雷傑納榮製藥 (REGN) 2020 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Regeneron Pharmaceuticals Third Quarter 2020 Earnings Call. (Operator Instructions)

女士們、先生們，感謝您的耐心等待，歡迎參加再生元製藥公司2020年第三季財報電話會議。 （操作說明）

I would now like to hand the conference over to your speaker Justin Holko. Please go ahead, sir.

現在我把會議交給發言人賈斯汀·霍爾科先生。請開始吧，先生。

Thank you, Deborah. Good morning, good afternoon and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the third quarter 2020 conference call. An archive of this webcast will be available on our website. 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 Commercial -- Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

謝謝黛博拉。全球各地的聽眾好友們，早安、下午好、晚上好。感謝您對再生元製藥的關注，歡迎參加2020年第三季電話會議。本次網路直播的存檔將在我們的網站上提供。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商務官兼首席財務官鮑勃·蘭德里。在我們發言結束後，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 forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, as well as intellectual property, pending litigation, other proceedings and competition. 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 September 30, 2020, which has been filed with the SEC today. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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、財務預測和指引、研發項目及相關預期里程碑、合作、財務、監管事項、支付方覆蓋範圍和報銷問題，以及知識產權、未決訴訟、其他程序和競爭相關的陳述。每項前瞻性陳述均受風險和不確定性的影響，這些風險和不確定性可能導致實際結果和事件與該陳述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9月30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. 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。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.

接下來，我將把電話交給我們的總裁兼執行長倫·施萊弗博士。

Thank you, Justin, and thanks to everyone joining today's call. In the third quarter, Regeneron delivered another strong financial performance of double-digit top and bottom line growth while achieving numerous milestones in our research and development pipeline and making remarkable progress against COVID-19 with our novel antibody cocktail.

謝謝賈斯汀，也謝謝今天所有參加電話會議的各位。第三季度，再生元公司再次取得了強勁的財務業績，營收和利潤均實現了兩位數增長，同時在研發管線方面也取得了多項里程碑式的進展，並且憑藉我們新型的抗體雞尾酒療法在對抗新冠病毒方面取得了顯著成果。

Importantly, our growth and financial strength is being fueled by an increasingly diversified set of revenue and earnings streams while we invest in R&D for the long term. Furthermore, our results show the importance of products that meaningfully address serious medical needs and have the power to transform lives even during a pandemic. EYLEA is a great example. EYLEA Global net sales were $2.1 billion in the quarter and grew 9% compared to the same period last year. In the U.S., sales rebounded from second quarter COVID lows to $1.3 billion and grew 11% versus prior year. The efficacy, safety and convenience that EYLEA offers in protecting eyesight had proven to be highly valued by treating physicians and their patients as the product again outperformed the anti-VEGF market for retinal diseases.

重要的是，我們不斷多元化的營收和獲利來源推動了公司的成長和財務實力，同時我們也持續投資於長期研發。此外，我們的業績表明，能夠切實解決重大醫療需求並有能力改變人們生活的產品至關重要，即使在疫情期間也不例外。 EYLEA 就是一個很好的例子。 EYLEA 全球淨銷售額在本季達到 21 億美元，年增 9%。在美國，銷售額從第二季受新冠疫情影響的低點反彈至 13 億美元，年增 11%。 EYLEA 在保護視力方面展現出的有效性、安全性和便捷性，已證明深受醫生和患者的青睞，該產品在視網膜疾病抗 VEGF 市場中再次表現出色。

Next, we continue to build momentum with Dupixent as we and Sanofi recorded our first ever quarter of more than $1 billion in sales. This milestone speaks to the power of Dupixent across a broad array of type 2 inflammatory diseases and to our team's ability to execute despite COVID-19. Adding to this momentum, we've recently announced results from another successful Phase III trial, this time in pediatric asthma. We are eager to submit these data for regulatory review and expect that Dupixent will remain a robust and durable growth driver for years to come.

接下來，我們與賽諾菲攜手，憑藉Dupixent持續保持強勁成長勢頭，實現了首季銷售額突破10億美元的佳績。這項里程碑式的成就彰顯了Dupixent在多種2型發炎性疾病治療中的強大療效，也體現了我們團隊在新冠疫情期間的卓越執行力。此外，我們近期也發表了另一項成功的III期臨床試驗結果，該試驗針對的是兒童氣喘。我們期待盡快將這些數據提交給監管機構審批，並預計Dupixent將在未來幾年內持續保持強勁且可持續的成長動能。

In oncology, we are solidifying our leadership position in cutaneous squamous cell carcinoma. Additionally, the FDA has granted priority review for our regulatory filings in lung cancer and basal cell carcinoma as we prepare for potential launches in these indications early next year.

在腫瘤領域，我們正在鞏固在皮膚鱗狀細胞癌領域的領先地位。此外，FDA已授予我們肺癌和基底細胞癌監管申報的優先審查權，我們正為明年年初在這些適應症領域的潛在上市做好準備。

Regeneron is also making critical advancements in the treatment of infectious diseases. Last month, the FDA approved Inmazeb, the first-ever treatment for Ebola virus infection. Building upon our work in Ebola, our team and rapid response technologies have developed our novel REGN-COV2 antibody cocktail in the fight against COVID-19. Last week, we announced another major data set from our outpatient study that showed our antibody cocktail significantly reduced viral loads as well as medically attended visits, such as emergency room visits and hospitalizations. We have submitted these data to regulators and eagerly await guidance on next steps.

再生元公司在傳染病治療領域也取得了重大進展。上個月，FDA批准了Inmazeb，這是第一個用於治療伊波拉病毒感染的藥物。基於我們在伊波拉病毒治療領域的研究成果，我們的團隊利用快速反應技術，開發了新型REGN-COV2抗體雞尾酒療法，用於對抗COVID-19。上週，我們公佈了另一項重要的門診研究數據，結果顯示，我們的抗體雞尾酒療法顯著降低了病毒量，並減少了就診次數，例如急診就診和住院治療。我們已將這些數據提交給監管機構，並熱切期待後續步驟的指導。

In closing, we could not be prouder of our teams and everything they have been able to achieve across the organization in the third quarter and in 2020 to date. Our momentum is accelerating with an impressive growth profile. In 2021, we look forward to building upon that momentum with several important launches for Libtayo, Dupixent and other programs, further enhancing our diverse growth platform. We are excited by the progress we are making against COVID-19, and we are confident that our investments in R&D to broaden and advance our pipeline across all stages will position Regeneron well for sustained growth.

最後，我們為我們的團隊以及他們在第三季和2020年至今在整個公司的成就感到無比自豪。我們正以令人矚目的成長動能加速發展。 2021年，我們期待在此基礎上，透過Libtayo、Dupixent和其他專案的幾項重要上市，進一步增強我們多元化的成長平台。我們對在對抗新冠疫情方面取得的進展感到振奮，並堅信，我們對研發的投入，旨在拓展和推進我們各個階段的產品線，這將使Regeneron在持續增長方面佔據有利地位。

Now I'll turn the call over to George.

現在我把電話交給喬治。

Thanks, Len. And as Len just pointed out, we are advancing programs across all stages of our diverse and growing portfolio.

謝謝，Len。正如Len剛才指出的，我們正在推動涵蓋我們多元化且不斷成長的業務組合中各個階段的專案。

With the pandemic unfortunately still raging and even escalating, we know there's a lot of focus on COVID 19, and we will start with our REGN-COV2 program. From the beginning, there was a lot of attention to our efforts against the coronavirus because of our success using a similar approach with Ebola. As you just heard from Len, we received FDA approval for our Ebola cocktail that our team delivered, validating our approach for not only this, but other deadly infectious diseases and particularly COVID-19. We're investigating REGN-COV2, our antibody cocktail for COVID-19 in infected patients as well as for prevention in several ongoing clinical trials.

鑑於疫情仍在肆虐甚至加劇，我們知道大家的關注點主要集中在新冠病毒上，我們將首先介紹我們的REGN-COV2計畫。從一開始，由於我們先前在伊波拉病毒的治療中成功運用了類似的方法，我們對抗新冠病毒的努力就備受關注。正如您剛才從Len那裡聽到的，我們團隊研發的伊波拉抗體雞尾酒療法已獲得FDA批准，這不僅驗證了我們的方法對伊波拉病毒的有效性，也驗證了該方法對其他致命傳染病，特別是新冠病毒的有效性。我們正在進行多項臨床試驗，研究REGN-COV2（一種用於治療新冠病毒感染患者以及預防新冠病毒感染的抗體雞尾酒療法）的療效。

Earlier this year, we released a descriptive analysis of the first 275 patients in the REGN-COV2 seamless Phase II/III trial in ambulatory patients. Importantly, we obtained insights into the natural history of COVID-19 from these early data. Large numbers of patients normally generate their own antibodies against the virus early on, and this robust endogenous immune response is associated with rapid clearance of the virus and decreased need for medical attention. That's why most patients do so well. However, some patients are slow to mount an immune response and are at higher risk for attended medical visits.

今年早些時候，我們發布了REGN-COV2無縫II/III期臨床試驗中前275名門診患者的描述性分析。重要的是，我們從這些早期數據中獲得了關於COVID-19自然病程的見解。通常情況下，大量患者會在早期產生針對病毒的自身抗體，這種強大的內源性免疫反應與病毒的快速清除和就醫需求的減少有關。這就是為什麼大多數患者預後良好的原因。然而，部分患者免疫反應較慢，因此就醫風險較高。

In line with this observation, our initial analysis show that providing our exogenous antibody cocktail did not provide much benefit to the fast responders, but it benefit those who did not mount their own immune responses efficiently, allowing REGN-COV2 to clear virus more rapidly and decrease the need for future medical attention in these otherwise slow responders.

與此觀察結果一致，我們的初步分析表明，提供我們的外源抗體混合物對快速反應者沒有帶來多少好處，但對那些自身免疫反應不有效的人有益，使 REGN-COV2 能夠更快地清除病毒，並減少這些原本反應較慢的人未來需要醫療護理的情況。

Last week, we provided important updates from this ongoing study in ambulatory COVID-19 patients. In a formal statistical way, we presented prospective validation of our earlier observation in a confirmatory analysis involving more than 500 additional patients. Data showed significant viral load reductions in patients treated with REGN-COV2 compared to placebo. And consistent with earlier data, these results were driven by the patients who had not mounted their own effective immune response at the time of treatment or had high viral loads at baseline. Importantly, results in the combined analysis of the first 799 patients enrolled in the study demonstrated a statistically significant reduction in medically attended visits, including hospitalizations and emergency room visits.

上週，我們發布了這項針對門診新冠肺炎患者的持續研究的重要進展。我們以正式的統計學方法，透過一項納入500多名患者的驗證性分析，對先前的觀察結果進行了前瞻性驗證。數據顯示，與安慰劑組相比，接受REGN-COV2治療的患者病毒量顯著降低。與先前的數據一致，這些結果主要來自那些在治療時自體免疫反應不佳或基線病毒量較高的患者。重要的是，對最初入組的799名患者的綜合分析結果顯示，患者的就診次數（包括住院和急診就診）顯著減少。

This effect was most prominent with patients with high risk factors, high viral loads and those who had not yet mounted their own immune response. We shared these data with the FDA as an update to our EUA submission and await regulatory feedback.

這種效應在具有高危險因子、高病毒量以及尚未產生自體免疫反應的患者中最為顯著。我們已將這些數據作為緊急使用授權申請的更新資訊提交給FDA，並等待監管部門的回饋。

We are investigating the potential benefit of this REGN-COV2 cocktail in different stages of disease in our other ongoing studies, our household contact study, which is testing the cocktail as a prophylactic treatment, and it has enrolled approximately 1,000 patients to date. In hospitalized patients, we have 2 ongoing studies, our study as well as the U.K. RECOVERY Protocol.

我們正在其他正在進行的研究中，探索這種 REGN-COV2 混合療法在不同疾病階段的潛在益處，例如我們的家庭接觸者研究，該研究正在測試這種混合療法作為預防性治療的有效性，迄今為止已招募了約 1000 名患者。在住院病患方面，我們有兩項正在進行的研究，一項是我們自己的研究，另一項是英國的 RECOVERY 計畫。

All Regeneron-sponsored COVID-19 treatment trials are being supervised by the same independent data monitoring committee, which recently recommended that we pause enrollment in 2 cohorts representing the most severe hospitalized patients, while recommending that all our other studies continue as initially designed, including the 2 less severe patient cohorts in our hospitalized patient study. Since the lower of the 2 REGN-COV2 doses demonstrated the activity comparable to the higher dose, suggesting that both doses maximize the benefit of this approach, we intend to investigate even lower doses going forward. If effective, this could allow us to extend the benefit of our cocktail to even more patients.

所有由再生元公司贊助的 COVID-19 治療試驗均由同一獨立數據監察委員會監督。該委員會近期建議我們暫停招募兩組病情最嚴重的住院患者，同時建議所有其他研究按原計劃繼續進行，包括我們住院患者研究中兩組病情較輕的患者。由於兩種 REGN-COV2 劑量中較低劑量的療效與較高劑量相當，顯示兩種劑量均能最大限度地發揮該療法的益處，因此我們計劃進一步研究更低劑量。如果有效，這將使我們能夠讓更多患者受益於我們的聯合療法。

As we await next steps on the regulatory front, we continue to ramp up production for REGN-COV2. Under our U.S. government agreement, we now expect to have 2.4-gram treatment doses ready for approximately 80,000 patients by the end of this month, 200,000 total doses ready by the first week of January and approximately 300,000 total doses ready by the end of January. We continue to increase our in-house production capacity for further doses of REGN-COV2 and are thrilled to be partnering with Roche to substantially expand global capacity of REGN-COV2 as their production comes online early next year.

在等待監管方面的下一步進展的同時，我們正持續提升REGN-COV2的生產能力。根據與美國政府達成的協議，我們預計本月底前將準備好可供約8萬名患者使用的2.4克治療劑量，1月第一周前將準備好總計20萬劑，1月底前將準備好總計約30萬劑。我們正持續提升REGN-COV2的內部產能，並很高興能與羅氏合作，隨著羅氏生產線於明年初投產，我們將大幅提升REGN-COV2的全球產能。

Moving on to Dupixent.

接下來是Dupixent。

We recently announced positive Phase III data in asthma for children ages 6 to 11. In this study, Dupixent reduced severe asthma attacks by up to 65% versus placebo over one year, and Dupixent also rapidly and sustainably improved lung function in these children. We are planning to file these data with regulators early next year. Additionally, in Europe, we received a positive CHMP committee recommendation for Dupixent in atopic dermatitis in children ages 6 to 11. The Dupixent clinical program continues to progress and expand across a wide range of type 2 inflammatory conditions.

我們近期公佈了Dupixent治療6至11歲兒童氣喘的積極III期臨床試驗數據。在該研究中，與安慰劑相比，Dupixent在一年內使嚴重氣喘發作減少了高達65%，且Dupixent還能快速且持續地改善這些兒童的肺功能。我們計劃於明年初向監管機構提交這些數據。此外，在歐洲，人用藥品委員會（CHMP）已對Dupixent治療6至11歲兒童異位性皮膚炎提出了積極的建議。 Dupixent的臨床計畫持續進行，並持續拓展至多種2型發炎性疾病領域。

In September, the FDA granted breakthrough therapy designation for Dupixent in eosinophilic esophagitis based on early Phase III results, which were recently presented at medical meetings. Before the end of the year, we expect to report Phase II data of Dupixent in combination with oral immunotherapy for peanut allergy. Additionally, Phase III studies are ongoing in several additional dermatology and pulmonary indications with readouts expected in 2022 and 2023, and we expect to begin additional Phase III pivotal trials by the end of the year. Putting this all together, Dupixent will soon be pivotal trials for 8 type 2 diseases that are not currently in the label and could address disease in nearly 1 million additional patients in the United States alone.

今年9月，FDA基於近期在醫學會議上發表的早期III期臨床試驗結果，授予Dupixent治療嗜酸性粒細胞性食道炎的突破性療法認定。我們預計在年底前公佈Dupixent合併口服免疫療法治療花生過敏的第二期臨床試驗數據。此外，Dupixent在多個皮膚病和肺部疾病適應症的III期臨床試驗正在進行中，預計將於2022年和2023年公佈結果，併計劃在年底前啟動其他III期關鍵性試驗。綜上所述，Dupixent即將進行針對8種目前未納入適應症的2型疾病的關鍵性試驗，預計僅在美國就可惠及近100萬名患者。

Dupixent is also an important part of our 2-pronged approach against chronic obstructive pulmonary disease, or COPD, along with etokimab, our anti interleukin-33 antibody. Based on achieving a prespecified efficacy milestone in an interim analysis of our first Phase III study in type 2 COPD, we initiated a second Dupixent Phase III study. Data readouts are expected in 2023. We believe that our anti IL-33 antibody could help an additional group of COPD patients beyond those with type 2 disease.

Dupixent 和我們的抗白細胞介素-33 抗體 etokimab 共同構成了我們對抗慢性阻塞性肺病 (COPD) 的雙管齊下療法的重要組成部分。基於我們在首個針對 2 型 COPD 的 III 期臨床試驗中期分析中達到預設的療效里程碑，我們啟動了第二個 Dupixent III 期臨床試驗。預計 2023 年公佈數據。我們相信，我們的抗 IL-33 抗體有望幫助除 2 型 COPD 患者以外的其他 COPD 患者群體。

Based on a proof-of-concept data that has been submitted for publication, we believe that blocking IL-33 could be especially useful in the former smoker COPD patient subset. The pivotal etokimab program, consisting of 2 parallel Phase III studies, will initiate by year-end. We hope that Dupixent and etokimab can provide real benefit for the many desperate patients suffering from COPD.

基於已提交發表的概念驗證數據，我們認為阻斷IL-33可能對先前吸菸的慢性阻塞性肺病（COPD）患者族群尤為有效。關鍵性的etokimab計畫包含兩個平行的III期臨床試驗，將於年底前啟動。我們希望Dupixent和etokimab能真正造福眾多飽受COPD折磨的病人。

Moving on to oncology and first Libtayo. At the European Society for Clinical Oncology, the ESMO meeting in September, we shared results of our first pivotal -- of our pivotal first line non-small cell lung cancer study as well as our locally advanced basal cell carcinoma or BCC study. These data are now filed as supplemental label applications with the regulators with the FDA recently awarding priority review for approval of Libtayo as a monotherapy in a proposed lung cancer indication with an action date of February 28, 2021.

接下來談談腫瘤學和利妥昔單抗（Libtayo）。在9月舉行的歐洲臨床腫瘤學會（ESMO）年會上，我們分享了第一個關鍵性研究的結果—包括第一線非小細胞肺癌研究和局部晚期基底細胞癌（BCC）研究。這些數據現已作為補充標籤申請提交給監管機構，美國食品藥物管理局（FDA）近期已授予利妥昔單抗優先審查資格，擬批准其作為單藥療法用於肺癌適應症，預計審批日期為2021年2月28日。

We also announced that we completed enrollment in the Libtayo chemotherapy combination trial in first line lung cancer with first results from this study available as early as next year. Also, the BCC results presented at ESMO showed that Libtayo has the potential to be the first approved treatment with a clinical benefit in the advanced BCC setting following failure of a hedgehog inhibitor. The FDA granted a priority review for our BCC filing with an action date of March 3, 2021. We continue to make significant progress with Libtayo as a foundation to our oncology strategy.

我們也宣布，Libtayo合併化療第一線治療肺癌的臨床試驗已完成病患招募，研究的首批結果最快將於明年公佈。此外，在ESMO大會上發表的基底細胞癌（BCC）研究結果顯示，Libtayo有望成為首個獲準用於治療晚期BCC且在Hedgehog抑制劑治療失敗後仍能帶來臨床效益的療法。 FDA已授予我們BCC申請優先審查資格，並將於2021年3月3日做出最終決定。我們將繼續以Libtayo為基礎，推動腫瘤治療策略的重大進展。

Moving on to our oncology bispecific efforts. We are in a pivotal program in non-Hodgkin's lymphomas for our CD20xCD3 bispecific odronextamab, also known as REGN1979. We are working towards initiating a pivotal program for REGN5458, our BCMAxCD3 bispecific for relapsed/refractory multiple myeloma. And in solid tumors, dose escalation for REGN4018, our MUC16xCD3 bispecific continues in the first-in-human study in ovarian cancer in which we are observing preliminary evidence of activity.

接下來談談我們在腫瘤雙特異性抗體的研究進展。我們正在進行一項針對非何杰金氏淋巴瘤的關鍵性研究，研究藥物為CD20×CD3雙特異性抗體odronextamab（也稱為REGN1979）。我們正致力於啟動一項針對復發/難治性多發性骨髓瘤的關鍵性研究，研究藥物為BCMA×CD3雙特異性抗體REGN5458。在實體腫瘤方面，我們正在繼續推進MUC16×CD3雙特異性抗體REGN4018的劑量遞增研究，目前已在卵巢癌的首次人體試驗中觀察到初步療效。

We are excited about the encouraging data we are observing in the studies of our CD3 class of bispecifics. However, we believe that our key potential advantage over other approaches is our ability to mix and match these CD3 bispecifics with not only our anti-PD-1, but also with our next class of bispecifics, the novel CD28 or costimulatory bispecifics. Our CD3 bispecifics currently in the clinic are designed to be paired with matching costim bispecifics for targets on a variety of different cancers with the intent to synergistically unleash the power of immuno-oncology more broadly than currently approved treatments.

我們對CD3類雙特異性抗體研究中觀察到的令人鼓舞的數據感到振奮。然而，我們相信，與其他療法相比，我們的關鍵潛在優勢在於能夠將這些CD3雙特異性抗體與我們的抗PD-1抗體以及我們下一代雙特異性抗體——新型CD28或共刺激雙特異性抗體——進行組合使用。我們目前正在臨床試驗中的CD3雙特異性抗體旨在與針對多種不同癌症靶點的匹配共刺激雙特異性抗體聯合使用，以期比目前已獲批准的療法更廣泛地協同釋放免疫腫瘤學的強大力量。

Our first costim bispecific, PSMAxCD28, in combination with Libtayo for prostate cancer is progressing through dose escalation cohorts, and thus far, the therapy is well tolerated. We will soon start trials with 2 novel costims, MUC16xCD28 in combination with either our MUC16xCD3 bispecific or with Libtayo for ovarian cancer. And our EGFRxCD28 in combination with Libtayo for solid tumors, including in lung, head and neck and colorectal cancers.

我們首個用於治療前列腺癌的共刺激雙特異性抗體PSMAxCD28與利妥昔單抗（Libtayo）聯合用藥正在進行劑量遞增隊列研究，迄今為止，該療法耐受性良好。我們即將啟動兩項新型共刺激抗體的臨床試驗：MUC16xCD28與我們的MUC16xCD3雙特異性抗體或利妥昔單抗聯合用於治療卵巢癌；以及EGFRxCD28與利妥昔單抗聯合用於治療實體瘤，包括肺癌、頭頸癌和結直腸癌。

The first member of a third class of tumor-targeting bispecifics, our MET X MET bispecific, has recently completed dose escalation and is currently in the dose expansion phase of the first-in-human trial. Remember, this bispecific targets 2 distinct epitopes on the MET oncogene, causing rapid internalization of this receptor and ablation of its signaling. MET mutations are present in 3% to 4% in MET gene amplifications and about another 3% of non-small cell lung cancers.

作為第三類腫瘤靶向雙特異性抗體的首個成員，我們的MET X MET雙特異性抗體已在近期完成劑量遞增試驗，目前正處於首次人體試驗的劑量擴展階段。此雙特異性抗體可針對MET癌基因上的兩個不同表位，可導致此受體快速內化並阻斷其訊號傳導。 MET基因擴增患者中MET突變的發生率約為3%至4%，非小細胞肺癌患者中MET突變的發生率約為3%。

Across our pipeline, we are pleased with the progress we are making across all stages of our rich oncology portfolio to compete, enhance and extend the power of immuno-oncology to more patients suffering from a wide variety of cancers. Beyond oncology, our pipeline continues to expand. In our C5 program, we will shortly begin dosing healthy volunteers in combination with Alnylam's C5 RNAi inhibitor, cemdisiran.

我們很高興看到，在腫瘤治療領域，我們豐富的產品組合在各個階段都取得了進展，致力於提升免疫腫瘤學的競爭力，並使其惠及更多患有各種癌症的患者。除了腫瘤領域，我們的產品線也不斷拓展。在C5計畫中，我們很快就會開始對健康志願者進行給藥試驗，將Alnylam公司的C5 RNAi抑制劑cemdisiran與C5 RNAi抑制劑合併使用。

The goal of the combination approach is to achieve convenient self-administration with a subcutaneous dosage form in addition to the more complete and durable blockade of the complement activation in patients suffering from paroxysmal nocturnal hematuria and other complement-mediated diseases. This will be the first example of a combination of an antibody with an RNAi against the same target. And we believe that this could be the first in a series innovative antibody RNA combination that could change the treatment paradigm in multiple disease settings.

此聯合療法的目標是在為陣發性睡眠性血尿及其他補體介導疾病患者提供更徹底、更持久的補體激活阻斷的同時，實現便捷的皮下給藥，方便患者自行給藥。這將是首例針對同一標靶的抗體與RNAi聯合應用。我們相信，這可能是未來一系列創新抗體-RNA聯合療法的開端，並有望改變多種疾病的治療模式。

We are also excited about additional collaborative programs with Alnylam, including utilization of their siRNA approach against targets that we have identified through our Regeneron Genetic Center. As Alnylam has just announced, we have initiated dosing in sRNA against one such target, HSD17B13, for the treatment of NASH. Additionally, I want to acknowledge an important milestone for another innovative collaboration we have with Intellia. In the very near term, the first patient should be dosed with the groundbreaking systemically delivered CRISPR/Cas9 gene editing therapy, a potential one-and-done treatment for transthyretin amyloidosis or ATTR.

我們也很高興能與Alnylam進行更多合作項目，包括利用他們的siRNA技術治療我們透過Regeneron基因中心發現的目標。正如Alnylam剛剛宣布的那樣，我們已經啟動了針對其中一個標靶HSD17B13的sRNA給藥試驗，用於治療NASH。此外，我還想提及我們與Intellia的另一項創新合作所取得的重要里程碑。在不久的將來，首位患者將接受突破性的全身性CRISPR/Cas9基因編輯療法，這是一種潛在的針對轉甲狀腺素蛋白澱粉樣變性（ATTR）的一次性治療方案。

As the first systemically administered gene editing intervention, we hope that this will provide proof-of-concept for future systemic gene editing efforts. Alnylam and Intellia collaborations represent an important new strategy for Regeneron as we attempt to broaden our efforts in the future of genetic therapies where we combine our capabilities and expertise to help empower those of our partners and to help change the practice of medicine and make new forms of gene therapy a reality.

作為第一個系統性基因編輯介入措施，我們希望這能為未來的系統性基因編輯研究提供概念驗證。 Alnylam 和 Intellia 的合作代表了 Regeneron 的一項重要新策略，我們致力於拓展未來基因療法領域的工作，結合自身能力和專業知識，賦能合作夥伴，助力變革醫學實踐，使新型基因療法成為現實。

By the end of this year, we and our collaborators will have introduced 8 new investigational therapies into the clinic, an accomplishment we are proud of in a challenging year. To conclude, we are looking forward to several catalysts over the next several months. We expect imminent updates and additional data readouts on our REGN-COV2 therapy, first regulatory approval for evinacumab by February of next year, approval for first line lung cancer and basal cell carcinoma indications for Libtayo, filing for Dupixent in pediatric asthma and many more to come. It is a very exciting time at Regeneron.

到今年年底，我們和我們的合作夥伴將有8種新的在研療法進入臨床試驗階段，在充滿挑戰的一年中取得這樣的成就，我們深感自豪。最後，我們期待未來幾個月內有幾項重要進展。我們預計很快就會公佈REGN-COV2療法的最新進展和更多數據，evinacumab預計將在明年2月獲得首個監管批准，Libtayo有望獲批用於一線治療肺癌和基底細胞癌，Dupixent有望提交用於治療兒童哮喘的申請，未來還有更多進展值得期待。對Regeneron而言，這是一個令人振奮的時刻。

With that, I would like to turn the call over to Marion.

接下來，我想把電話交給瑪莉安。

Thank you, George. Our third quarter commercial results reflect a solid execution across our core brands, EYLEA, Dupixent and Libtayo. We remain confident that the competitive strengths of our growing and diversified commercial portfolio will carry us through and beyond the COVID-19 environment.

謝謝喬治。我們第三季的商業表現反映了其核心品牌安樂死 (EYLEA)、度普利 (Dupixent) 和利必妥 (Libtayo) 的穩健表現。我們仍然堅信，我們不斷成長且多元化的商業組合所蘊含的競爭優勢，將幫助我們渡過新冠疫情難關，並實現長遠發展。

I'm going to begin with EYLEA, which grew 9% year-over-year to approximately $2.1 billion in global net sales. In the U.S., EYLEA grew 11% year-over-year with net sales of more than $1.3 billion as the anti-VEGF demand recovered. In the U.S., EYLEA outperformed the category with shared gains from both branded and unbranded competition. In fact, EYLEA's share of the branded U.S. category grew to more than 70% for the quarter based on volume, and EYLEA remains the #1 prescribed anti-VEGF therapy in wet AMD and diabetic eye disease.

我先來說說愛樂（EYLEA），其全球淨銷售額年增9%，達到約21億美元。在美國，隨著抗VEGF藥物需求的復甦，愛樂的淨銷售額年增11%，超過13億美元。在美國，愛樂的表現優於同類產品，其市佔率與品牌藥和非品牌藥均有成長。事實上，以銷量計算，愛樂在美國品牌藥市場的份額在本季度增長至70%以上，而愛樂仍然是治療濕性老年性黃斑部病變（AMD）和糖尿病眼部疾病的首選抗VEGF藥物。

Patient volume increased as those who delayed treatment earlier this year have returned to retina offices. EYLEA's market-leading clinical profile offering dosing flexibility, real-world experience and established safety led to a quicker recovery and stronger growth across all indications than the competition. EYLEA's flexible 12-week dosing regimen in wet AMD and the newly launched prefilled syringe also support EYLEA's market-leading value proposition. We are monitoring the recent spike in coronavirus cases across the country.

隨著今年稍早因故推遲治療的患者陸續返回視網膜診所就診，患者數量增加。 EYLEA 憑藉其市場領先的臨床優勢，包括靈活的給藥方案、豐富的真實世界經驗和可靠的安全性，在所有適應症領域均實現了比競爭對手更快的復甦和更強勁的增長。 EYLEA 針對濕性老年黃斑部病變 (AMD) 的靈活 12 週給藥方案以及新推出的預充式註射器，也進一步鞏固了 EYLEA 的市場領先價值主張。我們正在密切關注近期全國新冠病毒病例的激增情況。

In some hotspots, retina offices are beginning to see some modest reductions in patient volume, which may impact future EYLEA demand. That said, retina offices have become highly effective in managing their patients in this environment compared to the early days of the pandemic. In summary, EYLEA had an impressive quarter.

在一些疫情熱點地區，視網膜專科診所的患者數量開始出現小幅下降，這可能會影響未來對EYLEA的需求。儘管如此，與疫情初期相比，視網膜專科診所在當前環境下的患者管理方面已顯著提升。總而言之，EYLEA本季業績表現亮眼。

Turning next to Libtayo. Third quarter global net sales grew to $96 million. In the U.S., net sales were $72 million with consistent and steady volume growth aided by the gradual reopening of infusion centers and an increase in breadth of prescribing. Libtayo continues to drive overall market growth in advanced cutaneous squamous cell carcinoma and remains the most prescribed systemic treatment for CSCC. EYLEA remains the anti-PD-1 of choice with nearly 90% market share of the class.

接下來是利妥昔單抗（Libtayo）。第三季全球淨銷售額成長至9,600萬美元。在美國，淨銷售額為7,200萬美元，銷售持續穩定成長，這得益於輸液中心的逐步重新開放和處方範圍的擴大。利妥昔單抗繼續推動晚期皮膚鱗狀細胞癌（CSCC）市場的整體成長，並且仍然是CSCC最常用的全身治療藥物。艾力達（EYLEA）仍是首選的抗PD-1藥物，在該類藥物中佔據近90%的市佔率。

The overall profile of high response rate with many complete and durable responses positions Libtayo for continued growth. To fuel additional growth, we anticipate 2 new potential indication launches in non-small cell lung cancer and basal cell carcinoma in the first quarter of 2021. For basal cell carcinoma, we aim to build upon our success in CSCC and establish Libtayo as the standard of care for non-melanoma skin cancers. We expect Libtayo to be first-in-class and will work to establish it as the standard of care in second line BCC.

Libtayo 整體療效顯著，緩解率高，且許多患者獲得完全且持久的緩解，這為其持續增長奠定了基礎。為了進一步推動成長，我們預計將於 2021 年第一季推出兩項新的潛在適應症：非小細胞肺癌和基底細胞癌。對於基底細胞癌，我們的目標是在皮膚鱗狀細胞癌 (CSCC) 領域取得成功的基礎上，將 Libtayo 確立為非黑色素瘤皮膚癌的標準治療方案。我們期望 Libtayo 成為同類首創藥物，並將致力於將其確立為二線基底細胞癌的標準治療方案。

Non-small cell lung cancer is the largest opportunity within the PD-1 space with more than 200,000 new diagnosis of lung cancer in the U.S. each year. We plan to leverage our oncology presence as the majority of treatment centers and oncologists are familiar with Libtayo in CSCC. We believe that patients, providers and payers prefer choice in determining the most appropriate treatment.

非小細胞肺癌是PD-1標靶治療領域最大的機遇，美國每年新增肺癌病例超過20萬例。我們計劃充分利用我們在腫瘤領域的資源，因為大多數治療中心和腫瘤科醫生都熟悉Libtayo在皮膚鱗狀細胞癌（CSCC）中的應用。我們相信，患者、醫療服務提供者和支付者都希望在選擇最合適的治療方案時擁有更多選擇。

Libtayo demonstrated an overall survival benefit in a real world, higher-risk population of patients, including patients with stable brain metastases, infections and progressive disease. These data, along with an additional product attributes, support Libtayo as a potential new option for anti-PD-1 monotherapy in the treatment paradigm.

在真實世界中，Libtayo 在高風險患者族群（包括腦轉移穩定、感染和疾病進展的患者）中展現出整體生存獲益。這些數據以及其他產品特性支持 Libtayo 成為抗 PD-1 單藥治療領域中潛在的新選擇。

Finally, moving to Dupixent. Global net sales in the second quarter were $1.1 billion, representing 69% growth compared to the prior year.

最後，我們來看看Dupixent。第二季全球淨銷售額為11億美元，較上年同期成長69%。

In the U.S., broad-based growth across all indications contributed net sales of $851 million. Among all specialties, patient visits improved throughout the quarter as the health care field has adapted to treating patients in the COVID environment. Current weekly new patient starts have recovered and are nearing pre-pandemic levels. The 300-milligram pre-filled pen was launched this quarter, providing additional patient convenience and choice. Atopic dermatitis remains Dupixent's largest indication and is a significant growth driver based on its rapid onset, proven efficacy and well-established safety profile.

在美國，所有適應症的全面成長貢獻了8.51億美元的淨銷售額。隨著醫療保健領域適應新冠疫情下的治療模式，本季所有專科的患者就診量均有所改善。目前每週新增患者數量已恢復，接近疫情前水準。本季推出了300毫克預充填注射筆，為患者提供了更多便利和選擇。異位性皮膚炎仍然是Dupixent最大的適應症，並且由於其起效迅速、療效確切且安全性良好，因此是重要的成長驅動因素。

We continue to expand prescribing across both moderate and severe disease. Despite the impressive growth trajectory since launch, a low percentage of biologic eligible patients have been treated, leaving substantial opportunity for more patients to benefit. Our ongoing launches for both adolescents and pediatric patients are progressing very well. Since the May launch of the pediatric indication, we are seeing encouraging trends, comparable to the adolescent launch where initiations grew rapidly and HCPs were quick to prescribe. Significant runway is evident with approximately 400,000 adolescents and 90,000 children in this country that could benefit from Dupixent therapy.

我們持續擴大中重度疾病患者的處方範圍。儘管自上市以來成長勢頭強勁，但符合生物製劑治療條件的患者比例仍然較低，這意味著還有大量患者有機會從中獲益。我們針對青少年和兒童患者的持續上市進展順利。自從5月兒童適應症上市以來，我們看到了令人鼓舞的趨勢，與青少年適應症上市的情況類似，當時啟動治療的患者數量迅速增長，醫護人員也積極開立處方。顯然，市場潛力巨大，美國約有40萬青少年和9萬名兒童可能受益於Dupixent治療。

Moving to asthma, Dupixent continues to perform well in the competitive asthma space based on its clinical efficacy and safety profile. Our national DTC campaign is well underway, and we are seeing an uptick in new initiations. We look forward to submitting our pediatric clinical data to regulators, which could lead to further label expansion and benefit as many as 75,000 eligible children. Additionally, we see strong uptick in chronic rhinosinusitis with nasal polyps.

在氣喘治療領域，Dupixent憑藉其臨床療效和安全性，在競爭激烈的氣喘市場中持續表現出色。我們的全國直接面向消費者（DTC）推廣活動正在順利進行，新病例數也呈現成長趨勢。我們期待向監管機構提交兒科臨床數據，預計將進一步擴大適應症範圍，使多達75,000名符合條件的兒童受益。此外，我們也看到慢性鼻竇炎伴隨鼻息肉的病例數量顯著增加。

Since approval last year, patients have been initiated on Dupixent regardless of prior surgery, while the availability of elective surgeries has improved as healthcare facilities have reopened. Demand for Dupixent remained strong among ENTs and allergists. Dupixent is making an important contribution to our business, and we're excited about the significant opportunity for future growth from our in-line business and from new potential indications, age groups and geographies.

自去年獲準以來，無論患者之前是否接受過手術，都已開始接受Dupixent治療。隨著醫療機構的重新開放，擇期手術的可近性也得到了改善。耳鼻喉科醫生和過敏科醫生對Dupixent的需求仍然強勁。 Dupixent為我們的業務做出了重要貢獻，我們對現有產品線以及潛在新適應症、年齡層和地理市場帶來的巨大未來成長機會感到振奮。

In closing, our commercial teams delivered strong performance across our diversified portfolio. We have a set of meaningfully differentiated products that are growing despite COVID-19. Additionally, we will enter a new phase of launches in 2021, including evinacumab for HOFH, pediatric asthma for Dupixent and lung and BCC for Libtayo. These launches will add to our momentum and the significant growth of our business. These are very exciting times at Regeneron.

總之，我們的商業團隊在多元化的產品組合中取得了強勁的業績。我們擁有一系列具有顯著差異化優勢的產品，這些產品在新冠疫情的影響下仍保持成長。此外，我們將在2021年進入新一輪產品上市階段，包括用於治療HOFH的evinacumab、用於治療兒童氣喘的Dupixent以及用於治療肺癌和基底細胞癌的Libtayo。這些產品的上市將進一步鞏固我們的發展勢頭，並推動業務的顯著成長。對Regeneron而言，這是一個令人振奮的時期。

I'll turn the call to Bob.

我把電話轉給鮑伯。

Thank you, Marion. For the third quarter of 2020, Regeneron delivered strong based growth on both the top and bottom lines, resulting from continued execution across all aspects of our business. Improving Dupixent profitability and contributions from additional revenue sources highlight the continued diversification of our business.

謝謝您，Marion。 2020年第三季度，Regeneron在營收和利潤方面均實現了強勁成長，這得益於我們在業務各個方面持續高效的執行。 Dupixent獲利能力的提升以及其他收入來源的貢獻，凸顯了我們業務多元化的持續推進。

For the third quarter, total revenues grew 32% year-over-year to $2.29 billion, driven by strong U.S. EYLEA growth and higher Sanofi collaboration revenues as a result of increased Dupixent sales and achievement of a $50 million sales milestone. Non-GAAP diluted net income per share grew 25% year-over-year to $8.36 on non-GAAP net income of $961 million. Since Marion discussed our U.S. EYLEA results, I will start with our Bayer and Sanofi collaborations.

第三季度，總營收年增32%至22.9億美元，主要得益於美國安永（EYLEA）業務的強勁成長以及與賽諾菲合作帶來的營收成長，其中Dupixent銷售額的成長和5,000萬美元銷售里程碑的達成尤為顯著。非GAAP攤薄後每股淨收益年增25%至8.36美元，非GAAP淨利為9.61億美元。鑑於Marion已經討論了我們在美國安永的業績，我將首先介紹我們與拜耳和賽諾菲的合作。

Starting with the Bayer collaboration. Ex U.S. EYLEA net product sales reported to us by Bayer were $780 million, representing a growth of 7% on a reported basis, compared to the prior year and a 22% improvement from second quarter 2020 lows. Total Bayer collaboration revenue was $300 million, of which we recorded $288 million for our share of net profits from EYLEA sales outside the U.S. Total Sanofi collaboration revenue was $353 million in the third quarter. Our share of the profits from the commercialization of non-IO antibodies was $213 million. This compares favorably to profits of $94 million in the prior year, which was primarily driven by higher Dupixent profits. We also recognized a $50 million milestone payment from Sanofi as a result of Dupixent, Praluent and Kevzara ex U.S. sales achieving $1 billion in the trailing 12-month period.

首先來看與拜耳的合作。拜耳向我們報告的美國以外地區EYLEA淨產品銷售額為7.8億美元，按報告基準計算，較上年同期增長7%，較2020年第二季度的低點增長22%。拜耳合作總收入為3億美元，其中我們確認了2.88億美元，這是我們應得的美國以外地區EYLEA銷售淨利潤份額。第三季與賽諾菲的合作總收入為3.53億美元。我們從非免疫腫瘤抗體商業化中獲得的利潤份額為2.13億美元。這比去年同期的9,400萬美元利潤有所成長，去年同期獲利成長主要得益於Dupixent獲利的成長。此外，由於Dupixent、Praluent和Kevzara在美國以外地區的銷售額在過去12個月內達到10億美元，我們也確認了來自賽諾菲的5000萬美元里程碑付款。

Next, we announced in July a $450 million supply agreement with the U.S. government for batches of REGN-COV2. We record sales as batches are supplied to the government. In the third quarter of 2020, under this agreement, we recorded an initial $40 million of sales for REGN-COV2. We expect that in the fourth quarter of 2020, we will record sales approximating half of the value of this agreement. Sales for the remaining batches are expected to be recorded in the first quarter of 2021. In other revenue, we recorded $159 million versus $37 million in the prior year. The primary driver of this increase is the recognition of $70 million from the U.S. government associated with reimbursements of our Ebola and REGN-COV2 development recognition of $28 million in connection with the Regeneron Genetic Center sequencing a certain number of exomes as well as a reimbursement for ex U.S. supply of Praluent to Sanofi.

接下來，我們在7月宣布與美國政府達成價值4.5億美元的REGN-COV2供應協議。我們會在向政府交付批次產品時確認銷售額。根據該協議，我們在2020年第三季確認了REGN-COV2的初始銷售額4000萬美元。我們預計，在2020年第四季度，我們將確認約佔該協議金額一半的銷售額。剩餘批次的銷售額預計將在2021年第一季確認。在其他收入方面，我們確認了1.59億美元，而上年同期為3700萬美元。這一增長的主要原因是確認了來自美國政府的7000萬美元，其中包括我們埃博拉病毒研發的報銷款項；確認了與Regeneron基因中心對一定數量的外顯子組進行測序相關的2800萬美元；以及向賽諾菲提供的Praluent美國境外供應的報銷款項。

Looking ahead to fourth quarter and 2021, we expect the other revenue line to trend lower in the absence of an RGC milestone and reduced reimbursements from the U.S. government on Ebola.

展望第四季和 2021 年，我們預計由於 RGC 里程碑的缺失以及美國政府對伊波拉疫情的報銷減少，其他收入線將呈下降趨勢。

Moving to our expense base and starting with R&D. Non-GAAP R&D increased 35% year-over-year to $629 million, driven by significant clinical development costs for our REGN-COV2 antibody cocktail, higher headcount to support our expanding pipeline, increased clinical manufacturing activities and continued advancement of our partner programs with Alnylam, Intellia and other early-stage partners.

接下來我們來看費用組成，首先是研發。非GAAP研發支出年增35%至6.29億美元，主要原因是REGN-COV2抗體雞尾酒療法的重大臨床開發成本、為支持不斷擴大的產品線而增加的員工人數、增加的臨床生產活動以及與Alnylam、Intellia和其他早期合作夥伴的合作項目的持續推進。

Next, non-GAAP SG&A expense increased 10% year-over-year to $291 million. The year-over-year increase was largely driven by increased headcount as well as commercial costs for EYLEA and Praluent. Cost of collaboration and contract manufacturing was $143 million, compared to $110 million in the third quarter of 2019, primarily due to increased sales of Dupixent. Non-GAAP cost of goods increased 22% from the prior year related to higher sales of Libtayo and the inclusion of sales from Praluent and REGN-COV2.

其次，非GAAP銷售、管理及行政費用年增10%至2.91億美元。年成長主要受員工人數增加以及EYLEA和Praluent的商業成本所推動。合作及合約生產成本為1.43億美元，而2019年第三季為1.1億美元，主要原因是Dupixent的銷售額成長。非GAAP商品成本較上年同期成長22%，主要原因是Libtayo的銷售額成長以及Praluent和REGN-COV2銷售額的計入。

Turning now to taxes. The non-GAAP effective tax rate was 16.3% in the third quarter of 2020, compared to 13.6% in the third quarter of 2019, primarily due to discrete items to the quarters. Shifting now to cash flow and the balance sheet. Regeneron continues to maintain a strong balance sheet, ending the quarter with cash and marketable securities of $5.9 billion.

接下來談談稅務方面。 2020年第三季非GAAP實際稅率為16.3%，而2019年第三季為13.6%，主要是由於各季度存在一些特殊項目。接下來談談現金流和資產負債表。 Regeneron持續維持穩健的資產負債表，季末現金及有價證券總額為59億美元。

Our third quarter free cash flow was negatively impacted by the extension of EYLEA payment terms to support physician offices during COVID. We expect this will reverse in 2021 as payment terms return to normal. Additionally, in the quarter, we issued $2 billion of long-term debt, leveraging historically low interest rates while decreasing our cost of capital. With the issuance of this debt, we expect to incur approximately $45 million of incremental interest expense on an annual basis. Finally, we repurchased $100 million of stock in the third quarter as part of our $1 billion Board-authorized share buyback program.

由於為支持醫師診所應對新冠疫情，我們延長了安永（EYLEA）的付款期限，導致第三季自由現金流受到負面影響。我們預計，隨著付款期限恢復正常，這種情況將在2021年得到改善。此外，本季我們發行了20億美元的長期債務，並利用了歷史低利率，同時降低了我們的資本成本。發行這筆債務後，我們預計每年將新增約4,500萬美元的利息支出。最後，作為董事會批准的10億美元股票回購計畫的一部分，我們在第三季回購了1億美元的股票。

Now I'd like to spend a few moments to provide updates to our full year 2020 guidance. We updated our guidance on several expense line items where, in many cases, we either lowered or narrowed guidance range. Please refer to our press release for our entire updated 2020 guidance. Specific to R&D. We are revising upward our forecasted 2020 non-GAAP R&D expense to be in the range of $2.42 billion to $2.47 billion.

現在我想花幾分鐘時間更新我們2020年全年業績預期。我們更新了多項費用項目的預期，其中許多項目的預期範圍有所下調或縮小。請參閱我們的新聞稿，以了解完整的2020年業績預期更新。關於研發方面，我們將2020年非GAAP研發費用預期上調至24.2億美元至24.7億美元之間。

While we increased R&D guidance on our second call to reflect REGN-COV2 expenses, we have since substantially expanded the scope and enrollment targets across the REGN-COV2 clinical program, which will result in increased expenses in the fourth quarter and into first half 2021. Also, while we are not providing 2021 guidance today, we do expect that 2021 full year R&D expenses will increase to fund an advancing and expanding pipeline as well as early stage partnership assets.

儘管我們在第二次電話會議上提高了研發預期以反映REGN-COV2項目的費用，但此後我們大幅擴大了REGN-COV2臨床項目的範圍和入組目標，這將導致第四季度和2021年上半年的研發費用增加。此外，雖然我們今天不提供2021年的業績指引，但我們預計2021年全年的研發費用將會增加，以資助不斷推進和擴展的研發管線以及早期合作項目。

In conclusion, Regeneron's business remains healthy, and we continued to deliver strong year-over-year growth as we diversify our revenue and earnings and advance our robust pipeline. We remain well positioned for future growth with healthy core brands and multiple near-term launches while investing in our R&D engine to drive longer-term growth.

總而言之，Regeneron的業務依然穩健，隨著營收和獲利來源多元化以及強大的產品線推進，我們持續實現了強勁的年成長。憑藉健康的核心品牌和即將推出的多款新產品，我們已為未來的成長做好了充分準備，同時我們也在加大研發投入，以推動長期成長。

With that, I'd like to turn the call back to Justin.

那麼，我想把電話轉回給賈斯汀。

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

謝謝鮑勃。黛博拉，我們的發言到此結束。現在進入問答環節。目前有二十多位聽眾在排隊等候。為了確保我們能夠回答盡可能多的問題，我們將採取每人一個問題後再進行下一個問題的順序。黛博拉，請開始吧。

(Operator Instructions) And we'll go with our first question. We've got Carter Gould with Barclays.

（操作員說明）我們先來問第一個問題。我們請到了巴克萊銀行的卡特·古爾德。

I guess for George and Len, clearly, a lot of enthusiasm around the potential for the costims as we look to some of those readouts. I guess when we look to 2021, are we going to have a clear signal if these are living up to their promise in 2021? I know moving through some of these dose escalations takes time, but do you guys have confidence we'll be in a position to have a clear read on if they're living up to their hype next year?

我想，對於喬治和倫來說，顯然他們對聯合免疫療法的潛力充滿熱情，尤其是在我們期待一些試驗結果公佈的時候。我想，展望2021年，我們能否得到一個明確的訊號，判斷這些療法是否真的像他們承諾的那樣有效？我知道劑量遞增需要時間，但你們是否有信心，明年我們就能清楚了解這些療法是否真的像宣傳的那樣有效？

Well, it all depends on, as you said, these dose escalation studies, how they progress and proceed, we certainly hope that we will be getting signals of efficacy sooner rather than later, but it all depends on the clinical development and how that all goes. But we remain incredibly enthusiastic and excited about this class, and we're investing enormously. As I said, we have pairs of CD3 and CD28 bispecifics for numerous different cancers, not only the ones that are already in the clinic, but ones that will be entering into the pipeline over the next year or 2 or 3. So we're very excited about this class and the potential of combining them with the 2 sets of bispecifics as well as with the PD-1.

正如您所說，這一切都取決於這些劑量遞增研究的進展。我們當然希望能夠盡快看到療效訊號，但這最終取決於臨床開發的結果。不過，我們對這類藥物仍然充滿熱情和期待，並投入了大量資金。如我所說，我們針對多種癌症開發了CD3和CD28雙特異性抗體，不僅包括已經進入臨床試驗的藥物，還包括未來一兩年即將進入研發管線的藥物。因此，我們對這類藥物以及將其與兩組雙特異性抗體和PD-1聯合使用的潛力感到非常興奮。

Next question please.

下一個問題。

And your next question comes from Chris Raymond with Piper Sandler.

下一個問題來自克里斯·雷蒙德和派珀·桑德勒。

Just on REGN-COV2. Just wondering if you could walk through the biology behind why there would be a safety signal in these vented or high-flow oxygenated patients. I mean, I guess, especially given how clean it looked in mild-to-moderate cases, is there some threshold of viral load? Or is it underlying overactivation of the immune system that's driving this problem? And can you maybe describe the ADEs, please?

關於 REGN-COV2，我想請教一下，您能否解釋為什麼這些使用呼吸器或高流量吸氧的患者會出現安全訊號？我的意思是，考慮到輕度至中度病例的病毒量看起來都很低，是否存在病毒量閾值？或者說，是免疫系統過度活化導致了這個問題？您能否也描述一下不良反應（ADE）？

So first of all, we should point out that we remain blinded to what's going on in those 2 cohorts that were paused. They weren't halted, they were paused so that the IDMC could evaluate the ongoing patients and then decide what to do going forward. We do not know whether there really is any safety signal. And as you said, I think theoretically, there is not really a great deal of rationale why there might be a safety signal there. You could come up with all sorts of complicated scenarios to explain it. But until we're unblinded to the data, until we really get to look at it, at this point, it could simply be that there's lack of efficacy or maybe even early trends which will reverse. So as you said, theoretically, it does not make a great deal of sense. I think the whole concept of what they call ADE or antibody-dependent enhancement, is something that does not look like it's really playing a role in this disease. So we remain hopeful that there is not going to be a safety signal and eventually, at least in some subset of these patients, even the hospitalized patients that we may provide a benefit.

首先，我們需要指出，我們目前仍不清楚那兩個暫停的隊列的具體情況。它們並非完全停止，而是暫停，以便獨立資料監察委員會（IDMC）評估正在進行的患者，並決定下一步的治療方案。我們尚不清楚是否存在任何安全信號。正如您所說，我認為從理論上講，並沒有太多合理的理由來解釋為什麼會出現安全訊號。您可以提出各種複雜的假設來解釋它。但在我們揭盲之前，在我們真正能夠查看數據之前，目前來看，這可能只是療效不足，或者只是早期趨勢，而這些趨勢最終會逆轉。所以正如您所說，從理論上講，這並沒有太大的意義。我認為他們所說的抗體依賴性增強（ADE）的概念，似乎與這種疾病並沒有真正產生任何影響。因此，我們仍然希望不會出現安全訊號，最終，至少在某些患者群體中，甚至是住院患者，我們或許能夠從中受益。

Your next question comes from Evan Seigerman with Crédit Suisse.

下一個問題來自瑞士信貸的埃文·塞格曼。

I'll limit it to one. So in the 10-Q, you listed the EUA for the AB cocktail during this quarter. Is this official guidance from the FDA? And any idea as to what patient population that this EUA would be granted for?

我只問一個問題。在10-Q報告中，你們列出了本季AB雞尾酒療法的緊急使用授權（EUA）。這是FDA的官方指導嗎？你們知道這項緊急使用授權將適用於哪些病患群體嗎？

So it's Len. We have said that we are focusing on the patient population where the data comes from, which is outpatients who have the best baseline characteristics, which would make us think that they would benefit the most, whether that's risk factors or high viral titer or eventually perhaps low antibodies. Those are the sorts of patients we are focused on as an outpatient. There is no PDUFA time line for the EUA. We expect action in the relative near future, but there's no guarantee that will come. The FDA is doing a very careful analysis. We can tell from the kinds of questions we're getting. And we hope that it will be -- reach a successful conclusion. But we don't know the time line because there are no specific time lines. We do know they're working just about as hard as we can imagine and have seen the FDA work. So we're hopeful soon, we'll get an answer.

所以，我是Len。我們之前說過，我們專注於資料來源的患者群體，也就是那些基線特徵最佳的門診患者，我們認為他們最有可能從中獲益，無論這些特徵是風險因素、病毒滴度高，還是最終抗體水平低。這些就是我們身為門診病患關注的重點。目前還沒有針對緊急使用授權（EUA）的處方藥使用者付費法案（PDUFA）時間表。我們預計在不久的將來會有所行動，但並不能保證一定會有結果。 FDA正在進行非常謹慎的分析。從我們收到的問題類型就能看出這一點。我們希望最終能夠取得成功。但我們不知道具體時間表，因為目前還沒有具體的時間表。我們知道他們正在盡最大努力，我們也親眼目睹了FDA的工作。所以我們希望很快就能得到答案。

Your next question comes from Yatin Suneja with Guggenheim Partners.

下一個問題來自古根漢合夥公司的亞廷·蘇內賈。

Question is on EYLEA. Obviously, a very solid quarter. Can you maybe just give us some sense on the relative contribution from AMD versus other indication? How the market share is evolving in DME? What level of penetration you have achieved? And then obviously, COVID is spiking in the Q4...

問題是關於愛立信的。顯然，這是一個非常穩健的季度。您能否簡單介紹一下AMD與其他適應症的相對貢獻？ DME的市佔率變化如何？市場滲透率達到了什麼水準？另外，很明顯，新冠疫情在第四季出現了高峰…

Well, you have to ask one question. So far you're up to 3. Marion can handle the first one.

好吧，你只需要問一個問題。目前你已經問了三個。瑪莉安可以應付第一個問題。

I'll do -- I will do my best. And first, let me comment that in the times of pandemic, there probably was more of an impact on patients with diabetic eye disease not either receiving a diagnosis or coming in for treatment, but were starting to see recovery in that. I'm pleased to report that on the split of use of EYLEA by indication, we are approaching 60% for wet AMD, which means over 40% of our business is coming from other indications inclusive of the diabetic eye disease. So on balance, we continue to see diabetic eye disease as our largest future opportunity going forward, but we are the market-leading anti-VEGF therapy across all indications.

我會盡力而為。首先，我想說明的是，在疫情期間，糖尿病眼疾患者受到的影響可能更大，他們要么未能得到診斷，要么未能前來就診，但這種情況已經開始好轉。我很高興地報告，就EYLEA的適應症而言，我們用於治療濕性老年黃斑部病變（AMD）的藥物佔比已接近60%，這意味著我們超過40%的業務來自包括糖尿病眼病在內的其他適應症。因此，總的來說，我們仍然認為糖尿病眼疾是我們未來最大的發展機遇，但我們在所有適應症中都是市場領先的抗VEGF療法。

Your next question comes from Yaron Werber with Cowen.

下一個問題來自 Cowen 公司的 Yaron Werber。

Just a quick follow-up on the REGN-COV2. The ongoing studies, George, are still across all patients, not just seronegatives. You clearly saw activity in seronegatives. Lilly sort of, obviously, both with their single and combo, really didn't see the same data. So any explanation to that? And why are you still sort of doing studies across all patients?

關於REGN-COV2，我有個後續問題。 George，目前的研究仍然涵蓋所有患者，而不僅僅是血清陰性患者。你顯然在血清陰性患者中也觀察到了療效。禮來公司，無論是單藥還是聯合用藥，顯然都沒有觀察到同樣的效果。對此有什麼解釋嗎？為什麼你們還在繼續進行涵蓋所有患者的研究？

Yes. I'm not sure what you mean by Lilly didn't see the same thing. They didn't actually look for where their effect was. And right now, the way the program works is, we are not having any evidence of any untoward effect and maybe just a very small benefit in the seropositive patients who have their own antibodies. I think that if one could actually do point-of-care testing, which is unfortunately, at this moment, not immediately available in most cases. Once the drug might be available, let's say, under an EUA, you might want to limit it to patients based on those characteristics. However, because the benefit/risk does not have any evidence of negative untoward effects in those individuals, one could just treat the entire population, even though the benefit is mostly driven by those who, as we described, are seronegative, have higher viral loads and/or have high risk factors.

是的。我不確定您說的禮來公司沒有發現同樣的情況是什麼意思。他們其實並沒有去探究藥物的作用機轉。就目前而言，該計畫的運作方式是，我們沒有發現任何不良反應的證據，可能只有血清陽性且自身存在抗體的患者能從中獲得非常小的益處。我認為，如果能夠進行即時檢測（可惜的是，目前在大多數情況下，這種檢測還無法立即實現），那麼一旦該藥物獲准上市，例如透過緊急使用授權（EUA），或許應該根據這些特徵來限制其使用範圍。然而，由於這些人群的獲益/風險比沒有證據表明存在任何不良反應，因此可以對所有人群進行治療，即使獲益主要來自我們之前提到的那些血清陰性、病毒載量較高和/或具有高風險因素的人群。

Yes. Just -- so just to amplifying on what George said, Yaron, and he said it, I just think it's worth repeating that we did see an effect in the overall population. It's just, as he said, that effect was driven by the people who needed the antibody and that they hadn't mounted their own immune response. That observation, which is something that the team predicted, which is that people who mounted their own immune response wouldn't benefit so much from giving them more of an antibody makes perfect sense. And those that hadn't mounted their own immune response would benefit much more also makes perfect sense, and that is exactly what they saw. And you even see it in the placebo-treated patients that if you don't have antibodies, you start with a very high viral load. If you do have antibodies, you're already 3 logs lower. So all of the biology that George and the team predicted and described was borne out in a very exciting way. So I think it's just a matter of where you see the effect being driven by, not whether or not you can treat an entire population.

是的。亞倫，我只是想補充喬治剛才說的，他確實提到了，我覺得有必要重申一下，我們確實在整體人群中觀察到了效果。正如他所說，這種效果主要來自那些需要抗體且自體免疫反應尚未建立的人群。團隊先前預測，那些自體免疫反應已經建立的人群從更多抗體中獲益不大，而那些自身免疫反應尚未建立的人群獲益更大，這完全符合預期。而且，我們觀察到的情況也正是如此。即使在安慰劑組的患者中也能看到，如果沒有抗體，病毒量會非常高；而如果有抗體，病毒量已經降低了三個數量級。所以，喬治和他的團隊預測和描述的所有生物學現像都以一種令人振奮的方式得到了證實。因此，我認為關鍵在於觀察哪些人群的益處，而不是能否治療整個人群。

And I'm sure, by the way, if Lilly did the same detailed analysis, they would see that their benefit would also be driven by the same sets of patients. They just didn't do those analyses.

順便說一句，我確信，如果禮來公司也進行同樣的詳細分析，他們也會發現他們的益處同樣來自同一群病人。他們只是沒有進行這些分析而已。

Next question please.

下一個問題。

Next question comes from Geoffrey Porges with SVB Leerink.

下一個問題來自SVB Leerink的Geoffrey Porges。

Just a follow-up question on COV2. I'm just not sure how this is going to work. We can't even execute testing in this country reliably. So how are you going to screen the individuals who aren't mounting an immune response on an outpatient basis and then initiate treatment on an outpatient basis? It's just confusing. So help us understand that. And would it be sensible to treat everybody going to hospital for elective procedures of any kind or something else along those lines? It's just a little confusing how you're going to use this medicine.

關於新冠病毒，我還有一個後續問題。我不太確定這套方案具體該如何實施。我們國家連可靠的檢測都做不好。那麼，你們打算如何篩檢那些沒有產生免疫反應的門診患者，然後再進行門診治療呢？這太讓人困惑了。請你們解釋一下。另外，對所有因擇期手術或其他類似原因入院的患者進行治療是否合理？這種藥物的使用方式讓我有點摸不著頭腦。

Right. I think what -- as we just said, and as Len amplified on, the effect is seen in the overall population. It's just driven by those individuals who have the characteristics that we described. The notion is that just as in the clinical studies, it could be given to all of the eligible outpatients because there is no risk to be -- to the individuals who won't benefit the most. So I think that -- the strategy, of course, I think, would be taken would be to limit the drug right now without doing any of the advanced screening and so forth. But to the people who are at the highest risk of progressing to needing medical attention, give it to those people, irregardless if you don't have the point-of-care testing, irregardless of their baseline viral load or their antibody status. In the future, if such testing became available, then you might not want to waste the drug on the people who might not benefit. But initially, I think it would be given to the people who are at the highest risk of developing complications with the goal of preventing those. As we showed in the study, you will reduce dramatically the need for further medical attention. If you give it to individuals and the higher risk the population that you give it to, the NMT goes down. But the only reason really to limit it at this point is because there's going to be limitations for the amount of doses available to treat.

沒錯。我認為——正如我們剛才所說，也正如Len補充的，這種效果在整體人群中都能看到。只是它主要由那些具有我們所描述的特徵的個體所驅動。就像臨床研究一樣，這種藥物可以用於所有符合條件的門診患者，因為不會為那些無法從中獲益最多的人帶來風險。所以我認為——當然，我認為目前的策略是限制藥物的使用，暫不進行任何高級篩檢等等。但對於那些病情發展到需要就醫風險最高的人群，無論是否具備即時檢測能力，無論他們的基線病毒載量或抗體狀態如何，都應該給他們用藥。未來，如果這類檢測普及，那麼可能就不想把藥物浪費在那些可能無法獲益的人身上。但最初，我認為應該優先給那些併發症風險最高的人群用藥，以預防併發症的發生。正如我們在研究中所展示的，這將顯著降低患者後續就醫的需求。如果給患者使用，尤其是高風險族群，神經肌肉疾病發生率（NMT）會降低。但目前限制使用的唯一真正原因是，可用於治療的劑量有限。

Yes. Let me just also add to that, Geoff, 2 things. First of all, as -- I think George pointed out in his presentation when we first disclosed this data. There's a very high correlation between the baseline viral load and whether or not you have antibodies. It's -- on average, you're 3 logs higher if you don't have antibodies and viral load. So you could use viral load. And everybody who's going to get treated has a viral load test. They have a PCR test. It's reported as -- back as positive, but there's actual cycle time. So I think the testing of reporting -- a testing doesn't necessarily have to change, perhaps the reporting has to change in terms of what your cycle time is. A very low cycle time, meaning very high viral load predicts low or no antibodies. So that could be used, as George said, to screen patients.

是的。傑夫，我再補充兩點。首先，正如喬治在我們首次公佈這些數據時在他的演講中指出的那樣，基線病毒量與是否存在抗體之間存在非常高的相關性。平均而言，如果沒有抗體，病毒量會高出3個數量級。因此，我們可以利用病毒量。所有接受治療的患者都會進行病毒量檢測，也就是PCR檢測。檢測結果報告為陽性，但實際上存在一個週期時間。所以我認為檢測報告的方式——檢測本身不一定需要改變，或許需要改變的是報告方式，也就是周期時間的設定。非常短的周期時間，意味著非常高的病毒量，預示著抗體水平低或沒有抗體。正如喬治所說，這可以用來篩檢患者。

The second thing is our partner, Roche, is really one -- probably is the leading company for testing. They have a platform for antibodies that can test hundreds of millions of people per quarter, and it's deployed in, I think, like 70,000 different points of care. So we're working with them to see whether that test can be validated with our dataset or not. So I think there are lots of ways to get at this. You could use -- you can treat everybody, obviously, limiting to the people who have risk factors or you could start to narrow it down to people who have high viral load, low cycle time or eventually with our partners' capabilities, people who at point-of-care have no antibodies. So I think there's a lot of flexibility. It's just that we don't have all this buttoned down in this emergency situation. And it will probably evolve fairly quickly if we get an EUA.

第二點是，我們的合作夥伴羅氏公司是檢測領域的領導者之一，甚至可以說是領先的。他們擁有一個抗體檢測平台，每個季度可以檢測數億人，而且據我所知，該平台已部署在約7萬個不同的醫療點。因此，我們正在與他們合作，看看能否用我們的資料集驗證該檢測方法的有效性。我認為有很多方法可以解決這個問題。你可以——顯然，你可以治療所有人，但僅限於那些有風險因素的人；或者你可以開始縮小範圍，只針對病毒載量高、週期短的人，或者最終借助我們合作夥伴的能力，針對那些在醫療點檢測不到抗體的人。所以我認為有很多靈活的方案。只是在這種緊急情況下，我們還沒有完全確定所有方案。如果我們獲得緊急使用授權（EUA），情況可能會很快改變。

But just to simplify, initially, we believe it will be used in the overall population based on risk factors without regard to serology or viral load. And as Len said, eventually, as these approaches evolve and change, it may allow targeting of the drug to those who might even benefit the most.

但簡單來說，我們認為初期會根據風險因素在整體人群中使用，而不考慮血清學或病毒量。正如Len所說，最終，隨著這些方法的不斷發展和變化，或許能夠將藥物精準用於那些最有可能從中獲益的人群。

Next question please.

下一個問題。

Your next question comes from Cory Kasimov with JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

I have plenty more on COV2, but given the number we've already had there, I'll change the subject. I want to ask Bob about the R&D spend and really thinking about trends going forward. So in terms of the investment you're making on the antibody cocktail, how long do you expect this to kind of persist for? And just kind of overall, wondering if you can give us any sneak peek into 2021?

關於新冠病毒，我還有很多問題想問，但鑑於我們已經討論得夠多了，我就換個話題吧。我想問鮑伯關於研發投入以及未來的發展趨勢。就你們在抗體雞尾酒療法上的投資而言，你們預計這種投入會持續多久？另外，能否給我們透露2021年的計畫？

Sure. Thanks, Cory. Let me see if I can give you a little bit of color. So as I said in our prepared remarks, we're not going to provide 2021 R&D guidance today. We do expect that next year's R&D expenses will be higher to support pretty much everything that George said with regards to the expanding pipeline, early stage assets, the partnerships with Alnylam and Intellia, which are really starting to blossom and certainly our ongoing COVID-19 efforts.

當然。謝謝，科里。我來補充一些細節給你。正如我在事先準備好的演講稿中所說，我們今天不會提供2021年的研發指引。我們預計明年的研發支出將會更高，這主要是為了支持喬治提到的所有方面，包括不斷擴大的產品線、早期階段的資產、與Alnylam和Intellia的合作（這些合作正在蓬勃發展），以及我們持續進行的應對新冠疫情的工作。

If you look at 2020, where we sit right now, we anticipate spend of approximately $400 million on our efforts against COVID-19 within the year of 2020. So if you back that spend out from our full year 2020 non-GAAP R&D guidance midpoint, our underlying growth rate in R&D spend, excluding the COVID program efforts, is trending about 15% higher than our 2019 as our -- as we move forward. So Cory, I would use that kind of as a stake in the ground in terms of where we're going to go. I mean, certainly, our COVID-19 spending is going to continue on. People can see on clinicaltrials.gov the extent of the programs that we have, trials that we have going, that will play a factor into 2021.

展望2020年，就我們目前的狀況而言，我們預計2020年全年用於對抗新冠疫情的支出約為4億美元。因此，如果我們從2020年全年非GAAP研發支出指引的中點值中減去這筆支出，那麼我們研發支出（不包括新冠疫情相關項目）的潛在成長率將比2019年高出約15%。所以，科里，我會把這當作我們未來發展方向的一個基準。當然，我們用於對抗新冠疫情的支出將會持續下去。大家可以在clinicaltrials.gov網站上看到我們正在進行的項目和試驗的規模，這些都將對2021年產生影響。

Next question please.

下一個問題。

Your next question comes from Robyn Karnauskas with Truist.

下一個問題來自 Truist 的 Robyn Karnauskas。

Another one on COV2. So just because it seems like this pandemic is just getting much worse in the United States and globally, can you talk about your efforts to expand manufacturing next year beyond the 300,000? And then I was just curious, given how profile it was that the President and others got a different combination therapies, can you biologically talk about your thoughts on should this drug be combined with Dex or other drugs immediately upfront biologically? And when would you just start like maybe a combo trial that would sort of evaluate that, sort of really make sure that this is a cure rather than just reducing the viral load and reducing time to recover in some patients?

關於新冠病毒（COVID-19）的另一個問題。鑑於這場疫情在美國乃至全球似乎都在急劇惡化，您能否談談明年擴大產能、突破30萬株的計畫？另外，考慮到總統和其他一些人接受了不同的聯合療法，我很好奇，您能否從生物學的角度談談您認為這種藥物是否應該立即與地塞米鬆或其他藥物聯合使用？您何時會啟動一項聯合用藥試驗來評估這種療法，確保它能夠真正治癒新冠病毒，而不僅僅是降低病毒量和縮短部分患者的康復時間？

Right. George can -- sorry, I was going to say, George can deal with that. I was going to just deal quickly with the manufacturing question, which is we are scaling up and we expect to be able to make substantially more next year than we were able to make this year. Obviously, we'll have a full year of manufacturing, which we didn't -- we did not have a full year of manufacturing to deliver the 300,000 doses. And we expect to have more facilities that are now operational and dedicated, plus we expect to multiply that with our partner, Roche, who really has been a terrific partner so far. And they, as you know -- because we see their might because we compete with them in many fronts, they're really sophisticated in the biologics space with their Genentech history and their manufacturing capacity. And they're working very hard to bring online very enhanced and large manufacturing capacity. I'll let George deal with the question about combination therapy.

好的。喬治可以——抱歉，我本來想說，喬治可以處理這個問題。我只想快速談談生產方面的問題，那就是我們正在擴大生產規模，預計明年的產量將比今年大幅成長。顯然，我們將擁有一整年的生產能力，而今年我們沒有足夠的生產能力來完成30萬劑的交付。我們預計會有更多設施投入營運並投入使用，此外，我們也希望與合作夥伴羅氏公司共同擴大產能。到目前為止，羅氏一直是一位非常優秀的合作夥伴。正如您所知——因為我們在很多方面都與他們競爭，所以我們看到了他們的實力。憑藉基因泰克的歷史和強大的生產能力，他們在生物製劑領域非常成熟。他們正在努力提升和擴大生產能力。關於聯合療法的問題，就讓喬治來回答。

Yes. I think the most important thing to note is because the mechanism of action, our treatment is just an antibody that is essentially analogous to the endogenous antibodies that many of the individuals are making. As I described, we're just providing it to those people who are either slow or failing to make their own antibodies. There's no expectation and no mechanistic rationale for any safety interactions of concern. There should not be any reason why you couldn't mix this with essentially any drug that doesn't have untoward side effects because all we're doing is giving you more of the antibodies that your body normally makes. So that said, you could theoretically combine our treatment with any other treatment without any reason to believe that there would be negative interactions. I remind you that right now, where our data stands and where we are -- we have filed for the EUA is in the outpatient setting, where these other modalities are not being given at this point. So it's going to take future studies plus analyses in the hospitalized patients where you look at patients who had combination therapies to determine whether patients who have these combinations do better than patients who just receive one or the other therapy alone. But in the outpatient setting, right now with our data, it will be our antibody because those are not patients where remdesivir or dexamethasone is currently a standard of care.

是的。我認為最重要的是，由於我們療法的作用機制，它實際上是一種抗體，與許多人自身產生的內源性抗體基本上相似。正如我之前解釋的，我們只是為那些自身抗體生成緩慢或無法生成抗體的人提供這種抗體。目前沒有任何預期或機制上的合理性表明存在任何需要關注的安全交互作用。理論上，您可以將我們的療法與任何其他無不良副作用的藥物合併使用，因為我們所做的只是為您提供更多人體自身產生的抗體。也就是說，理論上您可以將我們的療法與任何其他療法合併使用，而無需擔心會產生任何不良交互作用。我提醒您，目前，我們掌握的數據以及我們申請緊急使用授權（EUA）的情況都僅限於門診治療，而其他療法目前尚未應用於門診。因此，我們需要對住院患者進行進一步的研究和分析，觀察接受聯合療法的患者，以確定聯合療法是否優於僅接受單一療法的患者。但在門診患者中，根據我們目前的數據，抗體療法可能更有效，因為瑞德西韋或地塞米松目前並非門診患者的標準治療方案。

Next question please. Next question.

下一個問題。下一個問題。

Alethia Young with Cantor.

阿萊西亞·楊與坎托爾。

I just want you guys to talk a little bit about the potential growth opportunity you see there. Obviously, you've had incredible launch so far, but you've gone deeper into commercial marketing and DTC. And I just kind of want to think about how do you drive deeper penetration into biologics, both -- biologic market, both in ADN and also -- sorry, asthma?

我想請你們談談你們認為的潛在成長機會。顯然，你們目前的上市成績非常出色，但你們也深入開展了商業行銷和直接面向消費者（DTC）的行銷。我想思考的是，你們如何更深入地滲透到生物製劑市場，包括ADN和——抱歉，還有氣喘？

Certainly, I'm happy to comment. And today, certainly, we reported, as did Sanofi, very strong results for Dupixent, both in the U.S. and ex U.S. markets. The really important thing to keep in mind is while we've made certainly inroads in helping atopic dermatitis patients and patients with respiratory conditions of asthma and nasal polyps, there is still are -- in all of those indications that are currently approved, not to mention the future indications, a lot of incremental unmet need.

當然，我很樂意發表評論。今天，我們和賽諾菲都公佈了Dupixent在美國和美國以外市場都非常強勁的業績。真正需要記住的是，雖然我們在幫助異位性皮膚炎患者以及患有氣喘和鼻息肉等呼吸系統疾病的患者方面取得了顯著進展，但在所有已獲批准的適應症中，以及未來的適應症中，仍然存在大量尚未滿足的新增需求。

And then beyond that, to your point of strategies and promotional platform and activities to advance the market, Dupixent has been very responsive to promotion. We've been seeing certainly uptick in new initiations and also a remarkable consistency of patients staying on therapy because of the results that they're receiving either in their skin condition or their respiratory condition. So we'll continue to do that. We're looking at a lot of different mechanisms for advancing our promotional platform. We have highly effective field teams in the marketplace. We also benefit from very strong reimbursement across indications and across age groups and certainly, we'll continue to advance on all the in-line indications we currently have, and we'll be very, very well prepared for our future indications as well.

此外，關於您提到的市場拓展策略、推廣平台和活動，Dupixent 對推廣活動的反應非常積極。我們看到新患者數量顯著增加，由於患者在皮膚或呼吸系統疾病方面取得了顯著療效，因此他們的治療依從性也非常高。因此，我們將繼續推進推廣工作。我們正在探索多種不同的推廣機制。我們在市場上擁有高效率的銷售團隊。此外，我們在各個適應症和各個年齡層都享有非常優良的健保報銷政策。當然，我們將繼續推動所有現有適應症的研發，並為未來的適應症做好充分準備。

Thanks Marion. Next question please.

謝謝瑪麗昂。請問下一個問題。

And your next question comes from Ronny Gal with Bernstein.

下一個問題來自伯恩斯坦的羅尼·加爾。

Congratulations on the very nice quarter. My question is actually on the EYLEA, Lucentis dynamics. You've shown a 10% revenue growth. They've shown a 5% revenue decline year-over-year. So obviously, capturing share. But I was wondering about the new patient volume. If you can just share with us, if you could, kind of like where are we in terms of patient starts versus a year ago? And how far do we have to go before we come back to line? And anything you can share about pricing terms as it seemed to be -- you just commented this in the press release, if you can give us a bit more there?

恭喜你們本季業績斐然。我的問題其實是關於安永和盧森蒂斯的動態。你們的營收成長了10%，而他們年減了5%。顯然，你們正在搶佔市場份額。但我更想了解一下新患者數量的情況。能否請您分享一下，與去年同期相比，我們目前的新增患者數量是多少？距離恢復到去年同期水準還有多遠？另外，關於定價條款，您似乎在新聞稿中提到過，能否再詳細解釋一下？

Ronny, in terms of performance of EYLEA in the anti-VEGF category, as I mentioned, we are seeing a rebound in terms of patient treatment coming back into offices. We see an advance in EYLEA's performance versus a year ago. And then coupled with that, we are seeing an increment in share gain from both branded and unbranded competitors. I also mentioned, if I just put it into volume terms for you in the branded marketplace that EYLEA now approaches just over, in fact, 70% of the branded market in the quarter by volume. So we're seeing robust performance and we would attribute that to EYLEA's overall value proposition for retina specialists in choosing anti-VEGF therapy, the -- certainly, the clinical profile, efficacy profile, flexibility of dosing. Now the prefilled syringe is incredibly timely is a convenience, but also in the current environment of office throughput and efficiency, and then beyond that, the established safety.

羅尼，就EYLEA在抗VEGF藥物領域的表現而言，正如我之前提到的，我們看到患者重返診間接受治療的情況有所回升。與一年前相比，EYLEA的表現有所提升。同時，我們看到EYLEA的市佔率也在不斷成長，無論是來自品牌藥或非品牌藥的競爭對手。我還提到，如果僅從銷售角度來看，EYLEA在本季品牌藥市場的佔有率實際上已經接近70%。因此，我們看到了強勁的業績，這主要歸功於EYLEA對視網膜專家而言具有的整體價值，尤其是在選擇抗VEGF療法時，其臨床療效、劑量靈活性等因素都至關重要。預充式註射器不僅非常方便快捷，而且在目前診所高效率的環境下也發揮了重要作用，此外，EYLEA的安全性也得到了充分的驗證。

Operator, we have time for 2 very quick questions if we could try to squeeze them in.

接線生，我們想問兩個很簡短的問題，能否盡量擠出時間問一下？

Your next question comes from Biren Amin with Jefferies.

下一個問題來自傑富瑞集團的比倫阿明。

Can you just talk about the competitive landscape in retina with your thoughts on faricimab, given we've -- they're going to have Phase III data relatively soon?

您能否談談您對 faricimab 在視網膜領域的競爭格局的看法？鑑於 faricimab 即將獲得 III 期臨床試驗數據。

Sure. So I think we all learned a lot about -- I'm sorry, Len, you go first. I'll come back if you'd like.

當然。所以我想我們都學到了很多——抱歉，萊恩，你先說吧。如果你願意，我稍後再回來。

No, no. Go ahead, Marion.

不，不。你繼續，瑪莉安。

No. I was just going to comment that I think that the -- for a product entering the marketplace today, it's not assumed anymore that a safety profile will be there until the product has actual market experience. So I just would mention at the start, we always monitor competition very, very carefully, both in market currently and future competition. But certainly, EYLEA sets a very high bar in terms of the clinical profile, the safety profile and the level of experience. But Len, over to you.

不。我只是想說，我認為對於如今進入市場的產品而言，在產品累積實際市場經驗之前，人們不再會想當然地認為其安全性已經具備。所以我想先強調，我們始終非常密切地關注競爭對手，包括現有市場和未來的競爭對手。當然，愛樂在臨床數據、安全性數據和經驗水平方面都樹立了非常高的標準。 Len，現在輪到你了。

No, I think you covered it. Let's go to the next question and the last question.

不，我覺得你已經回答過了。我們來看下一個問題和最後一個問題。

And your final question comes from Terence Flynn with Goldman Sachs.

最後一個問題來自高盛的特倫斯·弗林。

This is Dan on for Terence. Just for the Phase II trial of your BCMA bispecific antibody. Just wondering if you could share any more details on the trial and if you're working to develop a subcu formulation?

我是丹，替特倫斯問的。是關於你們BCMA雙特異性抗體的第二期臨床試驗。我想問你們能否分享更多關於這項試驗的細節，以及你們是否正在研發皮下注射劑型？

Yes. I think that right now, we'll -- you'll get updates on the BCMA program at ASH. We have announced that we're going to be entering into a pivotal program very soon. And I guess it's fair to say that it makes sense that we would be developing, yes, a subcutaneous formulation.

是的。我想現在，你們會在ASH會議上獲得BCMA專案的最新進展。我們已經宣布即將啟動一項關鍵性研究計畫。我想，開發皮下製劑也是順理成章的。

Thanks to everyone for joining today's call. We appreciate you dialing in, knowing that many other companies are reporting today. So thank you for your attention and for your questions. Bob Landry and the IR team will be available for additional questions and calls as needed today. Thank you, everyone. Be safe.

感謝各位參加今天的電話會議。我們非常感謝各位撥入，也知道今天還有很多其他公司要發布財報。感謝各位的關注與提問。 Bob Landry 和投資者關係團隊今天將繼續解答其他問題並接受電話諮詢。謝謝大家。祝大家平安。

This does conclude today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您可以掛斷電話了。