Biontech SE (BNTX) 2025 Q2 法說會逐字稿

Welcome to BioNTech second quarter 2025 earnings call. I would like to hand the call over to Doug Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

歡迎參加 BioNTech 2025 年第二季財報電話會議。我想把電話交給策略和投資人關係副總裁 Doug Maffei。請繼續。

Thank you, operator. Good morning, and good afternoon. Thank you for joining BioNTech's second quarter 2025 earnings call. As a reminder, the slides we will use during this call and the corresponding press release can be found in the investor relations section of our website. On the next slide, you will see our forward-looking statements disclaimer.

謝謝您，接線生。早安，下午好。感謝您參加 BioNTech 2025 年第二季財報電話會議。提醒一下，我們在本次電話會議中使用的幻燈片和相應的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。

Additional information about these statements and other risks are described in our filings with the US Securities and Exchange Commission, or SEC. 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.

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（SEC）提交的文件中。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。

On slide 3, you can find the agenda for today's call. I'm joined by the following members of BioNTech's management team; Ugur Sahin, Chief Executive Officer and Co-Founder; Oezlem Tuereci Chief Medical Officer and Co-Founder; Ramon Zapata, Chief Financial Officer; and Ryan Richardson, Chief Strategy Officer.

在第 3 張投影片上，您可以找到今天電話會議的議程。與我一起參加會議的還有 BioNTech 管理團隊的以下成員：執行長兼聯合創始人 Ugur Sahin、首席醫療官兼聯合創始人 Oezlem Tuereci、財務長 Ramon Zapata 和首席策略長 Ryan Richardson。

With this, I'll hand the call over to Ugur.

這樣，我就把發言權交給烏古爾 (Ugur)。

Thank you, Daug, and a warm welcome to you all as you join us today. Daug joined by BioNTech recently as our new Head of Investor Relations, and I would like to welcome him to the company. As previously announced, Ramon Zapata joined last month as our new Chief Financial Officer and will be speaking on the call today. Ramon is a seasoned financial leader with the breadth of international pharmaceutical experience from companies, including Novartis and Zambon.

謝謝你，Daug，熱情歡迎大家今天加入我們。Daug 最近加入 BioNTech，擔任我們的新投資者關係主管，我歡迎他加入公司。正如之前宣布的那樣，Ramon Zapata 上個月加入我們，擔任新首席財務官，並將在今天的電話會議上發表演講。Ramon 是一位經驗豐富的金融領袖，擁有在諾華和讚邦等公司任職的豐富國際製藥經驗。

Over 25 years of experience, Ramon has a deep understanding of market and business dynamics, resource optimization, and high-performing teams. We are delighted to have Ramon on board and look forward to working together in the coming months and years.

憑藉超過 25 年的經驗，Ramon 對市場和商業動態、資源優化和高效團隊有著深刻的理解。我們很高興 Ramon 加入我們，並期待在未來的幾個月和幾年裡共同努力。

Our long-serving Chief Strategy Officer, Ryan Richardson, will be retire BioNTech in September. I would like to thank Ryan for his many contributions and commitment as we develop BioNTech from a private clinical-stage biotech into a Nasdaq-listed fully integrated biotechnology company. Management Board and I wish Ryan all the best as he embarks on the next chapter of his career. I will now continue with our overarching vision and strategy.

我們長期任職的首席策略長 Ryan Richardson 將於 9 月從 BioNTech 退休。我要感謝 Ryan 的許多貢獻和承諾，我們將 BioNTech 從一家私營臨床階段生物技術公司發展成為納斯達克上市的完全整合的生物技術公司。我和管理委員會祝福 Ryan 在開啟職業生涯的新篇章時一切順利。我現在將繼續闡述我們的整體願景和策略。

As BioNTech has grown and evolved significantly over the years, our vision has remained unchanged to translate science into survival by building an immunotherapy powerhouse and becoming a fully integrated biopharmaceutical company with multiple approved therapies.

BioNTech 多年來不斷發展壯大，但我們的願景始終未變，那就是透過打造免疫療法強國，成為一家擁有多種獲批療法的完全整合的生物製藥公司，將科學轉化為生存之道。

We believe that the future of cancer treatment and the ability to improve cure rates will be driven by combination therapies that combine compounds with the synergistic mechanisms of action. Aligned to our vision, we are working to address the full continuum of cancer across different stages from resective cancers, which are in the adjuvant stage and at risk of recurrence to early-stage metastatic cancers as well as the late-stage cancers, which are refractory to multiple treatments.

我們相信，癌症治療的未來和提高治癒率的能力將由結合化合物和協同作用機制的聯合療法所推動。與我們的願景一致，我們正在努力解決不同階段的癌症的全部問題，從處於輔助階段且有復發風險的切除性癌症到早期轉移性癌症以及對多種治療具有抗藥性的晚期癌症。

We have built a robust pipeline with compounds from different drug classes that are well suited to achieve this across broad range of cancers, allowing for novel combination of next-generation immunomodulators with targeted therapies and mRNA cancer immunotherapy. With a clear focus, we will continue to invest in our technologies and drug candidates that have the potential to improve outcomes for patients across the wide range of tumor types.

我們已經建立了強大的產品線，其中包含來自不同藥物類別的化合物，非常適合在多種癌症中實現這一目標，從而實現下一代免疫調節劑與標靶療法和 mRNA 癌症免疫療法的新型組合。我們將以明確的重點，繼續投資於有可能改善各種腫瘤患者治療結果的技術和候選藥物。

We are focused on two consumer programs: our mRNA cancer immunotherapies, including FixVac and iNeST and our bispecific antibody BNT327 that targets PD-L1 and VEGF-A. Both approaches have disruptive potential and aligns to our vision. We believe these programs could establish new standards of care, enhancing patient outcomes in multiple cancer indications globally. We are investing significantly in the clinical development of this program across various cancer and stages. At the same time, we are building commercial infrastructure to enable future launches in key markets and enhancing manufacturing capabilities to support both clinical trials and commercial success.

我們專注於兩個消費者項目：我們的 mRNA 癌症免疫療法，包括 FixVac 和 iNeST，以及針對 PD-L1 和 VEGF-A 的雙特異性抗體 BNT327。這兩種方法都具有顛覆性的潛力，並且符合我們的願景。我們相信這些項目可以建立新的護理標準，改善全球多種癌症患者的治療效果。我們正在對該計畫針對不同癌症和不同階段的臨床開發進行大量投資。同時，我們正在建立商業基礎設施，以便未來在主要市場推出產品，並增強製造能力，以支持臨床試驗和商業成功。

Moving now to our key achievements from this quarter related to our outline strategy and vision. We believe BNT327 has the potential to become a standard of care treatment across a broad range of tumor types, including those currently treated with checkpoint inhibitors, and those where checkpoint inhibitors have previously not shown benefit.

現在談談本季與我們的概要策略和願景相關的主要成就。我們相信 BNT327 有潛力成為多種腫瘤類型的標準治療方法，包括目前使用檢查點抑制劑治療的腫瘤，以及先前檢查點抑制劑未顯示出益處的腫瘤。

Core to our strategy is developing combinations of BNT327 with a broad range of potentially synergistic therapies. With such combinations, we may be able to improve the safety and efficacy profile, thereby unlocking better clinical outcomes for as many patients as possible in areas of high unmet medical need. Earlier this year, we closed the acquisition of Biotheus, and with that fully integrated BNT327 into our pipeline.

我們策略的核心是開發 BNT327 與多種潛在協同療法的組合。透過這樣的組合，我們或許能夠提高安全性和有效性，從而為醫療需求未滿足的領域中盡可能多的患者帶來更好的臨床結果。今年早些時候，我們完成了對 Biotheus 的收購，並將 BNT327 完全整合到我們的產品線中。

In order to significantly accelerate and broaden its clinical development, we entered into a global 50-50 co-development and co-commercialization collaboration with BMS in June.

為了大幅加速和拓寬其臨床開發，我們在6月與BMS達成了全球50-50的共同開發和共同商業化合作。

Since the announcement, our teams have collaborated closely to shape joint development plans to unlock BNT327's full potential. We believe BNT327 has broad potential to be a next-generation IO backbone. We will continue to drive its clinical development with the goal to establish a new standard of care for cancer patients across multiple tumor types. In the quarter, we also dosed the first patient in a new cohort evaluating our NSCLC FixVac BNT116 in combination with our B7-H3 antibody drug conjugate, BNT324. This is another important source for the company in terms of novel combinations, combining an mRNA cancer immunotherapy with an ADC.

自宣布以來，我們的團隊密切合作，制定聯合開發計劃，以充分發揮 BNT327 的潛力。我們相信 BNT327 具有成為下一代 IO 主幹的廣泛潛力。我們將繼續推動其臨床發展，目標是為多種腫瘤類型的癌症患者建立新的護理標準。本季度，我們也對新隊列中的第一位患者進行了給藥，以評估我們的 NSCLC FixVac BNT116 與 B7-H3 抗體藥物偶聯物 BNT324 的聯合治療。這是該公司在新型組合方面的另一個重要來源，將 mRNA 癌症免疫療法與 ADC 結合。

We see great potential to combine targeted therapies such as ADCs with mRNA cancer immunotherapies. ADCs can debug metastatic tumors and alter the tumor microenvironment and mRNA cancer immunotherapies may be more effective in creating polyfunctional and durable tumor-associated antigen-specific T cell responses once the primary tumor is partially degraded.

我們看到將 ADC 等標靶療法與 mRNA 癌症免疫療法結合具有巨大的潛力。ADC 可以調試轉移性腫瘤並改變腫瘤微環境，一旦原發性腫瘤部分退化，mRNA 癌症免疫療法可能更有效地產生多功能且持久的腫瘤相關抗原特異性 T 細胞反應。

Also in the quarter, we took steps to strengthen mRNA as one of our platform technologies. We announced a strategic transaction to acquire CureVac in a public exchange offer. This planned transaction aims at complementing BioNTech's capabilities and proprietary technologies in mRNA design, delivery formulations and mRNA manufacturing.

本季度，我們也採取措施加強 mRNA 作為我們的平台技術之一。我們宣布了一項策略性交易，透過公開交換要約收購 CureVac。此次計劃中的交易旨在補充 BioNTech 在 mRNA 設計、遞送配方和 mRNA 製造方面的能力和專有技術。

With regard to our COVID-19 vaccine franchise, which is partnered with Pfizer, we are preparing for the global commercial rollout of our new variant-adapted COVID-19 vaccine for the upcoming season, pending regulatory approvals. Data recently presented and shared with regulators globally indicated that LP.8.1 strain adapted COVID-19 vaccines confer improved immune response against currently dominant and emerging sub-lineages compared to vaccine formulations used in the 2024, 2025 vaccination campaigns.

關於我們與輝瑞合作的 COVID-19 疫苗特許經營權，我們正在為即將到來的季節全球商業推出我們的新型變異 COVID-19 疫苗做準備，等待監管部門的批准。最近向全球監管機構提交和共享的數據表明，與 2024 年、2025 年疫苗接種活動中使用的疫苗製劑相比，LP.8.1 株適應的 COVID-19 疫苗可針對當前主要和新出現的亞譜系產生更好的免疫反應。

Lastly, we expanded our partnership with the UK government to broaden our regional R&D activities for innovative medicines with plans to invest up to GBP1 billion over the coming decade. The agreement builds on our existing multiyear collaboration aimed at accelerating clinical trials for personalized mRNA immunotherapies and focuses on establishing two new R&D centers and our London-based UK headquarters. We were able to achieve all this while maintaining a strong financial position.

最後，我們擴大了與英國政府的合作夥伴關係，以拓展我們在創新藥物領域的區域研發活動，並計劃在未來十年內投資高達 10 億英鎊。該協議以我們現有的多年合作為基礎，旨在加速個人化 mRNA 免疫療法的臨床試驗，並專注於建立兩個新的研發中心和位於倫敦的英國總部。我們在保持強勁財務狀況的同時實現了所有這些目標。

Leveraging our COVID-19 vaccine business and our [fortress] balance sheet, we will continue to invest significantly in the clinical development of our priority oncology programs across key tumor indications. Now coming to our recent landmark collaboration with BMS. We aim to establish BNT327 broadly as a new standard of care across multiple tumor types. We are currently advancing BNT327 across more than 10 indications, including two global registrational trials with more planned.

利用我們的 COVID-19 疫苗業務和我們的[堡壘]資產負債表，我們將繼續對關鍵腫瘤適應症的優先腫瘤學計畫的臨床開發進行大量投資。現在來談談我們最近與 BMS 的具有里程碑意義的合作。我們的目標是將 BNT327 廣泛確立為多種腫瘤類型的新治療標準。我們目前正在推動 BNT327 的 10 多種適應症研究，其中包括兩項全球註冊試驗，並計劃進行更多試驗。

Our early conviction around this modality and BNT327 has put us in a strong position. And if approved, we aim to be the first or second to launch in a number of indications to help patients in need. Our collaboration with BMS aims to strengthen both companies' position in oncology. Our decision to partner reflects our belief in the transformative potential of BNT327. In recent years, we have built out our capabilities to support the development and planned commercialization of our growing oncology pipeline.

我們對這種方式和 BNT327 的早期信念使我們處於有利地位。如果獲得批准，我們的目標是成為第一家或第二家在多個適應症上推出該藥物的公司，以幫助有需要的患者。我們與 BMS 的合作旨在加強兩家公司在腫瘤學領域的地位。我們決定合作反映了我們對 BNT327 變革潛力的信心。近年來，我們不斷增強能力，以支持我們不斷增長的腫瘤學產品線的開發和計劃商業化。

To support this growth, we have established a global clinical development organization, international clinical manufacturing capabilities, and have begun to establish a commercial organization.

為了支持這一成長，我們建立了全球臨床開發組織、國際臨床製造能力，並已開始建立商業組織。

Today, we are closer to the goal becoming a multi-product global oncology company and see this partnership as supporting that transition. With BMS deep immuno-oncology expertise, market presence, commercial capabilities, and global reach, they are the ideal partner for us and this asset. We also see commonality in their science-led approach and focus on shaping the oncology market through novel modalities and combinations. We have a clear shared vision in this regard, and I look forward to our companies working closely together.

今天，我們距離成為多產品全球腫瘤學公司的目標更近了一步，並將此次合作視為對這一轉變的支持。憑藉 BMS 深厚的免疫腫瘤學專業知識、市場影響力、商業能力和全球影響力，他們是我們和這項資產的理想合作夥伴。我們也看到他們在科學主導方法上的共同點，並專注於透過新穎的方式和組合來塑造腫瘤學市場。我們在這方面有著明確的共同願景，我期待我們兩家公司能夠密切合作。

I will now turn the call over to Oezlem to provide more details on select clinical programs.

現在我將把電話轉給 Oezlem，讓他提供有關精選臨床項目的更多詳細資訊。

Thank you, Ugur. I'm glad to be speaking with everyone today. Let me start by highlighting where we stand with the programs that are in our pipeline, with our PD-L1 GFA bispecific antibody BNT327, we have initiated two global trials in first line small cell and non-small cell lung cancer.

謝謝你，烏古爾。我很高興今天能和大家交談。首先，我要強調我們正在進行的計畫的現狀，利用我們的 PD-L1 GFA 雙特異性抗體 BNT327，我們已經啟動了針對一線小細胞和非小細胞肺癌的兩項全球試驗。

And we expect to start a third Phase III in first-line triple negative breast cancer later this year. We aim to further accelerate and expand the BNT327 development with a strategic partnership with Bristol-Myers Squibb.

我們預計今年稍後啟動一線三陰性乳癌的第三階段研究。我們旨在透過與百時美施貴寶建立戰略合作夥伴關係，進一步加速和擴大 BNT327 的開發。

For our mRNA cancer immunotherapies, including FixVac and iNeST, we anticipate sharing clinical updates in late 2025 and early 2026. As we look towards becoming a commercial oncology company, we are advancing toward our first oncology BLA submission with BNT323, our HER2 ADC in HER2-expressing second-line endometrial cancer. BNT327 localizes the blockade of PD-L1 and VEGF-A signaling to the tumor.

對於我們的 mRNA 癌症免疫療法，包括 FixVac 和 iNeST，我們預計將在 2025 年底和 2026 年初分享臨床更新。我們立志成為一家商業腫瘤學公司，我們正在推進我們的第一個腫瘤學 BLA 提交，其中 BNT323 是我們針對 HER2 表達的二線子宮內膜癌的 HER2 ADC。BNT327 定位阻斷 PD-L1 和 VEGF-A 訊號至腫瘤。

This bispecific is designed to deliver superior antitumor immune modulatory and anti-angiogenic effects compared to the combination of the two individual antibodies and with the potential to minimize adverse events associated with systemic anti-VEGF-A therapy. We now have data from over 1,200 patients, which show signals of single agent and combination anti-tumor activity across tumor types where checkpoint inhibitors are and are not effective.

與兩種單獨抗體的組合相比，這種雙特異性抗體旨在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抗 VEGF-A 治療相關的不良事件。我們目前擁有來自 1,200 多名患者的數據，這些數據顯示了檢查點抑制劑對各種腫瘤類型有效和無效的單一藥物和聯合抗腫瘤活性訊號。

Additionally, we have observed a manageable safety and tolerability profile at multiple dose levels with low rates of high-grade treatment-related adverse events. We have also seen low rates of high-grade adverse events typically observed with VEGF-A targeted therapies. In totality, the clinical data generated to date further strengthen our conviction in this asset and allow us to make informed and robust decision for our clinical development strategy. With this clinical database for BNT327 and with the anti-PD-L1 and anti-VEGF-A mechanism, having been evaluated and validated across numerous tumor types and in some cases, in combination with each other, we have a clear road map for development.

此外，我們觀察到多種劑量等級的可控安全性和耐受性特徵，且高階治療相關不良事件發生率較低。我們也發現，VEGF-A 標靶治療中常見的高階不良事件發生率較低。總體而言，迄今為止產生的臨床數據進一步增強了我們對這項資產的信心，並使我們能夠為臨床發展策略做出明智而穩健的決策。憑藉 BNT327 的臨床資料庫以及抗 PD-L1 和抗 VEGF-A 機制，我們已經在多種腫瘤類型中進行了評估和驗證，並且在某些情況下相互結合，因此我們擁有清晰的發展路線圖。

We aim to develop BNT327 in tumor types where checkpoint inhibitors have been successful for only a group of patients and also in tumor types where checkpoint inhibitors have not yet been successful in improving patient outcomes.

我們的目標是針對檢查點抑制劑僅對一組患者成功的腫瘤類型以及檢查點抑制劑尚未成功改善患者預後的腫瘤類型開發 BNT327。

We are pursuing a three-wave development strategy that we refer to as Establish, Combine, Broaden. We believe that this approach positions us to expand the therapeutic impact across a broader oncology landscape and realize the full potential of this asset. In the last quarter, we have continued to progress in executing this strategy.

我們正在推行「建立、結合、拓展」三波發展策略。我們相信，這種方法使我們能夠擴大在更廣泛的腫瘤學領域的治療影響，並充分發揮這項資產的潛力。上個季度，我們在執行這項策略方面繼續取得進展。

With our first wave of development, we aim to establish BNT327 combined with chemotherapy as a new standard of care for three key priority indications: small cell lung cancer, non-small cell lung cancer and triple-negative breast cancer. This first wave leverages clinical data from multiple Phase I and Phase II clinical trials generated and published in the last 12 months.

透過第一波開發，我們旨在將 BNT327 與化療結合，作為三大關鍵優先適應症的新治療標準：小細胞肺癌、非小細胞肺癌和三陰性乳癌。第一波利用了過去 12 個月內產生和發布的多個 I 期和 II 期臨床試驗的臨床數據。

These data have encouraged us to start multiple registrational studies in these indications. Our two global pivotal studies for BNT327 are progressing. The first ROSETTA Lung-01 is evaluating BNT327 in combination with chemotherapy versus atezolizumab in combination with chemotherapy as a first-line treatment of patients with extensive stage small-cell lung cancer.

這些數據鼓勵我們在這些適應症上進行多項註冊研究。我們針對 BNT327 的兩項全球關鍵研究正在取得進展。首個 ROSETTA Lung-01 正在評估 BNT327 合併化療與阿特珠單抗合併化療作為廣泛期小細胞肺癌患者的第一線治療。

The second, ROSETTA Lung-02 is evaluating BNT327 in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as a first-line treatment of patients with squamous or non-squamous non-small cell lung cancer regardless of PD-L1 status. We also plan to start a Phase III trial, ROSETTA Breast-01 in first-line triple-negative breast cancer later this year. The high medical need in these three indications and the clinical data we have seen so far in these tumor types are the reason for choosing these first indications. Extensive stage small cell lung cancer is an immunologically cold tumor for which high unmet need remains.

第二項研究 ROSETTA Lung-02 正在評估 BNT327 聯合化療與 pembrolizumab 聯合化療作為鱗狀或非鱗狀非小細胞肺癌患者的一線治療，無論 PD-L1 狀態如何。我們也計劃在今年稍後啟動針對第一線三陰性乳癌的 III 期試驗 ROSETTA Breast-01。這三種適應症的高醫療需求以及我們迄今為止在這些腫瘤類型中看到的臨床數據是選擇這些第一批適應症的原因。廣泛期小細胞肺癌是一種免疫冷性腫瘤，仍存在很大的未滿足需求。

Today, these patients are treated with a combination of atezolizumab and chemotherapy and experienced a median overall survival of 12.3 months as observed in the EMPOWER-1 Phase III clinical trial. Based on our emerging data, we believe that BNT327 has the potential to improve clinical outcomes for patients with small cell lung cancer.

如今，這些患者接受阿替利珠單抗和化療聯合治療，EMPOWER-1 III 期臨床試驗觀察到患者中位總存活期為 12.3 個月。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。

Earlier this year, at the European Lung Cancer Congress, we disclosed interim data from a Phase II clinical trial evaluating BNT327 in combination with chemotherapy as a first-line treatment for patients with extensive stage small-cell lung cancer. Beyond the encouraging response rate and median progression-free survival observed, the ELCC data also included for the first time, median overall survival data with a median overall survival of 16.8 months. While these data are still immature, we are encouraged by the findings.

今年早些時候，在歐洲肺癌大會上，我們披露了 II 期臨床試驗的中期數據，該試驗評估了 BNT327 聯合化療作為廣泛期小細胞肺癌患者一線治療的效果。除了令人鼓舞的反應率和觀察到的中位無惡化存活期之外，ELCC 數據還首次包括中位總體存活期數據，中位總體存活期為 16.8 個月。雖然這些數據還不成熟，但我們對這些發現感到鼓舞。

These data support our decision to evaluate BNT327 in combination with chemotherapy in the ongoing global randomized Phase III clinical trial with ROSETTA Lung-01. In the last quarter, we completed enrollment in the global Phase II dose optimization trial evaluating BNT327 in combination with chemotherapy in patients with untreated extensive stage small cell lung cancer and in patients with small cell lung cancer that progressed after first or second-line treatment, and we'll provide a data update from this clinical trial later this year. Another priority indication is non-small cell lung cancer as it's one of the most prevalent cancers globally.

這些數據支持我們決定在與 ROSETTA Lung-01 進行的全球隨機 III 期臨床試驗中評估 BNT327 與化療的聯合作用。上個季度，我們完成了全球 II 期劑量優化試驗的招募，該試驗評估了 BNT327 聯合化療對未經治療的廣泛期小細胞肺癌患者以及一線或二線治療後病情進展的小細胞肺癌患者的療效，我們將在今年晚些時候提供該臨床試驗的數據更新。另一個優先適應症是非小細胞肺癌，因為它是全球最常見的癌症之一。

Long-term outcomes depend on PD-L1 status and histology, but overall remain poor despite improvements in care by checkpoint inhibitors. At the ASCO Annual Meeting last year, we presented data from the Phase I trial evaluating BNT327 as a monotherapy first-line treatment in metastatic PD-L1 positive non-small cell lung cancer.

長期結果取決於 PD-L1 狀態和組織學，但儘管檢查點抑制劑改善了治療效果，但整體仍然較差。在去年的 ASCO 年會上，我們展示了評估 BNT327 作為轉移性 PD-L1 陽性非小細胞肺癌單一療法一線治療的 I 期試驗數據。

BNT327 monotherapy indicated encouraging anti-tumor activity across PD-L1 low and high tumors and manageable safety in this patient population. These data support our decision to start ROSETTA Lung-02, our global Phase III trial that evaluates BNT327 in combination with chemotherapy to improve on survival outcomes when compared to standard of care pembrolizumab in combination with chemotherapy as a first-line therapy for non-small cell lung cancer patients without actionable genomic alterations.

BNT327 單一療法在 PD-L1 低和高腫瘤中顯示出令人鼓舞的抗腫瘤活性，並且在該患者群體中具有可控的安全性。這些數據支持我們啟動 ROSETTA Lung-02 的決定，這是我們的全球 III 期試驗，該試驗評估了 BNT327 與化療聯合治療作為無可操作基因組改變的非小細胞肺癌患者的一線治療，與標準治療 pembrolizumab 與化療聯合治療相比，在改善生存結果方面的作用。

Today, we are enrolling patients in the Phase II part and expect to progress to the Phase III part later this year. Triple-negative breast cancer is also a priority indication for BNT327 based on the unmet need we see for patients and based on the clinical profile observed to date. Currently, Stage IV patients depending on their PD-L1 status are either treated with checkpoint inhibitor in combination with chemotherapy or with chemotherapy alone. PD-L1 positive patients have a median overall survival of 23 months, while PD-L1 negative patients have a median overall survival of 15.2 months as observed in the KEYNOTE-355 study. Data from a study in first-line metastatic triple-negative breast cancer showed that BNT327 in combination with chemotherapy has an encouragingly high objective response rate irrespective of PD-L1 status.

今天，我們正在招募第二階段的患者，預計今年稍後將進入第三階段。根據我們看到的患者未滿足的需求以及迄今為止觀察到的臨床情況，三陰性乳癌也是 BNT327 的優先適應症。目前，IV 期患者根據其 PD-L1 狀態可選擇使用檢查點抑制劑合併化療治療，或單獨使用化療治療。KEYNOTE-355 研究觀察到，PD-L1 陽性患者的中位總存活期為 23 個月，而 PD-L1 陰性患者的中位總存活期為 15.2 個月。一線轉移性三陰性乳癌研究數據顯示，無論 PD-L1 狀態如何，BNT327 合併化療均具有令人鼓舞的高客觀緩解率。

We also observed in the trial encouraging landmark overall survival rates such as 69.7% at 18 months for BNT327 in this setting, suggesting that effective control of disease can translate into improved overall survival.

我們也在試驗中觀察到令人鼓舞的里程碑式整體存活率，例如 BNT327 在這種情況下 18 個月的整體存活率達到 69.7%，這表明有效控制疾病可以轉化為提高整體存活率。

Based on these data, we plan to start a Phase III trial later this year in the first-line setting. We have also continued enrollment in our global Phase II dose optimization trial evaluating BNT327 in combination with chemotherapy in the first- and second-line treatment of patients with locally advanced or metastatic triple-negative breast cancer.

基於這些數據，我們計劃在今年稍後開始一線治療的 III 期試驗。我們也持續招募全球 II 期劑量優化試驗的患者，評估 BNT327 合併化療在局部晚期或轉移性三陰性乳癌患者的第一線和二線治療中的作用。

We plan to share data also from the Phase II trial at a medical meeting later this year. Our second wave of development with BNT327 reflects that IO plus ADC combos are an emerging treatment paradigm in oncology. We have started exploring combinations of BNT327 with our ADCs directed against TROP2, HER2 and B7-H3 from our partnerships with Duality informed by a robust database of single-agent data for these ADCs.

我們計劃在今年稍後的醫學會議上分享第二階段試驗的數據。我們對 BNT327 的第二波開發反映了 IO 加 ADC 組合是腫瘤學中新興的治療模式。我們已開始探索將 BNT327 與針對 TROP2、HER2 和 B7-H3 的 ADC 進行組合，這些 ADC 是由我們與 Duality 合作開發的，並由這些 ADC 的單一藥劑資料組成的強大資料庫提供資訊。

In the second quarter, we dosed the first patients in two new BNT327 ADC combination studies. The first is a Phase I/II clinical trial that is evaluating BNT327 in combination with BNT323, our HER2-targeted ADC in HR-positive and negative HER2 low and ultra-low metastatic breast cancer patients. The second is a Phase II clinical trial that is evaluating BNT327 in combination with BNT324, our B7-H3 ADC in multiple types of lung cancer, including non-small cell and small cell lung cancer patients, patients with known actionable genomic alterations and across treatment lines.

在第二季度，我們在兩項新的 BNT327 ADC 組合研究中對首批患者進行了給藥。第一項是 I/II 期臨床試驗，評估 BNT327 與 BNT323（我們的 HER2 標靶 ADC）聯合治療 HR 陽性和陰性 HER2 低轉移性和超低轉移性乳癌患者的療效。第二項是 II 期臨床試驗，正在評估 BNT327 與 BNT324（我們的 B7-H3 ADC）聯合治療多種類型肺癌的療效，包括非小細胞和小細胞肺癌患者、已知可操作基因組改變的患者以及跨治療線的患者。

In July, we also dosed the first patient in another Phase II trial that is evaluating BNT327 in combination with our B7-H3 ADC in additional tumor types, including hepatocellular carcinoma, cervical cancer, melanoma and head and neck squamous cell carcinoma.

7 月，我們也對另一項 II 期試驗的第一位患者進行了給藥，該試驗正在評估 BNT327 與我們的 B7-H3 ADC 聯合治療其他腫瘤類型，包括肝細胞癌、子宮頸癌、黑色素瘤和頭頸部鱗狀細胞癌。

Later this year, we plan to initiate our first clinical trial evaluating BNT327 in combination with BNT326, our HER3 targeted ADC. The first BNT327 ADC combination trial evaluating BNT327 in combination with BNT325, our TROP2 ADC in multiple tumor types was initiated a few months ago, and we are starting to get initial data.

今年晚些時候，我們計劃啟動首次臨床試驗，評估 BNT327 與 BNT326（我們的 HER3 標靶 ADC）的聯合作用。第一個 BNT327 ADC 組合試驗評估了 BNT327 與 BNT325（我們的 TROP2 ADC 在多種腫瘤類型中的組合）的組合，該試驗已於幾個月前啟動，我們開始獲得初步數據。

At the AACR Annual Meeting earlier this year, we demonstrated that when dosed in combination, BNT327 and our TROP2 ADC demonstrated superior antitumor effects preclinically compared to each drug alone. Our preliminary clinical data in a still small sample size suggests that BNT327 plus BNT325 had a manageable safety profile with few overlapping toxicities and clinically meaningful activity. These data provide the first early support for our ambition to combine BNT327 and ADCs with the aim of replacing the chemotherapy in some treatment regimens.

在今年稍早的 AACR 年會上，我們證明，BNT327 和我們的 TROP2 ADC 聯合使用時，與單獨使用每種藥物相比，在臨床前表現出更優異的抗腫瘤作用。我們在仍較小樣本量中獲得的初步臨床數據表明，BNT327 加 BNT325 具有可控的安全性，幾乎沒有重疊毒性和具有臨床意義的活性。這些數據為我們將 BNT327 與 ADC 結合起來以取代某些治療方案中的化療的目標提供了初步的早期支持。

We believe that combination regimens in which traditional chemotherapy is replaced by targeted chemotherapy in the form of ADCs may be more tolerable and potentially more efficacious, especially when those regimens are combining through synergistic approaches. Over the coming 12 to 18 months, we will gather preliminary clinical data from the signal-seeking BNT327 ADC combination clinical trials to help us define which ADC combinations in which indications to prioritize for late-stage development. The last wave of our [freeway] strategy aims at further broadening our global clinical development program with BNT327 through additional novel combinations and across additional tumor types. We anticipate that some of the early studies evaluating novel combinations or evaluating new tumor types will begin this year.

我們相信，以 ADC 形式的標靶化療取代傳統化療的聯合方案可能更容易耐受，並且可能更有效，尤其是當這些方案透過協同方法結合時。在未來的 12 到 18 個月內，我們將從尋求訊號的 BNT327 ADC 組合臨床試驗中收集初步臨床數據，以幫助我們確定在哪些適應症中優先考慮哪些 ADC 組合進行後期開發。我們的[高速公路]策略的最後一波旨在透過額外的新組合和跨越額外的腫瘤類型，進一步擴大我們的 BNT327 全球臨床開發計劃。我們預計，一些評估新組合或評估新腫瘤類型的早期研究將於今年開始。

One clinical trial, which we anticipate will begin soon is a Phase I/II clinical trial evaluating BNT327 in combination with the bispecific we are developing with our partner, Genmab, that targets both EpCAM and 4-1BB in metastatic colorectal cancer patients. EpCAM is highly expressed in colorectal cancer. The other arm of the molecule is a potent 4-1BB agonist. When activated 4-1BB signaling promotes T cell activity and survival. We are excited to bring this and other novel combinations into the clinic soon, and we look forward to updating you on these trials and their rationale as we move forward.

我們預計很快就會開始的一項臨床試驗是 I/II 期臨床試驗，該試驗將評估 BNT327 與我們與合作夥伴 Genmab 共同開發的雙特異性藥物的結合效果，該試驗針對轉移性結直腸癌患者的 EpCAM 和 4-1BB。EpCAM在大腸直腸癌中高度表現。分子的另一臂是強效的 4-1BB 激動劑。當活化時，4-1BB 訊號會促進 T 細胞活性和存活。我們很高興能很快將這種療法和其他新穎的組合帶入臨床，並且我們期待在未來向您通報這些試驗及其基本原理。

As demonstrated in these 3 ways, we have broad ambitions for BNT327 development that we continue to pursue with focus. Along with our partner, BMS, we feel uniquely positioned to fully leverage the complete breadth of potential of this molecule. We will work expeditiously to execute the next global registrational trials and accelerate bringing BNT327 to market in multiple areas.

正如這三種方式所顯示的，我們對 BNT327 開發抱持著遠大的抱負，並將繼續專注地追求。與我們的合作夥伴 BMS 一起，我們感到自己擁有獨特的優勢，可以充分利用這種分子的全部潛力。我們將盡快進行下一步全球註冊試驗，並加速將 BNT327 推向多個地區的市場。

Moving now to our mRNA cancer immunotherapy platform, which is the other cornerstone of our oncology strategy and includes iNeST and FixVac. Autogene cevumeran, also known as BNT122, developed in partnership with Genentech, is based on the iNeST platform. iNeST targets neoantigens, which are unique tumor-specific mutations and is manufactured on demand for each individual patient. We believe this approach to be best suited for the early stage, including adjuvant setting. FixVac in contrast targets shared non-mutated tumor antigens and is an off-the-shelf approach in combination with checkpoint immunotherapy.

現在轉到我們的 mRNA 癌症免疫治療平台，這是我們腫瘤學策略的另一個基石，包括 iNeST 和 FixVac。Autogene cevumeran，也稱為 BNT122，是與 Genentech 合作開發的，基於 iNeST 平台。 iNeST 針對新抗原，新抗原是獨特的腫瘤特異性突變，可根據每位患者的需求生產。我們相信這種方法最適合早期階段，包括輔助治療。相較之下，FixVac 針對的是共享的非突變腫瘤抗原，是與檢查點免疫療法結合的現成方法。

We believe that these programs have pan-tumor potential and could be combined with different modalities to address large patient populations with high unmet medical need. While our robust clinical development program continues for our whole mRNA cancer immunotherapy pipeline, we look forward to providing data updates from our trials later in late 2025 and 2026.

我們相信這些項目具有泛腫瘤潛力，並且可以與不同的方式結合，以滿足大量未滿足醫療需求的患者群體。雖然我們針對整個 mRNA 癌症免疫療法管線繼續進行強有力的臨床開發計劃，但我們期待在 2025 年底和 2026 年提供試驗數據更新。

While we are evaluating our mRNA cancer immunotherapies with approved checkpoint inhibitors or chemotherapy, we consider our mRNA cancer immunotherapies is ideal for novel-novel combinations and partners for both our immune modulators and our targeted therapies. We are excited to have recently dosed the first patient in an exploratory cohort evaluating our non-small cell lung cancer FixVac, BNT116 and our B7-H3 targeted ADC and anticipate dosing the first patient in the exploratory cohort with our HER3 targeted ADC soon. Given they are available off the shelf, we believe that our FixVac candidates are uniquely positioned as combination partners in the metastatic setting when patients do not have time to wait for fully personalized approaches.

雖然我們正在將我們的 mRNA 癌症免疫療法與已批准的檢查點抑制劑或化學療法進行評估，但我們認為我們的 mRNA 癌症免疫療法非常適合新型組合，並且是我們的免疫調節劑和標靶療法的合作夥伴。我們很高興最近為評估我們的非小細胞肺癌 FixVac、BNT116 和 B7-H3 靶向 ADC 的探索性隊列中的第一位患者進行了給藥，並預計很快將為探索性隊列中的第一位患者進行 HER3 靶向 ADC 的給藥。鑑於它們是現成的，我們相信我們的 FixVac 候選藥物在轉移性環境中具有獨特的優勢，可以作為組合合作夥伴，當患者沒有時間等待完全個人化的治療方法時。

Turning to the 2025 data update. Earlier this year, we announced that we received data from a Phase II trial evaluating our individualized RNA immunotherapy Autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone as a first-line treatment for patients with metastatic or advanced melanoma. The trial did not meet its primary endpoint of a statistically significant improvement in progression-free survival in this advanced patient population. However, we did observe a numerical trend favoring the combination arm in overall survival. We will be presenting the top line data from this trial at the upcoming ESMO Congress in October.

轉向2025年數​​據更新。今年早些時候，我們宣布收到了 II 期試驗的數據，該試驗評估了我們的個體化 RNA 免疫療法 Autogene cevumeran 與 pembrolizumab 聯合使用與單獨使用 pembrolizumab 作為轉移性或晚期黑色素瘤患者的一線治療效果。該試驗並未達到其主要終點，即在該晚期患者群體中實現無進展生存期的統計學上顯著改善。然而，我們確實觀察到了聯合治療組在整體存活率方面更有利的數值趨勢。我們將在十月即將舉行的 ESMO 大會上展示此次試驗的重要數據。

We believe that these data support our view that our fully individualized mRNA cancer immunotherapies are best positioned in earlier settings, such as adjuvant treatment regimen.

我們相信這些數據支持我們的觀點，即我們完全個人化的 mRNA 癌症免疫療法最適合用於早期治療，例如輔助治療方案。

In early settings, tumor mass is low, resistance and immune suppression mechanisms have not been established and the immune system is much healthier. And this is where all three of our current Phase II clinical trials are positioned. Last year, we announced that our FixVac candidate for melanoma, BNT111, met the primary endpoint in a randomized Phase II trial evaluating BNT111 in combination with cemiplimab and also assessing both antibodies alone in patients with anti-PD-1 relapsed or refractory melanoma. We will also be presenting these data at the upcoming ESMO Congress, and we will discuss the path forward for this program around then.

在早期，腫瘤質量較低，抵抗力和免疫抑制機制尚未建立，免疫系統更健康。這也是我們目前所有三項 II 期臨床試驗的定位。去年，我們宣布，我們的 FixVac 黑色素瘤候選藥物 BNT111 在一項隨機 II 期試驗中達到了主要終點，該試驗評估了 BNT111 與 cemiplimab 的聯合作用，並評估了抗 PD-1 復發或難治性黑色素瘤患者單獨使用這兩種抗體的效果。我們還將在即將舉行的 ESMO 大會上展示這些數據，並討論該計劃的未來發展方向。

Next, a data update from a cohort evaluating our non-small cell lung cancer FixVac, BNT116, in combination with cemiplimab as treatment for patients with unresectable Stage 3 non-small cell lung cancer after receiving concurrent chemo radiotherapy will be provided at the 2025 World Conference on Lung Cancer in September. We continue to generate clinical data for BNT116 in multiple non-small cell lung cancer treatment settings, demonstrating the broad potential of our FixVac approach.

接下來，我們將在 9 月舉行的 2025 年世界肺癌大會上提供一組隊列數據更新，該隊列評估我們的非小細胞肺癌 FixVac、BNT116 與 cemiplimab 聯合治療接受同步化放療後無法切除的 3 期非小細胞肺癌患者。我們繼續在多種非小細胞肺癌治療環境中產生 BNT116 的臨床數據，證明了我們的 FixVac 方法的廣泛潛力。

To conclude, we remain as strongly convinced as ever that our combination-based approach offers the potential to positively impact the future outcomes for patients in key indications such as in breast and lung cancer.

總而言之，我們仍然堅信，我們的組合療法有可能對乳癌和肺癌等關鍵適應症患者的未來結果產生積極影響。

With that, I will now pass the presentation to our CFO, Ramon Zapata.

現在，我將把簡報交給我們的財務長 Ramon Zapata。

Thank you, Ozlem. It's an honor to be here today for my first earnings call as BioNTech's Chief Financial Officer. Since joining, I've had the opportunity to meet many of our talented teams. I look forward to working with them and the Management Board to accelerate our common vision, which Ugur and Ozlem just walked us through.

謝謝你，奧茲勒姆。今天我很榮幸能夠以 BioNTech 財務長的身份來參加我的第一次財報電話會議。自從加入以來，我有機會認識我們許多才華橫溢的團隊。我期待與他們和管理委員會合作，加速實現我們的共同願景，Ugur 和 Ozlem 剛剛向我們介紹了這個願景。

As BioNTech navigates its transition towards becoming a multiproduct company in the oncology field, I will focus on driving sustainable organizational excellence and global execution in financial reporting, accounting, tax, treasury, and purchasing with the aim of furthering cost-effective value generation. As part of my responsibilities, I'm also looking forward to collaborating with Doug, our new Head of Investor Relations. Together, we are serving as your primary points of contact, and I hope to meet many of you in the coming weeks.

隨著 BioNTech 向腫瘤學領域的多產品公司轉型，我將專注於推動財務報告、會計、稅務、財務和採購方面的永續組織卓越和全球執行，以進一步實現具有成本效益的價值創造。作為我職責的一部分，我還期待與我們新投資者關係主管 Doug 合作。我們共同作為你們的主要聯絡點，我希望在接下來的幾週內與你們中的許多人見面。

With that, I will now cover our financial results for the second quarter of 2025. For the three months ended June 30, 2025, our total revenues reached approximately EUR261 million compared to EUR129 million for the second quarter of 2024. The increase compared to the second quarter of 2024 is mainly driven by higher revenues derived from our COVID-19 vaccine collaboration.

現在我將介紹我們 2025 年第二季的財務表現。截至 2025 年 6 月 30 日的三個月，我們的總營收達到約 2.61 億歐元，而 2024 年第二季為 1.29 億歐元。與 2024 年第二季相比的成長主要得益於我們 COVID-19 疫苗合作帶來的收入增加。

In addition, parts of our total revenues were also derived from a pandemic preparedness agreement with the German government, and from a onetime effect associated with Pfizer's opt-out from the development of our shingles program. Research and development expenses were approximately EUR509 million for the second quarter of 2025 compared to approximately EUR585 million for the comparative prior year period. The decrease was mainly driven by the reprioritization of clinical trials towards focused programs.

此外，我們的部分總收入也來自德國政府達成的流行病防範協議，以及輝瑞退出帶狀皰疹計畫開發所產生的一次性影響。2025 年第二季研發費用約 5.09 億歐元，去年同期約 5.85 億歐元。下降的主要原因是臨床試驗重新調整至重點項目。

SG&A expense amounted to approximately EUR138 million in the second quarter of 2025 compared to EUR184 million in the comparative prior year period. The decrease was primarily driven by a reduction in external services.

2025 年第二季銷售、一般及行政費用約為 1.38 億歐元，去年同期為 1.84 億歐元。下降的主要原因是外部服務的減少。

For the second quarter of 2025, we reported a net loss of EUR387 million compared to a net loss of EUR808 million for the comparative prior year period. Our basic and diluted loss per share for the second quarter of 2025 was EUR1.60 compared to a basic and diluted loss per share of EUR3.36 for the comparative prior year period. During the quarter, we maintained our strong financial position with EUR16 billion in cash plus security investments. This strategic cash reserve and robust financial position provides us the flexibility to fully pursue our long-term strategy in the coming years.

2025 年第二季度，我們報告淨虧損 3.87 億歐元，而去年同期淨虧損 8.08 億歐元。2025 年第二季度，我們的每股基本虧損和稀釋虧損為 1.60 歐元，而去年同期的每股基本虧損和稀釋虧損為 3.36 歐元。本季度，我們保持了強勁的財務狀況，擁有 160 億歐元的現金和證券投資。這種策略性現金儲備和穩健的財務狀況為我們提供了靈活性，可以在未來幾年全面推行我們的長期策略。

As part of that strategy, we will continue to invest in the development of our immunomodulator and individualized therapies and in the build-out of the manufacturing capacities and capabilities to support additional late-stage trials and commercialization of our growing oncology portfolio. To create long-term value, we aim to advance our clinical programs fast, responsibly and cost efficiently towards potential registration. And with that all in mind, I would like to guide you through what we anticipate to be the financial effects of the collaboration with BMS.

作為該策略的一部分，我們將繼續投資於免疫調節劑和個人化療法的開發，並擴大製造能力和能力，以支持額外的後期試驗和不斷增長的腫瘤學產品組合的商業化。為了創造長期價值，我們的目標是快速、負責任且經濟高效地推進我們的臨床項目，以獲得潛在的註冊。考慮到這一切，我想向您介紹我們預計與 BMS 合作將產生的財務影響。

As Ugur highlighted in the key strategic drivers of this partnership, it is a landmark deal that will allow us to broaden the potential clinical utility and global access to BNP327, a key piece of our diversification into oncology. I will now focus on the anticipated financial implications of this deal, which we believe will significantly strengthen our cash position and P&L for the years to come. As part of the agreement, we expect to receive USD1.5 billion in an upfront cash payment this year. This payment is to be reflected in our cash position as of Q3 2025. We also expect to receive USD2 billion in total noncontingent anniversary cash payments through 2028.

正如 Ugur 在此次合作的關鍵策略驅動力中所強調的那樣，這是一項具有里程碑意義的交易，它將使我們能夠拓寬 BNP327 的潛在臨床實用性和全球可及性，這是我們向腫瘤學多元化發展的關鍵一環。我現在將重點放在這筆交易的預期財務影響，我們相信這將在未來幾年顯著增強我們的現金狀況和損益。作為協議的一部分，我們預計今年將收到 15 億美元的預付現金付款。該付款將反映在我們截至 2025 年第三季的現金狀況。我們也預計到 2028 年將收到總計 20 億美元的非或有週年現金支付。

The upfront and noncontingent cash payments amounting to $3.5 billion are expected to be recognized as revenues over the development phase of BNP327. In addition, we will be eligible to receive up to USD7.6 billion in development, regulatory and commercial milestones. The majority of milestone payments are expected to be triggered upon approvals and during commercialization. All milestone payments are anticipated to be recognized as revenues following milestone achievement. Also, as part of the agreement, we will share joint BNP327 development and manufacturing costs on a 50-50 basis with BMS, subject to certain exceptions. Upon commercialization, global profits and losses will be equally shared between BMS and ourselves.

預計 35 億美元的預付款和非或有現金支付將在 BNP327 開發階段確認為收入。此外，我們還將有資格獲得高達 76 億美元的開發、監管和商業里程碑。預計大部分里程碑付款將在獲得批准和商業化期間觸發。預計所有里程碑付款將在里程碑實現後確認為收入。此外，作為協議的一部分，我們將與 BMS 以 50-50 的比例分擔 BNP327 的開發和製造成本，但須遵守某些例外情況。商業化後，全球利潤和損失將由 BMS 和我們平均分擔。

Turning to the next slide. We are reaffirming the company's financial guidance for the 2025 financial year with revenue expected to be in the range of EUR1.7 billion to EUR2.2 billion. Research and development expenses expected to be in the range of EUR2.6 billion to EUR2.8 billion, SG&A expenses expected to be in the range of EUR650 million to EUR750 million and capital expenditures expected to be in the range of EUR250 million to EUR350 million. We anticipate a revenue phasing weighted towards the last 3, 4 months of the year, driving the full year revenue figure. Given the COVID-19 vaccine market dynamics and shifting policy, specifically in the United States, we assume lower COVID-19 vaccination rates than the prior year. However, we continue to expect similar market share and pricing as compared to 2024. We continue to monitor current and potential further developments in law, public policy, international trade, and public sentiment as they continue to evolve and could further impact our anticipated COVID-19 vaccine revenues and expenses.

翻到下一張投影片。我們重申公司 2025 財年的財務指導，預計營收在 17 億歐元至 22 億歐元之間。研發費用預計在 26 億歐元至 28 億歐元之間，銷售、一般及行政費用預計在 6.5 億歐元至 7.5 億歐元之間，資本支出預計在 2.5 億歐元至 3.5 億歐元之間。我們預計營收將集中在今年最後 3、4 個月，推動全年營收成長。鑑於 COVID-19 疫苗市場動態和不斷變化的政策，特別是在美國，我們假設 COVID-19 疫苗接種率低於前一年。不過，我們預期市佔率和定價仍將與 2024 年相似。我們將繼續關注法律、公共政策、國際貿易和公眾情緒的當前和潛在的進一步發展，因為它們不斷發展，並可能進一步影響我們預期的 COVID-19 疫苗收入和支出。

In addition, regarding our revenue outlook, 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's territory. Beyond our COVID-19 vaccine business, we also expect revenues from our pandemic preparedness contract with the German government as well as revenues from our collaborations, now including BMS, and our service businesses to contribute to our overall group revenues.

此外，關於我們的收入前景，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%。除了我們的 COVID-19 疫苗業務外，我們還預計與德國政府簽訂的大流行病防範合約的收入以及我們與 BMS 的合作收入和服務業務的收入將為我們集團的整體收入做出貢獻。

To conclude, and looking ahead, we continue to diligently invest in our growth strategy while maintaining financial discipline. We remain focused on achieving long-term sustainable growth and generating value for patients and shareholders. With that, I would like to turn the call over to Ryan for concluding remarks. Thank you.

總而言之，展望未來，我們將繼續努力投資我們的成長策略，同時保持財務紀律。我們始終致力於實現長期可持續成長並為患者和股東創造價值。最後，我想將電話交給瑞安 (Ryan) 做總結演講。謝謝。

Thank you, Ramon. I will close our prepared remarks with a brief summary of our 2025 strategic priorities. As Ugur mentioned, we continue to focus on executing against two pan-tumor product opportunities, BNT327 and our mRNA cancer immunotherapies, FixVac and iNeST. We currently have multiple ongoing Phase II and III trials across these programs, reflecting our strategy to bring novel combinations to patients. We expect to generate additional meaningful data for these programs throughout this and early next year. We also continue to build out our commercial capabilities in oncology to support our goal of becoming a fully integrated biopharmaceutical company.

謝謝你，拉蒙。我將以我們 2025 年策略重點的簡要總結來結束我們的準備好的發言。正如 Ugur 所提到的，我們繼續專注於執行兩種泛腫瘤產品機會，即 BNT327 和我們的 mRNA 癌症免疫療法 FixVac 和 iNeST。目前，我們正在對這些項目進行多個 II 期和 III 期試驗，這反映了我們為患者帶來新型組合的策略。我們希望在今年和明年年初為這些專案產生更多有意義的數據。我們也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。

These include a broad global commercial leadership team to drive our transition to the commercial stage in oncology beginning with the potential approval and launch of BNT323 as early as 2026. In infectious diseases, we have continued to invest to maintain our and Pfizer's global leadership position in the COVID-19 vaccine market while advancing next generation and combination vaccines in the clinic. On the next slide, I would like to highlight some important investor events we'll be holding this year. Our second AI Day will take place on October 1.

其中包括一支廣泛的全球商業領導團隊，以推動我們向腫瘤學商業階段的過渡，最早將於 2026 年批准和推出 BNT323。在傳染病領域，我們持續投入，以維持我們和輝瑞在 COVID-19 疫苗市場的全球領導地位，同時在臨床上推動下一代疫苗和聯合疫苗。在下一張投影片中，我想重點介紹我們今年將舉辦的一些重要的投資者活動。我們的第二個人工智慧日將於 10 月 1 日舉行。

We also plan to hold our Innovation Series event on November 11, and we'll share more details on both events later in the year. Finally, I would like to conclude on a personal note. As Ugur mentioned, I will step down from my executive role at BioNTech at the end of September. As this is my last earnings call as Chief Strategy Officer, I would like to extend my deepest gratitude to those in the investment and analyst community who have been long-term supporters of our efforts to positively impact patients' lives.

我們還計劃於 11 月 11 日舉辦創新系列活動，並將在今年稍後分享有關這兩個活動的更多詳細資訊。最後，我想以個人觀點來結束我的演講。正如 Ugur 所提到的，我將於 9 月底辭去 BioNTech 的高階主管職務。這是我作為首席策略長的最後一次財報電話會議，我謹向長期支持我們為患者生活帶來積極影響的努力的投資和分析師社區的人們表示最深切的感謝。

I would also like to thank my colleagues on the supervisory and management boards as well as my teams for their dedication and collaboration during these crucial and fruitful years. It has been a true privilege to support BioNTech's transformation into one of the most exciting disruptors in our industry, and I'm very excited to follow the company's continued growth in the years to come.

我還要感謝監事會、管理委員會以及我的團隊的同事們在這關鍵而富有成果的歲月中的奉獻和合作。能夠支持 BioNTech 轉型為我們行業中最令人興奮的顛覆者之一，我感到非常榮幸，並且非常高興能夠關注公司在未來幾年的持續成長。

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) Tazeen Ahmad, Bank of America.

（操作員指示） Tazeen Ahmad，美國銀行。

Good morning, thanks for taking my question. First of all, Ryan, thanks for all of your help coming IPO onward and you'll be missed. Can I just ask for a little bit of clarity about how you're thinking about vaccine development on a go-forward basis. You've talked about continuing to invest in the infectious disease segment of the business. You talked about combination therapies. Just based on where you're seeing vaccination rates now, let's focus on the US, what do you think are going to be the products that are going to motivate people to perhaps increase their rate of vaccinations for ones that, for example, need annual or maybe biannual rates of vaccination just because it does seem like that indicate that those rates are tending to flow lower? And why does it make sense to continue investing in that?

早上好，感謝您回答我的問題。首先，Ryan，感謝您在 IPO 過程中提供的所有幫助，我們會想念您的。我能否稍微澄清一下您對未來疫苗研發的看法。您曾談到繼續投資傳染病業務領域。您談到了聯合療法。僅根據您現在看到的疫苗接種率，讓我們關注美國，您認為哪些產品可以激勵人們提高疫苗接種率，例如，對於那些需要每年或每兩年接種一次疫苗的人來說，僅僅因為這似乎表明這些接種率趨於下降？為什麼繼續投資是有意義的？

Yes. Thank you, Tazeen. I'll start off and appreciate the kind words. In terms of vaccine development, of course, our COVID-19 vaccine business is going to continue to be a priority for the company, along with building out oncology and entering the commercial stage. And I think in terms of the rates of vaccination, we've seen lower rates of vaccination for COVID-19 over the past couple of years, and we've guided to a range that we think reflects a similar ballpark this year.

是的。謝謝你，塔津。我首先要感謝這些善意的話語。在疫苗開發方面，當然，我們的 COVID-19 疫苗業務將繼續成為該公司的首要任務，同時也將拓展腫瘤學領域並進入商業階段。我認為，就疫苗接種率而言，在過去幾年中，我們看到 COVID-19 疫苗接種率有所下降，並且我們已將今年的疫苗接種率控制在一個我們認為大致相同的範圍內。

We've noted that, of course, that's still subject to certain policy dynamics, and we're continuing to track that. But we feel overall pretty good about the overall value proposition of the COVID-19 vaccine franchise. And so we've seen rates of about 20% over the last couple of years. Obviously, we're going to track that going in here to the second half of the year, which is the main part of the season, but we think we're on track overall to be ready to meet market demand. And we do think that even in a market that's focused on the high-risk population, that's still a substantial number of people, approximately 100 million in the United States. And this is also going to continue to be a global business.

當然，我們注意到，這仍然受到某些政策動態的影響，我們將繼續追蹤這一點。但總體而言，我們對 COVID-19 疫苗特許經營權的整體價值主張感到相當滿意。因此，我們看到過去幾年的利率約為 20%。顯然，我們將追蹤這一情況直至下半年，也就是本季的主要部分，但我們認為我們總體上已準備好滿足市場需求。我們確實認為，即使在一個專注於高風險族群的市場中，這仍然是一個相當大的數字，在美國大約有 1 億人。這也將繼續成為一項全球業務。

So I think overall, we're going to be prepared with Pfizer to continue market leadership in COVID-19. And I think as it relates to your question about what's driving demand, I think ultimately, it's going to continue to be based on the value proposition of these vaccines. And so we're going to continue to work on next-generation concepts, including exploring combination vaccines that we think could add additional value for patients in the coming years. And beyond COVID-19, too, we have a number of vaccine programs that are in either preclinical or Phase I development. Our strategy as it relates to vaccines aside from COVID will remain focused on leveraging partnerships to bring those forward.

因此我認為總體而言，我們將與輝瑞一起做好準備，繼續在 COVID-19 市場保持領先地位。我認為，就您關於需求驅動因素的問題而言，我認為最終它將繼續基於這些疫苗的價值主張。因此，我們將繼續研究下一代概念，包括探索我們認為可以在未來幾年為患者增加額外價值的聯合疫苗。除了 COVID-19 之外，我們還有許多疫苗項目處於臨床前或 I 期開發階段。除了 COVID 之外，我們的疫苗相關策略仍將專注於利用合作夥伴關係來推動這些疫苗的研發。

Thank you, Ryan, and thank you, Tim, for the question. I also believe that we expect the combination vaccines will gradually complement rather than replace stand-alone COVID-19 vaccine.

謝謝 Ryan 和 Tim 提出的問題。我還相信，我們預計聯合疫苗將逐漸補充而不是取代獨立的 COVID-19 疫苗。

There are several factors that may sustain demand for monovalent vaccine beyond convenience considerations, such as immunocompromised patients, overwhelming preference of 60-plus population to receive high-dose flu plus a mono COVID vaccine and some asynchronous vaccination schedules where patients need COVID-19 boosters. So I think as Ryan is mentioning, so we still hold a very high market share, more than 50% across worldwide with Pfizer, and we are prepared as well to keep developing our combination and keep leading in this market.

除了便利性考量之外，還有幾個因素可能會維持對單價疫苗的需求，例如免疫功能低下的患者、60 歲以上人群絕大多數傾向於接種高劑量流感疫苗加單一 COVID 疫苗，以及一些患者需要 COVID-19 加強劑的異步疫苗接種計劃。所以我認為，正如 Ryan 所提到的那樣，我們仍然佔有非常高的市場份額，與輝瑞一起在全球佔有超過 50% 的份額，而且我們也準備繼續開發我們的組合併保持在這個市場的領先地位。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

Great. Thanks for taking my question, and best of luck, Ryan, in next steps. I was just wondering on the 327 trial, ROSETTA Lung-02, if you can tell us the doses that you're exploring in the Phase II portion? And then can you just confirm again that you'd plan to release any top line data here from the Phase II portion before year-end? We didn't see that on the slides but just wanted to confirm the timing of that data release. Thank you.

偉大的。感謝您回答我的問題，祝 Ryan 在接下來的工作中一切順利。我只是想知道，關於 327 試驗 ROSETTA Lung-02，您是否可以告訴我們您在第二階段探索的劑量？那麼您能否再次確認您計劃在年底之前發布第二階段的任何頂線數據？我們沒有在投影片上看到這一點，只是想確認資料發布的時間。謝謝。

Yeah. Thank you, Terence. So I think the question is around doses for the Phase II portion and top line data. Oswan, do you want to take that?

是的。謝謝你，特倫斯。所以我認為問題在於第二階段的劑量和頂線數據。奧斯旺，你想拿走這個嗎？

Yes, I can take that. We will talk to doses actually for both trials, our Lung01 in small-cell lung cancer and Lung02 in non-small cell lung cancer later this year for the small cell lung cancer study, Part 1, you will hear already more in September on the WCLC.

是的，我可以接受。我們將在今年稍後討論兩項試驗的實際劑量，即小細胞肺癌研究的 Lung01 和非小細胞肺癌的 Lung02，這是小細胞肺癌研究的第 1 部分，您將在 9 月份的 WCLC 上聽到更多消息。

Daina Graybosch, Leerink Partners.

Daina Graybosch，Leerink Partners。

Hi, I wonder if you can talk more about BNT 327 in frontline TNBC and how you're thinking about the success of the TROP2 ADC, both in combo with PD-1 and without in PD-L1 high and low, if you could still do a study without a TROP2 ADC in frontline in your control arm or your active arm. And thank you.

你好，我想知道您是否可以更多地談談 BNT 327 在一線 TNBC 中的應用，以及您如何看待 TROP2 ADC 的成功，無論是與 PD-1 組合還是不在 PD-L1 高和低組合中，您是否仍然可以在對照組或活性組中進行一項沒有 TROP2 ADC 的一線研究。謝謝你。

Hi, Daina, I can take this question. Yeah, that's right. TNBC provides for BNT327 several opportunities. We have generated data in TNBC with chemotherapy in combo reaching a PFS between 13 to 14 months and highly encouraging OS data. And of course, the combination with TROP2 or other ADCs, we have also HER3 ADC could provide the opportunity to further increase the efficacy. And these are, as you might remember, one of the combo studies that we are doing at the moment is BNT327 and BNT325, our TROP2 ADC. And based on the data, we might decide also to go for a combo in this indication.

你好，Daina，我可以回答這個問題。是的，沒錯。TNBC 為 BNT327 提供了多種機會。我們已經產生了 TNBC 的數據，聯合化療的 PFS 達到​​ 13 至 14 個月，而 OS 數據非常令人鼓舞。當然，與 TROP2 或其他 ADC 的結合，我們也有 HER3 ADC 可以提供進一步提高療效的機會。您可能還記得，我們​​目前正在進行的組合研究之一是 BNT327 和 BNT325，即我們的 TROP2 ADC。根據數據，我們也可能決定在此適應症中採用組合療法。

Cory Kasimov, Evercore.

科里·卡西莫夫（Cory Kasimov），Evercore。

Hey, guys, first of all, Ryan, been great interacting with you over all these years and best of luck with what's coming up next. I guess I'll go with my first ever question for Ramon and thinking about the model, how do you see R&D spend now evolving over the intermediate to long term post your deal with Bristol? This collaboration should clearly offset a significant amount of future expenses, but is the plan to reallocate the majority of those to other programs or still somewhat TBD there? Thank you.

嘿，夥計們，首先，Ryan，這麼多年來和你互動很愉快，祝你接下來一切順利。我想我會向 Ramon 提出我的第一個問題，思考一下這個模型，在與布里斯托爾達成交易後，您認為現在的研發支出在中長期內會如何發展？這次合作顯然應該可以抵消大量的未來開支，但計劃是否將其中的大部分重新分配給其他項目，還是仍有待確定？謝謝。

Thank you, Cory, for the question. So I think increasing investments into our priority late-stage program, of course, BNT327 that now are going to be with collaboration, but also in mRNA cancer immunotherapies and ADCs would be some of the key drivers.

謝謝 Cory 提出的問題。因此，我認為增加對我們優先後期項目的投資，當然，BNT327 現在將與合作進行，但同時 mRNA 癌症免疫療法和 ADC 也將是一些關鍵驅動因素。

Now having said that, we will be very consistent with our portfolio prioritization strategy, and we also expect to decrease our R&D spending outside of these priority areas. So we expect R&D to increase in the second half of this year. And as we see the starting phases of the work in Phase III BNT327 in TNBC and BNT323 in EC as Ozlem was alluding to. And as we see how these programs are progressing as well in FixVac and iNeST, we will be, of course, updating you accordingly on how do we see this spending going more towards the 2-, 3-year period.

話雖如此，我們將非常堅持我們的投資組合優先策略，並且我們還希望減少這些優先領域之外的研發支出。因此我們預計今年下半年研發投入將會增加。正如我們所看到的，TNBC 的 BNT327 第三階段和 EC 的 BNT323 工作已啟動，正如 Ozlem 所暗示的那樣。隨著我們看到這些項目在 FixVac 和 iNeST 方面的進展，我們當然會相應地向您通報我們如何看待這些支出在未來 2 年或 3 年期間的增長情況。

Great. Thank you.

偉大的。謝謝。

Asad Haider, Goldman Sachs.

高盛的阿薩德·海德爾 (Asad Haider)。

Great, thanks. Congratulations on all the progress and best of luck, Ryan. Just one quick question back to the COVID question, just your assumption on lower vaccination rates relative to last year. You are keeping revenue guidance the same, recognizing it is a wide range. But any quantification in terms of the pushes and pulls with respect to vaccination uptake would be helpful.

太好了，謝謝。恭喜你所取得的所有進步，並祝你好運，瑞安。關於 COVID 的問題，我只想問一個簡單的問題，您認為疫苗接種率相對於去年有所下降。您保持收入指導不變，但要認識到它的範圍很廣。但任何有關疫苗接種推動和拉動因素的量化都會有所幫助。

And then second, just in the context of the deal with Bristol, maybe just double-click a little bit more on the acceleration strategy, specifically with respect to any new Phase III trials that have been planned since the announcement of the collaboration? And then also just on the development costs, given that they'll be 50-50, how should we be thinking about the cadence of R&D spend going forward? And then if I can just squeeze one last one on the FixVac's melanoma trial. If you could just double-click on what you're planning to present at ESMO and the overall plans for that program going forward? Thank you.

其次，僅在與布里斯託的交易背景下，也許只需稍微強調加速策略，特別是關於自宣布合作以來計劃進行的任何新的 III 期試驗？那麼就開發成本而言，考慮到它們將佔 50%，我們應該如何考慮未來研發支出的節奏？然後，如果我能在 FixVac 的黑色素瘤試驗中再擠出最後一個機會。您能否雙擊一下您計劃在 ESMO 上展示的內容以及該計劃未來的整體計劃？謝謝。

So great. I think Ramon, maybe you want to take the first two questions, and then Ozon can take the ESMO question.

太棒了。我認為 Ramon，也許你想回答前兩個問題，然後 Ozon 可以回答 ESMO 問題。

Yes. So thank you, Asad. I -- on the revenue guidance for the COVID-19 market. So as I was saying, so we anticipate that this revenue is going to be phased over the last three or four months of this year. Given the COVID-19 vaccine market dynamics and shifting policy, we assume that we will have lower COVID-19 vaccination rate than previous year, but we also need to take this into consideration with the fact that the vaccination rates in the US are already low at around 20%.

是的。所以謝謝你，阿薩德。我——關於 COVID-19 市場的收入指引。正如我所說的，我們預計這筆收入將在今年最後三、四個月分階段實現。鑑於新冠疫苗市場動態和政策變化，我們假設新冠疫苗接種率將低於去年，但我們也需要考慮到美國的疫苗接種率已經很低，約為 20% 這一事實。

So I mean, like this is going to be maybe a couple of points lower. But we are still believing that the pricing and our market share assumptions are going to be broadly in line with previous year. So that's what I would say on COVID.

所以我的意思是，這可能會低幾個點。但我們仍然相信定價和市佔率假設將與去年大致一致。這就是我對 COVID 的看法。

And then on BMS Phase III trials, in the collaboration, I think it's clear. So it's going to be a 50-50 development cost R&D spend, and we will -- as these programs progress through the different phases, so we will have transparency on these amounts.

然後在 BMS 第三階段試驗中，在合作中，我認為這很清楚。因此，研發費用將占到開發成本的 50%，隨著這些項目在不同階段的進展，我們將對這些金額保持透明度。

And of course, on the BMS collaboration, new trials are being considered and evaluated right now, and those decisions will be communicated once made.

當然，關於 BMS 合作，目前正在考慮和評估新的試驗，一旦做出就會公佈這些決定。

Yes. And there was, I think, a question for 111, our melanoma FixVac, which I can answer, namely what we are going to present at ESMO. We will -- this year, we will present the efficacy data. This trial has an objective response rate and duration of objective response rate primary endpoint. And this data will be matured until later this year and will be presented. We will also speak to secondary endpoints like PFS and OS and safety data, and there will be also some translational data characterization of the immune responses.

是的。我認為，有一個針對 111（我們的黑色素瘤 FixVac）的問題，我可以回答，也就是我們將在 ESMO 上展示的內容。今年我們將公佈功效數據。本試驗以客觀緩解率和客觀緩解率持續時間為主要終點。而這些數據要到今年稍後才會成熟並呈現。我們還將討論 PFS 和 OS 等次要終點以及安全性數據，並且還將有一些免疫反應的轉化數據表徵。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

Hey, thanks so much, and Ryan, it was really a pleasure working with you. I'll keep it a little more general. Look, under the new FDA regime, has the BioNTech team seen any shift in the FDA's willingness to accept Chinese data for your VEGF bispecific or the ADCs? And for 327, for NSCLC, small cell and then TNBC, can you tell us whether -- when you'd be able to satisfy Project Optimus regulatory requirements and proceed with the go-forward Phase III dose for these three indications?

嘿，非常感謝，Ryan，和你一起工作真的很愉快。我會讓它更通用一些。看，在新的 FDA 制度下，BioNTech 團隊是否看到 FDA 在接受您的 VEGF 雙特異性或 ADC 的中國數據方面的意願有任何轉變？對於 327，針對 NSCLC、小細胞肺癌和 TNBC，您能否告訴我們何時能夠滿足 Project Optimus 監管要求並繼續進行這三種適應症的 III 期劑量研究？

Great. Thank you, Akash. And Ugur do you want to take that?

偉大的。謝謝你，阿卡什。烏古爾，你想接受這個嗎？

Yes. We are discussing and finalizing these discussions currently for all three indications in which we are in Phase III trials. The discussions are very positive because, as you know, we are producing on top of the China data, which we have in early part four independent global studies, also some dose data and dose optimization data in the Western population. We think that within the next couple of weeks, we will be able to move ahead in all those three indications.

是的。我們正在針對處於 III 期試驗的所有三種適應症進行討論並最終確定這些討論。討論非常積極，因為如您所知，我們基於早期第四部分獨立全球研究中獲得的中國數據，也產生了西方人群的一些劑量數據和劑量優化數據。我們認為，在接下來的幾週內，我們將能夠在所有這三個方面取得進展。

Jessica Fye, JPMorgan.

潔西卡費伊（Jessica Fye），摩根大通。

Hey, guys, good morning, thanks for taking my questions. And Ryan, similarly, it's been great working with you over the years. I have a few on the pipeline. So with the upcoming global Phase II readouts for BNT327, can you remind us when you say, for example, the small cell data and non-small cell data is expected this year, will we see that data? And if so, what endpoints will we see? And what are the relevant benchmarks in those settings?

嘿，大家早安，感謝你們回答我的問題。瑞安，同樣，這些年來和你一起工作非常愉快。我有幾個正在籌備中。因此，隨著 BNT327 全球第二階段讀數即將公佈，您能否提醒我們，例如，今年預計會公佈小型蜂窩數據和非小型蜂窩數據，我們會看到這些數據嗎？如果是這樣，我們將看到什麼樣的終點？這些設定中的相關基準是什麼？

Second, for the registrational HER2-positive endometrial cohort, did that slip a bit? I think we were previously expecting to file by year-end '25, and now it sounds like data at a conference in '26. So I just want to confirm whether we'll hear top line data this year or what the timeline is. And then lastly, for the iNEST randomized Phase II in ctDNA-positive adjuvant colon cancer, can you just share your latest expectation for timing there?

其次，對於註冊的 HER2 陽性子宮內膜患者群體來說，情況是否有所下降？我認為我們之前預計在 25 年底之前提交文件，現在聽起來像是 26 年會議上的數據。所以我只是想確認我們是否會聽到今年的頂線數據或時間表是什麼。最後，對於 ctDNA 陽性輔助結腸癌的 iNEST 隨機 II 期研究，您能否分享您對研究時間的最新預期？

Yes. Thank you, Jess. I think maybe just on the last one, I can briefly comment and then hand over to Ozlem to speak to the benchmark to the small cell lung cancer and non-small cell. So on adjuvant CRC, we're maintaining our prior guidance that we were expecting data late 2025 or early '26, and we think we're on track to meet that in terms of the adjuvant CRC data for iNeST. Ozlem, do you want to address the 327 question?

是的。謝謝你，傑西。我想也許就最後一個問題，我可以簡單評論一下，然後交給 Ozlem 來談談小細胞肺癌和非小細胞肺癌的基準。因此，對於輔助性 CRC，我們維持先前的指導，即我們預計在 2025 年末或 2026 年初獲得數據，並且我們認為就 iNeST 的輔助性 CRC 數據而言，我們有望實現這一目標。Ozlem，你想回答第 327 題嗎？

Yes. The 327 question, the question was small cell lung cancer trial and our non-small cell lung cancer trial, the benchmark, right? Did I get that right? So for the small cell lung cancer -- actually, for both trials, our aim is to achieve clinically meaningful and statistically significant improvement over the standard of care for the small cell lung cancer trial, ROSA-01, our primary endpoint is OS. And for the non-small cell lung cancer trial, we have a dual endpoint, PFS and OS. And when I say standard of care, the benchmark trials or the benchmarks we are comparing agaiNeSTt non-small cell lung cancer is IMpower133 with median OS outcomes there.

是的。327 個問題，問題是小細胞肺癌試驗和我們的非小細胞肺癌試驗，基準，對嗎？我說得對嗎？因此對於小細胞肺癌 - 實際上，對於這兩項試驗，我們的目標是實現比小細胞肺癌試驗 ROSA-01 的治療標準具有臨床意義和統計學意義的改善，我們的主要終點是 OS。對於非小細胞肺癌試驗，我們有雙重終點，即 PFS 和 OS。當我說標準治療時，我們針對非小細胞肺癌所比較的基準測試或基準是 IMpower133，其中有中位數 OS 結果。

And for non-small cell lung cancer, as you know, we have both non-squamous and squamous histologies covered in our Phase III trial. And here, we refer to the KEYNOTE-189 and the KEYNOTE-407 studies as benchmarks. And I think there was a question regarding 323, right, when we will show data from that study. The plan is to share data from our single-arm second-line endometrial cancer study, which will also be the data package for BLA submission later this year. This data will be shared in early 2026. We want to make sure that the data further matures and that the data which will be shared with the community is in sync with the data we are planning to submit to FDA.

對於非小細胞肺癌，如您所知，我們的 III 期試驗涵蓋了非鱗狀和鱗狀組織學。在這裡，我們以 KEYNOTE-189 和 KEYNOTE-407 研究作為基準。我認為有一個關於 323 的問題，對，我們什麼時候會展示該研究的數據。該計劃旨在分享我們單臂二線子宮內膜癌研究的數據，這也將成為今年稍後提交 BLA 的數據包。這些數據將於 2026 年初共享。我們希望確保數據進一步成熟，並且與社區共享的數據與我們計劃提交給 FDA 的數據同步。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

(inaudible) on for Yaron. Congrats on your quarter, and thanks for taking our question. On the competition for BNT327, Pfizer said that their asset binds to -- when their asset binds to VEGF, it increases the affinity PD-1 by 100-fold. Is this kind of cooperative binding also true for BNT327? And are there any other points of differentiation you might note between yours and Pfizer's molecule besides obvious PD-1 versus PD-L1? Thanks so much.

（聽不清楚）為亞龍上場。恭喜您取得的季度成績，並感謝您回答我們的問題。關於 BNT327 的競爭，輝瑞表示，他們的資產與 VEGF 結合時，其親和力 PD-1 會增加 100 倍。這種合作結合對於 BNT327 也適用嗎？除了明顯的 PD-1 與 PD-L1 之外，您是否還注意到您的分子與輝瑞分子之間還有其他差異？非常感謝。

Do you want to take the question on whether or not 327 has a cooperative binding effect and other points of differentiation?

您想回答關於327是否具有合作約束力以及其他區別點的問題嗎？

Yes. I can take this question. I think the mechanism is more complicated than this. And we will present the mechanism probably mid next year in our conference. We are evaluating the mechanism for BNT327. As you know, it's a binder, which binds in the tumor microenvironment, PD-L1 and thereby provides opportunity to bind also in the tumor microenvironment to VEGF-A. And the combination of both has synergistic activities, but it's not simple. The increase of the affinity is more complicated.

是的。我可以回答這個問題。我認為這個機制比這更複雜。我們大概會在明年年中會議上介紹這個機制。我們正在評估 BNT327 的機制。如您所知，它是一種結合劑，可在腫瘤微環境中與 PD-L1 結合，從而提供在腫瘤微環境中與 VEGF-A 結合的機會。而兩者的結合有協同作用，但並不簡單。親和力的增加比較複雜。

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

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。