吉利德科學 (GILD) 2020 Q4 法說會逐字稿

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter 2020 Gilead Sciences Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

    女士們、先生們,感謝您的耐心等待,歡迎參加吉利德科學公司2020年第四季財報電話會議。 (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 first speaker today, to Andrew Ang, Senior Director of Investor Relations. Thank you. Please go ahead.

    現在我謹將會議交給今天的第一位發言人,投資者關係高級總監安德魯·昂先生。謝謝。請開始吧。

  • Andrew Ang

    Andrew Ang

  • Thank you, Diwal, and good afternoon, everyone. Just after the market closed today, we issued a press release with earnings results for the fourth quarter and full year 2020. The press release and detailed slides are available on the Investors section of the Gilead website.

    謝謝迪瓦爾,大家下午好。今天股市收盤後,我們發布了2020年第四季和全年獲利報告。新聞稿和詳細幻燈片可在吉利德公司網站的投資者關係頁面查看。

  • The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer; Johanna Mercier, Chief Commercial Officer; Merdad Parsey, Chief Medical Officer; and Andrew Dickinson, Chief Financial Officer. Also on the call and available for Q&A will be 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) 和首席財務官安德魯·迪金森 (Andrew Dickinson)。 Kite 執行長 Christy Shaw 也將出席會議並回答問題。

  • Before we begin with our prepared remarks, let me remind you that we will be making forward-looking statements, including risks and uncertainties 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 with 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. 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.

    在我們正式發言之前,請允許我提醒各位,我們將發表一些前瞻性聲明,其中包括與新冠疫情對吉利德業務、財務狀況和經營業績的影響相關的風險和不確定性;關於產品、候選產品、公司戰略、財務預測和資本運用方面的計劃和預期;以及2021年的財務指引。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,可能導致實際結果與這些聲明有重大差異。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(SEC)揭露文件。所有前瞻性聲明均基於吉利德目前可獲得的信息,吉利德不承擔更新任何此類前瞻性聲明的義務。

  • 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 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和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。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thank you, Andrew, and good afternoon, everyone. Thank you for joining us today. We're pleased to have this opportunity to provide an update on our progress and answer your questions. I'll begin by offering brief remarks and then hand off to the team to go into more detail.

    謝謝安德魯,大家下午好。感謝各位今天參加我們的會議。我們很高興有機會向大家報告最新進展並回答大家的問題。我先做個簡短的發言,然後交給團隊成員詳細解說。

  • Before we begin, I want to thank all those who contributed to the progress we will highlight today, both our teams across the company and our many partners and collaborators worldwide.

    在開始之前,我要感謝所有為我們今天將要重點介紹的進展做出貢獻的人,包括我們公司的各個團隊以及我們在世界各地的眾多合作夥伴和協作者。

  • Let me start by looking back at the fourth quarter. Our work continued across 3 main areas, as it has throughout 2020: responding to the pandemic with our antiviral therapy, Veklury; delivering on our commitment to people with HIV, cancer, viral hepatitis and other conditions; and thirdly, executing on our strategy.

    首先,我想回顧一下第四季。就像2020年全年一樣,我們的工作繼續圍繞著三大主要領域展開:一是利用我們的抗病毒療法Veklury應對疫情;二是履行我們對愛滋病、癌症、病毒性肝炎和其他疾病患者的承諾;三是執行我們的策略。

  • As a result of our efforts to expand and strengthen our portfolio, we're going into 2021 in a very different position to how we began 2020. Last month, we provided updated guidance for the fourth quarter and full year 2020 to ensure that you had a clear picture coming into today's earnings announcement. This updated guidance was largely based on the significant increase in the uptake of Veklury. In the United States alone, hospitalizations quadrupled between October and January. And approximately 1 out of every 2 patients hospitalized in the U.S. are being treated with Veklury today.

    由於我們努力拓展和強化產品組合,我們進入2021年時的處境與2020年初截然不同。上個月,我們更新了2020年第四季和全年業績指引,以確保您在今天的財報發布前對公司狀況有清晰的了解。此次更新的指引主要基於Veklury使用量的顯著成長。光是在美國,10月至1月期間的住院人數就增加了四倍。目前,美國每兩名住院患者中就有一名正在接受Veklury治療。

  • We're grateful that Veklury is able to play such an important role in getting patients out of the hospital faster, 5 days on average, based on the NIAID ACTT-1 trial, especially as many parts of the world struggle with hospital capacity.

    我們非常感激 Veklury 能夠在幫助患者更快出院方面發揮如此重要的作用,根據 NIAID ACTT-1 試驗,平均可縮短 5 天出院時間,尤其是在世界許多地區醫院容量不足的情況下。

  • The higher uptick of Veklury, along with the continued growth of our leading treatment for HIV, Biktarvy, helped to offset the ongoing impact to the pandemic on some parts of our business. Veklury and Biktarvy also helped to mitigate the expected impact of loss of exclusivity for Atripla and Truvada in October.

    Veklury銷量的強勁成長,以及我們領先的HIV治療藥物Biktarvy的持續成長,有助於抵消疫情對我們部分業務的持續影響。 Veklury和Biktarvy的銷售成長也有助於減輕Atripla和Truvada在10月失去獨家銷售權所帶來的預期影響。

  • Our efforts to build out our portfolio of medicines continued in the fourth quarter with our agreement to acquire MYR. The acquisition, which is on track to close in the first quarter of this year subject to regulatory clearances and other closing conditions, will bring us a first-in-class medicine called Hepcludex for the treatment of hepatitis D or HDV. This is the most severe form of viral hepatitis and affects some patients who are already infected with hepatitis B. Hepcludex is conditionally approved in Europe and has FDA breakthrough therapy designation as an investigational agent in the United States.

    第四季度,我們持續致力於拓展藥品組合,並達成了收購MYR的協議。該收購預計將於今年第一季完成,但需獲得監管部門批准並滿足其他成交條件。收購完成後,我們將獲得一種名為Hepcludex的首創藥物,用於治療丁型肝炎(HDV)。丁型肝炎是最嚴重的病毒性肝炎,部分已感染B型肝炎的患者也會罹患此病。 Hepcludex已在歐洲獲得有條件批准,並在美國獲得FDA突破性療法認定,目前仍處於研究階段。

  • The acquisition of Immunomedics closed in the fourth quarter, bringing the most significant recent addition to our pipeline today, Trodelvy. Trodelvy is a foundational medicine in our cancer portfolio with significant potential across multiple tumor types. We're very pleased with how the integration with Immunomedics is going and look forward to updating you on our progress with Trodelvy.

    對 Immunomedics 的收購已於第四季度完成,為我們的產品線帶來了迄今為止最重要的新成員——Trodelvy。 Trodelvy 是我們癌症產品組合中的基礎藥物,在多種腫瘤類型中具有巨大的潛力。我們對 Immunomedics 的整合進展感到非常滿意,並期待向您報告 Trodelvy 的最新進展。

  • Andy, Johanna and Merdad will share more detail on the quarter. I'd like to turn now to the year ahead. The first thing I would say is that we're moving forward with a clear path to growth. We have multiple opportunities in new therapeutic areas, especially oncology. We're very pleased with the strong and diverse oncology portfolio we have today. This portfolio consists of both marketed therapies, such as Trodelvy and Tecartus and Yescarta from Kite and programs across various stages of the pipeline. There are currently 27 internal ongoing clinical-stage programs for hematologic malignancies and solid tumors.

    Andy、Johanna 和 Merdad 將分享更多關於本季的詳情。現在我想展望未來一年。首先,我想說的是,我們正朝著清晰的成長路徑穩步前進。我們在新的治療領域,尤其是腫瘤領域,擁有許多機會。我們對目前強大且多元化的腫瘤產品組合感到非常滿意。此產品組合既包括已上市的療法,例如 Trodelvy 和 Tecartus,以及 Kite 公司的 Yescarta,也包括處於不同研發階段的專案。目前,我們有 27 個針對血液系統惡性腫瘤和實體腫瘤的內部在研臨床階段項目。

  • We also have many promising opt-in opportunities. One of those options is for the anti-TIGIT program through our collaboration with Arcus Biosciences. Earlier this week, it was announced that we are increasing our investment in Arcus to help fund the continued progress of the promising Arcus pipeline. The foundation for our near- and long-term growth is our continued leadership in antivirals. We are confident in the longevity of our HIV business. We expect Biktarvy to continue to be a mainstay of HIV treatment long into the future. And our investigational capsid inhibitor, lenacapavir, could be a best-in-class, long-acting option for both treatment and prevention. Lenacapavir is a highly potent, and importantly, its flexible dosing profile gives us the potential to develop multiple long-acting treatment and prevention options.

    我們還有許多前景看好的合作機會。其中之一是透過與 Arcus Biosciences 的合作進行的抗 TIGIT 計畫。本週早些時候,我們宣布將增加對 Arcus 的投資,以資助其前景可觀的研發管線的持續進展。我們近期和長期成長的基礎在於我們在抗病毒藥物領域的持續領先地位。我們對 HIV 業務的長期發展充滿信心。我們預計 Biktarvy 將在未來很長一段時間內繼續成為 HIV 治療的主要藥物。此外,我們正在研發的衣殼抑制劑 lenacapavir 有望成為同類最佳的長效治療和預防藥物。 Lenacapavir 是一種高效能藥物,更重要的是,其靈活的給藥方案使我們能夠開發多種長效治療和預防方案。

  • In 2021, we expect a number of important milestones in the areas I've just mentioned. Merdad will provide more detail on the regulatory milestones, and I will highlight a few for now within the broader context of what you can expect from us.

    2021年,我們預計在我剛才提到的領域將取得一系列重要里程碑。 Merdad將就監管方面的里程碑提供更多細節,在此我先簡要介紹其中幾個,以便大家更了解我們未來的發展方向。

  • Starting with our leadership in antivirals. We will, of course, be focused on the continued growth of Biktarvy and maintaining its leadership as the #1 prescribed treatment for HIV in major markets. We plan to file an NDA in the U.S. for lenacapavir in a heavily treatment-experienced population. This should be in the second half of the year. We will also continue to explore the right options for combinations.

    首先,我們將重點放在抗病毒藥物領域。當然,我們會繼續致力於Biktarvy的持續成長,並保持其在主要市場HIV治療藥物處方量排名第一的地位。我們計劃在美國提交lenacapavir的新藥申請,用於治療先前接受過大量治療的患者。預計今年下半年提交。此外,我們將繼續探索合適的合併用藥方案。

  • In viral hepatitis, we look forward to expanding our business in HBV and HDV by growing sales of Vemlidy in the U.S. and Asia, and pending completion of the MYR acquisition, the anticipated filing of a BLA in the second half of the year.

    在病毒性肝炎領域,我們期待透過在美國和亞洲增加 Vemlidy 的銷售額來擴大我們在 HBV 和 HDV 領域的業務,並且,在完成對 MYR 的收購後,預計將在今年下半年提交 BLA 申請。

  • For Veklury, we look to realize the full potential of the therapy as the pandemic evolves. As you know, we are studying new formulations and routes of administration for Veklury as a treatment for COVID-19.

    對於Veklury,我們希望隨著疫情的發展,充分發揮其治療潛力。如您所知,我們正在研究Veklury作為COVID-19治療藥物的新配方和給藥途徑。

  • With the strong antivirals business as our foundation, we are looking forward to the continued expansion of oncology as a new pillar of growth. Trodelvy, which will have its first full year on the market following approval, will be a significant contributor to our growth this year. We expect to hear about conversion from accelerated to full approval in the coming weeks based on the FDA review of the ASCENT data.

    憑藉強大的抗病毒業務,我們期待腫瘤業務的持續擴張成為新的成長支柱。 Trodelvy獲批上市後將迎來其上市後的第一個完整年度,預計將成為我們今年成長的重要貢獻者。我們預計,根據FDA對ASCENT研究數據的審查結果,未來幾週內將公佈Trodelvy從加速審批轉為全面審批的消息。

  • At the same time, we'll be pursuing the many pipeline opportunities for Trodelvy. It is currently being studied in 10 different tumor types. We expect to hear from the FDA on accelerated approval for Trodelvy in metastatic urothelial cancer in the first half of the year. And we're also anticipating a readout of the Phase III TROPiCS-02 study in hormone receptor-positive HER2-negative breast cancer in the second half.

    同時,我們將繼續推動Trodelvy的多項研發管線計畫。目前,該藥物正在針對10種不同的腫瘤類型進行研究。我們預計今年上半年將收到FDA關於Trodelvy用於治療轉移性尿路上皮癌的加速批准通知。此外,我們也期待在下半年公佈針對荷爾蒙受體陽性、HER2陰性乳癌的III期臨床試驗TROPiCS-02的結果。

  • Data from the Phase III ZUMA-7 study is expected in the first half of the year for Yescarta's potential expansion into second-line DLBCL. And we should see Phase Ib data from magrolimab in MDS in the second half of the year, with the possibility of a regulatory submission based on these results.

    預計今年上半年將公佈 ZUMA-7 III 期研究的數據,以評估 Yescarta 是否適合用於二線治療瀰漫性大 B 細胞淋巴瘤 (DLBCL)。此外,我們預計在今年下半年看到 magrolimab 用於治療骨髓增生異常症候群 (MDS) 的 Ib 期研究數據,並可能基於這些結果提交監管申請。

  • In addition, we'll assess opt-in opportunities throughout the year as data becomes available and continue to advance our internal programs.

    此外,我們將根據數據的可用性,在全年評估自願加入的機會,並繼續推進我們的內部計劃。

  • I want to add that we are focused on prioritizing in order to deliver on these opportunities. We now have a portfolio that allows us to be much more selective in terms of what we take forward. This means being very disciplined about investing where there's highest potential value. You've seen some of that with our decisions around filgotinib and our investment in Trodelvy.

    我想補充一點,我們專注於優先考慮這些機會。我們現在的投資組合讓我們在推進專案時更加挑剔。這意味著我們要嚴格把控投資方向,只投資那些最具潛在價值的項目。你們已經從我們對filgotinib和Trodelvy的投資決策中看到了這一點。

  • Just briefly on the enterprise-level activities. We will continue to expand our talent base and deepen our expertise outside antivirals as we did in 2020. We will also maintain our strong focus on inclusion and diversity. As part of this, we are strengthening our efforts to promote racial equity. Today, we announced that Gilead has become a founding member of a coalition called OneTen. This is a group of U.S. companies that is committed to hiring and promoting 1 million Black Americans into family-sustaining jobs over the next 10 years.

    簡單介紹一下公司層面的各項活動。我們將繼續擴大人才儲備,並像2020年一樣,深化我們在抗病毒藥物以外的專業領域。同時,我們也將繼續高度重視包容性和多元化。為此,我們正在加強促進種族平等。今天,我們宣布吉利德已成為名為「OneTen」的聯盟的創始成員。該聯盟由多家美國公司組成,致力於在未來十年內為100萬名非裔美國人提供足以養家糊口的就業機會。

  • In addition, we'll continue to advance our ESG program and targets in line with our strategy. We will update you on our progress in these areas each quarter. There's a lot of important work ahead of us in 2021, and we're very much looking forward to turning our opportunities into tangible progress that will benefit patients, communities and our shareholders.

    此外,我們將持續推進符合公司策略的ESG專案和目標。我們將每季向您報告這些領域的進展。 2021年我們面臨許多重要工作,我們非常期待將機會轉化為實際成果,造福病患、社區和股東。

  • With that, I'll now pass over the call to Andy.

    接下來,我會把電話轉給安迪。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Thank you, Dan, and good afternoon, everyone. Our performance was strong for the fourth quarter and full year 2020, a clear reflection of the solid underlying fundamentals of our business and the increased demand we saw for Veklury amid the COVID-19 pandemic. You will find our detailed Q4 and full year 2020 results in the press release and materials we have posted on our website. Today, I will review our Q4 and full year 2020 performance and provide our guidance for 2021.

    謝謝丹,大家下午好。我們2020年第四季和全年的業績表現強勁,這充分反映了我們業務穩健的基本面,以及在新冠疫情期間市場對Veklury的需求成長。您可以在我們網站上發布的新聞稿和資料中找到2020年第四季和全年的詳細業績。今天,我將回顧我們2020年第四季和全年的業績,並提供我們對2021年的展望。

  • Turning now to the financial highlights. Total revenues for the fourth quarter 2020 were $7.4 billion, with non-GAAP diluted earnings per share of $2.19. This compares to total revenue of $5.9 billion with non-GAAP diluted earnings per share of $1.10 for the same period last year. Non-GAAP diluted earnings per share for the quarter increased 99% year-over-year primarily due to higher product sales, improved gross margin driven by a prior year inventory charge and a lower tax rate. This was partially offset by increased R&D and SG&A investments, including $190 million charge recorded in the fourth quarter of 2020 related to amending our agreement with Galapagos.

    接下來是財務亮點。 2020年第四季總營收為74億美元,非GAAP攤薄後每股收益為2.19美元。相較之下,去年同期總營收為59億美元,非GAAP攤薄後每股收益為1.10美元。本季非GAAP攤薄後每股盈餘年增99%,主要得益於產品銷售成長、毛利率因上年存貨提列而提高以及稅率降低。但研發和銷售、管理及行政費用(SG&A)的增加部分抵銷了上述成長,其中包括2020年第四季計入的1.9億美元費用,該費用與修訂我們與Galapagos公司的協議有關。

  • Product sales for the fourth quarter and full year were $7.3 billion and $24.4 billion, up 26% and 10%, respectively, compared to the same periods last year as the most recent COVID-19 surge drove uptake of Veklury. Sequentially, this increase was partially offset by the loss of exclusivity of Atripla and Truvada in the U.S. in October.

    第四季和全年產品銷售額分別為73億美元和244億美元,較去年同期分別成長26%和10%,主要得益於最近一波新冠疫情推動了Veklury的銷量成長。但環比來看,這一成長部分被Atripla和Truvada在10月份在美國失去獨家銷售權所抵消。

  • Veklury contributed $1.9 billion and $2.8 billion in sales for the fourth quarter and full year 2020, largely driven by increased utilization and COVID-19 hospitalizations in the U.S. For the full year, excluding Veklury, product sales were down 3% due to the recent losses of exclusivity for Atripla, Truvada, Letairis and Ranexa in the U.S. as well as the impact of the COVID-19 pandemic on our HIV and HCV franchises.

    Veklury 在 2020 年第四季和全年分別貢獻了 19 億美元和 28 億美元的銷售額,這主要得益於美國 COVID-19 住院人數的增加和藥物使用量的增加。全年(不包括 Veklury)產品銷售額下降了 3%,因為 Atripla、Truvada、Letairis 和 Ranexa 在美國的獨家銷售權近期到期,以及 COVID-19 疫情對我們的 HIV 和 HCV 產品線的影響。

  • Despite the impact of the pandemic and the LOEs relating to Atripla and Truvada in the U.S., HIV revenue grew 3% year-over-year driven by Biktarvy and Descovy. For Q4, product sales excluding Veklury, decreased 4% sequentially primarily due to the Atripla and Truvada LOEs. Cell therapy revenues were up 34% for the fourth quarter and 33% for the year, primarily due to the continued uptake of Yescarta in Europe and the U.S. launch of Tecartus in July.

    儘管受到疫情影響以及美國市場Atripla和Truvada相關研發成果終止的影響,HIV治療業務收入仍同比增長3%,主要得益於Biktarvy和Descovy的強勁表現。第四季度,不計Veklury的銷售額環比下降4%,主要原因是Atripla和Truvada的研發成果終止。細胞療法業務營收第四季成長34%,全年成長33%,主要得益於Yescarta在歐洲市場的持續成長以及Tecartus於7月在美國的上市。

  • Now turning to expenses. Non-GAAP cost of goods sold was $918 million for the fourth quarter and $3.3 billion for the year, down 35% and 8%, respectively, compared to the same period last year. 2020 cost of goods sold was lower primarily because of a $500 million inventory write-down charge in Q4 of 2019. Excluding this, non-GAAP product margins remain relatively flat year-over-year.

    接下來談談費用。第四季非GAAP銷售成本為9.18億美元,全年為33億美元,分別較去年同期下降35%和8%。 2020年銷售成本下降的主要原因是2019年第四季提列了5億美元的存貨減損準備。剔除此項費用後,非GAAP產品利潤率與去年同期基本持平。

  • Non-GAAP R&D expense for the quarter was $1.5 billion, up 31% sequentially and up 37% year-over-year, primarily driven by the $190 million charge associated with the Galapagos amendment that I mentioned earlier and approximately $70 million in milestones paid to Pionyr, as well as pipeline investments in Trodelvy and magrolimab. For the full year, non-GAAP R&D expense was up 20% year-over-year, primarily due to our significant investment in Veklury. We also increased our investment in oncology programs, including Trodelvy and magrolimab.

    本季非GAAP研發費用為15億美元,季增31%,年增37%,主要受先前提及的與Galapagos修訂相關的1.9億美元費用、支付給Pionyr的約7000萬美元里程碑付款以及對Trodelvy和magrolimab等管線項目的投資所致。全年非GAAP研發費用年增20%,主要得益於我們對Veklury的大量投資。此外,我們也增加了對腫瘤計畫的投資,包括Trodelvy和magrolimab。

  • These increases in investment were partially offset by lower clinical expenses from the completion of certain inflammation programs and postponement of certain clinical trials due to the pandemic.

    由於疫情導致某些發炎治療項目完成,臨床支出減少,以及某些臨床試驗推遲,這些投資的增加部分被抵消。

  • Non-GAAP SG&A expense for the quarter was $1.5 billion, up 37% sequentially and up 25% year-over-year. The increase in the quarter was driven by the timing of marketing expenses related to Biktarvy, along with Veklury and Trodelvy commercialization efforts and higher spend on corporate grants to support philanthropic organizations.

    本季非GAAP銷售、管理及行政費用為15億美元,較上季成長37%,較去年同期成長25%。本季成長主要受Biktarvy相關行銷費用、Veklury和Trodelvy商業化推廣工作以及用於支持慈善機構的企業捐贈支出增加所致。

  • We allocated significant additional funds to nonprofit grantees in Q4 to support racial equity and social justice efforts, help our nonprofit grantees weather the pandemic and provide for our signature giving programs, including COMPASS, RADIAN and HepConnect.

    第四季度,我們向非營利受助機構撥付了大量額外資金,以支持種族平等和社會正義事業,幫助我們的非營利受助機構渡過疫情難關,並為我們的標誌性捐贈項目(包括 COMPASS、RADIAN 和 HepConnect)提供支持。

  • For the full year, non-GAAP SG&A expense increased 10% as a result of higher costs associated with the commercialization efforts for Veklury, our continued expansion in China, increased corporate grants, remdesivir donations and a $97 million charge related to a previously disclosed legal settlement.

    全年非GAAP SG&A費用成長10%,原因是與Veklury商業化工作相關的成本增加、我們在中國持續擴張、公司撥款增加、瑞德西韋捐贈以及與先前披露的法律和解相關的9700萬美元費用。

  • Turning to our balance sheet. During the quarter, we generated $1.9 billion of cash flow from operations, paid $858 million in dividends and drew down a $1 billion term loan in connection with the closing of our $21 billion acquisition of Immunomedics. For the year, we returned approximately 67% of free cash flow to our shareholders, consisting of $3.4 billion in dividends and $1.6 billion in share repurchases. We also repaid $1 billion of debt on January 1 of this year.

    接下來來看看我們的資產負債表。本季度,我們從經營活動中產生了19億美元的現金流,支付了8.58億美元的股息,並提取了10億美元的定期貸款,用於完成我們以210億美元收購Immunomedics的交易。全年來看,我們將約67%的自由現金流返還給了股東,其中包括34億美元的股息和16億美元的股票回購。此外,我們在今年1月1日償還了10億美元的債務。

  • Turning to our guidance for 2021. Our 2021 non-GAAP financial guidance is summarized on Slides 18 and 19 in the earnings presentation available on our website. As always, our guidance is based on our current expectations for our business in 2021, and results may vary depending upon, among other things, the impacts of the COVID-19 pandemic, which remain unpredictable.

    接下來談談我們對2021年的業績展望。我們2021年的非GAAP財務預測概述於我們網站上發布的獲利簡報的第18頁和第19頁。與以往一樣,我們的預測是基於我們對2021年業務的當前預期,實際結果可能因多種因素而有所不同,其中包括目前仍難以預測的COVID-19疫情的影響。

  • In addition, while our guidance reflects the impact of recent corporate development transactions and our planned acquisition of MYR, as well as funding for ordinary course partnering activities in 2021, our guidance does not factor in the possibility of any extraordinary business development costs or acquisitions or significant opt-ins that we may complete over the course of the coming year.

    此外,雖然我們的業績指引反映了近期企業發展交易和我們計劃收購 MYR 的影響,以及 2021 年常規合作活動的資金,但我們的業績指引並未考慮我們在未來一年內可能完成的任何特殊業務發展成本、收購或重大選擇加入。

  • With that background, we expect that product sales, excluding Veklury, for 2021 will be in the range of $21.7 billion to $22.1 billion. Due to the uncertainty related to the pandemic, we expect Veklury revenue to be in the range of USD 2 billion to USD 3 billion, which results in total product sales range of $23.7 billion to $25.1 billion.

    基於上述背景,我們預計2021年不包括Veklury在內的產品銷售額將在217億美元至221億美元之間。由於疫情帶來的不確定性,我們預期Veklury的營收將在20億美元至30億美元之間,這將導致產品總銷售額在237億美元至251億美元之間。

  • As we've discussed over the past quarters, Veklury, in many ways, acts as a hedge against the potential impacts of a continued COVID-19 pandemic.

    正如我們在過去幾季中所討論的那樣,Veklury 在許多方面可以對沖 COVID-19 疫情持續蔓延可能帶來的影響。

  • This guidance reflects anticipated revenue growth of approximately 9% to 10%, excluding LOEs in Veklury driven by growth from Biktarvy, Trodelvy, Vemlidy and our cell therapy franchise. And while there remains uncertainty with the pandemic, we are making certain assumptions regarding the recovery in underlying market dynamics starting in the second quarter of 2021. And as COVID-19 vaccinations accelerate, any delay with the vaccine rollouts or any significant reacceleration of the global pandemic could once again adversely impact our business.

    這項業績指引反映了我們預期約9%至10%的營收成長,其中不包括Veklury的長期支出,主要成長動力來自Biktarvy、Trodelvy、Vemlidy以及我們的細胞療法業務。儘管疫情仍存在不確定性,但我們對2021年第二季開始的市場動態復甦做出了一些假設。隨著新冠疫苗接種的加速推進,疫苗推廣的任何延遲或全球疫情的任何顯著反彈都可能再次對我們的業務產生不利影響。

  • As a reminder, looking ahead to Q1, we anticipate total product sales, excluding Veklury, will decline by a low single-digit percentage, similar to what we've seen over the past 3 years. This is expected to be driven by customary U.S. seasonal inventory patterns and buying patterns of public payers that negatively affect our payer mix in the first quarter.

    再次提醒,展望第一季度,我們預計除Veklury外,產品總銷售額將出現個位數百分比的下滑,與過去三年的情況類似。這預計是由於美國傳統的季節性庫存模式以及公共醫療保險機構的採購模式對我們第一季的支付方構成產生負面影響所致。

  • In addition, unlike prior years, Q1 of 2021 will also be impacted by the recent loss of exclusivity of Atripla and Truvada in the United States. Despite this anticipated sequential decline in Q1 total product sales, we remain very confident in the health of our business as reflected in our guidance for the coming year.

    此外,與往年不同,2021年第一季也將受到Atripla和Truvada在美國失去獨家銷售權的影響。儘管第一季產品總銷售額預計將環比下降,但我們對公司業務的健康狀況仍然充滿信心,這體現在我們對來年的業績預期中。

  • Turning to our expectations for our product gross margins in 2021. Our non-GAAP product gross margins are expected to be in the range of 87% to 88% in 2021, consistent with our historic range. With respect to our operating expenses in 2021, we expect that both non-GAAP R&D and non-GAAP SG&A expenses will see a flat to low single-digit percentage decline through disciplined expense management, with flexibility to continue investing in our R&D pipeline and other strategic opportunities going forward. This guidance includes the impact of our planned acquisition of MYR as well as our allocation of approximately $350 million for future investments and ordinary course R&D collaborations.

    接下來談談我們對2021年產品毛利率的預期。我們預計2021年非GAAP產品毛利率將在87%至88%之間,與我們過去的預期範圍一致。關於2021年的營運費用,我們預期透過嚴格的費用管理,非GAAP研發費用和非GAAP銷售、管理及行政費用將保持平穩或略微下降,同時我們仍可靈活地繼續投資於研發項目和其他戰略機會。這項預期已包含我們計劃收購MYR的影響​​,以及我們為未來投資和日常研發合作預留的約3.5億美元。

  • In addition, our SG&A guidance reflects the expected impact in 2021 of our oncology build-out and funding for a number of time-limited corporate initiatives related to information technology and data analytics.

    此外,我們的銷售、一般及行政費用指導反映了 2021 年腫瘤業務建設的預期影響,以及為與資訊科技和數據分析相關的多項有時限的企業計劃提供資金。

  • Our non-GAAP operating income is expected to be in the range of $11.5 billion to $12.9 billion in 2021. And our non-GAAP effective tax rate for the year is expected to be approximately 21%, which is higher than 2020, primarily due to a decrease in tax credits and settlements with tax authorities that reduced our 2020 tax rate. Non-GAAP diluted EPS is expected to be in the range of $6.75 per share to $7.45 per share driven by increased operational efficiencies as compared to 2020 and partially offset by the higher non-GAAP effective tax rate, along with greater projected interest expense and lower projected interest income as compared to 2020.

    我們預計2021年非GAAP營業收入將介於115億美元至129億美元之間。預計2021年非GAAP實際稅率約為21%,高於2020年,主要原因是稅收抵免和與稅務機關達成的和解協議減少了,而這些協議降低了我們2020年的稅率。預計2021年非GAAP攤薄後每股收益將在6.75美元至7.45美元之間,這主要得益於營運效率的提高,但部分被較高的非GAAP實際稅率、預計更高的利息支出以及預計低於2020年的利息收入所抵消。

  • Our balance sheet remains robust, and our capital allocation priorities are unchanged. We remain focused on continuing to prioritize investment in our business and R&D pipeline and maintaining a rigorous focus on disciplined expense management.

    我們的資產負債表依然穩健,資本配置重點維持不變。我們將繼續專注於優先投資於業務和研發項目,並嚴格把控成本。

  • Finally, we continue to be committed to growing our dividend over time, and we were pleased to announce earlier today that we have increased our dividend by 4.4% for 2021. Additionally, as we disclosed a few weeks ago, we plan to repay at least $4 billion of debt this year, including the $1 billion of debt we repaid at the beginning of this year. We also expect to repurchase shares to offset dilution from equity compensation plans.

    最後,我們始終致力於持續提高股息,並很高興地宣布,2021 年股息將提高 4.4%。此外,正如我們幾週前披露的那樣,我們計劃今年償還至少 40 億美元的債務,其中包括年初償還的 10 億美元債務。我們也計劃回購股票,以抵消股權激勵計畫帶來的稀釋。

  • I'll now turn the call over to Johanna.

    現在我將把電話交給喬安娜。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Andy, and good afternoon, everyone. I'll begin by taking you through some of the market dynamics we saw in the fourth quarter as we continue to navigate the COVID-19 pandemic and the impact that it's had on our business.

    謝謝安迪,大家下午好。首先,我將帶大家了解我們在第四季度看到的一些市場動態,以及我們繼續應對新冠疫情及其對我們業務的影響。

  • As we entered the quarter in the U.S. and around the world, the number of COVID-19 cases surged. This had 2 significant effects on our business. Recovery was dampened by our Hep C and HIV medications as people delayed visits to their health care providers. And the number of hospitalizations of patients with COVID-19 dramatically increased, leading to significant uptick of Veklury.

    進入本季度,美國和全球範圍內的新冠肺炎病例激增。這對我們的業務產生了兩大顯著影響。一方面,由於人們推遲就醫,我們的C肝和愛滋病藥物銷售下滑,導致復甦受阻。另一方面,新冠肺炎患者的住院人數急劇增加,導致Veklury銷量大幅成長。

  • Driven by Veklury, we had robust growth in Q4, with a 13% increase in total product sales compared to the prior quarter. Excluding Veklury revenues, our business declined 4% amid the pandemic and loss of exclusivity for Atripla and Truvada in the U.S. Overall, while we expect the pandemic to continue to cause near-term uncertainty, we're confident in the strong underlying trends, which I'll highlight for you this afternoon.

    受Veklury的強勁推動,我們在第四季度實現了穩健成長,產品總銷售額較上一季成長13%。若不計Veklury的收入,受疫情影響以及Atripla和Truvada在美國失去獨家銷售權的影響,我們的業務下滑了4%。總體而言,儘管我們預計疫情在短期內仍將帶來不確定性,但我們對強勁的潛在趨勢充滿信心,我將在今天下午重點介紹這些趨勢。

  • Starting with HIV. We saw 3% growth in sales across our HIV franchise in 2020 compared with the prior year despite the Atripla and Truvada LOE. Biktarvy continued to stand out in the HIV treatment market, growing 10% sequentially and 53% year-over-year. Biktarvy remains the #1 prescribed regimen across key global markets and in the U.S., where 1 in 2 new patients start on Biktarvy.

    首先來看HIV業務。儘管Atripla和Truvada的專利到期,我們2020年HIV產品線的銷售額仍比上年成長了3%。 Biktarvy在HIV治療市場持續維持領先地位,較上季成長10%,較去年同期成長53%。 Biktarvy仍然是全球主要市場和美國處方量最高的治療方案,在美國,每兩名新患者中就有一名使用Biktarvy作為起始治療方案。

  • In PrEP, we ended the year with a 46% U.S. market share for Descovy, exceeding our goal of 40% to 45%. As expected, we saw a generic competitor enter the market in Q4, impacting Truvada revenue as we work to maintain strong commercial assets for Descovy. Going forward, we expect demand for PrEP to recover as the pandemic subsides, and we will stay competitive growing the business with the market.

    在PrEP領域,Descovy在美國的市佔率在年底達到了46%,超過了我們設定的40%至45%的目標。正如預期,第四季度出現了仿製藥競爭對手,這影響了Truvada的收入,而我們正努力維持Descovy的強勁商業實力。展望未來,我們預期隨著疫情的消退,PrEP的需求將會復甦,我們將持續保持競爭力,與市場同步發展業務。

  • This generic competition and the surge in the pandemic led to a decline in Q4 HIV revenues of 6% sequentially and 7% year-over-year. In addition, in line with historical trends, we saw seasonal inventory build in Q4, which we expect to bleed out into Q1 of this year.

    仿製藥競爭和疫情的加劇導致第四季愛滋病業務收入較上季下降6%,較去年同期下降7%。此外,與歷史趨勢一致,我們觀察到第四季度季節性庫存增加,預計這些庫存將延續到今年第一季。

  • We're well positioned and confident in our leadership in HIV today and in the future. Biktarvy will continue to be a key growth driver as the go-to single-tablet regimen for HIV treatment, with patent protection extending to 2033 in the U.S. as well as the European Union. We remain enthusiastic about the prospects of growing our leadership as we advance our long-acting antiviral lenacapavir. Success in the long-acting market will depend on having a product candidate with the right profile for patients. We believe lenacapavir has the potential to be that product, and Merdad will share more detail about its profile in his remarks.

    我們目前在愛滋病治療領域處於領先地位,並對此充滿信心,相信未來也將如此。 Biktarvy 作為治療愛滋病的首選單片複方製劑,將繼續成為關鍵的成長動力,其在美國和歐盟的專利保護期均延長至 2033 年。我們正積極推動長效抗病毒藥物 lenacapavir 的研發,並對進一步鞏固我們的領先地位充滿信心。長效藥物市場的成功取決於候選產品是否具備適合患者的特質。我們相信 lenacapavir 有潛力成為這樣的產品,Merdad 將在演講中詳細介紹其特點。

  • Turning to Trodelvy. As Dan mentioned, we completed our acquisition of Immunomedics in October. During the quarter, Trodelvy recorded $64 million in sales, with $49 million of that revenue recognized by Gilead following the close of the acquisition for a full year totaling $137 million in revenue.

    接下來談談Trodelvy。正如Dan所提到的,我們已在10月完成了對Immunomedics的收購。該季度,Trodelvy的銷售額為6,400萬美元,其中4,900萬美元的收入在收購完成後由吉利德確認,全年總收入為1.37億美元。

  • I'm impressed with the progress the teams have made launching new medication amid the pandemic. In its first 8 months, Trodelvy has become the clear #1 therapy in third-line metastatic triple-negative breast cancer. The breadth of Trodelvy adoption and recognition of the product continues to grow, and we're now seeing unaided Trodelvy awareness of about 90% among physicians and academic institutions.

    我對各團隊在疫情期間成功推出新藥所取得的進展印象深刻。上市僅8個月,Trodelvy就成為第三線轉移性三陰性乳癌治療的首選療法。 Trodelvy的應用範圍和市場認可度持續成長,目前我們看到,在醫生和學術機構中,Trodelvy的認知度已達到約90%。

  • Our ambition is to achieve similar awareness numbers with community providers, which will be driven by the anticipated full FDA approval of Trodelvy for metastatic triple-negative breast cancer and publication of the previously presented ASCENT data in the first half of 2021. We're also on track to complete the European filing in the first quarter of this year.

    我們的目標是在社區醫療服務提供者中實現類似的認知度,這將得益於 FDA 預計在 2021 年上半年全面批准 Trodelvy 用於治療轉移性三陰性乳癌,以及先前發表的 ASCENT 數據。我們也預計在今年第一季完成歐洲的申報工作。

  • Specific to hepatitis. The COVID-19 surge impacted the recovery we saw in Q3 across our HCV franchise. Our HCV business showed 9% sequential decline, impacted by the pandemic and timing of purchases in markets outside the U.S. We continue to maintain anywhere between 50% and 60% market share across our core markets, which we believe sets us well for recovery.

    就肝炎業務而言,新冠疫情的爆發影響了我們丙型肝炎業務在第三季的復甦勢頭。受疫情以及美國以外市場採購時機的影響,我們的C型肝炎業務較上季下降了9%。我們在核心市場繼續保持50%至60%的市場份額,我們相信這為我們未來的復甦奠定了良好的基礎。

  • In HBV, we expect to continue to grow our business and anticipate sales exceeding $1 billion by 2022, driven by the U.S. and Asia markets. We're looking forward to closing the MYR acquisition, which will bring Hepcludex to Gilead, a medicine with a first-in-class and potentially best-in-class treatment for hepatitis D or HDV, an orphan disease that has been historically underdiagnosed and for which there were no approved treatment options prior to Hepcludex. HDV is the most severe form of viral hepatitis and is associated with poor long-term survival rates. We believe our experience in hepatitis and the operational synergies with respect to Gilead's existing field force in HBV will allow us to reach patients with HDV.

    在乙肝病毒(HBV)領域,我們預計將持續成長業務,並預計2022年銷售額將超過10億美元,主要成長動力來自美國和亞洲市場。我們期待完成對MYR的收購,這將使Hepcludex加入吉利德旗下。 Hepcludex是一種針對丁型肝炎(HDV)的首創藥物,並有望成為同類最佳療法。丁型肝炎是一種罕見疾病,歷史上診斷率一直偏低,在Hepcludex問世之前,尚無核准的治療方案。丁型肝炎是病毒性肝炎中最嚴重的類型,長期存活率較低。我們相信,憑藉我們在肝炎領域的經驗以及與吉利德現有乙肝病毒銷售團隊的協同效應,我們將能夠更好地服務於丁型肝炎患者。

  • Hepcludex already has conditional approval in Europe and remains an investigational agent in the U.S. Pending the close of the deal, we anticipate filing for U.S. approval in the second half of this year.

    Hepcludex 已在歐洲獲得有條件批准,目前在美國仍處於研究階段。待交易完成後,我們預計今年下半年向美國提交上市申請。

  • In closing, I just want to share a few remarks about Veklury. As Dan noted, Veklury remains an important treatment option for hospitalized patients with COVID-19. We're seeing utilization rates of 50% to 60% amongst eligible patients in the U.S. and are very proud of the role we played in helping patients during this challenging time.

    最後,我想就Veklury談談我的看法。正如Dan所指出的,Veklury仍然是新冠肺炎住院患者的重要治療選擇。在美國,符合條件的患者中,Veklury的使用率達到了50%到60%,我們為在這個充滿挑戰的時期幫助患者所發揮的作用感到非常自豪。

  • As we've seen over the past year, predicting the trajectory of the pandemic has proven difficult, to say the least. We anticipate demand will continue to fluctuate as COVID-19 cases rise and fall. While we're encouraged by the progress of our industry has made with the introduction of vaccines, we expect Veklury will remain a critical tool for patients and physicians well into the future.

    過去一年來,我們目睹了疫情發展軌蹟的預測難度之高。我們預計,隨著新冠肺炎病例的增減,市場需求將持續波動。儘管疫苗的推出令我們行業的進展令人鼓舞,但我們預計,Veklury 在未來很長一段時間內仍將是患者和醫生不可或缺的重要工具。

  • And now I'd like to turn the call over to Merdad.

    現在我想把電話交給梅爾達德。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Thanks, Johanna, and good afternoon, everyone. I'm pleased to share with you some updates on our pipeline as we made tremendous progress in 2020, expanding and diversifying our portfolio across our therapeutic areas. We entered 2021 with a larger, more balanced clinical pipeline that gives us the opportunity to advance important new therapies aimed at addressing significant unmet medical needs now and in the future. Through acquisitions, partnerships and by advancing internal candidates, we grew our portfolio of projects by 50% last year, and I look forward to sharing more about that with you today.

    謝謝Johanna,大家下午好。很高興與大家分享我們研發管線的最新進展。 2020年,我們在各個治療領域取得了巨大進展,拓展並豐富了我們的產品組合。進入2021年,我們擁有更大、更均衡的臨床研發管線,這使我們能夠推進旨在滿足當前及未來重大未滿足醫療需求的重要新療法。透過收購、合作以及推進內部候選藥物,我們去年的專案組合成長了50%,今天我將與大家分享更多相關資訊。

  • I'll start with oncology. In 2020, we significantly enhanced our oncology portfolio that now has 27 internal clinical-stage oncology programs aimed at patients with the greatest unmet medical needs. At the center of our oncology portfolio is, of course, Trodelvy. As Dan and Johanna mentioned, we anticipate several key clinical milestones this year that will help us broaden Trodelvy's use and understand which patients are most likely to benefit.

    我先從腫瘤領域說起。 2020年,我們大幅增強了腫瘤產品組合,目前擁有27個內部臨床階段的腫瘤項目,旨在滿足患者最迫切的未滿足醫療需求。當然,我們腫瘤產品組合的核心是Trodelvy。正如Dan和Johanna所提到的,我們預計今年將取得幾個關鍵的臨床里程碑,這將有助於我們擴大Trodelvy的應用範圍,並了解哪些患者最有可能從中獲益。

  • With the accelerated approval for third-line metastatic triple-negative breast cancer in hand, we look forward to the anticipated full approval of Trodelvy for patients with metastatic third-line triple-negative breast cancer, supported by the confirmatory Phase III ASCENT study. You'll recall that these are really strong data. Despite having received a median of 4 prior anticancer regimens, patients treated with Trodelvy showed a statistically significant and clinically meaningful improvement in overall survival, with a median survival of 12.1 months compared with 6.7 months for chemotherapy and hazard ratio of 0.48.

    隨著Trodelvy獲準用於第三線轉移性三陰性乳癌治療,我們期待Trodelvy能夠獲得全面核准,用於治療轉移性三線三陰性乳癌患者,而這主要得益於確診性III期ASCENT研究的支持。您可能還記得,這些數據非常有力。儘管患者先前接受過平均4種抗癌方案的治療,但接受Trodelvy治療的患者在總生存期方面仍表現出具有統計學意義和臨床意義的顯著改善,中位生存期為12.1個月,而化療組為6.7個月,風險比為0.48。

  • These data have been accepted for publication, and we anticipate publication of these results in a peer-reviewed journal early this year. These data have set Trodelvy on the path to becoming the new standard of care for patients with third-line metastatic triple-negative breast cancer.

    這些數據已被接受發表,我們預計將於今年年初在同行評審期刊上發表這些結果。這些數據使Trodelvy有望成為第三線轉移性三陰性乳癌患者的新標準治療方案。

  • Additional data have demonstrated that Trodelvy has a potential to transform care for people with metastatic urothelial carcinoma, the most common form of bladder cancer. We've submitted an application for accelerated approval to the FDA and anticipate a decision in the first half of this year.

    更多數據顯示,Trodelvy有望徹底改變轉移性尿路上皮癌(膀胱癌最常見的類型)患者的治療現況。我們已向FDA提交加速審批申請,預計今年上半年獲得批准。

  • Next, we're looking to further expand Trodelvy for patients with hormone receptor-positive, HER2-negative breast cancer, which accounts for approximately 70% to 75% of all forms of breast cancer. And those study results are expected in the second half of the year.

    接下來,我們計畫進一步擴大Trodelvy在荷爾蒙受體陽性、HER2陰性乳癌患者的應用範圍,這類乳癌約佔所有乳癌病例的70%至75%。相關研究結果預計今年下半年公佈。

  • Beyond breast and bladder cancers, we're working quickly to explore other tumors with the goal of establishing the breadth of Trodelvy's activity. We'll continue to evaluate the role of Trop-2 expression in tumors along the way. One of the trials we're leveraging is a TROPiCS-03 basket study where we continue to enroll patients. We plan to provide an update on this study, particularly in non-small cell lung cancer, in the second half of this year. We are proceeding at risk with plans to start a randomized study in lung cancer in the second half of the year as well, pending TROPiCS-03 data. We expect to begin a substantial number of new studies with Trodelvy this year, adding to the 4 internal and 13 ongoing investigator-sponsored studies.

    除了乳癌和膀胱癌之外,我們正迅速探索其他腫瘤,旨在全面了解Trodelvy的療效。我們將繼續評估Trop-2表現在腫瘤中的作用。我們正在利用的一項臨床試驗是TROPiCS-03籃子研究,該研究仍在招募患者。我們計劃在今年下半年發布研究的最新進展,尤其是在非小細胞肺癌方面。我們也積極推動一項肺癌隨機對照試驗,計劃在今年下半年啟動,具體時間取決於TROPiCS-03的數據。我們預計今年將啟動大量新的Trodelvy相關研究,目前已有4項內部研究和13項正在進行的研究者發起的研究。

  • Now moving on to magrolimab. We're rapidly advancing this program with the goal of helping patients with hematologic malignancies and exploring the role of CD47 inhibition in the treatment of solid tumors. The first solid tumor studies are set to begin as early as this year. We expect results from the Phase Ib study in MDS later this year, which will inform our ongoing discussions with the FDA. Pending these data, we could potentially file for accelerated approval. In addition, we've begun enrolling patients in the Phase III ENHANCE study intended to support full approval and to confirm the Phase Ib data.

    接下來我們來談談magrolimab。我們正在快速推進該項目,旨在幫助血液系統惡性腫瘤患者,並探索CD47抑制劑在實體腫瘤治療中的作用。首批實體瘤研究最快將於今年啟動。我們預計今年稍後將公佈MDS Ib期研究的結果,這些結果將為我們與FDA的持續磋商提供基礎。根據這些數據,我們可能會申請加速審批。此外,我們已開始招募患者參與III期ENHANCE研究,該研究旨在支持藥物的全面批准並驗證Ib期研究的數據。

  • Moving to Kite. We're very pleased with the process -- progress of our colleagues at Kite that is being made with the company's cell therapy medicines, bringing Yescarta and Tecartus to new diseases and to patients earlier in their treatment. In addition to the second-line DLBCL data that Dan mentioned, we're expected -- that are expected in the first half of this year, we filed for approval to expand the use of Yescarta to patients with indolent NHL. If approved, this would be the first CAR-T therapy for patients with this form of lymphoma.

    轉投Kite公司。我們對Kite公司同事們在細胞療法藥物研發方面的進展感到非常滿意,他們正努力將Yescarta和Tecartus應用於新的疾病領域,並讓患者在治療早期就能受益。除了Dan提到的二線DLBCL數據外,我們預計今年上半年也將公佈Yescarta用於治療惰性NHL患者的申請。如果獲得批准,這將是首個用於治療此類淋巴瘤的CAR-T療法。

  • We're also excited about the emerging data from our partnerships, including Arcus' anti-TIGIT and CD73 inhibitor programs, as well as our collaborations with Pionyr and Tizona, to name a few. Taken in total, these agreements in both oncology and other therapeutic areas allow us to expand the breadth of our portfolio with access to cutting-edge research programs in a way that manages the risk of our internal portfolio.

    我們對合作夥伴的初步成果也感到非常興奮,包括Arcus的抗TIGIT和CD73抑制劑項目,以及我們與Pionyr和Tizona等公司的合作。總而言之,這些在腫瘤學和其他治療領域的合作協議使我們能夠拓展產品組合,獲得前沿的研究項目,同時有效管理內部產品組合的風險。

  • We've intentionally constructed a pipeline with a large number of programs in Phase I and fewer derisked programs in Phases II and III with a goal of creating a long-term, sustainable, productive pipeline to fuel our future.

    我們特意建構了一個專案儲備體系,其中第一階段有大量的項目,第二階段和第三階段的風險降低項目較少,目標是創建一個長期、可持續、高效的專案儲備體系,為我們的未來提供動力。

  • Turning to HIV. I want to echo Johanna's comments about the impact once-daily Biktarvy has for people living with HIV. At the same time, we recognize some individuals prefer less frequent, long-acting regimens. We're excited about the potential of long-acting antivirals and believe that our capsid inhibitor, lenacapavir, has a number of attributes that have important possibilities for both treatment and prevention.

    談到愛滋病毒感染,我想附和一下Johanna關於每日一次服用Biktarvy對愛滋病毒感染者影響的看法。同時,我們也意識到有些患者更傾向於使用頻率較低、作用時間較長的治療方案。我們對長效抗病毒藥物的潛力感到振奮,並相信我們的衣殼抑制劑lenacapavir具有多種特性,在治療和預防方面都具有重要意義。

  • Beginning with treatment. People living with HIV tell us that either a weekly oral regimen or a subcutaneous injection every 3 to 6 months are preferred regimens. As we look at how we'll combine lenacapavir with other agents, the potential dosing flexibility of lenacapavir offers possibilities to explore in clinical research, both oral and subcutaneous administration. We expect to identify an internally developed agent or an external partner for lenacapavir to move into combination trials over the next 12 to 18 months. This will complement our first lenacapavir FDA filing expected in the second half of this year for use in the heavily treatment-experienced individuals with HIV.

    首先是治療。愛滋病毒感染者告訴我們,他們更傾向於每週口服一次或每3至6個月皮下注射一次的治療方案。我們正在研究如何將勒那卡帕韋與其他藥物合併使用,勒那卡帕韋潛在的給藥靈活性為臨床研究提供了探索的可能性,包括口服和皮下注射給藥途徑。我們預計在未來12至18個月內,找到一種內部研發的藥物或外部合作夥伴,將勒那卡帕韋與其他藥物合併用於臨床試驗。這將與我們預計於今年下半年向FDA提交的首個勒那卡帕韋申請相輔相成,該申請旨在用於治療既往接受過多種治療的愛滋病毒感染者。

  • Now turning to prevention. We also believe there are many people for whom a subcutaneous injection, possibly as infrequently as once every 6 months, could provide a significant advantage. I'm pleased to share that we'll begin Phase III studies this year with lenacapavir as monotherapy for the prevention of HIV. We're planning 2 Phase III studies.

    現在談談預防。我們也相信,對許多人來說,皮下注射(頻率低至每6個月一次)可能帶來顯著優勢。我很高興地宣布,我們將於今年啟動以lenacapavir為單藥療法預防HIV感染的III期臨床試驗。我們計劃進行兩項III期臨床試驗。

  • The first will be in cisgender men, transgender women and men and gender nonbinary people who have sex with men. That will begin in the first half of 2021. The second is in adolescent girls and young women, and that will begin in the second half of 2021.

    第一階段將針對順性別男性、跨性別女性和男性以及與男性發生性關係的非二元性別者,並將於2021年上半年開始。第二階段將針對青春期少女和年輕女性,將於2021年下半年開始。

  • Finally, I want to close with some commentary on Veklury and our ongoing commitment to patients amid the COVID-19 pandemic. Like so many others, we're encouraged to see the progress with the approval of the first vaccines and introduction of other therapeutics. Veklury continues to be a critical tool for patients and physicians in the fight against COVID-19. Clinical data from the randomized double-blind, placebo-controlled NIAID ACTT-1 trial has established the efficacy and safety of remdesivir. The Gilead-sponsored simple studies and real-world patient and physician experience continue to support the critical role of Veklury as a standard of care in the treatment of hospitalized patients with COVID-19.

    最後,我想就Veklury以及我們在COVID-19疫情期間對患者的持續承諾談幾點看法。和許多人一樣,我們很高興看到首批疫苗核准以及其他療法的推出。 Veklury仍然是病人和醫生對抗COVID-19的關鍵工具。來自NIAID ACTT-1隨機雙盲安慰劑對照試驗的臨床數據已證實瑞德西韋的有效性和安全性。吉利德公司贊助的簡單研究以及來自真實世界患者和醫生的經驗也持續支持Veklury作為COVID-19住院患者標準治療方案的關鍵作用。

  • Veklury is the only antiviral medicine that has been approved or granted temporary authorization for the treatment of COVID-19 in approximately 50 countries worldwide. We welcome the addition of new medicines that are helping to ease the burden, and we'll continue to work to understand how best to use Veklury and how to advance the use of Veklury in additional settings and formulations with the goal of treating additional patients who may benefit.

    Veklury是目前全球約50個國家唯一核准或獲得臨時授權用於治療COVID-19的抗病毒藥物。我們歡迎新藥的加入,它們有助於減輕患者的負擔。我們將繼續努力,探索如何更好地使用Veklury,以及如何在更多情況下和使用更多劑型,以期治療更多可能受益的患者。

  • As Dan shared with you, you can expect to hear from us often as we look ahead toward a number of exciting milestones. A growing pipeline means we hope to have more data to share and more news about regulatory filings. We're focused on delivering important transformative therapies to improve care for people with serious illnesses. And I look forward to discussing the expansion of Trodelvy, magrolimab data, the lenacapavir milestones and the initiation of key Phase III trials over the course of the year.

    正如丹之前所說,隨著我們展望未來一系列令人興奮的里程碑,我們將經常與大家分享相關資訊。不斷增長的研發管線意味著我們希望能夠分享更多數據,並發布更多關於監管申報的消息。我們致力於提供重要的變革性療法,以改善重症患者的治療。我期待在今年與大家探討Trodelvy的擴展、magrolimab的數據、lenacapavir的里程碑進展以及關鍵III期臨床試驗的啟動情況。

  • Now I'd like to open the call for questions. Operator?

    現在我想開始接受提問。接線生?

  • Operator

    Operator

  • (Operator Instructions) I show our first question comes from the line of Michael Yee from Jefferies.

    (操作說明)我展示的第一個問題來自 Jefferies 的 Michael Yee 的演講。

  • Michael Jonathan Yee - Equity Analyst

    Michael Jonathan Yee - Equity Analyst

  • Congrats on a great year. My question is maybe for Andy or Dan. When you think about the various uncertainties about growth that I think has been a bit of a controversy for Gilead and a little bit muddy for Veklury recently, do you think about 2021 as a growth year into 2022? And put another way, do you think that this is a trough period, and you're very confident about growth off this year?

    恭喜你們度過了精彩的一年。我的問題或許可以問Andy或Dan。考慮到吉利德(Gilead)和Veklury最近面臨的成長不確定性,以及由此引發的一些爭議,你們認為2021年會是2022年的成長年嗎?換句話說,你們認為目前是低潮期嗎?你們對今年的成長充滿信心嗎?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Michael. I'll start and then have Andy to provide a bit. Look, I think you heard us at JPMorgan. I think we reiterate our confidence that the next chapter of Gilead is here and that we are very confident in our ability to grow the business in the top and bottom line, excluding Veklury.

    謝謝,麥可。我先開始,然後安迪也補充幾句。我想你們都聽到了我們摩根大通的發言。我們再次重申,我們對吉利德的下一個篇章充滿信心,並且我們非常有信心在營收和利潤方面實現成長,但不包括Veklury。

  • It doesn't belie, our confidence in Veklury exists, but of course -- and we're seeing it track, obviously, very well with hospitalizations. But we also want to have, and we want you to have confidence in our ability to grow the underlying business excluding Veklury.

    這並非否定我們對Veklury的信心,當然,我們也看到它與住院人數的關聯性非常明顯。但我們也希望,並且希望你們對我們Veklury以外的其他業務成長能力充滿信心。

  • So yes, we're committed to that. I think you see that in the guidance that we delivered here today for 2021. And we're committed -- and that's despite the fact that we are offsetting a significant amount of generic erosion with Atripla and Truvada. So obviously, as we head into 2022 and beyond, we don't have that headwind as well.

    是的,我們對此充滿信心。我想大家可以從我們今天發布的2021年業績指引中看出這一點。我們依然堅持這一目標——即便我們正透過Atripla和Truvada來抵消相當一部分仿製藥的市佔率下滑。顯然,展望2022年及以後,我們將不再面臨這方面的挑戰。

  • So I would pass it over to Andy for some additional comments as well from your side, Andy.

    所以我想把這個問題轉給安迪,請你也補充一些意見,安迪。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Yes. Michael, thank you for the question and your comments on the year. The simple answer to your question is yes. I think that we do see this as a really important year where, as we said at JPMorgan, picking up on Dan's points, we expect to grow in the short term, the medium term and the long run from here. And we think we have all the puzzle pieces together that will allow us to do that.

    是的,邁克爾,感謝你的提問以及你對今年的評價。對於你的問題,答案是肯定的。我認為我們確實把今年視為非常重要的一年,正如我們在摩根大通所說的那樣,也呼應了丹的觀點,我們預計從現在開始,短期、中期和長期都將實現增長。而且我們認為我們已經具備了實現這一目標所需的所有條件。

  • Our guidance, and you see in some of the pages that we tried to help people think through the core business and the materials that we posted. And I would emphasize and focus people on the 9% to 10% growth in the core business, excluding the impact of the LOEs. So we're going to grow through the LOEs, and then we think we should have some additional momentum coming out of 2021 into the subsequent years.

    您可以在我們發布的一些頁面和資料中看到,我們試圖幫助大家理清核心業務思路。我想強調的是,核心業務預計將成長9%到10%,這還不包括長期支出的影響。因此,我們將在長期支出期間保持成長,我們認為從2021年開始,未來幾年應該會有額外的成長動能。

  • And we also have a very capital-efficient and efficient corporate model, as you know, Michael. So when you talk about kind of bottom line growth, we see a lot of potential for leverage as we're driving top line growth to really expand EPS growth over the coming years as well. So we're excited about where we are and where we're going and look forward to updating you throughout the year.

    如您所知,邁克爾,我們還擁有非常高效的資本利用率和企業營運模式。因此,談到利潤成長,我們看到了巨大的槓桿潛力,因為我們正在推動營收成長,從而在未來幾年真正提升每股收益。我們對目前的狀況和未來的發展方向都感到非常興奮,並期待今年持續向您報告最新進展。

  • Operator

    Operator

  • I see our next question comes from the line of Matthew Harrison from Morgan Stanley.

    我看到我們的下一個問題來自摩根士丹利的馬修·哈里森。

  • Matthew Kelsey Harrison - Executive Director

    Matthew Kelsey Harrison - Executive Director

  • I guess 2 part on lenacapavir for me. One, can you talk a little bit in detail about what internal combinations you might be pursuing in terms of mechanisms, and how you might be able to give us some idea around when we might see some initial data on those?

    我想問兩個關於lenacapavir的問題。第一,您能否詳細談談您可能正在研究的藥物內部組合機制,以及您能否大致告知我們何時能看到這些機制的初步數據?

  • And then second, can you just talk about the dosing frequency that you're going to be pursuing in the monotherapy studies? Are you going to look at 6 months only? Or are you going to look at other frequencies for the PrEP study?

    其次,您能否談談單藥治療研究中將採用的給藥頻率?您只打算每6個月給藥一次嗎?還是在PrEP研究中會採用其他給藥頻率?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Yes. Thanks, Matthew. I'm going to hand it over to Merdad, obviously. But just a couple of points to kind of frame this. So I think there are 2 points I want to make. One is Gilead has prided itself on making sure we really understand what patients need out there, every step of the way for the past couple of decades, which led us, obviously, to the robustness around Biktarvy as really the standard of care in the treatment setting, and Descovy.

    是的,謝謝馬修。接下來我肯定會把麥克風交給梅爾達德。不過,我想先說明幾點。我想強調兩點。第一,在過去的二十多年裡,吉利德一直致力於確保我們真正了解病人的需求,每一步都力求做到最好。正是這種對病人的關懷,使得比克塔維(Biktarvy)和德斯科維(Descovy)成為治療領域的標準療法。

  • And we also pursue a philosophy of having an anchor molecule. And what we're really excited about with capsid is this presents the opportunity for a true anchor molecule for long-acting that meets patients' needs, the types of needs that we think are really going to move -- potentially move some of the patients from a very convenient one from once-a-day to a less frequent dosing. So I remind you that we've got lots of options with lenacapavir, and I'll turn it over to Merdad to go through some of those. Over to you, Merdad.

    我們也秉持著以錨定分子為核心的理念。我們對衣殼蛋白真正感到興奮的地方在於,它為開發真正意義上的長效錨定分子提供了契機,能夠滿足患者的需求,我們認為這些需求將真正推動——甚至有可能使部分患者從非常便捷的每日一次給藥方案過渡到更低頻率的給藥方案。我提醒大家,我們有很多基於來那卡帕韋的選擇,接下來我將把發言權交給默達德,讓他來詳細介紹一下。默達德,請開始。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Thanks, Dan. Great question, Matthew. To your point, we haven't talked too much about it. Look, we have a number of internal assets that we can combine with lenacapavir. Given that lenacapavir is a capsid inhibitor, it gives us a lot of flexibility to look for what the second component could be there. So ranging from things like bictegravir and TAF to other things in our pipeline, we believe those can all internally form part of a combination regimen going forward. We would anticipate that we'll start doing Phase I studies this year, and then data will follow from that in terms of what -- which combination partner we would choose.

    謝謝丹。馬修,問得好。正如你所說,我們之前確實沒怎麼討論過這個問題。我們有一些內部資源可以和來那卡帕韋一起使用。鑑於來那卡帕韋是一種衣殼抑制劑,這讓我們在尋找第二個可能的聯合用藥方案時擁有很大的靈活性。從比克替拉韋和TAF到我們研發管線中的其他藥物,我們相信它們都可以成為未來聯合治療方案的一部分。我們預計今年將啟動I期臨床試驗,之後會根據試驗數據來決定最終選擇哪個合併用藥夥伴。

  • On the second part of your question whether we would look only at 6 months. I would say, it's important to think about lenacapavir both having oral and subcutaneous approaches. So on the oral side, we think we can dose orally about once a week. And so that could form one regimen that we would approach to go for a once-weekly oral regimen.

    關於您問題的第二部分,即我們是否只考慮6個月的療程。我想說,重要的是要同時考慮利那卡帕韋的口服和皮下注射兩種給藥途徑。就口服而言,我們認為可以每週口服一次。因此,這可以構成我們考慮的一種給藥方案,即每週一次的口服方案。

  • For subcu, it will partly depend on what the combination molecule would be and what dosing interval we can get with that. We'd certainly like to target 6 months. But if necessary, we can go to every 3 months or something like that. So it'll really depend on what the partner is.

    對於皮下注射,具體情況部分取決於合併用藥的分子類型以及給藥間隔。我們當然希望目標是6個月一次。但如有必要,我們可以改為每3個月一次,或類似的間隔。所以,這其實取決於聯合用藥的情況。

  • The key issue here is that we have a lot of flexibility with lenacapavir, and it gives us a lot of options to sort of see how we can work, and that's where we're going to go.

    關鍵在於,我們使用 lenacapavir 時有很多靈活性,這給了我們很多選擇,讓我們看看如何有效利用它,而這正是我們未來的方向。

  • And the last thing I'd say is for PrEP. The studies I mentioned, the ones that are getting started, are going to be every 6 months. So that is the regimen we're using for PrEP.

    最後我想說的是PrEP。我提到的那些研究,也就是正在啟動的那些研究,每6個月進行一次。這就是我們目前採用的PrEP方案。

  • Operator

    Operator

  • Our next question comes from the line of Alethia Young from Cantor.

    我們的下一個問題來自坎托爾的阿萊西亞·楊家族。

  • Alethia Rene Young - Director of Equity Research & Head of Healthcare Research

    Alethia Rene Young - Director of Equity Research & Head of Healthcare Research

  • Congrats on everything that you've done over the past 12 months. I kind of wanted to stay with lenacapavir a little bit. And it seems like there's a robust backbone potential. And I guess I want to get your perspective on the potential opportunity to grow the market from where you are since you could possibly use this in both treatment and prevention. Or do you kind of see it more like an opportunity for switches? And if so, like what drugs do you think Biktarvy switches are potentially likely same things?

    恭喜你過去12個月的成就。我其實還蠻想繼續關注lenacapavir的。而且它看起來確實很有潛力。我想聽聽你對目前市場成長機會的看法,因為lenacapavir既可以用於治療也可以用於預防。還是你覺得它更像是一個替代療法的機會?如果是這樣的話,你認為哪些藥物可能與Biktarvy的替代療法類似?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Yes. Thanks, Alethia. Thanks for the comment. Johanna and her team have done a lot of work on this. I'll let her start and see if anybody else in the team wants to add. Over to you, Johanna.

    是的,謝謝Alethia。感謝你的評論。 Johanna和她的團隊為此做了很多工作。我先讓她開始,看看團隊裡還有沒有人想補充。 Johanna,該你了。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Dan. Alethia, thanks for the question. I think that the way we're looking at it -- and I'll start with actually the first filing, right, which is heavily treatment experienced, which is expected to file towards the end of this year. I think that one for us was really an opportunity to go into the market, fast opportunity to get physician experience with lenacapavir and kind of create that foundation for lena.

    謝謝,丹。阿萊西亞,謝謝你的提問。我認為我們現在看待這個問題的方式——我先從第一個申請說起,對吧,就是那些經過大量治療的藥物,預計將在今年年底提交申請。我認為這對我們來說確實是一個進入市場的機會,一個快速獲得醫生使用lenacapavir的經驗,並為lena的上市奠定基礎的機會。

  • I would split up the question between treatment and PrEP. I think in treatment, the expectation is the market will continue to grow at the 2%, 3% that we've been seeing year-over-year. And so I think it'll be more of a little bit of a switch from oral to long-acting within the treatment. I think the real opportunity for expansion with long-actings will be in the prevention market. I -- we've said before that we've only scratched the surface at about 20%, 25% of the total market today in prevention with Truvada and Descovy. I think the opportunity really is to expand that market with long-actings that would make it much more flexible for folks, people at risk of HIV. And so I think that's a true expansion strategy but more in prevention than in treatment.

    我會把這個問題分成治療和暴露前預防(PrEP)兩個部分來討論。我認為在治療方面,市場預期會繼續保持我們目前看到的每年2%到3%的成長速度。因此,我認為治療領域更多的是從口服藥物到長效藥物的過渡。我認為長效藥物真正的擴張機會在於預防市場。我們之前說過,目前Truvada和Descovy在預防領域的市佔率僅佔20%到25%左右,這只是冰山一角。我認為真正的機會在於透過長效藥物來擴大這個市場,這將為那些面臨HIV感染風險的人提供更靈活的選擇。所以我認為這才是真正的擴張策略,但更體現在預防領域而非治療領域。

  • Operator

    Operator

  • Our next question comes from the line of Brian Abrahams from 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。

  • Brian Corey Abrahams - Senior Biotechnology Analyst

    Brian Corey Abrahams - Senior Biotechnology Analyst

  • Congrats on all the progress. I'm interested in learning more about the upside in use you might expect in Yescarta with the DLBCL second-line readout. And I guess I'm curious how much of -- any current hurdles are related to complexity of administration and the pandemic versus the labeled indication and available data? And when you do get the ZUMA-7 data, what are some of the pushes and pulls with respect to efficacy and safety that would guide how you'd look at the future growth opportunity in CAR-T?

    恭喜所有的進展。我很想了解Yescarta在瀰漫性大B細胞淋巴瘤(DLBCL)二線治療的應用前景。另外,我想問一下,目前遇到的障礙中,有多少是由於給藥方式的複雜性和疫情影響造成的,又有多少是由於適應症和現有數據造成的?當ZUMA-7研究數據公佈後,您認為在療效和安全性方面有哪些利弊,會影響您對CAR-T療法未來發展前景的看法?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Terrific. Well, thanks, Brian, for that. I mean we're very enthusiastic about the potential for Yescarta and, obviously, the second-line readout. And Christi's on the line, so I'll let her break down the different pieces of that for you between COVID and non-COVID and some of the dynamics. So over to you, Christi.

    太棒了。謝謝你,布萊恩。我們對Yescarta的潛力以及二線檢測結果都非常看好。克里斯蒂現在在線,我會讓她為大家詳細分析新冠患者和非新冠患者的情況以及一些相關動態。克里斯蒂,請你來吧。

  • Christi L. Shaw - CEO of Kite

    Christi L. Shaw - CEO of Kite

  • Sure. So overall, from a total self-therapy performance, we grew 33% year-over-year. As you look at Yescarta, it's growing externally outside the U.S. in what we call ACE, which is Europe, Canada and Australia. And also in the U.S., Tecartus is growing significantly above our expectations.

    當然。整體而言,從自我治療業務的整體表現來看,我們比去年同期成長了33%。 Yescarta的業務成長主要集中在美國以外的地區,我們稱之為ACE市場,包括歐洲、加拿大和澳洲。同時,Tecartus在美國的成長也遠超預期。

  • The dynamic in the U.S. for Yescarta is a couple fold. As we saw with our other CAR-T therapies in the market, the class overall has declined from 23% to 20%, which is significant in Q4. And the reason for that is referrals are down because of COVID obviously, and that's driving the majority of it, and also lack of ICU beds. The lack of ICU beds does disproportionately affect Yescarta because we're -- the majority of our sales are in the inpatient side.

    Yescarta在美國的市場動態主要受兩方面因素影響。正如我們之前在其他CAR-T療法市場所見,該類療法的整體市佔率已從23%下降至20%,這在第四季是一個顯著的降幅。造成此現象的原因顯而易見:一是新冠疫情導致轉診量下降,這顯然是造成市佔率下降的主要原因;二是重症監護病床的短缺。重症監護病床的短缺對Yescarta的影響尤其嚴重,因為我們的大部分銷售額都來自住院患者。

  • So as we look at what specifically, not just COVID overall, but you dig down to under what is COVID, you have the referral aspect. When the community physicians aren't seeing patients, patients aren't going into the offices. And then you also have, at the ATC, the issue of ICU bed capacity and where else can you treat those patients.

    所以,當我們具體分析新冠疫情時,不只是整體情況,而是深入探討新冠疫情的本質,就會發現轉診上的問題。當社區醫師無法接診病人時,病人自然也不會去診所。此外,對於急診中心來說,重症監護病床的容量也是一個問題,我們還需要考慮去哪裡治療這些病人。

  • So overall, it's -- the biggest driver is the class share decline and secondarily is the -- a little bit of the product sales based on the ICU beds. Does that help answer the question?

    所以總的來說,最大的驅動因素是市佔率下降,其次是重症監護病床相關的產品銷售下降。這樣解釋能解答這個問題嗎?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Brian, do you have something else? Okay. Great. Thank you.

    布萊恩,你還有其他事嗎?好的。太好了。謝謝。

  • Operator

    Operator

  • Our next question comes from the line of Geoffrey Porges from SVB Leerink.

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

  • Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

  • I'll just ask some slightly housekeeping questions. First, Andy, could you just give us a sense of what your share count guidance is for 2021? Secondly, Merdad, could you tell us whether you're seeing any remdesivir-resistant variants emerging, indeed, whether remdesivir is active against these variants that have been identified already? And then lastly, perhaps Dan could tell us, why shouldn't we look at the buy-in to Arcus as a positive indicator for your expectations for one of the upcoming readouts? Why would you have done that if you didn't -- weren't positively inclined to those events?

    我問幾個比較常規的問題。首先,Andy,你能大概說說你對2021年股份數量的預期嗎?其次,Merdad,你能告訴我們是否發現了任何對瑞德西韋有抗藥性的變異株嗎?瑞德西韋對已經發現的這些變異株是否有效?最後,Dan,或許你可以解釋一下,為什麼我們不應該把你們對Arcus的收購視為你們對即將公佈的某項資料抱持正面預期的一個訊號?如果你們不看好這些數據,為什麼會收購呢?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Geoff. So Andy, why don't you start, Merdad, and I'll bring it home.

    謝謝你,傑夫。安迪,梅爾達德,你先來吧,我來把它帶回家。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Geoff, on the share count, we're assuming a flat share count year-over-year. So to be to be clear, the EPS guidance is not being driven by share buybacks or share count. So our base assumption is that we will just do repurchases to offset employee stock issuance over the year. We maintain, obviously the flexibility to opportunistically repurchase more shares if we conclude over the year that that's a good use of our capital. But right now, the base case is that we will just repurchase shares to offset employee share issuance.

    傑夫,關於股份數量,我們假設與去年持平。所以要先明確的是,每股盈餘預期並非由股票回購或股份數量決定。我們的基本假設是,我們將透過回購來抵銷員工持股計畫。當然,如果年內我們認為這樣做能更好地利用資金,我們仍保留機會性地回購更多股份的彈性。但目前,基本假設是我們僅透過回購來抵銷員工持股計畫。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • And this is Merdad. Just to follow up on your question on resistance. So as you know, most of the variants that have popped up are in the spike protein. And that's been the source of the problem, which is why people are talking about sort of the vaccine issues and, potentially, the monoclonal antibodies because they're directed to the spike. But remdesivir targets the RNA polymerase. So in our case, so far with the variants that have come...

    我是Merdad。關於您提出的抗藥性問題,我再補充一下。如您所知,目前出現的大多數變異株都位於刺突蛋白上。這正是問題的根源,也是人們討論疫苗問題以及單株抗體(因為它們針對的是刺突蛋白)的原因。而瑞德西韋則針對RNA聚合酶。所以就目前的情況來看,就目前出現的變異株而言…

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • I thought I was, reading and they asked me a question.

    我當時正在看書,結果他們問了我一個問題。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Sorry. Sorry for the interruption. So for the -- in the RNA polymerase, we haven't seen so far mutants that would impact the efficacy of remdesivir, at least when we're looking at the sequences. So, so far, knock wood, we haven't seen anything.

    抱歉,打斷一下。關於RNA聚合酶的突變,目前為止,至少從序列分析來看,我們還沒有發現會影響瑞德西韋療效的突變體。所以,到目前為止,但願如此,我們還沒有發現任何問題。

  • Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

  • Sorry, Merdad, can I just follow up? Have you sequenced any individuals who failed remdesivir to see if there's any resistance in the virus?

    抱歉,Merdad,我可以再問一下嗎?您是否對瑞德西韋治療失敗的患者進行過基因定序,以查看病毒是否有抗藥性?

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • We have not, to my knowledge.

    據我所知,我們沒有。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • And Geoff, just bringing this home. I think it's a bit of a double-negative question. Let me put it into a positive. I think you can read into our continued investment in Arcus as us viewing the entirety of their portfolio as attractive, right, not any one asset, but I'll just mention a couple.

    傑夫,最後總結一下。我覺得這個問題有點雙重否定。讓我換個角度來說。我認為你可以理解為我們持續投資Arcus是因為我們看好他們的整體投資組合,對吧?不是說某一項資產特別吸引人,但我可以舉幾個例子。

  • Of course, in the TIGIT space, there are potentially 2 different mechanisms, as you know, both in FC and a non-FC receptor. There's a variety of adenosine programs. There's the PD-1. And there's a variety of earlier-stage programs. So I think you're absolutely right to see that additional investment as an additional confidence in the science and, frankly, the people at Arcus. And we're very, very pleased with the way we're cooperating and collaborating, it couldn't be more seamless. And the opportunity, I think, to think of...

    當然,如您所知,TIGIT領域可能存在兩種不同的機制,分別作用於FC受體和非FC受體。目前有多種腺苷類藥物研發項目,還有PD-1抑制劑,以及許多早期研發項目。所以我認為您完全正確,將這筆額外的投資視為對科學以及Arcus團隊的進一步信任。我們對目前的合作方式非常滿意,整個過程無比順暢。而且,我認為,這確實是一個值得思考的機會…

  • Operator

    Operator

  • So they will join momentarily.

    所以他們馬上就會匯合。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Sorry. Can you hear me now?

    抱歉,現在能聽到我說話了嗎?

  • Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

  • Yes, I can.

    是的,我可以。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Okay. I'll just finish up on the question, Geoff. I was just going to emphasize, in addition to the Arcus portfolio, the combination potential with our other agents. We're really excited about the potential to think about 2, possibly 3, drug combinations between what we have within our Gilead portfolio today, the Arcus portfolio and other options that we have now in the future. Thanks, Geoff.

    好的。我再補充一下這個問題,Geoff。我只想強調,除了Arcus的產品組合之外,它與其他藥物的合併使用潛力也不容忽視。我們非常興奮地考慮將吉利德現有產品組合、Arcus的產品組合以及我們未來可能擁有的其他選擇,開發出2種甚至3種藥物組合。謝謝,Geoff。

  • Operator

    Operator

  • I show our next question comes from the line of Robyn Karnauskas from Truist.

    我展示一下,我們的下一個問題來自 Truist 的 Robyn Karnauskas 的一條訊息。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • Two ones. I mean one on Arcus and ARC-7. I mean, obviously, if the triple works, that's game changing. I mean you're one of a few companies that has the triple. And I was just thinking about the amount of trials that you might want to begin at that point. So like talk to me a little bit about how you're thinking about margins and maintaining margins with so many trials that you might want to begin and the robustness of that. And then also talk to me about -- do you have a perspective on the likelihood of the combination of triple combination working versus the doublet because other people have the doublet. So just fitting your perspective on the confidence you have and then also on thinking about all these trials that you may want to begin. And if you can maintain some sort of -- give us some sense of margins and R&D expense going in the out-years.

    兩個。我是指Arcus和ARC-7。顯然,如果三聯療法成功,那將是顛覆性的。我的意思是,你們是少數幾家擁有三聯療法的公司之一。我當時就在想,到那時你們可能會啟動多少項試驗。所以,請跟我談談你們是如何考慮利潤率的,如何在啟動這麼多試驗的情況下維持利潤率,以及這種療法的穩健性。另外,請談談——你們如何看待三聯療法與雙聯療法相比的成功率,因為其他公司已經擁有雙聯療法。所以,請談談你們的信心,以及你們對可能啟動的所有這些試驗的看法。如果你們能夠維持一定的利潤率,請給我們一些關於未來幾年研發支出的預期。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Robyn, it's Andy. Let me start with -- we lost Dan again, I'm sorry. Let me start with the margin question. So we're not providing longer-term guidance. But we have flexibility in the way that we've structured the deals, as you know. So until we opt in, the R&D expense is borne by Arcus, as with many of our partnerships. Obviously, we're planning for a success and been looking at our R&D expense in the future and making sure that we have the flexibility in our capital structure and otherwise to push these programs forward if the data supports it. And we have a lot of leverage in our model. So we, again, have very strong margins. At a high level, Robyn, what I'd say is we don't expect that any of the opt-ins, unless we're really opting into all of the programs across the board that we have options on, would fundamentally change our margin profile. And if they did, obviously, that would be in the short term, potentially a good problem to have. So we're really comfortable with the structure that we have where we are at our margins today, where we see them going. We like our R&D load today in terms of the amount of scale we've added to our R&D programs and our spend levels. You see that we're going to work very hard to manage our expenses thoughtfully with our team. So from our vantage point, we're in a good spot.

    羅賓,我是安迪。首先,很抱歉丹又缺席了。先說說利潤率的問題。我們不提供長期業績指引。但正如你所知,我們在交易結構方面具有靈活性。因此,在我們選擇加入之前,研發費用由Arcus承擔,就像我們許多其他合作項目一樣。顯然,我們正在為專案的成功做準備,並一直在關注未來的研發支出,確保我們的資本結構和其他方面都有足夠的靈活性,以便在資料支援的情況下推進這些專案。我們的商業模式具有很高的槓桿率。所以,再次強調,我們的利潤率非常強勁。羅賓,總的來說,我認為除非我們真的全面選擇加入所有我們擁有選擇權的項目,否則任何選擇加入都不會從根本上改變我們的利潤率狀況。如果真的改變了,那顯然在短期內可能是一個「甜蜜的煩惱」。所以,我們對目前的架構、利潤率以及未來的發展方向都非常滿意。我們對目前的研發投入感到滿意,無論是研發項目的規模或支出水準都控制得很好。您可以看到,我們將與團隊一起努力,謹慎有效地管理各項支出。因此,從我們的角度來看,我們目前處境良好。

  • Let me hand it over to Merdad on the clinical question.

    關於臨床問題,我把問題交給梅爾達德來解答。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Yes. It's a great observation. And I think one of the things we really appreciate about the team at Arcus is they're really focused on 2 things with the TIGIT asset in particular. One is to try to be as fast as possible, taking the appropriate kinds of risks to make sure that we are really in the hunt, that we -- and I think what's exciting there is a possibility to be potentially second to market with that asset; and secondly, to look at combinations within the portfolio to look for evidence of even better activity that could really position us uniquely out there.

    是的,這是一個非常棒的觀察。我認為我們非常欣賞Arcus團隊的一點是,他們尤其專注於TIGIT資產的兩件事。第一,他們力求以最快的速度推進,承擔適當的風險,確保我們真正參與競爭,並且——我認為令人興奮的是,我們有可能成為該資產市場上的第二大競爭者;第二,他們會研究投資組合中的其他資產組合,尋找更強勁的增長勢頭,從而真正使我們在市場中佔據獨特的優勢。

  • So getting back to the earlier question about Arcus and our relationship there, they're a very impressive group and have been doing great work. So we're excited to see how those data play out.

    回到之前關於Arcus以及我們與他們關係的問題,他們是一個非常優秀的團隊,一直以來都做得非常好。所以我們很期待看到這些數據最終會如何呈現。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • Congrats on the year.

    恭喜你度過了美好的一年。

  • Operator

    Operator

  • Our next question comes from the line of Cory Kasimov from JPMorgan.

    我們的下一個問題來自摩根大通的科里·卡西莫夫。

  • Cory William Kasimov - Senior Biotechnology Analyst

    Cory William Kasimov - Senior Biotechnology Analyst

  • I was wondering if you could talk a little bit about the latest trends you're seeing in the PrEP market today and how we should be thinking about that, or really thinking about Descovy going forward in the face of Truvada generics, especially given that it wasn't in your more granular sales guidance slide, either up as like a headwind or a tailwind?

    我想請您談談您目前在 PrEP 市場看到的最新趨勢,以及我們應該如何看待這些趨勢,或者說,在 Truvada 仿製藥上市的情況下,我們應該如何看待 Descovy 的未來發展,尤其是在您更詳細的銷售預測幻燈片中,既沒有將其視為不利因素,也沒有將其視為有利因素?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Cory. Yes. Johanna, over to you, please.

    謝謝,科里。好的。喬安娜,請你發言。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Cory, for the question. Yes, so as I mentioned earlier, the share has been actually quite stable. So what we've seen is really, with Truvada LOE, what we've seen is a little bit of mix within Truvada, between branded and generics. But we haven't seen that impact the Descovy at all. On the contrary, it stayed strong at that level of share. And we expect that to continue to basically be anywhere between 40% and 45% or so throughout the year.

    謝謝Cory的提問。是的,正如我之前提到的,市場佔有率實際上相當穩定。我們看到,Truvada的剩餘產品中,品牌藥和仿製藥之間存在一些混合銷售。但這完全沒有影響到Descovy的市佔率。相反,Descovy的市佔率一直保持在較高水準。我們預計,全年Descovy的市佔率將維持在40%到45%左右。

  • Having said that, we did see a little bit of a decline quarter-over-quarter, that 6% or so. And that was largely due to the contracting to maintain strong commercial access. So the one difference has been much more around -- because it's TAF, because it's in prevention, it's highly commercially -- commercial payers. And so therefore, we're really quite focused on just making sure that people at risk have access to Descovy in light of the strong profile and safety profile that it offers.

    儘管如此,我們確實看到環比下降了約 6%。這主要是由於為了維持強勁的商業准入而簽訂的合約。因此,最大的不同在於——因為它是 TAF,因為它用於預防,而且具有很強的商業性——商業支付方。因此,鑑於 Descovy 具有良好的療效和安全性,我們目前非常注重確保高風險族群能夠獲得該藥物。

  • And so we've definitely seen erosion with Truvada, strong erosion in Q4, and that will continue as we think about coming quarters this year. But really from a Descovy standpoint, the expectation is that we continue to maintain strong commercial access. And obviously, that might mean a little bit more contracting, so a little bit more discounting on that front, but one that's important for us to make sure that people living at risk have access to Descovy as we continue forward. So hopefully, that kind of addresses your question on PrEP market.

    因此,我們確實看到Truvada的市佔率有所下降,尤其是在第四季度,隨著我們展望今年接下來的幾個季度,這種情況還會持續下去。但就Descovy而言,我們預期其市場准入將持續保持強勁。顯然,這可能意味著市場份額會略有縮減,折扣也會略有增加,但這對於我們確保高風險族群能夠持續獲得Descovy至關重要。希望以上內容能解答您關於PrEP市場的問題。

  • Operator

    Operator

  • Our next question comes from the line of Umer Raffat from Evercore.

    我們的下一個問題來自 Evercore 的 Umer Raffat。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I have 2, if I may. First, perhaps on Trodelvy. I know there's the HR-positive Phase III coming up in breast. And my question was that, originally, the protocol allowed for an interim ORR analysis to support an accelerated approval. I'm curious if that's still happening in the first half. And secondly, curious what the observations are to date from the inhaled remdesivir's Phase Ib in early COVID. And I'm mostly wondering, given the ongoing epidemic -- given the ongoing pandemic as well as given all the Phase III safety data, wouldn't the Phase Ib data form the basis for a potential EUA along with the safety data that exists?

    我有兩個問題,如果可以的話。首先,我想問一下關於Trodelvy的問題。我知道它即將進行一項針對乳癌的HR陽性III期臨床試驗。我的問題是,最初的方案允許進行中期客觀緩解率(ORR)分析以支持加速審批。我想知道在上半年是否仍會進行這項分析。其次,我想了解吸入型瑞德西韋在早期COVID-19患者中進行的Ib期臨床試驗迄今為止的觀察結果。我主要想知道,鑑於目前疫情仍在持續——考慮到全球大流行以及所有III期臨床試驗的安全性數據,Ib期臨床試驗的數據是否應該與現有的安全性數據一起,構成潛在的緊急使用授權(EUA)的基礎?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Umer, for those questions. Appreciate it. Merdad, please, on both of those.

    謝謝Umer的提問,非常感謝。請問這兩個問題我都回答「Merdad」嗎?

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Sure. So on Trodelvy, you're right that there was a planned ORR. And -- but we don't think that the ORR evaluation, the interim analysis, was actually going to form the substantive-enough data to get an approval in HR-positive.

    當然。關於Trodelvy,你說得對,確實有計劃進行ORR評估。但是-我們認為ORR評估,也就是中期分析,實際上並不能提供足夠實質的數據來獲得HR的積極批准。

  • So what we did is we looked initially at the study when -- as part of the evaluation. Together with the team in Immunomedics, we resized the study to power it appropriately for overall survival. And at the end of the year, we'll read out PFS, which we think has a much better opportunity for reading out and giving us a fileable end point.

    因此,我們首先對研究進行了評估。我們與Immunomedics團隊合作,調整了研究規模,使其能夠充分反映總生存期。年底,我們將公佈無惡化存活期(PFS)的數據,我們認為PFS更有可能得出可提交的終點結果。

  • So I think that was really the -- our conclusion was essentially that the ORR was only just going to cost us alpha, but not really get us something that we could file with. And we have not unblinded any data. We don't -- it was not based on anything other than wanting to get to the PFS.

    所以我覺得,我們的最終結論基本上是:ORR只會讓我們損失一些alpha值,但並不能為我們帶來任何可以提交申請的數據。而且我們沒有揭盲任何數據。我們這麼做的唯一目的就是為了取得PFS數據。

  • So on the inhaled remdesivir, it's going well. That study is moving through Phase I and has moved forward nicely. And no, the Phase I study is probably not adequate -- not probably, is not adequate for approval. It's -- when you move from parenteral to an inhaled approach, it's effectively moving it to a drug-device combination approach. And so all the issues there -- a PK bridge is usually when you can show that the exposure is the same. But since the exposure will be very different systemically, it will be -- primarily the, exposure will be in the lung. You can't do a bridging for PK. So it ends up being a clinical efficacy question as opposed to just a PK question. So the studies are designed to -- will be designed to go forward with evidence of clinical efficacy for approval.

    吸入型瑞德西韋的進展順利。該研究正在進行I期臨床試驗,進展良好。但是,I期臨床試驗的結果可能不足以——不是可能,而是肯定不足以——獲得批准。從腸外給藥途徑轉向吸入給藥途徑,實際上是轉向了藥物-器械聯合給藥途徑。因此,所有相關的問題—通常情況下,當能夠證明藥物暴露量相同時,可以進行藥物動力學橋接。但由於全身暴露量將截然不同,主要暴露部位為肺部。因此,無法進行藥物動力學橋接。最終,這變成了一個臨床療效問題,而不僅僅是一個藥物動力學問題。所以,這些研究旨在──將會設計成能夠提供臨床療效證據以獲得批准。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thank you, Merdad. Andy, I know we're kind of out of time. Should we try to take 1 or 2 more questions?

    謝謝你,梅爾達德。安迪,我知道我們時間不多了。我們再問一兩個問題好嗎?

  • Andrew Ang

    Andrew Ang

  • Yes, Dan, I think we thought we'd take 2 more questions.

    是的,丹,我想我們原本打算再回答兩個問題。

  • Operator

    Operator

  • Our next question comes from the line of Terence Flynn from Goldman Sachs.

    我們的下一個問題來自高盛的 Terence Flynn。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • I was just wondering if you can comment at all about breadth of prescribing with Trodelvy, what you're currently seeing out there, how you expect that to change over the course of the year? And then the randomized lung cancer trial that you mentioned, Merdad, would that be a Phase II or Phase III trial? And then just one for Andy on the expense cadence in 2021, what that looks like if you were to exclude kind of underlying remdesivir spend.

    我想請您談談Trodelvy的處方覆蓋範圍,您目前觀察到的情況,以及您預計今年內會有哪些變化?還有您提到的隨機肺癌試驗Merdad,它是II期還是III期試驗?最後,我想問Andy,關於2021年的費用結構,如果排除瑞德西韋的支出,費用結構會是什麼樣的?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Really good questions. Thanks for those, Terence. We'll start with Johanna, and then we'll go to Merdad on lung and then Andy on expense. So go ahead, Johanna.

    問題問得真好。謝謝你,特倫斯。我們先從喬安娜開始,然後是梅爾達德關於肺部疾病的問題,最後是安迪關於醫療費用的問題。那麼,喬安娜,請開始吧。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Okay. Thanks, Terence. Yes, so I think we're really pleased to see the evolution of Trodelvy, right? It's only 8 months in, so they haven't had a full year yet. And what we're seeing in 2020 is very encouraging. As of last October, more than 1 out of 4 patients were initiated on Trodelvy in third-line metastatic triple-negative breast cancer.

    好的,謝謝,特倫斯。是的,我們都非常高興看到Trodelvy的進展,對吧?它上市才8個月,還沒滿一年。但我們在2020年看到的情況非常令人鼓舞。截至去年10月,超過四分之一的轉移性三陰性乳癌第三線治療患者接受了Trodelvy治療。

  • What we also are seeing is, in December, when physicians were actually asked to report their own prescribing, so a little bit of an ATU-type approach, they were suggesting somewhere north of 40% of their third-line metastatic triple-negative breast cancer patients were receiving Trodelvy. And so we're seeing a nice uptake. I think we have an opportunity to continue that uptake as we think about expanding not only in the academic centers, but also with our community providers. And I think that's the opportunity as we think in the next little while. And I think that will be driven mostly with the fact that we'll be able to promote the overall survival data as soon as we have the FDA approval, the full approval for the ASCENT data and the publication. So all of those things will be important inflection points for us as we move forward.

    我們也看到,去年12月,當醫生被要求報告他們自己的處方情況時(這有點像ATU的方法),他們表示,超過40%的三線轉移性三陰性乳癌患者正在接受Trodelvy治療。因此,我們看到了不錯的接受度。我認為,隨著我們考慮不僅在學術中心,而且在社區醫療機構推廣,我們有機會繼續提高這種接受度。我認為這是我們未來一段時間的機會。我認為這主要取決於我們能否在獲得FDA批准、ASCENT研究數據獲得全面批准並發表後,盡快推廣總生存期數據。因此,所有這些都將是我們未來發展的重要轉捩點。

  • But we're very excited as we see physicians and are really getting physician feedback around making sure that they can get through their second-line options pretty quickly to get to third line. And we have very strong peer support as well in reimbursement. So there's been no barriers on that front either. So good shape so far.

    但我們很高興看到醫生們積極回饋,確保他們能夠盡快用完二線治療方案,從而順利過渡到三線治療。此外,我們在報銷方面也得到了同行的大力支持。因此,這方面也沒有遇到任何障礙。目前一切進展順利。

  • I'll turn it over to Merdad on the lung cancer question.

    關於肺癌的問題,我將交給梅爾達德來回答。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Yes. I think -- so just to be clear, maybe I'll just say both. So the study I was referencing that will read out for PFS is a hormone receptor-positive, HER2-negative study, that is a Phase III study. In -- for lung cancer, right now, it's a Phase I study. The TROPiCS-03 study is a Phase I basket trial. And pending those data, we would -- our plan is that we would open a Phase III trial in lung cancer in the second half of the year.

    是的。我想——為了更清楚地說明,我還是兩個都說。我之前提到的關於無惡化存活期(PFS)的研究是一項荷爾蒙受體陽性、HER2陰性的III期臨床試驗。而目前針對肺癌的研究是I期臨床試驗。 TROPiCS-03研究是一項I期籃子試驗。根據這些數據,我們的計畫是在今年下半年啟動一項針對肺癌的III期臨床試驗。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • And Terence, it's Andy. On your last question, we haven't provided specific expense guidance on any of our products, as you know. What we've said on remdesivir is that there still will be a meaningful amount of expenses in 2021, as you'd expect. But the expense load is lower than it was in 2020. So -- and we're not providing more specific guidance, but it's real -- it's important. We continue to see the significant potential for the product for patients. So we're continuing to invest appropriately. And it is baked into our guidance, but it is a reduction year-over-year.

    特倫斯,我是安迪。關於你最後一個問題,如你所知,我們沒有提供任何產品的具體費用預期。關於瑞德西韋,我們之前說過,正如你所預期的,2021年仍然會有相當可觀的費用。但費用負擔比2020年低。所以——我們不會提供更具體的預期,但這確實很重要——我們仍然看到該產品對患者的巨大潛力。因此,我們將繼續進行適當的投資。這已經體現在我們的預期中,但與去年相比有所下降。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks so much, Andy. So we'll take one more question, please.

    非常感謝,安迪。那麼,請再問一個問題吧。

  • Operator

    Operator

  • Our last question comes from the line of Phil Nadeau from Cowen and Company.

    最後一個問題來自 Cowen and Company 的 Phil Nadeau。

  • Philip M. Nadeau - MD & Senior Research Analyst

    Philip M. Nadeau - MD & Senior Research Analyst

  • Congrats on the progress. Just 2 follow-up questions for me. First, for Johanna on Descovy. You suggested that maybe there was a little price compression because of renegotiations with commercial plans with the availability of Truvada generic. As we're doing our modeling, should we expect another round of negotiations after more generics enter in Q2? And could that impact price in the second half of 2021?

    恭喜取得進展。我還有兩個後續問題。首先,關於Johanna提到的Descovy,您提到由於Truvada仿製藥上市,與商業計劃方重新談判,價格可能略有下降。當我們進行模型分析時,是否應該預期在第二季有更多仿製藥上市後會出現新一輪談判?這是否會對2021年下半年的價格產生影響?

  • And then, Merdad, a question for you on Trodelvy, just a follow-up on that Phase III lung cancer study. I believe this is the first time we've heard, you're kind of committed to moving forward there. What gave rise to that? Is it the data you're seeing from the basket study or something you saw at world lung? And what do you need to see from TROPICS-03 in order to stick with that plan?

    Merdad,關於Trodelvy,我有個問題想問你,是關於那項III期肺癌研究的後續。我相信這是我們第一次聽到你決心推進這項研究。是什麼促使你做出這個決定?是因為你從籃子試驗中看到的數據,還是你在世界肺癌大會上看到的?你需要從TROPICS-03試驗中看到什麼才能堅持這個計畫?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Phil. So Johanna and then Merdad, and then I'll just have a quick close.

    謝謝,菲爾。那麼,先是喬安娜,然後是梅爾達德,之後我就簡單結束一下。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Great. So thanks, Phil, for the question. Yes, so exactly what you've described. I think we're going to be very choiceful. And obviously, it needs to make sense. But there could be continued pressures. I think we've seen many of them, and we've been managing it as best we can to make sure that people living at risk still have access to Descovy as it really is quite differentiated.

    太好了。謝謝你的提問,菲爾。是的,正如你所描述的,我們會非常謹慎地進行選擇。當然,一切都必須合情合理。但我們可能會面臨持續的壓力。我認為我們已經看到了許多這樣的壓力,並且一直在盡最大努力應對,以確保那些生活在風險中的人們仍然能夠獲得Descovy,因為它確實具有很強的差異化優勢。

  • I think as you think about your model for 2021, there's 2 pieces. One is, as you know, the market in prevention was quite depressed because of the pandemic. And we started to see us coming out of it in Q3. But of course, in Q4, with the surge of cases and hospitalization, we saw that dampening again. Assuming that we come back to some new normal this year, we should see that market pick up again. So between the market pickup as well as some continued smaller price contractions, I think those 2 things will balance each other out quite nicely. Merdad?

    我認為,在考慮2021年的市場模型時,應該包含兩個面向。一方面,如你所知,由於疫情的影響,預防市場一度非常低迷。我們在第三季開始看到市場有所復甦。但到了第四季度,隨著病例和住院人數的激增,市場再次陷入低迷。假設今年我們能夠恢復到某種新的常態,市場應該會再回暖。因此,我認為市場回升加上持續的小幅價格下跌,這兩方面因素會相互抵消,達到一個不錯的平衡。對吧?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thank you. So yes, Merdad?

    謝謝。所以,是的,梅爾達德?

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Yes. And then on the Trodelvy, yes. So the way we're thinking about it is that, Phil, as you know, the disclosed data from Immunomedics on lung have been promising. Because of the competitive situation right now with other molecules in lung, our own interest in lung and the fact that we'll see additional data from TROPiCS-03, we are planning at risk to do a Phase III study. Now that will depend entirely on how the data read out and the strength of the data. We may need to or want to adapt from there, but we want to be aggressive and make sure that we don't we don't lose any advantage that we may have. So we're just being aggressive and based on our conviction on the molecule and the MOA.

    是的。關於Trodelvy,是的。 Phil,如你所知,Immunomedics公司公佈的肺癌數據令人鼓舞。鑑於目前肺癌領域其他分子的競爭情勢,以及我們自身對肺癌的興趣,再加上我們將看到TROPiCS-03的更多數據,我們計劃冒險進行一項III期臨床試驗。當然,這完全取決於數據的結果和數據強度。我們可能需要或想要根據結果進行調整,但我們希望積極主動,確保不會失去任何優勢。因此,我們採取積極主動的策略,是基於我們對該分子及其作用機制的信心。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Phil. And it just leaves me to just say a few things at the end. I mean I know I speak on behalf of the entire leadership team, that we're clearly behind this next chapter of growth in Gilead, and it's here. And it's a variety of things. Of course, it's a clear path to growth in a sustainable and diverse portfolio. It's also the fact that we have a stable dividend that we're committed to growing over time with the industry-leading dividend yield, consistently strong cash flow, robust balance sheet. So we're entering 2021 with confidence on this clear path to growth. And I think you'll see us deliver on our new opportunities in oncology and sustain our leadership in HIV. And we look forward to updating you every quarter on our progress throughout 2021.

    謝謝菲爾。最後我只想補充幾點。我知道我代表整個領導團隊發言,我們都堅定地支持吉利德的下一個成長篇章,而它已經到來。這其中有很多因素。當然,我們擁有清晰的成長路徑,建立可持續且多元化的產品組合。此外,我們還擁有穩定的股息,並致力於隨著行業領先的股息收益率、持續強勁的現金流和穩健的資產負債表,不斷提高股息。因此,我們對2021年充滿信心,並堅信這條清晰的成長路徑能夠持續下去。我相信大家會看到我們在腫瘤領域的新機會得以實現,並繼續保持我們在愛滋病領域的領先地位。我們期待在2021年的每個季度都向大家報告我們的進展。

  • So thank you all for joining. I'll let Andrew have the last word here, but I also want to make sure we thank all the colleagues at Gilead and our partners that made all this possible. So Andrew, over to you.

    感謝各位的參與。最後,我請安德魯發言,但我也要感謝吉利德的所有同事和合作夥伴,是他們的付出讓這一切成為可能。安德魯,接下來就交給你了。

  • Andrew Ang

    Andrew Ang

  • Well, thank you, Diwal, and thank you all for joining us today. We appreciate your continued interest in Gilead, and the team here looks forward to providing you with the updates on our future progress. Thanks again.

    迪瓦爾,謝謝你,也謝謝各位今天蒞臨。我們非常感謝大家一直以來對吉利德的關注,我們的團隊期待向大家報告我們未來的進展。再次感謝。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束。感謝各位的參與。現在可以掛斷電話了。