Biontech SE (BNTX) 2021 Q3 法說會逐字稿

Welcome to BioNTech Third Quarter 2021 Update Call. (Operator Instructions) I must advise you this call is being recorded today, Tuesday, the 9th of November 2021. And I would now like to hand the meeting over to the Vice President, Investor Relations and Strategy, Sylke Maas. Please go ahead.

歡迎來到 BioNTech 2021 年第三季度更新電話。 （操作員說明）我必須告訴您，今天，即 2021 年 11 月 9 日，星期二，這次電話會議正在錄音。我現在想將會議交給負責投資者關係和戰略的副總裁 Sylke Maas。請繼續。

Good morning and good afternoon. Thank you for joining us today to review BioNTech's Third Quarter 2021 Operational Progress and Financial Results. Before we start, we quote you to view the slides for this webcast as well as the operational and financial results' press release issued this morning, both of which are accessible on our website in our investor section.

早上好，下午好。感謝您今天加入我們，回顧 BioNTech 的 2021 年第三季度運營進展和財務業績。在我們開始之前，我們請您查看此網絡廣播的幻燈片以及今天上午發布的運營和財務結果新聞稿，這兩者都可以在我們網站的投資者部分訪問。

As shown on Slide 2, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, our current estimated COVID-19 vaccine revenue based on current contracted supply orders particularly for those figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2021, our continued global demand for our COVID-19 vaccine, our targets vaccine production capacity for 2021 and beyond, our ability to supply our COVID-19 vaccine.The plan steps in our pipeline program, the time for enrollment, initiation, completion and reporting of data from our clinical trials, and other risks described in our filings made with the U.S. Securities and Exchange Committee, including almost recent annual report on Form 20-F.

如幻燈片 2 所示，在今天的演示中，我們將做出幾項前瞻性陳述。這些前瞻性陳述包括但不限於我們當前根據當前合同供應訂單估計的 COVID-19 疫苗收入，特別是根據我們的合作夥伴提供的初步估計得出的數據、我們對 2021 年的估計財務業績、我們的全球對我們的 COVID-19 疫苗的持續需求、我們 2021 年及以後的目標疫苗生產能力、我們供應 COVID-19 疫苗的能力。我們的管道計劃中的計劃步驟、註冊、啟動、完成和報告數據的時間來自我們的臨床試驗，以及我們向美國證券交易委員會提交的文件中描述的其他風險，包括最近關於表格 20-F 的年度報告。

Actual results could differ from those we currently anticipate. You are therefore cautioned not to place undue reliance on any forward-looking statements, which speak only as of today, shared today during this conference call and webcast.

實際結果可能與我們目前的預期不同。因此，請注意不要過分依賴任何前瞻性陳述，這些陳述僅在今天發表，在今天的電話會議和網絡直播中分享。

Also please note that Slide 3 and 4 provide detailed and important safety information regarding our COVID-19 vaccine. Slide 5 is our agenda for our call today. I'm joined today by our CEO and Co-Founder, Ugur Sahin; Ozlem Tureci, our Chief Medical Officer and Co-Founder; Sean Marett, our Chief Business and Commercial Officer; and Jens Holstein, our Chief Financial Officer; Ryan Richardson, our Chief Strategy Officer; and Sierk Poetting, our Chief Operating Officer. I now turn the call over to Ugur Sahin. Ugur?

另請注意，幻燈片 3 和 4 提供了有關我們 COVID-19 疫苗的詳細而重要的安全信息。幻燈片 5 是我們今天的電話會議議程。今天，我們的首席執行官兼聯合創始人 Ugur Sahin 加入了我的行列； Ozlem Tureci，我們的首席醫療官兼聯合創始人；我們的首席商務官 Sean Marett；和我們的首席財務官 Jens Holstein；我們的首席戰略官 Ryan Richardson；和我們的首席運營官 Sierk Poetting。我現在把電話轉給 Ugur Sahin。烏古爾？

Thank you, Serge. Good morning and good afternoon, and thank you to everyone joining the call today. Today, I will walk you through the key highlights of last quarter's performance before inviting my team to go into further detail. Our strong performance continued in the third quarter in terms of commercial execution and clinical pipeline advancement. With our partner, Pfizer, we have shipped more than 2 billion doses of our COVID-19 vaccine to more than 152 countries or regions worldwide. We continue to be humbled by the impact of our vaccine and of our company is having, in addressing the global pandemic. We still have further to go to reach many parts of the world.

謝謝你，塞爾吉。早上好，下午好，感謝今天加入電話會議的所有人。今天，我將帶您了解上一季度業績的主要亮點，然後邀請我的團隊進一步詳細介紹。在商業執行和臨床管道推進方面，我們在第三季度繼續保持強勁表現。與我們的合作夥伴輝瑞（Pfizer）合作，我們已向全球超過 152 個國家或地區運送了超過 20 億劑 COVID-19 疫苗。我們繼續對我們的疫苗和我們公司在應對全球流行病方面的影響感到謙卑。我們還有更遠的路要走，才能到達世界許多地方。

We are prioritizing equitable vaccine access to low and middle income countries. In the first 3 quarters of 2021, we expanded our oncology pipeline faster than during any other period in our company's history. We initiated 3 randomized Phase 2 trials and multiple first-in-human trials. We will present data for 6 of our programs at the upcoming SITC conference, clearly demonstrating the progress in our cancer pipeline. [Jansen] will provide detail on some of these updates in her prepared remarks.

我們正在優先考慮讓低收入和中等收入國家公平獲得疫苗。在 2021 年的前 3 個季度，我們以比公司歷史上任何其他時期更快的速度擴展了我們的腫瘤學管道。我們啟動了 3 項隨機 2 期試驗和多項首次人體試驗。我們將在即將舉行的 SITC 會議上展示我們 6 個項目的數據，清楚地展示我們癌症管道的進展。 [Jansen] 將在她準備好的評論中提供其中一些更新的詳細信息。

Moving to Slide 7. Our strategy remains focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to patients were applied to address cancer and a growing list of infectious diseases. The transformation of BioNTech into a global fully integrated immunotherapy powerhouse is continuing at a rapid pace. We are adding talent to our team. We are expanding our capabilities and geographic presence. We are increasing our investment in automation, digitalization and AI technologies. Our vision is to build a high technology company of the coming age. We are developing and exporting innovations at the intersection of immunology and synthetic biology. We believe our innovations can make a profound difference for people around the world, and we remain committed to investing in the company to deliver on this vision in the years to come.

轉到幻燈片 7。我們的戰略仍然專注於將我們廣泛的下一代免疫療法和疫苗管道應用於患者，以應對癌症和越來越多的傳染病。 BioNTech 向全球全面整合免疫治療強國的轉變正在快速推進。我們正在為我們的團隊增加人才。我們正在擴大我們的能力和地理分佈。我們正在增加對自動化、數字化和人工智能技術的投資。我們的願景是建立一個未來時代的高科技公司。我們正在免疫學和合成生物學的交叉領域開發和輸出創新。我們相信我們的創新可以為世界各地的人們帶來深遠的影響，我們將繼續致力於投資公司，以在未來幾年實現這一願景。

Slide 8. We are driving innovations across multiple therapeutic platforms to harness the power of the immune system and to transform treatment paradigm in infectious disease and solid tumors. The last 18 months have demonstrated the power, flexibility and the speed of our mRNA vaccine technology. We have established a proven path to regulatory approval for our first mRNA vaccine and have created one of the largest safety databases for a pharmaceutical product. This is supported by our global manufacturing and distribution network that had capacity to provide millions of doses of vaccine supply for the world. Behind COVID-19, we are advancing a pipeline of 10 novel vaccines and immunotherapies for diseases which pose major global health challenges, including influenza, HIV Tuberculosis and Malaria. We plan to accelerate our efforts here and aim to initiate multiple clinical trials in the next 18 months.

幻燈片 8。我們正在推動多個治療平台的創新，以利用免疫系統的力量並改變傳染病和實體瘤的治療模式。過去 18 個月證明了我們的 mRNA 疫苗技術的力量、靈活性和速度。我們已經為我們的第一個 mRNA 疫苗建立了一條經過驗證的監管批准途徑，並創建了最大的藥品安全數據庫之一。這得到了我們的全球製造和分銷網絡的支持，該網絡有能力為世界提供數百萬劑疫苗供應。在 COVID-19 背後，我們正在推進 10 種新型疫苗和免疫療法的研發，這些疫苗和免疫療法對全球健康構成重大挑戰，包括流感、艾滋病毒結核病和瘧疾。我們計劃在這方面加快我們的努力，併計劃在未來 18 個月內啟動多項臨床試驗。

In oncology, we are building a toolbox of technologies across a range of drug classes. We now have 15 oncology product candidates in 19 ongoing clinical trials including 4 active Phase 2 trials. We are addressing a wide range of therapeutic targets with diverse and complementary modes of action. We believe that this multimodal approach opens up new and powerful combination therapy opportunities across a broad range of solid tumors where current standards of care remain not to be sufficient. Finally, we believe that the broad spectrum of our technologies will enable us to bring forward new treatment approaches that have the potential to broaden the disease horizon beyond oncology and infectious disease like autoimmune and inflammatory diseases and even regenerative medicine.

在腫瘤學領域，我們正在構建一個涵蓋一系列藥物類別的技術工具箱。我們現在在 19 項正在進行的臨床試驗中擁有 15 種腫瘤產品候選者，其中包括 4 項活躍的 2 期試驗。我們正在通過多樣化和互補的作用模式解決廣泛的治療目標。我們相信，這種多模式方法為廣泛的實體瘤開闢了新的和強大的聯合治療機會，目前的護理標準仍然不夠。最後，我們相信，我們廣泛的技術將使我們能夠提出新的治療方法，這些方法有可能拓寬疾病視野，超越腫瘤學和傳染病，如自身免疫和炎症性疾病，甚至再生醫學。

Slide 9 summarizes the key highlights for the third quarter. Our financial performance continues to be strong. We recorded in Q3 revenues of approximately EUR 6 billion, driven by the continued ramp up of COVID-19 vaccine production and delivery worldwide.

幻燈片 9 總結了第三季度的主要亮點。我們的財務表現繼續強勁。在全球 COVID-19 疫苗生產和交付持續增加的推動下，我們在第三季度的收入約為 60 億歐元。

Today, we are announcing a new expansion of our infectious disease toolkit, a new class of precision antibacterials through the acquisition of PhagoMed, an Austrian biotechnology company. The transaction complements our infectious disease pipeline of mRNA vaccines and mRNA encoded antibody with a new precision antibacterial technology that we believe could be useful against the global challenge of antimicrobial resistance. In the third quarter, we initiated dosing in our randomized Phase 2 trial of autogene cevumeran or BNT122, our iNeST candidate for the adjuvant treatment of higher vet colorectal cancer patients who are positive for circulating tumor DNA.

今天，我們宣布通過收購奧地利生物技術公司 PhagoMed 對我們的傳染病工具包進行新的擴展，這是一種新型精密抗菌藥物。該交易通過一種新的精密抗菌技術補充了我們的 mRNA 疫苗和 mRNA 編碼抗體的傳染病管道，我們認為該技術可能有助於應對全球抗菌素耐藥性挑戰。在第三季度，我們在 autogene cevumeran 或 BNT122 的隨機 2 期試驗中開始給藥，這是我們的 iNeST 候選藥物，用於輔助治療循環腫瘤 DNA 呈陽性的高級獸醫結直腸癌患者。

In addition, our FixVac product candidate, BNT111 was recently granted orphan designation by the U.S. FDA for the treatment of advanced checkpoint inhibitory refractory or resistant melanoma. In infectious diseases in September [5] highly initiated a first human study of BNT161, an influenza vaccine based on our mRNA technology. Moving to the highlights of our COVID-19 vaccine, we have now distributed a total of more than 2 billion vaccine doses globally. We expect to produce up to 3 billion doses for 2021 and expect to deliver up to 2.5 billion COVID-19 doses by the end of this year. In 2022, we expect our manufacturing capacity of up to 4 billion doses. Our COVID-19 vaccine has now received full BLA FDA approval in the United States for the use in individuals aged 16 and older. The U.S. FDA has also authorized a boosting with a third dose of the vaccine for some high-risk population than the AU, a booster dose has been approved for subjects, 18 years and older.

此外，我們的 FixVac 候選產品 BNT111最近被美國 FDA 授予孤兒藥資格，用於治療晚期檢查點抑制性難治性或耐藥性黑色素瘤。在 9 月的傳染病中 [5] 高度啟動了對 BNT161 的首次人體研究，這是一種基於我們 mRNA 技術的流感疫苗。轉到我們 COVID-19 疫苗的亮點，我們現在已經在全球分發了超過 20 億劑疫苗。我們預計到 2021 年將生產多達 30 億劑疫苗，並預計到今年年底將交付多達 25 億劑 COVID-19。到 2022 年，我們預計我們的製造能力將達到 40 億劑。我們的 COVID-19 疫苗現已在美國獲得 BLA FDA 的完全批准，可用於 16 歲及以上的個人。美國 FDA 還授權對非 AU 以外的一些高危人群進行第三劑疫苗的加強免疫，加強劑量已被批准用於 18 歲及以上的受試者。

To support the extension of the vaccine label to include children aged 5 to <12, a clinical data package has been submitted to regulators around the globe. The FDA has recently granted emergency use authorization of BNT162b2 in children aged 5 to 1 and the U.S. government purchase an additional 50 million pediatric doses. I feel humbled about our team's continued exceptional work and would like to close my remarks by emphasizing that even at BioNTech is transforming, we will continue to stay true to our vision and remain focused on our goal to bring next-generation immunotherapies to patients around the world. I will now turn the call over to Sean, who will provide updates on our COVID-19 program.

為支持將疫苗標籤擴展到 5 至 12 歲以下的兒童，已向全球監管機構提交了一份臨床數據包。 FDA 最近批准了 BNT162b2 在 5 至 1 歲兒童中的緊急使用授權，美國政府額外購買了 5000 萬劑兒科劑量。我對我們團隊持續的出色工作感到謙卑，並想通過強調即使在 BioNTech 正在轉型，我們將繼續忠於我們的願景並繼續專注於我們的目標，即為周圍的患者帶來下一代免疫療法。世界。我現在將把電話轉給 Sean，他將提供我們 COVID-19 計劃的最新信息。

Thanks, Ugur. It's a pleasure to be speaking with everyone today. Turning now to Slide 11. Together with our collaborated Pfizer and Fosun Pharma, we have established a global development program and distribution network for our COVID-19 vaccine. Our order book for 2021 continues to be strong with the addition of several new orders from the U.S., Japan and other regions, last quarter. Discussions with regard to additional contracts for 2022 and beyond remain ongoing. We anticipate that the additional 50 million pediatric doses ordered by the U.S. government should be delivered by April 30, 2022. With this order, the U.S. government has exercised its final purchase option under its existing supply agreement, bringing the total number of BNT162b2 doses secured under this agreement since the start of the pandemic to 600 million. We continue to lead in ensuring equitable vaccine access to low and middle income countries. BioNTech has pledged 2 billion doses by the end of 2022.

謝謝，烏古爾。今天很高興與大家交談。現在轉到幻燈片 11。我們與輝瑞和復星醫藥合作，為我們的 COVID-19 疫苗建立了全球開發計劃和分銷網絡。隨著上個季度來自美國、日本和其他地區的幾筆新訂單的增加，我們 2021 年的訂單繼續保持強勁。關於 2022 年及以後的額外合同的討論仍在進行中。我們預計美國政府訂購的額外 5000 萬劑兒科劑量應在 2022 年 4 月 30 日之前交付。通過該訂單，美國政府已根據其現有供應協議行使其最終購買選擇權，從而確保了 BNT162b2 劑量的總數根據該協議，自大流行開始以來達到 6 億。我們繼續帶頭確保低收入和中等收入國家公平獲得疫苗。 BioNTech 已承諾到 2022 年底提供 20 億劑疫苗。

And a significant amount of our remaining 2021 manufacturing will be allocated to equitable vaccine access. Importantly, we have expanded our agreement with the U.S. government from 500 million to 1 billion doses at a not-for-profit price for 2021 and 2022. These doses are intended for donation to low and lower middle income countries and organizations that support them. Our hope is that by increasing vaccine access in these regions, surges and infection will be brought under control in many parts of the world. We and our partner, Pfizer, are also expanding our global manufacturing capabilities with regional solutions in Africa and Latin America.

我們 2021 年剩餘的大量生產將分配給公平的疫苗獲取。重要的是，我們在 2021 年和 2022 年以非營利價格將與美國政府的協議從 5 億劑擴大到 10 億劑。這些劑量旨在捐贈給中低收入國家和支持它們的組織。我們的希望是，通過增加這些地區的疫苗接種率，世界許多地區的激增和感染將得到控制。我們和我們的合作夥伴輝瑞也在通過非洲和拉丁美洲的區域解決方案擴大我們的全球製造能力。

This includes the letter of intent we signed with Eurofarma laboratories in Brazil to manufacture our COVID-19 vaccine. Per the agreement, EuroPharma will obtain drug product from facilities in the United States and manufacturing of finished doses are expected to commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. Additionally, we recently signed a Memorandum of Understanding with the Rwandan government and Institut Pasteur de Dakar and announced plans to start the construction in mid-2022 of the first state-of-the-art manufacturing site for mRNA-based vaccines in the African Union.

這包括我們與巴西 Eurofarma 實驗室簽署的生產 COVID-19 疫苗的意向書。根據協議，EuroPharma 將從美國的工廠獲得藥品，預計將於 2022 年開始生產成品藥。在滿負荷運轉的情況下，預計年產量將超過 1 億劑成品藥。此外，我們最近與盧旺達政府和達喀爾巴斯德研究所簽署了一份諒解備忘錄，並宣布計劃於 2022 年年中開始在非洲聯盟建設第一個最先進的基於 mRNA 的疫苗生產基地.

We believe this facility can become a node in a decentralized and robust African end-to-end manufacturing network to provide sustainable vaccine supply on the African continent. Establishment of this regional network is expected to enable annual manufacturing capacity of several hundreds of million of mRNA vaccine doses. Moving to Slide 12. I will provide an update on our strategic key levers to expand the global reach of our vaccine. The slide provides an overview of progress across all areas, but I will only be highlighting those details, which haven't already been touched on by Ugur. Starting with our manufacturing capacity, we have worked continually with our partner, Pfizer, to increase the capacity of the global supply chain and manufacturing network, which now includes more than 20 facilities across 4 continents.

我們相信，該設施可以成為分散且強大的非洲端到端製造網絡中的一個節點，為非洲大陸提供可持續的疫苗供應。該區域網絡的建立有望實現每年數億劑 mRNA 疫苗的生產能力。轉到幻燈片 12。我將提供有關我們擴大疫苗全球覆蓋範圍的戰略關鍵槓桿的最新信息。幻燈片概述了所有領域的進展，但我只會強調那些 Ugur 尚未涉及的細節。從我們的製造能力開始，我們一直與我們的合作夥伴輝瑞公司合作，以提高全球供應鍊和製造網絡的能力，該網絡現在包括遍布 4 大洲的 20 多個工廠。

To expand our vaccine label and generate useful data in additional populations, we have multiple ongoing clinical trials, which we have detailed previously, including trials in younger children and pregnant women. We currently expect data for children 2 to 5 years of age and children 6 months to 2 years of age in late Q4 2021 or early Q1 2022. Ugur already highlighted our significant process on the regulatory front and our data in children of 5 to 11 years of age, which Ozlem will cover in detail. We have further optimized our vaccine formulations to simplify access globally, and we recently received authorization from both the FDA and EMA to store our vaccine for up to 9 months at -90 degree Celsius to -60 degrees Celsius.

為了擴大我們的疫苗標籤並在其他人群中產生有用的數據，我們正在進行多項臨床試驗，我們之前已經詳細介紹過，包括針對年幼兒童和孕婦的試驗。我們目前預計 2 至 5 歲兒童和 6 個月至 2 歲兒童的數據將在 2021 年第四季度末或 2022 年第一季度初提供。Ugur 已經強調了我們在監管方面的重要流程以及我們在 5 至 11 歲兒童中的數據年齡，Ozlem 將詳細介紹。我們進一步優化了我們的疫苗配方以簡化全球訪問，我們最近獲得了 FDA 和 EMA 的授權，可以在 -90 攝氏度至 -60 攝氏度的條件下將我們的疫苗儲存長達 9 個月。

Additionally, following a positive opinion from EMA CHMP, the EC approved a new formulation of BNT162b2 that further simplifies vaccine handling and with optimized storage conditions. The virus can be stored up to 10 weeks at standard refrigeration temperatures of 2 to 8 degrees Celsius. Our understanding of the human immune response to COVID-19 as well as emerging variants continues to evolve and our team is continuously evaluating the (inaudible) scientific data as well as data from our own clinical studies to rapidly respond to the changing dynamics of the pandemic. Multiple trials are ongoing to address the need for boosted dose of BNT162b2. We are currently studying very specific vaccine versions.

此外，根據 EMA CHMP 的積極意見，歐盟批准了一種新的 BNT162b2 配方，進一步簡化了疫苗的處理並優化了儲存條件。在 2 至 8 攝氏度的標準冷藏溫度下，該病毒可以儲存長達 10 週。我們對人類對 COVID-19 的免疫反應以及新出現的變體的理解不斷發展，我們的團隊正在不斷評估（聽不清）科學數據以及我們自己的臨床研究數據，以快速應對大流行的變化動態.正在進行多項試驗以解決增加 BNT162b2 劑量的需求。我們目前正在研究非常具體的疫苗版本。

While we don't plan to commercialize a very specific version of the vaccine at this time, we remain ready to adapt our technology manufacturing and regulatory process to ensure our vaccine provides robust protection against COVID-19. We are very pleased with the latest clinical and regulatory developments from our vaccine which demonstrate our strong execution in response to the COVID-19 pandemic. I'll now turn the call over to Ozlem who will provide details of our recent vaccine study results as well as provide an overview of our oncology programs. including positive data to be presented at the upcoming SITC conference.

雖然我們目前不打算將特定版本的疫苗商業化，但我們仍準備好調整我們的技術製造和監管流程，以確保我們的疫苗能夠為 COVID-19 提供強有力的保護。我們對我們疫苗的最新臨床和監管進展感到非常高興，這表明我們在應對 COVID-19 大流行方面的強大執行力。我現在將把電話轉給 Ozlem，他將提供我們最近的疫苗研究結果的詳細信息，並概述我們的腫瘤學項目。包括將在即將舉行的 SITC 會議上展示的積極數據。

Thank you, Sean. I'm going to share with you today new data for BNT162b2 and our future vaccine strategy to combat the COVID-19 pandemic. As summarized on Slide 13, BNT162b2 has demonstrated high efficacy in our Phase 3 pivotal trial with approximately 44,000 subjects, 95% efficacy after the second dose and subjects with and without evidence of infection. For 6 months following the 2-dose primary series in adults and adolescents aged 16 and over, 91% efficacy against symptomatic disease and 95% efficacy against the new disease was demonstrated. We estimate our vaccine has now been administered to over 1 billion adults and adolescents globally.

謝謝你，肖恩。今天我將與您分享 BNT162b2 的新數據以及我們未來對抗 COVID-19 大流行的疫苗戰略。正如幻燈片 13 所總結的，BNT162b2 在我們的 3 期關鍵試驗中顯示出高效，約有 44,000 名受試者，第二次給藥後有 95% 的療效，受試者有和沒有感染證據。在成人和 16 歲及以上青少年的 2 劑主要係列治療後的 6 個月內，證明了 91% 的針對症狀性疾病的功效和 95% 的針對新疾病的功效。我們估計，我們的疫苗現已為全球超過 10 億成人和青少年接種。

As we have recognized that the prevention of disease in children is reaching herd immunity are equally important, we have expanded our clinical trials in children. In 12- to 15-year-olds, our vaccine administered according to the same regimen as for adults, demonstrated strong protection with 100% vaccine efficacy against COVID-19 infection in those with and without evidence of prior infection and 100% efficacy against severe disease. The immune response was non-inferior compared to that elicited in 16- to 25-year-old and BNT162b2 demonstrated a well-tolerated safety profile, similar to the safety profile seen in adults.

由於我們認識到預防兒童疾病與達到群體免疫同樣重要，因此我們擴大了兒童臨床試驗。在 12 至 15 歲的兒童中，我們的疫苗按照與成人相同的方案接種，顯示出強大的保護作用，在有和沒有既往感染證據的人群中對 COVID-19 感染具有 100% 的疫苗效力，對嚴重的疫苗有 100% 的效力疾病。與在 16 至 25 歲人群中引發的免疫反應相比，免疫反應並不遜色，並且 BNT162b2 表現出良好的耐受性安全性，類似於在成人中觀察到的安全性。

In the 5- to 11-year old children, a 2-dose regimen of 10 micrograms administered 21 days apart produced robust neutralizing antibody titers, similar to that observed in adults age 16 to 25 and was well-tolerated. Vaccine efficacy against symptomatic COVID-19 infection was 98.7%, up to 1 month following the second dose and no cases of severe COVID-19 were seen in the BNT162b2 group. Clinical trials in children 6 months to 2 years of age and 2 to 5 years of age are underway. Building on our expanding label to make BNT162b2 acceptable for all ages, we expect data to be available from those age cohorts in the fourth quarter of 2021 or early first quarter 2022.

在 5 至 11 歲兒童中，間隔 21 天給藥 10 微克的 2 劑方案產生了強大的中和抗體滴度，類似於在 16 至 25 歲的成年人中觀察到的，並且耐受性良好。在第二次接種後長達 1 個月，疫苗對症狀性 COVID-19 感染的有效性為 98.7%，並且在 BNT162b2 組中未發現嚴重的 COVID-19 病例。正在對 6 個月至 2 歲和 2 至 5 歲的兒童進行臨床試驗。基於我們不斷擴大的標籤使 BNT162b2 為所有年齡段的人所接受，我們預計這些年齡段的數據將在 2021 年第四季度或 2022 年第一季度初提供。

On Slide 14, our clinical strategy, addressing the need for a 3rd dose booster to restore neutralizing antibody titers and vaccine efficacy given waning vaccine immunity at longer interval following a second dose is shown. Clinical data support a 1st dose booster to augment vaccine protection over time in adults over 16 years of age, including high-risk populations and immunocompromised individuals. We are evaluating the impact of a 1st dose booster on neutralizing antibody titers and T cell responses in approximately 300 subjects in our Phase 1 and Phase 2/3 trials. Additionally, we have undertaken a Phase 3 trial in up to 10,000 subjects to measure relative vaccine efficacy in those vaccinated with such a booster dose of BNT162b2 versus those who did not receive a booster dose following the primary 2-dose series.

在幻燈片 14 上，顯示了我們的臨床策略，即在第二劑疫苗後更長的時間間隔內，鑑於疫苗免疫力減弱，需要第三劑加強劑來恢復中和抗體滴度和疫苗效力。臨床數據支持第 1 劑加強劑可在 16 歲以上的成年人（包括高危人群和免疫功能低下的個體）中隨著時間的推移增強疫苗保護。在我們的 1 期和 2/3 期試驗中，我們正在評估大約 300 名受試者的第 1 劑加強劑對中和抗體滴度和 T 細胞反應的影響。此外，我們已經在多達 10,000 名受試者中進行了一項 3 期試驗，以測量那些接種了 BNT162b2 加強劑的人與那些在主要 2 劑系列後未接受加強劑的人的相對疫苗效力。

We are constantly monitoring new emerging variants and assessing the ability of BNT162b2 to neutralize these variants of concern. BNT162b2 has demonstrated high efficacy against variance of concern in both its ability to elicit antibodies that neutralize variants and from a vaccine effectiveness perspective, in the real world setting. As part of a prototype approach to prepare for emerging variants of concerns that may escape immunity, is elicited by our [ancestry] vaccine version. We are testing both variant encoding monovalent and multivalent vaccine. Clinical trials are underway, where our monovalent beta variant vaccine was administered to 300 vaccinated individuals in our Phase 3 trial as a 3rd dose and to 300 vaccine naive individuals.

我們不斷監測新出現的變體並評估 BNT162b2 中和這些關注變體的能力。在現實世界環境中，BNT162b2 在引發抗體中和變體的能力以及從疫苗有效性的角度來看，都證明了其對關注差異的高效性。作為原型方法的一部分，我們的 [祖先] 疫苗版本引發了為可能逃避免疫的新出現的擔憂變體做準備。我們正在測試編碼單價和多價疫苗的變體。臨床試驗正在進行中，在我們的 3 期試驗中，我們的單價 β 變體疫苗作為第 3 劑被給予 300 名接種疫苗的個體和 300 名未接種疫苗的個體。

Additionally, we have undertaken trials to evaluate a multivalent delta+alpha variant-encoding vaccine and monovalent vaccines, including either the data or the alpha variant administered as the first dose or in naive subjects in clinical trials. Data is expected in the first quarter of 2022. Data from these trials could support a flexible platform approach for product adaptation should be needed. Now to Slide 15. The graph on the left shows that in elderly adults neutralization has almost fallen to the level of detection by this assay after 7 to 9 months, boosting with observed dose between 7 and 9 months after the dose 2 induces a robust neutralization response beyond what was originally observed after dose 2. [Sera] obtained from participants 1 month after all 3 elicited high neutralization titers against the original ancestral strains, the beta variant and also the delta variant.

此外，我們還進行了評估多價 delta+alpha 變體編碼疫苗和單價疫苗的試驗，包括作為第一劑給藥的數據或 alpha 變體，或在臨床試驗中的幼稚受試者。預計數據將在 2022 年第一季度發布。來自這些試驗的數據可以支持靈活的平台方法以適應產品需要。現在到幻燈片 15。左圖顯示，在老年人中，中和在 7 到 9 個月後幾乎下降到該檢測的檢測水平，在第 2 劑誘導強中和後 7 到 9 個月之間觀察到的劑量加強反應超出了第 2 劑後最初觀察到的反應。 [血清] 在所有 3 種引發針對原始祖先菌株、β 變體和 delta 變體的高中和效價後 1 個月從參與者獲得。

Neutralization titers against the delta variant are over 5-fold over those observed after dose 2 in the age group 18 to 55 years and even over 11-fold in the older age group, 65 to 85 year old. The difference in neutralizing titers against the ancestral virus and the beta variant narrowed after the 1st dose compared to after the second dose, implying that in addition to prolonging protection, a 3rd dose booster may increase the breadth of neutralizing response against SARS-CoV-2 Variants. Data and support of a booster dose is further strengthened with evidence from a Phase 3 vaccine efficacy booster trials in 9,000 subjects. BNT162b2 demonstrated 95% relative vaccine efficacy, which reflects the reduction in disease occurrence in the booster group versus the nonboosted group in those without evidence of prior SARS-CoV-2 infection at a median of 11 months following the 2nd dose. Relative vaccine efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions.

在 18 至 55 歲的年齡組中，針對 delta 變體的中和效價比第 2 劑後觀察到的效價高出 5 倍以上，在 65 至 85 歲的老年組中甚至超過 11 倍。與第二劑相比，第一劑後針對祖先病毒和 β 變體的中和滴度差異縮小，這意味著除了延長保護時間外，第三劑加強劑可能會增加針對 SARS-CoV-2 的中和反應的廣度變體。來自 9,000 名受試者的 3 期疫苗效力加強試驗的證據進一步加強了加強劑量的數據和支持。 BNT162b2 顯示出 95% 的相對疫苗效力，這反映了在第 2 劑接種後的中位時間 11 個月時，在沒有證據表明先前感染過 SARS-CoV-2 的人群中，加強組與未加強組的疾病發生率相比有所降低。無論年齡、性別、種族、民族或合併症如何，相對疫苗效力都是一致的。

BNT162b2 was well tolerated and adverse events were similar to those observed previously in the clinical development program. Moving to Slide 16. The global distribution of BNT162b2 has generated a vast area of real-world vaccine effectiveness data in diverse population. It is reassuring to see higher rates of vaccine effectiveness post the primary 2 doses mirroring the high efficacy demonstrated against symptomatic infections, asymptomatic infections, severe infections, hospitalization and death in real-world vaccine effectiveness trials. Real world data confirms that vaccine effectiveness decreases over time as the interval after the second dose increases.

BNT162b2 耐受性良好，不良事件與之前在臨床開發計劃中觀察到的相似。轉到幻燈片 16。BNT162b2 的全球分佈在不同人群中產生了大量真實世界的疫苗有效性數據。令人欣慰的是，第 2 劑疫苗接種後的疫苗有效率更高，這反映了在現實世界疫苗有效性試驗中對有症狀感染、無症狀感染、嚴重感染、住院和死亡的高效能。現實世界的數據證實，隨著第二劑後間隔的增加，疫苗的有效性會隨著時間的推移而降低。

Vaccine effectiveness against hospitalization is still high. Real-world evidence shows also that higher vaccine effectiveness is restored with the 3rd dose booster, both against severe disease as well as confirmed infections as seen in Israel in those age 16 and older. Starting 12 days after a 3rd dose booster, there was a 10 fold reduction in risk of confirmed infection across all age groups compared to the cohort that received the initial 2-dose series. And 18 fold risk reduction in severe disease was observed in the 60 and over age group and a 22-fold risk reduction in those aged 46 to 60.

疫苗對住院的有效性仍然很高。現實世界的證據還表明，第 3 劑加強劑可以恢復更高的疫苗效力，既可以對抗嚴重疾病，也可以對抗以色列 16 歲及以上人群中的確診感染。從第 3 劑加強劑後 12 天開始，與接受初始 2 劑系列的隊列相比，所有年齡組的確診感染風險降低了 10 倍。在 60 歲及以上年齡組中觀察到嚴重疾病的風險降低了 18 倍，在 46 至 60 歲的人群中觀察到的風險降低了 22 倍。

With regard to COVID-19 associated deaths, 14-fold risk reduction was observed for those age 60 and over. Continued monitoring of real world data and immunogenicity data is warranted to understand the effect of booster doses on vaccine effectiveness against COVID-19 caused by SARS-CoV-2 and emerging variants. Now starting with Slide 18, the update on our immuno-oncology pipeline. We have multiple assets across different therapeutic modalities with potential to tackle tumors using complementary strategies either by targeting tumor cells directly or by modulating the immune response against the tumor.

對於與 COVID-19 相關的死亡，觀察到 60 歲及以上人群的風險降低了 14 倍。有必要繼續監測現實世界的數據和免疫原性數據，以了解加強劑量對由 SARS-CoV-2 和新興變體引起的 COVID-19 疫苗有效性的影響。現在從幻燈片 18 開始，我們的免疫腫瘤學管道更新。我們擁有跨越不同治療方式的多種資產，有可能通過直接靶向腫瘤細胞或通過調節針對腫瘤的免疫反應來使用互補策略來治療腫瘤。

Many of our product candidates have the potential to be combined with other pipeline assets. Slide 19 highlights our strong clinical execution in 2021. We are presenting several of these data updates in 7 presentations at the SITC 36th annual meeting. In total, we now have 4 ongoing randomized Phase 2 clinical trials, 3 of which started in 2021, an additional randomized Phase 2 trial for the next-generation immunomodulator, BNT311 that we are developing with our esteemed colleagues from Genmab is expected to start in the fourth quarter of 2021. We have also started 5 First-in-human clinical trials in our diverse therapeutic program.

我們的許多候選產品都有可能與其他管道資產相結合。幻燈片 19 突出了我們在 2021 年的強大臨床執行力。我們將在 SITC 第 36 屆年會上的 7 個演示文稿中介紹其中的幾個數據更新。總的來說，我們現在有 4 項正在進行的隨機 2 期臨床試驗，其中 3 項於 2021 年開始，另外一項針對下一代免疫調節劑 BNT311 的隨機 2 期試驗，我們正在與來自 Genmab 的尊敬的同事一起開發，預計將於2021 年第四季度。我們還在多樣化的治療計劃中啟動了 5 項首次人體臨床試驗。

Moving to Slide 20 and our iNeST product candidate, autogene cevumeran or BNT122. This program is partnered with Genentech, Roche. BNT122 is designed to target patient-specific neo-antigensand is a fully individualized cancer vaccines with 2 ongoing trials in metastatic cancers of which one is a randomized Phase 2 in first-line melanoma in combination with pembrolizumab. We are now moving into the adjuvant treatment space with a randomized Phase 2 trial in colorectal cancer patients, for which we announced first patient dose in October 2021. And as the second deadliest cancer worldwide, the medical need for novel therapies to treat colorectal cancer remains high. The current standard of care for stage II (high-risk) and Stage III patients with localized cancer is removal of the primary tumor and adjuvant chemotherapy followed by a watchful waiting to see if tumors recur.

轉到幻燈片 20 和我們的 iNeST 候選產品 autogene cevumeran 或 BNT122。該計劃與羅氏基因泰克公司合作。 BNT122旨在針對患者特異性新抗原，是一種完全個體化的癌症疫苗，目前正在進行兩項轉移性癌症試驗，其中一項是一線黑色素瘤與派姆單抗聯合的隨機二期臨床試驗。我們現在正在進入輔助治療領域，在結腸直腸癌患者中進行隨機 2 期試驗，我們在 2021 年 10 月宣布了首個患者劑量。作為全球第二大致命癌症，對治療結腸直腸癌的新療法的醫療需求仍然存在高的。目前對患有局部癌症的 II 期（高風險）和 III 期患者的護理標準是切除原發性腫瘤和輔助化療，然後觀察腫瘤是否復發。

A substantial proportion of these patients are expected to have the recurrence of the tumor within 2 to 3 years after that surgery. For this trial patients at high risk for recurrence will be identified with a highly sensitive drug test, detecting circulating tumor DNA and will receive our vaccine following 3 to 6 months after their adjuvant chemotherapy. In circulating tumor DNA positive colorectal cancer patients after adjuvant chemotherapy, a disease-free survival of only 6 months is estimated. The primary endpoint of our Phase II trial is disease free survival. Further objectives include overall survival and safety. The trial also has a biomarker cohort that includes patients irrespective of (inaudible) in tumor DNA status.

這些患者中的很大一部分預計會在手術後 2 至 3 年內復發。對於該試驗，復發風險高的患者將通過高度敏感的藥物測試進行鑑定，檢測循環腫瘤 DNA，並將在輔助化療後 3 至 6 個月後接受我們的疫苗。在輔助化療後循環腫瘤 DNA 陽性結直腸癌患者中，估計無病生存期僅為 6 個月。我們 II 期試驗的主要終點是無病生存。進一步的目標包括總體生存和安全。該試驗還有一個生物標誌物隊列，其中包括患者，無論腫瘤 DNA 狀態如何（聽不清）。

Slide 21 highlights our presence at the SITC Annual Meeting on November 10 to 14. We will present data across 6 programs and 4 therapeutic platforms and through our presentations and posters. Overall, the data that we are presenting show favorable safety profiles and promising signs of clinical activity for all 6 clinical programs. In the trials, we are reporting at SITC. We observed preliminary biological or clinical activity in the one of [European] and it's very difficult to treat patient population. More details will follow on the next slide.

幻燈片 21 突出顯示了我們在 11 月 10 日至 14 日舉行的 SITC 年會上的出席情況。我們將通過我們的演示文稿和海報展示 6 個項目和 4 個治療平台的數據。總體而言，我們提供的數據顯示了所有 6 個臨床項目的良好安全性和有希望的臨床活動跡象。在試驗中，我們在 SITC 進行報告。我們觀察到 [European] 之一的初步生物學或臨床活性，治療患者群體非常困難。更多細節將在下一張幻燈片中介紹。

On Slide 22, preliminary data of a [sub-analysis] from the Phase I trial of our candidate BNT111 from our wholly owned FixVac platform. BNT111 is our official (inaudible) vaccine that encodes a fixed set of 4 shared antigens covering up to 95% of cutaneous melanoma patients. Melanoma remains an area of unmet need, particularly for patients who have progressed upon checkpoint inhibitor treatment. More than half of those patients who do not respond to checkpoint inhibitor in patients with stage 4 disease still face poor outcomes.

在幻燈片 22 上，來自我們全資擁有的 FixVac 平台的候選 BNT111 I 期試驗的 [子分析] 的初步數據。 BNT111 是我們的官方（聽不清）疫苗，它編碼一組固定的 4 種共享抗原，覆蓋高達 95% 的皮膚黑色素瘤患者。黑色素瘤仍然是一個未滿足需求的領域，特別是對於在檢查點抑製劑治療後出現進展的患者。在 4 期疾病患者中，超過一半對檢查點抑製劑沒有反應的患者仍面臨不良預後。

Thus, we believe the next wave of development is combining checkpoint inhibitors with other agents. In 2020, we published promising data on BNT111 in checkpoint inhibitor experienced patients with detectable disease and metastatic melanoma in nature. Those results showed that BNT111 monotherapy and in combination with checkpoint inhibition was well tolerated and induced durable objective responses in this disease setting and triggered the initiation of our Phase II trial in checkpoint refractory or resistant melanoma testing BNT111 in combination with the anti-PD-1 cemiplimab in our partnership with Regeneron.

因此，我們認為下一波發展趨勢是將檢查點抑製劑與其他藥物結合使用。 2020 年，我們發表了關於 BNT111 在具有可檢測到疾病和轉移性黑色素瘤患者中的有希望的數據。這些結果表明，BNT111 單藥治療和檢查點抑制聯合治療具有良好的耐受性，並在這種疾病環境中誘導了持久的客觀反應，並引發了我們在檢查點難治性或耐藥性黑色素瘤測試 BNT111 與抗 PD-1 聯合的 II 期試驗的啟動cemiplimab 在我們與 Regeneron 的合作中。

A new analysis, which we are presenting at SITC includes a cohort of pretreated patients with Stage 3 and 4 cutaneous melanoma with no evidence of disease that received BNT111 monotherapy. Overall, BNT111 had a favorable safety profile with similar safety in patients with evidence of disease and without evidence of disease. Most treatment-related adverse events were mild to moderate flu like symptoms. Overall, the rate of serious adverse events was low. In line with our previous data on patients with evidence of disease BNT111 induced CD4 and CD8 T-cell responses, the ex vivo spot SA results showed that similar proportions of patients in both groups responded to at least 1 tumor-associated antigen of the vaccine.

我們在 SITC 上展示的一項新分析包括一組接受 BNT111 單藥治療且沒有疾病證據的 3 期和 4 期皮膚黑色素瘤患者。總體而言，BNT111 具有良好的安全性，在有疾病證據和無疾病證據的患者中具有相似的安全性。大多數與治療相關的不良事件是輕度至中度流感樣症狀。總體而言，嚴重不良事件的發生率較低。與我們之前關於有證據表明疾病 BNT111 誘導 CD4 和 CD8 T 細胞反應的患者的數據一致，離體 Spot SA 結果顯示，兩組中相似比例的患者對疫苗的至少一種腫瘤相關抗原有反應。

A substantial proportion of patients presented the novel T-cell responses only detectable after vaccination. The median disease-free survival of patients with no evidence of disease was 34.8 months highlighting that BNT111 monotherapy showed promising thickness of prolonged disease control in patients with no evidence of disease. The ability to induce T-cell immunity irrespective of the presence of clinically or radiologically detectable tumor is a potential sign of tumor surveillance mediated by BNT111.

相當大比例的患者表現出只有在接種疫苗後才能檢測到的新型 T 細胞反應。沒有疾病證據的患者的中位無病生存期為 34.8 個月，這表明 BNT111 單藥治療在沒有疾病證據的患者中顯示出有希望的長期疾病控制厚度。無論是否存在臨床或放射學可檢測到的腫瘤，誘導 T 細胞免疫的能力是 BNT111 介導的腫瘤監測的潛在跡象。

We believe that these findings have the potential to translate into a significant clinical benefit and encourage further development of BNT111 in earlier melanoma disease setting. We are also presenting data from our FixVac BNT112 Phase I/II trial shown on Slide 23, at SITC. BNT112 encodes a fixed set of 5 prostate associated antigens. The first in human Phase I/II trial assesses the safety and immunogenicity of BNT112 monotherapy or in combination with cemiplimab in patients with metastatic castration-resistant prostate cancer and with newly diagnosed high-risk localized prostate cancer.

我們相信這些發現有可能轉化為顯著的臨床益處，並鼓勵 BNT111 在早期黑色素瘤疾病環境中的進一步發展。我們還展示了來自 SITC 幻燈片 23 上的 FixVac BNT112 I/II 期試驗的數據。 BNT112 編碼一組固定的 5 種前列腺相關抗原。第一項人體 I/II 期試驗評估了 BNT112 單藥治療或與 cemiplimab 聯合治療轉移性去勢抵抗性前列腺癌和新診斷的高危局限性前列腺癌患者的安全性和免疫原性。

Prostate cancer is a major health issue with 1.3 million new cases worldwide each year. localized prostate cancer frequently becomes metastatic, which is invariably fatal. Prognosis remains poor and novel therapeutic approaches are required. Part 1 of the trial, which is BNT112 dose titrations is complete and the recommended dose range for Part 2 has been determined. Part 2, the dose expansion with BNT112 as a monotherapy and in combination with cemiplimab is currently recruiting. Preliminary results from the trial as of June 2021 are as follows: Nine patients have been treated with BNT112 monotherapy in Part I all with heavily pretreated late-stage cancer, 5 patients were treated in Part 2. Overall, most adverse events that occurred in Part 1 were mild or moderate.

前列腺癌是一個主要的健康問題，全世界每年有 130 萬新病例。局限性前列腺癌經常變成轉移性的，這總是致命的。預後仍然很差，需要新的治療方法。試驗的第 1 部分，即 BNT112 劑量滴定已完成，第 2 部分的推薦劑量範圍已確定。第 2 部分，目前正在招募 BNT112 作為單一療法並與 cemiplimab 聯合使用的劑量擴展。截至 2021 年 6 月，該試驗的初步結果如下：在第 I 部分中，有 9 名患者接受了 BNT112 單藥治療，均為經過大量預處理的晚期癌症，在第 2 部分中治療了 5 名患者。總體而言，在第 1 部分中發生的大多數不良事件1 為輕度或中度。

There were 2 instances of Grade 3 hypertension leading to dose reductions. Both patients recovered within 24 hours, and these events did not meet the criteria of dose limiting toxicity. All reported serious adverse events in Part 1 were considered unrelated to BNT112. No safety signals of concerns were identified in part 2 in which patients received BNT112 only or in combination with cemiplimab. All 7 patients who were ELISpot-evaluable exhibited detectable immune responses. We also confirm that all 5 tumor-associated antigens were immunogenic and identified T-cell responses to each antigen in at least 2 patients. Two patients with late-stage cancer treated with BNT112 monotherapy had decreases in prostate-specific antigen, the well-known prostate cancer biomarker.

有 2 例 3 級高血壓導致劑量減少。兩名患者均在 24 小時內康復，並且這些事件不符合劑量限制性毒性標準。第 1 部分中報告的所有嚴重不良事件均被認為與 BNT112 無關。在患者僅接受 BNT112 或與 cemiplimab 聯合治療的第 2 部分中，沒有發現值得關注的安全信號。所有 7 名可進行 ELISpot 評估的患者均表現出可檢測的免疫反應。我們還證實，所有 5 種腫瘤相關抗原均具有免疫原性，並在至少 2 名患者中鑑定出對每種抗原的 T 細胞反應。兩名接受 BNT112 單一療法治療的晚期癌症患者的前列腺特異性抗原（眾所周知的前列腺癌生物標誌物）減少了。

In summary, these data suggest that BNT112 has a tolerable safety profile, and enrollment to part 2 is ongoing in monotherapy as well as in combination with cemiplimab with first signal of activity in patients with advanced prostate cancer. Slide 24 and moving to BNT211 that comprises 2 drug products. Claudin-6 CAR-T cells and a CAR-T cell amplifying RNA vaccine in short CARVac. Claudin-6 CAR-T cells are equipped with a second-generation chimeric antigen receptor of high sensitivity and specificity for the tumor-specific antigen Claudin-6. Claudin-6 is absent in healthy adult tissues yet frequently expressed in high medical need cancer, making this tumor antigen an ideal target for CAR-T cell therapy. Preclinical studies demonstrated that CARVac drives in vivo expansion of transferred CAR-T cells, increasing their persistence and efficacy.

總之，這些數據表明 BNT112 具有可耐受的安全性，第 2 部分的招募正在進行中，單藥治療以及與 cemiplimab 聯合治療晚期前列腺癌患者的第一個活動信號。幻燈片 24 並移至包含 2 種藥品的 BNT211。 Claudin-6 CAR-T 細胞和 CAR-T 細胞擴增 RNA 疫苗（簡稱 CARVac）。 Claudin-6 CAR-T細胞配備了對腫瘤特異性抗原Claudin-6具有高敏感性和特異性的第二代嵌合抗原受體。 Claudin-6 在健康成人組織中不存在，但在高醫療需求癌症中經常表達，這使得這種腫瘤抗原成為 CAR-T 細胞治療的理想靶標。臨床前研究表明，CARVac 可促進轉移的 CAR-T 細胞的體內擴增，從而提高其持久性和功效。

BNT211 is expected to overcome CAR-T cell therapy limitations in patients with solid tumors. The first in human Phase I/II dose escalation trial evaluates the safety and efficacy of Claudin-6 CAR-T cell monotherapy and in combination with CARVac in patients with Claudin-6 positive, relapsed or refractory advanced solid tumors. Part 1 comprises Claudin-6 CAR-T monotherapy dose escalation cohorts and part 2 is a dose escalation of CAR-T combined with a fixed dose of CARVac. There are 3 dose level cohorts for each part. The subsequent dose expansion will focus on ovarian, testicular and endometrial cancers as well as other Claudin-6 positive cancers. As of July 21, dose level 2 of Part 1 and dose level 1 of part 2 are ongoing.

BNT211有望克服實體瘤患者的 CAR-T 細胞療法限制。第一項人體 I/II 期劑量遞增試驗評估了 Claudin-6 CAR-T 細胞單藥治療以及與 CARVac 聯合治療 Claudin-6 陽性、復發或難治性晚期實體瘤患者的安全性和有效性。第 1 部分包括 Claudin-6 CAR-T 單藥劑量遞增隊列，第 2 部分是 CAR-T 與固定劑量 CARVac 的劑量遞增。每個部分有 3 個劑量水平組。隨後的劑量擴展將集中於卵巢癌、睾丸癌和子宮內膜癌以及其他 Claudin-6 陽性癌症。截至 7 月 21 日，第 1 部分的劑量水平 2 和第 2 部分的劑量水平 1 正在進行中。

On Slide 25, we show preliminary results from the Phase I/II BNT211 clinical trial that will be presented at SITC. The 8 patients included in the analysis were all heavily pretreated with testicular ovarian and endometrial cancers and sarcoma. Patients received CAR-T cell monotherapy and free CAR-T-cells plus CARVac vaccine combination therapy. Claudin-6 CAR-T cells as monotherapy or combined with CARVac were well tolerated at the dose levels evaluated and no dose-limiting toxicities were observed. Some cases of cytokine release syndrome occurred while manageable with no signs of neurotoxicity. Increases of interleukin-6 and (inaudible) were transient and moderate. Patients receiving the combination therapy had transient flu like symptoms that resolved within 24 hours.

在幻燈片 25 上，我們展示了將在 SITC 上展示的 I/II 期 BNT211臨床試驗的初步結果。分析中包括的 8 名患者均接受過大量睾丸卵巢癌和子宮內膜癌以及肉瘤的預處理。患者接受了 CAR-T 細胞單藥治療和游離 CAR-T 細胞加 CARVac 疫苗聯合治療。 Claudin-6 CAR-T 細胞作為單一療法或與 CARVac 聯合在評估的劑量水平上具有良好的耐受性，並且未觀察到劑量限制性毒性。一些細胞因子釋放綜合徵病例在可控制的情況下發生，沒有神經毒性跡象。白細胞介素 6 和（聽不清）的增加是短暫的和中度的。接受聯合治療的患者有短暫的流感樣症狀，在 24 小時內消退。

The analysis of CAR-T cell frequency in the blood of a patient who revealed robust CAR-T cell engraftment up to day 17 post infusion. Further expansion was noted in 2 patients with liver metastasis accompanied by elevated (inaudible) . There were also encouraging signs of clinical activity in patients for which a 6-week tumor assessment was available. Three patients showed initial tumor shrinkage with tumor reduction between 18% and 27% according to RECIST. Signs of initial tumor shrinkage were identified even at the lowest dose tested. Data on the 1 additional patient evaluated between the abstract submission and the conference will be shared during the SITC presentation.

對一名患者血液中 CAR-T 細胞頻率的分析，該患者在輸注後第 17 天顯示出強大的 CAR-T 細胞植入。在 2 名伴有升高（聽不清）的肝轉移患者中註意到進一步擴大。在可以進行 6 週腫瘤評估的患者中，也有令人鼓舞的臨床活動跡象。根據 RECIST，3 名患者顯示初始腫瘤縮小，腫瘤縮小 18% 至 27%。即使在測試的最低劑量下也發現了初始腫瘤縮小的跡象。在提交摘要和會議之間評估的另外 1 名患者的數據將在 SITC 演示期間共享。

The data from the trial are very encouraging, and we look forward to presenting updated data from the open cohorts and especially for the combination part with CARVac at upcoming congresses. Now we move to a data update of our ongoing Phase I/II trial on our bispecific antibody, BNT311 which we are developing in collaboration with Genmab. Slide 26 shows the mechanism of action of BNT311 and the Phase I/II trial design. BNT311 is the first-in-class bispecific antibody designed to elicit an antitumor immune response by simultaneous and complementary blockade of PD-L1 on tumor cells and conditional 4-1BB stimulation on T cells and natural killer cells. Previous analysis presented at SITC 2020 showed encouraging signs of clinical activity and the manageable safety profile in patients with advanced solid tumors during the dose escalation phase of this ongoing Phase I/II trial. This data, along with a semi-mechanistic pharmacokinetic pharmacodynamic predictive model and translational work established 100-milligram of BNT311 every 3 weeks as the dose for expansion cohorts.

試驗數據非常令人鼓舞，我們期待在即將舉行的大會上展示來自開放隊列的更新數據，尤其是與 CARVac 的組合部分。現在我們開始對我們正在與 Genmab 合作開發的雙特異性抗體 BNT311 進行的 I/II 期試驗的數據更新。幻燈片 26 顯示了 BNT311 的作用機制和 I/II 期試驗設計。 BNT311是一流的雙特異性抗體，旨在通過同時互補阻斷腫瘤細胞上的PD-L1以及對T細胞和自然殺傷細胞進行條件性4-1BB刺激來引發抗腫瘤免疫反應。在 SITC 2020 上提交的先前分析顯示，在正在進行的 I / II 期試驗的劑量遞增階段，晚期實體瘤患者的臨床活動和可管理的安全性狀況令人鼓舞。該數據連同半機械藥代動力學藥效學預測模型和轉化工作建立了每 3 週 100 毫克 BNT311 作為擴展隊列的劑量。

For details on this model will be presented at SITC. Since the dose escalation, we have proceeded to the dose expansion cohort of heavily pretreated patients with relapsed or refractory advanced and/or metastatic solid tumors with preliminary data shown on Slide 27. The safety data are in line with our previous disclosure and most treatment-related adverse events were mild to moderate. Immunophenotyping of peripheral blood measurements of soluble immune mediators from serial blood samples and immunohistochemistry analysis of tumor biopsies showed that BNT311 elicited pharmacodynamic effect consistent with its proposed mechanism of action. We identified peripheral and tumor immune activity in patients, including the moderation of immune cytokines, the expansion of CD8 effector memory T cells and natural killer cell activation. 5 patients had partial responses and showed a trend towards greater induction of cytokines and immune endpoints compared to nonresponders.

有關此模型的詳細信息將在 SITC 上介紹。自劑量增加以來，我們已經對經過大量預處理的複發性或難治性晚期和/或轉移性實體瘤患者進行劑量擴展隊列，初步數據顯示在幻燈片 27 中。安全性數據與我們之前的披露和大多數治療-相關的不良事件為輕度至中度。對來自系列血液樣本的可溶性免疫介質的外周血測量結果進行免疫表型分析，並對腫瘤活檢組織進行免疫組織化學分析，結果表明 BNT311 引發的藥效學作用與其提出的作用機制一致。我們確定了患者的外周和腫瘤免疫活性，包括免疫細胞因子的調節、CD8 效應記憶 T 細胞的擴增和自然殺傷細胞的激活。與無反應者相比，5 名患者有部分反應，並顯示出更多誘導細胞因子和免疫終點的趨勢。

We also identified associations between disease control and the time from last anti-PD-1 therapy prior to the study treatment and PD-L1 expression on tumors. The disease control rates were higher among patients who have progressed with prior anti-PD-1 therapy within 8 months prior to the first dose of BNT311. Tumor reduction of any degree occurred mainly in patients with PD-L1 positive tumors. These findings support that patient selection and/or anti-PD-1 combination therapy may lead to further improved clinical efficacy. We expect to start a Phase II trial of BNT311 as monotherapy and in combination with pembrolizumab in refractory or relapsed metastatic non-small cell lung cancer within the next weeks.

我們還確定了疾病控制與研究治療前最後一次抗 PD-1 治療的時間與腫瘤上 PD-L1 表達之間的關聯。在首劑 BNT311 之前 8 個月內接受過抗 PD-1 治療的患者的疾病控制率更高。任何程度的腫瘤縮小主要發生在 PD-L1 陽性腫瘤患者中。這些發現支持患者選擇和/或抗 PD-1 聯合治療可能會進一步提高臨床療效。我們預計將在未來幾週內啟動 BNT311 作為單一療法並與 pembrolizumab 聯合治療難治性或複發性轉移性非小細胞肺癌的 II 期試驗。

On Slide 28, our second first-in-class bispecific antibody, BNT312, which we are also developing in collaboration with Genmab. It combines targeting and conditional activation of CD40 and 4-1BB on immune cells, resulting in enhanced priming and activation of tumor-specific immunity. The ongoing first-in-human trial evaluates the safety and antitumor activity of BNT312.

在幻燈片 28 上，我們還與 Genmab 合作開發了我們的第二個一流雙特異性抗體 BNT312。它結合了 CD40 和 4-1BB 對免疫細胞的靶向和條件激活，從而增強了腫瘤特異性免疫的啟動和激活。正在進行的首次人體試驗評估了 BNT312 的安全性和抗腫瘤活性。

As shown on Slide 29, as of July 1, 2021, 50 patients have received BNT312 monotherapy in the dose escalation part. The most common type of cancer include colorectal cancer, melanoma and non-small cell lung cancer, and patients have undergone a median of 2.5 treatment cycles. To date, the maximum tolerated dose has not been reached and BNT312 has demonstrated a favorable safety profile with treatment-related adverse events being mostly mild to moderate. 1 dose-limiting toxicity of transaminases elevation occurred at the 200-milligram dose and resolved upon corticosteroid administration. We have observed increases in peripheral monocytes and dendritic cell cytokines and also increased levels of CD8 and effector memory T-cells.

如幻燈片 29 所示，截至 2021 年 7 月 1 日，已有 50 名患者在劑量遞增部分接受了 BNT312 單藥治療。最常見的癌症類型包括結腸直腸癌、黑色素瘤和非小細胞肺癌，患者平均接受了 2.5 個治療週期。迄今為止，尚未達到最大耐受劑量，BNT312已證明具有良好的安全性，與治療相關的不良事件大多為輕度至中度。 1 轉氨酶升高的劑量限制性毒性發生在 200 毫克劑量，並在皮質類固醇給藥後消失。我們觀察到外周單核細胞和樹突狀細胞細胞因子的增加以及 CD8 和效應記憶 T 細胞水平的增加。

This suggests biological activity that is consistent with the proposed mechanism of action for BNT312. Moreover about half of these patients who had exhausted standard therapies achieved disease control, 2 patients with melanoma and neuroendocrine lung cancer who had confirmed partial responses. We have identified 100 milligrams every 3 weeks for dose expansion also for the (inaudible) body. The study was recently updated to include multiple expansion cohorts, including as a frontline treatment in head and neck squamous cell carcinoma, melanoma and pancreatic ductal adenocarcinoma additional expansion cohorts will include combination with pembrolizumab in first-line non-small cell lung cancer in combination with pembro and chemotherapy in first-line head and neck squamous cell carcinoma.

這表明生物活性與所提出的 BNT312 作用機制一致。此外，這些用盡標準療法的患者中約有一半實現了疾病控制，2 名黑色素瘤和神經內分泌肺癌患者已確認部分緩解。我們已經確定每 3 週 100 毫克用於（聽不清）身體的劑量擴展。該研究最近更新為包括多個擴展隊列，包括作為頭頸部鱗狀細胞癌、黑色素瘤和胰腺導管腺癌的一線治療，其他擴展隊列將包括與派姆單抗聯合治療一線非小細胞肺癌pembro 和化療在一線頭頸部鱗狀細胞癌中的應用。

As shown on Slide 30, at SITC, we will also present data from the Phase I/II trial in patients with solid tumors of our toll-like receptor 7 agonist product candidate, BNT411. BNT411 is a small molecule designed to activate both the adaptive and innate immune system for the toll-like receptor 7 pathway and to stimulate antigen-specific CD8 T cells, B cells and innate immune cells. During the dose escalation part, patients with metastatic or unresectable solid tumors that have exhausted available treatments will received BNT411 monotherapy at up to 8 different dose levels. In the second dose escalation arm, patients with chemotherapy-naïve extensive-stage small cell lung cancer, will received BNT411, in combination with cytotoxic therapies and [chocolate] checkpoint inhibitors.

如幻燈片 30 所示，在 SITC，我們還將展示我們的 toll 樣受體 7 激動劑候選產品 BNT411 在實體瘤患者中的 I/II 期試驗數據。 BNT411是一種小分子，旨在激活toll樣受體7通路的適應性和先天免疫系統，並刺激抗原特異性CD8 T細胞、B細胞和先天免疫細胞。在劑量遞增部分，已用盡可用治療的轉移性或不可切除實體瘤患者將接受多達 8 個不同劑量水平的 BNT411 單藥治療。在第二個劑量遞增組中，未經化療的廣泛期小細胞肺癌患者將接受 BNT411，聯合細胞毒療法和 [巧克力] 檢查點抑製劑。

The dose escalation part will be followed by dose expansion cohorts. As of July 1, 2021, 11 heavily pretreated patients have received BNT411 monotherapy. Thus far, type of 8 dose levels have been cleared for evaluation. To date, BNT411 had a tolerable safety profile with no dose-limiting toxicities. The only drug-related adverse events reported were a non-serious pyrexia and mytomoderate in India. The biological activity of BNT411 was consistent with its mechanism of action as indicated by the induction of plasma cytokines and increased levels of interferon gamma induced protein. Based on preliminary unclean data, the best response seen for BNT411 monotherapy in these few patients was 5 months of stable disease in a patient with anti-PD-1 pretreated squamous cell carcinoma (inaudible).

劑量遞增部分之後將是劑量擴展隊列。截至 2021 年 7 月 1 日，已有 11 名經過大量預處理的患者接受了 BNT411 單藥治療。到目前為止，8 種劑量水平的類型已被批准用於評估。迄今為止，BNT411 具有可耐受的安全性，沒有劑量限制性毒性。報告的唯一與藥物相關的不良事件是印度的非嚴重發熱和肌中度。 BNT411 的生物活性與其作用機制一致，如血漿細胞因子的誘導和乾擾素 γ 誘導蛋白水平的增加所示。根據初步的不干淨數據，BNT411 單藥治療在這少數患者中的最佳反應是抗 PD-1 預處理鱗狀細胞癌患者 5 個月的疾病穩定（聽不清）。

These data support the advancement of the trial into the dose escalation part in which patients receive BNT411 in combination with cytotoxic therapies and checkpoint inhibitors and recruitment into this therapy arm started in June. Recruitment for the expansion cohort is expected to begin next year. This encouraging data from our oncology programs, which we will present at SITC 2021, are indicative of significant progress in our oncology portfolio and they represent critical steps for us towards bringing cancer immunotherapy into the next generation. I now turn over to our Chief Financial Officer, Jens Holstein, who will discuss our financial results.

這些數據支持將試驗推進到劑量遞增部分，其中患者接受 BNT411聯合細胞毒性療法和檢查點抑製劑，並於 6 月開始招募該治療組。擴展隊列的招聘預計將於明年開始。我們將在 SITC 2021 上展示的來自我們腫瘤學項目的這些令人鼓舞的數據表明我們的腫瘤學產品組合取得了重大進展，它們代表了我們將癌症免疫療法帶入下一代的關鍵步驟。我現在轉交給我們的首席財務官 Jens Holstein，他將討論我們的財務業績。

Thank you, Ozlem, and a warm welcome to those of you on the phone. I will start my section by moving to our financial results for the third quarter of 2021, as shown on Slide 32. Total revenues were estimated to be approximately EUR 6.1 billion for the third quarter of 2021 compared to EUR 67.5 million for the comparative period in 2020. For the period of 9 months ended September 30, 2021, we reported estimated total revenues of around EUR 13.4 billion compared to EUR 136.9 million for the comparative prior year period. Total revenues increased due to this rapid increase in supply and sales of our COVID-19 vaccine worldwide.

謝謝你，Ozlem，並熱烈歡迎電話中的各位。我將從 2021 年第三季度的財務業績開始我的部分，如幻燈片 32 所示。2021 年第三季度的總收入估計約為 61 億歐元，而去年同期為 6750 萬歐元2020 年。截至 2021 年 9 月 30 日的 9 個月期間，我們報告的估計總收入約為 134 億歐元，而去年同期為 1.369 億歐元。由於我們在全球範圍內 COVID-19 疫苗的供應和銷售快速增長，總收入增加。

As a reminder, on our COVID-19 vaccine calibrations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution rights. A breakdown of our commercial revenues is shown on Slide 33. Our third quarter 2021 commercial revenues include approximately EUR 4.4 billion and respectively, EUR 10.2 billion for the first 3 quarters of 2021 that comprise our gross profit share generated by our collaboration partners in their respective territories as well as sales milestones. The sales milestones included in the figures I just mentioned amounted to EUR 17 million for the third quarter and EUR 432.8 million for the period of 9 months ended September 30, 2021.

提醒一下，在我們的 COVID-19 疫苗校準中，我們、輝瑞和復星醫藥之間已根據營銷和分銷權分配了區域。幻燈片 33 顯示了我們的商業收入明細。我們 2021 年第三季度的商業收入分別包括大約 44 億歐元和 2021 年前三個季度的 102 億歐元，這包括我們的合作夥伴在各自的毛利份額地區以及銷售里程碑。我剛才提到的數據中包含的銷售里程碑在第三季度達到了 1700 萬歐元，在截至 2021 年 9 月 30 日的 9 個月期間達到了 4.328 億歐元。

Similar to previous quarters, the figures for our profit share are estimated based on preliminary data shared between Pfizer and us and may be subject to adjustments pending final data on input parameters like sales volume and values as well as transfer prices. Any changes in our share of collaboration partners gross profit will be recognized prospectively. Our COVID-19 vaccine commercial revenues in the third quarter also include EUR 312.3 million in sales to our collaboration partners of products manufactured by us and EUR 1.4 billion of direct COVID-19 vaccine sales to customers in our territory which includes Germany and Turkey.

與前幾個季度類似，我們的利潤份額數據是根據輝瑞和我們之間共享的初步數據估算的，並且可能會根據銷售量和價值以及轉讓價格等輸入參數的最終數據進行調整。我們在合作夥伴毛利中所佔份額的任何變化都將被前瞻性地確認。我們在第三季度的 COVID-19 疫苗商業收入還包括向合作夥伴銷售我們製造的產品的 3.123 億歐元，以及向包括德國和土耳其在內的我們境內客戶的 14 億歐元直接 COVID-19 疫苗銷售。

For the period of 9 months ended September 30, 2021, we had sales to our collaboration partners of EUR 514.3 million and approximately EUR 2.6 billion direct COVID-19 vaccine sales in Germany and Turkey.

在截至 2021 年 9 月 30 日的 9 個月期間，我們向合作夥伴的銷售額為 5.143 億歐元，在德國和土耳其的 COVID-19 疫苗直接銷售額約為 26 億歐元。

Now returning back to Slide 32 and moving to cost of sales, which were estimated to be EUR 1.2 billion for the third quarter of 2021 compared to EUR 6.8 million for the comparative period in 2020. For the 9 months ended September 30, 2021, total cost of sales were estimated to be around EUR 2.3 billion compared to EUR 18.3 million for the comparative prior year period. The increase was driven by cost of sales recognized with respect to our COVID-19 vaccine sales and included the share of gross profit that we owe our collaboration partner Pfizer on our sales.

現在回到幻燈片 32 並轉向銷售成本，預計 2021 年第三季度為 12 億歐元，而 2020 年同期為 680 萬歐元。截至 2021 年 9 月 30 日的 9 個月，總計銷售成本估計約為 23 億歐元，而去年同期為 1830 萬歐元。這一增長是由我們的 COVID-19疫苗銷售確認的銷售成本推動的，其中包括我們在銷售中欠合作夥伴輝瑞公司的毛利潤份額。

Research and development expenses were EUR 260.4 million for the third quarter of 2021 compared to EUR 227.7 million for the comparative period in 2020. For the 9 months ended September 30, 2021, research and development expenses reached EUR 677.7 million compared to EUR 388 million for the comparative prior year period. The increase was mainly due to an increase in research and development expenses from the BNT162 program. As a reminder, development costs are shared equally between Pfizer and us. The increase was further driven by an increase in wages, benefits and social security expenses following an increase in head count.

2021 年第三季度的研發費用為 2.604 億歐元，而 2020 年同期為 2.277 億歐元。截至 2021 年 9 月 30 日的 9 個月，研發費用為 6.777 億歐元，上年同期為 3.88 億歐元上年比較期間。增加的主要原因是BNT162項目的研發費用增加。提醒一下，輝瑞和我們之間均攤開發成本。隨著員工人數的增加，工資、福利和社會保障費用的增加進一步推動了這一增長。

The recognition of inventor compensation expenses as well as expenses incurred under share-based payment arrangements from the company. General and administrative expenses was EUR 68.2 million for the third quarter of 2021 compared to EUR 23.5 million for the comparative prior year period. For the 9 months ended September 30, 2021, general and administrative expenses reached EUR 154.9 million compared to EUR 58.1 million for the comparative prior year period.

確認發明人補償費用以及公司在股份支付安排下發生的費用。 2021 年第三季度的一般和管理費用為 6820 萬歐元，而去年同期為 2350 萬歐元。截至 2021 年 9 月 30 日的 9 個月，一般和管理費用達到 1.549 億歐元，而去年同期為 5810 萬歐元。

Similar to R&D, the increase in G&A was driven by an increase in headcount and expenses incurred under the company's share-based payment arrangements, increase in expenses for purchased management, consulting and legal services as well as higher insurance premiums caused by the increased business volume. Interim income taxes were accrued in an amount of approximately EUR 1.5 billion for the third quarter of 2021, and around EUR 3.2 billion for the 9 months ended September 30, 2021, and were recognized using the estimated annual effective income tax rate of approximately 31%. For the third quarter of 2021, net profit reached approximately EUR 3.2 billion compared to a net loss of EUR 210 million for the comparative prior year period. For the 9 months ended September 30, 2021, total net profit reached approximately EUR 7.1 billion compared to a total net loss of EUR 351.7 million for the comparative prior year period.

與研發類似，G&A 的增長是由於員工人數和公司股份支付安排下發生的費用增加、購買的管理、諮詢和法律服務費用增加以及業務量增加導致的保險費增加. 2021 年第三季度的中期所得稅約為 15 億歐元，截至 2021 年 9 月 30 日的 9 個月約為 32 億歐元，並使用約 31% 的估計年度有效所得稅率確認. 2021 年第三季度，淨利潤達到約 32 億歐元，而去年同期的淨虧損為 2.1 億歐元。截至 2021 年 9 月 30 日的 9 個月，淨利潤總額達到約 71 億歐元，而去年同期的淨虧損總額為 3.517 億歐元。

As of September 30, 2021, cash and cash equivalents totaled EUR 2.4 billion. Please note that the contractual settlement of the gross profit share under our COVID-19 calibration with Pfizer as temporal offset of more than 1 calendar quarter. As far as the fiscal quarter for subsidiaries outside the United States differs from ours, creates an additional time lag between the recognition of revenues and the payment receipt. Consequently, trade receivables, which were outstanding as of September 30, 2021, where we received as payments only in October 2021, improving our cash position relative to the amount at September 30, 2021.

截至 2021 年 9 月 30 日，現金及現金等價物總額為 24 億歐元。請注意，根據我們與輝瑞（Pfizer）的 COVID-19 校準，毛利份額的合同結算是超過 1 個日曆季度的時間偏移。只要美國以外子公司的財政季度與我們的不同，就會在收入確認和付款收據之間產生額外的時間差。因此，截至 2021 年 9 月 30 日未償還的貿易應收賬款，我們僅在 2021 年 10 月才收到付款，相對於 2021 年 9 月 30 日的金額而言，我們的現金狀況有所改善。

Moving to Slide 34. Our outlook for the 2021 financial year has been updated. Based on planned deliveries of up to 2.5 billion doses in the calendar year 2021, we're providing estimated COVID-19 vaccine revenues of approximately EUR 16 billion to EUR 17 billion for the full 2021 financial year. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory. Expected revenues from sales to our collaboration partners, expected sales milestone payments from our collaboration partners and expected revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration part of the territories.

轉到幻燈片 34。我們對 2021 財年的展望已更新。根據計劃在 2021 日曆年交付多達 25 億劑疫苗，我們在 2021 財年提供的 COVID-19 疫苗收入估計約為 160 億歐元至 170 億歐元。這一估計反映了直接向我們地區的客戶銷售 COVID-19 疫苗的預期收入。向我們的合作夥伴銷售的預期收入、我們的合作夥伴的預期銷售里程碑付款以及與我們在合作地區合作部分的 COVID-19疫苗銷售毛利中的份額相關的預期收入。

Please note that this figure has been estimated at constant foreign exchange rates. Please keep in mind that we will deliver a significant number of doses to middle to low-income countries where prices are in line with income levels or at non-for-profit basis to serve the progress. We maintain our previous cost guidance for the fiscal year 2021 and expect to incur R&D expenses in a range of EUR 950 million to EUR 1.1 billion, reflecting a further ramp-up of R&D investments in the fourth quarter of 2021, given our plans to expand and accelerate our pipeline development. SG&A expenses are estimated to be in a range of EUR 250 million to EUR 300 million.

請注意，這個數字是按固定匯率估算的。請記住，我們將向價格與收入水平一致或以非營利為基礎的中低收入國家提供大量劑量，以服務於進展。我們維持之前對 2021 財年的成本指導，預計將產生 9.5 億歐元至 11 億歐元的研發費用，這反映了 2021 年第四季度研發投資的進一步增加，因為我們計劃擴大並加快我們的管道開發。 SG&A 費用估計在 2.5 億歐元至 3 億歐元之間。

Capital expenditures for the year 2021 are expected to be in the range of EUR 175 million to EUR 225 million. These figures have again been estimated at constant foreign exchange rates and reflect our current base case projections. Finally, please note that we still expect an estimated annual effective income tax rate of approximately 31% for the BioNTech Group. And with that, I turn the call to our Chief Strategy Officer, Ryan Richardson, for an update on our corporate development activities and concluding remarks. Thank you.

2021 年的資本支出預計在 1.75 億歐元至 2.25 億歐元之間。這些數字再次以固定匯率估算，反映了我們當前的基本情況預測。最後，請注意，我們仍預計 BioNTech 集團的年度有效所得稅率約為 31%。因此，我將電話轉給我們的首席戰略官 Ryan Richardson，以了解我們公司發展活動的最新情況和結束語。謝謝你。

Thanks, Jens. Moving now to Slide 36.

謝謝，詹斯。現在轉到幻燈片 36。

In the third quarter, we acquired PhagoMed, a biotechnology company based in Vienna Austria.

第三季度，我們收購了總部位於奧地利維也納的生物技術公司 PhagoMed。

The acquisition expands our infectious disease toolkit into synthetic license, a new class of precision antibacterials, which we believe have potential to address a wide range of pathogens and also the growing global challenge of antimicrobial resistance. In addition to its highly trained team, the acquisition brings us PhagoMed's LysinBuilder technology, a proprietary in silico therapeutics platform designed to enable the rapid production of recombinant natural license, which are optimized for potency, stability and manufacturing yield. The transaction, which closed in the third quarter included an upfront cash payment of approximately EUR 50 million in addition to potential future performance-based development milestones of up to EUR 100 million.

此次收購將我們的傳染病工具包擴展到合成許可，這是一類新的精密抗菌劑，我們相信它有可能解決廣泛的病原體以及日益嚴重的全球抗菌素耐藥性挑戰。除了訓練有素的團隊外，此次收購還為我們帶來了 PhagoMed 的 LysinBuilder 技術，這是一種專有的計算機治療平台，旨在實現重組天然許可的快速生產，並針對效力、穩定性和製造產量進行了優化。該交易於第三季度完成，包括約 5000 萬歐元的預付款現金，以及高達 1 億歐元的未來基於績效的潛在發展里程碑。

PhagoMed now operates as Biotech R&D Austria and will serve as Biotech's R&D hub for precision antibacterials. We are pleased to add this new class of precision therapies to our infectious disease portfolio of mRNA vaccines and mRNA encoded antibodies. As you can see on Slide 37, we continue to expand our infectious disease capabilities and pipeline to address global health challenges. In addition to our COVID-19 and influenza vaccine programs, which are partnered with Pfizer, we now have active research and preclinical development programs against more than 10 distinct infectious diseases, spanning both vaccine and therapeutic approaches.

PhagoMed 現在作為奧地利生物技術研發中心運營，並將作為 Biotech 精密抗菌藥物的研發中心。我們很高興將這種新型精準療法添加到我們的 mRNA 疫苗和 mRNA 編碼抗體的傳染病組合中。正如您在幻燈片 37 上看到的那樣，我們繼續擴大我們的傳染病能力和管道，以應對全球健康挑戰。除了與輝瑞合作的 COVID-19 和流感疫苗項目外，我們現在還針對 10 多種不同的傳染病開展了積極的研究和臨床前開發項目，涵蓋疫苗和治療方法。

Several of these programs could represent accelerated development opportunities. For example, we plan to initiate first-in-human trials for our malaria and tuberculosis mRNA vaccine candidates in 2022 and look forward to providing further program updates in the coming months. Slide 38 depicts our clinical stage oncology pipeline, comprising 15 programs in 19 ongoing clinical trials across 4 drug classes. With the new trial initiation so far this year. We now have 4 ongoing randomized Phase II trials in oncology. We expect our pipeline to continue to broaden as we head into 2022.

其中一些計劃可能代表加速發展的機會。例如，我們計劃在 2022 年啟動我們的瘧疾和肺結核 mRNA 候選疫苗的首次人體試驗，並期待在未來幾個月內提供進一步的計劃更新。幻燈片 38 描繪了我們的臨床階段腫瘤學管道，包括 4 個藥物類別的 19 個正在進行的臨床試驗中的 15 個項目。隨著今年到目前為止新的試驗開始。我們現在有 4 項正在進行的腫瘤學隨機 II 期試驗。隨著我們進入 2022 年，我們預計我們的管道將繼續擴大。

I would like to point out that even though we have strong partners for certain programs, including Roche, Genmab and Sanofi, the majority of our programs are fully owned. And even where we have partnered we have retained the right to co-commercialize our products in major markets alongside our partners.

我想指出，儘管我們在某些項目上有強大的合作夥伴，包括羅氏、Genmab 和賽諾菲，但我們的大部分項目都是完全擁有的。即使在我們合作的地方，我們也保留與我們的合作夥伴一起在主要市場共同商業化我們的產品的權利。

To close on Slide 39, we are poised to further accelerate the company's transformation as we head into the final stage of the year. Our COVID-19 vaccine continues to be in strong demand globally, and our production network continues to deliver at scale. Our oncology pipeline is advancing on multiple fronts and we are similarly broadening our infectious disease pipeline of novel vaccines and therapeutics behind COVID-19.

在幻燈片 39 結束時，我們準備在進入今年最後階段時進一步加速公司的轉型。我們的 COVID-19 疫苗在全球的需求持續強勁，我們的生產網絡繼續大規模交付。我們的腫瘤學產品線正在多個方面取得進展，我們同樣也在拓寬 COVID-19 背後的新型疫苗和療法的傳染病產品線。

Hiring top talent continues to be a strategic priority, and we have now expanded our team to more than 2,800 employees globally. We will continue to make investments in digital, automation and manufacturing with further mRNA production centers planned in Singapore and Africa. Finally, we continue to expand our global footprint across geographies, including in Europe, the U.S., Africa and Asia as we look to build long-term value for patients, our shareholders and society. And with that, we can now open up.

聘請頂尖人才仍然是我們的戰略重點，我們現在已將我們的團隊擴大到全球 2,800 多名員工。我們將繼續在數字化、自動化和製造方面進行投資，併計劃在新加坡和非洲建立更多的 mRNA 生產中心。最後，我們繼續在歐洲、美國、非洲和亞洲等地區擴大我們的全球足跡，因為我們希望為患者、我們的股東和社會創造長期價值。有了這個，我們現在可以打開了。

(Operator Instructions)

（操作員說明）

And your first request is from the line of Cory Kasimov from JPMorgan.

您的第一個請求來自摩根大通的 Cory Kasimov。

I think I'm starting in a pretty obvious place. But on a broad level, can you talk about the type of impact you see the oral antivirals having on the demand for COVID-19 vaccines and boosters over both the short and long term?

我想我從一個非常明顯的地方開始。但從廣義上講，您能否談談您認為口服抗病毒藥物在短期和長期內對 COVID-19 疫苗和增強劑需求的影響類型？

I can take this question.

我可以接受這個問題。

I hope that you can hear me, I'm at the airport and there might be background noise. So the oral inhibitors, of course, provide the opportunity for treatment if the disease is established. The key question is indeed that this come with a reduced vaccination rate in the overall population which we can't estimate at the moment. We have to understand, first of all, that how much this all inhibitors will be available in 2022 at which percentage. And we have, of course, to understand whether the high efficacy, which was reported the last -- over a longer time. We know that single treatments with inhibitors in viral disease often results in development of resistance -- resistances and we have really to wait and see how this type of additional treatment, which is fantastic to have now in the market will complement or even compete with vaccines. I personally don't believe that this will have a huge impact on the vaccination rate in the future, but we have to monitor the field in the upcoming future.

我希望你能聽到我的聲音，我在機場，可能會有背景噪音。因此，如果疾病確定，口服抑製劑當然會為治療提供機會。關鍵問題確實是，這伴隨著總體人口中疫苗接種率的降低，我們目前無法估計。首先，我們必須了解，到 2022 年，所有這些抑製劑將以多少百分比提供。當然，我們還需要了解最後一次報告的高效能是否持續更長的時間。我們知道，在病毒性疾病中使用抑製劑進行單一治療通常會導致耐藥性的產生——耐藥性，我們真的必須拭目以待，看看這種現在市場上非常棒的額外治療將如何補充甚至與疫苗競爭.我個人不認為這會對未來的疫苗接種率產生巨大影響，但我們必須在即將到來的未來對該領域進行監測。

Your next question is from the line of Chris Shibutani of Goldman Sachs.

您的下一個問題來自高盛的 Chris Shibutani。

Regarding the outlook for the Booster market, there are 2 important opportunities that impact the intermediate and the longer-term outlook for your vaccine revenues, one being boosters for the broader adult population, not just the high risk or elderly. And the second being what would be the potential frequency going forward longer term of subsequent boosters for instance, will it be annual. If we look back at how this played out for the original boosters, the evidence came a few months before regulators and the advisory groups address the issue and got on board. What's your expectation for the kind of evidence and the debate and how this will play out for these 2 issues: one, the broader population for booster recommendations; and two, the frequency of subsequent boosters longer term?

關於助推器市場的前景，有兩個重要機會會影響您的疫苗收入的中期和長期前景，一個是針對更廣泛的成年人口的助推器，而不僅僅是高風險人群或老年人。第二個是後續助推器的長期潛在頻率，例如，它是每年一次。如果我們回顧一下最初的助推器是如何發揮作用的，那麼證據是在監管機構和諮詢小組解決這個問題並加入之前幾個月出現的。您對這類證據和辯論的期望是什麼，以及這將如何解決這兩個問題：第一，更廣泛的人群接受加強建議；第二，長期後續助推器的頻率？

Yes. Yes, the value of booster vaccinations, not only for the elderly, but for the overall population is becoming more and more evident. So we have real world data, particularly from Israel showing that booster vaccinations in the overall population can reduce dramatically the rate of infections as compared to the sort of population who did not receive the booster vaccination in the range of 15 to 20 fold. And we have now evidence from our Phase III clinical trial where we compared the efficacy of the third dose -- of a booster dose in a randomized fashion and observed that an additional booster increases happen at an efficacy of more than 95%, which is in line with the strong antibody responses that we observed in this population. And this was the overall population, we didn't see any differences in the elderly and in the younger population, indicating that booster vaccinations really dramatically reduced the infection rate.

是的。是的，加強免疫接種的價值，不僅對老年人，而且對整個人口都越來越明顯。因此，我們有真實世界的數據，特別是來自以色列的數據顯示，與未接受加強疫苗接種的人群相比，總體人群中的加強疫苗接種可以顯著降低感染率，範圍為 15 到 20 倍。我們現在有來自我們的 III 期臨床試驗的證據，在該試驗中，我們以隨機方式比較了第三劑加強劑量的功效，並觀察到額外的加強劑量增加發生在超過 95% 的功效，這是在符合我們在該人群中觀察到的強烈抗體反應。這是總體人口，我們沒有看到老年人和年輕人之間的任何差異，這表明加強疫苗接種確實大大降低了感染率。

We believe that boosters have a great value in controlling the pandemic, particularly this winter where we have to deal on the one side with the challenge that overall population is not -- the vaccination rate is still not sufficient to control the delta variant. And with the increasing reining of vaccine responses, we will see also in the vaccinated population and increase of infection. So we clearly see that there is a scientific rationale for boosting the overall population. How this will continue next year, we don't know. We have just to collect the data. We, of course, know that the virus is relatively early in the evolution. We will definitely see further adaptations of the infection rate. We will see adaptations of antibody escape variants coming in, which will require -- which will probably require adaptation of the vaccine. But we can't say at the moment, when this is going to happen, that boosters are coming every 12 months or every 18 months or 24 months.

我們認為，加強劑在控制大流行方面具有很大的價值，特別是在今年冬天，我們一方面必須應對總體人口所沒有的挑戰——疫苗接種率仍然不足以控制 delta 變種。隨著疫苗反應的日益控制，我們還將看到接種疫苗的人群和感染的增加。所以我們清楚地看到，增加總人口是有科學依據的。明年這將如何繼續，我們不知道。我們只需要收集數據。當然，我們知道該病毒處於進化的相對早期。我們肯定會看到感染率的進一步調整。我們將看到抗體逃逸變體的適應出現，這將需要——這可能需要對疫苗進行適應。但目前我們不能說，當這種情況發生時，助推器每 12 個月或每 18 個月或 24 個月就會出現一次。

Our next question is from the line of Tazeen Ahmad from (inaudible).

我們的下一個問題來自（聽不清）的 Tazeen Ahmad。

Just a couple of points of clarification from me with regards to the SITC presentations. The first one for 111, should we expect to see an update on safety Or will there be an update on efficacy specifically? I think back in March, you had provided an update on disease per the survival numbers. Should we expect to see that updated at all? And then secondly, for 312, I think you're going to be giving a mini oral for that as well. Similar question, is the focus of that going to be primarily on safety or will we get a little bit more granularity on the doses that you're using in the dose escalation portion and what kind of efficacy do you expect there?

關於 SITC 演示文稿，我只需要澄清幾點。 111 的第一個，我們應該期待看到安全性的更新，還是會有專門的功效更新？我想早在三月份，您就根據生存人數提供了有關疾病的最新信息。我們應該期望看到更新嗎？其次，對於 312，我認為您也將為此進行一次小型口頭報告。類似的問題，重點是主要放在安全性上，還是我們會對您在劑量遞增部分使用的劑量進行更詳細的說明，以及您期望在那裡產生什麼樣的功效？

Yes. So for 111, we have now started the Phase II clinical testing and this trial will generate data earliest in 2023 from the Stage 2 clinical trial for 312. We will update on SITC about the clinical findings, of course, including the dose levels, yes. And we will certainly provide updates during ASCO -- ASCO and ESMO next year.

是的。所以對於 111，我們現在已經開始了 II 期臨床試驗，這項試驗最早將在 2023 年從 312 的 2 期臨床試驗中產生數據。我們將在 SITC 上更新臨床發現，當然，包括劑量水平，是的.我們肯定會在 ASCO 期間提供更新——明年的 ASCO 和 ESMO。

Your next question is from the line of Daina Graybosch of SVB Leering.

您的下一個問題來自 SVB Leering 的 Daina Graybosch。

I wonder if you could give us an update on where you are with your partner, Fosun, in China on regulatory approval and potential distribution?

我想知道您能否向我們介紹一下您與合作夥伴復星在中國的監管批准和潛在分銷方面的最新情況？

Yes, sure. I can take that one, Daina. So we have -- we were granted emergency use authorization in Q1 in Hong Kong and Macau, which is a Fosun territory. And we've been distributing vaccine to that region over the course of the year. We've also signed a 15 million dose deal with Taiwan, which is also Fosun commercialization territory and have commenced shipment of vaccine to the Taiwan territory. In Mainland China, we have submitted data for effectively a BLA approval, and we are still waiting for response from the regulator and still engage with the regulator to open up the approval pathway in Mainland China.

是的，當然。我可以拿那個，戴娜。所以我們 - 我們在第一季度在香港和澳門獲得了緊急使用授權，這是複星的領土。在這一年中，我們一直在向該地區分發疫苗。我們還與同為複星商業化領土的台灣簽署了1500萬劑的協議，並開始向台灣領土運送疫苗。在中國大陸，我們已經提交了有效BLA批准的數據，我們仍在等待監管機構的回應，並仍在與監管機構接觸，以開闢中國大陸的批准途徑。

Your next question is from the line of Akash Tewari from Jefferies.

您的下一個問題來自 Jefferies 的 Akash Tewari。

Just a few. To follow up on a prior question, what specifically in your feedback with the agency, would you have to show to support boosters for all. Do you feel like the agency is focused on a drop in protection for severe disease for the general population? And if so, what is the kind of threshold of protection that you think would support boosters for all versus not supporting boosters for all? And then consensus estimates for your COVID vaccine next year are around $16 billion. So in the ballpark of what you're tracking for 2021, can you talk about how many booster specific contract doses you've already locked up and if replicating the sales you had this year is a reasonable base case?

一些。要跟進之前的問題，即在您與該機構的反饋中，您必須展示哪些具體內容來支持所有人的助推器。您是否覺得該機構的重點是減少對普通人群的嚴重疾病的保護？如果是這樣，您認為支持所有人的助推器與不支持所有人的助推器的保護閾值是什麼？然後，明年對您的 COVID 疫苗的共識估計約為 160 億美元。因此，在您跟踪 2021 年的情況下，您能否談談您已經鎖定了多少特定於助推器的合同劑量，以及復制您今年的銷售是否是一個合理的基本案例？

I could take the first part of the question. And so it is what regulators convinces is, of course, the overall data package at the time point and when we requested authorization of the booster doses, we had data from antibody responses, increase of neutralizing antibody titers. And we had data coming in from real-world data from Israel. We have now an additional data package from the randomized trials, which we are going to submit to further support booster doses in the overall population showing a 95% -- more than 95% efficacy, relative efficacy in subjects who received the third dose.

我可以回答問題的第一部分。因此，監管機構確信的當然是當時的整體數據包，當我們要求授權加強劑量時，我們有來自抗體反應、中和抗體滴度增加的數據。我們的數據來自以色列的真實數據。我們現在有一個來自隨機試驗的額外數據包，我們將提交這些數據包，以進一步支持在接受第三劑的受試者中顯示 95% - 超過 95% 的療效和相對療效的總體人群中的加強劑量。

We believe that the increasing level of evidence for protection with -- from disease by booster doses is an increasingly good argument to enable also authorization of our vaccines in the overall population. My estimate is, even though we see a good protection against severe disease even after 8, 9 and 10 months, we will see also for protection from severe disease, a further decline, maybe in the direction of 80%. And if you calculate that the booster dose could increase the overall protection against the disease from 80% to 97% or 98% is a good reason to provide booster doses for the overall population. So we expect that the evidence will increase over the next few weeks and months and that this could lead to overall authorization of booster doses for the broader population.

我們認為，越來越多的證據表明通過加強劑量預防疾病是一個越來越好的論據，以使我們的疫苗也能夠在整個人群中獲得授權。我的估計是，即使我們在 8、9 和 10 個月後看到對嚴重疾病的良好保護，我們也會看到對嚴重疾病的保護，進一步下降，可能在 80% 的方向。如果您計算出加強劑量可以將對該疾病的整體保護從 80% 提高到 97% 或 98%，那麼這是為整個人群提供加強劑量的一個很好的理由。因此，我們預計在接下來的幾周和幾個月內，證據將會增加，這可能會導致對更廣泛人群進行加強劑量的總體授權。

And thank you, maybe for the second question, Akash, this is Jens. You know that we announced that we intend to build up the capacity of production that we are able, together with Pfizer to deliver next year to 4 billion. Overall, in terms of guiding of what the final number for revenues will be independent now of the split between Booster and standard sort of vaccination, you've got to bear with us until sometime early next year, please. Generally, you can envisage that at this point in time, we're unable to give any split in terms of how much is booster and what will be actually the contribution of basic vaccination. We all know that big parts of this world are still not vaccinated at all. Percentages are very low, specifically in low and middle-income countries still. And therefore, we have to look how things are evolving over time, and then we will sometime next year, give you an update on where we stand.

謝謝你，也許是第二個問題，Akash，我是 Jens。你知道我們宣布我們打算建立我們有能力的生產能力，與輝瑞一起在明年交付到 40 億。總體而言，就收入的最終數字而言，現在將獨立於助推器和標準類型的疫苗接種之間的差異，請您耐心等待我們，直到明年初的某個時候。一般來說，您可以設想，在這個時間點上，我們無法就加強疫苗的數量和基本疫苗接種的實際貢獻做出任何劃分。我們都知道，這個世界的大部分地區仍然根本沒有接種疫苗。百分比非常低，特別是在低收入和中等收入國家。因此，我們必須看看事情是如何隨著時間的推移而發展的，然後我們將在明年的某個時候向您提供我們所處位置的最新信息。

Your next question is from the line of Daniel Wendorff of ODDO BHF.

您的下一個問題來自 ODDO BHF 的 Daniel Wendorff。

My question would be, in general, related to vaccines eventually eligible for being booster shots against the new coronavirus. Is that something very likely only limited to the mRNA vaccines? Or do you see any kind of other vaccine class potentially could be eligible for booster shots potentially also just looking beyond the third dose, if it is necessary at one point in time to potentially have regular booster shots.

一般來說，我的問題與最終有資格成為新冠病毒加強注射的疫苗有關。這很可能僅限於 mRNA 疫苗嗎？或者您是否看到任何其他類型的疫苗都可能有資格進行加強注射，如果有必要在某個時間點進行常規加強注射，也可能只看第三劑以外的疫苗。

I didn't get the question. Could you specify your question again, please, I'm sorry.

我沒有得到這個問題。請您再次說明您的問題，對不起。

Yes. So in simple terms, will it be just mRNA vaccines being eligible for the booster shot? Or are there any new developments, other patients to other vaccines, which would also make them likely to be available booster shots.

是的。所以簡單來說，是否只有 mRNA 疫苗才有資格進行加強注射？或者是否有任何新的發展，其他患者對其他疫苗，這也將使他們有可能獲得加強注射。

We can't comment on other vaccines, but I don't see any pharma reason why other vaccines should not be eligible for boosters dosing. It is -- it will be based, of course, on the availability of data and evidence that they provide a good risk-benefit profile.

我們不能對其他疫苗發表評論，但我看不出其他疫苗不符合加強劑量接種條件的任何製藥原因。它是 - 當然，它將基於數據的可用性和證據，證明它們提供了良好的風險收益概況。

Your next question is from the line of Arlinda Lee from Canaccord.

您的下一個問題來自 Canaccord 的 Arlinda Lee。

I guess with your commitment to equitable access and certain price points during the pandemic, how do you think about pricing and access in terms of boosters, pricing for the children's doses that maybe 1/10 and 1/3 of the original adult dose and then potentially emerge out of the pandemic control?

我想，鑑於您在大流行期間對公平獲取和某些價格點的承諾，您如何看待助推器的定價和獲取，兒童劑量的定價可能是原始成人劑量的 1/10 和 1/3，然後可能擺脫大流行控制？

I'll take that one.

我會拿那個。

I think with the middle income, the low-income countries, as we move out of the pandemic you still have to consider what those countries can pay, and that will be a consideration in how we calculate a future ex-pandemic price. With the pediatric, again, I think you have to look at -- you have to look at it from a value perspective and not a straight reduction in milligrams or micrograms and a kick in terms of the price that we would consider. Again, I would say that there will certainly be a ex-pandemic price. And of course, we're currently working on that. We're still very much in the pandemic.

我認為對於中等收入國家和低收入國家，隨著我們擺脫大流行，您仍然必須考慮這些國家可以支付多少費用，這將是我們如何計算未來大流行病後價格的一個考慮因素。對於兒科，我認為您必須再次考慮 - 您必須從價值的角度來看待它，而不是直接減少毫克或微克以及我們會考慮的價格方面的影響。再說一次，我會說肯定會有大流行病前的價格。當然，我們目前正在努力。我們仍處於大流行之中。

And our last question today is from the line of Ali Merit from UBS.

我們今天的最後一個問題來自瑞銀的 Ali Merit。

Just on the business development strategy going forward. I guess just after the PhagoMed acquisition, should we expect to see more deals of that sort? And I guess going forward, are there particular therapeutic areas or modalities that you're looking at most closely or that you think kind of synergize best with your platform and pipeline currently?

只是關於未來的業務發展戰略。我猜在收購 PhagoMed 之後，我們是否應該期待看到更多此類交易？而且我想，展望未來，是否有您最密切關注的特定治療領域或方式，或者您認為目前與您的平台和管道最好的協同作用？

Yes, I can take that question. Thank you. So yes, I think you've seen us do 2 acquisitions this year. The first, the acquisition of the solid tumor assets from Kite, the TCR assets and cell therapy manufacturing facility in the United States. And then now you've seen the PhagoMed acquisition. And I do think you can expect to see more of these types of deals, and our key criteria will be to broaden our technology base. As with PhagoMed into new classes of medicines that I think are complementary to our pipeline, but also potentially clinical stage programs in our core therapeutic areas. And by that, I would include oncology and infectious disease has 2 key areas of focus.

是的，我可以接受這個問題。謝謝你。所以是的，我想你已經看到我們今年進行了 2 次收購。一是收購美國Kite公司的實體瘤資產、TCR資產和細胞療法製造廠。然後現在你已經看到了對 PhagoMed 的收購。而且我確實認為您可以期待看到更多此類交易，我們的關鍵標準將是擴大我們的技術基礎。與 PhagoMed 一樣，我認為這些新藥物可以補充我們的管道，但也可能是我們核心治療領域的臨床階段項目。至此，我將包括腫瘤學和傳染病有兩個重點關注領域。

Thank you. There are no further questions. Please continue.

謝謝你。沒有進一步的問題。請繼續。

Thank you. So with that, we would like to close the call today. Thank you for joining today's call, and we are looking forward to talking to you in the future. Thank you everyone.

謝謝你。因此，我們想結束今天的電話會議。感謝您加入今天的電話會議，我們期待在未來與您交談。謝謝大家。

That concludes the presentation today. Thank you for participating. You may disconnect.

今天的演講到此結束。感謝您的參與。您可以斷開連接。