吉利德科學 (GILD) 2020 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by and welcome to the Second Quarter 2020 Gilead Sciences Earnings Conference Call.

    女士們,先生們,感謝你們的支持,歡迎來到 Gilead Sciences 2020 年第二季度收益電話會議。

  • (Operator Instructions) Please be advised that today's conference may be recorded.

    (操作員說明)請注意,今天的會議可能會被錄製。

  • (Operator Instructions)

    (操作員說明)

  • I'd now like to hand the conference over to your host today, Mr. Douglas Maffei, Senior Director of Investor Relations.

    我現在想把會議交給今天的主持人,投資者關係高級總監 Douglas Maffei 先生。

  • Please go ahead.

    請繼續。

  • Douglas Maffei - Senior Director of IR

    Douglas Maffei - Senior Director of IR

  • Thank you, Liz, and good afternoon, everyone.

    謝謝你,Liz,大家下午好。

  • Just after market closed today, we issued a press release with earnings results for the first half and second quarter of 2020.

    今天收市後,我們發布了一份新聞稿,其中包含 2020 年上半年和第二季度的收益結果。

  • The press release and detailed slides are available on the Investors section of the Gilead website.

    新聞稿和詳細幻燈片可在 Gilead 網站的投資者部分獲取。

  • 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.

    今天電話會議的發言人是董事長兼首席執行官 Daniel O'Day; Johanna Mercier,首席商務官; Merdad Parsey,首席醫療官; Andrew Dickinson,首席財務官。

  • Also on the call and available for Q&A will be Christi Shaw, Chief Executive Officer of Kite; and Diana Brainard, SVP and Head of our Virology Therapeutic area.

    Kite 首席執行官克里斯蒂·肖 (Christi Shaw) 也將出席電話會議並參與問答環節;和我們病毒學治療領域的高級副總裁兼負責人 Diana Brainard。

  • 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 the results of operations, plans and expectations with respect to products, product candidates, corporate strategy, financial projections and the use of capital and 2020 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.

    在我們開始準備好的評論之前,讓我提醒您,我們將做出前瞻性陳述,包括與 COVID-19 大流行對吉利德(Gilead)業務、財務狀況和運營結果、計劃和結果的影響相關的風險和不確定性。對產品、候選產品、公司戰略、財務預測和資本使用以及 2020 年財務指導的預期,所有這些都涉及我們無法控制的某些假設、風險和不確定性,並可能導致實際結果與這些陳述存在重大差異.

  • A description of these risks can be found in the earnings press release and our latest SEC disclosure documents.

    這些風險的描述可以在收益新聞稿和我們最新的 SEC 披露文件中找到。

  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    所有前瞻性陳述均基於吉利德當前可獲得的信息,吉利德不承擔更新任何此類前瞻性陳述的義務。

  • Non-GAAP financial measures will be used to help you understand the company's underlying business performance.

    非 GAAP 財務指標將用於幫助您了解公司的基本業務績效。

  • The GAAP to non-GAAP reconciliations are provided in the earnings press release as well as on the Gilead website.

    收益新聞稿和 Gilead 網站上提供了 GAAP 與非 GAAP 對賬。

  • I will now turn the call over to Dan.

    我現在將電話轉給丹。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thank you, Doug, and good afternoon, everyone.

    謝謝你,道格,大家下午好。

  • I'd like to start by thanking our Gilead employees worldwide, who, along with our partners, continue to go above and beyond to meet our many responsibilities at this time.

    首先,我要感謝我們在全球的 Gilead 員工,他們與我們的合作夥伴一起,繼續超越自我,履行我們目前的許多職責。

  • Those responsibilities include advancing remdesivir, supporting work across our other medicines that are helping patients today and building our pipeline of future therapies.

    這些職責包括推進瑞德西韋、支持我們目前幫助患者的其他藥物的工作,以及建立我們未來療法的管道。

  • We'll cover each of those during today's call.

    我們將在今天的電話會議中介紹其中的每一個。

  • I'm pleased to have the team with me here to provide an overview, and we all look forward to answering your questions.

    我很高興有我的團隊在這裡提供概述,我們都期待著回答您的問題。

  • I'll start things off with some of my perspectives.

    我將從我的一些觀點開始。

  • The first thing I want to comment on is the continued strength and durability of our core HIV business.

    我要評論的第一件事是我們核心 HIV 業務的持續實力和持久性。

  • We've grown market share even as we navigated the expected impact of the COVID-19 pandemic, and we're already seeing early signs of recovery from that impact in some markets.

    即使我們應對了 COVID-19 大流行的預期影響,我們的市場份額也有所增加,而且我們已經看到一些市場從這種影響中復甦的早期跡象。

  • We are confident in our long-term leadership in HIV.

    我們對我們在 HIV 領域的長期領導地位充滿信心。

  • People living with HIV depend on innovative therapies that meet their needs and Gilead is and has always been focused on meeting those needs.

    艾滋病病毒感染者依賴於滿足他們需求的創新療法,而吉利德一直致力於滿足這些需求。

  • Biktarvy has become the gold standard in HIV treatment, and we're on track with our conversion to discovery for PrEP treatment.

    Biktarvy 已成為 HIV 治療的黃金標準,我們正朝著發現 PrEP 治療轉變的方向走上正軌。

  • The principles that have driven our HRD growth to date still apply and will continue to drive our growth in the future.

    迄今為止推動我們人力資源開發發展的原則仍然適用,並將繼續推動我們未來的發展。

  • The second area I want to comment on is our role in fighting the pandemic with remdesivir.

    我要評論的第二個方面是我們在使用瑞德西韋抗擊大流行中的作用。

  • There's a growing body of clinical and real-world data that continues to shape our understanding of the medicine.

    越來越多的臨床和現實數據繼續影響著我們對醫學的理解。

  • The data tell a consistent story of clinical benefit for patients suffering from COVID-19, across our SIMPLE studies, the NIAID data, the compassionate use data and more recently, the comparative analysis that used real-world data.

    在我們的 SIMPLE 研究、NIAID 數據、同情使用數據以及最近使用真實世界數據的比較分析中,數據講述了 COVID-19 患者臨床獲益的一致故事。

  • I'd also like to highlight some details on our efforts to ensure broad access to remdesivir in the second half of the year and beyond.

    我還想強調一些細節,說明我們為確保在今年下半年及以後廣泛使用瑞德西韋所做的努力。

  • As we discussed last time, we feel the full weight of our responsibilities with remdesivir, and that applies to the price we set following the donation period.

    正如我們上次討論的那樣,我們感到我們對 remdesivir 負有全部責任,這適用於我們在捐贈期後設定的價格。

  • We price remdesivir well below the value it provides to enable access at this critical time and ensure that we continue to meet our responsibilities in the future with further investment in remdesivir and in research that will help us to prepare for any future pandemics.

    我們將 remdesivir 定價遠低於它提供的價值,以便在這個關鍵時刻實現獲取,並確保我們在未來繼續履行我們的責任,進一步投資 remdesivir 和研究,這將幫助我們為未來的任何流行病做好準備。

  • The extensive clinical development work continues on remdesivir, so that we can potentially extend the treatment to many more patient groups.

    瑞德西韋的廣泛臨床開發工作仍在繼續,因此我們有可能將治療擴展到更多的患者群體。

  • We've begun clinical work on an inhaled solution that could be used outside the hospital, and we'll also conduct clinical trials using the intravenous formulation in the outpatient setting such as nursing homes.

    我們已經開始了一種可以在醫院外使用的吸入溶液的臨床研究,我們還將在療養院等門診環境中使用靜脈注射製劑進行臨床試驗。

  • Merdad will talk more about the development program later.

    Merdad 稍後將詳細討論開發計劃。

  • As you know, we've agreed to the U.S. government requests following discussions about the significant rise of COVID-19 infections in the United States that U.S. patients will receive 500 million treatment courses of our supply until the end of September when we expect to have enough remdesivir to meet real-time global demand.

    如您所知,在討論美國 COVID-19 感染顯著上升後,我們已同意美國政府的要求,即美國患者將在 9 月底之前接受我們供應的 5 億個療程,屆時我們預計足夠的瑞德西韋來滿足全球實時需求。

  • As announced yesterday, we're pleased to have reached an agreement with the European Commission, where they will centrally purchase remdesivir for patients in the European Union and the U.K. The European Commission will be responsible for all decisions regarding allocation among member states.

    正如昨天宣布的那樣,我們很高興與歐盟委員會達成協議,他們將為歐盟和英國的患者集中購買瑞德西韋。歐盟委員會將負責有關成員國之間分配的所有決定。

  • The remaining supply of remdesivir will be allocated to other countries with significant rates of COVID-19 infection.

    剩餘的瑞德西韋供應將分配給 COVID-19 感染率很高的其他國家。

  • We will see a significant increase in supplies in October as expected.

    正如預期的那樣,我們將在 10 月份看到供應量大幅增加。

  • The third theme I want to touch on is the progress we're making in shaping Gilead's growth story.

    我想談的第三個主題是我們在塑造吉利德成長故事方面取得的進展。

  • You may recall that we previously shared a framework outlining the 3 pillars that will shape Gilead's next chapter, and you'll see these in the slides on our website today as well.

    您可能還記得我們之前分享了一個框架,該框架概述了塑造 Gilead 下一章的 3 大支柱,您今天也會在我們網站上的幻燈片中看到這些。

  • I've already touched on the first pillar, which is our durable core business, and Johanna will describe our achievements on this front in more detail in a moment.

    我已經談到了第一個支柱,即我們持久的核心業務,Johanna 稍後會更詳細地描述我們在這方面取得的成就。

  • Pillar 2 is our pipeline, and we made important progress across several potentially transformational assets in a relatively short period of time with a balance of both internal innovation and acquired investigational compounds.

    支柱 2 是我們的管道,我們在相對較短的時間內在幾個潛在的轉型資產上取得了重要進展,平衡了內部創新和收購的研究化合物。

  • Pillar 3 is our strategy to drive future growth by accessing the highest-quality external innovation in order to serve more patients.

    支柱 3 是我們通過獲取最高質量的外部創新來推動未來增長的戰略,以便為更多患者提供服務。

  • The pace of our corporate development activities has not slowed down a bit during this pandemic time.

    疫情期間,我們企業發展活動的步伐絲毫沒有放緩。

  • I'd like to highlight the progress we made this year on executing on our immuno-oncology strategy.

    我想強調一下我們今年在執行免疫腫瘤學戰略方面取得的進展。

  • Our goal is to grow our immuno-oncology pipeline and our expertise, both through external opportunities and by advancing our internal efforts.

    我們的目標是通過外部機會和推進我們的內部努力來發展我們的免疫腫瘤學管道和我們的專業知識。

  • The range of immuno-oncology deals we've announced this year represent significant progress towards this goal.

    我們今年宣布的一系列免疫腫瘤學交易代表了朝著這一目標取得的重大進展。

  • These deals bring complementary scientific approaches and provide access to clinical and preclinical assets with a view to both mid- and long-term growth.

    這些交易帶來了互補的科學方法,並提供了獲得臨床和臨床前資產的機會,以期實現中長期增長。

  • Before I hand over to the team for the detailed comments in our progress, I want to briefly mention something that we see as another key area of responsibility for the company, the work against racial injustice.

    在我向團隊提出我們進展的詳細評論之前,我想簡要提一下我們認為是公司另一個關鍵責任領域的事情,即反對種族不平等的工作。

  • We are passionately committed to using Gilead's platform for what we see as a global issue that calls on everyone to play a role.

    我們熱情地致力於使用 Gilead 的平台來解決我們認為是一個全球性問題,呼籲每個人都發揮作用。

  • The leadership team and I have spent the past weeks listening carefully to black employees as they started to share with us how they, their families and their communities experienced racial injustice in various forums.

    在過去的幾周里,我和領導團隊一直在仔細聆聽黑人員工開始與我們分享他們、他們的家人和他們的社區如何在各種論壇上經歷種族不平等。

  • Gilead is committed to both immediate and long-term actions that will have a lasting impact for our employees and the communities that we serve.

    吉利德致力於立即和長期行動,這些行動將對我們的員工和我們所服務的社區產生持久影響。

  • Let me now hand the call off to Johanna, who will walk us through some of the key details related to our business performance.

    現在讓我將電話轉給 Johanna,她將向我們介紹與我們的業務績效相關的一些關鍵細節。

  • Over to you, Johanna.

    交給你了,約翰娜。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Dan, and good afternoon, everyone.

    謝謝,丹,大家下午好。

  • Let me start by saying that despite the anticipated impact of the pandemic, our business is solid and remains resilient.

    首先讓我說,儘管預計會受到大流行的影響,但我們的業務穩健且保持彈性。

  • While COVID-19 has had an impact on parts of our business this past quarter, we're built to withstand this kind of challenge, and we remain confident in the strength of our core business.

    儘管 COVID-19 在上個季度對我們的部分業務產生了影響,但我們能夠承受這種挑戰,並且我們對核心業務的實力仍然充滿信心。

  • No one can actually predict the progression of this pandemic, but we do see signs of recovery and partial return to normal in Europe as well as some parts of Asia, and we're confident that this will also play out in the U.S. once the incident stabilizes.

    沒有人能真正預測這一流行病的進展,但我們確實看到歐洲和亞洲部分地區出現復甦和部分恢復正常的跡象,我們相信一旦事件發生,美國也會出現這種情況穩定。

  • Turning now to the specifics of Q2 and the first half for business performance, starting with HIV.

    現在轉向第二季度和上半年的具體業務表現,從艾滋病毒開始。

  • Our HIV franchise is strong and durable.

    我們的 HIV 專營權強大而持久。

  • In both treatment and prevention, we have a patient-focused history of innovation and believe both will continue to be important drivers for the company over the next decade.

    在治療和預防方面,我們擁有以患者為中心的創新歷史,相信這兩者將在未來十年繼續成為公司的重要推動力。

  • In June, we hit our stated year-end goal, this conversion to TAF-based regimens on the treatment side and are now at 90% of our total portfolio.

    6 月,我們實現了既定的年終目標,即在治療方面轉換為基於 TAF 的方案,現在占我們總投資組合的 90%。

  • Biktarvy uptake continues to remain strong across geographies and is the #1 HIV treatment regimen across the U.S., EU5 and other key global markets in both naïve and switch.

    Biktarvy 的吸收在各個地區繼續保持強勁,並且是美國、歐盟 5 國和其他主要全球市場的第一大 HIV 治療方案,無論是初始治療還是轉換治療。

  • For PrEP, we achieved our goal of 40% to 45% Descovy conversion with 43% at the end of June.

    對於 PrEP,我們在 6 月底實現了 40% 至 45% 的 Descovy 轉化率目標,轉化率為 43%。

  • We continue to believe that physicians and patients are benefiting from choice and are increasingly seeing Biktarvy for treatment and Descovy for PrEP as the preferred option for their patients.

    我們仍然相信,醫生和患者正在從選擇中受益,並且越來越多地將用於治療的 Biktarvy 和用於 PrEP 的 Descovy 視為患者的首選。

  • The quarter overall was down year-on-year 1% and quarter-over-quarter by 3%.

    該季度整體同比下降 1%,環比下降 3%。

  • The impact on our HIV revenue, including Biktarvy, was primarily driven by inventory dynamics.

    對我們的 HIV 收入的影響,包括 Biktarvy,主要是由庫存動態驅動的。

  • In Q2, we saw a reversal of the pandemic-related stocking that happened in March during the onset of COVID across U.S. and Europe.

    在第二季度,我們看到 3 月份美國和歐洲 COVID 爆發期間發生的與大流行相關的庫存出現逆轉。

  • Also on the treatment side, as expected, we're seeing reduced switches due to the decline in patient visits and physicians not wanting to initiate new therapies during a pandemic.

    同樣在治療方面,正如預期的那樣,由於患者就診人數減少以及醫生不想在大流行期間啟動新療法,我們看到開關減少了。

  • We're also seeing an unfavorable shift in payer mix from commercial to government segments.

    我們還看到付款人組合從商業部門向政府部門的不利轉變。

  • Despite this, our overall demand remained robust with both the overall Gilead portfolio and Biktarvy gaining share quarter-over-quarter and year-on-year.

    儘管如此,我們的整體需求仍然強勁,吉利德(Gilead)的整體產品組合和比克托維(Biktarvy)的份額環比和同比均有所增長。

  • The pandemic impacted PrEP demand as expected, and we saw reduced initiations and therapy discontinuations due to fewer people seeing their health care providers and social dynamics.

    大流行如預期般影響了 PrEP 需求,我們看到由於較少的人看到他們的醫療保健提供者和社會動態而減少了啟動和治療中斷。

  • We're starting to see gradual recovery across our markets, including in the U.S., where we saw improving PrEP trends in June.

    我們開始看到我們的市場逐漸復蘇,包括在美國,我們在 6 月份看到 PrEP 趨勢有所改善。

  • Strong Biktarvy uptake and Descovy for PrEP conversion during the quarter underscores the confidence we have in our core HIV business as we expect to recover from the pandemic over the remainder of the year and going into 2021.

    本季度 Biktarvy 的強勁吸收和用於 PrEP 轉化的 Descovy 突顯了我們對我們的核心 HIV 業務的信心,因為我們預計將在今年剩餘時間內從大流行中恢復並進入 2021 年。

  • If we look at our HIV business, comparing the first half of revenue this year versus 2019, we see the robust underlying business with 6% growth.

    如果我們看看我們的 HIV 業務,將今年上半年的收入與 2019 年的收入進行比較,我們會看到強勁的基礎業務增長了 6%。

  • The half year view normalizes the inventory dynamics associated with the pandemic.

    半年視圖使與大流行相關的庫存動態正常化。

  • So now we turn to HCV.

    所以現在我們轉向 HCV。

  • Our HCV business, which is more like an acute business, was down 47% from Q2 of '19 and down 39% from Q1 this year.

    我們的 HCV 業務更像是一項急性業務,較 19 年第二季度下降 47%,較今年第一季度下降 39%。

  • As we discussed during the Q1 call, reduced or delayed physician visits naturally decreased both diagnosis and patient starts.

    正如我們在 Q1 電話會議中討論的那樣,減少或延遲醫生就診自然會減少診斷和患者開始。

  • U.S. HCV starts were down 42% quarter-over-quarter.

    美國 HCV 開工量環比下降 42%。

  • However, overall U.S. HCV share has held strong at about 60% across segments, which is up 11 points from Q2 2019.

    然而,美國 HCV 的總體份額在各細分市場中保持在 60% 左右,比 2019 年第二季度上升了 11 個百分點。

  • Similarly, we are seeing strong and consistent share in Europe as well.

    同樣,我們在歐洲也看到了強大而穩定的份額。

  • As other markets start to reopen, similar to what we saw in June and July across Europe, it's likely we will see many patients return throughout the rest of the year and into 2021.

    隨著其他市場開始重新開放,類似於我們在 6 月和 7 月在歐洲看到的情況,我們很可能會在今年剩餘時間和 2021 年看到許多患者返回。

  • As an example of this, in Italy, which was heavily impacted by COVID earlier this year, we saw a recovery in June as more patients, especially the higher-risk patients, started to return to their physicians and begin treatment.

    作為這方面的一個例子,在今年早些時候受到 COVID 嚴重影響的意大利,隨著更多患者,尤其是高危患者開始返回他們的醫生並開始治療,我們在 6 月份看到了復甦。

  • Before I close, just let me highlight for you a range of commercial opportunities on the horizon that make us also excited to be part of the Gilead team.

    在我結束之前,讓我向您強調即將出現的一系列商業機會,這些機會讓我們也很高興成為吉利德團隊的一員。

  • In the near term, we're pleased with the significant volume growth we're seeing in China despite the impact of COVID as we received foreign RDL approvals at the end of 2019.

    在短期內,我們對在中國看到的顯著銷量增長感到高興,儘管 COVID 的影響是我們在 2019 年底獲得外國 RDL 批准。

  • This also serves as the basis for expanding HBV business, which we expect to hit $1 billion globally by the end of 2022.

    這也是擴展 HBV 業務的基礎,我們預計到 2022 年底全球業務將達到 10 億美元。

  • We're preparing to launch filgotinib in RA in the coming months and are excited about the recent CHMP positive opinion.

    我們準備在未來幾個月內在 RA 中推出 filgotinib,並對最近 CHMP 的積極意見感到興奮。

  • As we look to the mid- to long term, we're accelerating our efforts to build our portfolio and expertise in immuno-oncology.

    從中長期來看,我們正在加快努力建立我們在免疫腫瘤學方面的產品組合和專業知識。

  • We see strong potential for magrolimab, where we recently highlighted key data at ASCO.

    我們看到了 magrolimab 的巨大潛力,我們最近在 ASCO 上強調了關鍵數據。

  • Magrolimab could be a very important therapy for MDS patients.

    Magrolimab 可能是 MDS 患者非常重要的治療方法。

  • And lastly, on HIV and lenacapavir, we believe that long actings will play a role in the future HIV market and see the potential for this compound to best meet patient needs.

    最後,關於 HIV 和 lenacapavir,我們相信長效藥物將在未來的 HIV 市場中發揮作用,並看到這種化合物有潛力最好地滿足患者的需求。

  • Merdad will share more on the clinical progress on lenacapavir in a moment.

    Merdad稍後會分享更多關於lenacapavir的臨床進展。

  • So let me end where I started.

    所以讓我在開始的地方結束。

  • Our core business is durable, the fundamental demand drivers of our HIV treatment and prevention businesses remain real, and we're optimistic heading into the second half of the year.

    我們的核心業務是持久的,我們 HIV 治療和預防業務的基本需求驅動因素仍然存在,我們對今年下半年持樂觀態度。

  • We have an incredible core portfolio driven by HIV, and we're building a compelling set of opportunities as we continue on our journey.

    我們擁有由 HIV 驅動的令人難以置信的核心產品組合,並且在我們繼續前進的過程中,我們正在創造一系列引人注目的機會。

  • And lastly, I just want to thank all 12,000 of our colleagues who have demonstrated that they can continue to deliver for patients who need our medicines, both in our base business and more recently with remdesivir.

    最後,我只想感謝我們所有 12,000 名同事,他們已經證明他們可以繼續為需要我們藥物的患者提供服務,無論是在我們的基礎業務中,還是在最近的瑞德西韋中。

  • It's the first time in my career I've seen a company go from an investigational compound to a launch product serving hundreds of thousands of patients in a matter of months, but it just reinforces for me Gilead's history and commitment to patient-focused innovation.

    在我的職業生涯中,這是我第一次看到一家公司在幾個月內從研究化合物轉變為為數十萬患者提供服務的上市產品,但這對我來說只是強化了 Gilead 的歷史和對以患者為中心的創新的承諾。

  • I'm very proud to be part of this team.

    我很自豪能成為這個團隊的一員。

  • Merdad, I'll turn it over to you.

    Merdad,我會把它交給你。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Thanks, Johanna, and good afternoon, everyone.

    謝謝,約翰娜,大家下午好。

  • I'm excited to be here and share with you some of the perspectives in our pipeline that continues to both progress and to grow despite these challenging times.

    我很高興來到這裡並與大家分享我們管道中的一些觀點,儘管這些充滿挑戰的時期仍在繼續進步和發展。

  • As you've seen, our pipeline expansion continued during this period, driven by the strategy that Dan referenced earlier.

    如您所見,在此期間,我們的渠道擴張仍在繼續,這是由 Dan 之前提到的戰略推動的。

  • Of course, remdesivir is an important part of the story.

    當然,瑞德西韋是故事的重要組成部分。

  • And while managing the added responsibility of working as diligently as possible on remdesivir, we're also able to make great strides across the rest of the pipeline.

    在管理盡可能勤奮地研究 remdesivir 的額外責任的同時,我們也能夠在管道的其餘部分取得長足進步。

  • Let me share some of those highlights with you.

    讓我與您分享其中的一些亮點。

  • We look at the pipeline for 3 key things.

    我們查看 3 項關鍵內容的管道。

  • We'd like to see that the level of diversification across the different therapeutic areas is good, the balance across the phases of development and the quality of the assets we have in development, along with our associated risks.

    我們希望看到不同治療領域的多元化水平良好,發展階段之間的平衡和我們在開發中的資產質量,以及我們相關的風險。

  • That's where I'd like to turn now.

    這就是我現在要轉向的地方。

  • We continue to build in each of our therapeutic areas as reflected in other exciting set of clinical data readouts and presentations at scientific meetings during this quarter.

    正如本季度科學會議上其他令人興奮的臨床數據讀數和演示文稿所反映的那樣,我們繼續在我們的每個治療領域進行建設。

  • This includes data that further validate our belief in some of our key assets, including magrolimab, lenacapavir and, of course, remdesivir.

    這包括進一步證實我們對我們的一些關鍵資產的信念的數據,包括 magrolimab、lenacapavir,當然還有瑞德西韋。

  • Let me share a few specific highlights in each of our strategic areas.

    讓我分享我們每個戰略領域的一些具體亮點。

  • In HIV, we continue to make progress on the next chapter of our commitment to people living with HIV by working on a long-acting option.

    在 HIV 方面,我們通過研究長效方案,繼續在我們對 HIV 感染者的承諾的下一章取得進展。

  • Lenacapavir, our investigational capsid inhibitor, continues to show promise as a potential agent, both for long-acting treatment and for prevention.

    Lenacapavir 是我們在研的衣殼抑製劑,繼續顯示出作為潛在藥物的潛力,既可用於長效治療,也可用於預防。

  • The Phase II/III study that has continued to enroll during the pandemic, and we look forward to data from this trial for highly treatment-experienced people with HIV, who often have few of any other options.

    在大流行期間繼續招募的 II/III 期研究,我們期待從該試驗中獲得針對具有高度治療經驗的 HIV 感染者的數據,他們通常沒有其他選擇。

  • People living with HIV tell us that the most desirable long-acting regimens are either a weekly oral or in every 3- to 6-month subcutaneous injection, preferably that can be self-administered.

    HIV 感染者告訴我們,最理想的長效方案是每周口服一次或每 3 至 6 個月皮下注射一次,最好是可以自行給藥。

  • The profile of lenacapavir gives us the potential to achieve both of these options, and therefore, the potential to be a key therapeutic component for both treatment and prevention.

    lenacapavir 的特性使我們有可能實現這兩種選擇,因此有可能成為治療和預防的關鍵治療成分。

  • Now turning to remdesivir.

    現在轉向瑞德西韋。

  • A lot of the data have been generated over the past 6 months that all inform us about the profile of remdesivir.

    過去 6 個月產生的大量數據都告訴我們瑞德西韋的概況。

  • As Dan pointed out, the thing that stands out is a consistency across these data, and I'd like to take a step back and highlight a few key pieces of the story.

    正如 Dan 所指出的,突出的是這些數據之間的一致性,我想退後一步並強調故事的幾個關鍵部分。

  • One piece is that we see, that recovery time for patients in the hospital is short.

    一件事情是我們看到,醫院裡的病人康復時間很短。

  • Another is that the 5-day course of treatment is appropriate for those patients.

    另一個是 5 天的療程適合這些患者。

  • And finally, if the drug is generally well tolerated.

    最後,如果藥物普遍耐受良好。

  • We've now published data that demonstrate a benefit in mortality compared with standard of care using a comparative analysis of real-world data.

    我們現在已經發布了數據,通過對真實世界數據的比較分析,證明與標準護理相比,死亡率有所降低。

  • As you know, there was a trend towards benefit in mortality at day 14 in the NIAID study, and we now await the final day 28 data from that trial as well.

    如您所知,在 NIAID 研究中,第 14 天的死亡率有降低的趨勢,我們現在也在等待該試驗的第 28 天的最後數據。

  • We also continue to pursue other ways to expand the utility of remdesivir, including new formulations and exploring how combinations could be more effective.

    我們還繼續尋求其他方法來擴大瑞德西韋的效用,包括新配方和探索組合如何更有效。

  • We've begun a Phase I study on an inhaled version of remdesivir that uses commercially available nebulizers.

    我們已經開始對使用市售霧化器的吸入型瑞德西韋進行 I 期研究。

  • Beyond that, we're working on the feasibility of a dry powder formulation for inhalation and a subcutaneous formulation.

    除此之外,我們正在研究用於吸入的干粉製劑和皮下製劑的可行性。

  • We're also supporting several clinical trials exploring potential combinations.

    我們還支持多項探索潛在組合的臨床試驗。

  • In each of those studies, remdesivir is being used as a backbone standard-of-care agent.

    在每一項研究中,瑞德西韋都被用作主要的標準治療藥物。

  • We're really proud of the role remdesivir has played in this pandemic, and I couldn't be prouder of the team that's worked so hard on this.

    我們為瑞德西韋在這場大流行病中發揮的作用感到非常自豪,我為為此付出如此努力的團隊感到無比自豪。

  • As a reminder, Diana Brainard, who leads our virology team, is here with us today and she'll be happy to share additional insights during the Q&A.

    提醒一下,領導我們病毒學團隊的戴安娜·布雷納德 (Diana Brainard) 今天和我們在一起,她很樂意在問答環節分享更多見解。

  • Moving on to filgotinib.

    繼續使用 filgotinib。

  • We continue to believe that this selective JAK inhibitor has a potential to provide a new option for patients suffering from a variety of inflammatory diseases.

    我們仍然相信,這種選擇性 JAK 抑製劑有可能為患有多種炎症性疾病的患者提供一種新的選擇。

  • I'd like to update you on recent discussions with regulators on rheumatoid arthritis.

    我想向您通報最近與監管機構就類風濕性關節炎進行的討論。

  • In Europe, we are pleased to receive a positive CHMP opinion for the treatment of adults with moderate to severe rheumatoid arthritis.

    在歐洲,我們很高興收到 CHMP 對治療成人中度至重度類風濕性關節炎的積極意見。

  • The opinion includes both 100- and 200-milligram doses and indicates use is appropriate as monotherapy and in combination with methotrexate.

    該意見包括 100 毫克和 200 毫克的劑量,並指出作為單一療法和與甲氨蝶呤聯合使用是合適的。

  • As a reminder, anticipates a scientific recommendation to the European Commission to grant marketing authorization in Europe.

    作為提醒,預計將向歐盟委員會提出科學建議,以授予其在歐洲的上市許可。

  • We continue to have ongoing dialogue with the FDA.

    我們繼續與 FDA 進行對話。

  • We've been informed that there will not be an Advisory Committee meeting and the PDUFA date remains unchanged.

    我們已獲悉,不會召開諮詢委員會會議,PDUFA 日期保持不變。

  • Moving on to oncology.

    繼續腫瘤學。

  • We made strides during the quarter and throughout the first half of the year in advancing our pipeline and accelerating our efforts to build our portfolio and expertise in immuno-oncology with several key transactions.

    我們在本季度和整個上半年取得了長足進步,推進了我們的管道,並通過幾項關鍵交易加快了我們在免疫腫瘤學方面建立我們的產品組合和專業知識的努力。

  • First, we completed the acquisition of Forty Seven that we announced during the first quarter.

    首先,我們完成了第一季度宣布的對四十七的收購。

  • This brings magrolimab into our core pipeline as an investigating compound currently being developed for MDS and AML, as well as much of the impressive Forty Seven team who now complement our internal team.

    這將 magrolimab 作為目前正在為 MDS 和 AML 開發的研究化合物以及現在補充我們內部團隊的令人印象深刻的 47 團隊的大部分成員納入我們的核心管道。

  • We're also very excited about the Arcus partnership, which provides our ability to have [tailed retractions] that work both for us and our partners.

    我們也對 Arcus 合作夥伴關係感到非常興奮,它使我們有能力進行[尾部撤回],這對我們和我們的合作夥伴都有效。

  • This partnership brings us a potentially differentiated (inaudible) compound as well as investigational high PD-1 monoclonal antibody.

    這種合作關係為我們帶來了一種潛在的差異化(聽不清)化合物以及研究性高 PD-1 單克隆抗體。

  • We're also excited to work with the excellent experienced clinical team at Arcus for the development of these programs.

    我們也很高興能與 Arcus 經驗豐富的優秀臨床團隊合作開發這些項目。

  • This partnership gives assumption [access] on everything in their pipeline and allows the Arcus team to continue to pursue groundbreaking signs.

    這種夥伴關係為他們管道中的所有東西提供了假設[訪問],並允許 Arcus 團隊繼續追求突破性的跡象。

  • Tizona and Pionyr are deals that give us options targeting other immuno-oncology approaches.

    Tizona 和 Pionyr 是為我們提供針對其他免疫腫瘤學方法的選擇的交易。

  • And in each of these transactions, we have the option to acquire the entire company based on clinical data.

    在每筆交易中,我們都可以選擇根據臨床數據收購整個公司。

  • These new programs build on our existing partnerships and our internal pipeline.

    這些新計劃建立在我們現有的合作夥伴關係和我們的內部管道之上。

  • In cell therapy, we all congratulate Christi Shaw and our colleagues at Kite for the recent approval of Tecartus for relapsed/refractory MCL.

    在細胞治療方面,我們都祝賀 Christi Shaw 和我們在 Kite 的同事最近批准 Tecartus 用於復發/難治性 MCL。

  • Kite and Gilead are now the first companies to have multiple approved cell therapy products that will bring benefit to even more patients with difficult-to-treat cancers.

    Kite 和 Gilead 現在是第一批擁有多種獲批細胞治療產品的公司,這些產品將為更多難治性癌症患者帶來益處。

  • The Kite team also reached a major milestone with the successful approval and launch in June of the MCL manufacturing site with the end-to-end production that expands the ability to treat more patients.

    Kite 團隊也達到了一個重要的里程碑,MCL 製造基地於 6 月獲得成功批准並啟動,其端到端生產擴大了治療更多患者的能力。

  • Christi is with us here today and happy to share more thoughts during the Q&A.

    克里斯蒂今天和我們在一起,很高興在問答環節分享更多想法。

  • Materials we've provided.

    我們提供的材料。

  • We've shared a summary of important upcoming milestones across the pipeline.

    我們已經分享了整個管道即將到來的重要里程碑的摘要。

  • In closing, our senior R&D team continues to build with the addition of leaders in data science, clinical biomarkers, pharmacology, clinical operations, portfolio management, inflammation and oncology.

    最後,隨著數據科學、臨床生物標誌物、藥理學、臨床操作、投資組合管理、炎症和腫瘤學領域的領導者的加入,我們的高級研發團隊繼續建設。

  • All of these leaders bring added expertise to an already world-class team, and we're excited to have them join us.

    所有這些領導者都為這個已經世界一流的團隊帶來了更多的專業知識,我們很高興他們能加入我們。

  • Let me turn the call now over to Andy.

    現在讓我把電話轉給安迪。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Thanks, Merdad, and good afternoon, everyone.

    謝謝,Merdad,大家下午好。

  • I'd like to cover three topics to round out our commentary before turning to Q&A.

    在轉向問答之前,我想涵蓋三個主題來完善我們的評論。

  • First, I'll provide a summary of our financial highlights for the quarter and the first half of 2020.

    首先,我將概述我們 2020 年第二季度和上半年的財務亮點。

  • Second, I will provide some additional color on the potential implications of COVID on the second half of 2020 based on updated assumptions drawn from external experts and outside thinking.

    其次,我將根據外部專家和外部思考得出的最新假設,為 COVID 對 2020 年下半年的潛在影響提供一些額外的色彩。

  • Finally, I'd like to pull all this together and review our revised 2020 financial guidance.

    最後,我想把所有這些放在一起,回顧一下我們修訂後的 2020 年財務指南。

  • As a reminder, the earnings materials posted on our website contain additional information, including the details of our 2020 revised financial guidance.

    提醒一下,我們網站上發布的收益材料包含更多信息,包括我們 2020 年修訂後的財務指南的詳細信息。

  • Turning now to our financial highlights.

    現在轉向我們的財務亮點。

  • Total revenues for the second quarter were $5.1 billion with non-GAAP diluted earnings per share of $1.11.

    第二季度總收入為 51 億美元,非 GAAP 攤薄後每股收益為 1.11 美元。

  • As noted in the earnings press release on a GAAP basis, we recorded a diluted loss per share of $2.66, primarily due to a $4.5 billion in-process research and development charge related to our acquisition of Forty Seven.

    正如在 GAAP 基礎上的收益新聞稿中指出的那樣,我們錄得每股 2.66 美元的攤薄虧損,這主要是由於與我們收購四十七公司相關的 45 億美元的正在進行的研發費用。

  • This compares to revenue of $5.7 billion with non-GAAP diluted earnings per share of $1.72 for the same period last year.

    相比之下,去年同期非 GAAP 稀釋每股收益為 1.72 美元,收入為 57 億美元。

  • Product sales for the second quarter were $5.1 billion, down 7% sequentially and down 10% year-over-year.

    第二季度產品銷售額為 51 億美元,環比下降 7%,同比下降 10%。

  • As anticipated, the second quarter product revenues were unfavorably impacted by COVID-19.

    正如預期的那樣,第二季度產品收入受到 COVID-19 的不利影響。

  • The year-over-year quarterly decline was also impacted by approximately $160 million of favorable adjustments recorded in the second quarter of 2019 for statutory rebates, primarily to HCV and HIV prior year sales in Europe.

    同比季度下降還受到 2019 年第二季度記錄的約 1.6 億美元的法定退稅有利調整的影響,主要是針對歐洲上一年的 HCV 和 HIV 銷售額。

  • This decline was partially offset by HIV growth driven by Biktarvy in the United States.

    這種下降部分被美國 Biktarvy 推動的 HIV 增長所抵消。

  • As Johanna mentioned, the quarter-over-quarter decreases in HIV revenues was primarily driven by the reversal of the Q1 increased buying patterns due to the pandemic as well as lower U.S. PrEP demand and unfavorable U.S. payer mix.

    正如 Johanna 所提到的,HIV 收入環比下降的主要原因是第一季度因大流行而增加的購買模式發生逆轉,以及美國 PrEP 需求下降和不利的美國付款人組合。

  • Sequentially, the decrease was partially offset by treatment growth and seasonable higher net price in the U.S. and inventory patterns.

    隨後,這一下降被治療增長和美國季節性較高的淨價以及庫存模式部分抵消。

  • The decrease in HCV revenues sequentially and year-over-year primarily reflects lower volume due to lower diagnoses and patient starts due to the pandemic.

    HCV 收入環比和同比下降主要反映了由於大流行導致的診斷和患者開始減少導致的銷量下降。

  • Yescarta revenues grew sequentially and year-over-year, primarily driven by the continued patient uptake in Europe.

    Yescarta 的收入環比和同比增長,主要是受歐洲患者持續增長的推動。

  • Overall product sales for the first half of the year were $10.5 billion compared to our $10.8 billion for 2019.

    與我們 2019 年的 108 億美元相比,今年上半年的整體產品銷售額為 105 億美元。

  • And excluding recent LOE products, Ranexa and Letairis, our business grew year-over-year despite the impact of the pandemic.

    除了最近的 LOE 產品 Ranexa 和 Letairis 之外,儘管受到大流行的影響,我們的業務仍同比增長。

  • If we compare the first half of 2020 versus the same time period in 2019, the HIV inventory dynamics associated with COVID-19 are normalized and our first half results demonstrate strong underlying HIV demand growth, with the business up 6% over 2019.

    如果我們將 2020 年上半年與 2019 年同期進行比較,與 COVID-19 相關的 HIV 庫存動態正常化,我們上半年的結果表明潛在的 HIV 需求增長強勁,業務比 2019 年增長 6%。

  • This reflects a strong and encouraging start to the year in our core HIV franchise despite the impact of COVID-19.

    儘管受到 COVID-19 的影響,這反映出我們的核心 HIV 專營權今年開局強勁且令人鼓舞。

  • You can find more information, including the geographic breakdown of revenues, in the materials we have posted.

    您可以在我們發布的材料中找到更多信息,包括收入的地理細分。

  • Now turning to expenses.

    現在轉向費用。

  • Non-GAAP R&D expense was $1.2 billion for the quarter, up 19% compared to the same period last year and up 18% sequentially, primarily due to our investment in remdesivir, including clinical trials and manufacturing scale-up costs.

    本季度非 GAAP 研發費用為 12 億美元,與去年同期相比增長 19%,環比增長 18%,這主要是由於我們對瑞德西韋的投資,包括臨床試驗和生產規模擴大成本。

  • Non-GAAP SG&A expense was $1.2 billion, up 6% compared to the same period last year and up 8% sequentially, primarily due to a $97 million accrual related to a previously disclosed Department of Justice investigation.

    非 GAAP SG&A 費用為 12 億美元,與去年同期相比增長 6%,環比增長 8%,這主要是由於與先前披露的司法部調查相關的 9700 萬美元應計費用。

  • From a liquidity standpoint, we continue to be very well positioned.

    從流動性的角度來看,我們仍然處於非常有利的地位。

  • During the quarter, we generated $2.6 billion in cash from operations, and we ended the quarter with $21.2 billion in cash and marketable debt securities.

    本季度,我們從運營中產生了 26 億美元的現金,本季度末我們擁有 212 億美元的現金和有價債務證券。

  • We completed our acquisition of Forty Seven this quarter for $4.7 billion, net of cash acquired.

    我們在本季度以 47 億美元(扣除收購的現金)完成了對四十七的收購。

  • We paid cash dividends of $856 million, and we repurchased 700,000 shares of stock for $54 million.

    我們支付了 8.56 億美元的現金股息,並以 5400 萬美元回購了 700,000 股股票。

  • Our strong balance sheet and investment portfolio are built to withstand macroeconomic events like COVID-19, and our capital allocation priorities remain unchanged.

    我們強大的資產負債表和投資組合旨在抵禦 COVID-19 等宏觀經濟事件,我們的資本配置優先順序保持不變。

  • We will continue to focus on investment to augment internal and external innovation in support of continued pipeline expansion.

    我們將繼續專注於投資,以加強內部和外部創新,以支持持續的管道擴張。

  • In addition, we intend to support and grow our dividend over time, provided that any dividend increase is, of course, subject to approval from our Board.

    此外,我們打算隨著時間的推移支持和增加我們的股息,前提是任何股息增加當然需要得到我們董事會的批准。

  • Finally, as it relates to repurchase of shares in 2020, we're on track relative to the directional guidance we provided in our fourth quarter 2019 and year-end earnings call in February.

    最後,由於涉及到 2020 年的股票回購,相對於我們在 2019 年第四季度和 2 月份的年終財報電話會議上提供的方向性指導,我們正在走上正軌。

  • Turning now to the COVID-19 impact on our revised guidance.

    現在談談 COVID-19 對我們修訂指南的影響。

  • Importantly, as you heard earlier in the call, the fundamentals and durability of our long-term outlook remain very strong.

    重要的是,正如您早些時候在電話會議中聽到的那樣,我們長期前景的基本面和持久性仍然非常強勁。

  • We expect that our core business will gradually recover starting in Q3, following peak pandemic impact on underlying treatment initiations and switch dynamics that we observed in the second quarter.

    我們預計,在我們在第二季度觀察到的大流行對基礎治療啟動和開關動態的影響達到峰值之後,我們的核心業務將從第三季度開始逐漸恢復。

  • We continue to expect minimal impact on our HIV treatment business over time with maintenance of high market share.

    隨著時間的推移,我們繼續期望在保持高市場份額的情況下對我們的 HIV 治療業務的影響最小。

  • In HCV, we expect patient starts to regain momentum in the third quarter and beyond.

    在 HCV 方面,我們預計患者在第三季度及以後開始恢復勢頭。

  • In addition, since our first quarter earnings call, we have established global pricing for remdesivir, and we have refined our expectation for remdesivir for the year.

    此外,自我們第一季度財報電話會議以來,我們已經確定了瑞德西韋的全球定價,並且我們改進了對瑞德西韋今年的預期。

  • As you would expect, there are still many uncertainties concerning the shape and duration of the recovery in the second half of the year as well as the availability and uptake of remdesivir.

    正如您所預料的那樣,關於下半年復甦的形式和持續時間以及瑞德西韋的可用性和使用情況,仍然存在許多不確定性。

  • With that as context, let me summarize the details of our revised full year guidance.

    以此為背景,讓我總結一下我們修訂後的全年指導的細節。

  • Our revised top line revenue range, including expected sales of remdesivir in 2020 is USD 23 billion to USD 25 billion.

    我們修改後的收入範圍(包括瑞德西韋在 2020 年的預期銷售額)為 230 億美元至 250 億美元。

  • We're increasing our 2020 R&D and SG&A expense expectations.

    我們正在提高 2020 年研發和 SG&A 費用預期。

  • Our guidance on expected product gross margin and effective tax rate for 2020 remained unchanged.

    我們對 2020 年預期產品毛利率和有效稅率的指引保持不變。

  • Our updated operating income range is $10.7 billion to $13 billion.

    我們更新後的營業收入範圍為 107 億美元至 130 億美元。

  • And finally, our updated non-GAAP EPS range is $6.25 to $7.65.

    最後,我們更新後的非 GAAP 每股收益範圍為 6.25 美元至 7.65 美元。

  • I'd like to highlight a few additional points that will give you more color on the assumptions that drove this updated guidance.

    我想強調一些額外的要點,這些要點將使您對推動此更新指南的假設有更多的了解。

  • On the expense side, R&D and SG&A guidance increased to reflect expected expenses for remdesivir, Forty Seven and the litigation accrual that I mentioned earlier.

    在費用方面,研發和 SG&A 指導有所增加,以反映我之前提到的 remdesivir、47 和訴訟應計費用的預期費用。

  • On remdesivir, as we've previously stated, we expect to manufacture 2 million or more treatment courses cumulatively in 2020.

    關於瑞德西韋,正如我們之前所說,我們預計到 2020 年將累計生產 200 萬個或更多療程。

  • Our revenue guidance reflects that we expect to sell 1 million to 1.5 million treatment courses of remdesivir this year.

    我們的收入指引反映出我們預計今年將銷售 100 萬至 150 萬個瑞德西韋療程。

  • We expect that remdesivir demand will be skewed towards the U.S. in the third quarter and that the proportion of ex U.S. sales will increase in the fourth quarter and beyond.

    我們預計瑞德西韋的需求將在第三季度偏向美國,而美國以外的銷售額比例將在第四季度及以後增加。

  • That said, the progression of the pandemic, the global economic backdrop, our supply expectations, the potential uptake of remdesivir in related matters continue to be dynamic and uncertain.

    儘管如此,大流行病的進展、全球經濟背景、我們的供應預期、瑞德西韋在相關問題上的潛在應用仍然是動態的和不確定的。

  • We expect to learn more over the coming months, and we'll update you on our latest thinking on our Q3 earnings call.

    我們希望在未來幾個月了解更多信息,我們將向您介紹我們對第三季度財報電話會議的最新想法。

  • Before I hand the call off for Q&A, I'd like to express my gratitude as well to our 12,000 Gilead employees globally.

    在我結束問答環節之前,我還要向全球 12,000 名吉利德員工表示感謝。

  • Without their spirit, dedication and resilience, nothing we strive to achieve for patients would be possible.

    沒有他們的精神、奉獻精神和堅韌不拔的精神,我們就不可能為患者努力實現任何目標。

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

    現在我想打開問題電話。

  • Liz?

    麗茲?

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from Tyler Van Buren with Piper Sandler.

    (操作員說明)我們的第一個問題來自 Tyler Van Buren 和 Piper Sandler。

  • Tyler Martin Van Buren - Principal & Senior Biotech Analyst

    Tyler Martin Van Buren - Principal & Senior Biotech Analyst

  • I guess with respect to the HCV and HIV share increases that you saw during the pandemic, you talked about coming out of the pandemic stronger.

    我想關於您在大流行期間看到的 HCV 和 HIV 份額的增加,您談到了從大流行中走出來更強大。

  • So could you just provide a little bit more color on that?

    那麼你能不能在上面提供更多的顏色?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Sure, Tyler.

    當然,泰勒。

  • I'll turn it right over to Johanna.

    我會把它轉交給約翰娜。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Okay.

    好的。

  • Thanks, Tyler.

    謝謝,泰勒。

  • Yes.

    是的。

  • So for example, in HIV, when you think about Biktarvy and Descovy, which is our 2 lead brands both for treatment and prevention, Biktarvy grew share.

    因此,例如,在 HIV 領域,當你想到 Biktarvy 和 Descovy,這是我們用於治療和預防的兩個主要品牌時,Biktarvy 的份額增加了。

  • So it's been growing here year-on-year but even quarter-over-quarter.

    因此,它在這裡逐年增長,甚至環比增長。

  • So we grew share to 33% in Q2 for Biktarvy.

    因此,我們在第二季度將 Biktarvy 的份額增加到 33%。

  • And then when you think about on a very large basis, you can appreciate, so that's about a -- just about a 1% share increase.

    然後當你在一個非常大的基礎上考慮時,你會欣賞,所以這大約是 - 大約 1% 的份額增長。

  • And then when you think about Descovy, we were -- we closed the quarter Q1 at about 37% here in the PrEP market, and we ended up at the end of June at 43%.

    然後當你想到 Descovy 時,我們 - 我們在 PrEP 市場的第一季度結束時約為 37%,我們在 6 月底以 43% 結束。

  • So I do think that despite some of the dynamics because of COVID-19 and some of the decrease in patient visits and screening, I still do think that the brands are solid because of their portfolio, because of what they offer for patients.

    因此,我確實認為,儘管 COVID-19 帶來了一些動態,並且患者就診和篩查有所減少,但我仍然認為這些品牌是可靠的,因為它們的產品組合,因為它們為患者提供的服務。

  • And one of the things, both of those brands are actually brands that in a COVID-19 environment are actually probably the best choice for patients.

    其中一件事,這兩個品牌實際上都是在 COVID-19 環境中實際上可能是患者最佳選擇的品牌。

  • Because if you think about Biktarvy and you think about no monitoring, no HLA testing, et cetera, those are really -- the rapid start with Biktarvy is critical for patients.

    因為如果你想到 Biktarvy 並且你想到沒有監測,沒有 HLA 測試等等,那麼那些真的 - Biktarvy 的快速啟動對患者來說是至關重要的。

  • And I think that that's also helping to support Biktarvy throughout this transition with the pandemic.

    而且我認為這也有助於在大流行病的整個過渡期間支持 Biktarvy。

  • Tyler Martin Van Buren - Principal & Senior Biotech Analyst

    Tyler Martin Van Buren - Principal & Senior Biotech Analyst

  • And just as a quick follow-up.

    就像快速跟進一樣。

  • With respect to the Biktarvy share gains, are those share gains or switches?

    關於 Biktarvy 的份額收益,這些份額收益還是轉換?

  • Are they different during the pandemic as they were prior to the pandemic?

    它們在大流行期間和大流行之前有什麼不同嗎?

  • Are they coming from -- is the regimens that they're taking share changed at all?

    他們是否來自——他們分享的養生法是否完全改變了?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Yes.

    是的。

  • The sourcing of business is actually about the same.

    業務的採購實際上是差不多的。

  • The only difference I would say is our -- the switch in treatment is obviously a little bit slower than what we've seen in the past just because physicians don't want to switch.

    我要說的唯一區別是我們——治療的轉變顯然比我們過去看到的要慢一點,因為醫生不想轉變。

  • There's actually guidelines that suggest no switching during the pandemic from drug to drug.

    實際上有指導方針建議在大流行期間不要從一種藥物切換到另一種藥物。

  • So it's more the naïve patient population that's feeding Biktarvy right now versus the switch population, and older compounds are keeping share.

    因此,現在餵養 Biktarvy 的是天真的患者群體,而不是轉換人群,而較老的化合物正在保持份額。

  • So since Gilead has about 75% within HIV, basically, what you're seeing is some of our older brands are keeping higher share versus then switching over to newer compounds like Biktarvy.

    因此,由於吉利德(Gilead)在 HIV 中有大約 75%,基本上,你所看到的是我們的一些老品牌保持著更高的份額,而不是轉向像 Biktarvy 這樣的新化合物。

  • Operator

    Operator

  • Our next question comes from Geoffrey Porges with SVB Leerink.

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

  • 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

  • So maybe a couple of questions on remdesivir.

    所以也許有幾個關於瑞德西韋的問題。

  • Andy, you indicated, I think you're going to sell 1 million to 1.5 million courses, but it sounds as though you're supplying 0.5 million courses just in Q3.

    安迪,你表示,我認為你將銷售 100 萬到 150 萬門課程,但聽起來你僅在第三季度就提供了 50 萬門課程。

  • So could you give us a sense of what your upside capacity is given the capacity initiatives that you have in place for the year?

    那麼,鑑於您今年實施的產能計劃,您能否讓我們了解一下您的上行能力?

  • And secondly, how you see the demand beyond those 500,000 courses in Q3, are you on an allocated basis already in Q4?

    其次,您如何看待第三季度超過 500,000 門課程的需求,您是否已經在第四季度進行了分配?

  • Or is there some uncertainty about the demand?

    還是需求存在一些不確定性?

  • And then could you just give us a sense of how you've incorporated that into your guidance?

    然後你能告訴我們你是如何將其納入你的指南的嗎?

  • There must be there's a huge range in your operating income.

    你的營業收入肯定有很大的範圍。

  • So I presume that's being driven by remdesivir.

    所以我認為這是由瑞德西韋驅動的。

  • But could you kind of give us more color on that?

    但是你能給我們更多的顏色嗎?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Andy, do you want...

    安迪,你要...

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Maybe I'll start with one final point and ask Johanna.

    也許我會從最後一點開始,然後問約翰娜。

  • Oh, go ahead, Dan.

    哦,繼續,丹。

  • I'm sorry.

    對不起。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Perfect.

    完美的。

  • No, that's great.

    不,那太好了。

  • Thank you.

    謝謝。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Maybe I'll ask Johanna to comment on the upside of the supply and the demand in Q3 and Q4.

    也許我會請 Johanna 對第三季度和第四季度的供應和需求的上行發表評論。

  • The -- there is a wide range, and it is driven by our remdesivir expectations.

    範圍很廣,這是由我們對 remdesivir 的期望驅動的。

  • So Johanna mentioned we're learning more week by week.

    所以 Johanna 提到我們每週都在學習更多。

  • We just started commercializing recently.

    我們最近才開始商業化。

  • So we do expect that we'll be able to narrow our thinking and give you an update on the -- in the third quarter, Geoff, as you would expect.

    因此,我們確實希望我們能夠縮小我們的思路,並在第三季度為您提供最新情況,傑夫,正如您所期望的那樣。

  • Johanna, do you want to touch base on the supply-and-demand question?

    約翰娜,你想談談供需問題嗎?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure.

    當然。

  • Yes, sure.

    是的,當然。

  • So I'll maybe just add to what Andy was saying for Q4 specifically.

    所以我可能會專門補充一下安迪對第四季度所說的話。

  • I think the uncertainties are multiple, and it's not just -- our supply actually is less of an uncertainty because I think we have a pretty good idea and the ramp-up has been impressive.

    我認為不確定性是多方面的,不僅僅是——我們的供應實際上沒有那麼多不確定性,因為我認為我們有一個很好的主意,而且增長令人印象深刻。

  • The team has done an incredible job ramping up, and you really see that ramp-up come through in Q4.

    該團隊完成了令人難以置信的提升工作,你真的看到了第四季度的提升。

  • We feel that, and I think Dan mentioned this, we feel that by early October, we should be in a place, assuming somewhat, I don't know if stable is the right word, but some stability within this pandemic globally across the numbers, we should be in a situation where global supply meets global demand, and that's a great place to be in.

    我們覺得,我想 Dan 提到過這一點,我們覺得到 10 月初,我們應該處於一個位置,我不知道穩定這個詞是否合適,但在全球範圍內,這種流行病在數字上有些穩定,我們應該處於全球供應滿足全球需求的情況,這是一個很好的地方。

  • We can't wait because it's been challenging thus far.

    我們等不及了,因為到目前為止它一直充滿挑戰。

  • The -- in Q4, the uncertainties are more around the pandemic itself and not really understanding does it stabilize, does it come to an all-time low, like we've seen in Europe, we really don't know.

    --在第四季度,不確定性更多地圍繞著大流行本身,並沒有真正了解它是否穩定下來,是否達到歷史最低點,就像我們在歐洲看到的那樣,我們真的不知道。

  • And so that's why it's a little bit tougher to manage on that front.

    這就是為什麼在這方面管理起來有點困難。

  • As mentioned before from a supply standpoint, by the end of December of this year, we should be in a position to have cumulatively of over 2 million treatment courses.

    前面講過,從供給上講,到今年12月底,我們應該能夠累計超過200萬個療程。

  • And some of those, obviously, were used during the donation and some are being used in Q3.

    顯然,其中一些是在捐贈期間使用的,還有一些是在第三季度使用的。

  • So the balance of that will be in play for Q4, and we're just working with all the different governments, not just the U.S. but governments around the world, to better understand what they think their real-time need is, and that's really our focus right now, is the real-time need.

    因此,第四季度將發揮平衡,我們正在與所有不同的政府合作,不僅是美國,還有世界各地的政府,以更好地了解他們認為他們的實時需求是什麼,這真的我們現在的重點是實時需求。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Geoff, and we'll update you and everybody else in quarter 3, obviously.

    Geoff,很明顯,我們會在第 3 季度向您和其他所有人通報最新情況。

  • So this is our best estimate at this stage.

    所以這是我們現階段的最佳估計。

  • Operator

    Operator

  • Our next question comes from Michael Yee with Jefferies.

    我們的下一個問題來自 Jefferies 的 Michael Yee。

  • Michael Jonathan Yee - Equity Analyst

    Michael Jonathan Yee - Equity Analyst

  • Following up on remdesivir, 2 questions.

    跟進瑞德西韋,2 個問題。

  • One is maybe you can make a comment about thinking about the actual demand and sales that you've actually done versus actually utilization.

    一個是也許你可以對你實際完成的實際需求和銷售與實際利用率的思考發表評論。

  • We've done some math around actual utilization and it sounds like a lot of this could actually be a former stockpiling.

    我們對實際利用率做了一些計算,聽起來其中很多實際上可能是以前的儲備。

  • So maybe you could just comment on that type of dynamic.

    所以也許你可以只評論那種類型的動態。

  • That would help us think about future use.

    這將有助於我們考慮未來的用途。

  • And then the second is just looking forward even a little bit, you've made some comments about injectable and inhaled.

    然後第二個只是期待一點點,你已經對注射劑和吸入劑發表了一些評論。

  • Is this just a PK question?

    這只是一個PK問題嗎?

  • What do you have to look for in Phase I data?

    您需要在第一階段數據中尋找什麼?

  • And what are the challenges?

    挑戰是什麼?

  • And would you have this data and know this by, say, fourth quarter?

    您是否會在第四季度之前獲得這些數據並知道這一點?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Sure.

    當然。

  • I'll start.

    我會開始。

  • And then Johanna, you add and then we'll go to Merdad on the injectable.

    然後 Johanna,你補充說,然後我們將去 Merdad 注射劑。

  • So first of all, Michael, I think, really, the vast majority of the remdesivir that we have today is being used.

    所以首先,邁克爾,我認為,實際上,我們今天擁有的絕大多數瑞德西韋都在使用。

  • The allocation process with the U.S. government has gotten better over time, and they really are allocating basically at least twice a month, sometimes more frequently to where the hotspots are in the United States, and that's the vast majority of the supply.

    隨著時間的推移,與美國政府的分配過程變得越來越好,他們基本上每月至少分配兩次,有時更頻繁地分配到美國的熱點地區,這是供應的絕大部分。

  • So we think there's probably very little demand that is not being utilized at this stage.

    所以我們認為在這個階段可能很少有未被利用的需求。

  • Of course, it's not completely efficient, and there are some pockets where you might have some hospitals that have more remdesivir than patients.

    當然,它並不是完全有效,而且在某些地方,有些醫院的瑞德西韋可能比患者多。

  • But right now, given the tremendous human need in the United States, in particular, and a variety of other countries we're working with, we're really just working on the real-time demand right now.

    但現在,考慮到美國的巨大人類需求,特別是我們正在與之合作的其他各種國家,我們現在真的只是在處理實時需求。

  • So that's being utilized.

    所以它正在被利用。

  • Johanna, do you have anything else you want to add to that?

    約翰娜,你還有什麼要補充的嗎?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Yes.

    是的。

  • Maybe, Dan, just to add to that, Michael, I would just add the fact that it's also based on incidents in epidemiology.

    也許,Dan,補充一點,Michael,我只想補充一個事實,它也是基於流行病學事件。

  • Everything we are doing, working with the U.S. government, working with ex U.S. governments as well, governments around the world, it's really based on the incidents.

    我們所做的一切,與美國政府合作,與前美國政府以及世界各國政府合作,都是基於這些事件。

  • And what we've seen so far is that because of the way we're managing it with the HHS, a lot -- some hospitals have actually said, "No, thank you.

    到目前為止,我們所看到的是,由於我們與 HHS 的管理方式,很多 - 一些醫院實際上已經說,“不,謝謝。

  • Give it to somebody who needs it.

    把它送給需要它的人。

  • We don't need it right now." So I do think that people are coming together to work through this, understanding that there is a shortage of supply and understanding that it really needs to go to patients in need.

    我們現在不需要它。”所以我確實認為人們正在齊心協力解決這個問題,了解供應短缺並了解確實需要將其提供給有需要的患者。

  • And the worst thing that could ever happen is products sitting idle somewhere.

    可能發生的最糟糕的事情是產品閒置在某個地方。

  • So we're being very, very careful to make sure that doesn't happen anywhere in the world.

    所以我們非常非常小心,以確保這種情況不會在世界任何地方發生。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • I think the earliest is October, Michael, that we would start to see actual demand and utilization perhaps be different and perhaps the opportunity for stockpiling, but not before October.

    我認為最早是 10 月,邁克爾,我們將開始看到實際需求和利用率可能有所不同,也許還有儲存的機會,但不會在 10 月之前。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Yes.

    是的。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Merdad, over to you on Michael's question.

    Merdad,關於 Michael 的問題交給你了。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Yes, yes.

    是的是的。

  • So what I'd say is, as I mentioned, we're working on both the inhaled and the subcu.

    所以我要說的是,正如我所提到的,我們正在研究吸入和 subcu。

  • The inhaled's ahead and is, as I mentioned, in Phase I right now in the dose-escalation phase.

    正如我提到的,吸入療法處於領先地位,目前處於劑量遞增階段的第一階段。

  • Our -- the hypothesis here is that the virus in many patients, especially earliest, is primarily in the lung.

    我們的 - 這裡的假設是,許多患者的病毒,尤其是最早的患者,主要存在於肺部。

  • And so the question is for a patient, can we treat an outpatient with an inhaled [version] or potentially even an inpatient.

    所以問題是針對患者的,我們可以用吸入 [版本] 治療門診患者,甚至可能是住院患者。

  • The inhaled version gets where it needs to be, the narrowing in the lung, and whether that would have a benefit for those patients.

    吸入版本達到了它需要的位置,肺部變窄,以及這是否會對這些患者有益。

  • So that's the extent we're going to be running with the inhaled version.

    這就是我們將使用吸入版本運行的範圍。

  • As far as subcutaneous, we'll continue to work on that.

    至於皮下,我們將繼續努力。

  • That currently is not in the clinic.

    目前不在診所。

  • And as I mentioned, we're looking at feasibility and other parameters of bringing that online.

    正如我提到的,我們正在研究將其上線的可行性和其他參數。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Michael, all good?

    邁克爾,一切都好嗎?

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Our next question comes from Terence Flynn with Goldman Sachs.

    我們的下一個問題來自高盛的特倫斯弗林。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • Thank you for all the work on the COVID front.

    感謝您在 COVID 戰線所做的所有工作。

  • Was wondering, first, just on the financials, if you could try to quantify the impact from COVID on a dollar basis that you saw in the quarter?

    想知道,首先,僅在財務方面,您是否可以嘗試以您在本季度看到的美元為基礎量化 COVID 的影響?

  • And then was wondering, as you think about capsid, obviously, important long-term opportunity for you guys.

    然後想知道,當你想到衣殼時,顯然,對你們來說是重要的長期機會。

  • Just conceptually, are you focused on finding a partner for that internally to continue to dominate the market in terms of share?

    從概念上講,您是否專注於在內部尋找合作夥伴以繼續在市場份額方面佔據主導地位?

  • Or are you open to looking for an external partner?

    或者您願意尋找外部合作夥伴嗎?

  • And as a result, splitting the economics on the future market?

    結果,在未來市場上分裂經濟?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Great.

    偉大的。

  • So why don't, Andy, you take the financials, and we'll have Diana take the capsid question.

    那麼為什麼不呢,安迪,你負責財務,我們會讓戴安娜負責衣殼問題。

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • Yes.

    是的。

  • Thanks, Dan.

    謝謝,丹。

  • And Terence, thanks for the question.

    特倫斯,謝謝你的提問。

  • As you know, we don't provide specific -- we didn't provide a specific guidance in terms of the COVID impact.

    如您所知,我們沒有提供具體的——我們沒有提供有關 COVID 影響的具體指導。

  • I would say, at a high level, it impacted our business exactly in the way that we expected, so it hit predominantly, as you heard from Johanna, in the HCV treatment and the HIV PrEP business.

    我會說,在高層次上,它完全按照我們預期的方式影響了我們的業務,所以正如你從 Johanna 那裡聽到的那樣,它主要影響了 HCV 治療和 HIV PrEP 業務。

  • The impact was substantially less than $0.5 billion on our top line revenue in the first half.

    上半年對我們的收入的影響遠低於 5 億美元。

  • So rather than thinking about it on a quarterly basis, Terence, I think it's easier to think about it on the first half basis as you've heard from other companies as well, given the pull forward of inventory at the end of the first quarter.

    因此,與其按季度考慮,特倫斯,我認為考慮到第一季度末庫存的提前,正如你從其他公司那裡聽到的那樣,考慮上半年更容易.

  • Hopefully, that's helpful.

    希望這會有所幫助。

  • Diana Brainard - SVP of HIV & Emerging Viral Infections

    Diana Brainard - SVP of HIV & Emerging Viral Infections

  • Great.

    偉大的。

  • And I can speak to our capsid inhibitor and our vision of our long-acting HIV franchise.

    我可以談談我們的衣殼抑製劑和我們對長效 HIV 專營權的願景。

  • And there, what I would say is we're looking at our past success and it's really been driven by focusing on trying to meet the needs of patients and doing that agnostic to where we come up with the compounds of the regimen.

    在那裡,我要說的是,我們正在審視過去的成功,它的真正推動力是專注於努力滿足患者的需求,並對我們提出該方案化合物的地方採取不可知論的態度。

  • So in the past, that's been through acquisitions.

    所以在過去,這是通過收購來實現的。

  • It's been through partnerships.

    這是通過合作夥伴關係。

  • And it's, of course, been through internal discovery.

    當然,這是通過內部發現實現的。

  • And we really do have unparalleled excellence in terms of our internal discovery, and we're doing a lot of work there to try to find a partner for capsid, but we're also open and always looking externally as well with the idea that we will be successful if we create the best regimen for patients.

    就我們的內部發現而言,我們確實擁有無與倫比的卓越,我們在那裡做了大量工作,試圖為 capsid 尋找合作夥伴,但我們也持開放態度,並且始終在外部尋找我們的想法如果我們為患者創造最好的治療方案,我們就會成功。

  • Operator

    Operator

  • Our next question comes from Brian Abrahams with RBC Capital Markets.

    我們的下一個問題來自 RBC Capital Markets 的 Brian Abrahams。

  • Brian Corey Abrahams - Senior Biotechnology Analyst

    Brian Corey Abrahams - Senior Biotechnology Analyst

  • Question on filgotinib.

    關於 filgotinib 的問題。

  • With the PDUFA upcoming and the current state of the pandemic, I'm curious, your latest thoughts on launch approach and potential for differentiation through the label or otherwise, how that shapes your commercial strategy.

    隨著 PDUFA 即將到來和大流行的現狀,我很好奇,您對發布方法的最新想法以及通過標籤或其他方式實現差異化的潛力,這將如何影響您的商業戰略。

  • And then I'm also wondering if there's any reason why the CHMP recommendations on dosing and indication wouldn't necessarily be illustrative of global positioning for the product.

    然後我還想知道是否有任何理由說明 CHMP 關於劑量和適應症的建議不一定能說明該產品的全球定位。

  • Do you think FDA and EMA are still looking at the JAK benefit/risk profiles differently?

    您是否認為 FDA 和 EMA 仍然以不同的方式看待 JAK 的益處/風險概況?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks.

    謝謝。

  • Maybe I can start...

    也許我可以開始...

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Yes.

    是的。

  • Go ahead, Johanna.

    去吧,約翰娜。

  • Why don't you start and if Merdad wants to add anything as well.

    你為什麼不開始,如果 Merdad 也想添加任何內容。

  • But go ahead, please.

    但是,請繼續。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Okay.

    好的。

  • Thanks, Brian, for the question.

    謝謝布賴恩提出這個問題。

  • So yes, so obviously, pleased with the recent positive CHMP opinion, and we are working -- we've been working diligently with the teams around the world to prepare for launch with filgotinib.

    所以,是的,很明顯,對最近 CHMP 的積極意見感到高興,我們正在努力——我們一直在與世界各地的團隊努力合作,為 filgotinib 的上市做準備。

  • We are looking at the COVID situation.

    我們正在研究 COVID 情況。

  • And in assessing the situation, to be honest with you, maybe a couple of months back, we were thinking virtual, not virtual.

    在評估情況時,說實話,也許幾個月前,我們在考慮虛擬,而不是虛擬。

  • But I think in light of kind of what -- where we're seeing the dynamics of the market, I think virtual is the way to go.

    但我認為,鑑於我們看到的市場動態,我認為虛擬是可行的方法。

  • And so we're looking at how we do this and the best approach.

    因此,我們正在研究如何做到這一點以及最佳方法。

  • So more to come on that front, a lot of work going on to make sure that we do this as competitively as possible.

    因此,在這方面還有更多工作要做,正在進行大量工作以確保我們盡可能有競爭力地做到這一點。

  • The -- from a differentiation standpoint, it's in line with what we've talked about before.

    - 從差異化的角度來看,它符合我們之前談到的內容。

  • We believe in the profile of filgotinib and the differentiation that it offers.

    我們相信 filgotinib 的概況及其提供的差異化。

  • And so therefore, that's really an opportunity medically to make sure that through our medical teams that conversation, that education, happens with physicians.

    因此,這在醫學上確實是一個機會,可以確保通過我們的醫療團隊與醫生進行對話、教育。

  • Merdad, do you want to comment on the regulatory piece?

    Merdad,你想對監管部分發表評論嗎?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • I think Merdad is -- he's having a bit of an audio issue.

    我認為 Merdad 是——他有一點音頻問題。

  • So I'll feed in here, Brian.

    所以我會在這裡餵食,布賴恩。

  • So I think it's kind of premature to anticipate exactly what's going to happen in different regulatory authorities around the world.

    因此,我認為現在準確預測世界各地不同監管機構將要發生的事情還為時過早。

  • We continue to have discussions with all regulatory authorities.

    我們繼續與所有監管機構進行討論。

  • Obviously, Europe was the first one out of the gate and we're pleased with that.

    顯然,歐洲是第一個走出大門的人,我們對此感到滿意。

  • And as soon as we have some additional information, we'll let you know.

    一旦我們有更多信息,我們就會通知您。

  • But it's difficult to speculate.

    但很難推測。

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Our next question comes from Alethia Young with Cantor Fitzgerald.

    我們的下一個問題來自 Alethia Young 和 Cantor Fitzgerald。

  • Alethia Rene Young - Head of Healthcare Research

    Alethia Rene Young - Head of Healthcare Research

  • Congrats on everything that you guys have been doing here.

    祝賀你們在這裡所做的一切。

  • It's incredible.

    太不可思議了。

  • I guess I just wanted you to kind of maybe talk big picture about like, of course, there's remdesivir, which could have some earlier kind of utility beyond in the treatment cycle.

    我想我只是想讓你談談大局,當然,還有瑞德西韋,它可能在治療週期之外有一些早期的效用。

  • But just where we are with vaccines as well and kind of how you think about the position you get from remdesivir maybe perhaps over the next couple of years, even though I know I'm asking to look at a crystal ball.

    但我們在疫苗方面的進展以及你如何看待你從 remdesivir 獲得的地位可能在未來幾年內,儘管我知道我要求看一個水晶球。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • You're a great cheerleader for us.

    你是我們偉大的啦啦隊隊長。

  • Thank you very much, Alethia.

    非常感謝你,Alethia。

  • So yes, obviously, I think our general position on this is that you will always need effective therapeutics and effective vaccines to control any type of a viral outbreak of any type and certainly one in a pandemic.

    所以,是的,很明顯,我認為我們對此的總體立場是,你將始終需要有效的治療方法和有效的疫苗來控制任何類型的病毒爆發,當然還有大流行中的病毒爆發。

  • So I think we're firmly committed to working to expand remdesivir's impact.

    所以我認為我們堅定地致力於擴大瑞德西韋的影響。

  • We really -- we're really pleased that every piece of data in our hands or in other people's hands have been consistent, consistent about the effect in terms of reduction in hospital space, consistent around the ability to use it earlier in hospital space and get even bigger impacts.

    我們真的 - 我們真的很高興我們手中或其他人手中的每條數據都是一致的,關於減少醫院空間的效果是一致的,在醫院空間早期使用它的能力方面是一致的,並且獲得更大的影響。

  • And I think that will continue regardless of vaccination.

    而且我認為無論是否接種疫苗,這種情況都會繼續。

  • And our hope, obviously, is like you have at the normal influenza, that with an effective vaccine appropriately administered to as many patients as will take a vaccine around the globe that you can reduce the number of patients that ever have to enter the hospital.

    顯然,我們的希望就像普通流感一樣,通過對全球範圍內接種疫苗的盡可能多的患者適當接種有效疫苗,您可以減少必須入院的患者數量。

  • But as we know, vaccines are never 100% effective.

    但正如我們所知,疫苗永遠不會 100% 有效。

  • They're never 100% utilized, so there will always be patients that need therapeutics.

    它們永遠不會 100% 被利用,因此總會有需要治療的患者。

  • And what we're excited about in terms of the potency of remdesivir is the ability to use it earlier on patients to get them out of the hospital faster and also to make sure that the types of work we're doing now that using remdesivir outside the hospital could prevent patients from ever having to go in.

    就瑞德西韋的效力而言,我們感到興奮的是能夠更早地在患者身上使用它,讓他們更快地出院,並確保我們現在所做的工作類型在外面使用瑞德西韋醫院可以避免病人不得不進去。

  • Of course, that's all to be determined.

    當然,這一切都需要確定。

  • So I think it will be hand in glove with vaccines.

    所以我認為它將與疫苗密切相關。

  • And obviously, we're looking forward also to the work that's going on in terms of looking at antiviral, a potent antiviral that's been proven like remdesivir in patients to be used perhaps in combination with other therapeutics to get an even stronger treatment effect.

    顯然,我們也期待在研究抗病毒藥物方面正在進行的工作,這是一種有效的抗病毒藥物,已被證明與患者的瑞德西韋類似,可能與其他療法結合使用以獲得更強的治療效果。

  • But that continues to be, I think, our view, and we're hoping, and I'm really proud to be working in this industry at this stage because my colleagues around the industry, I know, are doing everything possible, including the collaboration that they have with us in remdesivir, to bring new therapeutics and vaccines to patients.

    但我認為,這仍然是我們的觀點,我們希望,而且我為現階段在這個行業工作感到非常自豪,因為我知道我在這個行業的同事正在盡一切可能,包括他們與我們在瑞德西韋方面的合作,為患者帶來新的療法和疫苗。

  • And so we're excited about that.

    所以我們對此感到興奮。

  • So thank you very much for the question.

    非常感謝你提出這個問題。

  • Operator

    Operator

  • Our next question comes from Cory Kasimov with JPMorgan.

    我們的下一個問題來自摩根大通的 Cory Kasimov。

  • Matthew Thomas Holt - Analyst

    Matthew Thomas Holt - Analyst

  • This is Matthew on for Cory.

    這是科里的馬修。

  • So just to go back to Biktarvy, are you able to quantify how much of the 2Q weakness was due to inventory pull-through versus other factors that you mentioned?

    那麼回到 Biktarvy,您能否量化 2Q 疲軟中有多少是由於庫存拉動與您提到的其他因素造成的?

  • And should we expect these other factors, such as the shift in payer mix and slowdown in patients, which is to persist for the remainder of 2020?

    我們是否應該期待這些其他因素,例如付款人組合的變化和患者的放緩,這些因素將持續到 2020 年剩餘時間?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks.

    謝謝。

  • Over to you, Johanna.

    交給你了,約翰娜。

  • Thanks, Matthew.

    謝謝,馬修。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Matthew, for your questions.

    謝謝,馬修,你的問題。

  • If I understood it, so you broke up a little bit.

    如果我明白了,那麼你們分手了一點。

  • But if I understood it correctly, specific to Biktarvy and the shift and what's driving it, and it's really the inventory fluctuations.

    但如果我理解正確的話,具體到 Biktarvy 和轉變以及驅動它的是什麼,這真的是庫存波動。

  • That's what's driving the shift Q1 to Q2.

    這就是推動 Q1 到 Q2 轉變的原因。

  • And you can appreciate Q4, always a little bit higher.

    你可以欣賞 Q4,總是高一點。

  • It plays out in Q1, it bleeds out in Q1, but then we saw the uptake because of COVID-19 in late March, and we saw that bleed out in Q2.

    它在第一季度發揮作用,在第一季度流血,但隨後我們在 3 月下旬看到了由於 COVID-19 而引起的吸收,我們在第二季度看到了流血。

  • So it's really what's driving the Biktarvy piece.

    所以這真的是推動 Biktarvy 作品的原因。

  • We have seen a payer mix shift in the last 2 quarters, where due to unemployment, we're seeing a shift from commercial payers to government channels, specifically PHS and Medicaid.

    我們看到過去兩個季度付款人組合發生了變化,由於失業,我們看到從商業付款人轉向政府渠道,特別是 PHS 和 Medicaid。

  • But at this point in time, that's really not impacting or modestly impacting our business overall.

    但在這個時間點,這真的沒有影響或適度影響我們的整體業務。

  • So it's really inventory driven.

    所以它真的是庫存驅動的。

  • Hopefully, I answered your question.

    希望我回答了你的問題。

  • Matthew Thomas Holt - Analyst

    Matthew Thomas Holt - Analyst

  • Yes.

    是的。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Okay.

    好的。

  • Operator

    Operator

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

    我們的下一個問題來自美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • I had a strategic one for Dan or even Andy.

    我為丹甚至安迪準備了一個戰略性的。

  • Dan, when you took over the narrative for Gilead was a return to growth as Hep C was stabilizing.

    丹,當你接管吉利德(Gilead)的故事時,隨著丙肝的穩定,吉利德恢復了增長。

  • And of course, I get the headwinds from COVID, but sustainable growth has still been evasive.

    當然,我從 COVID 中得到了不利因素,但可持續增長仍然是迴避的。

  • So the question is, do you reinvest a new product that anchors your long-term growth?

    所以問題是,您是否對新產品進行再投資以實現長期增長?

  • Or do you feel like you need other assets?

    或者你覺得你需要其他資產嗎?

  • Obviously, I recognize that filgo and Kite are also in growth mode, but do you need other assets to help drive sustainable, more long-term growth?

    顯然,我承認 filgo 和 Kite 也處於增長模式,但你是否需要其他資產來幫助推動可持續的、更長期的增長?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Let me say it's certainly the latter to your question, Geoff.

    傑夫,讓我說你的問題肯定是後者。

  • And that is that as happy as we are that we can have an impact on patients in the COVID crisis with remdesivir, we completely understand that hopefully, by the way, for the world, that we'll get to a stage where the pandemic is much more predictable and remdesivir is playing a role, but not what we're relying upon for our mid- to long-term growth in the company.

    這就是我們很高興我們可以通過瑞德西韋對 COVID 危機中的患者產生影響,我們完全理解希望,順便說一下,對於世界來說,我們將進入大流行的階段更可預測,remdesivir 正在發揮作用,但不是我們公司中長期增長所依賴的。

  • So we believe that, rather, the continued emphasis on our core business to make sure that we not only continue to lead with HIV today but also tomorrow with the next-generation of medicines, combined with what we have in our internal pipeline, and then growing our overall immuno-oncology business, both Kite and outside of Kite.

    因此,我們相信,更確切地說,繼續強調我們的核心業務,以確保我們不僅在今天繼續引領 HIV,而且在明天繼續引領下一代藥物,結合我們內部管道中的產品,然後發展我們的整體免疫腫瘤學業務,包括 Kite 和 Kite 以外的業務。

  • And I think that's what you see as we think about now outside of virology, moving into inflammation, moving more deeply into oncology, particularly outside of Kite.

    我認為這就是我們現在在病毒學之外所看到的,進入炎症,更深入地進入腫瘤學,特別是在 Kite 之外。

  • You're going to continue to see, I think, more of what you've seen in the first half of this year, which is an ability to both optimize our current portfolio in-house and continue to do smart targeted deals that allow us to bring transformational medicine innovation into our house at different stages of development.

    我認為,你將繼續看到更多你在今年上半年看到的東西,這是一種能力,可以優化我們當前的內部投資組合,並繼續進行有針對性的智能交易,使我們能夠在不同的發展階段將轉化醫學創新帶入我們的房子。

  • And obviously, that goes along with different risk profiles, right?

    顯然,這伴隨著不同的風險狀況,對吧?

  • So -- and that's, I think, where the BD team under Andy's leadership has done a really good job of making sure we're doing fit-for-purpose transactions where we're going after first or best-in-class, and there's risk associated with it, we're trying to be prudent about how much capital we deploy up-front, particularly in the earlier stage assets and kind of pay for success over that period of time.

    所以——我認為,在 Andy 的領導下,BD 團隊在確保我們進行符合目的的交易方面做得非常好,我們追求一流或同類最佳,並且存在與之相關的風險,我們正試圖對我們預先部署多少資本持謹慎態度,特別是在早期階段的資產以及為那段時間的成功付出的代價。

  • And there are others where we've seen the late-stage data like Forty Seven where we feel quite confident and bullish about bringing that in and using the breadth and depth of Gilead to look at expense of life cycle management on a medicine like magrolimab that has a leading position in a competitive environment to allow us to think about multiple different indications in hematologic malignancies and possibly also looking at solid tumors.

    在其他一些地方,我們已經看到了像 47 這樣的後期數據,我們對引入這些數據並利用 Gilead 的廣度和深度來研究像 magrolimab 這樣的藥物的生命週期管理費用感到非常有信心和看好在競爭環境中處於領先地位,使我們能夠考慮血液系統惡性腫瘤的多種不同適應症,並可能還關注實體瘤。

  • So that type of a strategy is absolutely fundamental to rounding us and continuing to build on our mid- to long-term growth story.

    因此,這種類型的戰略絕對是我們四捨五入和繼續建立我們的中長期增長故事的基礎。

  • Andy, anything that you'd like to add from your side?

    Andy,你有什麼想補充的嗎?

  • Andrew D. Dickinson - Executive VP & CFO

    Andrew D. Dickinson - Executive VP & CFO

  • No, I think you said it well.

    不,我覺得你說的很好。

  • That captures it.

    那抓住了它。

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Our next question comes from Evan Seigerman with Crédit Suisse.

    我們的下一個問題來自 Crédit Suisse 的 Evan Seigerman。

  • Evan David Seigerman - VP & Senior Equity Research Analyst

    Evan David Seigerman - VP & Senior Equity Research Analyst

  • I actually have one for Christi.

    我實際上有一個給克里斯蒂。

  • I know you haven't spoken much on the call.

    我知道你在電話中沒有說太多。

  • Congrats on your very recent approval of Tecartus.

    祝賀您最近批准了 Tectartus。

  • Can you help us better understand kind of how you view the commercial potential for this asset?

    您能否幫助我們更好地了解您如何看待這項資產的商業潛力?

  • And have you seen any reversal in trends around CAR-T use this month versus, say, June or May?

    您是否看到本月 CAR-T 使用趨勢與 6 月或 5 月相比有任何逆轉?

  • And how should we think about the trajectory over the course of the year?

    我們應該如何考慮這一年的軌跡?

  • Christi L. Shaw - CEO of Kite

    Christi L. Shaw - CEO of Kite

  • Thanks for the question.

    謝謝你的問題。

  • Making sure I'm wide awake and listening.

    確保我完全清醒並傾聽。

  • So we're so pleased about being the first company to be able to deliver for mantle cell lymphoma patients Tecartus that has a curative intent.

    因此,我們很高興成為第一家能夠為套細胞淋巴瘤患者提供具有治療意圖的 Tectartus 的公司。

  • And so although it's not a huge opportunity relative to DLBCL or some of our other studies that will be coming up like second line, it really is a differentiator for us in the marketplace to continue to demonstrate our leadership.

    因此,儘管相對於 DLBCL 或我們其他一些將像二線一樣出現的研究,這不是一個巨大的機會,但它確實是我們在市場上繼續展示我們的領導地位的一個差異化因素。

  • Just like with Yescarta, our manufacturing footprint, we're gearing up.

    就像我們的製造足跡 Yescarta 一樣,我們正在加緊準備。

  • We have a ready to go in 7 days, authorized sites will all be all authorized for the new product within 30 days.

    我們準備好在 7 天內開始,授權網站將在 30 天內全部獲得新產品的授權。

  • So we're very hopeful that all of these patients that have nothing else to keep them alive actually have something that can help them with such great efficacy.

    因此,我們非常希望所有這些沒有其他辦法維持生命的患者實際上有一些東西可以幫助他們取得如此巨大的療效。

  • When we look at what happened in Q2, I'd say we were maybe pleasantly surprised that more patients were treated than we thought would be based on COVID.

    當我們查看第二季度發生的事情時,我想說的是,我們可能會驚喜地發現,接受治療的患者比我們想像的要多於基於 COVID 的患者。

  • I will say that what's happening now with the states in the U.S., we continue to see a slowdown versus what we saw in the Q1 in terms of registrations.

    我要說的是,美國各州現在正在發生的事情,我們繼續看到與我們在第一季度看到的註冊量相比放緩。

  • So I do think we're not going to see a huge uplift in Q3 and we could be flat, and I don't know if we maybe lose some growth.

    所以我確實認為我們不會在第三季度看到巨大的增長,我們可能會持平,而且我不知道我們是否會失去一些增長。

  • But right now, it's too early to tell.

    但現在下結論還為時過早。

  • But I'm not as optimistic about Q3, and hopefully, when we come out of the situation, it will get better.

    但我對第三季度並不樂觀,希望當我們走出困境時,情況會好轉。

  • And I'm really proud of the Kite team because as you can imagine, with all of the flights being canceled early on and with having to figure out which ATCs to bring T cells back to where you didn't originate, being able to hold T cells where we haven't before, the team hasn't missed a beat and hasn't missed a delivery.

    我真的為 Kite 團隊感到驕傲,因為正如你想像的那樣,所有航班都在早期被取消,並且必須弄清楚哪些 ATC 將 T 細胞帶回你沒有起源的地方,能夠保持我們以前沒有的 T 細胞,團隊沒有錯過任何一個節拍,也沒有錯過一次交付。

  • So as I look at the whole of Kite and we look at the whole of the opportunity, it's really multiple indications in a very short period of time with mantle cell lymphoma, non-Hodgkin's -- indolent non-Hodgkin's lymphoma by the end of this year being submitted.

    因此,當我審視整個 Kite 並審視整個機會時,它確實在很短的時間內出現了多種適應症,包括套細胞淋巴瘤、非霍奇金氏淋巴瘤——到本月底將出現惰性非霍奇金淋巴瘤提交的年份。

  • We have ALL being submitted and with priority review next year being approved.

    我們已提交所有申請,並在明年獲得優先審查。

  • And we also have the big indication of second-line DLBCL to be submitted next year.

    我們也有明年提交二線 DLBCL 的大跡象。

  • So as you look at that combination, I do think it gives us the best opportunity for growth and to potentially cure more patients of their cancer.

    因此,當你看到這種組合時,我確實認為它為我們提供了最好的成長機會,並有可能治愈更多的癌症患者。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Evan, and we're looking forward to hearing more from Christi as the Kite business develops.

    謝謝,埃文,隨著風箏業務的發展,我們期待聽到克里斯蒂的更多信息。

  • More to hear from you.

    想听聽更多。

  • Thanks, Evan.

    謝謝,埃文。

  • Operator

    Operator

  • Our next question comes from Matthew Harrison with Morgan Stanley.

    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 just want to ask a little bit more about filgotinib and MANTA.

    我只想多問一點關於 filgotinib 和 MANTA 的問題。

  • So it sounds like you finished enrollment, and I think the -- I think it's either about 3 months when you take the primary end point there.

    所以聽起來你已經完成了註冊,而且我認為 - 我認為你在那裡取得主要終點的時間大約是 3 個月。

  • So I'm just wondering how the timing of getting the data from MANTA, which it sounds like could come towards the end of this year versus the approval time line for filgotinib.

    所以我只是想知道從 MANTA 獲取數據的時間,聽起來可能會在今年年底與 filgotinib 的批准時間線相比。

  • How those 2 work and your ability to get that data to the FDA or how that influences the application.

    這兩個是如何工作的,以及您將數據提交給 FDA 的能力,或者這對應用程序有何影響。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thanks, Matthew.

    謝謝,馬修。

  • We'll turn it right over to Merdad.

    我們會把它交給 Merdad。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Matthew, it's Merdad.

    馬修,是梅爾達。

  • I hope everybody can hear me.

    我希望每個人都能聽到我的聲音。

  • Sorry, I got disconnected earlier.

    對不起,我之前掉線了。

  • So you're right, in some regards, Matthew, that the patients are all enrolled.

    所以你是對的,在某些方面,馬修,病人都被登記了。

  • I don't -- we don't anticipate that the 3 months is going to be the duration necessarily that would be sufficient for the regulators in terms of looking at both on track and recovery.

    我不——我們預計 3 個月的持續時間不會足以讓監管機構在關注正軌和復蘇方面取得足夠的進展。

  • So while that first 3 months is a critical period, we think that's the blinded period.

    因此,雖然前 3 個月是關鍵時期,但我們認為那是盲期。

  • There's probably longer to be that's necessary.

    可能需要更長的時間。

  • So we're looking at probably late in this year, early next year for us to have the data and then for us to submit it to the agency in the first half of next year.

    因此,我們可能會在今年晚些時候、明年年初尋找數據,然後在明年上半年將其提交給該機構。

  • Those are the kind of time lines we're looking at.

    這些就是我們正在研究的時間線。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • That's your question?

    那是你的問題?

  • Thanks, Matthew.

    謝謝,馬修。

  • Matthew Kelsey Harrison - Executive Director

    Matthew Kelsey Harrison - Executive Director

  • Yes.

    是的。

  • No, that's it.

    不,就是這樣。

  • Operator

    Operator

  • Our next question comes from Robyn Karnauskas with SunTrust.

    我們的下一個問題來自 SunTrust 的 Robyn Karnauskas。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • Quick ones.

    快速的。

  • Dan, any thoughts on what you think about the executive orders being implemented and how you might run the business if they were to do so going forward, especially on business development?

    丹,你對正在執行的行政命令有什麼想法,如果他們繼續這樣做,你會如何經營企業,尤其是在業務發展方面?

  • And for Christi, what would you like to augment your CAR-T portfolio?

    對於 Christi,您想增加什麼來增加您的 CAR-T 產品組合?

  • You've done a lot of deals in I-O.

    你在 I-O 方面做了很多交易。

  • What else do you think you might need to be competitive in the space with the bispecifics and other things being -- moving forward?

    您認為在雙特異性抗體和其他正在推進的領域中,您可能還需要什麼來保持競爭力?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Yes.

    是的。

  • Thanks, Robyn.

    謝謝,羅賓。

  • I mean, first of all, let me just take a big step back from the executive orders.

    我的意思是,首先,讓我從行政命令中退後一大步。

  • I mean, I know that we all agree at Gilead, that the current system in the U.S. needs to change, and we're leaning into that in a variety of different fronts, have been now for a couple of years.

    我的意思是,我知道我們在吉利德都同意,美國目前的系統需要改變,我們在各種不同的方面都傾向於改變,現在已經有幾年了。

  • What's really important is that when we look at changes in the U.S. system, that it's done in a way that ensures that patients are the one to benefit and at the same time that we maintain the U.S. innovation model.

    真正重要的是,當我們審視美國系統的變化時,它是以一種確保患者受益的方式完成的,同時我們保持美國的創新模式。

  • So the types of things that we've been working with, the different packages within the Congress and the Senate have all reflected that.

    因此,我們一直在處理的事情類型、國會和參議院的不同方案都反映了這一點。

  • And now as we look at these executive orders, we'll be looking forward to engaging with the White House and with others to have the very principles that I just mentioned articulated and that's where we'll go.

    現在,當我們審視這些行政命令時,我們將期待與白宮和其他人接觸,以闡明我剛才提到的原則,這就是我們要去的地方。

  • In terms of how that impacts, how we think about the future business, I would say that we have so many health care systems around the world, right, that we're working with.

    就這如何影響,我們如何看待未來的業務而言,我會說我們在世界各地有很多醫療保健系統,對,我們正在與之合作。

  • Of course, the U.S. is disproportionately important to us.

    當然,美國對我們來說非常重要。

  • But our belief firmly is that if you hold the bar high enough on transformational medicine, so in other words if you really think hard about first-in-class and best-in-class and keep the bar high, regard -- because remember, our cycle time is so long.

    但我們堅信,如果你對轉化醫學的標準足夠高,換句話說,如果你真的認真考慮一流和一流並保持高標準,請考慮——因為記住,我們的周期時間很長。

  • Our capital investment is a decade, that we can't be pivoting to one or the other particular governmental action.

    我們的資本投資是十年,我們不能轉向一項或另一項特定的政府行動。

  • The bottom line is we keep that bar high enough under any system, under any scenario, I think we'll do, first of all, well for patients and we'll do well for shareholders as a result of that.

    底線是我們在任何系統、任何情況下都將這個標准保持得足夠高,我認為我們首先會為患者做好,因此我們會為股東做好。

  • So that's my firm belief.

    所以這是我堅定的信念。

  • Christi, over to you on Robyn's question.

    克里斯蒂,關於羅賓的問題交給你了。

  • Christi L. Shaw - CEO of Kite

    Christi L. Shaw - CEO of Kite

  • Yes.

    是的。

  • Thanks, Robyn.

    謝謝,羅賓。

  • So I'd say in the short term, we're looking at how do we cure those patients that aren't getting the effects of CAR-T cell that we'd like.

    所以我想說,在短期內,我們正在研究如何治愈那些沒有獲得我們想要的 CAR-T 細胞效果的患者。

  • Yescarta is the only CAR-T that's been able to show the longest duration of over 3 years with almost 50% of patients being alive.

    Yescarta 是唯一能夠顯示最長持續時間超過 3 年且幾乎 50% 的患者存活的 CAR-T。

  • And how do we help the other 50% of the patients?

    我們如何幫助其他 50% 的患者?

  • So as you look at some of the portfolio that Gilead is building and being able to actually combine in the future other therapies, non-cell therapies with cell therapies would be one of our strategies to build on the strength of both of the companies together.

    因此,當您查看 Gilead 正在構建的一些產品組合併能夠在未來實際結合其他療法時,非細胞療法與細胞療法將是我們建立兩家公司實力的戰略之一。

  • And then as we look at the mid- to longer term, we've got 3 studies that are in solid tumor that have INDs, Phase I. And that would be our biggest long-term bet in terms of being able to really penetrate the solid tumor area.

    然後當我們著眼於中長期時,我們有 3 項實體瘤研究具有 IND,I 期。這將是我們最大的長期賭注,能夠真正滲透到實體瘤區。

  • And there are specific areas that are kind of the low-hanging fruit where the science is a little bit easier and others where it's very complex and the bar is just too high compared to standard of care.

    在某些特定領域,科學更容易實現,而在其他領域則非常複雜,而且與護理標準相比,門檻太高了。

  • So those 2 areas in terms of launching success today, being able to get more efficacy and lead in hematological malignancies and then moving to solid tumor.

    因此,就今天啟動成功而言,這兩個領域能夠獲得更多療效並導致血液惡性腫瘤,然後轉向實體瘤。

  • I will tell you, in addition, though, that we're not keeping our eyes closed or our head in the sand as we look at possible disruptors with allogeneic iPSC technology, NK cells.

    不過,我要告訴你的是,在我們研究同種異體 iPSC 技術 NK 細胞的可能干擾物時,我們並沒有閉上眼睛或把頭埋在沙子裡。

  • And that's what you see a lot of the business development deals that we did.

    這就是你看到的我們所做的許多業務發展交易。

  • Some of them, Kite alone with cell therapy, and some of them with Gilead where we can both partake in the potential positive outcomes that could come from that.

    其中一些,Kite 單獨進行細胞療法,其中一些與 Gilead 合作,我們都可以參與其中可能產生的潛在積極成果。

  • So as we look at different ways off the shelf that we're the first movers in that arena both internally and as we look at some of our partners externally.

    因此,當我們審視不同的現成方式時,無論是在內部還是在外部審視我們的一些合作夥伴時,我們都是該領域的先行者。

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Thank you, Robyn.

    謝謝你,羅賓。

  • So I know that we're kind of out of time.

    所以我知道我們有點沒時間了。

  • If there is one more question, we could take that in respect for everybody's time.

    如果還有一個問題,我們可以考慮到每個人的時間。

  • Operator

    Operator

  • Our last question comes from Umer Raffat with Evercore ISI.

    我們的最後一個問題來自 Evercore ISI 的 Umer Rafat。

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

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I have 2, if I may.

    如果可以的話,我有 2 個。

  • First, Merdad, curious what the feedback is from your team on the lung exposure of remdesivir with the IV form?

    首先,Merdad,想知道您的團隊對 IV 形式的瑞德西韋肺部暴露的反饋是什麼?

  • And how many fold higher can you get with the inhaled form at the highest dose?

    在最高劑量下,吸入劑型能提高多少倍?

  • I'd be very curious.

    我會很好奇。

  • And secondly, I know there's this Phase II trial coming up with -- in the multidrug-resistant patients in HIV for your capsid inhibitor.

    其次,我知道即將進行這項 II 期試驗——在 HIV 的多重耐藥患者中使用你的衣殼抑製劑。

  • My question is if that hits, why shouldn't it form the basis for an accelerated filing, given the unmet need in multidrug-resistant patients?

    我的問題是,如果成功了,鑑於多重耐藥患者的需求未得到滿足,為什麼它不應該成為加速申報的基礎?

  • Daniel P. O'Day - Chairman & CEO

    Daniel P. O'Day - Chairman & CEO

  • Umer, terrific.

    嗯,太棒了。

  • Merdad, I'll decide if -- you decide if you or Diana want to feed the numbers.

    Merdad,我來決定——你來決定是你還是 Diana 想要提供這些數字。

  • That's great.

    那太棒了。

  • Thanks.

    謝謝。

  • Merdad V. Parsey - Chief Medical Officer

    Merdad V. Parsey - Chief Medical Officer

  • Sure.

    當然。

  • Well, I'll do the lung exposure.

    好吧,我會做肺部暴露。

  • Diana, you can talk about capsid.

    戴安娜,你可以談談衣殼。

  • So we are targeting to get, with the inhaled version, as good as, and hopefully, greater exposure in the lung than we do with the IV.

    因此,我們的目標是通過吸入式獲得與靜脈注射一樣好的肺部暴露,並希望獲得更大的暴露。

  • We think we get, obviously, great exposure with the IV version, and we think we can do at least that good, if not better, depending on how high we can go and what the lung deposition is.

    顯然,我們認為我們通過 IV 版本獲得了很好的曝光,我們認為我們至少可以做得很好,如果不是更好,這取決於我們能達到多高和肺沉積是多少。

  • That's a very encouraging thing.

    這是一件非常鼓舞人心的事情。

  • We need to see how the trials go, but that's our goal.

    我們需要看看試驗的進展情況,但這是我們的目標。

  • Diana, do you want to talk about the capsid?

    戴安娜,你想談談衣殼嗎?

  • Diana Brainard - SVP of HIV & Emerging Viral Infections

    Diana Brainard - SVP of HIV & Emerging Viral Infections

  • Yes, that would be great.

    是啊,那樣最好了。

  • So Umer, in terms of that study in highly treatment-experienced patients, it's actually a Phase II/III.

    所以 Umer,就對高度治療經驗患者的研究而言,它實際上是 II / III 期。

  • Because of the urgent unmet need in that patient population, the agency granted us breakthrough designation.

    由於該患者群體的迫切需求未得到滿足,該機構授予我們突破性指定。

  • And they agreed that we could move directly from Phase Ib to a registrational trial in that population.

    他們同意我們可以直接從 Ib 階段轉移到該人群的註冊試驗。

  • And so the study that's ongoing right now, should the results pan out, will form the basis for an application for approval in the highly treatment-experienced patients with lenacapavir dosed every 6 months.

    因此,如果結果成功,目前正在進行的研究將成為申請批准每 6 個月服用一次 lenacapavir 的高度治療經驗患者的基礎。

  • Operator

    Operator

  • That concludes today's question-and-answer session.

    今天的問答環節到此結束。

  • I'd like to turn the call back to Douglas Maffei for closing remarks.

    我想將電話轉回給道格拉斯·馬菲 (Douglas Maffei) 以致閉幕詞。

  • Douglas Maffei - Senior Director of IR

    Douglas Maffei - Senior Director of IR

  • Thank you, Liz, and thank you all for joining us today.

    謝謝 Liz,也感謝大家今天加入我們。

  • We appreciate your continued interest in Gilead, and the team here looks forward to providing you with updates on our future progress.

    我們感謝您對吉利德的持續關注,這裡的團隊期待為您提供我們未來進展的最新信息。

  • Operator

    Operator

  • Ladies and gentlemen, thank you for participating in today's conference.

    女士們,先生們,感謝你們參加今天的會議。

  • This concludes the program.

    程序到此結束。

  • You may now disconnect.

    您現在可以斷開連接。

  • Everyone, have a great day.

    大家,祝你有美好的一天。