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Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the First 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,感謝你們的支持,歡迎來到 Gilead Sciences 2020 年第一季度收益電話會議。 (操作員說明)請注意,今天的會議正在錄製中。 (操作員說明)
It is now my pleasure to introduce Senior Director of Investor Relations, Doug Maffei.
現在我很高興介紹投資者關係高級總監 Doug Maffei。
Douglas Maffei - Senior Director of IR
Douglas Maffei - Senior Director of IR
Thank you, Andrew, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter 2020. The press release and detailed slides are available on the Investor Relations section of the Gilead website. The speakers on today's call will be: Daniel O'Day, Chairman and Chief Executive Officer; and Andrew Dickinson, Chief Financial Officer. Also on the call will be Johanna Mercier, Chief Commercial Officer; Merdad Parsey, Chief Medical Officer; Christi Shaw, Chief Executive Officer of Kite; and Diana Brainard, SVP and Head of HIV and Emerging Viruses Therapeutic area.
謝謝安德魯,大家下午好。今天收盤後,我們發布了一份新聞稿,其中包含 2020 年第一季度的收益結果。新聞稿和詳細幻燈片可在 Gilead 網站的投資者關係部分獲取。今天電話會議的發言人將是:董事長兼首席執行官 Daniel O'Day; Andrew Dickinson,首席財務官。首席商務官 Johanna Mercier 也將出席電話會議; Merdad Parsey,首席醫療官; Kite 首席執行官 Christi Shaw;戴安娜·布雷納德 (Diana Brainard),高級副總裁兼艾滋病毒和新興病毒治療領域負責人。
Before we begin with our prepared comments, 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 and results of operations, plans and expectations with regards to products, product candidates, 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. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents.
在開始我們準備好的評論之前,讓我提醒您,我們將做出前瞻性陳述,包括與 COVID-19 大流行對 Gilead 業務的影響相關的風險和不確定性,以及與產品相關的運營結果、計劃和預期、產品候選人、財務預測和資本使用以及 2020 年財務指導,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。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. The GAAP to non-GAAP reconciliations are provided in the earnings press release as well as on the Gilead website.
非 GAAP 財務指標將用於幫助您了解公司的基本業務績效。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 very much, Doug, and good afternoon, everyone. Well, as you can imagine, it's been an extraordinary week for Gilead given the terrific news on our investigational antiviral drug remdesivir. The news shared yesterday that the data showed the potential of remdesivir to help ease some of the burden of the pandemic is the outcome that we had all hoped would be possible. We're incredibly humbled to think about what this news could mean for patients and communities.
非常感謝,道格,大家下午好。好吧,正如你想像的那樣,鑑於我們的研究抗病毒藥物瑞德西韋的好消息,這對吉利德來說是不平凡的一周。昨天分享的消息稱,數據顯示瑞德西韋有可能幫助減輕大流行病的部分負擔,這是我們都希望能夠實現的結果。想到這個消息對患者和社區意味著什麼,我們感到無比謙卑。
I'd like to start by sharing my thanks to everyone who has helped to bring remdesivir to this point, including all those involved in the collaborative clinical trial, the trial investigators, governments, hospitals and above all the patients who participated. I want to acknowledge our internal teams that have been working day and night on remdesivir for the past 3 months, following many years of research long before the outbreak began. Because of the remdesivir news, the original focus for today's call has somewhat shifted. I'm sure you have a lot of questions on the results and the next steps. We'll provide an overview of what was a strong first quarter for Gilead, but with an abbreviated set of opening comments, so we can leave more time for questions.
首先,我想感謝所有幫助瑞德西韋走到這一步的人,包括所有參與合作臨床試驗的人、試驗研究人員、政府、醫院,尤其是所有參與的患者。我要感謝我們的內部團隊,他們在過去 3 個月裡夜以繼日地研究瑞德西韋,在疫情爆發之前很久就進行了多年的研究。由於瑞德西韋的消息,今天電話會議的原定重點有所轉移。我相信您對結果和後續步驟有很多疑問。我們將概述吉利德(Gilead)第一季度的強勁表現,但會提供一組簡短的開場評論,這樣我們就可以留出更多時間來提問。
I'll speak briefly about the quarter and remdesivir before turning the call over to Andy to discuss financial details and the impact of COVID-19 on our business. As Doug noted in the opening, Christi, Johanna, Merdad and Diana have joined us today to answer your questions at the end of the call.
在將電話轉給 Andy 討論財務細節和 COVID-19 對我們業務的影響之前,我將簡要介紹一下本季度和 remdesivir。正如 Doug 在開場白中指出的那樣,Christi、Johanna、Merdad 和 Diana 今天加入了我們,在電話會議結束時回答您的問題。
Gilead has been built to withstand significant challenges. There's a short-term uncertainty for all of us, but the solid foundations that Gilead has laid over the past 30 years and our focus on transformational therapeutics give us confidence in the long-term durability of the business. We'll do our best to provide you with a clear picture of where we are and what we expect as far as the near-term impact of COVID-19, while acknowledging that, as we all know, these are uncertain times with many unknowns, not least of which is how long the pandemic will last.
吉利德(Gilead)的建立是為了承受重大挑戰。我們所有人都存在短期不確定性,但吉利德在過去 30 年奠定的堅實基礎以及我們對轉化療法的關注讓我們對業務的長期持久性充滿信心。就 COVID-19 的近期影響而言,我們將盡最大努力讓您清楚地了解我們所處的位置以及我們的預期,同時承認,眾所周知,現在是充滿許多未知數的不確定時期,其中最重要的是大流行將持續多長時間。
So turning to the quarter, I'll use the framework we introduced at the start of the year with the 3 pillars that will shape our future: a strong core business, our internal pipeline and supplemental growth opportunities that are being enabled through our strategy.
因此,轉向本季度,我將使用我們在年初推出的框架和塑造我們未來的三大支柱:強大的核心業務、我們的內部管道和通過我們的戰略實現的補充增長機會。
Our performance in the first quarter demonstrated the strength of our foundational business once again with double-digit growth in HIV. We reached and in fact exceeded all of our targets. Revenues for our HIV franchise were up 14% year-over-year. This was driven by both treatment and prevention as Biktarvy remained the #1 prescribed HIV regimen in the U.S. during the quarter, and approximately 38% of individuals on PrEP are now taking Descovy. What I would say in general about where we stand in HIV is this: we are very confident in the underlying competitiveness of our products and our position as the leader in HIV. Completing the picture in our core antivirals business, we saw sustained revenues from our HCV franchise in the last quarter. Since the introduction of authorized generics in the U.S., we've regained market share and now hold around 61% of share through Asegua and Gilead.
我們在第一季度的業績再次證明了我們基礎業務的實力,艾滋病病毒呈兩位數增長。我們達到並實際上超過了我們所有的目標。我們的 HIV 專營權收入同比增長 14%。這是由治療和預防共同推動的,因為 Biktarvy 在本季度仍然是美國第一大 HIV 治療方案,大約 38% 的 PrEP 患者現在正在服用 Descovy。關於我們在 HIV 領域的立場,我一般要說的是:我們對我們產品的潛在競爭力以及我們作為 HIV 領域領導者的地位非常有信心。完成我們的核心抗病毒藥物業務後,我們在上個季度看到了來自 HCV 特許經營權的持續收入。自從在美國引入授權仿製藥以來,我們重新奪回了市場份額,現在通過 Asegua 和 Gilead 佔據了約 61% 的份額。
So moving from our core business to advancing our pipeline, I'll provide just a brief overview. More detailed information is available as part of our first quarter earnings materials in the Investor Relations sections of our website. Filgotinib, as you are aware, is under regulatory review in the United States, Europe and Japan as a potential treatment for rheumatoid arthritis. Our teams are preparing for a competitive launch and remain in close contact with regulators to understand the effect COVID-19 could have on review time lines. In HIV, we made progress across our pipeline, sharing important data at the Virtual CROI conference with our innovative long-acting antiviral and HIV cure programs, reinforcing our long-term commitment to people living with HIV.
因此,從我們的核心業務轉向推進我們的管道,我將提供一個簡短的概述。更多詳細信息可作為我們網站投資者關係部分第一季度收益材料的一部分提供。如您所知,Filgotinib 作為類風濕性關節炎的潛在治療藥物正在美國、歐洲和日本接受監管審查。我們的團隊正在為競爭性發布做準備,並與監管機構保持密切聯繫,以了解 COVID-19 可能對審查時間表產生的影響。在 HIV 方面,我們在整個管道中取得了進展,在虛擬 CROI 會議上與我們創新的長效抗病毒和 HIV 治療計劃共享重要數據,加強了我們對 HIV 感染者的長期承諾。
In cell therapy, the FDA accepted Kite BLA for KTE-X19 as a treatment for relapsed and refractory mantle cell lymphoma during the first quarter and granted a priority review designation. As you might recall, the European Medicines Agency validated our application in January. This represents really important progress. Patients with relapsed/refractory mantle cell lymphoma, a rare form of non-Hodgkin's lymphoma, are in need of new therapies. If approved, Kite would be the first company with 2 cell therapies on the market.
在細胞治療方面,FDA 在第一季度接受了用於 KTE-X19 的 Kite BLA 作為治療復發和難治性套細胞淋巴瘤的藥物,並授予優先審評資格。您可能還記得,歐洲藥品管理局在一月份驗證了我們的申請。這代表了非常重要的進步。復發/難治性套細胞淋巴瘤(一種罕見的非霍奇金淋巴瘤)患者需要新療法。如果獲得批准,Kite 將成為市場上第一家擁有兩種細胞療法的公司。
So I've touched on our strong core business and advancing our pipeline. Now I want to say a few words about the work we are doing to expand our pipeline through business development, including, of course, the acquisition of Forty Seven completed earlier this month. Acquiring Forty Seven is a great early example of our strategy in action. We said we would build on our core area of expertise, which, as you know, are virology and immunomodulation, that we would keep a high bar in that our business development efforts were focused on clinical stage assets, such as magrolimab, which we gained as a part of this acquisition. We're working to integrate the teams and the programs, a joint effort which I'm leading with Mark McCamish, the CEO of Forty Seven, with the objectives of keeping things moving smoothly with magrolimab and defining a working model that supports continued innovation.
所以我談到了我們強大的核心業務和推進我們的管道。現在我想談談我們正在做的通過業務發展擴大管道的工作,當然包括本月早些時候完成的對四十七的收購。收購四十七是我們戰略在行動中的一個很好的早期例子。我們說我們將建立在我們的核心專業領域,如你所知,是病毒學和免疫調節,我們將保持高標準,因為我們的業務發展努力集中在臨床階段資產,例如我們獲得的 magrolimab作為此次收購的一部分。我們正在努力整合團隊和項目,這是我與 47 的首席執行官馬克麥卡米甚領導的一項共同努力,目的是讓 magrolimab 的事情順利進行,並定義一個支持持續創新的工作模型。
Next month, researchers will present data on our next-generation cancer therapies virtually at ASCO, including magrolimab and a number of abstracts that highlight the Kite cell therapy portfolio. The presentations at ASCO underscore the strength of our scientific approach in immuno-oncology, and we look forward to sharing this latest research.
下個月,研究人員將在 ASCO 上以虛擬方式展示我們下一代癌症療法的數據,包括 magrolimab 和一些突出 Kite 細胞療法組合的摘要。在 ASCO 上的演講強調了我們在免疫腫瘤學方面科學方法的優勢,我們期待分享這一最新研究。
Beyond Forty Seven, our business development team remains as active as ever. In the last month, we've announced 3 partnerships: a collaboration with Second Genome to identify biomarkers and potential new drug targets in inflammation, a licensing agreement between Kite and TeneoBio covering the dual-targeting CAR-T therapies and a 3-year collaboration with oNKo-innate to discover cancer immunotherapies. Overall, we continue to maintain our momentum, and I'm pleased with all the progress we've made this quarter.
除了四十七,我們的業務開發團隊仍然一如既往地活躍。在上個月,我們宣布了 3 項合作夥伴關係:與 Second Genome 合作確定炎症中的生物標誌物和潛在的新藥靶點,Kite 和 TeneoBio 之間的許可協議涵蓋雙靶點 CAR-T 療法和為期 3 年的合作與 oNKo-innate 一起發現癌症免疫療法。總體而言,我們繼續保持勢頭,我對本季度取得的所有進展感到滿意。
I'll now turn to remdesivir. The study results shared yesterday from the randomized placebo-controlled Phase III NIAID study and from our own open-label Phase III simple study in patients with severe disease are important progress as we seek to understand the role that remdesivir might play in easing the burden of COVID-19 around the world. These trials are part of a suite of clinical trials investigating the effects of remdesivir. We designed the clinical research program to ask multiple questions in parallel, including which groups of patients are most likely to respond and when to treat and for how long. Various study designs were used, from placebo-controlled to open-label, to answer very specific questions in each case. We expected that the answers would emerge around the same time, and that taken together, they would form a clear picture of how remdesivir might best be used for patients.
我現在將轉向瑞德西韋。昨天分享的隨機安慰劑對照 III 期 NIAID 研究和我們自己的針對嚴重疾病患者的開放標籤 III 期簡單研究的研究結果是重要的進展,因為我們試圖了解瑞德西韋在減輕患者負擔方面可能發揮的作用世界各地的 COVID-19。這些試驗是一系列研究瑞德西韋效果的臨床試驗的一部分。我們將臨床研究計劃設計為同時提出多個問題,包括哪些患者組最有可能做出反應、何時治療以及治療多長時間。使用了各種研究設計,從安慰劑對照到開放標籤,以回答每種情況下非常具體的問題。我們預計答案會在大約同一時間出現,並且將它們放在一起,形成一幅清晰的畫面,說明如何最好地將瑞德西韋用於患者。
Yesterday, we answered important questions with the initial results of the NIAID trial and simple trials. The NIAID data demonstrated that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo. The results from the Gilead-sponsored simple study addressed a critical question about dosing. The data from the first of the simple studies showed similar clinical improvements in patients with severe symptoms of COVID-19 regardless of whether they received 5 or 10 days of treatment.
昨天,我們用 NIAID 試驗和簡單試驗的初步結果回答了重要問題。 NIAID 數據表明,接受瑞德西韋治療的 COVID-19 患者比接受安慰劑的類似患者恢復得更快。吉利德贊助的簡單研究的結果解決了有關劑量的關鍵問題。第一項簡單研究的數據顯示,無論接受 5 天還是 10 天的治療,具有嚴重 COVID-19 症狀的患者都有類似的臨床改善。
The ability to shorten duration for severely ill patients is very important. It means patients can go home earlier, hospital resources can be freed up and it has a positive impact, of course, on our supply. We have calculated having 1.5 million doses by the end of May, amounting to 140,000 treatment courses at a 10-day treatment duration. The Gilead simple study suggests we may now be able to significantly increase the number of courses available with a 5-day treatment duration for certain patients. As we announced previously, we are donating our entire existing supply, frankly because this is the right thing to do at this time and the human health need in the pandemic.
縮短重症患者病程的能力非常重要。這意味著患者可以早點回家,可以釋放醫院資源,當然,這對我們的供應也有積極影響。我們計算出到 5 月底有 150 萬劑,在 10 天的治療時間內達到 140,000 個療程。吉利德的簡單研究表明,我們現在可以顯著增加某些患者的 5 天治療持續時間的課程數量。正如我們之前宣布的那樣,坦率地說,我們將捐贈現有的全部供應品,因為這是目前正確的做法,也是大流行期間人類健康的需要。
As you know, we've been ramping up production since January. We've significantly reduced lead times and expanded our global network of partners. As additional raw materials come available, we'll have an exponential increase in supplies towards the latter half of this year. We hope to have produced enough supply to treat over 1 million patients by year-end.
如您所知,自 1 月以來我們一直在提高產量。我們大大縮短了交貨時間並擴大了我們的全球合作夥伴網絡。隨著更多原材料的供應,我們將在今年下半年的供應量呈指數級增長。我們希望在年底之前生產出足夠的供應來治療超過 100 萬名患者。
We are also working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production. It will be essential for countries to work together to create enough supply for people all over the world, and we look forward to these collaborative efforts.
我們還致力於建立一個全球製藥和化學品製造商聯盟,以擴大全球產能和生產。各國必須共同努力,為全世界人民創造足夠的供應,我們期待著這些合作努力。
For access and allocation, we'll work closely with governments and health care systems to provide access. We intend to allocate our available supply based on guiding principles that aim to direct global access for appropriate patients in urgent need of treatment. We recognize there's a lot of work left to be done and a long way to go in finding medical solutions to end the pandemic, and we'll continue to work with regulatory authorities on the best path forward for remdesivir. At the same time, all of us at Gilead are relieved and grateful that our efforts on remdesivir have led to this important progress at a time when we all need a beacon of hope.
對於訪問和分配,我們將與政府和醫療保健系統密切合作以提供訪問。我們打算根據指導原則分配我們的可用供應,這些指導原則旨在為急需治療的適當患者提供全球訪問。我們認識到還有很多工作要做,在尋找結束大流行的醫療解決方案方面還有很長的路要走,我們將繼續與監管機構合作,為瑞德西韋尋找最佳前進道路。與此同時,吉利德的所有人都感到欣慰和感激,因為我們在瑞德西韋方面的努力在我們都需要希望的燈塔的時候取得了這一重要進展。
Before I turn the call over to Andy, I want to reiterate how grateful we are for the partnership with many groups outside Gilead to support the work on remdesivir. The collaboration throughout this pandemic has been critical
在我把電話轉給安迪之前,我想重申我們非常感謝與吉利德以外的許多團體合作支持瑞德西韋的工作。在整個大流行期間的合作至關重要
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Andrew D. Dickinson - Executive VP & CFO
Andrew D. Dickinson - Executive VP & CFO
It sounds like we lost Dan. I'll just finish his -- I'll finish Dan's comments. We also want to say how proud we are of the way our employees have demonstrated such dedication to meeting the needs of patients, those with COVID-19 as well as those with conditions including HIV, viral hepatitis and cancer, who depend on us for their medications. So with that, I will turn to our financial comments, and then we'll move to Q&A.
聽起來我們失去了丹。我將完成他的——我將完成 Dan 的評論。我們還想說,我們對我們的員工表現出如此奉獻精神來滿足患者、COVID-19 患者以及患有 HIV、病毒性肝炎和癌症等疾病的患者的需求感到非常自豪,他們依賴於我們的治療藥物。因此,我將轉向我們的財務評論,然後我們將轉向問答環節。
Good afternoon, everyone. My name is Andy Dickinson. I'm the company's CFO. Before I start, I'd also like to acknowledge the incredible work of our 12,000 employees and what they're doing during these challenging times. Their dedication and resilience is really inspiring. In addition, from the outset, I'd like to emphasize that our core business is very strong, durable and provides a solid foundation to navigate the current environment.
大家下午好。我叫安迪·狄金森。我是公司的首席財務官。在開始之前,我還要感謝我們 12,000 名員工所做的出色工作,以及他們在這些充滿挑戰的時期所做的工作。他們的奉獻精神和韌性真的很鼓舞人心。此外,從一開始,我想強調的是,我們的核心業務非常強大、持久,並為駕馭當前環境提供了堅實的基礎。
We continue to have confidence in 2020 and beyond. The pandemic has not diminished that view at all, and we remain confident in our long-term outlook. I'd like to first briefly share some commentary on our very strong first quarter results, and I'll remind you that the earnings materials posted on our website contain all of the details, including preliminary color on the impact of COVID-19 on our business to date as well as our preliminary expectations for the coming months. We are happy to walk through the results and the impact of COVID-19 on our business to date in detail during the Q&A session.
我們對 2020 年及以後繼續充滿信心。大流行並沒有削弱這種觀點,我們對我們的長期前景仍然充滿信心。我想首先簡要分享一些關於我們非常強勁的第一季度業績的評論,我會提醒您,我們網站上發布的收益材料包含所有詳細信息,包括關於 COVID-19 對我們的影響的初步顏色迄今為止的業務以及我們對未來幾個月的初步預期。我們很高興在問答環節詳細介紹 COVID-19 迄今為止的結果和對我們業務的影響。
Starting with our revenues for the quarter. Total revenues for the first quarter were $5.5 billion, with non-GAAP earnings of $1.68 per diluted share. This compares to revenue of $5.3 billion with non-GAAP earnings of $1.67 per diluted share for the same period last year. Product sales for the first quarter were $5.5 billion, down 6% sequentially and up 5% year-over-year. I'd like to call out that we believe approximately $200 million of revenues were pulled forward in Q1, primarily for our HIV franchise, due to the COVID-19 pandemic across the U.S. and Europe. This was the result of payers and pharmacies providing greater access to medicines by allowing 90-day refills and in some cases early refills, among other offerings. We expect this to reverse itself out over subsequent quarters.
從我們本季度的收入開始。第一季度總收入為 55 億美元,非 GAAP 每股攤薄收益為 1.68 美元。相比之下,去年同期非美國通用會計準則每股攤薄收益為 1.67 美元,收入為 53 億美元。第一季度產品銷售額為 55 億美元,環比下降 6%,同比增長 5%。我想指出,由於美國和歐洲的 COVID-19 大流行,我們認為第一季度的收入增加了約 2 億美元,主要用於我們的 HIV 特許經營權。這是付款人和藥房通過允許 90 天續藥和在某些情況下提前續藥以及其他產品提供更多藥物獲取的結果。我們預計這會在隨後的幾個季度自行逆轉。
Now turning to our expenses. Non-GAAP R&D expense was $1 billion for the quarter, up 8% compared to the same period last year primarily due to the ramp-up of remdesivir, including manufacturing scale-up and clinical trial costs. Non-GAAP SG&A expense was $1.1 billion, up 4% compared to the same period last year, primarily due to higher promotional expenses in the United States related to our HIV products.
現在轉向我們的開支。本季度非 GAAP 研發費用為 10 億美元,比去年同期增長 8%,這主要是由於瑞德西韋的增加,包括生產規模擴大和臨床試驗成本。非 GAAP SG&A 費用為 11 億美元,比去年同期增長 4%,這主要是由於在美國與我們的 HIV 產品相關的促銷費用增加。
As Dan highlighted, we completed our acquisition of Forty Seven this month. We currently expect to incur approximately $120 million in expenses this year related to Forty Seven, primarily in research and development. In addition, I'd like to highlight that the acquisition qualifies as an asset acquisition, and as a result we currently expect to incur approximately $4.8 billion in GAAP R&D expense primarily related to in-process research and development.
正如丹強調的那樣,我們本月完成了對四十七的收購。我們目前預計今年與四十七相關的費用約為 1.2 億美元,主要用於研發。此外,我想強調此次收購符合資產收購的條件,因此我們目前預計將產生約 48 億美元的 GAAP 研發費用,主要與正在進行的研發有關。
Turning to our strong balance sheet. During the quarter, we generated $1.4 billion in cash from operations. We ended the quarter with $24.3 billion in cash and marketable debt securities. We repaid $500 million of debt, paid cash dividends of $874 million and repurchased 19 million shares of stock for $1.3 billion. I want to note that we paid approximately $4.9 billion in cash upon closing of Forty Seven in April.
轉向我們強大的資產負債表。本季度,我們從運營中產生了 14 億美元的現金。本季度結束時,我們擁有 243 億美元的現金和有價債務證券。我們償還了 5 億美元的債務,支付了 8.74 億美元的現金股息,並以 13 億美元的價格回購了 1900 萬股股票。我想指出的是,我們在四月份關閉四十七時支付了大約 49 億美元的現金。
Our strong balance sheet and disciplined allocation of capital has positioned us to continue to grow and build our business despite current environment and associated risk. We remain very confident in the durability of our business and expect to generate significant operating cash flow during 2020.
儘管當前環境和相關風險,我們強大的資產負債表和嚴格的資本分配使我們能夠繼續發展和建立我們的業務。我們對我們業務的持久性仍然充滿信心,並期望在 2020 年產生可觀的經營現金流。
I'll turn now to COVID-19 and its impact on our business. Like others, we have anticipated that there could be a short-term financial impact to our company and to the sector as a whole. We continue to carefully review our results to assess the potential magnitude of that impact. Towards the end of the quarter and in April, we did begin to see some effects on our business, primarily as fewer patients accessed health care and the number of new starts in HCV and HIV prevention began to slow. However, to date, the overall effect on our business has been modest, and it remains unclear what the ultimate impact will be. Given the significant uncertainty regarding the duration and magnitude of the COVID-19 pandemic, we are actively planning for a number of scenarios, and we'd like to focus on our base case assumptions today, which we are making from data drawn from a number of sources, including epidemiologists, economists and public health officials.
現在我將談談 COVID-19 及其對我們業務的影響。與其他人一樣,我們預計這可能會對我們公司和整個行業產生短期財務影響。我們將繼續仔細審查我們的結果,以評估該影響的潛在規模。在本季度末和 4 月,我們確實開始看到對我們業務的一些影響,主要是因為獲得醫療保健的患者越來越少,HCV 和 HIV 預防的新開始數量開始放緩。然而,迄今為止,對我們業務的總體影響不大,最終影響是什麼仍不清楚。鑑於 COVID-19 大流行的持續時間和規模存在很大的不確定性,我們正在積極規劃多種情景,我們今天想重點關注我們的基本案例假設,這些假設是我們根據從一些數據中得出的數據得出的消息來源,包括流行病學家、經濟學家和公共衛生官員。
First, these base case assumptions suggest that pandemic will peak between March and July. We would point to recent data from Johns Hopkins, which show trends reflecting a slowing of the rate of new cases since late March in the United States and a declining number of new cases in some critically affected regions of the world.
首先,這些基本情況假設表明大流行將在 3 月至 7 月之間達到頂峰。我們要指出的是約翰霍普金斯大學最近的數據,這些數據顯示的趨勢反映了自 3 月下旬以來美國新病例增長速度放緩,以及世界上一些受嚴重影響地區的新病例數量下降。
Second, if the virus returns in the fall or winter, the impact will be lessened due to preparedness and, hopefully, the emergence of therapeutics including potentially our own remdesivir. Third, the global economy will begin a recovery late in Q2 and return to the pre-COVID dynamics will be underway by year-end.
其次,如果病毒在秋季或冬季捲土重來,由於做好了準備,並且有望出現包括我們自己的瑞德西韋在內的治療方法,影響將會減弱。第三,全球經濟將在第二季度末開始復蘇,並在年底前恢復到 COVID 前的動態。
We have of course considered external views that anticipate more and less favorable scenarios, but we believe this base case provides the best foundation at this time to plan in this uncertain situation.
我們當然已經考慮了預期更多和更不利情景的外部觀點,但我們相信這個基本案例為目前在這種不確定情況下進行計劃提供了最好的基礎。
Let me share a few qualitative perspectives on potential business implications of this scenario. Please bear in mind the forward-looking statement disclosures we shared at the beginning of the call. I'd also like to highlight again that we have added significant commentary throughout the investor presentation that's posted on our website, and we would encourage you to review those materials.
讓我就此場景的潛在業務影響分享一些定性觀點。請記住我們在電話會議開始時分享的前瞻性聲明披露。我還想再次強調,我們在我們網站上發布的整個投資者介紹中添加了重要評論,我們鼓勵您查看這些材料。
There are 3 key takeaways from our perspective: first, we had a very strong quarter; second, to date, the impact on our business has been modest; and third, we remain very confident in our long-term outlook. That said, on the commercial side, driven by lessened health care provider access and fewer patient visits, we may see revenues adversely impacted in Q2 and potentially beyond. This would likely be different across our franchises, with our HCV franchise disproportionately affected due to the acute care nature of that therapy. We believe that the majority of any revenue decrease in HCV revenue due to the pandemic could be recouped in a warehousing-type effect later in 2020 or into 2021.
從我們的角度來看,有 3 個關鍵要點:首先,我們有一個非常強勁的季度;其次,迄今為止,對我們業務的影響不大;第三,我們對我們的長期前景仍然充滿信心。也就是說,在商業方面,由於醫療保健提供者訪問減少和患者就診次數減少,我們可能會看到第二季度及以後的收入受到不利影響。這在我們的特許經營中可能會有所不同,由於該療法的急性護理性質,我們的 HCV 特許經營受到不成比例的影響。我們認為,大流行導致的 HCV 收入減少的大部分都可以在 2020 年晚些時候或 2021 年通過倉儲式效應得到彌補。
In HIV, early signals suggest that switches both for treatment and prevention patients may be impacted by COVID-19 as people defer health care visits. Specifically, in April, we are observing reductions in Descovy for PrEP initiations and lower switch volume. PrEP refills may also be affected, but it's still too early to fully understand any trends here. In contrast, our HIV treatment business is less likely to be significantly impacted as we believe patients will continue to prioritize refilling their prescriptions and access their physicians through telemedicine.
在 HIV 中,早期信號表明,隨著人們推遲就醫,治療和預防患者的轉換可能會受到 COVID-19 的影響。具體來說,在 4 月,我們觀察到用於 PrEP 啟動的 Descovy 減少和較低的轉換量。 PrEP 補充劑也可能受到影響,但現在完全了解這裡的任何趨勢還為時過早。相比之下,我們的 HIV 治療業務不太可能受到重大影響,因為我們相信患者將繼續優先考慮重新配藥並通過遠程醫療聯繫他們的醫生。
In cell therapy, reduced access to authorized treatment centers could, unfortunately, result in critically ill patients having access challenges, which would impact the business.
不幸的是,在細胞療法中,減少進入授權治療中心的機會可能會導致重症患者難以進入,這將影響業務。
Turning to clinical development. Like many others in our industry, we are pausing enrollment for most trials. The exception to this is studies where patient outcomes are critically impacted, such as trials of our HIV capsid inhibitor in heavily pretreated individuals who have few other treatment options and some of our Kite programs that have enrolled patients with cancer who are critically ill. Enrollment in these studies is at the discretion of the investigators.
轉向臨床開發。與我們行業中的許多其他人一樣,我們暫停了大多數試驗的註冊。例外情況是患者結果受到嚴重影響的研究,例如我們的 HIV 衣殼抑製劑在經過大量預處理且幾乎沒有其他治療選擇的個體中進行的試驗,以及我們的一些 Kite 項目招募了危重癌症患者。是否參加這些研究由研究人員自行決定。
Overall, we expect reduced clinical development expenses in the short term. In addition, the dynamic could lead to delays in potential approvals for pipeline assets over the longer run. With challenge brings opportunity to help, and as Dan described earlier, we are excited by emerging results on remdesivir as a potential therapy for COVID-19.
總體而言,我們預計短期內臨床開發費用會減少。此外,從長遠來看,這種動態可能導致管道資產的潛在批准延遲。挑戰帶來幫助的機會,正如 Dan 之前所述,我們對瑞德西韋作為 COVID-19 潛在療法的新結果感到興奮。
As we ramp up further development and manufacturing of remdesivir, we will incur additional costs beyond those forecast at the beginning of the year. The magnitude of this investment is dependent on the continued evolution of the data, the duration of the pandemic and other factors. The potential range of this investment for 2020 is up to $1 billion, and the accounting treatment of this investment is dependent upon a number of factors, including potential regulatory approvals. Where authorized by regulatory authorities, Gilead will focus on making remdesivir both accessible and affordable to governments and patients around the world.
隨著我們加大瑞德西韋的進一步開發和製造力度,我們將產生超出年初預測的額外成本。這項投資的規模取決於數據的持續演變、大流行的持續時間和其他因素。 2020 年這項投資的潛在範圍高達 10 億美元,這項投資的會計處理取決於許多因素,包括潛在的監管批准。在獲得監管機構授權的情況下,吉利德(Gilead)將專注於讓世界各地的政府和患者都能獲得和負擔得起瑞德西韋。
Given the continued uncertainty in the trajectory of the pandemic and in remdesivir clinical data, it's premature to define what the right postdonation business model is to create a sustainable long-term supply for global needs. In the context of a strong underlying business in Q1 results, we will continue to monitor the situation and expect to provide additional insights and outlook on our Q2 earnings call.
鑑於大流行軌跡和瑞德西韋臨床數據的持續不確定性,現在定義正確的捐贈後商業模式是什麼來為全球需求創造可持續的長期供應還為時過早。在第一季度業績強勁的基礎業務的背景下,我們將繼續監測情況,並期望在我們的第二季度財報電話會議上提供更多的見解和展望。
I'd like to close by thanking our team for their extraordinary efforts and for delivering a very strong first quarter during these challenging times. We can now turn the call over to Q&A. Operator?
最後,我想感謝我們的團隊付出的非凡努力,感謝他們在這些充滿挑戰的時期提供了非常強勁的第一季度業績。我們現在可以將通話轉為問答環節。操作員?
Operator
Operator
(Operator Instructions) And our first question comes from the line of Michael Yee with Jefferies.
(操作員說明)我們的第一個問題來自 Michael Yee 與 Jefferies 的合作。
Michael Jonathan Yee - Equity Analyst
Michael Jonathan Yee - Equity Analyst
Dan, if you're there, obviously, I'm sure everyone would (technical difficulty)
丹,如果你在那裡,顯然,我相信每個人都會(技術難度)
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes, I'm back.
是的,我回來了。
Michael Jonathan Yee - Equity Analyst
Michael Jonathan Yee - Equity Analyst
My question is -- Dan, so my question is for you guys on remdesivir as it relates to (technical difficulty) can you just describe the inputs into how to think about what revenue [impact to] the positive remdesivir could have this year? What are the impacts on that, inputs into that? On expenses, you guys obviously don't (technical difficulty) expense guidance, you kind of walked through that. You described the (technical difficulty) dollars for remdesivir. Maybe just walk through the inputs there and how to think about why would it be on the low [end]? And comment on that because it makes the model (technical difficulty). So talk to that, to remdesivir.
我的問題是 - 丹,所以我的問題是關於瑞德西韋的問題,因為它與(技術困難)有關,你能描述一下如何考慮積極的瑞德西韋今年可能產生的收入 [影響] 嗎?對此有何影響,對此有何投入?在費用方面,你們顯然沒有(技術難度)費用指導,你們已經完成了。您描述了瑞德西韋的(技術難度)美元。也許只是瀏覽那裡的輸入,以及如何思考為什麼它會處於低[端]?並對此發表評論,因為它製作了模型(技術難度)。因此,請談談瑞德西韋。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thanks, Michael. I appreciate the question. And sorry, guys, that I got to cut off there before. Thanks, Andy, for picking up. And the only thing I want to conclude with as my comments is probably the most important comment, is to really thank the colleagues throughout Gilead that are working on remdesivir and non-remdesivir projects alike. They've really kept the momentum going in quarter 1, and I'm humbled and proud to be working with them. So Michael, thank you for the call. On the revenue side, it is just -- as Andy mentioned also, and I mentioned, it's too premature. There's a lot of moving parts right now. Our focus will be on making sure we come up with a sustainable model that allows us to provide remdesivir to patients around the globe that is intent on providing access and affordability. We're just now going through the clinical data, the demand scenarios, the regulatory approvals. All these things are essential for us to put inputs into our plan about how that will work post the donation. So we can't really give more insight into that at this stage. But certainly, when we can, we will.
謝謝,邁克爾。我很欣賞這個問題。對不起,伙計們,我之前必須在那里切斷。安迪,謝謝你來接我。作為我的評論可能是最重要的評論,我唯一想做的總結是,真正感謝整個吉利德公司的同事們,他們都在研究 remdesivir 和非 remdesivir 項目。他們確實在第一季度保持了勢頭,我很謙虛也很自豪能和他們一起工作。邁克爾,謝謝你的來電。在收入方面,就像安迪也提到的那樣,我也提到過,這還為時過早。現在有很多活動部件。我們的重點將是確保我們提出一個可持續的模式,使我們能夠為全球患者提供 remdesivir,旨在提供可及性和可負擔性。我們剛剛正在研究臨床數據、需求場景和監管批准。所有這些對於我們在捐贈後如何運作的計劃中投入投入都是必不可少的。因此,在現階段我們無法真正深入了解這一點。但可以肯定的是,當我們可以的時候,我們會的。
And on the expense side, Andy, I mean obviously you had mentioned already that up to $1 billion and unclear on how the accounting will occur, but perhaps you want to add something else to Michael's question?
在費用方面,安迪,我的意思是你顯然已經提到了高達 10 億美元,但不清楚會計將如何發生,但也許你想對邁克爾的問題添加其他內容?
Andrew D. Dickinson - Executive VP & CFO
Andrew D. Dickinson - Executive VP & CFO
Sure, Michael. At this point, it's too early to tell you where that's going to fall in the P&L, as there are a number of scenarios. It could -- those expenses could fall into cost of goods sold. As you know, they could be R&D expenses, and in some scenarios a portion of them could also be SG&A expenses. So at a high level, the expenses that we're referencing, as you would expect, come from manufacturing, predominantly, and to a lesser extent clinical trials. And I think that's our best good faith estimate at this time based on what we know in terms of the expenses that we see as we ramp up over the year. And we'll do everything we can to provide more color and commentary, in particular, on our Q2 earnings call.
當然,邁克爾。在這一點上,現在告訴您損益表的位置還為時過早,因為存在多種情況。它可以 - 這些費用可能屬於銷售商品的成本。如您所知,它們可能是研發費用,在某些情況下,其中一部分也可能是 SG&A 費用。因此,在高層次上,正如您所期望的那樣,我們所參考的費用主要來自製造,並且在較小程度上來自臨床試驗。我認為這是我們目前最好的誠信估計,基於我們在一年中增加的費用方面所了解的情況。我們將盡我們所能提供更多的顏色和評論,特別是在我們的第二季度財報電話會議上。
Michael Jonathan Yee - Equity Analyst
Michael Jonathan Yee - Equity Analyst
I appreciate it. $1 billion of expenses and not knowing the revenue. It's an interesting position. Appreciate it.
我很感激。 10 億美元的支出,卻不知道收入。這是一個有趣的位置。欣賞它。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thanks, Michael.
謝謝,邁克爾。
Operator
Operator
Our next question comes from the line of Cory Kasimov with JPMorgan.
我們的下一個問題來自摩根大通的 Cory Kasimov。
Cory William Kasimov - Senior Biotechnology Analyst
Cory William Kasimov - Senior Biotechnology Analyst
Wanted to also ask on remdesivir, no surprise. I was wondering if you could talk about the formulation work that's underway to potentially develop an oral and/or an inhaled version of the product. Like how far along might you be on this front? And when can we expect to see something more there?
還想問問關於瑞德西韋的問題,這並不奇怪。我想知道您是否可以談談正在進行的可能開發該產品的口服和/或吸入版本的配方工作。比如你在這方面能走多遠?我們什麼時候可以在那裡看到更多東西?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. Thanks, Cory. I'll start out and maybe others on the call want to add. But our focus, as you can imagine, since January, has been on ramping up the supply, particularly so that we have the lyophilized version that's appropriate for intravenous administration, the clinical program, all of that. So that's really where we've been. At the same time though, we have had a team -- just as with everything with this program, including the supply, we've had teams that have been really, since the very day 1 in January, been focusing on success. And so if successful, what -- how else could we potentially develop this medicine. I think that's been taken into account from the totality of the clinical trial program, looking at both critical, severe and moderate patients. But likewise, we've done the same thing with other alternative delivery mechanisms, presuming success, that might make it more convenient for patients or allow us to broaden the patient group that can benefit from a successful antiviral. And that work is, as you can imagine, still early, but we can say a couple of things. It's not -- this particular medicine, because it's heavily first-pass metabolized in the liver, is not really appropriate as an oral formulation.
是的。謝謝,科里。我會開始,也許電話中的其他人想要添加。但是,正如您想像的那樣,自 1 月以來,我們的重點一直是增加供應,特別是為了讓我們擁有適合靜脈注射、臨床計劃等所有這些的凍乾版本。這就是我們去過的地方。但與此同時,我們有一個團隊——就像這個項目的所有事情一樣,包括供應,我們有真正的團隊,從 1 月的第一天開始,就一直專注於成功。因此,如果成功,我們還能如何開發這種藥物。我認為從整個臨床試驗計劃中都考慮到了這一點,研究對象包括危重、重度和中度患者。但同樣,我們已經對其他替代遞送機製做了同樣的事情,假設成功,這可能會讓患者更方便,或者讓我們擴大可以從成功的抗病毒藥物中受益的患者群體。正如你想像的那樣,這項工作還很早,但我們可以說幾件事。它不是——這種特殊的藥物,因為它在肝臟中大量的首過代謝,並不適合作為口服製劑。
We've known that for years, probably a decade. But we are looking into things like subcutaneous formulations and potentially inhaled formulations. And although it's too premature to give you time lines on that, rest assured that we are -- we've been actively working on those. And as soon as we can give some time lines, we will. To see now, particularly because of the efficacy that we've seen this week, we'll continue to pursue those with a great sense of urgency. But time line is a little premature. Just know that we've been working on it now for several months. I don't know, Merdad, if you want to add anything? You're okay, good. Merdad is okay. Is that okay, Cory? I know you need more, but we'll give you more as soon as we can.
我們知道這一點已經很多年了,可能是十年了。但我們正在研究諸如皮下製劑和可能的吸入製劑之類的東西。儘管現在就此給出時間表還為時過早,但請放心,我們一直在積極努力。一旦我們可以給出一些時間表,我們就會。現在來看,特別是因為我們本週看到的效果,我們將繼續以強烈的緊迫感追求那些。但時間線有點早。只知道我們已經為此工作了幾個月。我不知道,Merdad,如果你想補充什麼?你沒事,很好。默達德還行。可以嗎,科里?我知道你需要更多,但我們會盡快給你更多。
Cory William Kasimov - Senior Biotechnology Analyst
Cory William Kasimov - Senior Biotechnology Analyst
No, no, fair enough. I appreciate you answering the question, and good luck with continued progress there.
不,不,很公平。感謝您回答這個問題,並祝您在那裡繼續取得進展好運。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thank you, Cory.
謝謝你,科里。
Operator
Operator
And our next question comes from the line of 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
2 questions on remdesivir, if I could, and appreciate all the work that you guys are doing to bring this treatment to patients. First off, on the NIAID study, can you give us any sense of the proportion of patients who are involved in the interim? Is there any additional update that we should be expecting that could be a gating factor to availability and your level of confidence that differences in baseline risk factors didn't influence those results as may have happened in the China study? And then just secondly, related to supply, any particular subsets of patients across the studies where you may be seeing the most optimal benefits that you might consider working with regulators to direct the agent to while you're scaling up?
2 個關於瑞德西韋的問題,如果可以的話,感謝你們為將這種治療帶給患者所做的所有工作。首先,關於 NIAID 研究,你能告訴我們參與過渡期的患者比例嗎?是否有任何我們應該期待的額外更新,這可能是可用性的門控因素,以及您對基線風險因素的差異不會影響這些結果的信心程度,就像在中國研究中可能發生的那樣?其次,與供應相關,在研究中您可能會看到您可能會考慮與監管機構合作以在您擴大規模時指導代理人的最佳利益的任何特定患者子集?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. Thanks, Brian. Sorry, just to be clear on your second one related to supply, you said is there any subset of patients? Can you just complete that one more time?
是的。謝謝,布萊恩。抱歉,關於您的第二個與供應相關的問題,您說的是有任何患者子集嗎?你能再完成一次嗎?
Brian Corey Abrahams - Senior Biotechnology Analyst
Brian Corey Abrahams - Senior Biotechnology Analyst
Yes. Any subset of patients where you might be seeing more benefits, more optimal benefits across the study where you might consider working with regulators to try and direct the agent to initially as supply gets...
是的。在整個研究中,您可能會看到更多益處、更多最佳益處的任何患者子集,您可能會考慮與監管機構合作,嘗試將代理人引導至最初供應獲得……
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
In terms of like an allocation. Yes, with limited allocation.
就好像一個配置而言。是的,分配有限。
Unidentified Company Representative
Unidentified Company Representative
Or limited (inaudible).
或有限(聽不清)。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes, got it, got it. Okay, I'm going to turn it over to Merdad, and I'll let Merdad take a stab at both of those. Please?
是的,明白了,明白了。好的,我將把它交給 Merdad,我會讓 Merdad 嘗試這兩個。請?
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Brian, on the first question -- this is Merdad. On the first question, we have not seen a lot of the baseline demography and the sorts of data that would help in terms of answering your question on the NIAID study. So I think we're all going to have to wait for those data to get published and get put out for us all to review. So I think that's pending, and we'll look for that to come out.
Brian,關於第一個問題——我是 Merdad。關於第一個問題,我們沒有看到很多基線人口統計數據和有助於回答您關於 NIAID 研究的問題的各種數據。所以我認為我們都將不得不等待這些數據發布並發布給我們所有人審查。所以我認為這是懸而未決的,我們會期待它出來。
In terms of patient subsets, I think our data, and if you look at who's been enrolled in the trials overall, I think we're clearly looking at the hospitalized patient population, and we're looking at patients who are requiring supplemental oxygen as the primary population that we're after, including those that may either become ventilated or may start out mechanically ventilated. Certainly, our data support that from our open-label trials. The NIAID study enrolled that breadth of patients, but we have not seen subgroup analyses of the different patient populations to give you clarity there. But we believe it will be in that fairly broad population early on.
就患者子集而言,我認為我們的數據,如果你看看誰參加了整個試驗,我認為我們顯然在看住院患者人數,我們正在看需要補充氧氣的患者我們所追求的主要人群,包括那些可能會變得通風或可能開始使用機械通風的人群。當然,我們的數據支持我們的開放標籤試驗。 NIAID 研究招募瞭如此廣泛的患者,但我們還沒有看到對不同患者群體的亞組分析來讓你清楚地了解這一點。但我們相信它會在早期出現在相當廣泛的人群中。
Operator
Operator
And our next question comes from the line of 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 just want to say great job on the whole -- to the whole team, really, for the -- for remdesivir development. A couple of points here. On COVID-19, have you guys looked at other nukes for earlier-stage patients? Just thinking about 938 or sofosbuvir. I know you guys have a lot probably that is there that could be more applicable to mild-to-moderate patients? And then on remdesivir access, is there a model to license out IP and/or manufacturing? I'm just thinking about how to accelerate perhaps broader access outside the U.S.?
我只想說,總體而言,對整個團隊來說,remdesivir 的開發做得很好。這裡有幾點。關於 COVID-19,你們有沒有為早期患者看過其他核武器?只是考慮 938 或 sofosbuvir。我知道你們有很多可能更適用於輕度至中度患者嗎?然後關於 remdesivir 的訪問,是否有許可 IP 和/或製造的模型?我只是在考慮如何加速美國以外更廣泛的訪問?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. Thanks so much, Geoff, for the thoughts. Everybody at Gilead will appreciate your sentiment. Let's start with COVID and the other nukes. I didn't know whether Merdad or Diana, you want to handle that? I'm not sure how you want to...
是的。非常感謝杰夫的想法。 Gilead 的每個人都會感謝您的意見。讓我們從 COVID 和其他核武器開始。我不知道是 Merdad 還是 Diana,你想處理嗎?我不確定你想怎樣...
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Sure. I think right now -- this is Merdad again, Geoff, thanks for the question. Right now, we do believe that remdesivir is the best molecule and has the best potency against the coronavirus. Anything we do, we look at -- and both we and others have been looking for other molecules that could have potency here. But remdesivir is certainly the most potent molecule that we have, and that's been our focus. We'll certainly keep looking there. One of the reasons we are focused on looking at alternative formulations for remdesivir is to address the question that you asked, which is how can we get to other patient populations who may benefit from the drug as outpatients, for example? And I think in the short run, I would -- I believe that, that's going to be the best -- the short to medium term, I think that will be the best approach for us to go.
當然。我想現在——我又是 Merdad,Geoff,謝謝你提出這個問題。目前,我們確實相信瑞德西韋是最好的分子,對冠狀病毒具有最好的效力。我們所做的任何事情,我們都在觀察——我們和其他人一直在尋找可能在這裡發揮效力的其他分子。但瑞德西韋無疑是我們擁有的最有效的分子,這一直是我們關注的焦點。我們肯定會繼續在那裡尋找。我們專注於尋找瑞德西韋替代製劑的原因之一是為了解決您提出的問題,例如,我們如何才能接觸到可能從該藥物中受益的其他患者群體,例如門診患者?我認為在短期內,我會——我相信,這將是最好的——從短期到中期,我認為這將是我們最好的方法。
And then I think your second question was about manufacturing, right?
然後我認為你的第二個問題是關於製造的,對吧?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. So I mean, Andy, maybe you want to take this question as well because you're leading a group on this.
是的。所以我的意思是,安迪,也許你也想回答這個問題,因為你正在領導一個小組解決這個問題。
Andrew D. Dickinson - Executive VP & CFO
Andrew D. Dickinson - Executive VP & CFO
Yes. And I'd be happy to. Geoff, thanks for your comments. Look, on the manufacturing side, I'd say a couple of things at a high level, is that, again, our primary focus is on providing access to patients around the world. So just like we did with our HIV medicines and HCV medicines, we are deeply focused on this. We are -- we have 2 separate work streams. One is working on our internal supply chain and making sure that we have a robust supply of starting materials, intermediates and a strong manufacturing consortium built with companies around the world. You've seen some of the references to that in Dan's CEO letters, and I would expect that we'll provide some additional information over the coming weeks and months.
是的。我很樂意。傑夫,謝謝你的評論。看,在製造方面,我想說幾件高層次的事情,我們的主要重點是為世界各地的患者提供服務。因此,就像我們對 HIV 藥物和 HCV 藥物所做的那樣,我們非常關注這一點。我們 - 我們有 2 個獨立的工作流。一個是致力於我們的內部供應鏈,確保我們擁有充足的起始材料、中間體供應,以及與世界各地的公司建立強大的製造聯盟。你已經在 Dan 的 CEO 信件中看到了一些對此的引用,我希望我們會在未來幾周和幾個月內提供一些額外的信息。
We do have a second work stream, where we are in discussions with large sophisticated companies around the globe, exploring the potential for other companies to help establish separate end-to-end manufacturing supply chains. The difficulty there, as you might imagine, is that given the scarcity of some of the starting materials, we want to make sure that we don't do anything to impact our supply chain, given that that is the quickest route to getting product to patients who need it all around the world. But we are looking at alternatives. It's too early to give you any specific guidance or to tell you where we're going to land on it. But we are working with a number of companies around the world that you and others know well to see what we could do together and if there's an opportunity to benefit patients in that way. So I'll leave it at that, and then you see...
我們確實有第二個工作流,我們正在與全球大型複雜公司進行討論,探索其他公司幫助建立獨立的端到端製造供應鏈的潛力。正如您可能想像的那樣,那裡的困難在於,鑑於某些起始材料的稀缺性,我們希望確保我們不會做任何影響我們供應鏈的事情,因為這是將產品運送到市場的最快途徑全世界需要它的患者。但我們正在尋找替代方案。現在給你任何具體指導或告訴你我們將在哪裡著陸還為時過早。但我們正在與世界各地的許多公司合作,您和其他人都非常了解這些公司,看看我們可以一起做些什麼,以及是否有機會以這種方式使患者受益。所以我會把它留在那兒,然後你會看到......
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
That's great, Andy, and appreciate your leadership there with your business development head on working with manufacturing. I would just add that we've been a student of other small molecules in this type of setting, whether it's Tamiflu in the past, in terms of kind of the scale-up and stockpiling that occurred there, or students of our own work, if you like, within our HIV portfolio between the developed and the developing world. So we're putting all that knowledge to work as we think about moving fast and wide in terms of our ability to produce supply, but also thinking very thoughtfully about a global footprint here which would allow for this to, as Andy said, have different geographic representation, which we think is going to be really important. So more to come on that, but we've had teams really focused on that day and night for the past several months, just to give you an idea of that. Thanks, Geoff.
太好了,安迪,感謝你在業務發展方面的領導能力,以及與製造業的合作。我只想補充一點,我們一直是此類環境中其他小分子的學生,無論是過去的達菲,就那裡發生的放大和儲存的種類而言,還是我們自己工作的學生,如果您願意,可以在我們的發達國家和發展中國家之間的 HIV 組合中進行。因此,我們正在將所有這些知識付諸實踐,因為我們考慮在我們的生產供應能力方面快速而廣泛地發展,同時也非常周到地考慮在這裡的全球足跡,正如安迪所說,這將允許它具有不同的地理代表性,我們認為這將非常重要。所以還有更多的事情要做,但在過去的幾個月裡,我們的團隊真的日夜專注於這一點,只是為了讓你了解這一點。謝謝,傑夫。
Operator
Operator
And our next question comes from the line of Geoffrey Porges with SVB Leerink.
我們的下一個問題來自 Geoffrey Porges 與 SVB Leerink 的對話。
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
And I can't help echo the comments and appreciate all the great communication as well, from Dan on down. So on remdesivir, I'll ask a controversial question, perhaps no surprise. But Dan, Gilead has generated attractive returns for investors and an attractive return on capital from treating hepatitis C and potentially nearly eliminating hepatitis C, from treating HIV and turning it into a chronic disease, and for building a really important global stockpile of an antiviral for influenza. So what's special about COVID? Should we assume that the capital returns or the profitability for providing a global treatment for COVID long-term after the first 200,000 or 300,000 courses are provided on a donation basis, should we assume the returns are going to be similar to the returns that you've generated in other parts of the business?
我忍不住贊同這些評論,並感謝所有偉大的交流,從 Dan 開始。所以關於瑞德西韋,我會問一個有爭議的問題,也許並不奇怪。但丹,吉利德已經為投資者帶來了誘人的回報,並通過治療丙型肝炎和可能幾乎消除丙型肝炎、治療艾滋病毒並將其轉變為慢性病以及建立真正重要的全球抗病毒藥物儲備來獲得誘人的資本回報。流感。那麼 COVID 有什麼特別之處呢?我們是否應該假設在捐贈的基礎上提供前 200,000 或 300,000 門課程後長期為 COVID 提供全球治療的資本回報或盈利能力,我們是否應該假設回報將與您的回報相似?在業務的其他部分產生了?
And then just quickly, can you give us an update on filgotinib? And can you launch this on a virtual basis? Or do you expect to be out of a virtual basis by the time that approval comes?
然後很快,你能給我們介紹一下 filgotinib 的最新情況嗎?你能在虛擬的基礎上啟動這個嗎?還是您希望在獲得批准時脫離虛擬基礎?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Terrific. So Johanna, I'll let you handle the filgotinib, but let me start with your first question, Geoff, and thanks again. And obviously, we are conscious of the fact that this is unique and this is different. You mentioned some parallels to HIV, HCV, even Tamiflu. But there's been no other time like this in the history of the planet that any of us have been alive, in terms of the far-reaching effect of this pandemic, both medically, from a patient perspective most importantly, but also economically. And so I think there is no guidebook out there. There is no rule book out there other than that we need to be very thoughtful about how we can make sure we provide access of our medicine to patients around the globe and do that in a sustainable way for the company, for you as shareholders, and we acknowledge that.
了不起。所以 Johanna,我會讓你處理 filgotinib,但讓我從你的第一個問題開始,Geoff,再次感謝。顯然,我們意識到這是獨一無二的,這是不同的。你提到了與 HIV、HCV,甚至達菲的一些相似之處。但是,就這種流行病的深遠影響而言,在這個星球的歷史上,我們還沒有過這樣的時刻,最重要的是,從患者的角度來看,還有經濟上的影響。所以我認為那裡沒有指南。除了我們需要非常周到地考慮如何確保我們為全球患者提供我們的藥物並以可持續的方式為公司、作為股東的您以及我們承認這一點。
And so point's well taken. And I would -- I guess, the short answer to your question is, I don't think there is a precedent for this. And so we understand our responsibility, and we understand our responsibility to a variety of different audiences as we approach this. So we'll be working back with you, and we'll certainly be getting feedback from different individuals as we evolve this and as we understand more data around this. But rest assured, we understand our responsibility.
所以這一點很好。我想——我想,對你的問題的簡短回答是,我認為沒有這方面的先例。因此,我們了解我們的責任,並且我們了解我們在處理此問題時對各種不同受眾的責任。因此,我們將與您合作,並且隨著我們對此進行改進以及了解更多有關此的數據,我們肯定會從不同的人那裡獲得反饋。但請放心,我們了解我們的責任。
With that, I'm going to turn it over to Johanna, please, to talk a little bit about filgotinib.
有了這個,我將把它交給 Johanna,請談談 filgotinib。
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
Sure. So Geoffrey, I think just a quick update on filgo. We basically have hired all of our home office personnel, both from a commercial and medical standpoint. We've hired our sales leadership, field leadership as well. And we're monitoring the situation really closely, to be honest with you, because nobody really knows when this ends or what's the new normal and when that begins. And so we're just kind of monitoring that and planning for success, to be honest with you, to make sure that we are ready for launch for the second half of 2020 across all the markets where we will get -- we hope to get regulatory approval, with the U.S., Japan as well as Europe towards the end of this year.
當然。所以 Geoffrey,我想只是對 filgo 的快速更新。從商業和醫療的角度來看,我們基本上已經僱用了所有在家辦公的人員。我們還聘請了銷售領導和現場領導。老實說,我們正在密切關注局勢,因為沒有人真正知道這種情況何時結束,什麼是新常態以及何時開始。因此,老實說,我們只是在監控併計劃成功,以確保我們已準備好在 2020 年下半年在我們將獲得的所有市場上推出——我們希望獲得美國、日本和歐洲將於今年年底獲得監管批准。
I think from a virtual launch standpoint, I think those are considerations that we're looking at in scenario planning, and we haven't made a decision. Obviously that will be linked to the timing of this pandemic.
我認為從虛擬發布的角度來看,我認為這些是我們在場景規劃中考慮的因素,我們還沒有做出決定。顯然,這將與這次大流行的時間有關。
Having said that, I will also tell you that a lot of our teams are doing virtual right now. Many of the markets are doing remote detailing, virtual speaker programs, et cetera, and working through this environment despite, obviously, the offices and patients not being open at this point in time. So we're working through all that and looking at the different scenarios. But I think we need to know a little bit more information on the timing of this pandemic and how that plays out towards the end of this year.
話雖如此,我還要告訴你,我們的很多團隊現在都在做虛擬的。許多市場都在進行遠程細節設計、虛擬揚聲器程序等,並在這種環境下工作,儘管很明顯,辦公室和患者目前還沒有開放。所以我們正在研究所有這些並研究不同的場景。但我認為我們需要了解更多關於這種流行病發生時間的信息,以及它在今年年底前的表現。
Operator
Operator
And our next question comes from the line of Matthew Harrison with Morgan Stanley.
我們的下一個問題來自 Matthew Harrison 與摩根士丹利的對話。
Matthew Kelsey Harrison - Executive Director
Matthew Kelsey Harrison - Executive Director
And thanks for all your work with remdesivir. I'm going to ask 2 on HIV. One, can you just talk a little bit about PrEP conversion with Descovy? I think you said you're at 38%, which is actually fairly close to the target you guys were talking about. Do you think you can do better than that or not this year? And then I also noticed in the back of the slides, you were talking about a long-acting bictegravir that you're putting into clinical studies. Maybe you could comment on that.
感謝您為瑞德西韋所做的所有工作。我要問 2 關於 HIV 的問題。第一,您能談談使用 Descovy 進行 PrEP 轉化嗎?我想你說你是 38%,這實際上非常接近你們談論的目標。你認為今年你能做得更好嗎?然後我還注意到在幻燈片的後面,你在談論一種你正在投入臨床研究的長效 bictegravir。也許你可以對此發表評論。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Terrific. Thank you so much, Matthew, for the comment. So Johanna, yes, why don't you start? And perhaps Diana can add on the development side.
了不起。馬修,非常感謝您的評論。所以約翰娜,是的,你為什麼不開始呢?也許戴安娜可以在開發方面添加。
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
Okay, great. Thanks for the question, Matt. So HIV overall business is, of course, another quarter, a solid quarter again, this year. It's the eighth consecutive quarter of double-digit growth. And that's obviously driven by both the treatment and the PrEP business.
好的,太好了。謝謝你的問題,馬特。因此,今年的 HIV 整體業務當然是另一個季度,又是一個穩定的季度。這是連續第八個季度實現兩位數增長。這顯然是由治療和 PrEP 業務推動的。
So your question specific to Descovy, yes, so we just hit 38%, and so tracking exactly to our plan, right? We had said anywhere between 40% to 45% towards the end of this year. So we feel confident with that number. Obviously, as Andy mentioned in his opening comments, there has been a little bit of a slowdown from a switch standpoint in the PrEP market for obvious reasons, because patients are not going to their -- to the physician's offices. But it's modest thus far, and we think a lot of those, we'll be able to recoup towards the end of this year when the pandemic does lift.
所以你的問題是針對 Descovy 的,是的,所以我們只達到了 38%,所以完全符合我們的計劃,對吧?我們曾說過,到今年年底,這一比例在 40% 到 45% 之間。所以我們對這個數字充滿信心。顯然,正如安迪在開場白中提到的那樣,由於顯而易見的原因,從 PrEP 市場的轉換角度來看,情況有所放緩,因為患者不會去他們的醫生辦公室。但到目前為止它是適度的,我們認為其中很多,我們將能夠在今年年底大流行確實解除時收回成本。
So we feel still very confident that, yes, we think we're going to be in the range of the 40%, 45% that we had originally set out. And maybe even if all goes well and we can get out of this pandemic a little bit earlier, maybe a little bit north of that.
所以我們仍然非常有信心,是的,我們認為我們將在我們最初設定的 40%、45% 的範圍內。也許即使一切順利,我們也可以早一點擺脫這場大流行病,也許再早一點。
So Diana, maybe to address the long acting?
所以戴安娜,也許是為了解決長效問題?
Diana Brainard - SVP of HIV & Emerging Viral Infections
Diana Brainard - SVP of HIV & Emerging Viral Infections
Yes, I'd be happy to. So as you probably know, we're really pursuing multiple shots on goal for developing a partner for our capsid inhibitor. We are looking at molecules across different classes. And part of that is looking at the integrase inhibitor class. And we've got really what's the best-in-class, ideal integrase inhibitor right now with bictegravir. And so we've -- one of our efforts has been in formulating that such that it could be a long-acting injectable and a potential sort of first-generation partner for a capsid inhibitor. We've made a lot of progress. As you know, we've got great formulation team here, and we're on the verge of getting that into the clinic.
是的,我很樂意。所以你可能知道,我們真的在追求多重目標,為我們的衣殼抑製劑開發合作夥伴。我們正在研究不同類別的分子。其中一部分是研究整合酶抑製劑類。我們現在真正擁有同類最佳、理想的整合酶抑製劑 bictegravir。所以我們已經 - 我們的一項努力是製定它可以成為一種長效注射劑和一種潛在的衣殼抑製劑的第一代合作夥伴。我們取得了很大的進步。如您所知,我們這裡有很棒的配方團隊,我們即將把它投入臨床。
Now most Phase I centers globally really have been shut down or paused. So timing there is a little bit uncertain, but we're ready and hoping to have data by the end of the year.
現在全球大多數一期中心確實已經關閉或暫停。所以時間有點不確定,但我們已經準備好並希望在今年年底之前獲得數據。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Great. Thank you, Diana. So why don't we go to the next question? Thanks, Matt.
偉大的。謝謝你,戴安娜。那我們為什麼不去下一個問題呢?謝謝,馬特。
Operator
Operator
Our next question comes from the line of Umer Raffat with Evercore.
我們的下一個問題來自 Evercore 的 Umer Rafat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Dan, we really admire Gilead's efforts during the pandemic and the drug donations, et cetera. But as we go beyond that, it does seem like there will be a commercial business in the broader COVID landscape. And I don't want to peg you to a dollar number, but I do want to ask this: do you envision Gilead's product offerings for COVID being beyond remdesivir? For example, PI combinations and/or even partnering with vaccine companies of sorts? I'm just trying to understand how you envision this category for Gilead, if I may.
丹,我們真的很欽佩吉利德在大流行和藥物捐贈等方面所做的努力。但隨著我們超越這一點,在更廣泛的 COVID 領域似乎確實會有商業業務。我不想把你固定在一個美元數字上,但我確實想問這個問題:你是否認為吉利德(Gilead)的 COVID 產品供應會超越瑞德西韋?例如,PI 組合和/或什至與各種疫苗公司合作?如果可以的話,我只是想了解您如何看待 Gilead 的這一類別。
And Merdad, if I may ask you a quick two-part question. First, do you have a certain lung concentration in mind that you're targeting? And is that much less than the 20 micromolars that was laid out in the New England Journal paper? And do we have any data from humans on what lung concentrations are we actually seeing with remdesivir with the dose that's in the clinic?
Merdad,如果我可以問你一個由兩部分組成的快速問題。首先,您是否有特定的肺部濃度作為目標?這比新英格蘭期刊論文中規定的 20 微摩爾要少得多嗎?我們是否有來自人類的任何數據,說明我們實際看到的瑞德西韋在臨床劑量下的肺部濃度是多少?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thank you, Umer. Thank you for your comments. Thank you for your thoughtful work. Yes, getting back to remdesivir and how do we see this playing out over time. Again, I'm going to have to come back to some of the basis of what I said before, which is we really need some time now to reflect upon a very volatile, changing situation to determine both on the clinical side, regulatory side, pandemic side, epidemiology, what the right sustainable model is. Rest assured that we'll come back to you as soon as we can digest that and as soon as, actually, a little bit more time passes, which was also one of the important reasons for the donation, to allow us to obtain more information as well, what that sustainable plan and model is.
謝謝你,烏默爾。謝謝您的意見。感謝您的周到工作。是的,回到瑞德西韋,我們如何看待它隨著時間的推移發揮作用。再一次,我將不得不回到我之前所說的一些基礎上,我們現在確實需要一些時間來反思一個非常不穩定、不斷變化的情況,以確定臨床方面、監管方面,流行病方面,流行病學,什麼是正確的可持續模式。請放心,我們會在消化完後儘快回复您,實際上,更多的時間過去了,這也是捐贈的重要原因之一,以便我們獲得更多信息同樣,可持續的計劃和模型是什麼。
But I'll just make a couple of comments on what you said, and it was also echoed by Dr. Fauci yesterday, which is with the NIAID results and the highly statistical significant reduction in time to recovery, this now changes the landscape, if you like, for drug development within COVID-19, being that one has to now think about comparing to remdesivir and/or looking at adding to remdesivir, which I think is exactly what the NIH trial is going to do now and I'm sure all of our collaborators within the drug development space. We have been working with them. We're going to continue to work with them on the most thoughtful hypotheses around how we might be give -- consider, just as one reflects upon the HIV building decades ago, that remdesivir becomes kind of the base therapy, and one looks to try to improve symptomology improvement, mortality improvement, expanding patient populations. And so that is yet another factor that will go in to how we determine how best to create a sustainable solution for remdesivir. But clearly, all those things we have been thinking about, and now we have to accelerate now that we have these trial results. So more to come on that.
但我只想對你所說的發表一些評論,昨天 Fauci 博士也對此表示贊同,NIAID 的結果和恢復時間的高度統計顯著減少,這現在改變了格局,如果你喜歡,對於 COVID-19 的藥物開發,現在必須考慮與 remdesivir 進行比較和/或考慮添加到 remdesivir,我認為這正是 NIH 試驗現在要做的,我敢肯定我們在藥物開發領域的所有合作者。我們一直在與他們合作。我們將繼續與他們合作,圍繞我們可能如何給予最深思熟慮的假設——考慮一下,就像人們反思幾十年前的艾滋病建設一樣,瑞德西韋成為一種基礎療法,人們希望嘗試改善症狀,改善死亡率,擴大患者人群。因此,這是影響我們如何確定如何最好地為瑞德西韋創造可持續解決方案的另一個因素。但很明顯,我們一直在考慮所有這些事情,現在我們有了這些試驗結果,現在我們必須加快速度。所以還有更多的事情要做。
I will have -- Merdad, you answer the lung question, if you could, please, for Umer.
我將 - Merdad,請你回答肺部問題,如果可以的話,請為 Umer。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes. Thanks, Dan. So what I would say is the concentration that we're looking for, as you know, we think our EC50 in human cells is in the tens of nanomolar range. And we know our serum concentration gets in the micromolar range. And so we should be more than adequately covered by achieving those levels with the current dosing paradigm that we have, probably by an order of magnitude or 2.
是的。謝謝,丹。所以我要說的是我們正在尋找的濃度,正如你所知,我們認為我們在人體細胞中的 EC50 在幾十納摩爾範圍內。我們知道我們的血清濃度在微摩爾範圍內。因此,我們應該通過使用我們當前的劑量範式達到這些水平來充分覆蓋我們,可能是一個數量級或 2 個數量級。
In -- certainly, in the serum and based on model data in nonhuman primates as well as mice, we see more than adequate concentrations getting into the lung of those animals and in vivo efficacy in those animals. And I think the clinical benefits we're seeing suggests that that's exactly what's happening in humans as well. So I think we're pretty comfortable with where we are in terms of both dosing and exposure, including in the lung.
在 - 當然,在血清中並基於非人類靈長類動物和小鼠的模型數據,我們看到超過足夠的濃度進入這些動物的肺部以及這些動物的體內功效。我認為我們所看到的臨床益處表明,這也正是人類正在發生的事情。所以我認為我們對我們在劑量和暴露方面的位置非常滿意,包括在肺部。
Operator
Operator
Our next question comes from the line of Alethia Young with Cantor Fitzgerald.
我們的下一個問題來自 Alethia Young 和 Cantor Fitzgerald 的台詞。
Alethia Rene Young - Head of Healthcare Research
Alethia Rene Young - Head of Healthcare Research
Thank you for your contribution in solving the world's problems. Maybe just 1.5 for me. Were you surprised just with the severe kind of working as it did with an antiretroviral that you kind of think that you might need to have people kind of earlier in the virus for it to work? And do you think it worked better there?
感謝您為解決世界問題所做的貢獻。也許對我來說只有 1.5。您是否對抗逆轉錄病毒藥物的嚴重工作感到驚訝,您認為您可能需要讓人們更早地感染病毒才能發揮作用?你認為它在那里工作得更好嗎?
And then the second question is just a little bit around HIV. Are you seeing buying patterns changing in the public markets, like the Medicaid, the prisons, et cetera, et cetera?
然後第二個問題是關於 HIV 的。您是否看到公共市場的購買模式發生了變化,例如醫療補助計劃、監獄等等?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. Thanks an awful lot, Alethia, again, for your comments. I'm going to turn the first question over to Merdad and the second one over to Johanna. But just as I do, on your first question, and I think Merdad can fill in the details here, but there's been a surprising consistency across all the different data elements in our clinical program, from compassionate use, to interrogating what we know about the China trial, to the severe trial, to the NIAID trial. And I think that is maybe not something that's completely well understood out there. And I think, Merdad, as a part of your response, I think it would be helpful for you to reflect upon that as well, if it's okay.
是的。再次感謝 Alethia 的評論。我要把第一個問題交給 Merdad,第二個問題交給 Johanna。但正如我所做的那樣,關於你的第一個問題,我認為 Merdad 可以在這裡填寫細節,但我們臨床計劃中所有不同數據元素的一致性令人驚訝,從同情使用到詢問我們對中國試驗,嚴酷試驗,NIAID 試驗。而且我認為這可能不是人們完全理解的東西。我認為,Merdad,作為你回應的一部分,如果可以的話,我認為這對你進行反思也會有所幫助。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes. No, of course. I think, Alethia, we all were using the parallel construct of influenza for our thinking around remdesivir, right, which was you got to get in really early given the viral kinetics in influenza. And getting in too late probably won't have much of an impact. And I remember an investor call a couple of months ago where I said that as well, and that was certainly our expectation. However, the wild card here, and what I think we're still learning is, what are the viral kinetics in patients with this virus. How long does that last, and how quickly does it go up? And how quickly can we have an impact on it?
是的。不,當然。我想,Alethia,我們都在使用流感的平行結構來思考 remdesivir,對吧,鑑於流感的病毒動力學,你必須儘早進入。來得太晚可能不會產生太大影響。我記得幾個月前我在一次投資者電話會議上也說過這句話,這當然是我們的期望。然而,這裡的外卡,我認為我們仍在學習的是,這種病毒患者的病毒動力學是什麼。這會持續多久,上升的速度有多快?我們能以多快的速度對其產生影響?
So I think the data are the data, essentially. We are seeing efficacy across both patient populations but also across trials that are really all tracking in the same direction, as Dan alluded to. So even if you look at the China data, the hazard ratios for improvement are consistently positive. The study was underpowered, and I think the hazard ratios we'll probably see from the NIAID study are going to be in the same ballpark. But with an appropriate sample size, they're highly statistically significant. Similarly, I think when we look at the mortality data and when we look at all of those different factors, this virus seems to be behaving differently. Remdesivir seems to be having efficacy in a relatively broad patient population. And so I think we're learning as we go. We'll learn more as more data are generated, right? We have our moderate data coming up where we'll be looking at an even less severely ill patient population. So there'll be more data coming out in that population that may add to our knowledge base here to understand the spectrum. And as we talked about earlier, understanding the efficacy in the subgroups in the NIAID study will be really interesting in this, and we don't have that information yet.
所以我認為數據本質上就是數據。正如 Dan 所暗示的,我們不僅在兩個患者群體中都看到了療效,而且在真正都朝著同一方向追踪的試驗中也看到了療效。因此,即使您查看中國數據,改進的風險比也始終為正。這項研究的效力不足,我認為我們可能會從 NIAID 研究中看到的風險比將處於相同的範圍內。但是在適當的樣本量下,它們具有高度的統計顯著性。同樣,我認為當我們查看死亡率數據以及所有這些不同因素時,這種病毒的表現似乎有所不同。瑞德西韋似乎對相對廣泛的患者群體有效。所以我認為我們邊走邊學。隨著更多數據的生成,我們會了解更多,對吧?我們將獲得適度的數據,我們將在這些數據中查看病情更輕的患者群體。因此,該人群中會出現更多數據,這些數據可能會增加我們在這裡的知識庫以了解頻譜。正如我們之前談到的,了解 NIAID 研究中亞組的療效將非常有趣,我們還沒有這些信息。
So I think all those data will contribute to our overall understanding of how early do you need to be in, do patients who have symptoms for less time do better. Those are certainly the trends, but there certainly seems to be benefit even in patients who have longer duration of symptoms right now.
因此,我認為所有這些數據將有助於我們全面了解您需要多早入院,症狀出現時間較短的患者是否會做得更好。這些當然是趨勢,但即使對目前症狀持續時間較長的患者,似乎也確實有好處。
Maybe I'll hand it off to Johanna for the HIV question.
也許我會把它交給 Johanna 來解決 HIV 問題。
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
Yes. Thanks, Merdad. So Alethia, just a couple of things. We have a couple of moving pieces in the first quarter for HIV. So I just want to -- because it's not just one piece that's making the difference here. And so the first one is obviously the seasonal inventory, right? There's a Q4 load up and then Q1 draw down. So that's definitely happening in Q1. Then we also had towards late March, like I'm sure many did as well, the prescription -- number of days per prescription rise and inventories rise towards end of March. So we had a bit of a mix of those 2 things. And specifically to government channels that you were asking the buying pattern, we do normally see in Q1 a little bit more of a higher mix towards government channels in the first quarter. And that obviously negatively impacts our payer mix. So that is definitely happening in the first quarter of this year.
是的。謝謝,梅爾達。所以 Alethia,只有幾件事。我們在第一季度有幾個關於艾滋病毒的活動。所以我只想——因為這不僅僅是一件讓這裡有所不同的作品。所以第一個顯然是季節性庫存,對吧? Q4 負載上升,然後 Q1 下降。所以這肯定會在第一季度發生。然後我們也在 3 月下旬,就像我相信很多人一樣,處方 - 每個處方的天數增加,庫存在 3 月底增加。所以我們有點混合了這兩件事。特別是對於您詢問購買模式的政府渠道,我們通常會在第一季度看到更多的政府渠道組合。這顯然對我們的付款人組合產生了負面影響。所以這肯定會在今年第一季度發生。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Great. Thank you, Johanna. Thank you, Alethia.
偉大的。謝謝你,約翰娜。謝謝你,阿勒西婭。
Operator
Operator
Our next question comes from the line of Mohit Bansal with Citigroup.
我們的下一個問題來自花旗集團的 Mohit Bansal。
Mohit Bansal - VP and Analyst
Mohit Bansal - VP and Analyst
Great. And I would also add my appreciation for your efforts against COVID-19. A quick one from my side, if you can help me. If you can -- can you please update us on your collaboration programs with Galapagos time lines at this point, both for IPF as well as osteoarthritis. And specifically on osteoarthritis program, how important is it for Gilead to see the -- see improvement in pain when we see the data for you to take a decision to opt in there?
偉大的。我還要感謝您為抗擊 COVID-19 所做的努力。如果你能幫助我,我身邊的一個快速的。如果可以的話——請您在這一點上向我們介紹您與加拉帕戈斯時間線的合作計劃,包括 IPF 和骨關節炎。特別是在骨關節炎項目上,當我們看到數據讓你決定選擇加入時,看到疼痛的改善對吉利德來說有多重要?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thank you, Mohit. I'm going to turn it over to Merdad. Thank you, Merdad.
謝謝你,莫希特。我要把它交給 Merdad。謝謝你,梅爾達。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes. Thanks for the question, Mohit. So with the IPF program, there is a scheduled interim analysis that will be coming up early next year, and we think things will stay on track. Again, I'll put some error bars around the pandemic, but I don't think that should be impacted, at least today. So that will be something that we'll be clearly looking forward to and it will be important to how we proceed there.
是的。謝謝你的問題,莫希特。因此,對於 IPF 計劃,明年初將進行預定的中期分析,我們認為事情會保持在正軌上。同樣,我會在大流行病周圍設置一些誤差線,但我認為這不會受到影響,至少在今天是這樣。因此,這將是我們非常期待的事情,這對我們將如何進行很重要。
In terms of the osteoarthritis, it's a great question. I think while seeing structural improvement is going to be really important and interesting, certainly, thus far, the regulatory guidance has included looking at symptoms like pain for improvement. So we can push on that, obviously, if we see structural improvement and we haven't been powered, for example, for pain, then we'll have to look at that and think about what the implications of that are and discuss it with the regulators. So I think what we'll be looking for is directionality on all the end points that we will be measuring to make a smart decision in terms of moving forward with that program.
就骨關節炎而言,這是一個很好的問題。我認為,雖然看到結構性改善將非常重要和有趣,但當然,到目前為止,監管指南包括觀察疼痛等症狀以進行改善。所以我們可以繼續推進,很明顯,如果我們看到結構性改善並且我們沒有動力,例如,疼痛,那麼我們將不得不研究它並思考它的含義並與監管機構。所以我認為我們要尋找的是我們將衡量的所有終點的方向性,以便在推進該計劃方面做出明智的決定。
Operator
Operator
Our next question comes from the line of Robyn Karnauskas with SunTrust.
我們的下一個問題來自 Robyn Karnauskas 與 SunTrust 的對話。
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
And again, great work on all the things you're doing to help us with COVID. So there's a lot of talk about remdesivir being approved for emergency use. Can you just clarify, does that mean that at that point in time, versus now where it's compassionate use, you actually could charge for the drug? And when you say affordable, does that mean a positive margin for the product? And lastly, from a science point of view, help me understand what would it take for some of these drugs, or your drug on top of other drugs, to work in a ventilator patient do you think, theoretically?
再說一遍,你們為幫助我們應對 COVID 所做的一切工作都非常出色。所以有很多關於瑞德西韋被批准用於緊急情況的討論。你能澄清一下嗎,這是否意味著在那個時間點,相對於現在的同情用藥,你實際上可以對藥物收費?當你說負擔得起時,這是否意味著產品的利潤率是正的?最後,從科學的角度,幫助我了解這些藥物中的一些,或者你的藥物在其他藥物之上,在理論上對呼吸機患者起作用需要什麼?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Great. So I'll turn the ventilator question over to Merdad in just a second. But thanks. We'll clarify the EUA. So yes, I mean, under an emergency use authorization, one could charge for the product. We made a decision, as you know, to donate 1.5 million vials, which is the entirety of our supply through the early summer. And that's for a variety of uses, right? I mean that's for clinical trials, as one would expect not to charge for those, of course, compassionate use, EAP in other countries. But also available is that supply for regulatory approvals around the world, and we'll allocate accordingly as regulatory approvals come online. So yes, it is possible to charge.
偉大的。所以我會在一秒鐘內將呼吸機問題轉交給 Merdad。但是謝謝。我們將澄清 EUA。所以是的,我的意思是,根據緊急使用授權,可以對產品收費。如您所知,我們決定捐贈 150 萬瓶,這是我們整個初夏的全部供應。這有多種用途,對吧?我的意思是這是針對臨床試驗的,因為在其他國家/地區,人們會期望不對那些當然是同情使用 EAP 收費。但也可以獲得全球監管批准的供應,我們將在監管批准上線時相應地進行分配。所以是的,可以收費。
I would just say that our goal here is to get a full approval for remdesivir. We feel the data supports that. And an EUA, therefore, is a step to really a more formalized approval. The reason the agency and we are talking about that is that these are extraordinary times, right? So weeks would make a difference to be able to get medicine to patients by enacting an EUA, if that's what the FDA chooses to do prior to another form of approval. And so it's a stepwise approach, which allows us to immediately address the humanitarian need, while still pursuing all the aspects of a normal approval, which we are doing with the FDA. So I think that's probably the most important point.
我只想說,我們的目標是獲得瑞德西韋的完全批准。我們認為數據支持這一點。因此,EUA 是真正獲得更正式批准的一步。該機構和我們談論的原因是現在是非常時期,對吧?因此,如果 FDA 在另一種形式的批准之前選擇這樣做,那麼通過制定 EUA 為患者提供藥物的時間將有所不同。因此,這是一種循序漸進的方法,使我們能夠立即解決人道主義需求,同時仍在尋求正常批准的所有方面,我們正在與 FDA 合作。所以我認為這可能是最重要的一點。
And again, I know, Robyn -- and trust us, we will be answering your questions on the sustainable model for remdesivir in the future -- in the near future. We just don't have the answers yet. And we -- but we deeply respect and appreciate the fact that when we get into millions of doses, we have to have a sustainable economic model that works here and that achieves access to -- and affordability to patients around the world. So more to come on that.
再一次,我知道,羅賓——相信我們,我們將在不久的將來回答你關於瑞德西韋可持續模型的問題。我們只是還沒有答案。而我們——但我們深深地尊重和讚賞這樣一個事實,即當我們接種數百萬劑疫苗時,我們必須擁有一個可持續的經濟模式,該模式可以在這裡發揮作用,並實現對世界各地患者的獲取和負擔能力。所以還有更多的事情要做。
If I could turn it over to Merdad on the ventilated treatment approach.
如果我可以將其轉交給 Merdad 關於通風治療方法。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes, Robyn, excellent question. Thanks. The criticality of this comes down to a timing question, right? It really comes down to how long is viral replication ongoing in the lungs of patients and how quickly do patients deteriorate to needing mechanical ventilation? Certainly, what we're seeing is that patients are very, very rapidly deteriorating. Some patients deteriorate rapidly. And so getting them antiviral therapy in that time frame where it seems that there's still viral replication going on certainly seems to be benefiting those patients. And probably what's going on -- and this is speculation on my part -- is by limiting the viral replication, you're going to limit the inflammation, you're going to reduce the number of people who develop lung injury, and you're going to get them off the ventilator faster. So the discharge rates that we're seeing, where the people are being discharged 4 days earlier, for example, in the NIAID study, underlying that are patients who are deescalating their need for oxygenation. And that leads them to getting on to room air more quickly. And I think it -- so there's a time element in all of this that I think is probably where we're benefiting these patients.
是的,羅賓,很好的問題。謝謝。這一點的關鍵性歸結為一個時間問題,對吧?這真的取決於病毒在患者肺部複製的持續時間以及患者惡化到需要機械通氣的速度有多快?當然,我們看到的是患者的病情正在非常、非常迅速地惡化。一些患者病情迅速惡化。因此,在病毒複製仍在進行的那個時間範圍內讓他們接受抗病毒治療,這顯然對這些患者有益。可能正在發生的事情——這是我的猜測——是通過限制病毒複製,你會限制炎症,你會減少患肺損傷的人數,而且你”我們要讓他們更快地脫離呼吸機。因此,我們看到的出院率,例如,在 NIAID 研究中,人們提前 4 天出院,其基礎是患者正在降低對氧合的需求。這導致他們更快地進入室內空氣。而且我認為 - 所以我認為所有這一切都有時間因素,這可能是我們使這些患者受益的地方。
Certainly, if you talk about people who've been ventilated for a week or 2 weeks, there, the question of whether an antiviral would be beneficial, I think, seems more difficult to tie into what's going on. But again, it comes down to understanding the viral kinetics here, and that's a work in progress, I think, for all of us.
當然,如果你談論那些已經通氣一周或兩週的人,我認為抗病毒藥物是否有益的問題似乎更難以與正在發生的事情聯繫起來。但是,歸根結底還是要了解這裡的病毒動力學,我認為這是我們所有人都在進行的工作。
Operator
Operator
Our next question comes from the line of Salim Syed with Mizuho.
我們的下一個問題來自 Salim Syed 與 Mizuho 的對話。
Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research
Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research
I echo all my peers' comments on the great work you guys have done on remdesivir. Dan, maybe just one for me, a high-level question here around your involvement maybe with folks in Washington, your discussions there. So obviously, like biotech for some time has been about -- from a Washington perspective, about drug pricing. And the rhetoric has been pretty negative. I'm wondering if the rhetoric has changed at all in your view when you're dealing with folks there. How it's particularly changed given you guys are so key to remdesivir and the solution to COVID-19?
我贊同所有同行對你們在瑞德西韋方面所做的出色工作的評論。丹,也許對我來說只是一個問題,這是一個關於你參與的高級別問題,可能與華盛頓的人們一起,你在那裡的討論。很明顯,從華盛頓的角度來看,生物技術已經有一段時間了——關於藥品定價。而且言論一直很消極。我想知道當您與那裡的人打交道時,您認為修辭是否完全改變了。鑑於你們對瑞德西韋和 COVID-19 的解決方案如此關鍵,它有何特別的變化?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. Thanks, Salim. Yes, these are unusual times for all of us, I'm sure in all of your areas of interest as well as ours. And so what I can say is that I think people have come together in a variety of ways. And certainly, that's also occurred to a certain degree in Washington. And I've spent a decent amount of time in Washington over the past several months, well, certainly before the shelter-in-place. And I think even then there is some change in the rhetoric. I think for highly innovative research-based companies that have immediately kind of shifted their efforts to solutions in the coronavirus, it's pretty impressive actually to -- and many of the peers in the industry that I stay in very close touch with have spared no expense to kind of pivot and shift.
是的。謝謝,薩利姆。是的,這對我們所有人來說都是不尋常的時期,我敢肯定在您和我們感興趣的所有領域。所以我能說的是,我認為人們以各種方式走到了一起。當然,這也在一定程度上發生在華盛頓。在過去的幾個月裡,我在華盛頓度過了相當多的時間,嗯,當然是在就地避難所之前。而且我認為即便如此,措辭也有一些變化。我認為對於高度創新的研究型公司來說,他們已經立即將他們的努力轉移到冠狀病毒的解決方案上,這實際上令人印象深刻——我與許多業內保持密切聯繫的同行不惜一切代價有點樞軸和轉變。
So I think at the end of the day, I think this will certainly help the industry's reputation. I think the ability to solve a human crisis like this, because of the decades of investment and the at-risk investment that's done by so many companies, people, I think, will -- and the general public will see that. And whether that's treatment -- different types of treatments or vaccines, I think that will be the case.
所以我認為歸根結底,我認為這肯定有助於提升行業聲譽。我認為,由於幾十年的投資和這麼多公司所做的風險投資,我認為解決人類危機的能力,我認為,人們將會——而且公眾會看到這一點。無論是治療——不同類型的治療還是疫苗,我認為情況都會如此。
But certainly, to your point, I think the tone is different in Washington. I think people are very appreciative and concerned about finding solutions here. And it's brought us all together, which I think is a good thing. I'm not suggesting that there won't continue to be focus and pressure on drug pricing. Of course, there will be. And we continue to work appropriately to make sure that, in particular, the patients that are bearing the brunt sometimes of some of the pharmaceutical pricing, that legislation is put into place that supports that and improves that for patients, and that we lean in as an industry and as a company to give more that flows through to patients. So all of those principles, I think, still apply, but it's being done now in a way where we can have an appreciation for the innovation the industry brings.
但當然,就你的觀點而言,我認為華盛頓的基調有所不同。我認為人們非常感激並關心在這裡找到解決方案。它讓我們所有人走到了一起,我認為這是一件好事。我並不是說藥品定價不會繼續受到關注和施加壓力。當然會有。我們將繼續適當地工作,以確保,尤其是那些有時首當其沖地承受某些藥品定價的患者,制定立法來支持並改善患者的情況,並確保我們作為一個行業和一家公司,為患者提供更多的服務。因此,我認為,所有這些原則仍然適用,但現在正在以一種我們可以欣賞行業帶來的創新的方式進行。
So more to come and a lot still to happen this year with the election coming up and with other things. But I think from a Gilead perspective, we stay focused on innovative medicines and making sure we have access programs, on leaning into legislation that supports the innovative industry and that supports reducing patient out-of-pocket costs, and that will be our focus accordingly, Salim. So hope that gives a little bit of a insight.
隨著選舉的臨近和其他事情的臨近,今年還有更多事情要做,還有很多事情要做。但我認為從吉利德的角度來看,我們仍然專注於創新藥物並確保我們有准入計劃,依靠支持創新行業和支持減少患者自付費用的立法,這將是我們相應的重點,薩利姆。所以希望這能提供一點洞察力。
Operator
Operator
Our next question comes from the line of Tyler Van Buren with Piper Sandler.
我們的下一個問題來自 Tyler Van Buren 和 Piper Sandler 的台詞。
Tyler Martin Van Buren - Principal & Senior Biotech Analyst
Tyler Martin Van Buren - Principal & Senior Biotech Analyst
Thanks for everything that you're doing, and have a couple more remdesivir questions, of course. Given your experience, your expertise in viral infections and all the natural history that you guys are collecting in real-time, wanted to ask you about your best, latest thoughts on the nature of COVID-19 recurrence. Your base case assumes a peak potentially by July, a return in the fall and winter, but a lower impact. So is it possible to provide a rough quantification of what that lower impact might be? And then also in subsequent years, is this something that you would expect in that base case to peter out or to be with us for potentially the next decade or 2?
感謝您所做的一切,當然還有一些關於瑞德西韋的問題。鑑於你們的經驗、你們在病毒感染方面的專業知識以及你們實時收集的所有自然歷史,我想問你們關於 COVID-19 復發性質的最佳、最新想法。您的基本情況假設可能在 7 月達到峰值,在秋季和冬季恢復,但影響較小。那麼是否可以粗略地量化較低的影響可能是什麼?然後在隨後的幾年中,您是否期望在該基本案例中這種情況會逐漸消失或在未來十年或兩年內與我們同在?
And then the second question is just following up on your earlier comments on FDA interactions and potential pathways to approval, which was helpful. Have you guys had labeling discussions? Is there any color you could provide there?
然後第二個問題只是跟進你之前關於 FDA 相互作用和潛在批准途徑的評論,這很有幫助。你們討論過標籤嗎?你有什麼顏色可以提供嗎?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
On remdesivir, right?
在瑞德西韋上,對嗎?
Tyler Martin Van Buren - Principal & Senior Biotech Analyst
Tyler Martin Van Buren - Principal & Senior Biotech Analyst
Yes.
是的。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. Okay. Sure. Thanks, Tyler, again, for the comments. And I might ask if Andy and Merdad want to comment on the first question. Let me start with the second.
是的。好的。當然。再次感謝 Tyler 的評論。我可能會問 Andy 和 Merdad 是否想對第一個問題發表評論。讓我從第二個開始。
So yes, we've been in constant dialogue with the agency on remdesivir. I just have to really also say how thankful we are for the FDA and other members of the government and the coronavirus task force that have really made themselves available, really literally all the time, when we need them and vice versa. So it's been a very good collaborative relationship.
所以是的,我們一直在與該機構就瑞德西韋進行對話。我還必須說,我們非常感謝 FDA 和政府的其他成員以及冠狀病毒特別工作組,他們真的隨時都可以在我們需要他們的時候提供幫助,反之亦然。所以這是一個非常好的合作關係。
In terms of remdesivir and the interactions with the FDA, I mean, we have been working with them on the submission. They've been open to receiving parts of the submission, which has been very helpful under a normal process, plus the whole EUA process that kind of goes on top of that. So yes, the answer is -- and you can imagine that, obviously, that's been going on for weeks and actually a couple of months now. But in the past 48 hours, it's increased in intensity. So we are, and the team is, in constant kind of information exchange with the agency right now, and they're getting information from us, obviously, from NIH and the NIAID trial, and there's a big sense of urgency here. I think FDA understands the importance of reacting quickly to this, and so it's intense right now. And we think the FDA will move quite quickly on their decisioning on the labeling side. So back to the lower impact on the base case.
就瑞德西韋以及與 FDA 的互動而言,我的意思是,我們一直在與他們合作提交申請。他們對接收提交的部分內容持開放態度,這在正常流程下非常有幫助,再加上整個 EUA 流程。所以是的,答案是——你可以想像,顯然,這已經持續了數週,實際上已經持續了幾個月。但在過去的 48 小時內,它的強度有所增加。所以我們和團隊現在正在與該機構進行持續的信息交流,他們正在從我們這裡獲取信息,顯然是來自 NIH 和 NIAID 試驗,這裡有很大的緊迫感。我認為 FDA 了解對此做出快速反應的重要性,因此現在非常緊張。我們認為 FDA 將在標籤方面迅速做出決定。所以回到對基本案例的較低影響。
I don't know, Merdad, from a scientific perspective, or Andy, if you want to provide any other -- I think we don't have a crystal ball, I guess I would say.
我不知道,Merdad,從科學的角度,或者 Andy,如果你想提供任何其他 - 我想我們沒有水晶球,我想我會說。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes. I think, Tyler, we're as much a consumer as others. I think we are -- obviously, our data are a snapshot into what's going on, but we use, for our modeling, we use the external epidemiology data and use that right now to get the broader picture. So I don't think we have any unique insights today that don't rely on the same sources that everyone else. So that's, I think, where we are. Obviously, as we capture more data, maybe that will change. But today, I think that's where we are.
是的。我認為,泰勒,我們和其他人一樣是消費者。我認為我們 - 顯然,我們的數據是正在發生的事情的快照,但我們使用,對於我們的建模,我們使用外部流行病學數據並立即使用它來獲得更廣泛的情況。所以我認為我們今天沒有任何獨特的見解不依賴於與其他人相同的來源。所以,我認為,這就是我們所處的位置。顯然,隨著我們捕獲更多數據,也許這種情況會改變。但是今天,我認為這就是我們所處的位置。
And I'll just echo what Dan said. I -- this has been an unprecedented time in terms of our interactions with the regulators, both here in the U.S. as well as outside the U.S. It's been really impressive and truly collaborative, working with the NIH and the FDA in parallel over the past couple of months; we talk constantly. And the same is true with the EMA. Same is true with Japan. We're talking to all the regulators in parallel. So it's been a pretty unique situation, and I think everyone understands the gravity. So that's been very helpful in moving forward collaboratively.
我將重複 Dan 所說的。我 - 就我們與監管機構的互動而言,這是前所未有的時間,無論是在美國還是在美國以外。這真的令人印象深刻並且真正合作,在過去的夫婦中與 NIH 和 FDA 並行工作幾個月;我們經常談話。 EMA 也是如此。日本也是如此。我們正在與所有監管機構同時交談。所以這是一個非常獨特的情況,我想每個人都明白引力。所以這對協作向前發展非常有幫助。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thanks Merdad. So we have time for one last question.
謝謝默達德。所以我們有時間回答最後一個問題。
Operator
Operator
Our last question comes from the line of Phil Nadeau with Cowen and Company.
我們的最後一個問題來自 Phil Nadeau 與 Cowen and Company 的合作。
Philip M. Nadeau - MD & Senior Research Analyst
Philip M. Nadeau - MD & Senior Research Analyst
And let me add my appreciation for your diligence in attacking COVID. Just 2 more questions on remdesivir. The first is on the upcoming data from the SIMPLE trial, the moderate trial due in May. Can you remind us how the enrollment criteria and end point definitions differed between the NIAID trial and that upcoming data set? And therefore, should we expect similar data? Or are there notable differences?
讓我對您在攻擊 COVID 方面的努力表示感謝。還有 2 個關於瑞德西韋的問題。第一個是 SIMPLE 試驗即將發布的數據,該試驗將於 5 月進行。您能否提醒我們 NIAID 試驗和即將發布的數據集的入組標準和終點定義有何不同?因此,我們應該期待類似的數據嗎?還是有顯著差異?
And then second, just a follow-up question on Tyler's. On the FDA approval pathway, Dan, your answer to Tyler's question suggests that you may not need any more data to get a formal FDA approval. The NIAID trial might be sufficient. Is that your current understanding of your FDA dialogue?
其次,只是關於泰勒的後續問題。在 FDA 批准途徑上,Dan,你對 Tyler 問題的回答表明你可能不需要更多數據來獲得 FDA 的正式批准。 NIAID 試驗可能就足夠了。這是您目前對 FDA 對話的理解嗎?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes. I'll let Merdad also discuss. So yes, I'm just -- look, the discussions are still ongoing in terms of what's required for a formal approval. But I meant to infer earlier is that the NIAID data are -- demonstrate safety and efficacy at a highly statistical level, right, which is usually the barrier for a full approval. So that's what we're working with them on. And I don't want to get ahead of the agency on that, if that's okay. So -- but again, I do believe that there is most likely kind of a two-step process, with potentially an EUA being granted and then moving on to the full approval.
是的。我會讓 Merdad 也討論一下。所以是的,我只是——看,關於正式批准所需條件的討論仍在進行中。但我的意思是早些時候推斷 NIAID 數據是——在高度統計水平上證明安全性和有效性,對,這通常是獲得完全批准的障礙。這就是我們正在與他們合作的內容。如果可以的話,我不想在這方面領先於該機構。所以——但我再次相信,最有可能的是一個兩步過程,可能會獲得 EUA,然後進入全面批准。
Having said that, can I turn to Merdad or Diana? Merdad, okay, on the first question.
話雖如此,我可以求助於 Merdad 或 Diana 嗎? Merdad,好的,關於第一個問題。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes. I was actually going to see if Diana wanted to answer that question.
是的。我實際上是想看看戴安娜是否想回答這個問題。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Okay. Yes, that's great. Diana, thank you.
好的。是的,那太好了。戴安娜,謝謝你。
Diana Brainard - SVP of HIV & Emerging Viral Infections
Diana Brainard - SVP of HIV & Emerging Viral Infections
Sure thing. Yes. So in terms of end points, the NIAID study looked at time to clinical recovery, [using] the 7-point ordinal scale. And the ordinal scale is really tracking throughout most of the major clinical trials right now. But as our understanding of the disease has evolved, the types of end points using that scale has evolved. And so NIAID changed to time to clinical recovery, which basically means no longer requiring medical care within the hospital, getting off of oxygen or live discharge.
當然可以。是的。因此,就終點而言,NIAID 研究著眼於臨床康復的時間,[使用] 7 點順序量表。現在大多數主要臨床試驗都在跟踪順序量表。但隨著我們對疾病的理解不斷發展,使用該量表的終點類型也在不斷發展。因此 NIAID 改為時間到臨床恢復,這基本上意味著不再需要在醫院內進行醫療護理、停止吸氧或帶電出院。
In our moderate study, we're looking -- we're using the ordinal scale as well, but we're looking at the day 11 distribution along that ordinal scale. So similar to what we did in our severe study, but looking at day 11 instead of day 14, recognizing that we're looking at a population that's less sick. So the moderate study is looking at patients who are hospitalized, but they're not hypoxic. They're not requiring oxygen. The NIAID study enrolled patients from -- starting there, but all the way through mechanical ventilation. So slightly different end points for slightly different patient populations. And most importantly, really looking at different questions. We're looking at treatment duration. They're looking at primary safety and efficacy with a placebo control.
在我們的適度研究中,我們正在尋找——我們也在使用序數尺度,但我們正在研究第 11 天沿著該序數尺度的分佈。與我們在嚴苛研究中所做的非常相似,但觀察的是第 11 天而不是第 14 天,認識到我們正在研究的是患病率較低的人群。所以適度的研究是針對住院的患者,但他們沒有缺氧。他們不需要氧氣。 NIAID 研究招募了患者——從那裡開始,但一直到機械通氣。對於略有不同的患者群體,終點略有不同。最重要的是,真正關注不同的問題。我們正在研究治療持續時間。他們正在研究安慰劑對照的主要安全性和有效性。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thanks a lot, Phil. So with that, I think we'll turn the call over to Doug to close. But let me just say thank you very much to all of you. And we really appreciate your trust and confidence in Gilead, and we'll continue to do our best throughout what we do for patients and certainly for COVID-19. So with that, Doug, do you want to have the last word?
非常感謝,菲爾。因此,我想我們會把電話轉給道格來關閉。但是,讓我對你們所有人說聲非常感謝。我們非常感謝您對吉利德的信任和信心,我們將繼續竭盡全力為患者,當然也為 COVID-19 所做的一切。那麼,道格,你想說最後一句話嗎?
Douglas Maffei - Senior Director of IR
Douglas Maffei - Senior Director of IR
Thank you, Dan, 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 updates on our future progress.
謝謝丹,感謝大家今天加入我們。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. This does conclude the program, and you may all disconnect.
女士們,先生們,感謝你們參加今天的會議。這確實結束了程序,你們都可以斷開連接。