雷傑納榮製藥 (REGN) 2020 Q1 法說會逐字稿

Welcome to the Regeneron Pharmaceuticals First Quarter 2020 Earnings Conference Call. My name is Crystal, and I will be your operator for today's call. (Operator Instructions) Please note that this conference is being recorded. I would now like to turn the conference over to Justin Holko, Vice President of Investor Relations. You may begin.

歡迎參加再生元製藥公司2020年第一季財報電話會議。我是Crystal，將擔任本次電話會議的接線生。 （接線生說明）請注意，本次會議正在錄音。現在我將會議交給投資人關係副總裁Justin Holko先生。您可以開始了。

Thank you, Crystal. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the First Quarter 2020 Conference Call. An archive of this webcast will be available on our website.

謝謝Crystal。各位全球聽眾，早安、下午好、晚上好。感謝您對Regeneron Pharmaceuticals的關注，歡迎參加2020年第一季電話會議。本次網路直播的存檔將在我們的網站上提供。

Joining me on the call today are Dr. Leonard Schleifer, Founder, President and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President and Chief Scientific Officer; Marion McCourt, Senior Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

今天與我一同參加電話會議的有：創始人、總裁兼首席執行官倫納德·施萊弗博士；聯合創始人、總裁兼首席科學官喬治·揚科波洛斯博士；高級副總裁兼商務主管瑪麗昂·麥考特；以及執行副總裁兼首席財務官鮑勃·蘭德里。在我們分別致詞後，我們將進入問答環節。

I would also like to remind you that remarks made on today's call include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings and competition.

我還要提醒各位，今天電話會議的發言包含Regeneron的前瞻性聲明。這些陳述可能包括但不限於與Regeneron及其產品和業務、財務預測和指導、研發項目及相關預期里程碑、合作、財務、監管事宜、支付方覆蓋範圍和報銷問題、知識產權、未決訴訟和其他程序以及競爭相關的陳述。

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended March 31, 2020, which has been filed with the SEC today. Regeneron does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

每項前瞻性聲明均受風險和不確定性因素的影響，這些因素可能導致實際結果和事件與該聲明中預測的結果和事件有重大差異。有關這些風險和其他重大風險的更完整描述，請參閱Regeneron向美國證券交易委員會提交的文件，包括其截至2020年3月31日的季度報告（10-Q表格），該報告已於今日提交給美國證券交易委員會。 Regeneron不承擔任何公開更新任何前瞻性聲明的義務，無論是因為新資訊、未來事件或其他原因。

In addition, please note that GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Additional information about those measures is also available on the investor and media section of our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions.

此外，請注意，今天的電話會議將討論GAAP和非GAAP財務指標。有關我們使用非GAAP財務指標以及這些指標與GAAP的調節表的信息，請參閱我們網站上發布的財務業績新聞稿。您也可以造訪我們網站的投資者和媒體專區，以獲取有關這些指標的更多資訊。電話會議結束後，Bob Landry和投資者關係團隊將解答您的其他問題。

With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer. Len?

那麼，現在讓我把電話交給我們的總裁兼執行長倫‧施萊弗博士。倫？

Thank you, Justin. And thank you to everyone for joining the call. I hope all of you are staying safe and well during this difficult time. We're living in a new reality, the reality of COVID-19. I am incredibly proud of the leadership role Regeneron is taking in the fight against COVID-19. Clearly, this pandemic is unprecedented in our lifetime, for our company, our country and the world and the world economies.

謝謝你，賈斯汀。也感謝各位參加這次電話會議。希望大家在這段艱難時期都能平安健康。我們正生活在一個全新的現實中──新冠肺炎疫情的現實。我為再生元公司在對抗新冠肺炎疫情中所扮演的領導角色感到無比自豪。顯然，這場疫情對我們公司、我們國家、全世界以及世界經濟而言，都是前所未見的。

Regeneron has spent decades and billions of dollars developing proprietary technologies that have created medical breakthroughs, such as DUPIXENT and our novel antibody cocktail for Ebola, which is now under FDA review. These same technologies are now well purposed for finding a treatment against the SARS-CoV-2 virus. We are making rapid progress in scaling up supply of our novel antibody cocktail, which we expect to be in clinical trials this June. We are optimistic about this approach, which George will describe in greater detail.

再生元公司數十年來投入數十億美元研發專有技術，取得了許多醫學突破，例如DUPIXENT和我們用於治療伊波拉病毒的新型抗體雞尾酒療法（目前正在接受FDA審查）。這些技術同樣適用於尋找SARS-CoV-2病毒的治療方法。我們正快速擴大新型抗體雞尾酒療法的供應規模，預計今年6月進入臨床試驗階段。我們對這項療法充滿信心，喬治將對此進行更詳細的闡述。

Also, we are working swiftly with our collaborator, Sanofi, to find a definitive answer on whether there is a role for KEVZARA in helping to alleviate the devastating inflammation that affects patients who are critically afflicted with this virus. We are grateful for the tremendous partnership across industries, governments and agencies such as the FDA and BARDA as we unite in the common cause to eradicate this disease.

此外，我們正與合作夥伴賽諾菲迅速展開合作，以期最終確定KEVZARA是否能夠幫助緩解重症患者所遭受的嚴重發炎。我們衷心感謝各行業、政府以及FDA和BARDA等機構的鼎力支持，讓我們能夠攜手共進，共同根除這種疾病。

Beyond our therapeutic efforts, we continue to respond to other urgent COVID-related needs. We recently produced and donated viral transport media to New York State for use in 500,000 test kits and have provided financial support to nonprofits at the heart of the pandemic response in New York and beyond.

除了治療工作之外，我們還持續回應其他與新冠疫情相關的緊急需求。近期，我們生產並向紐約州捐贈了病毒轉運培養基，用於生產50萬份檢測試劑盒；此外，我們也向紐約及其他地區奮戰在抗疫一線的非營利組織提供了資金支持。

Furthermore, we are sensitive to the rapidly evolving marketplace and working with customers to ensure that patients are able to receive the treatments they need to preserve vision as well as to treat inflammatory conditions, cancer and other ailments that persist despite the realities of social distancing.

此外，我們密切關注快速變化的市場，並與客戶合作，確保患者能夠獲得所需的治療，以保護視力，並治療發炎、癌症和其他疾病，這些疾病即使在保持社交距離的情況下仍然存在。

Turning to some brief commentary on the first quarter, where we delivered another strong performance. In the quarter, negative impacts from COVID-19 were minimal. Our core brands, EYLEA, DUPIXENT and Libtayo, drove significant top and bottom line growth based on demand, while we invested in and advanced our innovative pipeline.

接下來簡單回顧一下第一季度，我們再次取得了強勁的業績。本季，新冠疫情的負面影響微乎其微。我們的核心品牌安麗雅 (EYLEA)、度必能 (DUPIXENT) 和利必妥 (Libtayo) 在市場需求的推動下，實現了營收和利潤的顯著增長。同時，我們也加大了對創新產品線的投資與研發。

In this quarter, EYLEA global net product sales grew 6% to $1.85 billion, including U.S. EYLEA net sales growth of 9% to $1.17 billion. In the last 2 weeks of March and early April, overall demand and new patient starts were softer due to COVID-19. However, we are encouraged by the rebound in demand in the most recent weeks. Marion will give you more color on this.

本季度，安禮全球淨產品銷售額成長6%至18.5億美元，其中美國安禮淨銷售額成長9%至11.7億美元。受新冠肺炎疫情影響，3月最後兩週和4月初整體需求和新患者數量下降。然而，我們對最近幾週需求的反彈感到鼓舞。 Marion將為您帶來更詳細的介紹。

First quarter DUPIXENT sales more than doubled compared to last year and are now annualizing at more than $3.4 billion on continued market penetration and new launches in multiple disease settings. While there are early signs of impacts on new patient starts, we expect continued resilience for DUPIXENT during this COVID-19 period given the profound efficacy and safety profile.

第一季DUPIXENT的銷售額較去年同期成長超過一倍，目前年銷售額已超過34億美元，這得益於持續的市場滲透以及在多種疾病領域的新藥上市。儘管新患者用藥量已出現初步下降，但鑑於DUPIXENT卓越的療效和安全性，我們預計其在新冠疫情期間仍將保持強勁的市場韌性。

With an anticipated regulatory action in pediatric atopic dermatitis later this month and other data readouts in 2020 and initiation of new Phase III trials assessing DUPIXENT in several other type 2 inflammatory diseases, this exceptional medicine continues to be positioned for long-term growth.

隨著本月稍後兒科異位性皮膚炎監管部門預計將採取行動，以及 2020 年其他數據公佈，以及評估 DUPIXENT 在其他幾種 2 型炎症性疾病中的療效的新的 III 期試驗的啟動，這種卓越的藥物將繼續保持長期增長的勢頭。

Importantly, DUPIXENT is driving continued diversification of our earnings base and enhancing our strong current and long-term financial position. We also announced recently that we have completed the restructuring of our agreement with Sanofi on PRALUENT, which will lead to immediate accretion and further strengthen our overall portfolio.

重要的是，DUPIXENT 正在推動我們獲利基礎的持續多元化，並增強我們當前和長期的穩健財務狀況。我們近期也宣布，已完成與賽諾菲就 PRALUENT 達成的協議重組，這將立即帶來收益成長，並進一步增強我們的整體產品組合。

2020 has brought urgent new priorities. Even though we are experiencing impacts to trial enrollment and new study starts, we remain on track for several significant clinical milestones, particularly in oncology. Recently, we announced that our first-line clinical trial in lung cancer, assessing Libtayo was stopped early on an interim analysis due to superior overall survival versus chemotherapy. We will look to submit these data to regulators as soon as possible.

2020年帶來了新的緊迫任務。儘管臨床試驗的招募和新研究的啟動受到影響，但我們仍有望實現幾個重要的臨床里程碑，尤其是在腫瘤學領域。近期，我們宣布，由於Libtayo在肺癌第一線治療中展現出優於化療的整體存活率，我們已提前終止了此項臨床試驗。我們將盡快向監管機構提交相關數據。

We also intend to submit data for Libtayo in basal cell carcinoma and expect new data from our bispecifics program later this year. Additionally, the long-awaited Phase III readout from fasinumab, our anti-nerve growth factor program for osteoarthritis pain, will occur in the coming months.

我們也計劃提交Libtayo在基底細胞癌治療的數據，並預計今年稍後將公佈雙特異性抗體計畫的新數據。此外，備受期待的fasinumab（一種用於治療骨關節炎疼痛的抗神經生長因子藥物）的III期臨床試驗結果也將在未來幾個月內公佈。

Before handing the call over to George, I want to share the immense pride and gratitude we have for our people working hard at Regeneron during this time. Even in the current environment, our entire business is operating as our people drive important work forward that is essential to our mission, to patients and to near- and long-term value creation for shareholders.

在將電話交給喬治之前，我想表達我們對Regeneron全體員工在此期間辛勤工作的無比自豪和感激之情。即使在當前環境下，我們整個業務仍在正常運轉，這得益於我們員工積極推進各項重要工作，這些工作對我們的使命、對患者以及對股東的近期和長期價值創造都至關重要。

Our ability to do this rests on the talent and strength of our workforce, which in spite of COVID-related disruption, maintains incredible commitment, focus and effort to advance the breadth of Regeneron's work. They are the foundations for moving forward our mission in normal times and especially now. We are optimistic that Regeneron and our society will prevail through these unprecedented times, and we will work tirelessly to that end. Now I'll turn the call over to George.

我們之所以能夠做到這一點，並依賴員工的才華和實力。儘管受到新冠疫情的影響，他們仍保持著令人欽佩的敬業精神、專注力和努力，不斷推進Regeneron的各項工作。他們是我們在正常時期乃至當下推進使命的基石。我們樂觀地認為，Regeneron和我們的社會終將戰勝這場前所未有的挑戰，我們將為此不懈努力。現在，我將把電話交給George。

Thank you, Len. And since the devastating COVID-19 crisis is foremost on everyone's mind, I will first discuss our efforts in this area. As you all know, our state of the art and proprietary VelociSuite technologies, which we have built over the last few decades, can be very powerful for responding to new targets and pathogens, as we recently proved by rapidly creating an antiviral antibody cocktail as an effective treatment for Ebola.

謝謝Len。鑑於目前大家最關心的是毀滅性的新冠肺炎疫情，我首先要談談我們在這領域的努力。大家都知道，我們過去幾十年來研發的先進專有VelociSuite技術，在應對新的標靶和病原體方面非常有效，正如我們最近快速研製出一種抗病毒抗體雞尾酒療法，有效治療伊波拉病毒感染所證明的那樣。

Recall, the FDA recently granted priority review to this treatment for Ebola with the target action date of October 25, 2020, based on the results of the Phase III PALM clinical trial conducted in the Congo, which was stopped early because of our Regeneron EB3 antibody cocktail proving superior in preventing death compared to the previous standard of care, the so-called ZMapp antibody as well as to Remdesivir.

回顧一下，FDA 最近根據在剛果進行的 III 期 PALM 臨床試驗的結果，授予了這種伊波拉治療方法優先審查權，目標審批日期為 2020 年 10 月 25 日。由於我們的 Regeneron EB3 抗體雞尾酒療法在預防死亡方面優於先前的標準療法（即所謂的 ZMapp 抗體）以及瑞德西韋，因此試驗提前終止。

In terms of COVID-19, while society is awaiting an effective vaccine that could still be a year or 2 away, we are employing a two-pronged approach that could serve as a useful bridge and/or as an alternative to a vaccine.

就新冠肺炎而言，雖然社會仍在等待一種有效的疫苗，而這種疫苗可能還需要一到兩年的時間才能問世，但我們正在採取雙管齊下的方法，這可以作為疫苗的有效過渡手段和/或替代方案。

First, and most importantly, we are developing a novel antiviral antibody cocktail just as we did for Ebola. We have already announced that we have utilized our VelociSuite technologies to rapidly generate and select thousands of potent antiviral, fully human antibodies, from both our genetically humanized VelocImmune mice as well as from convalescing human volunteers, creating what we believe is the largest and deepest collection of potent antiviral antibodies to choose from.

首先，也是最重要的一點，我們正在開發一種新型抗病毒抗體混合物，就像我們之前開發伊波拉病毒抗體混合物一樣。我們已經宣布，我們利用VelociSuite技術，從我們基因改造的人源化VelocImmune小鼠以及康復中的健康志願者體內，快速生成並篩選出數千種強效的全人源抗病毒抗體，從而創建了我們認為規模最大、種類最豐富的強效抗病毒抗體庫。

We have selected two distinct antibody cocktails from this collection, our initial cocktail as well as a backup. And we have already begun large-scale manufacturing and anticipate initiating clinical trials with the lead cocktail in June. With Ebola, we set the record of 9 months from initiating the project to starting human trials.

我們從該系列抗體中篩選出兩種不同的抗體混合物，一種是初始混合物，另一種是備用混合物。我們已經開始大規模生產，預計6月啟動主要混合物的臨床試驗。在伊波拉病毒的研發過程中，我們創下了從計畫啟動到開始人體試驗僅用9個月的記錄。

Now we hope to break that record with 5 months from project initiation to the clinic. Based on our experience with Ebola and other viruses, we hope that this specifically designed antiviral approach has a significant chance for success in providing both a prophylactic treatment to prevent infection in those at risk as well as for treating those already infected and symptomatic.

現在，我們希望打破這項紀錄，從計畫啟動到進入臨床階段僅需5個月。基於我們應對伊波拉病毒和其他病毒的經驗，我們希望這種專門設計的抗病毒療法能夠取得顯著的成功，既能為高風險族群提供預防性治療，防止感染，又能治療已感染且出現症狀的患者。

Our second major COVID-19 approach involves repurposing KEVZARA, our anti-IL-6 receptor antibody approved in rheumatoid arthritis. Based on a small uncontrolled case series from China, there was reason to believe that blocking the IL-6 pathway might address the underlying inflammation leading to acute respiratory distress in, so-called, severe COVID-19 patients, meaning hospitalized patients needing oxygen support but not on ventilators as opposed to, so-called, critical patients who largely require ventilators.

我們針對新冠肺炎的第二個主要策略是重新利用KEVZARA，這是一種已獲準用於治療類風濕性關節炎的抗IL-6受體抗體。基於一項來自中國的小型非對照病例係列研究，我們有理由相信，阻斷IL-6通路可能有助於解決導致所謂重症新冠肺炎患者（即需要吸氧但無需呼吸機的住院患者，而非主要需要呼吸機的危重症患者）出現急性呼吸窘迫的潛在炎症。

We initiated an adaptive Phase II/III trial to explore KEVZARA in both the severe and critical patient populations. Our initial data from both the Phase II and Phase III portion of the trial indicated that KEVZARA, at least at the doses tested, which paralleled those used in the China reports, did not provide a major benefit for severe patients.

我們啟動了一項適應性 II/III 期臨床試驗，旨在探索 KEVZARA 在重症和重症患者群體中的療效。來自 II 期和 III 期臨床試驗的初步數據顯示，KEVZARA 至少在所測試的劑量下（與中國報告中使用的劑量相同），並未為重症患者帶來顯著獲益。

On the other hand, the Phase II portion of the trial suggested a potential benefit in critical patients. And the Phase III trial in this group is ongoing. Additional efforts, both in our program and by our Sanofi partners in Europe and the rest of the world are further testing both of these populations, including at higher doses.

另一方面，II期試驗結果表明，該藥物可能對重症患者有益。目前，針對該族群的III期試驗正在進行中。我們本身以及賽諾菲在歐洲和世界其他地區的合作夥伴正在進行更多工作，進一步測試這兩類人群，包括更高劑量組。

Our results and efforts with KEVZARA highlight the challenges with using repurposed drugs, the inability to rely on uncontrolled and even small controlled trials and thus the importance of running large, well-controlled Phase III studies to obtain real answers as to whether a drug has benefit. And the quantitative extent of that benefit even in a pandemic setting.

我們利用KEVZARA所取得的成果和所做的努力凸顯了使用老藥新用所面臨的挑戰，即不能依賴非對照試驗，甚至不能依賴小型對照試驗。因此，進行大規模、控制良好的III期臨床試驗至關重要，以便獲得關於藥物是否有效以及在疫情期間療效的量化結果。

It is important to point out that our efforts with COVID-19 are being developed under an ongoing collaboration with BARDA, a division within the U.S. Department of Health and Human Services, and also involve incredibly collaborative relationships with so many critical partners from the FDA to the leadership of New York State to the many hospitals and physicians at the front lines who make the effort to engage in these trials and the many stricken patients who volunteer to participate.

需要指出的是，我們應對 COVID-19 的努力是在與美國衛生與公眾服務部下屬機構 BARDA 的持續合作下進行的，同時也與眾多重要合作夥伴建立了密切的合作關係，包括 FDA、紐約州領導層、眾多奮戰在一線的醫院和醫生，以及眾多自願參與試驗的患病患者。

I also want to thank all the individuals at Regeneron who have continued to work tirelessly on these programs despite all the logistical and operational and health challenges created by the COVID-19 crisis.

我還要感謝 Regeneron 的所有員工，儘管面臨 COVID-19 危機帶來的後勤、營運和健康方面的挑戰，他們仍然不懈地為這些專案努力。

Moving on from COVID-19. I first want to touch upon our EYLEA programs. Physicians consider safety to be essential in selecting anti-VEGF treatment. Over the last several months, another recently approved anti-VEGF product was recently associated with a serious new vision-threatening safety concern, involving occlusive retinal vasculitis in the context of intraocular inflammation.

暫且放下新冠疫情，我想先談談我們的EYLEA計畫。醫生認為，在選擇抗VEGF治療方案時，安全性至關重要。過去幾個月裡，另一種近期獲準的抗VEGF產品被發現有嚴重的、可能威脅視力的安全性問題，即在眼內發炎的背景下引發閉塞性視網膜血管炎。

In light of the frequency and serious nature of the safety concern, Regeneron and our partner Bayer, conducted a broad review of our clinical trial database as well as our post-marketing global safety database to identify any similar safety events with EYLEA. In the clinical trial database from 8 Phase III trials involving tens of thousands of injections, there was no report consistent with the safety concern.

鑑於此安全問題的頻繁發生和嚴重性，Regeneron及其合作夥伴拜耳對我們的臨床試驗資料庫以及上市後全球安全資料庫進行了全面審查，以識別EYLEA是否存在類似的安全性事件。在包含數萬次注射的8個III期臨床試驗資料庫中，未發現與該安全問題相符的報告。

Moreover, in the extensive post-marketing experience involving more than 32 million doses of EYLEA, sold in more than 100 countries worldwide since its approval more than 8 years ago, the rate of any, possibly, related safety event was less than 1 out of every 6 million EYLEA doses sold. And such cases were always associated with presumed infectious Endophthalmitis.

此外，在超過3,200萬劑EYLEA（自8年前獲批以來，已在全球100多個國家銷售）的廣泛上市後經驗中，任何可能相關的安全事件發生率均低於每600萬劑EYLEA中發生1例。而且，這些病例都與疑似感染性眼內炎有關。

Thus, based on our reviews of the EYLEA clinical trial database and post-marketing surveillance, occlusive retinal vasculitis in the context of intraocular inflammation does not appear to be a safety concern with the use of EYLEA.

因此，根據我們對 EYLEA 臨床試驗資料庫和上市後監測的審查，在眼內發炎的情況下，閉塞性視網膜血管炎似乎不是使用 EYLEA 的安全性問題。

Next, I want to discuss DUPIXENT. Later this month, we anticipate an FDA decision extending DUPIXENT approval to 6 to 11-year old children suffering from atopic dermatitis. DUPIXENT would be the first biological indicated for this pediatric population. We hope this potential approval will continue to reflect the remarkable safety profile of DUPIXENT as evidenced by the absence of a black box warning or any associated serious infection risks, which are often seen with immunomodulatory biologics and with JAK inhibitors.

接下來，我想談談DUPIXENT。我們預計FDA將在本月稍後做出決定，並批准DUPIXENT用於治療6至11歲患有異位性皮膚炎的兒童。 DUPIXENT將成為首個獲準用於治療該兒科族群的生物製劑。我們希望此次潛在的批准能夠繼續體現DUPIXENT卓越的安全性，正如其未出現黑框警告或任何相關的嚴重感染風險所證明的那樣，而這些風險在免疫調節生物製劑和JAK抑製劑中較為常見。

We also expect FDA action on our 300-milligram auto-injector, which would allow for an additional dimension of convenience to an already strong profile for the medicine. Additionally, later this year, we anticipate data from our Phase III pediatric asthma trial, the Phase II portion of our eosinophilic esophagitis program, and we remind you that we have pivotal studies in chronic spontaneous urticaria, prurigo nodularis and bullous pemphigoid as well as studies in oral immunotherapy with our collaborator Aimmune.

我們也期待FDA批准我們的300毫克自動注射器，這將進一步提升該藥物的便利性，使其在原有優勢的基礎上更上一層樓。此外，我們預計今年稍後公佈兒科氣喘III期臨床試驗的數據，以及嗜酸性食道炎II期臨床試驗的數據。同時，我們也要提醒您，我們正在進行慢性自發性蕁麻疹、結節性癢疹和類天皰瘡的關鍵性研究，並與合作夥伴Aimmune共同進行口服免疫療法研究。

We continue to build on DUPIXENT's story, which has already changed the lives of so many people suffering from type 2 inflammatory diseases, such as asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyps with more than 150,000 patients treated globally since launch.

我們將繼續講述 DUPIXENT 的故事，它已經改變了許多患有 2 型發炎性疾病（如氣喘、異位性皮膚炎和伴有鼻息肉的慢性鼻竇炎）的人的生活，自上市以來，全球已有超過 15 萬名患者接受了治療。

Next, I'm excited to share important updates on our immuno-oncology efforts. As you know, most cancer patients are still not successfully addressed with immune therapies, leaving us with a major challenge of enhancing responsiveness in tumor settings where immune therapies already have some efficacy such as lung and melanoma, while also trying to extend the benefit to patients with tumors that are currently not highly responsive, such as prostate, pancreas and colon.

接下來，我很高興與大家分享我們在免疫腫瘤學領域的重要進展。如大家所知，目前大多數癌症患者仍無法透過免疫療法獲得有效治療，這給我們帶來了巨大的挑戰：一方面，如何在免疫療法已取得一定療效的腫瘤（例如肺癌和黑色素瘤）中提高療效；另一方面，我們也要努力將療效擴展到目前免疫療法效果不佳的腫瘤患者，例如前列腺癌、胰腺癌和結腸癌患者。

Having our own effective anti-PD-1 antibody is foundational for our efforts to enhance and extend the benefits of immunotherapy as we had hoped such an antibody could play an important role, both as a monotherapy, but also in combination with other antibodies and bispecifics, derived from our own homegrown pipeline as well as in combination with a number of collaborative agents and vaccines. Defying early optimism, developing effective anti-PD-1 antibodies has proven to be very challenging.

擁有我們自主研發的有效抗PD-1抗體，對於我們增強和擴大免疫療法的益處至關重要。我們一直希望這種抗體能發揮重要作用，既可以作為單藥療法，也可以與其他抗體和雙特異性抗體聯合使用，這些抗體和雙特異性抗體既來自我們自主研發的產品線，也可以與多種合作藥物和疫苗聯合使用。然而，與最初的樂觀預期相反，開發有效的抗PD-1抗體已被證明極具挑戰性。

It is remarkable that in the decade since the first approval of an immuno-oncology agent, only one PD-1 antibody has been approved as monotherapy in first-line non-small cell lung cancer. Although that therapy has on its own, completely changed the paradigm of how lung cancer is treated.

值得注意的是，自首個免疫腫瘤藥物獲批以來的十年間，僅有一種PD-1抗體被批准作為一線非小細胞肺癌的單藥療法。儘管如此，該療法本身已經徹底改變了肺癌的治療模式。

At the end of last year, we announced interim results from our first-line non-small cell lung cancer study in so-called PD-L1 high patients. Revealing that our PD-1 antibody, Libtayo, as monotherapy had objective response rates of 42% compared to 22% for chemotherapy, indicating profound clinical activity.

去年年底，我們公佈了PD-L1高表達患者的一線非小細胞肺癌研究的中期結果。結果顯示，我們的PD-1抗體藥物Libtayo作為單藥療法，客觀緩解率達42%，而化療組的客觀緩解率為22%，顯示該藥物具有顯著的臨床療效。

Just last week, we announced that the independent data monitoring committee recommendation led to an early termination of this Libtayo monotherapy trial due to a highly significant improvement in overall survival with Libtayo decreasing the risk of death by 32.4% compared to the platinum doublet chemotherapy. This result was obtained early despite 1/3 of the patients entering the trial within the past 6 months and chemotherapies -- chemotherapy patients being able to cross over to Libtayo upon disease progression.

就在上週，我們宣布，獨立數據監測委員會建議提前終止Libtayo單藥治療試驗，因為Libtayo顯著提高了患者的總生存期，與鉑類雙藥化療相比，Libtayo使死亡風險降低了32.4%。儘管三分之一的患者是在過去6個月內入組的，而且接受化療的患者在疾病進展後可以轉為接受Libtayo治療，但我們仍然提前取得了這一結果。

No new Libtayo safety signal was identified. We are planning to present detailed trial data at a future medical meeting and will complete regulatory submissions in the next few months. And just this morning, we announced that we had identified yet another first-in-class cancer setting, where Libtayo, as monotherapy, exhibited profound and clinically meaningful activity, just as we had previously done for squamous cell carcinoma of the skin, or CSCC, where Libtayo is rapidly becoming standard of care.

未發現新的利妥昔單抗（Libtayo）安全性訊號。我們計劃在未來的醫學會議上公佈詳細的試驗數據，並將在未來幾個月內完成監管申報。就在今天上午，我們宣布，我們又發現了一種首創的癌症適應症，利妥昔單抗作為單藥療法，在該適應症中展現出顯著且具有臨床意義的療效，正如我們之前在皮膚鱗狀細胞癌（CSCC）中所取得的成果一樣，利妥昔單抗正迅速成為CSCC的標準治療方案。

Our potentially pivotal study in second-line advanced basal cell carcinoma of the skin, or BCC, demonstrated clinically meaningful response rates of nearly 30% in locally advanced patients who had progressed on prior Hedgehog inhibitor treatment. Impressively, more than 85% of the patients who responded to treatment have experienced durable responses of more than 12 months. We intend to submit data to regulatory authorities in the coming months.

我們針對二線治療晚期皮膚基底細胞癌（BCC）進行的一項可能具有里程碑意義的研究顯示，在既往接受過Hedgehog抑制劑治療後病情進展的局部晚期患者中，臨床意義上的有效率接近30%。更令人矚目的是，超過85%的有效患者獲得了持續超過12個月的療效。我們計劃在未來幾個月內向監管機構提交相關數據。

Basal cell carcinoma presents another promising opportunity to extend our dermato-oncology portfolio beyond the current squamous cell carcinoma indication. BCC is the most common cancer in the world. While only a very small percentage of cases require systemic therapy, the extremely large incidence of this cancer means that there are still thousands of people with advanced basal cell carcinoma in need of treatment.

基底細胞癌為我們提供了一個極具前景的機會，可以將我們的皮膚腫瘤產品組合擴展到目前鱗狀細胞癌適應症之外。基底細胞癌是世界上最常見的癌症。雖然只有極少數病例需要全身性治療，但這種癌症的發生率極高，這意味著仍有成千上萬的晚期基底細胞癌患者需要治療。

I'd like to frame the significance of these milestones for cancer patients and for Regeneron. In aggregate, our studies have now demonstrated that Libtayo is a potent and effective PD-1 monotherapy treatment, where we now have the potential subject to regulatory approval to offer patients with lung cancer, a competitive alternative. In addition, and very unexpectedly to some, we have now been able to identify two new cancer settings where PD-1 monotherapy demonstrates profound clinical activity based on our studies. First, advanced squamous cell carcinoma of the skin and now advanced basal cell carcinoma of the skin.

我想闡述這些里程碑對癌症患者和再生元公司的重要意義。總體而言，我們的研究已證實，Libtayo 是一種強效的 PD-1 單藥療法，一旦獲得監管部門批准，我們有望為肺癌患者提供一種具有競爭力的替代療法。此外，有些人意料的是，基於我們的研究，我們發現了 PD-1 單藥療法在兩種新的癌症類型中展現出顯著的臨床療效。首先是晚期皮膚鱗狀細胞癌，現在又發現了晚期皮膚基底細胞癌。

Moreover, as Libtayo is establishing itself as a leading PD-1 antibody for monotherapy, it allows us to pursue our strategy of using it in combinations to enhance and extend benefit. For example, we are investigating Libtayo in combination studies with our two classes of bispecifics, our CD3 class as well as our costim class.

此外，由於Libtayo正逐漸成為領先的PD-1單藥治療抗體，這使我們能夠繼續推進聯合用藥策略，以增強和延長療效。例如，我們正在進行Libtayo與我們兩類雙特異性抗體（CD3類和共刺激類）聯合用藥的研究。

That is, we have already initiated a trial combining Libtayo with our PSMA costim bispecific to try to endow responsiveness in prostate cancer. We have also initiated a trial combining Libtayo with our MUC16xCD3 bispecific to enhance responsiveness in ovarian cancer. We're also starting trials combining Libtayo with our other checkpoint inhibitors and with other collaborative assets.

也就是說，我們已經啟動了一項試驗，將Libtayo與我們的PSMA共刺激雙特異性抗體合併使用，以期提高前列腺癌的治療反應性。我們也啟動了一項試驗，將Libtayo與我們的MUC16xCD3雙特異性抗體合併使用，以增強卵巢癌的治療反應性。此外，我們也將進行試驗，將Libtayo與我們的其他免疫檢查點抑制劑以及其他合作研發的藥物合併使用。

For example, we have initiated a trial combining Libtayo with our LAG3 antibody to try to enhance responsiveness of first-line melanoma, where we are also combining Libtayo with various collaboration assets and vaccines.

例如，我們啟動了一項試驗，將 Libtayo 與我們的 LAG3 抗體結合使用，以期提高一線黑色素瘤的療效，我們也將 Libtayo 與各種合作資產和疫苗結合使用。

I should note that although all our programs are being impacted by the COVID-19 crisis, and additional future impacts are difficult to predict, our bispecific programs, which have been particularly affected, are ones that we are working very hard on to try to continue to enroll. Our potential in pivotal programs for our CD20xCD3 bispecific are enrolling in relapsed refractory follicular lymphoma, in relapsed refractory diffuse large b-cell lymphoma and in this setting, following CAR-T cell therapy failure.

需要指出的是，儘管我們所有的項目都受到了新冠疫情的影響，而且未來可能的影響難以預測，但受影響尤為嚴重的雙特異性抗體項目，我們正在全力以赴地推進患者招募工作。我們針對CD20xCD3雙特異性抗體的關鍵性研究項目，主要針對復發難治性濾泡性淋巴瘤、復發難治性瀰漫性大B細胞淋巴瘤以及CAR-T細胞療法失敗後的重症患者。

We anticipate full enrollment over the next year. And I remind you that we have demonstrated very promising initial efficacy and durability in all of these settings. Similarly, our BCMAxCD3 bispecific for myeloma is continuing to enroll in its proof-of-concept study, where it continues to deliver promising activity, as is our MUC16xCD3 bispecific for ovarian carcinoma.

我們預計明年將完成全部受試者招募。我還要提醒各位，我們在所有這些適應症中都展現了非常令人鼓舞的初步療效和持久性。同樣，我們用於治療多發性骨髓瘤的BCMAxCD3雙特異性抗體正在繼續進行概念驗證研究，並持續展現出令人鼓舞的活性，我們用於治療卵巢癌的MUC16xCD3雙特異性抗體也是如此。

All together, these are very exciting times for immuno-oncology here at Regeneron as we believe we have therapies that are showing important promise as monotherapies as well as the opportunity to combine and match these therapies as is appropriate to enhance and extend the benefit for additional cancer patients in need.

總而言之，對於 Regeneron 的免疫腫瘤學而言，這是一個非常激動人心的時代，因為我們相信我們擁有一些療法，這些療法作為單一療法展現出重要的前景，並且有機會將這些療法進行適當組合和匹配，以增強和擴大更多有需要的癌症患者的獲益。

Before handing the call over to Marion, let me conclude with a couple of brief updates on other areas of the pipeline. We are on track to complete our regulatory submissions for evinacumab, our ANGPTL3 antibody for homozygous familial hypercholesterolemia patients later this year. Recall, in our Phase III trial, evinacumab reduced LDL, or bad cholesterol, by an impressive 49% in patients not well controlled with other lipid-lowering treatments, including anti PCSK9s.

在將電話交給 Marion 之前，我想簡要介紹一下我們研發管線的其他方面。我們正按計劃推進 evinacumab 的監管申報工作，這是一種針對純合子家族性高膽固醇血症患者的 ANGPTL3 抗體，預計將於今年稍後完成。回顧一下，在我們的 III 期臨床試驗中，evinacumab 使其他降脂療法（包括抗 PCSK9 藥物）控制不佳的患者的低密度脂蛋白膽固醇（LDL，即「壞膽固醇」）水平顯著降低了 49%。

We're also planning an FDA submission of the data package for GARETOSMAB, our Activin A Antibody for fibrodysplasia ossificans progressiva in the second half of 2020 following dramatic results, showing 90% reduction in new bone lesion formation and pending confirmation of these data from the second half of the study.

我們還計劃在 2020 年下半年向 FDA 提交 GARETOSMAB 的數據包，這是一種用於治療進行性骨化性纖維發育不良的 Activin A 抗體，此前該藥物取得了顯著成果，顯示新骨病變形成減少了 90%，目前正在等待研究下半部分數據的確認。

We continue to explore the prospects of our C5 antibody and the potentially game-changing nature of the combination of this antibody with the siRNA program, which we are performing in combination with Alnylam. We continue to move forward with intent on initiating registration studies over the next 12 months.

我們正持續探索C5抗體的前景，以及該抗體與我們和Alnylam公司共同進行的siRNA計畫結合可能帶來的顛覆性變革。我們將繼續推進相關工作，並計劃在未來12個月內啟動註冊研究。

Finally, the opioid crisis continues and the need for alternative chronic pain solutions remain. We are making progress with fasinumab, our nerve growth factor antibody for osteoarthritis pain. We completed enrollment in our Phase III studies last year, and we are expecting to see data midyear. With that, I will turn the call over to Marion.

最後，鴉片類藥物危機仍在持續，我們仍需要尋找其他慢性疼痛治療​​方案。我們用於治療骨關節炎疼痛的神經生長因子抗體藥物fasinumab正在取得進展。我們去年完成了III期臨床試驗的患者招募，預計將在年中獲得數據。接下來，我將把電話交給Marion。

Thank you, George. Our business performance in the first quarter reflects continued healthy demand-driven growth of our core brands, EYLEA, Libtayo and DUPIXENT. While COVID-19 began to impact our business in the latter half of March, our first quarter results were strong.

謝謝喬治。我們第一季的業績反映了核心品牌EYLEA、Libtayo和DUPIXENT持續健康的、市場需求驅動的成長。儘管新冠疫情在3月下旬開始對我們的業務造成影響，但我們第一季的業績依然強勁。

I'm going to begin with EYLEA performance. EYLEA had an impressive start to the quarter with continued share gains. Global net sales grew 6% year-over-year to more than $1.85 billion and U.S. net sales grew 9% to $1.17 billion versus the prior year.

我先來看安禮（EYLEA）的表現。安禮本季開局表現出色，市佔率持續成長。全球淨銷售額較去年同期成長6%，超過18.5億美元；美國淨銷售額較去年同期成長9%，達11.7億美元。

COVID-19 began to negatively impact EYLEA sales with a greater impact from the pandemic on patients with diabetic eye disease than on patients with wet AMD. There was a sharp decline in overall demand in the last 2 weeks of March and first 2 weeks of April, followed by a sharp rebound in the most recent 2 weeks.

新冠疫情開始對EYLEA的銷售產生負面影響，且對糖尿病眼疾患者的影響大於對濕性老年黃斑部病變（AMD）患者的影響。 3月最後兩週和4月前兩週整體需求急劇下降，隨後在最近兩週出現強勁反彈。

Overall, in the month of April, demand was approximately 15% lower than the same time last year. We're encouraged by the recent rebound, although it is difficult to predict future COVID-19 impact. Despite these circumstances, we've been extremely impressed with retina specialists' efforts to ensure continuity of patient care.

整體而言，4月份的需求量比去年同期下降了約15%。我們對近期的反彈感到鼓舞，儘管很難預測新冠疫情未來的影響。儘管面臨這些挑戰，視網膜專科醫生為確保患者護理的連續性所做的努力給我們留下了深刻的印象。

Physicians use EYLEA to preserve their patient's vision because of its breadth of indications, dosing flexibility, convenience and safety. EYLEA dosing can be extended up to 12 weeks in appropriate patients, and the recently launched Pre-filled Syringe offers additional efficiency of care.

由於 EYLEA 適應症廣泛、劑量靈活、使用方便且安全，醫生選擇使用 EYLEA 來保護患者的視力。對於合適的患者，EYLEA 的療程可延長至 12 週，而近期推出的預充式註射器則進一步提高了治療效率。

Additionally, we've evolved our efforts to support the retinal community through virtual engagement as well as providing patient aids to self-monitor vision. We have plans in place to support customers in meeting anticipated higher demand for EYLEA once social distancing measures are relaxed.

此外，我們已加強對視網膜疾病患者群體的支持，包括透過線上互動以及提供患者輔助工具幫助患者進行視力自我監測。我們已製定相關計劃，以便在社交隔離措施放鬆後，能夠更好地滿足客戶對EYLEA產品日益增長的需求。

In summary, we're confident that EYLEA can navigate through and grow beyond COVID-19.

總而言之，我們相信安怡能夠渡過 COVID-19 疫情難關並實現成長。

Turning to Libtayo. First quarter global net sales were $75 million. In the U.S., sales reached $62 million, and we continue to extend Libtayo leadership as the #1 systemic treatment for advanced cutaneous squamous cell carcinoma, or CSCC. We continue to grow Libtayo in CSCC with nearly 65% of CSCC patients who receive systemic therapy already being treated with an anti-PD-1.

接下來談談Libtayo。第一季全球淨銷售額為7500萬美元。在美國，銷售額達到6,200萬美元，Libtayo繼續保持其在晚期皮膚鱗狀細胞癌（CSCC）系統治療領域的領先地位，位居榜首。在接受系統治療的CSCC患者中，近65%已在使用抗PD-1藥物，Libtayo在CSCC領域的應用持續成長。

In addition to growing the market, we're also capturing more of the therapeutic class, demonstrated by nearly 90% of new PD 1 patients with CSCC receiving Libtayo. We're also closely monitoring the impact of COVID-19 on Libtayo. While office visits and chemotherapy administration have declined in general, Libtayo use remains steady and treatment decisions for eligible patients are being made on a case-by-case basis. Overall, we're proud of our progress with Libtayo.

除了拓展市場，我們也不斷擴大該治療類別的市場份額，近90%接受Libtayo治療的PD-1陽性皮膚鱗狀細胞癌（CSCC）新患者就證明了這一點。我們也密切關注新冠疫情對Libtayo的影響。儘管門診就診量和化療次數總體有所下降，但Libtayo的使用量依然保持穩定，符合條件的患者的治療方案將根據具體情況而定。總而言之，我們對Libtayo的進展感到自豪。

In addition, our team is busy preparing for potential future launches with our collaborator, Sanofi, in lung cancer and basal cell carcinoma. In 2019, the worldwide anti-PD-1 and PD-L1 market was just over $21 billion. In the U.S. alone, the 2019 market in non-small cell lung cancer was $13 billion, $8 billion of which was first-line, with the vast majority of sales still coming from KEYTRUDA. With more than 200,000 new diagnoses of lung cancer in the U.S. each year, oncologists prefer having a choice in determining the most appropriate treatment for patients.

此外，我們的團隊正與合作夥伴賽諾菲積極籌備未來在肺癌和基底細胞癌領域的潛在上市計畫。 2019年，全球抗PD-1和PD-L1藥物市場規模略高於210億美元。光是在美國，2019年非小細胞肺癌市場規模就達130億美元，其中80億美元為第一線治療，而絕大部分銷售額仍來自KEYTRUDA。美國每年新增肺癌病例超過20萬例，因此腫瘤科醫師更傾向於擁有更多選擇，以便為患者制定最合適的治療方案。

Finally, moving to DUPIXENT. Global net sales in the first quarter were $855 million. In the U.S., net sales reached $679 million, representing 124% growth compared to the prior year. We continue to grow prescribing across all indications, including new-to-brand patients. In the first quarter, we did not see a material impact of COVID-19 on DUPIXENT sales. In the month of April, the rate of new patient starts on DUPIXENT was impacted due to COVID-19.

最後，我們來看看DUPIXENT。第一季全球淨銷售額為8.55億美元。在美國，淨銷售額達到6.79億美元，年增124%。我們持續擴大所有適應症的處方量，包括新患者。第一季度，新冠疫情對DUPIXENT的銷售額沒有造成重大影響。 4月份，受新冠疫情影響，DUPIXENT的新患者起始用藥率下降。

DUPIXENT has several unique competitive advantages that assist physicians in today's challenging environment. It can be administered at home. It does not require laboratory analysis to initiate most new patients and DUPIXENT is not an immunosuppressant. Expected approval of the auto-injector in June will provide additional convenience for product administration.

DUPIXENT 具有多項獨特的競爭優勢，可協助醫師應對當今充滿挑戰的醫療環境。它可在家庭環境中自行給藥。大多數新患者無需進行實驗室檢測即可開始使用，而且 DUPIXENT 並非免疫抑制劑。預計 6 月自動注射器的核准將進一步方便患者的用藥。

Atopic dermatitis remains a significant growth driver for DUPIXENT. We've expanded prescribing across both moderate and severe disease, and the eligible treatment population continues to grow. In the first quarter of 2019, DUPIXENT was approved in adolescents, and we look forward to the PDUFA decision for 6 to 11-year olds targeted towards the end of May. We have seen rapid uptake of DUPIXENT in adolescents since its approval, largely due to physician experience in older populations, which provides comfort in its efficacy and safety in these younger patients.

異位性皮膚炎仍然是DUPIXENT的重要成長驅動因素。我們已擴大了中度和重度異位性皮膚炎的處方範圍，符合治療條件的患者群體也持續成長。 2019年第一季度，DUPIXENT核准用於青少年，我們期待5月底針對6至11歲兒童的PDUFA核准結果。自核准以來，DUPIXENT在青少年中的應用迅速增長，這主要得益於醫生在老年患者群體中積累的經驗，使他們對該藥物在青少年患者中的療效和安全性更有信心。

In asthma, DUPIXENT continues to outperform other recent biologic launches. We've seen limited volume impact from COVID-19, particularly since medications, such as DUPIXENT are vital for patients to maintain respiratory function. While in early days, the asthma DTC campaign is already generating significant patient interest.

在氣喘領域，DUPIXENT 的表現持續優於其他近期上市的生物製劑。新冠疫情對其銷售影響有限，尤其考慮到 DUPIXENT 等藥物對於患者維持呼吸功能至關重要。儘管氣喘直接面向消費者的行銷活動尚處於早期階段，但已引起患者的廣泛關注。

Finally, our commercial efforts in chronic rhinosinusitis with nasal polyps continue to contribute meaningfully to the brand. Patients have been initiated on DUPIXENT regardless of prior surgery since approval. And during the COVID-19 pandemic, there is an even greater need for DUPIXENT in these patients due to the limited availability of elective nasal polyp surgery. Taken together, we remain committed to realizing the tremendous growth potential of DUPIXENT through expanded indications, age groups and geographies.

最後，我們在慢性鼻竇炎伴隨鼻息肉領域的商業努力持續為品牌做出重要貢獻。自從核准以來，無論患者之前是否接受過手術，都已開始使用DUPIXENT。在新冠疫情期間，由於擇期鼻息肉手術資源有限，這些患者對DUPIXENT的需求更加迫切。綜上所述，我們將繼續致力於透過拓展適應症、覆蓋更多年齡層和更廣闊的地域，充分發揮DUPIXENT的巨大成長潛力。

In closing, despite the current circumstances, our brands remain resilient. We continue to execute on our strategy and are working diligently to meet the evolving needs of our customers and patients. I'll turn the call over now to Bob.

最後，儘管面臨當前情勢，我們的品牌依然保持韌性。我們將繼續執行既定策略，並努力滿足客戶和患者不斷變化的需求。現在我將把電話交給鮑伯。

Thanks, Marion. For the first quarter of 2020, Regeneron delivered solid results on both the top and bottom line despite COVID-19 beginning to impact our business operations in the latter half of March. Today, I will first briefly discuss the first quarter results and then conclude with our 2020 guidance.

謝謝，瑪莉安。儘管新冠疫情在3月下旬開始影響我們的業務運營，但再生元在2020年第一季依然取得了穩健的營收和利潤成長。今天，我將首先簡要介紹第一季的業績，然後展望我們2020年的業績展望。

Effective January 1, 2020, we implemented changes to our accounting presentation related to certain reimbursements and other payments from collaborators. As such, our first quarter 2020 and comparable 2019 financial statements have been prepared under the new accounting presentation. We made these changes to better reflect the nature of the company's revenues earned and costs incurred pursuant to arrangements with collaborators.

自2020年1月1日起，我們對與某些報銷款項及其他合作方付款相關的會計列報方式進行了調整。因此，我們2020年第一季及2019年同期財務報表均以新的會計列報方式編製。我們做出這些調整是為了更準確地反映公司根據與合作方的協議所獲得的收入和發生的成本的性質。

Importantly, these changes provide a simplified presentation of our financial results. They do not impact income from operations, income taxes, net income or net income per share. For more information regarding these changes, please refer to the slide presentation and FAQ on the Regeneron Investor Relations website.

重要的是，這些變更簡化了我們財務表現的呈現方式。它們不會影響營業收入、所得稅、淨收入或每股淨收入。有關這些變更的更多信息，請參閱 Regeneron 投資者關係網站上的幻燈片演示文稿和常見問題解答。

Turning now to the results. First quarter 2020 revenues grew 33% year-over-year to $1.83 billion, driven by continued growth of both EYLEA and Libtayo as well as higher Sanofi collaboration revenues as a result of strong performance from our DUPIXENT franchise. Non-GAAP diluted net income per share grew 48% year-over-year to $6.60 on non-GAAP net income of $771 million.

現在來看業績。 2020年第一季營收年增33%至18.3億美元，主要得益於EYLEA和Libtayo的持續成長，以及DUPIXENT產品線強勁表現帶來的賽諾菲合作營收成長。非GAAP攤薄後每股淨收益年增48%至6.60美元，非GAAP淨利為7.71億美元。

Since Marion discussed our U.S. EYLEA results, I will start with our Bayer and Sanofi collaborations. Starting with the Bayer collaboration. Ex U.S. EYLEA net product sales, which are reported to us by Bayer, were $682 million, representing growth of 2% on a reported basis compared to the prior year. Total Bayer collaboration revenue was $281 million, an increase of 7%. We recorded $254 million for our share of net profits from EYLEA sales outside the U.S.

既然Marion已經討論了我們在美國銷售的EYLEA的業績，那我就先從我們與拜耳和賽諾菲的合作說起。首先是與拜耳的合作。拜耳向我們報告的除美國以外，EYLEA的淨產品銷售額為6.82億美元，以報告基準計算，較上年增長2%。拜耳合作的總收入為2.81億美元，成長7%。我們從美國以外地區的EYLEA銷售中獲得了2.54億美元的淨利潤份額。

Total Sanofi collaboration revenue, which under the new accounting presentation, consists of our share of antibody profits and reimbursements for the manufacturing of commercial supplies was $247 million in the first quarter. Our share of the profits from the commercialization of non-IO antibodies was $171 million compared to a loss of $28 million in the prior period, driven by higher DUPIXENT profits.

根據新的會計準則，賽諾菲合作總收入（包括我們應佔的抗體利潤和商業供應品生產補償）在第一季為2.47億美元。我們從非免疫腫瘤抗體商業化中獲得的利潤份額為1.71億美元，而上一季則虧損2800萬美元，這主要得益於DUPIXENT利潤的增長。

Effective April 1, 2020, we finalized the planned PRALUENT restructuring with Sanofi. In the U.S., Regeneron will have sole responsibility for PRALUENT, and we have begun recording net product sales as of April 1. Outside the U.S., Sanofi will have sole responsibility for PRALUENT and will pay Regeneron a 5% royalty on such net product sales, which we will record in other revenue. As for Kevzara, Regeneron and Sanofi continue to assess potential terms of this restructuring following the recently launched clinical program evaluating KEVZARA in hospitalized patients with COVID-19.

自2020年4月1日起，我們與賽諾菲最終敲定了PRALUENT的重組計畫。在美國，Regeneron將全權負責PRALUENT的銷售，我們已於4月1日開始確認淨產品銷售額。在美國以外地區，賽諾菲將全權負責PRALUENT的銷售，並向Regeneron支付5%的淨產品銷售額特許權使用費，我們將把這部分費用計入其他收入。至於Kevzara，在近期啟動的針對COVID-19住院患者的Kevzara臨床評估計畫之後，Regeneron和賽諾菲仍在評估重組的潛在條款。

Moving to our expense basis, starting with R&D. Non-GAAP R&D increased 23% year-over-year to $527 million driven by advancements in our earlier-stage pipeline, higher headcount and an increase in clinical manufacturing activities.

接下來我們來看費用組成，首先是研發費用。非GAAP研發費用年增23%至5.27億美元，主要得益於早期研發管線的進展、員工人數的增加以及臨床生產活動的增加。

Next, first quarter 2020 non-GAAP SG&A expense increased 27% year-over-year to $307 million. The year-over-year increase was driven by higher headcount and commercial investments to support the continued growth of our business. First quarter 2020 non-GAAP cost of collaboration and contract manufacturing was $139 million compared to $101 million in the first quarter of 2019. The year-over-year increase in COCM was primarily due to manufacturing costs associated with higher global sales of DUPIXENT and manufacturing costs in connection with our BARDA Ebola agreement.

其次，2020年第一季非GAAP銷售、管理及行政費用較去年同期成長27%至3.07億美元。年成長主要受員工人數增加和為支持業務持續成長而進行的商業投資所致。 2020年第一季非GAAP合作及合約製造成本為1.39億美元，而2019年第一季為1.01億美元。合作及合約製造成本年增主要歸因於DUPIXENT全球銷售額成長帶來的製造成本增加，以及與我們和美國生物醫學高級研究與發展局（BARDA）達成的伊波拉病毒防治協議相關的製造成本增加。

Finally, we introduced a new line item called other operating income and expense this quarter. This line item is located within expenses and primarily consists of the recognition of upfront payments in development milestones that were initially deferred and are recognized over time from our collaborators, Sanofi, Teva and Mitsubishi Tanabe. For the first quarter of 2020, we recorded other operating income of $40 million compared to income of $57 million recorded in the first quarter of 2019.

最後，本季我們新增了一個名為「其他營業收入和支出」的項目。該項目位於「支出」項下，主要包括確認先前遞延的研發里程碑付款，這些款項將隨著時間的推移從我們的合作夥伴賽諾菲、梯瓦和三菱田邊製藥處分期確認。 2020年第一季度，我們錄得其他營業收入4,000萬美元，而2019年第一季則錄得該收入5,700萬美元。

Turning now to taxes. The non-GAAP effective tax rate was 9.5% in the first quarter of 2020 compared to 16% in the first quarter of 2019. The year-over-year decline in the non-GAAP effective tax rate was due to increased tax benefits associated with stock option exercises in the first quarter of 2020.

接下來談談稅務方面。 2020年第一季的非GAAP實際稅率為9.5%，而2019年第一季為16%。非GAAP實際稅率年減的原因是2020年第一季股票選擇權行使帶來的稅收優惠增加。

Shifting now to cash flow and the balance sheet. For the first quarter of 2020, Regeneron generated $528 million in free cash flow. In the quarter, we repurchased $273 million worth of shares in open market transactions. The pace of share repurchases slowed considerably towards the end of the first quarter of 2020, given the recent share price appreciation.

接下來我們來看現金流和資產負債表。 2020年第一季度，Regeneron公司產生了5.28億美元的自由現金流。該季度，我們透過公開市場交易回購了價值2.73億美元的股票。鑑於近期股價上漲，股票回購速度在2020年第一季末顯著放緩。

Our fully diluted share count that we report for a given quarter is highly sensitive to the average stock price. If the average stock price for the second quarter is similar to the current stock price levels, we would estimate that our weighted average share count used for calculating non-GAAP EPS for the second quarter will be in the range of 121 million to 123 million shares.

我們報告的季度完全稀釋後股份數量對平均股價高度敏感。如果第二季的平均股價與目前股價水準相近，我們預期用於計算第二季非GAAP每股盈餘的加權平均股數將在1.21億至1.23億股之間。

And finally, to the balance sheet. We ended the quarter with cash and marketable securities of $7.2 billion and minimal debt.

最後，我們來看資產負債表。本季末，我們持有現金及有價證券72億美元，負債極少。

Now I'd like to spend a few moments to discuss the financial outlook for the remainder of the year. We assume that the COVID-19 impact on our business will peak in the second quarter 2020. We anticipate a recovery as the year progresses as economies gradually reopen, social distancing guidelines are relaxed and doctor and hospital visits return to prior levels.

現在我想花幾分鐘時間談談今年剩餘時間的財務展望。我們預計新冠疫情對我們業務的影響將在2020年第二季達到高峰。隨著經濟逐步重啟、社交隔離措施放寬以及就診量和住院量恢復到疫情前的水平，我們預計業務將隨著時間的推移而復甦。

From a supply chain and manufacturing perspective, Regeneron has historically maintained high levels of inventory in the event of a prolonged impact to our manufacturing and production capabilities. Currently, we see minimal disruptions to our supply chain and our manufacturing activities, and we have adequate supply of commercial product on hand to meet demand.

從供應鏈和生產製造的角度來看，Regeneron歷來都保持著較高的庫存水平，以應對生產製造能力可能受到的長期影響。目前，我們的供應鏈和生產活動受到的干擾極小，現有充足的商業產品庫存足以滿足市場需求。

Our 2020 annual financial guidance reflects our latest assessment of our business in this current environment with limited precision. Certain elements of our spend will be dictated by the continued severity and length of the COVID-19 impact in our efforts associated with KEVZARA and our SARS-CoV-2 antibody cocktail. These factors may materially impact our guidance. We will assess carefully whether further updates to our guidance may be warranted.

我們的2020年度財務預期反映了我們對當前環境下業務的最新評估，但精確度有限。我們部分支出將取決於新冠疫情對我們KEVZARA和SARS-CoV-2抗體雞尾酒療法相關工作的持續嚴重程度和持續時間。這些因素可能會對我們的預期產生重大影響。我們將密切評估是否需要進一步更新預期。

Now moving to our 2020 financial guidance. And starting with R&D, we forecast our 2020 non-GAAP R&D expenses to be in the range of $1.9 billion to $2.04 billion. We are continuing to invest in our pipeline and research capabilities, which remain critical to the long-term growth of the business. Our oncology pipeline continues to grow. And as conditions allow, we intend to advance programs through development.

現在我們來看2020年的財務預期。首先是研發方面，我們預計2020年非GAAP研發支出將在19億美元至20.4億美元之間。我們將繼續投資於產品線和研發能力，這對公司的長期成長至關重要。我們的腫瘤產品線也在不斷壯大。我們將視情況推進專案研發進程。

Additionally, we are funding external partnership obligations as jointly developed molecules are rapidly advancing. Our R&D guidance also includes the portion related to our COVID-19 activities where we will be reimbursed at least in part by BARDA. Unlike R&D reimbursements from collaborations, which are netted in the R&D expense line item under the new accounting presentation, these reimbursements from BARDA will continue to be recorded in other revenue.

此外，由於聯合研發的分子藥物進展迅速，我們也為外部合作義務提供資金。我們的研發預算還包括與新冠肺炎相關的研發活動，其中至少一部分將由美國生物醫學高級研究與發展局 (BARDA) 報銷。與合作研發報銷款項（根據新的會計準則，這些款項將計入研發費用）不同，來自 BARDA 的報銷款項將繼續計入其他收入。

Next to SG&A. We forecast our 2020 non-GAAP SG&A expenses to be in the range of $1.19 billion to $1.29 billion. We are continuing to invest for product growth now and once the COVID-19 impact abates. For EYLEA, we are continuing to make investments in diabetic eye diseases. For Libtayo, launch preparations are underway for anticipated launches in basal cell and non-small cell lung cancer.

除了銷售、管理及行政費用（SG&A）之外，我們預計2020年非GAAP SG&A費用將在11.9億美元至12.9億美元之間。我們將持續投資產品成長，直到新冠疫情影響消退。對於安理國際（EYLEA），我們將繼續投資於糖尿病眼疾領域。對於利妥昔單抗（Libtayo），我們正在為預計在基底細胞癌和非小細胞肺癌領域的上市做準備。

Starting this year, we are providing guidance for COGS and COCM. For COGS, we forecast 2020 non-GAAP expenses to be in the range of $295 million to $355 million, primarily comprised of U.S. EYLEA, U.S. Libtayo and U.S. PRALUENT manufacturing costs in the payment to Sanofi for 50% of the gross margin associated with U.S. Libtayo. For COCM, we forecast 2020 non-GAAP expenses to be in the range of $600 million to $700 million, primarily comprised of global DUPIXENT, global KEVZARA, ex U.S. EYLEA, ex U.S. PRALUENT and Regeneron EB3 manufacturing costs.

從今年開始，我們將提供銷售成本 (COGS) 和成本製造成本 (COCM) 的指引。對於銷售成本，我們預測 2020 年非美國通用會計準則 (非GAAP) 支出將在 2.95 億美元至 3.55 億美元之間，主要包括美國 EYLEA、美國 Libtayo 和美國 PRALUENT 的生產成本，以及向賽諾菲支付的美國 Libtayo 相關毛利率的 50%。對於成本製造成本，我們預測 2020 年非GAAP 支出將在 6 億美元至 7 億美元之間，主要包括全球 DUPIXENT、全球 KEVZARA、不包括美國 EYLEA 和美國 PRALUENT 的生產成本以及 Regeneron EB3 的生產成本。

As a reminder, we are reimbursed for COCM costs. Reimbursements are recognized within the Sanofi and Bayer collaboration revenue lines and other revenues. Reimbursements should closely approximate COCM expenses for quarterly reporting periods, subject to timing and other considerations.

再次提醒，我們會獲得 COCM 成本的報銷。報銷款項計入賽諾菲和拜耳合作收入以及其他收入。根據時間和其他因素，季度報告期間的報銷金額應與 COCM 支出大致相等。

For the new line item of operating income and expense, we expect this to be in the range of $175 million to $205 million of income this year.

對於新增的營業收入和支出項目，我們預計今年的收入將在 1.75 億美元至 2.05 億美元之間。

And finally to tax. We anticipate our 2020 non-GAAP effective tax guidance to be in the range of 12% to 14%.

最後談談稅收。我們預計2020年非GAAP實際稅率將介於12%至14%之間。

In conclusion, we had a solid start to the year despite initial impacts from COVID-19. Our balance sheet, increasingly diversified commercial portfolio and robust pipeline enabled Regeneron to withstand the impacts of COVID-19 while making prudent investments in executing on meaningful near-term opportunities to position Regeneron for sustained long-term growth. With that, I'd like to turn the call back to Justin.

總之，儘管受到新冠疫情初期的影響，我們今年的開局依然穩健。憑藉穩健的資產負債表、日益多元化的商業組合以及強大的研發管線，Regeneron得以抵禦新冠疫情的衝擊，同時審慎地投資於具有重要意義的近期機遇，從而為Regeneron的長期持續增長奠定基礎。接下來，我將把發言權交還給Justin。

Thank you, Bob. Crystal, that concludes our prepared remarks. We'd now like to open the call for Q&A. Just a word that we have more than 20 callers in the queue, so to ensure that we are able to address as many as possible, we will answer 1 question from each caller before moving to the next. Please go ahead, Crystal.

謝謝鮑勃。克麗絲塔爾，我們的演講到此結束。現在進入問答環節。需要說明的是，目前有超過20位聽眾在排隊等候，為了確保我們能夠回答盡可能多的問題，我們將採取每位聽眾只回答一個問題的策略。克麗絲塔爾，請開始。

(Operator Instructions) Your first question comes from the line of Evan Seigerman from Crédit Suisse.

（操作說明）您的第一個問題來自瑞士信貸的 Evan Seigerman 的一條線。

Congrats on the progress this quarter. Thank you also for your efforts in combating the pandemic. So with data from both the frontline lung trial last week and basal cell carcinoma today, can you expand as to what's next for your oncology franchise? How do you plan on competing with the standard of care in the front line lung setting and more broadly across tumor types amenable to IO therapy?

恭喜本季取得的進展。也感謝您在對抗疫情所做的努力。鑑於上周公布的一線肺癌試驗數據和今天公佈的基底細胞癌試驗數據，您能否詳細介紹一下貴公司腫瘤治療業務的下一步計劃？您打算如何在一線肺癌治療領域以及更廣泛的適用於免疫腫瘤療法的腫瘤類型中與現有標準療法競爭？

Well so...George?

那麼……喬治？

And I guess that most importantly, as we noted, the lung field is dominated by leading antibody that has produced the most impressive data. We are very excited that our monotherapy trial has delivered data that looks very impressive in terms of the overall survival endpoint. And we have an ongoing combination trial with chemotherapy as well that we're excited about having it read out over the coming year or so.

而且，正如我們之前提到的，肺癌領域目前主要由領先的抗體藥物主導，這些抗體藥物已經取得了令人矚目的數據。我們非常高興地看到，我們的單藥治療試驗在總存活期方面取得了非常亮眼的成果。此外，我們還有一項正在進行的聯合化療試驗，我們期待在未來一年左右的時間內公佈試驗結果。

And so I think that this is going to position us well in such a large opportunity where physicians and patients are looking for alternatives to have an agent that has such profound activity as a monotherapy. But in addition, we have all these combination programs that I was referring to.

所以我認為這將使我們在這樣一個巨大的機會中佔據有利地位，因為醫生和患者都在尋找療效顯著的單藥療法替代方案。此外，我們還有我之前提到的所有合併用藥項目。

We have, we believe, one of the most exciting homegrown pipelines of additional agents that we could combine to not only enhance the activity in these settings where the PD-1 monotherapies are already active but also to extend to new settings and new indications, such as I mentioned, whether it be prostate cancer or ovarian cancer or others, where right now, the activity is not what we would want.

我們相信，我們擁有最令人興奮的本土研發管線之一，我們可以將這些藥物組合起來，不僅可以增強 PD-1 單藥療法在現有治療領域中的療效，還可以擴展到新的治療領域和新的適應症，例如我提到的前列腺癌、卵巢癌或其他癌症，目前這些領域的療效還達不到我們的預期。

So I think that we've put ourselves into a pretty exciting position, where we have some of the most exciting agents with identified profound clinical activity as monotherapies, but we now have the opportunity to mix and match these as is appropriate to enhance and extend the activity. So we're very excited about the oncology situation.

所以我認為我們已經處於一個非常令人振奮的境地，我們擁有一些最令人振奮的藥物，它們作為單藥療法已顯示出顯著的臨床療效，但現在我們有機會根據需要將這些藥物進行組合搭配，以增強和擴大療效。因此，我們對腫瘤治療領域的現況感到非常興奮。

Yes. And just to add on the commercial side, it's Len and maybe Marion can chime in. You know, obviously, we collaborate with Sanofi, where we take the lead in the United States. They take the lead outside the United States, but we work together with them. And this disease is dominated by lung cancer -- maybe Marion a little bit about the numbers, the incidence, prevalence, what kind of marketplace we're going into?

是的。關於商業方面，Len 和 Marion 或許可以補充一些內容。我們顯然與賽諾菲合作，在美國我們主導市場，在美國以外他們主導市場，但我們與他們共同合作。這種疾病主要由肺癌引起——或許 Marion 可以談談相關數據，例如發病率、盛行率，以及我們即將進入的市場類型？

Yes. So lung cancer is a disease with a very large incident population of more than 200,000 newly diagnosed patients each year. So we do think that there's tremendous opportunity and know that oncologists prefer having a choice in determining treatment for their patients.

是的。肺癌是一種發生率非常高的疾病，每年新增確診超過20萬例。因此，我們認為這方面存在巨大的機遇，我們也知道腫瘤科醫生更傾向於在為患者制定治療方案時擁有選擇權。

So we're excited about the data, and we'll work carefully with Sanofi on launch preparedness and certainly have built a commercial team that has extensive experience in competitive launches. We look forward to this opportunity if, in fact, we have an approval for lung and for basal cell.

我們對這些數據感到非常興奮，我們將與賽諾菲密切合作，並做好上市準備。我們已經組建了一支在競爭激烈的市場環境下擁有豐富上市經驗的商業團隊。如果我們的藥物最終獲準用於治療肺癌和基底細胞癌，我們將非常期待這個機會。

Your next question comes from the line of Geoffrey Porges with SVB Leerink.

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

Congratulations on both the surprisingly strong quarter, but also all the progress on the pipeline. George, we haven't had a lot of access to talk to you about the COVID programs. But could you just expand a little bit on the backup program, what its nature is? And the related question of what do you view as the risk of both ADE and also of the antibodies in some way contributing adversely to the inflammatory syndrome in the tail end of this disease?

恭喜你們本季業績出乎意料地強勁，同時也祝賀你們在研發管線方面取得的所有進展。喬治，我們之前很少有機會和你詳細討論新冠項目。能否詳細介紹備用方案，它的性質是什麼？以及相關的問題，你認為抗體依賴性增強（ADE）的風險有多大？抗體是否會以某種方式加劇疾病後期出現的發炎症候群？

Yes, those are great questions. So what we were able to generate because we have these very robust platforms, both the ability to get fully human antibodies from our genetically humanized mouse model as well as from recovering humans. We generated a collection of thousands and thousands of antibodies. Getting many antibodies that really were at the top end, historically, at the best level of binders and blockers and antiviral neutralizers that you've ever seen based on the literature and the history.

是的，這些都是很好的問題。我們之所以能夠達到這樣的成果，是因為我們擁有非常強大的平台，既能從基因人源化小鼠模型中獲得全人源抗體，也能從康復者身上獲得抗體。我們獲得了數以千計的抗體。其中許多抗體在結合、阻斷和抗病毒中和方面都達到了歷史最高水平，根據文獻和歷史數據，這些抗體的效力堪稱一流。

And so what we did was we simply selected several cocktails of the best antibodies where we put them together, and we created our initial cocktail and a backup cocktail just in case, for some reason something goes wrong with the initial cocktail. So they're actually quite similar. It's just a different collection of antibodies for the backup as well as for the primary.

因此，我們挑選了幾種最佳抗體混合物，將它們混合在一起，製成了初始混合物和備用混合物，以防初始混合物出現問題。所以它們實際上非常相似，只是備用混合物和初始混合物使用的抗體組合不同。

Now we think that based on the history of treating infectious disease and viral diseases with highly potent neutralizing antibodies, the risks of things such as antibody-dependent enhancement and so forth are actually quite limited. You actually see these, for example, in certain classes of viruses, the Flaviviruses, the Dengue type viruses and so forth, in particular, but that's because of the biology of the viruses there.

現在我們認為，根據以往使用高效中和抗體治療傳染病和病毒性疾病的經驗，抗體依賴性增強等風險實際上相當有限。當然，在某些類型的病毒中，例如黃病毒、登革熱病毒等，確實會觀察到這些現象，但這主要是由於這些病毒本身的生物學特性所致。

With most other viruses when you have highly potent neutralizing antibodies, these risks are mitigated. We do have -- in addition to our backup collection of antibodies, we do also have our antibody cocktails made with what we call uber stealth constant regions, which would completely mitigate against that possibility.

對於大多數其他病毒，只要擁有高效率的中和抗體，這些風險就能得到緩解。我們除了儲備抗體外，還擁有用我們稱為「超隱形恆定區」的抗體混合物，這可以完全消除這種可能性。

But for the current approaches that we're taking, we're going to be going forward with the fully armed antibodies because we think the risks of ADE with very potent neutralizing antibodies is actually quite low. So I think that the history of antiviral antibodies, our experience, the way they work, our own antibodies in other programs, most notably in Ebola, we think that there's a very significant chance that these specifically designed, very potent neutralizing antibodies will have a significant impact on the disease.

但就我們目前採取的策略而言，我們將繼續使用完全活化的抗體，因為我們認為使用強效中和抗體發生抗體依賴性增強（ADE）的風險實際上很低。因此，我認為，根據抗病毒抗體的歷史、我們的經驗、它們的作用機制，以及我們自身在其他項目（尤其是伊波拉病毒計畫）中使用的抗體，我們認為這些專門設計的強效中和抗體很有可能對這種疾病產生顯著影響。

We think that there's a great chance that they can be very powerful prophylactic and preventive agents. But we also think that they can treat patients who are already symptomatic with disease. And we don't think that right now, there's any evidence that suggests that the antibody response is what's contributing to the inflammatory responses in the lung.

我們認為它們很有可能成為非常有效的預防和控制藥物。但我們也認為它們可以治療已經出現症狀的患者。而我們認為目前沒有任何證據顯示抗體反應是導致肺部發炎反應的原因。

And as -- of course, as has already been seen and described in the disease, the majority of patients do recover and their recovery is coincident with their producing viral responses. So altogether, I think there's a lot of reason to have a lot of hope that this approach really has a chance to make a difference, as we said, both in prophylactic treatment but also in treating symptomatic patients.

當然，正如我們已經觀察到和描述的，大多數患者都能康復，而且他們的康復與體內產生病毒免疫反應同時發生。因此，總而言之，我認為我們有充分的理由對這種方法抱有希望，相信它確實有機會發揮作用，正如我們所說，無論是在預防性治療方面，還是在治療有症狀的患者方面。

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

我們的下一個問題來自摩根大通的科里·卡西莫夫。

Just to follow up on Jeff's question on the COVID-19 front. Curious how you're thinking about the clinical trial designs for your antibody cocktail, both from a prophylactic standpoint as well as a therapeutic? And on the latter, do you plan to either go head-to-head or on top of remdesivir if you run initial studies in a hospital setting?

關於傑夫提出的新冠肺炎方面的問題，我想補充一點。我很好奇您是如何考慮抗體雞尾酒療法的臨床試驗設計的，包括預防和治療兩個方面？關於治療方面，如果您在醫院進行初步研究，您計劃讓它與瑞德西韋直接比較，還是在瑞德西韋的基礎上再進行試驗？

Well, we're planning on doing 3 sets of trials in the prophylactic or prevention setting, in people who are at high-risk. In early treatment, that is patients who are not at the level that they would be normally hospitalized.

我們計劃在預防或預防性治療方面進行三組試驗，對象為高危險群。在早期治療方面，這些患者病情尚未達到通常需要住院治療的程度。

But patients who are identified, they're symptomatic. If they do go to an ER, they are sent home, but they don't need oxygen support. However, a significant number of them do develop more serious disease and then have to return to the hospital. So the idea would be to stop the disease in those individuals and stop the progression and the need for them going back to the hospital.

但確診的患者都有症狀。如果他們去急診室，會被送回家，但不需要吸氧氣。然而，其中相當一部分人病情會發展得更嚴重，不得不再次入院。所以，治療的目標是阻止這些患者的病情惡化，並避免他們再次入院。

And then we're also going to go to the hospitalized setting, very similar to what we're doing with KEVZARA and where the Remdesivir data has read out. So certainly, the only setting where it would be on top of an existing standard-of-care, potentially, would be in the late treatment setting, we would certainly be going on top of standard-of-care there, whether it be Remdesivir or maybe we'll see whether there's data from other agents by that time as well.

然後，我們也會進入住院治療階段，這與我們使用KEVZARA以及瑞德西韋資料公佈階段的情況非常相似。因此，瑞德西韋可能只會在現有標準治療的基礎上進行輔助治療，而這種情況可能只出現在後期治療階段。屆時，我們肯定會在標準治療的基礎上使用瑞德西韋，或者我們屆時可能會看到其他藥物的數據。

In the prophylactic setting, there is no need and there's also no other standard of care and in the same thing in the early treatment. And I would remind you once again that based, as I said, on our experience in other programs, and most notably, a good example is the Ebola program, the earlier that one treats, the better one does.

在預防方面，沒有必要，也沒有其他標準治療方案；早期治療也是如此。我再次提醒各位，正如我所說，根據我們在其他項目中的經驗，尤其是伊波拉項目，治療越早，效果越好。

I remind you early in the disease for Ebola, which is obviously a much more lethal disease with much higher levels of severe disease and death, we were able to save more than 90% of the patients when we went with early treatment. So I think that there's a lot of reason to think that in this setting, these sorts of antibodies, both in the prophylactic setting and in the early treatment setting can have really profound benefits on their own.

我提醒各位，在伊波拉疫情早期，這種疾病的致死率和重症率都高得多，但我們透過早期治療挽救了超過90%的患者。所以我認為，我們完全有理由相信，在這種情況下，無論是預防或早期治療，這類抗體本身就能帶來非常顯著的益處。

Your next question comes from the line of Tim Anderson from Wolfe Research.

你的下一個問題來自 Wolfe Research 的 Tim Anderson。

On your antibody cocktail. I'm wondering if you think Gilead's actions with Remdesivir essentially kind of set the bar for other companies in terms of what they may be expected to do, specifically in terms of giving away some portion of initial therapy free at the outset. So?

關於您的抗體雞尾酒療法。我想知道您是否認為吉利德在瑞德西韋方面的做法，實際上為其他公司樹立了標桿，尤其是在初期免費提供部分初始治療方面。所以呢？

Len, you want to take that? Len?

萊恩，你想拿那個嗎？萊恩？

Yes. Sorry. It's Len. We've spent all of our energy right now focused on getting the technical success that George described and that we hope to see. And in parallel, we have been working to clear manufacturing capacity in our New York plant so that we can make it at large scale. We hope to be able to have a couple hundred thousand doses by the end of the summer and then continue to manufacture from there. In terms of pricing, donations and fair values and all that sort of stuff, that's just got to come down the road a little bit.

是的，抱歉，我是Len。我們目前正全力以赴地推進George所描述的技術突破，這也是我們希望看到的。同時，我們也在努力清理紐約工廠的產能，以便能夠大規模生產。我們希望到夏末能夠生產幾十萬劑，然後繼續擴大生產規模。至於定價、捐款、公平價格等等問題，還需要一些時間來解決。

Your next question comes from the line of Ronny Gal from Bernstein.

你的下一個問題來自伯恩斯坦的 Ronny Gal 的一句台詞。

I want to go back to Libtayo in non-small cell lung cancer. I hear you about physicians wanting to have a choice in monotherapy between KEYTRUDA and a second product. The question is why should they choose Libtayo over KEYTRUDA?

我希望在非小細胞肺癌治療中重新使用利妥昔單抗（Libtayo）。我理解醫生們希望在單藥治療中能夠在凱瑞達（KEYTRUDA）和另一種藥物之間進行選擇。問題是，他們為什麼要選擇利妥昔單抗而不是凱瑞達？

I think you've got a product here which is, just to make the point, a few years, is the standard of care, used extensively. Can you just share with us in your data is -- are there elements of the data you're seeing from the trial that would suggest that there is any group of patients where physicians should prefer Libtayo over KEYTRUDA, what is your marketing argument here? And before -- I stop there, I just want to thank you for all the efforts you're making against COVID-19, just adding to my peers here.

我認為你們的產品，順便提一下，幾年來一直是標準療法，被廣泛使用。能否請您分享一下你們的數據——從試驗數據中，是否有任何因素表明，對於某些患者群體，醫生應該優先選擇Libtayo而不是KEYTRUDA？你們的市場推廣論點是什麼？最後，我想感謝你們為對抗新冠疫情所做的一切努力，我只是想和我的同行分享這份經驗。

Thanks, Ronny. It's Len. It's way too early for us to be making any comparative statements. We literally just recently got the good news from the data monitoring committee that we met with highly statistical significance, as George described, survival. We've got a lot more data to go. We've got a lot more studies to look at. It's not just one study. It's not just the cross-study comparison. There's going to be a lot more that goes into this, and we'll just have to see how this evolves. But the history of the industry typically is that if there's just a couple of competitors, you have to remember that the size of this market. Last year, it was about $22 billion, of which about 70% or 75% was lung cancer and that was largely driven by KEYTRUDA sales. So there's a pretty big opportunity to have some important alternatives. And you just have to wait, I'm sorry, Ronny, to see how this all evolves when we roll this out.

謝謝，羅尼。我是倫。現在就做出任何比較性聲明還為時過早。我們最近才從數據監測委員會得到好消息，正如喬治所說，我們的生存率達到了高度統計意義。我們還有很多數據需要分析，還有很多研究需要研究。這不僅僅是一項研究，也不僅僅是跨研究的比較。這其中涉及的因素很多，我們只能拭目以待。但行業歷史通常表明，即使只有幾個競爭對手，你也要記住這個市場的規模。去年，市場規模約220億美元，其中約70%到75%是肺癌，主要得益於KEYTRUDA的銷售。因此，我們有機會推出一些重要的替代療法。抱歉，羅尼，你只能耐心等待，看看我們推出這款產品後會如何發展。

Your next question comes from the line of Chris Raymond from Piper Sandler.

你的下一個問題來自 Piper Sandler 的 Chris Raymond 的台詞。

Just back to the antibody cocktail, I guess. So George, a lot of folks, I guess, close to the FDA and maybe some with a fairly loud voice on these COVID matters, so they keep talking about at least one of the therapies, one of the antibody therapies that's in development being available as early as this fall. So I guess, maybe just talk about how is that possible from a clinical development standpoint? And especially in light of the program you just described, George, with the 3 different settings. Obviously, when there's something that's even under an emergency use authorization available, how do you conduct that?

我想，我們還是回到抗體雞尾酒療法的話題。喬治，我想，很多與FDA關係密切的人，以及一些在新冠疫情問題上頗具影響力的人，都在談論至少有一種正在研發的抗體療法最早可能在今年秋季就能上市。所以我想，或許我們可以探討一下，從臨床研發的角度來看，這如何可能？特別是考慮到你剛才提到的項目，喬治，它涵蓋了三種不同的治療方案。顯然，當某種療法獲得緊急使用授權時，該如何進行推廣？

Well, yes. I think that these are all great questions. We're in unprecedented times. I think that the urgency and the collaborative spirit between regulators, between medical institutions, between companies has never been seen before. And also our commitment to this is something we've sort of done it before, but now we're trying to take it to the next level. So we are planning, as we said, in June, to simultaneously initiate trials in the 3 settings that we're actually talking about. We are thinking of ways to synergize between the 3 classes of trials that we're talking about. And we are hoping -- I mean, this is going to depend on a lot of factors, and there's obviously a lot of risk and concerns whether this can be done since it hasn't ever been done before. But we are really hoping that we'll be able to not only initiate these studies but able within a month or 2 to perhaps if these agents are working as well as we might hope they would work as well as for example, some of the precedents set by Ebola suggest that they might work, that we might, within that month or 2, be getting data. If we were to get data within those sort of time frames, as Len describes, we have already committed at risk to manufacturing the drug supply that could be providing by the end of the summer, hundreds and hundreds of thousands of doses of these antibodies. So you're right. It's never been done before. On the other hand, I don't think we ever had quite a pandemic like this before. And I think that some companies, like ours, have really put themselves in a position with the technologies, the commitments, the investments that we've made to put ourselves in a position to maybe help out and make a difference here and regulators like the FDA, BARDA, everybody is coming together to try to help us in this situation to meet the urgency and meet the dire need that we might have here. And so the hope is, yes, it might be possible by the end of the summer or the fall that our antibody treatment could be available. A lot of risks, a lot of concerns, but we are working as hard as we can with so many collaborators to try to turn that into a reality.

是的，我認為這些都是很好的問題。我們正處於前所未有的時期。監管機構、醫療機構和企業之間展現的緊迫感和合作精神是前所未有的。我們之前也曾在這方面做出過一些努力，但現在我們正試圖將其提升到一個新的水平。正如我們在六月提到的，我們計劃同時啟動我們正在討論的三種試驗方案。我們正在思考如何將這三類試驗方案進行協同增效。我們希望——當然，這取決於許多因素，而且由於以前從未有過先例，顯然存在許多風險和擔憂，我們不確定能否成功。但我們真心希望不僅能夠啟動這些研究，而且在一兩個月內，如果這些藥物真的像我們預期的那樣有效（例如，伊波拉病毒的一些先例表明它們可能有效），我們或許就能獲得數據。正如倫所描述的，如果我們能在這樣的時間範圍內獲得數據，我們已經冒著風險投入生產，到夏季結束時，這些抗體藥物的供應量將達到數十萬劑。所以你說得對，這以前從來沒有過。另一方面，我認為我們以前也從未經歷過如此大規模的全球大流行。我認為，像我們這樣的公司，憑藉技術、承諾和投資，已經讓自己處於有利地位，或許能夠在此發揮作用，做出貢獻。像FDA、BARDA這樣的監管機構，以及其他各方都在齊心協力，幫助我們應對當前的緊急情況和迫切需求。因此，我們希望，到夏末或秋季，我們的抗體療法或許就能問世。當然，其中存在著許多風險和擔憂，但我們正與眾多合作夥伴竭盡全力，力求將這一願景變為現實。

So we still have several callers -- sorry, we have several callers still in the queue. So we'll extend for a few more minutes if we can.

抱歉，還有幾位來電者在排隊。如果可以的話，我們會再延長幾分鐘。

Let me just put a finer point on that, for just a second. I completely agree with what George said. And I think if you listen carefully to what he was saying is that because we're doing 3 different types of studies, the timing on the different studies might be quite different. If you're dealing with people who already have the disease, then you're not waiting for that long period to occur when you're trying to prevent the disease. In people who already have the disease, the course of the disease sort of declares itself over a several week to month period. And so you could imagine, depending upon what's going on, how many people are actually showing up at the hospital, how many people are hospitalized in the ICU, that, that part could go a lot faster. But of course, you can imagine that George and the team have got a lot of great strategies for the early part to try and find people at high enough risk, which is the hard part in a preventative setting.

讓我再補充一點。我完全同意喬治的觀點。我認為，如果你仔細聽他的話，就會明白，因為我們同時進行三種不同類型的研究，所以不同研究的時間安排可能會大不相同。如果你研究的是已經生病的人，那麼在預防疾病時，你不需要等待那麼長時間的潛伏期。對於已經患病的人來說，疾病的病程會在幾週到幾個月內逐漸顯現。所以你可以想像，根據實際情況，例如有多少人實際到醫院就診，有多少人住進了加護病房，這部分進展可能會快得多。當然，你也可以想像，喬治和他的團隊已經制定了很多有效的策略，用於早期階段尋找高危險群，這在預防工作中才是難點所在。

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

你的下一個問題出自高盛的特倫斯·弗林之口。

Thanks as well from me for all your efforts on the COVID front. Maybe another one for George on bispecifics. I was just wondering if you've already generated data from your PSMA bispecific antibody as monotherapy. And if that's what led to your decision to initiate a combo trial with Libtayo? And then the second part of the question relates to your comment, George, about seeing continuing promising activity. I was wondering if that was only on the BCMA bispecific? Or if that also covered the MUC16 bispecific?

我也要感謝您在新冠疫情所做的一切努力。關於雙特異性抗體，我可能還會問喬治一個問題。我想知道您是否已經獲得了PSMA雙特異性抗體單藥治療的數據。這是否是您決定啟動與Libtayo合併用藥試驗的原因？第二個問題是關於您之前提到的持續觀察到的積極療效，喬治。我想知道這是否僅指BCMA雙特異性抗體？還是也包括MUC16雙特異性抗體？

Yes. Great questions. I guess, first of all, basically, we think that the bispecific costims. We've described these in the literature. We have a lot of data on them. On their own, they are designed to essentially have very little or no activity. And only when combined with either a CD3 bispecific or with a PD-1 agent, do they then essentially synergize and amplify the benefit or activate the benefit of the other agent. And we've done a lot of work on that. Quite a bit of published work has already been shown on that. And the early data in the clinic are supporting that in that the monotherapy costim was not intended and did not show single-agent activity. We are now in the combination program where we are hoping to now activate activity by adding the costim to the PD-1. That's how they were designed, that's what we're hoping to see, and that is what we are hoping to be able to generate data that we will be giving you information on in the future. In terms of the promising activity, I think that, yes, we have seen robust activity with the BCMA. We have not really reported anything on the MUC16. I can say that we are seeing evidence of activity, and we'll give you more details on that in future times.

是的，問得好。首先，我們認為雙特異性共刺激分子（我們在文獻中已經描述過，也掌握了大量數據）本身幾乎沒有活性。只有與CD3雙特異性抗體或PD-1抑制劑合併使用時，才能發揮協同作用，增強或活化另一種藥物的療效。我們在這方面做了許多研究，也已經發表了不少相關成果。早期的臨床數據也支持這一觀點，即單藥治療的共刺激分子並非預期用途，也未顯示出單藥活性。我們目前正在進行聯合用藥項目，希望透過將共刺激分子添加到PD-1抑制劑中來激活其活性。這正是它們的設計初衷，也是我們希望看到的，我們希望能夠獲得相關數據，並在未來與大家分享。就前景看好的方面而言，我認為BCMA確實展現了強勁的市場活動。關於MUC16，我們目前還沒有發布任何消息。但我可以肯定的是，我們已經看到了一些市場活動的跡象，未來我們會提供更多相關資訊。

One second, if I may. We appreciate all the comments from the analyst community thanking us for what we're doing. We just want to say we find your notes very useful and very helpful. The coverage of this pandemic, the useful information that all of you provide on what's going on, and what the rates are of this and that and what to be expected, we really appreciate that as well.

稍等片刻。我們非常感謝分析師們對我們工作的肯定和讚賞。我們想說，你們的筆記非常有用，也很有幫助。你們對疫情的報道，以及你們提供的關於疫情發展、各種指標以及未來趨勢的實用信息，我們都深表感謝。

Your next question comes from the line of Josh Schimmer from Evercore ISI.

你的下一個問題來自 Evercore ISI 的 Josh Schimmer。

Another one on COVID-19. How do you determine the optimal dose for passive immunization, especially if you have to adjust for different levels of exposure? How long do you think a single dose will confer protection? And then what are realistic goal in terms of the number of people you can support beyond August with prophylactic use considering potential supply constraints?

關於新冠病毒的另一個問題。如何確定被動免疫的最佳劑量，尤其是在需要根據不同暴露水平進行調整的情況下？您認為單劑疫苗能提供多久的保護？考慮到潛在的供應限制，在8月之後，您實際上能夠支持多少人使用預防性疫苗？

Okay. Well, basically, we have accumulated over many years now, a lot of understanding about the doses that one needs to block viral infection, particularly of respiratory and other diseases. So we actually know both in animal models and in humans, the blood levels to block respiratory infection. And so we are targeting to be significantly above those blood levels for a minimum of at least a month for the prophylactic setting. So there's no guarantees. Once again, these are all predictions based on experience in other programs with other viruses, but including, for example, the MERS coronavirus. And so we believe we have a good target blood level that we need to meet and achieve and stay above on for at least a month for the prophylaxis setting. And so the prophylaxis dosing is intended to last for at least a month. For example, in our RSV program -- for one of our programs there, we were able to have protection for several months. So minimum of a month is our current target based on maintaining blood levels that we believe you have to maintain above for preventing infection by respiratory viruses. What was the rest of the question?

好的。基本上，經過多年的積累，我們對阻斷病毒感染（特別是呼吸道疾病和其他疾病）所需的劑量有了很多了解。我們實際上已經透過動物模型和人體試驗確定了阻斷呼吸道感染所需的血中濃度。因此，我們的目標是在預防性用藥中，血中濃度至少要維持在顯著高於這些濃度的水平一個月以上。當然，這並不能保證一定有效。再次強調，這些都是基於我們在其他病毒（例如中東呼吸道症候群冠狀病毒）計畫中的經驗而做出的預測。因此，我們相信我們已經確定了一個合適的血中濃度目標，我們需要達到並維持該目標水準至少一個月以上，以達到預防性用藥的效果。預防性用藥的持續時間至少為一個月。例如，在我們的呼吸道合胞病毒（RSV）計畫中，我們實現了數月的保護。因此，我們目前的目標是至少維持一個月，這是基於我們認為預防呼吸道病毒感染所需的血液濃度。問題剩下的部分是什麼？

In terms of supply -- yes, I'll take that, George. Thanks. In terms of supply, we've going as fast as we can. We have an amazing capability in technology that allows us to get high producing cell lines very rapidly. We know how to make antibodies. We are one of the companies that can do this from end-to-end seamlessly. And so I'm optimistic that we can expand from the initial numbers we talked about and continue to manufacture. We have had inquiries from multiple other companies about perhaps wanting to manufacture our cocktail when we have good data, and we suspect maybe the government may want that to happen as well, where we can expand through collaborative efforts and sort of take the unprecedented step of letting some of our technology outside the company for this purpose as well because that's what probably will need to be done.

就供應而言——是的，我同意，喬治。謝謝。就供應而言，我們已經盡最大努力了。我們擁有強大的技術能力，可以非常迅速地獲得高產細胞系。我們知道如何生產抗體。我們是少數幾家能夠無縫完成從頭到尾整個流程的公司之一。因此，我樂觀地認為，我們可以在最初討論的數量基礎上擴大規模，並繼續生產。我們已經收到多家其他公司的問詢，他們可能希望在我們獲得可靠數據後生產我們的雞尾酒療法，我們懷疑政府也可能希望如此，這樣我們可以通過合作來擴大規模，並採取前所未有的舉措，將我們的一些技術對外開放，用於此目的，因為這很可能是必須做的。

Your next question comes from the line of Yaron Werber from Cowen.

你的下一個問題來自 Cowen 公司的 Yaron Werber。

I'm going to shift a little bit, George, and maybe fasinumab, just so we don't lose track of that program. It sounds like that data is coming up pretty soon, the Phase III osteoarthritis data. Any thoughts? And any thoughts on Pfizer filed fasinumab for approval? So this is totally overlooked, but I want to know what's kind of coming down if you can share.

喬治，我打算稍微調整一下話題，可能還會聊聊法西單抗，免得我們忽略了這個項目。聽起來，骨關節炎的III期臨床試驗數據很快就要公佈了。你有什麼想法嗎？還有，你對輝瑞提交法西單抗的上市申請有什麼看法？我知道這事兒可能被忽略了，但我很想知道接下來會有什麼進展，如果你能分享一下就太好了。

Yes. Our viewpoint with fasinumab is that for a long time now, as, obviously, I think, most people appreciate is that in many ways this is a very risky program in that there are -- there is a now well-defined adverse event that we are trying to titer around with the dose. And I think the major question for this program is whether we have been able to find a dose that threads the needle between the safety concern and between providing sufficient benefit to patients. I think if you see other competitors' data here, it's been a little difficult for others to thread the needle. So this is what we're going to see, especially when we see the data that comes out from our ongoing program that we'll be getting by the middle of this year, how well we've done to actually find a magic spot on the dose-response curve, where we have sufficient safety, but sufficient benefit, and how that might compare to what others have achieved. So we are as anxious and excited as you are to see whether we may have threaded this needle in a way that really provides an important alternative for patients, as we know, there is a crying, literally a crying need here for new pain medications and particularly for the osteoarthritis population, and we are hoping that we may have threaded that needle.

是的。我們對法西單抗的看法是，長期以來，正如大多數人所理解的那樣，在很多方面，這都是一個風險極高的項目，因為目前存在一種已明確定義的不良事件，我們正在嘗試透過調整劑量來規避它。我認為該計畫的主要問題在於，我們是否能夠找到一個既能保證安全性又能為患者帶來足夠療效的劑量。我認為，如果你查看其他競爭對手的數據，你會發現他們很難做到這一點。因此，我們將在今年年中之前看到我們正在進行的試驗項目的數據，屆時我們將看到我們在劑量反應曲線上找到「最佳點」的效果如何，既保證了足夠的安全性，又提供了足夠的療效，以及我們的結果與其他公司取得的成果相比如何。因此，我們和你們一樣焦慮和興奮，想看看我們是否找到了真正能為患者提供重要替代方案的方法。我們知道，目前迫切需要新的止痛藥，尤其是骨關節炎患者，我們希望我們已經找到了這種方法。

We're going to try to cut the call about quarter to the hour that leaves us with time for 1 to 2 more questions.

我們將盡量把通話時間控制在15分鐘左右，這樣我們還有時間再問1到2個問題。

Your next question comes from the line of Carter Gould from Barclays.

你的下一個問題來自巴克萊銀行的卡特·古爾德。

I pass on my congrats on the Libtayo data sets, and thank you for all the COVID efforts. Maybe just focusing back on Libtayo for a second. It sounds like most of the commentary is sort of reaffirmation of the development strategy here and sort of validation of the efforts to date. I guess -- but with this data in hand, particularly the lung data, does this sort of either accelerate your focus on broad -- further broadening out of the novel-novel combinations or potentially a shift to bringing in outside agents, maybe a shift in sort of that partnership strategy?

我謹向Libtayo資料集表示祝賀，並感謝你們在新冠疫情期間所做的一切努力。或許我們可以先回到Libtayo本身。聽起來大部分評論似乎都在重申目前的研發策略，並肯定迄今為止所做的努力。我想——但是，有了這些數據，特別是肺部數據，這是否會加速你們將研發重點放在更廣泛的領域——進一步拓展新型藥物組合之外的研發，或者轉向引入外部合作夥伴，或許會改變你們的合作策略？

Right. I think that this is really a landmark for the field, but also for us. KEYTRUDA has stood really unchallenged now, particularly in lung cancer, which is driving most of the sales for this entire field. Because others haven't actually been able to show that they've had a KEYTRUDA-like agent. I think that I understand the concerns about people talking about how are you going to compete? But having something that's already showing this profound clinical activity that we're now seeing as a monotherapy with also having also identified, this is another thing that people have to appreciate, new first-in-class indications that have been missed by the rest of the field. First, with cutaneous squamous cell carcinoma now with basal cell, I think, are establishing Libtayo as a legitimate monotherapy alternative. And as Len said, when you have opportunities such as $8 billion opportunities in first line, history shows that bona fide competitors with profound clinical activity, they are going to get significant shares. But I think it's exactly, as you said, we believe we are now in a position where we can compete in these monotherapy situations, but it only amplifies our excitement and our commitment to the combination approach. And of course, as you say, we are working hard to find the right outside collaborators. And I think we've already announced quite a few of them, that we're very excited about, that we're already starting combination studies on and so forth, but we are just as excited about our internal homegrown pipeline. We have been preparing a series of combination assets just for this moment now where we will have this potent, powerful PD-1 antibody of our own. Our entire strategy depended on it and now that the molecule has come through and proved that it really is a bona fide monotherapy competitor out there, we are now just doubly motivated and compelled to now build upon that with all these combination opportunities that have been coming out of our labs for the last few years. So we could not be more excited that we will now have the ability to not only compete as a monotherapy, but now to add with all these combinations, all these bispecifics, the costim bispecifics and so forth as well as these collaboration assets. And we think this is a really exciting time, not only for us but for the field because I hope you all realize how the immuno-oncology field, despite all the initial excitement, has not moved forward as much as I think we all would have wanted it to have moved forward. We haven't seen the magic combinations. We haven't seen the dramatic increases into new cancers. We think we have the opportunity to take that field to the next level and having the foundational PD-1 antibody of our own really gives us that opportunity. So these are really exciting times for us, but I think for the field that -- for the first time in a decade, maybe substantial new advances, a new age of immuno-oncology may be coming now.

沒錯。我認為這對整個領域來說都是一個里程碑，對我們公司來說也是如此。 KEYTRUDA 目前幾乎無人能敵，尤其是在肺癌領域，而肺癌正是整個領域銷售的主要驅動力。因為其他公司其實還沒有研發類似 KEYTRUDA 的藥物。我理解大家對如何競爭的擔憂。但是，KEYTRUDA 已經展現出如此顯著的臨床活性，我們現在看到的是它作為單藥療法的療效，而且我們還發現了其他公司之前忽略的全新首創適應症，這一點也值得大家重視。首先，KEYTRUDA 現在可以用於治療基底細胞癌等皮膚鱗狀細胞癌，我認為這些適應症正在確立 Libtayo 作為合法單藥療法的地位。正如 Len 所說，當第一線治療市場擁有 80 億美元的市場機會時，歷史表明，真正擁有顯著臨床活性的競爭對手將會獲得可觀的市場份額。但我認為正如您所說，我們相信我們現在有能力在單藥治療領域競爭，但這只會更加激發我們對聯合療法的熱情和決心。當然，正如您所說，我們正在努力尋找合適的外部合作夥伴。我認為我們已經宣布了不少合作方，我們對此感到非常興奮，並且已經開始進行聯合治療研究等等。但我們同樣對我們自主研發的藥物管線感到興奮。我們一直在準備一系列聯合療法，就是為了迎接這一刻——我們即將擁有我們自主研發的強效PD-1抗體。我們整個策略都依賴它，現在該分子已經成功上市，並證明它確實是一款名副其實的單藥療法競爭者，這讓我們更有動力，也更有決心在此基礎上，利用過去幾年我們實驗室研發的所有聯合療法機會，繼續發展壯大。我們無比激動地宣布，我們現在不僅能夠以單藥療法參與競爭，還能結合各種聯合療法，包括雙特異性抗體、共刺激雙特異性抗體等等，以及各種合作資源。我們認為這不僅對我們而言，對整個領域來說都是一個令人興奮的時刻。我希望大家都能意識到，儘管免疫腫瘤學領域最初令人振奮，但它的發展速度並沒有達到我們所有人的預期。我們還沒有看到神奇的聯合療法，也沒有看到針對新發癌症的療法顯著增長。我們認為我們有機會將這個領域推向新的高度，而我們自主研發的基礎性PD-1抗體正是我們實現這一目標的有力保障。因此，這對我們來說是一個令人興奮的時刻，但我認為，對於整個領域而言，十年來或許首次出現實質的新進展，免疫腫瘤學的新時代可能即將到來。

You can be sure we're getting together with our collaborator Sanofi on this and going to look carefully about how to move this forward, and how to compete well with the data we have and other data we want to get.

您可以放心，我們正在與合作夥伴賽諾菲一起研究如何推進這項工作，以及如何利用我們現有的數據和我們想要獲得的其他數據來取得良好的競爭優勢。

Your next question comes from the line of Geoff Meacham from Bank of America.

你的下一個問題來自美國銀行的傑夫‧米查姆。

I want to ask another one on COVID cocktail. Just to follow-up, George, on some of your earlier comments about rolling out efficacy studies next month. I'm assuming that or can I infer that you're bypassing traditional Phase I safety studies in healthies, and then when you think about manufacturing scale-up, what's the opportunity to outsource or to partner, should you have much higher demand and success, obviously, in the pivotal study?

我想再問一個關於新冠雞尾酒療法的問題。喬治，我想跟進一下你之前關於下個月進行療效研究的評論。我假設（或我可以推斷）你們跳過了傳統的健康人群I期安全性研究。那麼，如果關鍵性研究取得了顯著成功，且需求量大幅成長，在考慮擴大生產規模時，你們是否有可能選擇外包或合作？

Yes. I think that we have been already in active conversation with regulators exactly on the points that you talk about. And I think these are unprecedented times, and I think also when you have the history with these types of agents, it does allow you and it does allow the comfort of the regulators that one could be moving forward very quickly. And so as you might imagine, along the lines of the things that you proposed, these are exactly the sorts of things that we're talking about with regulators. And we're trying to employ into our designs. In terms of your second part of your question, I think Len already started talking about this point, which is we have made a huge commitment to enable our entire upstate New York manufacturing facility to be devoted to this effort, which on its own could supply hundreds of thousands, if not over the course of time, maybe even on the order of a million or so doses per month. However, even that might not be sufficient, depending on the demand, depending on whether there's a second wave, depending on what happens with vaccines and so forth. So we are actively talking about collaborations with others, who are very interested in bringing their resources to the table here, too. As we said, there's enormous collaborative spirit that I think we haven't seen before between companies to come together to help each other out, to really make a difference here in this pandemic. And so that opportunity is really out there. We're actively talking with people. And of course, it all depends on whether these antibodies deliver. But if they deliver and depending on the state of the pandemic, if there's more need, I am sure that there will be ways that either we on our own or with major collaborations will be able to supply more to more patients.

是的。我認為我們已經就您提到的這些要點與監管機構進行了積極的溝通。我認為目前的情況前所未有，而且我認為，鑑於我們以往使用這類藥物的經驗，這確實能夠讓我們和監管機構都感到放心，從而可以迅速推進相關工作。正如您所想，我們正是按照您提出的這些建議與監管機構討論，並努力將其融入我們的設計中。關於您問題的第二部分，我認為Len已經開始談到這一點了，那就是我們已經投入巨資，將我們在紐約州北部的整個生產設施用於這項工作，該設施本身每月就能供應數十萬劑，如果時間允許，甚至可能達到每月一百萬劑左右。然而，即便如此，也可能仍然不夠，這取決於需求、是否會出現第二波疫情、疫苗的進展等等。所以我們正在積極與其他機構洽談合作，他們也非常有興趣貢獻自己的資源。正如我們所說，各公司之間展現了前所未有的合作精神，大家齊心協力，互相幫助，力求在抗擊疫情中發揮重要作用。因此，這樣的機會確實存在。我們正在積極與各方洽談。當然，這一切都取決於這些抗體能否發揮作用。但如果它們有效，並且根據疫情發展情況，如果需求增加，我相信我們一定能夠找到方法，無論是依靠自身力量還是透過重要的合作，為更多患者提供更多抗體。

Okay. Crystal, last question. Unfortunately, we have a lot of people still in the queue, but this will be our last question

好的。 Crystal，最後一個問題。很遺憾，還有很多人在排隊，但這將是我們的最後一個問題了。

And your question comes from the line of Yatin Suneja with Guggenheim.

你的問題源自於 Yatin Suneja 與古根漢美術館的淵源。

I also appreciate all the effort on the COVID front. I also would like to compliment Bob for simplifying the accounting. Really appreciating a much cleaner guidance that you provided today. So the question is on the EYLEA front. I think, Marion, pre-COVID you were anticipating total market supply for Pre-filled Syringe by March, could you comment where you are in terms of the supply of PFS? And any impact you saw of PFS on EYLEA performance in 1Q? And also, I'm not sure if there was any inventory dynamic that you commented on EYLEA today.

我也很感謝大家在應對新冠疫情所做的努力。同時，我也要讚揚Bob簡化了會計處理流程。非常感謝您今天提供的清晰明了的指導。現在的問題是關於安永（EYLEA）的。 Marion，我記得在疫情爆發前，您預計預灌封注射器（PFS）的市場總供應量將在3月份達到目標，您能否談談目前PFS的供應情況？您認為PFS的供應對安永第一季的業績有何影響？另外，我不確定您今天是否提到安永的庫存動態。

Okay. So sure. Let me take those. I'll start with your last. So in terms of inventory, we have stayed at normal levels. So we're not seeing anything unusual in terms of inventory. Your next question on Pre-filled Syringe, we do think Pre-filled Syringe is a very attractive alternative in the marketplace. And the use of the Pre-filled Syringe has gone up to about 75% of total use of EYLEA. We have, as you know, introduced Pre-filled Syringe in a staggered way, starting towards the end of last year, but it's been very well received, and we do intend to have not only Pre-filled Syringe which, of course, is growing in popularity, but we'll also maintain vials in the marketplace. And then I believe the other item that you were commenting on was in terms of the COVID impact and as I shared, certainly in the first quarter, we had very robust performance with EYLEA and saw our sales grow in the U.S. marketplace, 9% in net sales over the prior year. We did see, as I mentioned, a decline in overall demand in the last 2 weeks of March, and that continued into the first 2 weeks of April, then we saw a sharp rebound in the most -- meaning a positive trend in the last 2 weeks. So that when you put all that together and all those factors together, demand in the month of April was approximately 15% lower than in the same period last year. But I go on to say, it's hard to predict what will happen with the COVID impact going forward, but we remain very confident in EYLEA's profile, our commitment to the retinal specialist community and the -- obviously, the very attractive profile we have, both clinically and from a safety standpoint with EYLEA. We're supporting our offices through appropriate promotion and support so that when patients flow -- returns in a more robust fashion, we certainly look forward to the opportunity to help those patients with EYLEA and support our prescribers.

好的，沒問題。讓我來回答這些問題。我先回答您最後一個問題。關於庫存，我們一直保持在正常水平。所以庫存方面沒有任何異常狀況。您下一個問題是關於預先灌封注射器的，我們認為預灌封注射器在市場上是一個非常有吸引力的選擇。預灌封注射器的使用量已佔EYLEA總用量的75%左右。如你所知，我們從去年底開始分階段推出預灌封注射器，但它的市場反應非常好。我們不僅計劃繼續銷售預灌封注射器（當然，預灌封注射器越來越受歡迎），還會繼續銷售西林瓶。我相信您提到的另一個問題是新冠疫情的影響。正如我之前所說，在第一季度，EYLEA的業績非常強勁，我們在美國市場的銷售額比去年同期成長了9%。正如我之前提到的，我們在三月最後兩週確實看到了整體需求的下降，這種下降趨勢一直延續到四月的前兩週，之後在最後兩週出現了強勁反彈——這意味著需求呈現積極的成長趨勢。因此，綜合所有這些因素，四月的需求量比去年同期下降了約15%。但我還要說，很難預測新冠疫情未來會如何影響市場，但我們仍然對EYLEA的市場表現、我們對視網膜專科醫生群體的承諾以及EYLEA在臨床和安全性方面所展現出的極具吸引力的優勢充滿信心。我們正在透過適當的推廣和支援來幫助我們的診所，以便在患者數量恢復正常時，我們能夠更好地幫助這些患者使用EYLEA，並為我們的處方醫生提供支援。

Thank you, everyone. That's going to conclude our call. We appreciate everybody hanging on a little longer today given all the things that we had to speak to and all the great questions that came in.

謝謝大家。今天的通話到此結束。感謝大家今天耐心等待，因為我們有很多內容要講，也回答了很多精彩的問題。

Bob Landry and the IR team will be available following the call to answer further questions. Thank you.

鮑勃·蘭德里和投資者關係團隊將在電話會議結束後解答其他問題。謝謝。

Stay safe.

注意安全。

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.

女士們、先生們，今天的會議到此結束。感謝各位的參與，祝您有美好的一天。大家可以斷開連線了。