of patients with metastatic TNBC are receiving Trodelvy. In urothelial cancer, at least 1 in 4 bladder cancer patients in the third line or later setting start treatment on Trodelvy. And with adoption in second line still early, there is continued opportunity for growth across both settings.

投影片13：Trodelvy。第三季營收達1.01億美元，季增13%，主要得益於轉移性三陰性乳癌（TNBC）市場佔有率的提升，部分原因是該藥物已擴展至第二線治療。 Trodelvy今年4月在美國獲準用於二線轉移性TNBC治療，我們估計目前約有15%的第二線患者正在接受Trodelvy治療。在第三線及以上治療方案中，我們估計約有三分之一的轉移性TNBC患者正在接受Trodelvy治療。在尿路上皮癌領域，至少四分之一的第三線及以上膀胱癌患者在接受Trodelvy治療之初便開始使用此藥。由於二線治療的應用仍處於早期階段，因此在兩種治療方案中都存在持續的成長空間。

We're pleased with the uptake so far and remain focused on broadening physician awareness in community settings. Following recent NCCN breast cancer and ESMO clinical guideline updates, Trodelvy is now included as a preferred regimen in second-line metastatic TNBC in both guidelines, and we expect this will drive further adoption. We are preparing the first commercial launches of Trodelvy for metastatic TNBC in Great Britain, Australia, Canada and Switzerland. And later this year, we are expecting a decision from the European Commission following the recent positive opinion from the CHMP.

我們對目前的市場接受度感到滿意，並將繼續致力於提高社區醫生對該藥物的認知。根據近期NCCN乳癌和ESMO臨床指引的更新，Trodelvy已被納入兩項指引中，作為二線轉移性三陰性乳癌的首選治療方案，我們預計這將進一步推動該藥物的普及。我們正準備在英國、澳洲、加拿大和瑞士率先推出Trodelvy用於治療轉移性三陰性乳癌。此外，我們預計今年晚些時候，在人用藥物委員會（CHMP）近期給出積極意見後，歐盟委員會也將做出最終決定。

Next, on Slide 14 and on behalf of Christi and the Kite team, our cell therapy products grew 51% year-over-year to $222 million. This was driven by LBCL demand and strong launches in both mantle cell lymphoma and follicular lymphoma, more than offsetting the expected impact of new U.S. entrants in LBCL. With the addition of our new MCL and FL indications, we are particularly proud that we have maintained our best-in-class manufacturing operations with a 97% reliability rate.

接下來，在第14張投影片中，我代表Christi和Kite團隊介紹，我們的細胞療法產品年增51%，達到2.22億美元。這主要得益於大B細胞淋巴瘤（LBCL）的需求，以及套細胞淋巴瘤和濾泡性淋巴瘤（FL）領域強勁的上市，完全抵消了美國新進入LBCL市場的產品可能帶來的影響。此外，隨著我們新增MCL和FL適應症，我們尤其自豪的是，我們保持了業內領先的生產營運水平，可靠性高達97%。

To support our expected growth, we are working to bring our new Maryland facility online in mid-2022, which will automate many of our manual processes and reduce costs.

為了支持我們預期的成長，我們正在努力使我們位於馬裡蘭州的新工廠在 2022 年年中投入使用，這將使我們的許多人工流程自動化並降低成本。

We also wanted to highlight the recent FDA approval of Tecartus in adult ALL. This makes Tecartus the first and only CAR T therapy now available to these eligible patients in the U.S. The Kite team has also filed a supplemental BLA for Yescarta in second-line LBCL which would bring us one step closer to potentially curing even more patients. Christi is here with the team and available to take questions on cell therapy during the Q&A.

我們也想重點介紹Tecartus近期獲得FDA核准用於治療成人急性淋巴性白血病（ALL）。這使得Tecartus成為目前美國首個也是唯一可用於此類患者的CAR-T療法。 Kite團隊也提交了Yescarta用於二線大B細胞淋巴瘤（LBCL）的補充生物製品許可申請（SBL），這將使我們離治癒更多患者的目標更近一步。 Christi將與團隊成員一起出席問答環節，並解答有關細胞療法的問題。

And with that, I'll hand it over to Merdad for pipeline update.

好了，接下來我將把任務交給 Merdad，讓他更新管道狀況。

Thank you, Johanna. As always, I'll focus today on the most important updates and refer you to the appendix of the earnings presentation for a more comprehensive view of our pipeline programs.

謝謝喬安娜。和往常一樣，今天我將重點介紹最重要的更新內容，如需更全面地了解我們的在研項目，請參閱收益報告的附錄。

First, on Slide 16, in HIV prevention. We've initiated the 5,000-plus participant Phase III purpose I trial setting lenacapavir for the prevention in adolescent girls and young women who are at risk of HIV infection. We're also in the initial stages of recruiting for purpose 2 to evaluate lenacapavir for prevention in over 3,000 cis-gender men, transgender and gender non-binary who have sex with men. We will provide updated timelines once enrollment is further along.

首先，在第16張投影片中，我們介紹了愛滋病預防方面的情況。我們已啟動一項超過5000名受試者的III期臨床試驗（目的1），旨在評估lenacapavir在有愛滋病感染風險的青少年女孩和年輕女性中的預防作用。同時，我們也在進行目的2的初步招募工作，以評估lenacapavir在3000多名與男性發生性行為的順性別男性、跨性別者和非二元性別者中的預防作用。一旦招募工作取得進一步進展，我們將提供更新的時間表。

In HIV treatment, the FDA granted priority review in August for lenacapavir for the treatment of people living with HIV who have developed multidrug resistance to other antiretrovirals. This is based on compelling CAPELLA data that demonstrated 81% of heavily treatment-experienced individuals achieved viral suppression when lenacapavir was combined with an optimized background regimen.

在愛滋病治療領域，FDA於8月授予lenacapavir優先審查資格，用於治療對其他抗愛滋病毒藥物產生多重抗藥性的愛滋病毒感染者。這項決定是基於CAPELLA研究的有力數據，該研究表明，lenacapavir聯合優化的基礎治療方案，可使81%的既往接受過多種治療的患者實現病毒抑制。

The PDUFA action date has been set for February 28, 2022, and if approved, lenacapavir would become the first available 6-month long-acting subcutaneous injection treatment for HIV.

PDUFA 行動日期已定於 2022 年 2 月 28 日，如果獲得批准，lenacapavir 將成為第一個可用於治療 HIV 的 6 個月長效皮下注射藥物。

Earlier this week, we announced that enrollment had started for the Phase II trial for the long-acting oral combination of lenacapavir and islatravir. This is part of our collaborative work with Merck to develop more flexible options for people living with HIV with a once-weekly oral pill. Gilead is leading the development and clinical work for this oral combination and Merck is leading the clinical work for the injectable combination that is expected to enter Phase I clinical trials next year.

本週早些時候，我們宣布了長效口服複方製劑lenacapavir和islatravir的第二期臨床試驗已啟動。這是我們與默克公司合作的一部分，旨在為HIV感染者開發更靈活的每週口服藥物方案。吉利德公司負責此口服複方製劑的研發和臨床試驗，而默克則負責預計明年進入I期臨床試驗的注射複方製劑的臨床試驗。

Moving to Veklury on Slide 17. We presented a late breaker at the IDWeek 2021 conference last month based on the Phase III PINETREE study, evaluating Veklury an outpatient intravenous COVID-19 treatment. The results demonstrated that a 3-day course of Veklury significantly reduced the risk of hospitalization for high-risk patients with COVID-19. In particular, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalizations or all-cause mortality by day 28 compared with placebo. There were no deaths in either arm of the study by day 28.

接下來是投影片 17 中的 Veklury。上個月，我們在 IDWeek 2021 會議上發表了一項基於 III 期 PINETREE 研究的最新成果，該研究評估了 Veklury 作為門診靜脈注射 COVID-19 治療藥物的療效。結果表明，為期 3 天的 Veklury 療程顯著降低了 COVID-19 高風險患者的住院風險。特別是，與安慰劑相比，Veklury 在第 28 天時，將 COVID-19 相關住院或全因死亡這一複合主要終點的風險降低了 87%，且具有統計意義。研究的兩個治療組在第 28 天均無死亡病例。

We stopped PINETREE enrollment at the halfway mark of 584 patients in April due to the COVID-19 landscape at the time, but the study remained blinded and collected outcome data in the enrolled patients. Upon analysis of those data, results were highly statistically significant and clinically meaningful, again, demonstrating the efficacy of Veklury. It also emphasizes the importance of early treatment with antiviral therapies.

由於當時新冠疫情情況嚴峻，我們在4月暫停了PINETREE研究的入組，當時已招募了584名患者，但研究仍保持盲法，並收集了已入組患者的結局數據。在對這些數據進行分析後，結果具有高度統計意義和臨床意義，再次證明了Veklury的療效。這也強調了早期使用抗病毒療法的重要性。

We have submitted these data to the FDA as an sNDA filing and are in discussions with other regulatory agencies to explore approval for IV Veklury in an outpatient setting. We're also continuing our work to develop novel oral antivirals for the treatment of COVID-19.

我們已將這些數據作為補充新藥物申請 (sNDA) 提交給 FDA，並正在與其他監管機構進行諮詢，探討批准靜脈注射 Veklury 用於門診治療。我們也持續致力於開發用於治療 COVID-19 的新型口服抗病毒藥物。

Moving to Slide 18. We continue to view Trodelvy as a pipeline in a product. Trodelvy targets Trop-2, which is overexpressed in many solid tumor cells. So we believe that Trodelvy can have a meaningful impact on a wide range of cancers in addition to the second-line metastatic TNBC and second-line bladder indications that are approved today.

翻到第18頁。我們仍然將Trodelvy視為產品線的一部分。 Trodelvy靶向Trop-2，Trop-2在許多實體瘤細胞中過度表現。因此，我們相信，除了目前已核准的二線轉移性三陰性乳癌和第二線膀胱癌適應症外，Trodelvy還可以對多種癌症產生顯著影響。

We're all eagerly anticipating the readout from the Phase III TROPiCS-02 study, our randomized Phase III trial in HR-positive HER2-negative metastatic breast cancer. As a reminder, this is an event-driven trial, evaluating disease progression, and we have not yet achieved the target number of events. As such, we now expect to have the top line data readout in late January or early February. To be clear, data analysis will only begin once we achieve the required number of events. We remain confident for the potential of Trodelvy to deliver a clinically meaningful benefit to patients with HR-positive HER2-negative metastatic breast cancer.

我們都在翹首以盼 TROPiCS-02 III 期研究的結果，這是一項針對 HR 陽性、HER2 陰性轉移性乳癌患者的隨機 III 期臨床試驗。需要提醒的是，這是一項以事件為驅動的試驗，旨在評估疾病進展，而我們尚未達到預期的事件數。因此，我們預計將於 1 月下旬或 2 月初公佈初步數據。需要明確的是，數據分析只有在達到所需的事件數後才會開始。我們仍然對 Trodelvy 為 HR 陽性、HER2 陰性轉移性乳癌患者帶來具有臨床意義的益處充滿信心。

We also continue to do advanced Trodelvy into registrational studies for other indications. For example, as recently posted on clinicaltrials.gov, we plan to initiate the Phase III trial in second to third line non-small cell lung cancer at risk and look forward to sharing updates for other solid tumors as we expand the program. As Dan mentioned, we'll also start to work with Merck on a new clinical study looking at Trodelvy in combination with Merck's Keytruda for first-line metastatic TNBC and plan to initiate the trial in the first half of 2022.

我們也持續推進Trodelvy在其他適應症的註冊研究。例如，正如最近在clinicaltrials.gov網站上發布的信息，我們計劃啟動Trodelvy在二線或三線治療高危非小細胞肺癌方面的III期臨床試驗，並期待隨著項目拓展，分享其他實體瘤的最新進展。正如Dan所提到的，我們還將與默克公司合作進行一項新的臨床研究，評估Trodelvy聯合默克公司的Keytruda用於一線治療轉移性三陰性乳癌的療效，並計劃於2022年上半年啟動該試驗。

Moving on to Slide 19. We continue to believe that with its synergistic potential and the safety profile observed to date, magrolimab could benefit patients with a variety of hematologic and solid tumors. As you know, our initial focus has been MDS and AML. While our commitment to these patients remains unchanged, we continue to evolve our clinical programs in the context of the recent developments in the MDS therapeutic landscape. The ongoing Phase III ENHANCE trial evaluating magrolimab in higher-risk MDS is on track and enrolling well. We will discuss our development plans and regulatory path forward with the FDA before the end of the year. Meanwhile, the data from our Phase Ib trial continues to mature, and we now expect to share top line data in the first quarter of 2022.

接下來是第19張投影片。我們仍然相信，憑藉其協同增效作用和迄今為止觀察到的安全性，magrolimab有望使多種血液腫瘤和實體瘤患者獲益。如您所知，我們最初的重點是MDS和AML。我們對這些患者的承諾始終不變，同時我們也根據MDS治療領域的最新進展不斷調整我們的臨床計畫。目前正在進行的評估magrolimab治療高危險MDS的III期ENHANCE試驗進展順利，患者招募良好。我們將在年底前與FDA討論我們的研發計畫和監管審批路徑。同時，我們的Ib期試驗數據也不斷完善，我們預計在2022年第一季公佈初步數據。

Looking beyond MDS, our ENHANCE-02 trial for magrolimab in first-line TP53 mutant AML is ongoing, targeting a new therapeutic option for nearly 2,000 patients in the U.S. In addition, an estimated 6,000 patients in the U.S. are diagnosed and treated annually with unfit AML. So we're expanding our development efforts to initiate a Phase III trial for first-line unfit AML by early next year.

除了MDS之外，我們正在進行針對第一線TP53突變型AML患者的magrolimab藥物ENHANCE-02試驗，旨在為美國近2,000名患者提供一種新的治療選擇。此外，據估計，美國每年約有6000名不適合接受治療的AML患者被診斷並接受治療。因此，我們正在擴大研發投入，並計劃於明年初啟動第一線不適合接受治療的AML患者的III期臨床試驗。

Over the past few months, we've initiated 2 solid tumor trials for magrolimab, one in head and neck cancer and a separate solid tumor basket study for patients with non-small cell lung cancer, small cell lung cancer and urothelial cancer. We also plan to initiate a third study in metastatic TNBC. Based on broad CD47 expression, we're excited by magrolimab's potential to be an effective therapy for solid tumors and look forward to sharing more updates as they become available.

過去幾個月，我們啟動了兩項針對magrolimab的實體瘤臨床試驗，一項針對頭頸癌，另一項針對非小細胞肺癌、小細胞肺癌和尿路上皮癌患者的實體瘤籃式試驗。我們也計劃啟動第三項針對轉移性三陰性乳癌（TNBC）的臨床試驗。基於其廣泛的CD47表達，我們對magrolimab作為實體瘤有效療法的潛力感到振奮，並期待在獲得更多資訊後與大家分享。

Next, on behalf of Christi and the Kite team, I also wanted to highlight the most recent approval for Tecartus in adults with relapsed or refractory ALL on Slide 20. There's an incredibly high unmet need for these patients with 50% of adult patients relapsing on currently available treatment. The approval was based on data from ZUMA-3, which demonstrated 65% of patients achieved complete remission. Additionally, as Johanna mentioned earlier, Kite has filed the sBLA for Yescarta in second-line LBCL. With a median follow-up of 2 years, the study met the primary endpoint of event-free survival with a hazard ratio of 0.398 and a p-value of less than 0.0001, representing a potential significant advance in the standard of care for LBCL patients. We look forward to reviewing the entire data set at ASH and expect an update next year on approval status.

接下來，我謹代表Christi和Kite團隊，重點介紹投影片20中Tecartus核准用於治療復發或難治性成人急性淋巴性白血病（ALL）的最新進展。目前，這類患者的未滿足需求非常高，50%的成人患者在使用現有治療方案後會復發。此次獲準基於ZUMA-3研究的數據，該研究顯示65%的患者達到了完全緩解。此外，正如Johanna先前提到的，Kite已提交Yescarta用於二線大B細胞淋巴瘤（LBCL）的補充生物製品許可申請（sBLA）。研究的中位追蹤時間為2年，達到了無事件存活期的主要終點，風險比為0.398，p值小於0.0001，代表LBCL患者標準治療方案可能取得重大進展。我們期待在ASH會議上審查全部數據，並預計明年將獲得關於其獲批狀態的最新資訊。

Lastly, moving to Slide 21. We remain very excited about our oncology partners, whose work spans many promising new pathways in oncology. For example, our partners at Arcus has a pipeline that includes not only anti-TIGIT candidates, but also CD73 and adenosine receptor inhibitors to promote immune responses and inhibit tumor growth. We continue to expect to trigger the opt-in review period for Arcus' domvanalimab, likely later this year or early next year, pending the review of more mature data. Additionally, through our partnerships, we have access to several candidates that could help modulate immunosuppressive and tumor permissive cell types and pathways, including Tizona's HLA-G checkpoint inhibitor, which recently expanded to a Phase Ib study; and Jounce's CCR8 inhibitor, which received IND clearance last quarter.

最後，請看第21張投影片。我們對腫瘤領域的合作夥伴仍然充滿信心，他們的研究涵蓋了腫瘤學領域許多極具前景的新方向。例如，我們的合作夥伴Arcus的研發管線不僅包括抗TIGIT候選藥物，還包括CD73和腺苷受體抑制劑，這些抑制劑能夠促進免疫反應並抑制腫瘤生長。我們仍然期待Arcus的domvanalimab能夠啟動選擇加入審查期，可能在今年稍後或明年年初，具體取決於更成熟的數據審查結果。此外，透過我們的合作關係，我們能夠獲得一些有助於調節免疫抑制細胞和腫瘤易感細胞類型及通路的新候選藥物，包括Tizona的HLA-G檢查點抑製劑（該藥物最近已擴展至Ib期研究）以及Jounce的CCR8抑製劑（該藥物已於上季度獲得IND批准）。

Other potential opt-in programs from partners include Pionyr's TREM1 and TREM2 antibodies, which are in Phase I trials in actively enrolling patients; and agenus' CD137 agonist, which is expected to be evaluated in the combination trial that will be initiated later this year.

其他合作夥伴可能提供的其他選擇加入方案包括 Pionyr 的 TREM1 和 TREM2 抗體（目前正在進行 I 期試驗，積極招募患者）；以及 agenus 的 CD137 激動劑（預計將在今年稍後啟動的聯合試驗中進行評估）。

In closing, on Slide 22, our teams are focused on executing across our oncology, virology and inflammation pipeline. And while it's still early days for our inflammation portfolio, we remain committed and invested in continuing to advance our pipeline across various mechanisms of action, such as IRAK4, alpha 4 beta 7 and TPL2. In combination with our opt-in partners, our pipeline portfolio spans many of the most promising targets across our 3 therapeutic focus areas. We're very excited and committed to build out our best-in-class and industry-leading franchises.

最後，在第22張投影片中，我們的團隊專注於推進腫瘤、病毒和發炎領域的研發管線。雖然我們的發炎產品組合仍處於早期階段，但我們仍致力於持續推進針對不同作用機制（例如IRAK4、α4β7和TPL2）的研發管線。結合我們已選擇加入的合作夥伴，我們的產品管線涵蓋了三大治療領域中許多最有前景的標靶。我們非常興奮，並致力於打造業界領先、一流的產品線。

I'll now hand it over to Andy.

現在我把它交給安迪。

Thank you, Merdad, and good afternoon, everyone. Moving to Slide 24. As you've heard from Johanna, our financial performance in the third quarter overall was strong, with total product sales up 13% year-over-year, driven by Veklury's continued role in the pandemic. Year-over-year total product sales, excluding Veklury, fell 3% due to lower Truvada and Atripla sales following their loss of exclusivity late last year, offset in part by the continued demand for Biktarvy and contributions from our new medicines such as Trodelvy.

謝謝Merdad，大家午安。接下來是第24張投影片。正如Johanna剛才提到的，我們第三季的整體財務業績表現強勁，產品總銷售額年增13%，這主要得益於Veklury在疫情期間的持續發揮。若不計入Veklury，產品總銷售額年減3%，原因是Truvada和Atripla在去年底失去獨家銷售權後銷售額下降，但Biktarvy的持續需求以及Trodelvy等新藥的貢獻部分抵消了這一影響。

Sequentially, total product sales excluding Veklury were up 2%, highlighting the ongoing pandemic recovery in HIV treatment and prep. This was partially offset by HCV, where new starts in both the U.S. and Europe continue to be impacted by the pandemic.

不計入Veklury，產品總銷售額較上季成長2%，凸顯了HIV治療和預防領域在疫情期間持續復甦的趨勢。但丙型肝炎的銷售額部分抵銷了這一成長，美國和歐洲的丙型肝炎新發病例仍受到疫情的影響。

Turning to the rest of the P&L. Non-GAAP product gross margin was 90%, 350 basis points higher year-over-year, reflecting the reversal of a previously recorded $175 million litigation reserve as well as lower royalty expense and a change in product mix. Non-GAAP R&D was $1.1 billion, down 4% year-over-year, reflecting lower remdesivir and inflammation-related expenses offset in part by increased clinical investment in Trodelvy and magrolimab.

接下來來看損益表的其他部分。非GAAP產品毛利率為90%，年增350個基點，這主要得益於先前提列的1.75億美元訴訟準備金的衝回、特許權使用費支出的降低以及產品組合的變化。非GAAP研發支出為11億美元，年減4%，這主要反映了瑞德西韋和發炎相關支出的減少，但部分被Trodelvy和magrolimab臨床投資的增加所抵消。

Non-GAAP SG&A was $1.2 billion, up 8% year-over-year, driven by increased promotional and marketing activities across all of our geographies, primarily for Trodelvy. On tax, we realized a higher effective tax rate of 18.9% for the third quarter were up 50 basis points year-over-year, primarily due to a prior year net discrete tax benefit. Overall, our non-GAAP diluted earnings per share was $2.65 for the quarter compared to $2.11 for the same period last year. The year-over-year increase primarily reflects higher Veklury sales and product gross margin offset by higher SG&A, lower interest income and higher effective tax rate.

非GAAP銷售、管理及行政費用為12億美元，年增8%，主要得益於我們在所有地區（尤其是Trodelvy）加大了促銷和行銷活動。稅務方面，第三季實際稅率為18.9%，較上年同期上升50個基點，主因是去年同期淨一次性稅優惠。整體而言，本季非GAAP攤薄後每股收益為2.65美元，去年同期為2.11美元。年比成長主要反映了Veklury銷售額和產品毛利率的成長，但部分被銷售、管理及行政費用增加、利息收入減少以及實際稅率上升所抵銷。

On Slide 25, you can see that Veklury has already exceeded our prior guidance for the year, with total revenues of $4.2 billion in the first 9 months. As a result, and with modestly updated expectations for the rest of our business, we are increasing our revenue and earnings per share guidance for the full year by 6% and 13% at the midpoint, respectively, as shown on Slide 26.

如投影片25所示，Veklury前9個月的總營收已達42億美元，超過了我們先前的年度預期。因此，結合對公司其他業務預期的適度調整，我們將全年營收和每股盈餘預期中位數分別上調6%和13%，如投影片26所示。

After the wave of infections and hospitalizations in recent months, we believe we have moved past the peak of the pandemic for the year. We continue to expect that Veklury will play an important role in the treatment of patients with COVID-19 globally. However, assuming we do not experience another surge, we expect Veklury revenue to step down significantly in the fourth quarter. As a result, we are raising our full year total product sales in the range of $26 billion to $26.3 billion, compared to our previous range of $24.4 billion to $25 billion, reflecting results year-to-date and Veklury performance. We now expect full year Veklury revenues to be in the range of $4.5 billion to $4.8 billion up from our prior outlook of $2.7 billion to $3.1 billion. We continue to expect that sales of Veklury will track COVID-19-related hospitalizations.

經過近幾個月的感染和住院潮，我們認為今年的疫情高峰已經過去。我們仍然預期Veklury將在全球新冠肺炎患者的治療中發揮重要作用。然而，假設不會出現新一輪疫情高峰，我們預計Veklury的營收將在第四季大幅下降。因此，我們將全年產品總銷售額預期從先前的244億美元至250億美元上調至260億美元至263億美元，這反映了年初至今的業績以及Veklury的表現。我們現在預計Veklury全年營收將在45億美元至48億美元之間，高於先前預期的27億美元至31億美元。我們仍然預期Veklury的銷售額將與新冠肺炎相關的住院人數保持同步成長。

We now expect full year total product sales excluding Veklury to be approximately $21.5 billion compared to the prior range of $21.7 billion to $21.9 billion, reflecting our performance year-to-date and continued pandemic-related impact.

我們現在預計，不包括 Veklury 在內的全年產品總銷售額約為 215 億美元，而此前的預期範圍為 217 億美元至 219 億美元，這反映了我們今年迄今為止的業績以及疫情持續帶來的影響。

As for the rest of our P&L, we expect our non-GAAP product gross margin to be approximately 87% compared to 86% to 87% previously, primarily reflecting the strong gross margin in the third quarter. For non-GAAP operating expenses, we now expect R&D to decline mid-single-digit percentage compared to 2020 levels as compared to our prior expectations of low to mid-single-digit percentage decline. We expect SG&A to be flat on a dollar basis compared to 2020 versus prior expectations of flat to low single-digit percentage decline. On our non-GAAP effective tax rate is still expected to be approximately 21% this year.

至於損益表的其他部分，我們預期非GAAP產品毛利率約為87%，高於先前預期的86%至87%，這主要反映了第三季強勁的毛利率。對於非GAAP營運費用，我們現在預期研發支出將較2020年水準下降個位數百分比，而先前的預期為個位數百分比下降幅度較小。我們預期銷售、管理及行政費用（SG&A）將與2020年持平，而先前的預期為持平或個位數百分比下降幅度較小。我們預計今年的非GAAP有效稅率仍約為21%。

Finally, with the updates to our revenue, product gross margin and operating expenses, we now expect our non-GAAP diluted EPS to be between $7.90 and $8.10 for the full year and GAAP diluted EPS to be between $5.50 and $5.70.

最後，根據我們對收入、產品毛利率和營運費用的更新，我們現在預計全年非GAAP稀釋後每股收益將在7.90美元至8.10美元之間，GAAP稀釋後每股收益將在5.50美元至5.70美元之間。

On capital allocation, our priorities have not changed. We continue to invest in our business and at the same time, we've returned over $1 billion in the third quarter and $3.2 billion year-to-date to our shareholders through both dividends and share repurchases. We have also repaid $3.75 billion in debt this year. And earlier today, we notified our 3 non-call 1 bondholders that we would exercise our ability to repay $1 billion of the notes early. Taken together, we now expect to pay down $4.75 billion of debt this year, significantly exceeding our prior guidance to pay down at least $4 billion.

在資本配置方面，我們的優先事項並沒有改變。我們持續投資自身業務，同時，第三季已透過股利和股票回購向股東返還超過10億美元，年初至今累計返還32億美元。此外，我們今年也償還了37.5億美元的債務。今天早些時候，我們通知了3家不可贖回債券持有人，我們將行使提前償還10億美元債券的權利。綜上所述，我們預計今年將償還47.5億美元的債務，遠超過先前至少償還40億美元的預期。

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

接下來，我將邀請接線生開始問答環節。

(Operator Instructions) Our first question comes from Matthew Harrison with Morgan Stanley.

（操作員說明）我們的第一個問題來自摩根士丹利的馬修·哈里森。

Probably unsurprisingly, my question is for Merdad. Merdad, can you just comment maybe in a little bit more detail in terms of the assumptions that you previously made on TROPiCS-02 and how they were tracking or not tracking that caused you to make this change and especially around the blinded event rate and anything else you were watching in the trial?

不出所料，我的問題要問Merdad。 Merdad，您能否更詳細地解釋一下您之前對TROPiCS-02所做的假設，以及這些假設是否符合預期，導致您做出此次改變，特別是關於盲法事件發生率以及您在試驗中觀察的其他任何方面？

Matthew, sure, happy to. Yes, look, I think, as you know, event-driven trials are inherently variable in terms of when the events occur and importantly, when those events come into the database. So we had initially thought we would hit the mark this year. But as time has gone by, our best projections right now is that we'll hit that mark next year. And as we said, I think we'll be able to share those results probably mid-January to mid-February time frame. So that's kind of how we're tracking to the events at this point.

馬修，當然，我很樂意。是的，你看，如你所知，事件驅動型試驗本身就存在不確定性，這體現在事件發生的時間，以及更重要的是，這些事件何時被錄入資料庫。所以我們最初認為今年就能達到目標。但隨著時間的推移，我們目前的最佳預測是明年才能達到目標。正如我們所說，我認為我們大概可以在一月中旬到二月中旬之間分享這些結果。這就是我們目前對這些事件的追蹤情況。

Our next question comes from Tyler Van Buren with Cowen.

下一個問題來自 Cowen 公司的 Tyler Van Buren。

I have another one on TROPiCS-02. Can you just remind us or help set expectations in terms of what you feel is a clinically meaningful benefit on PFS? A lot of people seem to be taking it at around 2 months. If you do reach that at a sub 2-month PFS benefit, say 1.6 or 1.7, would you guys still go ahead and file? Or how would you view the data?

我還有另一個關於TROPiCS-02的問題。您能否提醒我們一下，或是幫助我們設定關於PFS方面臨床意義效益的預期？很多人似乎在2個月左右就達到了這個益處。如果PFS獲益在2個月以內達到，例如1.6或1.7，你們還會繼續提交申請嗎？或者你們會如何看待這些數據？

Thanks, Tyler. Yes, Merdad?

謝謝，泰勒。什麼事，梅爾達德？

Tyler, thanks. Yes, I do think the consensus that folks have seen, we would agree that 2 months is sort of that threshold for clinically meaningful. I think if we were to fall short of that, which is a difficult place to speculate and not our expectations, but if that were to happen, we would look at the totality of the data. We want to look and see if there's other areas where we could provide benefit to patients, and we look at the totality of the data before deciding what we would do.

泰勒，謝謝。是的，我認為大家的共識是，兩個月是一個具有臨床意義的閾值。如果達不到這個時間，雖然很難預測，也不是我們預期的，但如果真的發生了，我們會全面分析數據。我們希望看看是否有其他方面可以造福患者，在決定下一步之前，我們會綜合考慮所有數據。

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。

Maybe let me focus on the remdesivir for a quick second. Andy, Johanna, I'm just trying to understand the reported number a little better. It's $1.5 billion in U.S. in third quarter, which if you sort of reexpress based on the remdesivir price point would imply maybe 750,000 patients on the drug in third quarter in U.S. And we know the total U.S. COVID hospitalizations were right around 750,000 in U.S. as well. Is it just a reporting artifact and HHS estimates? I'm just trying to understand why this was materially different than the 50% to 60% penetration remdesivir has historically had? And I'll spare my TROPiCS question for Merdad subsequent to the call.

或許我可以先快速談談瑞德西韋。安迪、喬安娜，我只是想更能理解一下報道中的數字。第三季美國瑞德西韋的銷售額是15億美元，如果以瑞德西韋的價格重新計算，這意味著第三季美國可能有75萬名病患在使用這種藥物。我們知道，美國新冠肺炎住院總數也差不多是75萬人。這只是報道上的偏差和美國衛生與公眾服務部（HHS）的估計嗎？我只是想弄清楚，為什麼這個數字與瑞德西韋以往50%到60%的市場滲透率有這麼大的差異？關於TROPiCS的問題，我會在電話會議結束後問Merdad。

Thanks, Umer. Go ahead, Johanna, do you want to hit that one?

謝謝，烏默。喬安娜，你想打那一桿嗎？

Sure. Umer, I think what -- so the $9 million that Dan referred to earlier is really a mix over the year, right? So that's a little bit different than what you're referring to. The $1.5 billion in the U.S., most of the sales actually of the total $1.9 billion, obviously, coming out of the U.S. and the patient population. So I can't track your math per se. But what I would say is that the U.S. patient population was the greatest. And if you just do the math on about a 5-day therapy on an average price for remdesivir that you would get to less than year 750, just doing it off the top of my head. So I think it's probably a little bit lower than that and higher in other parts of the world just because of price points.

當然。烏默，我想──丹之前提到的900萬美元其實是全年各項收入的總和，對吧？這和你提到的有點不一樣。你說的15億美元，實際上，總共19億美元的銷售額中，大部分都來自美國，而且病患群也最大。所以我沒辦法完全理解你的計算方法。但我想說的是，美國的患者群最大。如果你以瑞德西韋的平均價格，以5天療程計算，你算下來不到750美元，這只是我粗略估計。所以我認為實際費用可能比這略低，而世界其他地區的費用會更高，這只是價格差異造成的。

And Johanna, the -- maybe also to call Umer's question, the current market share of patients -- for patients...

還有 Johanna，——或許也可以呼應 Umer 的問題，目前患者的市場份額——對於患者而言…

Yes, but it's probably a little bit north of the 60% that you're referring to. We've seen -- obviously, we're looking at different databases. But we've seen up to close to 66%, 67% of share of Veklury in early days of hospitalization, obviously, often used with dexamethasone and other inflam products that -- anti-inflammatory products. But we do see the share increase, and we've seen that, obviously with the surge in August and September, we saw that take up both from a protocol standpoint, as well as play out in the usage itself in the U.S. specifically.

是的，但可能比您提到的60%略高一些。我們看到——當然，我們參考的是不同的資料庫——在住院初期，Veklury的使用率一度接近66%到67%，通常與地塞米松和其他抗發炎藥物聯合使用。但我們確實看到使用率上升，尤其是在8月和9月的激增中，我們看到，無論是從治療方案的角度來看，還是在美國的實際使用情況來看，Veklury的使用率都有所提高。

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。

Sticking with COVID, curious to learn more about your outlook on how COVID treatment will evolve into next year and beyond? And I'm curious if you could give us a little bit more color around the efforts to develop oral direct-acting antivirals for COVID that you spoke about at the beginning of the call. Are these primarily remdesivir derivatives, you're looking at protease inhibitors, potential combination cocktails? When might we learn more about those?

繼續談到新冠疫情，我很想了解您對明年及以後新冠治療發展趨勢的看法。另外，您剛才在電話會議開始時提到正在研發口服直接抗病毒藥物，我想更詳細地了解一下。這些藥物主要是瑞德西韋衍生物嗎？您是否也在研究蛋白酶抑制劑，或其他潛在的合併用藥方案？我們什麼時候能了解到更多相關資訊？

Yes. Thanks, Brian, I think we've all been a little bit shy about predicting how the pandemic will continue to evolve because I think we've proven to be not always right on that. I'm going to -- I'm going to let Merdad comment and also have the other team members have anything to comment. What I will say is back to the previous question from Umer is there's no doubt that we see a direct connection, correlation between remdesivir's use and outbreak. So that continues. And as Johanna says, we continue to get the market share. And there's also no doubt, Brian, your point that although injectable remdesivir continues to play a really important role around the world for hospitalized patients, and now the data, obviously, we have in the outpatient setting, we're not satisfied yet, and we want to continue to put our science to work. And maybe, Merdad, if you want to have any forecasts in the future of pandemic to end there, mate, you're welcome to.

是的。謝謝布萊恩，我想我們都對預測疫情的未來發展趨勢有些猶豫，因為我們已經證明，我們在這方面的預測並非總是正確的。接下來，我請梅爾達德發言，也請其他團隊成員發表意見。我想回到烏默之前的問題，毫無疑問，我們看到了瑞德西韋的使用與疫情爆發之間的直接聯繫和相關性。這一點仍在持續。正如喬安娜所說，我們的市場份額也在不斷增長。布萊恩，你的觀點也無可辯駁，雖然注射用瑞德西韋在世界各地的住院患者中繼續發揮著非常重要的作用，但就目前我們在門診方面的數據而言，我們顯然並不滿意，我們希望繼續運用我們的科學成果。梅爾達德，如果你想就疫情的未來發展做些預測，那就到此為止吧，當然可以。

No, don't. Thank you. No, I agree with Dan. I think it's incredibly difficult to predict outside of, I think, what we're all starting to believe is that it will be a combination of vaccines, therapeutics of various types, of course, anticipating changes in the virus over time, we'll have to keep an eye on it and see how it goes. Importantly, to date, none of the variants have shown any resistance to remdesivir. So we think that's a positive outcome so far. We haven't disclosed yet what the oral compounds are going to be. They're -- we are moving them forward as quickly as possible and we'll share those data as those molecules begin to mature. But our hope is that they certainly provide an alternative treatment option in particular in the outpatient setting with Veklury remaining really the -- a stalwart in the hospitalized and potentially the outpatient IV setting.

不，不用了。謝謝。不，我同意丹的觀點。我認為除了我們現在普遍認為的疫苗和各種療法的聯合應用之外，很難做出其他預測。當然，我們也要考慮到病毒會隨著時間推移而發生變化，所以我們必須密切關注疫情發展。重要的是，迄今為止，所有變異株均未對瑞德西韋產生抗藥性。因此，我們認為目前為止這是一個正面的結果。我們尚未公佈口服藥物的具體配方。我們正在盡快推進這些藥物的研發，一旦這些分子成熟，我們將分享相關數據。我們希望這些藥物能為患者提供一種新的治療選擇，尤其是在門診治療方面。同時，維魯瑞（Veklury）仍將是住院治療以及門診靜脈注射治療的主要藥物。

And I would just add, Brian, I think it's fair to say that, obviously, we continue to work on oral versions of remdesivir, as we've said before in the past. And to your point, I mean, from a scientific standpoint, the opportunity to look at combination therapy and oral medicines for COVID to also anticipate future viral resistance. So those are all themes. And then to Merdad's point, we will, of course, be updating you as those medicines continue to move forward.

我還要補充一點，布萊恩，我認為可以肯定的是，正如我們之前所說，我們仍在繼續研發瑞德西韋的口服版本。至於你提到的，從科學角度來看，研究聯合療法和口服藥物治療新冠肺炎，也有助於預測未來病毒抗藥性的問題。這些都是我們關注的重點。至於默達德所提到的，隨著這些藥物研發的進展，我們當然會及時向大家報告最新情況。

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

下一個問題來自美國銀行的傑夫‧米查姆。

Just had a bigger picture question on HIV. When you look in the pandemic, remdesivir has done quite well even this quarter and your oncology pipeline has really grown. But when you look at the core HIV business, the long-term growth rate we used to think was high single digits and it's much lower last year and this year. And I know you have generics, and I know the pandemic has affected the market. But the question is, do you think you'll go back to a higher long-term growth rate in HIV? And maybe just help us with the drivers of that.

我剛剛收到一個關於愛滋病業務的宏觀問題。從疫情來看，瑞德西韋本季表現相當不錯，你們的腫瘤產品線也發展迅速。但就核心愛滋病業務而言，我們先前認為的長期成長率應該在個位數以上，但去年和今年的成長率都遠低於預期。我知道你們有仿製藥，也知道疫情對市場造成了影響。但問題是，你們認為愛滋病業務的長期成長率會回升嗎？能否請您分析一下推動這成長的因素？

Thank you, Geoff. So Johanna?

謝謝你，傑夫。那麼，喬安娜呢？

Sure. Geoff, are you asking specific to the market or just generally?

當然可以。傑夫，你是問針對特定市場的情況，還是泛指某個市場？

For you guys, maybe, and for the market.

或許對你們來說是這樣，對市場來說也是。

Okay. So I think what we said in the second quarter was exactly kind of what's playing out today. So we have seen a little bit of a recovery in Q2, and we are seeing that recovery continue actually and accelerate a little bit into Q3. So we're at about 3% growth. We are at about 2% in Q2, and we were negative the 3 quarters before that. What we're assuming at this point is actually, we are going to get back from a market standpoint back to where we were prior to COVID. We're just starting from a much lower base. So it's going to take a little bit of time. So I think the assumption is that as we get to 2022, you'll see that kind of play out, assuming no other major surges come through. So that's from a market standpoint, which obviously will help from a -- from a product standpoint.

好的。我認為我們在第二季度所說的，與今天的情況基本吻合。我們在第二季度看到了一些復甦，而且這種復甦勢頭在第三季度仍在持續，甚至略有加速。目前我們的成長率約為3%。第二季約為2%，而前三個季度均為負成長。我們目前的預期是，從市場角度來看，我們將恢復到新冠疫情前的水準。只是我們現在的起點更低，所以這需要一些時間。我認為，到2022年，在沒有其他重大疫情衝擊的情況下，我們將看到這種趨勢。以上是從市場角度來看的，而這顯然也會對產品發展有幫助。

When you think about Biktarvy and you think about our growth year-on-year at about 20% and then, of course, double-digit growth on a quarterly basis as well, we have different dynamics going on. Obviously, demand is still strong. So we're quite pleased with that. We grew about 1.5% share over the last quarter, over 6% in a full year. So we're on a much larger base because we are a market leader. But we've also had some different pricing dynamics as well going on that are related to, obviously, the mix that we're looking at. So that's something that is impacted directly by the pandemic, right, as you think about your government versus commercial mix. And we've seen PHS channels specifically kind of grow a little bit more rapidly than any other segment over the last couple of quarters. So those are kind of the dynamics that we're dealing with. But if you look at the basic demand, very strong in double-digit growth.

當你想到Biktarvy，想到我們約20%的年增長率，以及當然還有兩位數的季度增長率時，你會發現我們面臨著不同的動態。顯然，需求依然強勁，我們對此非常滿意。上個季度我們的市佔率成長了約1.5%，全年成長超過6%。由於我們是市場領導者，所以我們的基數更大。但我們也面臨一些不同的定價動態，這顯然與我們正在關注的通路組合有關。這直接受到疫情的影響，正如你考慮到政府和商業管道的組合時所看到的那樣。在過去的幾個季度裡，我們發現公共衛生服務（PHS）管道的成長速度略高於其他任何管道。這就是我們正在應對的動態。但如果你看一下基本需求，你會發現它非常強勁，實現了兩位數的成長。

Geoff, it's probably -- it's Andy. It's also probably worth highlighting, again, the difference in the PrEP market and the treatment market. So I think as Johanna touched base on the treatment market, that's exactly right. Remember that a lot of the growth that you're referring to a couple of years ago was driven by the incredibly strong PrEP market as well. We think you will see that again. It's just going to take the introduction of lenacapavir in a couple of years to get there. So the dynamic in the treatment market, I think, is relatively constant with what we've seen historically. It's just we're building off a bigger base, as Johanna said, then the market will continue to grow. And then you should see the PrEP dynamic coming back in a couple of years in terms of driving additional growth.

傑夫，可能是──是安迪。再次強調PrEP市場和治療市場的差異也很有必要。正如喬安娜剛才提到的治療市場，你說得完全正確。別忘了，幾年前你提到的那波成長很大程度上也是由當時極其強勁的PrEP市場所推動的。我們認為這種情況還會再次出現。只是還需要幾年後lenacapavir的上市才能實現這一點。所以我認為，治療市場的動態與我們過去觀察到的情況基本上一致。正如喬安娜所說，我們現在是在一個更大的基礎上發展，市場將繼續成長。然後，你應該會在幾年後看到PrEP市場再次成為推動成長的主要動力。

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。

Sorry to go back to TROPiCS-02, but I do think it's important. And I wanted to ask Merdad what his view was on the importance of OS. Obviously, it would be immature, and I think math would suggest you could get OS later in '22. But if you do have a PFS benefit around 2 months, how confident are you that you'd still be okay and confident around OS heating and crossover and other impacts wouldn't impede that result. Maybe just comment on that a bit.

很抱歉又回到 TROPiCS-02 的話題，但我認為它很重要。我想問 Merdad 對 OS 重要性的看法。顯然，現在討論 OS 還不成熟，而且我認為根據數學計算，你可能要到 2022 年晚些時候才能獲得 OS。但是，如果你在大約兩個月後就能獲得 PFS 收益，你有多大把握認為 OS 的升溫、交叉以及其他影響因素不會影響到這個結果？能否就此發表一下看法？

Sure, Michael. Happy to. Yes. Look, I think as you recall, one of the reasons we modified the study, it's just important to go back to the early part of the year when we modified this trial, we expanded the sample size, and we changed the endpoint. And I think the main purpose behind modifying the sample size was to make sure that we could hit OS with the assumptions that we had in the trial. So I think if we hit PFS, we feel reasonably confident with all the caveats that you said, right, around crossover and things like that, that are more difficult to control, that we should be able to hit OS. So I think that's important. And I think that really gets to the other underlying issue around this delay, right, as we move from investigator to central overreads of the progression events. Those are the things that sort of have led to the slight delay here that we're talking about. But I think that all means we'll have a stronger outcome when the data are available.

當然，邁克爾。樂意效勞。是的。你看，我想你可能還記得，我們​​修改研究的原因之一，需要回顧一下年初我們修改這項試驗的情況，當時我們擴大了樣本量，並更改了終點。我認為修改樣本量的主要目的是為了確保在試驗的假設條件下，我們能夠達到總存活期（OS）的目標。所以，我認為如果我們能夠達到無惡化存活期（PFS），考慮到你提到的所有註意事項，例如交叉試驗等難以控制的因素，我們有相當大的信心能夠達到OS的目標。所以我認為這一點很重要。我認為這實際上也引出了導致數據延遲的另一個根本原因，對吧？因為我們需要從研究者對進展事件的判讀過渡到中心實驗室的判讀。這些因素導致了我們目前討論的輕微延遲。但我認為所有這些都意味著，當數據可用時，我們將獲得更可靠的結果。

And maybe just at the risk because I know there's been several questions on 02 just to complement what Merdad has said. I mean when we think about trials in the oncology space, which all of us have a lot of experience with, it's certainly not uncommon when you think about event-driven trials to have these slight adjustments to timelines. And I would just point out that, I mean initially, we anticipated that we would have this data. And to Merdad's point, with all the protocol adjustments that we did in the middle of the year in December of this year. And now we're talking about those data coming in mid-January to mid-February. So the timeline change is really very minor. And in terms of the trial conduct and the design, I mean nothing has changed in regards to our confidence for TROPiCS-02. So I just wanted to make sure I also had a chance to say that.

或許冒點風險，因為我知道大家對02號試爆有很多疑問，我只是想補充Merdad剛才說的話。我的意思是，當我們談到腫瘤領域的臨床試驗時（我們大家都有豐富的經驗），在以事件驅動的試驗中，時間安排出現一些細微調整是很常見的。我想指出的是，最初我們預計會獲得這些數據。正如Merdad所說，我們在今年12月對方案進行了調整。現在我們討論的是，這些數據將在1月中旬到2月中旬公佈。所以時間安排的調整其實非常小。至於試驗的實施與設計，我們對TROPiCS-02的信心沒有改變。所以我想確保我也有機會說明這一點。

Our next question comes from Cory Kasimov with JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

I just wanted to ask you about the Arcus TIGIT program. And with regard to the added data you expect to get on this asset to make the go, no-go decision. Is it just more durability? Or are you going to see more patients to -- basically just looking for your latest thoughts there on what it would take for you to opt in.

我只是想問您關於Arcus TIGIT專案的情況。關於您期望從該專案中獲得哪些額外數據來決定是否繼續推進，您認為僅僅是提高藥物的耐久性嗎？還是說您預計會接診更多病患？我主要是想了解您目前的想法，以及需要哪些條件才能促使您選擇參與專案。

Over to you, Merdad.

接下來就交給你了，梅爾達德。

Yes, sure. Thanks, Cory. Yes, we do anticipate that the data will mature, I think, is what we've been saying, and I think that's a combination of things, right? More patients per arm as well as longer observation time for the patients that are enrolled in the study. So we remain really interested in that and enthusiastic about that study. And as I said, I think we feel that it's likely that we'll be able to make our opt-in decision this year. So we continue to believe that, that's where we're headed with those data. So in total, I think we'll -- we do expect to see a larger, more robust data set to make a decision on. And as we said before, what we're looking for is clear separation of the doublet from single agent, and we're looking for an ORR of over 50% in the doublet and hopefully in the triplet as well. That would be upside for us.

是的，當然。謝謝，科里。是的，我們預期數據會逐漸成熟，我想我們一直都是這麼說的，我認為這取決於多種因素，對吧？例如每組納入更多患者，以及延長入組患者的觀察時間。所以我們仍然對這項研究非常感興趣，也充滿熱情。正如我所說，我們認為今年很可能就能做出是否選擇加入的決定。所以我們仍然相信，這就是我們最終會得出的結果。總而言之，我們期待看到更大、更可靠的數據集來做出決定。正如我們之前所說，我們正在尋找的是雙藥方案與單藥方案之間明顯的差異，我們希望雙藥方案的客觀緩解率（ORR）超過50%，也希望三藥方案的ORR能達到50%。這對我們來說將是利好消息。

Our next question comes from Andrew Galler with Wolfe Research.

我們的下一個問題來自 Wolfe Research 的 Andrew Galler。

I just have one on the HIV pipeline. So given you're collaborating with Merck on the lenacapavir-islatravir combo. One of your competitors in this space claim that frontline standard of care needs to include an integrase inhibitor. So given your experience with bictegravir, do you agree or not that an integrase inhibitor is always likely to be needed in a first-line setting?

我目前只有一項針對HIV的研發管線。鑑於您正在與默克公司合作開發lenacapavir-islatravir組合藥物，而您在這個領域的競爭對手之一聲稱一線標準治療方案需要包含整合酶抑制劑。那麼，根據您在使用bictegravir方面的經驗，您是否同意在一線治療中總是需要整合酶抑制劑？

Yes, thanks for the question. It's an interesting statement to make. We obviously don't believe that. That's why we're pursuing the combination approach that we are. So I think the data will tell the story in the long run. We're pretty confident that we can get there with the combination approach that we're taking right now.

是的，謝謝你的提問。這是一個很有意思的說法。我們顯然不認同這種觀點。正因如此，我們才採取了目前這種綜合策略。所以我認為，從長遠來看，數據會說明一切。我們非常有信心，透過目前這種綜合策略，我們能夠實現目標。

Our next question comes from Geoffrey Porges with SVB Leerink.

我們的下一個問題來自 SVB Leerink 的 Geoffrey Porges。

So I wanted to go back to the COVID impairment question for the core business. Perhaps you could give us a sense of where your starts for HCV and HIV in Q4 compared to Q4 2019. And then secondarily, do you expect those businesses to grow in 2022? I know it's early for guidance, but you've obviously developed your plan already. So it would just be helpful to see how you're thinking about COVID impact on those core businesses.

所以我想回到關於新冠疫​​情對核心業務影響的問題。您能否簡要介紹一下，與2019年第四季相比，C型肝炎和愛滋病業務的初始業績如何？其次，您預期這些業務在2022年會成長嗎？我知道現在給出業績指引還為時過早，但您顯然已經制定了計劃。因此，了解您如何看待新冠疫情對這些核心業務的影響將很有幫助。

Geoff, can I just clarify? You meant Q3 to Q3?

Geoff，我可以確認一下嗎？你是說第三季到第三季嗎？

No, we're in Q4 now. And I'm really trying to get a sense of -- you showed pretty clearly the decline in hospitalizations and in a number of different therapeutic categories we're recovering in Q4. So really wondering where we are today compared to Q4 2019.

不，現在已經是第四季了。我真的很想了解——您已經很清楚地展示了住院人數的下降，以及我們在第四季度許多不同治療類別中的復甦情況。所以我很想知道，與2019年第四季相比，我們目前的情況如何。

Got you. Johanna?

收到。喬安娜？

Sure. Let me start, Geoff, with HCV, and then I'll move on to HIV. So from an HCV standpoint, we talked about being about 8% under year-over-year. A lot of that has to do with timing and pricing adjustments. So it's not patient per se. We're actually flat pretty much year-over-year, about 2% positive. What we did see though is market starts declined in Q3, and that's directly related to the pandemic because less screening diagnosis they were down again in Q3. And so we believe that will pick back up. I wouldn't go so much to say that it will be an increase, right? But I would say that we should be able to hold flat because you typically see HCV patient starts decline over time just because there's less patients that need the cure, but not as quickly as what we're seeing in the quarter. So we do think that will pick back up. It's -- and so we would assume a little bit more tempered decline in 2022.

好的。 Geoff，我先從C型肝炎說起，然後再說愛滋病。就丙型肝炎而言，我們之前提到年比下降了約8%。這很大程度上與時間和價格調整有關。所以這並非患者數本身的問題。實際上，我們的患者數量與去年同期基本持平，陽性率約為2%。不過，我們確實看到第三季市場新開治療項目有所下降，這與疫情直接相關，因為篩檢診斷減少，第三季再次出現下降。因此，我們相信情況會好轉。我不會斷言一定會成長，對吧？但我認為我們應該能夠保持平穩，因為通常情況下，丙型肝炎新開治療計畫會隨著時間的推移而減少，僅僅是因為需要治癒的患者減少了，但不會像我們本季看到的那樣迅速下降。所以我們確實認為情況會好轉。我們預期2022年的下降幅度會更溫和一些。

The HIV piece of the puzzle, we still are seeing screenings and diagnosis less than pre-COVID-19. So we're seeing about screening 10% down versus 2019, and diagnosis are still 20% below 2019 levels. So as much as we're seeing recovery quarter-over-quarter, and we're excited about that because that's in line with what we had assumed, we're still not back to the levels that we need to be. And so I would say that you're now growing from a lower base, and it's kind of what we talked about in the last quarter, where the assumption was it would come right back. But the dynamic market in HIV is very small, and it's going to take a little bit longer and therefore, we're just growing from a lower base. And we do believe we'll get back to typical levels of a couple of single-digit growth from a market standpoint in 2022, it's just going to take us a couple of quarters to get there. So hopefully, that helps a little bit, gives you perspective.

就愛滋病防治而言，我們發現篩檢和診斷數量仍然低於新冠疫情前水準。篩檢量比2019年下降了約10%，診斷量比2019年水準低了20%。儘管我們看到每個季度都在復蘇，這讓我們感到欣慰，因為這與我們之前的預期相符，但我們仍未恢復到所需的水平。因此，我認為我們現在是從較低的基數開始成長的，這與我們上個季度討論的內容類似，當時我們假設會迅速恢復。但愛滋病市場規模很小，需要更長的時間才能恢復，因此我們是從較低的基數開始成長的。我們相信，從市場角度來看，到2022年我們將恢復到正常的個位數成長水平，只是需要幾個季度的時間才能實現。希望這些資訊能對您有所幫助，讓您對情況有所了解。

Our next question comes from Robyn Karnauskas with Truist Securities.

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

Just thinking big picture on your growth, your long-term growth, I mean obviously, a lot of questions here on Trodelvy and thinking about the HIV business as 2 core areas that are very important for your long-term growth. Can you talk about how your expectations of Trodelvy market opportunity have changed from your initial acquisition? And if you don't see the data that you want to see from TROPiCS-02, how are you going to think about your strategy for growing the business? Because it seems like that is core to the long-term future of the company.

從宏觀角度考慮貴公司的成長，特別是長期發展，顯然，這裡有很多關於Trodelvy的問題，而且HIV業務是貴公司長期發展至關重要的兩大核心領域。您能否談談自最初收購以來，您對Trodelvy市場機會的預期發生了哪些變化？如果您沒有從TROPiCS-02中獲得預期的數據，您將如何調整業務成長策略？因為這似乎對公司的長期未來至關重要。

Right. Thanks, Robyn. I'll let Andy start here and turn the ...

好的。謝謝你，羅賓。我讓安迪從這裡開始，然後…

Robyn, thanks for the question, and Johanna may want to weigh in as well. Look, I think there are a number of growth drivers. So if we just step back, when you think about long-term growth, there's been a number of questions. So just to paint the picture again. There are a number of growth drivers that we see driving. We don't provide specific long-term guidance. What we've said and we'll continue to say is that the HIV business, including the long-acting collaboration that you mentioned, Trodelvy, magrolimab, cell therapy and a number of the other programs, essentially the Arcus programs are expected to drive our long-term growth.

Robyn，謝謝你的提問，Johanna 也可能想發表一下看法。我認為有很多成長動力。如果我們回顧一下，從長期成長的角度來看，有很多問題。所以我再來梳理一下。我們看到有很多成長動力在推動成長。我們不提供具體的長期業績指引。我們過去說過，未來也會繼續強調的是，HIV 業務，包括你提到的長效合作項目 Trodelvy、magrolimab、細胞療法以及其他一些項目，基本上就是 Arcus 的項目，預計將推動我們的長期成長。

In the short run, we see a much more promising growth profile than we did historically. So we think that we've done a lot to turn the company around. And now the growth profile is improving significantly from our perspective. When you get to '24 or '25, again, we've said we see an expected inflection in our growth profile as a lot of these programs that are currently in the clinic, hopefully reach the commercialization, including a number of the Trodelvy programs.

短期來看，我們看到的成長前景比以往好得多。因此，我們認為我們已經為扭轉公司頹勢做了很多工作。現在，從我們的角度來看，成長前景正在顯著改善。我們之前也說過，到2024年或2025年，隨著許多目前正在進行臨床試驗的項目（包括Trodelvy的多個項目）有望實現商業化，我們預計增長前景將出現預期的拐點。

On Trodelvy, specifically, I think we continue to be very bullish on the prospects for Trodelvy overall, similar to where we were when we did the transaction. So you'll remember, we highlighted there are a number of ways to win with Trodelvy when we acquired Immunomedics. The hormone receptor positive study was just one of those studies. Obviously, we're excited about the work that we're doing in lung cancer and other areas. So there is a much broader clinical development plan for Trodelvy, and then the market probably fully appreciates today. The announcement with Merck earlier today is a good example of that. That will give you a sense of where we're going, and we expect to give you a much greater sense of that overall.

就Trodelvy而言，我認為我們仍然非常看好它的整體前景，與我們當初收購Immunomedics時的看法類似。您可能還記得，我們​​在收購Immunomedics時強調過，Trodelvy有很多致勝之道。荷爾蒙受體陽性研究只是其中之一。顯然，我們對在肺癌和其他領域的工作感到非常興奮。因此，Trodelvy有著更廣泛的臨床開發計劃，而市場可能已經充分認識到這一點。今天早些時候與默克公司發布的公告就是一個很好的例子。這將讓您了解我們的發展方向，我們預計未來將提供更全面的資訊。

So I think at a macro level, before I ask Johanna to comment, I'd say our expectations for Trodelvy have not changed. We continue to be very enthusiastic about where we are and where we're going. And there's lots of different ways for us to get there over time.

所以，在請Johanna發表評論之前，我想從宏觀層面來說，我們對Trodelvy的期望並沒有改變。我們依然對公司目前的狀況和未來的發展方向充滿熱情。而且，隨著時間的推移，我們有許多不同的途徑可以實現這些目標。

Yes. No, I -- thanks, Andy. I would just add, I think we are pleased with where we're going with Trodelvy today in the short term. We still believe that there's a lot of growth opportunities, specifically in the earlier line setting, both across triple-negative breast cancer as well as bladder cancer. And so we're seeing those opportunities play out. I think the guidelines are going to help us set up for success, let alone set up for future pipeline studies such as HR positive coming through, hopefully, in a positive way, as you mentioned, and that should just expand our market opportunity in more so. The only thing I would add to what Andy was saying is also on the HIV front, so not looking just at the oncology opportunities but also from an HIV standpoint, we still believe Biktarvy is foundational to our HIV opportunities in addition to, of course, lenacapavir that Merdad spoke to earlier. So we're excited about what we have going on there as well.

是的。不，我——謝謝，安迪。我只想補充一點，我認為我們對Trodelvy目前的短期發展感到滿意。我們仍然相信它有很多成長機會，尤其是在早期治療領域，包括三陰性乳癌和膀胱癌。我們正在見證這些機會的實現。我認為這些指南將有助於我們取得成功，更不用說為未來的管線研究奠定基礎了，例如HR陽性標靶治療，希望正如您所提到的，研究結果能夠積極，這將進一步擴大我們的市場機會。我唯一想補充的是安迪剛才提到的HIV方面，不僅從腫瘤學的角度來看，從HIV的角度來看，我們仍然認為Biktarvy是我們HIV治療領域的基礎，當然還有Merdad之前提到的lenacapavir。所以我們對這方面的進展也感到非常興奮。

Our next question comes from Ronny Gal with Bernstein.

下一個問題來自伯恩斯坦公司的羅尼·加爾。

I wanted to ask a little bit about the agreement about a combination of Trodelvy and Keytruda. Do you -- does Merck get a piece of the economics of Trodelvy? Can you talk a little bit about the elements of the agreement? And then one of your peers have signed an agreement with Merck on non-small cell lung cancer. And I was wondering, are those types of agreements exclusive, that is they can have another Trop-2 ADC in triple-negative breast cancer and you may partner with in lung cancer as well?

我想問一下關於Trodelvy和Keytruda聯合用藥的協議。默克能否從Trodelvy的收益中分一杯羹？能否談談協議的具體內容？另外，您的一位同行也與默克公司就非小細胞肺癌的治療簽署了協議。我想知道，這類協議是否具有排他性？也就是說，默克公司可能擁有另一種用於治療三陰性乳癌的Trop-2抗體偶聯藥物（ADC），而您也可能在肺癌領域與他們合作？

Yes. Ronny, it's Andy. Thank you for the question. It's relatively straightforward. This is a straightforward, simple clinical collaboration. Merck is providing Trodelvy. They obviously had input on the study design -- Keytruda, I'm sorry, Keytruda to the study. Thank you. They do not have any economics on Trodelvy as a result of the study, but they will enjoy, hopefully, the added benefits to Keytruda on their end. And these studies are not exclusive. So they have the ability to do other studies in the same area with other agents, including other Trop-2 antibodies, and we have the ability to do studies with other PD-1 inhibitors as well. And of course, we started in triple-negative breast cancer. You're highlighting that there's another study that they will do with another Trop-2 inhibitor in lung cancer. That, of course, is an area that we're going to look at as well. So I expect that there's more to come. But these are relatively straightforward, simple plain vanilla clinical collaborations.

是的，羅尼，我是安迪。謝謝你的提問。這其實很簡單。這是一項簡單直接的臨床合作。默克公司提供Trodelvy。他們顯然參與了研究設計——抱歉，是Keytruda。謝謝。他們不會因為這項研究而從Trodelvy中獲得任何經濟利益，但希望他們能從Keytruda的研究中受益。而這些研究並非獨家合作。他們有能力在同一領域使用其他藥物（包括其他Trop-2抗體）進行其他研究，我們也有能力使用其他PD-1抑制劑進行研究。當然，我們最初是從三陰性乳癌開始的。你提到他們還將使用另一種Trop-2抑制劑在肺癌領域進行另一項研究。當然，這也是我們將要關注的領域。所以我預計未來會有更多合作。但這些都是簡單直接的臨床合作。

And it's part of our strategy, right, Ronny, to scale the opportunity with Trodelvy because there's many things we can do ourselves. But frankly, given the multi-tumor opportunity for Trodelvy, engaging in partnerships like this allows us to expand much more than we could ourselves. And I think it's the beginning of what you'll see from us as we look to really expand out the promise and potential of Trodelvy.

羅尼，這正是我們策略的一部分，對吧？我們要利用 Trodelvy 來擴大市場機遇，因為很多事情我們自己也能做。但坦白說，考慮到 Trodelvy 在多種腫瘤治療方面的潛力，像這樣的合作能讓我們實現遠超自身能力的擴張。我認為這只是個開始，我們將努力真正拓展 Trodelvy 的應用前景和潛力。

Our next one comes from Brian Skorney with Baird.

接下來是 Baird 的 Brian Skorney 的報告。

I guess we'll be seeing a bunch of potentially transformative data in large B-cell lymphoma in a couple of months, I assume at ASH. I guess in addition to your own data, just kind of thoughts on given the POLARIX success, how do you think about the potential for CART19 to move upwards into the frontline setting? And does the success of Polivy actually change the market opportunity in your view for second line as well?

我想我們會在幾個月後，大概是在ASH大會上，看到一些關於大B細胞淋巴瘤的潛在變革性數據。除了您自己的數據之外，鑑於POLARIX的成功，您認為CART19療法有潛力進入一線治療嗎？ Polivy的成功是否也會改變您認為二線治療的市場前景？

Thanks, Brian. Christi, please.

謝謝你，布萊恩。克里斯蒂，謝謝。

Sure. So yes, we're very excited about our submission at the end of September for second line and expect to hear back on the status from FDA first half of next year. But we will be presenting the data at ASH, as you said. And CAR-T is really the only potential cure we're seeing right now. So when you look at the out-of-class second-line agents and moving to front line, it typically has been a delay to CAR-T. And now with this new study coming out, we'll have to see what that exact duration will be for those patients. We hope it will be successful, but we don't see a huge impact to our projections in the cell therapy marketplace. Second line actually allows us to basically double the market that we can play in, which is about 14,000 patients in the U.S. That, combined with you'll also see our frontline data ZUMA-12, which was completed, we'll be presenting that at ASH as well. So you'll see on our front line, second line and see how kind of it may stack up, although they're not head-to-head trial. So we're pretty confident in where we are and it doesn't really change our projections for the future of cell therapy or for our specific brands.

當然。是的，我們對9月底提交的二線治療申請感到非常興奮，並預計明年上半年就能收到FDA的回覆。正如您所說，我們會在ASH會議上公佈相關數據。 CAR-T療法是目前我們看到的唯一潛在治癒方法。因此，當我們審視其他非同類二線藥物，並轉向第一線治療時，通常需要等待一段時間才能使用CAR-T療法。現在，隨著這項新研究的公佈，我們需要觀察這些患者的特定等待時間。我們希望研究能夠成功，但我們預計它不會對我們在細胞治療市場的預測產生巨大影響。二線治療實際上使我們能夠進入的市場規模擴大了一倍，在美國大約有14,000名患者。此外，您還將看到我們已完成的第一線治療研究ZUMA-12的數據，我們也會在ASH會議上公佈這些數據。所以，您將會看到我們的一線和二線產品，並了解它們的整體表現，儘管它們並非直接對比試驗。因此，我們對目前的狀況相當有信心，這並不會改變我們對細胞療法未來發展或我們特定品牌的預測。

Our last question comes from Carter Gould with Barclays.

最後一個問題來自巴克萊銀行的卡特·古爾德。

Maybe just one on the lung study that's going to get started later this year for Trodelvy. You've characterized starting that study at risk, but presumably, you've had some insight from the basket study. Is that a fair assumption? And could we see data from that basket study maybe by the time we see TROPiCS-02 data?

或許只有一項關於Trodelvy肺部研究的數據，該研究將於今年稍後啟動。您曾表示啟動這項研究存在風險，但想必您已經從籃式研究中獲得了一些見解。這樣的假設合理嗎？我們能否在看到TROPiCS-02數據的同時，也看到籃式研究的數據？

Thanks. Great question. Our -- we're looking at the totality of the data we have. It's not just the TROPiCS-03 data. We're looking at the totality of the data in lung that we have -- we've accumulated, and that's really the approach we're taking. So I take your point, and it's arguably not that big a risk given the data we've seen. We -- I would not expect for us to be sharing those data around the time of the TROPiCS-02. But we do -- we will plan on sharing those data over time. So we'll definitely share those data over time. But for now, we're pretty excited by what we've seen in terms of the Trodelvy performance in non-small cell.

謝謝。問得好。我們正在分析我們掌握的所有數據，而不僅僅是TROPiCS-03的數據。我們正在分析我們累積的所有肺部數據，這正是我們採取的方法。所以我明白你的意思，考慮到我們目前掌握的數據，這或許不算是什麼大風險。我們預計不會在TROPiCS-02前後公佈這些數據，但我們計劃隨著時間的推移逐步分享這些數據。所以，我們肯定會隨著時間的推移分享這些數據。但就目前而言，我們對Trodelvy在非小細胞肺癌方面的表現感到非常興奮。

That's all the time we have for questions. I'd like to turn the call back to Jacquie Ross for closing remarks.

提問時間到此結束。現在請杰奎·羅斯女士作總結發言。

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

謝謝凱瑟琳，也謝謝各位今天蒞臨。我們感謝大家一直以來對吉利德的關注，並期待你們繼續關注我們的最新進展。

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

今天的電話會議到此結束。感謝您的參與。您可以斷開連線了。