Biontech SE (BNTX) 2024 Q4 法說會逐字稿

Good morning and good afternoon. Thank you for joining BioNTech's Foirter and full year 2024 earnings call.

早安，下午好。感謝您參加 BioNTech 的 Foirter 和 2024 年全年財報電話會議。

As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the US Securities and Exchange Commission.

提醒一下，我們在本次電話會議中使用的幻燈片以及我們今天早上發布的相應新聞稿可以在我們網站的投資者關係部分找到。在下一張投影片中，您將看到我們的前瞻性聲明免責聲明。有關這些聲明和其他風險的更多信息，請參閱我們向美國證券交易委員會提交的文件中。

Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide 3, you can find the agenda for today's call.

本次電話會議中的前瞻性陳述受重大風險和不確定性的影響，並且僅代表本次電話會議之日的觀點。我們不承擔更新或修改任何這些聲明的義務。在第 3 張投影片上，您可以找到今天電話會議的議程。

Today, I'm joined by the following members of BioNTech's management team; Ugur Sahin, Chief Executive Officer and Co-Founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; Jan Holstein, Chief Financial Officer; and Robin Richardson, Chief Strategy Officer.

今天，我與 BioNTech 管理團隊的以下成員一起出席； Ugur Sahin，首席執行官兼聯合創始人； Ozlem Tureci，首席醫療官兼聯合創始人； Jan Holstein，首席財務官；以及首席戰略官羅賓·理查森 (Robin Richardson)。

With this, I would like to hand over to Ugur.

現在，我想把權力移交給烏古爾。

Thank you, Michael. A warm welcome to all those joining us today. We will spend today's call on our key areas of focus for this year. Before we do so, I want to speak briefly about our original vision and the strategy to become an immunotherapy powerhouse and are fully interpreted bio pharmaceutical company with multiple approved products.

謝謝你，麥可。熱烈歡迎今天與我們一起參加的所有人。今天的電話會議我們將討論今年的重點領域。在此之前，我想簡單談談我們最初的願景和策略，成為一家免疫療法巨頭，並成為一家擁有多種獲批產品的全面詮釋的生物製藥公司。

While BioNTech has evolved significantly since its founding in 2008, our vision has remained steadfast to translate science into survival of patients by fully harnessing the power of the immune system to fight immune diseases, particularly cancer. In 2024, we made significant progress on this vision. Thanks to the excellent work and dedication of our BioNTech team, our collaboration partners and the trust of patients who participated in our clinical trials.

BioNTech 自 2008 年成立以來已取得了長足的發展，但我們的願景始終堅定不移，即充分利用免疫系統的力量對抗免疫疾病，尤其是癌症，將科學轉化為患者的生存。2024年，我們在這願景上取得了重大進展。感謝我們的 BioNTech 團隊、合作夥伴的出色工作和奉獻精神以及參與我們臨床試驗的患者的信任。

We have a clear focus -- we will continue to invest in our technologies and drug candidates that have the potential to improve outcomes for patients across a wide range of tumor types. In oncology, we have identified two key pan tumor programs. our mRNA cancer immunotherapy FixVac and iNeST, and our bispecific anti-PD-L1 anti-VEGF antibody BNT327. We believe that these programs have disruptive potential and aligned with our vision.

我們的重點很明確—我們將繼續投資於我們的技術和候選藥物，這些技術和候選藥物有可能改善各種腫瘤患者的治療結果。在腫瘤學方面，我們確定了兩個關鍵的泛腫瘤項目。我們的 mRNA 癌症免疫療法 FixVac 和 iNeST，以及我們的雙特異性抗 PD-L1 抗 VEGF 抗體 BNT327。我們相信這些計劃具有顛覆性的潛力並且符合我們的願景。

If successfully developed and approved, these programs could establish a new standard of care and enhance patient outcomes in multiple cancer indications globally. We are significantly investing in the clinical development of this program across various cancer types, building up commercial functions for the future commercialization in key markets and enhancing manufacturing capabilities to support both clinical type and commercial supply.

如果成功開發並獲得批准，這些計畫可以建立新的護理標準並改善全球多種癌症患者的治療效果。我們正在大力投資該計畫針對各種癌症類型的臨床開發，為未來在主要市場的商業化建立商業功能，並增強製造能力以支持臨床類型和商業供應。

In the infectious disease sector, we are advancing the development of our next-generation COVID-19 and combination vaccines. Our infectious disease product strategy focuses on sustainable value creation with active pipeline prioritization and a vigorous opportunity assessment based on strategic fit and operational efficiency. Consequently, as outlined in our 20-F filing today, we are prioritizing areas with disruptive potential for value generation.

在傳染病領域，我們正在推動下一代 COVID-19 疫苗和聯合疫苗的研發。我們的傳染病產品策略著重於永續價值創造，積極確定產品線優先級，並根據策略契合度和營運效率進行強大的機會評估。因此，正如我們今天的 20-F 文件所述，我們優先考慮具有顛覆性價值創造潛力的領域。

Moreover, we are planning to adjust our resources in manufacturing, administrative functions and clinical research over the next three years to further solidify efficient execution. Let me continue with a look back at what we have achieved in 2024. For our mRNA immunotherapies, we initiated the third Phase 2 trial, evaluating autogene cevumeran in adjuvant setting, namely in bladder cancer.

此外，我們計劃在未來三年內調整製造、行政職能和臨床研究的資源，以進一步鞏固高效的執行力。讓我繼續回顧一下我們在2024年所取得的成就。對於我們的 mRNA 免疫療法，我們啟動了第三階段 2 期試驗，評估自體基因西維美蘭在輔助治療（即膀胱癌）中的作用。

In early 2025, we also published two manicures describing our insights from two Phase 1 trials for autogene cevumeran. For three of the FixVac programs, we reported data, including the announcement that FixVac candidate BNT111 met the randomized Phase 2 trial in patients with anti-PD-1 with refractory melanoma.

2025 年初，我們也發表了兩篇論文，描述了我們從自基因西維美蘭的兩項 1 期試驗中獲得的見解。對於三個 FixVac 項目，我們報告了數據，包括宣布 FixVac 候選藥物 BNT111 滿足針對患有難治性黑色素瘤的抗 PD-1 患者的隨機 2 期試驗。

We presented multiple data sets for our next-generation IO, BNT327 at PD-L1 VEGF bispecific antibody, an initiated Phase 3 and Phase 3 trials in small cell lung cancer and non-small cell lung cancer. We plan to initiate a Phase 3 pile in triple-negative breast cancer this year.

我們展示了下一代 IO、BNT327（PD-L1 VEGF 雙特異性抗體）的多個資料集，並啟動了小細胞肺癌和非小細胞肺癌的 3 期和 3 期試驗。我們計劃今年啟動三陰性乳癌的 3 期臨床試驗。

We announced our intention to acquire to secure global control over BNT327 and expand our immunotherapy capabilities. This transaction closed earlier this year, and we are thrilled to welcome BioFire as a new arm of our operations in China.

我們宣布了收購意向，以確保對 BNT327 的全球控制權並擴大我們的免疫療法能力。該交易於今年稍早完成，我們非常高興地歡迎 BioFire 成為我們在中國業務的新分支。

With regard to our COVID-19 vaccine, we and maintained our leading market share globally. We also continued to progress several other programs in our early-stage infectious disease pardon. Lastly, we were able to achieve all this while maintaining our strong financial position. We believe these achievements position us well for further progress in 2025.

關於我們的新冠疫苗，我們在全球保持了領先的市場份額。我們也繼續推進早期傳染病赦免中的其他幾個項目。最後，我們在保持強勁財務狀況的同時實現了所有這些目標。我們相信，這些成就將為我們在 2025 年取得更大進步奠定基礎。

As already pointed out, in oncology, we are focused on the development of candidates addressing the full spectrum of solid tumors with a focus on two pan tumor programs. First, our personalized mRNA cancer immuno therapies including neoantigens for application primarily for the early stage, including adjuvant setting and our FixVac at immunotherapies targeting tumor-associated tensions in combination with checkpoint immunotherapy, respectively.

正如已經指出的，在腫瘤學方面，我們專注於開發針對全譜實體腫瘤的候選藥物，並專注於兩個泛腫瘤項目。首先，我們的個人化 mRNA 癌症免疫療法（包括新抗原）主要用於早期階段，包括輔助治療，而我們的 FixVac 免疫療法則分別針對腫瘤相關張力與檢查點免疫療法相結合。

Second, our PD-L1 biospecific antibody BNT327 which we believe has the potential to become a next-generation I-O backbone for the treatment of advanced cancers. We believe that both programs have panned tumor potential and could be combined with different modalities to address large patient population with high unmet medical need. 2025 will be an important year for these priority programs. We expect to generate and share new clinical data that will help inform our development strategy.

其次，我們相信我們的 PD-L1 生物特異性抗體 BNT327 有潛力成為治療晚期癌症的下一代 I-O 骨幹。我們相信這兩個項目都具有治療腫瘤的潛力，並且可以結合不同的治療方式來滿足大量未滿足醫療需求的患者群體。 2025年將是這些重點計畫實施的重要一年。我們希望產生和分享新的臨床數據，以幫助我們制定發展策略。

I want to take a moment to highlight our recently completed acquisition of We are excited to now formally welcome team to BioNTech, having worked for a year with the highly skilled and dedicated team at we have decided to plan for an acquisition of the company. Now as one company, we have the capabilities to accelerate and expand the global development of BNT327.

我想花點時間強調我們最近完成的收購。我們很高興現在正式歡迎團隊加入 BioNTech，在與這支技術精湛、敬業的團隊合作了一年後，我們決定計劃收購該公司。現在作為一家公司，我們有能力加速和擴大 BNT327 的全球發展。

However, there are other factors of this acquisition, which are also strategically important for us. We are going to build a strong and experienced clinical development organization in China that can help us to further accelerate the development across programs and tumor types.

然而，此次收購還有其他因素，對我們來說也具有策略重要性。我們將在中國建立一個強大且經驗豐富的臨床開發組織，以幫助我們進一步加速跨計畫和跨腫瘤類型的開發。

We believe this will facilitate more streamlined clinical development and decision-making, allowing us to bring other programs into late-stage and global development. This acquisition of biosis, we have now a fully integrated antibody manufacturing network in China. The sites supplies antibodies for clinical trials and could potentially support initial commercial supply for market launches.

我們相信這將促進更簡化的臨床開發和決策，使我們能夠將其他項目帶入後期和全球開發。透過收購 Biosis，我們目前在中國擁有一個完全整合的抗體製造網路。該站點為臨床試驗提供抗體，並可能支持市場推出的初始商業供應。

Lastly, comes with leading antibody engineering technology and expertise. With their capability, they have very quickly built a diverse pipeline of programs that we are evaluating and which we believe could offer additional value in the coming years.

最後，擁有領先的抗體工程技術和專業知識。憑藉他們的能力，他們很快就建立了多樣化的項目管道，我們正在評估這些項目，我們相信這些項目在未來幾年將提供額外的價值。

With that, I will turn the call over to Ozlem.

說完這些，我將把電話轉給奧茲勒姆。

Thank you, Ugur. Glad to be speaking with everyone today. Before talking about our focus programs introduced by Ugur, I wanted to take a minute to show our pipeline progress in 2024. If you compare our oncology pipeline today, to previous years, you can see that we have significantly increased the number of Phase 2 and 3 trials that are ongoing both as a total number and as a percentage of the total trials we are running.

謝謝你，烏古爾。很高興今天能與大家交談。在談論 Ugur 介紹的我們的重點項目之前，我想花一點時間來展示我們 2024 年的管道進度。如果將我們今天的腫瘤學研發管線與前幾年進行比較，您會發現，我們正在進行的 2 期和 3 期試驗的數量無論是總數還是占我們正在進行的總試驗數量的百分比都顯著增加。

When choosing which programs to move forward into late-stage trials, we maintain a high bar for prioritization, which is guided by clinical data, unmet medical need and commercial potential. As Ugur pointed out, our mRNA immunotherapies and our BNT327 centered clinical development program are dominantly represented in our pipeline, and particularly so in the advanced clinical stages with BNT327 becoming our platform for unique combinations with several of our other assets, in particular, our ADCs.

在選擇哪些項目進入後期試驗時，我們保持較高的優先排序標準，以臨床數據、未滿足的醫療需求和商業潛力為指導。正如 Ugur 指出的那樣，我們的 mRNA 免疫療法和以 BNT327 為中心的臨床開發計劃在我們的產品線中佔據主導地位，尤其是在後期臨床階段，BNT327 成為我們與其他幾種資產（特別是 ADC）進行獨特組合的平台。

As Ugur mentioned, 2025 will be an important year for both of our priority programs. BNT327 by localizing the blockade of PD-L1 and VEGF-A signaling to the tumor is designed to deliver superior antitumor immune modulatory and anti-angiogenic effects compared to the individual targeting of PD-L1 and VEGF-A with the potential to minimize adverse events associated with systemic anti-VEGF therapy. With the anti-PD-L1 and anti-VEGF-A mechanisms being validated across numerous tumor types and in some cases, in combination, we have a road map for development.

正如烏古爾所說，2025 年對我們兩個優先項目來說都是重要的一年。BNT327 透過定位阻斷 PD-L1 和 VEGF-A 訊號傳導至腫瘤，與單獨針對 PD-L1 和 VEGF-A 相比，可提供更優異的抗腫瘤免疫調節和抗血管生成作用，並有可能最大限度地減少與全身性抗 VEGF 治療相關的不良事件。隨著抗 PD-L1 和抗 VEGF-A 機制在多種腫瘤類型中得到驗證，並且在某些情況下結合起來，我們擁有了發展路線圖。

We have made strong progress over the past few months across all three waves of our BNT327 clinical development program. The first wave is focused on lung cancer and TNBC as key indications to establish BNT327 combined with standard of care chemophierapy with first approvals in first-line settings of these indications. We have completed enrollment in our global Phase 2 dose optimization studies in small cell lung cancer and TNBC.

過去幾個月，我們在 BNT327 臨床開發計畫的三輪中都取得了重大進展。第一波重點關注肺癌和三陰性乳癌 (TNBC) 作為關鍵適應症，以建立 BNT327 與標準護理化學療法相結合的療法，並在這些適應症的一線環境中首次獲得批准。我們已經完成了小細胞肺癌和三陰性乳癌 (TNBC) 全球 2 期劑量優化研究的招募。

In small cell lung cancer, we have begun enrolling patients in the global randomized Phase 3 trial. In TNBC, we will start a global registrational study later this year. In non-small cell lung cancer, we have begun enrolling patients in our global Phase 2 free registrational clinical trial.

對於小細胞肺癌，我們已經開始招募病患參與全球隨機 3 期試驗。在TNBC，我們將於今年稍後啟動一項全球註冊研究。在非小細胞肺癌領域，我們已經開始招募患者參加全球第二階段免費註冊臨床試驗。

Our second wave of development with BNT327 reflects that I-O plus ADC combos are an emerging treatment paradigm in oncology. We have started exploring combinations of BNT327 with four ADCs directed against TROP2, HER2, HER3, B7-H3 from our partnerships with and and informed by a robust database of single-agent data for BNT327-ADC combination study with our TROP2 ADC-BNT325 is already enrolling patients.

我們對 BNT327 的第二波開發反映了 I-O 加 ADC 組合是腫瘤學中新興的治療模式。我們已開始探索 BNT327 與四種針對 TROP2、HER2、HER3、B7-H3 的 ADC 的組合，這些 ADC 來自我們與和的合作，並由強大的單藥數據庫提供信息，用於 BNT327-ADC 與我們的 TROP2 ADC-BNT325 的組合研究，該研究已開始招募患者。

In the coming months, we expect to dose the first patients combining BNT327 with our HER2 ADC 323 and our B7H3 ADC. Throughout this year, we will evaluate the data from these initial combination trials and will start additional novel combinations across tumor types to broaden our global clinical development program with BNT327.

在接下來的幾個月裡，我們預計將為首批患者使用 BNT327 與我們的 HER2 ADC 323 和 B7H3 ADC 進行治療。今年全年，我們將評估這些初步組合試驗的數據，並將啟動更多跨腫瘤類型的新組合，以擴大我們利用 BNT327 的全球臨床開發計畫。

With this focused clinical development program, we aim to leverage BNT327's full potential. As previously mentioned, we expect 2025 to be a data-rich year across our whole pipeline and especially for BNT327. The first of these data sets will come later this month at the European Lung Cancer Congress and trials in small cell lung cancer.

透過這項重點臨床開發計劃，我們旨在充分發揮 BNT327 的潛力。如前所述，我們預計 2025 年將是我們整個產品線資料豐富的一年，尤其是 BNT327。首批數據集將於本月稍晚在歐洲肺癌大會和小細胞肺癌試驗中公佈。

Small cell lung cancer is a tumor type with notable incidents worldwide and an immunologically cold tumor for which high unmet need remains with current standard of care treatment with durability of responses is quite short and five-year survival rate for extended stage small-cell lung cancer is only 3%.

小細胞肺癌是全球發生率較高的腫瘤類型，屬於免疫冷性腫瘤，目前的標準治療仍存在很大的未滿足需求，且治療反應的持久性較短，晚期小細胞肺癌的五年存活率僅為3%。

Based on our emerging data, we believe that BNT327 has the potential to improve clinical outcomes for patients with small cell lung cancer. At ESMO 2023, data were presented which show encouraging activity of BNT327 in combination with standard of care chemotherapy in second-line small cell lung cancer, that has motivated us to pursue small cell lung cancer is one of our priority indications for BNT327.

根據我們新出現的數據，我們相信 BNT327 有可能改善小細胞肺癌患者的臨床結果。在 ESMO 2023 上，已發表的數據表明 BNT327 與標準化療聯合治療二線小細胞肺癌具有令人鼓舞的療效，這促使我們將小細胞肺癌作為 BNT327 的優先適應症之一。

We plan to present free data sets from trials in small cell lung cancer this year, including data from two separate single-arm Phase 2 trials evaluating BNT327 plus chemotherapy as the first or second line treatment for extensive stage small cell lung cancer.

我們計劃今年免費提供小細胞肺癌試驗的數據集，其中包括兩項獨立的單臂 2 期試驗的數據，這兩項試驗評估了 BNT327 聯合化療作為廣泛期小細胞肺癌的一線或二線治療。

These data sets continue to support our enthusiasm for evaluating the BNT327 for the potential treatment of first-line small cell lung cancer in our ongoing global Phase 3 trial. As Ryan will cover later, we expect to share additional important clinical data updates throughout the year.

這些數據集繼續支持我們在正在進行的全球 3 期試驗中評估 BNT327 對一線小細胞肺癌的潛在治療作用的熱情。正如 Ryan 稍後將介紹的那樣，我們希望全年分享更多重要的臨床數據更新。

Our mRNA cancer immune therapy platform, iNeST and FixVac are the other cornerstone of our oncology portfolio. Ortogensirumaran, a.k.a. BNT122 developed in partnership with Genentech is based on the iNeST platform. iNeST targets neoantigens, unique tumor-specific mutations and is manufactured on demand for each individual patient. FixVac in contrast targets three non-mutated tumor antigens and is an off-the-shelf approach.

我們的 mRNA 癌症免疫治療平台、iNeST 和 FixVac 是我們腫瘤學產品組合的另一個基石。Ortogensirumaran，又稱 BNT122，是與 Genentech 合作開發的，基於 iNeST 平台。 iNeST 針對新抗原、獨特的腫瘤特異性突變，並根據每個患者的需求生產。相較之下，FixVac 針對三種未突變的腫瘤抗原，是現成的方法。

Both platforms utilize our proprietary uridine mRNA LPX delivery technology. The discovery of these two different types of target antigens is one of our core competencies. Over the past several years, we've accumulated substantial data from iNeST and FixVac trials across various tumor types. These data consistently demonstrate that uridine mRNA LPX based immunotherapies have manageable safety profile where by used as single agent in combination with anti-PD-1, PD-L1 inhibitors or with chemotherapy.

這兩個平台都採用了我們專有的尿苷 mRNA LPX 傳遞技術。發現這兩種不同類型的標靶抗原是我們的核心競爭力之一。在過去的幾年裡，我們從針對各種腫瘤類型的 iNeST 和 FixVac 試驗中累積了大量數據。這些數據一致表明，基於尿苷 mRNA LPX 的免疫療法在作為單一藥物與抗 PD-1、PD-L1 抑制劑或化療聯合使用時具有可控的安全性。

Crucially, our data also indicate that these immunotherapies are highly effective at inducing and expanding high magnitude, functional and longest T cell responses in a significant proportion of patients. This robust immune response is a prerequisite for clinical activity. We have multiple trials with both FixVac and iNeST ongoing and have had multiple data reports in the past years and in particular, in 2024.

至關重要的是，我們的數據還表明，這些免疫療法在相當一部分患者中能夠高效地誘導和擴大高強度、功能性和最長的 T 細胞反應。這種強大的免疫反應是臨床活動的先決條件。我們對 FixVac 和 iNeST 進行了多次試驗，並在過去幾年，特別是 2024 年獲得了多份數據報告。

Today, I would like to focus on iNeST and recent data we have obtained in the trial highlighted here from which we recently published data in Nature Medicine. This is our first Phase 1 clinical trial of autogene cevumeran published in Nature Medicine which included over 200 patients with resistant refractory advanced and metastatic solid tumors.

今天，我想重點介紹 iNeST 以及我們在此重點介紹的試驗中獲得的最新數據，我們最近在《自然醫學》上發表了該試驗的數據。這是我們在《自然醫學》上發表的首個自基因西維美蘭 1 期臨床試驗，其中包括 200 多名患有抗藥性難治性晚期和轉移性實體瘤的患者。

This trial evaluated autogene cevumeran, both with and without the checkpoint inhibitor, atezolizumab. It is known that only a small fraction, 1% to 2% of cancer mutations spontaneously elicit an antitumor immune risk.

該試驗評估了自體西維美蘭與檢查點抑制劑阿特珠單抗合併使用和不合併使用的情況。已知只有一小部分（1% 到 2%）的癌症突變會自發性引發抗腫瘤免疫風險。

Our mRNA cancer immunotherapy approach aims to significantly increase these antitumor immune responses. In this Phase 1 trial, autogene cevumeran successfully induced T cell responses across multiple cancer types, converting a high portion of patients into immune responders.

我們的 mRNA 癌症免疫治療方法旨在顯著增強這些抗腫瘤免疫反應。在本次 1 期試驗中，自基因西維美蘭成功誘導多種癌症類型的 T 細胞反應，將大量患者轉化為免疫反應者。

The majority of these responses were fully epitopic directed against multiple mRNA-encoded neoantigens. And these responses were de novo, meaning they were newly generated against the encoded neoantigens and did not exist prior to treatment.

這些反應中的大多數是針對多種 mRNA 編碼的新抗原的完全表位。這些反應是從頭產生的，這意味著它們是針對編碼的新抗原新產生的，並且在治療之前並不存在。

In some patients, we observed up to two order of magnitude amplification of existing neoantigen-specific T cells. Furthermore, in several patients, we detected newly induced antitumor T cells infiltrating the tumor of treated patients. These findings demonstrate the potent immunogenicity of autogene cevumeran even in patients with advanced rapidly progressing cancers, which is a requisite for clinical activity.

在一些患者中，我們觀察到現有的新抗原特異性 T 細胞擴增了兩個數量級。此外，在幾名患者中，我們檢測到了新誘導的抗腫瘤 T 細胞浸潤到接受治療的患者的腫瘤中。這些發現證明了自基因西維美蘭即使在晚期快速進展癌症患者中也具有強大的免疫原性，這是臨床活動的必要條件。

In our ongoing Phase 2 clinical trials we aim to confirm these data and evaluate in which treatment setting and indications for immune responses translate best into clinical activity. While we saw strong immune responses in this Phase 1 trial, we observed modest signals of clinical activity, which was expected given that the Phase 1 trial was conducted in heavily pretreated resistant refractory fast-growing advanced cancer.

在我們正在進行的 2 期臨床試驗中，我們旨在確認這些數據並評估哪種治療環境和免疫反應指徵最能轉化為臨床活動。雖然我們在這個 I 期試驗中看到了強烈的免疫反應，但我們觀察到的臨床活動訊號並不明顯，這是意料之中的，因為 I 期試驗是在經過大量預先治療的抗藥性難治性快速生長晚期癌症中進行的。

We recently also received top line data from the MCODE-001 Phase 2 trial marked here on this slide. This was the first randomized proof-of-concept Phase 2 trial of an iNeST candidate, evaluating autogene cevumeran in combination with versus alone as first-line treatment for patients with metastatic or advanced melanoma.

我們最近也收到了這張投影片上標記的 MCODE-001 第 2 階段試驗的頂線資料。這是 iNeST 候選藥物的首次隨機概念驗證 2 期試驗，評估自體基因西維美蘭聯合用藥與單獨用藥作為轉移性或晚期黑色素瘤患者的一線治療。

This trial is part of the broader study program initiated in 2017 by our partner Genentech and us, designed to identify optimal treatment settings and patient populations for individualized mRNA cancer immunotherapies including early and late-stage cancers. initial data confirm our observations that autogene cevumeran induces high magnitude immune responses against encoded neoantigens in this advanced treatment setting.

該試驗是我們和合作夥伴 Genentech 於 2017 年發起的更廣泛研究計劃的一部分，旨在確定個人化 mRNA 癌症免疫療法（包括早期和晚期癌症）的最佳治療環境和患者群體。初步數據證實了我們的觀察結果，即自基因西維美蘭在這種先進的治療環境中誘導了針對編碼新抗原的高強度免疫反應。

Here in patients with advanced and metastatic melanoma, the trial did not meet its primary endpoint of a statistically significant improvement in progression-free survival. However, we did observe a numerical trend favoring the combination arm and overall survival. The combination of autogenerumuran with PD-1 blockade was well tolerated with adverse events consistent with the known safety profiles of the individual treatment.

對於晚期和轉移性黑色素瘤患者，該試驗未能達到其主要終點，即無惡化存活期在統計學上顯著改善。然而，我們確實觀察到了有利於聯合治療組和整體存活率的數值趨勢。Autogenerumuran 與 PD-1 阻斷的組合具有良好的耐受性，不良事件與已知的個別治療安全性一致。

We are continuing to analyze the results, including exploratory endpoints and biomarker correlation. We and our partner, Genentech, will share this data with the scientific community at an upcoming medical conference.

我們正在繼續分析結果，包括探索性終點和生物標記相關性。我們和我們的合作夥伴 Genentech 將在即將舉行的醫學會議上與科學界分享這些數據。

The outcome confirms what we have observed in our Phase 1 trial in patients with heavily pretreated resistant refractory fast-growing advanced cancers and provides valuable insights. Patients in the first-line metastatic melanoma setting has a substantial tumor burden and rapid disease progression.

此結果證實了我們在第一階段試驗中對接受過大量治療的抗藥性快速生長晚期癌症患者所觀察到的情況，並提供了寶貴的見解。一線轉移性黑色素瘤患者的腫瘤負擔很大，病情進展很快。

An effective immune response, even a potent one requires time to develop typically six to eight weeks based on our data. This time frame may be insufficient to control rapidly growing advanced disease and may require treatment combinations with other modalities. This experience, combined with our extensive translational data, reconfirm our strategic focus on using iNeST in the adjuvant setting, where patients have resectable cancer and minimal residual disease.

根據我們的數據，有效的免疫反應，即使是強效的免疫反應，也需要時間來發展，通常需要六到八週的時間。這個時間範圍可能不足以控制快速增長的晚期疾病，可能需要與其他方式合併治療。這一經驗，加上我們廣泛的轉化數據，再次確認了我們的策略重點是在輔助治療中使用 iNeST，在這種情況下，患者患有可切除的癌症和微小殘留疾病。

We believe this setting offers a strong biological rationale for success due to several reasons. Adjuvant therapy targets a much smaller number of residual tumor cells after surgery, the slower disease progression in the adjuvant setting without sufficient time for the vaccine-induced immune response to develop and mature. Also in earlier disease stages, mechanisms of resistance, clonal heterogeneity, and an immunosuppressive tumor microenvironment are typically less established.

我們相信，由於多種原因，這種設定為其成功提供了強有力的生物學原理。輔助治療針對的是手術後殘留的腫瘤細胞數量少得多，輔助治療中疾病進展較慢，沒有足夠的時間讓疫苗誘發的免疫反應發展和成熟。此外，在疾病的早期階段，抗藥性、克隆異質性和免疫抑制腫瘤微環境的機制通常尚未完全確定。

Patients in the adjuvant setting often have healthier immune systems and less compromised T cell function increasingly likelihood of a clinically meaningful response. This rationale is the reason why we strategically focused our advanced iNeST program on the adjuvant setting.

輔助治療的患者通常具有更健康的免疫系統和更少受損的 T 細胞功能，更有可能產生具有臨床意義的反應。正是出於這個原因，我們將先進的 iNeST 計劃策略性地集中在輔助治療上。

We currently have three ongoing randomized Phase 2 trials of autogene cevumeran, one in colorectal cancer that is enrolling stage two high-risk in Stage III CRC patients who are ctDNA positive after surgical resection and standard of care chemotherapy.

我們目前正在進行三項自基因西維美蘭的隨機 2 期試驗，其中一項針對結直腸癌，正在招募接受手術切除和標準化療後 ctDNA 呈陽性的 2 期高風險 CRC 患者。

These patients are at high risk of recurrence, often within the year. We continue to anticipate initial data from the study either late this year or in early 2026. These data will be critical for informing the next stages of development and regulatory discussions.

這些患者復發的風險很高，通常在一年內。我們預計研究的初步數據將在今年底或 2026 年初公佈。這些數據對於下一階段的開發和監管討論至關重要。

We are also evaluating autogene cevumeran as an adjuvant treatment for pancreatic cancer. This Phase 2 is informed by a small Phase 1 trial in which we showed strong immune responses induced by autogene cevumeran and their correlation with significant improvement of recurrence-free survival.

我們也正在評估自基因西維美蘭作為胰臟癌輔助治療的效果。這項第 2 階段研究是根據一項小型第 1 期試驗得出的，在該試驗中，我們展示了自基因西維美蘭誘導的強烈免疫反應及其與無復發生存期顯著改善的相關性。

A randomized control Phase 2 trial in bladder cancer was initiated in the fourth quarter of last year. We believe individualized cancer immunotherapies have a potential to change the current standard of care and improve overall survival by delaying or preventing recurrence of cancer metastases. 2025 will be an important year for BioNTech.

去年第四季啟動了一項針對膀胱癌的隨機對照 2 期試驗。我們相信個人化的癌症免疫療法有可能改變目前的治療標準，並透過延緩或預防癌症轉移的復發來提高整體存活率。 2025年對BioNTech來說將是重要的一年。

We are intensely focused on the execution of our late-stage trials, particularly in the adjuvant setting, where we believe our individualized mRNA immunotherapy approach has the greatest potential for clinical impact why we are evaluating novel I-O combination for the treatment of advanced rapidly progressing high-volume tumors.

我們高度重視後期試驗的執行，特別是在輔助治療方面，我們相信我們的個人化 mRNA 免疫治療方法具有最大的臨床影響潛力，因此我們正在評估用於治療晚期快速進展的大容量腫瘤的新型 I-O 組合。

We look forward to providing updates on our progress. With that, I will now pass the presentation to our CFO, Jens Holstein.

我們期待提供有關我們進展的最新資訊。現在，我將把簡報交給我們的財務長 Jens Holstein。

Thank you, Ozlem, and a warm welcome to everyone who has done in today's call. I'll start with our fourth quarter and full year results 2024. Then I'll share our 2025 financial guidance. In terms of our financial results, we executed the year according to our plans. We recognized around EUR2.8 billion in revenues meeting the approximate midpoint of our full year 2024 revenue guidance and with this slightly better than our previously announced expectations.

謝謝你，奧茲勒姆，並熱烈歡迎今天參加電話會議的所有人。我將從我們的 2024 年第四季和全年業績開始。然後我將分享我們 2025 年的財務指導。就我們的財務表現而言，我們今年的業績是按照計劃完成的。我們確認的收入約為 28 億歐元，大致達到我們 2024 年全年收入預期的中點，並且略好於我們先前宣布的預期。

Driven by effective cost management, we limited our full year 2024 losses before taxes to approximately EUR678 million and a diluted loss per share of EUR2.77. Our cash position, including cash equivalents and investments in securities amounted to EUR17.4 billion at the end of 2024. This leaves us financially well positioned to continue with the execution of our strategy in 2025.

在有效的成本管理的推動下，我們將 2024 年全年稅前虧損限制至約 6.78 億歐元，每股稀釋虧損為 2.77 歐元。截至 2024 年底，我們的現金狀況（包括現金等價物和證券投資）達到 174 億歐元。這使得我們在財務上處於有利地位，可以在 2025 年繼續執行我們的策略。

Please note that this year-end cash position has not yet reflected the closed acquisition of to the amount of approximately USD800 million and payments derived from the settlement of the contractual disputes with NIH at the University of Pennsylvania to the amount of USD792 million and USD467 million, respectively. We expect that the acquisition payment and the NIH payment totaling approximately USD1.6 billion will be reflected in our first quarter 2025 financial position.

請注意，本年末現金狀況尚未反映已完成的約 8 億美元收購以及賓州大學與 NIH 解決合約糾紛所得的分別 7.92 億美元和 4.67 億美元的付款。我們預計，收購付款和 NIH 付款總計約 16 億美元將反映在我們 2025 年第一季的財務狀況中。

We expect that the University of Pennsylvania settlement payment will be reflected in our second quarter 2025 financial position. With respect to the settlements, we also expect a reimbursement of approximately USD535 million from our partner Pfizer during 2025 and 2026.

我們預計賓州大學的和解金將反映在我們 2025 年第二季的財務狀況。關於和解，我們也預計我們的合作夥伴輝瑞將在 2025 年和 2026 年期間償還約 5.35 億美元。

I'll be moving now to the summary of our financial results for the fourth quarter and the full year of 2024 as shown on the next slide. For the three months ended December 31, 2024, we recognized total revenues of approximately EUR1.2 billion compared to approximately EUR1.5 billion in the prior year period.

我現在將轉到下一張投影片所示的第四季和 2024 年全年財務業績摘要。截至 2024 年 12 月 31 日的三個月，我們實現的總收入約為 12 億歐元，而去年同期約為 15 億歐元。

For the full year, we recognized around EUR2.8 billion compared to around EUR3.8 billion in 2023. The reduction was primarily driven by a lower COVID-19 vaccine market demand. In addition, write-downs by our collaboration partner, Pfizer, reduced our gross profit share and hence negatively influenced our revenues for 2024.

就全年而言，我們確認的利潤約為 28 億歐元，而 2023 年約為 38 億歐元。下降的主要原因是 COVID-19 疫苗市場需求下降。此外，我們的合作夥伴輝瑞公司的減記減少了我們的毛利份額，從而對我們 2024 年的收入產生了負面影響。

Research and development expenses reached EUR612 million for the fourth quarter of 2024 compared to EUR578 million for the comparative period in 2023. For 2024, R&D expenses amounted to approximately EUR2.3 billion compared to roughly EUR1.8 billion in 2023. The increase was mainly influenced by the planned advancing of our priority programs, including BNT327 towards late-stage development.

2024 年第四季研發費用達 6.12 億歐元，而 2023 年同期為 5.78 億歐元。2024 年研發費用約 23 億歐元，而 2023 年約 18 億歐元。這一增長主要受到我們優先項目（包括 BNT327）計劃推進的影響，該項目已進入後期開發階段。

SG&A expenses amounted to approximately EUR132 million for the fourth quarter of 2024 compared to EUR142 million in the same period of the previous year. For the 2024 financial year, SG&A expenses amounted to approximately EUR599 million compared to EUR558 million in 2023. The increase in SG&A expenses is primarily attributable to the build-out of our commercial organization.

2024 年第四季銷售、一般及行政費用約為 1.32 億歐元，去年同期為 1.42 億歐元。2024 財年的銷售、一般及行政費用約為 5.99 億歐元，而 2023 年為 5.58 億歐元。銷售、一般及行政費用的增加主要歸因於我們商業組織的擴張。

With respect to the company's other operating results, we reported negative EUR671 million for the 2024 financial year as compared to negative EUR188 million in 2023. This was mainly due to payments and expenses related to the above-mentioned contractual disputes with NIH UPenn, net of aforementioned related reimbursement by our collaboration partner, Pfizer.

關於公司的其他經營業績，我們報告 2024 財年為負 6.71 億歐元，而 2023 年為負 1.88 億歐元。這主要是由於與 NIH UPenn 的上述合約糾紛相關的付款和費用，扣除上述我們的合作夥伴輝瑞公司的相關報銷。

For the fourth quarter of 2024, we reported a net profit of approximately EUR260 million compared to around EUR458 million for the comparative period in 2023. For the full year 2024, we reported a net loss of EUR665 million compared to a net profit of EUR930 million in the prior year.

2024 年第四季度，我們報告的淨利潤約為 2.6 億歐元，而 2023 年同期的淨利潤約為 4.58 億歐元。2024 年全年，我們報告淨虧損 6.65 億歐元，而上一年淨利為 9.3 億歐元。

Our diluted earnings per share for the fourth quarter of 2024 amounted to EUR1.08 compared to EUR1.88 in the comparative period in 2023. For the 2024 financial year, our diluted loss per share amounted to EUR2.77 compared to EUR3.83 for the prior year.

2024 年第四季，我們的每股攤薄收益為 1.08 歐元，而 2023 年同期為 1.88 歐元。2024 財年，我們的每股攤薄虧損為 2.77 歐元，而前一年為 3.83 歐元。

Let's now continue with the next slide. As depicted on the slide, we executed well against our 2024 financial guidance update that was provided in our third quarter earnings call in November. Starting from the top, we achieved roughly the midpoint of our full year 2024 revenue guidance of EUR2.5 billion to EUR3.1 billion.

現在我們繼續下一張投影片。如投影片所示，我們按照 11 月第三季財報電話會議上提供的 2024 年財務指引更新執行得很好。從最高點開始，我們大致實現了 2024 年全年營收預期的中點，即 25 億歐元至 31 億歐元。

During our third quarter 2024 earnings call, we stated that we expected full year 2024 revenues to be at the low end of the guidance range. In the final month of the year, we experienced stronger-than-expected sales outside the US.

在我們 2024 年第三季財報電話會議上，我們表示預計 2024 年全年收入將處於指導範圍的低端。今年最後一個月，我們在美國以外的銷售表現強於預期。

On R&D, we report roughly EUR2.3 billion in expenses for 2024, slightly below the low end of our full year 2024 financial guidance range of EUR2.4 billion to EUR2.6 billion. This was in part driven by our active portfolio management and the shifting of some registrational study costs from 2024 to 2025.

在研發方面，我們報告 2024 年的支出約為 23 億歐元，略低於我們 2024 年全年財務指引範圍的低端 24 億歐元至 26 億歐元。這在一定程度上是由於我們積極的投資組合管理以及部分註冊研究成本從 2024 年轉移到 2025 年。

On SG&A and capital expenditures for operating activities we ended at the lower end of our 2024 expectations from our last earnings call. VTB's lower guidance ranges is a result of our continued cost monetary and financial discipline.

在銷售、一般及行政費用 (SG&A) 和經營活動資本支出方面，我們最終達到了上次收益電話會議中對 2024 年預期的低端。VTB 較低的指導範圍是我們持續的成本、金錢和財務紀律的結果。

Turning to the next slide, let me highlight now some key aspects for the company's outlook for the 2025 financial year. We expect total revenues in the range of EUR1.7 billion to EUR2.2 billion for 2025. Our revenue guidance assumes relatively stable vacillation rate, pricing and market share as compared to 2024.

翻到下一張投影片，現在讓我重點介紹一下公司 2025 財年展望的一些關鍵面向。我們預計 2025 年總收入將在 17 億歐元至 22 億歐元之間。我們的收入指引假設與 2024 年相比波動率、定價和市佔率相對穩定。

We also anticipate a revenue phasing similar to last year with the last three to four months driving the full year revenue figure. In addition, we estimate some inventory write-downs and other charges in the range of roughly 15% of BioNTech's share of gross profit from COVID-19 vaccine sales in Pfizer territory.

我們也預計收入分階段與去年類似，其中最後三到四個月將推動全年收入數字。此外，我們估計，一些庫存減記和其他費用約佔 BioNTech 在輝瑞地區 COVID-19 疫苗銷售毛利份額的 15%。

We also expect revenues related to our service business as well as revenues from the German pandemic preparedness agreement to contribute to our overall group revenues. Please note that potential changes in law or government policy at the state or national level and evolving public sentiment around vaccines and mRNA technology in the United States and/or elsewhere could also negatively influenced BioNTech's COVID-19 vaccine revenues and financial results.

我們也預計與我們的服務業務相關的收入以及來自德國大流行病防備協議的收入將有助於我們集團的整體收入。請注意，州或國家層級的法律或政府政策的潛在變化以及美國和/或其他地方圍繞疫苗和 mRNA 技術的公眾情緒的變化也可能對 BioNTech 的 COVID-19 疫苗收入和財務業績產生負面影響。

Turning to operating expenses. In 2025, we expect R&D expenses to be in the range of EUR2.6 billion to EUR2.8 billion. As compared to 2024, we expect to see an increase in investment into our priority late-stage programs in 2025, namely BNT327, our mRNA cancer immunotherapies and our ADC pipeline.

談到營運費用。2025年，我們預計研發費用將在26億歐元至28億歐元之間。與 2024 年相比，我們預計 2025 年對優先後期項目的投資將增加，即 BNT327、我們的 mRNA 癌症免疫療法和我們的 ADC 管線。

Consistent with our portfolio prioritization strategy, we also expect to decrease our R&D spend outside of our priority areas. We will continue to follow the data generated by our pipeline to ensure we are investing appropriately to drive innovation and create value.

與我們的投資組合優先策略一致，我們也希望減少優先領域以外的研發支出。我們將繼續關注我們的管道產生的數據，以確保我們進行適當的投資來推動創新和創造價值。

Next, SG&A. We expect SG&A expenses to be in the range of EUR650 million to EUR750 million. We are anticipating an increase compared to 2024 as we continue our commercial build-out for oncology and prepare for our first oncology launch. Lastly, capital expenditures for the 2025 financial year are expected to be in the range of EUR250 million to EUR350 million. With these investments, we're paving the way for multiple potential product launches.

接下來是銷售、一般及行政費用 (SG&A)。我們預計銷售、一般及行政費用將在 6.5 億歐元至 7.5 億歐元之間。隨著我們繼續推進腫瘤學商業化建設並為首次推出腫瘤學產品做準備，我們預計與 2024 年相比，這一數字將有所增長。最後，預計2025財年的資本支出將在2.5億歐元至3.5億歐元之間。透過這些投資，我們為多種潛在產品的發布鋪平了道路。

Investments include manufacturing expansion projects and investment in commercial IT systems to support portfolio growth and build capacity for the development and commercialization of our potentially disrupted pan-tumor technologies.

投資包括製造擴張項目和商業 IT 系統的投資，以支持產品組合成長並建立我們可能被顛覆的泛腫瘤技術的開發和商業化能力。

In summary, 2025 will be another year of continued transition for BioNTech with the aim to become a multiproduct commercial oncology company. We will continue to diligently invest in our long-term growth strategy. while maintaining strict financial discipline. With that, we remain focused on achieving long-term sustainable growth and generating value for patients and shareholders.

總而言之，2025 年將是 BioNTech 持續轉型的另一年，目標是成為多產品商業腫瘤學公司。我們將繼續努力投資我們的長期成長策略。同時保持嚴格的財務紀律。為此，我們將繼續專注於實現長期可持續成長並為患者和股東創造價值。

Now I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for our strategic outlook and concluding remarks. Thank you.

現在，我想將電話轉給我們的首席策略長瑞安·理查森 (Ryan Richardson)，請他介紹我們的策略展望並作總結發言。謝謝。

Thank you, Jens. I would like to end our prepared remarks with a summary of our priorities for 2025 and our key anticipated upcoming clinical and regulatory milestones for our oncology pipeline. This year, our focus will remain on executing on two pan-tumor product opportunities, BNT327 and our mRNA cancer immunotherapies.

謝謝你，詹斯。我想以總結我們 2025 年的優先事項以及我們腫瘤學管道即將實現的關鍵臨床和監管里程碑來結束我們的準備好的發言。今年，我們的重點仍將放在實施兩種泛腫瘤產品機會，即 BNT327 和我們的 mRNA 癌症免疫療法。

Each of these programs are in Phase 2 or Phase 3 trials and will generate data updates over the course of the year. We will continue to build out our commercial capabilities in oncology to support our goal of becoming a fully integrated biopharmaceutical company. In infectious disease, we will continue to invest to maintain our and Pfizer's global leadership position in the COVID-19 vaccine market while continuing to advance next-generation and combination vaccines in the clinic.

這些項目目前均處於第 2 階段或第 3 階段試驗，並將在一年內產生資料更新。我們將繼續增強我們在腫瘤學領域的商業能力，以支持我們成為一家完全整合的生物製藥公司的目標。在傳染病領域，我們將繼續投資，以保持我們和輝瑞在 COVID-19 疫苗市場的全球領導地位，同時繼續在臨床上推動下一代和聯合疫苗。

We expect to provide multiple updates from our early-stage infectious disease pipeline over the course of the year. We are in a catalyst-rich period for BioNTech. We plan to share multiple clinical updates across our focus programs throughout 2025, including an upcoming oncology conferences in March and April. In addition to the data for BNT327. We plan to share data updates for our mRNA cancer immunotherapies, iNeST and FixVac.

我們預計將在今年內提供早期傳染病研究管道的多項更新。我們正處於 BioNTech 催化劑豐富的時期。我們計劃在 2025 年全年分享我們重點項目的多項臨床更新，包括即將於 3 月和 4 月舉行的腫瘤學會議。除了 BNT327 的數據之外。我們計劃分享我們的 mRNA 癌症免疫療法、iNeST 和 FixVac 的數據更新。

And with regards to our first potential oncology product in HER2 ADC BNT323 we plan to share Phase 2 data from a single-arm registrational trial in HER2-expressing endometrial cancer as we prepare for a potential BLA submission later this year.

關於我們在 HER2 ADC BNT323 中的首個潛在腫瘤產品，我們計劃分享 HER2 表達子宮內膜癌單臂註冊試驗的 2 期數據，為今年稍後提交潛在的 BLA 做準備。

In closing, I would like to highlight on the next slide, important investor events we will be holding throughout the year. Our Annual General Meeting will take place on May 16. We are excited to once again host two innovation series events this year. The first will be another AI event on October 1. The second will be our R&D Day on November 18.

最後，我想在下一張投影片中強調我們全年將舉辦的重要投資人活動。我們的年度股東大會將於 5 月 16 日舉行。我們很高興今年再次舉辦兩場創新系列活動。第一場是 10 月 1 日的另一場人工智慧活動。第二個活動是 11 月 18 日的研發日。

We will share further details on both events later in the year.

我們將在今年稍後分享有關這兩項活動的更多細節。

With that, we would like to open the floor for questions.

現在，我們願意開始回答問題。

(Operator Instructions) Daina Graybosch, Leerink Partners.

（操作員指示） Daina Graybosch，Leerink Partners。

You had charges related to legal events that you talked about, Jens. There's a lot more IP cases going on and they seem to be accelerating and coming to some conclusions. And I wonder if you could just help give us an overview or road map of any particular ones that we should pay attention to that you think could have outcomes decided in the next quarters in this year.

詹斯，你所提到的指控與法律事件有關。智慧財產權案件正在不斷增多，而且似乎正在加速審理並得出一些結論。我想知道您是否可以幫助我們概述或規劃一些我們應該關注的具體問題，您認為這些問題可能會在今年下個季度產生結果。

Thanks, Daina, for the question. I mean it's very difficult to predict the timing of certain events in such legal disputes. I would like to refer to the 20-F where we have explained the circumstances in detail and I can't comment more than what we have published in 20-F.

謝謝戴娜提出的問題。我的意思是，在這樣的法律糾紛中，很難預測某些事件發生的時間。我想參考 20-F，我們在其中詳細解釋了相關情況，我無法對 20-F 中發布的內容發表更多評論。

Yes. I think, David, just to add to that. I think as we've said in the 20-F as well that we're confident in the strength of our IP estate and some of the -- sometimes these processes can go through multiple appeals processes, but we think we're in a good position and are going to continue to defend our IP estate, along with our partner, Pfizer.

是的。我認為，大衛，我只是想補充一點。我認為，正如我們在 20-F 中所說的那樣，我們對我們的智慧財產權資產的實力充滿信心，有時這些流程可能會經過多個上訴程序，但我們認為我們處於有利地位，並將繼續與我們的合作夥伴輝瑞一起捍衛我們的智慧財產權資產。

Great. And maybe one more because I would be quick. On the FixVac data that you're going to share this year of semlipamab. Can you just remind us of the context going into that, I recall that, that was a top line success and how we should be thinking about a vaccine in relapsed/refractory melanoma in context of Ozlem you sharing that the personalized vaccine didn't work in a metastatic melanoma setting.

偉大的。也許還會再多一個，因為我很快就會完成。關於您今年要分享的 semlipamab 的 FixVac 數據。您能否提醒我們當時的背景，我記得，那是一次頂級的成功，以及在 Ozlem 的背景下，我們應該如何看待復發/難治性黑色素瘤的疫苗，您分享了個性化疫苗在轉移性黑色素瘤環境中不起作用。

Thank you for the question. I'm not sure whether I got it correctly. So the question was with regard to our melanoma FixVac BNT11, right, where we have reported top line results that we have that it was a successful trial and that we have achieved the end point -- we will have data presentations on this later this year on one of the conferences and are also preparing a manuscript. So there will be more information about that.

謝謝你的提問。我不確定我是否理解正確。所以問題是關於我們黑色素瘤 FixVac BNT11 的，對吧，我們已經報告了最重要的結果，這是一次成功的試驗，我們已經達到了終點——我們將在今年晚些時候在一次會議上就此進行數據展示，同時也在準備一份手稿。因此將會有更多有關此的資訊。

As you pointed out, yes, we observed it for our iNeST first line setting. It seems that it's not the right one. So metastatic setting with advanced cancers and tumor -- higher tumor burden is not optimal. And which actually is not surprising. I have described the reasons for this which can explain a couple in my talk today.

正如您所指出的，是的，我們在 iNeST 第一行設定中觀察到了這一點。看來這不是正確的。因此，晚期癌症和腫瘤的轉移環境－較高的腫瘤負擔並不是最佳的。這其實並不奇怪。我在今天的演講中已經描述了其中的原因，可以解釋一些。

That's also why we are focusing our iNeST approach, our individualized cancer approach on the adjuvant setting and have initiated three trials in this setting. We believe that here of probability of getting robust clinical benefit is much higher due to simply the biology of adjuvant cancer.

這也是為什麼我們將 iNeST 方法、個人化癌症治療方法重點放在輔助治療上，並在此背景下啟動了三項試驗。我們相信，僅僅由於輔助癌症的生物學特性，獲得強勁臨床益處的可能性要高得多。

Daina, the key differences between the iNeST approach and FixVac approach is that FixVac can be applied immediately without any delay. And for the iNeST approach at the time point of the clinical price we had a turnaround times in the range of six to eight weeks, which is in a metastatic setting, really difficult because the tumors tend to progress, particularly by explanations ongoing and immune responses are built.

Daina，iNeST 方法和 FixVac 方法之間的主要區別在於 FixVac 可以立即應用，不會有任何延遲。對於 iNeST 方法，在臨床價格的時間點，我們的周轉時間在六到八週之間，這在轉移性環境中確實很困難，因為腫瘤往往會進展，特別是透過持續的解釋和免疫反應的建立。

So based on that, we early on adapted our strategy and went into the adjuvant stage the patients before they progress have been 6, 9, 12 months before events occur.

因此，基於此，我們很早就調整了策略，在患者病情進展之前就進入了輔助治療階段，此時距離事件發生已經過去了 6、9、12 個月。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

Just on 327, I know in the past, your teams alluded to the costs associated with developing an agent like this across different tumor types. And certainly, Merck is talking about running a lot of different Phase 3 trials over time. And you guys have hinted a potential 50-50 partnership. Where does BioNTech currently stand on the partnership question on 327, and what clinical or commercial capabilities would you be looking at for an external partner?

就在 327 上，我知道過去你們的團隊曾提到針對不同腫瘤類型開發這類藥物的相關成本。當然，默克公司正在談論隨著時間的推移進行許多不同的 3 期試驗。你們暗示了潛在的 50-50 合作關係。BioNTech 目前對 327 合作議題的立場為何？您會為外部合作夥伴尋求哪些臨床或商業能力？

Yes. Thanks, Akash. I'll start with that. So we're proceeding right now on our own. And actually, we think we have the capabilities to execute against 327 in these initial trials that we've started, and that's really the focal point this year.

是的。謝謝，阿卡什。我先從那裡開始。因此我們現在就自行行動。實際上，我們認為在已經開始的初步試驗中，我們有能力針對 327 執行任務，這確實是今年的重點。

So non-small cell lung cancer, small cell lung cancer and triple-negative breast cancer being the first indications, but we are looking at a much broader set of additional indications, including the ADC combinations, as we've alluded to in our prepared remarks. So that's really the focus for 2025.

因此，非小細胞肺癌、小細胞肺癌和三陰性乳癌是首批適應症，但我們正在研究更廣泛的其他適應症，包括 ADC 組合，正如我們在準備好的評論中提到的那樣。所以這確實是 2025 年的重點。

What we have said though is that we recognize that with such a broad potential IO backbone therapy. The combinations with other companies agents could prove useful down the road. And indeed, we have been approached by different companies who are interested in potentially combining with BNT327.

然而，我們已經說過，我們認識到骨幹免疫療法具有如此廣泛的潛力。與其他公司代理商的聯合在未來可能會非常有用。事實上，已經有不同的公司與我們接洽，他們有興趣將其與 BNT327 結合。

And so we are evaluating those potential collaborations and nothing to announce at this point. But I think given the broad applicability, it is plausible and actually probably likely that we'll enter into some combination partnerships over the next 12 to 18 months.

因此，我們正在評估這些潛在的合作，目前還沒有任何消息可以宣布。但我認為，鑑於其廣泛的適用性，我們在未來 12 到 18 個月內建立一些聯合合作夥伴關係是合理的，實際上很有可能。

I won't comment beyond that at this point, but we do think that it's worth -- given the breadth of the program potential that it's -- that it makes sense for us to evaluate all opportunities to potentially speed up and expand the program.

我現在不會對此發表進一步的評論，但我們確實認為，考慮到該計劃的潛力，評估所有可能加速和擴展該計劃的機會是有意義的。

Chris Shibutani, Goldman Sachs.

高盛的 Chris Shibutani。

With your plan for 327, obviously, the scope of opportunity is considerable. And as we think about the other leading player developing Summit Akeso, they're mapping out a pretty broad plan. Can you clarify how you see what you think will be differentiating in your approach.

顯然，有了您的 327 計劃，機會範圍就相當大了。當我們考慮開發 Summit Akeso 的另一家領先公司時，他們正在製定一個相當廣泛的計劃。您能否解釋一下您如何看待您的方法中存在的差異？

I think preliminarily, we noticed that you have maybe further along with TNBC, but is there some strategic overlay, whether it's thinking about PD-L1 agnosticism geographies, something that helps discern how your approach may be differentiated to ultimately also demonstrate differentiated clinical data.

我認為，初步來看，我們注意到您可能在 TNBC 方面取得了進一步進展，但是否存在一些策略性覆蓋，無論是考慮 PD-L1 不可知論地理區域，還是有助於辨別如何區分您的方法，最終也展示差異化的臨床數據。

I can start and Ugur and Ozlem can add. So I think the first point to mention, Chris, is that because we see such a broad potential therapeutic opportunity here for this product in terms of many different tumor indications, also different patient segments within tumor indications, both for PD-1, PD-L1 therapies have been successful, but also potentially in patient segments where PD-1 PD-L1 historically has not been successful.

我可以開始，Ugur 和 Ozlem 可以加入。因此，我認為首先要提到的一點是，克里斯，因為我們看到了該產品在許多不同腫瘤適應症方面具有如此廣泛的潛在治療機會，並且腫瘤適應症內的不同患者群體都對 PD-1、PD-L1 療法取得了成功，但也可能在 PD-1 PD-L1 歷史上未成功的患者群體中取得成功。

Given that potential breadth, we think that the most important element of strategy is actually going to be clinical development strategy and targeting the right patient groups and executing against those initial set of trials.

考慮到潛在的廣度，我們認為策略中最重要的元素實際上是臨床開發策略、瞄準正確的患者群體並針對最初的試驗進行執行。

The initial batch of trials are likely to involve chemotherapy combinations, and you see that with the three indications that we've disclosed so far. But down the road, as we've also mentioned, we think a further angle of differentiation is going to be other combinations, including with ADCs.

首批試驗可能涉及化療組合，從我們迄今揭露的三種適應症可以看出這一點。但從長遠來看，正如我們所提到的，我們認為進一步的區分角度將是其他組合，包括 ADC。

And I think there BioNTech is uniquely situated given the broad portfolio of both ADCs and also cancer vaccines that we have that could enable such novel combinations. I don't know, Ugur, do you want to --

我認為 BioNTech 具有獨特的優勢，因為我們擁有廣泛的 ADC 和癌症疫苗產品組合，可以實現這種新穎的組合。我不知道，Ugur，你想--

No. I guess, just -- it's really about the execution of the piles if you really consider the full spectrum will take many years in multiple indications. So then you revisit what has happened in the I-O also anti-PD-1 treatment -- and this is also process which went and is still ongoing in the last 10 years. And this is something which we expect also for the next generation of an anti-PD-1 blockade with the bispecific antibody.

不。我想，只是——如果你真的考慮到全譜治療需要花費很多年的時間才能在多種適應症中得到體現，那麼這實際上與樁的執行有關。那麼，您再回顧 I-O 和抗 PD-1 治療中發生的事情——這也是過去 10 年一直在進行的過程。這也是我們對下一代雙特異性抗體抗 PD-1 阻斷劑的期望。

So this is something where we see in the next year, the need to start multiple clinical sites in multiple indications, but not only do the trials in combination with standard of care, but also consider combinations with novel compounds that can help to differentiate the efficacy seen by BNT327 alone.

因此，我們認為明年需要在多個適應症中啟動多個臨床試驗點，但不僅要進行與標準治療相結合的試驗，還要考慮與新型化合物相結合，以幫助區分單獨使用 BNT327 所見的療效。

Can I follow up with a quick related question. Are you seeing any issues with enrollment of trials or competing for sites for enrollment of patients?

我可以跟進一個相關的快速問題嗎？您是否發現在試驗招募或病患招募地點競爭方面有任何問題？

We don't see anything specific. I mean you know that clinical trial enrollment in particular, those high medical need indications like non-small cell lung cancer and breast cancer and so on, is generally speaking, very competitive because there is a lot going on, but we don't see any specific effect on our trials and have actually very good enrollment, in particular, into the 327 trials, which seems to be a compound where investigators are very enthusiastic about.

我們沒有看到任何具體的東西。我的意思是，你知道，特別是那些具有高醫療需求的臨床試驗的招募，例如非小細胞肺癌和乳腺癌等，一般來說，競爭非常激烈，因為有很多事情要做，但我們沒有看到對我們的試驗有任何特定的影響，而且實際上招募情況非常好，特別是 327 項試驗，這似乎是研究人員非常熱衷的一種化合物。

Tazeen Ahmad, Bank of America Securities.

Tazeen Ahmad，美國銀行證券。

Can I just ask you what you're expecting the bar for efficacy to need to be for 323 for the endometrial data that you're expecting this year that would be able to support the filing this year. And then related to that, maybe the second part of the question is for Ryan.

我可以問一下您，對於您預計今年能夠支持今年提交申請的子宮內膜數據 323，您認為其有效性標準需要是多少。與此相關，也許問題的第二部分是針對瑞安的。

How are you preparing for the launch of 323 if, in fact, you're able to do so in 2026? And maybe I wanted to follow up on that previous question a few minutes ago about partnership. How are you thinking about building out commercial organization versus waiting to partner.

如果您確實能夠在 2026 年推出 323，那麼您將如何準備呢？也許我想繼續回答幾分鐘前關於合作關係的問題。您如何考慮建立商業組織而不是等待合作？

Yes. Thanks, Tazeen. So on the first question, just to clarify, I think you're asking the efficacy bar for BNT323 in endometrial cancer, correct?

是的。謝謝，Tazeen。因此，關於第一個問題，只是為了澄清一下，我認為您問的是 BNT323 對子宮內膜癌的療效標準​​，對嗎？

Yes.

是的。

Yes. So as you know, endometrial cancer as an indication where patients can be categorized into two and HER2 low tumors. And based on that, we expect efficient efficacies in the range of ADCs that have been evaluated in this indication. It's a single-arm study. The standard of care chemotherapy with a very short PFS and OS.

是的。因此，如您所知，子宮內膜癌作為一種適應症，患者可分為兩種和 HER2 低腫瘤。基於此，我們預期已針對此適應症進行評估的 ADC 範圍將具有有效的療效。這是一項單臂研究。標準治療化療的 PFS 和 OS 非常短。

As you know, the compound receive breakthrough designation in this indication. So we are confident that the results will fulfill the requirements for potential registration.

如您所知，該化合物在此適應症上獲得了突破性進展。因此，我們有信心結果將滿足潛在註冊的要求。

Yes. And to Ugur's point, I mean we've seen within HER2 response rates are around 50%. But increasingly, we're expecting in HER2 to move into the first line. And if we look at the other second-line therapies that are available, including bevacizumab plus chemo, we're seeing response rates far lower than that in terms of standard of care, so in the 20% range.

是的。關於 Ugur 的觀點，我的意思是我們已經看到 HER2 的反應率約為 50%。但我們越來越期待 HER2 進入第一線治療。如果我們看看其他可用的二線療法，包括貝伐單抗加化療，我們會發現其反應率遠低於標準治療，在 20% 左右。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

I know you mentioned you're going to have some 327 Phase 2 data for small cell lung cancer here over the next month or so. I was just wondering if you can help frame expectations there in terms of what you're hoping to see and actually how much data we'll get Will we get anything with respect to PFS, et cetera?

我知道您提到過，在接下來的一個月左右，您將獲得大約 327 個小細胞肺癌第 2 期數據。我只是想知道您是否可以幫助您根據您希望看到的內容以及我們實際上將獲得多少數據來製定期望，我們會獲得有關 PFS 等的任何資訊嗎？

So I think in the first instance, I'll start and Ozlem or Ugur can join. So we've already published some data in small cell lung cancer where we showed response rates in the 70% range or with a combination with chemotherapy. We're expecting that these data sets that are coming are to an extent going to further validate and expand on that and further justify our decision to move aggressively into pivotal trials in small cell.

所以我認為首先我會首發，然後奧茲勒姆或烏古爾可以加入。因此，我們已經發表了一些關於小細胞肺癌的數據，其中顯示治療反應率在 70% 左右或與化療相結合。我們期望這些即將獲得的數據集將在一定程度上進一步驗證和擴展這一點，並進一步證明我們積極進行小型蜂窩關鍵試驗的決定是正確的。

I think one of the unique things here is that we are going to be coming out with both data and first line and also additional data in second line. And so that's is going to build on the previous data sets that we put out there.

我認為這裡的獨特之處之一是我們將同時提供第一行資料以及第二行附加資料。這將以我們之前發布的數據集為基礎。

Yes. And there would be a data report this year, which will, on the one hand, be follow-up and update on an ongoing clinical trial, which has been presented last year. So you will get follow-up data, but also new data from our dose justification clinical trials, which we have initiated.

是的。今年將會有一份數據報告，一方面是去年提出的正在進行的臨床試驗的後續和更新。因此，您不僅會獲得後續數據，還會獲得我們啟動的劑量驗證臨床試驗的新數據。

Harry Gillis, Berenberg.

哈里·吉利斯 (Harry Gillis)，貝倫貝格 (Berenberg)。

Just on the 2025 revenue guidance, you talked about relative stability in vaccination rates, pricing and market share. I was just wondering if you could provide maybe some quantification or details on what those metrics look like at the low and high end of your guidance? And perhaps specifically what you're factoring into your forecast for US vaccination rates and any impacts from Sanofi's commercialization of the --

就在 2025 年的收入指引中，您談到了疫苗接種率、定價和市場份額的相對穩定性。我只是想知道您是否可以提供一些量化資訊或詳細信息，說明這些指標在您的指導下的低端和高端是什麼樣的？也許您在預測美國疫苗接種率時會考慮到哪些因素，以及賽諾菲商業化疫苗會產生哪些影響？--

Yes, thanks very much. Happy to take the question. So of course, as you pointed out, we -- our revenue guidance assumes relatively stable vaccination with some market share as we've seen 2024. We have, though, to include as a company, if you think about prices guidance that we have some write-offs to reflect, product returns write-offs consist out of write-offs of material like we've seen in '24.

是的，非常感謝。很高興回答這個問題。因此，當然，正如您所指出的，我們的收入指導假設疫苗接種相對穩定，並擁有一定的市場份額，正如我們在 2024 年所看到的那樣。不過，作為一家公司，如果你考慮價格指導，我們會反映出一些註銷，產品退貨註銷包括材料註銷，就像我們在 24 年看到的那樣。

We had one. We had KP2 variants and for us, and we had to face some write-offs here because Pfizer was producing it, and we, of course, have to take half of it. So it goes in our gross profit share. That's point number one.

我們有一個。我們有 KP2 變體，對我們來說，我們不得不面臨一些註銷，因為輝瑞正在生產它，當然，我們必須拿走其中的一半。我們的毛利份額也是如此。這是第一點。

The second is that we also took into account some minor price and volume effect in the US in 2025, reflecting a little bit potential competitive pressure here to your point of Sanofi. And thirdly, there is potentially also some risk that the EU is moving a little bit of a volume towards from 2025, contractually towards 2026, they're contractually having the opportunity to do so.

第二，我們也考慮了 2025 年美國的一些輕微的價格和銷售效應，這反映了賽諾菲在這方面面臨的一些潛在競爭壓力。第三，歐盟也可能存在一定的風險，即從 2025 年開始，按照合約規定，歐盟將把排放量稍微向 2026 年靠攏，根據合約規定，他們有機會這樣做。

And to some extent, we also have reflected that. And that explains why we are at the midpoint at this range.

而某種程度上我們也體現了這一點。這也解釋了為什麼我們處於這個範圍的中間點。

Cory Kasimov, Evercore.

科里·卡西莫夫（Cory Kasimov），Evercore。

I wanted to follow up on Terence's question regarding setting the stage for the update later this month at ELCC. Are you able to comment on how much follow-up you will have at the meeting? And what do you see as the appropriate comp at this stage?

我想跟進 Terence 提出的問題，關於為本月稍後在 ELCC 進行的更新做好準備。您能否評論一下此次會議將進行多少後續跟進？您認為現階段合適的補償是什麼？

So we will have PFS data. I cannot say from the top of my head, what would follow up time within this study is that we are even PFS data on our small cell lung cancer slide. And emerging data -- no, median OS, but emerging OS.

因此我們將獲得 PFS 數據。我無法立即說出，這項研究的後續時間是我們小細胞肺癌切片上的 PFS 數據。新興資料－不是中位 OS，而是新興 OS。

Yes. And the -- in terms of the standard of care, it continues to be in the first-line setting, continue to be Tecentriq plus chemotherapy with the benchmark.

是的。就治療標準而言，它仍然處於一線治療狀態，繼續以 Tecentriq 加化療為基準。

POR3 trial as a benchmark of web.

POR3 試用作為網路的基準。

Mohit Bansal, Wells Fargo.

富國銀行的 Mohit Bansal。

This is [Sadia Arman] on for Mohit. So another question on 327. With the competitor expected to read out their OS data in lung cancer later this year, how would you view read-through from those results to 327 in lung cancer?

這是 [Sadia Arman] 為 Mohit 主持的。關於 327 還有另一個問題。預計競爭對手將在今年稍後公佈其肺癌 OS 數據，您如何看待將這些結果讀通到肺癌 327 的數據？

And can you discuss any differences in how you're approaching development, specifically in non-small cell lung cancer from the competitor -- just any differences or similarities that you would highlight?

您能否談談您在開發方法上與競爭對手有何不同，特別是在非小細胞肺癌領域—您能強調哪些差異或相似之處？

Okay. Our lung cancer study is a actually two studies in one study. addressing the complete population of AGA negative first line lung cancer patients. That means the PD-L1 high PD-L1 low and PD-L1 negative population in squamous and nonsquamous patients. Our competitor is pembrolizumab and the treatment group received the BNT327 plus chemotherapy, and endpoints are, as usual, PFS and.

好的。我們的肺癌研究其實是兩項研究合而為一。解決所有 AGA 陰性第一線肺癌患者的問題。這意味著鱗狀和非鱗狀患者中存在 PD-L1 高、PD-L1 低和 PD-L1 陰性族群。我們的競爭對手是 pembrolizumab，治療組接受 BNT327 加化療，終點和往常一樣是 PFS。

Asthika Goonewardene, Truist Securities.

Asthika Goonewardene，Truist 證券公司。

Ozlem, you mentioned that you started recruiting patients with a Phase 2/3 trial in non-small cell lung cancer. Could you give a little bit more color on the size of that Phase 2 cohort. And if you plan on reporting that data and maybe a little bit of guidelines on expectations for enrolling that Phase 2 portion?

Ozlem，您提到您開始招募非小細胞肺癌 2/3 期試驗患者。能否詳細介紹一下第二階段隊列的規模？如果您打算報告該數據，並且可能對第 2 階段的招生預期提供一些指導？

And then related to this, guys, could you maybe comment on the statistical analysis of the study? And I believe you're considering the nonsquamous and squamous population separately, which is different from how your competitors Summit is doing their analysis of HARMONY3. So why do you prefer your method?

然後與此相關，夥計們，你們能否對這項研究的統計分析進行評論？我相信您正在分別考慮非鱗狀細胞癌和鱗狀細胞癌人群，這與您的競爭對手 Summit 對 HARMONY3 的分析方式不同。那麼為什麼您更喜歡自己的方法呢？

So what is the question, the size of our study. There were several questions. I think regarding the non-small cell lung cancer study. As Ugur has pointed out business in principle, like two studies in one because we want to explore in our Phase 2/3, both non-squamous squamous and so small cell lung cancer across all PD-1 status setting. That means with these different patient populations covered.

那麼問題是什麼呢？我們的研究規模是多少。有幾個問題。我認為是關於非小細胞肺癌的研究。正如 Ugur 指出的，原則上，就像兩項研究合而為一，因為我們想在第 2/3 階段探索所有 PD-1 狀態設定中的非鱗狀、鱗狀和小細胞肺癌。這意味著覆蓋不同的患者群體。

We have a center size, which is around 950-plus patients -- and we expect, based on earlier data, we have seen that all these histologies and also different PD-L1 strata can benefit from the BNT327, this is why we have been all covered in our study.

我們的中心規模約為 950 多名患者——根據早期數據，我們預計，所有這些組織學以及不同的 PD-L1 層都可以從 BNT327 中受益，這就是我們在研究中涵蓋所有內容的原因。

And we discussed also all options how to structure this clinical trial, including also having a single big cohort based on the discussion also with the FDA, we decided and to have two indications, particularly with the observations and recently reset in some of the clinical trials, they are nonsmall cell lung cancer and squamous -- non-squamous and squamous did show different type of results for some of the compounds is now more attention on the different sheets.

我們還討論瞭如何構建這項臨床試驗的所有選項，包括根據與 FDA 的討論設立一個大型隊列，我們決定有兩種適應症，特別是根據觀察結果和最近重新設定的一些臨床試驗，它們是非小細胞肺癌和鱗狀細胞癌 - 非鱗狀細胞癌和鱗狀細胞癌確實顯示出不同類型的結果，某些化合物現在在不同表格上引起了更多關注。

Got it. Guys, can I also just double click into this a little bit, please? Because the study, the Phase 2/3 recruiting 980-something patients. What proportion of that target enrollment is specifically for the Phase 2 component.

知道了。夥計們，我可以雙擊一下嗎？因為研究的第2/3階段招募了980多名患者。目標入學人數中有多少比例是專門針對第二階段的？

So Phase 2 component is around 40 patients. The Phase 3 component is 940 something. So I was basically reflecting the Phase 3 component with the center size. And this is equally ditributed across non-squamous and squamous non-small cell lung cancer studies, so to say. We will not as you can imagine, is about further optimizing the dose or justifying the dose. So it's not a technical part of the development.

因此，第二階段約有 40 名患者。第三階段組件有 940 多個。所以我基本上是用中心尺寸來反映第三階段的組成部分。可以這麼說，這在非鱗狀和鱗狀非小細胞肺癌研究中均勻分佈。我們不會像您想像的那樣，進一步優化劑量或證明劑量的合理性。所以它不是開發的技術部分。

Yaron Werber, Cowen.

亞倫·韋伯（Yaron Werber），考恩。

I have a quick question. Actually, I want to maybe shift to the ACIP latest decision not to hold an ACIP, not meeting this time it was flu. Just curious, I know it's early, but how would you handle this? Would you, at the end of the day, with Pfizer just used the World Health Organization recommendation for the COVID strains and I don't know whether you have any communication so far, what to expect.

我有一個簡單的問題。實際上，我可能想轉向 ACIP 的最新決定，不舉行 ACIP，這次因為流感而沒有開會。只是好奇，我知道現在還早，但是你會如何處理這個問題？最後，您是否會與輝瑞公司一起使用世界衛生組織針對 COVID 病毒株的建議？我不知道到目前為止您是否有任何溝通，預計會發生什麼。

Yes. Thanks, Yaron. Not too much to say at this stage.Obviously, we're following very closely to the policy environment for COVID-19 vaccines in the United States. Our expectation is that there will eventually be a strain selected and we're going to be in a position to respond very quickly as we have done over the last couple of years. But I'm afraid that at this point, that's pretty much all we can say.

是的。謝謝，亞倫。目前還不能透露太多。顯然，我們正在密切關注美國的新冠疫苗政策環境。我們的期望是最終會選出一種菌株，並且我們將能夠像過去幾年一樣迅速做出反應。但恐怕目前我們只能說這麼多了。

Jessica Fye, JPMorgan.

潔西卡費伊（Jessica Fye），摩根大通。

So beyond the small cell lung data coming up imminently for 327, can you just take us through what specifically the next 327 data releases will be and where we should look out for them? I realize there's a number of listed on the slide, but it just says 2025-plus.

那麼，除了即將發布的 327 小細胞肺部數據之外，您能否向我們介紹接下來將發布的 327 數據具體是什麼，以及我們應該在哪裡關注它們？我知道幻燈片上列出了很多數字，但上面只說了 2025 年以後。

So the question was about next upcoming BNT327 data after small cell lung cancer. One data package will be TNBC in which we also have a Phase 2 study ongoing and follow-up data on a previous study, which we have presented last year at the San Antonio conference, where we -- you will learn a bit more about further maturing OS.

所以問題是關於小細胞肺癌之後即將發布的 BNT327 數據。一個數據包將是 TNBC，其中我們還有一項正在進行的 2 期研究和之前研究的後續數據，我們去年在聖安東尼奧會議上展示了該研究，在那裡我們將——您將了解更多有關進一步成熟的 OS 的信息。

Additional report could be about other indication cohorts we have with 327, including also the first cohort where we combined with our ADCs, specifically our trial where we combined 327 with 325 or top two ADCs.

附加報告可能涉及我們擁有的 327 的其他適應症隊列，其中還包括我們與 ADC 結合的第一個隊列，特別是我們將 327 與 325 或前兩個 ADC 結合的試驗。

Thank you.

謝謝。