吉利德科學 (GILD) 2021 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Gilead Sciences Second Quarter 2021 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

您好，感謝您的耐心等待。歡迎參加吉利德科學公司2021財年第二季財報電話會議。 （操作說明）請注意，本次會議正在錄音。 （操作說明）

I would now like to hand the conference over to your speaker today, Jacquie Ross, VP, Investor Relations. Please go ahead.

現在我謹將會議交給今天的演講嘉賓，投資者關係副總裁傑奎·羅斯女士。請開始吧。

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

謝謝Joelle，大家下午好。今天收盤後，我們發布了2021年第二季財報。新聞稿、投影片和補充資料可在我們網站gilead.com的投資人關係欄位中查看。

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

今天電話會議的發言人包括：董事長兼首席執行官丹尼爾·奧戴 (Daniel O'Day)；首席商務官喬安娜·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 operations; 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 疫情對吉利德業務的影響、財務狀況和經營業績、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.

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

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

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。現在我將把電話會議交給丹。

Thank you, Jacquie, and good afternoon, everyone. Thank you for taking the time to join us here today. We're pleased to provide you with an update on our second quarter, where we delivered solid financial performance and significant progress on our increasingly diverse pipeline. 2021 is an important year for our pipeline, and we're very encouraged by the milestones we've achieved for therapies that are potentially transformative for Gilead and for patients. All of this reinforces our confidence in our strategic direction.

謝謝Jacquie，大家下午好。感謝各位今天抽空參加本次會議。我們很高興向大家報告第二季的業績，我們取得了穩健的財務表現，並且在日益多元化的產品線方面也取得了顯著進展。 2021年對我們的產品線來說至關重要，我們為在可能對吉利德和患者產生變革性影響的療法方面取得的里程碑式進展感到非常鼓舞。所有這些都增強了我們對自身戰略方向的信心。

I want to take this opportunity to thank our global community of Gilead and Kite employees, who consistently go above and beyond to drive progress with resilience and dedication. Different parts of the world are riding the ebb and flow of COVID-19 cases at various times, and while the vaccines give us hope and optimism, we are still very much living with the pandemic. Remdesivir continues to play an important role in fighting the virus and has now been used to treat an estimated 7 million hospitalized patients worldwide.

我想藉此機會感謝吉利德和凱特全球員工，他們始終不懈努力，以堅韌不拔的精神和高度的奉獻精神推動公司取得進展。世界各地新冠肺炎疫情的起伏不定，疫苗雖然為我們帶來了希望和樂觀，但我們仍然與疫情共存。瑞德西韋在對抗疫情中持續發揮重要作用，目前已用於治療全球約700萬住院患者。

Turning to the main highlights of the quarter on Slide 4, Q2 was a solid quarter overall. Veklury sales of $829 million were once again higher than anticipated, offsetting the lingering impact of the pandemic, particularly on HIV treatment. In light of this pandemic's impact, Biktarvy's performance is quite encouraging, revenue for the quarter was $2 billion, up 24% or $390 million from the same quarter last year. This more than offset the $322 million headwind associated with the impact of the Truvada and Atripla LOEs.

翻到投影片4，我們來看第二季的主要亮點。整體而言，第二季表現穩健。 Veklury的銷售額達到8.29億美元，再次超越預期，抵銷了疫情的持續影響，尤其是在HIV治療領域。考慮到疫情的影響，Biktarvy的業績相當令人鼓舞，該季度營收達到20億美元，較去年同期成長24%，即3.9億美元。這足以抵消Truvada和Atripla的長期合約終止帶來的3.22億美元的不利影響。

Much of that headwind is now, of course, behind us. Overall, our share of the HIV treatment market held steady quarter-over-quarter, and our PrEP share remained steady even with generic entries. These dynamics give us confidence that the underlying demand for our HIV products remains strong and positions us well for growth as the overall HIV market recovery gains momentum.

當然，大部分不利因素現在已經過去。總體而言，我們在愛滋病治療市場的份額環比保持穩定，即使仿製藥上市，我們的暴露前預防（PrEP）市場份額也保持穩定。這些動態讓我們相信，市場對我們愛滋病產品的潛在需求依然強勁，並為我們在愛滋病市場整體復甦勢頭增強時實現成長奠定了良好的基礎。

Moving to our clinical pipeline, 2021 is a catalyst heavy year for Gilead and we have delivered all of our key first half pipeline commitments. Among other milestones, we shared top line data from the highly anticipated ZUMA-7 trial where Yescarta improved event-free survival for second line Large B-cell Lymphoma, or LBCL patients by 60% compared to the standard of care. This is truly a landmark trial - the first and largest reported Phase III trial readout that demonstrates the efficacy and safety of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier lines.

展望我們的臨床研發管線，2021年對吉利德來說是充滿催化劑的一年，我們已完成上半年所有關鍵的研發管線承諾。其中一項重要里程碑是，我們公佈了備受矚目的ZUMA-7試驗的主要數據。該試驗顯示，與標準療法相比，Yescarta將二線大B細胞淋巴瘤（LBCL）患者的無事件存活期提高了60%。這是一項具有里程碑意義的試驗——首個也是迄今為止規模最大的III期臨床試驗，證實了細胞療法的有效性和安全性。我們很高興有機會將細胞療法的潛在益處帶給更早期的患者。

We shared positive Phase III data from MYR 301 that will help support our anticipated BLA filing for Hepcludex for HDV in the U.S. later this year, and we submitted our NDA for use of lenacapavir in the heavily treatment experienced population with multidrug resistance. This filing was based on data from the Phase II/III CAPELLA study presented earlier this month. We also shared strong lenacapavir data from the Phase II CALIBRATE study in HIV treatment, which will be used to inform our broader lenacapavir efforts. Our partner Arcus provided an interim update for ARC-7 that supports the continuation of both ARC-7 and ARC-10 trials for their anti-TIGIT candidate, domvanalimab.

我們分享了MYR 301 III期臨床試驗的積極數據，這將有助於我們今年稍後在美國提交Hepcludex用於治療HDV的生物製品許可申請（BLA）。此外，我們也提交了lenacapavir用於治療多重抗藥性且先前接受過大量治療人群的新藥申請（NDA）。該申請是基於本月初公佈的II/III期CAPELLA研究的數據。我們也分享了lenacapavir在HIV治療中II期CALIBRATE研究的強有力數據，這些數據將用於指導我們更廣泛的lenacapavir研發工作。我們的合作夥伴Arcus提供了ARC-7試驗的中期進展，支持其抗TIGIT候選藥物domvanalimab的ARC-7和ARC-10試驗繼續進行。

Lastly on Slide 4, we are beginning to see the positive impact of our strategy, which we introduced early last year. The business is diversifying across indications and therapies. In particular, we are seeing Cell Therapy and Trodelvy contribute to growth and expect they will be key growth drivers for Gilead. While we build out the oncology business, we remain focused and committed on ensuring the long-term competitive positioning of our virology portfolio.

最後，在第四張投影片中，我們開始看到去年初推出的策略帶來的正面影響。公司業務正在向更多適應症和療法領域拓展。尤其值得一提的是，細胞療法和Trodelvy正在為公司成長做出貢獻，我們預計它們將成為吉利德的關鍵成長驅動力。在拓展腫瘤業務的同時，我們將繼續專注於確保病毒學產品組合的長期競爭優勢。

Next, on Slide 5, we highlighted our pipeline execution so far this year, and I'd like to thank all those who helped us to deliver on this ambitious agenda, including our employees, the people who participated in the studies, our partners, and the study investigators. As we look ahead to the rest of the year, our target milestones include a progression free survival, or PFS, readout in our event-driven Phase III TROPiCS-02 study evaluating Trodelvy in hormone receptor [positive] (added by company after the call) /HER2 negative metastatic breast cancer; a Phase Ib readout for magrolimab in myelodysplastic syndrome, or MDS. Depending on the data timing and results, this could result in a BLA submission for accelerated approval; and initiation of the potential Phase II lenacapavir and islatravir long-acting oral combination. As you know, this is in collaboration with Merck and the development and formulation work remains on track.

接下來，在第五張投影片中，我們重點介紹了今年迄今為止的研發管線執行。我要感謝所有幫助我們實現這一宏偉目標的人員，包括我們的員工、參與研究的人員、我們的合作夥伴以及研究人員。展望今年剩餘時間，我們的目標里程碑包括：在以事件驅動的III期TROPiCS-02研究中獲得無進展生存期（PFS）數據，該研究評估了Trodelvy在激素受體陽性（公司在電話會議後補充）/HER2陰性轉移性乳腺癌中的療效期；獲得magrolimab在骨髓異常綜合徵（MDS）中的IbDS增生數據。根據數據發佈時間和結果，這可能促使我們提交生物製品許可申請（BLA）以尋求加速審批；以及啟動潛在的II期lenacapavir和islatravir長效口服聯合療法。如您所知，這是與默克公司合作進行的，目前研發和製劑工作進展順利。

We look forward to updating you next quarter about additional milestone progress. We understand the continued strong and consistent pipeline execution is critical to the extending the virology business and expanding further into oncology. We believe our current and pipeline therapies can address significant unmet medical needs. We are very encouraged by the progress Gilead and Kite are making. We are well on our way on our journey to expand and diversify into new therapeutic areas, and we are already seeing the evolution of both our pipeline and commercial portfolio.

我們期待在下個季度向您報告更多里程碑進展。我們深知，持續強勁且穩定的產品線推進對於拓展病毒學業務並進一步進軍腫瘤領域至關重要。我們相信，我們現有及在研療法能夠滿足重要的未滿足醫療需求。吉利德和凱特的進展令我們倍感鼓舞。我們正穩步推動拓展和多元化至新治療領域的策略，並且已經看到我們在產品線和商業化產品組合方面的顯著發展。

With that, I'll hand over to Johanna, who will share an update on our commercial performance in Q2.

接下來，我將把麥克風交給 Johanna，她將分享我們第二季的商業業績最新情況。

Thank you Dan, and good afternoon everyone. Starting on Slide 7, total product sales of $6.2 billion were up 21% year-over-year, primarily reflecting Veklury, which was not a contributor to revenue in the second quarter of 2020.

謝謝丹，大家下午好。從第7張投影片開始，產品總銷售額為62億美元，年增21%，這主要反映了Veklury的成長，該產品在2020年第二季沒有貢獻收入。

On Slide 8, Veklury second quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection and hospitalization in many regions. While hospitalizations trended lower in the second quarter, Veklury remained the therapy of choice in 3 out of 5 patients hospitalized with COVID-19. We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with remdesivir. It's truly remarkable and encouraging to see how remdesivir continues to play such a key role in fighting this global pandemic.

如幻燈片8所示，Veklury第二季度營收為8.29億美元，環比下降，這反映了許多地區疫苗接種率提高以及感染和住院人數下降的影響。儘管第二季住院人數呈下降趨勢，但Veklury仍是五分之三新冠肺炎住院患者的首選治療方案。我們估計，自2020年5月上市以來，全球約有700萬名患者接受了瑞德西韋治療。瑞德西韋在對抗這場全球疫情中持續發揮如此關鍵的作用，這的確令人矚目和鼓舞。

Excluding Veklury, total product sales of $5.3 billion were up 5% year-over-year. We saw growth in Cell Therapy and HCV, in addition to new revenue contributions from Trodelvy and, more modestly, Hepcludex for HDV. Additionally, other product revenues of $291 million grew 20% year-over-year, driven by increased demand for AmBisome outside the U.S. to treat mucormycosis, which has seen a rise in incidents in patients hospitalized with COVID-19. Sequentially, we saw 9% growth for total product sales, excluding Veklury, primarily driven by growth in Biktarvy.

剔除Veklury後，產品總銷售額達53億美元，較去年同期成長5%。細胞療法和丙型肝炎病毒（HCV）業務均實現成長，此外，Trodelvy和用於治療丁型肝炎病毒（HDV）的Hepcludex也貢獻了新的收入。其他產品收入達2.91億美元，年增20%，主要得益於美國以外地區對用於治療毛黴菌病的AmBisome的需求增加，而毛黴菌病在新冠肺炎住院患者中的發病率有所上升。環比來看，剔除Veklury後，產品總銷售額成長9%，主要得益於Biktarvy的成長。

Moving to Slide 9, HIV product sales were $3.9 billion, up 8% sequentially and down 2% year-over-year. Compared to the second quarter of 2020, total HIV revenue reflected strong Biktarvy growth that more than offset the $322 million lower revenue from Truvada and Atripla following their loss of exclusivity. Compared to last quarter, HIV grew $288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment.

翻到第9張投影片，HIV產品銷售額為39億美元，季增8%，年減2%。與2020年第二季相比，HIV總營收主要得益於Biktarvy的強勁成長，足以抵銷Truvada和Atripla因失去獨家銷售權而導致的3.22億美元營收下降。與上一季相比，HIV收入成長了2.88億美元，這反映了正常的季節性庫存波動以及治療需求的成長。

Biktarvy revenue of $2 billion was up 24% year-over-year and 9% sequentially, with quarter-over-quarter growth primarily driven by increased demand. Biktarvy remains the #1 prescribed therapy in the U.S. across naive, switch and continuing patients and remains #1 in naive across all EU5 countries. Approximately 70% of switches from both Gilead and non-Gilead regimens result in incremental revenue. Overall, and despite the ongoing impact of the pandemic, Biktarvy continues to gain market share with 1% share growth versus last quarter in both the U.S. as well as the EU5.

Biktarvy 的營收達 20 億美元，年增 24%，季增 9%，季增 主要得益於需求增加。 Biktarvy 仍然是美國處方量最高的療法，涵蓋初治患者、轉換治療患者和持續治療患者，並且在歐盟五國（EU5）的初治患者中也保持排名第一。約 70% 的轉換治療（無論是否使用吉利德的療法）都帶來了額外的收入。總體而言，儘管疫情持續影響，Biktarvy 的市佔率仍在擴大，在美國和歐盟五國（EU5）的市佔率均較上季成長了 1%。

Descovy revenues of $435 million grew 21% sequentially, due to a modest improvement in the demand for PReP and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first. As we highlighted in prior quarters, we've been working with payers to ensure patients continue to have access to Descovy in light of entry of generic alternatives for Truvada. We're really pleased to see this strong sequential growth in Descovy, and we continue to maintain mid-40% share despite generic impacts. Year-over-year, Descovy grew 4% largely due to higher demand for PrEP.

Descovy 營收達 4.35 億美元，季增 21%，主要得益於 PrEP 需求的小幅回升，以及通常第二季相比第一季更為有利的庫存和定價策略。正如我們在前幾個季度所強調的那樣，我們一直在與支付方合作，以確保患者在 Truvada 仿製藥上市的情況下仍能繼續獲得 Descovy 的供應。我們非常高興看到 Descovy 實現如此強勁的環比成長，儘管受到仿製藥的影響，我們仍保持著 40% 左右的市場份額。 Descovy 的營收年增 4%，主要得益於 PrEP 需求的成長。

Overall, PrEP demand is showing signs of recovery and is expected to continue to improve as pandemic restrictions phase out. Earlier this month, federal FAQs for the U.S. Preventative Services Task Force were released. It provided greater clarity as to the importance of PrEP in ending the epidemic, and we're really encouraged by this recent development. We hope it will help to minimize the barriers of PrEP use going forward.

整體而言，PrEP 的需求已呈現復甦跡象，預計隨著疫情限制措施的逐步解除，需求將持續改善。本月初，美國預防服務工作小組發布了聯邦常見問題。解答更清楚地闡明了 PrEP 在終結疫情中的重要性，我們對此感到非常鼓舞。我們希望這將有助於減少未來 PrEP 使用的障礙。

Before I transition to other products, I just wanted to take a moment to share some perspective on the HIV treatment market, given the longer-than-expected pandemic impact. In regions outside of the U.S., such as Europe, we're beginning to see signs of recovery in the dynamic market with second quarter trends generally in line with our expectations. In the U.S., however, the pace of pandemic recovery was slower than we expected in this last quarter. And while we're seeing signs of recovery in PrEP and some sequential growth in the treatment market, it's clear that it will take several quarters for treatment to return to pre-pandemic levels.

在介紹其他產品之前，我想先花點時間分享我對愛滋病治療市場的看法，因為疫情的影響持續時間比預期要長。在美國以外的地區，例如歐洲，我們已經開始看到這個充滿活力的市場出現復甦跡象，第二季的趨勢總體上符合我們的預期。然而，在美國，上個季度疫情後的復甦速度比我們預期的要慢。雖然我們看到PrEP市場出現了復甦跡象，治療市場也出現了一些環比增長，但很明顯，治療市場需要幾個季度的時間才能恢復到疫情前的水平。

In treatment, there are really 2 pandemic-related headwinds that we observed. First, lower HIV screening and diagnosis resulting in lower treatment initiation; and second, due to the limited support services available during the pandemic, we've seen a higher number of patients discontinue their HIV treatments. Taken together, these 2 factors have reduced the number of active patients on HIV therapy entering 2021, thereby reducing the overall volume of new and refill prescriptions we would expect to see in 2021.

在治療方面，我們觀察到與疫情相關的兩大不利因素。首先，HIV篩檢和診斷率下降，導致治療啟動率降低；其次，由於疫情期間可提供的支持服務有限，我們看到更多患者中斷了HIV治療。這兩個因素共同導致2021年初接受HIV治療的活躍患者人數減少，從而降低了我們預計2021年新處方和續方的總量。

We did, however, see growth resume from this lower base in the second quarter. After prior quarter-over-quarter declines, second quarter U.S. HIV treatment prescriptions grew 2%, and we expect the market to grow at historical rates once screening and diagnosis rates return to pre-pandemic levels. To continue our efforts to advance progress against the HIV epidemic, we are partnering with health care professionals, advocacy groups and policymakers to raise awareness of the unique challenges COVID-19 poses to HIV screening, diagnosis and adherence. Our goal is to help health care providers ensure that patients continue to be diagnosed and treated.

然而，我們看到第二季成長已從較低的基數恢復。在經歷了此前幾個季度的環比下滑後，美國第二季度愛滋病治療處方量增長了2%，我們預計一旦篩檢和診斷率恢復到疫情前水平，市場將以歷史速度增長。為了繼續推動對抗愛滋病疫情的工作，我們正與醫療保健專業人員、倡議團體和政策制定者合作，提高人們對新冠疫情對愛滋病篩檢、診斷和治療依從性帶來的獨特挑戰的認識。我們的目標是幫助醫療保健提供者確保患者能夠繼續得到診斷和治療。

Given the strength of the demand fundamentals for Biktarvy, Descovy for PrEP and other Gilead HIV products, we remain confident in our competitive positioning now that many communities are easing social distancing requirements. In the meantime, we continue to see strength in underlying treatment demand with no material changes in the competitive landscape, with our total Gilead treatment market share holding steady at 75% in the U.S. and just under 50% in Europe despite competition and the entry of new generics.

鑑於Biktarvy、用於PrEP的Descovy以及其他吉利德HIV產品的強勁需求基本面，我們依然對自身的競爭地位充滿信心，尤其是在許多社區逐步放寬社交隔離要求的情況下。同時，我們持續看到潛在的治療需求強勁，競爭格局未發生實質變化。儘管面臨競爭和新仿製藥的上市，吉利德在美國的治療市佔率仍穩定在75%，在歐洲也接近50%。

Next, on Slide 10, HCV product sales in the second quarter were $549 million, up 23% compared to last year, but patient starts remain well below pre-pandemic levels. The growth reflects a modest sequential recovery in HCV patient starts in the U.S. in Q2 '21, in addition to an artificially low Q2 of '20 that was impacted by unfavorable government rebate adjustments. We'll be watching for further signs of recovery in the third quarter. Both U.S. and EU Gilead market shares remain steady at around 60% and 50%, respectively.

接下來，在第10張投影片中，C型肝炎產品第二季銷售額為5.49億美元，較去年同期成長23%，但患者起始治療量仍遠低於疫情前水準。這一增長反映了2021年第二季度美國丙型肝炎患者起始治療量的環比溫和回升，此外，2020年第二季度的數據因政府補貼調整不利因素而人為偏低。我們將密切關注第三季是否出現進一步的復甦跡象。吉利德在美國和歐盟的市佔率分別穩定在60%和50%左右。

Moving to Slide 11, HBV and HDV product sales were $237 million, up 8% year-over-year with improving patient starts on Vemlidy, particularly in ex-U.S. markets. In its first full quarter as part of Gilead, Hepcludex contributed $7 million and is currently available in France, Germany and Austria. We're excited to be working with the various reimbursement authorities to increase patient access and expect to secure full reimbursement in the major European markets in 2022.

翻到第11頁，B肝和丁肝產品銷售額達2.37億美元，年增8%，主要得益於Vemlidy患者用藥量的增加，尤其是在美國以外的市場。 Hepcludex作為吉利德旗下產品，在其首個完整季度貢獻了700萬美元的銷售額，目前已在法國、德國和奧地利上市。我們很高興能與各健保機構合作，提高病患的用藥可近性，並預計在2022年實現歐洲主要市場的全額健保報銷。

Moving to Trodelvy on Slide 12, product sales in the second quarter were $89 million, up 24% quarter-over-quarter, driven by demand for the 2 new indications approved in April, namely second-line plus metastatic triple-negative breast cancer and urothelial cancer. We continue to be encouraged by the positive feedback from physicians on the Phase III ASCENT data, which demonstrated a 1-year medium overall survival benefit for second-line metastatic TNBC patients treated with Trodelvy.

根據投影片12的內容，Trodelvy第二季銷售額為8,900萬美元，較上季成長24%，主要得益於4月核准的兩項新適應症的需求，即二線及以上轉移性三陰性乳癌及尿路上皮癌。我們對醫生們對III期ASCENT研究數據的正面回饋感到鼓舞，該研究表明，接受Trodelvy治療的二線轉移性三陰性乳癌患者的1年中位總生存期獲益。

To build on this growing interest, we're increasing community awareness, especially the expanded indication to second line in TNBC. And we expect to see growing demand as breast cancer screening ramps back up to pre-pandemic levels. IQVIA data suggests that breast cancer screening volumes were about 20% lower in the U.S. in 2020 compared to 2019. This suggests as many as 41,500 breast cancer patients have not been diagnosed during the pandemic.

為了順應這日益增長的需求，我們正在提高公眾意識，特別是擴大其在三陰性乳癌二線治療中的適應症。我們預計，隨著乳癌篩檢恢復到疫情前水平，需求將會成長。 IQVIA 的數據顯示，2020 年美國乳癌篩檢量比 2019 年下降了約 20%。這意味著疫情期間可能有多達 41,500 名乳癌患者未能得到診斷。

On behalf of Christi and the Kite team, I'm pleased to share a Cell Therapy commercial update on Slide 13. Total cell therapy product sales totaled $219 million in the second quarter, representing 39% growth year-over-year, driven by both Yescarta and Tecartus. Yescarta growth was driven by strong demand in Europe as well as successful follicular lymphoma launch in the U.S. Increased competition, particularly in third-line LBCL, continues to raise the profile of cell therapy and is positive to Kite overall. We remain confident in Yescarta's competitive profile and positioning, and are particularly proud of Kite's industry-leading manufacturing turnaround time and reliability. Our results also reflected strong momentum from the Tecartus mantle cell lymphoma launch, highlighting the unmet medical need for MCL patients.

我謹代表Christi和Kite團隊，在第13頁幻燈片中分享細胞療法業務的最新進展。第二季細胞療法產品總銷售額達2.19億美元，較去年成長39%，主要得益於Yescarta和Tecartus兩款產品的強勁表現。 Yescarta的成長主要得益於歐洲市場的強勁需求以及其在美國成功上市的濾泡性淋巴瘤產品。日益激烈的競爭，尤其是在三線大B細胞淋巴瘤（LBCL）治療領域，持續提升了細胞療法的知名度，這對Kite的整體表現而言是利好消息。我們對Yescarta的競爭優勢和市場定位充滿信心，並為Kite行業領先的生產週期和可靠性感到自豪。此外，Tecartus套細胞淋巴瘤產品的上市也帶來了強勁的成長勢頭，凸顯了套細胞淋巴瘤（MCL）患者尚未滿足的醫療需求。

We continue to add new indications and geographies for our cell therapy products. For example, the Fosun-Kite joint venture recently received approval in China for Yescarta as the first cell therapy to treat third-line LBCL. And we're excited to see the top line data for ZUMA-7, getting us a step closer to second-line LBCL cell therapy. Even as we prepare for discussions with regulatory agencies later this year, commercial and manufacturing preparations are ramping up to ensure sufficient capacity and support for second-line LBCL demand in both the U.S. and in Europe. Christi is here with the team to take your questions on cell therapy later in the call. But for now, I'll hand it over to Merdad to walk us through the pipeline updates.

我們持續拓展細胞療法產品的適應症和市場。例如，復星-凱特合資公司近期在中國獲準Yescarta，成為首個用於治療第三線LBCL的細胞療法。同時，我們也欣喜地看到ZUMA-7的初步數據，這使我們距離二線LBCL細胞療法又更近了一步。儘管我們正準備在今年稍後與監管機構進行磋商，但商業化和生產準備工作也在加緊進行，以確保美國和歐洲市場對二線LBCL的需求能夠得到充足的產能和支持。稍後，Christi將與團隊一起回答您關於細胞療法的問題。現在，我將把發言權交給Merdad，讓他為我們介紹產品線的最新進展。

Thank you, Johanna. As Dan mentioned, it's been a gratifying year so far, to deliver on all our key pipeline commitments, supporting Gilead's ambitions to extend our leadership in HIV and creating a broader portfolio spanning virology and oncology and building our portfolio in inflammation. I'll spend our time today on the highlights of the quarter and pointed to the appendix of the earnings presentation for a more complete view of our pipeline activities.

謝謝喬安娜。正如丹所說，今年迄今為止的成果令人欣慰，我們實現了所有關鍵研發管線的承諾，支持了吉利德鞏固其在愛滋病領域領先地位的雄心壯志，並打造了涵蓋病毒學和腫瘤學的更廣泛的產品組合，同時還拓展了我們在炎症領域的產品線。今天我將重點介紹本季的亮點，並建議讀者參閱收益報告的附錄，以更全面地了解我們的研發管線活動。

First, in HIV, as you can see on Slide 15, programs for our investigational lenacapavir agent continue to progress. At the recent International Aid Society Meeting, we shared data from the Phase II/III CAPELLA study that evaluated heavily treatment experienced individuals who've already developed resistance to multiple antiretroviral drugs. CAPELLA demonstrated lenacapavir's potency in this difficult-to-treat population. Despite significant prior resistance, antiviral activity was observed starting at day 15.

首先，在愛滋病治療方面，如您在幻燈片15中所見，我們正在研發的藥物lenacapavir的計畫正在持續推進。在最近的國際愛滋病協會會議上，我們分享了CAPELLA II/III期研究的數據。該研究評估了已接受多種抗逆轉錄病毒藥物治療且產生抗藥性的重度感染者。 CAPELLA研究證實了lenacapavir對這類難治性族群的療效。儘管患者先前已存在顯著的抗藥性，但從第15天開始就觀察到了抗病毒活性。

By week 26, 81% of individuals had viral suppression when lenacapavir was combined with an optimized background regimen. Based on these data, we filed a new drug application. If approved, this would become the first 6-month long-acting subcutaneous injection regimen available and deliver a welcome new option for people living with HIV, who have developed multidrug resistance to other antiretrovirals.

到第26週，當lenacapavir與優化後的基礎治療方案合併使用時，81%的患者病毒量受到抑制。基於這些數據，我們提交了新藥申請。如果獲得批准，這將成為首個上市的6個月長效皮下注射方案，並為已對其他抗逆轉錄病毒藥物產生多重抗藥性的HIV感染者提供一個令人欣喜的新選擇。

Also with IAS, we presented strong interim results from the Phase II CALIBRATE study, evaluating lenacapavir in a treatment-naive population. In CALIBRATE, participants receive lenacapavir either as a subcutaneous injection or as a daily oral pill in combination with Descovy. At week 28, 94% of subjects achieved HIV-1 RNA loads of less than 50 copies per ml. These findings will be used to help inform our broader efforts establishing lenacapavir as a foundational agent for our long-acting franchise.

此外，我們也與IAS合作，公佈了II期CALIBRATE研究的中期結果，該研究評估了lenacapavir在初治人群中的療效。在CALIBRATE研究中，受試者接受lenacapavir皮下注射或每日口服片劑合併Descovy治療。在第28週，94%的受試者HIV-1 RNA量低於50拷貝/毫升。這些發現將有助於我們進一步推進lenacapavir作為我們長效藥物系列基礎藥物的研發工作。

Late last month, we screened the first patient for the Phase III PURPOSE-II trial, studying lenacapavir for HIV prevention in cisgender men, transgender women, transgender men and gender nonbinary people who have sex with men and are at risk of HIV infection. We expect to initiate the Phase III PURPOSE-I study of lenacapavir for HIV prevention in adolescent girls and young women later this year. Finally, we're actively working on the co-formulation for the long-acting investigational oral and injectable combination of lenacapavir and islatravir and expect to initiate the oral Phase II trial by the end of the year.

上月底，我們完成了首例患者入選 III 期 PURPOSE-II 試驗，該試驗旨在研究 lenacapavir 用於預防順性別男性、跨性別女性、跨性別男性以及與男性發生性行為且有 HIV 感染風險的非二元性別人群感染 HIV 的療效。我們預計今年稍後啟動 lenacapavir 用於預防青少年女孩和年輕女性感染 HIV 的 III 期 PURPOSE-I 研究。此外，我們正在積極研發 lenacapavir 和 islatravir 的長效口服和注射複方製劑，預計在年底前啟動口服 II 期試驗。

Moving on to HDV on Slide 16. Last month at the International Liver Congress, we presented data from the MYR301 and MYR204 programs. MYR301 is a Phase III registrational study evaluating bulevirtide as monotherapy for the treatment of HDV. Interim results demonstrated that bulevirtide was well tolerated in both cirrhotic and noncirrhotic patients, with compensated chronic HDV infections. At week 24, bulevirtide treatment was associated with significantly greater HDV RNA declines and improvements in biochemical measures of disease activity compared to no treatment.

接下來是投影片16關於HDV的內容。上個月在國際肝病大會上，我們展示了MYR301和MYR204計畫的數據。 MYR301是第三期註冊研究，旨在評估布維肽單一藥物治療HDV感染的療效。中期結果表明，布維肽在代償性慢性HDV感染的肝硬化和非肝硬化患者中均具有良好的耐受性。在第24週，與未接受治療的患者相比，布維肽治療組的HDV RNA水準顯著下降，且疾病活動度的生化指標也得到改善。

Moreover, there were no treatment-related serious adverse events leading to discontinuation. These results continue to support the effectiveness of the 2-milligram dose, which has received conditional approval from the EMA and will form the basis of the BLA filing plan for later this year in the U.S.

此外，未發生因治療相關的嚴重不良事件而導致停藥。這些結果繼續支持2毫克劑量的有效性，該劑量已獲得EMA的有條件批准，並將成為今年稍後在美國提交生物製品許可申請（BLA）計劃的基礎。

As part of our HDV cure efforts, we also presented interim data from the MYR204 Phase IIb study, investigating finite regimens of bulevirtide, both as monotherapy and in combination with PEG interferon alpha. Both monotherapy and combination treatments of bulevirtide were found to be generally well tolerated and more effective than PEG interferon alone through 24 weeks of therapy. The primary endpoint analysis occurs at 24 weeks after completion of therapy and includes virologic and biochemical response data. We look forward to sharing those data when available.

作為我們HDV治癒計畫的一部分，我們也發表了MYR204 IIb期研究的中期數據，該研究旨在評估布列維肽單一治療和聯合聚乙二醇幹擾素α治療的有限療程。研究發現，布列維肽單藥治療和合併治療的耐受性普遍良好，且在24週的療程內療效優於單獨使用聚乙二醇幹擾素α。主要終點分析將在治療結束後24週進行，包括病毒學和生化反應數據。我們期待在獲得這些數據後與大家分享。

Moving to Slide 17, and on behalf of Christi and the Kite team, as you know, we shared earlier the strong positive top line data from ZUMA-7, the landmark 359-patient Phase III study evaluating Yescarta in second-line LBCL. The study met the primary endpoint for event-free survival with a hazard ratio of 0.398, representing a 60% improvement in event-free survival compared to standard of care stem cell transplant. Yescarta had a safety profile comparable to or better than what we have seen in the third-line setting.

接下來是第17張投影片。如您所知，我代表Christi和Kite團隊，之前分享了ZUMA-7研究的強有力陽性頂線數據。 ZUMA-7是一項里程碑式的III期臨床研究，納入359名患者，旨在評估Yescarta在二線LBCL治療中的療效。研究達到了無事件存活期的主要終點，風險比為0.398，與標準治療方案（幹細胞移植）相比，無事件存活期提高了60%。 Yescarta的安全性與我們在三線治療中觀察到的安全性相當或更優。

This is a clinically and statistically meaningful improvement in outcomes that, if approved in the U.S., could extend Yescarta's reach to a total unique population of 14,000 patients annually in the second and third-line LBCL setting. ZUMA-7 also met the key secondary endpoint of objective response rate. As expected, data for overall survival is immature at this time, but the interim analysis suggests a favorable trend in this critical milestone.

這是一項具有臨床和統計學意義的療效改善，如果獲得美國批准，Yescarta 的適用範圍每年可擴大至 14,000 名接受二線和三線治療的 LBCL 患者。 ZUMA-7 研究也達到了客觀緩解率這一關鍵次要終點。如預期，目前總存活期的數據尚未成熟，但中期分析顯示，這一關鍵里程碑呈現出良好的發展趨勢。

In summary, we're very excited about the potential benefit to patients demonstrated in ZUMA-7 and look forward to beginning discussions with regulatory agencies later this year as we work towards potential SBLA and MAA filings for Yescarta in second-line LBCL. And separately, we're on track for the Phase II readout for our first line LBCL study before the end of the year.

總而言之，我們對ZUMA-7研究中展現出的潛在患者獲益感到非常振奮，並期待今年晚些時候與監管機構展開討論，為Yescarta在二線LBCL治療中的應用提交SBLA和MAA申請。此外，我們的第一線LBCL研究的II期數據也正按計畫推進，預計在年底前公佈。

Beyond LBCL, we've completed filing Yescarta with the EMA for patients with follicular lymphoma after 3 or more lines of systemic therapy. We also have a PDUFA date of October 1 under accelerated review with the FDA [for Yescarta's MALL]. And of course, while our internal focus remains on ontologist cell therapies, we continue our engagement in alternative approaches. Most recently partnering with Shoreline Biosciences to develop novel off the shelf allogeneic cell therapies based on natural killer targets for hematologic cancers.

除了大B細胞淋巴瘤（LBCL）之外，我們已完成向歐洲藥品管理局（EMA）提交Yescarta的上市申請，用於治療接受過3線或以上系統性治療的濾泡性淋巴瘤患者。此外，Yescarta的適應症——多發性淋巴瘤（MALL）——也已獲得美國食品藥物管理局（FDA）的加速審查，其處方藥用戶付費法案（PDUFA）批准日期定於10月1日。當然，儘管我們內部的重點仍然是本體細胞療法，但我們也持續探索其他治療方法。最近，我們與Shoreline Biosciences公司合作，共同開發基於自然殺手細胞標靶的新型現成異體細胞療法，用於治療血液腫瘤。

Slide 18 is a recap of our pipeline execution so far this year. In addition to the items we have discussed already, our partner Arcus has provided an early interim update of their Phase II ARC-7 trial in late June, demonstrating clinical activity in the anti-TIGIT domvanalimab-based doublet and triplet combinations. Zimberelimab, our anti-PD-1 antibody, saw similar levels of activity in the monotherapy arm compared to marketed anti-PD-1s. Based on the interim analysis, we're pleased that ARC-7 and the confirmatory Phase III ARC-10 trial will continue to enroll as planned. We look forward to seeing how the data mature with additional patients and duration of follow-up to inform our opt-in decision.

第 18 張投影片概述了我們今年迄今為止的研發管線執行情況。除了我們之前討論過的內容外，我們的合作夥伴 Arcus 在 6 月下旬發布了其 II 期 ARC-7 試驗的早期中期更新，結果顯示基於抗 TIGIT 藥物 domvanalimab 的雙藥和三藥聯合療法具有臨床活性。我們的抗 PD-1 抗體 Zimberelimab 在單一治療組中也展現出與已上市抗 PD-1 藥物相似的活性水準。基於中期分析，我們很高興 ARC-7 試驗和確證性 III 期 ARC-10 試驗將按計劃繼續進行患者招募。我們期待隨著更多患者的入組和追蹤時間的延長，數據將如何進一步完善，從而為我們是否選擇加入該試驗提供依據。

Separately, our partner, Galapagos, also shared data readouts from their Toledo SIK2/3 programs across psoriasis, ulcerative colitis and rheumatoid arthritis and the plaque psoriasis data from their TYK2 program. Both studies were early and had small samples, and we look forward to additional data.

此外，我們的合作夥伴 Galapagos 也分享了其 Toledo SIK2/3 項目在銀屑病、潰瘍性結腸炎和類風濕性關節炎方面的數據，以及其 TYK2 項目中的斑塊狀銀屑病數據。這兩項研究都處於早期階段，樣本量較小，我們期待獲得更多數據。

We also remain focused on the following upcoming milestones. For Trodelvy, we continue to target a TROPiCS-02 PFS readout this year. The study is an event-driven Phase III trial in patients with hormone receptor positive HER2-negative metastatic breast cancer. Pending data, we will evaluate and then determine the appropriate regulatory next steps. We estimate there are roughly 17,000 patients in the U.S. who could benefit from Trodelvy in this setting.

我們仍將重點關注以下即將到來的里程碑。對於Trodelvy，我們繼續致力於在今年獲得TROPiCS-02無惡化存活期（PFS）數據。該研究為事件驅動的III期臨床試驗，受試者為荷爾蒙受體陽性、HER2陰性的轉移性乳癌患者。待數據公佈後，我們將評估並確定後續的監管步驟。我們估計，美國約有17,000名患者可能從Trodelvy治療中獲益。

We continue to expect the Phase III non-small cell lung cancer for Trodelvy to initiate in the second half of this year. We plan to share an update from the TROPiCS-03 basket study on lung cancer later this year and will separately provide updates on head and neck squamous cell carcinoma and endometrial cancer as the data mature. We anticipate a Phase Ib readout from magrolimab in MDS later this year, and pending data will engage with regulators as we explore potential BLA filing for accelerated approval.

我們仍預期Trodelvy治療非小細胞肺癌的III期臨床試驗將在今年下半年啟動。我們計劃在今年稍後公佈TROPiCS-03肺癌籃式研究的最新進展，並將在數據成熟後單獨發布頭頸部鱗狀細胞癌和子宮內膜癌的最新進展。我們預計magrolimab治療MDS的Ib期臨床試驗結果將於今年稍後公佈，待公佈的數據將用於與監管機構溝通，探討申請生物製品許可申請（BLA）以尋求加速審批的可能性。

If approved, magrolimab will be the first-in-class checkpoint inhibitor targeting CD47 and Gilead's first frontline oncology indication. There's a significant unmet need for MDS, with no new treatments approved in 14 years despite 15,000 new patients being diagnosed each year in the U.S. alone. We continue our development efforts in AML and have enrolled our first patient in the Phase III frontline AML magrolimab study.

如果獲得批准，magrolimab 將成為首個針對 CD47 的免疫檢查點抑制劑，也是吉利德首個核准的第一線腫瘤適應症。骨髓增生異常綜合症 (MDS) 的治療需求龐大，儘管僅在美國每年就有 15,000 名新患者確診，但 14 年來卻沒有任何新的治療方法獲得批准。我們正持續推動 AML 的研發工作，目前已在 magrolimab 一線治療 AML 的 III 期臨床試驗中招募了首例患者。

Before I wrap up the pipeline discussion, I wanted to share an update on remdesivir. We've decided not to move forward with an inhaled formulation of remdesivir based on the results of our initial proof-of-concept study, suggesting suboptimal lung deposition. To address patient needs in the evolving pandemic, we are continuing our efforts on advancing multiple novel antivirals. We expect to submit IND filings later this year or early next year for these agents. We remain committed to supporting patients through this pandemic and continuing our legacy of developing antiviral therapeutics for the treatment of emerging diseases.

在結束關於產品線的討論之前，我想先分享一下瑞德西韋的最新進展。根據我們初步概念驗證研究的結果，我們決定不再推進瑞德西韋吸入製劑的研發，因為結果顯示其肺部沉積效果不佳。為了因應不斷變化的疫情情勢下患者的需求，我們正在持續推動多種新型抗病毒藥物的研發。我們預計將於今年稍後或明年初提交這些藥物的IND申請。我們將繼續致力於在疫情期間為患者提供支持，並延續我們研發抗病毒療法以治療新興疾病的傳統。

Finally, on Slide 19, I want to recognize the teams at Gilead and Kite. Compared to just 2 years ago, our pipeline has grown from 30 clinical stage programs to over 50 today, and resulted in a considerably more diverse set of assets that can be transformative, not only for patients but for Gilead. The Gilead and Kite teams have worked tirelessly to deliver on our pipeline programs during this time of dramatic growth despite the pandemic. It's a thrilling time to be part of the team, with tireless dedication and commitment to helping patients. I look forward to updating you on our progress in the quarters ahead.

最後，在第19頁投影片中，我想特別感謝吉利德和Kite的團隊。與兩年前相比，我們的研發管線已從30個臨床階段計畫成長到如今的50多個，並由此形成了更加多元化的資產組合，這些資產不僅能夠為病患帶來變革，也能為吉利德本身帶來變革。儘管面臨疫情的挑戰，吉利德和Kite的團隊仍然不懈努力，確保了我們在這段快速成長時期研發管線計畫的順利推進。能夠成為這個團隊的一員，我感到無比激動，因為大家始終秉持著為病人服務的不懈奉獻和堅定承諾。我期待在接下來的幾季中向大家報告我們的進展。

With that, I'll hand the call over to Andy to walk us through the financial results of the quarter.

接下來，我將把電話交給安迪，讓他為我們介紹本季的財務表現。

Thank you, Merdad, and good afternoon, everyone. Moving to Slide 21, our financial results in the second quarter were solid overall, with total product sales up 21% year-over-year, given the important role Veklury continues to play in this pandemic. Excluding Veklury, total product sales grew 5% year-over-year, with strong Biktarvy growth more than offsetting lower Truvada and Atripla revenues. In addition to impressive growth in cell therapy and, of course, the new revenue contribution associated with Trodelvy, which was not part of our portfolio in the second quarter of last year.

謝謝Merdad，大家午安。接下來看第21張投影片，我們第二季的財務業績整體穩健，產品總銷售額年增21%，這主要得益於Veklury在此次疫情中持續發揮的重要作用。若不計入Veklury，產品總銷售額年增5%，其中Biktarvy的強勁成長足以抵銷Truvada和Atripla營收的下降。此外，細胞療法也實現了令人矚目的成長，當然還有Trodelvy帶來的新收入貢獻，Trodelvy在去年第二季並不在我們的產品組合中。

Moving down the P&L, non-GAAP product gross margin was 86.4% in the second quarter, 210 basis points higher year-over-year and primarily associated with a lower royalty expense. Non-GAAP R&D was $1.1 billion, down 9% year-over-year, with lower remdesivir-related investments as compared to the same period last year, partly offset by higher investments across our pipeline, notably Trodelvy and magrolimab. Non-GAAP SG&A expense was $1.1 billion, down 4% year-over-year, primarily due to lower legal expenses, offset in part by continued commercial investment in Trodelvy and Veklury outside the United States.

從損益表來看，第二季非GAAP產品毛利率為86.4%，年增210個基點，主要得益於較低的特許權使用費支出。非GAAP研發支出為11億美元，年減9%，其中瑞德西韋相關投資較去年同期有所減少，但部分被其他在研產品（尤其是Trodelvy和magrolimab）的增加投資所抵銷。非GAAP銷售、管理及行政費用為11億美元，較去年同期下降4%，主要原因是法律費用減少，但部分被Trodelvy和Veklury在美國以外地區的持續商業投資所抵銷。

Moving to tax, we realized a lower effective tax rate of 19.6% for the quarter or down 320 basis points year-over-year due to a shift in geographic earnings mix. Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021 compared to $1.11 for the same period last year. The year-over-year improvement primarily reflects higher product sales due to Veklury, higher gross margin as well as lower operating expenses and a lower effective tax rate, offset by lower interest income. Overall, we're encouraged by our first half results shown on Slide 22.

就稅務方面而言，由於地域收益結構的變化，本季實際稅率降至19.6%，年減320個基點。整體而言，2021年第二季非GAAP攤薄後每股收益為1.87美元，去年同期為1.11美元。年比成長主要得益於Veklury帶來的產品銷售成長、毛利率提高以及營運費用和實際稅率的降低，但部分被利息收入的減少所抵銷。總的來說，我們對第22頁幻燈片所示的上半年業績感到鼓舞。

Moving to Slide 23, you can see that we are updating our guidance for 2021. As always, the duration and magnitude of the COVID-19 pandemic continue to be uncertain and the rate and degree of these pandemic impacts as well as the corresponding recovery from the pandemic may vary across our business. With that said, we now expect full year total product sales in the range of $24.4 billion to $25 billion compared to our previous range of $23.7 billion to $25.1 billion. The new range increases the midpoint from $24.4 billion to $24.7 billion, and reflects our solid results year-to-date as well as our updated expectations for the second half of the year.

翻到第23頁，您可以看到我們更新了2021年的業績預期。與以往一樣，新冠肺炎疫情的持續時間和嚴重程度仍然存在不確定性，疫情的影響速度和程度以及相應的復甦情況可能會因業務的不同而有所差異。儘管如此，我們現在預計全年產品總銷售額將在244億美元至250億美元之間，高於先前預測的237億美元至251億美元。新的預測區間將中位數從244億美元上調至247億美元，反映了我們年初至今的穩健表現以及我們對下半年業績的最新預期。

With first half Veklury revenue of $2.3 billion, we now expect full year Veklury revenue in the range of $2.7 billion to $3.1 billion compared to our previous $2 billion to $3 billion range. Our updated range reflects the ongoing role of Veklury in this pandemic and assumes we'll continue to see regional outbreaks. The situation continues to be dynamic, and we'll likely update our thinking again when we report our earnings after the third quarter.

上半年Veklury營收為23億美元，我們目前預計Veklury 全年營收將在27億美元至31億美元之間，高於先前預測的20億美元至30億美元。我們更新後的預期反映了Veklury在此次疫情中持續發揮的作用，並假設未來仍會出現區域性疫情爆發。疫情情況仍在不斷變化，我們可能會在第三季財報發布後再次調整預期。

Back to our guidance, we now expect total product sales excluding Veklury for the year to be in the range of USD 21.7 billion to $21.9 billion compared to our previous range of $21.7 billion to $22.1 billion. This tightening of the range reflects the longer-than-expected pandemic impact on our business, including the latest increase in COVID-19 cases. As Johanna discussed, the pandemic has most notably impacted our HIV treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuations than expected in 2020. It's taking longer than we expected for treated patient volumes to ramp back up to more normal levels, particularly in the United States.

回到我們的業績指引，我們現在預計，不包括Veklury在內，全年產品總銷售額將在217億美元至219億美元之間，低於此前預測的217億美元至221億美元。此次預測範圍收窄反映了疫情對我們業務的影響持續時間超出預期，包括近期新冠肺炎病例的增加。如同Johanna所討論的，疫情對我們的HIV治療業務影響最為顯著，2020年該業務的治療啟動數量遠低於預期，而治療中斷數量則高於預期。接受治療的患者數量恢復到正常水平所需的時間比我們預期的要長，尤其是在美國。

That said, we saw encouraging signs of recovery in the HIV market in the second quarter, and our guidance assumes recovery will continue through the remainder of the year. Based on market share dynamics, we remain very confident in our competitive positioning, and we believe we're well positioned as the recovery continues.

儘管如此，我們在第二季看到了愛滋病市場令人鼓舞的復甦跡象，我們的業績預期也基於復甦勢頭將持續到年底的假設。基於市場份額的動態變化，我們對自身的競爭地位仍然充滿信心，並相信隨著復甦的持續，我們已做好充分準備。

Looking at the rest of our P&L. We now expect non-GAAP product gross margin in the range of 86% to 87%, reflecting the lower mix of HIV revenue. We now expect non-GAAP R&D to decline low to mid-single-digit percentage compared to 2020 levels. This primarily reflects the timing of investments, and we remind you that the expenses in both R&D and SG&A are back-end loaded this year, increasing sequentially from Q2 into Q3 and then even more from Q3 into Q4. Our non-GAAP SG&A guidance remains unchanged at flat to low single-digit percentage decline over 2020.

再來看損益表的其他部分。我們現在預計非GAAP產品毛利率在86%至87%之間，這反映了HIV收入比例的下降。我們現在預期非GAAP研發支出將比2020年水準下降個位數百分比。這主要反映了投資的時間安排，我們在此提醒您，今年的研發和銷售、管理及行政費用均集中在下半年，從第二季度到第三季度環比增長，然後從第三季度到第四季度進一步增長。我們對非GAAP銷售、管理及行政費用的預期保持不變，預計與2020年相比持平或下降個位數百分比。

In R&D, we'll be ramping up additional studies with magrolimab, Trodelvy, long-acting combination work with lenacapavir for the treatment of HIV and other pipeline activities. And in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications such as with Trodelvy and Tecartus.

在研發方面，我們將加強對magrolimab、Trodelvy、長效lenacapavir聯合療法治療HIV以及其他在研藥物的研發力度。在銷售、管理及行政方面，我們將增加市場推廣力度，以支持我們不斷擴大的適應症組合，例如Trodelvy和Tecartus。

Finally, reflecting the updates to our revenue, gross margin and operating expense guidance, we now project non-GAAP diluted EPS between $6.90 per share and $7.25 per share for the year, and GAAP diluted EPS between $4.70 and $5.05. Additionally, our capital allocation priorities have not changed, and we remain committed to our dividend. Year-to-date, we've paid down $1 billion -- $1.25 billion in debt, and we're on track to repay at least $4 billion in debt by the end of the year.

最後，鑑於我們對營收、毛利率和營運費用預期進行了更新，我們目前預計全年非GAAP攤薄後每股收益在6.90美元至7.25美元之間，GAAP攤薄後每股收益在4.70美元至5.05美元之間。此外，我們的資本配置重點保持不變，我們將繼續履行派息承諾。今年迄今為止，我們已償還10億美元至12.5億美元的債務，並預計在年底前償還至少40億美元的債務。

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

接下來，我將邀請接線生開始問答環節。

(Operator Instructions) Our first question comes from Cory Kasimov with JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的 Cory Kasimov。

This is Gavin on for Cory. Just wanted to go back to the U.S. HIV business. Can you provide additional color, particularly in the context of why this is so much different from the ex U.S. markets? And what is the most important factor you'll be watching for to have confidence in the U.S. market normalizing?

這裡是 Gavin 替 Cory 發言。我想回到美國愛滋病市場這個話題。您能否提供更多細節，特別是關於為什麼美國市場與其他國家/地區的市場有如此大的差異？您認為美國市場恢復正常最需要關注的因素是什麼？

Yes. Thanks a lot, Gavin, for joining. I'm obviously going to turn that over to Johanna. I'd just point out that we continue to do really well in our share and certainly, Biktarvy growth and are well positioned as the market rebounds. And with that, I'll turn it over to Johanna for some specifics.

是的。非常感謝 Gavin 的參與。接下來我顯然要把發言權交給 Johanna。我只想指出，我們的市場份額和 Biktarvy 的成長都持續表現良好，並且我們已經做好了市場反彈的準備。接下來，我將把發言權交給 Johanna，請她詳細介紹一下。

Thanks. Gavin, thanks for your question. I think from a market dynamic standpoint, what we're seeing is we saw a little bit last year in Q2, most of the industry was actually slowing down pretty quickly in Q2. HIV took a little bit longer, and it's kind of that playing out in '21. It's taking a little bit longer to come back and bounce back.

謝謝。加文，謝謝你的提問。我認為從市場動態的角度來看，我們看到的情況和去年第二季差不多，當時大部分產業其實都迅速放緩了。愛滋病疫情的復甦速度稍慢一些，這種情況在2021年也再次出現。它需要更長的時間才能恢復並反彈。

One of the major reasons for that has to do with your dynamic market being much smaller in this market. You have a very large pool of patients that are just continuing patients. And you're really playing in the dynamic market with your naive patients coming in and your switches and your restarts, really around 5% or so. And so that's why it's taking a little bit longer as we're going through this.

其中一個主要原因在於，你們這個市場的動態市場規模要小得多。你們擁有龐大的持續就診患者群。而你們真正活躍的動態市場，是那些新入院、轉診和重新開始治療的患者，這些患者只佔大約5%左右。所以，這就是為什麼我們推進這項工作需要更長的時間。

From a different standpoint between U.S. and Europe, I think it has more to do with the fact that in Europe, there's diversity across some of the different countries as to the pandemics and the timing of kind of the recoveries or even some of the surges that happened. So it's a little bit more blended than what we've seen in the U.S. thus far. And so I think that's just what's playing out here. Obviously, the bigger impact being in the U.S. because that's where most of our business lies in HIV.

從美國和歐洲的不同角度來看，我認為這與歐洲各國疫情發展的差異有關，各國疫情的恢復時間甚至疫情高峰期都不盡相同。因此，歐洲的情況比我們目前在美國看到的情況更加複雜。我認為這就是目前歐洲疫情發展的原因。當然，疫情對美國的影響更大，因為我們的大部分愛滋病業務都在美國。

And just to close out on that, the -- that's from a market standpoint, and it's very different than kind of the fundamentals of our HIV business. I think what we've seen with Biktarvy, we're really quite pleased with in light of the fact that not only it's grown quarter-over-quarter by 1 point, both in the U.S. as well as in the EU5. But also, if you think about it over the last 12 months, it's grown 6 point share over a very strong base. We're just under 40%, we're at 39% share at this point in time. So we're very pleased with the continued growth of Biktarvy, and you can appreciate that because it's such a larger base, that's going to get more challenging as we move forward.

最後總結一下，這是從市場角度來看的，與我們愛滋病業務的基本面截然不同。考慮到Biktarvy在美國和歐盟五國（EU5）的季度環比增長了1個百分點，我們對它的表現非常滿意。而且，回顧過去12個月，它在非常強勁的基數上實現了6個百分點的市佔率成長。目前，我們的市佔率略低於40%，達到39%。因此，我們對Biktarvy的持續成長感到非常高興。當然，由於其基數龐大，未來發展將面臨更大的挑戰。

And that's why I think we're excited about the market coming back a little bit. We've seen it come back in Q2. Where the market goes, obviously, our HIV business goes because we own 75% of the market. And so therefore, we're watching that very closely, but we would expect that recovery to continue, although at a slower pace than we had originally expected.

這就是為什麼我們對市場略有回升感到興奮的原因。我們在第二季已經看到了復甦的跡象。市場走向顯然會影響到我們的愛滋病業務，因為我們佔據了75%的市場。因此，我們正在密切關注市場動態，但我們預計復甦勢頭將會持續，儘管速度會比我們最初預期的要慢一些。

That's great, Johanna. Anything on the indicators. I think you've mentioned but anything more on the indicators that you'll be looking for.

太好了，喬安娜。關於指標方面還有什麼要補充的嗎？我想你已經提過了，但你還需要關注哪些指標呢？

Yes. So we've been looking, of course, at the HIV screening and the diagnosis and how that's playing out. And we're still under by about 13% to -- below pre-COVID levels. So I think once those come back up, I think that would be something that we're watching very closely and also the drop-off rates. We talked a little bit in -- earlier about the adherence piece of the puzzle, because you have less patient support groups around, you have less surround sound around those HIV patients.

是的。所以我們一直在關注愛滋病毒篩檢和診斷的情況，以及目前的進展。目前我們的篩檢和診斷率仍比新冠疫情前的水準低約13%。因此，我認為一旦篩檢和診斷率回升，我們將密切關注這種情況，同時也關注患者的流失率。我們之前也稍微談到了依從性問題，因為患者支持小組減少了，愛滋病毒感染者周圍的支持也減少了。

You have a lot of those case managers and physicians that have moved over to treat COVID-19 and so for impacting HIV, a little bit disproportionately. And so we're also looking at those drop-offs. And we've seen those drop-offs come back to normal to pre-COVID levels just most recently. And so that's another positive sign to that recovery of the market.

許多病例管理人員和醫生都轉而治療新冠肺炎，因此對愛滋病的影響可能不成比例地更大。所以我們也在關注這些流失的病例。我們看到，最近這些流失的病例已經恢復到新冠疫情前的水準。這是市場復甦的另一個正面訊號。

And Gavin, obviously, just from a patient perspective, we have been and will continue to be dedicated to helping patients, particularly in underserved communities get back into the care system. I think that's something that Gilead prides itself on. And it's exceptionally important as a leader in HIV medicines to make sure we are always on the side of the patients as we emerge from this pandemic. So thanks for the question, Gavin.

加文，很顯然，從患者的角度來看，我們一直並將繼續致力於幫助患者，特別是那些服務不足社區的患者，重返醫療體系。我認為這是吉利德引以為傲的一點。身為愛滋病藥物領域的領導者，確保我們在走出這場疫情的過程中始終站在病人這邊至關重要。謝謝你的提問，加文。

Our next question comes from Terence Flynn with Goldman Sachs.

下一個問題來自高盛的 Terence Flynn。

Maybe a two-part for me. First for Johanna, just wondering if you can provide any more insight on the Trodelvy launch, specifically the split of sales by either setting or indication.

或許我可以分成兩個部分來問。首先是問Johanna，我想了解Trodelvy上市後的情況，特別是依照使用環境或適應症劃分的銷售情況。

And then for Merdad, can you remind us of the size of the lung cancer cohort in TROPiCS-03? And then how are you thinking about the potential risk of ILD in that population?

Merdad，您能否介紹一下TROPiCS-03研究中肺癌隊列的規模？您如何看待該族群中ILD的潛在風險？

Thanks, Terence. Yes, go ahead, Johanna.

謝謝你，特倫斯。好的，喬安娜，請繼續。

Sure. Thanks for the question. So yes, so we're really pleased with the Trodelvy sales. I had 24% growth quarter-over-quarter. I think, is a very strong quarter, and I think that really has to do with the approval, the second line plus approval that we got in metastatic triple negative breast cancer early April. It's also related to the fact that because now we have the full approval, we have the opportunity to promote the incredible overall survival data that we have with the ASCENT data. And so that's been a big piece of the puzzle.

當然。謝謝你的提問。是的，我們對Trodelvy的銷售情況非常滿意。環比增長了24%。我認為這是一個非常強勁的季度業績，這主要得益於我們在4月初獲得的轉移性三陰性乳癌二線治療的批准。此外，由於我們現在獲得了全面批准，我們有機會宣傳ASCENT研究中令人矚目的總生存期數據。因此，這無疑是業績成長的關鍵因素。

If you're asking me to split the sales per line of therapy, that's very challenging in light of the claims data that we have. But what I would say if it's more about bladder cancer versus triple-negative breast cancer, I would say most of that is triple-negative breast cancer, probably about a 90-10 ratio as our bladder cancer is much smaller. Although we've done some nice inroads there already and are looking at about just under 10% share in bladder right now with Trodelvy. So we're excited about that as well. Merdad?

如果你要我按治療線細分銷售額，鑑於我們掌握的理賠數據，這非常困難。但如果更專注於膀胱癌和三陰性乳癌的比較，我會說大部分銷售額都來自三陰性乳癌，比例大概是90比10，因為我們的膀胱癌市佔率要小得多。儘管如此，我們在膀胱癌領域已經取得了一些不錯的進展，目前Trodelvy的市佔率接近10%。所以我們對此也感到很興奮。 Merdad？

And then with TROPiCS-03, it's a basket study. So the ends per arm are not hard and fast. We'll probably be looking at data once we get to the 20, 30 range in there. But it's not predetermined. So I wouldn't want to overstate it.

至於 TROPiCS-03，這是一項籃子試驗研究。因此，每組試驗的終點指標並非一成不變。我們可能會在試驗達到 20 到 30 例患者規模時再分析數據。但這並非預先設定的，所以我不想誇大其詞。

Regarding ILD, we are definitely very sensitive to and watching for it, as you can imagine. To date, we haven't had any reports of that, but we're ever vigilant. So.

關於間質性肺病，正如您所想，我們對此非常重視並密切關注。到目前為止，我們尚未收到任何相關報告，但我們始終保持警惕。

Great. Thank you both. Thanks Terence. We'll get the next question now, please.

太好了。謝謝你們兩位。謝謝特倫斯。現在請問下一個問題。

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。

A question regarding HIV life cycle. You recently reported data for subcu lenacapavir-based combo with treatment-naive HIV. I'm curious, how do the learnings there with respect to the resistance profile you're observing, shape how you think about the future development steps vis-a-vis potentially exploring higher doses, more frequently -- more frequent than every 6-month injections and/or combining with agents that might have a higher intrinsic barrier resistance versus F/TAF.

關於HIV生命週期的問題。您最近報告了皮下注射lenacapavir聯合療法治療初治HIV感染者的數據。我很好奇，您觀察到的抗藥性光譜，如何影響您對未來研發步驟的思考，例如探索更高劑量、更頻繁的給藥（比每6個月注射一次更頻繁）和/或與可能具有比F/TAF更高固有屏障抗藥性的藥物聯合使用？

And then, I guess, along the lines of HIV life cycle, I'm also curious your level of confidence as to the potential of F/TAF to have exclusivity beyond 2025?

然後，我想，就 HIV 的生命週期而言，我也很好奇您對 F/TAF 在 2025 年以後保持獨家銷售權的信心程度如何？

Great. Why don't we have you start, Merdad, and perhaps Andy can comment a little bit on the second piece, too.

太好了。不如就讓你先開始吧，梅爾達德，或許安迪也可以對第二部分發表一些看法。

Yes, thanks. It's a very good question. And I think if you think about the patients in that trial, these are highly treatment-experienced patients who often develop resistance because of noncompliance. And when these subjects are getting a subcu injection of lenacapavir, remember that these patients are going to potentially continue to go off and on their oral regimens.

是的，謝謝。這是一個很好的問題。我想，如果你仔細想想那項試驗中的患者，他們都是接受過多種治療的患者，而且常常因為依從性差而產生抗藥性。當這些患者接受皮下注射來那卡帕韋時，請記住，他們可能會繼續中斷並重新開始口服藥物治療。

As we think about the future, as you know, we are -- for treatment going outside the highly treatment-experienced population, we're really thinking about how we're going to combine lenacapavir with other long-acting agents like islatravir. And as we do so, I think the concerns about patients potentially having effective monotherapy with lenacapavir go away in some regards, right, ensuring that patients are taking multiple agents at the same time is going to be really important for us.

如您所知，展望未來，對於非治療經驗人群，我們正在認真考慮如何將勒那卡帕韋與其他長效藥物（例如伊斯拉曲韋）聯合使用。我認為，隨著合併用藥，患者可能僅使用勒那卡帕韋單一藥物治療的療效問題在某種程度上會得到緩解。因此，確保患者同時服用多種藥物對我們來說至關重要。

Thanks, Merdad. And perhaps, Andy, you want to comment on the exclusivity question for Brian?

謝謝，Merdad。 Andy，或許你想就Brian的獨家代理商問題發表一下看法？

Sure. I'd be happy to. Brian, thanks for the question. As you know, there's litigation that's underway. There are some recent developments that the number of analysts wrote about. Our base case continues to be that there will be generics arriving in 2025 and 2026 in the U.S. and EU respectively, but we think we have a strong case and that there -- we look forward to continuing to prosecute the case and we'll see where it plays out. We should have an additional update later this year. So that's really where it stands.

當然可以，我很樂意。布萊恩，謝謝你的提問。正如你所知，目前訴訟正在進行中。一些分析師也撰文討論了最近的一些進展。我們的基本預測仍然是，仿製藥將分別於2025年和2026年在美國和歐盟上市，但我們認為我們的訴訟理由充分，我們期待繼續推進此案，並觀察最終結果。我們預計今年稍後會發布新的進展報告。目前情況就是這樣。

(Operator Instructions) Our next question comes from Geoffrey Porges with SVB Leerink.

（操作說明）我們的下一個問題來自 SVB Leerink 的 Geoffrey Porges。

So just a couple of parts in my question. Could you clarify a couple of your partnerships? There's been some news from Galapagos, you've invested over $5 billion there. Are you going to take on any of those drugs from the Toledo portfolio that the company recently highlighted?

我的問題只有幾個部分。您能否澄清一下您的一些合作關係？最近有消息指出您在 Galapagos 投資了超過 50 億美元。您是否會收購 Toledo 公司最近重點介紹的那些藥物？

And then related to that, your Arcus partnership. Does your guidance include the mild upfront cost of opting in for any of those programs? And what's the trigger and the window for when you can opt in to any of those 3 programs? Because they sort of appear on your pipeline slide, but it's not completely clear whether they're in or out. So could you clarify where you're going with those 2 partnerships?

另外，關於您與 Arcus 的合作。您的方案是否包含參與這些項目所需的少量前期費用？參與這三個項目的觸發條件和時間窗口是什麼？因為它們出現在您的專案介紹投影片上，但並不完全清楚它們是否包含在內。所以，您能否解釋一下您對這兩項合作的規劃？

Sure, Geoff. Thank you very much for the question. And I'll start a little bit and then ask Merdad and Andy, if he wants to add anything as well.

當然可以，傑夫。非常感謝你的提問。我會先簡單說幾句，然後再問梅爾達德和安迪，看他是否還有補充。

So I think, first and foremost, I think we're -- we believe deeply in partnerships. We have a robust internal portfolio. And we also, as you know, have designed these opt-ins as a way to expand our portfolio in different therapeutic areas. Starting with Galapagos, as you know, which was predominantly focused on inflammation.

所以，首先，我認為我們非常重視合作。我們擁有強大的內部產品組合。而且，如您所知，我們設計了這些自願加入機制，旨在拓展我們在不同治療領域的產品組合。首先是 Galapagos，如您所知，它主要專注於發炎治療。

At this stage, we don't have any opt-in milestones right now with Galapagos. We're working closely with them on their science and their discovery platform and some of their preclinical to clinical molecules to support them in their efforts. But at this stage, we don't have anything more to report other than like Galapagos has reported on the, for instance, Geoff, to your question on the Toledo program. But rest assured that as those programs evolve and mature and develop, we'll keep you informed.

現階段，我們與 Galapagos 之間沒有任何需要雙方共同參與的里程碑事件。我們正與他們緊密合作，支持他們的科學研究、發現平台以及一些從臨床前到臨床階段的分子。但目前，除了 Galapagos 已經報告過的資訊（例如，Geoff，關於你提到的 Toledo 專案）之外，我們沒有其他資訊可以透露。請放心，隨著這些專案的進展和成熟，我們會及時向你們報告。

Perhaps, Merdad, if you want to say anything else in Galapagos and bridge to Arcus?

或許，梅爾達德，如果你還想在加拉巴哥群島和通往阿爾庫斯的橋上說些什麼的話？

Yes. I think the stories are similar. We like to keep you apprised of what could potentially come into our portfolio, and we have the opt-in rights too for Arcus. I mean I think Dan laid out Galapagos well. For Arcus, we continue to wait for data to mature. And once the data get to a level of maturity where we can really make the call, that's when we'll have our opt-in. We have not included, and Andy will confirm for me, but we have not included the financials of a potential opt-in in our guidance at this point.

是的。我認為情況類似。我們希望讓您了解我們投資組合中可能新增的項目，而且我們也擁有Arcus的投資選擇權。我認為Dan對Galapagos的介紹很到位。至於Arcus，我們仍在等待資料成熟。一旦數據成熟到足以讓我們做出最終決定，我們就會啟動投資選擇權。目前，我們尚未將潛在投資選擇權的財務數據納入我們的業績指引，Andy可以向我確認這一點。

Andy, you want to (inaudible)

安迪，你想（聽不清楚）

That's correct. Yes. No, I'm happy to follow up here, Geoff, good question. And nothing has changed from the guidance at the beginning of the year. So our R&D spend and all of our expense guidance does not include the opt-ins on any of the programs that we have options to, including the 3 programs that you mentioned at Arcus.

沒錯。是的。不，我很樂意繼續解答這個問題，Geoff，問得好。年初的指導意見沒有任何改變。因此，我們的研發支出和所有費用指導意見均不包括我們可選擇參與的任何項目，包括您在Arcus提到的三個項目。

You also asked about the opt-in windows. The opt-in window for the first TIGIT antibody should be coming most likely at the end of this year. It could be early next year, but it's most likely at the end of this year, we'll have enough patient data to trigger the opt-in or our desire to opt in potentially early. On the other 2 programs, the adenosine programs at Arcus, that's most likely next year. And again, there may be additional data that comes this year that if it looks really strong. We want to move as quickly as we can, and we can opt in early, Geoff, on those programs.

您也問到了選擇加入視窗期。首個TIGIT抗體的選擇加入窗口期很可能會在今年年底到來。也可能是明年年初，但最有可能的是在今年年底，屆時我們將獲得足夠的患者數據來觸發選擇加入窗口期，或者說我們希望提前選擇加入。至於另外兩個項目，即Arcus的腺苷項目，很可能也是在明年。同樣，今年可能會有更多數據公佈，如果結果非常強勁，我們希望盡快推進，並提前選擇加入這些項目，Geoff。

And then on Toledo, it's relatively simple. And all of the Galapagos programs that opt-in comes after Phase II enabling studies. So the Toledo programs are a long ways away from a potential opt-in decision.

至於托萊多島，情況就相對簡單了。所有加拉巴哥群島的自願參與計畫都是在完成二期先導性研究後才進行的。因此，托萊多島的計畫距離最終決定是否參與還有很長的路要走。

Phase III enabling.

第三階段實施。

Yes, I'm sorry, Phase III enabling. Thank you.

是的，抱歉，是第三階段啟用程序。謝謝。

Geoff, and I'd just kind of round out to your question. I mean, there's obviously many other partnerships we have that we're working closely with at different phases, but those are the specific ones you asked about. Thank you very much for the question. Can we have the next question please?

傑夫，我再補充一下你的問題。我的意思是，我們當然還有許多其他合作夥伴，我們在不同的階段都與他們保持著密切的合作，但你問的就是這些。非常感謝你的提問。請問下一個問題可以嗎？

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。

A question for Dan or Merdad on COVID. There's a high expectation that vaccines are here for a while now that the Delta variant has really changed the dynamic. The question is, has the strategic value of Veklury change for you guys as new cases have ticked up? I know you decided not to pursue inhale, but is there a life cycle here worth investing in over the long term?

關於新冠疫​​情，我想問Dan或Merdad一個問題。鑑於Delta變異株的出現確實改變了疫情格局，大家普遍預期疫苗會在一段時間內問世。問題是，隨著新增病例的增加，Veklury對你們的策略價值是否改變了？我知道你們決定不開發吸入式疫苗，但從長遠來看，Veklury的生命週期是否值得投資？

Thanks, Geoff. I'll start, and then Merdad will either correct me or add important information to it. But I think -- I mean, just to emphasize, the importance of Gilead's legacy in antivirals and frankly, our strength in that too, to us as well. So being, of course, the first company to have -- and the only company to have an approved antiviral for COVID is no accident. Obviously, it's decades of experience, decades of investments in a variety of emerging viruses, including COVID, and we haven't stopped.

謝謝，傑夫。我先說，然後默達德會糾正我或補充一些重要資訊。但我想強調的是，吉利德在抗病毒藥物領域的悠久歷史以及我們在這方面的優勢對我們本身也至關重要。因此，我們成為第一家——也是唯一一家——擁有獲準用於治療新冠病毒的抗病毒藥物的公司，絕非偶然。這顯然是我們數十年來在包括新冠病毒在內的各種新發病毒領域積累的經驗和數十年投資的成果，而且我們從未停止過努力。

So to your point, Geoff, I think we're all learning about this pandemic as it rolls out. And it's certainly going through different phases, and we think will continue to go through different phases. And therefore, we are, if you like, kind of doubling down on an ability to think about antivirals outside the hospital setting, where remdesivir plays such an important role. And maybe with that, I'll hand it over to Merdad, as a clinician, how you might also see the future (inaudible) and also our role in it.

傑夫，你說的沒錯，我覺得我們都在隨著疫情的發展不斷了解它。疫情肯定在經歷不同的階段，我們認為還會繼續經歷不同的階段。因此，我們正在加倍努力，爭取在醫院以外的環境中使用抗病毒藥物，因為瑞德西韋在醫院環境中發揮著至關重要的作用。接下來，我想把麥克風交給梅爾達德，作為臨床醫生，你對未來（聽不清楚）以及我們在這個過程中扮演的角色有什麼看法？

Yes, thanks. I think we have, I think, been pretty consistently of the mindset that the vaccines will make a tremendous impact in the case numbers and those sorts of things. Even though I think even when we get to some sort of equilibrium, unfortunately, they'll continue to be, we believe, infections. People will continue to get infected and some proportion of those patients will end up in the hospital. So we do believe that Veklury in the hospitalized setting is going to be -- continue to be really important for treating those patients. And as Dan alluded to, we continue to believe and are committed to treatments -- making treatments available in the outpatient setting.

是的，謝謝。我認為我們一直以來都堅信，疫苗會對病例數等方面產生巨大影響。即便我認為，即使疫情達到某種平衡，但不幸的是，我們相信感染仍然會繼續發生。人們會繼續感染，其中一部分患者最終會住院。因此，我們相信，在住院治療中，Veklury 仍然對治療這些患者至關重要。正如 Dan 所提到的，我們仍然相信並致力於在門診提供治療方案。

So I wouldn't -- the inhaled nebulized approach didn't give us the results we were hoping for, the consistency we were looking for. But because we have other agents in our pipeline based on our virology expertise, we will be bringing those forward and really focusing on the outpatient setting there. So we continue to believe that having a treatment available for people, whether they're vaccinated or not, is going to be important for the foreseeable future.

所以，我不會——吸入霧化療法並沒有達到我們預期的效果和穩定性。但由於我們基於病毒學專業知識，還有其他藥物正在研發中，我們將優先推進這些藥物的研發，並專注於門診治療。因此，我們仍然認為，在可預見的未來，無論患者是否接種疫苗，擁有可用的治療方案都至關重要。

And Geoff, what I might add is that our preclinical folks continue to study remdesivir against a variety of variants. In fact, all 4 major variants of concerns, so the Alpha from the U.K., the Beta from South Africa, the Gamma from Brazil and the Delta from India, and all are fully sensitive against -- or remdesivir is as sensitive against all those strains. Which would make sense because we're not seeing any mutations in the polymerase remdesivir binding site. And so I think it's important as we think about next-generation products to also think about medicines that will be effective against these ongoing variants like remdesivir. It's an important bar for us as we move forward. Thanks, Geoff, for the question.

傑夫，我還要補充一點，我們的臨床前研究人員正在繼續研究瑞德西韋對各種變異株的療效。事實上，所有四種主要的關注變異株——英國的Alpha株、南非的Beta株、巴西的Gamma株和印度的Delta株——都對瑞德西韋完全敏感，或者說，瑞德西韋對所有這些毒株都同樣敏感。這很合理，因為我們沒有發現聚合酶瑞德西韋結合位點的任何突變。因此，我認為，在考慮下一代產品時，我們也必須考慮像瑞德西韋這樣能夠有效對抗這些不斷出現的變異株的藥物。這是我們前進道路上的一個重要標竿。謝謝你的提問，傑夫。

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 had 2 quick ones as well. First, have you had an interim PFS on the HR positive study of Trodelvy? And secondly, congrats on Bill Grossman's hire from Arcus. And I was wondering to what extent was the decision of Bill bring on board driven exclusively by Bill's familiarity with Arcus programs?

我也有兩個問題想問。首先，你們有沒有關於Trodelvy人力資源積極研究的中期可行性研究報告？其次，恭喜你們從Arcus挖來了Bill Grossman。我想知道，你們決定聘用Bill，在多大程度上只是因為他熟悉Arcus的專案？

Yes. Why don't you start, Merdad?

是的。梅爾達德，你為什麼不開始呢？

Yes. Thanks, Umer. Great questions. Yes, we have not done the interim PFS analysis as we've talked about, that will happen certainly before the end of the year, we hope. And we're -- that's still what we're tracking to. But we have not done the analysis yet. So we remain blinded to those data.

是的，謝謝，Umer。問得好。是的，正如我們之前討論的，我們還沒有進行中期無進展生存期（PFS）分析，但我們希望肯定會在年底前完成。我們——這仍然是我們努力的方向。但我們還沒有進行分析。所以我們目前還無法取得這些數據。

And then in terms of Bill, I think I wouldn't necessarily tie it as you're suggesting to Arcus, it's certainly an advantage for us that should we opt into Arcus programs, Bill will bring familiarity. But for us, Bill's experience and leadership and his excitement about being here and overseeing the overall portfolio were the drivers for Bill coming on board.

至於比爾，我覺得我不一定要像你建議的那樣把他和Arcus連結起來。當然，如果我們選擇加入Arcus的項目，比爾的熟悉程度對我們來說肯定是一個優勢。但對我們而言，比爾的經驗、領導能力以及他對加入我們、負責整個作品集的熱情，才是促使我們選擇他加入的主要原因。

Yes. And I would just add, Umer, I mean, look, many of us know Bill, you know him as well. Our relationship with Arcus is extremely important and continues to be. And this was an example of Bill seeing a career opportunity and seeing an evolution for his career that made sense for him. We certainly want to make sure that Arcus continues to have the skill set that it needs to be successful. We have the skill set that we need to be successful. I think it's just a good example of how partners collaborate at times. And so I just wanted to emphasize, our relationship with Arcus is unchanged and as strong as ever.

是的。我還要補充一點，烏默，我的意思是，我們很多人都認識比爾，你也認識他。我們與Arcus的關係非常重要，而且一直都是如此。比爾看到了一個職業發展機會，並認為這對他的職業發展很有意義。我們當然希望確保Arcus繼續擁有成功所需的技能。我們自身也擁有成功所需的技能。我認為這很好地體現了合作夥伴之間的協作方式。所以我想強調的是，我們與Arcus的關係一如既往地牢固。

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。

Maybe a question for Merdad on Trodelvy a couple of parts. In the TROPiCS-02 study, you had the smart decision to take a look at that, enlarge it, powered for PFS, et cetera. Did you have any information that could help give you confidence around the powering? And any information that would help you give confidence in the overall study such as the number of events that have passed or anything like that? Or even knowing that it had passed a futility, if you could even comment on that.

關於Trodelvy，我可能有幾個問題想問Merdad。在TROPiCS-02研究中，您做出了明智的決定，擴大了樣本量，並針對PFS等指標進行了統計效能分析。當時您是否有任何資訊可以增強您對統計效能分析的信心？以及是否有任何資訊可以增強您對整個研究的信心，例如已發生的事件數量或其他類似資訊？或者，如果您能就此發表一些看法，例如該研究是否已達到無效性終點，也請告知我們。

And then on the lung data that's coming up, can you just comment around your belief in the profile versus the competitor? Is it similar efficacy, better safety? Or how should we interpret that data when it comes later this year?

關於即將公佈的肺部數據，您能否談談您對該藥物與競爭對手相比的優勢和劣勢的看法？它的療效是否相似，安全性是否較高？或者我們應該如何解讀今年稍後公佈的這些數據？

Nice to hear your voice, Michael. Over to you, Merdad.

很高興聽到你的聲音，麥可。接下來就交給你了，梅爾達德。

Yes. Thanks, Michael. On the TROPiCS-02 study, we have not done a futility analysis. We are -- we continue to look to those data maturing and getting the number of events that we need for the PFS analysis that we have planned. We're pretty confident in our powering. And in particular, since we expanded the sample size to make sure that we are able to hit the PFS endpoint. Of course, the relevant issue is more the duration of PFS that we get. But from a powering standpoint, we're comfortable. And it's just a matter of seeing those data. From an ongoing event standpoint, I think we are where we thought we would be at this point, and it's really around just letting the events come in, make sure they get adjudicated, we clean the data in time to do the analysis properly. So that's where we are with that.

是的，謝謝，Michael。關於TROPiCS-02研究，我們尚未進行無效性分析。我們仍在等待資料成熟，以獲得計劃中的PFS分析所需的事件數量。我們對研究的統計效力相當有信心。特別是，我們擴大了樣本量，以確保能夠達到PFS終點。當然，更相關的問題是PFS的持續時間。但從統計效力的角度來看，我們感到滿意。現在只是需要觀察這些數據。從持續事件的角度來看，我認為我們目前的情況與預期一致，現在的關鍵在於等待事件的發生，確保它們得到判定，並及時清理資料以進行正確的分析。這就是我們目前的情況。

And then in terms of the lung data on efficacy, yes, I mean, I think -- as I think we've said before, we're really proceeding somewhat at risk and pretty aggressively, partly based on our belief in the drug, partly because of what we've seen with other agents in lung and partly based on our early data that you're familiar with in lung that we've seen. Of course, we want to make those data more robust while we go into the Phase III world. So we are going to augment our existing data to make sure that we are mitigating our risk somewhat.

至於肺部療效數據，是的，我的意思是，正如我們之前所說，我們確實在承擔一定風險，並且採取了相當積極的策略，部分原因是基於我們對該藥物的信心，部分原因是基於我們在其他肺部藥物方面觀察到的療效，部分原因是基於您已經了解的早期肺部數據。當然，我們希望在進入III期臨床試驗階段時，能夠讓這些數據更加可靠。因此，我們將補充現有數據，以確保我們能夠降低風險。

But thus far, I think what we are hoping for is efficacy that certainly is comparable to what the benchmark might be, even though I think it's too early to say what that benchmark is with the direct competitor. But we are, again, I think, confident about our ability to bring safety profile that hopefully, will be better for patients.

但就目前而言，我們希望達到的療效至少能與行業標竿相媲美，儘管現在就斷言直接競爭對手的標竿水平如何還為時過早。但我們仍然有信心，我們的產品能夠提供更好的安全性，從而造福患者。

Excellent. Thank you, Michael. Can we have the next question, please?

太好了。謝謝你，麥可。請問下一個問題可以嗎？

Our next question comes from Alethia Young with Cantor.

下一個問題來自坎托爾的阿萊西亞·楊。

I'm just curious about, again, going back to the Arcus collaboration with ARC-7. How do you think about what the hurdle is for a triple? Do you think that it has to be more than like some of the competitors like Roche [happen in double think]?

我只是好奇，再次回到Arcus與ARC-7的合作。您認為實現三重免疫的困難是什麼？您認為它是否需要比羅氏等一些競爭對手（在雙重思維中）做得更好？

Thanks, Alethia. Merdad?

謝謝，阿萊西亞。梅爾達德？

I think we have the luxury of being able to look at a singlet, a doublet and a triple here. We would be, of course, excited if the triplet differentiates from the doublet and provides better efficacy. I think that's what we'd be looking for. And so as the data mature, looking for some signals, some -- a reason to believe that the triplet is performing more robustly than the doublet is probably going to be our focus. We'd be very excited if that plays out. It gives us, I think, a pretty unique position.

我認為我們現在有得天獨厚的優勢，可以同時研究單藥、雙藥和三藥方案。當然，如果三藥方案能夠區別於雙藥方案，並展現出更高的療效，我們會非常興奮。我想這正是我們所追求的。因此，隨著數據的不斷完善，尋找一些訊號，一些能夠證明三藥方案比雙藥方案更穩健的證據，很可能成為我們研究的重點。如果結果如此，我們會非常興奮。我認為這讓我們擁有了相當獨特的優勢。

Thanks, Alethia. So I think we have time for one more question, and thanks, everybody, for your involvement. Can I have the last question, please?

謝謝阿萊西亞。我想我們還有時間再問一個問題，謝謝大家的參與。請問我可以問最後一個問題嗎？

And the last question comes from Ronny Gal with Bernstein.

最後一個問題來自伯恩斯坦的羅尼·加爾。

Question about the projections for HIV for the next couple of years. Part one, I guess, is you changed your reimbursement policy on 340B clinics next year. How big essentially is that difference in terms of what it creates for you? And where on P&L will it appear on revenue on SG&A?

關於未來幾年愛滋病防治預測的問題。首先，我想問的是，你們明年將調整340B診所的報銷政策。這項政策的調整對你們的實際影響有多大？在損益表中，這項調整在銷售、管理及行政費用（SG&A）部分會反映在哪個位置？

And the second one, you already mentioned the PrEP barriers are dropping with preventative treatment designation for PrEP. I can't figure if this is good or bad for you from the perspective of branded drug adoption, given that they don't have to cover branded drugs.

第二點，您已經提到，隨著PrEP被認定為預防性治療藥物，其使用障礙正在減少。考慮到他們不必報銷品牌藥，我無法判斷這對品牌藥的普及究竟是好是壞。

Thanks, Ronny. So over to you, Johanna.

謝謝你，羅尼。現在輪到你了，喬安娜。

Sure. Ronny, I'm assuming you're talking about the patient assistance program changes?

當然。羅尼，我猜你指的是病人援助計畫的變更吧？

Correct. Yes.

正確。是的。

Okay. So I want to differentiate that. Those aren't 340B changes. That's actually a program that's really in line with our commitment to help end the HIV epidemic. To date, the program has actually provided free drug to more than 250,000 individuals. And really, that's what it is. It's a free program that was always intended and will continue to provide free Gilead medication to eligible individuals to treat and prevent HIV.

好的。我想澄清一下。這些並非340B計劃的變更。這其實是一個與我們致力於終結愛滋流行的承諾相符的計畫。迄今為止，該計畫已為超過25萬人提供了免費藥物。的確，這就是它的本質。這是一個免費項目，其宗旨始終是並將繼續為符合條件的個人免費提供吉利德公司的藥物，用於治療和預防愛滋病。

Unfortunately, it was not intended to be a source of funding for organizations to deliver services, and that's what we're trying to reset a little bit. So the changes to our program model will protect our ability to be able to do this in the longer term and make it a sustainable program for us and more importantly, for patients. So that's the patient assistance program on that front.

遺憾的是，該計畫原本並非旨在為機構提供服務提供資金，而這正是我們試圖稍作調整的地方。因此，我們對專案模式的調整將保障我們長期進行這項工作的能力，並使其成為一個對我們自身以及更重要的患者而言都可持續的專案。以上就是病患援助計畫在這方面的情況。

The question you're asking me about PrEP, we're actually quite encouraged with the FAQs that came out from the U.S. PSTF. The -- and here's why. In the FAQ, they provide a lot more clarity than they had in the past, right? This isn't new. The recommendation actually came out, the Affordable Care Act recommendation came out 2 years ago. But what this provided was actually more details to it and clarity on the importance of PrEP in ending the epidemic and minimizing the barriers of use.

關於您問的PrEP問題，我們對美國預防服務工作小組（PSTF）發布的常見問題感到非常鼓舞。原因如下：這些常見問題解答比以往更清晰明了，對吧？這並非什麼新鮮事。事實上，早在兩年前，《平價醫療法案》就提出了相關建議。但這次的常見問題解答提供了更多細節，並闡明了PrEP在終結愛滋病流行和最大限度減少使用障礙方面的重要性。

And there's a couple of things in the FAQ that pop out for me. One is it truly supports physician and patient choice. And that's the piece where generics or nongenerics, right? So Truvada generics or Descovy would then need to be really -- the physicians and the patients get to decide together what is the right medicine for which patient. And of course, with the bone and renal safety benefits that Descovy brings, I think this is a great addition to the FAQs.

常見問題中有幾點讓我印象深刻。首先，它真正支持醫生和病人的選擇。這就涉及到仿製藥和非仿製藥的選擇，對吧？所以，無論是 Truvada 的仿製藥還是 Descovy，都需要由醫生和患者共同決定哪種藥物最適合哪位患者。當然，Descovy 還具有骨骼和腎臟方面的安全性優勢，我認為這是常見問題中一個非常重要的補充。

In addition to that, there's also some guidance around timely management of the request for this by payers, so to turn it around within 24 hours, which is quite different. than what's happening today. And then the last piece is $0 of out-of-pocket costs. So I think for patients, this is great news. And I also think for patient choice and physician choice, this is quite promising as well.

除此之外，還有一些關於支付方及時處理此類申請的指導意見，要求在24小時內完成審批，這與目前的情況大不相同。最後一點是患者無需自付費用。所以我認為這對患者來說是個好消息。而且，我認為這對病人和醫生來說也意義重大，因為這能讓他們擁有更多選擇權。

Ronny, I wanted to make sure we covered your question. Did we understand you correctly? I assume so, Ronny. Great. Well, thank you all very much.

羅尼，我想確認一下我們是否解答了你的問題。我們理解對了嗎？我想應該是的，羅尼。太好了。非常感謝大家。

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

感謝各位今天蒞臨本次活動。我們感謝您一直以來對吉利德的關注，並期待向您報告我們的最新進展。

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。