Biontech SE (BNTX) 2024 Q1 法說會逐字稿

Welcome to BioNTech's First Quarter 2024 Earnings Call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

歡迎參加 BioNTech 2024 年第一季財報電話會議。我想將電話轉交給策略和投資者關係副總裁維多利亞·邁斯納 (Victoria Meissner) 博士。請繼續。

Good morning and good afternoon. Thank you for joining BioNTech's First Quarter 2024 Earnings Call. As a reminder, the slides we will be using on this call and the corresponding press release published this morning, can be found in the Investor Relations section of our website.

早安，下午好。感謝您參加 BioNTech 2024 年第一季財報電話會議。提醒一下，我們將在本次電話會議中使用的幻燈片以及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。

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 U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties and speak only of the date of this conference call. We undertake no obligation to update or revise any of these statements.

在下一張投影片上，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資訊在我們向美國證券交易委員會提交的文件中進行了描述。本次電話會議中的前瞻性陳述存在重大風險和不確定性，並且僅涉及本次電話會議的日期。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. Today, I am 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; Jens Holstein, Chief Financial Officer; and Ryan Richardson, Chief Strategy Officer.

在投影片 3 上，您可以找到今天電話會議的議程。今天，BioNTech 管理團隊的以下成員加入了我的行列。 Ugur Sahin，執行長兼聯合創辦人； Ozlem Tureci 首席醫療長兼共同創辦人； Jens Holstein，財務長；瑞安·理查森（Ryan Richardson），首席策略長。

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

說到這裡，我想把事情交給烏古爾。

A warm welcome to all those joining us today. We believe that we are entering a transformational period for BioNTech. We have founded BioNTech with the vision to discover and develop scientific breakthrough that harness the immune system to fight diseases and bring new medicines to patients.

熱烈歡迎今天加入我們的所有人。我們相信 BioNTech 正在進入一個轉型期。我們創立 BioNTech 的願景是發現和開發利用免疫系統對抗疾病並為患者帶來新藥的科學突破。

In the years following our establishment we developed various therapeutic platforms, demonstrate the safety and clinical effectiveness of various drug candidates in early clinical trials. The period from now to 2030, is about forecasting this candidate into late-stage development and registrational trials to become a multiproduct company with the first product to be delivered by our late-stage oncology pipeline.

在我們成立後的幾年裡，我們開發了各種治療平台，在早期臨床試驗中證明了各種候選藥物的安全性和臨床有效性。從現在到 2030 年，預測該候選藥物進入後期開發和註冊試驗，成為多產品公司，並透過我們的後期腫瘤學管道交付第一個產品。

We are continuing to execute this vision and our strategic priorities with its intense focus. In the first quarter, we progressed our late-stage oncology pipeline on multiple fronts. We dosed the first patient in the pivotal Phase III clinical trial, evaluating our HER2 ADC BNT323 in HR+/HER2-low metastatic breast cancer.

我們將繼續高度關注地執行這一願景和我們的策略重點。在第一季度，我們在多個方面推進了後期腫瘤學管道。我們在關鍵的 III 期臨床試驗中對第一位患者進行了給藥，評估我們的 HER2 ADC BNT323 在 HR+/HER2-低轉移性乳癌中的作用。

At the AACR annual meeting, we presented 3-year follow-up data from a clinical trial evaluating our individualized mRNA cancer vaccines, autogene cevumeran in pancreatic cancer. This data showed encouraging relapse survival in certain patients with immunogenic response to the vaccine, demonstrating the promise of our vaccine platform to induce persistent de novo neoantigen-specific T cell responses that correlate with improvements in survival.

在 AACR 年會上，我們展示了一項臨床試驗的 3 年追蹤數據，該臨床試驗評估了我們的個人化 mRNA 癌症疫苗（自體 cevumeran）治療胰臟癌的效果。該數據顯示，某些對疫苗產生免疫原性反應的患者的復發存活率令人鼓舞，證明了我們的疫苗平台有望誘導持續的從頭新抗原特異性 T 細胞反應，從而與生存率的改善相關。

We have also taken significant steps for our first launches in oncology. Annemarie Hanekamp, an accomplished leader with a remarkable track record is joining our team in July to drive and execute our global commercialization strategy. We appointed a General Manager in the U.S., who has commenced building out our commercial operations in the U.S. and we appointed further expertise in our global commercial team.

我們也為首次在腫瘤學領域的推出採取了重大步驟。 Annemarie Hanekamp 是一位卓有成就、業績斐然的領導者，將於 7 月加入我們的團隊，推動和執行我們的全球商業化策略。我們在美國任命了一位總經理，他已開始在美國建立我們的商業業務，並且我們在我們的全球商業團隊中任命了更多的專業人士。

For our COVID-19 vaccine franchise, we initiated preparations to be on track to introduce a new variant adapted COVID-19 vaccine for the upcoming season. We have received preliminary strain selection recommendations from the World Health organization and European Medians Agency and plan to submit for regulatory approval later this month.

對於我們的 COVID-19 疫苗系列，我們已啟動準備工作，以便在即將到來的季節推出一種新的變體適應的 COVID-19 疫苗。我們已收到世界衛生組織和歐洲中位數管理局的初步菌株選擇建議，並計劃於本月稍後提交監管部門批准。

Today, Ozlem and I will focus on our oncology strategy, while Jens and Ryan will provide updates on our financial and corporate progress. Slide 6. Our oncology portfolio strategy is driven by understanding the key challenges in cancer. Cancer is genetically diverse and heterogeneous disease driven by the substantial acquisition of mutations. One consequence of this is that many treatments have an initial effect but are not associated with long-term remission or cure.

今天，Ozlem 和我將重點討論我們的腫瘤學策略，而 Jens 和 Ryan 將提供有關我們財務和公司進展的最新資訊。投影片 6。癌症是一種由大量突變驅動的遺傳多樣性和異質性疾病。其後果之一是許多治療方法具有初步效果，但與長期緩解或治癒無關。

Our aim is to provide solutions across the continuum of cancer disease and establish new treatment paradigms. We believe our cancer vaccine candidates are particularly suited for early intervention, while thoughtfully designed combination treatments are intended for advanced and high-volume tumors. We want to bring our therapies to as many patients as possible, and we want to use the potential power of our platforms alone and in combination.

我們的目標是提供整個癌症疾病的解決方案並建立新的治療範例。我們相信，我們的候選癌症疫苗特別適合早期幹預，而精心設計的聯合治療則適用於晚期和大體積腫瘤。我們希望將我們的療法帶給盡可能多的患者，我們希望單獨或聯合利用我們平台的潛在力量。

Slide 8, our therapeutic strategy brings together synergistic mechanisms of action across 3 key categories. The first are novel Immunomodulators or IO, which are designed to engage the immune system overcome cancer mediate immunosuppression and amplify immune responses. Second, targeted therapies, which include CAR T cell therapies and antibody drug conjugate that can dramatically reduce the tumor burden.

投影片 8，我們的治療策略匯集了 3 個關鍵類別的協同作用機制。第一個是新型免疫調節劑或 IO，旨在讓免疫系統克服癌症介導的免疫抑制並增強免疫反應。其次，標靶治療，包括 CAR T 細胞療法和抗體藥物偶聯物，可以顯著減輕腫瘤負擔。

The third category are mRNA vaccines, which are the centerpiece of our oncology strategy. Our mRNA cancer vaccines are designed to target multiple cancer antigens in parallel and can be individualized for each patient.

第三類是 mRNA 疫苗，它是我們腫瘤學策略的核心。我們的 mRNA 癌症疫苗旨在同時針對多種癌症抗原，並且可以針對每位患者進行個人化治療。

BioNTech was built from the very beginning as a technology-agnostic company. We do not limit ourselves to any one technology. We're interested in addressing unmet medical needs with the best possible solutions. Having a diversity of assets in our pipeline, we are positioned to pursue combination approaches that are proprietary and unique.

BioNTech 從一開始就是一家與科技無關的公司。我們不將自己局限於任何一種技術。我們有興趣透過最佳解決方案來解決未滿足的醫療需求。我們的管道中擁有多樣化的資產，我們有能力追求專有且獨特的組合方法。

This strategic advantage allow us to evaluate the activity of each individual compound and enables us to determine those patient population for which monotherapy or the logistic combinations are best suited. The potential for synergy in this combination is significant, enabling us to design treatment regimens that could lead to improved patient outcomes and broaden the scope of therapeutic options.

這項策略優勢使我們能夠評估每種化合物的活性，並使我們能夠確定最適合單一療法或邏輯組合的患者群體。這種組合的協同作用潛力巨大，使我們能夠設計出可以改善患者預後並擴大治療選擇範圍的治療方案。

We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the long-term survival rates for patients. Slide 9, to reiterate, we are entering a transformative period for BioNTech specifically in the development of our oncology pipeline and the formation of our oncology business, which will continue to evolve over the next few years.

我們相信，我們的策略有潛力解決癌症的根本挑戰，並推動患者長期存活率的顯著提高。幻燈片 9，重申一下，我們正在進入 BioNTech 的變革時期，特別是在我們的腫瘤產品線的開發和腫瘤業務的形成方面，這些業務將在未來幾年繼續發展。

In 2024, we are aiming to increase the number of potential pivotal trials across our lead programs to 10 or more by year-end. This trial will focus on areas of unmet medical needs, clinical indications in which we may achieve an expeditors path to market. And there after the first approval in the initial indication, is a high potential for expanding the market opportunity to additional indications.

2024 年，我們的目標是到年底將我們主導計畫中潛在的關鍵試驗數量增加到 10 項或更多。該試驗將重點關注未滿足的醫療需求和臨床適應症領域，我們可以在這些領域加快上市之路。在初始適應症首次獲得批准之後，將市場機會擴展到其他適應症的潛力很大。

Starting in 2025 and continuing into the following years, we expect to enter a period reached with pivotal data that if positive, could support regulatory submissions for marketing authorization across our pipeline. We have begun building a fully integrated oncology organization to support our transition into a global multiproduct company. This process will be accelerated this year as we bring our new Chief Commercial Officer on board.

從 2025 年開始並持續到接下來的幾年，我們預計將進入一個關鍵數據時期，如果這些數據是積極的，可以支持監管部門提交我們整個管道的營銷授權。我們已經開始建立一個完全整合的腫瘤學組織，以支持我們向全球多產品公司的轉型。隨著我們新任首席商務官的加入，這一進程將在今年加速。

Ultimately, we are building our organization to support multiple oncology launches beginning in 2026.

最終，我們正在建立我們的組織來支持從 2026 年開始的多個腫瘤學計畫的推出。

With that, I would like to thank you all for your ongoing support. I will now turn the call over to Ozlem.

在此，我要感謝大家一直以來的支持。我現在將把電話轉給 Ozlem。

Glad to be speaking with everyone today. As Ugur highlighted, we will focus in the next few years on increasing the number of potentially pivotal clinical trials to fuel our transition towards becoming a multiproduct company by 2030.

很高興今天能和大家交談。正如 Ugur 所強調的那樣，我們將在未來幾年重點關注增加潛在關鍵臨床試驗的數量，以推動我們在 2030 年之前轉型為多產品公司。

In oncology, we have already started to execute against this goal. This is why you can see that the late-stage part of our pipeline on this slide is enriched and populated with multiple trials that feature our priority assets such as our mRNA vaccine and also our most advanced ADCs and [IOs], including those which we consider as attractive backbone of unique combination treatments.

在腫瘤學領域，我們已經開始實現這一目標。這就是為什麼您可以看到這張投影片上我們管道的後期部分豐富並充滿了多項試驗，這些試驗具有我們的優先資產，例如我們的 mRNA 疫苗以及我們最先進的 ADC 和 [IO]，包括我們被視為獨特組合治療的有吸引力的支柱。

To highlight recent additions to our pipeline. One is the Phase III trial in collaboration with Duality Bio, evaluating BNT323 in patients with hormone receptor positive and HER2-low metastatic breast cancer that has progressed on hormone therapy and/or cyclin-dependent kinase 4/6 [broken].

突出顯示我們管道中最近新增的內容。其中一項是與Duality Bio 合作進行的III 期試驗，評估BNT323 在激素受體陽性且HER2 低的轉移性乳癌患者中的作用，這些患者在激素治療和/或細胞週期蛋白依賴性激酶4/ 6 治療中取得進展[已損壞]。

With BNT323, we are also planning to start a confirmatory Phase III trial this year in patients with metastatic endometrial cancer that will complement our ongoing single-arm trial in this indication. In our early-stage pipeline, we have started a Phase I/II trial in collaboration with Genmab evaluating BNT314 a bispecific antibody product candidate was EpCAM-dependent 4-1BB agonistic activity in light of the solid tumors.

對於 BNT323，我們還計劃今年在轉移性子宮內膜癌患者中啟動一項驗證性 III 期試驗，這將補充我們正在進行的該適應症的單臂試驗。在我們的早期管道中，我們已經與 Genmab 合作啟動了 I/II 期試驗，評估 BNT314（一種雙特異性抗體產品候選產品）針對實體瘤的 EpCAM 依賴性 4-1BB 激動活性。

Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approval in the next 18 months. Before highlighting some of the programs and platforms that we consider priority assets to contribute clinical progress, let me say a couple of words to execution.

我們的目標是在未來 18 個月內繼續推進我們的腫瘤學管道，以獲取關鍵數據並提交監管部門批准。在強調一些我們認為有助於臨床進展的優先資產的項目和平台之前，讓我先對執行說幾句話。

The coming years worthy about late-stage clinical trial execution, enrolling the patients to participate in clinical trials requires the coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global trial execution approach.

未來幾年值得進行後期臨床試驗，招募患者參與臨床試驗需要我們公司內部多個職能部門以及我們的合作夥伴和合作者的協調，他們是我們全球試驗執行方法不可或缺的一部分。

As we and our partners have increased the number of ongoing late-stage trials we have also drastically increased the number of patients that participate in trials, generating data for our fully owned and partner product candidates.

隨著我們和我們的合作夥伴增加正在進行的後期試驗的數量，我們也大幅增加了參與試驗的患者數量，為我們的全資和合作夥伴候選產品產生數據。

Comparing the average quarterly number of patients enrolled across the last few years here on this slide, on quarterly average in 2022 through the first quarter of 2024, we have increased the number of patients enrolled by over 400%.

比較這張投影片上過去幾年的平均季度入組患者人數，與 2022 年至 2024 年第一季的季度平均人數相比，我們入組的患者數量增加了 400% 以上。

On the back of this significant increase in enrollment and tug progress in clinical trial execution, we expect our clinical development pipeline to generate the corresponding increase in the number of data sets in the coming years.

在註冊人數顯著增加和臨床試驗執行的拖拉進展的背景下，我們預計我們的臨床開發管道將在未來幾年產生數據集數量的相應增加。

Our ultimate goal at BioNTech is to bring our database scientific breakthroughs to patients in need. Moving to our priority assets. Let me start with BNT327 or PM8002, a bispecific antibody, consisting of an anti-VEGF-A [SC silence IGG], fused to a humanized anti-PD-L1 VHH binder being developed in collaboration with our partner, Biotheus. BNT327 combined 2 validated mechanisms of action. VEGF A binding inhibits the VEGF A, VEGF-R access, blocks tumor angiogenesis, which leads to reduced tumor cell proliferation and survival. VEGF A inhibition also counter formation of the immunosuppressive tumor microenvironment as does the PD-L1 arm of its bBispecific antibody by rewarding PD-L1, PD-1 axis mediated T-cell exhaustion.

BioNTech 的最終目標是將我們的資料庫科學突破帶給有需要的患者。轉向我們的優先資產。讓我從 BNT327 或 PM8002 開始，這是一種雙特異性抗體，由與我們的合作夥伴 Biotheus 合作開發的人源化抗 PD-L1 VHH 結合物融合的抗 VEGF-A [SC 沉默 IGG] 組成。 BNT327 結合了 2 種經過驗證的作用機制。 VEGF A 結合抑制 VEGF A、VEGF-R 通路，阻斷腫瘤血管生成，進而導致腫瘤細胞增生和存活減少。 VEGF A 抑制還可以透過獎勵 PD-L1、PD-1 軸介導的 T 細胞耗竭來對抗免疫抑制性腫瘤微環境的形成，其 bBi 特異性抗體的 PD-L1 臂也是如此。

With PD-L1 arm also anchors this antibody to the tumor [badge] for efficient and localized scavenging of VEGF A, which may contribute to mitigate off tumor on target side effects, data from ongoing Phase I/II clinical trials across several indications in over 600 patients executed by our partner Biotheus have shown a favorable safety profile.

PD-L1 臂也將這種抗體錨定在腫瘤上，以有效、局部地清除VEGF A，這可能有助於減輕腫瘤對標靶的副作用，這些數據來自正在進行的I/II 期臨床試驗，涉及多個適應症。

Our partner Biotheus presented selected examples of this compound's performance in 2023, showing strong single compound activity and high response rates in combination with chemotherapy in triple-negative breast cancer and small cell lung cancer. In first-line TNBC in combination with nab-paclitaxel, almost 80% objective response rate, as shown on this slide.

我們的合作夥伴 Biotheus 在 2023 年展示了該化合物的性能精選示例，顯示出強大的單一化合物活性以及與化療聯合治療三陰性乳腺癌和小細胞肺癌的高緩解率。在第一線 TNBC 與白蛋白結合型紫杉醇合併治療中，客觀緩解率接近 80%，如這張投影片所示。

At ASCO now there will be more data disclosures and cervical in ovarian cancer and in non-small cell lung cancer. An investigational new drug application has been accepted by the FDA for further studies in the United States and we plan to start global trials in several indications this year.

現在，ASCO 將揭露更多子宮頸癌、卵巢癌和非小細胞肺癌的數據。 FDA 已接受一項研究性新藥申請，以便在美國進行進一步研究，我們計劃今年啟動多個適應症的全球試驗。

One area that we'll see increased development activity in the coming years will be our mRNA cancer vaccine candidates. mRNA cancer vaccines are the centerpiece of our pipeline and are pivotal to our goal of developing breakthroughs for cancer patients. The aim is to develop this technology as monotherapy in combination with standard of care and in combination with candidates from our proprietary pipeline.

未來幾年我們將看到開發活動增加的一個領域是我們的 mRNA 癌症候選疫苗。 mRNA 癌症疫苗是我們產品線的核心，對於我們為癌症患者取得突破的目標至關重要。目的是將這項技術開發為單一療法，與標準護理相結合，並與我們專有管道中的候選人相結合。

Our FixVac vaccines used sets of multiple antigens shared by patients across one tumor type. iNeST our individualized vaccine program partnered with Genentech identified neoantigens derived from cancer mutations that are unique to an individual tumor. While iNeST and FixVac target different types of cancer cell antigens, they are based on the same mRNA and delivery technology, namely our uridine and mRNA Lipoplex platform.

我們的 FixVac 疫苗使用了一種腫瘤類型患者共有的多種抗原。 iNeST 我們的個人化疫苗計畫與 Genentech 合作，鑑定出源自個體腫瘤特有的癌症突變的新抗原。雖然 iNeST 和 FixVac 針對不同類型的癌細胞抗原，但它們基於相同的 mRNA 和遞送技術，即我們的尿苷和 mRNA Lipoplex 平台。

Its distinct mechanism of action is that the delivered antigen is presented by professional antigen-presenting cells and lipid compartment body-wide in close proximity to T cells to be induced and that it comes with intrinsic adjuvanticity. These features by design from auto induction of higher magnitude T cell immune responses that we have been detecting in all our clinical trials across tumor types and for various types of targeted cancer set antigens as shown on the right-hand side of this slide.

其獨特的作用機制是，所遞送的抗原由專業抗原呈現細胞和全身範圍內的脂質室呈現，與待誘導的 T 細胞非常接近，並且具有內在的佐劑性。這些特徵是透過自動誘導更高強度的T 細胞免疫反應而設計的，我們在跨腫瘤類型和各種類型的靶向癌症集抗原的所有臨床試驗中檢測到這些免疫反應，如本幻燈片右側所示。

On the next slide, you can see exemplary data from different trials in different treatment settings and tumor types in which we are evaluating our neoantigen-based individualized cancer vaccines, including several years of follow-up. Our mRNA-based neoantigen vaccine has demonstrated the ability to induce de novo neoantigen-specific polyfunctional, polyspecific and persistent T cell responses at substantial magnitude in high proportions of treated patients, frequently against tumor antigens that were overlooked by the patient's immune system, so-called de novo immune responses.

在下一張投影片上，您可以看到不同治療環境和腫瘤類型的不同試驗的示範數據，我們正在評估基於新抗原的個人化癌症疫苗，包括幾年的追蹤。我們的基於mRNA 的新抗原疫苗已證明能夠在高比例的治療患者中誘導大量新抗原特異性、多功能、多特異性和持久的T 細胞反應，通常針對被患者免疫系統忽視的腫瘤抗原，因此-稱為從頭免疫反應。

We have shown that our vaccine-induced T cells persist over years and built immunological memory. And the 2 papers quoted on this slide, we have shown that vaccination with neoantigens encoding mRNA is associated with reduction of recurrences in patients. The favorite setting for developing our individualized vaccines are patients that have minimal residual disease or require adjuvant treatment to reduce the probability of recurrent.

我們已經證明，疫苗誘導的 T 細胞可以持續存在多年並建立免疫記憶。在這張投影片上引用的 2 篇論文中，我們已經證明，接種編碼 mRNA 的新抗原與減少患者復發有關。開發我們的個人化疫苗的最佳環境是具有微小殘留疾病或需要輔助治療以降低復發可能性的患者。

Today, we have iNeST and FixVac trials in multiple disease settings and indications and data releases from several of the trials shown on the slide upland. In our FixVac program, we are evaluating 4 vaccine candidates, which each target tumor-associated antigens specific to melanoma, HPV16+ head and neck cancer, prostate cancer and non-small lung cancer, as monotherapy and in several combinations.

今天，我們在多種疾病環境下進行了 iNeST 和 FixVac 試驗，並發布了幻燈片高地上顯示的幾項試驗的適應症和數據。在我們的 FixVac 計畫中，我們正在評估 4 種候選疫苗，每種疫苗都針對黑色素瘤、HPV16+ 頭頸癌、前列腺癌和非小細胞肺癌特異性的腫瘤相關抗原，作為單一療法和多種組合療法。

We shared early data for all FixVac candidates in the past years and plan to present additional data within next year. Further, we plan to start an additional trial with iNeST in the adjuvant setting with our collaborator Genentech. I would like to highlight 3 of these programs that are on our priority list. Two programs using our individualized cancer vaccine and cancer types that have a low tumor mutational burden and are resistant to immune therapy, namely colorectal cancer and PDAC and our NSCLC FixVac program.

我們分享了過去幾年所有 FixVac 候選人的早期數據，並計劃在明年內提供更多數據。此外，我們計劃與我們的合作夥伴 Genentech 在佐劑環境中開始一項 iNeST 的額外試驗。我想強調一下我們優先考慮的其中 3 個項目。兩個計畫使用我們的個人化癌症疫苗和腫瘤突變負荷低且對免疫治療具有抵抗力的癌症類型，即結直腸癌和 PDAC 以及我們的 NSCLC FixVac 計畫。

Starting with CRC with colorectal cancer. The majority of patients with early-stage localized and resectable CRC under more surgery followed by adjuvant chemotherapy standard of care in stage II high risk and Stage III disease after acumen treatment is record full weighting, 20% to 35% of patients experience recurrence of their disease.

從大腸直腸癌開始。 The majority of patients with early-stage localized and resectable CRC under more surgery followed by adjuvant chemotherapy standard of care in stage II high risk and Stage III disease after acumen treatment is record full weighting, 20% to 35% of patients experience recurrence of their疾病.

ctDNA is a marker for minimal residual disease and identified patients with high risk of such recurrence. We are running a Phase II trial with our individualized vaccine in stage II high-risk and Stage III resected CRC patients that are ctDNA positive port surgery. After adjuvant chemotherapy patients are randomized to either receive autogene cevumeran or individualized vaccine or observations. We expect the first readout of this trial in the second half of 2025.

ctDNA 是微小殘留疾病的標記物，可識別具有此類復發高風險的患者。我們正在對 ctDNA 陽性端口手術的 II 期高風險和 III 期切除的 CRC 患者進行 II 期試驗，使用我們的個體化疫苗。輔助化療後，患者被隨機分配接受自體 cevumeran 或個別化疫苗或觀察。我們預計該試驗的首次結果將於 2025 年下半年公佈。

Secondly, a randomized Phase II clinical trial evaluating our individualized vaccine in combination with the anti-PD-L1 agent, atezolizumab, followed by standard of care chemotherapy in patients with resected pancreatic cancer, the PDAC compared to chemotherapy alone was started in collaboration with Genentech in 2023 and is recruiting patients. PDAC is a high medical need tumor expected to become the second leading cause in cancer-related death, up to 85% of patients with localized pancreatic cancer that undergo surgical resection and adjuvant chemotherapy do experience recurrence of disease.

其次，與Genentech 合作啟動了一項隨機II 期臨床試驗，評估我們的個人化疫苗與抗PD-L1 藥物atezolizumab 的組合，然後對已切除的胰腺癌患者進行標準護理化療，與單獨化療進行比較。 PDAC 是一種醫療需求較高的腫瘤，預計將成為癌症相關死亡的第二大原因，高達 85% 的局限性胰腺癌患者在接受手術切除和輔助化療後確實會出現疾病復發。

This trial was initiated based on data from an investigator-initiated trial that were published last year and updated at AACR a few weeks ago. That Phase I trial showed that with our individualized vaccine combined with atezolizumab and standard of care adjuvant chemotherapy half of the 16 treated patients develop high-magnitude vaccine-induced immune responses and that these patients have a much lower risk of tumor recurrence at 1.5 years of medium follow up and continue to do so after a 3-year follow-up period.

該試驗是根據一項研究者發起的試驗的數據啟動的，該試驗於去年發表，並於幾週前在 AACR 進行了更新。此I 期試驗表明，透過我們的個人化疫苗結合atezolizumab 和標準護理輔助化療，16 名接受治療的患者中有一半出現了高強度的疫苗誘導的免疫反應，並且這些患者在1.5 年的治療後腫瘤復發的風險要低得多。

Moving to our off-the-shelf tumor-associated antigen-based mRNA cancer vaccine candidate, BNT116. BNT116 is an RNA lipoplex cancer vaccine candidate comprising 6 mRNAs, each including a tumor-associated antigen, Mage-A3, CLDN6.

轉向我們現成的基於腫瘤相關抗原的 mRNA 癌症候選疫苗 BNT116。 BNT116 是一種 RNA lipoplex 癌症候選疫苗，包含 6 個 mRNA，每個 mRNA 均包含腫瘤相關抗原、Mage-A3、CLDN6。

KK-LC-1, PRAME, MAGE-A4, and MAGE-C1. We have selected these tumor-associated antigens by an [initial] approach developed for design of FixVac vaccines for different tumor types. And based on low or lack of expression in toxicity relevant orders, expression and a substantial fraction of lung tumors of various histologies, immunogenicity and tumor biological role.

KK-LC-1、PRAME、MAGE-A4 和 MAGE-C1。我們透過為不同腫瘤類型設計 FixVac 疫苗而開發的[初始]方法選擇了這些腫瘤相關抗原。並基於毒性相關順序的低表達或缺乏表達，表達與大部分肺腫瘤的各種組織學、免疫原性和腫瘤生物學作用有關。

About 85% of and NSCLC specimens express at least 1 of the 6 selected tumor-associated antigens and more than 60% expressed at least 2 of them. BNT116 is currently being evaluated with our partner Regeneron in 2 clinical trials that cover various non-small cell lung cancer patient population. One is the Phase I trial, investigating BNT116 in adjuvant first-line and second-line tapsettings and various treatment regimens assisted on the left side of the slide.

約 85% 的 NSCLC 樣本表達 6 種選定的腫瘤相關抗原中的至少 1 種，超過 60% 的樣本表達至少其中 2 種。 BNT116 目前正在與我們的合作夥伴再生元 (Regeneron) 進行兩項臨床試驗的評估，這些試驗涵蓋了各種非小細胞肺癌患者群體。其中一項是 I 期試驗，研究 BNT116 在輔助一線和二線tapsettings 中的應用以及幻燈片左側輔助的各種治療方案。

We plan to introduce another unique combination cohorts into this multi-cohort Phase I trial. The second trial is a randomized Phase II, evaluating BNT116 in combination with cemiplimab in first-line treatment of patients with PD-L1 high expressing non-small cell cancer shown on the right side of the slide.

我們計劃在這個多隊列 I 期試驗中引入另一個獨特的組合隊列。第二個試驗是隨機 II 期試驗，評估 BNT116 合併 cemiplimab 對 PD-L1 高表達非小細胞癌患者的第一線治療，如幻燈片右側所示。

At AACR, we presented preliminary results from Cohort 3 of LuCa-MERIT-1, Phase I trial evaluating BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non-small cell lung cancer that progressed on PD-1, PD-L1 inhibitor and platinum-based chemotherapy.

在AACR 上，我們展示了LuCa-MERIT-1 第一階段試驗第3 組的初步結果，該試驗評估BNT116 聯合多西他賽治療使用PD-1、PD-L1 抑制劑進展的晚期不可切除或轉移性非小細胞肺癌患者和鉑類化療。

Combination treatment with BNT116 and docetaxel was active with an overall response rate of 30%, a disease control rate of 85%, median progression-free survival of 4.4 months, comparable to other FixVac candidates, BNT116 presents a manageable safety profile alone and in combination.

BNT116 和多西紫杉醇的合併治療效果良好，整體緩解率為30%，疾病控制率為85%，中位無惡化存活期為4.4 個月，與其他FixVac 候選藥物相比，BNT116 單獨使用和合併使用均呈現可控的安全性。

We expect further data from these cohorts in the next 12 months and that will inform further development of BNT116 in Lancet. The ASCO Annual Meeting is right around the corner. At ASCO, we and our partners will present new clinical data for several of our programs, data that is of relevance for making informed decisions about the direction of those project development.

我們預計在未來 12 個月內從這些隊列中獲得更多數據，這將為《柳葉刀》中 BNT116 的進一步開發提供資訊。 ASCO 年會即將召開。在 ASCO，我們和我們的合作夥伴將為我們的幾個項目提供新的臨床數據，這些數據與就這些項目開發方向做出明智的決策相關。

Firstly, we and Genmab plan to present data for BNT311 from our Phase II and post-IO non-small cell lung cancer patients. BNT311 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with 4-1BB costimulatory activation. Second, as already mentioned, monotherapy data from Phase II trials are planned to be presented for BNT327, the bispecific anti-VEGF-A, anti-PD-L1 antibody we are developing in collaboration with Biotheus.

首先，我們和 Genmab 計劃提供來自我們的 II 期和 IO 後非小細胞肺癌患者的 BNT311 數據。 BNT311 是一種將 PD-L1 檢查點抑制與 4-1BB 共刺激活化相結合的雙特異性候選抗體。其次，正如已經提到的，計劃提供 BNT327 的 II 期試驗的單藥治療數據，BNT327 是我們與 Biotheus 合作開發的雙特異性抗 VEGF-A、抗 PD-L1 抗體。

Third, we and our partner, MediLink plan to present first in human data for our free targeting ADC. Then we will also present epidemiologic data, including post-operative ctDNA prevalence and prognostic value from a non-interventional observational study in patients with resected high-risk stage II, stage III colorectal cancer that supports and informs the development of our individualized vaccine in this patient population.

第三，我們和我們的合作夥伴 MediLink 計畫首先為我們的免費標靶 ADC 提供人類數據。然後，我們還將提供流行病學數據，包括手術後ctDNA 盛行率和對已切除高風險II 期、III 期結直腸癌患者進行的非干預性觀察研究的預後價值，該數據支持並為我們在此領域開發個體化疫苗提供資訊。

And lastly, for BNT211, our CAR-T cell product candidate, we plan to initiate a potentially registrational trial in patients with germ cell tumors. At ASCO, we will present real-world evidence of overall survival and treatment patterns of this patient population in the U.S. that will inform the trial design for our Phase II trial.

最後，對於我們的 CAR-T 細胞候選產品 BNT211，我們計劃在生殖細胞腫瘤患者中啟動一項潛在的註冊試驗。在 ASCO，我們將提供美國該患者群體的整體存活率和治療模式的真實世界證據，這將為我們的 II 期試驗的試驗設計提供資訊。

With that, I will now pass the presentation to our CFO, Jens Holstein.

現在，我將把演講轉交給我們的財務長 Jens Holstein。

A warm welcome to everyone who has dialed in today's call. Let me begin my section with some key financial figures for Q1 2024. In the first quarter of 2024, we reported total revenues of approximately EUR 188 million driven mostly by commercial revenues from the sales of our COVID-19 vaccine. This revenue figure is consistent with our internal expectations for the period and reflects the seasonality that we expect in endemic environment for our COVID-19 vaccine.

熱烈歡迎所有撥打今天電話的人。讓我以 2024 年第一季的一些關鍵財務數據開始本節。這一收入數字與我們對該期間的內部預期一致，並反映了我們在流行環境下對 COVID-19 疫苗的季節性預期。

Our group revenues will continue to be driven largely by the uptake of our COVID-19 vaccines until oncology revenues will be recognized. We expect to recognize approximately 90% of our full year revenues in the last month of 2024, mostly in Q4.

在腫瘤學收入得到確認之前，我們的集團收入將繼續主要由我們的 COVID-19 疫苗的使用所推動。我們預計將在 2024 年最後一個月（主要是第四季）確認全年收入的約 90%。

In terms of our operational spending, we are also in line with our internal plans and ended the first quarter with a loss before tax of EUR 332 million. We maintained our strong financial position with EUR 16.9 billion in total cash plus security investments at the end of the quarter. As mentioned by my colleagues before, we started the year making real progress across our oncology pipeline. We dosed the first patient in our second pivotal Phase III trial and are on track to start multiple additional potentially registrational trials this year.

在營運支出方面，我們也符合內部計劃，第一季末稅前虧損為 3.32 億歐元。截至本季末，我們的現金加證券投資總額為 169 億歐元，維持了強勁的財務狀況。正如我的同事之前提到的，我們在今年開始時就在腫瘤學研發管線上取得了真正的進展。我們在第二個關鍵的 III 期試驗中對第一位患者進行了給藥，並有望在今年啟動多個額外的潛在註冊試驗。

Our focus remains on our late-stage clinical trials and to invest in our mRNA platform approaches that represent the core capability of BioNTech and differentiates us from others in the industry. We also continue to invest in our leading and profitable COVID-19 vaccine business.

我們的重點仍然是後期臨床試驗，並投資於我們的 mRNA 平台方法，這些方法代表了 BioNTech 的核心能力，並使我們與業內其他公司區分開來。我們也繼續投資於我們領先且獲利的 COVID-19 疫苗業務。

Alongside our partner, Pfizer, we are working on variant-adapted COVID-19 vaccines for the upcoming vaccination season. We also continue to invest in our leading and profitable COVID-19 vaccine business. Alongside our partner, Pfizer, we are working on variant-adapted COVID-19 vaccines for the upcoming vaccination season.

我們正在與我們的合作夥伴輝瑞公司合作，為即將到來的疫苗接種季節開發適應變體的 COVID-19 疫苗。我們也繼續投資於我們領先且獲利的 COVID-19 疫苗業務。我們正在與我們的合作夥伴輝瑞公司合作，為即將到來的疫苗接種季節開發適應變體的 COVID-19 疫苗。

We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand as approved.. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

我們還投資了一種COVID-19 流感組合疫苗候選藥物，我們預計該疫苗一旦獲得批准，可能會推動額外需求。的管道，並做好準備實現未來的可持續成長。

I'll now be going into a little more detail on our financial results for the first quarter of 2024. As noted earlier, our total revenues reported for the first quarter of 2024 reached EUR 188 million compared with approximately EUR 1.3 billion for the first quarter of 2023.

我現在將更詳細地介紹我們 2024 年第一季的財務業績。

Moving to cost of sales. These amounted to EUR 59.1 million for the first quarter of 2024 compared to EUR 96 million for the comparative prior year period. Research and development expenses reached EUR 508 million for the first quarter of 2024 compared to EUR 334 million for the comparative prior year period. The increase was mainly due to progressing clinical studies for our oncology pipeline and related personnel expenses to manage those.

轉向銷售成本。 2024 年第一季的金額為 5,910 萬歐元，而去年同期為 9,600 萬歐元。 2024 年第一季的研發費用達到 5.08 億歐元，而去年同期為 3.34 億歐元。這一增長主要是由於我們的腫瘤產品線的臨床研究進展以及管理這些產品的相關人員費用。

Sales and marketing expenses of EUR 16 million impaired in the first quarter of 2024 compared to EUR 12 million in the comparative prior year period. General and administrative expenses amounted to EUR 117 million for the first quarter of 2024 compared to EUR 112 million for the comparative prior year period. The increase in SG&A was mainly due to increased expenses for IT services as well as an increase in head count to support the scaling of our business.

2024 年第一季銷售和行銷費用減值 1,600 萬歐元，而去年同期為 1,200 萬歐元。 2024 年第一季的一般及管理費用為 1.17 億歐元，而去年同期為 1.12 億歐元。 SG&A 的增加主要是由於 IT 服務費用的增加以及支援業務擴展的人員數量的增加。

Income taxes were realized with an amount of EUR 16.7 million for the first quarter of 2024 compared to EUR 205.5 million of tax expenses for the comparative prior year period. The derived effective tax rate for the first quarter of 2024 was approximately 5% applicable on the negative income. For the first quarter of 2024, we reported a net loss of EUR 315 million compared to a net profit of approximately EUR 502 million for the comparative prior year period.

2024 年第一季的所得稅金額為 1,670 萬歐元，而去年同期的稅務費用為 2.055 億歐元。得出的 2024 年第一季適用於負收入的有效稅率約為 5%。 2024 年第一季度，我們報告淨虧損 3.15 億歐元，而去年同期淨利潤約為 5.02 億歐元。

Our loss per share for the first quarter of 2024 amounted to EUR 1.31 compared to a diluted profit per share of EUR 2.05 for the comparative prior year period. As indicated earlier this year, 2024 is a year for our company during which we will continue to invest in our long-term growth strategy.

2024 年第一季的每股虧損為 1.31 歐元，而去年同期的稀釋每股利潤為 2.05 歐元。正如今年稍早所指出的，2024 年是我們公司將繼續投資長期成長策略的一年。

We aim to have potentially 10-plus trials running by year-end 2024, which we believe will change the picture of the company going forward. Besides having a strong franchise in [fetches] diseases, we aim to have multiple oncology products reaching the market by 2026 onwards.

我們的目標是到 2024 年底進行 10 多項試驗，我們相信這將改變公司未來的面貌。除了在 [fetches] 疾病領域擁有強大的特許經營權外，我們的目標是到 2026 年起將多種腫瘤產品推向市場。

Turning to the next slide, I would like to emphasize that we have reiterated the company's financial guidance for the 2024 financial year. As mentioned previously, we expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4. Additionally, we also reiterate our R&D and SG&A guidance from our year-end call with EUR 2.4 billion to EUR 2.6 billion for R&D and EUR 700 million to EUR 800 million for SG&A expenses. Those expenses are expected to gradually increase quarter-by-quarter until year-end.

轉向下一張投影片，我想強調，我們重申了公司 2024 財年的財務指引。如前所述，我們預計將在 2024 年最後幾個月（主要是第四季）確認全年收入的約 90%。此外，我們也重申了年終電話會議中的研發和銷售及管理費用指引，其中研發費用為 24 億至 26 億歐元，銷售費用為 7 億至 8 億歐元。預計這些費用將逐漸增加，直到年底。

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

在此，我想將電話轉給我們的首席策略長 Ryan Richardson，以了解我們策略前景的最新情況和總結發言。

We are working with Pfizer to be ready to launch our variant-adapted COVID-19 vaccine in the second half of the year upon regulatory approval. Consistent with the WHO's recommendation. We expect that the updated vaccine will encode the JN.1 variant and will be monovalent. As of April 2024, over 90% of SARS-CoV-2 genetic sequences and publicly available databases were derived from the JN. 1 variant.

我們正在與輝瑞合作，準備在監管部門批准後於今年下半年推出我們的變體適應的 COVID-19 疫苗。與世界衛生組織的建議一致。我們預計更新後的疫苗將編碼 JN.1 變體並且是單價的。截至 2024 年 4 月，超過 90% 的 SARS-CoV-2 基因序列和公開資料庫均來自 JN。 1 個變體。

In 2023, we received strain inclusion recommendations from the WHO and other advisory committees in May and June and were granted approval in late August and September. This year, the time lines for strain selection and those anticipated for approval are expected to come earlier. The WHO and EMA have already received strain recommendations and expect additional regulatory updates in mid-May.

2023 年，我們於 5 月和 6 月收到了世界衛生組織和其他諮詢委員會的菌株納入建議，並於 8 月下旬和 9 月獲得批准。今年，菌株選擇和預期批准的時間預計會提前。 WHO 和 EMA 已收到菌株建議，預計 5 月中旬將會有更多監管更新。

We expect approval in the EU and FDA could come in late July and August, respectively. If this occurs, it could enable an earlier launch of vaccines relative to last year to support full vaccination campaigns.

我們預計歐盟和 FDA 的批准可能會分別在 7 月下旬和 8 月獲得。如果發生這種情況，可能會比去年更早推出疫苗，以支持全面的疫苗接種活動。

We are preparing to launch the variant-adapted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U.S. will continue to be served by government contracts, we do expect some new private markets in regions like the U.K. to open in 2024. This could enable individuals who may not qualify under existing immunization recommendations to access updated COVID-19 vaccine should they choose to do so.

我們正準備在全球 80 多個地區推出適應變異的 COVID-19 疫苗。雖然美國以外的大多數地區將繼續接受政府合約的服務，但我們確實預計英國等地區的一些新的私人市場將於2024 年開放。獲得更新的COVID-19他們應該選擇接種疫苗。

Turning to the next slide. Our aim is to create value for patients and shareholders by delivering sustained longterm growth and our strategy is to continue to invest in our technology platforms and diverse pipeline. We believe each of the drug classes we are investing in contain product candidates that aim to address major unmet needs and could unlock significant commercial potential.

轉到下一張投影片。我們的目標是透過持續的長期成長為患者和股東創造價值，我們的策略是繼續投資於我們的技術平台和多樣化的產品線。我們相信，我們投資的每一類藥物都包含旨在解決主要未滿足需求的候選產品，並且可以釋放巨大的商業潛力。

We are entering a catalyst-rich period over the next 12 to 24 months with data updates expected for more and more product candidates across each of these classes. We look forward to disclosing additional pivotal trials and more details on our go-to-market strategy for selected programs in the months ahead.

我們將在未來 12 至 24 個月內進入催化劑豐富的時期，預計每個類別中都會有越來越多的候選產品進行資料更新。我們期待在未來幾個月內披露更多關鍵試驗以及有關我們選定項目的上市策略的更多細節。

To conclude on the next slide, our aim is to transform medicine through successive wave of innovation. We remain focused on our near-term goal to have 10-plus potentially registrational trials initiated by year-end 2024 and to continue to ramp up our commercial readiness activities.

下一張投影片的結論是，我們的目標是透過連續不斷的創新浪潮來改變醫學。我們仍然專注於我們的近期目標，在 2024 年底之前啟動 10 多項潛在的註冊試驗，並繼續加強我們的商業準備活動。

Over the midterm, we aim to enter the commercial stage in oncology by 2026 with our first product candidates while advancing our pipeline of late-stage and novel combination therapies.

從中期來看，我們的目標是到 2026 年，我們的首批候選產品進入腫瘤學商業階段，同時推進我們的後期和新型聯合療法的研發管線。

Longer term, we aim to broaden our portfolio of approved products and transform BioNTech into a diversified multiproduct immunotherapy company that is in a position to redefine medicine. We are truly excited by the potential our technologies and pipeline hold to make a difference for patients around the world.

從長遠來看，我們的目標是擴大我們的核准產品組合，並將 BioNTech 轉型為一家能夠重新定義醫學的多元化多產品免疫治療公司。我們對我們的技術和產品線為世界各地的患者帶來改變的潛力感到非常興奮。

Before opening the floor for questions, I would like to highlight on the next slide, important investor events we will be holding this year. Our Annual General Meeting will take place on May 17, and our inaugural artificial intelligence and machine learning event will take place on October 1. Our main 2024 Innovation Series event is planned for November 14. We will share further details on these events in due course.

在開始提問之前，我想在下一張投影片上強調我們今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17 日舉行，我們的首屆人工智慧和機器學習活動將於10 月1 日舉行。有關這些活動的更多詳細資訊。

With that, I would like to open the call for questions.

至此，我想開始提問。

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

（操作員說明）您的第一個問題來自美國銀行的 Tazeen Ahmad。

For the data that you're going to be presenting at the upcoming ASCO conference as it relates to the Genmab compound, can you just remind us how many patients worth of data to expect? And once that data is presented, can you talk to us about the next steps in the development plan for that program?

對於您將在即將召開的 ASCO 會議上展示的與 Genmab 化合物相關的數據，您能否提醒我們預計有多少患者的數據值得？一旦提供了這些數據，您能否與我們談談該專案開發計劃的後續步驟？

The first question was about the number of patients which we will present for the second-line non-small cell lung cancer trial with BNT311. Did I get that right?

第一個問題是關於我們將介紹 BNT311 二線非小細胞肺癌試驗的患者數量。我做對了嗎？

Yes, that's right.

恩，那就對了。

So that will be -- I cannot tell you the specific numbers from the top of my head, but these will be around 100 patients, so a substantial number of patients.

所以，我無法直接告訴你具體的數字，但這些患者大約有 100 名，所以數量相當多。

And also what level of detail should we expect to see?

我們應該看到什麼程度的細節？

So you will see safety data, the activity data, which we have until then and ORR data.

因此，您將看到我們在此之前擁有的安全資料、活動資料以及 ORR 資料。

Okay. And what is the plan moving forward with this program?

好的。該計劃的後續計劃是什麼？

We are in the planning phase with our partner, Genmab, so that we cannot disclose any specifics at this time, but you will hear more about this program sometime later this year.

我們正與合作夥伴 Genmab 一起進行規劃，因此目前無法透露任何具體細節，但您將在今年稍後聽到有關該計劃的更多資訊。

(Operator Instructions) And your next question comes from the line of Daina Graybosch from Leerink Partners.

（操作員說明）您的下一個問題來自 Leerink Partners 的 Daina Graybosch。

I have another one on ASCO. So I wonder if you could talk more about the data we should expect from PM8002 at ASCO. And also, if you could talk about how this molecule compares to the competitor from Akeso Summit, which also is a bispecific of VEGF, but targeting PD-1 rather than your PD-L1. How much read-through positively can we take from the Akeso data to yours and from yours to the Akeso data for the overall approach?

我在 ASCO 上還有另一張。所以我想知道您是否可以更多地談談我們應該從 ASCO 的 PM8002 獲得的數據。另外，您能否談談該分子與 Akeso Summit 的競爭對手相比如何，後者也是 VEGF 的雙特異性分子，但針對的是 PD-1 而不是 PD-L1。我們可以從康方資料到您的資料以及從您的資料到康方資料的整體方法中獲得多少正面的解讀？

So we have, at the moment, the clinical target running in multiple indications, including also indications with single arm and combination. What we are going to update is on ASCO is on the cervical cancer, and platinum-resistant ovarian cancer and non-small cell lung cancer.

因此，目前我們的臨床目標有多種適應症，包括單臂和合併適應症。我們要更新的是ASCO關於子宮頸癌、鉑類抗藥性的卵巢癌和非小細胞肺癌的內容。

And you will see response data and safety data in this cohort. Just to remind you, we have presented already response data on the combination in triple-negative breast cancer and small cell lung cancer, which are very encouraging, showing also responses in the PD-L1 or cold tumors, PDL-1 negative or cold tumors.

您將在該佇列中看到回應資料和安全資料。只是提醒您，我們已經提供了三陰性乳癌和小細胞肺癌組合的反應數據，這些數據非常令人鼓舞，也顯示了對 PD-L1 或冷腫瘤、PDL-1 陰性或冷腫瘤的反應。

And we expect to present similar data now for non-small lung cancer. Of course, we do not have direct comparison competitive data with Akeso, but I think the data that we are seeing goes into the same direction and this bispecific and that means direct targeting of the PD-L1 access plus VEGF access is -- appears to be associated with a better response rate as well as a better safety profile as compared to anti-VEGF treatment.

我們預計現在將針對非小細胞肺癌提供類似的數據。當然，我們沒有與康方生物直接比較的競爭數據，但我認為我們看到的數據是同一個方向，而且這種雙特異性，這意味著直接靶向 PD-L1 通路和 VEGF 通路似乎與抗VEGF 治療相比，具有更好的反應率和更好的安全性。

So we are very excited about using these compounds as combination -- a combination of our approach for chemotherapies and in the upcoming future for ADCs.

因此，我們對將這些化合物作為組合使用感到非常興奮——這是我們的化療方法和未來 ADC 方法的結合。

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

您的下一個問題來自 Jefferies 的 Akash Tewari。

This is more high level. But in the past, I know the team has tried to position BioNTech as an earnings growth story. With that in mind, what is the best estimate for BioNTech returning to consistent profitability. Is this something that should occur once COVID flu enters the market? Or is this more tied to your oncology pipeline?

這是更高層次的。但在過去，我知道該團隊曾試圖將 BioNTech 定位為獲利成長的故事。考慮到這一點，BioNTech 恢復穩定獲利的最佳估計是多少。一旦新冠流感進入市場，這種情況就該發生嗎？或者這與您的腫瘤學管道更相關嗎？

And then separately, would you look to work with the large cap partner to launch your ADCs and broader oncology pipeline? Or would you look to build that commercial sales force internally?

然後，您是否會尋求與大型合作夥伴合作推出您的 ADC 和更廣泛的腫瘤學產品線？還是您希望在內部建立商業銷售團隊？

I'll start with maybe the second part of it. I think strategic partnerships have been one of the hallmarks in oncology early on and also with COVID-19. And I think, we will continue to evaluate partnerships asset by asset to see if that could help us accelerate certain assets, broaden their reach geographically or even help us reach profitability sooner for specific assets where there might be a partner that brings infrastructure that's relevant.

我將從第二部分開始。我認為策略夥伴關係一直是腫瘤學早期的標誌之一，也是 COVID-19 的標誌之一。我認為，我們將繼續逐項評估合作夥伴關係，看看這是否可以幫助我們加速某些資產的發展，擴大其地理範圍，甚至幫助我們更快地實現特定資產的盈利，因為可能有合作夥伴帶來相關的基礎設施。

Generally speaking though, we do -- now we have a strong balance sheet. We do want to retain more of the economics as a general matter of strategy. So I think that those partnering decisions are going to really be made on an asset-by-asset basis, while at the same time, we do commit to actually build a commercial presence in oncology in the major markets. And so that is going to be a priority over the next couple of years.

但總的來說，我們確實如此——現在我們擁有強大的資產負債表。我們確實希望保留更多的經濟學因素作為一般策略問題。因此，我認為這些合作決策將真正在逐個資產的基礎上做出，同時，我們確實致力於在主要市場的腫瘤學領域中真正建立商業存在。因此，這將成為未來幾年的優先事項。

I'll let Jens speak a little bit to the profitability point, but I'll just say high level at the outset that we do see, as you've alluded, that there's an opportunity here with the pipeline that we're building and advancing now into late-stage studies to deliver long-term sustained growth, driven by successive product launches.

我會讓 Jens 談談盈利點，但我只想從一開始就說，正如您所提到的，我們確實看到，我們正在建設的管道存在機會，目前正在進入後期研究，以在連續產品推出的推動下實現長期持續成長。

We've indicated 2026 as a significant time point in those plans, but really, the plans go beyond that, and that's why we put out the target of having 10 approval in oncology by 2030, highlighting that we do think that, that revenue growth can come from multiple indication approvals and multiple products.

我們已經指出2026 年是這些計劃中的一個重要時間點，但實際上，這些計劃超出了這一點，這就是為什麼我們提出了到2030 年在腫瘤學領域獲得10 個批准的目標，強調我們確實認為收入成長可以來自多種適應症批准和多種產品。

And so that -- our priority is to get on that long-term growth trajectory and, of course, being profitable is important. But the focus right now is really getting on that growth trajectory.

因此，我們的首要任務是走上長期成長軌道，當然，獲利也很重要。但現在的重點確實是走上成長軌道。

Thanks Ryan, I think you made the most important statement already. So I mean if you look into the revenue development going forward, of course, we see some potential upside when we have a COVID flu combination within the market. And how big that upside could be, we are not 100% clear yet. We haven't given any guidance for '25 in the ongoing years for that combination. We're going to see how it evolves. In terms of our spend, I think we have shown that we control the costs as good as we can as sensible as it is.

謝謝瑞安，我認為你已經做出了最重要的聲明。所以我的意思是，如果你研究未來的收入發展，當然，當市場上出現新冠流感組合時，我們會看到一些潛在的上行空間。我們還不能 100% 清楚這上升空間有多大。在接下來的幾年裡，我們沒有為 '25 的組合提供任何指導。我們將看看它如何演變。就我們的支出而言，我認為我們已經表明我們盡可能合理地控制了成本。

We want to create value in investing in our oncology portfolio. And to lift it, I think Ryan made the statement already. We are looking, of course, to have some partners here and there regionally to lift the value going forward. But we are very optimistic in terms of the growth that we have in front of us as a company.

我們希望在腫瘤學投資組合的投資中創造價值。為了解除這一點，我認為瑞安已經發表了聲明。當然，我們希望在各地尋找一些合作夥伴來提升未來的價值。但我們對公司面臨的成長非常樂觀。

Yes. And I think -- so what you're hearing from us, Akash, is in the very short term, we do think that the COVID combination vaccine with flu, if successful, the profitability is going to be dependent in part on Covid vaccination rates, and that's one of the near-term drivers that has the potential to bring those rates up.

是的。我認為，阿卡什，您從我們這裡聽到的消息是，在非常短期內，我們確實認為，新冠肺炎聯合流感疫苗如果成功，盈利能力將部分取決於新冠疫苗接種率，這是有可能提高這些利率的近期驅動因素之一。

Your question comes from the line of Jessica Fye from JPMorgan.

你的問題來自摩根大通的 Jessica Fye。

Coming back to BNT311 and the ASCO update, which regimen would you focus us on? And what element of the profile do you expect to best showcase the product's efficacy, and related to that, what's the right benchmark to compare that efficacy metric to?

回到 BNT311 和 ASCO 更新，您會關注哪種方案？您希望設定檔中的哪些元素能夠最好地展示產品的功效，與此相關的是，比較該功效指標的正確基準是什麼？

So the regimen we will be presenting will be a combination of BNT311 with pembrolizumab in second line non-small cell lung cancer and the post-CPI population to which you would then need to compare this regimen.

因此，我們將介紹的方案將是 BNT311 與派姆單抗聯合治療二線非小細胞肺癌和 CPI 後人群，您需要將其與該方案進行比較。

Maybe I'll just throw in one more. Can you recap a hypothetical list of what the 10 potentially registrational trials running by year-end might be? I imagine you contemplated a few scenarios here, but maybe you could throw out an example or two?

也許我會再丟一個。您能否概括一下年底前可能進行的 10 項註冊試驗的假設清單？我想您在這裡考慮了一些場景，但也許您可以舉出一兩個例子？

(inaudible) trials we are trying to activate or do you want examples. Is this the question? So we have several of them activated. One example is the BNT316 trial, our cooperation with OncoC4 an entire CTLA-4, which is in non-small cell lung cancer in PD-1, PD-L1 experience in Phase III. Another trial, which is potentially registrational is our breast cancer trial in HER2-low breast cancer with BNT323, also Phase III, which has started early this year. Then in this priority asset list, we have trials with autogene cevumeran, the individualized vaccine, we are codeveloping with Genentech Roche.

（聽不清楚）我們正在嘗試啟動試驗，或者您想要範例嗎？這是問題嗎？所以我們激活了其中的幾個。一個例子是BNT316試驗，我們與OncoC4合作了一整個CTLA-4，這是在非小細胞肺癌中PD-1、PD-L1的III期經驗。另一個可能註冊的試驗是我們使用 BNT323 進行 HER2 低乳癌的乳癌試驗，也是 III 期試驗，已於今年年初開始。然後在這個優先資產清單中，我們對 autogene cevumeran 進行了試驗，這是我們與基因泰克·羅氏共同開發的個體化疫苗。

One example is our colorectal cancer trial, which will read out in around 2026. Another example is our adjuvant pancreatic cancer trial. Additionally, we will activate trials with BNT327, so the PD-L1, VEGF compound, we have talked about earlier. So these are several of the examples of potentially registrational trials, we would like to activate by end of this year.

一個例子是我們的結直腸癌試驗，該試驗將於 2026 年左右公佈。此外，我們將啟動 BNT327 的試驗，即我們之前討論過的 PD-L1、VEGF 化合物。這些是潛在註冊試驗的幾個例子，我們希望在今年年底前啟動。

One very exciting one, I should also list here, which is our trial with our CAR-T cell, CLDN6 CAR-T-cell in testicular cancer.

我還應該在這裡列出一個非常令人興奮的一項，那就是我們的 CAR-T 細胞 CLDN6 CAR-T 細胞在睪丸癌中的試驗。

And your next question comes from the line of Yaron Werber from TD Calin.

您的下一個問題來自 TD Calin 的 Yaron Werber。

This is [Brendan] on for Yaron. Just a quick one from us actually on the infectious disease pipeline. It looks like we're going to have a Phase I update from the shingles vaccine sometime this year. But I wanted to also see where you're at with enrollment and potential timing to data for maybe malaria, HSV and TV programs and kind of if there's any notable updates on how you're prioritizing this part of the pipeline?

這是亞倫的[布倫丹]。我們只是簡單介紹一下傳染病方面的情況。看起來我們將在今年某個時候對帶狀皰疹疫苗進行第一階段更新。但我還想了解一下你們在瘧疾、單純皰疹病毒和電視節目數據的註冊和潛在時間安排方面處於什麼位置，以及你們如何優先考慮這部分管道的情況是否有任何值得注意的更新？

Yes, we will provide data updates actually on the HSV-2 car on the TB tile on the malaria time, which created safety and immunogenicity data in a Phase I and are proceeding now into a Phase II setting, and the data will come at various events until end of this year.

是的，我們將在瘧疾時間的TB 板塊上提供HSV-2 汽車的實際數據更新，這在第一階段創建了安全性和免疫原性數據，現在正在進入第二階段設置，數據將在不同的時間出現。

The next question comes from the line of Etzer Darout from BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Etzer Darout。

Just another bigger picture strategy question around oncology. The fact the early combination approaches rely on external molecules, but just curious about the strategy for moving combinations of internal assets, particularly combinations of immunotherapy and targeted therapy assets, moving those into proof-of-concept studies and when we could start maybe seeing some of those emerge.

這只是圍繞腫瘤學的另一個更大的戰略問題。事實上，早期的組合方法依賴外部分子，但只是對移動內部資產組合的策略感到好奇，特別是免疫治療和標靶治療資產的組合，將它們轉移到概念驗證研究中，以及我們什麼時候可以開始看到一些其中出現。

Yes. Excellent question. This is actually one of the [strengths] that we would like now to activate. So the first type of combination ties with internal assets is CLDN6 CAR-T cell therapy with a vaccine. We have recently reported data shown indeed synergy between the 2 of the combination, increasing the persistence of T cell. We will see start end of this year, the first combination price of our ADC compounds with our IO portfolio.

是的。很好的問題。這實際上是我們現在想要激活的[優勢]之一。因此，與內部資產的第一種組合連結是 CLDN6 CAR-T 細胞療法與疫苗。我們最近報告的數據顯示，兩者的組合確實具有協同作用，增加了 T 細胞的持久性。我們將在今年年底看到我們的 ADC 化合物與 IO 產品組合的第一個組合價格。

And actually, 2025 will be an intense year where we will do multiple combination price dedicated to a contribution of components price and safety assessments to bring us into the position to go into first registrational price in our convert in the second half of 2025.

事實上，2025 年將是緊張的一年，我們將進行多種組合價格，致力於組件價格和安全評估的貢獻，以使我們能夠在2025 年下半年進入我們的轉換中的第一個註冊價格。

And your next question comes from the line of Terence Flynn from Morgan Stanley.

你的下一個問題來自摩根士丹利的特倫斯·弗林。

For BNT122, it sounds like it was on your list of registrational trials. So just wondering for the data next year from that Phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. And then again, I noticed you had an ASCO presentation on some epidemiologic data here. Again, just what are you expecting to show there at ASCO? Or what would be the key learnings?

對於 BNT122，聽起來它在您的註冊試驗清單中。因此，我想知道明年 II 期 CRC 試驗的數據，您需要在功效基礎上顯示什麼才能考慮申請加速批准。再說一次，我注意到你們在這裡做了一些流行病學資料的 ASCO 演示。再說一遍，您希望在 ASCO 上展示什麼？或者說，關鍵的學習內容是什麼？

Yes. So this study is sufficiently powered Phase II study. It is in a patient population of colorectal cancer patients who are ctDNA positive. Multiple epidemiological studies have shown that this patient population have a very poor prognosis -- actually -- and PFS in this patient population after surgery is around 12 months, after chemotherapy its around 7 months. This is actually an early metastatic patient population, and the clinical trial compares standard of care, which is adjuvant chemotherapy in this patient population versus standard of care followed by the personal [SXC.]

是的。所以這項研究是足夠有力的第二階段研究。它存在於 ctDNA 陽性的結直腸癌患者群體中。多項流行病學研究表明，實際上，該患者群體的預後非常差，該患者群體手術後的 PFS 約為 12 個月，化療後約為 7 個月。這實際上是早期轉移患者群體，臨床試驗比較了護理標準，即該患者群體中的輔助化療與隨後的個人[SXC]護理標準。

The clinical care end plant is disease-free survival. And we expect and the endpoint analysis for this prior, in the second half of 2025. The tide is enrolling as expected at the moment. And of course, this is all what you can say everything else will depend on the totality of the data.

臨床護理最終植株無病存活。我們預計先前的終點分析將在 2025 年下半年進行。當然，這就是你能說的一切，其他一切都取決於數據的完整性。

Do you want to say a few words about the epidemiological study at ASCO?

您想簡單介紹一下 ASCO 的流行病學研究嗎？

Yes, I can do that. So what we will present at ASCO is an epidemiological study. So it's not a treatment study. And we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in our ongoing clinical trial with BNT122 in particular, also of subpopulations, which are ctDNA positive because that further informs our ongoing clinical trial.

是的，我可以做到。因此，我們將在 ASCO 上展示的是一項流行病學研究。所以這不是一項治療研究。我們進行了這項流行病學研究，以便更好地了解這些患者群體的預後。我們正在進行的 BNT122 臨床試驗特別針對 ctDNA 呈陽性的亞群，因為這進一步為我們正在進行的臨床試驗提供了資訊。

In addition, this epidemiological trial is a prescreening trial to identify patients to recruit into our investigational trials. So you will get, in particular, epidemiological data of CTDNA positivity rates in high-risk populations in colorectal cancer and the disease-free survivals which are seen in this subpopulation.

此外，這項流行病學試驗是一項預先篩選試驗，旨在確定招募患者參加我們的研究試驗。因此，您將獲得結直腸癌高風險族群 CTDNA 陽性率的流行病學數據以及該亞人群的無疾病存活率。

Your next question comes from the line of Ellie Merle from UBS. Okay, due to no response, I will go to the next question. Your next question comes from the line of Bill Maughan from Canaccord.

您的下一個問題來自瑞銀集團 (UBS) 的 Ellie Merle。好吧，由於沒有回應，我將進入下一個問題。您的下一個問題來自 Canaccord 的 Bill Maughan。

So as a technology-agnostic oncology company who has not yet gotten into radiotherapy, do you see the excitement recently in that field as warranted? And if so, could we expect BioNTech to potentially get some stake in radiotherapy combination or technology by partnership or just bringing it internally? It seems like a lot of the deal sizes recently could be in the range that BioNTech could look at?

那麼，作為一家尚未涉足放射治療領域、與技術無關的腫瘤學公司，您認為該領域最近的興奮是有道理的嗎？如果是這樣，我們是否可以期望 BioNTech 通過合作或只是內部引進來獲得放射治療組合或技術的一些股份？最近似乎很多交易規模都在 BioNTech 可以考慮的範圍內？

Yes. So indeed, value immunotherapy is reaching our maturity. This is one of the aspects that we are following. We are currently not looking for opportunities for in-licensing, but some of the research that we are doing internally could go into that direction. We could talk about this end of this year when we have validation data.

是的。事實上，有價值的免疫療法正在成熟。這是我們正在關注的方面之一。我們目前並未尋找引入許可的機會，但我們內部正在進行的一些研究可能會朝這個方向發展。當我們有驗證數據時，我們可以在今年年底討論。

And your next question comes from the line of Hartaj Singh from Oppenheimer.

你的下一個問題來自奧本海默的 Hartaj Singh。

I just want to ask a question on the slide where you listed the average quarterly patient enrollment. Over the last couple of years, we've seen actually a real difficulty with companies in oncology, just because of the vast number of trials going on in oncology and IO recruiting patients. I mean you've seen a really nice acceleration from 2022 to '23 in the first quarter of '24. So can you just put some color behind that or meat on the bone of what exactly are you doing? Is it just the ability to -- the trials getting RV approved more trials actually moving ahead to late stage, maybe spending more patients on recruiting trials at site. I'd love to hear that.

我只想問投影片上的一個問題，您在投影片上列出了平均季度病患入組人數。在過去的幾年裡，我們看到腫瘤學領域的公司實際上遇到了真正的困難，只是因為在腫瘤學和 IO 招募患者方面正在進行大量試驗。我的意思是，從 2022 年到 23 年，在 24 年第一季度，您已經看到了非常好的加速。那麼你能在你到底在做什麼的基礎上添加一些顏色或肉嗎？這只是能力——讓 RV 批准的試驗更多的試驗實際上進入了後期階段，可能會花費更多的患者在現場招募試驗。我很想聽聽這個。

And then how does this change your thinking on potential readouts? I mean -- it's nice to see the improvement in enrollment, but how does that translate to when readouts could actually happen?

那麼這將如何改變您對潛在讀數的看法？我的意思是——很高興看到入學率的提高，但這如何轉化為實際讀出的時間？

Yes. Let me take the first part of the question. So in the time line of 2020 to 2022, 2023, of course, we dealt with early clinical trials, which are typically recruiting a lower number of patients and defining based on those escalations of cohorts, safety assessment, biomarker assessment and so on. And we are now reaching a phase where we are multiple ties in Phase II and first clinical trials in Phase III, which naturally allow us to enroll faster and ensure that we get the statistics.

是的。讓我回答問題的第一部分。當然，在2020 年到2022 年、2023 年的時間線上，我們進行了早期臨床試驗，這些試驗通常招募較少數量的患者，並根據隊列的升級、安全性評估、生物標記評估等進行定義。我們現在正處於第二階段的多重連結和第三階段的首次臨床試驗的階段，這自然使我們能夠更快地註冊並確保我們獲得統計數據。

This is also the reason why we are now are able to move multiple clinical trials into registration trials end of this year. And for all of the registrational trials, we will provide the time line then we expect to read out.

這也是我們現在能夠在今年底將多項臨床試驗轉入註冊試驗的原因。對於所有註冊試驗，我們將提供時間表，然後我們預計會讀出。

As Ryan alluded the first read out for our first potential registration trial is in [endomesrial] cancer, will be will be next year, second half of -- or mid next year with the opportunity to get authorization end of next year. And we will have multiple internal read outs for -- to be presented at ASCO and ESMO and City this year on the current year running cohorts.

正如瑞安所提到的，我們的第一個潛在註冊試驗的第一個結果是針對[子宮內膜]癌症，將在明年下半年或明年中期進行，並有機會在明年底獲得授權。我們將在今年的 ASCO、ESMO 和 City 會議上就本年度的跑步隊列進行多次內部宣讀。

If I may add to that, you have pointed out quite correctly that patient recruitment becomes more and more difficult. We are in the fortunate situation that we have a richness of different assets and thereby a design space to choose those assets and combination trials, which can give us several hits on our target to become a multiproduct oncology company by 2030.

如果我可以補充一點，您已經非常正確地指出，患者招募變得越來越困難。我們很幸運，我們擁有豐富的不同資產，因此有一個設計空間來選擇這些資產和組合試驗，這可以讓我們實現到 2030 年成為多產品腫瘤公司的目標。

But it was very clear to us from the very beginning that this also means that we have to improve our capability to execute these clinical trials. So we have invested, and this is what this bar chart shows, we have invested major efforts to mature our clinical development operations, organization and also to grow it.

但我們從一開始就非常清楚，這也意味著我們必須提升執行這些臨床試驗的能力。所以我們已經投資了，這就是這個長條圖所顯示的，我們投入了巨大的努力來成熟我們的臨床開發業務、組織並發展它。

And we also have invested into models such as working with partners with our partner companies to enroll into our joint trials and public private partnership, for example, the partnership we have with U.K. in which we are building a cancer vaccine launch that and thereby mobilizing on a national level, large numbers of clinical sites. And this is basically what these numbers reflect.

我們也投資了一些模型，例如與我們的合作夥伴公司合作，參加我們的聯合試驗和公私合作夥伴關係，例如，我們與英國的合作夥伴關係，我們正在推出癌症疫苗，從而動員人們具有國家級、大量的臨床站點。這些數字基本上反映了這一點。

And your next question comes from the line of Ellie Merle, UBS.

您的下一個問題來自瑞銀集團的 Ellie Merle。

Just for your HER2 ADC, where you got breakthrough [din] endometrial cancer late last year, and I think you just mentioned you expect to have the pivotal data in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of this pivotal study and also how you're thinking about the opportunity for this asset in endometrial and where it would fit in the broader landscape there?

就你們的 HER2 ADC 而言，去年年底你們在子宮內膜癌方面取得了突破性進展，我想你們剛剛提到，如果我沒聽錯的話，你們預計將在明年下半年獲得關鍵數據。您能否告訴我們更多有關這項關鍵研究的設計的信息，以及您如何考慮該資產在子宮內膜中的機會以及它在更廣泛的領域中的應用？

[The turning part is a single pipe] in this population. And it is the registration will be based on safety data and response data and durability of response data. And this will be combined with confirmatory trial for which we still are in the planning phase, and we will inform, yes, in the in around 3 to 4 months about the design of the complementary trial.

[轉動部分是單管]在這個人群中。並且註冊將基於安全資料和回應資料以及回應資料的持久性。這將與我們仍處於規劃階段的驗證性試驗相結合，是的，我們將在大約 3 到 4 個月內告知補充試驗的設計。

Your next question comes from the line of Simon Baker from Redbud Atlantic.

您的下一個問題來自紫荊花大西洋公司的西蒙貝克（Simon Baker）。

It's on SG&A. Your guidance implies an increase of between EUR 160 million and EUR [260] million this year. I would assume a large part of that is the global commercial footprint build-out. I just wondering if you could give us an idea of how that phases over this year and also '24 versus '25? Is most of the spend this year or is most of it in 2025? Some idea of the cadence of that build-out would be great.

這是在 SG&A 上。您的指導意味著今年將增加 1.6 億至 [2.60] 億歐元。我認為其中很大一部分是全球商業足跡的擴張。我只是想知道您能否告訴我們今年的情況以及「24 與 25」的情況？大部分支出是今年支出還是 2025 年支出？如果能了解一下擴建的節奏就太好了。

You should expect for '24 that we have a slight increase of quarter-by-quarter in terms of S&M cost and the G&A costs there in '24. And then for '25, likely to have a further increase in the setup. Of course, you start to hire personnel for the commercialization [force] to only shortly before you launch, and that will -- the timing of that will drive the spend of '25.

您應該預計到 24 年我們的 S&M 成本和 G&A 成本將逐季略有增加。然後到 25 年，可能會進一步增加設定。當然，你只在發布前不久才開始僱用商業化人員，而這將推動 25 年的支出。

Your next question comes from the line of Yifeng Liu from HSBC.

你的下一個問題來自匯豐銀行劉一峰。

Just one question on your HER2 ADC in breast cancer. How do you think about the biomarker expection there when you have HER2-low and HER perhaps and whether you think about HER2 ultra low as well in the design of your pivotal study?

只是關於乳癌 HER2 ADC 的一個問題。當您有 HER2-low 和 HER 時，您如何看待那裡的生物標記預期？

Yes. This is a good question indeed. Indeed the question is about HER2-low 1 plus 2 plus or even ultra low or even negative. So we are considering all patient cohorts in our prior design and will make a decision on the patient population to be enrolled and the patient population to be analyzed later on. In the -- for the upcoming price and will most likely report about the clinical priority signed end of this year.

是的。這確實是一個好問題。事實上，問題是關於 HER2-低 1 加 2 加甚至超低甚至負。因此，我們在先前的設計中考慮了所有患者群體，並將決定要招募的患者群體以及稍後要分析的患者群體。在即將到來的價格中，很可能會報告今年年底簽署的臨床優先事項。

And your final question comes from the line of Suzanne [for Tuen from VOK.]

你的最後一個問題來自 Suzanne [VOK 的 Tuen]。

This is Suzanne from VoK, which relates to business development and M&A. Last year, you were fairly active on deal-making front. So can you give (inaudible) of what we expect going forward for this and next year. You have a lot of cash on hand, but also a lot of projects to run and many moving parts on the profitability side. So I was wondering if you're continuing to pursue similar deals and assets as previously? Or did your appetite change?

我是來自 VoK 的 Suzanne，負責業務開發和併購。去年，您在交易方面相當活躍。那麼您能否提供（聽不清楚）我們對今年和明年的預期？你手頭上有大量現金，但也有很多項目需要運行，並且盈利方面還有很多變動因素。所以我想知道你們是否會像以前一樣繼續尋求類似的交易和資產？還是你的食慾改變了？

I think our focus this year is more on clinical execution. That said, we will be opportunistic. And if we're open to synergistic assets, but I think you can expect the general level of activity in terms of number of deals to be decreased this year.

我認為今年我們的重點更多是臨床執行。也就是說，我們將是機會主義的。如果我們對協同資產持開放態度，但我認為今年交易數量的整體活動水準將會下降。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。