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Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Third 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 年第三季度收益電話會議。
(Operator Instructions) Please be advised that today's conference is being recorded record.
(操作員說明)請注意,今天的會議正在錄製中。
(Operator Instructions)
(操作員說明)
I would now like to hand the conference over to your speaker today to Douglas Maffei, Senior Director of Investor Relations.
我現在想將今天的會議轉交給投資者關係高級總監道格拉斯·馬菲 (Douglas Maffei)。
Thank you.
謝謝。
Please go ahead, sir.
請繼續,先生。
Douglas Maffei - Senior Director of IR
Douglas Maffei - Senior Director of IR
Thank you, Dilem, and good afternoon, everyone.
謝謝 Dilem,大家下午好。
Just after market closed today, we issued a press release with earnings results for the third quarter of 2020.
今天收市後,我們發布了一份新聞稿,其中包含 2020 年第三季度的收益結果。
The press release and detailed slides are available on the Investors section of our website.
新聞稿和詳細幻燈片可在我們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 question-and-answer 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 Christi Shaw 也將出席電話會議並接受問答;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 business, financial conditions and results of operations; plans and expectations with regards 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 those 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 Gilead 業務、財務狀況和運營結果的影響相關的風險和不確定性;關於產品、候選產品、公司戰略、財務預測和資本使用的計劃和期望;和 2020 年財務指南,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。
This has really been a pivotal quarter for Gilead.
對於吉利德來說,這確實是一個關鍵的季度。
With last week's closing of the Immunomedics acquisition, we've effectively transformed our near- and long-term growth story.
隨著上週完成對 Immunomedics 的收購,我們有效地改變了我們的近期和長期增長故事。
Trodelvy, an improved medicine for third line metastatic triple-negative breast cancer, has tremendous potential for patients today and significant pan-tumor potential for the future.
Trodelvy 是一種改進的三線轉移性三陰性乳腺癌藥物,對當今的患者俱有巨大的潛力,對未來具有顯著的泛腫瘤潛力。
We are all excited to deliver on that potential, along with the teams from Immunomedics who became a part of the Gilead family last week.
我們都很高興能與上週加入吉利德家族的 Immunomedics 團隊一起發揮這種潛力。
I want to take this opportunity to thank everyone at Immunomedics for the extraordinary work that you've done on Trodelvy to date.
我想藉此機會感謝 Immunomedics 的每個人,感謝你們迄今為止在 Trodelvy 上所做的出色工作。
It's an honor to work with all of you now to build on those efforts for the benefit of patients with cancer around the world.
很榮幸現在能與你們所有人合作,在這些努力的基礎上再接再厲,造福世界各地的癌症患者。
The acquisition is undoubtedly an inflection point in terms of our growth and adds to the growing pipeline of transformational medicines that we've been strengthening over the course of the year.
就我們的增長而言,此次收購無疑是一個轉折點,並增加了我們在過去一年中一直在加強的不斷增長的轉化藥物管道。
All of this is building on the strong foundation of our core business.
所有這一切都建立在我們核心業務的堅實基礎之上。
We've seen the strength and durability of our HIV business once again in the past quarter, and we're confident in our long-term leadership.
在過去一個季度,我們再次看到了我們 HIV 業務的實力和持久性,我們對我們的長期領導地位充滿信心。
I'd like to briefly talk about the changing nature of our growth prospects driven primarily by the acquisition of Immunomedics.
我想簡要談談主要由收購 Immunomedics 推動的我們增長前景的變化。
I'll also touch on our core business, and I'll say a few words about Veklury or remdesivir, and which just gained FDA approval, and then Johanna and Merdad will pick up with more details.
我還會談談我們的核心業務,我會簡單介紹一下剛剛獲得 FDA 批准的 Veklury 或瑞德西韋,然後 Johanna 和 Merdad 會提供更多細節。
I'll start with Immunomedics and Trodelvy.
我將從 Immunomedics 和 Trodelvy 開始。
The acquisition of Immunomedics is the largest transaction in Gilead's history and undoubtedly marks the turning point for the company.
收購 Immunomedics 是吉利德歷史上最大的一筆交易,無疑標誌著公司的轉折點。
As you know, Trodelvy is already approved in the U.S. for third line metastatic triple-negative breast cancer.
如您所知,Trodelvy 已在美國獲批用於轉移性三陰性乳腺癌的三線治療。
The recent data at ESMO underscored its transformative potential for this particularly challenging form of cancer as well as the potential for treating bladder cancer.
ESMO 最近的數據強調了它對這種特別具有挑戰性的癌症形式的變革潛力以及治療膀胱癌的潛力。
We will explore expansion into earlier lines of therapy in the short term.
我們將探索在短期內擴展到更早的治療線。
And overall, we see Trodelvy as a pipeline and a product.
總的來說,我們將 Trodelvy 視為一種管道和一種產品。
The prevalence of Trop-2 in multiple cancer types means Trodelvy has pan-tumor potential.
Trop-2 在多種癌症類型中的流行意味著 Trodelvy 具有泛腫瘤潛力。
Secondly, in addition to its extensive potential as a monotherapy, Trodelvy stands out because of the way it lends itself to combinations.
其次,除了作為單一療法的廣泛潛力外,Trodelvy 還因其適合組合的方式而脫穎而出。
The early data are promising, and we look forward to exploring combinations with various types of agents going forward.
早期數據很有希望,我們期待著探索未來與各種類型代理的組合。
The acquisition gives us an immediate presence in the field of solid tumors and brings us the significant expertise of the teams from Immunomedics.
此次收購使我們能夠立即進入實體瘤領域,並為我們帶來來自 Immunomedics 團隊的重要專業知識。
We're complementing our existing strengths in hemologic cancers through our combined Kite and Gilead pipeline and building on the important progress we've already made this year in building our oncology pipeline.
我們正在通過我們的 Kite 和 Gilead 管道組合來補充我們在血液癌症方面的現有優勢,並在我們今年在建立我們的腫瘤管道方面取得的重要進展的基礎上再接再厲。
Including Immunomedics, we have completed a total of 10 transactions in oncology so far this year.
包括 Immunomedics 在內,我們今年迄今共完成了 10 筆腫瘤交易。
I'll just mention 2 of the significant opportunities that are the results of those transactions.
我只想提一下這些交易帶來的兩個重要機會。
Magrolimab is now in Phase III for MDS and offer some potential first-in-class option utilizing the CD47 pathway to activate the innate immune system.
Magrolimab 現在處於 MDS 的 III 期,並提供一些潛在的一流選擇,利用 CD47 通路激活先天免疫系統。
Our partnership with Arcus is progressing well.
我們與 Arcus 的合作進展順利。
We are particularly excited by the potential of the TIGIT compound as well as other work that's coming out of that collaboration.
我們對 TIGIT 化合物的潛力以及該合作的其他工作感到特別興奮。
In cell therapy, we're now the only company with 2 FDA approved therapies, Yescarta and Tecartus from Kite.
在細胞療法方面,我們現在是唯一一家擁有 2 種 FDA 批准療法的公司,即來自 Kite 的 Yescarta 和 Tecartus。
Earlier this month, we received a positive opinion for KTE-X19 from the European Medicines Agency, the committee for medicinal products for human use.
本月早些時候,我們收到了歐洲藥品管理局(人用藥品委員會)對 KTE-X19 的積極評價。
I'm also pleased to announce that the FDA has accepted the Yescarta sBLA for relapsed or refractory follicular lymphoma and marginal cell lymphoma after 2 or more lines of systemic therapy.
我也很高興地宣布,FDA 已接受 Yescarta sBLA 用於 2 線或更多線的全身治療後的複發或難治性濾泡性淋巴瘤和邊緣細胞淋巴瘤。
The agency also granted priority review for this application.
該機構還對該申請授予了優先審查權。
ZUMA-7, the industry's first ever randomized trial in cell therapy and the only cell therapy in second line with overall survival as an endpoint, will be delayed slightly due to the slowdown in the rates of events.
ZUMA-7 是業界首個細胞療法隨機試驗,也是唯一以總生存期為終點的二線細胞療法,由於事件發生率的放緩,該試驗將略有延遲。
However, we expect the data in the first half of 2021.
不過,我們預計 2021 年上半年的數據。
And based upon that data, we're ready to submit quickly after.
基於這些數據,我們準備好在之後快速提交。
In summary, we made great progress in building out and advancing our pipeline to drive growth this year, and Trodelvy represents a true growth inflection point, changing our outlook significantly and positioning Gilead as an important contributor in the field of oncology.
總而言之,今年我們在構建和推進我們的管道以推動增長方面取得了很大進展,而 Trodelvy 代表了一個真正的增長拐點,顯著改變了我們的前景,並將吉利德定位為腫瘤學領域的重要貢獻者。
The foundation for all this additional growth is our durable core business.
所有這些額外增長的基礎是我們持久的核心業務。
In HIV, we saw a solid rebound in the third quarter with 14% quarterly sequential growth in the global franchise.
在 HIV 方面,我們在第三季度看到了強勁的反彈,全球特許經營權的季度環比增長為 14%。
While COVID-19 continues to impact our business, there were clear signs of recovery in the third quarter.
雖然 COVID-19 繼續影響我們的業務,但第三季度出現了明顯的複蘇跡象。
Moreover, the underlying demand is strong as Biktarvy continues to be the treatment of choice for patients and providers.
此外,潛在需求強勁,因為 Biktarvy 繼續成為患者和提供者的首選治療方法。
On the prevention side, we exceeded the goal we set at the beginning of the year of switching 40% to 45% of clinically appropriate at-risk individuals on PrEP to Descovy.
在預防方面,我們超過了我們在年初設定的目標,即將 40% 至 45% 的臨床合適的 PrEP 高危個體轉換為 Descovy。
As of October 1, we were at 46%.
截至 10 月 1 日,我們的比例為 46%。
Johanna will share more perspectives on our third quarter sales in a few moments.
稍後,Johanna 將分享更多關於我們第三季度銷售的觀點。
Finally, I'd like to briefly comment on remdesivir, which we now report -- refer to by its brand name of Veklury.
最後,我想簡要評論一下我們現在報告的瑞德西韋——指的是其品牌名稱 Veklury。
Veklury received full FDA approval this month for treating hospitalized patients with COVID-19.
Veklury 本月獲得 FDA 的全面批准,用於治療 COVID-19住院患者。
It's the only FDA-approved therapy for COVID-19, in addition to being authorized or approved for use in more than 50 countries worldwide.
它是 FDA 批准的唯一一種治療 COVID-19 的療法,此外還被授權或批准在全球 50 多個國家/地區使用。
We are also now in a position to meet global demand because of the work we've done since January to ramp up our supply.
由於我們自 1 月以來為增加供應所做的工作,我們現在也能夠滿足全球需求。
But first, stepping back for just a moment to recognize how remarkable it is that we are in this position today.
但首先,退後一步,認識到我們今天處於這個位置是多麼了不起。
At the start of the year, most of the world had not even heard of COVID-19.
今年年初,世界上大多數人甚至都沒有聽說過 COVID-19。
The scientific community moved very little about the virus or its devastating potential.
科學界對這種病毒或其破壞性潛力幾乎沒有動靜。
Today, less than 10 months later, we have an FDA-approved therapy that is helping patients around the world to recover faster.
今天,不到 10 個月後,我們有了一種 FDA 批准的療法,可以幫助世界各地的患者更快康復。
And for some groups of patients, Veklury is lowering the risk of death.
對於某些患者群體,Veklury 正在降低死亡風險。
All of this comes at a time when the rates of hospitalization, sadly in many places, are increasing.
所有這一切都發生在住院率上升的時候,遺憾的是在許多地方。
We have repeatedly seen the clinical benefits of Veklury across multiple clinical trials.
我們在多項臨床試驗中反复看到了 Veklury 的臨床益處。
In the past quarter, these benefits have been unequivocally demonstrated by the gold standard of global clinical trials.
在過去的一個季度中,全球臨床試驗的黃金標準明確地證明了這些好處。
The definitive results from the fully powered, double-blind, placebo-controlled and randomized NIAID ACTT-1 trial showed an average reduction in recovery time of 5 days.
完全有效、雙盲、安慰劑對照和隨機 NIAID ACTT-1 試驗的最終結果顯示恢復時間平均減少 5 天。
I sometimes imagine how I would feel if a family member was hospitalized for COVID-19, and I'm sure many of you think of this as well.
我有時會想像,如果我的家人因 COVID-19 而住院,我會有什麼感受,我相信你們中的許多人也會想到這一點。
I'm extremely grateful that a therapy exists that has been validated with all of the rigor required for an FDA approval and whose benefits have been demonstrating peer-reviewed data from a trial that is, without question, the pinnacle of clinical studies today.
我非常感謝存在一種療法,該療法已經過 FDA 批准所需的所有嚴格驗證,其好處是證明了來自一項試驗的同行評審數據,毫無疑問,這是當今臨床研究的巔峰之作。
Merdad will talk about all the recent data on Veklury, including what we've seen from the WHO study and the ongoing development program shortly.
Merdad 將談論有關 Veklury 的所有最新數據,包括我們從 WHO 研究和即將進行的開發計劃中看到的數據。
Johanna will talk about the recent move to a commercial distribution model in the U.S., which is going very well.
Johanna 將談論最近在美國轉向商業分銷模式的情況,該模式進展順利。
I'd just like to close on Veklury by stressing my gratitude once again to all the Gilead employees who've put their hearts and souls into this work since January, along with our many partners.
在結束 Veklury 時,我想再次強調我對自一月份以來全心全意投入這項工作的所有 Gilead 員工以及我們的許多合作夥伴的感激之情。
On behalf of all of us, I want to say how privileged we feel to play a role in helping with the pandemic and be able to put our antiviral expertise to work for patients with COVID-19.
我想代表我們所有人說,我們感到非常榮幸能夠在幫助應對大流行病方面發揮作用,並能夠將我們的抗病毒專業知識用於治療 COVID-19 患者。
I also want to emphasize that we will continue to do all it takes to fulfill our responsibility with Veklury.
我還想強調,我們將繼續盡一切努力履行我們對 Veklury 的責任。
To wrap up my prepared remarks, I want to emphasize that our portfolio and pipeline are much stronger going into the fourth quarter and 2021.
總結我準備好的發言,我想強調的是,進入第四季度和 2021 年,我們的投資組合和渠道將更加強大。
By executing on our strategy in a disciplined way throughout the past 12 months, we have significantly changed the nature of our growth process, especially following the acquisition of Immunomedics, and we have maintained the long-term durability of our core HIV franchise.
在過去的 12 個月裡,通過有條不紊地執行我們的戰略,我們已經顯著改變了我們成長過程的性質,尤其是在收購 Immunomedics 之後,並且我們保持了核心 HIV 特許經營權的長期持久性。
We're not done, of course, but we made significant progress.
當然,我們還沒有完成,但我們取得了重大進展。
And for that, I want to thank all the teams at Gilead and Kite and our many partners worldwide.
為此,我要感謝 Gilead 和 Kite 的所有團隊以及我們在全球的眾多合作夥伴。
With this, I'll hand the call now over to Johanna.
有了這個,我現在就把電話轉給約翰娜。
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
Thanks, Dan, and good afternoon, everyone.
謝謝,丹,大家下午好。
I want to begin by building on Dan's comments about our durable core business.
我想從丹對我們耐用核心業務的評論開始。
Our results through Q3 amid the ongoing COVID-19 pandemic have been strong.
在持續的 COVID-19 大流行中,我們通過第三季度的結果一直很強勁。
And as anticipated, we continue to see signs of recovery during the quarter in underlying demand trends across our core franchises in U.S. and Europe.
正如預期的那樣,我們在本季度繼續看到我們在美國和歐洲的核心特許經營權的潛在需求趨勢出現復甦跡象。
Looking at our HIV business.
看看我們的 HIV 業務。
We continue to make great progress in both treatment and prevention.
我們繼續在治療和預防方面取得重大進展。
Biktarvy in treatment and Descovy for prevention continue to gain share quarter-over-quarter.
用於治療的 Biktarvy 和用於預防的 Descovy 繼續按季度增加份額。
In treatment, Biktarvy remains the #1 regimen across key global markets.
在治療方面,Biktarvy 仍然是全球主要市場的第一方案。
In the U.S., 1 in 2 new patients start on Biktarvy.
在美國,每 2 個新患者中就有 1 個開始服用 Biktarvy。
And roughly 1 in 2 patients switching to Biktarvy do so from a non-Gilead single tablet regimen, growing overall Gilead share.
大約有二分之一的患者從非 Gilead 的單一片劑方案轉向 Biktarvy,從而增加了 Gilead 的整體份額。
In PrEP, despite COVID dynamics, we continue to make progress with Descovy with 46% conversion of clinically appropriate individuals at risk at the end of September, exceeding our stated goal of 40% to 45%.
在 PrEP 中,儘管有 COVID 動態,我們繼續在 Descovy 方面取得進展,到 9 月底,有 46% 的臨床上合適的風險個體轉化,超過了我們規定的 40% 至 45% 的目標。
Our overall HIV revenue in Q3 was very strong with 14% sequential growth over Q2 and 8% year-over-year growth driven by both strong demand fundamentals and normalized inventory dynamics.
我們在第三季度的整體 HIV 收入非常強勁,在強勁的需求基本面和正常的庫存動態的推動下,第二季度環比增長 14%,同比增長 8%。
The unique quarterly phasing of inventory dynamics this year and the recent Truvada loss of exclusivity will impact our sequential quarterly revenue dynamics in the fourth quarter.
今年獨特的季度庫存動態和最近 Truvada 失去獨家經營權將影響我們第四季度的連續季度收入動態。
With 91% of Gilead's U.S. patients having converted to TAF-based regimens, we will continue to build on our strength in HIV, including long-acting formulations for both treatment and prevention.
吉利德 (Gilead) 91% 的美國患者已轉變為基於 TAF 的治療方案,我們將繼續鞏固我們在 HIV 方面的實力,包括用於治療和預防的長效製劑。
Now briefly on HCV.
現在簡要介紹一下 HCV。
Our HCV business showed 4% sequential growth over Q2 while down 31% from Q3 last year due to lower patient starts year-on-year.
我們的 HCV 業務比第二季度環比增長 4%,但由於患者開始同比減少,比去年第三季度下降 31%。
As markets started to reopen in the U.S. and Europe, we saw an increase in diagnosis and patient starts in Q3.
隨著美國和歐洲市場開始重新開放,我們看到第三季度診斷和患者開始增加。
Our stock market share across core markets puts us in a position of strength as patients return through the rest of the year and into 2021.
隨著患者在今年餘下時間和 2021 年回歸,我們在核心市場的股票市場份額使我們處於優勢地位。
I'd like to now highlight some specifics on the initial commercialization of Veklury, which began in the third quarter.
我現在想強調一些關於 Veklury 最初商業化的細節,該商業化始於第三季度。
As our teams have begun reaching out to physicians and hospital systems, it has been incredibly inspiring to hear their stories of how they have used this medication and what it meant to patients as well as their loved ones.
隨著我們的團隊開始接觸醫生和醫院系統,聽到他們講述他們如何使用這種藥物以及它對患者和他們所愛的人意味著什麼的故事,非常鼓舞人心。
As a reminder, the commercial model in the third quarter was governed by an agreement with the U.S. government to allocate 90% of our supply to patients in the U.S. through a partnership with the U.S. Department of Health and Human Services.
提醒一下,第三季度的商業模式受與美國政府達成的一項協議的約束,該協議通過與美國衛生與公眾服務部的合作將我們 90% 的供應分配給美國患者。
During the quarter, we recorded Veklury sales of $873 million.
本季度,我們錄得 Veklury 銷售額為 8.73 億美元。
A portion of inventory that will be consumed in Q4 was recognized as revenue in the third quarter.
將在第四季度消耗的部分庫存在第三季度確認為收入。
As Dan mentioned, we have now pivoted beginning October 1 to a more traditional commercial model, working directly with AmerisourceBergen to provide Veklury directly to U.S. hospitals.
正如 Dan 提到的,我們現在已經從 10 月 1 日開始轉向更傳統的商業模式,直接與 AmerisourceBergen 合作,直接向美國醫院提供 Veklury。
AmerisourceBergen will remain our sole distributor of Veklury through the end of the year to ensure consistency and continuity.
到今年年底,AmerisourceBergen 仍將是我們 Veklury 的獨家經銷商,以確保一致性和連續性。
In Europe, we signed a joint procurement agreement with the European Commission on October 8 that enables participating countries in the EU, the European economic area and the U.K. to purchase Veklury to meet both real-time demand and stockpiling needs coordinated by the European Commission.
在歐洲,我們於 10 月 8 日與歐盟委員會簽署了一項聯合採購協議,使歐盟、歐洲經濟區和英國的參與國能夠採購 Veklury,以滿足歐盟委員會協調的實時需求和庫存需求。
This agreement temporarily removes the need for country-by-country reimbursement processes that typically follow marketing authorization, recognizing the urgency of the current health crisis.
該協議暫時消除了通常遵循營銷授權的逐國報銷流程的需要,認識到當前健康危機的緊迫性。
It encompasses purchases of Veklury over the next 6 months and can be extended if needed.
它包括在未來 6 個月內購買 Veklury,如果需要可以延長。
Predicting the underlying demand of core Veklury continues to be challenging given so many variables, including incidence rates, hospitalization rate as well as future vaccines and emerging treatments.
鑑於許多變量,包括發病率、住院率以及未來疫苗和新興療法,預測核心 Veklury 的潛在需求仍然具有挑戰性。
Now turning to Trodelvy.
現在轉向 Trodelvy。
As you know, the Immunomedics deal closed less than a week ago, and we're already working closely with the joint team to ensure the continuity of Trodelvy's strong launch in third line metastatic triple-negative breast cancer and accelerate its future potential.
如您所知,與 Immunomedics 的交易在不到一周前結束,我們已經在與聯合團隊密切合作,以確保 Trodelvy 在三線轉移性三陰性乳腺癌中的強勁上市的連續性,並加速其未來潛力。
It is a true catalyst for growth, and the joint team is energized as we continue to accelerate the work on this transformational therapy together as one team.
它是真正的增長催化劑,隨著我們作為一個團隊繼續加速這一轉化療法的工作,聯合團隊充滿活力。
While not part of our third quarter results, I'd like to highlight Immunomedics Q3 results for Trodelvy in the U.S. Trodelvy achieved $53 million in net sales in Q3, the first full quarter of commercial availability.
雖然不是我們第三季度業績的一部分,但我想強調美國 Trodelvy 的 Immunomedics 第三季度業績。Trodelvy 在第三季度實現了 5300 萬美元的淨銷售額,這是商業可用性的第一個完整季度。
Total net sales were $73 million in the first 5 months of commercial launch in the midst of a pandemic.
在大流行期間商業發布的前 5 個月,總淨銷售額為 7300 萬美元。
Over 1,000 accounts ordered Trodelvy in the first 5 months of commercial launch, and of those, that 488 were new and unique in Q3.
超過 1,000 個帳戶在商業發布的前 5 個月訂購了 Trodelvy,其中 488 個在第三季度是新的和獨特的。
We've seen robust adoption continue in Q3 in both community and academic centers.
我們已經看到社區和學術中心在第三季度繼續大力採用。
We look forward to expanding commercialization to Europe and other markets around the world as quickly as possible, starting with an EU submission in Q1 of next year.
我們期待盡快將商業化擴展到歐洲和世界其他市場,從明年第一季度的歐盟提交開始。
And to close, a few words on Jyseleca, which is the brand name for filgotinib.
最後,關於 Jyseleca 的幾句話,這是 filgotinib 的品牌名稱。
Jyseleca has now launched in Germany, and launch planning is well underway across Europe as well as Japan.
Jyseleca 現已在德國上市,歐洲和日本的上市計劃也在順利進行。
We anticipate sales in both regions during the fourth quarter.
我們預計第四季度這兩個地區的銷售額。
Despite a crowded and competitive marketplace, the teams are well prepared to differentiate Jyseleca.
儘管市場競爭激烈,但團隊已做好充分準備,讓 Jyseleca 脫穎而出。
We look forward to updating you on our progress in the future.
我們期待著向您通報我們未來的進展。
Merdad will provide a little bit more color on the ongoing regulatory considerations and our thinking there.
Merdad 將為正在進行的監管考慮和我們在那裡的想法提供更多色彩。
And so with that, I'd like to turn the call over to Merdad.
因此,我想把電話轉給 Merdad。
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 pleased to share some perspectives on several critical pipeline-related updates and progress.
我很高興就幾個與管道相關的關鍵更新和進展分享一些觀點。
Starting with Veklury.
從 Veklury 開始。
We're very pleased with the recent full approval of Veklury by the FDA.
我們對 FDA 最近對 Veklury 的全面批准感到非常高興。
Veklury is now approved in the U.S. for the treatment of hospitalized patients with COVID-19-based disease on a strong and consistent body of evidence from 3 rigorous, randomized, controlled clinical trials over the past 6 months to inform us about the profile of Veklury.
Veklury 現在在美國被批准用於治療基於 COVID-19的疾病的住院患者,基於過去 6 個月中來自 3 項嚴格、隨機、對照臨床試驗的強有力和一致的證據,讓我們了解 Veklury 的概況.
It's the first antiviral treatment proven to help patients hospitalized with COVID-19 recover and leave the hospital more quickly, a significant benefit for patients, their families and society.
這是第一種被證明可以幫助住院的 COVID-19 患者康復並更快出院的抗病毒治療,這對患者、他們的家人和社會來說都是一個重大的好處。
The results include the double blind, placebo-controlled NIAID Phase III ACTT-1 trial published recently in the New England Journal of Medicine.
結果包括最近發表在新英格蘭醫學雜誌上的雙盲、安慰劑對照 NIAID III 期 ACTT-1 試驗。
The study met its primary endpoint of time to clinical recovery through day 29, demonstrating Veklury plus standard of care reduced the time of recovery through day 29 compared with placebo plus standard of care from 15 to 10 days with a p-value of less than 0.001.
該研究在第 29 天達到了臨床恢復時間的主要終點,表明 Veklury 加標準護理將恢復時間縮短到 29 天,而安慰劑加標準護理從 15 天減少到 10 天,p 值小於 0.001 .
The key secondary endpoint of clinical status at day 15 was also met.
還達到了第 15 天臨床狀態的關鍵次要終點。
Patients receiving Veklury were 50% more likely to have improved by day 15 compared with those receiving placebo, and the effect was maintained through day 29.
與接受安慰劑的患者相比,接受 Veklury 治療的患者在第 15 天出現改善的可能性高出 50%,並且這種效果一直持續到第 29 天。
The secondary mortality endpoint in the overall population only showed a trend towards reduced mortality with a p-value of 0.07.
總體人口中的次要死亡率終點僅顯示出死亡率降低的趨勢,p 值為 0.07。
Recall that when we started these trials with the NIAID, we knew very little about the disease itself and didn't know which patients might be most likely to benefit from Veklury.
回想一下,當我們開始使用 NIAID 進行這些試驗時,我們對疾病本身知之甚少,也不知道哪些患者最有可能從 Veklury 中受益。
Given the range of disease severity in the overall study population and the emerging understanding that clinical outcomes are highly dependent on a patient's requirement for oxygen at baseline, an exploratory post-hoc analysis was conducted to determine whether there were differences in mortality based on patients' baseline clinical status with respect to the requirement for oxygen support.
鑑於整個研究人群的疾病嚴重程度範圍以及臨床結果高度依賴於基線時患者對氧氣的需求的新認識,進行了探索性事後分析以確定是否存在基於患者的死亡率差異關於氧氣支持需求的基線臨床狀態。
In this post-hoc analysis, in patients requiring low flow oxygen at baseline, the largest subgroup of patients in the trial, over 40% of patients, those who received Veklury had a 72% reduction in mortality at day 15 and a 70% reduction in mortality at day 29, with confidence intervals that do not cross one.
在這項事後分析中,在基線時需要低流量氧氣的患者中,試驗中最大的患者亞組,超過 40% 的患者,接受 Veklury 治療的患者在第 15 天的死亡率降低了 72%,在第 15 天死亡率降低了 70%第 29 天的死亡率,置信區間不超過 1。
These results are what we would have expected and hoped for with an antiviral therapy that should have the most impact when given earlier in the course of the disease before the inflammatory cascade leads to critical illness.
這些結果是我們對抗病毒療法的預期和希望,如果在炎症級聯反應導致危重疾病之前在病程早期給予抗病毒療法,應該會產生最大的影響。
These data add to the breadth of evidence from 2 additional randomized controlled clinical trials, establishing the use of Veklury as a standard of care for the treatment of COVID-19 in hospitalized patients.
這些數據增加了另外 2 項隨機對照臨床試驗的證據范圍,確立了使用 Veklury 作為治療住院患者 COVID-19的護理標準。
All 3 of these Phase III trials have been published in peer-reviewed journals, and the raw data was shared with the FDA as part of the NDA review process for them to perform their own independent analyses as is their standard approach.
所有這 3 項 III 期試驗都已在同行評審的期刊上發表,原始數據作為 NDA 審查過程的一部分與 FDA 共享,以便他們按照他們的標準方法進行自己的獨立分析。
We continue to pursue other ways to expand the utility of remdesivir as a backbone of treatment, including exploring how combinations could be more effective and new means of administering the drug that don't require intravenous administration.
我們繼續尋求其他方法來擴大瑞德西韋作為治療支柱的效用,包括探索組合如何更有效以及不需要靜脈內給藥的新給藥方式。
Now last week, interim results from the World Health Organization's SOLIDARITY trial were released through a preprint server.
上週,世界衛生組織的 SOLIDARITY 試驗的中期結果通過預印本服務器發布。
These results don't alter the demonstration of efficacy observed with remdesivir in the studies I just described.
這些結果不會改變我剛才描述的研究中使用瑞德西韋觀察到的療效證明。
That trial was intentionally designed to be pragmatic and enable participation across a wide range of health care settings.
該試驗的設計目的是務實,並使參與範圍廣泛的醫療保健環境成為可能。
There are components of the study design and data that should provide pause.
研究設計和數據的某些組成部分應該暫停。
These may be clarified or placed into appropriate context during the peer review process.
這些可能會在同行評審過程中得到澄清或置於適當的背景下。
Given that we haven't received the data, nor have there been peer-reviewed -- nor have these data been peer reviewed, it's difficult for us to discuss the study.
鑑於我們還沒有收到數據,也沒有經過同行評審——這些數據也沒有經過同行評審,我們很難討論這項研究。
Some of the issues we and others have identified in WHO's study include the lack of a PCR confirmation of COVID-19 at the time of enrollment, the lack of distinction between patients requiring low-flow or high-flow oxygen in the results, no data monitoring, no data verification and 20% of the data being reported as missing from the preliminary analysis.
我們和其他人在 WHO 的研究中發現的一些問題包括在登記時缺乏對 COVID-19 的 PCR 確認,結果中需要低流量或高流量氧氣的患者之間缺乏區別,沒有數據監測,沒有數據驗證和 20% 的數據被報告為初步分析中缺失。
We can only speculate at this point that these factors may have contributed to the negative outcomes reported in this study.
我們目前只能推測這些因素可能導致了本研究報告的負面結果。
It is, however, important to note that the totality of data generated thus far for Veklury suggests that antivirals are most effective earlier in the disease course.
然而,重要的是要注意,迄今為止為 Veklury 生成的全部數據表明,抗病毒藥物在疾病過程的早期最有效。
As you get sicker, inflammation, such as ARDS or fibrosis, potentially things like vascular blood clots and bacterial pneumonias, could kick in.
隨著病情加重,ARDS 或纖維化等炎症、血管血栓和細菌性肺炎等潛在疾病可能會發作。
The NIAID data suggests that patients on low-flow oxygen are those that show the greatest benefit in time to discharge and mortality.
NIAID 數據表明,使用低流量氧氣的患者在出院時間和死亡率方面表現出最大優勢。
An antiviral doesn't clear inflammation or blood clots once they're formed.
一旦炎症或血塊形成,抗病毒藥物就無法清除它們。
So this makes sense.
所以這是有道理的。
Sicker patients on high-flow oxygen and mechanical ventilation may need an antiviral, but it will be insufficient to treat the inflammation.
接受高流量氧氣和機械通氣的病情較重的患者可能需要抗病毒藥物,但這不足以治療炎症。
In those patients, treatment in addition to antivirals, such as dexamethasone, may be beneficial and have been demonstrated to be that way using WHO data.
在這些患者中,除抗病毒藥物(例如地塞米松)之外的治療可能有益,並且已使用 WHO 數據證明是這種治療方式。
We look forward to learning more about the SOLIDARITY trial results and sharing this information with regulators once we have the data in hand.
我們期待更多地了解 SOLIDARITY 試驗結果,並在掌握數據後與監管機構分享這些信息。
Most importantly, at this moment, the world is combating a pandemic that isn't going away.
最重要的是,此時此刻,世界正在抗擊一場不會消失的流行病。
As we see infections once again on the rise across the U.S. and Europe, it's critical that physicians have every tool possible at their disposal and that patients are encouraged to seek care for what we know can be a rapidly progressing and deadly virus.
當我們看到美國和歐洲的感染人數再次上升時,至關重要的是醫生必須擁有一切可能的工具,並鼓勵患者就我們所知可能是一種快速發展的致命病毒尋求治療。
We're proud of the role Veklury has played in this pandemic, and I'm proud of and profoundly grateful to the team who's worked so hard to advance this medicine for patients, including those collaborators at the NIAID, the investigators and patients who've been integral to the conduct of these studies.
我們為 Veklury 在這場大流行病中發揮的作用感到自豪,我為努力為患者推進這種藥物的團隊感到自豪並深表感謝,包括 NIAID 的合作者、研究人員和患者這些研究的開展不可或缺。
We regularly receive letters of gratitude from people who've been treated with Veklury, and we're grateful for the opportunity to provide this important treatment during this time.
我們經常收到接受過 Veklury 治療的人的感謝信,我們很高興有機會在這段時間提供這種重要的治療。
So now I'd like to turn to oncology.
所以現在我想轉向腫瘤學。
As Dan mentioned, we're very excited now to have the Trodelvy program in-house with the closing of the Immunomedics transaction.
正如 Dan 所提到的,隨著 Immunomedics 交易的結束,我們現在非常高興在內部擁有 Trodelvy 計劃。
We're excited to welcome the impressive Immunomedics team to Gilead.
我們很高興歡迎令人印象深刻的 Immunomedics 團隊加入吉利德。
As Dan and Johanna both mentioned, Trodelvy represents a growth inflection point for the company, and I'd like to highlight recent progress that has us excited about the full potential of this medicine.
正如 Dan 和 Johanna 都提到的那樣,Trodelvy 代表了公司的增長拐點,我想強調最近的進展,這些進展讓我們對這種藥物的全部潛力感到興奮。
You may have seen the ESMO data that Immunomedics presented from the confirmatory Phase III ASCENT study.
您可能已經看到 Immunomedics 從驗證性 III 期 ASCENT 研究中提供的 ESMO 數據。
In this study, despite having received a median of 4 prior anticancer treatments, patients treated with Trodelvy showed a statistically significant and clinically meaningful improvement in overall survival with a median of 12.1 months versus 6.7 months for chemotherapy and a hazard ratio of 0.48 and a p-value of less than 0.0001.
在這項研究中,儘管之前接受過 4 次抗癌治療,接受 Trodelvy 治療的患者在總生存期方面顯示出具有統計學意義和臨床意義的改善,中位生存期為 12.1 個月,而化療為 6.7 個月,風險比為 0.48 和 p - 小於 0.0001 的值。
Trodelvy also demonstrated a statistically significant improvement in ORR, 35% versus 5%; and CBR, 45% versus 9%, when compared with chemotherapy.
Trodelvy 還證明 ORR 有統計學意義的顯著改善,分別為 35% 和 5%;與化療相比,CBR 分別為 45% 和 9%。
These remarkable results should establish Trodelvy as a new standard of care in patients with third line metastatic TNBC.
這些顯著的結果應該將 Trodelvy 確立為三線轉移性 TNBC 患者的新護理標準。
In urothelial cancer, another area of focus, as reported at ESMO last month, Immunomedics released a positive results from cohort I of the pivotal Phase II TROPHY U-01 study of Trodelvy in cisplatin-eligible patients with metastatic urothelial cancer.
正如上個月在 ESMO 上報導的那樣,在另一個重點領域尿路上皮癌中,Immunomedics 發布了 Trodelvy 在符合順鉑條件的轉移性尿路上皮癌患者中的關鍵 II 期 TROPHY U-01 研究隊列 I 的陽性結果。
These results confirm the interim findings in prior Phase I/II study results showing Trodelvy has significant activity and is well tolerated in patients with heavily pretreated metastatic urothelial cancer who progressed despite platinum-based chemotherapy and checkpoint inhibitors.
這些結果證實了先前 I/II 期研究結果的中期發現,表明 Trodelvy 具有顯著的活性,並且在經過大量預處理的轉移性尿路上皮癌患者中具有良好的耐受性,這些患者儘管接受了基於鉑的化療和檢查點抑製劑,但仍進展順利。
Trodelvy has the potential to be an important new treatment for patients with metastatic urothelial cancer.
Trodelvy 有可能成為轉移性尿路上皮癌患者的重要新療法。
Based on these exciting data, in terms of the path forward for Trodelvy, the BLA -- supplemental BLA seeking expansion of Trodelvy's label to include the ASCENT result is expected to be submitted in Q4 to the FDA under the RTOR program.
基於這些令人興奮的數據,就 Trodelvy 的前進道路而言,BLA——尋求擴大 Trodelvy 標籤以包括 ASCENT 結果的補充 BLA 預計將在第四季度根據 RTOR 計劃提交給 FDA。
The sBLA submission to the FDA for an accelerated approval of Trodelvy in metastatic urothelial cancer is expected in Q4 as well.
預計第四季度還將向 FDA 提交 sBLA 申請,以加速批准 Trodelvy 治療轉移性尿路上皮癌。
In addition, the MAA for Trodelvy in metastatic TNBC in Europe is planned for submission to the EMA in the first quarter of 2021.
此外,歐洲轉移性 TNBC 的 Trodelvy MAA 計劃於 2021 年第一季度提交給 EMA。
The potential for Trodelvy in earlier lines of therapy and additional tumor types is something we're really excited to explore.
Trodelvy 在早期治療和其他腫瘤類型中的潛力是我們非常期待探索的東西。
Results from studies with combinations of PARP inhibitors and separately checkpoint inhibitors give us even more options to explore the potential of this new treatment for patients.
PARP 抑製劑和單獨檢查點抑製劑組合的研究結果為我們提供了更多選擇,以探索這種新療法對患者的潛力。
Beyond Trodelvy, I'd like to highlight other opportunities in our oncology pipeline that continue to excite us.
除了 Trodelvy 之外,我還想強調我們腫瘤管道中繼續令我們興奮的其他機會。
On magrolimab, our anti-CD47 asset, we continue to pursue options for filing an accelerated approval pathway, from magrolimab in addition to azacitidine and MDS in 2021 based on the ongoing single-arm study.
在我們的抗 CD47 資產 magrolimab 上,我們繼續尋求根據正在進行的單臂研究,在 2021 年從 magrolimab 以及阿扎胞苷和 MDS 申請加速批准途徑。
As with all single-arm studies, the risk and the FDA will make a decision based on the totality of the data and whether the data support a substantial benefit from available standard of care.
與所有單臂研究一樣,風險和 FDA 將根據數據的整體性以及數據是否支持現有護理標準帶來的實質性益處做出決定。
The recent breakthrough designation for magrolimab provides recognition by the FDA the potential for magrolimab and enables us to have more frequent FDA interactions.
magrolimab 最近獲得的突破性指定讓 FDA 認識到 magrolimab 的潛力,並使我們能夠更頻繁地與 FDA 進行互動。
We also have obtained prime designation from magrolimab, another recognition of the potential for magrolimab.
我們還獲得了 magrolimab 的主要指定,這是對 magrolimab 潛力的另一種認可。
We've initiated our enhanced randomized Phase III study comparing magrolimab plus azacitidine versus azacitidine alone in higher-risk MDS patients to confirm the Phase I results for potential full approval.
我們已經啟動了我們的增強型隨機 III 期研究,比較 magrolimab 加阿扎胞苷與單獨使用阿扎胞苷在高風險 MDS 患者中的療效,以確認 I 期結果可能獲得全面批准。
The emerging data from our partner, Arcus, is very exciting, and we look forward to updating you in due course.
來自我們的合作夥伴 Arcus 的新興數據非常令人興奮,我們期待在適當的時候為您更新。
Moving to antivirals.
轉向抗病毒藥物。
We continue to be excited about lenacapavir, the company's investigational long-acting HIV-1 capsid inhibitor, an injectable administered every 6 months.
我們繼續對該公司正在研究的長效 HIV-1 衣殼抑製劑 lenacapavir 感到興奮,這是一種每 6 個月注射一次的藥物。
The study in evaluating lenacapavir in highly treatment-experienced HIV patients is progressing, and we're on track for a planned filing in 2021.
在高度治療經驗的 HIV 患者中評估 lenacapavir 的研究正在取得進展,我們正按計劃在 2021 年提交申請。
We also recently announced the addition of a new study arm of lenacapavir to the women's -- to the existing planned women's HIV prevention study, evaluating Descovy and Truvada in women at risk of HIV.
我們最近還宣佈在現有計劃的女性 HIV 預防研究中增加一個新的女性 lenacapavir 研究組,評估 Descovy 和 Truvada 在女性感染 HIV 風險中的作用。
In parallel, we will also initiate a study of lenacapavir for HIV prevention in men and transgender people who have sex with men.
與此同時,我們還將啟動一項關於來那卡韋在男性和男男性行為者中預防 HIV 的研究。
Turning to filgotinib.
轉向 filgotinib。
We're excited about the launch of Jyseleca for rheumatoid arthritis in Europe.
我們很高興在歐洲推出用於治療類風濕性關節炎的 Jyseleca。
During the quarter, we shared data from the Phase IIb/III selection trial in ulcerative colitis showing filgotinib 200-milligram induced remission at week 10 and achieved endoscopic histologic and 6-month corticosteroid free remission at week 58 with a consistent safety profile.
在本季度,我們分享了潰瘍性結腸炎 IIb / III 期選擇試驗的數據,顯示 filgotinib 200 毫克在第 10 週誘導緩解,並在第 58 週實現內窺鏡組織學和 6 個月無皮質類固醇緩解,並具有一致的安全性。
We plan to file filgotinib for ulcerative colitis in Europe before the year-end and Japan early next year.
我們計劃在年底前在歐洲和明年初在日本提交用於潰瘍性結腸炎的 filgotinib。
As we previously shared, in August, the FDA issued a complete response letter for filgotinib in rheumatoid arthritis, requesting data from the MANTA and MANTA-RAy studies and expressing concerns regarding the benefit/risk profile of the 200-milligram dose.
正如我們之前分享的那樣,8 月,FDA 發布了關於類風濕性關節炎絲裂黴素的完整回复函,要求 MANTA 和 MANTA-RAy 研究提供數據,並對 200 毫克劑量的益處/風險概況表示擔憂。
We met with the FDA for a Type C meeting to discuss MANTA, and we'll meet again for a Type A meeting in Q4 to further discuss the CRL.
我們與 FDA 舉行了 C 類會議,討論 MANTA,我們將在第四季度再次舉行 A 類會議,進一步討論 CRL。
In the meantime, we're pausing screening and enrollment for ongoing trials in psoriatic arthritis, ankylosing spondylitis and uveitis as we believe the FDA meeting will inform the broader filgotinib development program.
與此同時,我們正在暫停銀屑病關節炎、強直性脊柱炎和葡萄膜炎正在進行的試驗的篩查和註冊,因為我們相信 FDA 會議將為更廣泛的 filgotinib 開發計劃提供信息。
We continue to believe in the benefit/risk profile of filgotinib.
我們仍然相信 filgotinib 的益處/風險狀況。
I'd also like to highlight that we remain committed to inflammation into our long-term collaboration with Galapagos.
我還想強調的是,我們仍然致力於將炎症融入我們與加拉帕戈斯的長期合作中。
Finally, I wanted to highlight that we are focused on ongoing strategic portfolio review and disciplined prioritization of our overall portfolio.
最後,我想強調的是,我們專注於持續的戰略投資組合審查和對我們的整體投資組合進行嚴格的優先排序。
We've shared a summary of important upcoming milestones across the pipeline in the materials we've provided.
我們在我們提供的材料中分享了整個管道即將到來的重要里程碑的摘要。
I'll turn over the call to Andy now.
我現在將電話轉給安迪。
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。
Our third quarter performance was strong, and it reflects the solid underlying fundamentals in our core HIV franchise and the start of the post-donation phase for Veklury.
我們第三季度的表現強勁,反映了我們核心 HIV 特許經營的堅實基礎以及 Veklury 捐贈後階段的開始。
It also reflects the ongoing and dynamic impact of the COVID-19 pandemic.
它還反映了 COVID-19 大流行的持續和動態影響。
You will find our detailed Q3 results in the press release and materials we have posted.
您將在我們發布的新聞稿和材料中找到我們詳細的第三季度結果。
In my following remarks, I will review elements of our Q3 performance and provide you with an update on our full year guidance.
在接下來的評論中,我將回顧我們第三季度業績的要素,並向您提供我們全年指導的最新情況。
Turning now to the financial highlights.
現在轉向財務亮點。
Total revenues for the third quarter of 2020 were $6.6 billion, with non-GAAP diluted earnings per share of $2.11.
2020 年第三季度總收入為 66 億美元,非 GAAP 攤薄後每股收益為 2.11 美元。
This compares to total revenue of $5.6 billion and non-GAAP diluted earnings per share of $1.64 for the same period last year.
相比之下,去年同期的總收入為 56 億美元,非 GAAP 稀釋後每股收益為 1.64 美元。
Non-GAAP diluted earnings per share for the third quarter of 2020 increased 29% year-over-year, primarily due to higher operating income driven by growth in HIV product sales and our initial Veklury sales as well as lower non-GAAP tax rate.
2020 年第三季度非 GAAP 攤薄後每股收益同比增長 29%,這主要是由於 HIV 產品銷售和我們最初的 Veklury 銷售額增長以及較低的非 GAAP 稅率推動營業收入增加。
As noted in the earnings press release, on a GAAP basis, the third quarter diluted earnings per share was $0.29, primarily due to $1.2 billion in charges related to our collaborations and equity investments in building out our oncology pipeline as well as a $900 million loss from unfavorable changes in the fair value of our equity investment in Galapagos.
正如收益新聞稿中所述,根據 GAAP,第三季度攤薄後每股收益為 0.29 美元,這主要是由於與我們在構建腫瘤管道方面的合作和股權投資相關的 12 億美元費用以及 9 億美元的虧損由於我們在加拉帕戈斯群島的股權投資的公允價值發生不利變化。
Product sales for the third quarter of 2020 were $6.5 billion, up 28% sequentially and up 18% year-over-year, primarily due to Veklury sales and our core HIV products driven by stronger demand as well as higher volume as channel inventory continues to normalize in the United States.
2020 年第三季度的產品銷售額為 65 億美元,環比增長 28%,同比增長 18%,這主要是由於 Veklury 的銷售和我們的核心 HIV 產品受到強勁需求的推動,以及渠道庫存持續增加導致銷量增加在美國正常化。
HIV revenues grew sequentially 14% driven by a continued patient uptake of Biktarvy and Descovy for PrEP and increased channel inventory purchases in the United States.
受患者持續使用 Biktarvy 和 Descovy 治療 PrEP 以及美國渠道庫存採購增加的推動,HIV 收入環比增長了 14%。
HIV revenues increased 8% year-over-year, primarily due to higher demand driven by Biktarvy, and as I said earlier, the normalization of inventory purchases in the U.S., partially offset by lower sales of Truvada.
HIV 收入同比增長 8%,這主要是由於 Biktarvy 推動的更高需求,而且正如我之前所說,美國庫存採購正常化,部分被 Truvada 銷售額下降所抵消。
HCV revenues grew 4% sequentially, primarily due to higher patient starts in the United States and Europe, but the revenues were down 31% year-over-year, primarily due to the COVID-19 pandemic and its impact on patient starts.
HCV 收入環比增長 4%,這主要是由於美國和歐洲的患者啟動率較高,但收入同比下降 31%,這主要是由於 COVID-19 大流行及其對患者啟動的影響。
Cell therapy revenues were down 6% sequentially due to COVID-19 and up 25% year-over-year driven by continued patient uptake and expansion of Yescarta in Europe.
由於 COVID-19,細胞療法收入環比下降了 6%,而在歐洲患者持續接受和 Yescarta 擴張的推動下,細胞療法收入同比增長了 25%。
Now turning to our expenses.
現在轉向我們的開支。
Non-GAAP R&D expense was $1.2 billion for the quarter, down 3% sequentially and up 12% year-over-year.
本季度非 GAAP 研發費用為 12 億美元,環比下降 3%,同比增長 12%。
The sequential decrease was primarily driven by lower investments in remdesivir in the third quarter.
環比下降主要是由於第三季度對瑞德西韋的投資減少。
The year-over-year increase was primarily driven by higher investments in remdesivir, partially offset by positives or deferrals of certain clinical trials due to the COVID-19 pandemic.
同比增長主要是由於對瑞德西韋的投資增加,部分被 COVID-19 大流行導致的某些臨床試驗的積極或推遲所抵消。
Non-GAAP SG&A expense was $1.1 billion, down 6% sequentially and up 5% year-over-year.
非 GAAP SG&A 費用為 11 億美元,環比下降 6%,同比增長 5%。
The sequential decrease in expenses was primarily driven by the second quarter accrual of $97 million related to a Department of Justice matter, which subsequently settled in the third quarter.
支出的環比下降主要是由於第二季度與司法部事務相關的 9700 萬美元應計費用,該事務隨後於第三季度解決。
The year-over-year increase was primarily driven by headcount growth, partially offset by lower marketing spend due to COVID-19.
同比增長主要是由員工人數增長推動的,部分被 COVID-19 導致的營銷支出減少所抵消。
Now moving to the balance sheet and cash flow.
現在轉向資產負債表和現金流量。
We finished the quarter with $26 billion in cash and marketable debt securities.
我們以 260 億美元的現金和有價債務證券結束了本季度。
During the quarter, we generated $2.3 billion in cash flow from operations.
本季度,我們從運營中產生了 23 億美元的現金流。
We paid dividends of $861 million.
我們支付了 8.61 億美元的股息。
We repaid $2 billion of maturing debt, and we repurchased $201 million of stock.
我們償還了 20 億美元的到期債務,並回購了 2.01 億美元的股票。
In addition, we issued $7.25 billion of senior notes and arranged a $1 billion term loan, which we drew down in Q4 to partially fund the acquisition of Immunomedics.
此外,我們發行了 72.5 億美元的優先票據並安排了 10 億美元的定期貸款,我們在第四季度提取了這筆貸款,用於為收購 Immunomedics 提供部分資金。
After closing the Immunomedics acquisition, our balance sheet remains strong, and our capital allocation priorities remain unchanged.
在完成對 Immunomedics 的收購後,我們的資產負債表依然強勁,我們的資本配置優先順序保持不變。
We have, however, curtailed our share repurchase program in the near term as we focus on paying down debt incurred in the acquisition.
然而,由於我們專注於償還收購中產生的債務,我們已在短期內縮減了我們的股票回購計劃。
As Dan indicated, the acquisition will immediately accelerate our revenue growth and is expected to be neutral to accretive to our non-GAAP EPS in 2023 -- by 2023 and significantly accretive thereafter.
正如 Dan 所指出的那樣,此次收購將立即加速我們的收入增長,預計到 2023 年對我們的非 GAAP 每股收益增長保持中性——到 2023 年,此後將顯著增長。
Turning now to COVID and its continued impact on our business and the broader business environment.
現在轉向 COVID 及其對我們的業務和更廣泛的業務環境的持續影響。
As we do every quarter, we've updated our base case utilizing external projections and views.
正如我們每個季度所做的那樣,我們利用外部預測和視圖更新了我們的基本案例。
As you know, the pandemic continues to progress in unpredictable ways.
如您所知,大流行繼續以不可預測的方式發展。
The recent uptick of infection and hospitalization rates in the U.S. and Europe is obviously of concern to all and will potentially impact the business environment during the fourth quarter and into 2021.
美國和歐洲近期感染率和住院率的上升顯然引起了所有人的關注,並將可能影響第四季度和 2021 年的商業環境。
Globally, external views suggest widespread vaccination will not become a reality until late in 2021.
在全球範圍內,外部觀點表明,廣泛接種疫苗要到 2021 年底才能成為現實。
As a result, we expect the pandemic to continue to impact our business and broader market dynamics, including, in particular, HCV, HIV PrEP and Veklury demand into 2021 and potentially beyond.
因此,我們預計這種流行病將繼續影響我們的業務和更廣泛的市場動態,特別是丙肝病毒、艾滋病毒 PrEP 和 Veklury 需求到 2021 年甚至可能更久。
We also expect that our HIV treatment business will continue to remain largely unaffected and that the remainder of our core business will continue to recover in the fourth quarter and into the first half of 2021.
我們還預計我們的 HIV 治療業務將繼續基本不受影響,我們的核心業務的其餘部分將在第四季度和 2021 年上半年繼續復甦。
With that as context, let me turn to our updated full year 2020 guidance.
以此為背景,讓我轉向我們更新的 2020 年全年指南。
It's important to reiterate that we are operating in a highly complex and dynamic environment, and the projections are subject to greater uncertainty than has historically been the case.
重要的是要重申,我們在一個高度複雜和多變的環境中運營,而且這些預測比以往任何時候都面臨更大的不確定性。
We have reaffirmed and narrowed our revenue guidance range to $23 billion to $23.5 billion, reflecting the latest estimates for Veklury.
我們重申並縮小了我們的收入指導範圍至 230 億美元至 235 億美元,反映了對 Veklury 的最新估計。
The guidance range provided during our second quarter earnings reflected underlying uncertainty in demand -- in the demand dynamics for Veklury given the nature of this pandemic, and as Johanna mentioned earlier, factors such as the rate of infections by region, severity, hospitalizations and stockpiling demand, all of which have been difficult to forecast.
我們在第二季度收益中提供的指導範圍反映了需求的潛在不確定性——鑑於這種流行病的性質,Veklury 的需求動態以及正如 Johanna 之前提到的那樣,各地區的感染率、嚴重程度、住院率和庫存等因素需求,所有這些都很難預測。
On the expense side, we're raising our SG&A expense guidance to low double-digit percentage growth, reflecting the Immunomedics acquisition.
在費用方面,我們將我們的 SG&A 費用指導提高到較低的兩位數百分比增長,反映了對 Immunomedics 的收購。
Our full year operating income guidance range is reaffirmed and narrowed and is now USD 10.7 billion to USD 11.2 billion.
我們的全年營業收入指導範圍得到重申和縮小,現在為 107 億美元至 112 億美元。
Our full year non-GAAP EPS range is also reaffirmed and narrowed and is now $6.25 to -- $6.25 to $6.60 per share.
我們的全年非 GAAP 每股收益範圍也得到重申和縮小,現在為每股 6.25 美元至 - 6.25 美元至 6.60 美元。
As we think about our performance to date and our guidance, we are encouraged by the significant process we've made in such a challenging environment this year.
當我們考慮我們迄今為止的表現和我們的指導時,我們對今年在如此具有挑戰性的環境中取得的重要進展感到鼓舞。
Before we hand the call off for Q&A, we would like to express our gratitude to our 12,000 Gilead and Kite employees globally.
在我們結束問答環節之前,我們要向全球 12,000 名 Gilead 和 Kite 員工表示感謝。
Their spirit, dedication and resilience make it possible for us to have a meaningful impact on patients with some of the world's hardest-to-treat diseases.
他們的精神、奉獻精神和韌性使我們能夠對患有世界上一些最難治療的疾病的患者產生有意義的影響。
We'd now like to open the call for questions.
我們現在想開始提問。
Operator
Operator
(Operator Instructions) I show our first question comes from the line of Matthew Harrison from Morgan Stanley.
(操作員說明)我顯示我們的第一個問題來自摩根士丹利的馬修哈里森。
Matthew Kelsey Harrison - Executive Director
Matthew Kelsey Harrison - Executive Director
I guess on filgotinib, can you guys maybe just describe what you're thinking in terms of the potential outcomes here once you have that Type A meeting?
我想關於 filgotinib,你們能不能描述一下你們在舉行 A 類會議後的潛在結果方面的想法?
Is this something where you could decide not to launch the drug in the U.S. at all?
這是你可以決定根本不在美國推出這種藥物的地方嗎?
Or is this more a nuanced approach where maybe you won't move forward with RA but move forward with the IBD indication?
或者這是一種更微妙的方法,您可能不會繼續使用 RA,而是繼續使用 IBD 適應症?
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Matthew, it's Merdad.
馬修,是梅爾達。
Yes, I think the outcomes -- it's hard to predict what the outcomes are.
是的,我認為結果——很難預測結果是什麼。
I do think that both the options you suggested are possible.
我確實認為您建議的兩種選擇都是可能的。
And I would sort of tend towards your latter approach, which is that we would -- if things aren't able to move forward with RA, we'd like to keep the door open for us to continue to move forward in IBD and continue those discussions, obviously, dependent on the MANTA and the MANTA-RAy data outcome.
而且我會傾向於你的後一種方法,那就是我們會 - 如果事情無法在 RA 上取得進展,我們希望為我們繼續在 IBD 上前進並繼續顯然,這些討論取決於 MANTA 和 MANTA-RAy 數據結果。
Operator
Operator
I show our next question comes from the line of Evan Seigerman from Crédit Suisse.
我展示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
So with the recent review of Galapagos' Toledo program, Merdad, what do you really need to see from the proof-of-concept trials to opt in and be comfortable, potentially incorporating this into your portfolio given your focus on portfolio optimization?
因此,通過最近對加拉帕戈斯的托萊多計劃 Merdad 的審查,您真正需要從概念驗證試驗中看到什麼才能選擇加入並感到舒適,鑑於您專注於投資組合優化,可能會將其納入您的投資組合?
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes.
是的。
Thanks.
謝謝。
Great question.
很好的問題。
They're doing a really great job of exploring the potential of that program in multiple indications.
他們在探索該項目在多種適應症中的潛力方面做得非常出色。
And they have a great approach of trying to get there quickly, looking for early signals of activity.
他們有一個很好的方法來嘗試快速到達那裡,尋找活動的早期信號。
On our end, we -- obviously, we would like to see the programs de-risked to the appropriate level at the time that we opt in.
在我們這邊,我們 - 顯然,我們希望看到這些項目在我們選擇加入時將風險降低到適當的水平。
That will vary based on the signals we see and the magnitude of the improvement that we see.
這將根據我們看到的信號和我們看到的改進程度而有所不同。
So obviously, if you saw hypothetically a huge response in one indication that was really unexpected and blew it out of the water, we might opt in more early.
所以很明顯,如果你假設在一個真正出乎意料的跡像中看到了巨大的反應並將其吹出水面,我們可能會更早地選擇加入。
Whereas if it's more nuanced in a small trial, we might want to flesh that out a little bit more before we opt in.
然而,如果它在一個小試驗中更細微,我們可能希望在我們選擇加入之前更加充實一點。
Our contract allows us to continue to work with them as the program's already de-risked, and our desire is to opt in and move as quickly as possible once we have an appropriate level of risk.
我們的合同允許我們繼續與他們合作,因為該項目已經消除了風險,我們的願望是一旦我們有適當的風險水平就選擇加入並儘快行動。
Operator
Operator
Our next question comes from the line of Cory Kasimov from JPMorgan.
我們的下一個問題來自摩根大通的 Cory Kasimov。
Cory William Kasimov - Senior Biotechnology Analyst
Cory William Kasimov - Senior Biotechnology Analyst
Wanted to ask about remdesivir and the change to guidance now.
現在想詢問有關瑞德西韋和指南變更的問題。
I guess I'm just trying to better understand kind of what has changed since your guidance in 2Q that leads to the lowering of fiscal year guidance by $1.5 billion, and I mean just given the pace of infections that we're seeing across the country.
我想我只是想更好地了解自您在第二季度的指導以來發生了什麼變化,導致財政年度指導降低 15 億美元,我的意思是考慮到我們在全國看到的感染速度.
Can you just kind of go into a little bit more detail on why this -- why the lowering and kind of how this market is evolving in your eyes?
你能否更詳細地解釋一下為什麼會這樣——為什麼這個市場在你眼中會下降以及它是如何演變的?
Andrew D. Dickinson - Executive VP & CFO
Andrew D. Dickinson - Executive VP & CFO
Cory, it's Andy.
科里,是安迪。
I'll start, and Johanna can jump in as well.
我先開始,Johanna 也可以加入。
I think it's relatively straightforward.
我認為這是相對簡單的。
I mean it's a dynamic situation.
我的意思是這是一個動態的情況。
It's very difficult to forecast, as we've discussed.
正如我們所討論的,這很難預測。
And as I think most people understand, the rate of hospitalizations is the biggest factor that has moved around a lot over the last 6 months, and it continues to move today.
正如我認為大多數人都理解的那樣,住院率是過去 6 個月內變化很大的最大因素,並且今天仍在繼續變化。
So what you're seeing is our -- the latest estimate based on the information that we have.
所以你看到的是我們——根據我們掌握的信息做出的最新估計。
We're pleased with the uptake in the third quarter, obviously, with the formal U.S. approval, the joint procurement agreement in place, Johanna and her team, I think, have a better sense of where we see the year.
我們對第三季度的進展感到滿意,顯然,隨著美國的正式批准,聯合採購協議的實施,約翰娜和她的團隊,我認為,對今年的情況有了更好的認識。
But it's still very dynamic, and it's unusual compared to what we're -- what you have to typically forecast.
但它仍然非常有活力,與我們通常要預測的相比,它是不尋常的。
Johanna, if you want to add anything to that.
約翰娜,如果你想補充什麼。
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
Yes.
是的。
Maybe just to add to that, Andy, I think what we're also seeing is the severity of the disease.
也許只是為了補充一點,安迪,我認為我們還看到了這種疾病的嚴重性。
So I think as you saw through the summer months, even though there were surges going through the U.S. mostly, some of those were younger patient population.
所以我認為,正如你在整個夏季所看到的那樣,儘管美國的人數激增,但其中一些是年輕的患者群體。
And therefore, the hospitalization rates really dropped over the summer months.
因此,住院率在夏季真的下降了。
We were seeing closer to 12% to 15% late Q2.
我們看到第二季度末接近 12% 到 15%。
And as you go into Q3, they're closer to 5%.
當你進入第三季度時,它們接近 5%。
So we're really tracking those very closely.
所以我們真的非常密切地跟踪這些。
It's not just the incidence.
這不僅僅是發病率。
It's really, to Andy's point, the hospitalization rates.
在安迪看來,這真的是住院率。
And obviously, the assumption is, in light of the surge this fall, both in Europe as well as in the U.S., that those numbers will pop back up a little bit.
顯然,假設是,鑑於今年秋天歐洲和美國的激增,這些數字會略有回升。
So that would be one piece of the puzzle.
所以這將是拼圖的一部分。
The other piece, I would say, is we looked at some of our assumptions around stockpiling.
另一部分,我想說的是,我們研究了一些關於庫存的假設。
And although we've seen some stockpiling, not at the level that we had originally projected, and so we're adapting to that as well.
儘管我們看到了一些庫存,但沒有達到我們最初預計的水平,因此我們也在適應這種情況。
Operator
Operator
Our next question comes from the line of Michael Yee from 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
I wanted to follow up a little more on filgotinib.
我想進一步了解 filgotinib。
Obviously, it's an important driver, and you said you'll have a Type A meeting, and you'll make some decisions.
顯然,這是一個重要的驅動因素,你說你將舉行 A 類會議,你將做出一些決定。
Can you just clarify what you would actually learn from a Type A?
你能澄清一下你實際上會從 A 型身上學到什麼嗎?
And if you were to, as you said, maybe keep IBD, isn't 200 milligrams really important, and so that would tie together with RA being approved at 200?
如果你像你說的那樣,可能會保留 IBD,那麼 200 毫克真的不重要嗎,所以這會與 RA 在 200 時獲得批准聯繫在一起嗎?
So maybe just explain a little bit where these scenarios would evolve from.
所以也許只是解釋一下這些場景會從哪裡演變而來。
And could you just make tough decisions to not go forward at all?
你能不能做出艱難的決定,根本不前進?
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Sure, Michael.
當然,邁克爾。
Yes, couldn't agree more.
是的,完全同意。
Look, I think the conversation we'll have in the Type A meeting will center around really what level of evidence the FDA would be looking for on both of those issues, right, in terms of trying to get to a better benefit/risk understanding.
聽著,我認為我們將在 A 類會議上進行的對話將真正圍繞 FDA 將在這兩個問題上尋找什麼級別的證據,對,在試圖更好地理解利益/風險方面.
And so that will depend -- so we need to find that out from the 200-milligram standpoint, and we need to find it out from the MANTA and MANTA-RAy standpoint.
因此,這將取決於 - 所以我們需要從 200 毫克的角度找出答案,我們需要從 MANTA 和 MANTA-RAy 的角度找出答案。
So those 2 things we will get guidance from the FDA and -- at the Type A meeting.
因此,我們將從 FDA 和 A 類會議上獲得這兩件事的指導。
And then based on that outcome, we will make some decisions how to go forward, whether it's -- whether there's a clear path, whether we have to only go forward in IBD or whether 200 milligrams is not viable until MANTA reads out, MANTA-RAy readout.
然後根據這個結果,我們將做出一些如何前進的決定,無論是——是否有一條清晰的道路,我們是否必須只在 IBD 上前進,或者在 MANTA 讀出之前 200 毫克是否可行,MANTA-射線讀數。
All those are possibilities, so it's hard to speculate what the outcome of that will be.
所有這些都是可能性,所以很難推測結果會是什麼。
We'll be transparent obviously as we have that discussion with how we'll proceed.
在討論我們將如何進行時,我們顯然會保持透明。
Operator
Operator
Our next question comes from the line of Geoffrey Porges from SVB Leerink.
我們的下一個問題來自 SVB Leerink 的 Geoffrey Porges。
Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst
Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst
One question -- a multipart question on Veklury and then a quick one on Trodelvy.
一個問題——一個關於 Veklury 的多部分問題,然後是一個關於 Trodelvy 的快速問題。
So on the Veklury, could you give us a sense of how many patients have been treated so far at least in the quarter and disclose for us what the inventory stocking was?
那麼在 Veklury 上,您能否告訴我們至少在本季度到目前為止有多少患者接受了治療,並為我們透露庫存量是多少?
And then a little bit of color about what proportion of hospitalized patients are getting remdesivir because we get the sense the standard of care.
然後是關於有多少住院患者正在接受瑞德西韋的一些顏色,因為我們感覺到護理標準。
And then Merdad, could you just talk a little bit about the profile of Trodelvy and combinations?
然後是 Merdad,你能談談 Trodelvy 和組合的概況嗎?
It does have some significant safety and tolerability liabilities.
它確實有一些重要的安全性和耐受性責任。
So which of the combinations do you think it makes the most sense to use it in?
那麼您認為在哪些組合中使用它最有意義?
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
So let me start, Geoff, with the Veklury question around usage.
Geoff,讓我從關於使用的 Veklury 問題開始。
So what we've seen is, obviously, in Q3, a little bit of an interesting dynamic in light of most of the supply was committed through the HHS to U.S. patient population.
所以我們看到的是,顯然,在第三季度,鑑於大部分供應是通過 HHS 向美國患者群體承諾的,有一點有趣的動態。
So there was a bit of an inventory build through the Q3 that you're going to see play out in Q4 in the U.S. specifically.
因此,您將在美國的第四季度看到第三季度的一些庫存構建。
We're also in a situation due to the incredible work that's been done by our manufacturing teams to be in a situation where our current supply now is at a level where it is exceeding global demand.
由於我們的製造團隊所做的令人難以置信的工作,我們目前的供應量現在處於超過全球需求的水平,因此我們也處於這種情況。
So we feel very confident in making sure we can -- global demand around the world, namely in Europe right now, in light of not only the door procurement agreement, but in light of the recent surge that you're seeing across countries in Europe.
因此,我們非常有信心確保我們能夠做到——全球需求,即目前在歐洲,不僅考慮到門採購協議,而且考慮到最近歐洲各國的需求激增.
I think to your point about percentage of patients, it really varies across countries but also regions.
我認為關於患者百分比的觀點,它確實因國家和地區而異。
And I do think that, that percentage is increasing as we speak.
而且我確實認為,這個百分比在我們說話時正在增加。
As the FDA approval came out last week, we're already seeing a lot more noise around that, but also in light of the fact that we have a field team, so medical and commercial that are now going out to make sure that physicians are aware and educated on where best to use Veklury.
隨著 FDA 上週的批准,我們已經看到了更多的聲音,但也考慮到我們有一個現場團隊,所以醫療和商業現在正在出去確保醫生是了解並了解最好使用 Veklury 的地方。
And I think that's one of the pieces that's the most important.
我認為這是最重要的部分之一。
So that's playing out as we speak.
因此,正如我們所說的那樣。
But we have seen probably out of hospitalization rates in many countries anywhere between 40% to 50% in the U.S. usage of remdesivir.
但我們已經看到,在美國使用瑞德西韋的情況下,許多國家的住院率可能在 40% 到 50% 之間。
And of course, that number will only grow as people better understand the data now that it's been published as well as approved through the FDA.
當然,這個數字只會隨著人們更好地理解數據而增長,因為它已經發布並通過 FDA 批准。
And maybe, Merdad, on Trodelvy.
也許,Merdad,在 Trodelvy 上。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes.
是的。
And I'll take the Trodelvy question, Geoffrey.
我將回答 Trodelvy 問題,Geoffrey。
Yes, look, I think what we know so far with the Trodelvy (inaudible) combo is a couple of things.
是的,看,我認為到目前為止我們對 Trodelvy(聽不清)組合的了解有幾件事。
One is just looking at the combos where it's been tested, there's data with the parts, and there's data with the -- with checkpoint inhibitors.
一個只是查看經過測試的組合,有部件的數據,還有檢查點抑製劑的數據。
And so far, those data seem to support the ability to go forward with combos, and that obviously opens a number of doors there for us to investigate.
到目前為止,這些數據似乎支持推進組合的能力,這顯然為我們打開了許多調查之門。
When we look at the adverse event profile and we look at what -- and we talk to the investigators about what they're seeing and how they're managing it, the toxins, largely the neutropenia and the diarrhea, and often that the investigators are saying that, that toxicity seems to be manageable, something they're comfortable managing.
當我們查看不良事件概況時,我們會查看什麼——我們會與研究人員討論他們所看到的情況以及他們是如何處理的,毒素,主要是中性粒細胞減少症和腹瀉,而且研究人員通常會是說,這種毒性似乎是可以控制的,這是他們樂於管理的事情。
And we're getting a lot of encouragement to move earlier in lines of therapy based on that adverse event profile.
我們得到了很多鼓勵,可以根據該不良事件概況提前進行治療。
The individual combinations will be dictated by the indication that we're in, right, whether it's breast, urothelial, lung.
個體組合將取決於我們所處的適應症,正確的,無論是乳房、尿路上皮還是肺。
Those combinations will depend.
這些組合將取決於。
But I think a big one will probably be the checkpoint inhibitors, where I think we're optimistic and have reasonably good data about being able to combine there.
但我認為一個大的可能是檢查點抑製劑,我認為我們很樂觀並且有相當好的數據可以在那裡結合。
Operator
Operator
Our next question comes from the line of Alethia Young from Cantor Fitzgerald.
我們的下一個問題來自 Cantor Fitzgerald 的 Alethia Young。
Alethia Rene Young - Head of Healthcare Research
Alethia Rene Young - Head of Healthcare Research
I just wanted to talk a little bit about kind of big picture immunology.
我只想談一談免疫學的大局。
So maybe depending on what you decide with filgotinib next year based on some of the conversations, like how are you thinking about the space?
因此,也許取決於你明年根據一些對話對 filgotinib 做出的決定,比如你如何看待這個空間?
Are you still committed?
你還承諾嗎?
Would you consider doing M&A?
您會考慮進行併購嗎?
Or do you have an internal pipeline that continue to drive potential revenues there?
或者您是否有一個內部渠道可以繼續推動那裡的潛在收入?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Thanks, Alethia.
謝謝,阿勒西婭。
I'll start and then maybe Merdad can add as well.
我會開始,然後也許 Merdad 也可以添加。
But first of all, I mean nothing has changed about our dedication to our 3 disease areas.
但首先,我的意思是我們對 3 個疾病領域的投入沒有任何改變。
As you know, I mean our strategy that we announced at the beginning of the year was based upon 2 really strong scientific disciplines that we have from a discovery perspective at Gilead and with our partners, and that is antivirals and immunomodulation.
如你所知,我的意思是我們在今年年初宣布的戰略基於我們在吉利德和我們的合作夥伴從發現的角度來看擁有的兩個非常強大的科學學科,即抗病毒藥物和免疫調節。
And we've been firmly focused on that strategy in terms of how it plays out in both antivirals, inflammation and fibrosis and then also oncology.
我們一直堅定地關注這一戰略,因為它在抗病毒藥物、炎症和纖維化以及腫瘤學中的作用。
So we think there's a lot of synergies associated with that science.
所以我們認為這門科學有很多協同作用。
Obviously, immunology, as you know, goes across so many disease states.
顯然,如您所知,免疫學涉及許多疾病狀態。
Immunology plays in the antivirals, for instance, particularly when we look at some of our HBV cure programs.
例如,免疫學在抗病毒藥物中發揮作用,尤其是當我們查看我們的一些 HBV 治愈計劃時。
But clearly, in the field of inflammation, we've already spoken about where we stand with filgotinib.
但很明顯,在炎症領域,我們已經談到了我們對 filgotinib 的立場。
We have a variety of follow-on agents within our Gilead research, with our partners with Galapagos, and we'll maintain an external view on opportunities to continue to advance our inflammation portfolio in-house.
在我們的 Gilead 研究中,我們有多種後續藥物,我們與加拉帕戈斯群島的合作夥伴一起,我們將保持對機會的外部看法,以繼續在內部推進我們的炎症產品組合。
And you can see, of course, what we've done in the oncology field, predominantly immuno-oncology over the past year, really building up our oncology base based upon -- largely based upon immuno-oncology.
當然,你可以看到我們在腫瘤學領域所做的工作,過去一年主要是免疫腫瘤學,真正建立了我們的腫瘤學基礎——主要是基於免疫腫瘤學。
Trodelvy allows us to have a really strong footprint now into solid tumors in a pan-tumor way, which we think will be very complementary to our first-in-class, best-in-class immuno-oncology portfolio.
Trodelvy 讓我們現在能夠以泛腫瘤的方式在實體瘤領域擁有真正強大的足跡,我們認為這將與我們一流、一流的免疫腫瘤產品組合形成互補。
Merdad, maybe you want to add as well your view on the -- on that question as well.
Merdad,也許你還想補充一下你對這個問題的看法。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
I think you hit all the key points, Dan.
我認為你說到了所有要點,丹。
I think we -- the only thing I'd add is I think we really have a great team here, and I think that team is going to be really great about charting our future in immunology.
我認為我們——我唯一要補充的是我認為我們這裡真的有一支很棒的團隊,我認為這個團隊在規劃我們免疫學的未來方面會非常出色。
But as Dan said, we remain committed to that, and we'll continue to look at both near- and long-term opportunities there that makes sense for us in the portfolio.
但正如丹所說,我們仍然致力於這一點,我們將繼續關注對我們的投資組合有意義的近期和長期機會。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
I mean maybe, Merdad, it's just important to emphasize the unmet medical need in that area.
我的意思是,Merdad,強調該地區未滿足的醫療需求很重要。
It's still a very significant.
這仍然是一個非常重要的。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes.
是的。
And we look at -- maybe the only other thing I'd add is that we look at it through a fairly broad lens of what immunology means.
我們看——也許我要補充的唯一一件事是我們通過一個相當廣泛的視角來看待它,了解免疫學的含義。
There are a lot of indications with a lot of unmet need that persist in that space, and we'll be looking for that transformative profile.
有很多跡象表明該領域存在大量未滿足的需求,我們將尋找這種變革性的概況。
Operator
Operator
Our next question comes from the line of Carter Gould from Barclays.
我們的下一個問題來自巴克萊銀行的 Carter Gould。
Carter Lewis Gould - Senior Analyst
Carter Lewis Gould - Senior Analyst
Maybe just to follow up on that same sort of question on portfolio construction.
也許只是為了跟進關於投資組合構建的同類問題。
Historically, old Gilead was routinely criticized for not being as disciplined with many of its mid-stage assets.
從歷史上看,老吉利德(Gilead)經常被批評對其許多中期資產沒有遵守紀律。
Clearly, the pipeline is much broader.
顯然,管道要寬得多。
You guys highlighted sort of a return to discipline.
你們強調了紀律的回歸。
Yet, it doesn't seem to be apparent, I guess, when we look through the pipeline side.
然而,我猜,當我們從管道一側看時,它似乎並不明顯。
When you think about the size and breadth of the pipeline today, are you comfortable with that?
當您考慮當今管道的規模和廣度時,您對此感到滿意嗎?
And I guess will we start to see some of those prioritization decisions start to manifest soon?
我想我們會開始看到其中一些優先級決策很快開始顯現嗎?
Or if there's things you can point to today, that would be helpful.
或者,如果您今天可以指出一些事情,那將會很有幫助。
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes, Carter.
是的,卡特。
Again, I think the entire team here is dedicated to putting together a portfolio management process that's state of the art.
同樣,我認為這裡的整個團隊都致力於整合最先進的投資組合管理流程。
I think your question is very well taken.
我認為你的問題很好。
It's a work in progress, right?
這是一項正在進行的工作,對吧?
So we're -- first of all, we've hired a lot of new people into the organization with terrific expertise in new -- in different therapeutic areas.
所以我們——首先,我們在不同的治療領域聘請了很多新人,他們在新的領域擁有極好的專業知識。
We're putting processes into place across research and development, into our commercial organization to help us make decisions accordingly.
我們正在將整個研發流程落實到我們的商業組織中,以幫助我們做出相應的決策。
And I think you'll see some of those play out in the near term as well.
而且我認為您也會在短期內看到其中一些發揮作用。
But the philosophy that Merdad and Johanna and the rest of the team and I are firmly committed to is drawing the line at a level that makes sure that the programs that hurdle that line are really first and best in class.
但 Merdad 和 Johanna 以及團隊的其他成員和我堅定地致力於在一定程度上劃清界限,確保跨越這條界限的程序真正是一流的和最好的。
And I'm really pleased with how the organizations progress, both from an operational perspective, but then also from a scientific perspective over the course of the past year.
我對這些組織在過去一年中的進展感到非常滿意,無論是從運營角度還是從科學角度來看。
But as you know, I mean this is a continual process, and we need to make sure that we're constantly looking at the outside environment, looking at the unmet medical need, going back to where that line is drawn in our organization and making consequential decisions on the portfolio.
但正如你所知,我的意思是這是一個持續的過程,我們需要確保我們不斷關注外部環境,關注未滿足的醫療需求,回到我們組織中劃定的界限並做出投資組合的相應決策。
And we intend to do that.
我們打算這樣做。
We intend to make tough decisions and fund those most attractive opportunities.
我們打算做出艱難的決定並為那些最具吸引力的機會提供資金。
I would also say the other thing we're looking very hard at is a balance in our portfolio.
我還要說的是,我們正在努力尋找的另一件事是我們投資組合的平衡。
I think in the past, Gilead has also been -- seen as a company that went after a lot of high-risk/high-reward projects.
我認為在過去,吉利德也被視為一家追求許多高風險/高回報項目的公司。
In some cases, those were not successful in the late stages.
在某些情況下,這些在後期階段並不成功。
I think we're firmly committed to having a balanced portfolio, where we're always holding the bar high for innovation, but making sure we derisk as much as possible earlier in the stages of development such that when you get into the late-stage investments in Phase III, things have been de-risked, and therefore, your ability to succeed rises as well.
我認為我們堅定地致力於擁有一個平衡的投資組合,我們始終堅持創新的高標準,但要確保我們在開發階段的早期盡可能多地降低風險,這樣當你進入後期階段時在第三階段的投資中,事情已經被去風險化,因此,你成功的能力也會提高。
So these are all very conscious things we're working on together.
所以這些都是我們正在共同努力的非常有意識的事情。
Merdad, again, I apologize if -- you've trained me well.
Merdad,如果你對我進行了很好的培訓,我再次表示歉意。
You may very well have some things to add on that as one of the leaders in organizing this portfolio.
作為組織此投資組合的領導者之一,您很可能有一些要補充的東西。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
The only thing I'd add, Carter, it's a really insightful question.
卡特,我唯一要補充的是,這是一個非常有見地的問題。
And it's something that we -- as Dan said, we're really committed to doing.
正如丹所說,這是我們真正致力於做的事情。
And what I would say is that you will see us exercising that discipline.
我要說的是,你會看到我們行使這種紀律。
That will be something that will be apparent sooner than later, and recognize that there are a lot of things that are in-flight that it don't make sense to deprioritize because they're already ongoing.
這將是遲早會顯而易見的事情,並認識到有很多事情正在進行中,因為它們已經在進行中,所以取消優先級是沒有意義的。
So we'll let those things read out.
所以我們會讓這些內容讀出來。
So it'll probably take a little bit longer for everything to get taken care of in the wash, if you will.
因此,如果您願意的話,可能需要更長的時間才能在洗滌過程中處理好所有事情。
But you will definitely see that playing out with us as data get read out and as new things enter into the portfolio, that we'll be exercising that discipline to make sure we're making some tough decisions.
但你肯定會看到,隨著數據被讀出以及新事物進入投資組合,我們將與我們一起玩,我們將行使紀律以確保我們做出一些艱難的決定。
Operator
Operator
Our next question comes from the line of Brian Abrahams from 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 HIV and inventory and stockpiling.
關於艾滋病毒以及庫存和儲存的問題。
I'm wondering if you could quantify if what you observed in the third quarter was a benefit or just normalization.
我想知道您是否可以量化您在第三季度觀察到的情況是有益的還是正常化。
And if you look to fourth quarter and beyond, what should we expect with respect to potential stockpiling just given the newest COVID spike versus inventory drawdowns?
如果您展望第四季度及以後,考慮到最新的 COVID 飆升與庫存縮減,我們應該對潛在庫存有何期待?
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
So maybe I'll take that one, Brian.
所以也許我會接受那個,布賴恩。
I think that as we're seeing Q3 -- this whole year, and I'm sure everybody is kind of seeing this, this full year has been really interesting when it comes to inventory because we've seen a pattern that's very different than prior years, obviously, due to COVID-19.
我認為當我們看到第三季度時——這一整年,我相信每個人都會看到這一點,這一整年在庫存方面真的很有趣,因為我們看到了一種與以往截然不同的模式顯然,前幾年是由於 COVID-19。
The expectation that we have this year is, as you normally see in Q4, you actually do have a lift in product supply at the end of December.
我們今年的預期是,正如您通常在第四季度看到的那樣,您實際上在 12 月底確實會增加產品供應。
That plays into our total inventory for 2020.
這影響到我們 2020 年的總庫存。
Having said that, that's a little bit also impacted by the fact that Truvada's LOE, and there's now a generic on the market with Teva as of early October.
話雖如此,這也有點受到 Truvada 的 LOE 的影響,而且截至 10 月初,Teva 已經在市場上推出了仿製藥。
And so we believe that number is a little lower than the norm that we've seen in the past.
因此,我們認為這個數字略低於我們過去看到的標準。
We haven't assumed a dish stockpiling to your point about COVID-19 because it's already -- usually, Q4 is already on the rise versus other quarters.
我們還沒有假設你對 COVID-19 的看法,因為它已經——通常,與其他季度相比,第四季度已經在上升。
So we've assumed that.
所以我們假設了。
What we've seen in Q3 to the first part of your question, I think, is just normalization of the last couple of quarters.
我認為,我們在第 3 季度看到的問題的第一部分只是過去幾個季度的正常化。
And you kind of -- if you recall, Q1 usually draw down on Q4 supply.
而且你有點 - 如果你還記得的話,第一季度通常會減少第四季度的供應。
What we saw is a pickup in March because of COVID-19 that then kind of bled out in Q2, and then we saw a pickup again in Q3, which I think is really the normalization of those 3 quarters.
我們看到的是 3 月份的回升,因為 COVID-19,然後在第二季度出現回升,然後我們在第三季度再次看到回升,我認為這實際上是這三個季度的正常化。
So assuming Q4 is like other quarters in the past, that's what's currently in our current projection.
因此,假設第四季度與過去的其他季度一樣,這就是我們目前的預測。
Hopefully, that addresses the thinking there for HIV.
希望這能解決那裡對 HIV 的想法。
Operator
Operator
Our next question comes from the line of Tyler Van Buren from Piper Sandler.
我們的下一個問題來自 Piper Sandler 的 Tyler Van Buren。
Tyler Martin Van Buren - Principal & Senior Biotech Analyst
Tyler Martin Van Buren - Principal & Senior Biotech Analyst
I was just hoping to get a little bit more precision on the Veklury guidance.
我只是希望在 Veklury 指南上獲得更精確的信息。
I guess if you take the midpoint of the updated guidance relative to the guidance in the beginning of the year and the Q3 sales, it could suggest that sales could be down significantly in Q4 quarter-over-quarter.
我想如果你將更新後的指導與年初的指導和第三季度的銷售額相比較,這可能表明第四季度的銷售額可能會比上一季度大幅下降。
So -- but then obviously, the core business has been impacted a bit by the pandemic, which could offset and make it more flat.
所以——但很明顯,核心業務受到了大流行的一些影響,這可能會抵消並使其更加平穩。
So wanted to understand what your modeling for Veklury in Q4 or what your guidance incorporates.
所以想了解您在第四季度為 Veklury 建模的內容或您的指導包含的內容。
And then the second part of the question is, on the outpatient and the inhaled studies, can you give any more granularity on when we should expect that data?
然後問題的第二部分是,關於門診和吸入研究,你能否更詳細地說明我們應該何時獲得這些數據?
And how much do you think demand could increase if those studies are successful?
如果這些研究成功,您認為需求會增加多少?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Great.
偉大的。
Thanks.
謝謝。
So Andy, why don't you handle the guidance, and maybe we'll go to Diana for the updates on Veklury's next generation.
所以安迪,你為什麼不處理指導,也許我們會去戴安娜了解 Veklury 下一代的更新。
Andrew D. Dickinson - Executive VP & CFO
Andrew D. Dickinson - Executive VP & CFO
Sure.
當然。
Tyler, thanks for the question.
泰勒,謝謝你的提問。
Appreciate it.
欣賞它。
We're not providing specific product guidance, as you know, and we typically don't.
如您所知,我們不會提供具體的產品指南,而且通常不會。
But as you suggested and as we mentioned earlier, the revision in guidance is tied not entirely, but almost entirely, to expectations around Veklury.
但正如您所建議的以及我們之前提到的那樣,指南的修訂並不完全但幾乎完全與圍繞 Veklury 的期望相關聯。
Johanna also mentioned that there was some excess inventory in the channel as a result of the terrific work that our manufacturing team did, and you'll see in our materials that we're on track to meet the expectation that we had set in terms of 2 million treatment courses by the end of the year.
Johanna 還提到,由於我們的製造團隊所做的出色工作,渠道中存在一些過剩庫存,您會在我們的材料中看到我們有望滿足我們設定的預期年底完成200萬個療程。
So as inventory was moving into the channel in the third quarter at the same time that hospitalization rates and the severity of the outbreak in the U.S., at least at that time was coming down, there was less demand in the third quarter than expected.
因此,由於庫存在第三季度進入渠道,同時美國的住院率和疫情的嚴重程度正在下降,至少在那個時候是這樣,第三季度的需求低於預期。
And then you see that play through in the fourth quarter.
然後你會在第四節看到這一點。
So we didn't recognize revenue for all of the Veklury that was shipped in the third quarter, to be clear.
因此,我們沒有確認第三季度出貨的所有 Veklury 的收入。
Some of that was constrained, and then you see that playing through in the fourth quarter and the full year guidance.
其中一些受到限制,然後你會看到第四季度和全年指導中的表現。
So we can't be more specific than that.
所以我們不能比這更具體。
Happy to provide any additional color that we can, but we're not going to provide specific product level guidance.
很高興提供我們可以提供的任何其他顏色,但我們不會提供具體的產品級別指導。
Maybe over to Diana.
也許交給戴安娜。
Diana Brainard - SVP of HIV & Emerging Viral Infections
Diana Brainard - SVP of HIV & Emerging Viral Infections
Tyler, so our outpatient study is ongoing.
Tyler,我們的門診研究正在進行中。
We're recruiting actively.
我們正在積極招聘。
And in terms of our predictions, we think that, that study will wrap up early next year, and we should have results in the first quarter.
就我們的預測而言,我們認為該研究將在明年初結束,我們應該會在第一季度得出結果。
It is harder than is typical to predict the dynamics of trial enrollment for COVID-19.
預測 COVID-19 試驗註冊的動態比通常情況下更難。
So much depends on the number of cases, the competition with other clinical trials.
這在很大程度上取決於病例數,以及與其他臨床試驗的競爭。
So we're going to have to kind of take it month by month and see how the dynamics go.
所以我們將不得不逐月觀察,看看動態如何。
As you know, we're approved with Veklury for hospitalized patients or patients in -- equivalent in-patient setting.
如您所知,我們已獲准使用 Veklury 治療住院患者或處於同等住院環境中的患者。
So in terms of then what that does for us, once we have the trial results, if it were successful, we would then look to getting an expanded label for that population.
因此,就那對我們有什麼作用而言,一旦我們獲得試驗結果,如果它成功了,我們就會尋求為該人群擴大標籤。
So that would be further down the line.
因此,這將進一步深入。
But our first step is to get the study enrolled and see how Veklury performs in the outpatient setting, where we're trying to prevent hospitalization rather than hasten recovery in the hospital.
但我們的第一步是讓這項研究入組,看看 Veklury 在門診環境中的表現如何,我們試圖避免住院,而不是在醫院加速康復。
Operator
Operator
Our next question comes from the line of Umer Raffat from Evercore.
我們的下一個問題來自 Evercore 的 Umer Rafat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Just 2 very quick ones.
只有 2 個非常快的。
First, on Biktarvy, perhaps.
首先,也許是在 Biktarvy 上。
The IMS trends don't appear particularly encouraging for the last 6 months or so.
在過去 6 個月左右的時間裡,IMS 趨勢似乎並不特別令人鼓舞。
I know it's growing, but not the way it was in the past.
我知道它在增長,但不像過去那樣。
I just -- I would love to get your take on that.
我只是——我很想听聽你的看法。
And secondly, on the capsid inhibitor, Merdad, how are you thinking about possible candidates for a combo?
其次,關於衣殼抑製劑 Merdad,您如何考慮組合的可能候選者?
I know there are other companies with HIV candidates as well, and this has been an ongoing question.
我知道還有其他公司也有 HIV 候選人,這一直是一個持續的問題。
Where are you guys headed at?
你們要去哪裡?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Sure.
當然。
Johanna can start, and then take it from there.
約翰娜可以開始,然後從那裡開始。
Johanna, you want to start?
約翰娜,你想開始嗎?
Johanna Mercier - Chief Commercial Officer
Johanna Mercier - Chief Commercial Officer
Yes.
是的。
Thanks, Umer.
謝謝,烏默爾。
So listen, we're really proud of actually the Biktarvy growth.
所以聽著,我們真的為 Biktarvy 的增長感到自豪。
And I think that if you look at the share growth, it's basically 8 points of share year-on-year when you think about as Q3 '19 to Q3 '20.
而且我認為,如果你看一下份額增長,當你考慮 19 年第三季度到 20 年第三季度時,它基本上是同比增長 8 個百分點。
And when you look at Q2 to Q3, it's a point of share.
當您查看 Q2 到 Q3 時,這是一個共享點。
So we do think that the growth continues.
因此,我們確實認為增長仍在繼續。
Where we've seen a little bit more of an impact is from a market standpoint because if you think about the impact of COVID-19, it had a larger impact in our HIV treatment business really when it comes to switches.
從市場的角度來看,我們看到了更多的影響,因為如果你考慮 COVID-19 的影響,它對我們的 HIV 治療業務產生了更大的影響。
And so it'll impact disproportionately newer agents in the market because physicians aren't switching to newer agents.
因此,它將對市場上的新藥產生不成比例的影響,因為醫生不會轉向新藥。
But obviously, Biktarvy is part of that pool.
但顯然,Biktarvy 是該池的一部分。
The overall share of Gilead still remains really strong because of that because we -- more than 75% of patients are actually on a Gilead compound.
因此,吉利德的整體份額仍然非常強勁,因為我們 - 超過 75% 的患者實際上使用吉利德化合物。
And so therefore, they're just remaining, there's less switches.
因此,它們只是保留下來,開關更少。
We've seen that rebound a little bit in Q3.
我們在第三季度看到了一點反彈。
We expect that to continue through Q4.
我們預計這種情況將持續到第四季度。
But I think, overall, if you think about it in the U.S., which is our larger business, right now, 1 out of 2 -- actually, more than 1 out of 2 patients starts on Biktarvy.
但我認為,總的來說,如果你考慮一下美國,這是我們更大的業務,現在,每 2 名患者中就有 1 名——實際上,每 2 名患者中就有超過 1 名開始使用 Biktarvy。
We have about a 56% share of naive patients.
我們有大約 56% 的天真患者。
And when you think about the switches, although the market for switches are a little bit lower, we're still roughly about 1 in 2 patients going to Biktarvy, and they're going to Biktarvy from a non-Gilead single treatment regimen, which I also think is a great place to be.
當你考慮開關時,雖然開關的市場有點低,但我們仍然大約有二分之一的患者去 Biktarvy,他們將從非 Gilead 單一治療方案轉向 Biktarvy,這我也認為這是一個很棒的地方。
So we continue to feel extremely confident in Biktarvy's continued growth because you're seeing it basically happen across all of the markets around the world to really consolidate around Biktarvy, in addition to the fact that COVID-19 is actually for naive patients, a real advantage with Biktarvy because of the rapid start.
因此,我們繼續對 Biktarvy 的持續增長充滿信心,因為你看到它基本上發生在世界各地的所有市場,真正圍繞 Biktarvy 進行整合,此外 COVID-19 實際上是針對天真的患者,一個真正的由於快速啟動,Biktarvy 具有優勢。
And that's something that even guidelines are recognizing in light of the fact that you don't need to -- there's no genotype testing, there's no HLA testing, et cetera.
鑑於您不需要的事實,即使是指導方針也承認這一點——沒有基因型測試,沒有 HLA 測試,等等。
So that's also helping to continue to grow our share in the naive patient population.
因此,這也有助於繼續增加我們在天真的患者群體中的份額。
So with that, Merdad or Diana on the capsid.
因此,Merdad 或 Diana 在衣殼上。
Merdad V. Parsey - Chief Medical Officer
Merdad V. Parsey - Chief Medical Officer
Yes.
是的。
I have to take that.
我必須接受那個。
Umer, the -- as you mentioned, look, we have both internal candidates for combining with lenacapavir, and we remain open.
Umer,正如你提到的,看,我們有兩個與 lenacapavir 結合的內部候選人,我們仍然開放。
As you said, there are other agents out there that could potentially be combination partners.
正如您所說,還有其他代理人可能成為聯合夥伴。
And we remain definitely open to figuring out what's in the best interest of patients, and we'll continue to be diligent on that front.
我們仍然絕對願意找出什麼最符合患者的利益,我們將繼續在這方面努力。
So I think both possibilities remain there.
所以我認為這兩種可能性都存在。
Operator
Operator
And I show our last question comes from the line of Geoff Meacham from Bank of America.
我表明我們的最後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 had a couple on remdesivir.
我剛吃了幾次瑞德西韋。
Dan, you've talked about it likely not making a major long-term contribution.
丹,你已經談到它可能不會做出重大的長期貢獻。
So I just wanted to ask, are the investments in nebulized or next-gen programs still a priority in the near term?
所以我只想問,對霧化或下一代項目的投資在短期內仍然是優先事項嗎?
And the second one related is, how do you manage inventories for when the infection step down happens, which is hopefully sometime next year?
第二個相關的問題是,當感染減少時,你如何管理庫存,希望是在明年的某個時候?
Daniel P. O'Day - Chairman & CEO
Daniel P. O'Day - Chairman & CEO
Yes.
是的。
Thanks, Geoff, for the question.
謝謝杰夫提出這個問題。
Really helpful, I mean, to hear your context on that.
真的很有幫助,我的意思是,聽聽你的背景。
I mean let me say a couple of things, first of all.
我的意思是讓我先說幾件事。
I mean we think Veklury/remdesivir will make a significant contribution certainly to Gilead.
我的意思是,我們認為 Veklury/remdesivir 肯定會對 Gilead 做出重大貢獻。
I mean it already has, as you've seen in the sales to date, and we think through the end of this year and into 2021, and potentially, on a seasonal basis beyond.
我的意思是它已經有了,正如你在迄今為止的銷售中看到的那樣,我們認為到今年年底和 2021 年,並且有可能在以後的季節性基礎上。
I mean one has to -- there's a lot we still don't know about the pandemic, of course.
我的意思是,人們必須——當然,關於這一流行病,我們還有很多不了解的地方。
But I think what we do know is that in order to get us all back to normal, this is going to take a variety of approaches.
但我認為我們所知道的是,為了讓我們所有人恢復正常,這將採取多種方法。
Of course, it's going to take vaccines.
當然,它要接種疫苗。
It's going to take therapeutics in the hospital.
它將在醫院接受治療。
It's going to potentially take combinations of therapies in the hospitals, and then it's going to need therapeutics pre-hospitals.
它可能會在醫院採取多種療法,然後需要院前治療。
So I think we're proud to be at the front end of this with a very potent antiviral, which is a bedrock, I think, of any approach to a pandemic.
所以我認為我們很自豪能夠以一種非常有效的抗病毒藥物處於這一領域的前端,我認為這是任何應對大流行病方法的基石。
But it -- we'll continue to need investment.
但它——我們將繼續需要投資。
We're fully committed to the investment in line extensions here and in seeing where else we might be able to play in that continuum from pre-hospital setting to hospitalized patients.
我們完全致力於在這裡進行生產線擴展的投資,並看看我們可以在從院前環境到住院患者的連續體中發揮作用的其他地方。
Obviously, we're not going to play in the area of vaccines but in area of therapeutics.
顯然,我們不會在疫苗領域發揮作用,而是在治療領域發揮作用。
We think there's a very good return on that investment.
我們認為這項投資有很好的回報。
I think the challenge we have is, by the way, we used to have a Tamiflu when I was at Roche, is it becomes difficult to predict.
我認為我們面臨的挑戰是,順便說一句,當我在羅氏時,我們曾經使用過達菲,它是否變得難以預測。
And you've seen it already in our -- at the half year, of course, we gave quite wide guidance to give us opportunities to understand where the pandemic was going and exactly how this will play a role in it.
你已經在我們的半年裡看到了——當然,我們給出了相當廣泛的指導,讓我們有機會了解大流行的發展方向,以及這將如何在其中發揮作用。
And now what we've done is we've reaffirmed that guidance, but we've narrowed it.
現在我們所做的是重申了該指導,但我們縮小了範圍。
And I think as we go into next year and the year after, we're just going to need to stay adaptable and flexible on how much of a contributor Veklury is to us, but we do feel very strongly that Veklury will contribute to our overall sales, be an important source of cash for our business and allow us to pay down debt and make sure that we continue to invest in the routine part of our business in antivirals and beyond.
而且我認為,隨著我們進入明年和後年,我們只需要保持適應性和靈活性,了解 Veklury 對我們的貢獻程度,但我們確實非常強烈地認為 Veklury 將為我們的整體做出貢獻銷售,成為我們業務的重要現金來源,使我們能夠償還債務,並確保我們繼續投資於抗病毒藥物及其他業務的常規部分。
I think the other statement I would make, though, Geoff, is that as a result of both the internal and external portfolio development over the past year, and in particular, the Immunomedics and Trodelvy transaction, excluding Veklury, we're now very confident in our ability to grow in the short and midterm.
不過,Geoff,我想我要發表的另一個聲明是,由於過去一年內部和外部投資組合的發展,特別是 Immunomedics 和 Trodelvy 交易(不包括 Veklury),我們現在非常有信心我們在短期和中期增長的能力。
So I think Veklury will come on top of that and may have year-to-year variability.
所以我認為 Veklury 將最重要,並且可能會有逐年的變化。
But I think that's really the story of today's call and the evolution of the course of the past year.
但我認為這確實是今天的電話會議的故事和過去一年課程的演變。
And thanks for giving me the opportunity to kind of put that into context.
感謝您給我機會將其放入上下文中。
Operator
Operator
Thank you.
謝謝。
This concludes the Q&A session.
問答環節到此結束。
At this time, I'd like to turn the call over to Douglas Maffei for closing remarks.
此時,我想將電話轉給 Douglas Maffei 作結束語。
Douglas Maffei - Senior Director of IR
Douglas Maffei - Senior Director of IR
Thank you, Dilem, and thank you all for joining us today.
謝謝 Dilem,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.
女士們,先生們,謝謝你們。
This concludes today's presentation.
今天的演講到此結束。
Thank you for participating.
感謝您的參與。
You may now disconnect.
您現在可以斷開連接。