Biontech SE (BNTX) 2022 Q4 法說會逐字稿

Welcome to the BioNTech Fourth Quarter and Year-End Update Call. I would now like to hand the call over to Michael Horowitz, Investor Relations and Strategy. Please go ahead, Michael.

歡迎來到 BioNTech 第四季度和年終更新電話會議。我現在想把電話轉給投資者關係和戰略部的 Michael Horowitz。請繼續，邁克爾。

Good morning and afternoon. Thank you for joining us today for BioNTech's Fourth Quarter and Full Year 2022 Earnings Call. As a brief reminder, the slides that accompany this call in the fourth quarter and full year 2022 press release that was issued this morning can be found in the Investors section of our website. As outlined on Slide 2, you can see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20-F. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.

早上好，下午好。感謝您今天加入我們參加 BioNTech 的第四季度和 2022 年全年收益電話會議。簡要提醒一下，今天上午發布的第四季度和 2022 年全年新聞稿的電話會議幻燈片可以在我們網站的投資者部分找到。如幻燈片 2 所述，您可以看到我們的前瞻性聲明免責聲明。我們向美國證券交易委員會提交的文件中描述了有關這些聲明和其他風險的更多信息，包括我們最近的 20-F 表格年度報告。電話會議的前瞻性陳述存在重大風險和不確定性，僅在電話會議的原始日期發表，我們不承擔更新或修改任何聲明的義務。

On Slides 3 and 4, you can see detailed safety information regarding our COVID-19 vaccine. And on Slide 5, you can find the agenda for today's call. Today, I'm joined by the following members of BioNTech's management team. Our CEO and Co-Founder, Ugur Sahin; Ozlem Tureci, our Chief Medical Officer and Co-Founder; Jens Holstein, our Chief Financial Officer; and Ryan Richardson, our Chief Strategy Officer. I would like to turn the call over to Ugur Sahin.

在幻燈片 3 和 4 上，您可以看到有關我們的 COVID-19 疫苗的詳細安全信息。在幻燈片 5 上，您可以找到今天電話會議的議程。今天，BioNTech 管理團隊的以下成員加入了我的行列。我們的首席執行官兼聯合創始人 Ugur Sahin； Ozlem Tureci，我們的首席醫療官兼聯合創始人；我們的首席財務官 Jens Holstein；和我們的首席戰略官 Ryan Richardson。我想把電話轉給 Ugur Sahin。

Thank you, Michael. Good morning and good afternoon, and a warm welcome to all the call participants. We appreciate your continued support. Today, I will summarize our fourth quarter and full year 2022 highlights and priorities before I pass the call over to my team to provide some further details.

謝謝你，邁克爾。早上好，下午好，熱烈歡迎所有電話會議參與者。感謝您一直以來的支持。今天，在將電話轉交給我的團隊以提供更多詳細信息之前，我將總結我們第四季度和 2022 年全年的亮點和優先事項。

Slide 7. We and Pfizer continued our global leadership in the fight against COVID-19 in 2022. We achieved our supply target for the year with approximately 2 billion doses in vials, which included the successful global launch of our first variant adaptive vaccine. In the beginning of 2022, there was no clear regulatory pathway about how to introduce variant adapted vaccines. With our diligence scientific and clinical approach, we were able to navigate the regulatory uncertainties.

幻燈片 7。2022 年，我們和輝瑞在抗擊 COVID-19 的鬥爭中繼續保持全球領導地位。我們實現了當年的供應目標，瓶裝約 20 億劑，其中包括在全球成功推出首個變體適應性疫苗。在 2022 年初，關於如何引入變異適應疫苗還沒有明確的監管途徑。憑藉我們勤奮的科學和臨床方法，我們能夠應對監管的不確定性。

We have evaluated various variant vaccine candidates manufactured and have shipped about 550 million doses by mid-December. We maintained and continued to build on the strong market position we have established for our COVID-19 vaccine franchise to further label expansion in regions around the world. I would like to thank our team and our partners for the stedfast commitment, which contributed to these successes.

我們評估了生產的各種候選變體疫苗，到 12 月中旬已運送了約 5.5 億劑。我們保持並繼續鞏固我們為 COVID-19 疫苗專營權建立的強大市場地位，以進一步擴大在世界各地的標籤。我要感謝我們的團隊和我們的合作夥伴堅定不移的承諾，他們為這些成功做出了貢獻。

Moving to the next slide. We also continued the rapid advancement and expansion of our clinical pipeline in 2022 and early 2023. We presented clinical data updates for programs from 4 distinct platforms at major medical congresses. In addition to advancing multiple new COVID-19 programs throughout the year, which led to 2 new product launches, we initiated 9 Phase I trials. This included 5 start in immuno-oncology and 4 in infectious disease.

移動到下一張幻燈片。我們還在 2022 年和 2023 年初繼續快速推進和擴展我們的臨床管道。我們在主要醫學大會上展示了來自 4 個不同平台的項目的臨床數據更新。除了全年推進多個新的 COVID-19 項目，從而推出 2 個新產品外，我們還啟動了 9 個 I 期試驗。這包括免疫腫瘤學的 5 個開始和傳染病的 4 個開始。

Slide 9. Turning to the next slide. In 2022, we have started 4 new collaborations, broadened our pipeline, expanded our team by more than 1,500 new professionals and continued to strengthen our financial position. Slide 10. Our drug discovery strategy is technology-agnostic and aims to use modular technology platforms to produce novel product candidates. We continue to enhance and connect our platform technologies in 2022 and complemented our internal capabilities and pipeline with several new partnerships.

幻燈片 9。轉到下一張幻燈片。 2022 年，我們開始了 4 項新的合作，拓寬了我們的管道，將我們的團隊擴大了 1,500 多名新專業人員，並繼續加強了我們的財務狀況。幻燈片 10。我們的藥物發現策略與技術無關，旨在使用模塊化技術平台生產新的候選產品。我們將在 2022 年繼續增強和連接我們的平台技術，並通過幾個新的合作夥伴關係補充我們的內部能力和管道。

One of those, which I am particularly excited about is our partnership with OncoC4, which based on our next-generation checkpoint immunomodulator platform with the addition of a novel anti-CTLA-4 antibody, which has shown a differentiated safety and activity profile.

其中一個讓我特別興奮的是我們與 OncoC4 的合作夥伴關係，它基於我們的下一代檢查點免疫調節劑平台，添加了一種新型抗 CTLA-4 抗體，該抗體顯示出差異化的安全性和活性特徵。

We believe this antibody is suitable for the development as monotherapy, but also can be combined with multiple product candidates in BioNTech's pipeline. I will come back to that in a few minutes. Slide 11. The next slide, we kept our strategic priorities for 2023. The third is to build and strengthen our COVID-19 franchise. We believe that the COVID-19 market will continue to be dynamic, and we are investing with our partner, Pfizer, in multiple next-generation programs, which have the potential to drive future growth.

我們相信這種抗體適合作為單一療法進行開發，但也可以與 BioNTech 管道中的多個候選產品相結合。我會在幾分鐘後回到這個話題。幻燈片 11。下一張幻燈片，我們保留了 2023 年的戰略重點。第三是建立和加強我們的 COVID-19 特許經營權。我們相信 COVID-19 市場將繼續充滿活力，我們正在與我們的合作夥伴輝瑞投資多個下一代項目，這些項目有可能推動未來的增長。

This includes Variant-adapted vaccines, our T-cell enhancing vaccine and our flu combination vaccine. In immuno-oncology, our goal is to initiate multiple registrational starts in the next 12 to 18 months. Our most advanced programs include our mRNA cancer vaccines, our first cell therapy and several novel antibody programs. We are preparing to advance this program to registration studies. Third, we aim to expand our portfolio of novel vaccines against infectious diseases with high medical need.

這包括變體適應疫苗、我們的 T 細胞增強疫苗和我們的流感聯合疫苗。在免疫腫瘤學方面，我們的目標是在未來 12 到 18 個月內啟動多項註冊。我們最先進的項目包括我們的 mRNA 癌症疫苗、我們的第一個細胞療法和幾個新的抗體項目。我們正準備將該項目推進到註冊研究階段。第三，我們的目標是擴大我們針對具有高醫療需求的傳染病的新型疫苗組合。

To date, we have already initiated programs against HSV-2, Malaria and Shingles. And (inaudible). Slide 12. Moving now to the next slide. With the new collaboration with OncoC4, we bring an exciting new Checkpoint Inhibitor molecule into our immuno-oncology portfolio that is going to enter the first registrational trial within the coming weeks.

迄今為止，我們已經啟動了針對 HSV-2、瘧疾和帶狀皰疹的計劃。和（聽不清）。幻燈片 12。現在轉到下一張幻燈片。通過與 OncoC4 的新合作，我們將一種令人興奮的新檢查點抑製劑分子引入我們的免疫腫瘤學產品組合，該產品將在未來幾週內進入首次註冊試驗。

The first anti-scale antibody ipilimumab was approved in 2011 by the FDA followed by tremelimumab a couple of years later. To date, these 2 anti-CTLA-4 antibodies have been approved in 7 cancer indication either as a monotherapy or in combination therapy. Approved anti-CTLA-4 antibodies have shown lasting emissions in a fraction of responding patients. However, the associated high rate of toxicity especially in combination with anti-PD1 therapy limits the further use of this antibody.

第一種抗水垢抗體 ipilimumab 於 2011 年獲得 FDA 批准，幾年後又獲得了 tremelimumab。迄今為止，這 2 種抗 CTLA-4 抗體已作為單一療法或聯合療法被批准用於 7 種癌症適應症。批准的抗 CTLA-4 抗體在一小部分有反應的患者中顯示出持久的排放。然而，相關的高毒性率尤其是與抗 PD1 療法聯合使用限制了該抗體的進一步使用。

ON392, the anti-CCR4 antibody from OncoC4 was designed to exert and improve therapeutic index to a unique mechanism of action, which enables depletion of intra-tumoral Tregs but preserved Treg function in healthy human tissues by CTLA-4 recycling. We believe this could allow for a longer dosing of this checkpoint inhibitor molecule, which in turn could building spectrum of antitumor efficacy.

ON392 是來自 OncoC4 的抗 CCR4 抗體，旨在通過獨特的作用機制發揮和提高治療指數，通過 CTLA-4 循環利用，能夠消除腫瘤內的 Treg，但保留健康人體組織中的 Treg 功能。我們相信這可以允許更長時間地使用這種檢查點抑製劑分子，這反過來可以建立抗腫瘤功效的範圍。

Our goal is to continue to develop this antibody as a single agent I/O compound and in combination with anti-PD1. Moreover, we will evaluate its potential in combination with our own immunotherapy candidates. 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, who will give more background on the new assets and our pipeline.

我們的目標是繼續開發這種抗體作為單一藥物 I/O 化合物並與抗 PD1 聯合使用。此外，我們將結合我們自己的免疫療法候選人來評估其潛力。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，他將提供有關新資產和我們管道的更多背景信息。

Thank you, Ugur. I'm delighted to speak with everyone today and provide our pipeline update. In 2022, we've presented several clinical data updates from our oncology programs from 4 distinct platforms. A selection is shown on Slide 14.

謝謝你，烏古爾。我很高興今天能與大家交談並提供我們的管道更新。 2022 年，我們從 4 個不同的平台上展示了我們腫瘤學項目的幾項臨床數據更新。選擇顯示在幻燈片 14 上。

At ASCO in June, we presented preliminary data from the ongoing investigator-initiated First-in-Human Phase I study, evaluating the safety and tolerability of Autogene cevumeran, our iNeST program, in combination with 1 dose of anti-PDL1 immune checkpoint inhibitor, atezolizumab; and standard of care chemotherapy for adjuvant treatment of patients with resected pancreatic ductal adenocarcinoma.

在 6 月的 ASCO 上，我們展示了正在進行的研究者發起的第一期人體 I 期研究的初步數據，評估了我們的 iNeST 計劃 Autogene cevumeran 與 1 劑抗 PDL1 免疫檢查點抑製劑聯合使用的安全性和耐受性，阿特珠單抗；和用於輔助治療已切除胰腺導管腺癌患者的護理化療標準。

Autogene cevumeran was well tolerated and induced high magnitude de-novo, neoantigen-specific T-cell responses in a fraction of patients. These patients also have significantly lower recurrent free survival as compared to those without vaccine-induced de-novo immune response. We are planning a Phase II trial in this patient population to open later this year.

Autogene cevumeran 具有良好的耐受性，並在一小部分患者中誘導了高強度的新抗原特異性 T 細胞反應。與沒有疫苗誘導的新生免疫反應的患者相比，這些患者的複發性自由生存率也顯著降低。我們計劃在今年晚些時候在這一患者群體中開展 II 期試驗。

We had several presentations featuring our BNT211 program this year. At the ESMO Congress in September, we presented updates from our ongoing Phase I/II trial, evaluating the safety and preliminary efficacy of BNT211, our CAR-T cell therapy candidate in patients with relapsed or refractory cloud and positive solid tumors.

今年，我們進行了幾次以 BNT211 計劃為特色的演講。在 9 月的 ESMO 大會上，我們介紹了正在進行的 I/II 期試驗的最新情況，評估了 BNT211 的安全性和初步療效，BNT211 是我們的 CAR-T 細胞療法候選藥物，用於治療復發或難治性雲和陽性實體瘤患者。

The data showed a manageable safety profile and clinical responses. In patients with testicular cancer, the objective response rate was 57% and disease control rate was 85%. This year, we are expecting a data update from the ongoing Phase I/II trial and we are planning to start a Phase II trial in second line platinum resistant testicular cancer in 2024.

數據顯示了可控的安全性和臨床反應。在睾丸癌患者中，客觀緩解率為57%，疾病控制率為85%。今年，我們期待正在進行的 I/II 期試驗的數據更新，我們計劃在 2024 年開始二線鉑耐藥睾丸癌的 II 期試驗。

For BNT113, a candidate from our fixed back program, we presented preliminary safety data from the safety run-in phase of the ongoing Phase II trial evaluating BNT113 in combination with pembro versus pembro monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive PDL1 positive head, neck squamous cell carcinoma at ESMO-IO in December 2022.

對於 BNT113，我們固定背部計劃的候選藥物，我們提供了來自正在進行的 II 期試驗的安全磨合階段的初步安全數據，該試驗評估 BNT113 聯合 pembro 與 pembro 單一療法作為不可切除復發或轉移患者的一線治療2022 年 12 月 ESMO-IO 的 HPV16 陽性 PDL1 陽性頭頸部鱗狀細胞癌。

Also at ESMO-IO, we and our partner Genmab presented safety and preliminary antitumor activity data from patients with advanced metastatic squamous cell carcinoma treated with chemotherapy, pembrolizumab and BNT312, a first-in-class bi-specific antibody combining CD4 and 4-1BB checkpoint activation.

同樣在 ESMO-IO，我們和我們的合作夥伴 Genmab 展示了接受化療、pembrolizumab 和 BNT312 治療的晚期轉移性鱗狀細胞癌患者的安全性和初步抗腫瘤活性數據，BNT312 是一種結合 CD4 和 4-1BB 的一流雙特異性抗體檢查點激活。

The combination of BNT312, with pembro, with or without chemotherapy, was well tolerated with no reported DLTs and showed encouraging early activity with 2 partial responses and 2 complete responses in all 4 evaluable patients. We will be sharing more data on several of our oncology pipeline candidates throughout this year.

BNT312與 pembro 的組合，有或沒有化療，耐受性良好，沒有報告 DLT，並且顯示出令人鼓舞的早期活動，在所有 4 名可評估患者中有 2 例部分反應和 2 例完全反應。今年，我們將分享更多關於我們的幾個腫瘤管道候選人的數據。

Slide 15 provides an overview of our oncology pipeline, including the collaboration Ugur mentioned earlier, we have a total of 20 oncology product candidates across 4 different drug classes in 24 ongoing clinical trials, 5 of which are randomized Phase II trials.

幻燈片 15 概述了我們的腫瘤管道，包括前面提到的合作 Ugur，我們在 24 個正在進行的臨床試驗中共有 4 個不同藥物類別的 20 個腫瘤候選產品，其中 5 個是隨機 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 product candidates offer the potential to be combined with other pipeline assets under development.

我們的計劃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。我們的許多候選產品都有可能與其他正在開發的管道資產相結合。

In the course of 2022, we started First-in-Human clinical trials, one on BNT116 together with our partner, Regeneron; a fixed back program in non-small cell lung cancer, 2 RiboMabs programs, namely BNT141 that targets called in 182 positive tumors and the T cell engager, BNT142, including 6 positive tumors.

在 2022 年期間，我們開始了首次人體臨床試驗，其中一項是與我們的合作夥伴 Regeneron 一起在 BNT116 上進行；非小細胞肺癌的一個固定的反向程序，2 個 RiboMabs 程序，即靶向調用 182 個陽性腫瘤的 BNT141 和 T 細胞接合器 BNT142，包括 6 個陽性腫瘤。

Further, 2 immune modulating antibodies, namely BNT313, a HexaBody targeting CD27 and BNT322, 2 new product candidates from our collaboration with Genmab are being evaluated in solid tumors. Turning now to Slide 16 and our new collaboration with OncoC4 and their next-generation entire CTLA-4 antibody, ONC-392.

此外，2 種免疫調節抗體，即 BNT313，一種靶向 CD27 的 HexaBody 和 BNT322，我們與 Genmab 合作的 2 種新候選產品正在實體瘤中進行評估。現在轉到幻燈片 16 以及我們與 OncoC4 及其下一代完整 CTLA-4 抗體 ONC-392 的新合作。

We are very excited to work with our colleagues from OncoC4 on this promising compound. In preclinical models, 392 has shown the most potent antitumor activity, while inducing the least autoimmunity. CTLA-4 recycled between the self-service and the endosome where it is prevented from lysosomal degradation and recycled back to the cell surface. Interruption of this process is associated with the development of autoimmunity.

我們很高興能與 OncoC4 的同事一起研究這種有前途的化合物。在臨床前模型中，392 顯示出最有效的抗腫瘤活性，同時誘導的自身免疫性最低。 CTLA-4 在自助服務和核內體之間循環，防止溶酶體降解並循環回細胞表面。這個過程的中斷與自身免疫的發展有關。

Approved anti-CTLA-4 antibodies such as ipilimumab disrupt CTLA-4 recycling and induce lysosomal degradation and thereby, immune-related adverse events. In contrast, ONC-392 dissociates from the formal acute in the endosome and allows normal recycling of both the antibody and the CTLA-4 molecule and this is designed for stronger cancer r therapeutic effect and less immune-related adverse effects.

已批准的抗 CTLA-4 抗體（如易普利姆瑪）會破壞 CTLA-4 循環並誘導溶酶體降解，從而導致免疫相關的不良事件。相比之下，ONC-392 與內體中的正式急性解離並允許抗體和 CTLA-4 分子的正常循環，這是為更強的癌症治療效果和更少的免疫相關副作用而設計的。

Turning to Slide 17. ONC-392 is being tested in a trial that investigates dose escalation as single agent and in combination with pembro and in which indications such as IO naive and refractory resistant non-small cell lung cancer and melanoma are being treated with the recommended Phase II dose. ONC-392 is a single agent was well tolerated in a 0.1 to 10 mg per kg dose range.

轉到幻燈片 17。ONC-392 正在一項試驗中進行測試，該試驗研究劑量遞增作為單一藥物並與 pembro 聯合使用，其中 IO 初治和難治性耐藥非小細胞肺癌和黑色素瘤等適應症正在接受治療推薦的 II 期劑量。 ONC-392 是一種單一藥物，在 0.1 至 10 mg/kg 的劑量範圍內具有良好的耐受性。

No does limiting toxicities were observed and MTD was not reached. The recommended Phase II dose is 10 mg per kg every 3 weeks as monotherapy. Patients that received 10 mg per kg were treated up to 12 weeks in this study.

沒有觀察到限制性毒性，也沒有達到 MTD。建議的 II 期劑量為每 3 週 10 mg/kg 作為單一療法。在這項研究中，接受 10 mg/kg 劑量的患者接受長達 12 週的治療。

ONC-392 in combination with pembro was administered at 3 and 6 mg per kg and was well tolerated with longest dosing at 3 mg per kg for up to 18 cycles and continuing.

ONC-392 與 pembro 的聯合給藥劑量為 3 mg/kg 和 6 mg/kg，耐受性良好，最長劑量為 3 mg/kg，長達 18 個週期並持續給藥。

No DLTs were observed and MTD was not reached in the combination setting. Severe immune-related adverse event rate in the combo dose escalation cohorts was 23%, which is considered lower than what was reported for comparable IO-IO combinations. Recommended Phase II dose for combination is 6 mg per kg.

未觀察到 DLT，並且在組合設置中未達到 MTD。組合劑量遞增隊列中與免疫相關的嚴重不良事件發生率為 23%，這被認為低於可比較的 IO-IO 組合報告的發生率。建議的 II 期組合劑量為 6 mg/kg。

In summary, ONC-392 dosed as monotherapy or in combination was well tolerated and the safety profile appears to allow higher dosing for a longer duration of treatment as compared to ipilimumab.

總之，與易普利姆瑪相比，ONC-392 作為單一療法或組合給藥具有良好的耐受性，並且安全性似乎允許更高的劑量和更長的治療持續時間。

Slide 18 shows efficacy data on ONC-392 from various cohorts of the trial as: A, monotherapy in patients with ovarian cancer; B, in combination with pembro in various solid tumors; and C, in combination with pembro in relapsed/refractory melanoma patients. The left tenor shows 28 evaluable ovarian cancer patients who have failed multiple lines of systemic therapy and received ONC-392 at 10 mg per kg monotherapy.

幻燈片 18 顯示了來自不同試驗隊列的 ONC-392 的療效數據：A，卵巢癌患者的單一療法； B、聯合pembro治療各種實體瘤；和 C，與 pembro 聯合治療復發/難治性黑色素瘤患者。左圖顯示 28 名可評估的卵巢癌患者，這些患者多線全身治療失敗並接受了 10 mg/kg 單藥治療的 ONC-392。

The objective response rate was 21% and the disease control rate was 50% with 1 complete response, 5 partial responses and 8 stable diseases. In the middle, you see data of patients with various solid cancers treated with either 3 or 6 mg per kg ONC-392 in combination with 200 mg per kg pembro. A data cut ONC-392 showed PRs in 3 of 10 evaluable patients. The right panel shows data from IO or IO-IO experienced refractory resistant patients with advanced melanoma treated with ONC-392 6 mg per kg and pembro, the 200 mg every 3 weeks.

客觀緩解率為21%，疾病控制率為50%，其中完全緩解1例，部分緩解5例，疾病穩定8例。在中間，您可以看到使用 3 或 6 mg/kg ONC-392 與 200 mg/kg pembro 聯合治療的各種實體癌患者的數據。數據削減 ONC-392 顯示 10 名可評估患者中有 3 名達到 PR。右圖顯示來自 IO 或 IO-IO 的難治性耐藥晚期黑色素瘤患者的數據，這些患者使用每公斤 6 毫克的 ONC-392 和每 3 週 200 毫克的 pembro 進行治療。

Out of the 6 first patients enrolled, 5 had a partial response and 1 had stable disease. Based on these promising data, Phase II study, evaluating ONC-392 in combination with pembro in platinum-resistant ovarian cancer patients has started in 2022. A Phase III study evaluating ONC-392 as monotherapy, where the docetaxel in patients with metastatic non-small cell lung cancer who have progressed on anti-PD1, PDL1 antibody-based therapy is planned to start this year.

在最初登記的 6 名患者中，5 名部分緩解，1 名病情穩定。基於這些有希望的數據，評估 ONC-392 聯合 pembro 治療鉑耐藥卵巢癌患者的 II 期研究已於 2022 年開始。一項評估 ONC-392 作為單一療法的 III 期研究，其中多西他賽用於非轉移性非抗 PD1 治療取得進展的小細胞肺癌患者，計劃於今年開始基於 PDL1 抗體的治療。

Slide 19 highlights our infectious disease pipeline. In the past months, we started multiple first-in-human trials with our mRNA vaccine candidates, including next-generation COVID-19, the combination of COVID-19 and influenza, malaria, HSV-2 and shingles vaccine candidates. In addition, we expect to enter the clinic with a tuberculosis vaccine candidate this year. These programs build on our validated platform of nucleoside-modified mRNA LNPs with optimized backbone design to address diseases with a significant global need.

幻燈片 19 重點介紹了我們的傳染病管道。在過去的幾個月裡，我們開始了多項 mRNA 候選疫苗的首次人體試驗，包括下一代 COVID-19、COVID-19 與流感、瘧疾、HSV-2 和帶狀皰疹候選疫苗的組合。此外，我們預計今年將有一種結核病候選疫苗進入臨床。這些項目建立在我們經過驗證的核苷修飾 mRNA LNPs 平台之上，具有優化的骨架設計，以解決具有重大全球需求的疾病。

Slide 20. As of December 2022, the original COVID-19 vaccine has been authorized or approved for emergency use or temporary use or granted market authorization in over 100 countries and regions around the world. Through rapid execution, we have broadened the label of our original and Omicron BA.4-5 adapted Bivalent vaccine across different age groups. This included full marketing authorization for original COVID-19 vaccine.

Slide 20. 截至 2022 年 12 月，原 COVID-19 疫苗已在全球 100 多個國家和地區獲得緊急使用或臨時使用或批准上市。通過快速執行，我們擴大了我們原始和 Omicron BA.4-5 改編的雙價疫苗在不同年齡組的標籤。這包括原始 COVID-19 疫苗的完整營銷授權。

The conversion applies to all existing and upcoming indications and formulations of the COMIRNATY Product Group authorized in the European Union, including original Omicron BA.1 and BA.4-5 adapted by valent vaccines as booster doses for individuals aged 12 years and older. In addition, we received EC approval for full market authorization for a filmic dose of original COVID-19 vaccine as a free dose series for children aged 6 months through 4 years and another EC approval for a fourth dose booster of original COVID-19 vaccine in individuals 12 years of age and older at an interval of at least 3 months between the administration of our original COVID-19 vaccine in the last prior dose of COVID-19 vaccine.

轉換適用於歐盟授權的 COMIRNATY 產品組的所有現有和即將出現的適應症和製劑，包括原 Omicron BA.1 和 BA.4-5 經 valent 疫苗改編為 12 歲及以上個人的加強劑量。此外，我們還獲得了 EC 的全面市場授權，批准將電影劑量的原始 COVID-19 疫苗作為 6 個月至 4 歲兒童的免費劑量系列，並在 EC 批准第四劑原始 COVID-19 疫苗加強劑12 歲及以上的個人，在之前最後一劑 COVID-19 疫苗之間至少間隔 3 個月接種我們的原始 COVID-19 疫苗。

In addition to the approvals of our original COVID-19 vaccine, we received several approvals and authorization of the original Omicron BA.4-5 adapted Bivalent vaccine booster, including an FDA, EUA and EC approval for 5 for 11 years of age and an FDA EUA as a third free mix dose in the free dose primary series and a single booster dose at least 2 months after completion of primary vaccination with free doses of our original COVID-19 vaccine for children 6 months through 4 years of age.

除了我們原始的 COVID-19 疫苗的批准外，我們還獲得了原始 Omicron BA.4-5 改編雙價疫苗加強劑的多項批准和授權，包括 FDA、EUA 和 EC 批准 5 歲 11 歲和FDA EUA 作為免費劑量初級系列中的第三次免費混合劑量和單次加強劑量，在完成初級疫苗接種後至少 2 個月，免費劑量的 6 個月至 4 歲兒童使用我們的原始 COVID-19 疫苗。

In December 2022, BionTech and Fosun Pharma received full regulatory approval of our 30-microgram original COVID-19 vaccine as well as of 30-microgram booster dose of our original Omicron BA.5 adapted by valent vaccine in individuals 12 years and older in Hong Kong. We continue to monitor protection offered by the original and our original Omicron adapted by the land vaccines against emerging SARS-CoV-2 variants.

2022 年 12 月，BionTech 和復星醫藥獲得了我們的 30 微克原裝 COVID-19 疫苗以及 30 微克原裝 Omicron BA.5 增強劑的全面監管批准，該劑量由 valent 疫苗改編而成，適用於香港 12 歲及以上的個人孔。我們將繼續監測原始的和我們原始的 Omicron 提供的保護，這些保護由土地疫苗改編，以對抗新出現的 SARS-CoV-2 變體。

Slide 21. In February this year, we and Pfizer announced the start of a Phase I/II trial of our mRNA vaccine candidates against shingles, also known as Varicella Zoster. The mRNA Shingrix vaccine candidates encode different versions of glycoprotein E on the surface of a varicella-zoster virus. The glycoprotein is important for viral replication and the set sales spread after reactivation of the virus in the nerve cells.

幻燈片 21。今年 2 月，我們和輝瑞公司宣布開始針對帶狀皰疹（也稱為水痘帶狀皰疹）候選 mRNA 疫苗進行 I/II 期試驗。 mRNA Shingrix 候選疫苗在水痘-帶狀皰疹病毒表面編碼不同版本的糖蛋白 E。糖蛋白對於病毒複製很重要，並且在病毒在神經細胞中重新激活後設定的銷售傳播。

The Phase I/II multi-center randomized controlled dose selection study will evaluate the safety, tolerability and immunogenicity of mRNA vaccine candidates against shingles.

I/II 期多中心隨機對照劑量選擇研究將評估針對帶狀皰疹的 mRNA 候選疫苗的安全性、耐受性和免疫原性。

The study is aiming to enroll up to 900 heavy volunteers 69 years of age and is being concluded in the United States. Phase I will help select for optimal mRNA vaccine candidate date, dose level, dosing schedule and formulation for advancement to Phase II. Participants in the study will be followed to determine how long protection may last.

該研究旨在招募多達 900 名 69 歲的重型志願者，並正在美國結束。第一階段將幫助選擇最佳 mRNA 疫苗候選日期、劑量水平、給藥時間表和配方，以推進到第二階段。將跟踪研究的參與者以確定保護可以持續多長時間。

While there are currently approved vaccines for Shingles and Pfizer, we aim to utilize our mRNA technology to develop a vaccine that demonstrates high efficacy is better tolerated and is efficient to be produced globally. 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.

雖然目前已批准用於帶狀皰疹和輝瑞的疫苗，但我們的目標是利用我們的 mRNA 技術開發一種疫苗，該疫苗具有更高的療效，耐受性更好，並且可以在全球範圍內高效生產。我期待在接下來的幾個月中提供更多的程序更新。我現在將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結果。

Thank you, Ozlem, and a warm welcome to everyone who do in today's call. I'll start my section with key highlights for the 2022 financial year. During the 2022 financial year, we were able to again maintain a strong performance. I would like to underline this by diving into some of the key financial figures for the past year.

謝謝你，Ozlem，並熱烈歡迎所有參與今天電話會議的人。我將從 2022 財年的主要亮點開始我的部分。在 2022 財政年度，我們能夠再次保持強勁的表現。我想通過深入研究過去一年的一些關鍵財務數據來強調這一點。

Our total revenues reported for the 2022 financial year reached EUR 17.3 billion and mainly comprise EUR 17.1 billion COVID-19 vaccines revenues, whereby we met the upper end of our updated guidance from November 2022. Based on our strong profit during the year ended December 31, 2022, we generated an operating cash flow of EUR 13.6 billion and generated earnings per share on a fully diluted basis of EUR 37.77.

我們報告的 2022 財年總收入達到 173 億歐元，主要包括 171 億歐元的 COVID-19 疫苗收入，由此我們達到了 2022 年 11 月更新指南的上限。基於我們截至 12 月 31 日的年度的強勁利潤，到 2022 年，我們產生了 136 億歐元的運營現金流，並在完全攤薄的基礎上產生了 37.77 歐元的每股收益。

With respect to the company's financial position, we ended the 2022 financial year with EUR 13.9 billion of cash and cash equivalents. Subsequent to the end of the year, we have received EUR 1.8 billion in cash from our collaboration partner, Pfizer, settling our gross profit share for the third quarter of 2022.

關於公司的財務狀況，我們在 2022 財政年度結束時擁有 139 億歐元的現金和現金等價物。年底之後，我們從我們的合作夥伴輝瑞那裡收到了 18 億歐元的現金，用於結算我們 2022 年第三季度的毛利份額。

Let's continue with the next slide that presents the comparison between our actuals of the 2022 financial year to the guidance recently updated in our last earnings call in November 2022. As just mentioned, we recognized EUR 17.1 billion COVID-19 vaccine revenues in reaching the upper end of our guidance of EUR 16 million to EUR 17 million.

讓我們繼續看下一張幻燈片，該幻燈片展示了我們 2022 財年的實際情況與我們在 2022 年 11 月的上一次財報電話會議上最近更新的指導意見之間的比較。正如剛才提到的，我們認識到 171 億歐元的 COVID-19 疫苗收入達到了上限我們的指導結束時為 1600 萬歐元至 1700 萬歐元。

In total, we invoiced approximately 2 billion doses in 2022. I'll come back to the allocation of the COVID-19 vaccine revenues in more detail in one of the following slides. During the 2022 financial year, our R&D expenses reached EUR 1.537 billion, so that we ended the year around the upper end of our guidance for March of 2022.

總的來說，我們在 2022 年開出了大約 20 億劑的發票。我將在下面的一張幻燈片中更詳細地回到 COVID-19 疫苗收入的分配。在 2022 財年，我們的研發費用達到 15.37 億歐元，因此我們在 2022 年 3 月的指引上限附近結束了這一年。

The expenses resulting from the prelaunch production of our Omicron adapted Bivalent COVID-19 vaccines contributed to our R&D spend. Our core R&D activities focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations.

我們的 Omicron 適用的雙價 COVID-19 疫苗的上市前生產產生的費用為我們的研發支出做出了貢獻。我們的核心研發活動側重於擴大和加速我們現有的腫瘤學和傳染病候選產品管道，符合我們的預期。

Moving to SG&A expenses. During the 2022 financial year, we recognized EUR 544 million SG&A expenses, and hence, met our guidance from March of 2022. The expenses were mainly driven by supporting our rapid growth, including accelerating our internal operating activities.

轉到 SG&A 費用。在 2022 財年，我們確認了 5.44 億歐元的 SG&A 費用，因此達到了我們 2022 年 3 月的指導。這些費用主要是為了支持我們的快速增長，包括加速我們的內部運營活動。

Our 2022 financial year capital expenditures amounted to EUR 363 million and included investments in infrastructure and production capacities.

我們 2022 財年的資本支出總計 3.63 億歐元，其中包括對基礎設施和生產能力的投資。

The spending remained below our expectation, mainly due to certain delays in finishing our various construction projects. During the 2022 financial year, we reached an annual effective income tax rate of 27%, meeting our amended guidance. Certain current tax savings associated with the expenses from the share-based payment programs have been recognized in equity directly. Hence, those cost-effective savings did not have an impact on our annual effective income tax rate under IFRS. Considering this effect, though, the cash effective tax rate is about 24%.

支出仍低於我們的預期，主要是由於我們的各種建設項目的完成出現一定程度的延誤。在 2022 財政年度，我們達到了 27% 的年度有效所得稅率，符合我們修訂後的指導方針。與基於股份的支付計劃的費用相關的某些當期節稅已直接在權益中確認。因此，這些具有成本效益的節省不會對我們在 IFRS 下的年度有效所得稅率產生影響。不過，考慮到這一影響，現金有效稅率約為 24%。

Let's now switch to the next page. The 2022 financial year COVID-19 vaccine revenues of EUR 17.1 billion reached the upper end of our guidance, benefiting from stronger-than-expected revenues by our collaboration partners and some favorable U.S. dollar development. Compared to the previous year, we saw a decrease in our COVID-19 vaccine sales which corresponds with the demand of COVID-19 vaccines.

現在讓我們切換到下一頁。 2022 財年 COVID-19 疫苗收入為 171 億歐元，達到了我們指導的上限，這得益於我們的合作夥伴的收入強於預期以及一些有利的美元發展。與上一年相比，我們發現 COVID-19 疫苗的銷售額有所下降，這與 COVID-19 疫苗的需求相對應。

Let me give you some more details on our revenue stream. As a reminder, on 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 12.7 billion related to our share of gross profit from COVID-19 vaccine sales in the collaboration partner territories.

讓我給你一些關於我們收入流的更多細節。提醒一下，在我們的 COVID-19 疫苗合作中，已根據營銷和分銷權在我們、輝瑞和復星醫藥之間分配了區域。我們的 COVID-19 疫苗收入包括 127 億歐元，與我們在合作夥伴地區的 COVID-19 疫苗銷售毛利份額相關。

These revenues represent a net figure, meaning that we generate a 100% gross margin on those revenues. As we have mentioned in the past and explained in more detail on 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.

這些收入代表淨額，這意味著我們從這些收入中獲得 100% 的毛利率。正如我們過去提到並在我們的財務報表和向美國證券交易委員會提交的文件中更詳細地解釋的那樣，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公司與我們共享的初步數據估算的。

Our COVID-19 vaccine revenues from direct COVID-19 vaccine sales to customers in our territory reached EUR 3.2 billion during the 2022 financial year. Revenues in our territory were significantly driven by shipments of the Omicron adapted Bivalent COVID-19 vaccine cells towards the end of 2020.

在 2022 財政年度，我們通過直接向我們境內的客戶銷售 COVID-19 疫苗而獲得的 COVID-19 疫苗收入達到 32 億歐元。到 2020 年底，Omicron 改裝的雙價 COVID-19 疫苗電池的出貨量極大地推動了我們地區的收入。

Also included in our COVID-19 vaccine revenues were EUR 1.2 billion of revenues from sales to our collaboration partners for the 2022 financial year.

我們的 COVID-19 疫苗收入中還包括 2022 財年向合作夥伴銷售的 12 億歐元收入。

The sales under the collaboration with Pfizer are influenced from time to time by manufacturing variances such as expenses due to write-offs of inventories and costs related to production capacity derived from contract manufacturing organizations that became redundant. I'll be moving to our financial results for the fourth quarter and the full year of 2022.

與輝瑞合作的銷售額不時受到製造差異的影響，例如由於庫存註銷產生的費用以及與合同製造組織產生的產能相關的成本變得多餘。我將轉向我們第四季度和 2022 年全年的財務業績。

Having explained our revenues on the previous slide, let me move to cost of sales that amounted to EUR 0.2 billion in the fourth quarter of 2022 compared to EUR 0.6 million for the comparative prior year period. This drop was mainly caused by the release of provisions in Q4. For the 2022 financial year, the cost of sales amounted to EUR 3 billion compared to EUR 2.9 billion for the comparative prior year period.

在上一張幻燈片中解釋了我們的收入之後，讓我轉到 2022 年第四季度的銷售成本為 2 億歐元，而去年同期為 60 萬歐元。這一下降主要是由於四季度計提撥備所致。 2022 財年的銷售成本為 30 億歐元，上年同期為 29 億歐元。

The cost of sales included cost of sales from our COVID-19 vaccine sales comprised the share of gross profit that we owe our collaboration for Pfizer based on our sales. In addition, cost of sales was impacted by expenses arising from inventory write-offs and expenses or production capacity derived from contracts with contract manufacturing organizations that became redundant. The effects were driven by the introduction of the new COVID-19 vaccine formulation.

銷售成本包括我們 COVID-19 疫苗銷售的銷售成本，包括我們根據我們的銷售欠輝瑞合作的毛利潤份額。此外，銷售成本受到庫存註銷產生的費用以及與合同製造組織簽訂的合同產生的費用或產能變得多餘的影響。這些影響是由新的 COVID-19 疫苗配方的引入推動的。

The switch from the monovalent vaccine to our Omicron adaptive and COVID-19 vaccine and due to the accelerating internal manufacturing capacities during the year-end of December 31, 2022. Research and development expenses reached EUR 0.5 billion for the fourth quarter of 2022 compared to EUR 0.3 billion for the comparative period in 2021. For the 2022 financial year, research and development expenses amounted to approximately EUR 1.5 billion, as stated before, compared to EUR 0.9 billion for the comparative prior year period.

從單價疫苗轉向我們的 Omicron 適應性和 COVID-19 疫苗，以及由於截至 2022 年 12 月 31 日年底內部製造能力的加速。2022 年第四季度的研發費用達到 5 億歐元，相比之下2021 年同期為 3 億歐元。如前所述，2022 財年的研發費用約為 15 億歐元，而上年同期為 9 億歐元。

The increase was mainly due to expenses in connection with the development and production of our Omicron adaptive Bivalent COVID-19 vaccine and from progressing the clinical studies for our pipeline candidates. The increase was further driven by an increase in wages, benefits and social security expenses resulting from an increase in headcount as well as expenses incurred under our share-based payment region.

增加的主要原因是與我們的 Omicron 適應性雙價 COVID-19疫苗的開發和生產以及為我們的候選管道進行臨床研究相關的費用。員工人數增加導致工資、福利和社會保障費用增加，以及我們在股份支付領域產生的費用，進一步推動了這一增長。

General and administrative expenses amounted to EUR 0.1 billion for both the fourth quarter of 2022 as well as for the competitive period in 2021. For the 2022 financial year, general and administrative expenses were EUR 0.5 million compared to EUR 0.3 billion for the comparative prior year period.

2022 年第四季度和 2021 年競爭期間的一般和行政費用均為 1 億歐元。2022 財年的一般和行政費用為 50 萬歐元，而上年同期為 3 億歐元時期。

The increase in G&A was mainly due to the increased expenses for IT consulting and IT services, increased expenses for purchased external services as well as an increase in wages, benefits and social security expenses resulting mainly from an increase in headcount. Our business development transactions also contributed to the increase in general and administrative expense.

G&A 的增加主要是由於 IT 諮詢和 IT 服務費用的增加，外購服務費用的增加以及員工人數增加導致的工資、福利和社會保障費用的增加。我們的業務發展交易也導致了一般和行政費用的增加。

Income taxes were accrued with an amount of EUR 0.9 billion for the fourth quarter of 2022 compared to EUR 1.5 million for the comparative period in 2021. For the 2022 financial year, income taxes reached an amount of EUR 3.5 billion compared to EUR 4.8 billion for the comparative prior year period. The derived effective income tax rate for the 2022 financial year was approximately 27% and is in line with our expectations.

2022 年第四季度應計所得稅為 9 億歐元，而 2021 年同期為 150 萬歐元。2022 財年的所得稅為 35 億歐元，而 2022 年同期為 48 億歐元。上一年的比較期間。得出的 2022 財年實際所得稅率約為 27%，符合我們的預期。

For the fourth quarter of 2022, net profit reached EUR 2.3 billion compared to EUR 3.2 billion for the comparative period in 2021. For the year ended 31 2022, net profit reached EUR 9.4 million compared to EUR 10.3 billion for the comparative prior year period. Our diluted earnings per share for the fourth quarter of 2022 amounted to EUR 9.26 compared to EUR 12.80 for the comparative period in 2021. For the 2022 financial year, our diluted earnings per share amounted to EUR 37.77 compared to EUR 39.63 in 2021.

2022 年第四季度，淨利潤達到 23 億歐元，而 2021 年同期為 32 億歐元。截至 2022 年第四季度，淨利潤達到 940 萬歐元，而去年同期為 103 億歐元。我們 2022 年第四季度的攤薄每股收益為 9.26 歐元，而 2021 年同期為 12.80 歐元。在 2022 財年，我們的攤薄每股收益為 37.77 歐元，而 2021 年為 39.63 歐元。

Let's now move to the following slide and have a look at the return to our shareholders during the 2022 financial year. We believe that our shareholders should benefit from our strong performance.

現在讓我們轉到下一張幻燈片，看看 2022 財年我們股東的回報。我們相信我們的股東應該從我們的強勁表現中受益。

Following the Annual General Meeting in June 2022, a special cash dividend of EUR 2 per ordinary share was paid out to our shareholders, which led to an aggregate payment of approximately EUR 0.5 million. In addition, in March 2022, we authorized a share repurchase program of ADSs, allowing us to repurchase ADSs in the amount of up to USD 1.5 billion during the year 2022 and 2023.

在 2022 年 6 月的年度股東大會之後，我們向股東派發了每股普通股 2 歐元的特別現金股息，總計約 50 萬歐元。此外，在 2022 年 3 月，我們批准了美國存託憑證的股票回購計劃，允許我們在 2022 年和 2023 年回購金額高達 15 億美元的美國存託憑證。

On May 2, 2022, the first tranche of our share repurchase program of ADS with a value of up to USD 1 billion commenced and this tranche ended on October 10, 2022. In November 2022, we authorized the second tranche of our share repurchase program of ADS with a value of up to USD 0.5 billion which then started on December 7, 2022. During the period from May 2, 2022 to March 17, 2023, when the trading plan for the second tranche of our share repurchase program expired, a total number of 9,166,684 ADS assets were repurchased representing approximately 3.7% of our share capital.

2022 年 5 月 2 日，我們開始了價值高達 10 億美元的 ADS 股票回購計劃的第一部分，該部分於 2022 年 10 月 10 日結束。2022 年 11 月，我們授權了第二部分股票回購計劃價值高達 5 億美元的 ADS，然後於 2022 年 12 月 7 日開始。在 2022 年 5 月 2 日至 2023 年 3 月 17 日期間，當我們的股票回購計劃第二期交易計劃到期時，回購了 9,166,684 項美國存託憑證資產，約占我們股本的 3.7%。

The ADS were repurchased at an average price of USD 142.04 for a total net consideration of approximately USD 1.3 billion under the program. The repurchase ADSs were partially used to satisfy settlement obligations under our share-based payment arrangements.

回購 ADS 的平均價格為 142.04 美元，該計劃的總淨對價約為 13 億美元。回購的 ADS 部分用於履行我們基於股份的支付安排下的結算義務。

Before I provide our 2023 financial guidance, I would like to provide some of the key assumptions and considerations which, amongst others, in our guidance are described on the following page, specifically on the expected full year 2023 COVID-19 vaccine revenues. We expect a transition from an advanced purchase agreement environment to commercial market ordering starting in 2023. In addition, our revenue guidance is based on the assumption that vaccine developers will be asked to adapt the COVID-19 vaccine to newly circulating variants or sublineages of SARS-CoV-2.

在我提供 2023 年財務指南之前，我想提供一些關鍵假設和考慮因素，除其他外，我們的指南在下頁進行了描述，特別是 2023 年 COVID-19 疫苗的預期全年收入。我們預計從 2023 年開始從高級採購協議環境過渡到商業市場訂購。此外，我們的收入指導是基於這樣的假設，即疫苗開發商將被要求使 COVID-19 疫苗適應新流行的 SARS 變種或亞系-CoV-2。

Our COVID-19 vaccine revenue guidance reflects as well expected deliveries under existing or committed supply contracts and anticipated sales through traditional commercial orders. Currently, a renegotiation of the existing contract with the European Commission is ongoing with the potential for a rephasing of dose deliveries across multiple years and for a volume reduction.

我們的 COVID-19 疫苗收入指南反映了現有或承諾的供應合同下的預期交付以及通過傳統商業訂單的預期銷售。目前，正在與歐盟委員會重新談判現有合同，可能會重新調整多年的劑量交付並減少數量。

While we expect the need for a new variant adapted vaccine will increase demand, a fewer primary vaccinations and lower population wide levels the boosters are anticipated. We're also seeing seasonal demand will drive revenue generation to fit significantly towards the second half of the year 2023.

雖然我們預計對新變體適應疫苗的需求將增加需求，但預計初級疫苗接種次數會減少，而加強劑的人群水平也會降低。我們還看到季節性需求將推動創收，以適應 2023 年下半年的增長。

Let's now turn to the next slide. I would like to share with you the company's outlook for the 2023 financial year. Please note, the following numbers reflect current base case projections include potential effects caused by or driven from additional collaborations or potential M&A transactions to the extent they have been disclosed and are calculated based on constant currency rates.

現在讓我們翻到下一張幻燈片。我想與大家分享公司對 2023 財年的展望。請注意，以下數字反映了當前的基本情況預測，包括由額外合作或潛在併購交易引起或驅動的潛在影響（在已披露的範圍內），並根據固定匯率計算。

We believe that we and our collaboration partner, Pfizer and Fosun, are well positioned for the future as a leading COVID-19 vaccine provider. For the 2023 financial year, we estimate COVID-19 vaccine revenues of somewhere around EUR 5 billion based on the previously mentioned base assumptions.

我們相信，我們和我們的合作夥伴輝瑞和復星在未來作為領先的 COVID-19 疫苗供應商處於有利地位。對於 2023 財年，我們根據前面提到的基本假設估計 COVID-19 疫苗收入約為 50 億歐元。

Thanks to the company's continued strong financial performance we've never been in a better position to accelerate the advancement of our diversified clinical pipeline and to invest into the further transformation of BioNTech. We aim to accelerate our late-stage programs and expand our platform across our 4 drug classes. We believe the development, regulatory approval and commercialization of our clinical pipeline is a basis for our continuing success.

由於公司持續強勁的財務業績，我們處於前所未有的有利地位，可以加速我們多元化臨床管道的發展，並投資於 BioNTech 的進一步轉型。我們的目標是加速我們的後期項目，並在我們的 4 個藥物類別中擴展我們的平台。我們相信，我們臨床管道的開發、監管批准和商業化是我們持續成功的基礎。

The responsible use of our financial resources generated from the sale of our COVID-19 vaccines Paramount to BioNTech as well, broadly accelerating our existing pipeline of product candidates in oncology and APACHE diseases as well as expanding our capabilities in other disease areas will be our focus.

負責任地使用我們的 COVID-19 疫苗銷售產生的財務資源對 BioNTech 也至關重要，廣泛加速我們現有的腫瘤學和 APACHE 疾病候選產品管道以及擴大我們在其他疾病領域的能力將是我們的重點.

As already shown in the course of last week, we intend to invest in broadening our pipeline going forward. For the 2023 financial year, we plan to spend between EUR 2.4 billion and EUR 2.6 billion in R&D expenses. SG&A expenses are estimated to be in the range of EUR 650 million to EUR 750 million as we plan to continue to invest in making BioNTech the global, fully integrated immunotherapy powerhouse.

正如上週已經表明的那樣，我們打算投資擴大我們未來的渠道。在 2023 財年，我們計劃在研發費用上支出 24 億至 26 億歐元。 SG&A 費用估計在 6.5 億至 7.5 億歐元之間，因為我們計劃繼續投資，使 BioNTech 成為全球性的、完全整合的免疫療法強國。

Capital expenditures for our existing business for the 2023 financial year are expected to be in the range of EUR 500 million to EUR 600 million. We are, for example, planning to further expand and enhance our R&D and manufacturing facilities and to invest in a state-of-the-art IT infrastructure to support our digitalization process in especially the R&D area.

我們現有業務在 2023 財年的資本支出預計在 5 億至 6 億歐元之間。例如，我們計劃進一步擴大和加強我們的研發和製造設施，並投資最先進的 IT 基礎設施，以支持我們尤其是研發領域的數字化進程。

Finally, we expect the estimated annual cash effective income tax rate for the BioNTech Group at around 27%. Please be reminded that the financial guidance does not include the impact from further M&A activities or collaborations that the company might invest in during the calendar year of 2023.

最後，我們預計 BioNTech 集團的年度現金有效所得稅率估計約為 27%。請注意，財務指引不包括公司在 2023 年可能投資的進一步併購活動或合作的影響。

I would like now to take the opportunity to highlight our capital allocation framework. The key areas are at the center of our activities. First and foremost, R&D. We have proven to the world that our science and the translation into novel medicines can really make a difference for people worldwide. We believe that our technologies and science can further improve people's health and how we cope with various diseases. Therefore, we intend to further accelerate our initiatives to create additional long-term value for patients, our shareholders and society as a whole.

我現在想藉此機會強調我們的資本配置框架。關鍵領域是我們活動的中心。首先是研發。我們已經向世界證明，我們的科學和新藥的轉化確實可以為全世界的人們帶來改變。我們相信我們的技術和科學可以進一步改善人們的健康以及我們應對各種疾病的方式。因此，我們打算進一步加快我們的舉措，為患者、我們的股東和整個社會創造更多的長期價值。

This remains the key area of our investments going forward. Secondly, M&A and business development. To supplement our technologies and digital capabilities, we strive to extend and augment our expertise with synergistic acquisitions and collaborations.

這仍然是我們未來投資的關鍵領域。其次，併購和業務發展。為了補充我們的技術和數字能力，我們努力通過協同收購和合作來擴展和增強我們的專業知識。

For example, in January 2023, we announced a strategic partnership with the U.K. government to provide up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030. Also in January 2023, we announced an agreement to acquire InstaDeep Limited, a leading global technology company in the field of artificial intelligence and machine learning in a long-time strategic partner.

例如，2023 年 1 月，我們宣布與英國政府建立戰略合作夥伴關係，到 2030 年為多達 10,000 名患者提供個性化 mRNA 癌症免疫療法。同樣在 2023 年 1 月，我們宣布了一項收購 InstaDeep Limited 的協議，InstaDeep Limited 是一家全球領先的科技公司人工智能和機器學習領域的長期戰略合作夥伴。

The transaction is subject to customary closing conditions and regulatory approvals. On Monday of last week, we announced that we entered into an exclusive worldwide license and collaboration agreement with U.S.-based to co-develop and commercialize their next-generation anti-CTLA-4 monoclonal antibody candidates.

該交易須遵守慣例成交條件和監管部門的批准。上週一，我們宣布與美國公司簽訂全球獨家許可和合作協議，共同開發和商業化他們的下一代抗 CTLA-4 單克隆抗體候選藥物。

Thirdly, we would like our shareholders to again participate in our success. Consequently, we'll start an additional share repurchase program of ADS person to which we may repurchase ADSs in the amount of up to USD 0.5 billion during the year 2023.

第三，我們希望我們的股東再次參與我們的成功。因此，我們將啟動一項額外的 ADS 人股票回購計劃，我們可能會在 2023 年回購高達 5 億美元的 ADS。

2022 has been a truly successful year for BioNTech. 2023 is expected to be a year where contractual agreements with governments are starting to move into a commercial handful like setting. First, in the U.S. later in other jurisdictions. We rate this as an opportunity with more and more countries moving towards a standard commercial setting in the years to come.

2022 年對 BioNTech 來說是真正成功的一年。預計 2023 年將是與政府簽訂的合同協議開始進入類似商業環境的一年。首先，在美國，然後在其他司法管轄區。我們認為這是一個機會，未來幾年將有越來越多的國家轉向標準商業環境。

We believe to be well placed given the favorable technology basis that mRNA offers for COVID-19 vaccines and based on the commercial partnership with Pfizer that has been tremendously successful for partners. We expect to financially benefit from our COVID-19 franchise in the next years and anticipate relevant and ongoing profit and cash flow contribution from our vaccine given the existing relation of revenues and costs for BioNTech.

鑑於 mRNA 為 COVID-19 疫苗提供的有利技術基礎，以及基於與輝瑞公司的商業合作夥伴關係，我們認為我們處於有利地位，這種合作夥伴關係為合作夥伴帶來了巨大的成功。鑑於 BioNTech 的現有收入和成本關係，我們預計未來幾年將從我們的 COVID-19特許經營權中獲得經濟利益，並預計我們疫苗的相關和持續的利潤和現金流貢獻。

And with that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategic outlook for 2023 and concluding remarks. Thank you.

因此，我想將電話轉給我們的首席戰略官 Ryan Richardson，以了解我們 2023 年戰略展望的最新情況和結束語。謝謝。

Thank you, Jens. To wrap up our prepared remarks, I'll provide a brief summary of the strategic outlook for our COVID-19 vaccine franchise and our broader infectious disease vaccine in oncology portfolios before concluding with a few important dates to mark on your calendars.

謝謝你，延斯。為了結束我們準備好的發言，我將簡要總結我們的 COVID-19 疫苗特許經營權和我們在腫瘤學產品組合中更廣泛的傳染病疫苗的戰略前景，然後以幾個重要的日期結束，以便在您的日曆上標記。

Moving to the next slide. As Jens mentioned, we expect our first commercial market opening in the second half of the year in the United States. We expect this to follow strain selection in the May-June time frame and subsequent booster rollout for the fall season. It will likely take a few years to fully transition from a pandemic to steady-state market.

移動到下一張幻燈片。正如 Jens 所提到的，我們預計我們的第一個商業市場將於今年下半年在美國開放。我們預計這將遵循 5 月至 6 月時間範圍內的菌株選擇以及隨後秋季的助推器推出。從大流行病市場完全過渡到穩態市場可能需要幾年時間。

As this transition occurs, in the midterm, we see growth potential for our COVID-19 vaccine franchise driven by a continued shift to private markets globally. If successful and ongoing trials, our next-generation COVID-19 vaccines and combination vaccine being developed with Pfizer could contribute to this longer-term growth potential. We expect data updates over the course of the year on these pipeline programs.

隨著這種轉變的發生，在中期，我們看到我們的 COVID-19 疫苗特許經營權的增長潛力受到全球持續轉向私人市場的推動。如果成功且正在進行的試驗，我們與輝瑞公司正在開發的下一代 COVID-19 疫苗和聯合疫苗可能有助於實現這一長期增長潛力。我們預計這些管道計劃在一年中的數據更新。

Turning to the next slide. COVID-19 remained a major cause of hospitalizations and death globally in 2022. We far outpacing the level caused by seasonal influenza. Last year, in the United States, there were approximately 264,000 deaths and 1.5 million hospitalizations related to COVID-19.

轉到下一張幻燈片。 COVID-19 仍然是 2022 年全球住院和死亡的主要原因。我們遠遠超過了季節性流感造成的水平。去年，在美國，與 COVID-19 相關的死亡人數約為 264,000 人，住院人數為 150 萬人。

In the same period, there were approximately 36,000 deaths and 450,000 hospitalizations due to influenza. Despite the significantly higher burden of disease, COVID-19 vaccine doses administered in the U.S. according to the CDC, lagged those of seasonal flu at approximately 171 million flu doses versus approximately 144 million COVID-19 vaccine doses.

同期，約有 36,000 人死於流感，450,000 人住院。儘管疾病負擔明顯增加，但根據疾病預防控制中心的數據，美國接種的 COVID-19 疫苗劑量仍落後於季節性流感疫苗，約為 1.71 億劑流感疫苗和約 1.44 億劑 COVID-19 疫苗。

To note, these volumes include both Bivalent boosters, which rolled out in the fall and boosters administered earlier in the year. While not a perfect analog, we continue to believe that flu volumes represent a benchmark that is relevant for the mid- to long-term COVID-19 annual booster market. While overall volumes are likely to remain lower than flu in 2023 and we believe that the disease burden and relatively high vaccine efficacy support increased uptake over time.

需要注意的是，這些數量包括秋季推出的二價助推器和今年早些時候管理的助推器。雖然不是完美的類比，但我們仍然認為流感量代表了與中長期 COVID-19 年度助推器市場相關的基準。雖然到 2023 年總體數量可能仍低於流感，但我們認為隨著時間的推移，疾病負擔和相對較高的疫苗效力支持增加攝入量。

Turning ahead to the next slide. We continue to advance our infectious disease vaccine portfolio outside of COVID-19, including 2 additional Pfizer-partnered vaccine programs and our growing pipeline of wholly-owned vaccines. Our focus here is on prophylactic vaccines against diseases of high global incidents and medical need. The diseases we are targeting with our technology platforms include those where no marketed vaccine exists as in the case of HSV-2 or where there is room to improve on currently marketed products as in the case of malaria.

轉到下一張幻燈片。我們繼續推進我們在 COVID-19 之外的傳染病疫苗組合，包括 2 個額外的輝瑞合作疫苗項目和我們不斷增長的全資疫苗產品線。我們這裡的重點是針對全球高事件和醫療需求的疾病的預防性疫苗。我們的技術平台針對的疾病包括尚無市售疫苗的疾病（如 HSV-2）或目前市售產品有改進空間的疾病（如瘧疾）。

We anticipate multiple additional trial starts in the next 12 months. As you can see from the right-hand side of the slide, we also anticipate multiple data updates from these newer infectious disease vaccine programs over the course of the year.

我們預計在接下來的 12 個月內將開始多項額外的試驗。正如您從幻燈片右側看到的那樣，我們還預計這些較新的傳染病疫苗計劃在這一年中會更新多個數據。

Turning to the next slide and our 2023 strategic outlook in oncology. As Ugur stated earlier in the call, we plan to initiate multiple registrational trials in the next 12 to 18 months. In parallel, we plan to accelerate the build-out of our oncology commercial capabilities in 2023 and '24 with the goal of commercial readiness in the United States, EU and other selected regions, to support first oncology launches from 2026 onwards.

轉到下一張幻燈片和我們 2023 年的腫瘤學戰略展望。正如 Ugur 在電話會議早些時候所說，我們計劃在未來 12 到 18 個月內啟動多項註冊試驗。與此同時，我們計劃在 2023 年和 24 年加速構建我們的腫瘤學商業能力，目標是在美國、歐盟和其他選定地區做好商業準備，以支持從 2026 年開始的首次腫瘤學上市。

We anticipate further M&A and/or product candidate in-licensing will further complement our organic pipeline with synergistic programs. Finally, we expect several pipeline updates from our oncology pipeline in 2023, including from our individualized cancer vaccine program in first-line melanoma, BNT122, our CLDN6 CAR-T program, BNT211, and from several of our next-generation checkpoint programs, including BNT311 and 312.

我們預計進一步的併購和/或產品候選許可將通過協同計劃進一步補充我們的有機管道。最後，我們預計 2023 年我們的腫瘤管線將進行幾項管線更新，包括我們的一線黑色素瘤個性化癌症疫苗計劃 BNT122、我們的 CLDN6 CAR-T 計劃 BNT211，以及我們的幾個下一代檢查點計劃，包括BNT311 和 312。

The next slide summarizes our pipeline news flow expected this year. Many of these points have been covered, so I won't go through them in detail again here. What is clear is that our pipeline of 26 clinical stage programs will lead to many readouts this year across a range of our technology platforms and also now across multiple therapeutic areas. We expect this broadening will continue as we look to accelerate selected programs towards registrational trials and ultimately, the market.

下一張幻燈片總結了我們今年預期的管道新聞流。其中許多要點已經涵蓋，因此我不會在這裡再次詳細介紹它們。顯而易見的是，我們的 26 個臨床階段項目管道今年將在我們的一系列技術平台上產生許多讀數，現在也跨越多個治療領域。我們預計，隨著我們希望加速選定的項目進入註冊試驗並最終進入市場，這種擴大將繼續下去。

Before concluding and opening up the floor for questions, I would like to highlight on the next slide that we will hold our Annual General Meeting on May 25 and our next Innovation Series event on November 7. We will provide further details in the coming weeks on both events. With that, I would like to thank our shareholders for their continued support. Now I'll conclude our remarks and open the floor for questions.

在結束並開始提問之前，我想在下一張幻燈片中強調，我們將在 5 月 25 日舉行年度大會，並在 11 月 7 日舉行下一次創新系列活動。我們將在未來幾週內提供更多詳細信息兩個事件。在此，我要感謝我們的股東一直以來的支持。現在我將結束我們的發言並開始提問。

(Operator Instructions) And your first question comes from the line of Tazeen Ahmad from Bank of America.

（操作員說明）您的第一個問題來自美國銀行的 Tazeen Ahmad。

One point of clarification. Maybe this is best for Ryan to answer. On issuing your EUR 5 billion in revenues to expect from the COVID franchise, can you walk us through what the drivers were that you used, it does seem to be a slightly lower number than perhaps the Street have been expecting. And can you tell us what of those drivers could still be variable that could still be potentially a reason to have to adjust, let's say, later in the year?

一點澄清。也許這是瑞安最好的回答。關於從 COVID 專營權中獲得 50 億歐元的預期收入，您能否向我們介紹一下您使用的驅動程序是什麼，它似乎確實比華爾街預期的數字略低。你能告訴我們這些驅動因素中有哪些仍然是可變的，可能仍然是必須調整的潛在原因，比方說，在今年晚些時候？

And then secondly, you talk about M&A. I'm just wondering what are the types of candidates that BioNTech would think to be most beneficial because you are in several clinical trials planned and already started, what would be the most complementary to what you're trying to do?

其次，你談到了併購。我只是想知道 BioNTech 認為最有益的候選人類型是什麼，因為您正在進行計劃並已經開始的幾項臨床試驗，什麼是對您正在嘗試做的事情的最大補充？

Yes. Thank you, Tazeen. I'm going to turn it over to Jens, actually for the first part of the question, and I'll come back to in a second.

是的。謝謝你，塔贊。我將把它交給 Jens，實際上是針對問題的第一部分，我稍後會回來。

Yes, Tazeen, thanks for the question. So just maybe jumping back to the one slide that I had mentioned in my speech. Of course, there are -- what we will see is that there is a shift from this typical structure of delivering to governments. And as we have seen it in the last 2 years towards the commercial part -- commercial setting. And that will offer us some opportunities going forward.

是的，Tazeen，謝謝你的提問。那麼也許回到我在演講中提到的那張幻燈片。當然，我們將看到這種向政府提供服務的典型結構正在發生轉變。正如我們在過去 2 年中看到的那樣，在商業部分——商業環境中。這將為我們提供一些前進的機會。

'23, from our perspective, it's a little bit of a transitional year in that respect because there are still some doses with governments that we expect will be moved into the market. And therefore, we expect further upside in the time to come thereafter. And of course, looking at the opportunity beyond that, new variants, and we are expecting new variants coming up in the future, of course, will then require additional vaccines that the mRNA technology is capable of delivering.

'23，從我們的角度來看，這在這方面有點過渡的一年，因為我們預計政府仍有一些劑量將進入市場。因此，我們預計此後會進一步上漲。當然，考慮到除此之外的機會，新變種，我們預計未來會出現新變種，當然，這將需要 mRNA 技術能夠提供的額外疫苗。

On top, of course, when you have a commercial setting and that will start from our perspective in the U.S. in the second half of this year, we'll then also jump over into other jurisdictions, as I mentioned before. So -- and the speed here is very difficult to anticipate. Europe, probably, we will see that in Germany and some other jurisdictions in Europe. And then you will move away from the multi-dose wells towards single-dose wells.

當然，最重要的是，當你有商業環境時，這將從我們今年下半年在美國的角度出發，然後我們也會跳到其他司法管轄區，正如我之前提到的。所以——這裡的速度很難預測。歐洲，我們可能會在德國和歐洲的其他一些司法管轄區看到這一點。然後您將從多劑量孔轉向單劑量孔。

And of course, pricing for those will be very different, too. So we got to await. We're very positive in terms of the further development of our franchise.

當然，這些產品的定價也會大不相同。所以我們必須等待。我們對特許經營權的進一步發展非常積極。

And I've highlighted as well that -- if you look into our cost structure versus other cost structures of players in the market, we do quite well because of the gross profit share that we have with our partner, Pfizer. So overall, we are very positive in terms of our COVID-19 vaccine franchise development going forward. And Ryan, do you want to add?

我也強調了這一點——如果你看看我們的成本結構與市場上其他參與者的成本結構，我們做得很好，因為我們與合作夥伴輝瑞公司的毛利潤份額。因此，總的來說，我們對 COVID-19 疫苗特許經營權的未來發展非常樂觀。還有瑞安，你想補充嗎？

Yes, I would just second the point that one of the factors underpinning the approximate EUR 5 billion of revenue guidance is the European Union contract, which, as you know, is our largest contract. And as we stated here, again on this call, it is subject to ongoing renegotiation. So again, just a testament to the fact that demand on the ground does matter. And so that's something that we'll continue to provide updates as we have them. But that's been factored in anticipated update to that contract has been factored into these numbers.

是的，我只想說支持大約 50 億歐元收入指導的因素之一是歐盟合同，正如你所知，這是我們最大的合同。正如我們在這裡所說，再次在這次電話會議上，它需要進行持續的重新談判。因此，再次證明實地需求確實很重要。因此，我們將繼續提供更新。但這已被計入這些數字中，該合同的預期更新已被計入。

The M&A part of your question. I think you asked what's the sweet spot and what are we looking for? I think first and foremost, we're looking for synergistic assets that could complement our BioNTech proprietary pipeline. And I think a good example of the sort of -- that sort of sweet spot is the novel anti-CTLA-4 molecule that we've just announced and expanded on today. It appears to have a differentiated profile. We think it could have potential as a monotherapy and potentially expand treatment possibilities with an IO mechanism, but also could also potentially synergize with our own pipeline down the road.

您問題的併購部分。我想你問過甜蜜點是什麼，我們在尋找什麼？我認為首先，我們正在尋找可以補充我們 BioNTech 專有管道的協同資產。我認為一個很好的例子——那種甜蜜點是我們今天剛剛宣布並擴展的新型抗 CTLA-4 分子。它似乎具有差異化的特徵。我們認為它可能具有作為單一療法的潛力，並有可能通過 IO 機制擴大治療的可能性，但也有可能與我們自己的管道協同作用。

So I think that's a good example. Phase II about to be Phase III so mid- to late-stage assets. And we've got a number of those still in the deal pipeline, some at more advanced stages.

所以我認為這是一個很好的例子。二期即將成為三期中後期資產。我們有一些仍在交易管道中，有些處於更高級的階段。

Is there a dollar number, Ryan, that would be an upper limit of how much BioNTech is looking to spend right now?

Ryan，是否有一個美元數字，這將是 BioNTech 現在希望花費多少的上限？

So our sweet spot, I think, as a normal course would be a sub-$1 billion. And I think we certainly like the proposition of this deal, the OncoC4 deal where we paid $200 million upfront and then there are some success-based milestones and royalties, but where we share some development costs, but we take control of the asset and can really direct the development.

因此，我認為，作為正常課程，我們的最佳選擇是低於 10 億美元。我認為我們當然喜歡這筆交易的提議，OncoC4 交易，我們預付了 2 億美元，然後有一些基於成功的里程碑和特許權使用費，但我們分擔了一些開發成本，但我們控制了資產並且可以真正指導發展。

I think that's really what we're looking to do. There could be some variation depending on the asset in question. But I think we really like that sort of approach. We will look at larger deals, but I think the sweet spot for us is the sort of product-centric, product-focused in licensing and/or M&A.

我認為這正是我們想要做的。根據相關資產的不同，可能會有一些變化。但我認為我們真的很喜歡這種方法。我們會考慮更大的交易，但我認為對我們來說最佳點是那種以產品為中心，以產品為中心的許可和/或併購。

And the next question comes from the line of Daina Graybosch from SVB Securities.

下一個問題來自 SVB 證券公司的 Daina Graybosch。

I have a couple oncology pipeline questions. First, and you just hinted at it, Ryan. Really interested in how you are planning to expand the ONC-392 development now that you have it in your hands? And should we expect any head-to-head studies with ipi/nivo to really prove out the broader therapeutic window and potentially better efficacy?

我有幾個腫瘤管道問題。首先，你只是暗示過，Ryan。既然您已經掌握了 ONC-392，您真的對計劃如何擴展它的開發感興趣嗎？我們是否應該期待任何與 ipi/nivo 的頭對頭研究真正證明更廣泛的治療窗口和潛在更好的療效？

And then a second program is -- second question, sorry, is now that you have a really large portfolio, really interested in the criteria you're using for go, no go. In particular, in this presentation, you highlighted focus programs in oncology. And I wonder why these programs and what did they show to reach that focused program bar? And what does that mean for those programs that aren't focused programs?

然後第二個程序是——第二個問題，抱歉，現在你有一個非常大的投資組合，對你使用的標準很感興趣，不。特別是，在本次演講中，您強調了腫瘤學的重點項目。我想知道為什麼這些程序以及它們顯示了什麼來達到那個集中的程序欄？這對那些不是重點項目的項目意味著什麼？

Ugur, do you want to take that?

烏古爾，你要拿那個嗎？

Yes, I can take that. Daina, thanks for the questions. So first of all, ONC-392, so the key differentiator that we believe is important for ONC-392 is the ability. The larger therapeutic window and the ability to induce a higher exposure and prolonged exposure to the anti-CTLA-4 mechanism, particularly by the anticipated mechanism of depletion of Tregs in the tumor micro environment. And as compared to do approved anti-CTLA-4 molecules preserving plafond lymphatic Treg function.

是的，我可以接受。黛娜，謝謝你的提問。所以首先是 ONC-392，所以我們認為對 ONC-392 很重要的關鍵區別是能力。更大的治療窗口和誘導更高暴露和延長暴露於抗 CTLA-4 機制的能力，特別是通過腫瘤微環境中 Tregs 的預期消耗機制。與批准的抗 CTLA-4 分子相比，保留了 plafond 淋巴 Treg 功能。

We are not planning to go into any head-to-head studies for -- with the approved products. We are exploring, we are going to explore 2 types of applications. One application based on the single compound activity of ONC-392 observed, for example, in ovarian cancer, and we will also report about single compound activity in non-small cell lung cancer patients, allowing us without side-to-side control to go into indications in which ipilimumab or other anti-CTLA-4 antibodies are not authorized so far.

我們不打算對批准的產品進行任何頭對頭的研究。我們正在探索，我們將探索兩種類型的應用程序。一個基於觀察到的 ONC-392 單一化合物活性的應用，例如，在卵巢癌中，我們還將報告非小細胞肺癌患者的單一化合物活性，使我們無需側對側控制即可ipilimumab 或其他抗 CTLA-4 抗體目前尚未獲批的適應症。

The second is, indeed, using this as a combination partner. We believe that anti-CTLA-4 is well tolerated is also an excellent combination partner, particularly for our cancer vaccine pipeline. We have demonstrated in the past synergy of our personalized vaccines with anti-PD1. But we believe that, particularly for some type of vaccines we would also see synergy with anti-CTLA-4 mechanism.

第二個確實是將其用作組合合作夥伴。我們相信抗 CTLA-4 具有良好的耐受性，也是一個很好的組合夥伴，特別是對於我們的癌症疫苗管道。我們在過去展示了我們的個性化疫苗與抗 PD1 的協同作用。但我們相信，特別是對於某些類型的疫苗，我們還會看到與抗 CTLA-4 機制的協同作用。

So the third question that you have addressed is how we define focus. We defined focus in the setting that we would like to address 2 key goals with regard to personalized cancer immunotherapy. On the one side, personal cancer immunotherapy increasing the overall response rate and activity in a single indication, but also in the second way personal cancer immunotherapy allowing to provide clinical benefit with our portfolio to patients along their disease journey, meaning from the very beginning of the disease as well in the late stage.

所以你提到的第三個問題是我們如何定義焦點。我們將焦點定義在我們希望解決與個性化癌症免疫療法相關的 2 個關鍵目標的環境中。一方面，個體癌症免疫療法提高了單一適應症的總體反應率和活性，另一方面，個體癌症免疫療法允許我們的產品組合在患者的疾病旅程中為患者提供臨床益處，這意味著從一開始病也到了晚期。

And this is what drives the selection of the compound -- compounds as Ryan said, one key aspect is the compound going to add additional close gaps in our portfolio. And the second is the compound going to increase the impact of our compounds by synergistic effects.

這就是推動化合物選擇的原因——正如 Ryan 所說的化合物，一個關鍵方面是化合物將在我們的產品組合中增加額外的緊密差距。第二個是化合物將通過協同效應增加我們化合物的影響。

And the next question comes from the line of Matthew Harrison from Morgan Stanley.

下一個問題來自摩根士丹利的馬修哈里森。

A couple PCV-related questions for me. First, just on timing. I just wanted to confirm, previously, I think you had talked about first half of '23 for that data on the slide that says 2023. I just wondered if there was a shift in the timing or not? And then second, as we think about the outcome of the study, could you just talk sort of broadly about how we should -- what kind of expectations we should have for that study and what you would deem as a positive result? And I ask it sort of in the context that for some mid-stage trials, a p-value that's greater than 0.05 can also be deemed as something you might move ahead with. So could you just talk about that?

問我幾個與 PCV 相關的問題。首先，只是在時間上。我只是想確認一下，之前，我認為你已經談到了 23 年上半年的幻燈片上顯示 2023 年的數據。我只是想知道時間是否有變化？其次，當我們考慮研究的結果時，您能否大致談談我們應該如何——我們應該對這項研究抱有什麼樣的期望，以及您認為什麼是積極的結果？我問這個問題的背景是，對於一些中期試驗，大於 0.05 的 p 值也可以被視為您可以繼續進行的事情。那麼你能談談這個嗎？

Thanks, Matt. So I'll take the first part and then perhaps Ugur can take the second part on the interpretation of the data. In terms of the readout, so if you're correct that we have broadened actually JPMorgan, we brought into the readout timing expectation to full year 2023. So I think it's fair to say that, that could come in the second half.

謝謝，馬特。所以我先講第一部分，然後也許 Ugur 可以講第二部分關於數據的解釋。就讀數而言，如果你是正確的，我們實際上已經擴大了摩根大通，我們將讀數時間預期納入了 2023 年全年。所以我認為可以公平地說，這可能會在下半年出現。

Yes. And the second -- the second question is related to how to interpret the outcome. So the clinical trial is intended to evaluate the potential activity of a personalized cancer vaccine in combination with PD-1 in advanced metastatic stage setting. We would assess the activity of the compound of cost in the -- for melanoma and the melanoma went from a single IO indication into a constellation there.

是的。第二個問題與如何解釋結果有關。因此，該臨床試驗旨在評估個性化癌症疫苗與 PD-1 在晚期轉移階段環境中的潛在活性。我們將評估成本化合物的活動——對於黑色素瘤，黑色素瘤從單一的 IO 適應症變成了一個星座。

Now several combination price -- combination compounds are approved. So that means a potential positive result would be seen also in the context of what is the residual medical need in this indication and how big is the bar to continue in the first-line melanoma setting. The second indication is that a positive time in the first-line metastatic setting would also trigger potential additional indications in the first-line in combination with checkpoint blockade.

現在幾種組合價格——組合化合物被批准。因此，這意味著在該適應症的剩餘醫療需求是什麼以及一線黑色素瘤環境中繼續存在的障礙有多大的背景下，也可以看到潛在的陽性結果。第二個跡像是一線轉移設置中的陽性時間也將觸發與檢查點封鎖相結合的一線潛在的額外適應症。

And the next question comes from the line of Akash Tewari from Jefferies.

下一個問題來自 Jefferies 的 Akash Tewari。

This is Ivy on for Akash. We have a couple, if we may. So maybe start with the first one. On your COVID guidance, I think Pfizer right now is guiding for full penetration of COVID vaccine in the second half of this decade. I think they are guiding around 100 million to 160 million global dose per year going forward. We're now saying like the market is baking in a much lower demand for vaccines at the current valuation. That's just what's your thoughts on Pfizer's assumptions?

這是阿卡什的常春藤。如果可以的話，我們有一對。所以也許從第一個開始。關於您的 COVID 指南，我認為輝瑞目前正在指導 COVID 疫苗在本十年後五年的全面普及。我認為他們正在指導未來每年大約 1 億到 1.6 億的全球劑量。我們現在說的是，按照目前的估值，市場對疫苗的需求要低得多。這就是您對輝瑞公司假設的看法？

It looks like there's divergence between your 2023 guidance and Pfizer's, which is like 5 billion versus, I guess, 6.5 billion implied by Pfizer's guidance? I guess then it's like with the increased OpEx spend, you guided this year from around $2 billion in 2022 to greater than $3 billion in 2023. Is this fair for us to assume that COVID business may not be cash generating this year?

看起來你們的 2023 年指導與輝瑞的指導之間存在差異，大約是 50 億美元，而輝瑞的指導暗示是 65 億美元？我想這就像隨著運營支出的增加，你將今年的運營支出從 2022 年的 20 億美元左右增加到 2023 年的 30 億美元以上。我們假設 COVID 業務今年可能不會產生現金是否公平？

So I'll start, and I'm sure Jens will chime in here. So in terms of the comparison to the Pfizer guidance, I would just say that first on the market, I think there was a market part of your question. So I think consistent with what Pfizer has disclosed, we believe that 2023 could be a trough year for the COVID market as it transitions over the course of a couple of years. to a sort of steady state, more commercially driven market.

所以我要開始了，我相信 Jens 會插話。因此，就與輝瑞指南的比較而言，我只想說首先在市場上，我認為你的問題有市場部分。因此，我認為與輝瑞披露的一致，我們認為 2023 年可能是 COVID 市場的低谷年，因為它在幾年的過程中發生了轉變。到一種穩定的狀態，更商業化的市場。

And so you've hopefully heard that reflected in our comments today. That won't happen fully this year because we still have a number of countries.

因此，希望您已經在我們今天的評論中聽到了這一點。這不會在今年完全發生，因為我們還有許多國家/地區。

In fact, a majority of countries that are still under government contracts that are still, let's say, a relic or a follow-on from the pandemic, right? We do expect some commercial markets to open this year, but that process, again, the transition period will take time. That transition period, we expect could lead to a potential for increased volumes as we transition to that and also increase prices. But again, that could also take some time. And we've noted today a couple of drivers -- potential drivers over the midterm that could contribute to that growth potential, namely enhanced uptake of COVID-19 vaccines, but also potential follow-on vaccines.

事實上，大多數仍在政府合同下的國家，比方說，仍然是大流行病的遺留物或後遺症，對吧？我們確實預計一些商業市場今年會開放，但這個過程，同樣，過渡期需要時間。我們預計，隨著我們過渡到那個過渡期，可能會導致銷量增加，同時價格也會上漲。但同樣，這也可能需要一些時間。我們今天注意到了幾個驅動因素——中期的潛在驅動因素可能有助於這種增長潛力，即增加 COVID-19 疫苗的使用，以及潛在的後續疫苗。

Our next-generation vaccines, for example, that are in Phase I and/or combination vaccines could be important midterm contributors to that. And maybe on the guidance, again, the guidance comparison point to Pfizer, you've highlighted the sort of $12 billion rough Pfizer estimate. Maybe Jens can speak to how that's -- you can't just split that in half when you compare our guidance to Pfizer's.

例如，我們處於第一階段的下一代疫苗和/或聯合疫苗可能是重要的中期貢獻者。也許在指南中，與輝瑞公司的指南比較點，你強調了輝瑞公司 120 億美元的粗略估計。也許 Jens 可以說這是怎麼回事——當你將我們的指導與輝瑞的指導進行比較時，你不能把它分成兩半。

Yes. It was awfully difficult to understand you actually due to the line. But what we could understand is -- and Ryan was referring to this. I mean, of course, as you know, our revenue guidance is coming from 3 different areas, basically from the Pfizer part, the profit share that we have with Pfizer. And of course, profit share means that you have a residue figure from Pfizer and you got to see that they're -- you got to take into account that there are COGS there.

是的。由於線路原因，實際上很難理解你。但我們可以理解的是——Ryan 指的是這個。我的意思是，當然，正如你所知，我們的收入指導來自 3 個不同的領域，基本上來自輝瑞部分，我們與輝瑞的利潤份額。當然，利潤分成意味著你有來自輝瑞的殘留數據，你必須看到它們——你必須考慮到那裡有 COGS。

Of some magnitude that are reducing that revenue figure to come to the gross profit. So if you assume something like -- and you see, if you look into our figures, you see something like a figure the full year of 82.7 -- sorry, gross profiting of 82.7%. You have to assume a certain percentage for COGS. If you take EUR 2 million -- EUR 12 million -- EUR 12 billion that you mentioned, you take some 80% gross margin, yes, you're coming to something that makes already sense in that respect. We also have some revenues that will -- that we are generating by selling the products to Pfizer.

在一定程度上減少了收入數字以達到毛利潤。因此，如果你假設類似的東西——你看，如果你查看我們的數據，你會看到全年 82.7% 的數字——抱歉，毛利潤為 82.7%。您必須為 COGS 承擔一定的百分比。如果你拿 200 萬歐元——1200 萬歐元——你提到的 120 億歐元，你會得到大約 80% 的毛利率，是的，在這方面你會得到一些已經有意義的東西。我們也有一些收入——我們通過將產品出售給輝瑞公司來產生這些收入。

They have a very little contribution revenue -- very little profit contribution -- sorry, I'm mixing up here. And then, of course, we have our revenues towards Germany and Turkey. And here, we have a profit share with Pfizer. And if you take all this into account, the USD 5 billion to USD 13.5 billion that Pfizer has guided for '23, I think that fits well with what you've seen in '21, and it fits quite well to what you've seen in 2020.

他們的貢獻收入很少——利潤貢獻很少——抱歉，我在這裡混淆了。然後，當然，我們的收入來自德國和土耳其。在這裡，我們與輝瑞公司分享利潤。如果你考慮到所有這些，輝瑞為 23 年指導的 50 億美元到 135 億美元，我認為這與你在 21 年看到的非常吻合，而且非常適合你所看到的見於2020年。

Yes. I think maybe to the last part of your question about profitability, I think what you've heard from us today in terms of our guidance is that we do expect to remain profitable this year. And more importantly, to your point about COVID profitability in the years to come, while we're not issuing guidance today, I think our expectation, as Jens mentioned in his speech is that COVID, because of the cost structure of our partnership with Pfizer, where we can keep our fixed costs very lean, we expect the product to be highly cash generative for us.

是的。我想也許對於你關於盈利能力的問題的最後一部分，我想你今天從我們那裡聽到的關於我們的指導意見是我們確實希望今年保持盈利。更重要的是，關於未來幾年 COVID 盈利能力的觀點，雖然我們今天沒有發布指導意見，但我認為正如 Jens 在他的演講中提到的那樣，我們的期望是 COVID，因為我們與輝瑞合作的成本結構，在我們可以保持固定成本非常精簡的情況下，我們希望該產品能夠為我們帶來高現金收益。

That's exactly what I said. So if you take the 5 -- around about EUR 5 billion as a guidance, revenue figure as a guidance and you take some 20% for COGSs, that we have reported in the past and that sort of ballpark 15% to 20%. And then you take our EUR 2.4 billion to EUR 2.6 billion for R&D spend and EUR 650 million to EUR 750 million SG&A spend. You see that based on our current plans, on our full development plan. So not adding any additional M&A or collaborations impact on to those figures that for '23, we expect to be profitable. And going forward, as Ryan said, this COVID franchise will contribute further profits in the years to come. That's our anticipation for the future.

這正是我所說的。因此，如果您將 5 - 大約 50 億歐元作為指導，將收入數字作為指導，並且您對 COGS 取大約 20%，我們過去曾報告過，大概是 15% 到 20%。然後您將我們的 24 億至 26 億歐元用於研發支出，以及 6.5 億至 7.5 億歐元的 SG&A 支出。你會看到，根據我們目前的計劃，根據我們的完整髮展計劃。因此，如果不對這些數字增加任何額外的併購或合作影響，我們預計 23 年將實現盈利。展望未來，正如 Ryan 所說，這個 COVID 特許經營權將在未來幾年貢獻更多利潤。這是我們對未來的期待。

Got it. That's super helpful. One quick follow-up, if I may. Just when should we expect to see Bivalent data? And will you top line the data when it is becoming available?

知道了。這非常有幫助。一個快速跟進，如果可以的話。我們什麼時候應該期望看到二價數據？當數據可用時，您會在數據上排行嗎？

Sorry, just to clarify, your question was when will we see Bivalent VE data? Or when will there be a Bivalent...

抱歉，澄清一下，您的問題是我們什麼時候能看到二價 VE 數據？或者什麼時候會有二價...

Yes. When should we expect to see Bivalent VE data? And will you top line, when it's available?

是的。我們什麼時候應該看到二價 VE 數據？當它可用時，你會頂線嗎？

Yes. So we're not guiding to VE data for Bivalent. We have published safety and immunogenicity data last year. Our focus at this point for the vaccine is actually looking forward and to strain selection for the fall season. And we expect that, that -- we're in discussions with regulators around that. Our expectation is that, that will be based on safety and immunogenicity data there further discussions to be had over the coming months, but our expectation is that the new stressed in May, June. I don't know Ugur if you want to...

是的。所以我們不指導二價的 VE 數據。我們去年發布了安全性和免疫原性數據。我們在這一點上對疫苗的關注實際上是期待和為秋季選擇毒株。我們預計，我們正在與監管機構就此進行討論。我們的期望是，這將基於安全性和免疫原性數據，在未來幾個月內將進行進一步討論，但我們的期望是新的強調在 5 月、6 月。不知道烏古爾你要不要...

I'm not sure whether the Bivalent data refer to COVID or the COVID flu combination.

我不確定二價數據是指 COVID 還是 COVID 流感組合。

That's for COVID.

那是針對 COVID 的。

For COVID, yes, we -- so the process for updating the vaccines will be most likely as it was last year. And based on immunogenicity data and safety data in a smaller cohort of subjects. No VE data.

對於 COVID，是的，我們——所以更新疫苗的過程很可能與去年一樣。並且基於較小的受試者隊列中的免疫原性數據和安全性數據。沒有 VE 數據。

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

下一個問題來自 Cowen 的 Yaron Werber。

Great. I just have a couple. The first one is on BNT211. What solid tumor data do you anticipate having this year? Is it going to be something outside of the secular in ovarian and sort of what comes to mind?

偉大的。我只有一對。第一個在 BNT211 上。您預計今年會有哪些實體瘤數據？它會是卵巢中世俗之外的東西嗎？會想到什麼嗎？

And then secondly, on -- just to go back on BNT122. The PFS should have potentially read out second half next year. So as you're thinking about releasing data in the second half of this year, is it that you're waiting for the survival data? Or sort of what are the gate marks that you're waiting for you to release that data?

其次，關於 - 只是回到 BNT122。 PFS 應該有可能在明年下半年讀出。所以你們考慮下半年出數據，是不是在等生存數據？或者您正在等待您發布該數據的門標誌是什麼？

Thank you for your question. BNT211, we have a clinical trial ongoing, which recruits patients who have called in 6 positive cancers, specifically testicular cancer. And as you have already pointed out, we have already reported some of that data. We will have a larger cohort of testicular cancer patients. .

謝謝你的問題。 BNT211，我們正在進行一項臨床試驗，該試驗招募了 6 種陽性癌症，特別是睾丸癌的患者。正如您已經指出的那樣，我們已經報告了其中一些數據。我們將有更多的睾丸癌患者。 .

And this will be one part of the data we will report this year. On top of that, the clinical trial is continuing to enroll patients with ovarian cancer with endometrial cancer, other CLDN6 positive cancer types like gastric and small cell lung cancer, for example, so that also these indications will be reported.

這將是我們今年報告的數據的一部分。最重要的是，臨床試驗正在繼續招募患有子宮內膜癌的卵巢癌患者，其他 CLDN6 陽性癌症類型，例如胃癌和小細胞肺癌，因此也將報告這些適應症。

Maybe I can take the question. So we are indeed collecting objective response data, PFS data as well as documenting OS data and potentially read out in the second half of 2023 will be most likely limited to PFS and ORR data.

也許我可以回答這個問題。因此，我們確實在收集客觀的反應數據、PFS 數據以及記錄 OS 數據，並且可能在 2023 年下半年讀出的數據很可能僅限於 PFS 和 ORR 數據。

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

下一個問題來自高盛的 Chris Shibutani。

This is Steven on for Chris. Two for me. So currently, in select territories, BioNTech and Pfizer have a 50-50 gross profit share. Can you speak to what the economics of that might look like for a COVID combo vaccine if that's proved in the future?

這是克里斯的史蒂文。兩個給我。因此，目前，在特定地區，BioNTech 和輝瑞公司的毛利潤份額為 50-50。如果未來得到證實，您能否談談 COVID 組合疫苗的經濟效益如何？

And then with the renegotiations with the European Commission, where there's potentially lower volume and potential rephasing, could you elaborate on what that might mean for price, could we see a higher price going forward with that contract?

然後隨著與歐盟委員會的重新談判，可能會降低交易量和重新定相，你能否詳細說明這對價格意味著什麼，我們能否看到該合同的價格更高？

Yes. Maybe let me start with this, and then Ryan can chime in. So for the combination of COVID flu, we can't give you any details. This is confidential in the discussions with our partner Pfizer. And then in terms of the EC, of course, I mean, these are also ongoing discussions, as you know. We wanted to make sure and be transparent that this outcomes could be the case that the existing 450 million doses contract that we have with the EC could be split over several years or that potentially a certain volume could go down overall.

是的。也許讓我先從這個開始，然後 Ryan 可以插話。所以對於 COVID 流感的組合，我們不能給你任何細節。在與我們的合作夥伴輝瑞公司的討論中，這是保密的。然後就 EC 而言，當然，我的意思是，正如你所知，這些也在持續討論。我們希望確保並保持透明，這樣的結果可能是我們與 EC 簽訂的現有 4.5 億劑合同可能會在幾年內拆分，或者某個數量可能會整體下降。

But on the details in terms of pricing, you've got to bear with us. Yes, we can't give any details here. We're in the middle of negotiations, so we can't give any more details than what I just said.

但在定價方面的細節，你必須忍受我們。是的，我們不能在這裡提供任何細節。我們正在談判中，所以我們不能提供比我剛才所說更多的細節。

Yes. And I would just add the point that -- as you know, Steven, for the COVID vaccine, we have a 50-50 gross profit share with Pfizer. We only carry SG&A expenses or S&M expenses in those BioNTech commercial territories, affected the vast majority of sales and marketing expenses is with Pfizer and outside of our collaboration, which means that our effective economics on the product are well above 50%.

是的。我只想補充一點——正如你所知，史蒂文，對於 COVID 疫苗，我們與輝瑞公司有 50-50 的毛利份額。我們只在那些 BioNTech 商業領域承擔 SG&A 費用或 S&M 費用，影響的絕大部分銷售和營銷費用與輝瑞有關，並且不在我們的合作範圍內，這意味著我們在產品上的有效經濟性遠高於 50%。

I think on flu, that's different. On the flu mono program, we had licensed that to Pfizer back before COVID-19. As you may recall, so it's more of a licensing agreement. We don't bear any of the development costs for the Flu mono program. So it's a very different structure. We do have -- we are eligible to receive milestones and royalties on Flu mono. So I think until we can disclose more on the combo economics, I think it's safe for you to assume that it's somewhere in between those 2 and that we do think it would be economically meaningful to us from a P&L perspective, but that's all we can say at this point.

我認為流感是不同的。在流感單藥項目中，我們在 COVID-19 之前就已將其授權給輝瑞。您可能還記得，所以它更像是一個許可協議。我們不承擔 Flu mono 程序的任何開發成本。所以這是一個非常不同的結構。我們確實有——我們有資格獲得 Flu mono 的里程碑和版稅。所以我認為，在我們可以披露更多有關組合經濟學的信息之前，我認為您可以安全地假設它介於這兩者之間，並且我們確實認為從損益的角度來看它對我們具有經濟意義，但這就是我們所能做的說到這裡。

We will now take our last question for today. And the last question comes from the line of Jessica Fye from JPMorgan.

我們現在將回答今天的最後一個問題。最後一個問題來自摩根大通的 Jessica Fye。

Forgive me if this seems a bit redundant, but I just want to follow up on an earlier question or 2. I just want to confirm that the comment that an anticipated update to the European contract has been factored into your numbers means that any apparent disconnect between the guidance you're providing and that Pfizer gave earlier this year is not solely driven by a disconnect on assumptions around gross profitability of the COVID vaccine business, but is also driven by just different overall revenue or assumed doses delivered?

如果這看起來有點多餘，請原諒我，但我只是想跟進之前的問題或 2。我只是想確認一下，歐洲合同的預期更新已被計入您的數字的評論意味著任何明顯的脫節您提供的指導與輝瑞今年早些時候提供的指導之間的差異，不僅是由於對 COVID 疫苗業務毛利潤率假設的脫節，而且還受到總收入或假設交付劑量不同的影響？

So Jess. I'll start, and Jens should jump in here. So we obviously work very closely with Pfizer on multiple levels in estimating market potential, estimating uptake of the vaccine, et cetera. There are a number of factors that do impact the 2 companies' communications. It's not only expectations around the EU contract.

所以傑斯。我要開始了，Jens 應該插進來。因此，我們顯然與輝瑞公司在多個層面上密切合作，以評估市場潛力、評估疫苗的使用情況等。有許多因素確實會影響兩家公司的溝通。這不僅僅是圍繞歐盟合同的期望。

We also have different financial calendar years, which Jens can probably best speak to, which also may have an impact. I think also you have to differentiate between contracted doses, which I think is perhaps what you may be referring to in terms of the Pfizer disclosure and estimated revenue from full contracted doses versus our guidance today, which is based on our estimate -- our best estimates of expected revenue for the year, which factors in -- does factor into your point. Some potential changes to the EU contract. I don't know, Jens, would you?

我們也有不同的財政日曆年，Jens 可能最能與之交談，這也可能會產生影響。我認為你還必須區分合同劑量，我認為這可能是你所指的輝瑞披露和完全合同劑量的估計收入與我們今天的指導，這是基於我們的估計 - 我們最好的對年度預期收入的估計，其中的因素 - 確實會影響您的觀點。歐盟合同的一些潛在變化。我不知道，詹斯，你呢？

Yes. No, you basically mentioned this, right. I mean, of course, we can't comment on the way of Pfizer is communicating. They've done that while back a few weeks back when they gave out their guidance at that point in time as well as at our point in time today, there is no conclusion on how the contract with the European EV units would look like. What sort of volumes we're talking about, what sort of spread over several years, we're talking about or pricing or anything of this kind. Every company got to do their own sort of guiding. I believe if you compare the figures, and I try to explain that a little bit before. we're not far away, actually. If you compare that, there is -- if you really do the math, I think you come to the conclusion that Pfizer and now sells in terms of that COVID business are very well aligned also in terms of the number that we have presented and Pfizer has presented.

是的。不，你基本上提到了這個，對吧。我的意思是，當然，我們不能評論輝瑞公司的溝通方式。幾週前，當他們在那個時間點以及我們今天的時間點給出他們的指導時，他們已經這樣做了，關於與歐洲電動汽車部門的合同會是什麼樣子還沒有定論。我們在談論什麼樣的數量，在幾年內傳播什麼樣的東西，我們在談論或定價或任何類似的東西。每家公司都必須做自己的指導。我相信如果你比較這些數字，我會試著在之前解釋一下。實際上，我們並不遙遠。如果你比較一下，有——如果你真的做數學，我想你會得出結論，輝瑞和現在在 COVID 業務方面的銷售在我們提供的數字和輝瑞方面也非常一致已經提出。

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

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。