Biontech SE (BNTX) 2022 Q3 法說會逐字稿

Welcome to the BioNTech Third Quarter 2022 Update Call. I would like to hand the call over to the Vice President of Investor Relations and Strategy, Sylke Maas. Please go ahead, Sylke.

歡迎來到 BioNTech 2022 年第三季度更新電話會議。我想將這個電話轉給投資者關係和戰略副總裁 Sylke Maas。請繼續，西爾克。

Thank you all for joining us today as we review our third quarter operational highlights and provide you with some financial update. BioNTech is in exciting phase of its corporate development, and we are delighted to share our progress with you. A few housekeeping items before we start. I invite you to view the slides that accompany the webcast and the third quarter 2022 press release, both of which were issued this morning and can be found in the Investors section of our website.

感謝大家今天加入我們，因為我們回顧了第三季度的運營亮點並為您提供了一些財務更新。 BioNTech 正處於其企業發展的激動人心的階段，我們很高興與您分享我們的進展。在我們開始之前有一些家務。我邀請您查看網絡廣播和 2022 年第三季度新聞稿隨附的幻燈片，這兩份文件均於今天上午發布，可在我們網站的“投資者”部分找到。

Taking the first look at Slide 2, I would like to remind you that during today's presentation, we will make several forward-looking statements. These forward-looking statements include, but are not limited to our COVID-19 vaccine revenues as we include figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2022, the continued global demand for our COVID-19 vaccine, expected COVID-19 vaccine production, supply and deliveries for 2022 and beyond.

先看幻燈片 2，我想提醒您，在今天的演示中，我們將做出一些前瞻性陳述。這些前瞻性陳述包括但不限於我們的 COVID-19 疫苗收入，因為我們包括來自合作夥伴提供的初步估計的數據、我們對 2022 年的估計財務業績、全球對我們 COVID-19 疫苗的持續需求，預計 2022 年及以後的 COVID-19 疫苗生產、供應和交付。

The planned next steps in our pipeline programs; the timing for enrollment initiation, completion and reporting of data from our clinical trials; the timing of and, our ability to obtain and maintain regulatory approval for our product candidates; and other risks described in our filings made with the U.S. Securities and Exchange Commission, including our most recent quarterly report filed today.

我們管道計劃中計劃的下一步；開始註冊、完成和報告我們臨床試驗數據的時間；獲得和維持對我們的產品候選者的監管批准的時間和能力；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，包括我們今天提交的最新季度報告。

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 the conference call and webcast. Also please note that Slides 3 and 4 provide detailed and important safety information regarding our COVID-19 vaccine.

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。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。

Finally, today's agenda can be found on Slide 5. It is my pleasure to welcome the BioNTech management team, who will guide you through our third quarter update. I'm joined by Ugur Sahin, CEO; and Co-founder of BioNTech; Ozlem Tureci, our Chief Medical Officer and Co-Founder; Jens Holstein, our Chief Financial Officer; and Ryan Richardson, our Chief Strategy Officer. With that, I would like to turn the call over to Ugur.

最後，今天的議程可以在幻燈片 5 上找到。我很高興歡迎 BioNTech 管理團隊，他們將指導您完成我們第三季度的更新。首席執行官 Ugur Sahin 也加入了我的行列； BioNTech 聯合創始人； Ozlem Tureci，我們的首席醫療官兼聯合創始人； Jens Holstein，我們的首席財務官；和我們的首席戰略官 Ryan Richardson。有了這個，我想把電話轉給 Ugur。

Thank you, Sylke. A warm welcome to all participants of today's conference call. I'm pleased to update you on BioNTech's operational progress during the third quarter of 2022.

謝謝你，西爾克。熱烈歡迎今天電話會議的所有參與者。我很高興向您介紹 BioNTech 在 2022 年第三季度的運營進展情況。

Before I start, let me value the fundamentals of our success. With our deep expertise in immuno-oncology, our scientific rigor, our fully integrated spectrum of translational research and manufacturing competencies, we succeeded, together with our partner, Pfizer, in developing and supplying various adapted vaccines globally. We did so at an unprecedented speed.

在開始之前，讓我重視我們成功的基礎。憑藉我們在免疫腫瘤學方面的深厚專業知識、我們的科學嚴謹性、我們全面整合的轉化研究和製造能力，我們與我們的合作夥伴輝瑞（Pfizer）一起成功地在全球開發和供應各種適應性疫苗。我們以前所未有的速度這樣做了。

Since BioNTech's inception, we have pursued our vision to establish a fully integrated global immunotherapy powerhouse aspiring to translate science into survival. We follow a technology-agnostic, solution-focused multi-platform strategy. Our innovation engine leverages various emerging technologies and therapeutic approaches. Our aim is to address high unmet medical needs in oncology, infectious diseases and beyond.

自 BioNTech 成立以來，我們一直追求我們的願景，即建立一個完全整合的全球免疫治療強國，致力於將科學轉化為生存。我們遵循與技術無關、以解決方案為中心的多平台戰略。我們的創新引擎利用了各種新興技術和治療方法。我們的目標是解決腫瘤學、傳染病及其他領域未得到滿足的高度醫療需求。

We are advancing a diversified pipeline of immunotherapies and are chasing an unprecedented opportunity to accelerate our progress towards our long-term vision to bring the next generation of immunotherapies to patients.

我們正在推進多元化的免疫療法管道，並正在追逐前所未有的機會，以加快實現我們為患者帶來下一代免疫療法的長期願景的進展。

Moving to our third quarter highlights. We reported total revenues of EUR 3.5 billion, contributing to total revenues of EUR 13 billion for the first 9 months of the year. The strong performance can be attributed to the continued successful execution in our COVID-19 vaccine franchise, and reflects shipments of the Omicron-adapted vaccine booster, which started early in September. We are updating our 2022 financial guidance by raising our vaccine revenues estimated to EUR 16 billion to EUR 17 billion.

轉到我們的第三季度亮點。我們報告的總收入為 35 億歐元，今年前 9 個月的總收入為 130 億歐元。強勁的表現可歸因於我們在 COVID-19 疫苗特許經營中的持續成功執行，並反映了 9 月初開始的適用於 Omicron 的疫苗助推器的出貨量。我們正在更新我們的 2022 年財務指導，將疫苗收入估計從 160 億歐元提高到 170 億歐元。

We have expanded our team to more than 4,000 employees around the world. We are expanding our global M&A manufacturing network to ensure access to our innovative medicines worldwide. We recently signed a letter of intent with Australia's State of Victoria for strategic partnerships to establishing an mRNA research and innovation center and have to translate encouraging academic research into the clinic. We will establish one of our modular BioNTainer manufacturing facilities in Melbourne to enable end-to-end clinical scale manufacturing of mRNA product candidates.

我們的團隊已擴大到全球 4,000 多名員工。我們正在擴大我們的全球併購製造網絡，以確保在全球範圍內獲得我們的創新藥物。我們最近與澳大利亞維多利亞州簽署了一份意向書，旨在建立 mRNA 研究和創新中心的戰略合作夥伴關係，並且必須將令人鼓舞的學術研究轉化為臨床。我們將在墨爾本建立我們的模塊化 BioNTainer 製造設施之一，以實現 mRNA 候選產品的端到端臨床規模製造。

In oncology, we are executing across our broad pipeline. We have advanced a total of 19 candidates in 24 ongoing clinical tariffs, including 5 Phase II trials. In the third quarter, 3 new programs enter Phase 1. At this year's ESMO Conference in September, we presented another positive clinical update for BNT211 for the treatment of solid tumors. Ozlem will share more detail on the data update momentarily.

在腫瘤學領域，我們正在廣泛的管道中執行。我們在 24 項正在進行的臨床關稅中總共推進了 19 名候選人，其中包括 5 項 II 期試驗。第三季度，3個新項目進入第一階段。在今年9月的ESMO會議上，我們展示了BNT211治療實體瘤的另一個積極臨床更新。 Ozlem 將立即分享有關數據更新的更多細節。

Slide 7 highlights our quarter 3 progress of our COVID-19 franchise. This quarter, we and our partner, Pfizer, continued to build on our global COVID-19 vaccine leadership with first-to-market Omicron BA.4/BA.5 adapted vaccine launches across multiple countries and regions worldwide.

幻燈片 7 突出顯示了我們第三季度 COVID-19 特許經營的進展。本季度，我們和我們的合作夥伴輝瑞（Pfizer）繼續鞏固我們在全球 COVID-19 疫苗方面的領先地位，在全球多個國家和地區推出了率先上市的 Omicron BA.4/BA.5 疫苗。

As of mid of October 2022, we have invoiced approximately 300 million doses of our BA.1 or BA.4/BA.5-adapted bivalent vaccine with multiple regulatory developments around our original COMIRNATY vaccine. The vaccine is undergoing conversion to full market approval in several regions around the globe. It has received full marketing authorization in the EU for all existing and upcoming indications and formulations.

截至 2022 年 10 月中旬，我們已經開發了大約 3 億劑 BA.1 或 BA.4/BA.5 適應二價疫苗，並圍繞我們最初的 COMIRNATY 疫苗進行了多項監管開發。該疫苗正在全球多個地區轉變為完全市場批准。它已在歐盟獲得所有現有和即將推出的適應症和配方的全面上市許可。

Additionally, we received EC approval for 3-dose primary series in children aged 6 months to 5 years in the EU and for a third booster dose for children aged 5 to 11 years. The third booster dose was recently approved by the EC for individuals aged 12 and older. With this regulatory approvals, our COVID-19 vaccine is one of the broadest labels among available vaccines.

此外，我們獲得了 EC 批准，用於歐盟 6 個月至 5 歲兒童的 3 劑初級系列和 5 至 11 歲兒童的第三劑加強劑量。歐盟委員會最近批准了第三劑加強劑量用於 12 歲及以上的個人。有了這項監管批准，我們的 COVID-19 疫苗是現有疫苗中最廣泛的標籤之一。

Our Omicron BA.4/5 bivalent vaccine boosters now have approvals for use in more than 45 countries and regions worldwide. We recently reported initial positive data at the 30-day post boost time point in the Phase II clinical trial of our Omicron BA.4/5 adapted bivalent vaccine in individuals 12 years and older.

我們的 Omicron BA.4/5 二價疫苗增強劑現已獲准在全球超過 45 個國家和地區使用。我們最近在 12 歲及以上的個體中報告了我們的 Omicron BA.4/5 適應二價疫苗的 II 期臨床試驗中加強後 30 天時間點的初步陽性數據。

Additionally, we initiated a Phase I/11 trial of the Omicron BA.4/5 bivalent vaccine in children aged 6 months to 11 years. At the end of October, as part of our ongoing collaboration, we and our partner, Pfizer, initiated a Phase I clinical trial evaluating our Omicron BA.4/5 adapted bivalent vaccine in combination with an mRNA influenza vaccine.

此外，我們還在 6 個月至 11 歲的兒童中啟動了 Omicron BA.4/5 二價疫苗的 I/11 期試驗。 10 月底，作為我們正在進行的合作的一部分，我們和我們的合作夥伴輝瑞（Pfizer）啟動了一項 I 期臨床試驗，評估我們的 Omicron BA.4/5 適應二價疫苗與 mRNA 流感疫苗的組合。

The mRNA influenza vaccine candidate is also partnered with Pfizer and has now advanced to Phase III clinical testing after positive data from the Phase II trial were reported in second quarter of this year.

該 mRNA 流感疫苗候選藥物還與輝瑞公司合作，在今年第二季度報告了 II 期試驗的陽性數據後，現已進入 III 期臨床試驗。

Slide 8 highlights our COVID-19 vaccine execution on a global scale. Our mRNA platform and established processes allows for development, testing and manufacturing of variant-adapted vaccine at an unprecedented speed, supporting a rapid regulatory path.

幻燈片 8 重點介紹了我們在全球範圍內的 COVID-19 疫苗執行情況。我們的 mRNA 平台和成熟的流程允許以前所未有的速度開發、測試和製造適應變體的疫苗，支持快速的監管路徑。

With the occurrence of Omicron end of 2021, we and Pfizer started evaluating monovalent and bivalent vaccines directed against Omicron sublineages and other strains of SARS-CoV-2. Data from these studies were presented to regulatory agencies in June and July 2022, which supported regulators' definition of the most appropriate regulatory pathway.

隨著 2021 年底 Omicron 的出現，我們和輝瑞公司開始評估針對 Omicron 亞系和其他 SARS-CoV-2 毒株的單價和二價疫苗。這些研究的數據於 2022 年 6 月和 2022 年 7 月提交給監管機構，這支持了監管機構對最合適監管途徑的定義。

It took us approximately 2 months to go from the first regulatory recommendation for BA.4/5 adapted vaccine for our first shipment of the respective vaccine. The ability to execute with such a speed was enabled by 3 factors: our continued surveillance and analysis of variance of concern, our extensive and proactive COVID-19 clinical program and the rapid manufacturing adaptation. We are well positioned to supply countries and regions around the globe.

從第一個針對 BA.4/5 適應疫苗的監管建議開始，我們花了大約 2 個月的時間才首次出貨相應的疫苗。以這樣的速度執行的能力是由 3 個因素促成的：我們對關注點的持續監測和分析、我們廣泛而積極的 COVID-19 臨床計劃和快速的製造適應。我們有能力為全球國家和地區供貨。

I thank our team and collaborators for their tireless efforts to make this accomplishment possible again in such a short period of time.

我感謝我們的團隊和合作者為在如此短的時間內再次取得這一成就所做的不懈努力。

Slide 9. The need for an Omicron BA.4/5-adapted booster supported by current research, including our own data, as shown on Slide 9. In the Northern Hemisphere, we tend to see case numbers steadily rising. Epidemiologically speaking, BA.4/5 and their related sublineages continue to be the dominant strains. Omicron BA.4/5 adapted bivalent vaccines may also consider robust protection against potential future emerging Omicron sublineages or new variants of concern that are closer to the wilt-type strain.

幻燈片 9。當前研究（包括我們自己的數據）支持的 Omicron BA.4/5 適應性助推器的需求，如幻燈片 9 所示。在北半球，我們傾向於看到病例數穩步上升。從流行病學上講，BA.4/5 及其相關亞系仍然是主要菌株。 Omicron BA.4/5 適應的二價疫苗也可以考慮對潛在的未來新興 Omicron 亞系或更接近枯萎型菌株的關注的新變體提供強有力的保護。

The enhance neutralization breadth may be driven by expansion of memory B cells against epitopes shared broadly among variants as well as in part induction of de novo immune responses against new epitopes. Moreover, expansion and preservation of T cell responses may protect against severe disease.

增強的中和廣度可能是由記憶 B 細胞針對變體之間廣泛共享的表位的擴增以及部分誘導針對新表位的從頭免疫反應來驅動的。此外，T 細胞反應的擴增和保存可以預防嚴重疾病。

Slide 10. Looking at the evolution of COVID-19 pandemic and current real-world evidence, we anticipate a long-term need for annual or seasonal variant adapted boosters. If the virus is in a state of continuous evolution, the possibility of a new wave of infections driven by novel immune evasive trends remain. We are vigilantly monitoring the landscape and are prepared to adapt our vaccines as needed.

幻燈片 10. 著眼於 COVID-19 大流行的演變和當前的現實世界證據，我們預計長期需要適應年度或季節性變異的助推器。如果病毒處於不斷進化的狀態，那麼由新的免疫規避趨勢驅動的新一波感染的可能性仍然存在。我們正在密切關注形勢，並準備根據需要調整我們的疫苗。

The risk of severe COVID-19 disease remains high in the vulnerable population. The full extent of the prevalence of COVID-19 patients who go on to experience longer term health consequences is also not yet fully understood.

脆弱人群患嚴重 COVID-19 疾病的風險仍然很高。繼續經歷長期健康後果的 COVID-19 患者的患病率的全部程度也尚未完全了解。

Clinical data has demonstrated that boosters extend the protection offered by COVID-19 vaccine, which research has shown natural immunity acquired by SARS-CoV-2 infection is variable across individuals and the protection it offers wanes over time. The booster restores an enhanced infection-acquired immune protection and further reduces the risk of reinfection.

臨床數據表明，加強劑可延長 COVID-19 疫苗提供的保護作用，研究表明 SARS-CoV-2 感染獲得的自然免疫力因個體而異，並且其提供的保護作用會隨著時間的推移而減弱。增強劑可恢復增強的感染獲得性免疫保護，並進一步降低再感染的風險。

Slide 11 shows our framework to support a sustainable vaccine business in the future. First, we have demonstrated the safety, tolerability and efficacy of our mRNA COVID-19 vaccines. Second, we have shown our ability to rapidly adapt our products and processes to address emerging variance of concern.

幻燈片 11 顯示了我們支持未來可持續疫苗業務的框架。首先，我們已經證明了我們的 mRNA COVID-19 疫苗的安全性、耐受性和有效性。其次，我們已經展示了我們快速調整我們的產品和流程以解決新出現的關注差異的能力。

Third, our expertise at navigating the evolving regulatory landscape on a global scale has positioned us as a first mover and enabled us to receive one of the broadest labels among currently available COVID-19 vaccines. This applies to both the original COMIRNATY vaccine and our Omicron BA.4/5 adapted vaccines.

第三，我們在全球範圍內駕馭不斷變化的監管環境方面的專業知識使我們成為先行者，並使我們能夠獲得目前可用的 COVID-19 疫苗中最廣泛的標籤之一。這適用於原始 COMIRNATY 疫苗和我們的 Omicron BA.4/5 適應疫苗。

Fourth, with continued innovation, we are improving the already strong product profile of our COVID-19 vaccine, targeting continued protection from current and future virus threats.

第四，通過持續創新，我們正在改進我們已經強大的 COVID-19 疫苗的產品配置，旨在持續保護免受當前和未來的病毒威脅。

These 4 pillars are built on our validated mRNA platform, of proven science, discovery, development, manufacturing and commercialization, and position us for success as we continue to expand and advance our pipeline and build our 21st century immunotherapy powerhouse.

這 4 個支柱建立在我們經過驗證的 mRNA 平台之上，具有經過驗證的科學、發現、開發、製造和商業化，在我們繼續擴大和推進我們的管道並建立我們的 21 世紀免疫治療強國的過程中，使我們取得成功。

With that, I would like to thank you all for your confidence in our success and your continued support and turn the call over to Ozlem.

有了這個，我要感謝大家對我們成功的信心和持續的支持，並將電話轉給 Ozlem。

Thank you, Ugur. I'm delighted to provide you with our COVID-19 vaccine and pipeline update to date. On Slide 13, we have our multi-pronged innovation strategy to respond to the evolving pandemic and improve upon our vaccines with next-generation approaches that generate broader and more durable immunity. We have successfully delivered our first variant-adapted vaccines to address Omicron BA.1 and BA.4/5 variants.

謝謝你，烏古爾。我很高興為您提供我們迄今為止的 COVID-19 疫苗和管道更新。在幻燈片 13 上，我們制定了多管齊下的創新戰略，以應對不斷演變的流行病，並通過產生更廣泛和更持久免疫力的下一代方法改進我們的疫苗。我們已經成功交付了我們的第一個變體適應疫苗，以應對 Omicron BA.1 和 BA.4/5 變體。

We believe that our vaccine has potential to be combined with a seasonal flu vaccine. Across many parts of the world, people are currently receiving the only COVID-19 vaccine booster at the same time as their flu shot. Health agencies, including the U.S. CDC now recommend coadministration of COVID-19 booster with the annual influenza vaccine. A combination product has the potential to provide seasonal protection from both viruses with a single shot. We are working together with our partner, Pfizer, to develop an influenza combination vaccine, which leverages our mRNA technology.

我們相信我們的疫苗有可能與季節性流感疫苗結合使用。在世界許多地方，人們目前在接種流感疫苗的同時接種唯一的 COVID-19 疫苗加強劑。包括美國疾病預防控制中心在內的衛生機構現在建議將 COVID-19 加強劑與年度流感疫苗聯合使用。組合產品有可能一次性提供針對兩種病毒的季節性保護。我們正在與我們的合作夥伴輝瑞（Pfizer）合作開發一種流感聯合疫苗，該疫苗利用我們的 mRNA 技術。

In the midterm, we are also developing next-generation engineered vaccine candidates to expand the breadth of the immune response and provide more durable protection. This includes our T cell-enhancing vaccine candidate and engineered spike vaccine approaches. Our approach is supported by insights from continuous surveillance of variants and our robust clinical program.

在中期，我們還在開發下一代工程疫苗候選物，以擴大免疫反應的廣度並提供更持久的保護。這包括我們的 T 細胞增強候選疫苗和工程刺突疫苗方法。我們的方法得到了持續監測變體和我們強大的臨床計劃的見解的支持。

On Slide 14, our innovation strategy has already yielded success with our Omicron BA.4/BA.5 adapted by bivalent vaccine, approved for use in more than 45 countries and regions around the world through the rapid execution that Ugur highlighted. We are continuing to broaden the label of our Omicron BA.4/5 adapted bivalent vaccines across different age groups.

在幻燈片 14 上，我們的創新戰略已經取得了成功，我們的 Omicron BA.4/BA.5 採用了二價疫苗，通過 Ugur 強調的快速執行，批准在全球超過 45 個國家和地區使用。我們將繼續在不同年齡段擴大我們的 Omicron BA.4/5 適應二價疫苗的標籤。

This includes FDA emergency use authorization for individuals aged 5 and older in the U.S. In the EU, we received EC marketing authorization for individuals aged 12 and older. Submission for ages 5 to 11 years in the EU has been completed, and we are awaiting CHMP recommendation.

這包括美國 5 歲及以上個人的 FDA 緊急使用授權。在歐盟，我們獲得了 12 歲及以上個人的 EC 營銷授權。歐盟 5 至 11 歲的提交已完成，我們正在等待 CHMP 推薦。

As a next step, we plan to submit data to regulatory agencies from our ongoing trial in age 6 months to 4 years in the first quarter of 2023 to extend accept to our Omicron-adapted bivalent vaccine to young children. Our regulatory activities are supported by our ongoing clinical program evaluating the BA.4/5 adapted boosters in various age groups.

作為下一步，我們計劃在 2023 年第一季度向監管機構提交我們正在進行的 6 個月至 4 歲試驗的數據，以將我們的 Omicron 適應型二價疫苗的接受範圍擴大到幼兒。我們的監管活動得到了我們正在進行的臨床計劃的支持，該計劃評估了不同年齡組的 BA.4/5 適應助推器。

Slide 15 highlights the positive data in the ages 18 and older cohort reported from the ongoing Phase II/III trial of our BA.4/5 adapted booster in individuals 12 years and up. The study was initiated in August and enrolled approximately 900 healthy volunteers aged 12 and order, all of whom had already received at least 3 doses of an approved COVID-19 vaccine.

幻燈片 15 突出顯示了 18 歲及以上人群中的積極數據，這些數據來自我們正在進行的 12 歲及以上個體的 BA.4/5 適應增強劑的 II/III 期試驗。該研究於 8 月啟動，招募了大約 900 名 12 歲及以下的健康志願者，他們都已經接受了至少 3 劑經批准的 COVID-19 疫苗。

The adults who received either 30 or 60 micrograms of BA.4/5 adapted bivalent booster over original vaccine as a comparator. Adolescents aged 12 to 17 received a 30-microgram dose of Omicron-adapted vaccine over original vaccine. The data at the 30-day time point is in from the sentinel cohort, which included 40 people in each age group, 18 to 55 years of age and older than 55 years, each having received the 30-microgram dose of a bivalent COVID-19 vaccine. The comparator group included 40 individuals over 55 years of age who received the original vaccine. The data showed that the safety and tolerability profile of the bivalent booster remains favorable and similar to the original vaccine.

接受 30 或 60 微克 BA.4/5 的成年人在原始疫苗的基礎上採用二價加強劑作為比較劑。與原始疫苗相比，12 至 17 歲的青少年接受了 30 微克劑量的 Omicron 適應疫苗。 30 天時間點的數據來自哨兵隊列，其中包括每個年齡組的 40 人，18 至 55 歲和 55 歲以上，每個人都接受了 30 微克劑量的二價 COVID- 19疫苗。比較組包括 40 名 55 歲以上接種原始疫苗的人。數據顯示，二價加強劑的安全性和耐受性特徵仍然有利，並且與原始疫苗相似。

On Slide 16, you can see the titers of neutralizing antibodies broken down by age goup and by prevaccination status. While 18 to 55 year old had a 9.5-fold increase over baseline, for the group as a whole, the increase was notably higher, namely 16-fold for those who are baseline negative. In the individuals who were older than 55 years, the group, as a whole, experienced a 13.2-fold increase in neutralization titers, whereas for individuals who were negative at the baseline experienced 28.3-fold increase. These responses were higher than those observed in the comparator group receiving the original vaccine who saw only a 2.9-fold increase over baseline.

在幻燈片 16 上，您可以看到按年齡組和疫苗接種前狀態分解的中和抗體滴度。雖然 18 至 55 歲的人群比基線增加了 9.5 倍，但對於整個群體來說，增幅明顯更高，即基線陰性的人增加了 16 倍。在 55 歲以上的個體中，整個組的中和滴度增加了 13.2 倍，而基線為陰性的個體則增加了 28.3 倍。這些反應高於在接受原始疫苗的對照組中觀察到的反應，對照組僅比基線增加 2.9 倍。

There was not much difference between the groups who were negative or positive at baseline in the comparator. The reference strain neutralization titers were at least as high as that observed in those who received the original vaccine. Overall, adult saw a substantial increase in response with the bivalent vaccine compared to the original vaccine and the improvements were most pronounced in those over age 55 and those who were baseline negative prior to vaccination.

在比較器中基線時為陰性或陽性的組之間沒有太大差異。參考毒株中和滴度至少與在接受原始疫苗的人中觀察到的一樣高。總體而言，與原始疫苗相比，成人對二價疫苗的反應顯著增加，並且在 55 歲以上和接種前基線陰性的人中改善最為明顯。

Given that Omicron BA.4/BA.5 and their sublineages continue to be the dominant circulating strains, these data provide strong evidence of protection that boosting with the bivalent vaccine can provide to adult, particularly the elderly.

鑑於 Omicron BA.4/BA.5 及其亞系仍然是主要的循環毒株，這些數據提供了強有力的證據，證明二價疫苗加強免疫可以為成年人，特別是老年人提供保護。

Slide 17. The second pillar of our innovation strategy includes our collaboration with Pfizer to develop a COVID-19 influenza combination vaccine built on BioNTech's validated mRNA technology. The Phase I clinical trial has been initiated to evaluate the safety, tolerability and immunogenicity of mRNA quadrivalent influenza vaccine candidate in combination with our Omicron BA.4/BA.5 adapted bivalent vaccine.

幻燈片 17。我們創新戰略的第二個支柱包括我們與輝瑞公司合作開發一種基於 BioNTech 經驗證的 mRNA 技術的 COVID-19 流感聯合疫苗。已啟動 I 期臨床試驗，以評估 mRNA 四價流感疫苗候選者與我們的 Omicron BA.4/BA.5 適應二價疫苗組合的安全性、耐受性和免疫原性。

We are building on the experience made in the BNT161 program partnered with Pfizer developing an influenza mRNA monovalent vaccine, for which a Phase III trial was initiated by Pfizer in September.

我們正在利用 BNT161 計劃與輝瑞公司合作開發流感 mRNA 單價疫苗的經驗，輝瑞公司於 9 月啟動了一項 III 期試驗。

In the combination trial, the quadrivalent influenza vaccine candidate contained a 2 type A strains and 2 Type B strains that have been selected for the current season traditional to vaccine. 180 people aged 18 to 64 will be enrolled across 6 trial arms to test various combinations of the influenza vaccine candidate and the Omicron adapted vaccine at 30 and 60 microgram doses for influenza vaccine candidates individually and the standard license influenza vaccine as the comparator arm.

在聯合試驗中，四價流感候選疫苗包含 2 種 A 型毒株和 2 種 B 型毒株，這些毒株已被選為當季傳統疫苗。 180 名 18 至 64 歲的人將在 6 個試驗組中登記，以分別測試流感疫苗候選者和 Omicron 適應疫苗的各種組合，分別用於流感疫苗候選者的 30 和 60 微克劑量，並將標准許可流感疫苗作為比較組。

Slide 18 details our 2 development tracks to create next-generation vaccine. One track includes our engineered spike protein vaccine candidates designed to exhibit broad neutralizing antibody protection against the vast array of variants, including those, which have not yet evolved. The other track of vaccine candidates designed to enhance the T response against SARS-CoV-2.

幻燈片 18 詳細介紹了我們創建下一代疫苗的 2 個開發軌道。一條路線包括我們的工程化刺突蛋白候選疫苗，旨在對大量變體（包括尚未進化的變體）表現出廣泛的中和抗體保護。旨在增強針對 SARS-CoV-2 的 T 反應的另一類候選疫苗。

Our first-testing candidate for this program, the BNT162b4 targets multiple, highly conserved, non-spike proteins that have been selected based on their potential to engage with T cell arm of the immune system. This approach has the potential to increase immune resilience, enhance and broaden T cell response and provide memory T cell resistance and durability of B cell response. A clinical trial starts in combination with our Omicron BA.4/BA.5 adapted bivalent vaccine is expected in the coming weeks.

我們對該計劃的第一個測試候選者 BNT162b4 靶向多種高度保守的非尖峰蛋白，這些蛋白是根據它們與免疫系統 T 細胞臂結合的潛力而選擇的。這種方法有可能增加免疫恢復力，增強和擴大 T 細胞反應，並提供記憶 T 細胞抗性和 B 細胞反應的持久性。預計未來幾週將與我們的 Omicron BA.4/BA.5 適應二價疫苗進行臨床試驗。

Slide 19 highlights our infectious disease pipeline. In addition to the previously mentioned COVID-19 vaccine trial initiations from the third quarter, we expect the start of multiple first-in-human trials of our mRNA candidates over the coming months. This includes our shingles and HSB2 vaccine candidates, which are expected to enter the clinic in the final part of this year.

幻燈片 19 突出顯示了我們的傳染病管道。除了前面提到的從第三季度開始的 COVID-19 疫苗試驗外，我們預計未來幾個月將開始對我們的 mRNA 候選者進行多項首次人體試驗。這包括我們的帶狀皰疹和 HSB2 候選疫苗，預計將在今年下半年進入臨床。

Our malaria vaccine candidate trial, either in the fourth quarter of 2022 or early '23, and our tuberculosis vaccine candidates expected to dose the first patient in early 2023. These programs are built on our validated platform of nucleoside-modified mRNA LNPs with optimized backbone design to address diseases with a significant global need.

我們的瘧疾候選疫苗試驗，無論是在 2022 年第四季度還是 23 年初，我們的結核病候選疫苗預計將在 2023 年初對第一名患者進行給藥。這些計劃建立在我們經過驗證的核苷修飾 mRNA LNP 平台之上，具有優化的主幹旨在解決具有重大全球需求的疾病。

Moving to our oncology program update. Slide 20 provides an overview of our oncology pipeline that is grounded in our multi-modality toolbox and advanced through focused execution. We now have a total of 19 oncology product candidates across 4 different drug classes in 24 ongoing clinical trials, 5 of which are randomized Phase II trials.

轉到我們的腫瘤學計劃更新。幻燈片 20 概述了我們的腫瘤學管道，該管道基於我們的多模態工具箱，並通過集中執行來推進。我們現在在 24 項正在進行的臨床試驗中共有 19 種腫瘤產品候選者，涵蓋 4 個不同的藥物類別，其中 5 項是隨機 II 期試驗。

Our programs address areas of high unmet need and have a potential to tackle tumors using complementary strategies by targeting tumor cells directly or by modulating the immune response against the tumor. Many of our products can be a potential to be combined with other pipeline assets.

我們的項目解決了高度未滿足需求的領域，並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解決腫瘤問題。我們的許多產品都有可能與其他管道資產相結合。

In the third quarter of 2022, preclinical programs advanced to Phase I clinical testing. This includes our FixVac candidate BNT116 for second-line treatment of non-small cell lung cancer and our bispecific RiboMabs product candidate BNT142 for solid tumors. In collaboration with Genmab, we recently initiated a Phase I study evaluating BNT313, our anti-CD27 Hexabody product candidate in solid tumors.

2022年第三季度，臨床前項目進入I期臨床試驗。這包括我們用於非小細胞肺癌二線治療的 FixVac 候選 BNT116 和我們用於實體瘤的雙特異性 RiboMabs 產品候選 BNT142。與 Genmab 合作，我們最近啟動了一項評估 BNT313 的 I 期研究，BNT313是我們在實體瘤中的抗 CD27 Hexabody 產品候選者。

At the ESMO Immuno-Oncology Congress in December 2022, we expect to have two presentations. One is about preliminary safety data from the safety run in part of a study that precedes randomization in the ongoing Phase II trial of our FixVac program, BNT113. This trial is evaluating BNT113 in combination with pembrolizumab in patients with first-line HPV16-positive, PD-L1-positive head and neck squares carcinoma.

在 2022 年 12 月的 ESMO 免疫腫瘤學大會上，我們預計會有兩個演講。一個是關於安全運行的初步安全數據，該數據是在我們正在進行的 FixVac 計劃 BNT113 的 II 期試驗中隨機化之前的一部分研究。該試驗正在評估 BNT113 與 pembrolizumab 聯合用於一線 HPV16 陽性、PD-L1 陽性頭頸部方形癌患者的療效。

The other is preliminary efficacy and safety data from another Genmab collaboration, the Phase I trial of BNT312, a CD40 4-1BB dual body in advance solid tumors. Finally, we have BNT211, our next-generation CAR-T therapy product candidate designed to overcome first generation CAR-T cell therapy gene mutation in patients with solid tumors. We recently presented follow-on data for BNT211 at the ESMO Annual Conference. The Phase I dose escalation data continued to show encouraging clinical activity and safety.

另一個是另一項 Genmab 合作的初步療效和安全性數據，即 BNT312 的 I 期試驗，一種 CD40 4-1BB 雙體提前實體瘤。最後，我們擁有 BNT211，這是我們的下一代 CAR-T 治療產品候選者，旨在克服實體瘤患者的第一代 CAR-T 細胞治療基因突變。我們最近在 ESMO 年會上展示了 BNT211 的後續數據。 I 期劑量遞增數據繼續顯示出令人鼓舞的臨床活性和安全性。

Turning to Slide 21. BNT211 is a chimeric antigen receptor directing T cells against the novel target Claudin-6, that is tested alone and in combination with the Car T cell amplifying mRNA vaccine called CARVac encoding Claudin-6. CARVac is based on our uridine mRNA-lipoplex technology used in other cancer vaccine candidate programs.

轉到幻燈片 21。BNT211 是一種嵌合抗原受體，可引導 T 細胞對抗新的靶標 Claudin-6，該受體單獨進行測試，並與稱為 CARVac 編碼 Claudin-6 的 Car T 細胞擴增 mRNA 疫苗聯合進行測試。 CARVac 基於我們在其他癌症疫苗候選項目中使用的尿苷 mRNA-lipoplex 技術。

Claudin-6 CAR-T cells is fixed with a second-generation chimeric antigen receptor of high sensitivity and specificity for the carcinoembryonic tumor-specific antigen Claudin-6. Claudin-6 is absent in healthy adult tissue, yet frequently expressed in high medical need cancer, making the tumor antigen an ideal candidate for CAR-T cell therapy.

Claudin-6 CAR-T細胞固定有對癌胚腫瘤特異性抗原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，這使得腫瘤抗原成為 CAR-T 細胞治療的理想候選者。

The ongoing first-in-human Phase I/II trial is evaluating the safety and efficacy of Claudin-6 CAR-T cells as monotherapy and in combination with CARVac in patients with Claudin-6 positive relapsed/refractory advanced solid tumors. Our dose escalation study is testing pre-dose levels of Claudin-6 CAR-T cells, as monotherapy as well as in combination with the fixed dose of RNA vaccine. The expansion cohorts include patients with ovarian, testicular and endometrial cancers and rare Claudin-6 positive cancer types.

正在進行的首次人體 I/II 期試驗正在評估 Claudin-6 CAR-T 細胞作為單一療法以及與 CARVac 聯合用於 Claudin-6 陽性複發/難治性晚期實體瘤患者的安全性和有效性。我們的劑量遞增研究正在測試 Claudin-6 CAR-T 細胞的劑量前水平，作為單一療法以及與固定劑量的 RNA 疫苗聯合使用。擴展隊列包括患有卵巢癌、睾丸癌和子宮內膜癌以及罕見的 Claudin-6 陽性癌症類型的患者。

Slide 22 provides a summary of the ESMO presentation that included data from 21 heavily pretreated patients who received Claudin-6 CAT T cells at 2 dose levels, 1x10 to the 7 and 1x10 to the 8, alone or in combination with CARVac. Patients received lymphodepletion for treatment with BNT211 with the exception of two testicular cancer patients. The CAR-T cells as monotherapy and combined with CARVac were well tolerated.

幻燈片 22 提供了 ESMO 演示文稿的摘要，其中包括來自 21 名接受過大量預處理的患者的數據，這些患者接受了 2 個劑量水平的 Claudin-6 CAT T 細胞，1x10 到 7 和 1x10 到 8，單獨或與 CARVac 組合。除兩名睾丸癌患者外，患者接受了 BNT211 治療的淋巴清除。 CAR-T 細胞作為單一療法並與 CARVac 聯合使用具有良好的耐受性。

Adverse events included manageable cytokine release syndrome and one transient grade 1 ICANS dose-limiting toxicities were observed in two patients, both were manageable, and the patients fully recovered. One was prolonged cytopenia in the dose level 2 monotherapy group in a patient with testicular cancer after lymphodepletion. The second was hemophagocytic lymphohistiocytosis in the dose level 2 combination group prior to administration of CARVac. The maximum tolerated dose has not yet been reached.

不良事件包括可控的細胞因子釋放綜合徵和在兩名患者中觀察到的一種短暫的 1 級 ICANS 劑量限制性毒性，兩者都是可控的，並且患者完全康復。一個是在淋巴清除後睾丸癌患者的劑量水平 2 單藥治療組中長期血細胞減少。第二個是在給予 CARVac 之前劑量水平 2 聯合組中的噬血細胞性淋巴組織細胞增多症。尚未達到最大耐受劑量。

We observed dose-dependent expansion of CAR-T cells in all patients. As of August 16, overall response rate was 33% and disease control rate was 67%. This includes one complete response, 6 partial responses and 7 patients with stable disease. We are particularly encouraged by the observed activity in patients with testicular cancer, receiving the 1x10 to the 8 CAR-T dose levels after lymphodepletion. Of 7 evaluable testicular cancer patients included in the analysis, one had a confirmed complete response, three had partial responses, and two had stable disease, resulting in a disease control rate of 85% and an overall response rate of 57%.

我們在所有患者中觀察到 CAR-T 細胞的劑量依賴性擴增。截至8月16日，總體緩解率為33%，疾病控制率為67%。這包括 1 名完全緩解、6 名部分緩解和 7 名病情穩定的患者。我們對在睾丸癌患者中觀察到的活動感到特別鼓舞，他們在淋巴清除後接受 1x10 到 8 的 CAR-T 劑量水平。在納入分析的 7 名可評估睾丸癌患者中，1 名確認完全緩解，3 名部分緩解，2 名疾病穩定，疾病控制率為 85%，總體緩解率為 57%。

Slide 23, shows engraftment and expansion of infused CAR-T cells in all patients with persistence from more than 100 and in some cases, 200 days, including in the patient with a complete response shown in blue. In cases of CAR-T cell redosing, which has expanded successfully as shown here in the 10 to 7th dose levels.

幻燈片 23 顯示了注入的 CAR-T 細胞在所有患者中的植入和擴增，持續時間超過 100 天，在某些情況下，持續時間為 200 天，包括以藍色顯示完全反應的患者。在 CAR-T 細胞重新給藥的情況下，它已成功擴展，如此處所示的第 10 至第 7 劑量水平。

Slide 24 highlights testicular cancer patients, where we saw encouraging signs of activity with impressive tumor shrinkage, as you can see in these CT scans. For 11 patients with testicular cancer who received lymphodepletion regimen, the response rate reached 45% and even 57% when looking only at the 1x10 to the 8 CAR-T cells. The disease control rate was 85% at 1x10 to the 8 CAR-T dose level. One patient at the 1x10 to the 8 CAR-T dose level was assessed by the investigator as having a complete response at 12 weeks. This complete response continued and was confirmed at the 18-week and 52-week time point. We are very encouraged by the safety and clinical activity data from this promising program.

幻燈片 24 突出顯示了睾丸癌患者，正如您在這些 CT 掃描中看到的那樣，我們看到了令人鼓舞的活動跡象和令人印象深刻的腫瘤縮小。對於11名接受淋巴清掃方案的睾丸癌患者，僅觀察1x10對8個CAR-T細胞的反應率達到45%甚至57%。在 1x10 至 8 CAR-T 劑量水平下，疾病控制率為 85%。一名 1x10 至 8 CAR-T 劑量水平的患者在 12 週時被研究者評估為完全緩解。這種完全的反應繼續並在 18 周和 52 週的時間點得到證實。我們對這個有前途的項目的安全性和臨床活動數據感到非常鼓舞。

Turning now to Slide 25, and our next-generation immuno-modulators partnered with Genmab. These programs, which aim to prime and activate antitumor T cell and natural killer cell function are continuing to advance. Extracts to cover this conference were just announced earlier today. We will present a poster highlighting preclinical results supporting BNT311, our bispecific antibody designed to elicit conditional 4-1BB co-stimulation concurrent with PD-L1 blockade.

現在轉到幻燈片 25，我們的下一代免疫調節劑與 Genmab 合作。這些旨在啟動和激活抗腫瘤 T 細胞和自然殺傷細胞功能的程序正在繼續推進。今天早些時候剛剛宣布了這次會議的摘錄。我們將展示一張海報，重點介紹支持 BNT311 的臨床前結果，BNT311 是我們的雙特異性抗體，旨在引發條件性 4-1BB 共刺激與 PD-L1 阻斷同時進行。

Additionally, an extract of preclinical data demonstrating the mechanism of action of BNT313 has been accepted for poster presentation. BNT313 is an anti-CD27 antibody that carries a Hex summarization enhancing domain to support antibody (inaudible) that drives the B27 clustering on the T-cell surface necessary for activation. BNT313 is designed to induce CD27 agonist activity without binding to Fc gamma receptor-bearing cells and thus circumvent T-cell depletion.

此外，展示 BNT313 作用機制的臨床前數據摘錄已被接受用於海報展示。 BNT313 是一種抗 CD27 抗體，它帶有一個 Hex 總結增強結構域，以支持驅動 B27 在 T 細胞表面聚集的抗體（聽不清），這是激活所必需的。 BNT313 旨在誘導 CD27 激動劑活性而不與 Fc γ 受體軸承細胞結合，從而避免 T 細胞耗竭。

A Phase I clinical trial of BNT313 was initiated (inaudible). As previously mentioned, for our BNT312 program, an abstract has been accepted for presentation at the ESMO Immuno-Oncology Congress in December. Overall, the progress of these programs is very encouraging for us.

BNT313 的 I 期臨床試驗已啟動（聽不清）。如前所述，對於我們的 BNT312 計劃，摘要已被接受在 12 月的 ESMO 免疫腫瘤學大會上發表。總的來說，這些計劃的進展對我們來說是非常令人鼓舞的。

I look forward to providing additional program updates in the coming months. I will now pass the presentation to our CFO, Jens Holstein, who will present our financial results.

我期待在未來幾個月內提供額外的程序更新。我現在將把演示文稿交給我們的首席財務官 Jens Holstein，他將介紹我們的財務業績。

Thank you, Ozlem, and a warm welcome to those of you on the phone. I would like to begin by presenting the key financial highlights for the third quarter of 2022, which you can find on Slide 27. Our total reported revenues for the third quarter reached EUR 3.5 billion. Together with a strong first half year, we are in line with our prior year revenues for the year-to-date figures. I will elaborate on this shortly.

謝謝你，Ozlem，並熱烈歡迎電話中的各位。首先，我想介紹 2022 年第三季度的主要財務亮點，您可以在幻燈片 27 上找到。我們第三季度報告的總收入達到 35 億歐元。加上上半年的強勁表現，我們的年初至今收入與上一年的收入一致。我將很快詳細說明這一點。

Given this top line number, we delivered operating income of EUR 2.4 billion, and generated earnings per share on a fully diluted basis of EUR 6.98. With respect to the company's liquidity position, we ended the third quarter of 2022 with EUR 13.4 billion of cash and cash equivalents as well as trade receivables of around EUR 7.3 billion. The trade receivables are primarily derived from our collaboration with Pfizer and remained outstanding due to the contractual settlement of the gross profit share under the collaboration.

鑑於這一最高數字，我們實現了 24 億歐元的營業收入，並在完全攤薄的基礎上產生了 6.98 歐元的每股收益。關於公司的流動性狀況，截至 2022 年第三季度，我們擁有 134 億歐元的現金和現金等價物以及約 73 億歐元的貿易應收賬款。貿易應收款項主要來自我們與輝瑞的合作，並且由於合作下毛利份額的合同結算而仍未結清。

As of October 15, we collected EUR 3.2 billion in cash from our outstanding trade receivables at September 30, improving our cash position and, in turn, reducing our trade receivable position subsequent to the end of Q3.

截至 10 月 15 日，我們從 9 月 30 日的未償還貿易應收賬款中收取了 32 億歐元現金，改善了我們的現金狀況，進而減少了第三季度末之後的貿易應收賬款頭寸。

Continuing with Slide 28. We recognized EUR 3.4 billion of COVID-19 vaccine revenues during the third quarter and EUR 12.9 billion during the first 9 months. Revenues for the first 9 months are in line with our expectations. We believe the development of the pandemic has been and remains dynamic, causing a rephasing of orders and, with this, fluctuations in quarterly revenues. Let me give you some more details on our revenue streams.

繼續幻燈片 28。我們在第三季度確認了 34 億歐元的 COVID-19 疫苗收入，在前 9 個月確認了 129 億歐元。前 9 個月的收入符合我們的預期。我們認為，大流行的發展一直並且仍然是動態的，導致訂單重新調整，並因此導致季度收入波動。讓我給你一些關於我們收入來源的更多細節。

Under our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution rights. Our COVID-19 vaccine revenues included EUR 2.5 billion for the third quarter and EUR 9.1 billion for the first 9 months that are related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners' respective territories.

根據我們的 COVID-19 疫苗合作，我們、輝瑞和復星醫藥之間根據營銷和分銷權分配了領土。我們的 COVID-19 疫苗收入包括第三季度的 25 億歐元和前 9 個月的 91 億歐元，這與我們在合作夥伴各自地區的 COVID-19 疫苗銷售毛利中所佔的份額有關。

These revenues represent a net figure, which means we generate 100% gross margin of those revenues. As we have mentioned in the past, and explained in more detail in our financial statements and filings with the SEC, our profit share is, to some extent, estimated based on preliminary data shared between our collaboration partner, Pfizer, and us.

這些收入代表一個淨數字，這意味著我們產生了這些收入的 100% 的毛利率。正如我們過去提到的，並在我們的財務報表和提交給美國證券交易委員會的文件中更詳細地解釋過，我們的利潤份額在某種程度上是根據我們的合作夥伴輝瑞和我們之間共享的初步數據估算的。

The gross profit share is also impacted by write-offs, so for example, for vaccine doses produced by our collaboration partner, Pfizer. Those write-offs reduced the gross profit share between the 2 companies, and therefore, reduced BioNTech's revenue figure, but not those of our partner, Pfizer.

毛利份額也受到沖銷的影響，例如，我們的合作夥伴輝瑞公司生產的疫苗劑量。這些沖銷減少了兩家公司之間的毛利潤份額，因此減少了 BioNTech 的收入數字，但沒有減少我們的合作夥伴輝瑞公司的收入數字。

Our Cohort 19 vaccine revenues from direct COVID-19 vaccine sales to customers in our territory were EUR 0.6 billion for the third quarter and EUR 2.3 billion for the first 9 months. Those revenues were significantly driven by the orders that were placed in late 2021 following the then emergent Omicron variant, and the Omicron adapted vaccine launches started beginning of September 2022. Also included in our COVID-19 vaccine revenues were EUR 0.3 billion for the third quarter and EUR 1.5 billion for the first 9 months of revenues from sales to our collaboration partners.

第三季度，我們從直接向我們境內的客戶銷售 COVID-19 疫苗的 Cohort 19 疫苗收入為 6 億歐元，前 9 個月為 23 億歐元。這些收入主要受到當時出現的 Omicron 變體之後於 2021 年底下達的訂單的推動，並且 Omicron 適應疫苗的發佈於 2022 年 9 月開始。第三季度我們的 COVID-19 疫苗收入還包括 3 億歐元前 9 個月向我們的合作夥伴銷售的收入為 15 億歐元。

Now I'd like to move on to our detailed financial results for the third quarter and first 9 months of 2022, as shown on Slide 29. As I discussed revenues on the previous slide, let me move to cost of sales that reached approximately EUR 0.8 billion in the third quarter of 2022 compared to EUR 1.2 billion for the comparative prior year period.

現在我想談談我們在第三季度和 2022 年前 9 個月的詳細財務業績，如幻燈片 29 所示。正如我在上一張幻燈片上討論的收入一樣，讓我談談達到約歐元的銷售成本2022 年第三季度為 8 億歐元，而去年同期為 12 億歐元。

For the first 9 months of 2022, the cost of sales reached approximately EUR 2.8 billion compared to EUR 2.3 billion for the comparative prior year period. The change in cost of sales resulted mainly from the recognition costs related to our COVID-19 vaccine revenues in our own territories, including the share of gross profit that we owe to Pfizer.

2022 年前 9 個月，銷售成本達到約 28 億歐元，而去年同期為 23 億歐元。銷售成本的變化主要是由於與我們在自己領土上的 COVID-19疫苗收入相關的確認成本，包括我們欠輝瑞的毛利潤份額。

In addition, cost of sales were impacted by expenses arising from inventory write-offs and expenses for production capacities derived from contracts with contract manufacturing organizations. Research and development expenses reached EUR 341.8 million for the third quarter of 2022 compared to EUR 260.4 million for the comparative prior year in 2021.

此外，銷售成本受到庫存沖銷產生的費用和與合同製造組織的合同產生的生產能力費用的影響。 2022 年第三季度的研發費用達到 3.418 億歐元，而 2021 年同期為 2.604 億歐元。

For the first 9 months of 2022, research and development expenses amounted to EUR 1 billion compared to EUR 0.7 billion for the comparative prior year period. The increase was mainly due to the increased head count and higher expenses in the context of the share-based payments.

2022 年前 9 個月的研發費用為 10 億歐元，而去年同期為 7 億歐元。增加的主要原因是員工人數增加和股份支付背景下的費用增加。

General and administrative expenses reached EUR 141 million for the third quarter of 2022 compared to EUR 68.2 million for the comparative period in 2021. For the first 9 months of 2022, general and administrative expenses reached EUR 361.8 million compared to EUR 154.9 million for the comparative prior year period. The increase in G&A was mainly driven by the planned increase in headcount and increased expenses for purchased external services.

2022 年第三季度的一般和管理費用達到 1.41 億歐元，而 2021 年可比期間為 6820 萬歐元。2022 年前 9 個月，一般和管理費用達到 3.618 億歐元，而可比期間為 1.549 億歐元上一年期間。 G&A 的增加主要是由於計劃中的員工人數增加和購買的外部服務費用增加所致。

Income taxes were accrued with an amount of EUR 0.7 billion for the third quarter of 2022 compared to EUR 1.5 billion for the comparative period in 2021. For the first 9 months of 2022, income taxes were accrued with an amount of EUR 2.6 billion compared to EUR 3.2 billion for the comparative prior year period. The derived effective income tax rate for the first 9 months of 2022 was 26.8%.

2022 年第三季度應計所得稅金額為 7 億歐元，而 2021 年可比期間為 15 億歐元。2022 年前 9 個月應計所得稅金額為 26 億歐元，相比之下上年同期為 32 億歐元。 2022 年前 9 個月的派生有效所得稅率為 26.8%。

In the third quarter of 2022, net profit reached EUR 1.8 billion compared to EUR 3.2 billion for the comparative period in 2021. In the first 9 months of 2022, net profit reached EUR 7.2 billion compared to EUR 7.1 billion for the comparative prior year period. Our diluted earnings per share for the third quarter of 2022 amounted to EUR 6.9 compared to EUR 12.35 for the competitive period in 2021. For the first 9 months of 2022, our diluted earnings per share was EUR 27.7 compared to EUR 27.46 in 2021.

2022 年第三季度，淨利潤達到 18 億歐元，而 2021 年同期為 32 億歐元。2022 年前 9 個月，淨利潤達到 72 億歐元，而去年同期為 71 億歐元.我們在 2022 年第三季度的稀釋後每股收益為 6.9 歐元，而在 2021 年競爭期間為 12.35 歐元。在 2022 年前 9 個月，我們的稀釋後每股收益為 27.7 歐元，而 2021 年為 27.46 歐元。

Now let's move to Slide 30 for the outlook for the 2022 financial year. We are updating our 2022 financial guidance, raising our COVID-19 vaccine revenue estimate for the full year to the upper end of the original range, EUR 16 billion to EUR 17 billion from EUR 13 billion to EUR 17 billion previously. The narrowed guidance reflects delivery of the Omicron-adapted bivalent vaccine boosters, which started early in September and is expected to continue throughout the fourth quarter of 2022, as well as higher prices and a positive foreign currency effect.

現在讓我們轉到幻燈片 30，了解 2022 財年的前景。我們正在更新我們的 2022 年財務指導，將我們對全年 COVID-19 疫苗收入的估計從原來的 130 億歐元提高到 170 億歐元，從原來的 160 億歐元提高到 170 億歐元。縮小的指導反映了適用於 Omicron 的二價疫苗增強劑的交付，該增強劑於 9 月初開始，預計將持續到 2022 年第四季度，以及更高的價格和積極的外匯影響。

We reiterate our planned expenses and CapEx, which we have summarized for you on the slide. We also updated the estimated annual effective income tax rate from previously 28% to approximately 27%, which is a further improvement to previous year.

我們重申我們在幻燈片上為您總結的計劃費用和資本支出。我們還將估計的年度有效所得稅稅率從之前的 28% 更新至約 27%，這比上一年有進一步的改善。

I will be moving to the completion of the first tranche of our share repurchase program, as shown on Slide 31. The share repurchase program approved by the Management Board and the Supervisory Board permits the repurchase of ADSs for a value of up to $1.5 billion over 2 years. Our intention is to use some or all of the repurchase ADSs to meet pending obligations from share-based payment arrangements. The first tranche of the repurchase program had a value of up to USD 1 billion and began on May 2, 2022, and ended October 10, 2022.

如幻燈片 31 所示，我將完成我們股票回購計劃的第一部分。管理委員會和監事會批准的股票回購計劃允許回購價值高達 15 億美元的美國存託股。 2年。我們的意圖是使用部分或全部回購 ADS 來履行基於股份的支付安排的未決義務。回購計劃的第一期價值高達 10 億美元，於 2022 年 5 月 2 日開始，至 2022 年 10 月 10 日結束。

As shown on the slide, a total of 6,945,513 ADSs were repurchased at an average price of USD 143.98, representing 2.8% of the shares issued as of April 30, 2022. In addition, we had paid out a dividend of approximately EUR 0.5 billion to shareholders in 2022. In November, the second tranche of the repurchase program with a value of up to $0.5 billion has been approved, commencing on December 7 this year. More information and an overview of the buybacks can be found on our IR website.

如幻燈片所示，共回購了 6,945,513 股美國存託憑證，平均價格為 143.98 美元，佔截至 2022 年 4 月 30 日已發行股份的 2.8%。此外，我們已向2022 年股東大會。11 月，第二批價值高達 5 億美元的回購計劃已獲批准，於今年 12 月 7 日開始。更多信息和回購概述可以在我們的投資者關係網站上找到。

With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our outlook for 2022 and concluding remarks.

有了這個，我想把電話轉給我們的首席戰略官瑞安理查森，以了解我們對 2022 年的展望和結束語的最新情況。

Thank you, Jens. Turning to Slide 33. Our COVID-19 vaccine continued to play a major role in addressing the pandemic, with the launch of variant-adaptive B4/B5 vaccine. We and our partners have received approval in over 45 countries and territories since our first approval in August this year, and have rapidly deployed approximately 300 million doses of our variant-adaptive vaccines as of mid-October.

謝謝你，詹斯。轉到幻燈片 33。隨著變體適應性 B4/B5 疫苗的推出，我們的 COVID-19 疫苗繼續在應對大流行中發揮重要作用。自今年 8 月首次獲得批准以來，我們和我們的合作夥伴已在超過 45 個國家和地區獲得批准，截至 10 月中旬，我們已迅速部署了約 3 億劑變異適應疫苗。

We have updated our full year 2022 order book and now expect to invoice up to 2.1 billion doses this year, reflecting some rephasing of deliveries to early 2023 due to supply availabilities and projected uptake of our variant-adapted vaccines. By year-end, we expect to fulfill both our existing contract with the United States government for 105 million doses, and our contract with the European Union for 650 million doses.

我們已經更新了我們的 2022 年全年訂單，現在預計今年將開具多達 21 億劑的發票，這反映了由於供應可用性和我們的變體適應疫苗的預計吸收，到 2023 年初交付的一些重新安排。到年底，我們預計將履行與美國政府簽訂的 1.05 億劑合同以及與歐盟簽訂的 6.5 億劑合同。

As we turn to 2023, we anticipate that the COVID-19 vaccine market will start to shift toward a hybrid public private market, with some geographies, namely the United States, likely shifting to a commercial contracting model in 2023. In the United States, we and our partner, Pfizer, expect the list price for a single dose vial of adult vaccine to be in the range of $110 to $130 per dose, reflecting both the cost effectiveness and public health value of our vaccine.

當我們轉向 2023 年時，我們預計 COVID-19 疫苗市場將開始轉向混合公私市場，一些地區，即美國，可能會在 2023 年轉向商業承包模式。在美國，我們和我們的合作夥伴輝瑞（Pfizer）預計單劑小瓶成人疫苗的標價將在每劑 110 美元至 130 美元之間，這反映了我們疫苗的成本效益和公共衛生價值。

In the future, we expect seasonal demand to be weighted to the second half of the year, consistent with other seasonal respiratory infectious disease vaccines. As shown on Slide 34, we continue to make progress against our 2022 clinical milestones. As we enter the final months of the year, we expect a number of additional updates, some of which are shown here and on the following 2 slides.

未來，我們預計季節性需求將加權至下半年，與其他季節性呼吸道傳染病疫苗一致。如幻燈片 34 所示，我們繼續在 2022 年臨床里程碑方面取得進展。隨著我們進入今年的最後幾個月，我們預計會有一些額外的更新，其中一些顯示在這里和下面的 2 張幻燈片中。

In infectious diseases, we expect continued expansion of our COVID-19 vaccine pipeline with multiple next-generation vaccine constructs entering the clinic before year-end. We also expect data updates from our ongoing clinical trials evaluating our variant-adaptive vaccine. Outside of COVID-19, we plan for multiple mRNA vaccines to enter the clinic this year and early next year. By the end of 2023, we expect to have up to 5 new clinical trial starts in infectious diseases.

在傳染病方面，我們預計我們的 COVID-19 疫苗管道將繼續擴大，多種下一代疫苗結構將在年底前進入臨床。我們還期待我們正在進行的評估我們的變體適應性疫苗的臨床試驗的數據更新。在 COVID-19 之外，我們計劃在今年和明年初讓多種 mRNA 疫苗進入臨床。到 2023 年底，我們預計將有多達 5 個新的傳染病臨床試驗開始。

Turning to Slide 35. In oncology, alongside the first patient dosed in the Phase I trial evaluating BNT313, our anti-CD27 HexaBody partnered with Genmab, which we announced today. By year-end, we also expect to have the first patient dose for a second Phase I trial evaluating BNT116 in first line NSCLC. We also will present a clinical data update at the ESMO IO Annual Meeting in December for BNT312.

轉到幻燈片 35。在腫瘤學方面，除了在評估 BNT313 的 I 期試驗中給藥的第一位患者之外，我們的抗 CD27 HexaBody 與我們今天宣布的 Genmab 合作。到年底，我們還預計將獲得第一批患者劑量，用於評估 BNT116 在一線 NSCLC 中的第二期 I 期試驗。我們還將在 12 月的 ESMO IO 年會上介紹 BNT312的臨床數據更新。

Our CD40 4-1BB dual body partnered with Genmab. As we look ahead to 2023, we expect a busy year for our oncology pipeline, with as many as 10 clinical trial updates across a diverse range of programs.

我們的 CD40 4-1BB 雙體與 Genmab 合作。展望 2023 年，我們預計我們的腫瘤學管道將是忙碌的一年，將有多達 10 項臨床試驗更新，涵蓋各種項目。

Concluding on Slide 36, we expect 2023 to be a momentous year for BioNTech. We will continue to invest for the long term in our next-generation COVID-19 vaccine pipeline as we continue to deliver our variant-adapted vaccine around the world. We will continue to expand and accelerate our innovative oncology and infectious disease pipelines in anticipation of multiple late-stage data readouts and clinical trial starts that we expect will fuel future growth. And with increasing balance sheet strength, which we expect into next year, we will continue to reinvest in the company to build world-class capabilities and accelerate our growth.

在幻燈片 36 上得出結論，我們預計 2023 年對於 BioNTech 來說將是重要的一年。隨著我們繼續在世界各地提供我們的變體適應疫苗，我們將繼續長期投資於我們的下一代 COVID-19 疫苗管道。我們將繼續擴大和加速我們的創新腫瘤學和傳染病管道，以期待多個後期數據讀出和臨床試驗的開始，我們預計這將推動未來的增長。隨著資產負債表實力的增強，我們預計到明年，我們將繼續對公司進行再投資，以建立世界一流的能力並加速我們的增長。

We will also continue to look for additive bolt-on BD and M&A opportunities that fit with our strategy. We remain as optimistic as ever in our ability to continue to create long-term value for patients, our shareholders and society. I would like to take the opportunity to thank our shareholders for their continued support, and we'll now open the floor for questions.

我們還將繼續尋找符合我們戰略的附加附加 BD 和併購機會。我們對繼續為患者、股東和社會創造長期價值的能力保持樂觀。我想藉此機會感謝我們的股東一直以來的支持，我們現在開始提問。

(Operator Instructions) We will now go to our first question. One moment, please. And your first question comes from the line of Tazeen Ahmad from Bank of America.

（操作員說明）我們現在將轉到第一個問題。稍等一會兒。您的第一個問題來自美國銀行的 Tazeen Ahmad。

Can I just get some color from how long do you think that the current BA.4/5 bivalent shot is going to be in use? Should we expect it to have any coverage of the newer variants, like, for example, the BQ.1 or BQ1.1? And if it doesn't, how should we think about some of the shipments that you mentioned in your prepared remarks that have been shifted into 2023. With those be delayed until later next year to the parties that have ordered and have the right to delay shipment for a newer version of the vaccine?

我可以從您認為當前的 BA.4/5 二價鏡頭將使用多長時間獲得一些顏色嗎？我們是否應該期望它涵蓋較新的變體，例如 BQ.1 或 BQ1.1？如果沒有，我們應該如何考慮你在準備好的評論中提到的一些貨物已經轉移到 2023 年。這些貨物被推遲到明年晚些時候，那些已經訂購併有權延遲的各方運送更新版本的疫苗？

I would like to respond to your first question, Tazeen. With regard to how long the BA.4/5 Omicron-adapted vaccines would allow us to respond to the pandemic. That will really depend on how the virus further evolves. Some of currently emerging variants of concern are closely related with BA.4/BA.5 are from the BA.2 lineage. And there is some probability that there will be cross neutralization and cross protection against these variants. We will continue to test this by cross neutralization assays, which are ongoing and can then say more. But it really depends on how the virus further evolves.

我想回答你的第一個問題，Tazeen。關於 BA.4/5 Omicron 適應疫苗將使我們能夠應對大流行多長時間。這實際上將取決於病毒如何進一步發展。當前出現的一些與 BA.4/BA.5 密切相關的關注變體來自 BA.2 譜系。並且有一定的可能性會對這些變體進行交叉中和和交叉保護。我們將繼續通過交叉中和分析來測試這一點，這些分析正在進行中，然後可以說更多。但這真的取決於病毒如何進一步發展。

Ryan, do you want to take the second question, or should I give an answer?

Ryan，你想回答第二個問題，還是我應該回答？

Yes. Absolutely. I can start over. So on the question of shifting of doses, Tazeen. A significant portion of those doses that were shifted for delivery next year were actually donation doses to a variety of countries around the world. So really, we see that dynamic as not specifically related to the variant vaccine in question. And generally speaking, these contracts are flexible. So while we see some of those doses shifted to 2023, we still have -- expect a significant proportion of contracted doses next year and beyond. And that could be -- those contracts can be served by, again, either the current vaccine or future vaccines, if a future variant vaccine is needed.

是的。絕對地。我可以重新開始。所以關於劑量轉移的問題，Tazeen。明年轉移用於交付的這些劑量中的很大一部分實際上是捐贈給世界各地不同國家的劑量。所以真的，我們認為這種動態與所討論的變體疫苗沒有特別的關係。一般來說，這些合同是靈活的。因此，雖然我們看到其中一些劑量轉移到 2023 年，但我們仍然 - 預計明年及以後會有很大一部分合同劑量。這可能是——如果需要未來的變種疫苗，這些合同可以再次由當前的疫苗或未來的疫苗提供服務。

We will now go to our next question. One moment please. And your next question comes from the line of Matthew Harrison from Morgan Stanley.

我們現在將進入下一個問題。稍等一會兒。您的下一個問題來自摩根士丹利的 Matthew Harrison。

This is Steve on for Matthew. My question is, as you think about the PCV data next year, what kind of PFS difference would you like to see to think about moving it ahead?

這是馬修的史蒂夫。我的問題是，當您考慮明年的 PCV 數據時，您希望看到什麼樣的 PFS 差異來考慮推動它？

So just to clarify the question. You referenced the PCV. So you're talking about the INS program?

所以只是為了澄清這個問題。您引用了 PCV。所以你說的是INS程序？

In melanoma, yes.

在黑色素瘤中，是的。

In melanoma. And your question, just to clarify, your question is what PFS improvement are we looking for?

在黑色素瘤中。你的問題，只是為了澄清，你的問題是我們在尋找什麼 PFS 改進？

Yes.

是的。

Ugur, do you want to address that?

Ugur，你想解決這個問題嗎？

Yes. I think this is too early to give -- to define a threshold. We are working with that ratios. We have to understand whether any type of improvement is in line with the further progress in the field that was made in the frontline melanoma. We have to align this understanding also with the progress that we have made in the manufacturing of our INS platform.

是的。我認為現在給出一個閾值還為時過早。我們正在處理這個比率。我們必須了解是否有任何類型的改進符合在一線黑色素瘤領域取得的進一步進展。我們還必須將這種理解與我們在 INS 平台製造方面取得的進展保持一致。

So we in the meantime, improved the algorithm and reduced the turnaround time for the vaccine and came up with process improvements. And this would also require discussions with the authorities to make the final decision that we will progress and can just use the study to expand the clinical trial for a potential accelerated approval or do a confirmatory trial.

因此，我們同時改進了算法並縮短了疫苗的周轉時間，並提出了流程改進。這還需要與當局討論，以做出最終決定，我們將取得進展，並且可以利用這項研究來擴大臨床試驗，以獲得潛在的加速批准或進行確認試驗。

And your next question comes from the line of Chris Shibutani from Goldman Sachs.

您的下一個問題來自高盛的 Chris Shibutani。

Recent media reports suggest the potential for distribution of your COVID vaccine in China with the initial target population being expats. As we're trying to better understand the potential scope of this opportunity, thinking in terms of units and pricing, can you, #1, give us any updates on development when perhaps your vaccine might be approved in China? #2, would this be an approval that might enable broader distribution to Chinese nationals? And then on the price front, help us at all with anything that we can understand about the potential pricing in that market?

最近的媒體報導表明，您的 COVID 疫苗有可能在中國分發，最初的目標人群是外國人。當我們試圖更好地了解這個機會的潛在範圍時，從單位和定價方面考慮，當您的疫苗可能在中國獲得批准時，您能否向我們提供有關開發的最新信息？ #2，這是否是一項可以更廣泛地分發給中國公民的批准？然後在價格方面，幫助我們了解有關該市場潛在定價的任何信息？

Yes. Thanks for the question, Chris. I think it's a little too early actually to get some specifics there. We have seen some positive reengagement as has been reported, and we can confirm that we have been taking part in some discussions, which are very positive. However, it's still too early to say, or to try to predict to what extent an approval for the expat population could be granted, when it might be granted, what that would mean commercially? So at this stage, we're continuing to monitor the situation very carefully and hope to provide updates in the near future.

是的。謝謝你的問題，克里斯。我認為現在在這裡獲得一些細節還為時過早。正如報導的那樣，我們已經看到了一些積極的重新參與，我們可以確認我們一直在參與一些非常積極的討論。然而，現在說或試圖預測在多大程度上可以批准外籍人士，何時批准，這在商業上意味著什麼還為時過早？因此，在現階段，我們將繼續非常仔細地監控情況，並希望在不久的將來提供更新。

And your next question comes from Jessica Fye from JPMorgan.

您的下一個問題來自摩根大通的 Jessica Fye。

On the COVID-19 vaccine market, Moderna has talked about how they expect the COVID-booster market to be in the range of 500 million to 600 million doses per year, not unlike flu, but potentially a bit below that in 2023, and working up to that 500 million to 600 million thereafter. Do you share that view that cover vaccine volumes could trail that 500 million, 600 million range next year, but then increase in '24 and beyond to something closer to the flu range?

在 COVID-19 疫苗市場上，Moderna 談到了他們如何預計 COVID 助推器市場將在每年 5 億至 6 億劑的範圍內，與流感類似，但在 2023 年可能會略低於這一水平，並且正在發揮作用之後高達 5 億到 6 億。您是否同意這樣的觀點，即明年的疫苗覆蓋量可能會落後於 5 億、6 億的範圍，但隨後會在 24 年及以後增加到更接近流感的範圍？

Yes. Maybe I'll start -- this is Jens. I will start with answering the question and then Ryan might chime in or Ugur. I think we all know that the pandemic has evolved well this year. And how it will evolve in the future is really very difficult to predict at this point in time. But we all know that COVID is a deadly disease. It's much more deadly than flu. We see much higher death rate, dead cases than we know from flu. And elderly people and high-risk patients will be, for sure, the population that needs vaccinations.

是的。也許我會開始——我是 Jens。我將從回答問題開始，然後 Ryan 可能會插話或 Ugur。我想我們都知道，今年的大流行病發展得很好。而它在未來會如何發展，目前真的很難預測。但是我們都知道COVID是一種致命的疾病。它比流感更致命。我們看到的死亡率和死亡病例比我們所知道的流感要高得多。老年人和高危患者肯定是需要接種疫苗的人群。

But of course, everyone else, too, who feels he or she needs to be protected against severe diseases. So that's maybe the base first. Going forward, I mean, it all depends on if and how often additional variants will pop up and how severe those variants will be going forward. At some point, it is -- there is a high likelihood, of course, that there could be a flu-like business model coming up.

但當然，其他所有認為自己需要受到保護以免受嚴重疾病侵害的人也是如此。所以這可能是基礎。展望未來，我的意思是，這一切都取決於是否會出現其他變體以及多久會出現其他變體，以及這些變體的嚴重程度。當然，在某個時候，很有可能會出現類似流感的商業模式。

It remains based on what I said before on the fact that COVID is a deadly disease, a large multibillion-dollar market going forward. And specifically, in such an endemic scenario that the private market opens up, we know that pricing will be very different to the current pricing that we had. So there is upside at that end.

它仍然基於我之前所說的事實，即 COVID 是一種致命的疾病，這是一個未來數十億美元的巨大市場。具體來說，在私人市場開放的這種流行情況下，我們知道定價將與我們當前的定價大不相同。所以在這方面有好處。

And in addition, maybe last comment from my end. I think BioNTech and Pfizer together have shown and have proven that we are well placed in the market. We have I think a very good market position, and we have been able, over the time, to defend that market position very well. So we are very confident that, going forward, this remains a very sizable, very good market for us. And Ryan, you maybe want to add something?

此外，也許是我最後的評論。我認為 BioNTech 和輝瑞共同展示並證明了我們在市場上處於有利地位。我認為我們擁有非常好的市場地位，並且隨著時間的推移，我們能夠很好地捍衛這一市場地位。因此，我們非常有信心，展望未來，這對我們來說仍然是一個非常可觀、非常好的市場。 Ryan，你可能想補充點什麼？

No, I think you covered most of it. I would just second the notion that in 2023 -- it's not -- we're not going to yet be into a true endemic market because it will be a hybrid market with significant contracted volumes. And also we expect emergence of a private market on top. I think the volume numbers that you've said are plausible. We have still seen evidence of higher uptick in the booster segment than, for example, we see with flu. And so that's one data point there. And obviously, here, we do expect a very different price point versus the flu market. So I think those factors combine to create the multibillion long-term market opportunity that we expect that you've just outlined.

不，我認為你涵蓋了大部分內容。我只是支持這樣的觀點，即在 2023 年——它不是——我們還不會進入一個真正的地方性市場，因為它將是一個具有大量合同量的混合市場。而且我們還預計會出現一個私人市場。我認為你所說的數量是合理的。我們仍然看到增強劑部分的上升幅度高於例如流感的證據。這就是那裡的一個數據點。顯然，在這裡，我們確實預計與流感市場的價格點會有很大不同。所以我認為這些因素結合起來創造了我們期望你剛剛概述的數十億的長期市場機會。

We'll now go to our next question. And your question comes from Daina Graybosch from SVB Leerink.

我們現在將進入下一個問題。您的問題來自 SVB Leerink 的 Daina Graybosch。

I want to ask about some academic applications that were posted as preprints from the (inaudible) recently, and they were on their own looking at the immunogenicity of the bivalent boosters versus another booster for wild-type monovalent. And their data showed pretty modest increases in antibody titers with the bivalent booster, much more modest than what you today have shown in the greater-than-55 population.

我想問一下最近（聽不清）作為預印本發布的一些學術申請，他們自己研究了二價增強劑的免疫原性與野生型單價增強劑的免疫原性。他們的數據顯示，二價增強劑的抗體滴度增加相當溫和，比你今天在 55 歲以上人群中所顯示的要溫和得多。

I wonder if you can talk about how you interpret their data. And if their data, let's say, is correct, in that you get a very modest difference with the bivalent, let's say, for younger people under 55. What does that tell you about the bivalent booster? Weather boosters will be needed and what kind of booster we may need in the future?

我想知道您是否可以談談您如何解釋他們的數據。如果他們的數據是正確的，比如說，對於 55 歲以下的年輕人，您與二價的差異非常小。關於二價助推器，這告訴了您什麼？將需要天氣助推器，未來我們可能需要什麼樣的助推器？

Daina, thank you for the question. So first of all, to the preprint, of course, we studies the preprint and we see that the study is missing to differentiate between individuals who had prior infection and without prior infection. And we have seen in our data set that this is really important to come to conclusions since individuals without prior infections have a much higher increase with regard to the overall for neutralizing titers and as compared to those who have been -- who had prior infections.

戴娜，謝謝你的問題。因此，首先，對於預印本，當然，我們研究了預印本，我們發現該研究缺少區分先前感染和未感染的個體。我們已經在我們的數據集中看到，得出結論非常重要，因為與之前感染過的人相比，沒有先前感染的個體在總體中和滴度方面的增加要高得多。

And so our data, we have published a 7-day data and 1-month data, and the data are very consistent within the groups, with homogeneous findings. We are confident that the report that we made also with the larger number of subjects, even not very large, with a larger number of subjects will be -- will turn out to be the real findings.

所以我們的數據，我們發布了7天的數據和1個月的數據，組內的數據非常一致，結果同質化。我們相信，我們針對更多主題（即使不是很大）以及更多主題所做的報告將成為真正的發現。

So just to repeat the key finding is that, so far, in the elderly population, we have a fourfold higher increase in neutralization titers as compared to the wilt-type vaccine. And we are talking here about the immediate antibody response. What we have also to consider is that every vaccination as a variant-adapted vaccine has a second effect. The second effect is the induction with a clear delay of immune responses and forming of de novo B-cell responses that come up later in the timeframe of 3-plus months.

因此，僅重複一下關鍵發現，到目前為止，在老年人群中，與枯萎型疫苗相比，我們的中和滴度增加了四倍。我們在這裡談論的是即時的抗體反應。我們還必須考慮的是，每一種疫苗作為一種變體適應疫苗都有第二個效果。第二個影響是誘導免疫反應明顯延遲，並在 3 個多月的時間框架內形成新的 B 細胞反應。

So we believe that in -- as in the flu case, we will need to have a booster market with variant-adapted vaccines to retrain the immune system to the new variant sequences. And this can't be addressed by sticking to the existing wilt-type vaccine. Just to also repeat findings that were generated with the wilt-type vaccine, even the booster with the wilt-type vaccine reduces the severe disease rate and reduces the mortality.

因此，我們相信，就像在流感案例中一樣，我們將需要一個具有變體適應疫苗的助推器市場，以重新訓練免疫系統以適應新的變體序列。而這不能通過堅持現有的枯萎型疫苗來解決。只是為了重複使用枯萎型疫苗產生的發現，即使是使用枯萎型疫苗的加強劑也可以降低嚴重疾病的發生率並降低死亡率。

So that means, regardless whether we are immunizing, boosting with wilt-type or with variant-adapted vaccines, we have a reduction of severe disease rate. And with the variant-adapted vaccines, we have now an evidence that the neutralization titers appeared to be significantly higher with the wilt-type vaccine.

所以這意味著，無論我們是用枯萎病疫苗還是用適應變體的疫苗進行免疫、加強免疫，我們都可以降低重症發病率。對於變體適應疫苗，我們現在有證據表明枯萎型疫苗的中和效價似乎顯著更高。

We will now go to our next question. And your next question comes from the line of Akash Tewari from Jefferies.

我們現在將進入下一個問題。您的下一個問題來自 Jefferies 的 Akash Tewari。

This is (inaudible) for Akash. We have one on COVID vaccine sales. So how many of the total 300 million EU contracted doses remain to be delivered in 2023? Also, you mentioned some of your shipments have been pushed to next year. So in total, how many confirmed orders are there for next year? (inaudible) 2023 total vaccine sales of around 10 billion. Do you feel you will be able to hit the number with your existing orders signed for 2023?

這對 Akash 來說是（聽不清）。我們有一個關於 COVID 疫苗銷售的信息。那麼，到 2023 年，歐盟 3 億劑合同中仍有多少劑需要交付？另外，您提到您的一些貨物已被推遲到明年。那麼明年總共有多少已確認的訂單？ （聽不清）2023 年疫苗總銷售額約為 100 億。您是否認為您能夠在 2023 年簽署的現有訂單中達到這個數字？

Well, so yes, thank you for the question. I think, look, I'll start, and then I think Jens Holstein will chime in. So I think you first asked about next year and the EU contract. And I think what we announced in our prepared remarks was that we plan to deliver the planned doses for the EU this year that we plan for 2022, and also complete the U.S. -- existing U.S. contract that was announced earlier this year.

嗯，是的，謝謝你的問題。我想，看，我會開始，然後我認為 Jens Holstein 會插話。所以我想你首先詢問了明年和歐盟的合同。我認為我們在準備好的評論中宣布的是，我們計劃在今年為歐盟提供計劃在 2022 年實施的計劃劑量，並完成今年早些時候宣布的美國現有合同。

We were not disclosing an order book number for next year. What we can tell you is that, of course, our signed -- overall signed orders have continued to grow throughout this year overall, regardless of the delivery time period, but we're not guiding at the moment to a future order book because we think it's premature to do so, and frankly, not relevant or not as relevant now given that the demand picture continues to be dynamic, that we continue to expect the emergence of a private market in some geographies next year as we mentioned.

我們沒有透露明年的訂單號。當然，我們可以告訴您的是，無論交付時間如何，我們簽署的總體簽署訂單在今年總體上都在持續增長，但我們目前並未指導未來的訂單，因為我們認為現在這樣做還為時過早，坦率地說，鑑於需求情況仍然是動態的，我們繼續預計明年在某些地區會出現私人市場，正如我們所提到的那樣，現在不相關或不相關。

So it's really more of a hybrid market next year. But overall, we feel very good about overall demand and how we're tracking to be able to serve that. Jens, maybe you want to add to it?

所以明年它實際上更像是一個混合市場。但總的來說，我們對整體需求以及我們如何跟踪能夠滿足需求感到非常滿意。 Jens，也許你想補充一下？

Yes. Okay, sorry, Ryan. I myself had a little bit of problem to understand you because of the line. The connection was not that good. But as you pointed out correctly, we deliver according to the plan for 2022 for the EU. We're not expecting any shift here. We had, as you know, contractual agreements signed for '23 with the EU, 450 million doses and an option of 450 million doses.

是的。好的，對不起，瑞恩。由於線路的原因，我自己在理解您方面有點問題。連接不是那麼好。但正如您正確指出的那樣，我們按照歐盟 2022 年的計劃交付。我們預計這裡不會有任何變化。如你所知，我們與歐盟簽署了 23 年的合同協議，4.5 億劑和 4.5 億劑的選擇權。

But as Ryan correctly said, I think maybe for the EU, that might be at a later point in time. But overall, I think we got to move away from this thinking on the order book because what we have seen is there're certain shifts. It all depends on market demand, on the evolvement of variants that are coming up. And specifically, as Ryan correctly said, there will be markets that move into a private setting going forward, assuming that this is seen as an endemic market going forward.

但正如瑞恩所說的那樣，我認為對於歐盟來說，這可能會在以後的某個時間點進行。但總的來說，我認為我們必須擺脫這種對訂單的想法，因為我們已經看到存在某些變化。這一切都取決於市場需求，取決於即將出現的變體的演變。具體來說，正如瑞恩正確所說，假設這被視為未來的地方性市場，未來將會有市場進入私人環境。

And that will take probably a few years. And then I think the danger really is to draw the wrong conclusions from some number on an order book, and therefore, we are moving away from giving some guidance on this.

這可能需要幾年時間。然後我認為危險真的是從訂單簿上的某個數字得出錯誤的結論，因此，我們正在放棄對此提供一些指導。

We'll now go to our next question. And the next question comes from Yaron Werber from Cowen.

我們現在將進入下一個問題。下一個問題來自 Cowen 的 Yaron Werber。

This is Brendan, on for Yaron. Congrats on another strong quarter. Just a quick one from us. When we think about maybe the emergence of future variants and look at kind of the time line from the first Omicron wave in December and then BA.4/5, maybe around April or so, then rollout by September of your BA.4/5 booster, do you think this is more or less the reasonable time line we could expect for future variants in terms of your interactions with FDA and materials and data, you need to get them really to get future boosters authorized? Or are there important considerations we should really be keeping in mind as the landscape inevitably shifts over the coming months and years?

我是 Brendan，代表 Yaron。祝賀另一個強勁的季度。只是我們的一個快速。當我們考慮未來變體的出現時，看看從 12 月的第一個 Omicron 浪潮到 BA.4/5 的時間線，可能在 4 月左右，然後在 9 月推出你的 BA.4/5助推器，您認為這或多或少是我們對未來變體與 FDA 以及材料和數據的交互預期的合理時間線，您需要讓它們真正獲得未來助推器的授權嗎？或者，隨著未來幾個月和幾年的形勢不可避免地發生變化，我們是否真的應該牢記重要的考慮因素？

Ugur, do you want to take that?

烏古爾，你想拿那個嗎？

Yes, I can take that. I think the future vaccine adaptation and booster process will depend on two aspects. One, the regulatory landscape, and the second one is how fast we can respond to new variants. Starting with the second part is, as you know, the BA.4/5 variant emerged only recently. And the FDA -- after the FDA decisions, we were able to come up with an adaptive vaccine and enable delivery within about 2 months.

是的，我可以接受。我認為未來的疫苗適應和加強過程將取決於兩個方面。一是監管環境，二是我們對新變體的響應速度。如您所知，從第二部分開始，BA.4/5 變體是最近才出現的。還有 FDA——在 FDA 做出決定之後，我們能夠提出一種適應性疫苗並在大約 2 個月內實現交付。

So that means our processes, internal processes for vaccine adaptations are now even faster than what we had indicated beginning 2022, and we are going to further optimize the vaccine adaptation process to be able to respond quickly to new variants.

因此，這意味著我們的流程和疫苗適應的內部流程現在甚至比我們從 2022 年開始時指出的還要快，我們將進一步優化疫苗適應過程，以便能夠對新變種做出快速反應。

And the second thing, what is important is, and we have now the case with the FDA and with the EMA. We got an authorization of the vaccines based on pre-existing clinical data on multiple variants. And just to remind everyone, we have done multiple clinical trials with different variants and the safety profile that we have identified was always consistent for all variant-adapted vaccines.

第二件事，重要的是，我們現在有 FDA 和 EMA 的案例。我們根據多個變體的預先存在的臨床數據獲得了疫苗的授權。提醒大家，我們已經對不同的變體進行了多項臨床試驗，並且我們確定的安全性特徵對於所有適應變體的疫苗始終是一致的。

And the second aspect is that we found that preclinical data and clinical data in subjects with flu infections are very predictive on what we are seeing in the clinical setting. And authorization now of this variant-adapted BA.4/5 vaccine followed this logic and enabled rapid authorization and availability of a BA.4/5 adapted vaccine.

第二個方面是，我們發現流感感染受試者的臨床前數據和臨床數據對我們在臨床環境中看到的情況具有很強的預測性。現在，這種適應變體的 BA.4/5 疫苗的授權遵循了這一邏輯，並能夠快速授權和獲得適應 BA.4/5 的疫苗。

And we believe that this will become also in future, the model -- the working model. That means once new variants emerge that require a boosting, we will be able to respond quickly, and there will be a regulatory process to allow that such variant-adapted vaccines can get -- can be delivered within a few months after the emergence of the variant.

我們相信這也將成為未來的模式——工作模式。這意味著一旦出現需要加強的新變種，我們將能夠迅速做出反應，並且將有一個監管程序允許這種適應變種的疫苗可以在出現後的幾個月內交付。變體。

We will now go to our next question. And the question comes from Ellie Merle from UBS.

我們現在將進入下一個問題。問題來自瑞銀的 Ellie Merle。

Just a financial one, given you booked the gross profits from the Pfizer collaboration, can you comment, I guess, on your latest thoughts on how you're thinking about the profit margin and the Pfizer collaboration, COVID business longer term, and how you see that changing? And also how this could change if there, say, were to be a combination COVID flu vaccine, for instance?

只是財務問題，鑑於您從輝瑞合作中獲得了毛利潤，我猜您能否評論一下您對利潤率和輝瑞合作、COVID 業務長期以及您如何看待的最新想法？看到變化了嗎？還有，例如，如果有一種組合的 COVID 流感疫苗，這會如何改變？

Yes. Thanks, Ellie, for the question. Not an easy question to answer, I have to say. Well, in terms of the gross margin, I think you have seen pretty stable gross margin development throughout the year. I mean, in the quarters, you have some ups and downs once in a while given that we had some write-offs and we have elaborated on this in the documentations that we have published.

是的。謝謝，艾莉，你的問題。我不得不說，這不是一個容易回答的問題。好吧，就毛利率而言，我認為您全年看到了相當穩定的毛利率發展。我的意思是，在這些季度中，您偶爾會出現一些起伏，因為我們有一些核銷，並且我們已經在我們發布的文件中對此進行了詳細說明。

Going forward, I mean, with the higher pricing, of course, it depends then what the costs are, what the COGS will be that we have to deduct. It's a bit too early to really give you clear guidance on this, what that means for our gross margin for '23 and the years beyond. And specifically then, when flu comes in, which will take a while, we will see that at a later point in time.

展望未來，我的意思是，隨著更高的定價，當然，這取決於成本是多少，我們必須扣除的銷貨成本是多少。現在給你明確的指導還為時過早，這對我們 23 年及以後的毛利率意味著什麼。具體來說，當流感來襲時，這將需要一段時間，我們將在稍後的時間看到這一點。

So there will be some mixture that we will see going forward, and therefore, you've got to bear with us a little bit until we're able to really give you some more clarity on the impact.

因此，我們將看到未來會出現一些混合情況，因此，在我們能夠真正讓您更清楚地了解影響之前，您必須忍受我們一點。

And your next question comes from the line of Simon Baker from Redburn.

您的下一個問題來自 Redburn 的 Simon Baker。

A question on pricing, if I may. You very helpfully gave us the list price range for the U.S. of around $110 to $130 per single dose. I appreciate it's not the same thing, but I just wonder how we should think about contrasting that number with the $64 per dose that CMS talked about in April. Obviously, your's covers a far broader remit than the CMS was talking about, but just how we can think about how those numbers triangulate together?

如果可以的話，關於定價的問題。您非常有幫助地向我們提供了美國的標價範圍，每劑約 110 至 130 美元。我很欣賞這不是一回事，但我只是想知道我們應該如何考慮將這個數字與 CMS 在 4 月份談到的每劑 64 美元進行對比。顯然，您所涵蓋的範圍比 CMS 所說的要廣泛得多，但是我們如何才能考慮這些數字是如何三角化的呢？

And on a similar point, could you give us any early indications for pricing outside the U.S. for 2023?

同樣，您能否為我們提供 2023 年美國以外定價的任何早期跡象？

Yes. Thank you, Simon. I mean as you know, we're expecting this market to be a heavily-tiered priced market like for any other vaccines. And so the price that we've quoted there is a U.S. list price. We would expect, of course, that sometimes there can be differences depending on the segment that you're in. That's pretty much all we can tell you at this point.

是的。謝謝你，西蒙。我的意思是，正如你所知，我們預計這個市場將像任何其他疫苗一樣成為一個高度分級的定價市場。因此，我們所報的價格是美國標價。當然，我們希望有時會根據您所在的細分市場而有所不同。這就是我們目前可以告訴您的全部內容。

In terms of the dynamic, we do think that this market will have some important differences to some of the other vaccine markets like flu in the sense that it's -- we expect that this will not be -- this will be a branded market for the foreseeable future. And there's also a very different market structure here than you have in some of the other vaccine markets where you have many, many players.

就動態而言，我們確實認為這個市場將與流感等其他一些疫苗市場產生一些重要差異，因為它是——我們預計這不會是——這將是一個品牌市場可以預見的將來。而且，這裡的市場結構也與其他一些擁有許多參與者的疫苗市場非常不同。

And so I think we're -- we do feel like we're in a good position here by virtue of having a very strong product, with a very strong product profile, both on safety and efficacy and have continued to build up our safety database and have a strong brand.

所以我認為我們 - 我們確實覺得我們在這里處於有利位置，因為我們擁有非常強大的產品，在安全性和有效性方面具有非常強大的產品形象，並繼續加強我們的安全性數據庫並擁有強大的品牌。

So I think we feel good about our -- about the price that we put out there, but that's pretty much what we can say at this point. In some geographies, there could be differences, and there's likely to still be a link to volumes on some level, as you would expect in a heavily contracted market like this where you have purchases in bulk.

所以我認為我們對我們的價格感覺很好，但這就是我們現在可以說的。在某些地區，可能存在差異，並且在某種程度上仍可能與數量有關，正如您在像這樣一個大量採購的嚴重合同市場中所期望的那樣。

And maybe to add to what Ryan just said. I mean what Pfizer said to the topic, that pricing has been set given -- or in relation to what sort of benefit we see that we bring with the product. Of course, as Ryan said, it's also a question of volume. So I mean, we have signed huge contracts with various governments. The contract size with other parties in the U.S. market to use that example is, of course, a totally different one, and that will have an implication.

也許是為了補充 Ryan 剛才所說的話。我的意思是輝瑞對這個話題所說的話，定價已經給定了——或者與我們看到的產品帶來的好處有關。當然，正如瑞恩所說，這也是數量的問題。所以我的意思是，我們已經與各國政府簽訂了巨額合同。使用該示例與美國市場其他方的合同規模當然是完全不同的，這將產生影響。

Overall, I mean, how the pricing will develop over time is to be expected to go up, of course, because more and more countries, if it becomes endemic of course, that's the base assumption for this, will then have similar sort of developments and what the pricing that means in Japan or in Europe -- when the European contract runs out, that has to be seen. It's a bit early to really be -- to be able to give you more precise indications here. But that's the sort of broad direction that we see.

總的來說，我的意思是，隨著時間的推移，定價將如何發展，當然，因為越來越多的國家，如果它成為地方病，這是基本假設，那麼就會有類似的發展以及定價在日本或歐洲意味著什麼——當歐洲合同到期時，必須看到這一點。現在還為時過早 - 能夠在這里為您提供更準確的指示。但這就是我們所看到的大方向。

We will take one more question. And the question comes from the line of Zhiqiang Shu from Berenberg.

我們再回答一個問題。這個問題來自貝倫貝格的舒志強一行。

Great. I want to ask broadly on the mRNA cancer vaccine. Obviously, there is some skepticism around the cancer vaccine space. So maybe, Ugur, can you discuss a bit of your confidence on this modality in the cancer vaccine space? And maybe some updated thoughts on where whether this modality will play the most significant role?

偉大的。我想廣泛地詢問有關 mRNA 癌症疫苗的問題。顯然，對癌症疫苗領域存在一些懷疑。那麼也許，Ugur，你能談談你對癌症疫苗領域這種模式的信心嗎？或許還有一些關於這種模式是否將發揮最重要作用的最新想法？

And a quick follow-up on BNT211, the CAR-T. Can you also discuss the potential registration path for this program given you have seen quite encouraging data from early trials?

并快速跟進 BNT211，即 CAR-T。鑑於您從早期試驗中看到了令人鼓舞的數據，您能否也討論一下該計劃的潛在註冊途徑？

Thank you, Zhiqiang. So let's start with the cancer vaccine question, and Ozlem will take the question related to the (inaudible). So of course, there are -- the discussion about cancer vaccine is the same. Why do you believe that cancer vaccines will work in the background of so many failures in the past.

謝謝你，志強。因此，讓我們從癌症疫苗問題開始，Ozlem 將回答與（聽不清）相關的問題。所以當然，關於癌症疫苗的討論也是一樣的。為什麼你認為癌症疫苗會在過去如此多的失敗背景下發揮作用。

So my answer is always the same. We believe that cancer vaccines must be positioned in a way that they can do the job, and we believe that the best market and the best indication and clinical setting to address cancer vaccine is post surgery, where tumors are in a micrometastatic manner left. So this is minimal residual disease or ctDNA-positive patients after surgery.

所以我的答案總是一樣的。我們認為，癌症疫苗必須以能夠完成這項工作的方式進行定位，我們認為解決癌症疫苗的最佳市場、最佳適應症和臨床環境是手術後，其中腫瘤以微轉移的方式留下。所以這是最小殘留病或手術後ctDNA陽性的患者。

And we know that in this setting, there is a huge medical need. To give you just examples, in colorectal cancer, about 30% of patients after surgery have a relapse in the time of 2 to 3 years after surgery. In triple-negative breast cancer, this is also in the range of 30% to 40% in the first 4 years after surgery. In pancreatic cancer, it's even about 70% of patients relapsing after surgery. And the same is -- similar data described for stomach cancer, GI cancers and so on.

我們知道，在這種情況下，有巨大的醫療需求。舉個例子，在結直腸癌中，大約 30% 的患者在術後 2 到 3 年內會復發。在三陰性乳腺癌中，手術後前 4 年這一比例也在 30% 至 40% 的範圍內。在胰腺癌中，甚至約 70% 的患者術後復發。同樣是——針對胃癌、胃腸道癌症等描述的類似數據。

That's where we want to position our personalized cancer vaccines, allowing us to induce neoantigen-specific immune responses, T cell. We know now from clinical data, early clinical data in pancreatic cancer, in melanoma patients and also from publications of either academic groups that this could be an ideal setting to induce strong T cell responses that could have to control and eliminate residual tumor cells. And Ozlem, would you like to take the second question?

這就是我們想要定位我們的個性化癌症疫苗的地方，讓我們能夠誘導新抗原特異性免疫反應，T 細胞。我們現在從臨床數據、胰腺癌、黑色素瘤患者的早期臨床數據以及任一學術團體的出版物中得知，這可能是誘導強 T 細胞反應的理想環境，而這種反應可能必須控制和消除殘留的腫瘤細胞。 Ozlem，你願意回答第二個問題嗎？

Yes. This was about our CAR-T cell program, BNT211, (inaudible) and the regulatory path, which we would foresee there. Let me remind you that in this program, we are still actually in the dose finding part of our Phase I/II trial, which means that we have only tested the first 2 dose levels or 3 dose levels of our CAR-T cells and are also still in the process of exploring whether adding to this new CAR-T cell product vaccine makes a difference or not and how the treatment regimen should be.

是的。這是關於我們的 CAR-T 細胞計劃 BNT211（聽不清）和我們可以預見的監管路徑。讓我提醒您，在這個計劃中，我們實際上仍處於 I/II 期試驗的劑量尋找部分，這意味著我們只測試了我們的 CAR-T 細胞的前 2 個劑量水平或 3 個劑量水平，並且是也仍在探索添加到這種新的 CAR-T 細胞產品疫苗中是否會產生影響以及治療方案應該如何。

Having said that, we are also very excited as you about the data, which we already see at this early stage, namely a manageable safety plus exciting clinical activity, in particular, in the patients with testicular cancer. Therefore, we are also -- have also started about thinking about the best regulatory path here. We have not made any positions and cannot speak about that at this time point, but will, for sure, do next year.

話雖如此，我們也對我們在早期階段已經看到的數據感到非常興奮，即可控的安全性加上令人興奮的臨床活動，特別是在睾丸癌患者中。因此，我們也 - 也開始考慮這裡的最佳監管路徑。我們目前還沒有發表任何立場，也不能談論這一點，但肯定會在明年發表。

I will now hand the call back for closing remarks.

我現在將回電以結束髮言。

Thank you for joining today's call. We look forward to talking to you soon. Stay safe. thank you and bye-bye.

感謝您加入今天的電話會議。我們期待很快與您交談。注意安全。謝謝你，再見。

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝你。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。